Monthly Archives: August 2021

BOSTON--(BUSINESS WIRE)--Gamida Cell Ltd. (Nasdaq: GMDA), an advanced cell therapy company committed to cures for blood cancers and serious blood diseases, today announced that the company will host a conference call and live audio webcast on Wednesday, August 11, 2021, at 8:00 a.m. ET to review its second quarter 2021 financial results and provide an update on the company.

Management will discuss the companys progress during the quarter, including advances in the development of omidubicel, which has the potential to be the first approved cell therapy for blood cancer patients in need of an allogeneic bone marrow transplant, following the planned BLA submission in the fourth quarter of 2021. Gamida Cell will also provide an update on its pipeline of NAM-enabled natural killer (NK) cell therapies, including GDA-201 and genetically-modified NK cell constructs. The Company is planning an IND submission to support the initiation of a Phase 1/2 clinical study of cryopreserved, off-the-shelf GDA-201 in patients with follicular and diffuse large b-cell lymphomas.

The webcast will be available on the Investors & Media section of the Gamida Cell website at http://www.gamida-cell.com. To participate in the live call, please dial 866-930-5560 (domestic) or 409-216-0605 (international) and refer to conference ID number 9949715. A replay of the webcast will be available approximately two hours after the event, for approximately 30 days.

About Gamida Cell

Gamida Cell is an advanced cell therapy company committed to cures for patients with blood cancers and serious blood diseases. We harness our cell expansion platform to create therapies with the potential to redefine standards of care in areas of serious medical need. For additional information, please visit http://www.gamida-cell.com or follow Gamida Cell on LinkedIn or Twitter at @GamidaCellTx.

Cautionary Note Regarding Forward Looking Statements

This press release contains forward-looking statements as that term is defined in the Private Securities Litigation Reform Act of 1995, including with respect to the anticipated submission of a BLA for omidubicel and an IND for GDA-201, which statements are subject to a number of risks, uncertainties and assumptions, including, but not limited to Gamida Cells ability to prepare regulatory filings and the review process therefor; complications in Gamida Cells ability to manufacture its products; and clinical, scientific, regulatory and technical developments. In light of these risks and uncertainties, and other risks and uncertainties that are described in the Risk Factors section and other sections of Gamida Cells Annual Report on Form 20-F, filed with the Securities and Exchange Commission (SEC) on March 9, 2021, as amended on March 22, 2021, and other filings that Gamida Cell makes with the SEC from time to time (which are available at http://www.sec.gov), the events and circumstances discussed in such forward-looking statements may not occur, and Gamida Cells actual results could differ materially and adversely from those anticipated or implied thereby. Any forward-looking statements speak only as of the date of this press release and are based on information available to Gamida Cell as of the date of this release.

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Gamida Cell Announces the Date of Its Second Quarter 2021 Financial Results and Webcast - Business Wire

Tycel Jovelle Phillips, MD, discusses the future of CAR T-cell therapy in mantle cell lymphoma patients.

Tycel Jovelle Phillips, MD, clinical associate professor, Division of Hematology and Oncology, Department of Internal Medicine, Rogel Cancer Center, Michigan Medicine, discusses the future of CAR T-cell therapy in mantle cell lymphoma (MCL) patients.

Based on published data, CAR T-cell therapy appears to be agnostic to some of the high-risk features that distinguish frontline treatment outcomes in patients with MCL, Phillips says. As such, this modality may have clinical utility as up-front treatment to improve outcomes in patients with high-risk disease, Phillips explains. However, developing improved toxicity management, particularly with regard to CAR T-cell therapyrelated neurotoxicity, is important in MCL, Phillips adds.

Increased exposure to using CAR T-cell therapy will increase provider comfortability with the modality and improve toxicity-management strategies, Phillips continues. With additional data emerging, FDA approvals of novel CAR T-cell therapies in MCL could be on the horizon to provide more options to patients, Phillips concludes.

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Dr. Phillips on the Future of CAR T-Cell Therapy in MCL - OncLive

The powerhouse of the cellis powering a new collaboration pact between Astellas Pharma and Minovia Therapeutics, with the latter receiving $20 million upfront for the joint work on cell therapies.

The Japanese Big Pharma will also pay the U.S.-Israel biotechup to $420 million in biobucks for each cell therapy commercialized for diseases caused by mitochondrial dysfunction, under the terms of the deal revealed Friday.

Mitochondrial dysfunction occurs when the mitochondria, which produce much of a cell's energy, don't work as well as they should due to another disease or condition. Many conditions can lead to secondary mitochondrial dysfunction and affect other diseases, including Alzheimer's disease, muscular dystrophy, Lou Gehrig's disease, diabetes and cancer.

