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MorphoSys and Incyte Announce the European Commission Approval of Minjuvi(R) (tafasitamab) in Combination with Lenalidomide for the Treatment of…

Posted: August 31, 2021 at 2:39 am

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-The decision by the European Commission is based on data from the L-MIND study evaluating tafasitamab in combination with lenalidomide as a treatment for patients with relapsed or refractory DLBCL

- Minjuvi is a new therapeutic option for eligible DLBCL patients in the European Union (EU), addressing an urgent unmet medical need

- In Europe, each year approximately 16,000 patients are diagnosed with relapsed or refractory DLBCL1,2,3

PLANEGG/MUNICH, GERMANY and WILMINGTON, DE / ACCESSWIRE / August 26, 2021 / MorphoSys AG (FSE:MOR; NASDAQ:MOR) and Incyte (INCY) today announced that the European Commission (EC) has granted conditional marketing authorization for Minjuvi (tafasitamab) in combination with lenalidomide, followed by Minjuvi monotherapy, for the treatment of adult patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL) who are not eligible for autologous stem cell transplant (ASCT). The EC Decision follows the positive opinion received from the European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) in June 2021 recommending the conditional marketing authorization of Minjuvi.

"People living with relapsed or refractory DLBCL in the EU have historically had limited treatment options and a poor prognosis. However, with the EC's approval of Minjuvi, eligible patients now have a new and much needed treatment option," said Herv Hoppenot, Chief Executive Officer, Incyte. "We will now focus our efforts on working with individual countries in Europe to provide people access to this new treatment."

"The approval of Minjuvi is a crucial milestone for patients with relapsed or refractory DLBCL in Europe, "said Jean-Paul Kress, M.D., Chief Executive Officer, MorphoSys. "DLBCL is the most common type of non-Hodgkin lymphoma in adults and Minjuvi addresses an urgent unmet medical need for the 30-40% of people who do not respond to or relapse after initial therapy."

The conditional approval is based on the results from the L-MIND study evaluating the safety and efficacy of tafasitamab in combination with lenalidomide as a treatment for patients with relapsed or refractory DLBCL who are not eligible for autologous stem cell transplant (ASCT). The results showed best objective response rate (ORR) of 56.8% (primary endpoint), including a complete response (CR) rate of 39.5% and a partial response rate (PR) of 17.3%, as assessed by an independent review committee. The median duration of response (mDOR) was 43.9 months after a minimum follow up of 35 months (secondary endpoint). Tafasitamab together with lenalidomide was shown to provide a clinically meaningful response and the side effects were manageable. Warnings and precautions for tafasitamab include infusion-related reactions, myelosuppression, including neutropenia and thrombocytopenia, infections and tumour lysis syndrome.

"The data from the L-MIND study demonstrate the potential benefits, including long duration of response, that tafasitamab may have for eligible DLBCL patients," said Professor Pier Luigi Zinzani M.D., Ph.D., Head of Lymphoma Group at University of Bologna. "It is encouraging to see new treatments become available for these patients, especially given the historical lack of treatment options in this area."

Incyte and MorphoSys share global development rights to tafasitamab; Incyte has exclusive commercialization rights to tafasitamab outside the United States. Tafasitamab is co-marketed by Incyte and MorphoSys under the brand name Monjuvi in the U.S., and is marketed by Incyte under the brand name Minjuvi in the EU.

About Diffuse Large B-Cell Lymphoma

DLBCL is the most common type of non-Hodgkin lymphoma in adults worldwide, comprising 40% of all cases4 , and is characterized by rapidly growing masses of malignant B-cells in the lymph nodes, spleen, liver, bone marrow or other organs5 . It is an aggressive disease with about one in three patients not responding to initial therapy or relapsing thereafter6 . In Europe, each year approximately 16,000 patients are diagnosed with relapsed or refractory DLBCL7,8,9 .

About L-MIND

The L-MIND trial is a single arm, open-label Phase 2 study (NCT02399085) investigating the combination of tafasitamab and lenalidomide in patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL) who have had at least one, but no more than three prior lines of therapy, including an anti-CD20 targeting therapy (e.g., rituximab), who are not eligible for high-dose chemotherapy (HCD) or autologous stem cell transplant (ASCT). The study's primary endpoint is overall response rate (ORR). Secondary outcome measures include duration of response (DoR), progression-free survival (PFS) and overall survival (OS). The study reached its primary completion in May 2019.

For more information about L-MIND, visit https://clinicaltrials.gov/ct2/show/NCT02399085 .

About Minjuvi (tafasitamab) Tafasitamab is a humanized Fc-modified cytolytic CD19 targeting monoclonal antibody. In 2010, MorphoSys licensed exclusive worldwide rights to develop and commercialize tafasitamab from Xencor, Inc. Tafasitamab incorporates an XmAb engineered Fc domain, which mediates B-cell lysis through apoptosis and immune effector mechanism including Antibody-Dependent Cell-Mediated Cytotoxicity (ADCC) and Antibody-Dependent Cellular Phagocytosis (ADCP).

In the United States, Monjuvi(tafasitamab-cxix) is approved by the U.S. Food and Drug Administration in combination with lenalidomide for the treatment of adult patients with relapsed or refractory DLBCL not otherwise specified, including DLBCL arising from low grade lymphoma, and who are not eligible for autologous stem cell transplant (ASCT). This indication is approved under accelerated approval based on overall response rate. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial(s).

In Europe, Minjuvi (tafasitamab) received conditional approval, in combination with lenalidomide, followed by Minjuvi monotherapy, for the treatment of adult patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL) who are not eligible for autologous stem cell transplant (ASCT).

Tafasitamab is being clinically investigated as a therapeutic option in B-cell malignancies in several ongoing combination trials.

Minjuvi and Monjuvi are registered trademarks of MorphoSys AG. Tafasitamab is co-marketed by Incyte and MorphoSys under the brand name Monjuvi in the U.S., and marketed by Incyte under the brand name Minjuvi in the EU.

XmAb is a registered trademark of Xencor, Inc.

Safety Information from the EU Summary of Product Characteristics (SmPC)

Infusion-related reactions may occur and have been reported more frequently during the first infusion. Patients should be monitored closely throughout the infusion and should be advised to contact their healthcare professionals if they experience signs and symptoms of infusion related reactions including fever, chills, rash or breathing problems within 24 hours of infusion. A premedication should be administered to patients prior to starting tafasitamab infusion. Based on the severity of the infusion-related reaction, tafasitamab infusion should be interrupted or discontinued and appropriate medical management should be instituted.

Fatal and serious infections, including opportunistic infections, occurred in patients during treatment with Minjuvi.

Minjuvi should be administered to patients with an active infection only if the infection is treated appropriately and well controlled. Patients with a history of recurring or chronic infections may be at increased risk of infection and should be monitored appropriately. Patients should be advised to contact their healthcare professionals if fever or other evidence of potential infection, such as chills, cough or pain on urination, develops.

Treatment with Minjuvi in combination with lenalidomide should not be initiated in female patients unless pregnancy has been excluded.

The most common adverse reactions were infections, neutropenia, asthenia, anemia, diarrhea, thrombocytopenia, cough, oedema peripheral, pyrexia and decreased appetite.

Minjuvi may cause serious adverse reactions. The most common serious adverse reactions were infection, including pneumonia and febrile neutropenia.

Treatment with tafasitamab can cause serious or severe myelosuppression including neutropenia, thrombocytopenia and anemia. Complete blood counts should be monitored throughout treatment and prior to administration of each treatment cycle.

