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NeoImmuneTech Receives U.S. FDA IND Clearance for Phase 2 Study of NT-I7 (efineptakin alfa) in combination with PD-L1 checkpoint inhibitor in First-line Non-small Cell Lung Cancer

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NeoImmuneTech, Inc., a clinical-stage T cell-focused biopharmaceutical company, today announced that the U.S. Food and Drug Administration (FDA) has cleared its investigational new drug (IND) application for the combination of its lead drug candidate, NT-I7 (efineptakin alfa), a novel long-acting human interleukin-7 (IL-7), and atezolizumab (Tecentriq®) for the treatment of patients with previously untreated, PD-L1-expressing, locally advanced or metastatic non-small cell lung cancer (NSCLC). This IND clearance allows NeoImmuneTech (NIT) to initiate a multicenter Phase 2 study evaluating the anti-tumor efficacy and safety of NT-I7 in combination with atezolizumab as a first-line (1L) treatment for NSCLC.

NSCLC accounts for 80-85% of all cases of lung cancer, which is the most commonly diagnosed cancer worldwide, with an estimated 2.1 million new cases in 2018 globally. It is also the leading cause of cancer death in most countries, with an estimated 1.76 million lung cancer deaths occurred in 2018 worldwide. Atezolizumab monotherapy has been approved as 1L treatment for metastatic NSCLC patients with high PD-L1 expression, while the combinations of atezolizumab with chemotherapies and with or without bevacizumab (Avastin®) have been approved for 1L treatment of metastatic non-squamous NSCLC regardless of PD-L1 expression.

"There is a clear need for new chemo-free treatment options for patients with NSCLC, and we are pleased to combine our NT-I7 with one of the field's leading cancer therapeutics as a potential treatment for 1L NSCLC," said NgocDiep Le, M.D., Ph.D., Executive Vice President and Chief Medical Officer of NIT. "NT-I7 has the potential to address multiple immune resistance mechanisms; therefore, we believe that adding NT-I7 to atezolizumab may provide clinical benefit to NSCLC patients with lower level of PD-L1 expression as well as increase the depth and breadth of the response to single-agent atezolizumab."

Se Hwan Yang, Ph.D., President and Chief Executive Officer of NIT, added "NT-I7's unique ability to amplify and increase the functionality of T cells and exhibition of favorable safety profile make it an excellent combination partner with atezolizumab. Based on strong scientific rationale and preclinical data, we anticipate that this chemo-free combination therapy could significantly improve clinical outcomes for NSCLC patients who do not benefit from or cannot tolerate currently available treatments."

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 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.

About NeoImmuneTech

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 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. For more information, please visit www.neoimmunetech.com.

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