Receives Orphan Drug Designation for Retinoblastoma from the U.S. FDA
Synthetic Biologics, Inc., a diversified clinical-stage company developing therapeutics designed to treat diseases in areas of high unmet need, today announced that VCN Biosciences, S.L.'s (VCN) VCN-01 received Orphan Drug Designation for retinoblastoma from the U.S. Food & Drug Administration (FDA). This announcement follows Synthetic Biologics' recent announcement that it had entered a definitive agreement to acquire VCN, which is subject to conditions that must be met prior to closing. VCN is developing a new oncolytic adenovirus (OV) platform designed to trigger tumor cell death and promote immune cell infiltration into tumors.
The FDA's Office of Orphan Products Development grants orphan status to drugs being developed to treat, diagnose or prevent a rare disease or condition affecting fewer than 200,000 people in the United States. Orphan Drug Designation is designed to provide drug developers with various benefits to support the development of novel drugs, including the potential for market exclusivity for seven years upon FDA approval, eligibility for tax credits for qualified clinical trials, waiver of application fees, reduced annual product fees, clinical protocol assistance and potential qualification for expedited development programs.
Steven Shallcross, Chief Executive Officer and Chief Financial Officer of Synthetic Biologics, commented, "We are pleased to report that VCN's VCN-01 was granted Orphan Drug Designation for retinoblastoma by the FDA. We believe VCN-01 may represent a novel rescue therapy for patients who fail standard therapy, or may be used as an adjunct to chemotherapy, to provide improved outcomes for these patients. We are highly encouraged by the preliminary clinical data thus far and look forward to conducting a pivotal Phase 2/3 trial in these patients following our expected completion of the acquisition."
About VCN Biosciences
VCN Biosciences is a clinical-stage immuno-oncology company focused on the development of the next generation of oncolytic adenoviruses. VCN candidates are designed to obtain clinical activity after systemic administration and are able to remodel the complex matrix in the tumor to allow enhanced spreading of therapeutic molecules and the immune system. VCN Biosciences lead product, VCN-01, is a oncolytic adenovirus with unique characteristics being studied in clinical trials for cancers for which there is no cure, including pancreatic carcinoma and retinoblastoma. For more information, please visit www.vcnbiosciences.com.
About Synthetic Biologics, Inc.
Synthetic Biologics, Inc. (NYSE American: SYN) is diversified clinical-stage company developing therapeutics designed to treat diseases in areas of high unmet need. The Company recently announced it has entered into a definitive agreement to acquire VCN Biosciences, S.L. (VCN), which is developing a new oncolytic adenovirus (OV) platform designed for intravenous (IV) delivery to trigger tumor cell death and promote immune cell infiltration into tumors. The transaction is expected to close during the first quarter of 2022, and is subject to, among other things, the approval by the Spanish government of the Company's acquisition of VCN under Spain's Foreign Investment Act and other customary closing conditions. In addition, the Company's lead candidates are: (1) SYN-004 (ribaxamase) which is designed to degrade certain commonly used intravenous (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 (2) 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.
Feb 09, 2022