About MorphoSys MorphoSys (FSE & NASDAQ: MOR) is a commercial-stage biopharmaceutical company dedicated to the discovery, development and commercialization of innovative therapies for people living with cancer and autoimmune diseases. Based on its leading expertise in antibody and protein technologies, MorphoSys is advancing its own pipeline of new drug candidates and has created antibodies which are developed by partners in different areas of unmet medical need. In 2017, Tremfya (guselkumab) - developed by Janssen Research & Development, LLC and marketed by Janssen Biotech, Inc., for the treatment of plaque psoriasis - became the first drug based on MorphoSys' antibody technology to receive regulatory approval. In July 2020, the U.S. Food and Drug Administration (FDA) granted accelerated approval of the company's proprietary product Monjuvi (tafasitamab-cxix) in combination with lenalidomide in patients with a certain type of lymphoma. Headquartered near Munich, Germany, the MorphoSys Group, including the fully owned U.S. subsidiaries MorphoSys US Inc. and Constellation Pharmaceuticals, Inc., has more than 750 employees. For more information visit http://www.morphosys.com or http://www.morphosys-us.com.

Tremfya is a registered trademark of Janssen Biotech, Inc.

About Incyte

Incyte is a Wilmington, Delaware-based, global biopharmaceutical company focused on finding solutions for serious unmet medical needs through the discovery, development and commercialization of proprietary therapeutics. For additional information on Incyte, please visit Incyte.com and follow @Incyte.

MorphoSys Forward-looking Statements

This communication contains certain forward-looking statements concerning the MorphoSys group of companies. The forward-looking statements contained herein represent the judgment of MorphoSys as of the date of this release and involve known and unknown risks and uncertainties, which might cause the actual results, financial condition and liquidity, performance or achievements of MorphoSys, or industry results, to be materially different from any historic or future results, financial conditions and liquidity, performance or achievements expressed or implied by such forward-looking statements. In addition, even if MorphoSys' results, performance, financial condition and liquidity, and the development of the industry in which it operates are consistent with such forward-looking statements, they may not be predictive of results or developments in future periods. Among the factors that may result in differences are that MorphoSys' expectations may be incorrect, the inherent uncertainties associated with competitive developments, clinical trial and product development activities and regulatory approval requirements, MorphoSys' reliance on collaborations with third parties, estimating the commercial potential of its development programs and other risks indicated in the risk factors included in MorphoSys' Annual Report on Form 20-F and other filings with the U.S. Securities and Exchange Commission. Given these uncertainties, the reader is advised not to place any undue reliance on such forward-looking statements. These forward-looking statements speak only as of the date of publication of this document. MorphoSys expressly disclaims any obligation to update any such forward-looking statements in this document to reflect any change in its expectations with regard thereto or any change in events, conditions or circumstances on which any such statement is based or that may affect the likelihood that actual results will differ from those set forth in the forward-looking statements, unless specifically required by law or regulation.

Incyte Forward-looking Statements

Except for the historical information set forth herein, the matters set forth in this press release, including statements regarding the Company's expectations relating to the use of tafasitamab for treatment of adult patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL), the Company's ongoing clinical development program for tafasitamab, and its DLBCL program generally, contain predictions, estimates, and other forward-looking statements.

These forward-looking statements are based on the Company's current expectations and subject to risks and uncertainties that may cause actual results to differ materially, including unanticipated developments in and risks related to: unanticipated delays; further research and development and the results of clinical trials possibly being unsuccessful or insufficient to meet applicable regulatory standards or warrant continued development; the ability to enroll sufficient numbers of subjects in clinical trials and the ability to enroll subjects in accordance with planned schedules; the effects of the COVID-19 pandemic and measures to address the pandemic on the Company's clinical trials, supply chain, and other third-party providers and development and discovery operations; determinations made by the European Commission and other regulatory authorities; the Company's dependence on its relationships with its collaboration partners; the efficacy or safety of the Company's products and the products of the Company's collaboration partners; the acceptance of the Company's products and the products of the Company's collaboration partners in the marketplace; market competition; sales, marketing, manufacturing, and distribution requirements; and other risks detailed from time to time in the Company's reports filed with the Securities and Exchange Commission, including its annual report and its quarterly report on Form 10-Q for the quarter ended June 30, 2021. The Company disclaims any intent or obligation to update these forward-looking statements.

# # #

For more information, please contact:

MorphoSys Media contacts: Thomas BiegiTel.: +49 (0)89 / 89927 26079Thomas.Biegi@morphosys.com

Jeanette BressiTel: +1 617-404-7816jeanette.bressi@morphosys.com

Investor Contact: Dr. Julia NeugebauerTel: +49 (0)89 / 899 27 179julia.neugebauer@morphosys.com

Myles CloustonTel: +1-857-772-0240myles.clouston@morphosys.com

Incyte Media: Ela ZawislakTel: + 41 21 581 5200ezawislak@incyte.com

Catalina LovemanTel: + 1 302 498 6171cloveman@incyte.com

Investors: Christine ChiouTel: +1 302 498 5914cchiou@incyte.com

References

1DRG Epidemiology data.2Kantar Market Research (TPP testing 2018).3Friedberg, Jonathan W. Relapsed/Refractory Diffuse Large B-Cell Lymphoma. Hematology Am Soc Hematol Educ Program 2011; 2011:498-505. doi: 10.1182/asheducation-2011.1.498.4Cancer Research UK. Diffuse large B cell lymphoma. Available at https://www.cancerresearchuk.org/about-cancer/non-hodgkin-lymphoma/types/diffuse-large-B-cell-lymphoma. Accessed: May 2021.5Sarkozy C, et al. Management of relapsed/refractory DLBCL. Best Practice Research & Clinical Haematology. 2018 31:209-16. doi.org/10.1016/j.beha.2018.07.014.6Skrabek P, et al. Emerging therapies for the treatment of relapsed or refractory diffuse large B cell lymphoma. Current Oncology. 2019 26(4): 253-265. doi.org/10.3747/co.26.5421.7DRG Epidemiology data.8Kantar Market Research (TPP testing 2018).9Friedberg, Jonathan W. Relapsed/Refractory Diffuse Large B-Cell Lymphoma. Hematology Am Soc Hematol Educ Program 2011; 2011:498-505. doi: 10.1182/asheducation-2011.1.498.

SOURCE: MorphoSys AG

View source version on accesswire.com: https://www.accesswire.com/661575/MorphoSys-and-Incyte-Announce-the-European-Commission-Approval-of-MinjuviR-tafasitamab-in-Combination-with-Lenalidomide-for-the-Treatment-of-Adults-with-Relapsed-or-Refractory-Diffuse-Large-B-Cell-Lymphoma

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MorphoSys and Incyte Announce the European Commission Approval of Minjuvi(R) (tafasitamab) in Combination with Lenalidomide for the Treatment of...

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Incyte and MorphoSys Announce the European Commission Approval of Minjuvi (tafasitamab) in Combination With Lenalidomide for the Treatment of Adults…

Posted: at 2:39 am

WILMINGTON, Del. & PLANEGG, Germany & MUNICH--(BUSINESS WIRE)--Incyte (Nasdaq:INCY) and MorphoSys AG (FSE:MOR; NASDAQ:MOR) today announced that the European Commission (EC) has granted conditional marketing authorization for Minjuvi (tafasitamab) in combination with lenalidomide, followed by Minjuvi monotherapy, for the treatment of adult patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL) who are not eligible for autologous stem cell transplant (ASCT). The EC decision follows the positive opinion received from the European Medicines Agencys Committee for Medicinal Products for Human Use (CHMP) in June 2021 recommending the conditional marketing authorization of Minjuvi.

People living with relapsed or refractory DLBCL in the EU, have historically had limited treatment options and a poor prognosis. However, with the ECs approval of Minjuvi, eligible patients now have a new and much needed treatment option, said Herv Hoppenot, Chief Executive Officer, Incyte. We will now focus our efforts on working with individual countries in Europe to provide people access to this new treatment.

