Context Therapeutics® Reports Encouraging Preliminary Phase 2 Data for ONA-XR in Metastatic Breast Cancer

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Data presented at San Antonio Breast Cancer Symposium® demonstrate preliminary 4-month PFS rate of 44% in ongoing Phase 2 trial in second- or third-line metastatic breast cancer
PFS follows recently disclosed positive preliminary data in ongoing Phase 2 endometrial cancer trial
PHILADELPHIA, Dec. 08, 2022 (GLOBE NEWSWIRE) — Context Therapeutics Inc. (“Context” or the “Company”) (Nasdaq: CNTX), a women’s oncology company developing novel treatments for breast and gynecologic cancers, announced preliminary Phase 2 data from the ongoing SMILE trial of onapristone extended release (ONA-XR), the company’s novel, first-in-class, potent, orally administered progesterone receptor (PR) antagonist, in metastatic breast cancer.
Being conducted in collaboration with the Wisconsin Oncology Network, the Phase 2 SMILE trial is evaluating ONA-XR in combination with fulvestrant in patients with ER+, HER2- advanced or metastatic breast cancer who progressed on prior CDK4/6 inhibitor therapy. Preliminary Phase 2 findings highlight a 4-month progression free survival (PFS) rate of 44%, and favorable safety and tolerability. The data were presented at the 2022 San Antonio Breast Cancer Symposium® (SABCS®).

Context Therapeutics and The Menarini Group Announce Clinical Trial Collaboration and Supply Agreement to Evaluate ONA-XR and Elacestrant Combination

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Context Therapeutics Inc. (“Context” or the “Company”) (Nasdaq: CNTX), a women’s oncology company developing small molecule and immunotherapy treatments for breast and gynecological cancers, and The Menarini Group (“Menarini”) today announced a clinical trial collaboration and supply agreement for Menarini’s oral selective estrogen receptor degrader (SERD), elacestrant.

Context Therapeutics® Announces Encouraging Preclinical Data from Two Programs to be Presented at the American Association for Cancer Research (AACR) Annual Meeting 2022

Context Therapeutics logo
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Context Therapeutics Inc. (“Context” or the “Company”) (Nasdaq: CNTX), a women’s oncology company developing small molecule and immunotherapy treatments for breast and gynecological cancers, today announced encouraging preclinical data from two pipeline programs, including in vivo combination and immunomodulation data evaluating onapristone extended release (ONA-XR), the company’s lead clinical program. The data are being presented at the American Association for Cancer Research (AACR) Annual Meeting 2022.

Context Therapeutics® Strengthens Research & Development Team

Headshots of Christopher Beck and Mark Fletcher, with Context Therapeutics logo
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Context Therapeutics Inc. (“Context” or the “Company”) (Nasdaq: CNTX), a women’s oncology company developing small molecule and immunotherapy treatments for breast and gynecological cancers, today announced the appointments of Christopher Beck as SVP of Operations and Mark Fletcher, Ph.D., as VP of R&D. Context also announced the planned retirement of its current Head of CMC, Bill Rencher, Ph.D., who will move into an advisory role with the Company.

Context Therapeutics® Announces Positive Data from ONA-XR in Early Breast Cancer at 2021 San Antonio Breast Cancer Symposium

Context Therapeutics logo
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Context Therapeutics Inc. (Nasdaq: CNTX), a women’s oncology company developing small molecule and immunotherapy treatments for breast and gynecological cancers, today announced that data from the window-of-opportunity clinical trial of onapristone extended release (ONA-XR) in postmenopausal patients with progesterone receptor positive (PR+) early breast cancer demonstrated ONA-XR significantly increased suppression of tumor cell proliferation. The data were presented today during the 2021 San Antonio Breast Cancer Symposium (SABCS).

Context Therapeutics Doses First Patient in Breast Cancer Trial

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Coming off a $28.75 million initial public offering last week, Context Therapeutics dosed its first patient in a mid-stage breast cancer study assessing the combination of the progesterone receptor ONA-XR in combination with an estrogen receptor antagonist.

Context Therapeutics® and Tyligand Bioscience Reach ONA-XR Manufacturing Optimization Milestone

advance medicines for female cancers
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Context Therapeutics Inc., a women’s oncology company developing advanced small molecule and immunotherapy treatments to transform care for hormone-driven breast and gynecological cancers, and Tyligand Bioscience, Ltd., a leader in small molecule drug discovery and development, today announced the successful completion of ONA-XR (onapristone extended release) manufacturing process optimization pursuant to the collaboration agreement entered into between the parties in March 2020.