A2 Biotherapeutics, Inc.

A2 Bio has two ongoing Phase I/II clinical trials investigating two of its CAR-T programmes. Credit: THOMAS COEX via Getty Images. US-based biotech company A2 Biotherapeutics (A2 Bio) has secured $80m in funding to advance its pipeline of chimeric antigen receptor (CAR)-T cell therapies for solid tumour cancers. The Series C financing, backed by investors such as The Column Group and Samsara BioCapital, will support the company’s three clinical programmes and further development of its proprietary Imod platform technology. CAR-T cell therapies have demonstrated significant success in treating blood cancers, with several approved therapies on the market. However, developing effective CAR-T treatments for solid tumours has been far more challenging. A2 Bio aims to address these difficulties with its logic-gated cell therapies, designed to target cancer cells while sparing healthy tissue. This approach uses two receptors: an activator that identifies tumour-specific antigens and a blocker that binds to antigens on normal cells, preventing unintended damage. The company is conducting two Phase I/II clinical trials under its EVEREST programme. EVEREST-1 (NCT05736731) evaluates A2B530, targeting carcinoembryonic antigen (CEA) for pancreatic, lung, and colorectal cancers. Both programmes utilise the BASECAMP-1 pre-screening study, which incorporates AI to identify eligible patients efficiently. In March 2024, A2 Bio received the US Food and Drug Administration’s (FDA) orphan drug designation for A2B530 to treat colorectal cancer. This status brings development incentives for the company, including tax credits for clinical trial costs, prescription drug user fee exemptions and the possibility of up to seven years of market exclusivity upon regulatory approval. Meanwhile, EVEREST-2 (NCT06051695) focuses on A2B694, targeting mesothelin (MSLN) for pancreatic, ovarian, lung, colorectal, and mesothelioma cancers, with up to 230 patients set to be enrolled. A third CAR-T program, with an undisclosed target, is expected to begin this quarter. Unlike the first two programmes with autologous therapies – using a patient’s cells for therapy – the third programme is developing an “off-the-shelf” therapy using donor cells – known as allogeneic. This approach aims to overcome the scalability and manufacturing challenges associated with autologous CAR-T therapies. The company’s Imod platform underpins A2 Bio’s cell therapy strategy. The Tmod platform’s dual-receptor design, comprising an activator that targets tumour cells and a blocker for normal cells, addresses the issue with other solid tumour cancer treatments. It acts by selectively targeting tumour cells while sparing healthy ones. This novel approach is designed to address a critical limitation of existing CAR-T therapies, particularly in solid tumours, which require more nuanced differentiation from normal tissues. Free Whitepaper Optimise your cell therapy process: a guide to cell thawing Typically carried out at the point of care, errors in cell therapy thawing could compromise treatment efficacy, leading to significant patient impact as well as high costs and a compromised reputation for the product’s developer. This guide addresses how cell thawing has historically developed into the new techniques used today, along with the physical and biological implications of key metrics and components such as warming rate and ice structure. Also included are reviews of key studies from scientific literature and a consideration of the interactions between cooling and warming rates, as applicable to cell and gene therapies. Thank you. You will receive an email shortly. Please check your inbox to download the Whitepaper. By Cytiva Thematic By downloading this Whitepaper, you acknowledge that GlobalData may share your information with Cytiva Thematic and that your personal data will be used as described in their Privacy Policy

