Latest news with #ReinierHernandez
Business Wire
3 days ago
- Business
- Business Wire
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
Business Wire
28-05-2025
- Business
- Business Wire
Archeus Technologies and Wisconsin Alumni Research Foundation Partner to Advance Radiopharmaceutical Therapy ART-101 into Clinical Development for Prostate Cancer
MADISON, Wis.--(BUSINESS WIRE)-- Archeus Technologies, a company developing multiple differentiated radiopharmaceutical therapies, and the Wisconsin Alumni Research Foundation (WARF), the patenting and licensing arm of the University of Wisconsin–Madison (UW), today announced a strategic collaboration to advance ART-101 – a promising receptor-based targeting molecule – into clinical development. ART-101 was discovered and developed at the Advanced Radiotheranostics Lab at UW–Madison, led by Dr. Reinier Hernandez, assistant professor of medical physics at the University of Wisconsin School of Medicine and Public Health. Aided by robust support from WARF through the WARF Accelerator, ART-101 has demonstrated enhanced pharmacology in preclinical studies, including significantly higher tumor uptake and retention relative to FDA-approved prostate cancer treatment Pluvicto ® (177Lu-PSMA-617). It has also shown superior pharmacokinetics, dosimetry and normal tissue toxicity profiles. Through a collaboration agreement with WARF, Archeus Technologies will lead Phase 1 clinical development of this asset with trial initiation planned for 2025. ART-101 is a next-generation prostate-specific membrane antigen (PSMA)-targeting small molecule. It is being evaluated as a radiopharmaceutical agent with the potential to deliver alpha-emitting isotopes with greater tolerability compared with current standards of care. 'With strong preclinical data supporting the continued development of ART-101, Archeus is eager to lead the evaluation of this novel candidate through first-in-human studies,' said Evan Sengbusch, Ph.D., chief executive officer of Archeus Technologies. 'Leveraging our team's proven experience ushering new radiopharmaceutical agents from concept through clinical translation, paired with our close collaboration with UW as a world-class radiopharmaceutical research organization, Archeus is uniquely positioned to progress ART-101 into the next stage of development. This asset adds to our Phase 1-ready portfolio of differentiated radiopharmaceutical therapies with the potential to provide curative responses to cancers that are particularly challenging to treat.' 'WARF is committed to investing in cutting-edge technologies and therapeutic candidates, like ART-101, that have significant potential to advance the theranostics landscape as well as treatment options for patients in need,' said Jeanine Burmania, senior director of intellectual property and licensing at WARF. 'Encouraging preclinical data suggest that ART-101 could help increase lifespan and be more effective in treating prostate cancer than current therapies. We're pleased to partner with Archeus Technologies to continue the development of this innovative asset and look forward to better understanding its role to potentially improve outcomes for prostate cancer patients.' ART-101 is compatible with multiple therapeutic isotopes, including actinium-225, lutetium-177 and terbium-161. When paired with these isotopes, preclinical data show that ART-101 provides significant potential benefit that could lead to improved outcomes for prostate cancer patients. About Archeus Technologies Archeus Technologies is a company developing differentiated 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 novel radiopharmaceutical therapy agents and companion diagnostic assets with the potential to provide curative responses to patients with advanced disease. 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 About WARF Celebrating a century of service in 1925, the Wisconsin Alumni Research Foundation (WARF) patents and licenses discoveries from UW-Madison research, manages an investment portfolio generated from licensing and investment proceeds, and provides annual grants to the University of Wisconsin-Madison and the Morgridge Institute for Research to support further scientific investigation and research. By driving collaborations among researchers, investors, industry and entrepreneurs, WARF commercializes innovations from campus through various initiatives. WARF Accelerator improves the commercialization potential of university intellectual property through industry engagement and investment in proof-of-concept milestones to validate market potential, demonstrate commercial value and de-risk technology. WARF Therapeutics partners with UW-Madison and Morgridge Institute researchers employing an industry-focused approach to improve the value propositions of drug candidates. WARF Ventures is an early-stage venture fund that invests in startups based on UW/WARF technologies. Learn more at
