CD5

Trial is evaluating VIPER-101, a novel, gene edited, autologous dual-population CAR-T therapy in patients with T cell lymphoma VIPER-101 was developed with Vittoria’s proprietary Senza5 platform that features CD5 modulation and a proprietary 5-day manufacturing process Dec. 19, 2024 -- Vittoria Biotherapeutics, Inc., a clinical-stage immunotherapy company specializing in the development of innovative cell therapies for hard-to-treat diseases, today announced that in November, the first patient was dosed in its Phase 1 clinical trial of VIPER-101. VIPER-101 is an enabled autologous cell therapy designed to treat relapsed and/or refractory (r/r) T cell lymphoma, a severe disease with limited treatment options. VIPER-101 incorporates Vittoria’s proprietary Senza5™ platform which integrates CD5 gene-editing technology with a rapid, 5-day manufacturing process to deliver a potent and targeted therapy for r/r T cell lymphoma. This innovative approach is intended to enhance the efficacy and safety profile of conventional autologous cell therapies, offering new hope to patients whose cancers have not responded to traditional lines of treatment. “This milestone represents a pivotal step forward in our mission to develop transformative therapies for patients with difficult-to-treat diseases,” said Nicholas Siciliano, Ph.D., Chief Executive Officer of Vittoria Biotherapeutics. "By addressing the key limitations of existing CAR-T therapies, VIPER-101 is uniquely engineered to enhance the potency, durability, and safety of treatment. We are eager to evaluate its therapeutic potential and look forward to generating meaningful data that could redefine the treatment paradigm for patients battling T cell lymphoma.” Marco Ruella, M.D., Scientific Founder of Vittoria Biotherapeutics and a Physician-Scientist in the Perelman School of Medicine at the University of Pennsylvania added, “Despite advances in cell therapy, patients with T cell lymphoma continue to have limited treatment options. Bringing this innovative approach into the clinic represents the culmination of years of dedicated research aimed at addressing the need for new treatment options for these patients.” The open-label Phase 1 study is designed to assess safety and preliminary efficacy, and to determine the recommended Phase 2 dose (RP2D) of VIPER-101 in patients with r/r CD5 positive nodal T cell non-Hodgkin lymphoma (NHL). The study is currently recruiting patients and additional information can be found at ClinicalTrials.gov (NCT06420089). The Company anticipates preliminary data from the trial in 2025. VIPER-101 is a gene-edited, autologous, dual-population cell therapy being evaluated as a potential treatment for patients with T cell lymphoma. VIPER-101 is designed to target CD5, which is present on cancer cells in more than 85% of patients with T cell lymphoma. VIPER-101 leverages the company’s proprietary Senza5 platform technology, which enhances T cell effector function by abrogating CD5-mediated immunosuppression through gene editing. In preclinical studies, VIPER-101 has shown superior efficacy compared to classical CD5-targeted CAR T. Senza5™ is a proprietary cell therapy engineering and manufacturing platform that combines the power of genetic engineering and a proprietary five-day manufacturing process to maximize stemness, durability, and efficacy of its produced cell therapies by disabling the CD5 signaling pathway on engineered CAR T cells and bypassing CD5's immunosuppressive effects to amplify the therapy’s antitumor activity. The expedited five-day manufacturing process further enhances stemness, which promotes greater in vivo expansion and durability and the potential for longer-lasting responses. Senza5 can be widely utilized to improve the efficacy of engineered T cell therapies by acting on the fundamental biology of T cells. Vittoria Biotherapeutics, Inc., a clinical-stage immunotherapy company, is developing novel CAR T cell therapies that transcend the limitations of current cell therapies. Based on technology exclusively licensed from the University of Pennsylvania, the Company’s proprietary Senza5™ platform unlocks the cytotoxic potential of engineered T cells and utilizes a five-day manufacturing process to maximize stemness, durability, and potency. By acting on the fundamental biology of T cells, Senza5 can be used to improve the efficacy of engineered T cell therapies with pipeline applications in solid tumors and autoimmune diseases. To learn more, visit vittoriabio.com and follow us on LinkedIn. Editor’s Note: Dr. Ruella is the scientific founder of, a paid consultant for, and an equity holder in, Vittoria Biotherapeutics. The University of Pennsylvania holds equity in ViTToria Biotherapeutics, has received sponsored research funding from Vittoria, has licensed certain intellectual property to Vittoria, and may receive future funding and financial consideration based on development and commercialization of certain products by Vittoria. The content above comes from the network. if any infringement, please contact us to modify.

