Fortitude Biomedicines Announces Lead Program Targeting Disease-Driven T-cell Signaling Pathways for the Treatment of Axial Spondyloarthritis

  • Appointment of Dr. Rahul Patel as Senior Vice President of Clinical Development strengthens leadership team and provides critical support to accelerate clinical development of lead program

Waltham, MA – April 7, 2026 – Fortitude Biomedicines, Inc., (Fortitude) a leading biopharmaceutical company focused on immune cell targeting biologics and molecular glue payload–enabled antibody–drug conjugates (ADCs) for the treatment of a wide range of autoimmune diseases and cancers, announced today that the Company’s lead program is a first-in-class T-cell targeting bispecific antibody for the potential treatment of Axial Spondyloarthritis (AxSpA). Appointment of Rahul Patel, MD, FACR, as Senior Vice President of Clinical Development strengthens the leadership team and accelerates clinical efforts advancing Fortitude’s therapeutic programs.

AxSpA is a chronic, debilitating inflammatory disease affecting the axial skeleton. It impacts more than 1.8 million people in the United States and more than 50 million patients worldwide. The disease typically begins in younger adults under the age of 40 and is characterized by persistent inflammatory back pain, stiffness, and enthesitis (inflammation of tendons and ligaments attached to the bone). Without timely and effective treatment, AxSpA can lead to progressive structural damage and long-term functional impairment. This not only diminishes patients’ quality of life but also contributes to loss of productivity and places a significant economic burden on families and the healthcare systems.

Fortitude’s lead program in development for treatment of AxSpA has shown promising preclinical biological activity, with selective and durable suppression of disease-driven T-cell signaling pathways in preclinical animal models and is expected to enter the clinic in first half of 2027.

“With more than 50 percent of AxSpA patients unable to achieve adequate disease control, there continues to be a large unmet need in management of this disease. We are excited with the promising preclinical activity seen with our lead program.” said Dr. Jesse Chen, President and CEO of Fortitude. “As a board-certified rheumatologist and experienced drug developer, Rahul’s addition to the leadership team will provide critical support in the strategic clinical advancement of our therapeutic programs.”

“I am pleased to join Fortitude, to coordinate with exceptional team members and to advance an innovative pipeline of therapeutics,” said Dr. Patel. “There remains a significant unmet need in rheumatology, including in AxSpA, for therapies that can advance the field further and potentially offer a higher bar of efficacy. I look forward to working with the Fortitude team as we advance to a clinical stage biotech ahead.”

About Fortitude Biomedicines

Fortitude Biomedicines is a private biotechnology company headquartered in Waltham, Massachusetts, pioneering next-generation immune cell targeting biologics and an antibody–drug conjugate (ADC) platform powered by proprietary molecular glue payloads. By integrating the precision targeting of ADCs with the catalytic power of targeted protein degradation, the company is developing transformative therapies with the potential to expand the therapeutic window of ADCs, overcome resistance mechanisms, and unlock new target space. Leveraging a robust discovery engine and an experienced team of drug hunters, Fortitude is building a differentiated pipeline of biologics and ADCs aimed at delivering meaningful benefits to patients with high unmet medical need.

Contacts

Investor Relations and Media Contact
IR@fortitudebio.com

Yan Wan

Vice President, China Site Head

Ms. Wan brings extensive expertise in corporate operations, with a versatile background spanning human resources, procurement, legal, IT, finance, government affairs, and R&D alliance management. Prior to joining Fortitude Biomedicines, she served as General Manager, China at Terns Pharmaceuticals, where she played a pivotal role in the company’s launch, operational build-out, and successful NASDAQ IPO.

Earlier in her career, Ms. Wan provided HR leadership supporting both the commercial franchise and global drug development units at Novartis China. She began her operations career in Germany at an overseas R&D center. Ms. Wan holds dual bachelor’s degrees in Literature and Economics from Wuhan University of Technology, as well as a postgraduate degree from the University of Hong Kong Business School.

Kathy Derakhchan, Ph.D.

Executive Director, Preclinical Development

Dr. Derakhchan leads preclinical development efforts at Fortitude Biomedicines. She has proven track record of leading multiple successful IND/NDA filings with corresponding track record of publications in peer-reviewed journals and presentations at scientific conferences. Dr. Derakhchan has extensive experience in engaging with regulatory authorities and in developing, designing, and overseeing non-GLP, GLP, and IND-enabling pharmacology, PK/PD efficacy, safety pharmacology, investigative toxicology and general toxicology evaluations of therapeutics from early-stage discovery to FIH and post approval. Prior to joining Fortitude, she held positions of increasing responsibility at Amgen, Shire and Takeda. Dr. Derakhchan received her PhD in Pharmacology from Université de Montréal.​

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Rahul Patel, M.D., FACR

Senior Vice President, Clinical Development

Dr. Patel leads Fortitude Biomedicine’s Clinical Development efforts of the company’s therapeutic programs. He is a board-certified rheumatologist with more than 15 years of experience in clinical drug development within the biopharmaceutical industry. His work has contributed to the successful regulatory submission and approval of two immunotherapies. Prior to joining Fortitude, Dr. Patel founded AyurBioConsulting, where he provided strategic and operational support on programs focused on autoimmune disease indications. Previously, he served as Executive Medical Director at ImmPACT-Bio and KyvernaTherapeutics. Over the course of his career, he held positions of increasing responsibility at BioCryst, PRA Health Sciences, Sanofi and PAREXEL. Dr. Patel earned his Doctor of Medicine from Baylor College of Medicine and completed his fellowship in Rheumatology at University of Texas Southwestern Medical Center.

