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Oncternal Therapeutics, Inc. (Nasdaq: ONCT) is a clinical-stage biopharmaceutical company dedicated to developing innovative oncology therapies targeting cancers with significant unmet medical needs. The company's diverse product pipeline aims to address a wide range of malignancies, advancing novel therapeutic approaches with the potential to significantly improve patient outcomes.
One of Oncternal's flagship products is zilovertamab, a humanized monoclonal antibody that targets the receptor-tyrosine kinase-like orphan receptor 1 (ROR1). Currently in Phase 1/2 clinical trial, zilovertamab is being tested in combination with ibrutinib for mantle cell lymphoma and chronic lymphocytic leukemia, as well as in combination with paclitaxel for HER2-negative metastatic breast cancer.
Another key product in the pipeline is ONCT-216, a small molecule designed to inhibit ETS-family oncoproteins. ONCT-216 is undergoing Phase 1 trials to treat Ewing sarcoma, among other potential indications.
Oncternal is also developing ONCT-808, a CAR-T cell therapy targeting ROR1, showing promise in preclinical models against various hematological malignancies and solid tumors. Furthermore, ONCT-534, a dual-action androgen receptor inhibitor, is in Phase 1/2 trials for advanced prostate cancer, addressing resistance mechanisms common in patients who have relapsed after standard treatments.
Financially, Oncternal remains robust, with ongoing clinical trials supported by solid operational funding. The company maintains strategic partnerships and collaborations to foster innovation and expedite the development of its therapeutic candidates. With a focus on unmet medical needs, Oncternal Therapeutics is at the forefront of oncology research, aiming to bring new hope to patients worldwide.
Oncternal Therapeutics announced the initiation of its Phase 3 global study, ZILO-301 (NCT05431179), for zilovertamab, targeting relapsed/refractory mantle cell lymphoma (MCL). The study, the first to evaluate this novel therapy, aims to enroll 365 patients across 50-100 sites globally, with screening and enrollment expected to begin soon following IRB approval. The trial will assess the drug's efficacy alongside ibrutinib, with key endpoints including Objective Response Rate (ORR) and progression-free survival (PFS). Interim results aim to support a BLA submission for faster FDA approval.
Oncternal Therapeutics, Inc. (Nasdaq: ONCT) announced its participation in the Cantor Oncology, Hematology & HemeOnc Conference on September 28, 2022, in New York City. CEO James Breitmeyer will join the "Multiple Myeloma & Lymphoma" panel at 4:15 PM (ET) and conduct one-on-one meetings. Oncternal is focused on developing innovative oncology therapies, with its lead program, zilovertamab, aimed at hematological malignancies and prostate cancer.
Oncternal Therapeutics (Nasdaq: ONCT) announced its participation in the H.C. Wainwright 24th Annual Global Investment Conference from September 12-14, 2022. CEO James Breitmeyer will present a corporate overview starting September 12th at 7:00am (ET), available on demand. The presentation can be accessed for 30 days on their investor website. Oncternal is focused on developing novel oncology therapies, including zilovertamab for hematological cancers and ONCT-808, a CAR-T cell therapy.
Oncternal Therapeutics reported promising interim results from its Phase 1/2 study of zilovertamab combined with ibrutinib for mantle cell lymphoma (MCL) and chronic lymphocytic leukemia (CLL). This combination showed an 85% objective response rate and a 41% complete response rate in MCL patients, significantly higher than historical data for ibrutinib alone. The company has cash reserves of $78.9 million, expected to last into the first half of 2024. Upcoming milestones include the initiation of the Phase 3 study ZILO-301 in September 2022 and IND submissions for ONCT-808.
Oncternal Therapeutics (Nasdaq: ONCT) announced it will release its second quarter 2022 financial results after the market closes on August 9, 2022. A management webcast will follow at 2:00 p.m. PT (5:00 p.m. ET) to discuss the financial results and provide a business update.
The company focuses on developing innovative oncology therapies, particularly targeting hematological malignancies and prostate cancer, with products like zilovertamab and ONCT-808 in various stages of clinical development.
Oncternal Therapeutics announced a collaboration with Pharmacyclics to support its Phase 3 trial, ZILO-301, for treating relapsed or refractory mantle cell lymphoma (MCL) with zilovertamab and ibrutinib. The agreement will provide ibrutinib and facilitate ZILO-301's initiation in Q3 2022. Zilovertamab, a monoclonal antibody targeting ROR1, aims to address unmet medical needs in oncology. This collaboration underscores Oncternal's strategic pursuit of impactful cancer therapies as it progresses through critical clinical trials.
Oncternal Therapeutics (Nasdaq: ONCT) announced the presentation of preclinical data on its ROR1-targeting cell therapies at the EHA 2022 Hybrid Congress. This includes work from the Karolinska Institutet, showing ROR1 CAR-T and NK cells can recognize targets and exhibit anti-tumor activity in mantle cell lymphoma models. The company is advancing its lead therapy, ONCT-808, towards an Investigational New Drug application, with the first patient expected to be dosed soon. Zilovertamab, another candidate, is under evaluation in multiple clinical trials.
Oncternal Therapeutics (Nasdaq: ONCT) announced a poster presentation for its Phase 3 ZILO-301 clinical trial, evaluating zilovertamab combined with ibrutinib in treating relapsed or refractory mantle cell lymphoma (R/R MCL). This trial aims to prove superior efficacy over ibrutinib alone. Interim data showcased an objective response rate (ORR) of 85% and a complete response rate (CR) of 41%, significantly higher than the historical rates of 66% and 20%, respectively. The trial initiates in Q3 2022, targeting approximately 250 patients.
Oncternal Therapeutics (Nasdaq: ONCT) has announced its participation in the Jefferies Healthcare Conference from June 8-10, 2022. The company's CEO, James Breitmeyer, will present a corporate overview on June 8th at 9:30 AM ET, and one-on-one meetings will be available.
The company focuses on developing innovative oncology therapies, with lead programs targeting ROR1 through investigational drugs like zilovertamab and ONCT-808. For more information, visit oncternal.com.
Oncternal Therapeutics, Inc. (Nasdaq: ONCT) announced the granting of an inducement award to new Head of Clinical Science, Ted Shih, on June 1, 2022. This award, part of the 2021 Employment Inducement Incentive Award Plan, includes an option to purchase 70,000 shares of common stock, vesting over four years. The approval came from Oncternal’s independent compensation committee, ensuring compliance with Nasdaq rules. Oncternal focuses on developing therapies for cancers with significant unmet medical needs, including ongoing clinical trials for its lead product, zilovertamab.
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