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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 Inc. (NASDAQ:CNTX) is advancing therapies for solid tumors, focusing on Claudin 6 (CLDN6). The company is developing CTIM-76, a bispecific antibody targeting CLDN6, estimated to potentially treat 62,500 metastatic cancer patients in the U.S. CLDN6's unique presence in specific cancers, like ovarian and lung cancers, enables targeted T cell activation, minimizing damage to healthy cells. Context aims to address the limitations of current treatments, which can harm both cancerous and healthy cells, causing significant side effects. The company is set to present preclinical data at the AACR Annual Meeting on April 17 and plans to submit an IND filing by Q1 2024 for clinical trials. For more details, visit www.contexttherapeutics.com.
Context Therapeutics Inc. (Nasdaq: CNTX) announced that CEO Martin Lehr will participate in two virtual investor conferences in April 2023. The details are: Diamond Equity Emerging Growth Invitational Investor Conference presentation on April 5 at 9:40 a.m. ET, and 22nd Annual Needham Virtual Healthcare Conference on April 19 at 8:45 a.m. ET, where one-on-one meetings will also occur. Context is focused on developing CTIM-76, a bispecific antibody targeting CLDN6-positive tumors, currently in preclinical development. For further information, visit contexttherapeutics.com.
Context Therapeutics Inc. (Nasdaq: CNTX) announced a strategic shift prioritizing the development of CTIM-76, a Claudin 6 (CLDN6) bispecific antibody to treat solid tumors, while discontinuing the ONA-XR program. The company reported a net loss of $14.8 million for 2022, an increase from $10.5 million in 2021. Cash and equivalents at year-end were approximately $35.5 million, expected to fund operations into late 2024. The IND application for CTIM-76 is anticipated in Q1 2024. Preclinical data will be presented at the AACR Annual Meeting 2023. The decision to cease ONA-XR development was influenced by challenging market conditions and study findings.
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.
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