The collab license pact focuses specifically on allogeneic mitochondrial cell therapies. Astellas will contribute cells from its genetically-engineered, induced pluripotent stem cells. Minovia meanwhile will hand forth its mitochondrial augmentation therapy platform. The biotech is currently testing the MAT platform in a phase 1 study of Pearson Syndrome, a childhood bone marrow disease.

RELATED:Mitochondrial biotech Minovia Therapeutics nabs biopharma veteran Jacobs as new chief medical officer

"We, at Astellas, have positioned mitochondrial biology as one of the Primary Focuses of our research and development strategy to develop therapies for patients with unmet medical needs. One of the aspirations of this Primary Focus is to establish a mitochondrial cell therapy platform," saidAstellas Chief Financial Officer Naoki Okamura in a statement.

The goal is to treat diseases by transferring healthy mitochondria to restore patients' tissues. This involves isolating a patient's own cells, providing them with healthy mitochondria from a donor and then re-infusing back into the patient.

The mitochondrial biology pact with Minovia follows Astellas' deals in the space in recent years. The Big Pharma acquiredMitobridge in late 2017 and, more recently, Nanna Therapeutics in April 2020.

The Mitobridge deal appears to have produced three clinical-stage assets for the Astellas pipeline. Mitobridge is listed as a partner on Astellas'mitochondria biology primary focus areas in a July 30 pipeline update, with a phase 2 acute kidney injury small molecule, a phase 2 primary mitochondrial myopathy small molecule and a phase 1 Duchenne muscular dystrophy treatment hopeful.

RELATED:Astellas buys DMD drug in $450M mitochondrial takeover

"We share with Astellas both their passion for mitochondrial science and their commitment to patients in need of new therapies," said Natalie Yivgi-Ohana, Ph.D., Minovias CEO and co-founder, in a statement.

Editor's note: This article has been updated to delete an inaccurate reference to a collaboration between Takeda and PeptiDream.

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Astellas to pay Minovia $20M upfront, with $420M on the table per product, for mitochondrial cell therapies - FierceBiotech

A new technology for cellular immunotherapy developed by Abramson Cancer Center researchers at Penn Medicine showed promising anti-tumor activity in the lab against hard-to-treat cancers driven by the once-considered undruggable KRAS mutation, including lung, colorectal, and pancreatic.

The study, published in Nature Communications, successfully demonstrates using human cells that a T-cell receptor, or TCR, therapy could be designed to mobilize an immune system attack on mutated KRAS solid tumors and shrink them. The preclinical work has laid the groundwork for the first-in-human clinical trial now in the planning stages for the treatment of advanced pancreatic cancer in patients whose tumors harbor specific KRAS mutations and express a specific type of human leukocyte antigen, or HLA, the therapy is built to recognize.

Weve shown that targeting mutant KRAS immunologically is feasible and potentially generalizable for a group of patients with lung, colorectal, and pancreatic tumors, says senior author Beatriz M. Carreno, an associate professor of pathology and laboratory medicine in the Perelman School of Medicine and a member of the Center for Cellular Immunotherapies, the Abramson Cancer Center, and Parker Institute for Cancer Immunotherapy at Penn. We look forward to taking this research to the next level and closer to clinical study.

Read more at Penn Medicine News.

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New cell therapy shows potential against solid tumors with KRAS mutations | Penn Today - Penn Today

MAINZ, Germany & Santa Monica, USA, August 4, 2021 -- https://www.globenewswire.com/Tracker?data=rd-GqRgZzMAvrqdXdlZCZtWIr-1HWyTArNNvmD50nTmy38yKOl694yPgCc1EUzlDcRwLvaSZZ4fDi_mgCtCcJHiWNl88xlgxSPnv7IbOjjdeab0WzFWQKlkR5EzJDzicbrsnGiyKImvL-HFAKL7CGwmGLHJXTKW7ZvKM4rA9sRBshh27SsRpJTPn8ZFQ9mHnC2si1RVdrYRU2P6aVAtM0VY2r5t4-AalziVQxO5lq6c= BioNTech SE (Nasdaq: BNTX, "BioNTech") and https://www.globenewswire.com/Tracker?data=H4C-hcf0HQdKBoPKhwSfI4dvQNZwKgjelS-XFyvXgYZRzf9yCeu4jV8cdqdaf7EVB8oISc0ioLW8qxctEjXrVQ== Kite, a Gilead Company (Nasdaq: GILD, "Kite") today announced the closing of the acquisition of the solid tumor neoantigen T cell receptor (TCR) R&D platform and clinical manufacturing facility's assets and leases in Gaithersburg, MD, from Kite. The transaction was https://www.globenewswire.com/Tracker?data=CtfxPETleqKZM8FjmNb2p9VDNQ4MG3ZK6vmaRnxQ3pgf0UeqRarcrzirdVO3a2EY7kIq1yRgO0Ekv6qJ86ZCKTaSJwZAkvIn7l2EXxmRfhq8rm7TRzW5qtOC9Kkvxsz_PbRdNy01WcUUEuJtqg7qEMkuqbswaA55I44kcWX52X6xqtFQTuoqDOq5d4s3RkQ0mVEF99kdYR5kBf3wLPuW9w== announced on July 19, 2021.

