T-cell lymphoma recurrent

Mission BioCapital and 4BIO Capital led the financing with significant participation from new and existing investors, raising over $51 million to date Funds will support Phase 2 development of March Bio’s lead CD5 CAR-T therapy, MB-105, for T-cell lymphoma and pipeline candidates HOUSTON, Oct. 23, 2024 (GLOBE NEWSWIRE) -- March Biosciences (March Bio), an emerging clinical stage biotechnology company committed to combating challenging cancers and other diseases, today announced the close of a $28.4 million oversubscribed Series A financing. Mission BioCapital and 4BIO Capital led the financing, with participation from KdT Ventures, Alexandria Venture Investments, Volnay Therapeutics, Modi Ventures, and Mansueto Investments. Existing investors TMC Venture Fund, Cancer Focus Fund, and Small Ventures also participated in the round. March Bio has raised over $51 million to date inclusive of all dilutive and non-dilutive funding. Since its inception as a spinout of the Center for Cell and Gene Therapy (Baylor College of Medicine, Houston Methodist Hospital, Texas Children’s Hospital), March Bio has rapidly advanced its innovative autologous chimeric antigen receptor T-cell (CAR-T) therapy, MB-105, in development for the treatment of relapsed and refractory CD5 positive T-cell lymphoma. MB-105 is specifically engineered to overcome major hurdles related to T-cell targeting by overcoming T-cell fratricide while maintaining high potency against CD5 positive tumor cells. MB-105 has demonstrated a favorable safety profile and durable remissions in relapsed T-cell lymphoma patients in a Phase 1 clinical trial at Baylor College of Medicine, with plans to begin a Phase 2 clinical trial in early 2025. Proceeds from the financing will support the Phase 2 clinical development of MB-105 to expand on this data with optimized manufacturing processes. “This oversubscribed financing enables us to advance our first-in-class CAR-T therapy, MB-105, into a Phase 2 trial for T-cell lymphoma – an indication with an exceptionally poor prognosis and few treatment options,” said Sarah Hein, Co-Founder and Chief Executive Officer of March Biosciences. “With the support and confidence of our investors, we are not only advancing our lead program but also expanding our pipeline, underscoring our commitment to delivering best-in-class therapies to patients that can change the treatment paradigm for these challenging cancers.” The new financing coincides with an announcement that the company has partnered with Volnay Therapeutics, a cell therapy venture studio led by a team of highly experienced cell therapy development veterans. March Biosciences will work with Volnay for technical oversight to develop a robust and scalable manufacturing process for MB-105 through clinical development and potential commercialization, a critical component of a successful autologous cell therapy program. Concurrent with the partnership announcement, Volnay Co-Founder and CEO Stefan Wildt, who held key R&D leadership positions in cell and gene therapy units at Novartis and Takeda, is joining March Bio’s Board of Directors. “For far too long, T-cell cancers have been an innovation desert with patients facing a dismal prognosis. March Bio’s innovative autologous CAR-T approach brings patients new hope,” said Owen Smith, Partner at 4BIO Capital. “MB-105 is specifically engineered for relapsed and refractory CD5 positive T-cell lymphomas and I am delighted that this targeted approach combined with the incredible team led by Sarah is moving rapidly into Phase 2 to bring this exciting new treatment to patients. We are honored to be a co-lead investor in March Bio and to help support the company as it continues in its mission to bring transformative therapies to those in urgent need.” “The team at March Biosciences is leveraging powerful science and promising clinical data to tackle cancers with significant unmet need,” said Cassidy Blundell, Partner at Mission BioCapital. “We're excited to support their journey and believe their focused approach with MB-105 could lead to significant breakthroughs in the CAR-T space.” Cassidy Blundell of Mission BioCapital and Owen Smith of 4BIO Capital are also joining March Bio’s Board of Directors. The financing will also provide resources for the ongoing development of undisclosed pipeline products, as well as for general corporate proceeds. 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 next early year. The company has raised over $50M to date, inclusive of this current financing and support from the Cancer Prevention & Research Institute of Texas (CPRIT) and the NIH SBIR program. Learn more at www.march.bio. About 4BIO Capital4BIO Capital (“4BIO”) is an international venture capital firm focused on investing in advanced therapies, including genomic medicines and other emerging technologies, to unlock the treatments of the future. 