Trial is evaluating VIPER-101, a novel, gene edited, autologous dual-population CAR-T therapy in patients with T cell lymphoma VIPER-101 was developed with Vittoria’s proprietary Senza5 platform that features CD5 modulation and a proprietary 5-day manufacturing process PHILADELPHIA, PA, USA I December 19, 2024 I Vittoria Biotherapeutics, Inc., a clinical-stage immunotherapy company specializing in the development of innovative cell therapies for hard-to-treat diseases, today announced that in November, the first patient was dosed in its Phase 1 clinical trial of VIPER-101. VIPER-101 is an enabled autologous cell therapy designed to treat relapsed and/or refractory (r/r) T cell lymphoma, a severe disease with limited treatment options. VIPER-101 incorporates Vittoria’s proprietary Senza5™ platform which integrates CD5 gene-editing technology with a rapid, 5-day manufacturing process to deliver a potent and targeted therapy for r/r T cell lymphoma. This innovative approach is intended to enhance the efficacy and safety profile of conventional autologous cell therapies, offering new hope to patients whose cancers have not responded to traditional lines of treatment. “This milestone represents a pivotal step forward in our mission to develop transformative therapies for patients with difficult-to-treat diseases,” said Nicholas Siciliano, Ph.D., Chief Executive Officer of Vittoria Biotherapeutics. “By addressing the key limitations of existing CAR-T therapies, VIPER-101 is uniquely engineered to enhance the potency, durability, and safety of treatment. We are eager to evaluate its therapeutic potential and look forward to generating meaningful data that could redefine the treatment paradigm for patients battling T cell lymphoma.” Marco Ruella, M.D., Scientific Founder of Vittoria Biotherapeutics and a Physician-Scientist in the Perelman School of Medicine at the University of Pennsylvania added, “Despite advances in cell therapy, patients with T cell lymphoma continue to have limited treatment options. Bringing this innovative approach into the clinic represents the culmination of years of dedicated research aimed at addressing the need for new treatment options for these patients.” The open-label Phase 1 study is designed to assess safety and preliminary efficacy, and to determine the recommended Phase 2 dose (RP2D) of VIPER-101 in patients with r/r CD5 positive nodal T cell non-Hodgkin lymphoma (NHL). The study is currently recruiting patients and additional information can be found at ClinicalTrials.gov ( NCT06420089 ). The Company anticipates preliminary data from the trial in 2025. About VIPER-101 VIPER-101 is a gene-edited, autologous, dual-population cell therapy being evaluated as a potential treatment for patients with T cell lymphoma. VIPER-101 is designed to target CD5, which is present on cancer cells in more than 85% of patients with T cell lymphoma. VIPER-101 leverages the company’s proprietary Senza5 platform technology, which enhances T cell effector function by abrogating CD5-mediated immunosuppression through gene editing. In preclinical studies, VIPER-101 has shown superior efficacy compared to classical CD5-targeted CAR T. About Senza5™ Senza5™ is a proprietary cell therapy engineering and manufacturing platform that combines the power of genetic engineering and a proprietary five-day manufacturing process to maximize stemness, durability, and efficacy of its produced cell therapies by disabling the CD5 signaling pathway on engineered CAR T cells and bypassing CD5’s immunosuppressive effects to amplify the therapy’s antitumor activity. The expedited five-day manufacturing process further enhances stemness, which promotes greater in vivo expansion and durability and the potential for longer-lasting responses. Senza5 can be widely utilized to improve the efficacy of engineered T cell therapies by acting on the fundamental biology of T cells. About Vittoria Biotherapeutics Vittoria Biotherapeutics, Inc., a clinical-stage immunotherapy company, is developing novel CAR T cell therapies that transcend the limitations of current cell therapies. Based on technology exclusively licensed from the University of Pennsylvania, the Company’s proprietary Senza5™ platform unlocks the cytotoxic potential of engineered T cells and utilizes a five-day manufacturing process to maximize stemness, durability, and potency. By acting on the fundamental biology of T cells, Senza5 can be used to improve the efficacy of engineered T cell therapies with pipeline applications in solid tumors and autoimmune diseases. To learn more, visit vittoriabio.com and follow us on LinkedIn . SOURCE: Vittoria Biotherapeutics