AGOURA HILLS, Calif.--( BUSINESS WIRE )--A2 Biotherapeutics, Inc. (A2 Bio), a clinical-stage cell therapy company developing first-in-class logic-gated cell therapies to selectively target tumor cells and protect normal cells, today announced the closing of its $80 million Series C financing round, supported by a syndicate of investors that includes The Column Group and Samsara BioCapital. Proceeds will fund the company’s three clinical development programs and advancement of its pipeline of CAR-T cell therapies based on its proprietary Tmod™ platform technology. “ We are excited by the initial clinical data from our lead programs, which we believe validates our proprietary logic-gate technology approach to solid tumor cancers,” said Jim Robinson, chief executive officer of A2 Bio. “ This funding will enable us to continue ongoing clinical development of our CAR-T cell therapies as well as fund the potential next phase of development.” A2 Bio is currently conducting two seamless phase 1/2 clinical studies: EVEREST-1 studying A2B530 for pancreatic, lung and colorectal cancers by targeting carcinoembryonic antigen (CEA); and EVEREST-2 studying A2B694 for pancreatic, ovarian, lung, colorectal and mesothelioma cancers by targeting mesothelin (MSLN). Patients are enrolled in EVEREST-1 and EVEREST-2 through the BASECAMP-1 prescreening study. BASECAMP-1 utilizes artificial intelligence (AI)-enabled precision diagnostics, as a cost-effective, high-yield approach to identify eligible patients for all A2 Bio clinical studies. 1 A2 Biotherapeutics, established in 2018, is a fully integrated discovery, development and manufacturing company based in Agoura Hills, Calif. A2 Bio plans to direct the Series C funds to support the company’s three clinical studies, as well as to advance preclinical programs using its Tmod™ platform for potential clinical targets representing significant unmet needs in cancer and beyond. About the Tmod™ Platform A2 Bio has pioneered a precision-targeting cellular system – the Tmod™ platform – that incorporates two receptors, an activator and a blocker, to aim the powerful armaments of immune cells directly at tumors to unequivocally differentiate tumors from normal tissues. The activator recognizes antigens on tumor cells that trigger their destruction, while the blocker recognizes antigens on normal cells that protect them. This novel blocker technology enables precise, personalized and effective T cell targeting. The blocker component equips Tmod™ cells with the capacity to identify tumors as distinct from normal cells. About A2 Bio A2 Biotherapeutics, Inc. (A2 Bio) is a clinical-stage biotech company developing first-in-class logic-gated cell therapies to address the high unmet need in cancers. A2 Bio invented the proprietary Tmod™ cell therapy platform to tackle the fundamental challenge in cancer treatment—the ability of cancer medicines to distinguish between tumor and normal cells. For more information, please visit the company’s website at www.a2bio.com . References 1 Lozac’hmeur A, Danek T, Yang Q, Rosasco MG, Welch JS, Go WY, Ng EW, Mardiros A, Maloney DG, Garon EB, Kirtane K, Simeone DM, Molina JR, Salahudeen AA, Stein MM, Hecht JR. Detecting HLA loss of heterozygosity within a standard diagnostic sequencing workflow for prognostic and therapeutic opportunities. NPJ Precis Oncol. 2024 Aug 5;8(1):174. doi: 10.1038/s41698-024-00665-z. PMID: 39103508; PMCID: PMC11300791.

A2 Biotherapeutics has raised $80 million to run three experimental CAR-T programs for solid tumor cancers. The biotech is developing what it calls logic-gated cell therapies, which it believes will attack cancer cells while sparing normal ones. A2 Bio equips its cell therapies with two different receptors, one of which attaches only to proteins found on normal cells. As a result, when both receptors are bound, the cell therapy is inactivated. But for cancer cells, only one receptor is triggered, and the therapy attacks. “The logic gate — the best way to think about it is very rudimentary — it’s kill this, not that,” said A2 Bio CEO Jim Robinson, who joined the company in April after Scott Foraker left. Investors in the round include The Column Group and Samsara BioCapital, as well as other unnamed investors. The company previously announced a $62 million Series B extension in 2022 and a $71 million Series B in 2020. The cell therapy biotech is currently running two clinical programs, and it plans to start a third this quarter. The first targets a protein called carcinoembryonic antigen, and A2 Bio is studying that therapy for pancreatic, lung and colorectal cancers. Robinson said that early-stage study has dosed 14 patients. The second program targets a protein overexpressed in various cancers called mesothelin, and A2 Bio is studying that experimental therapy for pancreatic, ovarian, lung, colorectal and mesothelioma cancers. So far, the study has dosed five patients, according to Robinson. Notably, the company is developing CAR-T cell therapies for solid tumor cancers, which have been far more challenging to develop cell therapies for than blood cancers. The seven approved CAR-T cell therapies are all indicated for blood cancers. However, other forms of cell therapy, such as Iovance Biotherapeutics’ treatment using tumor-infiltrating lymphocytes , were approved last year for solid tumor cancers in a major milestone for the field. Both of A2 Bio’s therapies in the clinic use a patient’s own cells to engineer the cell therapy, like the currently approved CAR-T therapies. But A2 Bio is also developing a third therapy with an undisclosed target that is “off-the-shelf,” which means it is instead engineered using donor cells. It’s a tall task, as the companies that have tried to develop off-the-shelf CAR-T cell therapies have found little success so far.