FDA Clears Investigational New Drug Application for OP-3136
“We are very pleased to have received notification from the FDA that OP-3136 may proceed into the clinic,” said David C. Myles, Ph.D., Chief Discovery and Non-Clinical Development Officer of Olema Oncology. “The compelling activity demonstrated by OP-3136 in preclinical models both as a single agent and in combination with palazestrant has generated strong investigator interest in OP-3136. We expect to initiate the Phase 1 clinical trial early next year and are excited by OP-3136’s potential in breast cancer and beyond.”
Share:
More News
Lamine Mbow, Global Head of Discovery Research, Boehringer Ingelheim, said: “We are building a broad pipeline of ADCs addressing novel tumor target space to develop next-generation cancer treatments. By combining our deep expertise in cancer treatment development with Synaffix’s clinical-stage platform technology, we aim to accelerate the delivery of first-in-class
“The initial therapy of high-risk, non-muscle invasive bladder cancer with BCG has not advanced in decades. Today’s pivotal Phase 3 CREST results are potentially practice-changing, representing the first advance in therapy for BCG-naïve, high-risk, non-muscle invasive cancer in over 30 years,” said Roger Dansey, M.D., Chief Oncology Officer, Pfizer. “These
“Receiving FDA IND clearance is an important milestone in the advancement of TYRA-300 and for patients with NMIBC who urgently need better tolerated therapeutic options,” commented Doug Warner, Chief Medical Officer of TYRA. “We look forward to leveraging Erik’s impressive background to guide our development plans in NMIBC. We expect
“As a leader in hematologic malignancies, AbbVie is committed to advancing innovative treatments for complex cancers like multiple myeloma through our relentless R&D efforts and collaborations,” said Mariana Cota Stirner, M.D., Ph.D., vice president, therapeutic area head for hematology, AbbVie. “We look forward to partnering with Simcere Zaiming, to advance
