Medicenna Therapeutics Selects Kalon as Contract Manufacturer for New Cancer Drug

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First commercial project focuses on manufacturing of novel therapeutic for children with brain cancer.

Accelerating Drug Development

College Station-based Kalon Biotherapeutics today 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 microbial-based 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 high-affinity 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.”


About Kalon Biotherapeutics

Kalon Biotherapeutics is a private company formed by The Texas A&M University System in spring 2011. It was formed to provide advanced biologics development manufacturing in the National Center for Therapeutics Manufacturing (NCTM), a state-of-the-art cGMP flexible biomanufacturing facility that utilizes self-contained, mobile clean rooms (MCRs) for conducting multiple biomanufacturing projects in a ballroom environment, all under a single roof. Kalon enables rapid, cost-effective drug development through a flexible and scalable clinical manufacturing platform with capabilities to support all classes of biological drug products, including vaccines, monoclonal antibodies, cellular and gene therapies. Kalon is a key partner of Research Valley’s One Health Plus Biocorridor™ “One-Stop-Shop” Biotech Infrastructure Pipeline, to discover new therapies in plant, animal and human health; perform preclinical evaluations; and utilize flexible, scalable Biotech Infrastructure Pipeline biopharmaceutical manufacturing, all in one convenient location.

About Medicenna Therapeutics

Medicenna Therapeutics, Inc. is a clinical stage immune-oncology company developing first-in-class Empowered Cytokines™, a novel and dramatically superior approach to cancer therapy. Medicenna’s mission is to be the leader in the development and commercialization of Empowered Cytokines® and Superkines® for the treatment of cancer. The company aims to achieve its goals by combining its own expertise with that of world class collaborators to develop a unique set of Superkines™ (engineered cytokines) that can be fused with pro-apoptotic proteins to precisely deliver potent cell-killing agents to cancer cells, the pro-tumor micro-environment and cancer stem cells without harming healthy cells.

Contact: Thomas Graham (512) 270-4742; tgraham(at)crosswindpr(dot)com

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