The approval of Minjuvi is a crucial milestone for patients with relapsed or refractory DLBCL in Europe, said Jean-Paul Kress, M.D., Chief Executive Officer, MorphoSys. DLBCL is the most common type of non-Hodgkin lymphoma in adults and Minjuvi addresses an urgent unmet medical need for the 30-40% of people who do not respond to or relapse, after initial therapy.

The conditional approval is based on the results from the L-MIND study evaluating the safety and efficacy of Minjuvi in combination with lenalidomide as a treatment for patients with relapsed or refractory DLBCL who are not eligible for autologous stem cell transplant (ASCT). The results showed best objective response rate (ORR) of 56.8% (primary endpoint), including a complete response (CR) rate of 39.5% and a partial response rate (PR) of 17.3%, as assessed by an independent review committee. The median duration of response (mDOR) was 43.9 months after a minimum follow up of 35 months (secondary endpoint). Minjuvi together with lenalidomide was shown to provide a clinically meaningful response and the side effects were manageable. Warnings and precautions for Minjuvi include infusion-related reactions, myelosuppression, including neutropenia and thrombocytopenia, infections and tumour lysis syndrome.

The data from the L-MIND study demonstrate the potential benefits, including long duration of response, that tafasitamab may have for eligible DLBCL patients, said Professor Pier Luigi Zinzani M.D., Ph.D., Head of the Lymphoma Group at University of Bologna. It is encouraging to see new treatments become available for these patients, especially given the historical lack of treatment options in this area.

Incyte and MorphoSys share global development rights to tafasitamab; Incyte has exclusive commercialization rights to tafasitamab outside the United States. Tafasitamab is co-marketed by Incyte and MorphoSys under the brand name Monjuvi in the U.S., and is marketed by Incyte under the brand name Minjuvi in the EU.

About Diffuse Large B-Cell LymphomaDLBCL is the most common type of non-Hodgkin lymphoma in adults worldwide, comprising 40% of all cases4, and is characterized by rapidly growing masses of malignant B-cells in the lymph nodes, spleen, liver, bone marrow or other organs5. It is an aggressive disease with about one in three patients not responding to initial therapy or relapsing thereafter6. In Europe, each year approximately 16,000 patients are diagnosed with relapsed or refractory DLBCL7,8,9.

About L-MINDThe L-MIND trial is a single arm, open-label Phase 2 study (NCT02399085) investigating the combination of tafasitamab and lenalidomide in patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL) who have had at least one, but no more than three prior lines of therapy, including an anti-CD20 targeting therapy (e.g., rituximab), who are not eligible for high-dose chemotherapy (HDC) or autologous stem cell transplant (ASCT). The studys primary endpoint is overall response rate (ORR). Secondary outcome measures include duration of response (DoR), progression-free survival (PFS) and overall survival (OS). The study reached its primary completion in May 2019.

For more information about L-MIND, visit https://clinicaltrials.gov/ct2/show/NCT02399085.

About Minjuvi (tafasitamab)Tafasitamab is a humanized Fc-modified cytolytic CD19 targeting monoclonal antibody. In 2010, MorphoSys licensed exclusive worldwide rights to develop and commercialize tafasitamab from Xencor, Inc. Tafasitamab incorporates an XmAb engineered Fc domain, which mediates B-cell lysis through apoptosis and immune effector mechanism including Antibody-Dependent Cell-Mediated Cytotoxicity (ADCC) and Antibody-Dependent Cellular Phagocytosis (ADCP).

In the United States, Monjuvi (tafasitamab-cxix) is approved by the U.S. Food and Drug Administration in combination with lenalidomide for the treatment of adult patients with relapsed or refractory DLBCL not otherwise specified, including DLBCL arising from low grade lymphoma, and who are not eligible for autologous stem cell transplant (ASCT). This indication is approved under accelerated approval based on overall response rate. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial(s).

In Europe, Minjuvi (tafasitamab) received conditional approval, in combination with lenalidomide, followed by Minjuvi monotherapy, for the treatment of adult patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL) who are not eligible for autologous stem cell transplant (ASCT).

Tafasitamab is being clinically investigated as a therapeutic option in B-cell malignancies in several ongoing combination trials.

Minjuvi and Monjuvi are registered trademarks of MorphoSys AG. Tafasitamab is co-marketed by Incyte and MorphoSys under the brand name Monjuvi in the U.S., and marketed by Incyte under the brand name Minjuvi in the EU.

XmAb is a registered trademark of Xencor, Inc.

Safety Information from the EU Summary of Product Characteristics (SmPC)Infusion-related reactions may occur and have been reported more frequently during the first infusion. Patients should be monitored closely throughout the infusion and should be advised to contact their healthcare professionals if they experience signs and symptoms of infusion related reactions including fever, chills, rash or breathing problems within 24 hours of infusion. A premedication should be administered to patients prior to starting tafasitamab infusion. Based on the severity of the infusion-related reaction, tafasitamab infusion should be interrupted or discontinued and appropriate medical management should be instituted.

Fatal and serious infections, including opportunistic infections, occurred in patients during treatment with Minjuvi.

Minjuvi should be administered to patients with an active infection only if the infection is treated appropriately and well controlled. Patients with a history of recurring or chronic infections may be at increased risk of infection and should be monitored appropriately. Patients should be advised to contact their healthcare professionals if fever or other evidence of potential infection, such as chills, cough or pain on urination, develops.

Treatment with Minjuvi in combination with lenalidomide should not be initiated in female patients unless pregnancy has been excluded.

The most common adverse reactions were infections, neutropenia, asthenia, anemia, diarrhea, thrombocytopenia, cough, oedema peripheral, pyrexia and decreased appetite.

Minjuvi may cause serious adverse reactions. The most common serious adverse reactions were infection, including pneumonia and febrile neutropenia.

Treatment with tafasitamab can cause serious or severe myelosuppression including neutropenia, thrombocytopenia and anemia. Complete blood counts should be monitored throughout treatment and prior to administration of each treatment cycle.

About IncyteIncyte is a Wilmington, Delaware-based, global biopharmaceutical company focused on finding solutions for serious unmet medical needs through the discovery, development and commercialization of proprietary therapeutics. For additional information on Incyte, please visit Incyte.com and follow @Incyte.

About MorphoSysMorphoSys (FSE & NASDAQ: MOR) is a commercial-stage biopharmaceutical company dedicated to the discovery, development and commercialization of innovative therapies for people living with cancer and autoimmune diseases. Based on its leading expertise in antibody and protein technologies, MorphoSys is advancing its own pipeline of new drug candidates and has created antibodies which are developed by partners in different areas of unmet medical need. In 2017, Tremfya (guselkumab) developed by Janssen Research & Development, LLC and marketed by Janssen Biotech, Inc., for the treatment of plaque psoriasis became the first drug based on MorphoSys antibody technology to receive regulatory approval. In July 2020, the U.S. Food and Drug Administration (FDA) granted accelerated approval of the companys proprietary product Monjuvi (tafasitamab-cxix) in combination with lenalidomide in patients with a certain type of lymphoma. Headquartered near Munich, Germany, the MorphoSys Group, including the fully owned U.S. subsidiaries MorphoSys US Inc. and Constellation Pharmaceuticals, Inc., has more than 750 employees. For more information visit http://www.morphosys.com or http://www.morphosys-us.com.

Tremfya is a registered trademark of Janssen Biotech, Inc.

Incyte Forward-looking StatementsExcept for the historical information set forth herein, the matters set forth in this press release, including statements regarding the Companys expectations relating to the use of tafasitamab for treatment of adult patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL), the Companys ongoing clinical development program for tafasitamab, and its DLBCL program generally, contain predictions, estimates, and other forward-looking statements.

