Rapid, Personalized T cell Therapies for Cancer

David Apelian

CEO

David Apelian, MD, PhD, MBA, brings extensive clinical development, research, and regulatory experience, spanning more than 20 years in large pharma and biotechnology companies across multiple therapeutic areas including hepatology, immuno-oncology, and rare diseases.

Dr. Apelian was most recently COO and Executive Medical Officer at Eiger Biopharma where he was responsible for the strategy and execution of late stage clinical development programs including chronic hepatitis D, progeria, and post-bariatric hypoglycemia where he still serves on the board of directors. He also served as Executive VP and Chief Medical Officer of Achillion Pharmaceuticals, Inc., a position he held since 2013. He was instrumental in securing an HCV partnership between Achillion and J&J, which resulted in a $225 million equity investment. From 2005 to 2013, Dr. Apelian was Chief Medical Officer and subsequently head of all R&D and Regulatory Affairs for the immune oncology company GlobeImmune. At Bristol-Myers Squibb he served as Medical Lead for Baraclude an antiviral for chronic HBV through NDA filing. Prior to that, Dr. Apelian was Clinical Director in the Department of Hepatology & Gastroenterology at Schering Plough, where he coordinated a supplemental NDA filing for interferon alpha-2b and ribavirin for the treatment of pediatric patients with chronic HCV.

Dr. Apelian completed his residency training in pediatrics at New York Hospital, Cornell Medical Center and is board certified in Pediatrics. He received a PhD in Biochemistry from Rutgers University, an MD from the University of Medicine and Dentistry of New Jersey and an MBA from Quinnipiac University. He earned a BA in Biochemistry from Rutgers University.

Mark Shlomchik

Co-Founder and Chief Scientific Officer

Mark Shlomchik received MD and PhD degrees from the University of Pennsylvania and did his residency in pathology and laboratory medicine at the Hospital of the University of Pennsylvania.

He was appointed to the faculty of Yale University School of Medicine in 1993 where he remained until 2013 when he moved to the University of Pittsburgh to become the UPMC Endowed Professor and Chair of the Department of Immunology.

Dr. Shlomchik is known for his world-leading research in systemic autoimmune diseases and B cell immune responses and memory. He has published over 160 original research and 30 review articles. The TCXpress technology originated and was developed in Dr. Shlomchik’s lab.

Warren Shlomchik

Co-Founder and Scientific Advisory Board Chairman

Warren Shlomchik received his undergraduate degree from Harvard College and his MD from the University of Pennsylvania School of Medicine. He did his residency in Internal Medicine at Weill Cornel Medical Center/New York Hospital in New York City, followed by a fellowship in hematology and oncology at the Hospital of the University of Pennsylvania.

He was appointed to the faculty of the Yale University School of Medicine in 1999 where he became a tenured professor and remained until 2015, when he moved to the University of Pittsburgh to become the Director of Hematopoietic Stem Cell Transplantation and Cell Therapies, and leader of the program in hematologic malignancies at the UPMC Hillman Cancer Center.

Dr. Shlomchik is an internationally recognized leading researcher in the areas of stem cell transplantation, graft-vs.-host disease and graft-vs-leukemia responses. He has performed high impact work in preclinical models as well as developed and brought to the clinic a novel approach for minimizing GVHD post-transplantation.

Michael Geffner

Chief Medical Officer

Michael Geffner, MD, MBA, joins BlueSphere Bio from Achillion Pharmaceuticals (now a wholly-owned subsidiary of Alexion Pharmaceuticals), where he was Senior Vice President and led the Hematology clinical development efforts for the company as well as global medical affairs for all Achillion programs.  Dr. Geffner designed, implemented, and managed all global Hematology clinical trials in Paroxysmal Nocturnal Hemoglobinuria with the company’s lead asset, danicopan (an oral, small molecule factor D inhibitor of the complement system’s Alternative Pathway). Prior to Achillion, Dr. Geffner spent 15 years in various positions of increasing responsibility at Schering-Plough and Merck, including Clinical Development, Clinical Operations, and Medical Affairs.