The acquisition strengthens BioNTech's cell therapy pipeline by accelerating the individualized solid tumor Neoantigen TCR cell therapy research and development program. It also expands the Company's cell therapy capabilities and manufacturing footprint in North America, building on its https://www.globenewswire.com/Tracker?data=VdCDxXoP-JoGhXT3wCAyucc4Lk9MyzwgAaIOz2VimsXf8opXSPOGA3ASQ1yCdSh1dokBArMCqzmyLMofB2u2YL4Flw5Y-VI613GHw5ARdG9rGuNJ0i5sKnxnz5Jq-gq7mFbZBuIIhM7aN2hx3XE2XB1qaYXfFR-baRhDJCm56nV6Z_7foaUzGn36eWoDNFcFkwL58FTs4cIVuT6D4FHfSoaXEFc0b_1Zi3TIH0oHDb61D3mk92r8SUNKZPBOB57q acquisition of Neon Therapeutics in 2020. With three acquisitions completed in the last 14 months, BioNTech confirms its strategy of complementing organic growth through targeted acquisitions that expand its capabilities and accelerate development of its broad immunotherapy pipeline.

All Kite employees at the Gaithersburg facility were offered employment with BioNTech prior to closing. The plant will be fully integrated into BioNTech's US-operations and the global manufacturing network.

About BioNTech

Biopharmaceutical New Technologies is a next generation immunotherapy company pioneering novel therapies for cancer and other serious diseases. The Company exploits a wide array of computational discovery and therapeutic drug platforms for the rapid development of novel biopharmaceuticals. Its broad portfolio of oncology product candidates includes individualized and off-the-shelf mRNA-based therapies, innovative chimeric antigen receptor T cells, bispecific checkpoint immuno-modulators, targeted cancer antibodies and small molecules. Based on its deep expertise in mRNA vaccine development and in-house manufacturing capabilities, BioNTech and its collaborators are developing multiple mRNA vaccine candidates for a range of infectious diseases alongside its diverse oncology pipeline. BioNTech has established a broad set of relationships with multiple global pharmaceutical collaborators, including Genmab, Sanofi, Bayer Animal Health, Genentech, a member of the Roche Group, Regeneron, Genevant, Fosun Pharma and Pfizer. For more information, please visit http://www.BioNTech.de.

BioNTech Forward-Looking Statements

This press release contains "forward-looking statements" of BioNTech within the meaning of the Private Securities Litigation Reform Act of 1995. These forward-looking statements may include, but may not be limited to, express or implied statements regarding the expected impact of the acquisition on BioNTech's business; the creation of long-term value for BioNTech shareholders; potential synergies between BioNTech and the acquired Kite assets; and BioNTech's global expansion strategy. Any forward-looking statements in this press release are based on BioNTech management's current expectations and beliefs of future events, and are subject to a number of risks and uncertainties that could cause actual results to differ materially and adversely from those set forth in or implied by such forward-looking statements. These risks and uncertainties include, but are not limited to: the reaction of third parties to the proposed merger, the retention of employees at the acquired sites, BioNTech's plans with respect to the acquired assets, the future growth of BioNTech's business and the possibility that integration following the proposed acquisition may be more difficult than expected, uncertainties related to the initiation, timing and conduct of studies and other development requirements for the acquired TCR product candidates; the risk that any one or more of the acquired product candidates will not be successfully developed and commercialized; the risk that the results of preclinical studies and clinical trials may not be predictive of future results in connection with future studies or trials; and risks related to BioNTech's ability to protect and maintain the acquired intellectual property position.