These forward-looking statements are based on the Companys current expectations and subject to risks and uncertainties that may cause actual results to differ materially, including unanticipated developments in and risks related to: unanticipated delays; further research and development and the results of clinical trials possibly being unsuccessful or insufficient to meet applicable regulatory standards or warrant continued development; the ability to enroll sufficient numbers of subjects in clinical trials and the ability to enroll subjects in accordance with planned schedules; the effects of the COVID-19 pandemic and measures to address the pandemic on the Companys clinical trials, supply chain, and other third-party providers and development and discovery operations; determinations made by the European Commission and other regulatory authorities; the Companys dependence on its relationships with its collaboration partners; the efficacy or safety of the Companys products and the products of the Companys collaboration partners; the acceptance of the Companys products and the products of the Companys collaboration partners in the marketplace; market competition; sales, marketing, manufacturing, and distribution requirements; and other risks detailed from time to time in the Companys reports filed with the Securities and Exchange Commission, including its annual report and its quarterly report on Form 10-Q for the quarter ended June 30, 2021. The Company disclaims any intent or obligation to update these forward-looking statements.

MorphoSys Forward-looking StatementsThis communication contains certain forward-looking statements concerning the MorphoSys group of companies. The forward-looking statements contained herein represent the judgment of MorphoSys as of the date of this release and involve known and unknown risks and uncertainties, which might cause the actual results, financial condition and liquidity, performance or achievements of MorphoSys, or industry results, to be materially different from any historic or future results, financial conditions and liquidity, performance or achievements expressed or implied by such forward-looking statements. In addition, even if MorphoSys' results, performance, financial condition and liquidity, and the development of the industry in which it operates are consistent with such forward-looking statements, they may not be predictive of results or developments in future periods. Among the factors that may result in differences are that MorphoSys' expectations may be incorrect, the inherent uncertainties associated with competitive developments, clinical trial and product development activities and regulatory approval requirements, MorphoSys' reliance on collaborations with third parties, estimating the commercial potential of its development programs and other risks indicated in the risk factors included in MorphoSys' Annual Report on Form 20-F and other filings with the U.S. Securities and Exchange Commission. Given these uncertainties, the reader is advised not to place any undue reliance on such forward-looking statements. These forward-looking statements speak only as of the date of publication of this document. MorphoSys expressly disclaims any obligation to update any such forward-looking statements in this document to reflect any change in its expectations with regard thereto or any change in events, conditions or circumstances on which any such statement is based or that may affect the likelihood that actual results will differ from those set forth in the forward-looking statements, unless specifically required by law or regulation.

_____________________1 DRG Epidemiology data.2 Kantar Market Research (TPP testing 2018).3 Friedberg, Jonathan W. Relapsed/Refractory Diffuse Large B-Cell Lymphoma. Hematology Am Soc Hematol Educ Program 2011; 2011:498-505. doi: 10.1182/asheducation-2011.1.498.4 Cancer Research UK. Diffuse large B cell lymphoma. Available at https://www.cancerresearchuk.org/about-cancer/non-hodgkin-lymphoma/types/diffuse-large-B-cell-lymphoma. Accessed: May 2021.5 Sarkozy C, et al. Management of relapsed/refractory DLBCL. Best Practice Research & Clinical Haematology. 2018 31:20916. doi.org/10.1016/j.beha.2018.07.014.6 Skrabek P, et al. Emerging therapies for the treatment of relapsed or refractory diffuse large B cell lymphoma. Current Oncology. 2019 26(4): 253265. doi.org/10.3747/co.26.5421.7 DRG Epidemiology data.8 Kantar Market Research (TPP testing 2018).9 Friedberg, Jonathan W. Relapsed/Refractory Diffuse Large B-Cell Lymphoma. Hematology Am Soc Hematol Educ Program 2011; 2011:498-505. doi: 10.1182/asheducation-2011.1.498.

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Incyte and MorphoSys Announce the European Commission Approval of Minjuvi (tafasitamab) in Combination With Lenalidomide for the Treatment of Adults...

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Rock snot discovered in another Pennsylvania waterway – pennlive.com

Posted: September 12, 2020 at 12:56 am

Rock snot, an invasive aquatic alga, has been discovered in another Pennsylvania stream.

According to the Pennsylvania Fish and Boat Commission, Didymospheria geminata has been confirmed in Quemahoning Creek in Somerset County.

The algae has been dubbed rock snot because of its appearance when wet. When squeezed dry, the tan to greenish beige alga feels like moist cotton or wool.

Didymo does not present a public health hazard, but it can cause ecological damage by smothering other organisms which also live on the riverbed and support the food web for the resident fish community.

In response to the discovery, the commission and the Pennsylvania Department of Environmental Protection have reminded anglers and boaters that cleaning their gear is the easiest, most effective means to prevent its spread to other waters.

We may not be able to eliminate didymo from infected waterways, but there are things we can do to slow or prevent its spread to other waters, said Heather Smiles, chief of the commissions Division of Environmental Services.

Didymo cells can easily be carried downstream and can be picked up by any items or equipment in contact with infected water including fishing tackle, waders, recreational equipment, boats and trailers.

It takes just one live didymo cell to start a new colony of the alga.

The commission urges anglers and boaters to clean their gear before leaving a water body and allow it to dry completely before entering another water. After equipment is dry to the touch, allow to dry another 48 hours.

Thick and dense material such as life jackets or felt-soled wading gear will hold moisture longer, take longer to dry and can be more difficult to clean.

Soaking equipment in hot water containing dishwashing detergent (2 cups of detergent for every 2.5 gallons of water) for 20 minutes or more also will kill didymo. If hot water is not available, a commercial hot-water car wash also makes a good location to wash boats, motors and trailers.

At the other end of the temperature range, freezing items solid for at least 24 hours is effective.

If cleaning, drying or freezing is not practical, the commission suggests that the equipments use be limited to a single waterway.

The section of Quemahoning Creek where the alga was found provides fishing opportunities for stocked trout as well as warm-water and cool-water fish. The commission annually stocks fingerling brown and rainbow trout.

Since 2007 didymo has been detected in the West Branch and main stem of the Delaware River, Dyberry Creek in Wayne County, Youghiogheny River watershed in Fayette County and Pine Creek in Lycoming County.

Question about nature or the outdoors? Contact Marcus Schneck at mschneck@pennlive.com.

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Rock snot discovered in another Pennsylvania waterway - pennlive.com

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Bone Marrow and Stem Cell Transplants ChristianaCare

Posted: June 20, 2020 at 2:47 am

Bone marrow and stem cell transplants can be life-saving for people with blood cancers, solid tumors and some non-cancerous blood disorders. The Helen F. Graham Cancer Center & Research Institutes Bone Marrow Transplant Unit at Christiana Hospital offers todays most advanced and sophisticated techniques for patients who need peripheral blood stem cells (those that mature into red or white blood cells, or platelets) or bone-marrow transplants, including the newest, low-dose chemotherapy mini transplants. Transplants may be autologous (self-donated) or allogeneic (from a related or unrelated donor).

The hematologists/oncologists who specialize in bone-marrow and stem-cell therapy are part of a multidisciplinary team of experts ready to assist you and your family as you face the challenges of recovery. This team may include members of the Lymphoma Multidisciplinary Center who meet regularly at the Helen F. Graham Cancer Center & Research Institute.

As a candidate for bone marrow or stem cell transplantation, you will be assisted by a nurse navigatoran oncology-certified or masters prepared oncology nursewho will be on hand to answer your questions throughout your entire treatment. Your nurse navigator will work closely with the members of your treatment team to help you get the care and support services you need, both in and out of the hospital.

