Novel Antibody Contraceptive Enters Phase 1 Trial
ZabBio, Inc., announced today that the IND for their first-in-class contraceptive, ZB-06, is active and that the Phase 1 trial is enrolling (ClinicalTrials.gov, NCT04731818). The development of ZB-06 is the result of a long-term collaboration between ZabBio, Boston University, Mucommune, and Kentucky BioProcessing.
ZB-06, a vaginal film, is uniquely positioned as a female-controlled, non-hormonal, ondemand contraceptive. The long-term goal of this collaboration is creation of a multi-purpose prevention technology (MPT) with both contraceptive and antiviral (HIV, herpes) activities. This collaboration has previously conducted a Phase 1 trial of an anti-viral product, MB66. The final product will include the anti-viral activities of MB66 and the contraceptive activity of ZB-06.
The active ingredient of ZB-06 is a human contraceptive antibody (HCA) manufactured by Kentucky BioProcessing, Inc., using their rapid antibody manufacturing platform (RAMP). The ZB-06 Phase 1 trial, which will test ZB-06 film for safety and efficacy, will be led by
Professor Andrea Thurman at the Jones Institute for Reproductive Medicine at Eastern Virginia Medical School. “We are very excited to be part of the clinical testing of this non-hormonal, on demand, contraceptive for women at our Clinical Research Center at EVMS,” says Prof. Thurman.
Professor Deborah Anderson of Boston University, a leading reproductive biologist and one of the principal investigators of the project said, “This project is the culmination of years of basic research. It is very exciting to take our product into clinical development.”
“Our goal is to provide new, clinically efficacious, and cost-effective, contraceptive options for women,” said Dr. Kevin Whaley CEO of ZabBio, the Sponsor of the ZB-06 trial.
Funding for the development of both the ZB-06 and the clinical trial is provided by Contraceptive Research Center grant P50HD096957 from the Eunice Kennedy Shriver National Institute of Child Health and Human Development of the National Institutes of Health. INDenabling preclinical testing was funded by The Bill & Melinda Gates Foundation (INV#-009770).
March 9, 2021, San Diego, CA
For further information please contact Dr. Miles Brennan:
About ZabBio, Inc.
ZabBio is a privately held company in San Diego, CA dedicated to developing monoclonal antibody-based products that address unmet needs in infectious diseases and reproductive health. To ensure access, ZabBio intends to produce products at scale and cost that meet the demands of large, cost-sensitive markets.
About Boston University
Boston University School of Medicine is one of the largest research programs in the United States with grants totaling $865M that fund an array of basic science, translational and clinical research.
Mucommune is a privately held company in Durham, NC spun out from research at the Eshelman School of
Pharmacy at University of North Carolina. Mucommune is advancing a first in-class platform that harnesses the synergy between antibodies and mucus to reinforce the mucus barrier for mucosal health, as well as proprietary technologies for sustained vaginal drug delivery. Mucommune is dedicated to addressing unmet needs in female reproductive health.
Eastern Virginia Medical School (EVMS) founded in 1973 (Norfolk VA) is an academic health center dedicated to achieving excellence in medical and health professions education, research and patient care. We value creating and fostering a diverse and cohesive faculty, professional staff and student body as the surest way to achieve our mission. Adhering to the highest ethical standards, we will strive to improve the health of our community and to be recognized as a national center of intellectual and clinical strength in medicine and Health Professions. Our commitment to ensuring institutional effectiveness is demonstrated by the continuous assessment processes we use to improve program performance and student learning outcomes. EVMS is affiliated with Sentara Norfolk General Hospital, a level I trauma center and major tertiary referral center for the region. Clinical trials are conducted at the Jones Institute of Reproductive Health, on the campus of EVMS. The first IVF cycle in the US occurred at the Jones Institute.
About Kentucky BioProcessing (KBP)
British American Tobacco “BAT”-owned KBP is located in Owensboro, KY., where it began operations in 2006. In
January 2014, KBP was acquired by and became an independently operated, wholly-owned subsidiary of Reynolds American Inc. (RAI), owned by BAT. KBP continues to house its large, multilevel indoor plant-growth space, as well as its research and production laboratories, clean rooms and manufacturing operations in Owensboro. KBP develops and executes processes to transform tobacco plants into “biomanufacturing factories” that efficiently produce complex proteins they would not otherwise produce. With the right commercial partner, the company can grow, harvest and process as many as 3 million protein-producing plants in a production cycle that typically takes about 6 weeks – compared with many months using traditional biomanufacturing methods. The company uses licensed and proprietary technologies to temporarily encode tobacco plants with the genetic instructions to produce specific target proteins. The plants are grown in an automated, climate-controlled environment that can be adjusted to optimize their production of a protein of interest.