College Station-based Kalon Biotherapeutics recently announced Canadian biopharmaceutical company Medicenna Therapeutics has selected it to manufacture materials that will accelerate the development, testing and phase3/ commercialization of several promising new cancer drugs in the pipeline.
“Kalon’s contract with Medicenna represents an exciting opportunity to use our microbialbased cGMP manufacturing expertise on several promising biotherapeutics,” said Andrew Strong, president and chief executive officer of Kalon. “We look forward to a long and productive relationship with Medicenna, with the potential to bring many life-saving drugs to market.”
“With Kalon’s expertise and manufacturing capabilities, we hope within a very short time to take early research programs on several promising new drugs through clinical development to final FDA and EMA approval and phase 3/commercialization,” said Fahar Merchant, president and chief executive of Medicenna Therapeutics. “Our relationship with Kalon will allow us to focus on our core competencies, and thus move these new therapies through the pipeline much more rapidly than would have been possible otherwise.”
Kalon Biotherapeutics provides advanced biologics contract development and manufacturing at the National Center for Therapeutics Manufacturing located on the campus of Texas A&M in College Station, Texas. Building on its relationship with Texas A&M’s Center for Innovation in Advanced Development and Manufacturing (CIADM), as a contract development and manufacturing organization (CDMO), Kalon provides clients with comprehensive services for biological therapeutics and vaccines, from drug development through manufacture. Kalon’s services span a full range of capabilities in multiple host cell systems, including mammalian, microbial, insect cell, and live and attenuated viral systems. Capabilities include process development through large-scale cGMP manufacturing. Kalon also has significant internal capabilities for making and storing cGMP cell banks, performing stability studies and supporting commercial registration of new biological-based products.
Kalon’s first project with Medicenna is for a clinical trial testing the effectiveness of Medicenna’s first-in-class Empowered Cytokines™ (ECs) for children with brain cancer. The agreement provides for Kalon to manufacture the material that will be used in human clinical trials in children and adults with brain cancer.
MDNA55 is Medicenna’s lead EC in clinical development for the treatment of central nervous system (CNS) cancers. It has been granted orphan drug status by the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA), and received fast-track designation by the FDA. MDNA55 is a fusion of a highaffinity variant of IL-4 with a fragment of the pseudomonas exotoxin (PE). Once internalized into the target cell, the toxin component of MDNASS arrests protein synthesis, thereby inducing apoptosis, or cell death. It targets the IL-4R, which is over-expressed in several CNS cancers, such as glioblastoma multiforme (GBM), diffuse intrinsic pontine glioma (DIPG), medulloblastoma and other gliomas, with little or no expression of IL-4R in the normal brain. Further, the glioma micro-environment is supported by a robust population of myeloid derived suppressor cells (MDSCs) that over-express IL-4R.
The next generation of IL-4 ECs consists of MDNA56 and MDNA57, which carry a fully human pro-apoptotic payload. Whereas MDNA55 has the ability to target both type 1 and type 2 IL-4R, MDNA56 and MDNA57 have specific bias toward either the type 1 or type 2, respectively. Unlike MDNA55, the fully human fusions are designed for repeated systemic administration and ideal where localized delivery is not an option. With 20 different types of cancers known to over-express the type 1 or type 2 IL-4R, the potential to directly target the tumor, cancer stem cells and also the tumor micro-environment is an exciting new development in cancer therapy, particularly in combination with cancer vaccines.
“The Kalon-Medicenna contract creates a critical bridge in the development of these cancer therapeutics,” said Strong. “It presents a tremendous opportunity to advance research in the area of glioblastoma, while establishing Texas and, more specifically, Kalon as the ’go-to‘ provider of biologics development and manufacturing services.”