Category Archives: Cell Therapy

Oncternal Therapeutics

SAN DIEGO, Oct. 03, 2022 (GLOBE NEWSWIRE) -- Oncternal Therapeutics, Inc. (Nasdaq: ONCT), a clinical-stage biopharmaceutical company focused on the development of novel oncology therapies, today announced the receipt of a Study May Proceed letter from the U.S. Food and Drug Administration (FDA), 30 days after submitting its Investigational New Drug (IND) application for a Phase 1/2 dose escalation study of ONCT-808, an autologous chimeric antigen receptor (CAR) T therapy targeting ROR1, in patients with aggressive B cell non-Hodgkins lymphoma (B NHL), including those who have failed previous CD19 CAR T treatment.

We are very pleased with the clearance of our IND application for our lead autologous CAR T product candidate, ONCT-808, said James Breitmeyer, M.D., Ph.D., Oncternals President and CEO. This will be our second clinical program focusing on the important ROR1 cancer target, following the initiation of our phase 3 study for our ROR1 antibody zilovertamab, announced last week. ROR1 is an exciting and promising target that is highly expressed in a wide range of cancers and is an ideal candidate for cell therapy applications due to its highly specific tumor expression, and association with tumor survival mechanisms. Our initial dose finding study will enroll patients with aggressive B NHL, including those that have failed prior CD19 therapy, which represent a significant unmet need in the market today. We expect to initiate the study in the coming months and to present interim results at a scientific conference in 2023.

About Oncternal TherapeuticsOncternal Therapeuticsis a clinical-stage biopharmaceutical company focused on the development of novel oncology therapies for the treatment of patients with cancers that have critical unmet medical need. Oncternal pursues drug development targeting promising, yet untapped biological pathways implicated in cancer generation or progression, focusing on hematological malignancies and prostate cancer. The lead clinical program iszilovertamab, an investigational monoclonal antibody designed to inhibit the function of Receptor Tyrosine Kinase-Like Orphan Receptor 1 (ROR1). ZILO-301, a global Phase 3 Study to evaluate zilovertamab in combination with ibrutinib for the treatment of patients with relapsed/refractory mantle cell lymphoma (MCL) has been initiated (NCT05431179). Zilovertamab continues to be evaluated in an ongoing Phase 1/2 study in combination with ibrutinib for the treatment of patients with MCL and chronic lymphocytic leukemia (CLL), and this trial was recently amended to include patients with marginal zone lymphoma (MZL). Zilovertamab is also being evaluated in two investigator-initiated studies, including a Phase 2 clinical trial of zilovertamab in combination with venetoclax, a Bcl-2 inhibitor, in patients with relapsed/refractory CLL, and in a Phase 1b study of zilovertamab in combination with docetaxel in patients with metastatic castration-resistant prostate cancer (mCRPC). Oncternal is also moving into the clinic with ONCT-808, an autologous chimeric antigen receptor T (CAR T) cell therapy that targets ROR1, with an active U.S. IND as of the end of September 2022 for the treatment of patients with relapsed or refractory aggressive B cell lymphoma, including patients who have failed previous CD19 CAR T treatment. The preclinical pipeline also includesONCT-534, a dual-action androgen receptor inhibitor (DAARI) that is undergoing final IND-enabling studies, as a potential treatment for castration resistant prostate cancer, including those with unmet medical need due to resistance to approved, standard of care androgen receptor inhibitors. More information is available athttps://oncternal.com/.

Forward Looking InformationOncternal cautions you that statements included in this press release that are not a description of historical facts are forward-looking statements. In some cases, you can identify forward-looking statements by terms such as may, will, should, expect, plan, anticipate, could, intend, target, project, contemplates, believes, estimates, predicts, potential or continue or the negatives of these terms or other similar expressions. These statements are based on Oncternals current beliefs and expectations. Forward-looking statements include statements regarding the expected timing of initiation and interim updates for Oncternals planned study of ONCT-808. Forward-looking statements are subject to risks and uncertainties inherent in Oncternals business, including risks associated with the clinical development and process for obtaining regulatory approval of Oncternals product candidates, such as potential delays in the commencement, enrollment and completion of clinical trials; we have not conducted head-to-head studies of zilovertamab in combination with ibrutinib compared to ibrutinib monotherapy and data from separate studies may not be directly comparable due to the differences in study protocols, conditions and patient populations; the risk that interim results of a clinical trial do not predict final results and that one or more of the clinical outcomes may materially change as patient enrollment continues, following more comprehensive reviews of the data, as follow-up on the outcome of any particular patient continues, and as more patient data become available; later developments with the FDA may be inconsistent with the minutes from the completed end of Phase 2 meeting, including that the proposed Study ZILO-301 that may not support registration of zilovertamab in combination with ibrutinib which is a review issue with the FDA upon submission of a BLA; and other risks described in Oncternals filings with theU.S. Securities and Exchange Commission. All forward-looking statements in this press release are current only as of the date hereof and, except as required by applicable law, Oncternal undertakes no obligation to revise or update any forward-looking statement, or to make any other forward-looking statements, whether as a result of new information, future events or otherwise. All forward-looking statements are qualified in their entirety by this cautionary statement. This caution is made under the safe harbor provisions of the Private Securities Litigation Reform Act of 1995.

