Orphan Drug Designation by US FDA for MB-108 (HSV-1 oncolytic virus) to Treat Malignant Glioma
Manuel Litchman, M.D., President and Chief Executive Officer of Mustang, said, “The Orphan Drug Designation for MB-108 is significant for Mustang, as it could provide additional market exclusivity and we hope to advance MB-108, in combination with MB-101, as a potential treatment option for patients living with malignant glioma, including patients with recurrent glioblastoma (“GBM”) and high-grade astrocytomas, where there is historically a median overall survival of six months. Our novel therapeutic strategy, combining our MB-108 oncolytic virus with MB-101 CAR-T cell therapy, could be the first-ever industry-sponsored trial of its kind for the treatment of malignant glioma. As such, Mustang plans to also request Orphan Drug Designation from the FDA for MB-101 (IL13Rα2‐targeted CAR-T cell therapy) in malignant gliomas. These advancements highlight our dedication to potentially improving outcomes for patients battling difficult-to-treat cancers.”
Share:
More News
David Gauden DPhil, CEO of Blue Earth Therapeutics said, “This is an important step forward in the development of Lutetium (177Lu) rhPSMA-10.1 injection and builds on the strong data seen in the Phase 1 clinical trial. Commencement of treatment of patients at full intended therapeutic dosing levels provides a great
Susan Galbraith, Executive Vice President, Oncology Haematology R&D, AstraZeneca, said: “The clinically meaningful improvement in pathologic complete response and the safety data seen in DESTINY-Breast11 highlight the potential of Enhertu to challenge the current standard of care in early-stage HER2-positive breast cancer. Enhertu is already an important treatment option in
“This clinical trial and the FDA clearance represents a pivotal milestone in our mission to develop precise, data-driven cancer therapies for patients with limited treatment options,” said Panna Sharma, President and CEO of Lantern Pharma. “The STK11 and KEAP1 mutant NSCLC population represents an important market opportunity and, a group
“The growing body of evidence supporting combinations of ADCs and immunotherapies is encouraging, including the recent success of the ASCENT-04 trial combining sacituzumab govitecan with pembrolizumab in metastatic TNBC,” said Steven Isakoff, M.D., Ph.D., Medical Oncologist and Director of Breast Cancer Clinical Research at Massachusetts General Hospital. “Invikafusp alfa is
