Per the agreement, WuXi Biologics, as the exclusive CDMO partner will provide biologics development and cGMP manufacturing services for OncoC4's products from early R&D and preclinical activities to post commercialization. OncoC4 will leverage WuXi Biologics' process development and manufacturing capabilities and expertise in cell line development, formulation development as well as drug substance and drug product manufacture.
The two companies expand the strategic collaboration by using the proprietary WuXiBody® bispecific antibody platform to research and develop certain bispecific antibodies. Under the terms of the agreement, OncoC4 has rights to use the WuXiBody® platform to research and develop bispecific antibodies. For any potential bispecific antibody products commercialized from the WuXiBody® platform, in addition to an upfront payment, WuXi Biologics will receive development and commercialization milestones as well as tiered royalties on net sales of such bispecific antibody.
These new agreements build on the companies' successful multi-year relationship. Since 2017, WuXi Biologics has been providing services to OncoC4 (formerly known as OncoImmune), including comprehensive and integrated CMC services for the ONC-392 clinical program.
Dr. Yang Liu, Chairman, CEO and Founder of OncoC4, commented, "This long-term supply agreement is another significant step forward in our relationship with WuXi Biologics. It allows OncoC4 to leverage world-class manufacturing capacity to meet the challenges associated with the production of our best-in-class and first-in-class biologics, that include bispecific antibodies and antibody-drug conjugates that target innate and adaptive immune checkpoints for cancer treatment."
Dr. Chris Chen, CEO of WuXi Biologics, commented, "We are honored to be OncoC4's exclusive CDMO partner for its full therapeutic pipeline, which is another great example of our follow and win the molecule strategy. This partnership is a strong validation of our premier quality and project execution excellence. We are looking forward to enabling OncoC4 to make innovative life-saving biologics more available and affordable to patients across the globe."
Based in Rockville, Maryland, OncoC4 is a privately-held, clinical-stage biopharmaceutical company that is actively engaged in the discovery and development of novel biologicals for cancer treatment. OncoC4 is a spinout of OncoImmune that was acquired by Merck in December 2020. As part of the acquisition of OncoImmune by Merck, OncoC4 retains the original assets except for the CD24Fc and was infused with additional funds from Merck to invigorate the product development pipeline focusing on best-in-class and first-in-class immunotherapies for oncology.
OncoC4's lead clinical candidate is ONC-392, a next generation anti-CTLA-4 antibody capable of uncoupling the cancer therapeutic effects from immunotherapy-related adverse effects. A first-in-human Phase I clinical trial for ONC-392 was initiated in 2020 and is currently enrolling cancer patients to assess the safety, pharmacokinetics, and efficacy of ONC-392 as a single agent in advanced solid tumors and in combination with anti-PD(L)1 standard of care in Non- Small Cell Lung Cancer (PRESERVE-001, NCT04140526).
OncoC4's new products represent new paradigms of therapeutic targeting of not only adaptive immune checkpoints including CTLA-4 and PD-L1, but also innate immune checkpoint CD24-Siglec 10, which was discovered by OncoC4 founders. Technology platforms includes humanized antibodies, bispecific antibody and antibody-drug conjugates. For more details, please visit www.oncoc4.com.
About WuXi Biologics
WuXi Biologics (stock code: 2269.HK), a Hong Kong-listed company, is a leading global open-access biologics technology platform offering end-to-end solutions to empower organizations to discover, develop, and manufacture biologics from concept to commercial manufacturing. The company's history and achievements demonstrate its commitment to providing a truly one-stop service offering and strong value proposition to its global clients.
As of March 22, 2021, there were a total of 361 integrated projects, including 190 projects in pre-clinical development stage, 137 projects in early-phase (phase I and II) clinical development, 32 projects in late-phase (phase III) development and 2 projects in commercial manufacturing. With total estimated capacity for biopharmaceutical production planned in China, Ireland, the U.S., Germany, and Singapore around 430,000 liters after 2024, WuXi Biologics will provide its biomanufacturing partners with a robust and premier-quality global supply chain network.
WuXi Biologics views Environmental, Social, and Governance (ESG) as an integral component of its ethos and business strategy and has established an ESG committee led by the CEO to increase the efficiency while advancing commitment to sustainability. For more information about WuXi Biologics, please visit: www.wuxibiologics.com.
SOURCE WuXi Biologics