For a discussion of these and other risks and uncertainties, see BioNTech's Annual Report on Form 20-F for the Year Ended December 31, 2020, filed with the SEC on March 30, 2021, which is available on the SEC's website at http://www.sec.gov. All information in this press release is as of the date of the release, and BioNTech undertakes no duty to update this information unless required by law.

About Kite

Kite, a Gilead Company, is a global biopharmaceutical company based in Santa Monica, California, with commercial manufacturing operations in North America and Europe. Kite's singular focus is cell therapy to treat and potentially cure cancer. As the cell therapy leader, Kite has more approved CAR T indications to help more patients than any other company. For more information on Kite, please visit http://www.kitepharma.com.

About Gilead Sciences

Gilead Sciences, Inc. is a biopharmaceutical company that has pursued and achieved breakthroughs in medicine for more than three decades, with the goal of creating a healthier world for all people. The company is committed to advancing innovative medicines to prevent and treat life-threatening diseases, including HIV, viral hepatitis and cancer. Gilead operates in more than 35 countries worldwide, with headquarters in Foster City, California.

Kite, the Kite logo and GILEAD are trademarks of Gilead Sciences, Inc. or its related companies.

For more information on Kite, please visit the company's website at https://www.globenewswire.com/Tracker?data=Vx9hjgANMsd296jYISCp9j5WTYOgbp1nUaGrtGdY-XwKsS7q8Xbas0WOSSPaMevMAi3MH0WpwnrbcpP4m0_tvro9p6_0zCOeoQMoEQTwGSU= http://www.kitepharma.com or call Gilead Public Affairs at 1-800-GILEAD-5 or 1-650-574-3000. Follow Kite on social media on Twitter https://www.globenewswire.com/Tracker?data=iFWoF7pnp6Sh28S8ykqkp00YZ8BkMxqeqTTN_f3GN6cKOqpAwF6R_rBzCXTp0ou8Ljvs_HYgoCeh_F5CL_DGrBR3uS3BoS-KKJVmcoIPTdI= (@KitePharma) and https://www.globenewswire.com/Tracker?data=3NXdf6zn8By3dflg7qXH5uT4yrCKpqWnXKZIDQG92uIXhw6KVuzYROc6TJiexbaWoeod6tPERXdEsroV6DXYhpiDebAF6jhGuRnoNNYHMgk_rh3okHpNqqIoK_9hEfL_ LinkedIn.

Gilead and Kite Forward-Looking Statements

This press release includes forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995 that are subject to risks, uncertainties and other factors. These and other risks, uncertainties and other factors are described in detail in Gilead's Quarterly Report on Form 10-Q for the quarter ended March 31, 2021, as filed with the U.S. Securities and Exchange Commission. These risks, uncertainties and other factors could cause actual results to differ materially from those referred to in the forward-looking statements. All statements other than statements of historical fact are statements that could be deemed forward-looking statements. Investors are cautioned that any such forward-looking statements are not guarantees of future performance and involve risks and uncertainties and are cautioned not to place undue reliance on these forward-looking statements. All forward-looking statements are based on information currently available to Kite and Gilead, and Kite and Gilead assume no obligation and disclaim any intent to update any such forward-looking statements.

BioNTech Contacts

Media Relations

Jasmina Alatovic

+49 (0)6131 9084 1513

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Investor Relations

Sylke Maas, Ph.D.

+49 (0)6131 9084 1074

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Kite Contacts

Mary Lynn Carver, Media

+1 (410) 443-1853

Jacquie Ross, Investors

+1 (650) 358-1054

(END) Dow Jones Newswires

August 04, 2021 07:00 ET (11:00 GMT)

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Press Release : BioNTech Completes Acquisition of Kite's Neoantigen TCR Cell Therapy R&D Platform and Manufacturing Facility in Gaithersburg, Maryland...

Bijal Shah, MD, MS, discusses the results of treatment with the chimeric antigen receptor T-cell therapy brexucabtagne autoleucel in the ZUMA-3 trial in patients with acute lymphoblastic leukemia.

Bijal Shah, MD, MS, an associate member in the Department of Malignant Hematology at Moffitt Cancer Center, discusses the results of treatment with the chimeric antigen receptor (CAR) T-cell therapy brexucabtagne autoleucel (Tecartus) in the ZUMA-3 trial (NCT02614066) in patients with acute lymphoblastic leukemia (ALL).

Shah hopes that he and his fellow investigators have done enough to show the FDA that this treatment is safe option to treat patients with ALL. Patients in the ZUMA-3 trial had a 71% complete remission (CR) rate with CAR T-cell therapy, which Shah says is unheard of in this population. These patients had progressed on previous therapies or after transplant. Patients achieved deep remissions and most had minimal residual disease negativity after treatment. These were real remissions, as opposed to cosmetic remissions, according to Shah.