Your evaluation and treatment team may include the following:

Together, these specialists, in consultation with your primary-care doctor, will work with you to create the most appropriate and effective plan of treatment for your blood disorder.

New techniques for stimulating stem cells and the use of peripheral blood stem cells have led to shorter treatment times and better results for many patients. Similarly, low-dose, immunosuppressive chemotherapy and radiation prior to transplant has become a viable option, especially for older patients.

Participation in clinical research studies such as those sponsored by the National Cancer Institutes Community Clinical Oncology Program, particularly in the Cancer and Leukemia Group B, as well as in other national and local studies, offers access to the very latest treatment protocols. A research nurse will meet with you to discuss potential participation in a clinical treatment study.

We participate in the donor-matching program and will tailor your transplant to your body and your disease. Membership in the National Marrow Donor Program enables searches on a national and international level to locate potential bone-marrow donors who may be unrelated but whose tissue is the right match for you. We also participate in the International Bone Marrow Transplant Registry and the Autologous Blood and Marrow Transplant Registry.

The Bone Marrow Transplant Unit is one of the only such programs in our region, serving patients in Delaware and surrounding communities in Maryland, Pennsylvania and New Jersey. The majority of the bone-marrow and stem-cell transplants are performed on an outpatient basis. However, the bone-marrow transplant program operates a fully equipped inpatient unit for procedures requiring longer hospital stays. We can assist you and your family to find overnight accommodations when necessary.

Helen F. Graham Cancer Center & Research Institute4701 Ogletown-Stanton Road, Newark, DE 19713 directions302-623-4500

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‘Billion Dollar Burger’ Asks: What Is Meat? – Delaware First Media

Posted: June 17, 2020 at 9:42 am

What is meat? You might say it's simple: water, fat, muscle, connective tissue you know, all that tasty-sounding stuff.

But those at the forefront of developing cell-cultured meat have a different idea. Maybe meat is the product not of killing animals but of cultural consensus.

At the center of Chase Purdy's briskly paced and quietly bold Billion Dollar Burger: Inside Big Tech's Race for the Future of Food is Josh Tetrick, a San Francisco-based entrepreneur and CEO of Just Inc. Tetrick's company and a handful of others like it are growing cell-cultured meat that tastes, feels and looks like the livestock-harvested meat that people are used to except without the farms and killing of animals. And before anyone raises a skeptical brow: Yes, it's actually meat. Technically, at least. The struggle for mainstream acceptance of cell-cultured meat is real. Convincing the American public that cells grown in "serum" in a big vat is meat will be challenging, but it could happen and sooner than you might think.

Meat, it seems, is all about what consumers are used to. For the sake of the planet and the future of food sustainability, it might be time to reconsider meat harvested from dead animals. If we're going to eat meat at all, eliminating the need to kill an animal that consumes food resources humans could otherwise be using and that's also captive to an industry that pollutes the air and soil and deforests broad swaths of the planet might be a good start.

One of Purdy's strengths is his ease in exposition. He can even be charmingly teacherlike at times. Take, for instance, how he describes how cell-cultured meat is grown, starting with cells taken from a live animal.

"The scientists at cell-cultured meat companies identify which cells are stem cells. Whereas ordinary cells have limited utility, stem cells can divide and multiply many times, and they can transform into any of the more than two hundred types of cells that operate within animal bodies.

Think of our cells as individuals on a building construction site. Some are assigned to lay cement, some are trained as carpenters, and another might be an electrician. Together, they work harmoniously to build different components of the larger structure. But it is possible to pluck a cement worker from her job, send her to classes where she'll learn about wiring, plugs, and sockets. Then she can be sent back into the field as a newly trained electrician. The same thing can happen on a molecular level."

That's not all though. Scientists grow those cells in a kind of liquid. Because lab-grown meat doesn't have blood to circulate nutrients like living bodies do, scientists at Just and companies like it use a kind of "serum" that contains sugars, lipids, hormones and amino acids, as well as many hundreds of proteins that carry out functions such as transporting insulin, which helps grow cultured vertebrate cells, or transferrin, which delivers iron to cells. Oh, and all this takes place in vats that can look straight out of a brewery.

In covering the business side of cell-cultured meat, Purdy could have written a hagiographic account of Tetrick and Just; refreshingly, he chose not to. This could have been another Steve Jobs-type story no one needs, where a visionary has a great idea that will change the world and then, after the world gets changed wait for it said visionary gets really rich too. Then, as Americans, we're left undecided as to whether we admire the accomplishment or the wealth more. Instead, Purdy's book reads more realistically, like the teasing out of a tangled dance among entrenched meat producers, a few ambitious start-ups, early pioneers, regulatory complications and consumer skepticism.

It's the lack of heroes that, in part, makes this such an interesting story and topic. Tetrick knew from his early years that he cared about animal welfare and that he wanted to do something good for the world. He drifted through law school and still was unsure about a proper course for his life. He decided on cell-cultured meat as a cause and business because he saw opportunity and it aligned with his values and so he decided to take it. And in the depiction of Tetrick, Purdy is careful to allow him to tell his story, as well as capture others' stories of him, some of which are unflattering. Meat, however, stays front and center in this story. It keeps you hungry.

Still, there's the moral and ethical matter of manipulating nature to serve human ends. Sure, other forms of this kind of manipulation go by the names "civilization" or "technology," but the issues arising from cell-cultured meat aren't minor. Essentially it's cloning. Purdy asks Peter Singer, a Princeton University bioethics professor and the author of Animal Liberation, whether growing meat in vats violates the natural order and if he has a problem with it. "No, I don't, to be honest," Singer says. "I think we can and always have striven to do better than nature. ... I don't think nature is in any way a gold standard."

Alice Waters, famous chef of Chez Panisse in Berkeley, Calif., sees things differently. She tells Purdy: "I really think of my food as deeply connected to nature. It has to do with seasonality; it has to do with a complexity of soil that grows the vegetables that the animals eat. I think it's what nourishes us." This might be true, but most people don't (and can't) get their meat locally sourced, even if that would be ideal. Sustainable consumption of meat might just require more cell-cultured meat than its livestock-harvested antecedent.

Purdy rightly leaves the humans vs. nature debate aside, though, after teasing out the positions, and gets back to the big question: What is meat? Philosopher Friedrich Nietzsche wrote that "there is no feast without cruelty," but he clearly did not live to see the still ambiguous but encouraging promise of cell-cultured meat. Meat, oddly enough, might just be what we agree meat is. Heretofore it was the flesh of a dead animal. Now it can be engineered in a lab to have the same properties that a living animal's flesh would have.

If the taste and texture are the same and if the cost is manageable, why not? Now, when someone says, "It tastes like chicken," you can say: "It is chicken." It's grilling without the killing.

Nicholas Cannariato is a writer and editor based in Chicago.

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Data from Incytes Oncology Portfolio Accepted for Presentation at the ASCO and EHA Virtual Meetings – Yahoo Finance

Posted: May 20, 2020 at 10:46 pm

Incyte (Nasdaq: INCY) today announced that multiple abstracts highlighting data from clinical trials of medicines that are being developed in-house and through partnerships with Novartis, MorphoSys and Takeda will be presented at the upcoming 2020 American Society of Clinical Oncology Virtual Meeting (ASCO20; May 29 May 31); and at the virtual 25th Congress of the European Hematology Association (EHA25; June 11 14).

"We are pleased to have virtual platforms such as ASCO20 and EHA25 to continue sharing important data with the scientific community in a timely manner," said Steven Stein, M.D., Chief Medical Officer, Incyte. "These data demonstrate the strength of our broad oncology portfolio and our partnerships; and reinforce our commitment to finding solutions that can help meet patients needs."

