Innovative anti-cancer ADC is approved by the FDA to open clinical trials

Innovative anti-cancer ADC is approved by the FDA to open clinical trials

January 31, 2018 Source: WuXi PharmaTech

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Recently, biotechnology company BioAtla announced that the US FDA has approved its new drug clinical application (IND) for the new drug BA3011. BA3011 is a novel antibody-drug conjugate (CAB-AXL-ADC) targeting AXL for the treatment of solid tumor patients. The IND application is planned for the first human trial of CAB-AXL-ADC in patients with locally advanced or metastatic solid tumors, with open-label multicenter dose escalation and dose extension studies. CAB-AXL-ADC will be BioConnect's first CAB research product for clinical trials in the United States.

AXL receptor tyrosine kinases are highly expressed in a variety of cancer types that can lead to poor prognosis. AXL is the primary mechanism leading to drug resistance in a variety of anticancer therapies. In addition, AXL is one of the factors that inhibit the innate immune response, which may also limit the patient's response to treatment, including tumor immunology (IO) therapy. Although the AXL receptor is an attractive target for tumor therapy, it is ubiquitous in many normal organs in the body. In order to minimize the off-target toxicity of drug binding to AXL receptors on normal cells, BioAtla is developing its CAB antibody-drug conjugate (ADC) targeting AXL using its patented CAB technology, and hopes that the drug will bind. The AXL receptor in the tumor microenvironment exerts a toxic effect on cancer cells.

Conditionally Active Biologics (CABs) are BioAtla's proprietary protein discovery, evolution and expression technology platforms. These proteins can be monoclonal antibodies, enzymes and other proteins, designed at the time of microphysiological conditions inside and outside the cell (eg pH, oxidation, temperature, pressure, presence of certain ions, hydrophobicity and any combination of these) Changes are given different functions.

Studies have shown that the internal environment of the tumor has a specificity different from normal tissue, called the tumor microenvironment, mainly caused by the unique glycolysis metabolism (called Warburg effect) associated with cancer cells. CAB proteins are designed to deliver therapeutic payloads and/or activate immune responses at specific sites and under specific conditions in the body and are only active in specific cellular microenvironments. In addition, if the CAB is transferred from the lesion to the normal cellular microenvironment, it will switch to the "off" state, and vice versa, this "on and off" switching is designed to be reversible. CAB can be used to develop a variety of drugs, including antibodies, antibody drug conjugates (ADCs), bispecific antibodies, CAR-T therapies, and combination therapies.

BioAtla is a global biotechnology company with operations in San Diego, California and Beijing, China. BioAtla is primarily developing new monoclonal antibody and other protein therapy candidates that are more selective, more potent, and more cost effective and predictive in manufacturing than traditional antibodies. .

Reference materials:

[1] Bioatla Announces FDA Clearance Of Investigational NewDrug Application For CAB-AXL-ADC Therapeutic

[2] BioAtla official website

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