Antengene and Bristol Myers Squibb Announce Clinical Collaboration to Evaluate ATG-017 in Combination with Opdivo® for Advanced Solid Tumors

Shanghai and Hong KongDecember 13, 2021PR Newswire -- Antengene Corporation ("Antengene", Stock Code: 6996.HK), a leading innovative biopharmaceutical company dedicated to the research and development and commercialization of first-in-class and/or best-in-class therapies for blood and solid tumor indications, announced today,The company has reached a clinical cooperation agreement with Bristol-Myers Squibb Company to jointly carry out a study aimed at evaluatingATG-017 in combination with Bristol-Myers Squibb's PD-1 checkpoint inhibitor Opdivo^®An Open-Label Phase 1/2 Clinical Study of the Safety, Pharmacokinetics, and Preliminary Efficacy of Nivolumab for the Treatment of Advanced Solid Tumors。

Dr. James Mei, Founder, Chairman and CEO of Antengene Corporation, stated: "This clinical collaboration with Bristol-Myers Squibb Company highlights Antengene's development strategy of combining pipeline products with therapies of different mechanisms to explore novel treatments that can significantly improve cancer therapy. We are very pleased to have reached this clinical agreement with Bristol-Myers Squibb Company and look forward to initiating patient enrollment for this highly promising combination therapy study in the first half of 2022."

ATG-017 is a selective oral inhibitor targeting extracellular signal-regulated kinase 1 and 2 (ERK1/2). Opdivo^®It is an anti-PD-1 antibody drug that binds to the human programmed cell death protein receptor-1 (PD-1) on the surface of activated T cells.This study is based on the preclinical data already available from Antengene Corporation, part of which has been recently presented at the Society for Immunotherapy of Cancer (SITC).SITC) Annual Meeting.Data show that the combination of ERK1/2 inhibitors and immune checkpoint inhibitors (CPI) exerts synergistic efficacy in CPI-resistant tumor models.

Dr. Kevin Lynch, Chief Medical Officer of ANTENGENE CORPORATION, stated: "We believe that the effective combination of targeted drugs with cancer immunotherapy holds tremendous therapeutic potential and is highly likely to bring new breakthroughs in cancer treatment. We consider ATG-017 to have the potential for combination with multiple drugs. In preclinical studies, ATG-017 combined with immune checkpoint inhibitors demonstrated strong synergy in mouse models of drug-resistant or refractory tumors. In this Phase 1/2 clinical study, we will clinically validate previous findings. The data from this study will support the design of subsequent research, and if positive, will further reveal the synergistic efficacy of ATG-017 combined with cancer immunotherapy drugs and its potential to transform tumors from 'cold' to 'hot.' Potent ERK inhibition can reverse tumor suppression within the tumor microenvironment and prevent ERK-mediated CPI-resistant tumor recurrence and highly malignant tumor progression. This represents a significant unmet clinical need in current cancer treatment."

ATG-017 is currently being evaluated in an open-label, multi-center, Phase 1/2 dose-finding study named ERASER for the treatment of patients with RAS-MAPK pathway mutations.The trial consists of two phases: dose escalation and dose expansion, and will evaluate ATG-017 as a monotherapy and in combination therapy, with the PD-1 checkpoint inhibitor as the first combination drug.

According to the agreement,ANTENGENE CORPORATION will be responsible for the conduct of the clinical trial and provide funding support. Bristol-Myers Squibb Company will supply Opdivo required for the dose escalation and dose expansion studies in the combination therapy.^®ANTENGENE CORPORATION owns the global commercialization and development rights of ATG-017. Opdivo^®It is a trademark of Bristol-Myers Squibb Company.

AboutATG-017

ATG-017 is a potent and selective small molecule inhibitor targeting extracellular signal-regulated kinase 1 and 2 (ERK1/2). ERK1/2 are serine/threonine protein kinases that function as the terminal kinases in the RAS-MAPK signaling pathway. This cascade regulates various cellular processes, including cell proliferation. Dysregulation of the RAS-MAPK pathway occurs in more than 30% of cancer patients, with the most common alterations being RAS or BRAF gene mutations across multiple tumor types. ERK inhibitors can simultaneously target diseases with RAS and BRAF mutations.

ANTENGENE CORPORATION recently presented relevant preclinical research data at the 2021 Society for Immunotherapy of Cancer (SITC) Annual Meeting. The data showed that ATG-017 in combination with anti-PD-L1 monoclonal antibody (Atezolizumab) achieved tumor conversion from "cold" to "hot" in mouse tumor models resistant to immune checkpoint inhibitors.

About ANTENGENE CORPORATION

ANTENGENE CORPORATION (referred to as "Antengene", Hong Kong Stock Exchange stock code: 6996.HK) is a leading biopharmaceutical company driven by research and development, dedicated to providing the most advanced therapies for patients in the Asia-Pacific region and around the world to treat cancer and other life-threatening diseases. Since its official operation in 2017, Antengene has established a rich product pipeline that extends from preclinical to clinical stages through collaborations and self-developed initiatives. Currently, Antengene has 15 products under development, of which 5 products have Asia-Pacific rights including the Greater China market, and 10 products have global rights. Antengene has obtained 20 clinical trial applications (IND) in the United States and multiple Asia-Pacific markets, and submitted 6 new drug applications (NDA), with Selinexor already approved for marketing in South Korea via priority review. Antengene will continue to..."Doctors Without Borders, Innovation Never Ends"With a vision of focusing on the early research and development, clinical studies, drug manufacturing, and commercialization of first-in-class and best-in-class therapies to address unmet clinical needs."

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