Context Therapeutics & Integral Molecular Enter Collaboration & License Agreement 

Context Therapeutics and Integral Molecular recently announced a research collaboration and licensing agreement for the development of an anti-claudin 6 (CLDN6) bispecific monoclonal antibody (BsMAb) for gynecologic cancer therapy.

CLDN6 is a membrane protein expressed in multiple cancers, including ovarian, endometrial, lung and gastric cancers. The protein is absent from healthy adult tissues and high levels in patient tumors are correlated with poor prognosis.

Under the terms of the agreement, Integral Molecular and Context will develop CLDN6 bispecific antibodies that trigger the activation of T cells and eliminate cancer cells displaying CLND6. Context will conduct preclinical and all clinical development, as well as regulatory and commercial activities through exclusive worldwide rights to develop and commercialize the novel CLDN6 candidates. Integral Molecular will receive an undisclosed upfront payment and will be eligible to receive development, regulatory and sales milestone payments and high-single-digit to low-double-digit percent royalties on net sales. IND-enabling studies of the first BsMAb candidate are expected to commence in 2022, with advancement to clinical stage anticipated in 2023.

“The structural complexity of CLDN6 and its similarity to proteins expressed on healthy tissue have previously limited its exploitation for targeted oncology therapies,” said Martin Lehr, Chief Executive Officer of Context. “By combining Integral Molecular’s expertise in the field of antibody discovery and Context’s experience developing therapies for women’s cancers, we hope to develop a best-in-class targeted therapeutic for CLDN6-positive gynecologic tumors.”

To overcome the challenges associated with antibody discovery against CLND6, Integral Molecular employed its MPS antibody discovery platform designed to isolate antibodies against the most challenging membrane protein targets.

“Our CLDN6 monoclonal antibody exhibits best-in-class target selectivity,” said Benjamin Doranz, PhD, Chief Executive Officer of Integral Molecular. “There is a strong need for therapies that provide more specific and less toxic treatments for gynecologic cancers, and we look forward to our partnership with Context that will enable better treatments for women.”

Context Therapeutics LLC is a women’s oncology company developing advanced small molecule and immunotherapy treatments to transform care for hormone-driven breast and gynecological cancers. The company’s robust clinical program for lead candidate onapristone extended release (ONA-XR) comprises four ongoing Phase 2 clinical trials in hormone-driven breast, ovarian and endometrial cancer, as well as a window of opportunity trial in breast cancer. ONA-XR is a novel, first-in-class complete antagonist of the progesterone receptor, a key unchecked mechanism in hormone-driven women’s cancers. Also nearing the clinic is a cutting-edge bispecific antibody targeting Claudin 6, a potential revolutionary immunotherapy for gynecological cancers. Context is headquartered in Philadelphia, PA. For more information, visit www.contexttherapeutics.com.

Integral Molecular (www.integralmolecular.com) is the industry leader in discovering and characterizing therapeutic antibodies against membrane proteins, an important group of drug targets found on the surfaces of cells and viruses. Integral Molecular’s technologies have been integrated into the drug discovery pipelines of over 400 biotech and pharmaceutical companies to help discover new therapies for cancer, diabetes, autoimmune disorders and viral threats such as SARS-CoV-2, Ebola, Zika, and dengue virus.