Tuesday, April 16, 2024

CT011 Therapy for Hepatocellular Carcinoma Receives IND Clearance

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The Investigational New Drug (IND) clearance has been granted for CT011, a targeted therapy for patients suffering from stage IIIa hepatocellular carcinoma (HCC) with a high risk of post-surgical recurrence. The treatment is specifically designed to target Glypican-3 (GPC3), a protein associated with hepatocellular carcinoma. GPC3 was initially identified as a viable target for Chimeric Antigen Receptor T-cell (CAR T-cell) therapy and has since been advanced to clinical trials for hepatocellular carcinoma treatment.

Evidence from case reports suggests that patients with advanced HCC have achieved disease-free survival of over seven years with this treatment. The potential of CAR-T for solid tumors will continue to be investigated, to bring new treatment options to patients. HCC is the most common histologic subtype of primary liver cancer, ranking as the sixth most prevalent type of cancer globally.

In 2019, IND clearance was obtained from the National Medical Products Administration (NMPA) to treat GPC3-positive solid tumors, marking the first time a CAR T-cell therapy against solid tumors achieved this in China. Following this clearance, CARsgen Therapeutics completed enrolment for a Phase I trial in the country.

Hepatocellular Carcinoma

CARsgen’s Breakthrough Collaborations in CAR T-Cell Therapy for Hepatocellular Carcinoma

In 2020, CARsgen entered into a collaboration with Huadong Medicine to commercialize CT053, another CAR T-cell therapy product, zevorcabtagene autoleucel (zevor-cel), in mainland China. The fully human, autologous BCMA CAR T-cell product candidate, CT053, is designed to treat relapsed or refractory multiple myeloma (R/R MM). CARsgen operates in both the US and China, focusing on the development of CAR T-cell therapies for the treatment of haematologic malignancies and solid tumors.

The IND clearance for CT011 signifies progress in the treatment of HCC, particularly for patients with GPC3-positive stage IIIa HCC who are at a high risk of recurrence after surgical resection. The clearance further highlights the potential of CAR-T therapies in the treatment of solid tumors. The ongoing exploration of CAR-T for solid tumors promises to bring new treatment possibilities for patients. The collaboration between CARsgen and Huadong Medicine demonstrates the potential for CAR T-cell therapies in the future of cancer treatment.

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