16 Nov 2021

Clinical Trial Supply Agreement with Merck KGaA and Pfizer

IMUGENE LIMITED ACN 009 179 551 WWW.IMUGENE.COM info@imugene.com ASX Announcement Imugene Announce s Clinical Trial Supply Agreement with Merck KGaA, Darmstadt, Germany and Pfizer to Evaluate H ER - Vaxx in Combination with Avelumab for Treatment of Gastric Cancer __________________ _____________________________________________________________________ • New clinical trial supply agreement with Merck KGaA, Darmstadt, Germany and Pfizer Inc. • Avelumab (BAVENCIO ® ) to be provide d to Imugene for Phase 2 clinical study in HER - 2 positive gastric or gastroesophageal junction adenocarcinomas (neoHERIZON) • neoHERIZON will assess HER - Vaxx in combination wi th chemotherapy with or without a velumab in HER - 2 positive g astric c ancer Sydney, Australia , 16 November 2021 AEST – Imugene (ASX: IMU) today announced a new clinical trial supply agreement with Merck KGaA, Darmstadt, Germany (ETR: MRK) and Pfizer Inc. (NYSE: PFE) to evaluate the safety and efficacy of Imugene’s H ER - Vaxx , a B - cell activating immunotherapy, in combination with avelumab , an immune checkpoint inhibitor targeting PD - L1, in patien ts with HER - 2 positive gastric cancer . Avelumab, which is marketed as BAVENCIO ® , is co - developed and co - commercialized by Merck KGaA, Darmstadt, Germany and Pfizer Inc. neoHERIZON is an open - label, multi - center, randomized, Phase 2 clinical trial designed to assess the safety and efficacy of perioperative HER - Vaxx combined with chemotherapy with or without avelumab compared to chemotherapy alone in patients with HER - 2 positive gastric or gastroesophageal junction adenocarcinomas. The study’s primary endpoint is pathologic complete response. Secondary endpoints include safety and biomarker evaluation . “We are very excited for th e opportunity to treat patients with this new generation of HER - 2 targeted B - cell immunotherapy , which has the potential to address significant unmet need in early HER - 2 overexpressi ng gastric cancer that remains a challenging indication with poor prognos i s. The combination of chemotherapy and HER - Vaxx alone or in combination with a velumab in this type of gastric cancer may support a better treatment outcome for patients " said Dirk Arn old M.D., Ph.D., Director of the Asklepios Tumorzentrum in Hamburg. “Imugene is excited to announce this collaboration with Merck KGaA, Darmstadt, Germany and Pfizer. H ER - Vaxx ha s shown a tolerable safety profile and encouraging efficacy in patients with metastatic HER - 2 positive gastric cancer , and we are looking forward to evaluating H ER - Vaxx with avelumab in the perioperative clinical setting ,” said Leslie Chong, Managing Director & Chief Executi ve Officer of Imugene. “Working together, we’re committed to finding ways to address the unmet needs of patients living with cancer.” Eff ective immediately, u nder the terms of the agreement, Imugene will be the sponsor of the study and will fund the clinical study from existing budgets and resources . Merck KGaA, Darmstadt, Germany and Pfizer will provide avelumab for the duration of the study. About Gastric and Gastro - esophageal C ancer Perioperative (pre - and post - surgery) treatment in g astric or gastro - esophageal cancer remains an unmet need for patients with HER - 2 positive tumo u rs . The current standard of care is limited to chemotherapy, radiotherapy, and surgery when gastric cancer is diagnosed in its early stages . Immune checkpoint inhibitor s have been successfully introduced to metastatic gastric cancer. Moving HER - Vaxx into ear lier gastric ca ncer in combination with chemotherapy or a n immune checkpoint inhibitor may improve treatment outcome s for patients with th is difficult to treat cancer. 2 IMUGENE LIMITED ACN 009 179 551 About HER - Vaxx Imugene’s HER - Vaxx is a B - cell peptide cancer immunotherapy designed to treat tumours that over - express the HER - 2/neu receptor, such as gastric, breast, ovarian, lung and pancreatic cancers. The immunotherapy is constructed from several B cell epitopes der ived from the extracellular domain of HER - 2/neu. It has been shown in pre - clinical studies and in Phase 1 and 2 studies to stimulate a potent polyclonal antibody response to HER - 2/neu, a well - known and validated cancer target. For more information pleas e contact: Leslie Chong Managing Director and Chief Executive Officer i nfo@imugene.com Investor Enquir i es investor@imugene.com Media Enquir i es Matt Wright matt@nwrcommunications.com.au Follow us on Twitter @TeamImugene Like us on Facebook @Imugene Connect with us on LinkedIn @Imugene Limited About Imugene (ASX:IMU) Imugene is a clinical stage immuno - oncology company developing a range of new and novel immunotherapies that seek to act ivate the immune system of cancer patients to treat and eradicate tumo u rs. Our unique platform technologies seek to harness the body’s immune system against tumours, potentially achieving a similar or greater effect than synthetically manufactured monoclon al antibody and other immunotherapies. Our product pipeline includes multiple immunotherapy B - cell vaccine candidates and an oncolytic virotherapy (CF33) aimed at treating a variety of cancers in combination with standard of care drugs and emerging immunot herapies such as CAR T’s for solid tumo u rs. We are supported by a leading team of international cancer experts with extensive experience in developing new cancer therapies with many approved for sale and marketing for global markets. Our vision is to help transform and improve the treatment of cancer and the lives of the millions of patients who need effective treatments. This vision is backed by a growing body of clinical evidence and peer - reviewed research. Imugene is well funded and resourced, to de liver on its commercial and clinical milestones. Together with leading specialists and medical professionals, we believe Imugene’s immuno - oncology therapies will become foundation treatments for cancer. Our goal is to ensure that Imugene and its sharehold ers are at the forefront of this rapidly growing global market. Release authorised by the Managing Director and Chief Executive Officer Imugene Limited, Level 3, 62 Lygon Street, Carlton, VIC, 3053, Australia
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