Resources realigned to focus primarily on in vivo macrophage engineering platform for fibrosis, oncology and autoimmune disease therapies
Development of CT-0525 to be discontinued; workforce reduced by 34%
PHILADELPHIA, Dec. 9, 2024 /PRNewswire/ -- Carisma Therapeutics Inc. (Nasdaq: CARM) ("Carisma" or the "Company"), a leader in macrophage-focused therapeutics, today announced a strategic reprioritization of its pipeline, cessation of development of CT-0525, and a reduction in the workforce by 34%. These measures will enable Carisma to focus its resources on advancing its in vivo macrophage engineering platform for the development of fibrosis, oncology and autoimmune disease therapies. This decision aligns Carisma's efforts with next-generation, high-potential programs addressing significant unmet patient needs while enhancing operational efficiency.
"Following a comprehensive review of our portfolio, we have made the strategic decision to prioritize advancing our in vivo macrophage engineering platform," said Steven Kelly, President and Chief Executive Officer of Carisma. "The compelling data generated by both the Moderna-partnered in vivo CAR-M oncology programs as well as our internal liver fibrosis program underscore the potential to revolutionize treatment paradigms with an innovative and patient-centric approach."
"These strategic initiatives, re-directing our investments to the in vivo macrophage engineering platform, discontinuing development of our anti-HER2 program and reducing our workforce, aim to streamline our operations and reduce operating expenses over time," Kelly continued. "While these decisions are very challenging, they are made in the best interest of our shareholders. We remain deeply grateful for the significant contributions of the employees departing Carisma."
Reprioritization Plan, Pipeline Updates, and Upcoming Milestones:
As part of this reprioritization of our pipeline, Carisma will discontinue development of the anti-human epidermal growth factor receptor 2 ("anti-HER2") program, and redirect the Company's focus to developing off-the-shelf products using its in vivo macrophage engineering platform:
Fibrosis
Carisma's initial fibrosis program is focused on addressing liver fibrosis, a significant global health challenge. Preclinical data presented at the American Association for the Study of Liver Diseases (AASLD) Liver Meeting® 2024 demonstrated the potential of Carisma's engineered macrophages to reduce inflammation, resolve fibrosis, and promote liver regeneration.
The Company plans to nominate a development candidate for its liver fibrosis program in the first quarter of 2025, reflecting its expertise in macrophage biology and fibrotic diseases.
Oncology
In collaboration with Moderna, Inc. (Nasdaq: MRNA), Carisma is advancing multiple programs utilizing an in vivo chimeric antigen receptor macrophage and monocyte ("CAR-M") plus mRNA/LNP approach. The lead program is an anti-glypican 3 (GPC3) in vivo CAR-M therapy that has demonstrated the potential for this scalable, patient-friendly approach to transform solid tumor therapy. In addition to this program, Moderna has nominated four undisclosed oncology research targets under the collaboration and has the right to designate up to ten oncology targets as development targets.
Autoimmune
In collaboration with Moderna, Carisma has two in vivo CAR-M research programs for the treatment of autoimmune diseases associated with two distinct targets where there is significant unmet medical need.
Carisma retains all rights in autoimmune disease beyond these two nominated targets.
Discontinuation of anti-HER2 Development
The Company's decision was based on an assessment of the competitive landscape in anti-HER2 treatments, including the impact of recently approved anti-HER2 therapies on HER2 antigen loss/downregulation, and the effects on the future development strategy of any anti-HER2 treatment.
The Company has completed patient enrollment of the Phase 1 clinical trial of CT-0525 and will not enroll patients in the previously planned Cohort 3 of the study.
Based on the data available to date from the anti-HER2 program, CAR-M cell therapy has been shown to be safe, well-tolerated, and feasible to manufacture, and it holds the potential to become a meaningful treatment option for patients.
Corporate Updates
As part of the strategic restructuring, Carisma will reduce its workforce by 34%. The Company expects the reduction in workforce to be substantially complete and to pay the majority of related reduction in workforce amounts by the end of the first quarter of 2025. The Company is committed to supporting affected employees through this transition.
As part of the workforce reductions, our Chief Financial Officer, Richard Morris, our General Counsel, Eric Siegel, and our Senior Vice President, Human Resources, Terry Shields, will leave the Company effective December 31, 2024. Carisma expresses gratitude for their contributions.
The Company expects to incur approximately $2.7 million in connection with the reduction in the workforce, which primarily represents one-time employee termination benefits directly associated with the workforce reduction.
About Carisma
Carisma Therapeutics is a biopharmaceutical Company pioneering macrophage engineering to develop groundbreaking therapies for fibrosis, cancer, and other diseases. With a strong commitment to patient-centric innovation, Carisma aims to deliver scalable, next-generation solutions that transform treatment paradigms. Carisma is headquartered in Philadelphia, PA. For more information, please visit www.Carismatx.com.
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SOURCE Carisma Therapeutics Inc.
