The LYT-200 program for the treatment of solid tumors including cholangiocarcinoma is progressing through clinical development, according to a press release from PureTech, the developers of the drug candidate.

The company has completed the monotherapy dose-escalation portion of the program, the primary objective of which was to assess the safety and tolerability of escalating doses of LYT-200 to identify the right dose to use in a second portion.

Six cohorts of patients were treated with escalating doses of treatment ranging between 0.2 mg/kg and 16.0 mg/kg twice a month. So far, no dose-limiting toxicities were reported. Results from this portion of the trial are expected by the end of the year. The company is now set to begin evaluating weekly doses of the treatment.


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The program will also soon start enrolling participants to evaluate LYT-200 together with chemotherapy or an anti-PD-1 monoclonal antibody. Results from this portion of the program are expected in 2023.

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Finally, based on promising preclinical data using LYT-200 in models of leukemia, the company also plans to initiate a clinical trial by the end of the year using LYT-200 as a single agent in patients with leukemia.

“We are very pleased with the progress of our Phase 1 evaluation of LYT-200, which has demonstrated favorable safety and tolerability as a single agent at all doses studied to date without any dose-limiting toxicities,” Aleksandra Filipovic, MD, PhD, the head of oncology at PureTech, said in the press release.

“We look forward to the continued evaluation of this novel therapy as a potential treatment for metastatic solid tumors as well as the initiation of clinical studies in leukemia.”

LYT-200 is a fully human IgG4 monoclonal antibody that inhibits the activity of galectin-9, an important molecule that tumors and immune cells express. Experiments in preclinical models have shown that galectin-9 stops the immune system from recognizing and destroying cancer cells.

Reference

PureTech initiates late-stage clinical study of wholly-owned candidate LYT-100 (deupirfenidone) in IPF and advances LYT-200 (anti-galectin-9 mAb). News release. PureTech; June 30, 2022.