Welcome to our dedicated page for Context Therapeutics news (Ticker: CNTX), a resource for investors and traders seeking the latest updates and insights on Context Therapeutics stock.
Context Therapeutics Inc. (Nasdaq: CNTX) is a clinical-stage biopharmaceutical company pioneering T cell-engaging bispecific antibody therapies for solid tumors. This page serves as the definitive source for verified news and official updates about the company's innovative oncology pipeline, including clinical trial progress, regulatory milestones, and strategic partnerships.
Investors and researchers will find curated updates on key programs like CTIM-76 (targeting CLDN6+ cancers) and CT-95/CT-202 bispecific antibodies. All content is sourced directly from company filings and press releases, ensuring reliability for those monitoring developments in precision cancer immunotherapy.
Our news coverage focuses on three critical areas: Clinical Trial Advancements (Phase 1/2 updates, patient enrollment), Regulatory Progress (FDA communications, trial design approvals), and Strategic Collaborations (research partnerships, intellectual property developments). Each update is contextualized to show its significance within the broader oncology treatment landscape.
Bookmark this page for streamlined access to Context Therapeutics' latest developments in bispecific antibody research. Check back regularly for real-time updates on their mission to transform care for hormone-driven and treatment-resistant cancers.
Context Therapeutics (Nasdaq: CNTX), a clinical-stage biopharmaceutical company, announced that its preclinical candidate CTIM-76, a Claudin 6 x CD3 bispecific antibody, has been selected for a poster presentation at the AACR Annual Meeting 2023 on April 17, 2023. The focus of the presentation is on the development of CTIM-76 for treating ovarian cancer. Context will also host a webinar featuring updates on this program and results from the presentation. CTIM-76 targets tumors with Claudin 6 expression, showing promise for significant patient populations.
Context Therapeutics Inc. (Nasdaq: CNTX) announced promising initial data from the Phase 2 OATH clinical trial for ONA-XR, indicating confirmed tumor shrinkage in two of the first 12 patients. The trial, which examines the efficacy of ONA-XR combined with anastrozole for treating hormone receptor positive metastatic endometrial cancer, shows a 4-month progression-free survival rate of 77% and an overall response rate of 22%. The treatment exhibited favorable safety profiles compared to traditional chemotherapy, with no significant grade 3 or higher adverse events reported. Updated results are expected in Q2 2023.
Context Therapeutics Inc. (Nasdaq: CNTX) announced the FDA approval of ORSERDU (elacestrant) for treating advanced breast cancer in postmenopausal women and adult men with estrogen receptor-positive, HER2-negative cancers that have progressed after at least one course of endocrine therapy. ORSERDU demonstrated improved efficacy over standard treatment (fulvestrant), with a 45% reduction in risk of progression or death in patients with ESR1 mutations. The ongoing ELONA trial aims to evaluate ORSERDU in combination with Context’s ONA-XR. Context focuses on innovative treatments for solid tumors, particularly female cancers.
Context Therapeutics (Nasdaq: CNTX) has partnered with Lonza to support the development and manufacturing of CTIM-76, a CLDN6 x CD3 bispecific antibody targeting solid tumors. The collaboration will leverage Lonza’s expertise in complex protein development, providing services such as manufacturability assessment and process development. CTIM-76 is in preclinical stages and aims to selectively target CLDN6-positive tumors, including ovarian and endometrial cancers. This strategic partnership is anticipated to enhance the clinical development of CTIM-76.
Context Therapeutics (Nasdaq: CNTX) has nominated CTIM-76 as its clinical candidate for Claudin 6 bispecific antibody therapy. Preliminary data from ongoing Phase 2 clinical trials of its ONA-XR therapy show promising results in treating metastatic endometrial and breast cancers. The company reported a 77% progression-free survival rate at four months for ONA-XR combined with anastrozole in endometrial cancer. ONA-XR is also being tested with fulvestrant for breast cancer. Additionally, the ELONA trial has begun enrolling patients. Cash on hand totals $39.4 million.
Context Therapeutics (Nasdaq: CNTX) presented preliminary data at the San Antonio Breast Cancer Symposium showing a 44% four-month progression-free survival (PFS) rate in its ongoing Phase 2 SMILE trial for metastatic breast cancer. The trial evaluates onapristone extended release (ONA-XR) in combination with fulvestrant for patients who previously failed CDK4/6 inhibitor therapy. Additionally, a 77% PFS rate was reported in a similar ongoing Phase 2 trial for endometrial cancer. The company aims to address unmet needs in both breast and endometrial cancers with ONA-XR.
Context Therapeutics (CNTX) has selected CTIM-76 as its lead candidate targeting Claudin 6-positive cancers. This bispecific antibody is anticipated to advance rapidly with an IND submission to the FDA expected in Q1 2024. CTIM-76 shows high selectivity for CLDN6, which is prevalent in cancers such as ovarian and endometrial, while avoiding activation of normal cells. The company highlights the potential for scalable manufacturing and low immunogenicity risk. A webinar discussing CTIM-76 will be held on December 1, 2022, featuring insights from Context's team.
Context Therapeutics (CNTX) provided a positive update on ONA-XR's clinical trials for treating PR+ recurrent endometrial cancer, reporting a preliminary 4-month PFS rate of 77.7%. The company has cash reserves of $39 million, expected to fund operations into Q1 2024. They initiated the Phase 1b trial for ONA-XR combined with elacestrant and continue to assess ONA-XR across ongoing trials. However, R&D expenses increased significantly to $2.1 million for Q3 2022, and the net loss widened to $3.9 million compared to the previous year.
Context Therapeutics (Nasdaq: CNTX) announced an updated cash guidance extending its runway into Q1 2024. The company will focus on advancing the ONA-XR ELONA Phase 1b/2 clinical trial while deferring noncritical R&D and reducing overhead costs. The trial evaluates ONA-XR in combination with Menarini’s elacestrant for treating metastatic breast cancer. Additionally, Context plans to nominate a CLDN6xCD3 bispecific antibody development candidate and submit an IND in Q1 2024. Preliminary data from ongoing trials is expected in late 2022.
Context Therapeutics Inc. (Nasdaq: CNTX), focused on women's oncology, announces CEO Martin Lehr's participation in a fireside chat at the H.C. Wainwright 24th Annual Global Investment Conference from September 12-14, 2022. The chat will be available on demand starting September 12 at 7 a.m. ET. The company will also hold in-person meetings at the conference in New York City. Context is advancing treatments for breast and gynecological cancers, with ongoing Phase 2 trials for its drug candidate, Onapristone extended release (ONA-XR).