Key abstracts accepted by ASCO and EHA include:

ASCO Abstracts

Oral, poster discussion and poster sessions, as well as track-based clinical science symposia, accepted for presentation at ASCO will be available on demand beginning Friday, May 29, 2020, 8:00 AM ET.

Oral Presentations

Capmatinib in Patients with High-Level MET-Amplified Advanced Non-Small Cell Lung Cancer (NSCLC): Results from the Phase 2 GEOMETRY mono-1 Study (Abstract #9509, Session: MET Mutations: The Meat of the Matter)1

Interim Analysis (IA) of OPTIC: A Dose-Ranging Study of Three Ponatinib (PON) Starting Doses (Abstract #7502, Session: Hematologic MalignanciesLeukemia, Myelodysplastic Syndromes, and Allotransplant)2

E-Poster Presentations

An Independent Review of Arterial Occlusive Events (AOEs) in the Ponatinib (PON) Phase 2 PACE Trial (NCT01207440) in Patients (pts) with Ph+ Leukemia (Abstract #7550, Session: Hematologic MalignanciesLeukemia, Myelodysplastic Syndromes, and Allotransplant)2

Re-MIND Study: A Propensity Score-Based 1:1 Matched Comparison of Tafasitamab + Lenalidomide (L-MIND) Versus Lenalidomide Monotherapy (Real-World Data) in Transplant-Ineligible Patients with Relapsed/Refractory (r/r) Diffuse Large B-cell Lymphoma (DLBCL) (Abstract #8020, Session: Hematologic MalignanciesLymphoma and Chronic Lymphocytic Leukemia)3

Safety and Efficacy of Pemigatinib Plus Pembrolizumab Combination Therapy in Patients (pts) with Advanced Malignancies: Results from FIGHT-101, an Open-Label Phase 1/2 study (Abstract #3606, Session: Developmental TherapeuticsMolecularly Targeted Agents and Tumor Biology)

Capmatinib in Patients with METex14-Mutated or High-Level MET-Amplified Advanced Non-Small-Cell Lung Cancer (NSCLC): Results from Cohort 6 of the Phase 2 GEOMETRY mono-1 study (Abstract #9520, Session: Lung CancerNon-Small Cell Metastatic)1

Pan-Cancer Analysis of FGFR1-3 Genomic Alterations to Reveal a Complex Molecular Landscape (Abstract #3620, Session: Developmental TherapeuticsMolecularly Targeted Agents and Tumor Biology)

EHA Abstracts

Oral abstract presentations and e-posters accepted for presentation at EHA will be available on the on-demand Virtual Congress platform beginning Friday, June 12, 2020, at 8:30 AM CEST.

Oral Presentations

Addition of Parsaclisib, a PI3K inhibitor, in Patients with Suboptimal Response to Ruxolitinib (Rux): A Phase 2 Study in Patients (Pts) with Myelofibrosis (MF) (Abstract #S216, Session: Novel Therapies and Pitfalls in MPN)

Ruxolitinib Versus Best Available Therapy in Patients with Steroid-Refractory Acute Graft-Versus-Host Disease: Overall Response Rate by Baseline Characteristics in the Randomized Phase 3 REACH2 Trial (Abstract #S255, Session: Stem Cell Transplantation Clinical: Graft-Versus-Host Disease)1

GRAVITAS-301: A Randomized, Double-Blind Phase 3 Study of Itacitinib or Placebo in Combination with Corticosteroids for Initial Treatment of Patients with Acute Graft-Versus-Host Disease (Abstract #S256, Session: Stem Cell Transplantation Clinical: Graft-Versus-Host Disease)

Interim Analysis from the OPTIC Trial, a Dose-Ranging Study of 3 Starting Doses of Ponatinib (Abstract #S172, Session: Chronic Myeloid Leukemia (CML) Clinical)2

Re-MIND Study: Comparison of Tafasitamab + Lenalidomide (L-Mind) vs Lenalidomide Monotherapy (Real-World Data) in Transplant-Ineligible Patients with Relapsed/Refractory Diffuse Large B-Cell Lymphoma (Abstract #S238, Aggressive Lymphomas: Observational Studies)3

Story continues

E-Poster Presentations

Real-World Survival in Elderly Patients with Myelofibrosis in the United States: Ruxolitinib Exposed vs Unexposed (Abstract #EP1124, Session: Myeloproliferative Neoplasms Clinical)

Real-World Survival in Elderly Patients with Myelofibrosis in the United States: Pre- vs Post-Ruxolitinib Approval (Abstract # EP1120, Session: Myeloproliferative Neoplasms Clinical)

Machine-Learning to Predict Hydroxyurea (HU) Failure and Incidence of Thromboembolic Events (TEs) with HU vs Ruxolitinib Switch Therapy in Polycythemia Vera Patients (Abstract #EP1117, Session: Myeloproliferative Neoplasms Clinical)1

Patient-Reported Physical, Emotional and Economic Impact of Myeloproliferative Neoplasms in an Expansion of the MPN Landmark Survey (Abstract #EP1112, Session: Myeloproliferative Neoplasms Clinical)1

Ruxolitinib in PV Patients Resistant and/or Intolerant to Hydroxyurea: Interim Analysis of a European Multi-Centric Observational Study (Abstract #EP1115, Session: Myeloproliferative Neoplasms Clinical)1

Treatment and Disease Management Practices in Patients with MPNs in 6 Countries: An Expansion of the MPN Landmark Survey (Abstract #EP1123, Session: Myeloproliferative Neoplasms Clinical)1

Retrospective Independent Review of Arterial Occlusive Events (AOEs) in the Phase 2 PACE Trial of Ponatinib in Philadelphia Chromosome Positive (Ph+) Leukemia (Abstract #EP759, Session: Chronic Myeloid Leukemia (CML) Clinical)2

The RealLife Study Evaluating the Efficacy and Safety of Ponatinib "Topase" Reveals Induction of Deep Molecular Responses in a Cohort of 75 TKI-Resistant or Intolerant patients with CML (Abstract #EP765, Session: Chronic Myeloid Leukemia (CML) Clinical)

Combination of Tafasitamab (MOR208) and Lenalidomide Enhances Tumor Cell Death of B-cell Lymphoma in Vitro (Abstract #EP1343, Session: Lymphoma Biology & Translational Research)3

Long-Term Outcomes from the Phase II L-MIND Study of Tafasitamab (Mor208) Plus Lenalidomide in Patients with Relapsed or Refractory Diffuse Large B-Cell Lymphoma (Abstract #EP1201, Session: Aggressive Non-Hodgkin Lymphoma - Clinical)3

Expression of CD19 Antigen on Chronic Lymphocytic Leukemia Cells After Tafasitamab (Anti-CD19) Treatment: Phase I Trial Data (Abstract #EP671, Chronic Lymphocytic Leukemia and Related Disorders - Biology & Translational Research)3

For full session details and data presentation listings, please see the ASCO20 (https://meetinglibrary.asco.org) and EHA25 (https://learningcenter.ehaweb.org/eha) online programs.

About IncyteIncyte is a Wilmington, Delaware-based, global biopharmaceutical company focused on finding solutions for serious unmet medical needs through the discovery, development and commercialization of proprietary therapeutics. For additional information on Incyte, please visit Incyte.com and follow @Incyte.

Forward-Looking StatementsExcept for the historical information set forth herein, the matters set forth in this press release, including statements regarding the presentation of data from the Companys or partner companys ongoing clinical development pipeline, and whether or when any development compounds will be approved or commercially available for use in humans anywhere in the world outside of the already approved indications in specific regions, its presentation plans for the upcoming ASCO and EHA meetings and its goal of improving the lives of patients, contain predictions, estimates and other forward-looking statements.