Contact Information:

InvestorsRichard Vincent 858-434-1113rvincent@oncternal.com

MediaCorey Davis, Ph.D. LifeSci Advisors 212-915-2577 cdavis@lifesciadvisors.com

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Oncternal Therapeutics Receives IND Clearance for ONCT-808, its autologous CAR T Product Candidate Targeting ROR1 for the Treatment of Aggressive B...

CONTACTLetisia Marquez(626) 476-7593lemarquez@coh.org

LOS ANGELES City of Hope, one of the largest cancer research and treatment organizations in the United States, announced today a $15 million gift from City of Hope patient and cancer survivor Ted Schwartz that will be used entirely to further accelerate immunotherapy research and treatment innovations, such as the chimeric antigen receptor (CAR) T cell therapy that saved his life. Schwartz, who is now cancer free, achieved complete remission at City of Hope in 2020 with the centers leading CAR T cell therapy after a 16-year battle with lymphoma, provided the gift to City of Hope to advance treatment options that offer better outcomes and quality of life for people living with cancer.

Schwartz made the gift in honor of the team at City of Hope and his trusted physician and friend Steven Rosen, M.D., City of Hopes provost and chief scientific officer, and Morgan & Helen Chu Directors Chair of the Beckman Research Institute, who will direct the research funds with a core committee. City of Hope, a global leader in CAR T cell therapy, has built one of the most comprehensive CAR T clinical research programs in the world. The Schwartz family gift will be used to establish two funds at City of Hope: the Accelerator Fund for Immunotherapeutics to provide immediate support for City of Hopes immunotherapy teams and the Immunotherapeutics Research Endowment Fund, a planned gift to provide steady support for research teams to explore new potential therapies for decades to come.

In an expression of gratitude for the Schwartz gift, City of Hope is naming a planned 1.65-acre park in honor of the Schwartz family. The Ted Schwartz Family Hope and Healing Park will open in 2024 on City of Hopes Los Angeles campus and offer a peaceful space for patients and visitors. This garden will provide comfort, hope and inspiration to people who are battling cancer, and their families, Schwartz said, "as I understand clearly what they are experiencing. Schwartz continues to mentor and coach other patients receiving CAR T and other advanced treatments in an effort to extend hope.

The CAR T treatment I received at City of Hope is what finally helped me conquer lymphoma after a long 16-year battle, including multiple rounds of chemotherapy and radiation. Im an early beneficiary of advances in this exciting immunotherapy, and I want the research to progress so more people can experience remission sooner, Schwartz added. My family and I provide this gift in honor of my friend and physician, Dr. Rosen. Dr. Rosen and his colleagues at City of Hope, who treat every patient with the utmost dignity and care, continue to lead the way in advancing world-class CAR T and other advanced treatments, and help others avoid some of the hardships and side effects associated with some current treatments and experience longer-lasting remission.

City of Hope, a leader in blood cancer research and treatment and a pioneer of CAR T cell therapy, applies proprietary CAR T-cell technology across clinical and preclinical programs to address some of the hardest-to-treat cancers. City of Hope is conducting over 70 CAR T and other immune effector cell trials and to-date, approximately 1,000 patients have participated in those trials or have been treated with Food & Drug Administration-approved CAR T cell therapies. Due to City of Hopes longstanding expertise delivering CAR T therapy, most CAR T treatments currently administered at City of Hope are provided in an outpatient setting.

A century of leading-edge research centered around patients has positioned City of Hope at the forefront of groundbreaking discovery in CAR T cell therapy. We now have one of the largest CAR T cell programs in the world. CAR T treatment holds remarkable promise for so many patients, like Ted, who are battling difficult to treat cancers, Rosen said. The Schwartz familys gift will allow us to continue advancing promising immunotherapy research in our City of Hope labs and produce meaningful options for patients in need of more targeted lifesaving treatments.

Immunotherapy harnesses the power of patients own immune systems to recognize and fight cancer, often producing lasting results with fewer side effects compared to surgery, chemotherapy or radiation. CAR T cell therapy is a powerful form of immunotherapy. CAR T cell therapy works by taking immune cells from a patients bloodstream, reprogramming the cells to recognize and attack a specific protein found in cancer cells, then reintroducing them into the patients system, where they can destroy targeted tumor cells.

We are so appreciative of Teds commitment to accelerating the immunotherapeutics research at City of Hope so that more patients like Ted will benefit from our innovative work, said Elizabeth Budde, M.D., Ph.D., executive medical director, City of Hopes Enterprise Immune Effector Cell Therapy.

City of Hope is at the forefront of developing personalized treatments that create hope where it was not possible before, and Ted knows firsthand that cancer patients cannot afford to wait. Philanthropic partnerships play a crucial role in accelerating the development of novel cancer therapies and cures, said Kristin Bertell, chief philanthropy officer at City of Hope. We are so grateful to Ted and his family for their courage, resilience and incredible generosity to ensure lifesaving therapies are brought more quickly to patients who need them.

