On October 1, 2019 Tmunity Therapeutics, Inc., a private clinical-stage biotherapeutics company focused on saving and improving lives by delivering the full potential of next-generation T-cell immunotherapy, reported it has entered into an exclusive license and research collaboration agreement with Children’s Hospital of Philadelphia (CHOP) to advance a glypican 2 (GPC2) chimeric antigen receptor T-cell (CAR-T) therapy for the treatment of neuroblastoma, a rare cancer that affects the developing nervous system (Press release, Tmunity Therapeutics, OCT 1, 2019, View Source [SID1234539992]). The therapy also has expansion potential in medulloblastoma and small cell lung cancer, among several other pediatric and adult cancers that express an abundance of the GPC2 protein on their cell surface.

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John Maris, MD and Kristopher Bosse, MD, pediatric oncologists and physician-scientists at CHOP, identified and validated the oncoprotein GPC2. It is highly expressed on neuroblastomas but not detectable at appreciable levels in normal childhood tissues. In a seminal paper published in Cancer Cell in 2017, the CHOP team determined that GPC2 may be less susceptible to immune escape mechanisms due to its requirement for neuroblastoma proliferation. Their work validated GPC2 as a nonmutated neuroblastoma oncoprotein and established a strong foundation for GPC2 as an immunotherapeutic target. "This new collaboration builds upon our prior studies and pairs Tmunity’s experience in engineering and developing CAR-T cells with CHOP’s expertise in the biology of this family of cell surface molecules across neuroblastoma and several other cancers," said Dr. Bosse, an Assistant Professor of Pediatrics at the Perelman School of Medicine at the University of Pennsylvania and CHOP.

"The collaboration with CHOP expands our network of world-class academic collaborators and progresses our strategy to build a pediatric oncology franchise and advance novel T-cell therapies for devastating diseases. By combining the scientific insights and research at CHOP with the T-cell development, regulatory, and manufacturing capabilities and expertise at Tmunity, we created a formidable team to attack this deadly cancer," said Usman "Oz" Azam, MD, President and Chief Executive Officer of Tmunity. "We look forward to working with Dr. Maris, Dr. Bosse, and their teams to advance GPC2 T-cell therapy and offer hope to patients with limited options."

Neuroblastoma is a rare cancer that affects the development of the nervous system by attacking immature nerve cells as early as the embryonic stage. Each year, about 800 children are diagnosed with neuroblastoma in the U.S., and overall survival rates are less than 50%. Current chemotherapy options for these patients are limited and highly toxic, which highlight the urgent need for new treatments for this disease, which improve overall survival and reduce long-term toxicity.

"We are excited to collaborate with Tmunity to accelerate the development of GPC2 for neuroblastoma," said John Maris, MD, co-head of the Pediatric Cancer Dream Team and Giulio D’Angio Chair in Neuroblastoma Research at CHOP. "Our studies have confirmed that GPC2 is an important target in neuroblastoma and other aggressive malignancies. We look forward to one day bringing, GPC2 T-cell therapies to the clinic and to patients in need."

Under the terms of the agreement, Tmunity will collaborate with CHOP to initiate IND-enabling studies and advance quickly into the clinic. Tmunity will be responsible for leading the development, manufacturing, regulatory, and commercialization of the GPC2 T-cell therapy. The majority of the preclinical studies will be performed by CHOP. Deal terms were not disclosed.