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NuCana plc develops cancer medicines based on its proprietary ProTide technology, with news centered on the ADR-listed clinical-stage biopharmaceutical company’s oncology pipeline and corporate updates. Recurring releases describe NUC-7738, a novel anti-cancer agent being studied as a monotherapy in advanced solid tumors and with pembrolizumab in melanoma, and NUC-3373, a 5-fluorouracil-derived new chemical entity being studied with pembrolizumab and docetaxel in advanced solid tumors and lung cancer.
Company updates also cover clinical and translational data presentations, patent protection for NUC-7738, quarterly and annual financial results, cash runway commentary, executive and board changes, and Nasdaq continued-listing matters for NuCana’s American depositary shares.
NuCana plc (NASDAQ: NCNA) announced the completion of patient enrollment for its Phase III NuTide:121 study, which will facilitate a second interim analysis by the second half of 2022. The study is evaluating Acelarin combined with cisplatin against the standard of care, gemcitabine plus cisplatin, for advanced biliary tract cancer. Acelarin's potential for accelerated FDA approval hinges on achieving a statistically significant improvement in the Objective Response Rate (ORR) in interim analyses. The company aims to enroll up to 828 patients in total.
NuCana plc (NASDAQ: NCNA) reported Q3 2021 financial results, noting a cash position of £71.0 million and a net loss of £8.0 million, improving from £8.4 million in Q3 2020.
They completed enrollment of 418 patients for a Phase III study on Acelarin for biliary tract cancer, which may lead to accelerated FDA approval.
The FDA granted Fast Track designation for Acelarin, and positive clinical data for NUC-3373 and NUC-7738 was presented at ESMO 2021.
Several key milestones are anticipated in Q4 2021 and H1 2022.
NuCana plc (NASDAQ: NCNA) announced that CEO Hugh Griffith and CFO Don Munoz will present at the Jefferies 2021 London Healthcare Conference on November 17, 2021, at 4:20 PM GMT. The event will include one-on-one meetings and will be webcast live, with replays available on the company’s website. NuCana focuses on enhancing cancer treatment outcomes using its ProTide technology. Its pipeline includes three ProTides in clinical development, notably Acelarin and NUC-3373, aimed at resistant cancers.
NuCana plc (Nasdaq: NCNA) has appointed Elliott M. Levy, M.D. to its Board of Directors. Dr. Levy, former Senior Vice President at Amgen, brings over 20 years of experience in drug development. He has played a significant role in the creation of 20 approved medicines. His expertise will be crucial as NuCana advances its pipeline of ProTides aimed at improving cancer treatment. The company focuses on transforming nucleoside analogs into better therapies. Dr. Levy expressed excitement about joining NuCana at a pivotal time in its growth.
NuCana plc (NASDAQ: NCNA) announced that the FDA has granted Fast Track designation for Acelarin (NUC-1031), currently in a Phase III study for advanced biliary tract cancer. This designation aims to expedite the development and review of drugs addressing serious conditions. The company has enrolled 418 patients, with the first interim analysis expected in early 2022, potentially allowing for accelerated approval. Acelarin is significant as there are currently no approved first-line treatments for this cancer type, which sees approximately 178,000 new cases annually worldwide.
NuCana plc (NASDAQ: NCNA) announced positive results for its cancer drugs NUC-3373 and NUC-7738 during the ESMO Congress 2021. Data from the Phase 1b/2 study of NUC-3373 revealed promising efficacy in patients with metastatic colorectal cancer, showing tumor reductions in several patients. NUC-3373 was well-tolerated with no severe toxicities. Additionally, interim results for NUC-7738 indicated encouraging anti-cancer activity across various tumors. Acelarin's ongoing study in biliary tract cancer is also noteworthy, with the first interim analysis expected in 2022.
NuCana plc (NASDAQ: NCNA) has completed enrollment for 418 patients in its Phase III NuTide:121 study, aiming for first interim analysis in H1 2022. The study evaluates Acelarin plus cisplatin versus the standard gemcitabine plus cisplatin for advanced biliary tract cancer. A statistically significant improvement in Objective Response Rate (ORR) could support an NDA submission under the FDA's Accelerated Approval Program. The study plans to enroll up to 828 patients, seeking to validate further data for full approval.
NuCana plc (NASDAQ: NCNA) will feature its executives Hugh Griffith and Don Munoz in three virtual investor conferences in September 2021. The events include Citi’s 16th Annual BioPharma Virtual Conference from September 8-10, the H.C. Wainwright 23rd Annual Global Investment Conference from September 13-15, and Oppenheimer’s Virtual Fall Healthcare Life Sciences & MedTech Summit on September 22, with a live presentation at 9:05 AM ET. Webcasts of the presentations will be available on the company's website post-event.
NuCana plc (NASDAQ: NCNA) reported its Q2 2021 financial results, showing a net loss of £9.1 million, widening from £6.1 million in Q2 2020. Cash reserves decreased to £73.4 million from £78.6 million in Q1 2021. The company continues to expand its clinical programs, particularly the NuTide studies on NUC-3373 and NUC-7738. Looking ahead, NuCana anticipates key milestones in 2022, including interim data analysis for Acelarin, potentially enabling an NDA submission under the FDA’s accelerated approval. New Chief Medical Officer, Dr. Jeffrey Bloss, joins to aid in development efforts.
NuCana plc announced the appointment of Jeffrey D. Bloss, M.D. as Chief Medical Officer to enhance its leadership team. Dr. Bloss, with over 25 years in oncology, has played a role in developing and commercializing numerous oncology drugs. He is expected to support the advancement of NuCana’s ProTide pipeline, which includes ongoing Phase III studies for Acelarin and NUC-3373. The company aims to improve treatment outcomes for cancer patients through innovative therapies.