US FDA RMAT Designation Granted to Orca-Q® for the Treatment of High-Risk Hematologic Malignancies
“The FDA’s RMAT designation for Orca-Q recognizes the significant unmet need for patients with serious hematologic malignancies and validates the promising clinical findings from our ongoing Phase 1 study,” said Nate Fernhoff, Ph.D., co-founder and chief executive officer at Orca Bio. “As this is our second cell therapy candidate to receive RMAT status, we have experienced firsthand how this program can support accelerated development and enhanced communication with the FDA. With our newly expanded Phase 1 study continuing to enroll patients and additional data expected later this year, we remain focused on advancing our high-precision approach to deliver an important new treatment to patients with blood cancer.”
Share:
More News
Dr. Michael Ge, CEO of Kelun-Biotech said, “We are delighted to see the acceptance of the fifth indication application for sac-TMT. Compared to immunotherapy alone, the ADC combination with KEYTRUDA® as first-line treatment for PD-L1-positive NSCLC has achieved not only positive results in PFS, but also a trend toward benefit
“We are excited to work with Merck to advance this promising investigational combination in RAS-driven cancers,” said Jonathan E. Lim, M.D., Erasca’s chairman, CEO, and co-founder. “RAS mutations activate the RAS/MAPK pathway and promote an immunosuppressive environment. Non-clinical data suggest that targeting the pathway with ERAS-0015 may complement PD-1 blockade
“Dosing the first patient in the ASPENOVA Phase 3 clinical trial represents a significant milestone in our development of azenosertib for patients with platinum-resistant ovarian cancer,” said Ingmar Bruns, M.D., Chief Medical Officer of Zentalis. “With DENALI Part 2 progressing toward a year-end readout that may support accelerated approval and
“The depth, durability, and consistency of responses observed across both the total population and BTKi-treated subsets underscore iopofosine’s potential as a meaningful new treatment option in WM and differentiate it from currently available therapies,” said Jarrod Longcor, chief operating officer of Cellectar Biosciences. “With the completion of at least 12-month