Pioneering a New Class of Targeted Radiotherapeutics to Stop Cancer

Michael Zalutsky, Ph.D., is a cofounder of Z-Alpha Therapeutics and serves as its Chief Technical Officer. He is also the Jonathan Spicehandler, M.D., Professor in Radiology and Radiation Oncology at Duke University Medical School as well as Professor of Biomedical Engineering and Director of the Radiopharmaceutical Chemistry Laboratory. The author of more than 400 scientific publications and patents, his primary research interest is radiochemistry applied to targeted radionuclide therapy and molecular imaging. A major focus of his research has been the development of targeted radiotherapeutics labeled with the α-particle emitter ²¹¹At, including its production, labeling chemistry, radiation dosimetry and first clinical translation of an ²¹¹At-labeled targeted radiotherapeutic. In addition, his laboratory has been responsible for the development and validation of some of the most widely used methodologies for labeling proteins including nanobodies with radiohalogens including ¹⁸F, ¹³¹I and ²¹¹At. Dr. Zalutsky’s awards include the Aebersold Award from the Society of Nuclear Medicine for Outstanding Achievement in Basic Nuclear Medicine Science, and a MERIT Award from the National Cancer Institute for his research in targeted α-particle radiotherapy. Prior to joining the faculty at Duke, Dr. Zalutsky held positions at Argonne National Laboratory, University of Chicago, and Harvard Medical School.

Dr. Pomper is a cofounder of and Scientific Advisor to Z-Alpha. He is also a Professor and the Chair of Radiology at the University of Texas Southwestern Medical Center. He received undergraduate, graduate (organic chemistry) and medical degrees from the University of Illinois at Urbana-Champaign. He completed an internship (Osler Medical Service), residencies in radiology and nuclear medicine, and a fellowship in neuroradiology at Johns Hopkins University, where he remained a member of the faculty for nearly 30 years. His primary interests are in the development and translation of radiopharmaceutical-based imaging and therapeutic agents for cancer. His group synthesized the first small-molecule imaging agent targeting the prostate-specific membrane antigen (PSMA). He is the co-inventor of PYLARIFY®, the first commercial PSMA-targeted imaging agent approved by the FDA. He is a member of the National Academy of Medicine and the National Academy of Inventors.

Dr. Peter Huang is the President & CSO of Z-Alpha, bringing over 20 years of experience in oncology and immunology drug discovery and development, with expertise in radiotherapy, ADC, and small molecules. Prior to joining Z-Alpha, he served as CSO at Zai Lab, where he led discovery and translational medicine efforts, helping develop Zai’s research pipeline. Before that, Dr. Huang held positions of increasing responsibility at Zentalis Pharmaceuticals, most recently as SVP of Discovery Research. In that role, he oversaw the company’s drug portfolio and pipeline, built its discovery platform, led the development of multiple clinical candidates, and directed translational research to support clinical programs. Earlier in his career, Dr. Huang was a medicinal chemist at Pfizer, focusing on small-molecule oncology drug discovery. He is a key inventor of more than 10 clinical compounds, including lorlatinib, an FDA-approved ALK inhibitor, and azenosertib, a promising WEE1 inhibitor. Dr. Huang has authored or co-authored over 100 peer-reviewed publications and patents, and was honored with the American Chemical Society’s 2021 Heroes of Chemistry award. He earned his Ph.D. in organic chemistry from Iowa State University and completed his postdoctoral fellowship at the University of Chicago.

Dr Colin Hayward has been in oncology drug development for over 20 years, working with biotech, large pharma and CROs. He qualified in medicine at the University of London, UK (Guys and St Thomas’s, MB BS) in 1994 and began his pharma career at Roche with global roles in Switzerland working on Rituxan and Avastin. As Chief Medical Officer (CMO) of Premier Research, he built and led the medical, pharmacovigilance, writing and regulatory teams. Before joining Z-Alpha, Colin grew his oncology expertise to the field of radiopharmaceuticals as CMO of Telix, building the clinical foundations for the growth of the company from 2020 to 2024 with a diagnostic NDA and several early and late-stage development compounds.

Cameron Davis serves as our Vice President, Head of Finance & Operations. Mr. Davis oversees company fundraising activities, strategic advisory, investor relations and the treasury, FP&A, and accounting functions. Mr. Davis possesses nearly 15 years of strategic and operational financial management experience at public and private companies in the biotechnology industry.

Prior to joining Z-Alpha, Mr. Davis served as Sr. Director of Finance at Zentalis Pharmaceuticals. Earlier in his career, he spent over eight years at the public accounting firm PwC in San Diego and Basel, Switzerland. He received his B.S. in Business Administration from San Diego State University and is a Certified Public Accountant (Inactive).

Valia Barreras is a Radiochemist with over 25 years of experience in the Nuclear Medicine and Radiopharmaceutical fields, specializing in medical isotope production. As Vice President Radiopharmaceutical Facilities at Z-Alpha Therapeutics, she leads the design and build of the Z-Alpha Center of Excellence, a fully vertically integrated facility for the development and commercial production of ²¹¹At- drug products.

