Restoring Self Tolerance to the Immune System to Transform the Treatment of Autoimmune Diseases

Restoring Self Tolerance to the Immune System to Transform the Treatment of Autoimmune Diseases

Restoring Self Tolerance to the Immune System to Transform the Treatment of Autoimmune Diseases

Our Mission

Autoimmune diseases place a staggering toll on our healthcare system and on the lives of patients living with these serious chronic diseases. There are more than 100 different autoimmune diseases, including rheumatoid arthritis, Type 1 diabetes, multiple sclerosis, lupus, Crohn’s disease, and ulcerative colitis.

There is no cure for autoimmune diseases. Currently, available therapies attempt to manage disease symptoms, often relying on immunosuppressive medications that globally dampen immune responses and are burdened with many side effects, which is particularly challenging given the chronic nature of these diseases.

RegCell’s goal is to fundamentally change the way we treat autoimmune diseases by offering therapies that don’t simply address symptoms but provide function and balance to the immune system by restoring long-term immune tolerance in patients with autoimmunity. Our approach is based on the enormous body of work of our scientific founder, Dr. Shimon Sakaguchi.

Dr Sakaguchi is credited with discovering regulatory T cells (Treg) and characterization of their role in maintaining immune tolerance and preventing autoimmune diseases. He has worked extensively to translate this discovery into a therapeutic platform. RegCell’s mission is to utilize this platform to deliver life-changing cell therapies to redefine self-tolerance in patients with autoimmune diseases.

Our Mission

Autoimmune diseases place a staggering toll on our healthcare system and on the lives of patients living with these serious chronic diseases. There are more than 100 different autoimmune diseases, including rheumatoid arthritis, Type 1 diabetes, multiple sclerosis, lupus, Crohn’s disease, and ulcerative colitis.

There is no cure for autoimmune diseases. Currently, available therapies attempt to manage disease symptoms, often relying on immunosuppressive medications that globally dampen immune responses and are burdened with many side effects, which is particularly challenging given the chronic nature of these diseases.

RegCell’s goal is to fundamentally change the way we treat autoimmune diseases by offering therapies that don’t simply address symptoms but provide function and balance to the immune system by restoring long-term immune tolerance in patients with autoimmunity. Our approach is based on the enormous body of work of our scientific founder, Dr. Shimon Sakaguchi.

Dr Sakaguchi is credited with discovering regulatory T cells (Treg) and characterization of their role in maintaining immune tolerance and preventing autoimmune diseases. He has worked extensively to translate this discovery into a therapeutic platform. RegCell’s mission is to utilize this platform to deliver life-changing cell therapies to redefine self-tolerance in patients with autoimmune diseases.

Leadership

Michael McCullar, PhD

Chief Executive Officer

Mike has a wealth of experience in the biotech and pharmaceutical industries, spanning more than two decades.

Michael McCullar, PhD

Chief Executive Officer

Mike has a wealth of experience in the biotech and pharmaceutical industries, spanning more than two decades. Throughout his career, he has been involved in various aspects of drug development and played pivotal roles in the success of several pharmaceutical companies. Dr. McCullar formerly served as the CEO of OnQuality Pharmaceuticals, where he provided executive leadership to this targeted oncology supportive therapy company focused on developing pioneering medications tailored to address the intricacies of cancer treatment-related toxicities. Before that, he was Chief Operating Officer at Tolero Pharmaceuticals, where he had a prominent role in the company’s acquisition by Sumitomo Dainippon Pharma and also served as the Senior Vice President of Business Development at Astex Pharmaceuticals, during it’s acquisition by Otsuka Pharmaceuticals. Dr. McCullar has held several high-level executive positions at SuperGen, showcasing his commitment and upward career path within the company. His journey at SuperGen culminated in the role of Senior Vice President of Strategy and Operations, where his expertise paved the way for the U.S. Food and Drug Administration (FDA) approval of Dacogen as a treatment for myelodysplastic syndromes, and the acquisition of Astex Therapeutics, which resulted in the formation of Astex Pharmaceuticals, Inc.

Mike holds a Ph.D. in Toxicology from the University of California, Riverside and an MBA from the W.P. Carey School of Business at Arizona State University.

James Ahlers

Chief Financial Officer

James is an accomplished leader with over 30 years of experience building life science businesses.

James Ahlers

Chief Financial Officer

James is an accomplished leader with over 30 years of experience building life science businesses.

