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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 (Nasdaq: ONCT) has released updated data from its Phase 1/2 Study of ONCT-534 for relapsed or refractory metastatic Castration-Resistant Prostate Cancer (mCRPC). The study included 15 patients receiving once-daily (QD) dosing and 6 patients receiving twice-daily (BID) dosing. Key findings include:
1. BID dosing was well-tolerated with no related Grade 3 or higher toxicities.
2. One patient showed a 50% PSA reduction and 16% reduction in target lesions after four weeks of 300 mg BID dosing.
3. Promising effects on androgen receptor (AR)-regulated genes and AR nuclear translocation were observed in six additional patients.
4. Some non-responders showed neuroendocrine features associated with AR-independent disease.
Despite discontinuing the ONCT-534-101 trial, the company sees potential in exploring BID dosing and earlier therapy lines for advanced prostate cancer. Oncternal continues to explore strategic alternatives for its product candidates.
Oncternal Therapeutics (Nasdaq: ONCT) has announced the termination of its clinical studies and plans to explore strategic alternatives. The company is discontinuing trials for ONCT-534, a dual action androgen receptor inhibitor for metastatic castration resistant cancer, and ONCT-808, a ROR1-targeting autologous CAR T program for aggressive B-cell lymphoma. Interim Phase 1 results for ONCT-534 showed no clinically meaningful improvements in 20 patients across eight dosing cohorts. ONCT-808 demonstrated anti-tumor activity but faced safety concerns. The company will now focus on maximizing stockholder value through potential asset sales, licensing, or business combinations. Oncternal will discontinue all product development and reduce its workforce to preserve cash resources.
Oncternal Therapeutics (Nasdaq: ONCT) provided a business update and reported Q2 2024 financial results. Key highlights include:
1. Phase 1/2 study of ONCT-534 for advanced prostate cancer progressing without dose-limiting toxicities; 1200 mg cohort enrolled.
2. Phase 1/2 study of ONCT-808, a ROR1-targeting CAR T cell therapy, for aggressive B-cell lymphoma is enrolling patients.
3. Cash position of $21.4 million as of June 30, 2024, with runway into Q1 2025.
4. Q2 2024 financials: $0.8 million grant revenue, $9.7 million operating expenses, $8.6 million net loss ($2.89 per share).
5. Upcoming milestones: Initial ONCT-534 data in Q3 2024, additional data in Q4 2024; ONCT-808 clinical data update in Q4 2024.
Oncternal Therapeutics (Nasdaq: ONCT), a clinical-stage biopharmaceutical company focused on developing novel oncology therapies, has announced its plans to release its second quarter 2024 financial results. The company will report these results after the U.S. financial markets close on Thursday, August 8, 2024. Following the release, Oncternal's management team will host a webcast at 2:00 p.m. PT (5:00 p.m. ET) to provide a comprehensive business update and discuss the financial results in detail. Investors and interested parties can access the live webcast through the company's investor relations website at investor.oncternal.com. The webcast will remain archived on the site for a minimum of 30 days for those unable to attend the live event.
Oncternal Therapeutics (Nasdaq: ONCT) has announced significant progress in its Phase 1/2 study of ONCT-534, a dual-action androgen receptor inhibitor (DAARI) for treating metastatic castration-resistant prostate cancer. The company has completed enrollment and initiated dosing for the sixth dose cohort, with patients receiving 1200 mg of ONCT-534 orally once daily. This decision followed a review of data from the fifth dose cohort (600 mg daily) by the study's Safety Review Committee.
Key points:
- No dose-limiting toxicities observed to date
- Strong patient demand continues
- Initial update on safety and efficacy expected in Q3 2024
- Update will include data from the 1200 mg dose cohort
Oncternal Therapeutics (Nasdaq: ONCT), a biopharmaceutical company developing novel oncology therapies, announced that its President and CEO, James Breitmeyer, M.D., Ph.D., will present at the JonesTrading Healthcare Seaside Summit. The event will take place from July 14-16, 2024, in San Diego, California.
The presentation is scheduled for Monday, July 15, 2024, at 2:30pm PT. For those interested in attending, webcast registration is available via a provided link. Replays of the presentation will be accessible on the Events & Presentations page of the company's Investor section for at least 30 days post-event.
Oncternal Therapeutics announced the completion of enrollment and initiation of dosing for the fifth dose cohort in its Phase 1/2 study of ONCT-534. This study targets patients with metastatic castration-resistant prostate cancer who have relapsed or are refractory to current androgen receptor pathway inhibitors (ARPI). The fifth cohort patients will receive a 600 mg daily dose of ONCT-534, following a safety review of the 300 mg dose cohort which showed no dose-limiting toxicities. Initial safety and efficacy results, focusing on prostate-specific antigen (PSA) levels, will be available in Q3 2024.
The company reports strong patient demand and continued site expansion for the study. The Chief Medical Officer, Salim Yazji, M.D., expressed optimism about the drug's tolerability and the forthcoming detailed clinical data.
Oncternal Therapeutics, a clinical-stage biopharmaceutical company, provided a business update and reported first quarter 2024 financial results. The company is progressing well with its Phase 1/2 studies for ONCT-534 and ONCT-808, focusing on prostate cancer and B-cell lymphoma, respectively. They also announced a cash balance of $27.0 million as of March 31, 2024, which is projected to fund operations until Q1 2025.
Oncternal Therapeutics, a clinical-stage biopharmaceutical company, will report its first quarter 2024 financial results on May 9, 2024. The company focuses on developing novel oncology therapies and will host a webcast to discuss the results and provide a business update.
Oncternal Therapeutics, a clinical-stage biopharmaceutical company, granted an inducement award to a new Senior Director, Clinical Data Management, Anne C. Hansen. The award includes an option to purchase 5,000 shares of Oncternal common stock, with a 10-year term and vesting over four years. The approval was made under the company's 2021 Employment Inducement Incentive Award Plan, following Nasdaq Rule 5635(c)(4).
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