Before joining Z-Alpha, Ms Barreras worked as a consultant at Orchestra Life Sciences, where she supported multiple clients in matters related to production of Therapeutic and Diagnostic radiopharmaceuticals, facility design, equipment selection, supply chain, among others. Valia is also a cyclotrons subject matter expert, with hands-on experience in accelerator operations (TRIUMF, Canada) and having worked for over a decade at Advanced Cyclotron Systems Inc (ACSI), where she participated in the development and commercialization of innovative cyclotron and targetry technologies. Valia holds a Bachelor of Sciences degree in Radiochemistry from the Higher Institute of Nuclear Sciences and Technology in Havana, Cuba and an MBA from Simon Fraser University in Vancouver, Canada.

Chris Drake serves as Z-Alpha’s Vice President, CMC, with responsibility for all CMC activities in the Company. Dr. Drake joined Z-Alpha from Telix Pharmaceuticals, where he held various positions including Vice President, Radiochemistry, overseeing development and manufacturing activities for radiopharmaceutical drug products across Telix’s portfolio.
 
Dr. Drake obtained his Ph.D. in Organic Chemistry from Imperial College London, working on polymeric vectors for gene therapy. He then moved to UCSF as a postdoc, working on the development of fluorescent imaging agents and various radiofluorination methodologies. He then joined SOFIE Biosciences, initially as a Radiochemist working on automating radiosyntheses using the ELIXYS platform. After SOFIE acquired the Zevacor radiopharmacy network, Dr. Drake became Director of Radiopharmaceutical Manufacturing, leading a group focused on new product implementation and lifecycle management for PET drugs. He left SOFIE in 2021 and joined the Frederick National Laboratory for Cancer Research as Director of PET Drug Evaluation before joining Telix.

Mike currently serves as the Vice President Regulatory Affairs at Z-Alpha Therapeutics. Prior to joining Z-Alpha, he held multiple leadership roles, including Vice President Global Regulatory Affairs at Telix Pharmaceuticals (ASX: TLX, NASDAQ: TLX). He has led various submissions of NDA, NDS, BLA, DMF and MAA applications. Mike was the regulatory lead and point of contact for the US approval of Illuccix®. Prior to this he was responsible for Regulatory Affairs and Quality at Zevacor Molecular. Mike has overseen quality management system development and has successfully led radiopharmaceutical US pre-approval inspections. Mike brings over 15 years of experience in pharmaceutical development from early stage to commercial approval and holds a BS in Chemistry from George Mason University and MS in Regulatory Affairs from San Diego State University.

Dr. Grace Sarkissian is the Vice President, Program Management of Z-Alpha Therapeutics, bringing over 17 years of experience in the execution and management of R&D programs from early discovery through Phase 2, with a focus on oncology and autoimmune disease drug discovery and development. Dr. Sarkissian has helped discover and develop nine clinical-stage drugs across a variety of modalities, including small molecules, heterobifunctional degraders, biologics, and ADCs. Prior to joining Z-Alpha, she served as Vice President, Head of Operations at Sera Medicines, a biologics-focused accelerator funded by RA Capital Management. While at Sera Medicines, she led corporate operations and program management for both Sera and its spinout companies, Climb Bio and Navigator Medicines. Prior to that, Dr. Sarkissian held program management and team leader positions of increasing responsibility at Zentalis Pharmaceuticals, ValenzaBio (acquired by ACELYRIN), C4 Therapeutics, FORMA Therapeutics (acquired by Novo Nordisk), and Makoto Life Sciences. She earned her Ph.D. in Biological and Biomedical Sciences from Harvard University under the direction of Dr. Thomas M. Roberts and her Bachelor of Arts in Biology from New York University.

Brian Kenney has 25+ years of experience in the pharmaceutical and biotechnology industry focusing on the management and oversight of global clinical trials ranging from early-stage to late-stage drug development to include post-marketing life cycle management. Prior to joining Z-Alpha, he served as Executive Director, Clinical Operations at Zentalis Pharmaceutcals, an oncology focused company overseeing various programs and global clinical trials. Mr. Kenney has held positions of increasing responsibility at various pharmaceutical and biotechnology companies such as Anaptys Bio, a company focusing on immunology therapies for autoimmune and inflammatory diseases where he led the Clinical Operations team through the successful execution of the operational clinical strategy that resulted in achieving the company’s first patient dosed. While at Cadence Pharmaceuticals (acquired by Mallinckrodt), he was instrumental in implementing the company strategy which led to the submission and FDA approval of Ofirmev®. At Elan Pharmaceuticals he was responsible for the company’s hospital products late-stage development and life-cycle management. Mr. Kenney obtained a Bachelor of Science in Biology from San Diego State University.

Dr. Ronan Le Moigne is a seasoned oncology drug developer with over 19 years of experience spanning target validation, preclinical pharmacology, toxicology, DMPK, and translational sciences. As Vice President of Biology at Z-Alpha Therapeutics, he leads the discovery of novel therapeutic targets for oncology. Previously, he was Executive Director of Clinical Translational Sciences at ESSA Pharma, where his work on androgen receptor inhibitors advanced masofaniten to Phase 2 trials. At Cleave Biosciences, between 2012 to 2018, he spearheaded preclinical development of first-in-class p97 inhibitors. Earlier in his career at Sanofi (Paris & Boston), he contributed to diverse oncology programs, including cabazitaxel, isatuximab, aflibercept, HSP90, p53 and PI3K pathway inhibitors. Dr. Le Moigne holds a PhD in Cancer Biology from the University of Paris XI and a BS in Physiology from the University of Bretagne Occidentale, France.