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Carisma Therapeutics Granted FDA Fast Track Designation for CT-0525 for the Treatment of HER2-overexpressing Solid Tumors

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Carisma Therapeutics (Nasdaq: CARM) announced that the FDA granted Fast Track designation for CT-0525, a gene-modified cellular therapy for HER2-overexpressing solid tumors. This designation aims to expedite the development and review of therapies addressing serious conditions with unmet medical needs. The Phase 1 clinical trial is ongoing, focusing on safety, tolerability, and manufacturing feasibility. Initial data is expected by the end of 2024. The trial targets patients with advanced or metastatic solid tumors unresponsive to standard therapies.

Positive
  • FDA Fast Track designation for CT-0525.
  • Potential to address unmet medical needs for HER2-overexpressing solid tumors.
  • Phase 1 clinical trial ongoing, initial data expected by end of 2024.
Negative
  • The designation itself does not guarantee approval.
  • Clinical trial results may not meet expectations, posing risks to investors.

The FDA's Fast Track designation for CT-0525, a CAR-Monocyte therapy targeting HER2-overexpressing solid tumors, is significant. HER2-overexpression is a well-known marker in various aggressive cancers, such as breast and gastric cancers. Traditional treatments, like trastuzumab and pertuzumab, have limitations, particularly in advanced cases. CT-0525's unique mechanism—using autologous cells modified to express CAR-M proteins—offers a potentially innovative approach. It might overcome resistance seen in conventional therapies. This designation could accelerate access to a novel therapeutic option, presenting a potential breakthrough in solid tumor treatment. Close monitoring of clinical trial results will be crucial.

The Fast Track designation for CT-0525 can positively impact Carisma Therapeutics' market valuation and investor sentiment. Fast Track status often leads to a streamlined review process, reducing time to market, which can be a critical factor in the biopharmaceutical industry. This designation typically signals confidence from the FDA in the underlying science. Investors should note that while promising, CT-0525 is still in early clinical trials. The initial Phase 1 data, expected by end of 2024, will be a key milestone. Successful data could lead to increased funding opportunities, partnerships and a stronger market position within the immunotherapy sector.

In the broader context of cancer therapeutics, FDA Fast Track designation for CT-0525 highlights a growing interest in addressing unmet needs in oncology. The global cancer therapy market is highly competitive and rapidly evolving with significant R&D investments. Fast Track status not only boosts Carisma's visibility in this space but also enhances its competitive edge against peers. Investors should consider the potential market size for HER2-overexpressing cancers and how CT-0525 might position itself relative to existing treatments. Moreover, the designation can attract strategic partnerships and collaborations, further supporting Carisma's growth trajectory.

Fast Track designation highlights potential for CT-0525 to address unmet need for patients with solid tumors

Initial Phase 1 data expected by year-end 2024

PHILADELPHIA, June 25, 2024 /PRNewswire/ -- Carisma Therapeutics Inc. (Nasdaq: CARM) ("Carisma" or the "Company"), a clinical stage biopharmaceutical company focused on discovering and developing innovative immunotherapies, announced today that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation for CT-0525, an ex vivo gene-modified autologous chimeric antigen receptor-monocyte (CAR-Monocyte) cellular therapy intended to treat solid tumors that overexpress human epidermal growth factor receptor 2 (HER2).

The FDA's Fast Track program is aimed to facilitate the development, and expedite the review, of novel potential therapies that are designed to treat serious conditions and have the potential to address significant unmet medical need. 

"Receiving Fast Track designation for CT-0525 from the FDA marks a significant milestone for Carisma, highlighting the FDA's recognition of the serious and life-threatening nature of these malignancies and the potential of CT-0525 to meet this critical medical need," said Eugene P. Kennedy, M.D., Chief Medical Officer of Carisma. "We are committed to working closely with the FDA to accelerate the development of CT-0525. Currently, we are enrolling patients in the Phase 1 clinical trial and remain on track to report initial clinical data by the end of 2024."

The Phase 1 clinical trial for CT-0525 is an open-label study designed to assess the safety, tolerability, and manufacturing feasibility of CT-0525. This trial will enroll participants with locally advanced (unresectable) or metastatic solid tumors overexpressing HER2 whose disease has progressed on standard approved therapies. The initial study design will consist of two dose escalation cohorts. Further details of the trial can be found at www.clinicaltrials.gov under NCT identifier: NCT06254807.