4BIO’s objective is to invest in, support, and grow early-stage companies developing treatments in areas of high unmet medical need, with the ultimate goal of ensuring access to these potentially curative therapies for all patients. Specifically, it looks for viable, high-quality opportunities in cell and gene therapy, RNA-based therapy, targeted therapies, and the microbiome. The 4BIO team comprises leading advanced therapy scientists and experienced life science investors who have collectively published over 250 scientific articles in prestigious academic journals including Nature, The Lancet, Cell, and the New England Journal of Medicine. 4BIO has both an unrivalled network within the advanced therapy sector and a unique understanding of the criteria that define a successful investment opportunity in this space. For more information, visit www.4biocapital.com. About Mission BioCapitalMission BioCapital is a biotech venture capital firm focused on making pivotal early-stage investments in life sciences companies. They support portfolio companies through a unique combination of shared lab space, capital investment, and access to strategic partners. With offices in the nation’s leading life sciences clusters in Cambridge, MA and San Francisco, Mission BioCapital is dedicated to helping entrepreneurial scientists build successful companies, from idea to exit. Learn more at missionbiocapital.com. About Volnay TherapeuticsVolnay Therapeutics is a biotech venture builder dedicated to accelerating the development of innovative cell and gene therapies. With decades of experience in drug development, Volnay identifies promising therapeutic assets and enabling technologies with disruptive potential and provides both capital and operational expertise to drive these ventures forward. By focusing on innovation in product manufacturing, commercial viability and capital efficiency, Volnay aims to deliver significant value to patients and investors alike. Visit www.volnaytx.com. Forward-Looking StatementThis press release contains forward-looking statements that involve risks and uncertainties, including those related to the clinical development of MB-105 and other potential therapies. 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 progress of clinical trials, regulatory approvals, market demand for new therapies, and competitive dynamics in the biotechnology sector. Contacts: Corporate:Sarah HeinChief Executive Officer sarah@march.bio Media:Jon YuMarchBioPR@icrhealthcare.com

A nimble Houston startup has raised a concise $28.4 million Series A to start a mid-stage trial. The company, named March Biosciences, will enter Phase 2 early next year with an autologous CAR-T cell therapy for relapsed and refractory CD5+ T cell lymphoma, it said Wednesday morning. CEO Sarah Hein told Endpoints News its total financing to date of $51 million won’t fully fund the upcoming Phase 2, which will take place at multiple sites in the US. The candidate, MB-105, went through a Phase 1 at Baylor College of Medicine and showed an overall response rate of 44% , with two complete responses, according to a publication in Blood in March. “The people who understand how difficult [T cell lymphoma] is understand that you typically just don’t see responders, much less long-term survivors. So that led to a lot of excitement,” Hein said. Mission BioCapital and 4BIO Capital led March’s Series A. Austin-based KdT Ventures also took part, as did Alexandria Venture Investments, Modi Ventures, Mansueto Investments, TMC Venture Fund, Cancer Focus Fund, Small Ventures and Volnay Therapeutics. Volnay is a stealth-stage cell therapy venture studio led by Stefan Wildt and Nebojsa Milovic. March said it will work with Volnay to create manufacturing processes for MB-105 for both clinical development and potential commercialization. Hein pointed out Wildt and Milovic’s work on helping launch Novartis’ cell therapy Kymriah and helping build the “cell engine at Takeda.” The four-employee startup operates out of Portal Innovations, a life sciences investor and lab operator. Hein declined to comment on the future path for its other pipeline programs, including CD7 autologous CAR-T MB-107, allogeneic multi-CAR MB-112 and MB-301, whose target is undisclosed. Hein co-founded the company in 2022 after helping recruit researchers to the cancer therapeutics accelerator at Texas Medical Center Innovation. Prior to that, she was VP of operations at another Houston cancer biotech called Courier Therapeutics, which was bought by Valo Health for up to $510 million in 2021, according to her LinkedIn bio. March traces back to chief scientific officer Maksim Mamonkin and Malcolm Brenner, a Baylor professor behind other CAR-T projects, including collaborations with Celgene and bluebird bio. Brenner was also involved in now-shuttered Singapore cell therapy company Tessa Therapeutics .

