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Synthetic Biologics Announces Formation of Scientific Advisory Board to Advance Oncology Pipeline

Scientific Advisory Board of leading experts in oncolytic adenoviruses and gene therapies strengthens transformative clinical development strategy and extension into oncology

ROCKVILLE, Md., May 05, 2022 (GLOBE NEWSWIRE) -- Synthetic Biologics, Inc. (NYSE American: SYN), a diversified clinical-stage company developing therapeutics designed to treat diseases in areas of high unmet need, today announced the strengthening of its oncology leadership team with the formation of a Scientific Advisory Board (SAB) composed of key opinion leaders in oncolytic viruses and gene therapies. The SAB will work cohesively with the Synthetic Biologics’ leadership team to support the Company’s transformative clinical development strategy and extension into oncology.

“We are honored to be working with this group of world-class scientific leaders to advise us as we develop Synthetic Biologics’ unique, clinical-stage oncolytic viruses optimized for intravenous administration,” said Steven A. Shallcross, Chief Executive Officer of Synthetic Biologics. “These distinguished leaders have made groundbreaking scientific advances in their respective fields of oncology, immunology and gene therapy, and we look forward to their counsel as Synthetic Biologics advances its oncolytic adenovirus (OV) development program to address devastating cancers with high unmet need.”

The founding members of the SAB are included below.

Chair: Ramon Alemany, Ph.D., is Head of the Immunotherapy and Virotherapy Group at the Translational Research Laboratory of the Institut Catala d’Oncologia (ICO) and Institut de Investigacio Biomedica de Bellvitage (IDIBELL). Dr. Alemany is a co-founder of VCN Biosciences and is an internationally recognized expert in oncolytic adenoviruses for cancer treatment. He has held various research positions across leading academic institutions, including MD Anderson Cancer Center, Baxter Healthcare Group and the University of Alabama at Birmingham. Dr. Alemany earned both his Ph.D., and B.S., from the University of Barcelona.

Member: Mark S. Blumenkranz, M.D., MMS, is HJ Smead Professor Emeritus in the Department of Ophthalmology at Stanford University. Dr. Blumenkranz was an early innovator in vitrectomy techniques to treat complex forms of retinal detachment and helped to usher in the modern era of intravitreal and surgical adjuvant drug therapy. He has served on the Editorial Boards of The American Journal of Ophthalmology, Retina, Ophthalmology, and Graefe’s Archives for Ophthalmology. Dr. Blumenkranz earned his M.D., from Brown University.

Member: Ennio Antonio Chiocca, M.D., Ph.D., is Harvey W. Cushing Professor of Neurosurgery at Harvard Medical School, Neurosurgeon-in-Chief and Chairman, Department of Neurosurgery and Co-Director, Institute for the Neurosciences at Brigham and Women’s Faulkner Hospital. He is also the Surgical Director, Center for Neuro-oncology at Dana-Farber Cancer Institute. His research focuses on developing novel genetic and immunotherapeutic approaches for malignant brain tumors, with a particular interest in engineering viruses that can kill tumor cells without affecting normal brain cells. Dr. Chiocca earned his M.D., Ph.D., from the University of Texas Medical School at Houston and the Graduate School of Biomedical Sciences.

Member: Daniel DiMaio, M.D., Ph.D., is the Waldemar Von Zedtwitz Professor of Genetics and Professor of Molecular Biophysics and Biochemistry, and of Therapeutic Radiology at Yale School of Medicine, as well as a Senior Advisor to the Director, Yale Cancer Center. Dr. DiMaio brings an unparalleled depth of knowledge and experience in the fields of human genetics, tumor virology, and cancer research. Dr. DiMaio earned his Ph.D., from Johns Hopkins University School of Medicine and his B.S., from Yale University.

Member: Tom Dubensky, Ph.D., President of Tempest Therapeutics, a clinical-stage biotechnology company developing small molecules to treat cancer through mechanisms that directly kill tumor cells and activate tumor-specific immunity. He was the founding CEO of Tempest and brings significant industry expertise in discovery, development and clinical translation across cancer immunotherapy and infectious disease indications. Dr. Dubensky earned his Ph.D., at the University of Colorado Health Sciences Center.