Cell and gene therapy veteran and Board member elected Chair following recent $28.4M Series A financing to advance Phase 2 development of lead CAR-T therapy for T-cell lymphoma and pipelineHOUSTON, Dec. 19, 2024 (GLOBE NEWSWIRE) -- March Biosciences (March Bio), an emerging clinical stage biotechnology company committed to combating challenging cancers and other diseases, today announced the election of Peter Olagunju as Chair of its Board of Directors. The election of Mr. Olagunju, who joined the company's board in August 2023, follows March Bio's recently closed $28.4 million Series A financing as it advances clinical development of MB-105, its lead CAR-T therapy candidate for relapsed and refractory CD5 positive T-cell lymphoma. “Peter's strategic vision and deep expertise in cell therapy development and manufacturing operations has been invaluable since he joined our board,” said Sarah Hein, Co-Founder and Chief Executive Officer of March Biosciences. “He becomes Board Chair at a pivotal time as we leverage our recent Series A funding to initiate a Phase 2 clinical trial for MB-105, expand our pipeline and strengthen our manufacturing capabilities. Peter's leadership will be crucial in helping us deliver this potentially transformative therapy to patients with limited treatment options.” Mr. Olagunju has over 20 years of experience in cell and gene therapy development and commercialization. He currently serves as CEO of Stealth Mode Biotech in Boston, a position he has held since May 2024. He previously served as Chief Operating Officer at TCR² Therapeutics and held executive leadership positions at FerGene and Bluebird Bio, playing an integral role in the development and commercialization of six FDA-approved cell and gene therapies. Through his consulting firm Olio, LLC, he has provided strategic and tactical support for cell and gene therapy companies in areas including corporate strategy, technical operations, and financing. “March Bio has made remarkable progress in advancing its innovative CD5 CAR-T platform technology, demonstrating promising clinical results in T-cell lymphoma patients with significant unmet needs,” said Mr. Olagunju. “Having spent my career developing and commercializing cell and gene therapies, I am excited about MB-105's potential to overcome the historical challenges of treating T-cell malignancies. I am honored to serve as Board Chair and work alongside the talented March Bio team as we focus on executing our Phase 2 clinical program and establishing a robust manufacturing process to support future commercialization.” March Bio's lead program, MB-105, is a first-in-class CD5-targeted CAR-T therapy in development for relapsed and refractory CD5-positive T-cell lymphoma. The company plans to initiate a Phase 2 clinical trial in early 2025 following encouraging safety and efficacy signals in the ongoing Phase 1 study at Baylor College of Medicine. About March BiosciencesHouston-based March Biosciences, launched from the Center for Cell and Gene Therapy (Baylor College of Medicine, Houston Methodist Hospital, Texas Children’s Hospital), is dedicated to addressing challenging cancers unresponsive to current immunotherapies. Its lead asset, MB-105, is a CD5-targeted CAR-T cell therapy currently in Phase 1 trials in patients with refractory T-cell lymphoma and leukemia, with promising signals of efficacy and safety to date. A Phase 2 trial is expected to begin in early 2025. The company has raised over $51 million to date, inclusive of venture financing, support from the Cancer Prevention & Research Institute of Texas (CPRIT), and the NIH SBIR program. Learn more at www.march.bio. Forward-Looking Statements This press release contains forward-looking statements that involve risks and uncertainties. Any statement describing March Biosciences’ goals, expectations, financial or other projections, intentions or beliefs is a forward-looking statement and should be considered an at-risk statement. Words such as “believes,” “expects,” “anticipates,” “could,” “should,” “would,” “seeks,” “aims,” “plans,” “potential,” “will,” “milestone” and similar expressions are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words. Actual results may differ materially from those projected in these forward-looking statements. Factors that could cause actual results to differ materially include, but are not limited to, the clinical development of MB-105, the progress of clinical trials for pipeline candidates, regulatory approvals, market demand for new therapies, competitive dynamics in the biotechnology sector, and macroeconomic conditions. Contacts: Corporate:Sarah HeinChief Executive Officersarah@march.bio Media: Jon YuMarchBioPR@icrhealthcare.com