US FDA grants Fast Track Designation for SHP2 inhibitor BBP-398 in Combination with LUMAKRAS® (sotorasib)
“The survival rate following a diagnosis of NSCLC with a KRAS mutation is extremely poor. We are hopeful that by launching this clinical trial with Amgen, we may be able to fill the current gap in unmet medical need for these cancer patients,” said Frank McCormick, Ph.D., chairman of oncology at BridgeBio. “We are grateful the FDA has granted our program Fast Track designation and are hopeful it will allow us to address the needs of these patients more quickly following diagnosis.”
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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
