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Exelixis Inc. reports developments from its oncology business, including commercial performance for the cabozantinib franchise and clinical and regulatory updates across cancer programs. The company discovers, develops and commercializes cancer medicines, with CABOMETYX® (cabozantinib) as its flagship commercial product and COMETRIQ® also part of its cabozantinib portfolio.
Recurring updates include quarterly financial results, product revenue trends, financial guidance, pipeline milestones and investor conference presentations. Exelixis also discusses zanzalintinib, an investigational oral kinase inhibitor, and a broader pipeline of small molecules and biotherapeutics targeting additional tumor types and indications.
Exelixis announced that the COSMIC-311 phase 3 trial for cabozantinib (CABOMETYX) in patients with radioiodine-refractory differentiated thyroid cancer met its co-primary endpoint, showing a significant 78% reduction in risk of disease progression or death (hazard ratio 0.22, p0.0001). Following these interim results, the independent monitoring committee recommended stopping enrollment. The company plans to discuss these results with the U.S. FDA and share detailed findings at an upcoming medical conference, marking a significant advancement in treatment options for this patient population.
Exelixis, Inc. (Nasdaq: EXEL) has exercised its exclusive option for Iconic Therapeutics' leading oncology antibody-drug conjugate (ADC) program, XB002. This program targets Tissue Factor (TF) and includes Zymeworks' linker-payload technology, aiming for a better safety profile. Exelixis will be responsible for the clinical development and commercialization of XB002. An additional payment of $20 million has been made to Iconic following the initial $7.5 million payment from a 2019 agreement. Exelixis plans to file an IND application with the FDA to start a Phase 1 clinical trial in early 2021.
Exelixis, Inc. (NASDAQ: EXEL) announced that its partner, Takeda Pharmaceutical, received approval from Japan's Ministry of Health to market CABOMETYX® (cabozantinib) for unresectable hepatocellular carcinoma (HCC) patients who have failed prior systemic therapy. This approval is based on results from the CELESTIAL and Cabozantinib-2003 clinical trials. Exelixis is eligible for a $15 million milestone payment upon first commercial sale, expected in Q4 2020. The collaboration with Takeda includes potential future milestones and royalties on net sales in Japan.
Exelixis, Inc. (Nasdaq: EXEL) announced participation in December's virtual investor conferences, including the Piper Sandler 32nd Annual Virtual Healthcare Conference and the Evercore ISI 3rd Annual HealthCONx. The Piper Sandler fireside chat is available for on-demand streaming on Exelixis' website. Additionally, Exelixis is set to present at Evercore ISI on December 1 at 3:05 PM EST. Investors can access these sessions on the company's website, where replays will be available for 14 days.
Exelixis focuses on developing cancer therapies and is recognized for its growth in the biopharmaceutical sector.
Exelixis, Inc. (Nasdaq: EXEL) will participate in two virtual investor conferences in November 2020. The company will present at the Credit Suisse 29th Annual Virtual Healthcare Conference on November 10 at 4:15 PM EST and at the Stifel 2020 Virtual Healthcare Conference on November 18 at 2:00 PM EST. Interested parties can access the webcasts via the Exelixis website and replays will be available for 14 days. Exelixis focuses on oncology, with significant products like CABOMETYX and COMETRIQ.
Exelixis announced that its partner, Takeda Pharmaceutical, submitted a supplemental application to the Japanese Ministry of Health for CABOMETYX in combination with OPDIVO for treating advanced renal cell carcinoma (RCC). This application is based on the pivotal CheckMate -9ER trial, showing superior overall survival and progression-free survival compared to sunitinib. Exelixis is eligible for a $10 million milestone payment with potential for additional payments and royalties. This marks significant progress in addressing the needs of patients with advanced kidney cancer.
Exelixis, Inc. (NASDAQ: EXEL) announced the enrollment of the first patient in the dose-escalation cohort of a phase 1 trial (NCT03845166) for XL092, a next-generation oral tyrosine kinase inhibitor. This trial evaluates XL092 alone and in combination with atezolizumab for patients with advanced solid tumors. Preliminary findings suggest that XL092 may promote an immune-permissive environment and have a shorter pharmacokinetic half-life compared to cabozantinib, aiding in tolerability management. The trial, initiated in February 2019, will eventually explore various cancer types.
Exelixis, Inc. (Nasdaq: EXEL) will announce its third quarter 2020 financial results on November 5, 2020, after market close. Management will host a conference call at 5:00 p.m. EST to discuss the results and provide business updates. Interested parties can access the event via the company’s website or by phone. Exelixis focuses on developing innovative therapies for difficult-to-treat cancers and has successfully brought multiple products to market. They are committed to increasing their pipeline through effective partnerships and reinvestment strategies.
Exelixis, Inc. (Nasdaq: EXEL) and Aurigene Discovery Technologies Limited released new preclinical data indicating that AUR102, a selective covalent inhibitor of CDK7, shows significant anti-tumor activity across various cancer cell lines. Key findings include potent anti-proliferative activity and complete tumor regression in multiple xenograft models. AUR102 displays synergy with established chemotherapies and demonstrates complete target engagement. The data will be presented at the upcoming EORTC-NCI-AACR Symposium. Exelixis plans an Investigational New Drug filing for AUR102, enhancing its oncology pipeline.
Exelixis, Inc. (NASDAQ: EXEL) announced new data supporting the clinical development of XL092, a next-generation oral tyrosine kinase inhibitor targeting kinases involved in cancer growth. This data will be presented at the 32nd EORTC-NCI-AACR Symposium on October 24-25. The findings suggest XL092 has significant anti-tumor activity with a shorter half-life compared to cabozantinib. The ongoing phase 1 trial will also explore the combination of XL092 with atezolizumab in various solid tumors, enhancing its therapeutic potential.