On January 25, 2022 Immix Biopharma, Inc. (Nasdaq: IMMX) ("ImmixBio", "Company", "We" or "Us"), a biopharmaceutical company pioneering Tissue-Specific Therapeutics (TSTx) targeting oncology and immuno-dysregulated diseases, reported data showing that IMX-110 + anti-PD-1 produced 63-day median survival in a genetic pancreatic cancer mouse model in which mice develop their own pancreatic cancer and have an intact immune system (Press release, Immix Biopharma, JAN 25, 2022, View Source [SID1234606772]). Historically, according to Winograd et al., 2015, 42-days is the median survival produced by a 4-drug combination: 2 chemotherapies (gemcitabine, nab-paclitaxel) and 2 immunotherapies (anti-PD-1, anti-CD40) in the same genetic pancreatic cancer mouse model.
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"This data highlights why we are excited to collaborate with BeiGene on our planned 2022 Phase 1b/2a combination clinical trial of IMX-110 + BeiGene anti-PD-1 tislelizumab in advanced solid tumors," said Ilya Rachman, MD PhD, CEO of ImmixBio. "We believe this upcoming combination clinical trial will allow us to rapidly expand into multiple oncology indications."
The U.S. Food and Drug Administration ("FDA") has approved orphan drug designation ("ODD") for IMX-110 for the treatment of soft tissue sarcoma. Additionally, the FDA has approved rare pediatric disease ("RPD") designation to IMX-110 for the treatment of a life-threatening pediatric cancer in children, rhabdomyosarcoma.
In January 2021, BeiGene and Novartis entered into a collaboration and license agreement granting Novartis rights to develop, manufacture, and commercialize anti-PD-1 tislelizumab in North America, Europe, and Japan in exchange for an upfront payment by Novartis of US$650 million plus royalties and milestone payments.
As of January 2022, anti-PD-1 tisleizumab has been approved or granted conditional approval in 6 cancer indications in China, including non-squamous non-small cell lung cancer ("NSCLC"), squamous NSCLC, classical Hodgkin’s lymphoma, Hepatocellular Carcinoma, and urothelial carcinoma.