Oncternal Therapeutics Inc - ONCT STOCK NEWS

Oncternal Therapeutics announced a consensus with the FDA regarding the Phase 3 superiority clinical trial ZILO-301 for zilovertamab, aimed at treating relapsed or refractory mantle cell lymphoma (MCL). The agreement includes key design features and operational details, with clinical trials slated to begin in Q2 2022. This marks a significant milestone for Oncternal as they align on the potential commercialization path for zilovertamab. The primary endpoint for ZILO-301 will be progression-free survival, with an interim analysis for accelerated FDA approval.

Oncternal Therapeutics presented encouraging interim data from the Phase 1/2 CIRLL clinical trial for zilovertamab in combination with ibrutinib, focusing on mantle cell lymphoma (MCL) and chronic lymphocytic leukemia (CLL). The objective response rate (ORR) was 81% in heavily pre-treated MCL patients, with a complete response (CR) rate of 35% and median progression-free survival (PFS) of 35.9 months. For CLL, the ORR was 91% and landmark PFS reached 100% at 36 months for patients with ≤ 2 prior therapies. The combination therapy showed a favorable safety profile compared to ibrutinib alone.

Oncternal Therapeutics, Inc. (Nasdaq: ONCT) announced the granting of an inducement award to new Clinical Trial Manager Carina Freedman on December 1, 2021. The award includes an option to purchase 34,100 shares of common stock, with a 10-year term and an exercise price equal to the stock's closing price on the grant date. The shares will vest over four years, reflecting a strategy to attract talent under Nasdaq regulations.

Oncternal Therapeutics (Nasdaq: ONCT) announced updated interim clinical data from its Phase 2 expansion cohort of the Phase 1/2 trial for ONCT-216, targeting relapsed or refractory Ewing sarcoma. Presented at the CTOS 2021 Virtual Meeting, the trial showed two complete responses, including one patient who maintained a 24-month durable complete response. The drug was generally well tolerated, with manageable side effects. The ongoing study aims to optimize dosing to address unmet medical needs in this patient population.

Oncternal Therapeutics (Nasdaq: ONCT) announced its participation in the 12th Annual Jefferies London Healthcare Conference, with a virtual presentation available on-demand from November 18, 2021, at 8:00 a.m. GMT until November 19, 2021, at 5:00 p.m. GMT. CEO James Breitmeyer will present, and the webcast link is accessible here. Oncternal focuses on developing novel oncology therapies, including its investigational drugs targeting ROR1 and Ewing sarcoma.

Oncternal Therapeutics, Inc. (NASDAQ: ONCT) reported progress in its oncology pipeline, including zilovertamab for mantle cell lymphoma, with ongoing FDA discussions for registration pathways. The company identified ONCT-808 as its lead candidate for CAR-T therapies and established a collaboration with Celularity Inc. for ROR1-targeted therapies. Additionally, ONCT-534 was designated as a lead candidate in their preclinical androgen receptor inhibitor program for advanced prostate cancer. Financially, the company reported a net loss of $9.6 million for Q3 2021, with $97.4 million in cash reserves sufficient to fund operations into 2023.

Oncternal Therapeutics (Nasdaq: ONCT) has joined the Karolinska Institutet’s NextGenNK Competence Center to advance NK cell-based cancer immunotherapies. This collaboration aims to enhance the development of ROR1-targeting therapies, leveraging Karolinska's research and Oncternal's expertise. Oncternal's clinical pipeline includes cirmtuzumab, a monoclonal antibody targeting ROR1, undergoing trials for various cancers. The partnership is expected to address significant unmet medical needs in oncology.

Oncternal Therapeutics, Inc. (Nasdaq: ONCT) has established a Cell Therapy Scientific Advisory Board (SAB) to enhance its efforts in developing novel cell therapies targeting ROR1, a receptor linked to various cancers. The SAB consists of experts from academia and industry, focusing on advancing research, preclinical development, and clinical applications. Cirmtuzumab, Oncternal's investigational antibody, shows promise in ongoing Phase 1/2 trials for treating mantle cell lymphoma and chronic lymphocytic leukemia. The company aims to expedite the delivery of effective therapies to patients through this strategic advisory group.

Oncternal Therapeutics announced an inducement award to new Clinical Trial Manager Mohab Hassanin on November 1, 2021. The award includes an option to purchase 34,100 shares of common stock, vesting over four years. This grant aligns with the company’s 2021 Employment Inducement Incentive Award Plan and complies with Nasdaq rules. The company focuses on innovative oncology therapies addressing critical needs, including cirmtuzumab in trials for mantle cell lymphoma and breast cancer, and TK216 for Ewing sarcoma.