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About Context Therapeutics Inc.
Context Therapeutics Inc. (Nasdaq: CNTX) is a clinical-stage biopharmaceutical company dedicated to advancing innovative therapies for solid tumors. Headquartered in Philadelphia, the company focuses on developing T cell engaging (TCE) bispecific antibodies, a cutting-edge immunotherapy approach that redirects the body's immune system to target and destroy cancer cells. With a robust pipeline of clinical-stage assets, Context is at the forefront of addressing unmet medical needs in oncology, particularly in hormone-dependent and underserved cancers.
Core Focus: T Cell Engaging Bispecific Antibodies
Context Therapeutics specializes in TCE bispecific antibodies, which are engineered to bind simultaneously to tumor-specific antigens and T cells, facilitating targeted immune responses against cancer cells. Their lead program, CTIM-76, targets Claudin 6 (CLDN6), a protein highly expressed in multiple solid tumors but absent in most healthy tissues, ensuring specificity and minimizing off-target effects. Additionally, their pipeline includes CT-95, a Mesothelin (MSLN) x CD3 bispecific antibody, and CT-202, a Nectin-4 x CD3 bispecific antibody, both of which are being developed to treat advanced cancers with limited therapeutic options.
Innovative Pipeline and Development Strategy
Context's pipeline reflects a strategic emphasis on addressing solid tumors with high unmet needs. The company's therapies are designed for scalability and low immunogenicity, ensuring broader accessibility and reduced adverse effects. CTIM-76 is currently in Phase 1 clinical trials, targeting gynecologic and testicular cancers, while CT-95 and CT-202 are advancing toward clinical development. Context's acquisition of promising assets like CT-95 and CT-202 underscores their commitment to building a diverse and innovative portfolio of TCE therapeutics.
Market Position and Competitive Landscape
Operating in the highly competitive oncology sector, Context Therapeutics differentiates itself through its focus on bispecific antibody technology and its ability to address limitations of first-generation therapies. By targeting tumor-specific proteins like CLDN6, MSLN, and Nectin-4, the company positions itself as a leader in developing next-generation immunotherapies. Their approach to scalable manufacturing and robust preclinical data further strengthens their competitive edge. Key competitors include other biotech firms specializing in immuno-oncology, but Context's emphasis on underserved cancer types and differentiated product profiles sets them apart.
Commitment to Addressing Unmet Medical Needs
Context Therapeutics is driven by a mission to transform the treatment landscape for solid tumors. By leveraging advanced TCE technology and focusing on cancers with limited therapeutic options, the company aims to provide hope to patients and families affected by these challenging diseases. Their strategic acquisitions, robust pipeline, and focus on innovation highlight their dedication to improving patient outcomes and advancing the field of oncology.
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.
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