Baylor College of Medicine and Cell Medica said today they will partner to develop a pipeline of next-generation cellular immunotherapy products designed to fight cancer by attacking solid tumors.

Baylor has provided Cell Medica with an exclusive license to its proprietary natural killer T (NKT) cell immunotherapy platform, five product candidates to be developed by Baylor research teams specializing in genetically engineered immune cells, and an option to license future product candidates, the partners said today.

Baylor and Cell Medica said their partnership includes a co-development component designed to combine Baylor’s expertise in the creation of modified immune cell technologies with Cell Medica’s know-how in manufacturing and commercializing cell therapy products.

“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,” Cell Medica CEO Gregg Sando said in a statement.

The partners’ development plan will apply chimeric antigen receptor (CAR) technology to NKT cells as a novel immune cell type with biological properties that according to Baylor and Cell Medica may be particularly effective for targeting solid tumors.

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, Baylor and Cell Medica said.

The collaboration will build on research with CAR-modified NKT cells by Leonid Metelitsa, M.D., professor of pediatrics–oncology at Baylor. In published research, Metelitsa and his team have shown the potential therapeutic advantages of functionally enhanced CAR-modified NKT cells in preclinical 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.

Baylor has agreed to conduct preclinical and Phase I clinical research under the guidance of the collaboration’s Joint Steering Committee, including members from both organizations. Cell Medica agreed to work in parallel to support early product development and use its experience in manufacturing clinical-grade cell therapies since 2008 to establish 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 partners said.

Co-development funding will be available to research teams at Baylor toward new technologies, which may be used to create therapeutic products using modified NKT cells and other immune cells or to improve manufacturing systems.

Baylor said its Innovation Development Center (IDC) helped structure the co-development partnership and will oversee the college’s alliance management function. 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. Preclinical development work for two of the programs will be carried out by Gianpietro Dotti, M.D., and Barbara Savoldo, M.D., Ph.D., at the Lineberger Comprehensive Cancer Center, University of North Carolina. The Joint Steering Committee will review new product opportunities on a regular basis, Baylor and Cell Medica said.

The co-development partnership builds upon an ongoing collaboration between Baylor and Cell Medica, supported by the Cancer Prevention and Research Institute of Texas (CPRIT), to develop baltaleucel-T for a range of cancers associated with the oncogenic Epstein-Barr virus.

The value of the collaboration was not disclosed, although Cell Medica has paid Baylor an upfront fee for the exclusive licensing arrangements and will make additional payments to exercise its exclusive option to license future products.

As part of its upfront payment, privately held Cell Medica agreed to pay Baylor in preference shares that are convertible into common shares.

Baylor is also eligible for payments tied to achieving late-stage clinical, regulatory approval, and sales milestones, as well as single-digit royalties for the successful development of specific products.

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