Alphageneron Announces Successful Completion of FDA Pre-IND Meeting of Proposed Phase II Clinical Trial for NK Cell Therapy with Advanced (stage III & Stage IV) NSCLC Patients

CAMBRIDGE, Mass., Oct. 18, 2021 (GLOBE NEWSWIRE) — Alphageneron Pharmaceuticals, Inc. (“Alphageneron” or the “Company”), a clinical stage pharmaceutical company with a robust product portfolio of autologous and allogeneic natural killer (“NK”) cell, allogeneic CAR NK cell and antibody-based therapies targeting highly resistant tumors and viral infections, announces the successful completion of a pre-IND (“Investigational New Drug”) meeting with the U.S. Food and Drug Administration (“FDA”) regarding a proposed multi-site Phase II Clinical Trial plan for its ENKASTIM™ autologous NK cell therapy for treating advanced (stage III and stage IV) non-small cell lung cancer (“NSCLC”).   “We are delighted with the outcome of the Pre-IND meeting with the US FDA which was supported by clinical data from a prior Phase II Clinical Trial involving patients with advanced (stage IIIb) NSCLC in Germany. Although the number of patients was small, the prior Phase II Clinical Trial demonstrated the therapy was safe and had promising signs of efficacy in the most commonly diagnosed cancer and the leading cause of cancer deaths worldwide.” The pre-IND meeting was supported by two previously completed clinical trials in Germany, both approved by the Paul Ehrlich Institute (German ‘FDA’). A Phase I clinical trial conducted with eleven (11) metastatic colorectal cancer patients and one (1) NSCLC patient who received ENKASTIM™ after Standard of Care (SOC), demonstrated safety and signs of efficacy. A Phase IIa clinical trial (randomized, controlled) involving fourteen (14) patients with advanced (Stage IIIb) NSCLC reported that of the seven (7) patients treated with ENKASTIM™ after SOC radio-chemotherapy, five (5) patients experienced a clinical benefit (71%), including one complete response (CR) and one partial response (PR). In the control group of seven (7) patients who received SOC RCT alone, only two (2) patients experienced a clinical benefit. One of the patients who received ENKASTIM™ after SOC and went on to receive OPDIVO® (nivolumab), a PD-1 checkpoint inhibitor, achieved 33 months of Progression-free survival (PFS). This contrasts with a median survival of 9 months for historic controls.1, 2 “We are delighted with the outcome of the Pre-IND meeting with the US FDA which was supported by clinical data from a prior Phase II Clinical Trial involving patients with advanced (stage IIIb) NSCLC in Germany. Although the number of patients was small, the prior Phase II Clinical Trial demonstrated the therapy was safe and had promising signs of efficacy in the most commonly diagnosed cancer and the leading cause of cancer deaths worldwide.” said A. Graham Pockley, PhD, Chief Scientific Officer of Alphageneron. ”Based upon our recent FDA interaction, we are working diligently to finalize the protocol design to initiate our first multi-site Phase II Clinical Trial to treat patients with advanced (stage III and IV) NSCLC in 2022, an important milestone for the company.” added Robert K. Brooks, JD, Chairman and Chief Executive Officer of Alphageneron. Alphageneron is preparing to file an IND for a large (up to n=250) multi-site open label First In Class Phase IIa Clinical Trial administering ENKASTIM™ autologous NK Cell Therapy, after SOC, in two cohorts of Advanced NSCLC patients, namely Cohort A, patients with (stage IV) metastatic NSCLC; and, Cohort B, patients with advanced (stage III) NSCLC. The FDA’s Pre-IND teleconference meeting and written response suggestions help define the IND protocol for a proposed Phase II clinical study that could lead to future clinical registration trials or towards commercial approval. “I am excited about the potential for this proposed Phase II clinical trial of ENKASTIM™ NK cell therapy to address a significant unmet clinical need for patients with metastatic or advanced NSCLC,” stated Yanis Boumber, MD, PhD, Associate Professor, a Thoracic, Head & Neck Medical Oncologist at Feinberg School of Medicine, Northwestern University, Chicago, IL, and a Scientific Advisor to Alphageneron. About Advanced NSCLC Lung cancer is the leading cause of cancer-related mortality in the world. In 2020, over 2 million people were diagnosed with lung cancer, and 1.8 million died of the disease (WHO). An estimated 85% of lung cancer is NSCLC. When NSCLC is diagnosed as stage III or stage IV, it is considered advanced; and, 40% of NSCLC patients present at an advanced stage. There remains a high unmet clinical need to improve the treatment of advanced NSCLC that has a poor prognosis. The global market for NSCLC therapeutics was $16B in 2018 and is expected to reach $42B by 2025 (Fortune Business Insights). About ENKASTIM™ NK Cell Therapy ENKASTIM™ is an autologous unmodified NK cell therapy that activates the patient’s own NK cells to target cancers expressing membrane Hsp70 (“mHsp70”), a cancer-specific biomarker which is highly expressed on malignant cancer cells, but not on normal cells. ENKASTIM™ is manufactured by ex vivo incubation of a patient’s peripheral blood mononuclear cells (“PBMCs”), obtained by leukapheresis in an out-patient setting, with a patented Hsp70-derived synthetic peptide (named “TKD”) and low-dose interleukin-2 (“IL-2”) for under five (5) days, after which the cells are reinfused into the patient. About Alphageneron Pharmaceuticals Alphageneron is a privately held clinical-stage biopharmaceutical company developing autologous and allogeneic natural killer (NK) cell, allogeneic Chimeric Antibody Receptor (CAR) NK cell, and antibody-based cancer therapeutics, all supported by a Companion Diagnostic. In 2020, Alphageneron signed an Exclusive Option to Purchase Agreement with Multimmune, GmbH, Munich, Germany; as well as, an Exclusive License Agreement, of its therapeutic and diagnostic technology, for all indications worldwide. Forward-looking Statement Statements in this message that are not based on historical or current facts, and constitute “forward-looking statements” within the meaning of the U.S. Private Securities Litigation Reform Act of 1995. Such forward-looking statements involve known and unknown risks, uncertainties and other factors that may cause the actual results, events or developments to be materially different from any future results, events or developments expressed or implied by such forward-looking statements. Although Alphageneron believes that expectations conveyed by the forward-looking statements are reasonable based on the information available to it on the date such statements were made, no assurances can be given as to the future results, approvals or achievements. Given these uncertainties, readers are cautioned not to place undue reliance on such forward-looking statements, and should assume the Company has no obligation to update forward-looking statements except as otherwise required by applicable law. 1Krause SW, Gastpar R, Andreesen R, Gross C, Ullrich H, Thonigs G, et al. Treatment of colon and lung cancer patients with ex vivo heat shock protein 70-peptide-activated, autologous natural killer cells: A clinical phase I trial. Clin Cancer Res (2004) 10:3699-3707. 2Multhoff G, Seier S, Stangl S, Sievert W, Shevtsov M, Werner C, et al. Targeted natural killer cell based adoptive immunotherapy for the treatment of patients with NSCLC after radiochemotherapy – a randomized phase II clinical study. Clinical Cancer Research (2020) 26:5368-5379. doi:10.1158/1078-0432.CCR-20-1141 Contacts Alphageneron PharmaceuticalsHeadquarters Tel. (617) 520-6659Florida office Tel. (754) [email protected]