This efficacy translated into pronounced benefits in relapse-free survival, duration of remission, and overall survival. Patients who achieved CR did not reach a median overall survival with CAR T. Shah feels that this is incredible for this patient population. CAR T-cell therapy was expected to be a meaningful treatment in ALL, and now the data show it can be used safely.

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ZUMA-3 Trial of CAR T Results in Impressive Efficacy for Patients With ALL - Targeted Oncology

PITTSBURGH, Aug. 04, 2021 (GLOBE NEWSWIRE) -- A new collaboration among UPMC Hillman Cancer Center, the University of Pittsburgh and New Jersey-based biotechnology company Avalon GloboCare Corp. (NASDAQ: AVCO) aims to develop new cancer immunotherapy approaches and streamline manufacturing processes to bring these powerful treatments to cancer patients within days instead of weeks.

Cancer immunotherapy, which stimulates and trains a patients own immune system to target and kill tumors while leaving healthy cells intact, is an effective treatment for many cancer patients. One of these therapies, chimeric antigen receptor (CAR) T-cell therapy, alters a patients own T-cells to kill their cancer cells. This approach has been successful for some patients with leukemias, lymphomas and more recently, multiple myeloma, but only a limited number of patients have been able to benefit from these therapies.

The new collaboration, led by Yen-Michael S. Hsu, M.D., Ph.D., director of the Immunologic Monitoring and Cellular Products Laboratory (IMCPL) at UPMC Hillman, seeks to develop next-generation CAR-based cellular therapies to make them accessible to a wider range of cancer patients.

CAR T-cell therapies approved by the U.S. Food and Drug Administration (FDA) are personalized therapies, made from the patients own cells. Current therapies use a DNA-based viral vector to engineer expression of the CAR against an antigen present on tumor cells. Patient cells are modified in the laboratory and infused back into the patient in a process that takes several weeks.

With Avalon GloboCare FLASH-CARtechnology, we will use an innovative messenger ribonucleic acid (mRNA)-based technology platform that will allow researchers to create CAR cellular therapies much faster than before -- in just one to two days, said Hsu. We also believe this approach will reduce toxicity and overall cost associated with current CAR T-cell therapies, meaning more cancer patients could be eligible for this type of cellular therapy.

The researchers are also using the technology to develop next-generation, personalized CAR T-cell therapies, including engineering cells that target more than one tumor antigen, enhancing their ability to target and kill cancer cells. Hillmans IMCPL and Avalon GloboCare are developing a treatment for patients with relapsed or refractory B-cell lymphoblastic leukemia and non-Hodgkin lymphoma. Human clinical trials are poised to begin in mid-2022.

Another goal, according to Hsu, is to make universal or off-the-shelf CAR-based cancer immunotherapies. Unlike personalized treatments, this universal cellular therapy will be derived from a healthy donor, manufactured in bulk and readily available to treat patients without delay

A clinician could order this cellular immunotherapy in the same way as antibody or oral cancer treatment, reducing the time a patient has to wait for treatment. Because this cellular therapy would be made in a large batch, the cost of manufacturing would be much lower, resulting in a lower cost of the final cellular therapy products for patients, said Hsu.

The researchers are also working to streamline and enhance the quality of CAR T-cell manufacturing with Avalons Point-of-Care Modular Autonomous Processing System onsite at UPMC Hillman, a National Cancer Institute-designated comprehensive cancer center.

As an FDA-registered, Foundation for Accreditation of Cellular Therapy-accredited laboratory, the IMCPL supports investigator-initiated research and technical expertise in translating laboratory research into clinical biologic products. The mission of the lab is to deliver high-quality and safe translation of cutting-edge scientific breakthroughs into cellular therapies for improving cancer care and human health.

About UPMC Hillman Cancer CenterUPMC Hillman Cancer Center is the regions only National Cancer Institute-designated Comprehensive Cancer Center and is one of the largest integrated community cancer networks in the United States. Backed by the collective strength of UPMCwhich is ranked No. 15 for cancer care nationally by U.S. News & World Reportand the University of Pittsburgh School of Medicine, UPMC Hillman Cancer Center has nearly 70 locations throughout Pennsylvania, Ohio, New York, and Maryland, with cancer centers and partnerships internationally. The more than 2,000 physicians, researchers, and staff are leaders in molecular and cellular cancer biology, cancer immunology, cancer virology, biobehavioral cancer control, and cancer epidemiology, prevention, and therapeutics. UPMC Hillman Cancer Center is transforming cancer research, care, and preventionone patient at a time.

