NeoImmuneTech, Inc. announced 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). 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 combined. 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. Tecentriq® (atezolizumab) is a registered trademark of Genentech, a member of the Roche Group. 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. NeoImmuneTech, Inc. (NIT) is a clinical-stage T cell-focused biopharmaceutical company, dedicated to expanding the horizon of immuno-oncology and enhancing immunity to infectious diseases. NIT is led by the scientific founder and inventor of NT-I7 (efineptakin alfa) and complemented by a strong executive team with rich industry experience at companies such as Novartis, BMS, 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 as monotherapy and in combination with various immunotherapeutics.