Orphan Drug Designation for IMM-1-104 by FDA in the Treatment of Pancreatic Cancer
“The FDA’s granting of orphan drug designation for IMM-1-104 underscores the urgent need for new therapies that meaningfully improve outcomes for pancreatic cancer patients and represents an important milestone in the development of our lead asset,” said Ben Zeskind, Ph.D., Co-Founder and CEO of Immuneering. “I believe our recently announced positive initial Phase 2a data, from our arm investigating IMM-1-104 in combination with modified gemcitabine/nab-paclitaxel in pancreatic cancer, speaks to IMM-1-104’s potential to improve upon the current standard of care in this indication. Importantly, in the same trial we are also studying IMM-1-104 in combination with modified FOLFIRINOX, as well as in monotherapy for pancreatic cancer. We look forward to providing initial data from at least one additional arm of the Phase 2a portion of our Phase 1/2a trial before the end of the year.”
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