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City of Hope's mission is to deliver the cures of tomorrow to the people who need them today. Founded in 1913, City of Hope has grown into one of the largest cancer research and treatment organizations in the U.S. and one of the leading research centers for diabetes and other life-threatening illnesses. As an independent, National Cancer Institute-designated comprehensive cancer center, City of Hope brings a uniquely integrated model to patients, spanning cancer care, research and development, academics and training, and innovation initiatives. Research and technology developed at City of Hope has been the basis for numerous breakthrough cancer medicines, as well as human synthetic insulin and monoclonal antibodies. A leader in bone marrow transplantation and immunotherapy, such as CAR T cell therapy, City of Hopes personalized treatment protocols help advance cancer care throughout the world.

With a goal of expanding access to the latest discoveries and leading-edge care to more patients, families and communities, City of Hopes growing national system includes its main Los Angeles campus, a network of clinical care locations across Southern California, a new cancer center in Orange County, California and Cancer Treatment Centers of America. City of Hopes affiliated family of organizations includes Translational Genomics Research Institute and AccessHopeTM. For more information about City of Hope, follow us on Facebook, Twitter, YouTube, Instagram and LinkedIn.

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City of Hope To Accelerate Immunotherapy Research And Treatment Innovation with $15 Million Gift From Ted Schwartz Family - City of Hope

CARLSBAD, Calif.--(BUSINESS WIRE)--Lineage Cell Therapeutics, Inc. (NYSE American and TASE: LCTX), a clinical-stage biotechnology company developing allogeneic cell therapies for unmet medical needs, announced today the opening of a new research and development (R&D) facility in Carlsbad, California, and the expansion of its Good Manufacturing Practice (GMP) manufacturing facility based in Jerusalem, Israel. Lineages new Carlsbad facility will broaden the Companys R&D capabilities in the U.S. and support the development of current and future allogeneic cell transplant programs. The expansion of Lineages Israel-based facility will increase the Companys infrastructure, including development and optimization of larger-scale clinical manufacturing processes, and continued execution under its ongoing collaboration with Roche and Genentech for RG6501 (OpRegen), a retinal pigment epithelium cell replacement therapy which has completed enrollment in a Phase 1/2a clinical trial for the treatment of geographic atrophy (GA) secondary to age-related macular degeneration (AMD).

We have elected to increase our R&D footprint at our existing GMP manufacturing facility and establish a new R&D facility in Carlsbad, California, stated Brian M. Culley, Lineage CEO. These steps will permit us to expand our process development and analytical testing capabilities and conduct exploratory work on future programs, whether owned by us or our current or future partners. This move also is expected to reduce our reliance on certain vendors, which may reduce costs and risks of timeline uncertainty or supply chain disruption. The additional capacity also can help us become an even more capable partner in prospective alliances for new products and allow us to explore additional uses for our current cell transplant programs.

Mr. Culley added, Challenges in the biotech sector are unlikely to persist indefinitely. We believe it is important to take steps, even in this environment, to be positioned for a future recovery. The modest investments we are making today, partially offset by the termination of the lease for our research facility in Alameda, California in January of next year, will help centralize our operations and put us in a position of greater readiness for future success.

About Lineage Cell Therapeutics, Inc.

Lineage Cell Therapeutics is a clinical-stage biotechnology company developing novel cell therapies for unmet medical needs. Lineages programs are based on its robust proprietary cell-based therapy platform and associated in-house development and manufacturing capabilities. With this platform Lineage develops and manufactures specialized, terminally differentiated human cells from its pluripotent and progenitor cell starting materials. These differentiated cells are developed to either replace or support cells that are dysfunctional or absent due to degenerative disease or traumatic injury or administered as a means of helping the body mount an effective immune response to cancer. Lineages clinical programs are in markets with billion dollar opportunities and include five allogeneic (off-the-shelf) product candidates: (i) OpRegen, a retinal pigment epithelial cell therapy in development for the treatment of geographic atrophy secondary to age-related macular degeneration, is being developed under a worldwide collaboration with Roche and Genentech, a member of the Roche Group; (ii) OPC1, an oligodendrocyte progenitor cell therapy in Phase 1/2a development for the treatment of acute spinal cord injuries; (iii) VAC2, a dendritic cell therapy produced from Lineages VAC technology platform for immuno-oncology and infectious disease, currently in Phase 1 clinical development for the treatment of non-small cell lung cancer; (iv) ANP1, an auditory neuronal progenitor cell therapy for the potential treatment of auditory neuropathy; and (v) PNC1, a photoreceptor neural cell therapy for the treatment of vision loss due to photoreceptor dysfunction or damage. For more information, please visit http://www.lineagecell.com or follow the company on Twitter @LineageCell.

