CTIM-76 nominated as Claudin 6 x CD3 bispecific antibody clinical candidate
Encouraging endometrial and breast cancer data in ongoing ONA-XR Phase 2 trials, with additional data updates expected in 2023
ELONA breast cancer trial open and enrolled first patient
PHILADELPHIA, Jan. 04, 2023 (GLOBE NEWSWIRE) — Context Therapeutics Inc. (“Context” or the “Company”) (Nasdaq: CNTX), a clinical-stage biopharmaceutical company developing novel treatments for solid tumors, with a primary focus on female cancers, today provided 2022 year-end updates and corporate guidance for 2023.
“I am proud of the substantial progress the Context team made in 2022. 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,” said Martin Lehr, CEO of Context. “In 2023, we will continue to advance ONA-XR across the endometrial (OATH) and breast (SMILE and ELONA) cancer clinical trials. We expect 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 Q4 2023. In addition, we look forward to rapidly advancing CTIM-76 toward IND submission in Q1 2024.”
Key Highlights
Cash Guidance
The Company had cash and cash equivalents of $39.4 million as of September 30, 2022. The Company expects its current level of cash and cash equivalents will enable the Company to fund its operations into Q1 2024.
About Context Therapeutics®
Context Therapeutics Inc. (Nasdaq: CNTX) is a clinical-stage biopharmaceutical company committed to advancing medicines for solid tumors, with a primary focus on female cancers. The Company’s pipeline includes small molecule and bispecific antibody drug candidates that target cancer signaling pathways. Context is developing CTIM-76, a selective Claudin 6 (CLDN6) x CD3 bispecific antibody for CLDN6 positive tumors, currently in preclinical development. Context is also developing onapristone extended release (ONA-XR), a novel, first-in-class potent and selective progesterone receptor antagonist, currently in three Phase 2 clinical trials and one Phase 1b/2 clinical trial in hormone-driven breast, ovarian, and endometrial cancers. Context is headquartered in Philadelphia. For more information, please visit www.contexttherapeutics.com or follow the Company on Twitter and LinkedIn.
References
[1] Makker V, et al.; KEYNOTE-775 Investigators. Lenvatinib plus Pembrolizumab for Advanced Endometrial Cancer. N Engl J Med. 2022 Feb 3;386(5):437-448.
[2] Bidard FC, et al; EMERALD Investigators. Elacestrant Versus Standard Endocrine Therapy for Estrogen Receptor-Positive, Human Epidermal Growth Factor Receptor 2-Negative Advanced Breast Cancer: Results From the Randomized Phase III EMERALD Trial. J Clin Oncol. 2022 Oct 1;40(28):3246-3256.
Forward-looking Statements
This press release contains “forward-looking statements” that involve substantial risks and uncertainties for purposes of the safe harbor provided by the Private Securities Litigation Reform Act of 1995. Any statements, other than statements of historical fact, included in this press release regarding strategy, future operations, prospects, plans and objectives of management, including words such as “may,” “will,” “expect,” “anticipate,” “plan,” “intend,” and similar expressions (as well as other words or expressions referencing future events, conditions or circumstances) are forward-looking statements. These include, without limitation, statements regarding (i) the expectation to provide a clinical data update from the OATH trial in mid-2023, as well as a Phase 2 data update from the SMILE trial and Phase 1b data for the ELONA trial in the fourth quarter of 2023, (ii) the expectation to have an IND submission for CTIM-76 in the first quarter of 2024, (iii) the selectivity, potency, and safety profile of CTIM-76, (iv) the timing, enrollment and results of our clinical trials, (v) the potential benefits and side effect profile of our product candidates, (vi) the likelihood data will support future development, and (vii) the likelihood of obtaining regulatory approval of our product candidates. Forward-looking statements in this release involve substantial risks and uncertainties that could cause actual results to differ materially from those expressed or implied by the forward-looking statements, and we, therefore cannot assure you that our plans, intentions, expectations or strategies will be attained or achieved. Other factors that may cause actual results to differ from those expressed or implied in the forward-looking statements in this press release are discussed in our filings with the U.S. Securities and Exchange Commission, including the section titled “Risk Factors” contained therein. Except as otherwise required by law, we disclaim any intention or obligation to update or revise any forward-looking statements, which speak only as of the date they were made, whether as a result of new information, future events or circumstances or otherwise.
Media Contact:
Gina Cestari
6 Degrees
917-797-7904
gcestari@6degreespr.com
Investor Relations Contact:
Laine Yonker
Edison Group
lyonker@edisongroup.com
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