About the University of Pittsburgh School of MedicineAs one of the nations leading academic centers for biomedical research, the University of Pittsburgh School of Medicine integrates advanced technology with basic science across a broad range of disciplines in a continuous quest to harness the power of new knowledge and improve the human condition. Driven mainly by the School of Medicine and its affiliates, Pitt has ranked among the top 10 recipients of funding from the National Institutes of Health since 1998. In rankings recently released by the National Science Foundation, Pitt ranked fifth among all American universities in total federal science and engineering research and development support.

Likewise, the School of Medicine is equally committed to advancing the quality and strength of its medical and graduate education programs, for which it is recognized as an innovative leader, and to training highly skilled, compassionate clinicians and creative scientists well-equipped to engage in world-class research. The School of Medicine is the academic partner of UPMC, which has collaborated with the University to raise the standard of medical excellence in Pittsburgh and to position health care as a driving force behind the regions economy. For more information about the School of Medicine, see http://www.medschool.pitt.edu.

About Avalon GloboCare Corp.Avalon GloboCare Corp. (NASDAQ: AVCO) is a clinical-stage, vertically integrated, leading CellTech bio-developer dedicated to advancing and empowering innovative, transformative immune effector cell therapy, exosome technology, as well as COVID-19 related diagnostics and therapeutics. Avalon also provides strategic advisory and outsourcing services to facilitate and enhance its clients' growth and development, as well as competitiveness in healthcare and CellTech industry markets. Through its subsidiary structure with unique integration of verticals from innovative R&D to automated bioproduction and accelerated clinical development, Avalon is establishing a leading role in the fields of cellular immunotherapy (including CAR-T/NK), exosome technology (ACTEX), and regenerative therapeutics. For more information about Avalon GloboCare, please visit http://www.avalon-globocare.com.

For the latest updates on Avalon GloboCare's developments, please follow our twitter at @avalongc_avco

Forward-Looking StatementsCertain statements contained in this press release may constitute "forward-looking statements." Forward-looking statements provide current expectations of future events based on certain assumptions and include any statement that does not directly relate to any historical or current fact. Actual results may differ materially from those indicated by such forward-looking statements as a result of various important factors as disclosed in our filings with the Securities and Exchange Commission located at their website (http://www.sec.gov). In addition to these factors, actual future performance, outcomes, and results may differ materially because of more general factors including (without limitation) general industry and market conditions and growth rates, economic conditions, and governmental and public policy changes. The forward-looking statements included in this press release represent the Company's views as of the date of this press release and these views could change. However, while the Company may elect to update these forward-looking statements at some point in the future, the Company specifically disclaims any obligation to do so. These forward-looking statements should not be relied upon as representing the Company's views as of any date subsequent to the date of the press release.

Contact Information:Avalon GloboCare Corp.4400 Route 9, Suite 3100Freehold, NJ 07728PR@Avalon-GloboCare.com

Investor Relations:Crescendo Communications, LLCTel: (212) 671-1020 Ext. 304avco@crescendo-ir.com

Contact: Cyndy PattonMobile: 412-415-6085E-mail: PattonC4@upmc.edu

Contact: Asher JonesMobile: 412-639-6222E-mail: JonesAG@upmc.edu

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UPMC and Pitt Develop New Cancer Immunotherapy with Avalon - GlobeNewswire

The heavily regulated and complex biopharmaceutical industry has been slow to change and adopt automated practices. A shift toward automation is a vital step forward to making breakthrough therapies more scalable and viable to help save patients lives. While the hurdles must be carefully considered, it is now time to accelerate digital transformation to enable the application of smart technologies, and specifically, to advance the cell and gene therapy industry.Motivated by pandemic-driven changes in human resources and consumer behaviors, many companies in multiple sectors and regions were forced to accelerate their adoption of automated and other digital technologies. Many of these changes are here to stay.

In biopharma, automation and digital technologies are increasingly being incorporated throughout the entire drug development process, from the discovery of disease mechanisms to the industrial manufacture of regulatory approved therapies. Many laboratories are switching from paper records to electronic laboratory notebooks (ELNs) and digital laboratory information management systems (LIMS). This is the case in most biopharma labs as well as smaller, academic research institutions.

Many therapeutics begin in academic research laboratories, where basic research is performed to better understand disease pathways and identify novel targets for potential treatment. Transitioning a therapy from an academic lab to commercial scale can be particularly challenging for cell and gene therapies as academic teams may not focus on the scalability of production methods for industrial manufacturing.