Forward-Looking Statements

Lineage cautions you that all statements, other than statements of historical facts, contained in this press release, are forward-looking statements. Forward-looking statements, in some cases, can be identified by terms such as believe, aim, may, will, estimate, continue, anticipate, design, intend, expect, could, can, plan, potential, predict, seek, should, would, contemplate, project, target, tend to, or the negative version of these words and similar expressions. Such statements include, but are not limited to, statements relating to: the potential benefits of the new and expanded facilities to the Company and its operations, including the broadening of the Companys R&D capabilities, increasing development and optimization of larger-scale clinical manufacturing processes, the expansion of the Companys process development and analytical testing capabilities and ability to conduct exploratory work on future programs, the increase in the Companys manufacturing facilities, the decreased reliance on certain vendors, the reduction in costs and risks of timeline uncertainty and supply chain disruption, and the improvement in the Companys position of greater readiness for future success. Forward-looking statements involve known and unknown risks, uncertainties and other factors that may cause Lineages actual results, performance or achievements to be materially different from future results, performance or achievements expressed or implied by the forward-looking statements in this press release, including, but not limited to, the following risks: that potential benefits of the new and expanded facilities to the Company and its operations may not be realized as quickly as expected or at all; that we may need to allocate our cash to unexpected events and expenses causing us to use our cash more quickly than expected; that positive findings in early clinical and/or nonclinical studies of a product candidate may not be predictive of success in subsequent clinical and/or nonclinical studies of that candidate; that competing alternative therapies may adversely impact the commercial potential of OpRegen; that Roche and Genentech may not successfully advance OpRegen or be successful in completing further clinical trials for OpRegen and/or obtaining regulatory approval for OpRegen in any particular jurisdiction; that we may not establish new partnerships or expand existing collaborations; that we do not successfully broaden awareness of our mission or accomplishments; that Lineage may not be able to manufacture sufficient clinical quantities of its product candidates in accordance with current good manufacturing practice; and those risks and uncertainties inherent in Lineages business and other risks discussed in Lineages filings with the Securities and Exchange Commission (SEC). Lineages forward-looking statements are based upon its current expectations and involve assumptions that may never materialize or may prove to be incorrect. All forward-looking statements are expressly qualified in their entirety by these cautionary statements. Further information regarding these and other risks is included under the heading Risk Factors in Lineages periodic reports with the SEC, including Lineages most recent Annual Report on Form 10-K and Quarterly Report on Form 10-Q filed with the SEC and its other reports, which are available from the SECs website. You are cautioned not to place undue reliance on forward-looking statements, which speak only as of the date on which they were made. Lineage undertakes no obligation to update such statements to reflect events that occur or circumstances that exist after the date on which they were made, except as required by law.

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Lineage Establishes New R&D Facility in U.S. and Expands Current GMP Manufacturing Facility in Israel - Business Wire

Century Therapeutics, Inc.

PHILADELPHIA, Oct. 03, 2022 (GLOBE NEWSWIRE) -- Century Therapeutics (NASDAQ: IPSC), an innovative biotechnology company developing induced pluripotent stem cell (iPSC)-derived cell therapies in immuno-oncology, today announced the appointment of Daphne Quimi and Timothy Walbert to the Companys Board of Directors. Ms. Quimi is currently Chief Financial Officer of Amicus Therapeutics and brings experience in public accounting and financial reporting to Century. Mr. Walbert is currently Chairman, President, and Chief Executive Officer of Horizon Therapeutics, and brings expertise in product portfolio building and commercialization. In conjunction with these new appointments, Century also announced that Eli Casdin, Chief Investment Officer of Casdin Capital, has resigned from the Board of Directors, effective as of October 1, 2022.

I am thrilled to welcome both Daphne and Tim to our Board. They will each play critical roles as we accelerate our next-generation cell therapy platform, said Lalo Flores, Ph.D., Chief Executive Officer, Century Therapeutics. Daphnes strong financial background and experience at both biotechnology and large pharmaceutical companies will be a tremendous asset as we enter the next transformative years for Century. Tims background, which includes numerous product launches, will be instrumental to our continued evolution, particularly as we progress our pipeline candidates with the ultimate goal of delivering innovative cancer therapies. Additionally, on behalf of the management, Board and all of our employees, we would like to thank Eli for his contributions to Centurys rapid growth and his leadership in our early formative years, where he was a key strategic thought partner.

Before serving as Amicuss Chief Financial officer, Ms. Quimi was Amicuss Senior Vice President, Finance and Corporate Controller. Ms. Quimi is currently a member of the Board of Directors at Amylyx Pharmaceuticals. Prior to Amicus, Ms. Quimi served as Director of Consolidations and External Reporting at Bristol-Myers Squibb. She also held roles of increasing responsibility in the finance department at Johnson & Johnson. Earlier in her career she worked for KPMG. Ms. Quimi received a B.S. in Accountancy from Monmouth University and an M.B.A from the Stern School of Business of New York University.

In addition to his current role of President and Chief Executive Officer of Horizon Therapeutics, Mr. Walbert has served as Chairman of Horizons Board of Directors since 2010. Before joining Horizon, Mr. Walbert served as President, Chief Executive Officer and Director of IDM Pharma Inc., and also held prior senior roles at NeoPharm Inc., Abbott (AbbVie), G.D. Searle & Company, Merck & Co. Inc. and Wyeth. Mr. Walbert received a B.A. in Business from Muhlenberg College.

