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NorthStar Medical Radioisotopes has signed a long-term supply agreement with Clovis Oncology (CLVS) for actinium-225 (Ac-225), a therapeutic medical radioisotope. NorthStar will provide high-purity, non-carrier-added Ac-225 for Clovis's lead peptide-targeted therapeutic candidate, FAP-2286, which targets fibroblast activation protein across various tumors. The agreement aims to enhance the availability of targeted radiopharmaceutical therapies. NorthStar plans to begin Ac-225 production in late 2023 and submit a Drug Master File to the FDA in 2024.
Clovis Oncology (NASDAQ: CLVS) presented initial Phase 1 data from the LuMIERE clinical study for FAP-2286, a targeted radiotherapy candidate. Nine patients were treated with 177Lu-FAP-2286, showing a manageable safety profile and preliminary evidence of activity, including a confirmed partial response in one patient. No serious adverse events related to the treatment were reported, and recruitment for a higher dose cohort is ongoing. FAP-2286 demonstrated high tumor uptake and delayed retention across various solid tumors, suggesting its potential as a theranostic agent.
Clovis Oncology announced significant findings from the Phase 3 ATHENA trial of Rubraca in treating advanced ovarian cancer. The trial demonstrated improved progression-free survival (PFS) for patients receiving Rubraca compared to placebo. Specifically, the HRD-positive population saw a median PFS of 28.7 months versus 11.3 months for placebo. The ATHENA-MONO data will be presented at the 2022 ASCO Annual Meeting, highlighting the drug's efficacy regardless of biomarker status. The safety profile of Rubraca aligns with existing labels in the U.S. and Europe.
Clovis Oncology (Nasdaq: CLVS) announced that President and CEO Patrick J. Mahaffy will present at the BofA Securities 2022 Healthcare Conference on May 11, 2022, at 10:00 a.m. Pacific time. The event will take place at the Encore hotel in Las Vegas.
A live webcast of the presentation will be accessible via the company’s investor relations page, with a replay available for 30 days post-event. Clovis Oncology focuses on developing innovative anti-cancer agents and diagnostic tools aimed at specific cancer populations.
Clovis Oncology reported positive results from the ATHENA study, showing Rubraca (rucaparib) significantly improves progression-free survival (PFS) in first-line ovarian cancer patients. The median PFS for Rubraca was 20.2 months compared to 9.2 months for placebo in the intent-to-treat population. The company reported Q1 2022 net product revenues of $34.2 million, a decline of 10% year-over-year. R&D expenses decreased by 20% to $42.3 million. Clovis anticipates two additional Phase 3 readouts in the next 12 months and ongoing development of its targeted radiotherapy candidate, FAP-2286.
Clovis Oncology (NASDAQ: CLVS) announced the presentation of seven abstracts at the 2022 ASCO Annual Meeting, including late-breaking data from the ATHENA-MONO Phase 3 clinical trial that evaluates Rubraca monotherapy in ovarian cancer. The study's results demonstrate Rubraca's efficacy as a maintenance treatment following first-line chemotherapy. Additional analyses of Rubraca and PARP inhibitors will also be presented. The meeting is scheduled for June 3-7, 2022, in Chicago, with Clovis emphasizing the significance of these findings for patient treatment.
Clovis Oncology will release its first quarter 2022 financial results on May 4, 2022, prior to the US market opening. A conference call, including a live audio webcast, will occur at 8:30am ET for detailed discussions on results. Interested parties can access the webcast on the Clovis Oncology website, with a replay available for 30 days. Investors can participate by calling 888.440.4615 for US and 646.960.0682 for international attendees, using conference ID 2259685.
Clovis Oncology announced significant findings at the AACR Annual Meeting 2022, highlighting the efficacy of FAP-2286 in tumor retention compared to FAPI-46, promising greater tumor inhibition. Phase 1 data from the LuMIERE trial, assessing FAP-2286 as both a therapeutic and imaging agent for solid tumors, is anticipated later this year. Additionally, Rubraca's efficacy was found comparable in non-BRCA HRR gene-altered tumors as in BRCA1/2 models. The Phase 1 LuMIERE trial will involve approximately 50 patients, aiming to establish the safety and recommended dosing schedule for FAP-2286.
Clovis Oncology announced positive results from the ATHENA-MONO trial, where Rubraca significantly improved progression-free survival (PFS) in patients with advanced ovarian cancer compared to placebo. In the intent-to-treat population, the median PFS was 20.2 months for Rubraca versus 9.2 months for placebo. The study also showed benefits in HRD-positive and exploratory HRD-negative groups. Clovis aims to submit a supplemental New Drug Application to the FDA in Q2 2022 and a European submission in Q3 2022, expanding Rubraca's indication for first-line maintenance treatment.
Clovis Oncology, Inc. (NASDAQ: CLVS) has entered into a development agreement with Evergreen Theragnostics to create actinium-225-labeled FAP-2286. This collaboration focuses on developing radiolabeling chemistry and analytical methods for future pre-clinical and clinical studies. Actinium-225 is highlighted for its therapeutic potential in cancer treatment due to its effective radiation delivery while minimizing systemic toxicity. The manufacturing will occur at Evergreen's specialized facility in Springfield, N.J., aimed at supporting targeted cancer therapies.
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