Top-line Data from Ph 2b Trial of IGV-001 in Newly Diagnosed GBM Announced

“Today marks a pivotal moment for both Imvax and for the people affected by ndGBM. For the past decade, the Imvax team has been dedicated to advancing the development of IGV-001, and the results from this Phase 2b study bring us meaningfully closer to achieving that goal. Thanks to the strong support of our investors, Imvax has the resources and expertise to execute on a clear strategy for IGV-001,” said John P. Furey, Executive Chair of the Imvax Board of Directors. “We are preparing to meet with FDA to discuss the regulatory pathway for IGV-001 and what we believe is a strongly positive risk-benefit profile, especially given the large unmet medical need in ndGBM. Finally, we are profoundly grateful to the investigators, patients, and their families for their commitment to this study.”

Share:

More News

“From the outset, our goal has been to build a discovery engine that systematically unlocks high-value, challenging targets and delivers first-in-class precision medicines,” said Adam Friedman, M.D., Ph.D., Chief Executive Officer of Antares. “This collaboration lets us scale that engine alongside Novartis’ world-class development capabilities and global reach, so we

“We are very pleased that the iDMC has recommended continuation of the landmark OVATION 3 clinical trial without modification, representing another important validation of the remarkable efficacy and safety data previously reported and further indicating the potential for IMNN-001 to represent a historic advance in the treatment of ovarian cancer,”

“VS-7375 has demonstrated anti-tumor activity across multiple dose levels and tumor types, encouraging signals from rational combination strategies, and a favorable safety profile that improves meaningfully beyond the first treatment cycle, underscoring its potential to be not only the best-in-class oral KRAS G12D inhibitor, but also the preferred treatment option

“We are pleased that the FDA has demonstrated urgency in reconsidering the RP1 BLA with an expeditious action date in recognition of the significant unmet need for advanced melanoma patients and support from the broader melanoma community,” said Sushil Patel, Ph.D., CEO of Replimune. “We look forward to a productive