These forward-looking statements are based on the Companys current expectations and subject to risks and uncertainties that may cause actual results to differ materially, including unanticipated developments in and risks related to: unanticipated delays; further research and development and the results of clinical trials possibly being unsuccessful or insufficient to meet applicable regulatory standards or warrant continued development; the ability to enroll sufficient numbers of subjects in clinical trials; determinations made by the FDA; the Companys dependence on its relationships with its collaboration partners; the efficacy or safety of the Companys products and the products of the Companys collaboration partners; the acceptance of the Companys products and the products of the Companys collaboration partners in the marketplace; market competition; sales, marketing, manufacturing and distribution requirements; greater than expected expenses; expenses relating to litigation or strategic activities; and other risks detailed from time to time in the Companys reports filed with the Securities and Exchange Commission, including its Form 10-K for the year ended March 31, 2020. The Company disclaims any intent or obligation to update these forward-looking statements.

1Novartis-sponsored; 2Takeda-sponsored; 3MorphoSys-sponsored

View source version on businesswire.com: https://www.businesswire.com/news/home/20200514005695/en/

Contacts

Media Catalina Loveman+1 302 498 6171cloveman@incyte.com

Investors Michael Booth, DPhil+1 302 498 5914mbooth@incyte.com

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Stem Cell therapy Middletown Delaware 19709

Posted: February 10, 2020 at 2:46 pm

Stem Cell Therapy Middletown DE 19709

Stem cell treatment has become a popular dispute in the worldwide medical scene. This extremely controversial therapy has gotten blended viewpoints from various stakeholders in the health care market and has actually also brought in the interest of politicians, spiritual leaders and the general population at large. Stem cell therapy is thought about a revolutionary treatment for individuals experiencing a wide range of degenerative conditions. Some common questions regarding this therapy are addressed below.

Are you a stem cell therapy specialist close to Middletown DE 19709?Contact us for more information.

Stem cells can be referred to as blank state or non-specialized cells that have the ability to become specialized cells in the body such as bone, muscle, nerve or organ cells. This indicates that these special cells can be used to regrow or establish a wide range of broken cells and tissues in the body. Stem cell therapy is therefore a treatment that aims at accomplishing tissue regrowth and can be utilized to treat health conditions and illnesses such as osteoarthritis, degenerative disc illness, spine injury, muscular degeneration, motor neuron disease, ALS, Parkinsons, heart disease and much more.

Being a treatment that is still under research study, stem cell treatment has actually not been completely accepted as a feasible treatment alternative for the above discussed health conditions and health problems. A lot of studio is currently being carried out by scientists and medical experts in various parts of the world to make this treatment viable and efficient. There are however numerous restrictions enforced by federal governments on research involving embryonic stem cells.

Currently, there have not been numerous case studies performed for this kind of treatment. Nevertheless, with the few case studies that have been conducted, one of the major issues that has actually been raised is the boost in a patients threat of developing cancer. Cancer is brought on by the quick reproduction of cells that have a tendency not to pass away so easily. Stem cells have actually been associated with comparable growth factors that may result in formation of growths and other malignant cells in clients.

Contact us for more information about stem cell doctor in Middletown DE 19709

Stem cells can be extracted from a young embryo after conception. These stem cells are frequently referred to as embryonic stem cells. After the stem cells are extracted from the embryo, the embryo is ended. This is generally among the significant causes of debate in the field of stem cell research study. Many people suggest that termination of an embryo is unethical and inappropriate.

New research has nevertheless shown pledge as scientists aim at establishing stem cells that do not form into growths in later treatment phases. These stem cells can therefore successfully change into other kinds of specialized cells. This treatment is therefore worth researching into as lots of clients can benefit from this innovative treatment.

Stem cells can still be gotten through other means as they can be discovered in the blood, bone marrow and umbilical cords of adult human beings. Typical body cells can likewise be reverse-engineered to become stem cells that have actually limited capabilities.

stem cell doctor in Middletown DE 19709

Stem cell therapy has actually become a popular dispute in the global medical scene. This highly controversial treatment has actually gotten combined opinions from different stakeholders in the health care market and has likewise drawn in the interest of political leaders, spiritual leaders and the basic population at large. Stem cell treatment is thought about a revolutionary treatment for people struggling with a wide variety of degenerative conditions. Some common concerns concerning this treatment are addressed listed below.

4.96

Main address:Middletown, Delaware, 19709

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First CAR-T cell cancer therapy patient in Delaware – Dover Post

Posted: at 2:46 pm

'This is the beginning of my new life'

I thought my cancer diagnosis was a death sentence, said Lynnette Williams-Briggs, 60, of Seaford, Delaware, who was diagnosed with advanced B-cell lymphoma in 2018.

Briggs cancer is now in complete remission thanks to successful chimeric antigen receptor CAR-T cell therapy she received in August atChristianaCaresHelen F. Graham Cancer Center & Research InstitutesBone Marrow and Stem Cell Transplant Program.

I can breathe again. This is the beginning of my new life, Williams-Briggs said following the treatment that restored her hope for a second chance at life.

She was the first patient to receive CAR-T cell therapy in Delaware. A second patient was treated in December 2019, and doctors are preparing several more patients for CAR-T cell transplants in coming weeks.

The U.S. Food and Drug Administration has approved CAR-T cell therapy to treat patients like Williams-Briggs with highly resistant, B-cell blood cancers, for whom other available options have failed.

CAR-T cell therapy is only available at select cancer centers with specialized expertise in cellular therapies that are recognized for quality by the Foundation for the Accreditation of Cellular Therapy.

The Graham Cancer Centers Bone Marrow and Stem Cell Transplant Program is the only one in Delaware that is certified to treat adult patients with advanced B-cell lymphomas and children and young adults (to age 25) with acute lymphoblastic leukemia, using an FDA-approved drug.

CAR-T cell therapy is highly personalized medicine that attempts to use the bodys natural defenses to fight against cancer. The transplant team extracts millions of T cells, from the patients bloodstream, using a specialized blood filtration process called leukapheresis. The collected T cells are flash-frozen and sent to a lab for reprogramming, and then later infused back into the patient using a process similar to a blood transfusion.

The therapy is considered a living drug with potential benefits that could last for years.

When we first met Ms. Williams-Briggs, her cancer had progressed rapidly despite a third round of chemotherapy, so we knew we had to move quickly, said Graham Cancer Center Hematologist Peter Abdelmessieh, D.O. He worked closely with the bone marrow/stem cell transplant team and Graham Cancer Center leadership over the course of just eight months to develop the CAR-T cell therapy program.

It was truly a team effort to bring CAR-T cell therapy to our community so quickly, Dr. Abdelmessieh said.

CAR-T cell therapy has been extremely effective for many patients like Williams-Briggs, whose PET scan at 90 days confirmed her remission.

The supercharged T cells Williams-Briggs received were genetically modified in the lab to sprout new surface tools that improve their ability to recognize, latch onto and destroy other cells (including cancer cells) that express a specific antigen called CD19. These reprogrammed cells continue to multiply in the body after treatment, remaining on guard to seek and destroy any new cancers that might develop.

With continued success in increasing numbers of patients, it is conceivable that in the not too distant future, CAR-T cell therapy could become the new standard of care, replacing chemotherapy and stem cell transplants for many cancers, Dr. Abdelmessieh said.

The extended recovery period for CAR-T cell therapy is generally two to three months. After the infusion, patients may spend up to three weeks in the hospital to monitor treatment response and any side effects.

During the first 30 days after leaving the hospital, patients are required to remain close to the treatment center for regular follow-up care.

