Shanghai and Hong Kong, December 12, 2021 /PRNewswire/ - Antengene Corporation Limited ("Antengene" SEHK: 6996.HK), a leading innovative global biopharmaceutical company dedicated to discovery, development and commercialization And/or best-in-class drugs to treat cancer and other life-threatening diseases, today announced a clinical trial collaboration to evaluate the safety, Pharmacokinetics and initial efficacy (nivolumab). The open-label Phase 1/2 trial will evaluate the study combination as a potential treatment option for patients with advanced solid tumors.
"Our clinical collaboration with Bristol Myers Squibb underscores Antengene's commitment to exploring joint solutions in our product portfolio and other mechanisms of action that may change cancer treatment," said Jay Mei, MD, founder and CEO of Antengene. "We are very pleased to have this clinical collaboration with Bristol Myers Squibb and look forward to registering for this exciting joint program in the first half of 2022."
ATG-017 is an oral selective inhibitor of extracellular signal-regulated protein kinase 1 and 2 (ERK1/2). Opdivo® is a human programmed death receptor-1 (PD-1) blocking antibody that binds to the PD-1 receptor expressed on activated T cells. This collaboration builds on Antengene’s pre-clinical data set, some of which have been demonstrated at the Society for Cancer Immunotherapy (SITC) in 2021, which shows a combination of ERK1/2 inhibitors and immune checkpoint inhibitors (CPI) Work collaboratively to produce improved efficacy in preclinical immune CPI-resistant cancer models.
"Antengene believes that a reasonable combination of targeted therapies and immuno-oncology drugs may provide the greatest chance of success for the next advancement in cancer treatment," said Kevin Lynch, MD, chief medical officer of Antengene. "We believe that ATG-017 can be used in a variety of combinations. In preclinical studies, the combination of ATG-017 and immune CPI has shown promising synergistic effects in resistant and refractory murine tumor models. With our 1 With the launch of the Phase/2 joint trial, we will work hard to verify these promising findings in the clinic. We believe that these data will provide information for the design of future studies. If it is positive, it will prove that ATG-017 has a synergistic effect with immuno-oncology drugs And make the potential of "cold" tumor "hot". The potent inhibition of ERK may reverse the immunosuppressive tumor microenvironment or prevent ERK-mediated disease progression, which may be a characteristic of CPI resistance and hyperprogressive diseases . This represents a major unmet need in cancer treatment," continued Dr. Lynch.
ATG-017 is currently studying patients with confirmed mutations in the RAS-MAPK pathway in a Phase 1/2 open-label, multi-center dose exploration study "ERASER". The trial was conducted in two parts, the dose escalation and the dose expansion part to explore monotherapy and combination therapy, PD-1 checkpoint inhibitor as the first partner drug.
Under the terms of the agreement, Antengene will sponsor and fund the study, and Bristol-Myers Squibb will provide Opdivo® for the combined dose escalation and combined dose expansion portion of the trial. Antengene owns the global commercial and development rights of ATG-017. Opdivo® is a trademark of Bristol-Myers Squibb Company.
ATG-017 is a potent and selective small molecule extracellular signal-regulated kinase 1 and 2 (ERK1/2) inhibitor. ERK1/2 is a related protein-serine/threonine kinase that functions as a terminal kinase in the RAS-MAPK signal transduction cascade. This cascade regulates a variety of cellular processes, including proliferation. The RAS-MAPK pathway is dysregulated in more than 30% of human cancers, and the most common changes are observed in the RAS or BRAF genes in multiple tumor types. ERK inhibitors can target RAS and BRAF mutation diseases.
Antengene recently published data at the 2021 Society for Cancer Immunotherapy (SITC 2021) meeting, detailing convincing preclinical results, showing that ATG-017 and anti-PD-L1 monoclonal antibody (atezolizumab) are used in invasive immune examinations The combination in the point-resistant murine cancer model makes "cold" tumors "hot".
Antengene Corporation Limited ("Antengene", HKEx code: 6996.HK) is a leading clinical-stage R&D-driven global biopharmaceutical company, focusing on providing innovative first-class/first-class therapeutic drugs for oncology and other life-threatening diseases. Driven by its vision of "treating patients without borders", Itanium aims to provide patients in the Asia-Pacific region and around the world with the most advanced anti-cancer drugs. Since starting operations in 2017, Antiy Gene has obtained 20 investigational new drug (IND) approvals in Asia Pacific and the United States, and submitted 6 new drug applications (NDAs) in multiple Asia Pacific markets, of which selinexor/ATG-010 was obtained in Korea The NDA has been approved through the priority review process. Antengene has established a broad and ever-expanding pipeline of 15 clinical and preclinical assets through the use of partnerships and internal drug discovery. The company owns the global copyrights of 10 programs and the copyrights of 5 programs in the Asia-Pacific region, including the Greater China region.
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For more information, please contact: Investor Contact: Donald Lung Email: Donald.Lung@antengene.com Mobile: +86 18420672158 Public Relations Contact: Peter Qian Email: Peter.Qian@antengene.com Mobile: +86 13062747000
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