About Century Therapeutics

Century Therapeutics (NASDAQ: IPSC) is harnessing the power of adult stem cells to develop curative cell therapy products for cancer that we believe will allow us to overcome the limitations of first-generation cell therapies. Our genetically engineered, iPSC-derived iNK and iT cell product candidates are designed to specifically target hematologic and solid tumor cancers. We are leveraging our expertise in cellular reprogramming, genetic engineering, and manufacturing to develop therapies with the potential to overcome many of the challenges inherent to cell therapy and provide a significant advantage over existing cell therapy technologies. We believe our commitment to developing off-the-shelf cell therapies will expand patient access and provide an unparalleled opportunity to advance the course of cancer care. For more information on Century Therapeutics please visit http://www.centurytx.com.

Century Therapeutics Forward-Looking Statement

This press release contains forward-looking statements within the meaning of, and made pursuant to the safe harbor provisions of, The Private Securities Litigation Reform Act of 1995. In some cases, you can identify forward-looking statements by terms such as may, might, will, should, expect, plan, aim, seek, anticipate, could, intend, target, project, contemplate, believe, estimate, predict, forecast, potential or continue or the negative of these terms or other similar expressions. These statements are not guarantees of future performance These risks and uncertainties are described more fully in the Risk Factors section of our most recent filings with the Securities and Exchange Commission and available at http://www.sec.gov. You should not rely on these forward-looking statements as predictions of future events. The events and circumstances reflected in our forward-looking statements may not be achieved or occur, and actual results could differ materially from those projected in the forward-looking statements. Except as required by applicable law, we do not plan to publicly update or revise any forward-looking statements contained herein, whether as a result of any new information, future events, changed circumstances or otherwise.

For More Information:

Company: Elizabeth Krutoholow investor.relations@centurytx.com

Investors: Melissa Forst/Maghan Meyers century@argotpartners.com

Media: Joshua R. Mansbach century@argotpartners.com

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Century Therapeutics Announces Appointment of Daphne Quimi and Timothy Walbert to its Board of Directors - Yahoo Finance

WATERTOWN, Mass.--(BUSINESS WIRE)--SQZ Biotechnologies Company (NYSE: SQZ), focused on unlocking the full potential of cell therapies for multiple therapeutic areas, today announced the publication of preclinical research on the SQZ Activating Antigen Carrier (AAC) platform. The data, published in Frontiers in Immunology, demonstrated that the companys Cell Squeeze platform can be used to generate AACs by engineering red blood cells (RBCs) with antigen and adjuvant that can drive antigen-specific activation of T cells both in mouse in vivo and human in vitro systems. The study also used a mouse tumor model to show that the efficacy of the AAC therapy could be further enhanced by combining with the chemotherapeutic agent, Cisplatin.

This paper demonstrates the potential of our technology to generate an effective red blood cell-derived cancer immunotherapy, said Howard Bernstein, M.D., Ph.D., Chief Scientific Officer at SQZ Biotechnologies. The ability of the Cell Squeeze platform to engineer RBCs to leverage the natural process of RBC clearance for T cell activation represents a promising new therapeutic approach to cancer treatment. We look forward to building on these preclinical results in our ongoing Phase 1/2 clinical trial.

The companys engineered RBCs are designed to transport their cargo of antigen and adjuvant to professional antigen presenting cells (APCs) in the body. The published data demonstrate that when these professional APCs process the engineered RBC, they present the desired antigen to endogenous T cells and drive their activation. This approach to generate RBC therapeutics could be tailored to deliver a variety of antigen and adjuvant materials, and other possible agents, to potentially enhance different aspects of anti-tumor immunity.

We are excited about the preclinical findings of our AAC program, which has shown potential in both monotherapy settings and in combination with chemotherapy, said Scott Loughhead, Ph.D., VP of Translational Research at SQZ Biotechnologies. AACs represent a truly differentiated approach that offers the opportunity for broad applicability across solid tumor types.

Study Findings:

About SQZ-AAC-HPVSQZ AACs are generated by squeezing red blood cells (RBCs) with antigens and activating adjuvant. The process is tuned to make the engineered RBCs appear aged. Once administered to patients, SQZ AACs aim to be rapidly taken up by professional antigen presenting cells through a natural process to destroy aged RBCs in the body known as eryptosis. After being taken up, the encapsulated antigen and adjuvant within SQZ AACs is released, allowing for antigen processing and maturation of professional, endogenous antigen presenting cells in the lymphoid organs, and drives subsequent activation of HPV-specific T cells. SQZ-AAC-HPV is the first product candidate from the SQZ AAC platform.

About Human Papillomavirus Positive CancersHuman papillomavirus (HPV) is one of the most common viruses worldwide and certain strains persist for many years, often leading to cancer. According to the Centers for Disease Control (CDC), in the United States HPV+ tumors represent 3% of all cancers in women and 2% of all cancers in men, resulting in over 39,000 new cases of HPV+ tumors every year. HPV infection is larger outside of the U.S., and according to the International Journal of Cancer, HPV+ tumors account for 4.5% of all cancers worldwide resulting in approximately 630,000 new cases every year. According to the CDC, HPV infection plays a significant role in the formation of more than 90% of anal and cervical cancers, and most cases of vaginal (75%), oropharyngeal (70%), vulval (70%) and penile (60%) cancers.

