What About Women? This Company Targets Female-Focused Cancers

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There’s a significant body of research that points to the possibility that women have been overlooked in healthcare for years. Quite specifically in regards to hormone-driven cancer–of which nearly 70% of women with breast, ovarian, and endometrial cancer suffer. But there is a glaring unmet need: for example, nearly 50% of women with HR-positive breast cancer discontinue treatment due to side effects. The majority of women with ovarian cancer, even with a complete “first-line” response to chemotherapy, will die. Even when diagnosed at an early stage, those with endometrial cancer find difficulties in targeting tumors. 

Female cancers including breast, ovarian and endometrial, can progress simply because of the levels of estrogen and progesterone in the body, a key contributor of cancer growth. This causes an issue for clinicians attempting to treat the diseases, as it presents relapse and resistance challenges. The result is that antiestrogens, used to shrink tumors and block the production of these hormones, end up being one of the only treatments for patients. However, with growing clinical resistance to antiestrogens, a remaining option for patients is side-effect laden chemotherapy.

That’s why Context Therapeutics Inc. CNTX is seeking to develop a novel therapeutic option that can close this gap for women, providing better care for these often aggressive cancers. The biggest hurdles in oncology drug development, according to the company, lie in therapeutic “relapse and resistance.”

The team, with members who have built products like Kisqali™, Femara™ and Afinitor™ to treat multiple forms of cancer, are now focused on Context Therapeutics’ two new clinical programs:  Onapristone Extended Release (ONA-XR) and an antigen bispecific monoclonal antibody (bsAb) to target Claudin 6 (CLDN6).

Its lead and most advanced product candidate is ONA-XR, the only known full progesterone receptor antagonist. Currently, approved drugs only target estrogen while progesterone is left to run freely. ONA-XR is designed to block the progesterone interaction with its receptor and prevent cancer cells from hijacking progesterone to regenerate and metastasize. ONA-XR is being evaluated in three Phase 2 clinical trials and one Phase 1b/2 clinical trial in hormone-driven breast, ovarian and endometrial cancer. Early data from these trials is anticipated in 2022.

Context's second product candidate combines precision medicine and immunotherapy to target CLDN6. CLDN6xCD3 bsAb is an anti-CD3 x anti-CLDN6 bsAb. Essentially, its job is to attack malignant cells that express CLDN6, which is a protein target present in ovarian and endometrial cancers. This protein target does not exist in healthy tissues, resulting in the potential destruction of the problem at hand. This program is in a preclinical stage.

In 2021, Context completed an initial public offering of common stock, raising $28.75 million in gross proceeds, and closed a private placement which resulted in $31.25 million in gross proceeds, which extends the company’s cash runway into 2024. In addition, Context released data from one of its ONA-XR trials, demonstrating the drug “significantly increased suppression of tumor cell proliferation” in postmenopausal patients with progesterone receptor positive early breast cancer at the 2021 San Antonio Breast Cancer Symposium. The company says it is gearing up to have a big year, including additional preliminary data readouts from its ONA-XR clinical trials.

Through its product pipeline and focus, the company states that its mission is simple: Provide women and their families a powerful addition to the current standard of care for hormone-driven cancers. In Context CEO Martin Lehr’s words, “We believe it is possible. We will find a way.”

This article may contain “forward-looking statements” regarding Context Therapeutics within the meaning of securities laws concerning future performance, projections, and opportunities that may involve substantial risks and uncertainties. Actual results may differ from those expressed or implied, and Context undertakes no obligation to update these statements as a result of new information or future events. Please see Context’s filings with the U.S. Securities and Exchange Commission regarding such risks, including the section titled “Risk Factors” contained in such filings.

This post contains sponsored advertising content. This content is for informational purposes only and is not intended to be investing advice.