If 2021 was a pivotal year for Context Therapeutics (NASDAQ:CNTX) Inc, 2022 promises to be even more so.
Fresh from a US$31.25 million fundraise and last October’s debut on the Nasdaq, the clinical-stage biopharmaceutical company focused on bettering the lives of women living with cancer, is developing advanced small molecule and immunotherapy treatments to transform care for hormone-driven breast and gynecological cancers.
Context has two drugs in its pipeline. Its lead candidate, onapristone extended-release (ONA-XR), a progesterone receptor antagonist, is in Phase 2 development. Its second program, CLDN6xCD3, a bispecific antibody targeting Claudin 6, a protein that's enriched in ovarian and endometrial cancer, is in the preclinical stage.
In April, the company expects to present updates on its clinical candidates at the annual meeting of the American Association for Cancer Research, a focal point of the cancer research community, where scientists, clinicians, other health care professionals, survivors, patients, and advocates gather to share the latest advances in cancer science and medicine.
“We anticipate having a fairly substantial presence there for our assets, where we'll present mechanistic data that we hope will further underwrite the development of both programs,” Context’s CEO Martin Lehr told Proactive.
“There's a lot of momentum building for Context this year. We'll have initial clinical data from two of our ONA-XR studies this summer and then the remaining two will have initial data by year-end. We went public in October because we knew that 2022, particularly the first half, would have a lot of activity for the company," he added.
Women’s cancers spreading globally
Breast, ovarian, and endometrial cancers are a growing problem globally. While these cancers have traditionally been an issue in the US and Western Europe, the adoption of Western diets is thought to have resulted in a rising number of cases in Asia, Lehr explained.
In the US, he said the three cancers will result in well over 100,000 deaths in 2022 alone, while fatalities in Europe are likely to be in the 100,000 to 125,000 range.
“The problem stems from two issues: one, it's just a very large funnel, with so many patients diagnosed per year, and that means many patients will progress to the metastatic disease stage wherein survivorship is unfortunately poor,” Lehr said.
“The second issue is a lack of therapeutic options. So, while there are drugs that are approved to treat these cancers, once the patient has metastatic disease, rarely are those treatments curative,” he added.
To address the problem, Context aims to develop novel therapies that can prolong life for these women.
The company CEO said: “We want to prolong life and provide a very high quality of life for patients living with these cancers. We want patients to be able to enjoy everyday activities including interacting with their children or being able to go for walks. Most of all, we want them to feel that people would not otherwise know that they're battling quite literally for their lives against these horrible diseases.”
Gaining a competitive advantage
As a relatively small company, Lehr said Context needs to choose therapeutic approaches where it doesn’t have to tussle with the larger pharmaceutical companies.
That means identifying technical hurdles to develop a drug to block a target, overcome the target and gain a competitive, first-mover advantage.
Lehr said ONA-XR is the only progesterone receptor antagonist in clinical development, and as far as Context is aware through publicly available documents, the only full inhibitor of the progesterone receptor, so the most complete antagonism of the target.
In the second program targeting Claudin 6, he said Context is in a competitive race with German biotech company BioNTech.
“What we want to focus on are targets that are technically challenging to develop a drug against, places where we can be first or second to market and really excel as a small company competing against the big guys,” he said.
Encouraging results
In the case of ONA-XR, the clinical program started in 2014, and the drug has been administered to over 128 subjects to date. That includes a Phase 1 clinical trial in women with progesterone receptor-positive breast, ovarian, and endometrial cancers, as well as a prostate clinical trial. More recently, he said ONA-XR has been the subject of three ongoing Phase 2 clinical trials and one Phase 1b/2 clinical trial: two in metastatic breast cancer, one in endometrial cancer, and one in a rare form of ovarian cancer called granulosa cell tumor of the ovary.
“The data so far has been encouraging,” Lehr said. “We've seen monotherapy clinical activity and the drug does appear to be having an impact on the tumor as it relates to growth and signaling pathways that are important in driving the growth of that tumor. We've also seen promising safety and tolerability to date.”
“Certainly, the drug isn't perfect, but what we've seen is that patients can enjoy a higher quality of life while taking our drug either alone or in combination with other drugs," he added.
Partnerships with big pharma
Lehr revealed that Context aspires to be a company that’s not necessarily fully integrated, focusing instead on preclinical through Phase 2 trials. It will use other companies’ discovery engines to acquire assets but doesn’t plan to conduct in-house research of its own.
Once it reaches late-stage development of drugs, he said the plan is to partner with larger pharmaceutical companies that have existing infrastructure, leaving Context to continue building its drug pipeline over time.
Lehr noted that last year’s financings raised $60 million in gross proceeds and left the company with sufficient capital until 2024 as it funds its existing clinical trials, preclinical development of its second asset, and provides some excess cash to take advantage of opportunities, such as an additional clinical trial or acquiring a third asset.
Like many other biotech companies, Context has been oversold and is cheaper relative to other health offerings on the Nasdaq. Following its 2021 fundraising, he said, the company's stock is currently trading at a 50% discount to its cash position.
“People who invest now are basically getting a free investment into our pipeline because it's so undervalued,” Lehr said. “We think there are a lot of potential reasons for investors to get in, essentially at the ground floor, and hopefully be along for the ride over the next couple of years. Ultimately, our goal is towards the end of 2023 to be in Phase 3 clinical development.”
Contact the author at stephen.gunnion@proactiveinvestors.com