About SQZ BiotechnologiesSQZ Biotechnologies is a clinical-stage biotechnology company focused on unlocking the full potential of cell therapies to benefit patients with cancer, autoimmune and infectious diseases. The companys proprietary Cell Squeeze technology offers the unique ability to deliver multiple biological materials into many patient cell types to engineer what we believe can be a broad range of potential therapeutics. Our goal is to create well-tolerated cell therapies that can provide therapeutic benefit for patients and improve the patient experience over existing cell therapy approaches. With accelerated production timelines under 24 hours and the opportunity to eliminate preconditioning and lengthy hospital stays, our approach could change the way people think about cell therapies. The companys first therapeutic applications seek to generate target-specific immune responses, both in immune activation for the treatment of solid tumors and in immune tolerance for the treatment of unwanted immune reactions and autoimmune diseases. For more information, please visit http://www.sqzbiotech.com.

Forward Looking StatementThis press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. All statements contained that do not relate to matters of historical fact should be considered forward-looking statements, including without limitation statements relating to events and presentations, platform and clinical development, product candidates, preclinical and clinical activities, progress and outcomes, development plans, clinical safety and efficacy results, and therapeutic potential. These forward-looking statements are based on management's current expectations. Actual results could differ from those projected in any forward-looking statements due to several risk factors. Such factors include, among others, risks and uncertainties related to our limited operating history; our significant losses incurred since inception and expectation to incur significant additional losses for the foreseeable future; the development of our initial product candidates, upon which our business is highly dependent; the impact of the COVID-19 pandemic on our operations and clinical activities; our need for additional funding and our cash runway; the lengthy, expensive, and uncertain process of clinical drug development, including uncertain outcomes of clinical trials and potential delays in regulatory approval; our ability to maintain our relationships with our third party vendors; and protection of our proprietary technology, intellectual property portfolio and the confidentiality of our trade secrets. These and other important factors discussed under the caption "Risk Factors" in our Annual Report on Form 10-K and other filings with the U.S. Securities and Exchange Commission could cause actual results to differ materially from those indicated by the forward-looking statements. Any forward-looking statements represent management's estimates as of this date and SQZ undertakes no duty to update these forward-looking statements, whether as a result of new information, the occurrence of current events, or otherwise, unless required by law.

Certain information contained in this press release relates to or is based on studies, publications, surveys and other data obtained from third-party sources and our own internal estimates and research. While we believe these third-party sources to be reliable as of the date of this press release, we have not independently verified, and we make no representation as to the adequacy, fairness, accuracy, or completeness of any information obtained from third-party sources.

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SQZ Biotechnologies Publishes Preclinical Research Demonstrating SQZ AAC Platform's Potential as an Effective Red Blood Cell-Derived Immunotherapy -...

Dennis James roundtables on The Menace Podcast have features some serious star power, but none may be bigger than the eight-time Mr. Olympia, Ronnie Coleman, who joined DJ, Milos Sarcev, and Chris Cormier on the Sept. 25 episode.

In the beginning of the discussion, James asked Coleman about his stem cell treatments. After numerous surgeries, Coleman had been dealing with a lot of pain. However, his treatments had made a huge difference in the right way. He told the panel that pain is no longer an issue.

I have to keep going, though, thats the only thing. Ive had five treatments so far, Coleman said. They have cut my pain medications in half.

James eventually brought up the 2022 Mr. Olympia, and mentioned that when Coleman made predictions about contests, he was usually right. When asked about new talent coming in and placing high, Coleman predicted that the top three will remain the same as it did in 2021, referencing defending two-time winner Big Ramy, 2019 winner Brandon Curry, and 2021 Peoples Champion Hadi Choopan.

I see the same guys in the same top three, Coleman prophesized. Andrew [Jacked], Nick, and maybe the 212 guy, [Derek] Lunsford, can crack the top five. I dont see any of them making it in the top three, though.

James also suggested that some people feel this years Olympia may be the best ever. The eight-time Mr. Olympia agreed with Sarcev that 1999 may go down as the most memorable contest ever.

Me, Flex [Wheeler], Kevin [Levrone}, Chris [Cormier], and Nasser [El Sonbaty] were there, and everybody was in good shape and good condition back then.

The panel also discussed Colemans career in detail going back to his amateur days, his frequent traveling and popularity in spite of not competing in 15 years, and much more. Subscribe to the Muscle & Fitness YouTube channel to see this episode of TMP in its entirety, and subscribe so you can see more episodes as well as other great content. New episodes of TMP drop every Sunday at 3 PM Eastern time.

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Ronnie Coleman Says He's Nearly Pain Free Thanks to Stem Cell Therapy - Muscle & Fitness

PlasmidFactory is the second investment of ArchiMeds MED Platform II, which began fundraising in January

Trans-Atlantic private equity healthcare specialist ArchiMed has invested in Bielefeld, Germany-based PlasmidFactory. Founded in 2000, PlasmidFactory is the leading contract manufacturer and service provider for plasmid and minicircle DNA.

PlasmidFactory develops and manufactures exceptionally high-grade plasmids and minicircles, used to modify cells and produce viral gene therapy vectors like AAV, LV and mRNA for combating everything from viruses like COVID-19 to seemingly intractable diseases like cancer, cystic fibrosis, heart disease, diabetes, hemophilia and AIDs (including CAR-T cell applications). Plasmids are notably a key component for the production of mRNA COVID-19 vaccines.