The ability to offer potentially life-saving CAR-T cell therapy is one more reason our patients need not travel further than the Graham Cancer Center for state-of-the-science cancer treatment, said Nicholas J. Petrelli, M.D., Bank of America medical director of the Helen F. Graham Cancer Center & Research Institute.

The Bone Marrow and Stem Cell Transplant Program is an outstanding example of how well our clinical teams work together to drive innovation in patient care.

Although patients normally do not experience the side effects associated with chemotherapy, such as nausea, vomiting or hair loss, CAR-T cell therapy is not without risks. A common side effect, which Williams-Briggs also experienced, is cytokine release syndrome. This is an inflammatory condition that causes flu-like symptoms that may be mild or severe.

The transplant team responded quickly to manage her symptoms while she received expert care on the Bone Marrow Transplant and Oncology unit at Christiana Hospital.

From the moment I first met with my transplant team, I felt like I was part of one big loving family that extended beyond my own loved ones, Williams-Briggs said.

Dr. Abdelmessieh and my ChristianaCare family gave me hope to keep fighting when I really didnt think I would make it. I would have driven anywhere to get life-saving treatment, but I am thankful that I did not have to. I found my miracle closer to home.

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Gore, Mayo Clinic team up to deliver breakthrough medical therapies – Plastics Today

Posted: December 17, 2019 at 3:49 am

Materials science company W. L. Gore & Associates Inc. (Newark, DE) has announced a joint venture with the Mayo Clinic (Rochester, MN) to further develop a therapeutic system using stem cells and bio-absorbable scaffolds to treat a condition affecting patients with Crohns disease. Avobis Bio, based in Delaware, will draw on the expertise of scientists and medical professionals from both organizations to build on the encouraging results of an investigational treatment for perianal fistulas.

A debilitating condition that affects patients with Crohns disease, perianal fistulas are painful tunneling wounds connecting the anus to the skin, explained Gore in a press release. Few healing options exist, and patients endure multiple surgeries and ongoing risk of life-threatening complications, said Gore.

"Perianal fistulas are truly life-altering for Crohn's patients, and treatment options have eluded gastroenterologists and surgeons for years," added William Faubion Jr., MD, a Mayo Clinic gastroenterologist who specializes in inflammatory bowel diseases.

The innovative treatment involves harvesting a patients own mesenchymal stem cells, which then are populated on Gore's bioabsorbable polymer scaffold and surgically implanted in the fistula. A phase I clinical trial showed that 76% of patients healed within a year. If this outcome is validated in a larger trial, Gore said that it would dramatically exceed outcomes achieved with existing treatments.

This project is the initial focus of Avobis Bio, which describes its overall mission as an exploration of the use of mesenchymal stem cells combined with enabling bioabsorbable scaffolds that enhance the effectiveness of the cells in stimulating the body to heal.

Delivering a patients mesenchymal stem cells on a synthetic scaffold that biodegrades over time may be a first-of-its-kind medical therapy, noted Joe Carlson, a reporter at the Minneapolis-based Star Tribune reporting on the joint venture. If successful, Avobis Bio may one day offer a variety of tissue and organ-repair therapies combining Mayo's stem cell expertise and Gore's medical materials, he wrote.

Gore is perhaps best known to the public for its Gore-Tex outerwear, but the privately held $3.7 billion engineering and manufacturing firm sells products in an array of industries, including a line of medical devices designed to repair nonnatural holes in body organs, added Carlson. Mayo has used Gore-made devices for many years.

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Global Stem Cell Therapy Market 2019-2025 Analyzed by Business Growth, Development Factors, Applications, and Future Prospects – Technology Magazine

Posted: at 3:49 am

Autologous stem cell therapy market segment is anticipated to witness around 10% growth throughout the forecast timeframe. Autologous stem cell therapy has high compatibility with patients immune system and showcases strong efficacy. Additionally, it eliminates the need for finding donor and reduces the overall cost of treatment. Aforementioned advantages offered by autologous stem cell therapy will augment its demand thereby, escalating segment growth.

Oncology segment held over 37% revenue in 2018. Increasing prevalence of cancer globally will increase the demand for advanced stem cell Therapy. Metastatic cancer cells are difficult to destroy utilizing conventional methods. Radiations and chemotherapy cannot eradicate the disease completely and also results in several complications. Stem cells have unique properties such as secretion of bioactive factors and migration towards cancer cells promotes tumor targeting that are proven to be effective in treatment of cancer. Aforementioned factors will escalate the segmental growth.Rising government initiatives for promoting stem cell therapy in developed as well as developing countries will propel industry growth. Increasing government spending on research activities aimed at development of stem cell therapy for treatment of life-threatening diseases such as cancer. The government ensures that laboratories, research and academic centers are well-equipped with necessary equipment and advanced devices for facilitating the stem cell therapy research processes. Aforementioned factors are expected to boost the stem cell therapy market growth.

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Increasing efforts undertaken by companies for improving efficacy of stem cell therapy will fuel industry growth. Stem cells possess totipotency that enables them to transform into any differentiated cell. Stem cells play pivotal role in treatment of chronic diseases such as cancer, cardiovascular diseases and degenerative disorders. 0Currently, hematopoietic, embryonic and mesenchymal cells are being researched as they have the ability to cure several complications. Companies commercialize these stem cell products for providing effective therapy that should prove beneficial for the industry growth. However, ethical issues associated with stem cell therapy may affect industry growth to some extent.

Hospitals segment was valued around USD 4 billion in 2018. Significant growth is attributed to increasing prevalence of chronic diseases. Annually, large number of patients prefer stem cell therapy offered at hospitals as a treatment option to avoid complications caused due to invasive methods. Hospitals have dedicated resources allocated for providing uncompromised care to patients that speeds up the recovery process. Moreover, hospitals affiliated with government authorities receives enough funding and have the ability to provide superior quality stem cell therapy. Above mentioned factors will augment patients preference towards hospitals that will exceed segment growth.

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Asia Pacific stem cell therapy market held around 20% revenue in 2018. Substantial revenue share can be attributed to the increasing awareness regarding availability of stem cell therapies. Moreover, government encourages scientists and researchers to carry out studies and thesis on stem cell therapies in order to develop innovative solutions for treating chronic diseases. Also, several developing countries in the region have witnessed industry growth opportunities as government provide funds to establish stem cell centers. For instance, in Singapore JTC Corporation has established Biopolis, that is a biomedical research center of stem cell science. Such government initiatives in Asian countries will positively impact regional market growth.

More Insightful [emailprotected] https://www.marketwatch.com/press-release/15bn-by-2025-stem-cell-therapy-market-2019-set-for-massive-growth-2019-07-22

Prominent industry players operational in stem cell therapy market are Astellas Pharma Inc, Cellectis, Celyad, Novadip Biosciences, Gamida Cell, Capricor Therapeutics, Cellular Dynamics, CESCA Therapeutics, DiscGenics, OxStem, Mesoblast Ltd, ReNeuron Group and Takeda Pharmaceuticals. Industry players implement various strategies such as collaboration, acquisition, merger, product launch to sustain in the market. For instance, in February 2018, Astellas acquired Universal Cells so that they can utilize proprietary technology to manufacture pluripotent stem cells. This strategy will help Astellas to develop innovative solutions that will provide competitive advantage to company.

Related Reports:

Vaccines Market: https://www.marketwatch.com/press-release/global-vaccines-market-size-2019-outlook-opportunity-and-demand-analysis-report-by-2025-2019-09-12

Patient Handling Equipment Market: https://www.marketwatch.com/press-release/patient-handling-equipment-market-size-2019-outlook-opportunity-and-demand-analysis-report-by-2025-2019-09-12

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Global Stem Cell Therapy Market 2019-2025 Analyzed by Business Growth, Development Factors, Applications, and Future Prospects - Technology Magazine

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