As a finance leader he has raised in excess of $2 billion of capital through equity, debt and complex structured instruments in both private and public Companies. He also has extensive cross‐functional management experience including Human Resources, Program Management, Information Technology and Business Development. He has led multiple complex transactions including M&A, technology acquisitions, partnerships, recapitalizations and initial public offerings. Since 2019, James has served as a consultant providing strategic advice and serving as interim CFO to life science companies, including Arsenal Biosciences, Intensity Therapeutics, RenovoRx. Prior to that he spent more than 20 years at Intarcia Therapeutics. As a consultant he was a key member of the team that established operation in 1997, ultimately joining Intarcia as Chief Financial Officer in 2020 through 2019.

James holds a BS in Accounting from University of San Francisco.

Marty Giedlin, PhD

Chief Technology Officer

Marty is a seasoned immunologist with over 20 years of expertise in recombinant protein, cell and gene therapies and vaccine development.

Marty Giedlin, PhD

Chief Technology Officer

Marty is a seasoned immunologist with over 20 years of expertise in recombinant protein, cell and gene therapies and vaccine development. His experience spans research, pharmacology, toxicology, process development, and manufacturing. Marty has extensive knowledge in biologics, chemistry-manufacturing-controls (CMC), quality assurance/control (QA/QC), and assay development, with expertise in adenovirus, T cells, NK cells and CD34+ stem cells.

Marty previously was SVP of Technical Operations of Senti Biosciences developing adoptive cell therapies, SVP at PACT Pharma leading their process development group developing a non-viral process for generating autologous T cells. Marty was also Executive Director, Process Development, at Novartis where he was a key leader in the development of the clinical and commercial manufacturing processes for KYMRIAH.

Marty holds a PhD in Microbiology/Immunology, Virginia Commonwealth University School of Medicine and a BS in Biology and Chemistry, University of Notre Dame.

Tony Hurley

Chief Technical Operations Officer

Tony brings over 30 years of extensive pharmaceutical experience in technical operations with a focus on cell therapy, biologics manufacturing and aseptic processing.

Tony Hurley

Chief Technical Operations Officer

Tony brings over 30 years of extensive pharmaceutical experience in technical operations with a focus on cell therapy, biologics manufacturing and aseptic processing.

Previously Tony has served as SVP of Technical Operations at Amplify Bio and Head of Technical Operations at Intarcia Therapeutics, where he led Manufacturing, Quality, Process Development, and Supply Chain functions. He was also SVP Manufacturing at PACT Pharma. Prior to these roles, Tony held various positions of increasing responsibility at Roche/Genentech, including Head of Global External Manufacturing for Biologics, Head of Global Quality for both Drug Product and Drug Substance Biologics operations and VP and Plant Manager of Production Operations in South San Francisco. Prior to his tenure at Genentech, Tony spent approximately 17 years at GlaxoSmithKline, primarily in manufacturing, including 5 years as Site Director of Anti-Infective Operations at GlaxoSmithKline’s Upper Merion Pennsylvania site.

Tony holds a B.Sc. in Chemical Engineering from MTU, Ireland and a M.Sc. in Industrial Engineering from Rutgers, The State University, NJ.

Board of Directors

Steve Kanner, PhD

Dr Kanner currently serves as the chief scientific officer of Caribou Biosciences, Inc (Nasdaq: CRBU) a clinical-stage biotechnology company developing allogeneic cell therapies based on their CRISPR genome-editing technology.

Steve Kanner, PhD

Dr Kanner currently serves as the chief scientific officer of Caribou Biosciences, Inc (Nasdaq: CRBU) a clinical-stage biotechnology company developing allogeneic cell therapies based on their CRISPR genome-editing technology. Previously he was vice president, head of biology, at Arrowhead Pharmaceuticals, leading a department in discovery of RNAi therapeutics for oncology, genetic diseases, and other indications. Prior to Arrowhead Pharmaceuticals, he served in various positions of increasing responsibility in both oncology and inflammation drug discovery at Bristol-Myers Squibb, Agensys/Astellas, and Astex Pharmaceuticals. He has authored over 90 publications in both peer-reviewed journals and books and is an inventor on numerous US and foreign patents and patent applications. Steve received his undergraduate degree in genetics from the University of California, Berkeley and his PhD in immunology and microbiology from the University of Miami’s Miller School of Medicine. His post-doctoral fellowship was funded by a National Institutes of Health grant and was conducted at the University of Virginia.

