Fast Track Designation from the FDA for EO-3021 for the Treatment of Adult Patients with Advanced or Metastatic Gastric or GEJ Cancer Expressing Claudin 18.2
“We are delighted to receive Fast Track designation for EO-3021, which marks an encouraging recognition of the unmet medical need in patients with Claudin 18.2-expressing tumors, as well as the potential for EO-3021 to deliver improved therapeutic outcomes,” said Joseph Ferra, President and Chief Executive Officer of Elevation Oncology. “This designation is based on nonclinical and initial clinical data from our ongoing Phase 1 clinical trial. As we announced in August, early results showed a confirmed overall response rate of 42.8% in a Claudin 18.2-enriched subset of gastric and GEJ cancer. In addition, we observed differentiated tolerability, with minimal MMAE-associated toxicities, including no neutropenia or peripheral neuropathy/hypoesthesia. We are grateful for the opportunity to potentially expedite the delivery of EO-3021 and look forward to advancing through monotherapy dose expansion and reporting additional data from our ongoing trial in the first half of 2025, and to initiating the combination portion of our study later this year.”
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
