CHICAGO, March 14, 2022 — PRNewswire — SIWA Therapeutics, Inc. (“SIWA”), a Chicago-based biopharmaceutical company announced today that SIWA’s proprietary humanized monoclonal antibody, SIWA318H, is efficacious in an immune competent humanized mouse xenograft model for pancreatic cancer. The study was conducted by the Translational Genomics research Institute (“TGEN”), pursuant to a SIWA-sponsored research agreement.
Results of the pancreatic cancer study in humanized mice treated with SIWA318H included:
- Both the SIWA318H high dose and low dose treatment groups showed significant anti-tumor activity in a PSN1 human pancreatic cancer mouse xenograft tumor model by significantly reducing tumor growth (P-Value < 0.0001);
- There was a significantly higher number of complete remission cases in the treated groups compared to the isotype-treated control group.
- 37.5% (6 out of 16 mice) treated with SIWA318H high dose had a complete remission response; (P-value = 0.0325)
- 43.8% (7 out of 16 mice) treated with SIWA318H low dose had a complete remission response; (P-value = 0.0143)
- SIWA318H treated mice had a favorable overall survival of more than 45 days compared to only 26 days of median overall survival for control animals, strongly suggesting potential clinical benefit for the treatment of pancreatic cancer in humans.
- There were no significant differences in body weight changes between the control and treatment groups, indicating SIWA318H at the doses used were well-tolerated.
“We are very pleased with the findings of SIWA318H in this study and what this means in the fight against cancer,” said Lewis Gruber, CEO and Chief Scientific Officer of SIWA. “SIWA has developed a two-pronged attack on cancer by using SIWA318H to clear cancer cells as well as the senescent cells in the tumor micro-environment that support them. We believe this ability to target both cancer cells and senescent cells makes SIWA318H a comprehensive immunotherapy for virtually all cancers as well as for stopping cancer progression, metastasis, and relapse.”
SIWA indicated that based upon its results with pancreatic cancer and metastasis, and based upon results showing statistically significant reduction in lung metastases in a 4T1 mouse model of triple negative breast cancer using a mouth homolog of SIWA318H (P-value ≤ 0.001), it expects to file its first IND with the FDA in 2023 for pancreatic cancer. It also expects to request that the FDA grant a FastTrack designation.