一次情報の記録
重要申請提出
TransCode、TTX-MC138の大腸がんを対象としたPhase 2a試験のIND修正申請を提出
TransCodeとQuantum Leapは、治癒的治療後にctDNA陽性となった大腸がん患者を対象としたTTX-MC138のPhase 2a用量拡大試験について、FDAへのIND修正申請を提出した。試験は最大45例を登録予定で、PRE-I-SPYプラットフォームの下、2026年前半に開始予定である。
主要事実
出典の抜粋
EX-99.1 2 tm265309d1_ex99-1.htm EXHIBIT 99.1 Exhibit 99.1 TransCode Therapeutics and Quantum Leap Announce Submission of IND Amendment for Phase 2a Clinical Trial with TTX-MC138 BOSTON, February 05, 2026 - TransCode Therapeutics, Inc. (NASDAQ: RNAZ) (TransCode), a clinical stage company pioneering immuno-oncology and RNA therapeutics for the treatment of high risk and advanced cancers, in collaboration with Quantum Leap Healthcare Collaborative (Quantum Leap), today announced the submission to the U.S. Food and Drug Administration (FDA) of an Investigational New Drug (IND) application amendment for a planned Phase 2a clinical trial with TransCode’s lead therapeutic candidate, TTX-MC138. The study will be conducted by Quantum Leap within their PRE-I-SPY program, a leading platform for in