Member: Josep Tabernero, M.D., Ph.D., is Head of the Medical Oncology Department at the Vall d’Hebron University Hospital, Director of the Vall d’Hebron Institute of Oncology (VHIO) and Professor of Medicine at UVic. Dr. Tabernero’s research focuses on potentiating molecular therapies and targeting specific oncoproteins for personalized care. Dr. Tabernero serves on the Editorial Boards of various top-tier journals including Annals of Oncology, ESMO Open, Cancer Discovery and Clinical Cancer Research. Dr. Tabernero earned his M.D., and Ph.D., degrees from the Universitat Autonoma de Barcelona, Spain.

About Synthetic Biologics, Inc.

Synthetic Biologics, Inc. (NYSE American: SYN) is a diversified clinical-stage company developing therapeutics designed to treat diseases in areas of high unmet need. The Company recently consummated the acquisition of VCN Biosciences, S.L. (VCN), which is developing a new oncolytic adenovirus (OV) platform designed for intravenous (IV), intravitreal and antitumoral delivery to trigger tumor cell death, improve access of co-administered cancer therapies to the tumor, and promote a robust and sustained anti-tumor response by the patient’s immune system. The Company's lead clinical candidates are: (1) VCN-01, an oncolytic adenovirus designed to replicate selectively and aggressively within tumor cells, and to degrade the tumor stroma barrier that serves as a significant physical and immunosuppressive barrier to cancer treatment; (2) SYN-004 (ribaxamase) which is designed to degrade certain commonly used IV beta-lactam antibiotics within the gastrointestinal (GI) tract to prevent (a) microbiome damage, (b) Clostridioides difficile infection (CDI), (c) overgrowth of pathogenic organisms, (d) the emergence of antimicrobial resistance (AMR), and (e) acute graft-versus-host-disease (aGVHD) in allogeneic hematopoietic cell transplant (HCT) recipients; and (3) SYN-020, a recombinant oral formulation of the enzyme intestinal alkaline phosphatase (IAP) produced under cGMP conditions and intended to treat ,both local GI and systemic diseases. For more information, please visit Synthetic Biologics' website at www.syntheticbiologics.com.

Forward-Looking Statements

This release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. In some cases forward-looking statements can be identified by terminology such as "may," "should," "potential," "continue," "expects," "anticipates," "intends," "plans," "believes," "estimates," and similar expressions, and include statements regarding advancing Synthetic Biologics’ oncolytic adenovirus (OV) development program and the contributions to be made by the scientific advisory board members. These forward-looking statements are based on management's expectations and assumptions as of the date of this press release and are subject to a number of risks and uncertainties, many of which are difficult to predict that could cause actual results to differ materially from current expectations and assumptions from those set forth or implied by any forward-looking statements. Important factors that could cause actual results to differ materially from current expectations include, among others, whether the combined business of Synthetic Biologics and VCN will be successful; Synthetic Biologics' and VCN's product candidates demonstrating safety and effectiveness, as well as results that are consistent with prior results; the ability to initiate and complete clinical trials on time and achieve the desired results and benefits; continuing clinical trial enrollment as expected; the ability to obtain regulatory approval for commercialization of product candidates or to comply with ongoing regulatory requirements, regulatory limitations relating to Synthetic Biologics' and VCN's ability to promote or commercialize their product candidates for the specific indications; acceptance of product candidates in the marketplace and the successful development, marketing or sale of Synthetic Biologics' and VCN's products; developments by competitors that render such products obsolete or non-competitive; Synthetic Biologics' and VCN's ability to maintain license agreements;, the continued maintenance and growth of Synthetic Biologics' and VCN's patent estate; the ability to continue to remain well financed;, and other factors described in Synthetic Biologics' Annual Report on Form 10-K for the year ended December 31, 2021 and its other filings with the SEC, including subsequent periodic reports on Forms 10-Q and 8-K. The information in this release is provided only as of the date of this release, and Synthetic Biologics undertakes no obligation to update any forward-looking statements contained in this release on account of new information, future events, or otherwise, except as required by law.

For further information, please contact:

Investor Relations:

Chris Calabrese

LifeSci Advisors, LLC

ccalabrese@lifesciadvisors.com

917-680-5608


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Source: Synthetic Biologics, Inc.