WuXi Biologics Congratulates BioAtla on FDA Clearance of IND Application for CAB-AXL-ADC
SHANGHAI, January 31, 2018 — WuXi Biologics (2269.HK), a leading global open-access biologics technology platform company offering end-to-end solutions for biologics discovery, development and manufacturing, congratulates its partner BioAtla® LLC for U.S. Investigational New Drug application (IND) clearance.
BioAtla is a global biotechnology company focused on the development of Conditionally Active Biologic (CAB) protein therapeutics. U.S. Food and Drug Administration (U.S. FDA) has cleared BioAtla’s IND for BA3011, a novel conditionally active AXL-targeted antibody-drug conjugate (CAB-AXL-ADC), in patients with solid tumors. Under this IND, the company intends to initiate a first-in-human, open label, multicenter, dose escalation and dose expansion study of CAB-AXL-ADC in patients with locally advanced or metastatic solid tumors. CAB-AXL-ADC is BioAtla’s first CAB investigational product to enter clinical trials in the United States.
The AXL receptor tyrosine kinase is often highly expressed in several cancer types that can lead to poor prognosis. A principal role of AXL appears to be in sustaining a major mechanism of resistance to diverse anticancer therapies. In addition, AXL is a factor in the repression of the innate immune response which may also limit response to treatment including immuno-oncology (IO) therapy. While this makes the AXL receptor an attractive target for tumor therapy, the AXL receptor is also prevalent in normal tissue of several organs in the body. To minimize on-target-off-tumor toxicity of binding to AXL receptors on normal cells, BioAtla applies its proprietary CAB technology to develop its CAB antibody-drug conjugate (ADC) targeting AXL with the intent to activate binding to the AXL receptor only in the tumor microenvironment and deliver the toxic payload to the cancerous cells.
“Congratulations to BioAtla on achieving this great company milestone of 1st CAB-ADC IND,” said Dr. Chris Chen, Chief Executive Officer of WuXi Biologics. “We are honored to enable innovative partners like BioAtla through WuXi Biologics’ integrated and open-access biologics technology platform, and we wish the program great clinical success to benefit patients worldwide.”
About Conditionally Active Biologics (CABs)
Conditionally Active Biologic proteins are generated using BioAtla’s proprietary protein discovery, evolution and expression technologies. These proteins can be monoclonal antibodies, enzymes and other proteins designed with functions dependent on changes in microphysiological conditions (e.g., pH level, oxidation, temperature, pressure, presence of certain ions, hydrophobicity and combinations thereof) both outside and inside cells.
Studies have shown that cancerous tumors create highly specific conditions at their site that are not present in normal tissue. These cancerous microenvironments are primarily a result of the well understood unique glycolytic metabolism associated with cancer cells, referred to as the Warburg Effect. CAB proteins are designed to deliver their therapeutic payload and/or recruit the immune response in specific and selected locations and conditions within the body and to be active only in the presence of a particular cellular microenvironment. In addition, the activation is designed to be reversible to repeatedly switch “on and off” should the CAB move from a diseased to a normal cellular microenvironment and vice versa. CABs can be developed in a variety of formats including antibodies, antibody drug conjugates (ADCs), bi-specifics, chimeric antigen receptor T-cells (CAR-Ts) and combination therapies.
About BioAtla® LLC
BioAtla is a global biotechnology company with operations in San Diego, California, and Beijing, China. BioAtla develops novel monoclonal antibody and other protein therapeutic product candidates designed to have more selective targeting, greater efficacy, and more cost-efficient and predictable manufacturing than traditional antibodies. For more information on BioAtla, please visit www.bioatla.com.
About WuXi Biologics
WuXi Biologics, a Hong Kong-listed company, is a leading global open-access biologics technology platform in the world offering end-to-end solutions to empower organizations to discover, develop and manufacture biologics from concept to commercial manufacturing. Our company history and achievements demonstrate our commitment to providing a truly ONE-stop service offering and value proposition to our global clients. For more information on WuXi Biologics, please visit www.wuxibiologics.com.