NeoImmuneTech Announces First Patient Dosed in Phase 2 Study of NT-I7 (efineptakin alfa) with PD-L1 Checkpoint Inhibitor in High-Risk Skin Cancers

On February 7, 2022 NeoImmuneTech, Inc. (KOSDAQ: 950220), a clinical-stage T cell-focused biopharmaceutical company, reported that the first patient has been dosed in the Phase 2a portion of a study evaluating NT-I7 (efineptakin alfa), a novel long-acting human interleukin-7 (IL-7), in combination with the PD-L1 targeting drug atezolizumab (Tecentriq), in patients with advanced high-risk skin cancers including melanoma, merkel cell carcinoma (MCC), and cutaneous squamous cell carcinoma (cSCC) (Press release, NeoImmuneTech, FEB 7, 2022, View Source [SID1234607804]).

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All three of these skin cancers can grow rapidly and have the potential to be fatal if left untreated. While cSCC is considered a more treatable form of skin cancer, it affects millions of patients per year in the U.S. alone and represents up to 50% of all skin cancer cases. Melanoma and MCC are less common forms of skin cancer, but they are notable for spreading rapidly and carrying a high risk for recurrence. Skin cancer is the most common form of cancer in the U.S., accounting for more diagnoses than all other cancers combined1.

"We are excited to move into the Phase 2 portion of this important clinical trial, now that the safety and tolerability of the combination has been demonstrated," said Se Hwan Yang, Ph.D., President and CEO of NIT. "NT-I7’s established ability to amplify T cells coupled with its excellent safety profile gives us great confidence that combinations with checkpoint inhibitor therapies like atezolizumab could improve clinical outcomes. We look forward to watching this next phase of the trial unfold and potentially set the foundation for a new immunotherapeutic option for the many patients living with these forms of skin cancer."

This open-label, multicenter Phase 2a study will evaluate the safety, tolerability and anti-tumor effect of the combination therapy. Roche will supply NeoImmuneTech with atezolizumab for the clinical trial. More information can be found at www.neoimmunetech.com or www.clinicaltrials.gov, identifier: NCT03901573.

Tecentriq (atezolizumab) is a registered trademark of Genentech, a member of the Roche Group.

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 enhanced 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). In clinical trials to date, NT-I7 has exhibited favorable PK/PD and safety profiles, both as a monotherapy and in combination with other anticancer treatments. 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.