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Context Therapeutics Inc. reports developments as a clinical-stage biopharmaceutical company advancing T cell engaging bispecific antibodies for solid tumors. Its news centers on oncology programs including CTIM-76, a CLDN6 x CD3 bispecific antibody; CT-95, a MSLN x CD3 bispecific antibody; and CT-202, a Nectin-4 x CD3 bispecific antibody.
Recurring updates cover clinical and preclinical data, regulatory designations, scientific conference presentations, operating results, research and development spending, liquidity, investor-conference activity and equity-based employee inducement grants. CTIM-76 has received FDA Fast Track designation for platinum-resistant ovarian cancer, adding regulatory status to the company's solid-tumor development disclosures.
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).
Context Therapeutics (CNTX) announced a collaboration with Menarini Group to assess ONA-XR alongside elacestrant in metastatic breast cancer. The company reported a net loss of $4.0 million for Q2 2022, an improvement from $5.0 million in Q2 2021. Cash reserves stood at $42.9 million as of June 30, 2022, projected to sustain operations until Q4 2023. Notable pipeline advancements include ongoing Phase 2 trials with preliminary data anticipated in Q4 2022 and plans to initiate the ELONA trial by year-end.
Context Therapeutics (Nasdaq: CNTX) announced a collaboration with Menarini Group to support a Phase 1b/2 clinical trial of ONA-XR, an oral progesterone receptor antagonist, combined with elacestrant, a selective estrogen receptor degrader. Targeting ER+, PR+, HER2- metastatic breast cancer patients previously treated with a CDK4/6 inhibitor, this trial aims to explore enhanced tumor control through dual ER and PR blockade. Elacestrant showed a 30% reduction in progression risk compared to standard therapies. The trial is set to initiate in Q4 2022.
Context Therapeutics Inc. (Nasdaq: CNTX) reported its Q1 2022 financial results, revealing a net loss of $3.4 million compared to $0.9 million in Q1 2021. Cash and cash equivalents declined to $45.7 million from $49.7 million at year-end 2021. The company presented promising data from its ONA-XR clinical trial at the AACR Annual Meeting and has ongoing Phase 2 trials for breast, ovarian, and endometrial cancers. Preliminary data from these trials is expected later in 2022, alongside the selection of a candidate for the CLDN6xCD3 program.
Context Therapeutics Inc. (Nasdaq: CNTX) announced promising results from its Phase 2 trial of ONA-XR, a progesterone receptor antagonist, in treating advanced granulosa cell tumors. The results will be presented at the ASCO Annual Meeting scheduled for June 3-7, 2022. The study has progressed to evaluate ONA-XR in combination with the antiestrogen anastrozole. CEO Martin Lehr expressed optimism about ONA-XR's potential in targeting this rare ovarian cancer type. The abstract highlights significant activity of ONA-XR, marking a pivotal step in Context's clinical program for women's oncology therapies.