FDA places clinical hold on ATA3219 CAR-T therapy for the treatment of NHL
“We intend to work closely with the FDA to address these issues as expeditiously as possible,” said Cokey Nguyen, Ph.D., President and Chief Executive Officer of Atara. “We are encouraged with ongoing correspondence with the Agency and a potential path to submitting the necessary data to release the clinical hold. Patient safety remains our priority and maintaining the highest standards for our programs.”
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“This represents a significant milestone in advancing MB-105 as a potential treatment option for patients with T-cell lymphoma who currently face extremely limited therapeutic choices,” said Sarah Hein, Co-Founder and Chief Executive Officer of March Biosciences. “CAR-T therapies have revolutionized the treatment of B-cell lymphomas and leukemias but have not
Chris Ehrlich, CERo Therapeutics CEO added, “CBCI is a world-renowned cancer center, and we believe their participation in our AML trial is continued validation of the scientific work performed to date with CER-1236. We look forward to announcing enrollment and initial dosing in the near term for this trial and
“Treating the first patient in the GUARDIAN-101 trial marks a pivotal milestone in Clasp’s mission to transform patient outcomes through precision immunotherapy,” said Dr. Lauren Harshman, M.D., SVP of Clinical Development at Clasp Therapeutics. “Advancing CLSP-1025 into the clinic is an important step in validating the potential of our pHLAre
“AP402 targets p95HER2, a truncated form of HER2 present in 30-40% of HER2-positive cancers, which is associated with exceptionally poor prognosis, and not addressable by conventional anti-HER2 therapies,” said Dr. Jeng Her, Ph.D., Founder and Chief Executive Officer of AP Biosciences. “AP402 represents the only T-cell engager in human trials
