ZabBio

Team Members:

Kevin J. Whaley, Ph.D. serves as CRC PD/PI (joint with Dr. Anderson), as Co-Leader of the Executive Committee, and as Project Leader (PL) of Project 1 (Industrialization of Antibody-based Contraceptive MPTs). He has worked on contraception, MPT development and monoclonal antibody technology for his entire career. He studied the molecular mechanisms of gossypol (male contraceptive) at the Indian Institute of Science (Bangalore) and the Oregon Regional Primate Research Center.  He was a founding member of the ReProtect team at Johns Hopkins University that developed BufferGel. He co-founded Mapp Biopharmaceutical, Inc. (San Diego, CA) to commercialize monoclonal antibodies for contraception and the prevention of infectious diseases.  He is co-founder of the Alliance for Microbicide Development. He served as Co-PI and Leader of the Industrial (monoclonal antibody) Core on the recently completed NIAID-sponsored IPCP multicenter microbicide program grant (U19 AI096898) with Dr. Anderson.  He is currently the CEO of Mapp Biopharmaceutical Inc., a company that designs monoclonal antibodies for infectious diseases, and ZabBio, a company that makes monoclonal antibodies for reproductive health needs.

Thomas Moench, M.D. serves as a special advisor to the program. Dr. Moench served as a physician/scientist on the faculty of Johns Hopkins University (JHU) for over 10 years where he conducted research in contraception, animal models of HIV transmission, and the pathophysiology of sexually transmitted diseases.  He founded ReProtect with Drs. Whaley and Cone at JHU, and co-invented BufferGel, a topical microbicide/contraceptive gel that demonstrated contraceptive effectiveness in a large Phase 3 clinical trial.  He also invented the Duet cervical barrier device for the delivery of microbicides and contraceptives. As such, he has experience in both clinical research and the industrialization of contraceptives, microbicides and vaginal devices. He has collaborated with Drs. Anderson and Whaley for over 20 years, most recently in the capacity of Co-PI of the NIAID-sponsored IPCP multicenter microbicide program and Co-PI of the first CRC project. He is currently the Medical Director at Mapp Biopharmaceutical, and a part-time employee at Mucommune.

Marshall Hoke, M.S., R.A.C. serves as Director of Regulatory Affairs at ZabBio and is responsible for regulatory strategy and filings.

Henry Pham. serves as A/R|Research Associate II at ZabBio and is responsible for administrative management of the ZabBio subcontract.

Specific Aims for Project 1:

1. Manufacture GMP HCA drug substance (DS) and product (film DP). 

       1.1  Develop ZB-06 DP Commercial Scale Manufacturing Process

       1.2  Manufacture and Release DS and DP for Pharm/Tox Lot

       1.3  Manufacture and Release DS and DP for Clinical Lot

       1.4  Stability Testing of DS and DP from Pharm/Tox and Clinical Lots

2. Conduct IND-enabling preclinical studies of ZB-06 film.

       2.1  Rabbit Vaginal Irritation Study

       2.2  Rat Repeat Dose Toxicology Study

3. Provide Regulatory and Quality Support for Manufacturing and Clinical Studies of ZB-06 Film.

       3.1  Quality Oversight of Pharm/Tox DS and DP Manufacture

       3.2  Pre-IND Filing

       3.3  Quality Oversight of DS and DP Manufacture

       3.4  IND Filing

       3.5  Sponsor Oversight: Phase 1 Safety and Tolerability Study

       3.6  Sponsor Oversight: Phase 2a PCT Dose Ranging Study

       3.7  Quality Oversight of Pharm/Tox and Clinical DS and DP Stability