In his most recent role prior to Achillion, he was the U.S. head of the Anti-infectives, hospital/specialty care and anesthesia Medical Affairs teams for Merck. In this role, he led the HIV, HCV, antibiotic, antifungal, and anesthesia/surgical portfolios and also served as the medical affairs integration lead for the acquisition of Cubist Pharmaceuticals.

At Schering Plough, Dr. Geffner was a key leader of the Peg-Intron NDA team and also designed and conducted the first phase 2 clinical trial for Boceprevir at Schering-Plough. He made significant contributions to the integration process when Schering Plough acquired Organon Biosciences and integrated their portfolio and team into his clinical operations team. The structure launched by Dr. Geffner in North America was then adapted and launched worldwide at Schering Plough and he assisted in rolling out this structure around the globe. He also led Clinical Operations for Europe II, Middle East and Africa, which contained approximately 70 countries. He continued in an operations capacity when Schering-Plough was acquired by Merck and led clinical operations for North America at Merck and had a team that covered all phases of research, with well over 100 clinical trials in the portfolio and a team size that exceeded 400 individuals.

Dr. Geffner is a U.S. licensed physician with dual board certification from the American Board of Pediatrics and the American Board of Psychiatry and Neurology with special competency in Child Neurology. He is a graduate of Albany Medical College and holds an MBA from Fairleigh Dickinson University.

Jeanne Cunicelli

Board Member

Jeanne Cunicelli, MBA, is Executive Vice President at UPMC Enterprises where she leads business initiatives on behalf of the Immune Transplant and Therapy Center (ITTC), as well as broader translational sciences efforts.

She has over 20 years of experience in the investment and life sciences industries. Prior to working with UPMC, she was a Managing Director at Bay City Capital where she focused on investments in medical device, drug delivery, and drug development companies. She is a member of the board of trustees of Carnegie Mellon University.

Ms. Cunicelli received an MBA in Finance from the University of San Francisco and holds a B.A. in Cognitive Psychology from Carnegie Mellon University.

Tal Heppenstall

Board Member

Tal Heppenstall has been the treasurer of UPMC since 2003 and executive vice president since 2013. He is responsible for overseeing the day-to-day cash needs of UPMC, along with the management of the organization’s investments and pension portfolio, as well as oversight of its outstanding municipal bonds and other debt.

In his role as president of UPMC Enterprises, Mr. Heppenstall leads world-class professionals who are focused on creating exceptional health care innovations. His team seeks out opportunities to commercialize UPMC-developed technologies for broader application across the entire health care industry and invests in promising health care businesses.

Previously, Mr. Heppenstall served as managing director at RBC Dain Rauscher Inc., president of PriMuni LLC, senior vice president at PNC Capital Markets and vice president at Butcher & Singer. He earned a bachelor’s degree from the University of Virginia and a master’s degree from Carnegie Mellon University.

Constantinos Panousis

Co-Founder and Vice President of Research and Development

Constantinos G. Panousis received a Chemistry degree from the University of Athens Greece, and his PhD from the University of Pittsburgh. Dr. Panousis completed his post-Doctoral training as a Molecular Pharmacologist in Indianapolis with the Eli Lilly and Company.

In 2000, he joined Hoffman La-Roche in Basel, Switzerland where he served as a Senior Principal Scientist in the department of Metabolic Diseases where he led several preclinical programs, having one moving to Phase I clinical trials. In 2008, he returned to the US to continue his drug discovery efforts for Diabetes and Acute Kidney injury indications with Hoffman La Roche in Nutley, NJ.

In 2011, he returned to Pittsburgh where he held consulting and research positions at the University of Pittsburgh until he joined Dr. Shlomchik’s lab in 2017.

Dr. Panousis, BlueSphere Bio’s Vice President of Research and Development and one of its founders, played an instrumental role in the development of the TCXpress technology.

Greg Delgoffe

Scientific Advisory Board

Greg Delgoffe, PhD, is an Assistant Professor of Immunology at the University of Pittsburgh, he is also a research scientist at UPMC Hillman Cancer Center’s Tumor Microenvironment Center. His laboratory seeks to understand how cancer cells use fuel from their local environment, starving infiltrating immune cells and preventing them from attacking cancer cells.

