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
Tacton Appoints Former IFS Executive Merlin Knott as Chief Commercial Officer to Accelerate Global Growth and Scale Beyond CPQ2.10.2026 15:00:00 CEST | Press release
Enterprise software veteran to lead Tacton’s united commercial organization and partner expansion worldwide. Tacton, a global leader in Configure, Price, Quote (CPQ) software and configuration solutions for manufacturers of complex products, today announced the appointment of Merlin Knott as Chief Commercial Officer (CCO). In this role, Knott will lead Tacton’s global commercial organization, including marketing, sales, and pre-sales, aligning the teams responsible for bringing Tacton’s solutions to market, and driving value to its customers and partners globally. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20261002794882/en/ Merlin Knott, Chief Commercial Officer, Tacton Knott joins Tacton with decades of experience building and scaling commercial organizations across the enterprise software industry. Most recently, he held senior leadership roles at IFS, the world’s leading provider of Industrial AI software, where he led
EDW Presents 2026 Data Quality Award to Repeat Winner Domivest2.10.2026 15:00:00 CEST | Press release
European DataWarehouse (EDW) presented its fifth annual Data Quality Award at the 2026 TSI Congress in Berlin. This year, EDW's Best Data Quality – Deal of the Year (2026) award was presented to Domivest B.V. for its transaction Domi 2023-1 B.V., recognising the firm's outstanding commitment to accurate, complete, and consistent reporting. The award is based on EDW's proprietary data quality scoring methodology, which evaluates transactions against thousands of validation rules and checks. Data quality excellence is not a one-off achievement. The fact that the same issuers continue to rank among the top performers year after year demonstrates that superior data quality is the result of sustained commitment, robust processes, and ongoing investment. "Receiving the Data Quality Award for a second time means a great deal to us. Transparent, accurate loan-level data is key to investor trust in our transactions, and we are grateful to European DataWarehouse for recognising the work our trea
ILiAD Biotechnologies Expands BPZE1 Public Health and Commercial Potential with Publication of Pediatric Phase 2b Study in The Lancet Infectious Diseases2.10.2026 14:00:00 CEST | Press release
Intranasal pertussis vaccine candidate BPZE1 demonstrates robust nasal mucosal and systemic immune responses with a favorable safety profile in children ages 6 through 17 yearsFirst pediatric clinical trial builds on 5 prior adult BPZE1 clinical studiesDemonstrates safety and immunogenicity of BPZE1 in acellular pertussis vaccine primed individualsNo interference observed when BPZE1 co-administered with diphtheria and tetanus antigens ILiAD Biotechnologies, Inc. (ILiAD), an advanced clinical stage biotech company focused on the prevention and treatment of disease caused by Bordetella pertussis, today announced the publication of results from its Phase 2b SUPER (Stand Up to Pertussis) clinical trial in The Lancet Infectious Diseases. This randomized, double blind, placebo- and active-comparator-controlled trial demonstrated that BPZE1, a live attenuated intranasal pertussis vaccine, induced robust nasal mucosal immune responses in healthy children aged 6 through 17 years (LINK). The stu
NIQ Brings New AI and Automation Capabilities to Retail Space Planning and Merchandising2.10.2026 12:45:00 CEST | Press release
New AI and automation capabilities help retailers close execution gaps and scale merchandising decisions across every store. NielsenIQ (NYSE: NIQ), a leading consumer intelligence company, today announced new AI and automation capabilities for NIQ Spaceman®, its retail space planning and merchandising platform trusted by more than 600 retailers across 65+ countries. The enhancements help retailers create store-specific planograms up to 50 times faster, identify execution and compliance gaps, and scale merchandising decisions across their store networks through expanded cloud-based access. "Retailers are under increasing pressure to localize assortments, execute consistently across stores, and respond more quickly to changing shopper behavior," said Natalie Williams, SVP, Product at NIQ. "These enhancements help simplify that process by embedding agentic AI directly into merchandising workflows and automating traditionally manual planning tasks. That means teams can spend less time buil
Compass Pathways Announces New Employee Inducement Grants Under Nasdaq Listing Rule 5635(c)(4)2.10.2026 12:30:00 CEST | Press release
Compass Pathways plc (Nasdaq: CMPS), a biotechnology company dedicated to unlocking urgently needed new treatment options in mental health care, announced today that Compass granted equity awards under the Compass Pathways plc 2026 Inducement Plan to one senior leader and ten newly hired non-executive employees. The equity awards for the senior leader were granted on September 30, 2026 and consisted of options to purchase an aggregate of 121,800 shares and restricted share units covering an aggregate of 58,000 shares. The options have an exercise price per share equal to $12.44. The equity awards to the ten newly hired non-executive employees were granted on October 1, 2026 and consisted of options to purchase an aggregate of 97,100 shares and restricted share units or, in the case of employees in the United Kingdom nominal cost options, covering an aggregate of 46,200 shares. These options have an exercise price per share equal to $11.95, the closing price of the Company’s American De
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