CAR-M(Inceptor Bio)

Pre-clinical data demonstrate robust anti-tumor activity and a novel off-the-shelf approach for GPC3+ solid tumors PHILADELPHIA, Nov. 5, 2024 /PRNewswire/ -- Carisma Therapeutics Inc. (Nasdaq: CARM) ("Carisma" or the "Company"), a clinical-stage biopharmaceutical company focused on discovering and developing innovative immunotherapies, today announced the upcoming presentation of new pre-clinical data on its anti-GPC3 in vivo chimeric antigen receptor macrophage and monocyte (together, "CAR-M") therapy for the treatment of hepatocellular carcinoma ("HCC"), developed in collaboration with Moderna, Inc. (Nasdaq: MRNA). The data will be presented in a poster session at the Society for Immunotherapy of Cancer ("SITC") Annual Meeting in Houston, Texas, on November 8, 2024. The abstract, titled "Pre-Clinical Efficacy of a Novel Anti-GPC3 In Vivo CAR-M for Hepatocellular Carcinoma," presents the first pre-clinical data on the development candidate targeting Glypican-3 ("GPC3"), a tumor-associated antigen commonly expressed in HCC. This novel off-the-shelf approach reprograms endogenous myeloid cells in vivo using lipid nanoparticles ("LNP") to deliver mRNA encoding CARs. The data show that this in vivo CAR-M therapy has significant potential as a treatment for GPC3+ solid tumors, including HCC. "Our data at SITC this year highlights the groundbreaking potential of the in vivo CAR-M platform," said Steven Kelly, President and Chief Executive Officer of Carisma. "The pre-clinical results demonstrate robust anti-tumor activity and pave the way for an off-the-shelf therapy for hard-to-treat cancers like hepatocellular carcinoma. This data underscores the progress we've made, and we're eager to advance this promising therapy into clinical development." SITC Presentations Details: Title: Pre-clinical efficacy of a novel anti-GPC3 in vivo CAR-M for hepatocellular carcinoma Publication Number: 329 Session Date & Time: Friday, Nov. 8, 2024 Location: Exhibit Halls A B George R. Brown Convention Center Title: A Phase 1, First-in-Human study of autologous monocytes engineered to express an anti-HER2 chimeric antigen receptor (CAR) in participants with HER2 overexpressing solid tumors Publication Number: 659 Session Date & Time: Friday, Nov. 8, 2024 Location: Exhibit Halls A B George R. Brown Convention Center The poster presented at SITC 2024 will be available online in the "Publications" section of Carisma's website at following the start of the poster session. About Carisma Therapeutics Carisma Therapeutics Inc. is a clinical-stage biopharmaceutical company focused on utilizing our proprietary macrophage and monocyte cell engineering platform to develop transformative immunotherapies to treat cancer and other serious diseases. We have created a comprehensive, differentiated proprietary cell therapy platform focused on engineered macrophages and monocytes, cells that play a crucial role in both the innate and adaptive immune response. Carisma is headquartered in Philadelphia, PA. For more information, please visit . Cautionary Note on Forward-Looking Statements This press release contains forward-looking statements within the meaning of the "safe harbor" provisions of the Private Securities Litigation Reform Act of 1995, including, but not limited to, anticipated discovery, preclinical and clinical development activities for Carisma's product candidates, the potential safety, efficacy, benefits and addressable market for Carisma's product candidates, and clinical trial results for Carisma's product candidates. All statements other than statements of historical fact are statements that could be deemed forward-looking statements. The words "believes," "anticipates," "estimates," "plans," "expects," "intends," "may," "could," "should," "potential," "likely," "projects," "continue," "will," "schedule," and "would" and similar expressions are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words. These forward-looking statements are predictions based on the Company's current expectations and projections about future events and various assumptions. Although Carisma believes that the expectations reflected in such forward-looking statements are reasonable, Carisma cannot guarantee future events, results, actions, levels of activity, performance or achievements, and the timing and results of biotechnology development and potential regulatory approval is inherently uncertain. Forward-looking statements are subject to risks and uncertainties that may cause Carisma's actual activities or results to differ significantly from those expressed