24/7 Market News- FDA Grants Immuneering Orphan Drug Designation for IMM-1-104 in the Treatment of Pancreatic Cancer
DENVER, Colo., Oct 15, 2024 (247marketnews.com)- Immuneering (NASDAQ: IMRX) reported that the U.S. Food and Drug Administration (FDA) granted orphan drug designation to IMM-1-104 for pancreatic cancer treatment.
IMM-1-104 is currently in a Phase 2a clinical trial in patients with advanced solid tumors, including pancreatic cancer, in which positive initial response data was recently reported for first line pancreatic cancer patients treated in combination with modified gemcitabine/nab-paclitaxel.
Ben Zeskind, Ph.D., Immuneering’s Co-Founder and CEO, commented, “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,
“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.”
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