PlasmidFactory is the second buy-and-build investment of ArchiMeds MED Platform II fund, which began fundraising in January. The fund currently exceeds in size its predecessor fund, the fully-invested, 1.5 billion MED Platform I fund. A final target size for MED Platform II has not been disclosed.

PlasmidFactory has seen its revenues grow an average of 100 percent annually since 2019. The company opened a new HQ (High Quality) production facility in May, 2022 that generates exceptionally pure, cutting-edge plasmids. With the investment and support of ArchiMed, PlasmidFactory will shortly fund the construction of an even larger GMP (Good Manufacturing Practices) compliant facility.

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ArchiMed invests in PlasmidFactory, a German gene and cell therapy specialist - BSA bureau

Personalized treatment for advanced melanoma using tumor-infiltrating lymphocytes (TILs)T cells with a proven ability to recognize and fight cancerreduced the risk of disease progression or death compared with checkpoint inhibitor immunotherapy, according to research presented at the European Society for Medical Oncology (ESMO) Congress 2022.

This study shows for the first time in a randomized, controlled trial that cell therapy can be efficacious and beneficial for patients with solid cancers, lead investigator John Haanen, MD, of the Netherlands Cancer Institute in Amsterdam, said in an ESMO press release. For patients with melanoma, we see a 50% reduction in the chance of progression of the disease or dying from the disease, which is absolutely practice changing.

Melanoma is among the malignancies most susceptible to immunotherapy, treatment that helps the immune system fight cancer. Standard therapy for advanced melanoma may include the PD-1 checkpoint inhibitors Keytruda (pembrolizumab) or Opdivo (nivolumab), which restore T-cell activity against cancer cells, or the CTLA-4 inhibitor Yervoy (ipilimumab), which promotes T-cell proliferation.

Tumor-infiltrating lymphocyte therapy is a customized treatment that involves collecting T cells from a patients tumor sample, multiplying them in a laboratory and reinfusing the expanded cells back into the body. TIL therapy is not newit was developed at the National Cancer Institute in the 1980sbut while some patients had very good outcomes, the side effects could be severe, and it took a backseat to checkpoint inhibitor immunotherapy.

The Phase III M14TIL trial compared TIL therapy versus Yervoy in 168 adults with previously treated unresectable (inoperable) Stage IIIC to Stage IV melanoma, nearly 90% of whom had progressed despite treatment with a PD-1 inhibitor. This is the first randomized, controlled trial to compare TIL therapy against a checkpoint inhibitor.

[Checkpoint inhibitors] have a very good safety profile and quite high efficacy and are now often given as first-line therapy, Haanen said. But if patients fail first-line treatments, then the options become very scarce, particularly for patients failing anti-PD-1 drugs, so there is a real unmet need.

The participants were randomly assigned to receive a single round of TIL therapy or up to four doses of Yervoy administered by IV infusion every three weeks. Those assigned to the TIL group were hospitalized and underwent strong chemotherapy to reduce the number of existing lymphocytes and make room for the new ones. After the cell infusion, they received high doses of interleukin-2, a cytokine that stimulates T-cell growth and activity.

People treated with TIL therapy had significantly longer progression-free survival (PFS), meaning they were still alive without disease progression. The median PFS time was 7.2 months with TIL therapy versus 3.1 months with Yervoy, and the PFS rates at six months were 53% versus 21%, respectively. Overall survival also appeared to be longer in the TIL group (25.8 months versus 18.9 months), but follow-up is ongoing. The overall response rate, or tumor shrinkage, was more than twice as high in the TIL group (49% versus 21%), and the complete response rate, or full remission, was nearly three times as high (20% versus 7%).

TIL treatment was generally safe, but side effects were common. Everyone who received TIL therapy and 57% of those treated with Yervoy experienced Grade 3 or higher adverse events. Common side effects included white blood cell and platelet deficiencies, which can lead to infections and excessive bleeding. Most of the adverse events were attributable to the accompanying chemotherapy or interleukin-2 rather than the TILs themselves. However, Haanen noted, these side effects are well manageable and most resolve by the time patients leave the hospital after their TIL therapy.

Speculating about why TIL therapy is effective after PD-1 checkpoint inhibitors have stopped working, Haanen said, We think that the mechanism of resistance to anti-PD-1 treatment is mostly delivered by the tumor microenvironment. So when we take these cells out of their natural environment, reactivate them in the laboratory, grow them up to very large numbers and give them back to the patients, we can overcome some of the escape mechanisms.

Haanen added that TIL therapy has the potential to work against a wide variety of solid tumors, and clinical trials are currently underway for people with many malignancies, including lung, cervical and head and neck cancers.

However, the process is labor-intensive and expensive, which could limit its commercial potential. This study was conducted by academic researchers in the Netherlands and Denmark without pharmaceutical industry involvement. The Netherlands government has agreed to use TIL therapy, and the researchers are seeking approval from the European Medicines Agency. In the United States, the Food and Drug Administration has strict requirements for cell-based therapies, and it may be difficult to win approval without industry support for specific products. That was the path taken by CAR-T therapy, which modifies a patients T cells to make them better cancer fighters rather than relying on naturally occurring immune cells.

