DE-INCYTE
21.8.2024 17:41:34 CEST | Business Wire | Press release
Incyte (Nasdaq: INCY) today announced that the Company will present key data from its oncology portfolio at the upcoming European Society of Medical Oncology (ESMO) Congress 2024, to be held September 13-17 in Barcelona and virtually.
"The data at ESMO underscore the progress across our oncology portfolio and the potential to impact patients where additional treatment options are needed. Notably, a Presidential Symposium will feature new, pivotal results from the Phase 3 POD1UM-303/InterAACT2 study of retifanlimab (Zynyz®) for the treatment of squamous cell anal carcinoma (SCAC). The POD1UM-303 data will support the supplemental Biologics License Application (sBLA) filing for retifanlimab in SCAC planned by year end 2024," said Pablo Cagnoni M.D., President, Head of Research and Development, Incyte. "We will also present new data on INCB123667, a potential first-in-class CDK2 inhibitor, which we believe has the potential to enhance outcomes and serve as a foundational treatment for platinum-resistant ovarian and other cancers."
Details on the abstracts accepted for presentation at ESMO include:
Presidential Symposium
Retifanlimab (PD-1)
POD1UM-303/InterAACT2: Phase 3 Study of Retifanlimab With Carboplatin-Paclitaxel (C-P) in Patients (Pts) With Inoperable Locally Recurrent or Metastatic Squamous Cell Carcinoma of the Anal Canal (SCAC) Not Previously Treated With Systemic Chemotherapy
Presidential Symposium I: Practice-changing trials. Presentation Number: LBA2. Presentation Time: 10:50-11:02 a.m. ET (4:50-5:02 p.m. CET), September 14, 2024
Mini Oral Session
INCB123667
Safety and Tolerability of INCB123667, a Selective CDK2 Inhibitor, in Patients (Pts) With Advanced Solid Tumors: A Phase 1 Study
Mini oral session: Developmental therapeutics. Presentation Number: 617MO. Presentation Time: 9:35 – 9:40 a.m. ET (3:35-3:40 p.m. CET), September 14, 2024
Conference Call and Webcast
Incyte will host an in-person analyst and investor event on Saturday, September 14, 2024, from 1:00-2:30 p.m. ET (7:00-8:30 p.m. CEST) to discuss key data presentations at ESMO including data from the POD1UM-303 Presidential Symposia and its CDK2 inhibitor program. The CDK2 data presentation will include new results from a later data cut-off, as well as the data included in the ESMO accepted abstract and mini-oral presentation. The event will be webcasted and can be accessed via the Events and Presentations tab of the Investor section of Incyte.com and it will be available for replay for 90 days.
Conference call details will be provided on the Investor section of Incyte.com.
Abstracts will be available to registered attendees on the ESMO Virtual Congress platform beginning on September 9, 2024. All accepted abstracts will be published in the ESMO Congress 2024 Abstract Book, a supplement to the official ESMO journal, Annals of Oncology.
More information regarding the 2024 ESMO Congress can be found at https://www.esmo.org/meeting-calendar/esmo-congress-2024.
About Retifanlimab (Zynyz®)
Retifanlimab (Zynyz®), is an intravenous PD-1 inhibitor indicated in the U.S. for the treatment of adult patients with metastatic or recurrent locally advanced Merkel cell carcinoma (MCC). This indication is approved under accelerated approval based on tumor response rate and duration of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trials.
Zynyz is marketed by Incyte in the U.S. In 2017, Incyte entered into an exclusive collaboration and license agreement with MacroGenics, Inc. for global rights to retifanlimab.
Zynyz is a trademark of Incyte.
About Incyte
A global biopharmaceutical company on a mission to Solve On., Incyte follows the science to find solutions for patients with unmet medical needs. Through the discovery, development and commercialization of proprietary therapeutics, Incyte has established a portfolio of first-in-class medicines for patients and a strong pipeline of products in Oncology and Inflammation & Autoimmunity. Headquartered in Wilmington, Delaware, Incyte has operations in North America, Europe and Asia.
For additional information on Incyte, please visit Incyte.com or follow us on social media: LinkedIn, X, Instagram, Facebook, YouTube.
Incyte Forward-Looking Statements
Except for the historical information set forth herein, the matters set forth in this press release, including statements regarding the presentation of data from Incyte’s clinical development pipeline, the potential for retifanlimab and INCB123667 to positively impact patients and plans to submit an sBLA for retifanlimab in SCAC by year end 2024, contain predictions, estimates, and other forward-looking statements.
These forward-looking statements are based on our current expectations and are subject to risks and uncertainties that may cause actual results to differ materially, including unanticipated developments in and risks related to: unanticipated delays; further research and development and the results of clinical trials possibly being unsuccessful or insufficient to meet applicable regulatory standards or warrant continued development; the ability to enroll sufficient numbers of subjects in clinical trials and the ability to enroll subjects in accordance with planned schedules; determinations made by the FDA and regulatory agencies outside of the United States; the efficacy or safety of our products; the acceptance of our products in the marketplace; market competition; unexpected variations in the demand for our products and the products of our collaboration partners; the effects of announced or unexpected price regulation or limitations on reimbursement or coverage for our products; sales, marketing, manufacturing, and distribution requirements, including our ability to successfully commercialize and build commercial infrastructure for newly approved products and any additional new products that become approved; and other risks detailed from time to time in our reports filed with the U.S. Securities and Exchange Commission, including our annual report on Form 10-K and our quarterly report on Form 10-Q for the quarter ended June 30, 2024. We disclaim any intent or obligation to update these forward-looking statements.
