On July 20, 2020 NeoImmuneTech, Inc., a clinical-stage T cell-focused biopharmaceutical company, reported that the U.S. Food and Drug Administration (FDA) has cleared its investigational new drug (IND) application for the combination of NeoImmuneTech’s NT-I7 (efineptakin alfa), a novel long-acting human interleukin-7 (IL-7), and Bristol Myers Squibb’s Opdivo (nivolumab), a PD-1 blocking antibody, for the treatment of patients with advanced or metastatic gastric, gastro-esophageal junction (GEJ), or esophageal adenocarcinoma (EAC) (Press release, NeoImmuneTech, JUL 20, 2020, View Source [SID1234562139]). This IND clearance allows NeoImmuneTech (NIT) to initiate a randomized Phase 2 study comparing NT-I7 + nivolumab versus nivolumab to evaluate preliminary anti-tumor activity and to establish safety and tolerability of the combination in these patients.
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"This new clearance marks another key milestone in our rapidly expanding clinical program of NT-I7, our unique T cell amplifier. NT-I7’s excellent safety profile and function as an immune enhancer can potentially broaden and deepen the anti-tumor response in combination with checkpoint inhibitors such as Opdivo," said NgocDiep Le, MD, PhD, Executive Vice President and Chief Medical Officer of NIT. "At present, there are only limited treatment options available for patients with advanced gastric cancer after failure of two prior treatments. We look forward to initiating the study as soon as possible to address high unmet medical need in these patient populations."
The results of this Phase 2, proof-of-principle study will be used to further clinical development of this combination in selected clinical settings and tumor types.
"As a company, we work tirelessly to expand our development of NT-I7, both as a single agent and in combination with current immunotherapeutics where it has the potential to further expand the patient populations that could benefit from such therapies," said Se Hwan Yang, PhD, President and Chief Executive Officer of NIT. "NT-I7 is uniquely positioned to support such immunotherapy treatments, as it may be able to increase the number and diversity of T cells that are activated by checkpoint inhibition to fight cancer more effectively. We hope that our dedication and effort can bring NT-I7 to patients in need in the foreseeable future."
Opdivo is a registered trademark of Bristol Myers Squibb.
About NT-I7
NT-I7 (efineptakin alfa) is the only clinical-stage long-acting human IL-7, and is being developed for oncologic and immunologic indications, in which T-cell amplification and increased functionality may provide clinical benefit. IL-7 is a fundamental cytokine for naïve and memory T-cell development and for sustaining immune response to chronic antigens (as in cancer) or foreign antigens (as in infectious diseases). NT-I7 exhibits favorable PK/PD and safety profiles, making it an ideal combination partner. NT-I7 is being studied in multiple clinical trials in solid tumors and as a vaccine adjuvant. Studies are being planned for testing in hematologic malignancies, additional solid tumors and other immunology-focused indications.