Archeus Technologies Receives FDA Clearance of Investigational New Drug Application for ART-101 in Development for the Treatment of Prostate Cancer
MADISON, Wis.--(BUSINESS WIRE)-- Archeus Technologies, a company developing radiopharmaceutical therapies for the treatment of patients with cancer, today announced that the U.S. Food and Drug Administration (FDA) has cleared its Investigational New Drug (IND) application for ART-101, a novel receptor-based targeting small molecule that Archeus has developed for the imaging and treatment of prostate cancer. This IND clearance enables Archeus to initiate a Phase 1 clinical trial in men with metastatic castration-resistant prostate cancer (mCRPC), which is expected to start later this year.
ART-101 was discovered and developed by Reinier Hernandez, Ph.D., assistant professor of medical physics at the University of Wisconsin–Madison, with robust development support from the Wisconsin Alumni Research Foundation. The therapy targets prostate-specific membrane antigen (PSMA), similar to several FDA-approved imaging and therapeutic agents. However, preclinical data demonstrates that ART-101 exhibits higher tumor uptake and retention, as well as lower normal tissue and salivary gland uptake, relative to current FDA-approved PSMA-targeting agents. Archeus plans to evaluate ART-101 as a theranostic radiopharmaceutical agent with the potential to deliver alpha particle-emitting isotopes with greater efficacy and safety compared with current standards of care.
'This IND clearance marks an important milestone for Archeus as we prepare to initiate the first of multiple clinical trials set to begin this year from our broader portfolio of differentiated radiopharmaceutical assets for difficult-to-treat cancers,' said Evan Sengbusch, Ph.D., chief executive officer of Archeus Technologies. 'ART-101 represents a promising approach to targeting PSMA-positive prostate cancer with the potential to deliver meaningful clinical benefit and reduced side effects for patients. We are eager to begin evaluating ART-101 in patients to better understand its full therapeutic potential.'
In addition, Archeus received IND clearances in October 2024 for its lead therapeutic candidate, ARC-706, and companion diagnostic, ARC-166. The company plans to advance the two assets - together as a theranostic pair - into clinical development this year. Archeus is developing ARC-706 for combination use with certain validated immunotherapies across a range of cancer types. Preclinical data indicate that this radiopharmaceutical agent and treatment paradigm may produce curative responses, as well as immune memory against cancers that are otherwise resistant to these immunotherapies.
About Archeus Technologies
Archeus Technologies is a company developing radiopharmaceutical therapies for some of the most difficult-to-treat cancers. Starting with its Phase 1-ready therapeutic candidate, ARC-706, the company has assembled a growing pipeline of differentiated radiopharmaceutical therapy agents and companion diagnostic assets with the potential to provide curative responses to patients with advanced cancer. Archeus is led by an executive team with proven radiopharmaceutical expertise and a demonstrated record of advancing innovative agents from discovery through clinical development. In addition, Archeus has a long-standing strategic collaboration with the University of Wisconsin–Madison (UW), a global leader in radiopharmaceuticals and theranostics. To learn more, visit ArcheusTech.com.
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It is not known if OPZELURA is safe and effective in children less than 12 years of age with atopic dermatitis or nonsegmental vitiligo. About Incyte Dermatology Incyte's science-first approach and expertise in immunology has formed the foundation of the company. Today, we are building on this legacy as we discover and develop innovative dermatology treatments to bring solutions to patients in need. We strive to identify and develop therapies to modulate immune pathways driving uncontrolled inflammation. Specifically, our efforts in dermatology are focused on a number of immune-mediated dermatologic conditions with a high unmet medical need, including atopic dermatitis, vitiligo, hidradenitis suppurativa, lichen sclerosus, and prurigo nodularis. To learn more, visit the Dermatology section of 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 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 potential for ruxolitinib cream to provide a successful treatment option for pediatric patients with AD; Incyte's plans to work with FDA; and Incyte's expectations with regard to the PDUFA date for its sNDA and regulatory approval, 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 other regulatory agencies; 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 March 31, 2025. We disclaim any intent or obligation to update these forward-looking statements. View source version on Contacts Media media@ Investors ir@ Error in retrieving data Sign in to access your portfolio Error in retrieving data Error in retrieving data Error in retrieving data Error in retrieving data
