Carisma Presents Phase 1 Data of CAR-M Therapy with 7-Day Turnaround; Four Chinese Companies Report Pipeline Progress and Recent IPO Filings

CT-0508 is a CAR-M cell therapy targeting HER2, used for the treatment of recurrent/refractory HER2-overexpressing solid tumors.Macrophages are professional antigen-presenting cells that can be polarized into an anti-tumor or M1 macrophage phenotype, and upregulate genes that enhance the activation/recruitment of immune cells (such as T cells), making them more effective in activating the patient's own adaptive immune system.

▲CT-0508 (Source: Official Website)）

In addition, the characteristics of Carisma's genetically engineered CAR-M have been fine-tuned during the research and development process.The modified CAR-M cell therapy meets the key criteria that Carisma Therapeutics, Inc. believes are necessary for treating solid tumors.: (1) Enter the solid tumor microenvironment with the ability to selectively destroy cancer cells; (2) Survive in the adverse solid tumor environment and maintain an anti-tumor phenotype in the presence of immunosuppressive factors; (3) Activate adaptive immune responses, trigger long-term anti-tumor immunity, and prevent antigen-negative recurrence.

▲The Key to Conquering Solid Tumors (Source: Official Website)）

The trials presented here were conducted using a multi-day infusion regimen (Group 1) or a single-day high-dose infusion (Group 2).The results of the first group showed that CT-0508 remodeled and activated the tumor microenvironment and triggered anti-tumor T-cell immunity, with an increase in exhausted CD8+ T cells post-treatment., the results support the ongoing combination study with K drug. Both groups showed that CT-0508 was well tolerated, with no dose-limiting toxicity reported to date.

Dr. Michael Klichinsky, co-founder and chief scientific officer of Carisma Therapeutics, stated: "As the CT-0508 trial progresses, we are hopeful to see consistent results supporting the safety, feasibility, and mechanism of action of this CAR-M therapy. We look forward to the continued development of this treatment."

To accelerate the manufacturing of its CAR-M therapy, Carisma has developed a robust manufacturing process aimed at enhancing scalability, reliability, and flexibility, which can support the R&D of all its CAR-M pipelines.And the entire process from collection to reinfusion can be completed within 7 days.。

▲CAR-M Preparation Process (Source: Official Website)）

First useGranulocyte Colony-Stimulating Factor (G-CSF)After mobilization, perform apheresis, then screen outCD14+ Monocytes, then cultured and differentiated into macrophages in the presence of granulocyte-macrophage colony-stimulating factor (GM-CSF), followed by transduction with Ad5f35 encoding CAR to obtain CAR-M, which is then infused back into the patient after cryopreservation transport.

It is worth mentioning that in March last year, Carisma Therapeutics reached a preliminary strategic cooperation agreement with Novartis. According to the agreement, Novartis will clinically manufacture CT-0508, and Carisma's manufacturing process will be transferred to Novartis' Cell Therapy Center in the United States. The news at that time mentioned that this clinical manufacturing plan would start this year.

The number of companies laying out CAR-M is not large, and the entire track is still in its infancy, with some progress made recently.

In April this year,CellOrigin BiotechThe kick-off meeting for the SY001 cell injection clinical trial project was successfully held at the Linyi Cancer Hospital. It is reported that the "Exploratory Clinical Trial of Safety, Tolerance, Pharmacokinetics, and Preliminary Efficacy of a Single-Center, Single-Arm, Dose-Escalation Study of SY001 Injection in Late-Stage Solid Tumor Subjects" by Saiyuan Biotechnology is the first clinical trial of a CAR-M macrophage product to be officially launched in China.

In addition, in January, the GMP production base and R&D center of Carisma Therapeutics were officially put into operation. The total construction area of the production base exceeds 3,500 square meters, and the R&D center covers an area of more than 1,000 square meters, which will further meet the needs of research and production.

Also in April, the first technology platform in China driven by gene editing, biomaterials, and synthetic biology for engineered macrophages was established.Kunshi BiotechOfficially opened in Suzhou Industrial Park. Kunshi Bio focuses on the development and clinical application of macrophage-based drugs for treating solid tumors. It has established the "24H-CAR" technology platform, which can complete the preparation of CAR-M on the same day.

In July this year, Associate Professor Ning Pengbo's team from the School of Life Science and Technology at Xidian University collaborated with ShaanxiGiant Health BioA "uPA scavenger"-type macrophage (uPAR-MΦ) was constructed using gene reprogramming and loaded with poly(lactic-co-glycolic acid)-encapsulated chemotherapy drug gemcitabine, providing a genetically engineered macrophage-based live cell drug platform for treating cancer metastasis.

In the same month,Carisma TherapeuticsBiological Announces the Official Launch of the First CAR-M Therapeutic Product Targeting Solid Tumors in an Investigator-Initiated Clinical Study (IIT), Entering the Subject Recruitment Phase. Notably, Yuanmai Cellular Biological secured tens of millions in angel financing and strategic investment from the Nanjing Innovation Investment Group within less than a month.

Overall, CAR-M therapy is a promising cellular therapy. However, there are not many products that have entered the clinical stage, and more clinical data is needed to validate its efficacy and safety in the treatment of solid tumors. The release of Carisma's data this time enriches the supporting data for this therapy, and we also look forward to the future clinical results of its combination with K medicine.

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