Additionally, the requirements for transitioning from small-scale to large-scale manufacturing facilities can be stringent, especially when Good Manufacturing Practice (GMP) regulations must be met. To make the production methods originally devised at the research bench useable at scale, they may need to be radically altered, for example, by altering a batch production process into an automated continuous one.

Fortunately, the scale required for autologous cell therapies is not large. But not all cell therapies will be required only in small, single lots. The priority placed on developing allogeneic cell therapies, which are sourced from donors who are unrelated to the patient, means that large-scale production methods will also be needed, to produce large volumes of these therapies for multiple patients.

While genomic therapies, like traditional small molecule drugs, often include synthesis steps, they also often employ living cells in their manufacture and are relatively large, akin to the production and size of biologic drugs. These and other similarities may account for why pre-existing technologies and methods have largely been transplanted from the other two major drug modalities to discover and produce genomic medicines.

However, these transplanted technologies and methods are not always all that well suited to genomic medicines. Technologies and methods stemming from disparate processes and workflows can make it more difficult to incorporate digital transformation and automation, resulting in islands of automation. Clearly, there is a need for dedicated solutions designed specifically for gene and cell therapies.

These solutions can take many forms, including a digital approach. By focusing on key pain points expressed by their partners in the cell and gene therapy industry, cell therapy experts have determined that there are generally two kinds of solutions needed. One needs to address key bottlenecks within the various processes in the drug discovery and drug-making journey, and the other needs to address more overarching issues within the broader workflow. This includes solutions designed to better integrate various steps in the drug discovery, development and manufacturing processes, as well as enable more end-to-end visibility and control.

As more biopharma companies and academic institutions digitally transform their operations and infrastructure, automation, including that driven by artificial intelligence, can deliver much-anticipated improvements in terms of reducing hands-on time, resource utilization, and even risk, while at the same time increasing process and product consistency, scalability, and regulatory compliance.

Although hurdles remain, such as the continued need for bespoke solutions for this relatively new drug modality, the future is bright as the COVID-19 vaccines herald the advent of the genomic medicines age one where we hope to see realized the promise of cell and gene therapies to deliver long-term remission and even cures for patients with some of the most difficult-to-treat diseases.

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Automating Manufacturing Is Critical for Advancing Cell and Gene Therapies - Technology Networks

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SAN DIEGO, Aug. 04, 2021 (GLOBE NEWSWIRE) -- Fate Therapeutics, Inc. (NASDAQ: FATE), a clinical-stage biopharmaceutical company dedicated to the development of programmed cellular immunotherapies for cancer, today announced the appointment of Yuan Xu, Ph.D., to its Board of Directors as an independent director. Dr. Xu brings to Fate Therapeutics over 25 years of discovery, development, manufacturing, and commercial experience in the global biopharmaceuticals business, most recently serving as the Chief Executive Officer and Board Member of Legend Biotech Corporation where she led the companys efforts in advancing ciltacabtagene autoleucel (cilta-cel) from proof-of-concept in 2018 to BLA preparation in 2020.

Yuan is an accomplished leader and innovator with extensive experience in guiding development and scaling manufacture of novel therapies, including CAR T-cell therapies such as cilta-cel, saidScott Wolchko, President and Chief Executive Officer ofFate Therapeutics. We are excited to work with Yuan, and we look forward to benefiting from her deep domain expertise as the Company advances its off-the-shelf, iPSC-derived NK and T-cell product candidates further into clinical development, transitions to large-scale manufacture, and establishes technical operations to support commercial approval.

Dr. Xu joined Legend Biotech Corporation in March 2018 as chief executive officer and as a director, playing a leading role in the companys IPO, clinical development of the autologous CAR T-cell therapy cilta-cel, and partnership with Janssen until her resignation in August 2020. Prior to Legend, Dr.Xu was Senior Vice President at Merck from August 2015 to August 2017, where she led discovery, preclinical and technical development, and manufacture of the Biologics & Vaccines subdivision. Dr. Xu was Vice President at Gilead from March 2014 to August 2015, where she led biologics and vaccines development and oversaw all operational aspects of the companys Oceanside manufacturing facility as Site Head, and was Vice President at Novartis from 2008 to 2014, where she led several functions in the U.S. and Europe including the biotherapeutics development unit focusing on innovative medicines such as engineered cell therapies, gene therapies, and antibody drug conjugates. Dr. Xu currently serves as an independent director on the board of directors of Akero Therapeutics, Inc. (Nasdaq: AKRO).