Click here to read the study abstract.Click here formore reports from ESMO 2022.Click here to learn more about immunotherapy for cancer.

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T-Cell Therapy Delays Disease Progression for People With Advanced Melanoma - Cancer Health Treatment News

Osteoarthritis (OA) is a slowly progressive joint disease that is a major cause of disability and pain among the elderly, second only to cardiovascular disease. The OA space is characterised by a high level of unmet clinical need driven by the limited effectiveness of currently available analgesics and the lack of disease-modifying OA drugs (DMOADs). The current standards of care (SOCs) in OA focus on symptom management and are made up of generic pharmaceuticals, including nonsteroidal anti-inflammatory drugs (NSAIDs), opioids, antidepressants, and intra-articular injections. As such, key opinion leaders (KOLs) interviewed by GlobalData strongly believe that the development of DMOADs is the greatest current unmet need in the OA space.

Increased research into OA over the past decade has led to the identification of new targets, and this progress is reflected in the current OA pipeline. Cell-based therapies have the potential to address this unmet need within the OA space to some degree. Within the OA late-stage pipeline, there are two cell-based therapies that GlobalData believes have significant clinical and commercial potential. These are TissueGenes Invossa and Organogenesis Holdings ReNu, both of which have shown disease-modifying efficacy in clinical trials. Invossa has demonstrated the efficacy and safety of a single shot for up to three years, as outlined by Lew in a 2019 study published in Osteoarthritis and Cartilage (NCT03383471). Similarly, ReNu also showed positive efficacy and safety for up to 12 months from a single intra-articular injection (NCT02318511, NCT03063099).

Commercially, these therapies have the potential to be first-in-class DMOADs and to establish a novel paradigm in OA treatment and management. According to GlobalDatas primary research, while GlobalData initially expects a slow uptake for such cell-based therapies due to their high price, as they will require some time to prove their cost-effectiveness, the uptake is likely to improve following the initial lag period as physicians become accustomed to the therapy and as their cost-effectiveness becomes more apparent. Furthermore, the high price associated with these biologics may lead to reimbursement barriers in the genericised OA market, especially in the five major European markets (5EU: France, Germany, Italy, Spain and the UK), where a greater emphasis is placed on drug pricing and cost-effectiveness compared with the US.

However, even with the entry of cell therapies to the market, the unmet need for improved analgesics will likely continue to be largely unfulfilled, and an abundance of opportunities for the development of novel analgesics and additional DMOADs will remain. OA is considered to be a heterogeneous disease with a complicated pathophysiology and unclear aetiology. As such, distinct OA patient populations exist, and therapies targeting these subgroups are needed. Moreover, OA is most prevalent in elderly patients who often have other comorbid conditions, such as diabetes or hypertension, but the currently available treatment modalities for OA are often contraindicated in these patients. Therefore, one of the remaining unmet needs in this disease area is for therapies that address OA and are appropriate to use despite the comorbidities an elderly patient may have.

Overall, considering the novel analgesics and DMOADs in the OA pipeline, GlobalData expects the OA treatment algorithm to change significantly in the future, with cell therapies garnering significant market share during the next decade.

Cell & Gene Therapy coverage on Pharmaceutical Technology is supported by Cytiva.

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Cell-based therapies set to become major players in the osteoarthritis market - Pharmaceutical Technology

Boasting an outstanding safety record, lentiviral vectors (LVV) are key components in CAR-T cell therapy manufacturing. Unfortunately, owing to the lack of a robust and scalable production platform, therapy providers too often experience highly variable quality, inconsistent yields, and poor recoveries, leading to severe disruptions in the supply chain, said the partners.

By combining Cellares automation and robotics technology with iVexSols viral vector expertise, the two entities aim to develop consistent, high-quality solutions for viral vector manufacturing to improve access to this critical reagent.

iVexSol will supply Cellares with high-quality LVV to support the development of its automated, closed, end-to-end cell therapy manufacturing platform, the Cell Shuttle with an eye on leveraging that technology to automate the entire manufacturing process, including vector production.

While Cellares primary focus has always been cell therapy manufacturing, it said it intentionally developed its Cell Shuttle in a manner that provides flexibility in the processes and technologies that it can support. The platform can be easily adjusted to different customer processing needs and supports a variety of cell therapy modalities.

That company's CEO, Fabian Gerlinghaus, told BioPharma-Reporter: "Both Cellares and iVexSol are focused on creating access to cell therapies. In addition to the actual cell therapy manufacturing bottleneck, we also need to solve the viral vector manufacturing bottleneck. We're working with iVexSol to explore how our automated and flexible bioprocessing technologies can be leveraged to create optimized solutions for viral vector manufacturing. This is a natural fit for our technology since the flexibility to support different bioprocessing workflows has been a central pillar of our architecture from the beginning."

Financial terms of the agreement have not been disclosed.

We spoke to Gerlinghaus back in May where he outlined why automation is key to making cell therapy manufacturing a viable industry.

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Solving CAR-T's viral vector problem: Cellares and iVexSol team up to streamline manufacturing - BioPharma-Reporter.com