HOUSTON, Nov. 18, 2015 /PRNewswire/ -- Memgen, LLC announced the presentation of preclinical results for its lead product, ISF35, during the 30th Annual Meeting of the Society of Immunotherapy of Cancer (SITC) in National Harbor, Maryland. The research was led by Willem Overwijk, Ph.D. and Manisha Singh, Ph.D. of The University of Texas MD Anderson Cancer Center in Houston, TX.
A poster presentation, entitled Induction of Potent Systemic Anti-Melanoma Immunity through Intratumoral CD40 Activation and Checkpoint Blockade, described results from preclinical studies in mice bearing established B16 melanomas treated intratumorally with a replication defective adenovirus encoding the chimeric immunostimulatory protein ISF35. Additional results evaluating ISF35 treatment combined with anti-PD-1 and anti-CTLA-4 blocking antibodies were also presented.
Intratumoral administration of ISF35 generated CD8 T-cell-directed anti-tumor immunity in both injected and distal non-injected tumors in mice, with tumor growth inhibition and regression. Furthermore, combining ISF35 with anti-PD-1 was highly synergistic and induced even greater numbers of melanoma-specific CD8 T cells. Finally, concomitant treatment of mice with the triple combination of ISF35/anti-PD-1/anti-CTLA-4 further improved the efficacy of treatment and led to complete regression of the melanoma tumors in approximately 50% of mice in addition to generation of memory CD8 T cell responses.
"There have been significant advances in the survival and treatment of many cancer types with immune-oncology (IO) drugs, primarily as monotherapy with checkpoint inhibitors," said Mark Cantwell, PhD, Memgen President and co-inventor of ISF35. "With the next wave of clinical development aiming to find the right combinations of IO drugs that improve patient outcomes while still keeping a tolerable safety profile, the preclinical results provide strong support that ISF35 in combination with checkpoint inhibitors can achieve this goal. We look forward to soon beginning a phase I/II clinical trial of ISF35 and Keytruda (pembrolizumab) in refractory metastatic melanoma. This trial will be an important step in identifying synergistic combinations that will enhance checkpoint immunotherapies."
Memgen's lead product, ISF35, is a first-in-class, T-cell cancer immunotherapy that promotes an anti-tumor immune response. This immuno-oncology (IO) drug can be combined with checkpoint inhibitors to potentially treat a broad range of cancer types, including but not limited to lung cancer, metastatic melanoma, and hepatocellular carcinoma.
A phase I/II clinical trial of ISF35 and Keytruda (pembrolizumab) in refractory metastatic melanoma is planned. Memgen is actively seeking a partner interested in developing and bringing ISF35 to market. ISF35 has worldwide patent protection and also qualifies for twelve years of US biologics marketing exclusivity and orphan drug designation in multiple indications. www.memgenbio.com.
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