Established in 2022, Cytodigm is a preclinical-stage biopharmaceutical company developing next-generation therapeutics by leveraging its proprietary technologies to increase targetability and delivery efficiency while reducing immunogenicity and toxicity. Cytodigm is advancing Cytofinity™ and Sigfinity™, its lipid-based nanoparticle platforms, to deliver nucleic acid therapeutics for in vivo cell, gene, and immune therapy to various organs and cells. In the meantime, Cytodigm is applying its Zetafinity® polymer nanoparticles, a clinically proven delivery system, to enable the treatment of solid tumors.
Cytodigm’s business model is to develop therapeutics to clinical proof of concept for its technology platforms, leverage platform value through collaborations with other biopharmaceutical companies, and out-license the technology for different disease indications.
Dr. Bin Wu is the Founder and CEO of Cytodigm. He founded Phosphorex in 2005. As the President and CEO, he led Phosphorex to become an industry leader in drug delivery, providing innovative technologies and development services to the pharmaceutical and biotech industry before it was acquired by Ampersand Capital Partners in 2022. Dr. Wu has over 20 years of experience in biodegradable polymeric microspheres, lipid and polymer nanoparticles, and targeted delivery of small molecules, peptides, proteins, and nucleic acids. He is the inventor of over 20 US patents and 30 international PCT applications. Dr. Wu holds a Ph.D. in Polymer Chemistry from the University of Massachusetts Amherst.
Hanspeter Waldner has 20+ years of research, drug discovery, and development experience in industry and academia. Before Cytodigm, he held senior leadership positions at various biotechs, focusing on gene and cell therapies. Most recently, he served as SVP at Sensei Bio where he and his team advanced the development of two innovative cancer immunotherapies. At BlueRock Therapeutics, he built and led the Immunology department and initiated a stem cell-based therapy program for autoimmune diseases. He guided scientific and therapeutic strategies and successfully identified and implemented research and license opportunities with industry and academic partners. At CRISPR Therapeutics, he led and oversaw gene-edited cell therapy programs from discovery to early development, resulting in the clinical evaluation of three cancer CAR T cell therapies. Prior to industry, he was a faculty member at Harvard Medical School and Penn State University, leading teams in autoimmune disease research. He earned his Ph.D. in Molecular and Cellular Biology from the University of Basel and his M.S. in Immunology from the Swiss Federal Institute of Technology.
Daniel is Chief Operating Officer of Ventus Therapeutics. Previously, he was the Chief Business Officer at Arrakis Therapeutics and BIND Therapeutics and held positions at Biogen in Corporate Development, Discovery Research, and Commercial Operations. He founded and served as President of Biogen’s biosimilars business. Daniel is deeply experienced in building high-growth organizations in the US and abroad, designing and implementing creative strategies to build corporate value, financing innovative companies from inception through IPO, negotiating and managing corporate collaborations, and leading groups of diverse functional experts. He received a B.S. in Biochemistry from Boston College and an MBA from Harvard University.
Dr. Tracy is Founder and President, Tracy BioConsulting, LLC. Dr. Tracy is known internationally for developing innovative first-in class complex injectables and nucleic acid therapeutics and vaccines. Dr. Tracy played a key role in developing Onpattro®, the first RNAi therapeutic approved by the FDA, EMA and other regulatory agencies worldwide. He has also played an important role in the development of lipid nanoparticle technology used in mRNA COVID-19 vaccines granted regulatory approval worldwide. Previously, he developed several complex injectable sustained release products that have been commercialized including Vivitrol®, Bydureon®, and Nutropin® Depot, which was the first long-acting protein product approved by the FDA. Dr. Tracy has extensive experience in the development of nano and microparticle-based products and other sterile injectable formulations from research through IND filing and commercialization. He has been recognized by peers internationally for accomplishments and leadership in the pharmaceutical product development, bioengineering, and delivery fields. Dr. Tracy is a Past-President and Fellow of the Controlled Release Society (CRS) and a Fellow of the American Institute for Medical and Biological Engineering (AIMBE).
Dr. Zale previously served as the vice president of development at Bind Therapeutics, a biopharmaceutical developing polymer nanoparticles for treating cancer until acquired by Pfizer in 2006. From 1993 to 2005, Stephen worked at and, in 2003, became Vice President of Injectable Products R&D at Alkermes, where he led the group responsible for formulating Alkermes’ biodegradable polymer-based microsphere products, including Nutropin Depot, Risperdal CONSTA, and Vivitrol. Prior to joining Alkermes, he led the Bioseparations R&D group at Sepracor Inc., a biopharmaceutical company. Stephen received his Ph.D. in Biochemical Engineering and a B.S. in Chemistry, both from MIT.