Fate Therapeutics has pioneered the field of iPSC-derived cell therapy, and has established a clear leadership position in the development of off-the-shelf NK and T-cell cancer immunotherapy with its robust clinical pipeline, novel iPSC product platform, and high-value strategic collaborations, said Dr. Xu. I look forward to working closely with the Companys board and management team as we move into late-stage clinical development, scale manufacture, and seek to make these innovative cancer medicines more broadly accessible to patients.

Early in her career, Dr. Xu held positions at Amgen, Chiron, GlaxoSmithKline and Genentech. Dr. Xu received a B.S. in biochemistry from Nanjing University and a Ph.D. in biochemistry from the University of Maryland, and she completed her post-doctoral training in virology and gene therapy at the University of California, San Diego.

About Fate Therapeutics iPSC Product PlatformThe Companys proprietary induced pluripotent stem cell (iPSC) product platform enables mass production of off-the-shelf, engineered, homogeneous cell products that are designed to be administered with multiple doses to deliver more effective pharmacologic activity, including in combination with other cancer treatments. Human iPSCs possess the unique dual properties of unlimited self-renewal and differentiation potential into all cell types of the body. The Companys first-of-kind approach involves engineering human iPSCs in a one-time genetic modification event and selecting a single engineered iPSC for maintenance as a clonal master iPSC line. Analogous to master cell lines used to manufacture biopharmaceutical drug products such as monoclonal antibodies, clonal master iPSC lines are a renewable source for manufacturing cell therapy products which are well-defined and uniform in composition, can be mass produced at significant scale in a cost-effective manner, and can be delivered off-the-shelf for patient treatment. As a result, the Companys platform is uniquely designed to overcome numerous limitations associated with the production of cell therapies using patient- or donor-sourced cells, which is logistically complex and expensive and is subject to batch-to-batch and cell-to-cell variability that can affect clinical safety and efficacy. Fate Therapeutics iPSC product platform is supported by an intellectual property portfolio of over 350 issued patents and 150 pending patent applications.

About Fate Therapeutics, Inc.Fate Therapeutics is a clinical-stage biopharmaceutical company dedicated to the development of first-in-class cellular immunotherapies for patients with cancer. The Company has established a leadership position in the clinical development and manufacture of universal, off-the-shelf cell products using its proprietary induced pluripotent stem cell (iPSC) product platform. The Companys immuno-oncology pipeline includes off-the-shelf, iPSC-derived natural killer (NK) cell and T-cell product candidates, which are designed to synergize with well-established cancer therapies, including immune checkpoint inhibitors and monoclonal antibodies, and to target tumor-associated antigens using chimeric antigen receptors (CARs). Fate Therapeutics is headquartered in San Diego, CA. For more information, please visit http://www.fatetherapeutics.com.

Forward-Looking StatementsThis release contains "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995 including statements regarding the advancement of, plans related to, and the therapeutic potential of the Company's product candidates, the Companys clinical development and manufacturing strategies, and the Companys plans for the clinical investigation and manufacture of its product candidates. These and any other forward-looking statements in this release are based on management's current expectations of future events and are subject to a number of risks and uncertainties that could cause actual results to differ materially and adversely from those set forth in or implied by such forward-looking statements. These risks and uncertainties include, but are not limited to, the risk that results observed in studies of its product candidates, including preclinical studies and clinical trials of any of its product candidates, will not be observed in ongoing or future studies involving these product candidates, the risk that the Company may cease or delay clinical development of any of its product candidates for a variety of reasons (including requirements that may be imposed by regulatory authorities on the initiation or conduct of clinical trials, the amount and type of data to be generated, or otherwise to support regulatory approval, difficulties or delays in subject enrollment and continuation in current and planned clinical trials, difficulties in manufacturing or supplying the Companys product candidates for clinical testing, and any adverse events or other negative results that may be observed during preclinical or clinical development), and the risk that its product candidates may not produce therapeutic benefits or may cause other unanticipated adverse effects. For a discussion of other risks and uncertainties, and other important factors, any of which could cause the Companys actual results to differ from those contained in the forward-looking statements, see the risks and uncertainties detailed in the Companys periodic filings with the Securities and Exchange Commission, including but not limited to the Companys most recently filed periodic report, and from time to time in the Companys press releases and other investor communications.Fate Therapeutics is providing the information in this release as of this date and does not undertake any obligation to update any forward-looking statements contained in this release as a result of new information, future events or otherwise.

Contact:Christina TartagliaStern Investor Relations, Inc.212.362.1200christina@sternir.com

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