ROCKVILLE, Md.--(BUSINESS WIRE)--NeoImmuneTech, Inc., a clinical-stage T cell-focused biopharmaceutical company, today announced it has entered into a clinical collaboration agreement with Bristol Myers Squibb (NYSE: BMY) to evaluate the combination of NeoImmuneTech’s NT-I7 (also known as Hyleukin-7™), a long-acting IL-7, and Bristol Myers Squibb’s Opdivo® (nivolumab), a PD-1 blocking antibody.
The goal of the Phase 2 study is to establish safety and tolerability, and to evaluate preliminary anti-tumor activity of the combination in subjects with advanced or metastatic gastric, gastro-esophageal junction (GEJ), or esophageal adenocarcinoma (EAC). The results of this study will be used to further clinical development of this combination in these tumor types.
“According to the American Cancer Society1, approximately 46,000 Americans will be diagnosed with gastric and/or esophageal cancers in 2020, and 27,200 will die from these devastating diseases,” said NgocDiep Le, M.D., Ph.D., Executive VP and Chief Medical Officer of NeoImmuneTech (NIT). “This Phase 2 trial is based on the scientific rationale and results of preclinical studies demonstrating that NT-I7, our unique T-cell amplifier, worked synergistically with checkpoint inhibitors such as Opdivo® to broaden and deepen the anti-tumor response.”
Se Hwan Yang, Ph.D., President and Chief Executive Officer of NIT, added: “The clinical collaboration between NeoImmuneTech and Bristol Myers Squibb is based on our shared commitment to developing new therapeutic options that could improve outcomes for patients living with serious diseases such as gastric, GEJ or esophageal cancers. Further, it strengthens NIT’s position as pioneers of T cell-centered immuno-oncology therapeutics by focusing on enhanced clinical outcomes through a novel mechanism of action.”
Under the terms of the agreement, NeoImmuneTech will be the sponsor of the trial and Bristol Myers Squibb will supply nivolumab for use in the study. While the first study will focus on gastric/GEJ/EAC cancers, under the terms of this Master Clinical Trial Collaboration Agreement, the two companies may conduct additional combination trials in the future.
Opdivo® is a registered trademark of Bristol Myers Squibb.
NT-I7 (also known as Hyleukin-7™) is the only clinical-stage long-acting human IL-7 and is uniquely positioned to address unmet medical needs in immuno-oncology. IL-7 is a fundamental cytokine for naïve and memory T-cell development and for sustaining immune response to chronic antigens (as in cancer). NT-I7\'s exhibits a favorable PK/PD and safety profiles, making it an ideal combination partner for immunotherapy standard of care (SOC) such as Checkpoint Inhibitor and CAR-T therapies. NT-I7 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.
NeoImmuneTech, Inc. (NIT) is a clinical-stage T cell-focused biopharmaceutical company, dedicated to expanding the horizon of immuno-oncology. NIT is led by the scientific founder and inventor of NT-I7 and complemented by a strong executive team with rich industry experience at companies such as Novartis, Bristol Myers Squibb, GSK, Pfizer, Amgen, Eli Lilly, MedImmune/AstraZeneca and PwC. NIT is expanding rapidly in personnel and operations, as well as partnering with industry and academic leaders to investigate NT-I7 in combination with various immunotherapeutics. For more information, please visit www.neoimmunetech.com.
1 American Cancer Society: Cancer Facts and Figures 2020. Atlanta, Ga: American Cancer Society, 2020. Available online. Last accessed January 17, 2020.