Cartherics Advances First-in-Class TAG-72-Targeted CAR-NK Therapy CTH-401 Toward IND Submission in Early 2025

Feb 04, 2024 13:35 CST Updated 13:35

Cartherics

Developer of Immunotherapy Products

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On February 1, 2024, Cartherics, a biotechnology company developing immunocyte therapies for cancer treatment, announced that it had successfully completed a pre-Investigational New Drug (pre-IND) meeting with the U.S. Food and Drug Administration (FDA). The company will initiate Phase I/II clinical trials for its leading NK cell therapy product, CTH-401, aimed at treating ovarian cancer.

The purpose of the meeting is to obtain valuable guidance from the FDA on the activities that need to be completed before submitting an IND application, particularly those supporting non-clinical studies.This is the CTH-401 applicationAn important milestone for IND.

Cartherics Receives Positive FDA Feedback on CTH-401 Development Plan, Providing a Clear Pathway for IND Submission and Validating the Company’s Approach to Creating and Developing CTH-401

Cartherics CEO Professor Alan Trounson AO commented"The pre-IND meeting for CTH-401 is an important milestone for Cartherics. Based on the FDA's guidance, we are confident in successfully submitting the IND application by early 2025."

CTH-401 is currently among the drugs under research.OnlyNK Cell Product with Chimeric Antigen Receptor (CAR) Targeting Adenocarcinoma-Specific Antigen TAG-72TAG-72 is a validated tumor marker that is widely expressed in a series of solid tumors, including ovarian cancer, gastric cancer, colorectal cancer, prostate cancer, and pancreatic cancer. Cartherics has demonstrated that CTH-401 is highly effective at killing ovarian cancer cells in both tissue culture and animal models.And plans to launch the first clinical trial in early 2025.。

The company is also developing autologous CAR-T cell therapies. These therapies use T cells from the patient's own immune system, which are modified to effectively combat the patient's cancer cells.

On April 27, 2023, Shunxi Holding Group signed a contract with Cartherics in Melbourne, Australia, and jointly announced,Shunxi Holding Group Obtains Authorization to Develop, Manufacture, and Commercialize Cartherics' CAR-T Cell Product CTH-004 in Greater China, used for the treatment of various solid tumors, including ovarian cancer.CTH-004 is generated by genetically modifying patient T cells, inserting chimeric antigen receptors (CAR) to target the marker (TAG-72) on ovarian cancer cells, and deleting genes involved in the suppression of T cell function.

R&D Pipeline

Reference: Company's official website