On March 26, 2020 Innovent Biologics, Inc. ("Innovent" or the "Company") (HKEX: 01801), a world-class biopharmaceutical company that develops and commercializes high quality medicines for the treatment of oncology, autoimmune, metabolic and other major diseases, and Alector, Inc. ("Alector", Nasdaq ticker symbol: ALEC), a clinical stage biotechnology company and leader in the discovery and development of immune system focused therapeutics, jointly reported that they have entered into a licensing agreement to develop and commercialize an anti-SIRP-alpha antibody (Alector’s project code: AL008) for the treatment of oncology indications in China (Press release, Innovent Biologics, MAR 26, 2020, View Source [SID1234555834]).
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AL008 is Alector’s novel antibody targeting the CD47-SIRP-alpha pathway, a potent survival pathway co-opted by tumors to evade the innate immune system. AL008 is a first-in-class SIRP-alpha inhibitor with a unique dual mechanism of action that non-competitively antagonizes the CD47-SIRP-alpha pathway by inducing the internalization and degradation of the inhibitory receptor on macrophages to relieve immune suppression (a "don’t eat me signal") while also engaging Fc gamma to promote immuno-stimulatory pathways that drive anti-tumor immunity.
"Alector has been a pioneer in discovering and developing first-in-class therapeutics modulating the innate immune system since their founding and AL008 represents another successful program from their pipeline," said Dr. Michael Yu, Founder, Chairman and CEO of Innovent Biologics. "Currently, we have a successfully commercialized PD-1 inhibiting antibody, Tyvyt (sintilimab injection), targeting the adaptive immune system and we believe in the importance of modulating innate immune system in oncology as well, especially the SIRP-alpha-CD47 pathway. We believe that AL008 will complement perfectly with our current pipeline, further solidifying our position in this promising space while providing more options to patients in need."
"We are excited to enter into a collaboration with Innovent, one of the premier Chinese biologics companies, which has a fully-integrated multi-functional platform. We have been impressed with the diligence and speed that the Innovent team brings to bear to advance their development programs through clinical trials and beyond. We believe AL008 has great potential and look forward to demonstrating this in the clinic," said Dr. Arnon Rosenthal, Co-Founder and CEO of Alector. "We will be collaborating closely with Innovent to rapidly advance AL008 through clinical trials in order to get this program to benefit more patients both in China and globally."
Under the agreement, Innovent will lead the development and commercialization of the molecule in China, including the manufacturing of the product. Alector will lead development of AL008 outside of China. Financial terms are not disclosed.
About AL008
AL008 is an anti-SIRP-alpha antibody that non-competitively antagonizes the CD47-SIRP-alpha pathway by inducing the internalization and degradation of the inhibitory receptor on macrophages to relieve immune suppression (a "don’t eat me signal) while also engaging Fc gamma to promote immuno-stimulatory pathways that drive anti-tumor immunity. Tumor associated macrophages are associated with poor prognosis in many cancer types and are believed to inhibit the anti-tumor immune response. Targeting the CD47-SIRP-alpha pathway has shown activity in myeloid and lymphoid cancers, but additional agents targeting this pathway are needed to enhance activity and improve safety in solid tumors. AL008 monotherapy reduces tumor growth and enhances M1 macrophage activation in a humanized pre-clinical model. In comparison with other SIRP-alpha targeting antibodies, AL008 binds to all common alleles of SIRP-alpha and has best-in-class potency in tumor cell phagocytosis. AL008 promotes T cell function and in preclinical studies is not associated with depletion of red blood cells or platelets. These data highlight the potential potency of this differentiated mechanism of simultaneously providing immune-activating signals while removing immune-checkpoint signals and demonstrate the potential activity for AL008.