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Context Therapeutics has $39.4M cash runway to advance pipeline programs; data update from OATH Phase 2 trial likely in mid-2023

Published: 09:40 04 Jan 2023 EST

Context Therapeutics - has 39.4M cash runway to advance pipeline programs; data update from OATH Phase 2 trial likely in mid-2023
The company's ELONA Phase 1b/2 breast cancer trial is open and enrolled its first patient in January this year

Context Therapeutics Inc (NASDAQ:CNTX) has indicated in its corporate guidance for 2023 that with ample cash on hand, the company has the scope to advance its pipeline programs.

As of September 30, 2022, the Philadelphia-based women’s oncology company developing treatments for breast and gynecological cancers, had cash, and equivalents which totaled $39.4 million. Context said this is expected to “fund its operations into 1Q 2024.”

During 4Q 2022, Context presented preclinical data introducing CTIM-76 as a potent CLDN6-directed immunotherapy. CLDN6 is an emerging, potentially high-value oncology target that is expressed in a broad range of cancers and CLDN6 expression is associated with diminished survival in cancer patients. Context says there are nearly 62,000 patients in the US with CLDN6-positive metastatic cancers, including lung, ovarian, endometrial, gastric, and testicular cancers. Currently, there are no FDA-approved treatments targeting CLDN6.

READ: Context Therapeutics finds lead clinical development candidate for cancer treatment in CTIM-76

CTIM-76 was found to be 28 times more potent than a competing approach utilizing a bispecific T-cell engager (BiTE) format. The data was presented during a webinar hosted by Context in December last year.

Investigational New Drug (IND) enabling studies are scheduled for 2023 with an IND filing to support human clinical trials expected in 1Q 2024, noted the company.

"We achieved key corporate milestones including nominating CTIM-76 as our Claudin 6 (CLDN6) bispecific antibody clinical candidate and delivering preliminary data in clinical trials of onapristone extended release (ONA-XR), our highly potent and selective progesterone receptor antagonist," Context Therapeutics CEO Martin Lehr said in a statement.

Context’s pipeline includes small molecule and bispecific antibody drug candidates that target cancer signaling pathways. ONA-XR is a novel, potent and selective progesterone receptor antagonist, which is currently in three Phase 2 trials and one Phase 1/2 trial in hormone-driven breast, ovarian, and endometrial cancers.

"In 2023, we will continue to advance ONA-XR across the endometrial (OATH) and breast (SMILE and ELONA) cancer clinical trials,” said Lehr.

Lehr added that Context expects to provide a clinical data update from the ongoing OATH Phase 2 trial in mid-2023, as well as a Phase 2 data update and Phase 1b data from the SMILE and ELONA breast cancer trials, respectively, in 4Q 2023.

“In addition, we look forward to rapidly advancing CTIM-76 toward IND submission in 1Q 2024," Lehr added.

Investors can read about Context’s ONA-XR ongoing Phase 2 trials which show encouraging endometrial and breast cancer data here.

ELONA Phase 1b/2 breast cancer trial

In January this year, Context enrolled the first patient in the ELONA study, an open-label, Phase 1b/2 breast cancer clinical trial being conducted in partnership with The Menarini Group. The ELONA study is designed to explore the efficacy of ONA-XR in combination with elacestrant, Menarini’s selective estrogen receptor degrader, in patients with locally advanced or metastatic breast cancer who have received prior treatment with a CDK4/6 inhibitor.

In Menarini’s recently completed EMERALD Phase 3 trial, elacestrant demonstrated a 0.9-month PFS improvement versus the standard-of-care fulvestrant (2.8 vs 1.9 months) in a similar treatment population and as a result may become the standard-of-care antiestrogen treatment. 

Compared to elacestrant alone, Context says it believes that the combination of ONA-XR plus elacestrant “may more completely inhibit progesterone and estrogen hormone signaling that is required for breast cancer growth” and metastasis.   

“Such a combination would potentially improve outcomes in patients without adding significant toxicity,” noted the company.

Contact the author Uttara Choudhury at uttara@proactiveinvestors.com

Follow her on Twitter: @UttaraProactive

Context Therapeutics CEO Marty Lehr notes progress towards the clinic with...

Context Therapeutics (NASDAQ:CNTX) CEO Marty Lehr takes Proactive's Stephen Gunnion through progress with the company's lead program, CTIM-76. Lehr explained that CTIM-76 is a T cell engaging bispecific antibody targeting Claudin 6 (CLDN6) on tumor cells and CD3 on immune cells. The...

on 08/10/2023