FDA Clears IND Application for UB-VV111, a CD19 Directed in situ CAR-T for Heme Malignancies

“The IND clearance for UB-VV111 is a significant milestone in Umoja’s mission to develop off-the- shelf therapies that overcome the limitations of current ex vivo cellular immunotherapies,” said Andrew Scharenberg, M.D., Co-Founder and Chief Executive Officer of Umoja. “We are proud to be a leader of the in vivo space, aiming to remove many of the barriers and challenges of early- generation ex vivo CAR T-cell therapies, from the difficult, lengthy, and costly manufacturing process to the arduous administration experience. Physicians and patients have been waiting for something better and we are excited to initiate our first clinical trial.”

Share:

More News

“The eNRGy study highlights that NRG1 fusions are an actionable therapeutic target and the importance of developing biomarker-driven therapies like zenocutuzumab,” said Debasish Roychowdhury, MD, Chief Technology Officer at Partner Therapeutics. “We are deeply grateful to the Merus team that designed, researched and developed zenocutuzumab, the eNRGy trial investigators, and

Pnina Fishman, CSO & Chairperson of Can-Fite BioPharma, commented: “We are pleased to offer this compassionate use program with Namodenoson for eligible patient in the US to address the unmet medical needs for pancreatic cancer. Initiating this program is another milestone achieved for Namodenoson, and concurrently to our ongoing Phase

“We are deeply disappointed by these results from our Phase 1 trial. Despite continuing to demonstrate differentiated safety as a more combinable ADC, updated efficacy data suggest that treatment with EO-3021 does not meet our bar for success and is insufficient to provide patients a competitive benefit-risk profile compared to

Søren Bregenholt, CEO of Alligator, commented: “The FDA’s recognition of HLX22/AC101’s potential with Orphan Drug Designation is a notable recognition. While Alligator’s is not directly involved in the development of HLX22/AC101, we continue to follow its progress as it potentially represents future income to Alligator.”