Positive preclinical findings were discussed in an oral presentation titled “A novel antibody-drug conjugate directed to the ALK receptor tyrosine kinase demonstrates efficacy in models of neuroblastoma” at the American Association for Cancer Research (AACR) Annual Meeting, which is taking place in New Orleans, Louisiana, April 16-20, 2016.

Neuroblastoma, a leading cause of childhood cancer deaths, is a malignancy arising from the sympathetic nervous system that typically presents in early childhood. It often originates in the adrenal glands, but may also develop in the abdomen, chest, or in nerve tissue near the spine. There are an estimated 650 new cases of neuroblastoma diagnosed in the United States each year. Neuroblastoma contributes significant morbidity and mortality despite continued dose escalation of intensive chemotherapy and radiotherapy in individual patients.

The oral presentation reviewed data, generated by the laboratory of Yael Mossé, MD, Associate Professor of Pediatrics, University of Pennsylvania Perelman School of Medicine, and a member of The Children’s Hospital of Philadelphia (CHOP) Division of Oncology, Neuroblastoma Developmental Therapeutics Program, from preclinical studies evaluating an anti-ALK-ADC drug candidate, which consists of an anti-ALK antibody discovered by researchers at Kolltan Pharmaceuticals (KTN0125) conjugated to a thienoindole cytotoxic agent (TEI), in a panel of extensively characterized human neuroblastoma cell lines harboring wild-type and mutant ALK.

The data demonstrate in vitro and in vivo anti-tumor activity in ALK-expressing, multidrug-resistant neuroblastoma models, independent of mutation status.

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Kolltan Pharmaceuticals is a privately held clinical-stage company focused on the discovery and development of novel antibody-based drugs targeting receptor tyrosine kinases (RTKs) for use in oncology and immunology.

“The preclinical data presented by our collaborators provide a compelling rationale to move our ALK-ADC program into development for the treatment of pediatric neuroblastoma and other ALK-expressing childhood cancers. This program is extremely novel and has the potential to be a first-in-class drug targeting the ALK receptor tyrosine kinase in line with our mission to bring innovative biologics to patients,” noted Gerald McMahon, Ph.D., President and Chief Executive Officer of Kolltan Pharmaceuticals.

“Neuroblastoma remains a very difficult disease to cure and there is a clear need for novel targeted therapies directed at the ALK receptor tyrosine kinase, which is expressed in the majority of neuroblastomas. These data suggest a novel ALK-targeting drug candidate that has anti-tumor activity in both ALK mutated and wild-type neuroblastoma models,” Mossé commented.

“KTN0125 is a prototype monoclonal antibody that was selected for its high binding affinity and ALK-dependent cytotoxic activity when conjugated to thienoindoles. The observed in vitro and in vivo activity of KTN0125-TEI supports our commitment to develop this novel therapeutic drug candidate for children with this devastating malignancy,” Diego Alvarado, Ph.D., Director of Research at Kolltan added.

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