Dr. Delgoffe is the recipient of a Young Investigator Award from the Alliance for Cancer Gene Therapy.

Ulrich von Andrian

Scientific Advisory Board

Ulrich von Andrian, MD, is The Edward Mallinckrodt Jr. Professor of Immunopathology, Microbiology and Immunobiology at Harvard Medical School. Von Andrian focuses his research on immune cell trafficking, specifically on how T-cells migrate to and within surrounding lymph nodes and how immune responses are generated in those lymph nodes.

Dr. von Andrian is a member of the European Academy of Sciences and a recipient of the BD Biosciences Investigator Award from the American Association of Immunologists.

Carl June

Scientific Advisory Board

Carl June, MD, is the Director of both the Center for Cellular Immunotherapies and the Parker Institute for Cancer Immunotherapy at the University of Pennsylvania, where he is also the Richard W. Vague Professor in Immunotherapy in the Department of Pathology and Laboratory Medicine at Penn’s Perelman School of Medicine. His lab has pioneered decades of immunotherapy breakthroughs, including the first successful use of gene transfer therapy to treat cancer and the country’s first Food and Drug Administration-approved personalized cellular therapy for cancer.

Dr. June was elected to the Institute of Medicine in 2012 and the American Academy of Arts and Sciences in 2014. He is the recipient of the Richard V. Smalley Memorial Award from the Society for Immunotherapy of Cancer and the AACR-CRI Lloyd J. Old Award in Cancer Immunology.

Marc Jenkins

Scientific Advisory Board

Marc Jenkins, PhD, is the Regents and Distinguished McKnight University Professor in the Department of Microbiology and Immunology and director of the Center for Immunology at the University of Minnesota. He studies CD4+ T lymphocytes and the signals that these cells need to become activated by antigens, where in the body activation occurs, and how activation results in immune memory.

Dr. Jenkins is a past President of the American Association of Immunologists and a recipient of the Mentoring and Lifetime Achievement Awards from that organization. He was elected to the National Academy of Sciences in 2020.

James Onuffer

Vice President of Product Development

James Onuffer, PhD joined BlueSphere Bio, Inc. as Vice President, Product Development in 2020. Prior to joining BlueSphere, Dr. Onuffer held the position of Vice President, Synthetic Biology and Immunology at F1 Oncology, Inc. where he led discovery and development efforts in autologous adoptive immunotherapy products and cell manufacturing systems for targeting solid tumors with chimeric antigen receptors (CAR-T). These efforts led to two developed products being advanced to first-in-human clinical trials of CAB-CAR-T AND logic gate control technology in patients with recurrent or refractory stage IV metastatic renal cell carcinoma (mRCC) and other solid tumors.

Previously, Dr. Onuffer served as an independent consultant in the Biotech/Pharma space, advising clients on cell-based immunotherapy, immunology and synthetic biology. From 2009 to 2015, Dr. Onuffer was responsible for the establishment and coordination of a translational medicine laboratory at the University of California, San Francisco as part of an NIH sponsored Nanomedicine Center, where he served as Associate Director and Laboratory Head. At UCSF, he initiated and spearheaded the engineering of novel synthetic T-cell responses and safety control systems for use in cell-based immunotherapy. Key technology developed by the UCSF group formed the basis of the pre-clinical stage company Cell Design Labs which was subsequently acquired by Gilead Sciences and Kite in 2017. From 1995 to 2007, Dr. Onuffer was at Berlex Biosciences, a subsidiary of Schering AG, where he led several therapeutic discovery and development programs in the Department of Immunology and served as a speaker and committee member in the corporate review of projects throughout the Berlex/Schering AG global organization.

Dr. Onuffer received his BS in Microbiology from The Pennsylvania State University and his PhD in Biochemistry in the Molecular and Cell Biology Department at the University of California, Berkeley. He has authored multiple scientific articles during his career and is an inventor on several patents in the small molecule, biologics, and cell therapy space.