FDA Clears IND for MTX-531, Enabling Ph 1 Trial in Advanced Solid Tumors
“IND clearance marks an important milestone for MEKanistic and advances MTX-531 into the clinic,” said Danny Cunagin, chief executive officer of MEKanistic Therapeutics. “We believe MTX-531’s differentiated dual-targeting approach has the potential to address meaningful unmet needs in oncology, provide new options for cancer patients and support a new treatment approach for hard-to-treat cancers.”
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“Today’s acceptance of the supplemental BLA represents an important milestone for ImmunityBio and for patients with BCG-unresponsive NMIBC,” said Richard Adcock, President and CEO of ImmunityBio. “ANKTIVA is already approved for patients with CIS with or without papillary disease, and this application has the potential to expand access to patients
The first patient was treated with [212Pb]VMT-α-NET in a fourth cohort of the Company’s ongoing Phase 1/2a clinical trial of [212Pb]VMT-α-NET in patients with unresectable or metastatic somatostatin receptor type 2 (SSTR2) expressing neuroendocrine tumors (NETs). This cohort explores optimizing a 20 mCi cumulative dose by front-loading, with 6.0 mCi
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