Fast Track Designation Granted for VMT01 for the Diagnosis & Treatment of MC1R-Positive Melanoma
“We are pleased with the FDA’s recognition of the need for additional treatment options for patients with metastatic melanoma,” said Dr. Markus Puhlmann, Perspective Therapeutics’ Chief Medical Officer. “We are dedicated to working closely with the agency to accelerate VMT01’s clinical development. Having recently completed the observation period for dose limiting toxicity in seven patients enrolled in Cohort 2 of our Phase 1/2a study, we look forward to sharing safety observations with the Safety Monitoring Committee (“SMC”) and in a scientific forum later this year. Additionally, pending institutional review board approval, we plan to open a VMT01/anti-PD-1 combination cohort.”
Share:
More News
“Antengene announced it has entered into a global clinical collaboration with MSD to evaluate the combination of ATG-022, a CLDN18.2-targeting antibody-drug conjugate (ADC), and MSD’s anti-PD-1 therapy, KEYTRUDA® (pembrolizumab) in patients with advanced solid tumors. At the 2025 American Society of Clinical Oncology Gastrointestinal Cancers Symposium (ASCO GI 2025), Antengene
“Advanced esophageal squamous cell carcinoma is a difficult-to-treat disease, and unfortunately overall survival remains low,” said Marjorie Green, MD, senior vice president and head of oncology, global clinical development, Merck Research Laboratories. “The initiation of the pivotal Phase 3 IDeate-Esophageal01 clinical trial demonstrates our shared commitment with Daiichi Sankyo to
“Overall response rate (ORR) was 97% (114/117) with a complete response/stringent complete response (CR/sCR) rate of 68% (79/117) and a very good partial response or higher (>VGPR) rate of 85% (100/117), per International Myeloma Working Group (IMWG) criteria as investigator-assessed. Of those evaluable for minimal residual disease (MRD) testing at
“EMA approval of the MIRACLE trial protocol is a huge milestone for us. Although we’re already seeing recruitment in our first non-EU country, we believe that this expansion into the EU really supercharges our recruitment potential,” said Walter Klemp, Chairman and CEO of Moleculin. “Importantly, when combined with the sites