Michael McCullar, PhD

CEO RegCell, Inc.

Mike has a wealth of experience in the biotech and pharmaceutical industries, spanning more than two decades.

Shuh Narumiya, MD PhD

Dr. Narumiya is Professor and Former Chair of the Department of Drug Discovery Medicine, and the Director of the Medical Innovation Centre at Kyoto University Graduate School of Medicine.

Shuh Narumiya, MD PhD

Dr. Narumiya is Professor and Former Chair of the Department of Drug Discovery Medicine, and the Director of the Medical Innovation Centre at Kyoto University Graduate School of Medicine. His research spans from pharmacology, cell biology, biochemistry, and molecular biology to pathophysiology of diseases in areas of the prostaglandin receptors and Rho GTPase. He has published more than 500 original and review articles. Dr Narumiya established the Kyoto University model of academia-industry alliance for drug discovery by managing the Astellas Pharma-Kyoto University Project from 2007-2016. He has received many honors including the Gold Medal from the Giovanni Lorenzini Foundation, the Purple Ribbon from the Japanese Government, the Takeda Prize in Medicine, the Uehara Prize, the Imperial Prize from the Japan Academy, and the Ulysses Medal from University College Dublin. In 2017 he was named Person of Cultural Merit of Japan.

Shimon Sakaguchi, MD, PhD

Dr. Sakaguchi is a Distinguished Professor of Osaka University and a member of the US National Academy of Sciences.

Shimon Sakaguchi, MD, PhD

Dr. Sakaguchi is a Distinguished Professor of Osaka University and a member of the US National Academy of Sciences. He is credited with the discovery of regulatory T cells (Treg) and characterization of their role in maintaining immune tolerance and preventing autoimmune diseases. Dr. Sakaguchi is a leading authority on Treg biology and function. He was designated as a Person of Cultural Merit by the Japanese Government in 2017 and has been awarded many international acknowledgments including: the Cancer Research Institute’s William B. Coley Award, the Keio Medical Science Prize, the Canada Gairdner International Award, the Crafoord Prize, the Paul Ehrlich and Ludwig Darmstaedter Prize, and the Robert Koch Award. In 2009 Dr. Sakaguchi received the Medal with Purple Ribbon and in 2019 he received the Order of Culture, the highest accolade for Japanese scholars, from the Emperor of Japan.

Atsushi Usami, PhD

Dr. Usami is a Partner and Board Director at UTEC, where he leads venture investments and provides hands-on support to seed and early-stage startups, with a primary focus on the life sciences sector.

Atsushi Usami, PhD

Dr. Usami is a Partner and Board Director at UTEC, where he leads venture investments and provides hands-on support to seed and early-stage startups, with a primary focus on the life sciences sector. He played a pivotal role in co-founding companies such as OriCiro Genomics, Inc. (acquired by Moderna, Inc.) and Repertoire Genesis, Inc. (acquired by Eurofins Scientific SE), supporting not only their initial investments but also their business development and growth.  Dr. Usami currently serves on the boards of around 10 startups across Japan and the U.S. In recognition of his contributions, he was named one of Japan’s most influential venture capitalists by Forbes Japan in 2023. He received the Venture Capitalist Encouragement Award at the 23rd Japan Venture Awards. He also serves as a project evaluation committee member for the Japan Agency for Medical Research and Development (AMED). Before joining UTEC in 2013, Dr. Usami worked as a consultant at the Mitsubishi Research Institute, where he advised pharmaceutical companies, medical device manufacturers, and other industrial clients on mid- to long-term business planning and new business development. He holds a Ph.D. in Pharmaceutical Sciences from the University of Tokyo.

Koji Yasuda, PhD, DVM

Dr Yasuda is a principal with Fast Track Initiative (“FTI”).

Koji Yasuda, PhD, DVM

Dr Yasuda is a principal with Fast Track Initiative (“FTI”). Prior to joining FTI, he held positions at Pfizer and Takeda, leading clinical biomarker strategy and advancing several Oncology and Gastroenterology assets through early phases of clinical development. He was also part of the initial scientific core team at Kintai Therapeutics, a startup from Flagship Pioneering, which is now part of Sail Biomedicines.

Dr Yasuda holds a PhD in Computational Biology from Harvard University, a Doctor of Veterinary Medicine (DVM), and a Bachelor of Science (BS) degree from Cornell University.

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