in any forward-looking statement, including risks and uncertainties related to Carisma's ability to advance its product candidates, the receipt and timing of potential regulatory designations, approvals and commercialization of product candidates, clinical trial sites and our ability to enroll eligible patients, supply chain and manufacturing facilities, Carisma's ability to maintain and recognize the benefits of certain designations received by product candidates, the timing and results of preclinical and clinical trials, Carisma's ability to fund development activities and achieve development goals, Carisma's ability to protect intellectual property, and other risks and uncertainties described under the heading "Risk Factors" in Carisma's Annual Report on Form 10-K for the year ended December 31, 2023, its Quarterly Reports on Form 10-Q and other documents that Carisma files from time to time with the Securities and Exchange Commission. These forward-looking statements speak only as of the date of this press release, and Carisma undertakes no obligation to revise or update any forward-looking statements to reflect events or circumstances after the date hereof, except as may be required by law. Investors: Shveta Dighe Head of Investor Relations [email protected] Media Contact: Julia Stern (763) 350-5223 [email protected] SOURCE Carisma Therapeutics Inc. WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

Under the terms of the deal, Carisma will receive research funding from Moderna and could also receive other payments if certain development, regulatory and commercial milestones are met, along with royalties from net sales. Carisma Therapeutics has been working for years to develop cell therapies using macrophages, immune cells that are better at attacking solid tumors than the T cells that currently dominate the industry. In a partnership with Moderna, now expanded to two undisclosed autoimmune targets, the biotech hopes to seriously simplify cell therapy by bypassing the need to culture patient cells out of the body.The technique is called in vivo CAR-M therapy."The nomination of the two autoimmune targets is a significant milestone in our mission to harness the power of macrophages to treat a broader range of diseases,” Carisma President and CEO Steven Kelly said in a Sept. 10 release. “Our innovative CAR-M technology has the potential to revolutionize the treatment landscape for patients suffering from these debilitating conditions."The two autoimmune targets will be exclusively partnered with Moderna, the release said, while Carisma will retain all rights in autoimmune diseases beyond these targets. CAR-M therapy, like CAR-T cell therapy, involves collecting immune cells from patients and genetically modifying them to target a disease-causing cell, like a cancer cell. These reprogrammed cells are then reintroduced into the patient and set loose to fight the disease.Conversely, Moderna has been working with Carisma to reprogram macrophages while they’re still inside a patient’s body by using mRNA. Under the expanded partnership, the two companies plan to use Moderna’s mRNA-delivery nanoparticle platform to transport mRNA that codes for autoimmune targets directly into macrophages. It's expected that the macrophages will naturally turn the mRNA into an antigen protein that they would then target on the overreactive immune cells that cause autoimmune diseases. In this way, macrophages wouldn't have to be removed and engineered to express the antigen in the lab.Under the terms of the deal, Carisma will receive research funding from Moderna and could also receive other payments if certain development, regulatory and commercial milestones are met, along with royalties from net sales, according to the release. Carisma is in charge of the discovery and optimization of development candidates while Moderna will lead the clinical development and commercialization of any therapeutics that result from the partnership, the release said. In June, Carisma received a Fast Track Designation from the FDA for a CAR-M therapy treating HER2-overexpressing solid tumors; initial phase 1 data are expected later this year. At the Society for Immunotherapy of Cancer’s annual conference in Nov. 2023, Carisma presented data showing that mice given CAR-M mRNA either directly into tumors or intravenously saw their macrophages successfully reprogrammed and tumors shrink.There are currently no approved CAR-M therapies. A phase 1 adenocarcinoma trial with another mRNA-based CAR-M, MCY-M11, was terminated by the sponsor, MaxCyte, in 2021 due to a shift in focus.