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
PharmaMar has submitted a Marketing Authorization Application to the European Medicines Agency for Zepzelca® (lurbinectedin) in combination with atezolizumab (Tecentriq®) for the maintenance treatment of adult patients with extensive-stage small cell lung cancer, whose disease has not progressed after first-line induction therapy with atezolizumab, carboplatin and etoposide. The MAA submission
“At SR One, our mission is to invest in companies that we believe have the ability to innovate and advance transformational new therapies in areas of high unmet medical need,” said Simeon George, M.D., Chief Executive Officer and Managing Partner at SR One. “Fore Bio is focused on resetting the
The study demonstrated a statistically significant and clinically meaningful improvement in the primary endpoint of TACE-progression-free survival (TACE PFS*), and the other primary endpoint of overall survival (OS) is immature at the prespecified first interim analysis. Meanwhile, a clinically meaningful PFS by RECIST v1.1** was also observed. Detailed findings from
“The positive CHMP recommendation for the Itovebi-based regimen represents a significant step towards providing people in the EU with PIK3CA-mutated, ER-positive advanced breast cancer with a targeted therapy in the first-line setting,” said Levi Garraway, M.D., Ph.D., Roche’s Chief Medical Officer and Head of Global Product Development. “This recommendation is
