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Phase 1b/2a study will evaluate the safety and efficacy of the combination of Hyleukin-7™ (NT-I7) and KEYTRUDA® (pembrolizumab) in patients with Relapsed/Refractory Advanced Solid Tumors

December 11, 2019 08:30 AM Eastern Standard Time

ROCKVILLE, Md.--()--NeoImmuneTech, Inc., a clinical-stage T cell-focused biopharmaceutical company, announced today it has entered into a clinical collaboration agreement with Merck, known as MSD outside of the United States and Canada, through a subsidiary, to evaluate the combination of NeoImmuneTech’s Hyleukin-7™ (NT-I7) and Merck’s anti-PD-1 therapy, KEYTRUDA® (pembrolizumab) in a basket study in patients with relapsed/refractory (R/R) advanced solid tumors.

The goal of the Phase 1b/2a study is to establish a recommended dosing regimen and explore the preliminary anti-tumor activity of the combination in patients with both checkpoint inhibitor (CPI)-treated and CPI-naïve R/R tumors. The results of this study will be used to further clinical development of this combination in select tumor types.

Although immunotherapy has become the new paradigm in cancer treatment, the majority of patients fail to respond. For tumors that are considered non-responsive to CPIs, such as microsatellite stable colorectal cancer and pancreatic cancer, the response to single-agent CPI has been low,” said NgocDiep Le, M.D., Ph.D., NIT’s Executive VP and Chief Medical Officer. “Since immunotherapies rely heavily on the anti-tumor activity of T cells, Hyleukin-7’s demonstrated ability to increase multiple T-cell subsets potentially enhances the breadth and depth of the response to CPIs such as KEYTRUDA®.”

Se Hwan Yang, Ph.D., NIT’s Co-President and Chief Executive Officer, added: “We are excited to partner with Merck in our endeavor to provide new treatment options for patients whose tumors do not respond to CPIs or have progressed after CPI treatment. This combination approach could open the door to expanding the use of immunotherapy to these patients and ultimately improve clinical outcomes.”

KEYTRUDA® is a registered trademark of Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc., Kenilworth, N.J., USA.


About Hyleukin-7™
Hyleukin-7™ (NT-I7), the only clinical-stage long-acting human IL-7, is uniquely positioned to address unmet medical needs in immuno-oncology. IL-7 is a fundamental cytokine for T-cell development and for sustaining immune response to chronic antigens (as in cancer). Hyleukin-7's favorable PK/PD and safety profiles make it an ideal combination partner for immunotherapy standard of care (SOC) such as Checkpoint Inhibitor and CAR-T therapies. Hyleukin-7 is being studied in multiple clinical trials in solid tumors, and being planned for testing in hematologic malignancies, additional solid tumors and other immunology-focused indications.


About NeoImmuneTech
NeoImmuneTech, Inc. (NIT) is a clinical-stage T cell-focused biopharmaceutical company dedicated to expanding the immuno-oncology frontier with Hyleukin-7 and beyond. NIT is partnering with industry and academic leaders to investigate Hyleukin-7 in combination with various immunotherapeutics. For more information, please visit www.neoimmunetech.com.


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