On July 17, 2016 Cell Medica, a leader in developing, marketing and manufacturing cellular therapeutics for cancer and infections, reported a ground-breaking co-development partnership with Baylor College of Medicine (Baylor) to develop next-generation technologies for engineering immune cells with enhanced functions for the treatment of solid tumors (Press release, Cell Medica, JUN 17, 2016, View Source [SID1234527733]). The collaboration provides Cell Medica with an exclusive license over several Baylor cell and gene technologies and an option to license new products introduced into the co-development partnership by Baylor’s leading research teams in the field of genetically engineered immune cells.
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Next generation technology
The collaboration will build on the recent clinical success of advanced chimeric antigen receptors (CARs) to enable human immune cells to recognize and kill cancer cells expressing tumor-associated antigens. The development plan will apply the CAR technology to natural killer T (NKT) cells as a novel immune cell type with biological properties that may be particularly effective for targeting solid tumors. NKT cells are known to infiltrate tissues where solid tumors arise and kill both malignant cells and cancer-enabling cells such as tumor-associated macrophages. The development plan also includes a genetically engineered T cell receptor (TCR) for use in NKT cells and T cells. The next-generation product concepts will combine the targeting aspects of CAR and TCR technologies with functional engineering to enable the modified immune cells to counteract the powerful inhibitory mechanisms that tumor cells deploy to evade the immune response. Cell Medica expects the collaboration to generate a significant number of new products for its cellular immunotherapy pipeline.
Co-development structure
The collaboration will accelerate the pioneering work of Dr. Leonid Metelitsa, Professor of Paediatrics – Oncology, with CAR-modified NKT cells. In published research, Metelitsa and his team have shown the potential therapeutic advantages of functionally enhanced CAR-modified NKT cells in pre-clinical cancer models. Metelitsa’s research team is part of Texas Children’s Cancer Center and the Center for Cell and Gene Therapy (CAGT) at Baylor College of Medicine, Texas Children’s Hospital and Houston Methodist Hospital. The CAGT has more than 20 years of experience working with genetically modified immune cells for the treatment of cancer and has conducted more than 40 clinical studies investigating cellular immunotherapies for the treatment of cancer.
Within the co-development structure, Baylor will conduct the pre-clinical and Phase I clinical research under the guidance of the Joint Steering Committee including members from both organizations. Cell Medica will work in parallel to support early product development and will use its substantial experience in manufacturing clinical-grade cell therapies since 2008 to establish robust production processes suitable for industrial scale-up. Following completion of successful Phase I studies, the products will transfer to Cell Medica for later-stage clinical development and commercialization.
The co-development funding will be available to research teams at Baylor with respect to new technologies, which may be utilized to create therapeutic products using modified NKT cells and other immune cells or to improve manufacturing systems. Baylor’s Innovation Development Center (IDC), led by Andrew Wooten, helped to structure this unique co-development partnership and will be responsible for Baylor’s alliance management function. As part of these responsibilities, the IDC will identify complementary technologies from ongoing Baylor research programs that may be included within the co-development plan.
Five product programs have been defined for the initial development plan in addition to a general process technology program. The preclinical development work for two of these programs will be executed by Drs. Gianpietro Dotti and Barbara Savoldo at the Lineberger Comprehensive Cancer Center, University of North Carolina. The Joint Steering Committee for the collaboration will review new product opportunities on a regular basis.
The co-development partnership builds upon the ongoing successful collaboration between Baylor and Cell Medica, supported by the Cancer Prevention and Research Institute of Texas (CPRIT), to develop baltaleucel-T for the treatment of a range of cancers associated with the oncogenic Epstein Barr virus.
License, Option and Co-development Arrangements
Cell Medica has entered into a License and Option Agreement for two platform patents related to engineered NKT cells, three target cancer antigens for CAR-modified NKT cells and a T cell receptor (TCR) technology. In addition, Baylor and Cell Medica have signed a co-development agreement under which Cell Medica will fund research aimed at new products as well as concepts/technologies in both oncology and non-oncology applications. Cell Medica will have an exclusive option to license future products within the co-development plan. Cell Medica has paid an up-front fee for the exclusive licensing arrangements and will make additional payments to exercise its exclusive option to license future products. Baylor is eligible to receive further payments related to late-stage clinical, regulatory approval and sales milestones, as well as single digit royalties for the successful development of specific products. As part of the up-front consideration, Baylor will receive Cell Medica Preference Shares, which are convertible into Common Shares. Specific financial terms have not been disclosed.
"We are very pleased to partner with Cell Medica in a collaboration aimed at unlocking the huge potential of cellular immunotherapy for the benefit of cancer patients," said Dr. Adam Kuspa, senior vice president and dean for research at Baylor College of Medicine. "The co-development partnership represents a novel aspect of this collaboration which will fully engage Baylor in the early stage development work, including Phase I studies".
"This collaboration with Baylor College of Medicine will place Cell Medica at the forefront of new product concepts for CAR-modified immune cells," noted Gregg Sando, CEO of Cell Medica. "Baylor’s leading research capability in this field should add significantly to our pipeline of high value products targeting cancer types that do not respond to conventional treatments."