About CT-0525

CT-0525 is a first-in-class, ex vivo gene-modified autologous chimeric antigen receptor-monocyte (CAR-Monocyte) cellular therapy intended to treat solid tumors that overexpress human epidermal growth factor receptor 2 (HER2). It is being studied in a multi-center, open label, Phase 1 clinical trial for patients with advanced/metastatic HER2-overexpressing solid tumors that have progressed on available therapies. The CAR-Monocyte approach has the potential to address some of the challenges of treating solid tumors with cell therapies, including tumor infiltration, immunosuppression within the tumor microenvironment, and antigen heterogeneity. CT-0525 has the potential to enable significant dose escalation, enhance tumor infiltration, increase persistence, and reduce manufacturing time compared to macrophage therapy.

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 www.carismatx.com.

Cautionary Note on Forward-Looking Statements

Statements in this press release about future expectations, plans and prospects, as well as any other statements regarding matters that are not historical facts, may constitute "forward-looking statements" within the meaning of The Private Securities Litigation Reform Act of 1995. These statements include, but are not limited to, statements relating to Carisma's business, strategy, future operations, cash runway, the advancement of Carisma's product candidates and product pipeline, and clinical development of Carisma's product candidates, including expectations regarding timing of initiation and results of clinical trials. The words "anticipate," "believe," "contemplate," "continue," "could," "estimate," "expect," "goals," "intend," "may," "might," "outlook," "plan," "project," "potential," "predict," "target," "possible," "will," "would," "could," "should," and similar expressions are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words.

Any forward-looking statements are based on management's current expectations of future events and are subject to a number of risks and uncertainties that could cause actual results to differ materially and adversely from those set forth in, or implied by, such forward-looking statements. These risks and uncertainties include, but are not limited to, (i) Carisma's ability to realize the anticipated benefits of its pipeline reprioritization and corporate restructuring, (ii) Carisma's ability to obtain, maintain and protect its intellectual property rights related to its product candidates; (iii) Carisma's ability to advance the development of its product candidates under the timelines it anticipates in planned and future clinical trials and with its current financial and human resources; (iv) Carisma's ability to replicate in later clinical trials positive results found in preclinical studies and early-stage clinical trials of its product candidates; (v) Carisma's ability to realize the anticipated benefits of its research and development programs, strategic partnerships, research and licensing programs and academic and other collaborations; (vi) regulatory requirements or developments and Carisma's ability to obtain and maintain necessary approvals from the U.S. Food and Drug Administration and other regulatory authorities related to its product candidates; (vii) changes to clinical trial designs and regulatory pathways; (viii) risks associated with Carisma's ability to manage expenses; (ix) changes in capital resource requirements; (x) risks related to the inability of Carisma to obtain sufficient additional capital to continue to advance its product candidates and its preclinical programs; and (xi) legislative, regulatory, political and economic developments.

For a discussion of these risks and uncertainties, and other important factors, any of which could cause Carisma's actual results to differ from those contained in the forward-looking statements, see the "Risk Factors" set forth in the Company's Annual Report on Form 10-K for the year ended December 31, 2023, the Company's Quarterly Report on Form 10-Q for the Quarter ended March 31, 2024, as well as discussions of potential risks, uncertainties, and other important factors in Carisma's other recent filings with the Securities and Exchange Commission. Any forward-looking statements that are made in this press release speak as of the date of this press release. Carisma undertakes no obligation to revise the forward-looking statements or to update them to reflect events or circumstances occurring after the date of this press release, whether as a result of new information, future developments or otherwise, except as required by the federal securities laws.

Investors:
Shveta Dighe
Head of Investor Relations
investors@carismatx.com

Media Contact:
Julia Stern
(763) 350-5223
jstern@realchemistry.com

Cision View original content to download multimedia:https://www.prnewswire.com/news-releases/carisma-therapeutics-granted-fda-fast-track-designation-for-ct-0525-for-the-treatment-of-her2overexpressing-solid-tumors-302180804.html

SOURCE Carisma Therapeutics Inc.

FAQ

What is the significance of FDA Fast Track designation for Carisma Therapeutics (CARM)?

The FDA Fast Track designation aims to expedite the development and review of CT-0525, highlighting its potential to address significant unmet medical needs for HER2-overexpressing solid tumors.

When will Carisma Therapeutics (CARM) release initial data for the CT-0525 clinical trial?

Carisma Therapeutics expects to report initial data from the Phase 1 clinical trial of CT-0525 by the end of 2024.

What is CT-0525 developed to treat?

CT-0525 is developed to treat HER2-overexpressing solid tumors, which are locally advanced or metastatic and unresponsive to standard therapies.

What phase is the CT-0525 clinical trial currently in?

The CT-0525 clinical trial is currently in Phase 1, assessing its safety, tolerability, and manufacturing feasibility.

What is the stock symbol for Carisma Therapeutics?

The stock symbol for Carisma Therapeutics is CARM.

Carisma Therapeutics, Inc.

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