Catalent, the leading global provider of advanced delivery technologies, development, and manufacturing solutions for drugs, biologics, cell and gene therapies, and consumer health products, announced that it has signed an agreement with Zumutor Biologics, Inc., to manufacture Zumutor’s lead candidate, ZM008, for the treatment of solid tumors. Zumutor is a biologics company that develops novel immuno-oncotherapeutics to drive transformational improvements in cancer treatment.
ZM008 is a first-in-class monoclonal antibody targeting tumor cell receptors that block natural killer (NK) cell inhibitory signals and enables NK cell activation to generate a potent immune response. NK cells are a type of cytotoxic lymphocyte (white blood cell) and are a critical component in the innate human immune system, which ZM008 can utilize to target solid tumor cells for diseases such as prostate cancer.
“We were able to fast track the development of ZM008 by leveraging INABLR, our proprietary antibody discovery platform,” stated Kavitha Iyer, Founder & CEO of Zumutor Biologics. “Robust preclinical data for ZM008 demonstrates tumor cell death, immune cell infiltration, and tumor growth inhibition. In vivo studies demonstrate anti-tumor efficacy as a monotherapy or in combination with immune checkpoint inhibitors. Development is on track for investigational new drug filing by the end of 2020, and we have placed our trust in Catalent to deliver on-time and with the highest quality in true partnership.”
Under the terms of the agreement, Catalent Biologics will provide process optimization and drug substance manufacturing services from its site in Madison, Wisconsin. The site is currently undergoing a significant expansion, with the build-out of two new suites, each with a 2 x 2,000-liter single-use bioreactor system, providing additional clinical and commercial production. The expansion is scheduled to be completed by mid-2021 and will more than double Catalent Biologics’ commercial biomanufacturing capacity.
“Catalent values the long-standing partnership and technical relationship that we have developed with Zumutor over the years,” commented Mike Riley, Region President, Catalent Biologics, North America. “We are excited to work on this innovative lead candidate as the company prepares to take it into the clinic and beyond and look forward to working closely with Zumutor to support its clinical development and commercialization needs.”
About Zumutor Biologics, Inc.
Zumutor Biologics, Inc., is a next generation Tumor-Directed IO therapeutics company headquartered in Cambridge, MA with R & D Lab in Bangalore, India. The 25-strong science team works seamlessly with a world renowned scientific advisory board with expertise in immuno-oncology and clinical development. Zumutor’s assets include a pipeline of immuno-oncotherapeutics molecules, two proprietary antibody discovery platforms and a robust IP portfolio with a landscape beyond 2034. For more information, visit www.zumutor.com.
ABOUT CATALENT BIOLOGICS
For more than two decades, Catalent Biologics has built capabilities and experience in development, manufacturing, and analytical services for new biological entities, cell and gene therapies, biosimilars, and antibody-drug conjugates. Catalent has worked with 600+ mAbs and 80+ proteins, and 13 biopharmaceutical drugs produced using GPEx® cell line development technology have been approved and marketed, with more than 120 ongoing clinical trials utilizing therapeutic candidates developed using the GPEx platform. A further 26 commercially-approved products have employed Catalent Biologics’ capabilities through to aseptic fill/finish. Catalent has recently acquired MaSTherCell, a technology-focused cell and gene therapy development and manufacturing partner with facilities in the U.S. and Europe. With expertise in both autologous and allogeneic cell therapy development and manufacturing, this latest acquisition complements Paragon Gene Therapy’s industry-leading capabilities and expertise in the development and manufacturing of adeno-associated virus (AAV) vectors, next-generation vaccines and oncolytic virus production. Its manufacturing facilities in Baltimore, Maryland have produced over 100 GMP batches across 40 clinical and commercial programs. Using advanced technology and tailored solutions for clinical through commercial supply, Catalent Biologics brings better biologic treatments to patients, faster. For more information on Catalent Biologics, visit www.catalent.com/biologics.
Catalent is the leading global provider of advanced delivery technologies, development, and manufacturing solutions for drugs, biologics, cell and gene therapies, and consumer health products. With over 85 years serving the industry, Catalent has proven expertise in bringing more customer products to market faster, enhancing product performance and ensuring reliable global clinical and commercial product supply. Catalent employs over 13,000 people, including over 2,400 scientists and technicians, at more than 35 facilities, and in fiscal year 2019 generated over $2.5 billion in annual revenue. Catalent is headquartered in Somerset, New Jersey. For more information, visit www.catalent.com.