On August 24, 2022 Tachyon Therapeutics, Inc. ("Tachyon" or "the Company"), a private biotechnology company developing transformative cancer therapies against novel targets, reported that the U.S. Food and Drug Administration (FDA) has cleared the Company’s Investigational New Drug (IND) application to develop TACH101 for the treatment of advanced solid tumors (Press release, Tachyon Therapeutics, AUG 24, 2022, View Source [SID1234618615]).

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"The approval of this IND marks a significant milestone for the Company, as TACH101 will be the first KDM4 inhibitor to enter clinical stage," said Dr. Frank Perabo, CEO of Tachyon. "Based on encouraging preclinical data, we believe that this novel epigenetic drug candidate holds promise to become a safe and effective treatment option for patients with advanced solid tumors, and we look forward to starting a clinical trial later this year."

The first-in-human clinical study of TACH101 is expected to commence in Q4 2022 and will include a Phase 1a open-label, single-arm, dose escalation portion to evaluate the safety and tolerability of orally administered TACH101 in subjects with advanced and metastatic solid tumors. Once the recommended Phase 2 dose (RP2D) is determined, the Phase 1b dose expansion portion is planned to commence in select tumor types including gastrointestinal and colorectal cancers.