03 January 2022 | Monday | News
Image Source : Public Domain
Antengene Corporation Limited ("Antengene" SEHK: 6996.HK), a leading innovative, global biopharmaceutical company dedicated to discovering, developing and commercializing first-in-class and/or best-in-class medicines for cancer and other life-threatening diseases, announced today that the first patient has been dosed in the Phase Ib/II, open-label multi-center, REACH trial to evaluate ATG-016 (eltanexor) monotherapy in subjects with advanced solid tumors including those with genetic mutations (such as K-ras or p53) or a viral association (such as Epstein Barr Virus (EBV) and Human Papilloma Virus (HPV). Enrollment in the study is already underway.
"The opening of the REACH trial is a very important milestone for Antengene. As the second study of ATG-016 to be conducted in mainland China, it highlights our approach of running our own, complementary, additional studies in China on partnered products," said Jay Mei, M.D., Ph.D, Founder and CEO of Antengene. "Furthermore, this study underscores Antengene's commitment to focusing our clinical development efforts on diseases that are particularly prevalent in China versus the US," continued Dr. Mei.
ATG-016/eltanexor and other SINE (Selective Inhibitor of Nuclear Export) compounds inhibit the nuclear chaperone protein called Exportin 1 (XPO1) that helps cancers grow by removing tumor suppressor proteins from the nucleus. ATG-016 is an orally-active, highly-specific next-generation XPO1 inhibitor with an improved pharmacological profile and reduced brain penetration versus the first novel SINE compound, ATG-010/selinexor. These attributes can potentially enable more frequent dosing and a better tolerated dosing regimen. ATG-016 demonstrated preliminary anti-tumor activity in a Phase I study in advanced solid tumors and hematologic malignancies. SINE compounds also inhibit replication of viruses that utilize XPO1 machinery. In preclinical studies, ATG-016 demonstrated an inhibitory effect on the growth of cancer induced by viruses such as EBV and HPV.
"The REACH study is designed to evaluate the safety, pharmacokinetics and preliminary efficacy of ATG-016/eltanexor monotherapy in patients with progressive or resistant disease, building on promising, published Phase I results. With 70% of cancer patients remaining as non-responders or progressing after initial response, Antengene has prioritized the development of treatments for advanced or resistant cancers," said Kevin Lynch, M.D., Antengene's Chief Medical Officer. "We remain grateful to all of the healthcare professionals, scientists, patients, and families involved with Antengene's clinical studies," continued Dr. Lynch.