Soquelitinib is a potential first-in-class ITK inhibitor with broad potential in cancer and immune diseases There are currently no fully approved agents for the treatment of relapsed PTCL and soquelitinib has been granted Orphan Drug Designation and Fast Track Designation by the FDA Sept. 10, 2024 -- Corvus Pharmaceuticals, Inc. (NASDAQ: CRVS), a clinical-stage biopharmaceutical company, today announced that it has initiated a registrational Phase 3 clinical trial of soquelitinib for patients with relapsed/refractory peripheral T-cell lymphoma (PTCL). The clinical trial is a randomized, controlled study that will evaluate the efficacy and safety of soquelitinib compared to standard of care chemotherapy. "The initiation of the soquelitinib Phase 3 trial for relapsed PTCL is an important milestone for Corvus and for patients suffering with this disease," said Richard A. Miller, M.D., co-founder, president and chief executive officer of Corvus. "Soquelitinib has a unique mechanism of action based on selective ITK inhibition, which we believe has potential for the treatment of T cell lymphomas, as well as for solid tumors and a broad range of immune diseases.” The clinical trial (NCT06561048) is designed to enroll approximately 150 patients with relapsed/refractory PTCL who have failed one to three prior lines of therapy. Patients will be randomized in a 1:1 ratio to receive either 200mg dose of soquelitinib two-times a day or standard of care chemotherapy with either belinostat or pralatrexate. The primary endpoint of the clinical trial is progression-free survival and secondary endpoints include overall survival, objective response rate, and duration of response. The trial is expected to enroll patients at approximately 40 sites in the United States, Canada, Australia and South Korea. "We are excited to participate in this Phase 3 trial evaluating a new therapy for patients with relapsed/refractory PTCL," said Swaminathan P. Iyer, M.D., principal investigator of the study and Professor in the Department of Lymphoma and Myeloma at The University of Texas MD Anderson Cancer Center. "In earlier stage trials, soquelitinib has been well-tolerated and has demonstrated durable anti-tumor activity in patients with very advanced disease. Soquelitinib’s novel mechanism of action results in enhancement of the host anti-tumor response. In general, chemotherapy drugs have not produced lasting remissions and are sometimes associated with significant toxicity. There has been a scarcity of new ideas for the treatment of PTCL and we are eager to see if soquelitinib can offer these patients a more effective and safer treatment." Corvus Pharmaceuticals is a clinical-stage biopharmaceutical company pioneering the development of ITK inhibition as a new approach to immunotherapy for a broad range of cancer and immune diseases. The Company’s lead product candidate is soquelitinib, an investigational, oral, small molecule drug that selectively inhibits ITK. Its other clinical-stage candidates are being developed for a variety of cancer indications. For more information, visit www.corvuspharma.com. Peripheral T cell lymphoma (PTCL) is a heterogeneous group of malignancies accounting for about 10% of non-Hodgkin’s lymphomas (NHL) in western populations, reaching 20% to 25% of NHL in some parts of Asia and South America. The most common subtypes are PTCL-not otherwise specified (PTCL-NOS) and T follicular helper cell lymphoma. Initial therapy for these diseases is typically combination chemotherapy, however, approximately 75% of patients either do not respond or relapse within the first two years. Patients in relapse are treated with various chemotherapy agents but have poor overall outcomes with median progression-free survival in the 3 to 4 month range and overall median survival of 6 to 12 months. There are no approved drugs in relapsed PTCL based on randomized trials.PTCL is a disease of mature helper T cells that express ITK, often containing numerous genetic mutations and frequently associated with viral infection. Most often the malignant cells of PTCL express a Th2 phenotype. Soquelitinib (formerly CPI-818) is an investigational small molecule drug given orally designed to selectively inhibit ITK (interleukin-2-inducible T cell kinase), an enzyme that is expressed predominantly in T cells and plays a role in T cell and natural killer (NK) cell immune function. Based on interim results from a Phase 1/1b clinical trial in patients with refractory T cell lymphomas, which demonstrated tumor responses in very advanced, refractory, difficult to treat T cell malignancies, the Company has initiated a registrational Phase 3 clinical trial (NCT06561048) of soquelitinib in patients with relapsed PTCL. Soquelitinib is also now being investigated in a randomized placebo controlled phase 1 clinical trial in patients with atopic dermatitis. The immunologic effects of soquelitinib lead to what is known as Th1 skewing and inhibition of Th2 and Th17 cells. Research on soquelitinib’s mechanism of action suggests that it has the potential to control differentiation of normal T helper cells and enhance immune responses to tumors by augmenting the generation of cytotoxic killer T cells and the production of cytokines that inhibit cancer cell survival. Soquelitinib has also been shown to prevent T cell exhaustion, a major limitation of current immunotherapy and CAR-T therapies. Soquelitinib has been shown to affect T cell differentiation and induce the generation of Th1 helper cells while blocking the development of both Th2 and Th17 cells and production of their secreted cytokines. Th1 T cells are required for immunity to tumors, viral infections and other infectious diseases. Th2 and Th17 helper T cells are involved in the pathogenesis of many autoimmune and allergic diseases. The Company believes the inhibition of specific molecular targets in T cells may be of therapeutic benefit for patients with cancers, including solid tumors, and in patients with autoimmune and allergic diseases. The content above comes from the network. if any infringement, please contact us to modify.