Keith Dewedoff

Acting CFO

Keith brings more than 20 years of experience in the life sciences industry to Fortitude Biomedicines, ranging from venture-backed biotech startups to commercial publicly traded companies. Prior to joining Fortitude, he served as CFO at Carbon Biosciences, Code Biotherapeutics, and Ceptur Therapeutics; additionally, he was an advisor to various venture funds. Keith is also CFO & advisor to Spy Biotech,  co-founder and exec chairman of Kaizen Biosciences and advisor at Danforth Health. Keith holds a Bachelor of Science in Economics & Management from Northeastern University.

Stephen Monks, Ph.D.

Acting Chief Development Officer

Dr. Stephen Monks leads Fortitude Biomedicine’s Development efforts. He is a seasoned biopharmaceutical development executive with more than 25 years of experience guiding CMC strategy, technical development, and regulatory execution from early research through late-stage clinical development. Before consulting, Dr. Monks served as Chief Technology Officer at Pyxis Oncology, where he led the technical build-out of the company’s ADC and immuno-oncology antibody platforms and also oversaw the company’s CMC strategy, CDMO selection and management, and regulatory planning efforts to support pipeline advancement. Dr. Monks received his PhD in Biochemistry from University of Melbourne, Australia.

Wendi Ni

Director, Head of Corporate Development

Wendi leads the Operations and Corporate Development efforts of Fortitude Biomedicines. She has more than ten years of research experience and is passionate about building biotech startups. Prior to joining Fortitude, she was Senior Scientist at Novartis, driving drug discovery efforts across various modalities, including antibody-drug conjugates, bispecifics, and radioligand therapy. Wendi received her Master of Science in Pharmacology and Drug Development from Tufts University School of Medicine.

Matthew Huggins, Ph.D.

Principal Scientist, Immunology

Dr. Huggins is an immunologist with expertise in preclinical drug development across autoimmune diseases and oncology. At Fortitude, he serves as project lead for the company’s lead program, driving the research strategy for advancing this development candidate into the clinic. Prior to joining Fortitude, Matthew led multiple early-stage discovery programs from proof of concept through IND-enabling studies. Dr. Huggins received his Ph.D. in Immunology from the Mayo Clinic in 2017.

Haibo Liu, Ph.D.

Director, Medicinal Chemistry

Dr. Liu leads the GLUE-DACTM platform and ADC Discovery efforts at Fortitude Biomedicines. He is an accomplished medical chemist bringing over 15 years of drug discovery experience. Prior to joining Fortitude, he was the Director of Chemistry at Matchpoint Therapeutics. He held positions of increasing responsibility at Avila, Celgene, BMS, and Matchpoint. Dr. Liu received his Ph.D. in Chemistry from Stanford University.

Jan Theunissen, Ph.D.

Vice President, Discovery

Dr. Jan Theunissen leads Discovery efforts at Fortitude Biomedicines and brings over 15 years of industry experience in antibody drug development across diverse target classes and disease indications. He is an accomplished biotechnology leader with deep expertise in the preclinical discovery and development of novel antibodies and antibody-drug conjugates. Prior to joining Fortitude, he served as Director of Biology at Mersana Therapeutics and Senior Director of Research at Iconic Therapeutics. Earlier in his career, Dr. Theunissen held positions of increasing responsibility at Amgen, Igenica Biotherapeutics, and Gilead Sciences. Dr. Theunissen received his PhD in Molecular Biology from Cornell University.

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Jesse Chen, Ph.D.

President and CEO

Jesse is the Founder, President and CEO of Fortitude Biomedicines. A serial entrepreneur, he previously co-founded both TRIANA Biomedicines and Avilar Therapeutics. Before launching Fortitude, he served as Chief Technology Officer at TRIANA Biomedicines. Jesse brings nearly two decades of discovery research and management experience, spanning early discovery through preclinical development. He previously served as an entrepreneur-in-residence for RA Capital Management. Prior to joining RA Capital, he was Senior Director of Discovery at Kymera Therapeutics, responsible for building the company’s industry-leading targeted protein degradation platform and pipeline. Jesse held roles of increasing responsibility at Moderna Therapeutics and Millennium Pharmaceuticals, leading efforts to developing novel platforms and discovery programs.