To view this piece of content from cts.businesswire.com, please give your consent at the top of this page.
View source version on businesswire.com: https://www.businesswire.com/news/home/20240821420609/en/
About Business Wire
Subscribe to releases from Business Wire
Subscribe to all the latest releases from Business Wire by registering your e-mail address below. You can unsubscribe at any time.
Latest releases from Business Wire
Prodalim Strengthens its Functional Platform to Enter the Fast-Growing Nutraceutical Market with the Acquisition of Sylvestre, a Market Leader in Botanical Extracts Based in Brazil12.3.2026 11:45:00 CET | Press release
The acquisition positions Prodalim to deepen its fast-growing functional beverage solutions offering, accelerate its expansion into the US functional ingredients market, and broaden its presence across emerging markets Prodalim, a global leader in juice and specialty ingredients solutions, announced today the acquisition of Sylvestre, a leading Brazilian producer of botanicals and functional extracts addressing the nutraceutical market. Sylvestre’s existing owners and management team will remain with the company and support its integration into Prodalim’s platform. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260312584318/en/ Founded in 1992 in Brazil, Sylvestre is a trusted supplier of high-quality natural ingredients, specializing in botanical extracts, fruit powders, superfruits, teas, and unique functional plant-based solutions sourced from the rich and diverse Brazilian flora. With a portfolio of more than 200 natural
Compass Pathways to Present at Stifel 2026 Virtual CNS Forum on March 18, 202612.3.2026 11:30:00 CET | Press release
Compass Pathways plc (Nasdaq: CMPS), a biotechnology company dedicated to accelerating patient access to evidence-based innovation in mental health, announced today that management will attend the Stifel 2026 Virtual CNS Forum, from March 17-18, 2026, and will participate in a fireside chat on March 18, 2026, at 10:30am ET. A live audio webcast of this event will be accessible from the “Events” page of the Investors section of the Compass website. A replay of the webcast will be accessible for 30 days following each event. About Compass Pathways Compass Pathways plc (Nasdaq: CMPS) is a biotechnology company dedicated to accelerating patient access to evidence-based innovation in mental health. We are motivated by the need to find better ways to help and empower people with serious mental health conditions who are not helped by existing treatments. We are pioneering a new paradigm for treating mental health conditions focused on rapid and durable responses through the development of our
WHOOP and Samuel Ross MBE Announce First Limited-Edition Collection Drop for PROJECT TERRAIN12.3.2026 11:00:00 CET | Press release
The new WHOOP x SR_A collection includes bespoke, performance-driven WHOOP bands, apparel and outerwear WHOOP, the human performance company, today announces that the first limited-edition collection drop of PROJECT TERRAIN, the multi-year collaboration between WHOOP and Samuel Ross MBE via SR_A, is now available for purchase. The debut collection introduces a technical garment system engineered for movement across environments - redefining the city as a modern training ground for daily performance. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260312513358/en/ WHOOP and Samuel Ross MBE Announce First Limited-Edition Collection Drop for PROJECT TERRAIN PROJECT TERRAIN marks a first for WHOOP, featuring reimagined executions of WHOOP bands, elevated WHOOP Body apparel, and the company’s first entry into technical outerwear. Designed as a unified system, each piece integrates the WHOOP device intentionally and visibly, transf
NAFFCO Group and Verona Shelters Launch Strategic Joint Venture to Scale Civil and Military Shelter Production Globally12.3.2026 10:56:00 CET | Press release
NAFFCO Group has entered into a Joint Venture Agreement with Verona Shelters to form a strategic partnership dedicated to developing and manufacturing advanced civil defense and military shelter solutions in the United Arab Emirates. The partnership significantly expands global production capacity for protective shelter infrastructure at a time when governments and critical industries are strengthening resilience and civil preparedness. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260312010187/en/ Left: Verona Shelters: Eng. Shaikha Ali Rashed Al Kaabi, (MD UAE) and Mikko Lahtonen, (Executive Director Middle-East); Naffco Group: Eng. Khalid Al-Khatib (CEO); Mr. Ahmed Khalid Al-Khatib, (Group Managing Director); Mr.Ali Khalid Al-Khatib, (Group Managing Director); Ms.Nour Alyazji, (Business Development Director) The collaboration combines NAFFCO’s global leadership in safety engineering and large-scale manufacturing with Ver
Smiths Detection Celebrates Sale of its 2,000th HI-SCAN 6040 CTiX 3D X-ray Scanner12.3.2026 10:00:00 CET | Press release
Major milestone reinforces Smiths Detection’s position as the world’s most trusted provider of advanced screening solutions, deployed at more than 100 airports Smiths Detection, a global leader in threat detection and screening solutions, today announces the sale of its 2,000th HI-SCAN 6040 CTiX, an industry-leading 3D X-ray scanner with high-resolution 3D computed tomography images and intelligent AI-driven automatic detection capabilities. The HI-SCAN 6040 CTiX is deployed across over 100 airports in Europe, Asia-Pacific, the Middle East and the Americas. Operational experience across these regions has demonstrated consistent benefits for airports and passengers alike. Fewer false alarms mean faster, more reliable screening, and as threat profiles change, the technology keeps pace, strengthening security resilience over time. Meanwhile, in eligible locations, passengers no longer need to remove laptops or liquids from their bags, a small change that has a real impact on congestion at
In our pressroom you can read all our latest releases, find our press contacts, images, documents and other relevant information about us.
Visit our pressroom