Novomedison, Central Nervous System Lymphoma Treatment ‘Poseltinib’ Approved by MFDS for Phase 2 IND

On September 15, 2024 Novomedison (CEO Young-il Koh and Myeong-se Lee), a new drug development company, reported on the 5th that it received approval from the Ministry of Food and Drug Safety for a phase 2 clinical trial of Poseltinib, a BTK/TEC inhibitor (Press release, NOBO Medicine, SEP 15, 2024, View Source;cat=12&nid=299064 [SID1234649254]).

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Poseltinib, currently under development by Novomedison, is a small molecule compound that Hanmi Pharmaceutical and Novomedison are jointly developing. The company explains that it is a substance that shows more potent activity against BTK, TEC, and BMX kinases than existing BTK inhibitors and has fewer side effects, so it can be effective in treating various malignant B-cell lymphomas.

This phase 2 clinical trial will evaluate the efficacy and safety of posseltinib in patients with relapsed and refractory central nervous system lymphoma, and will be conducted as a multi-institutional joint clinical trial at Seoul National University Hospital, Bundang Seoul National University Hospital, Samsung Seoul Hospital, Seoul Asan Medical Center, and Chonnam National University Hospital.

Meanwhile, Novomedison is also conducting an investigator-led multicenter Phase 2 clinical trial of posseltinib in relapsed and refractory diffuse large B-cell lymphoma, and announced interim results at ASCO (Free ASCO Whitepaper) (American Society of Clinical Oncology) this year. The trial has now completed patient recruitment, and efficacy and safety results are scheduled to be announced at ASH (Free ASH Whitepaper) (American Society of Hematology) in December.