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Agreements

Date: 0000-00-00

Type of information: Establishment of a new subsidiary in the EU

Compound: companion diagnostic to identify patients across tumor types suitable for treatment with larotrectinib

Company: Loxo Oncology (USA - CT) Ventana Medical Systems,(USA), a member of the Roche Group (Switzerland)

Therapeutic area: Cancer - Oncology - Diagnostic

Type agreement:

Action mechanism: companion diagnostic/kinase inhibitor. LOXO-101 is a potent, oral, selective inhibitor of tropomyosin receptor kinase (TRK) signaling molecules. The TRK family (TRKA, TRKB, and TRKC) has been implicated in diverse tumor types such as lung cancer, head and neck cancer, melanoma, colorectal cancer, sarcoma, and breast cancer. LOXO-101 was built specifically to inhibit TRK and is currently being evaluated in a Phase 1 dose escalation trial for patients with advanced solid tumors. LOXO-101 was developed in collaboration with Array BioPharma. The compound is being evaluated in the NAVIGATE global Phase 2 multi-center basket trial in patients with solid tumors that harbor TRK gene fusions, and the SCOUT Phase 1/2 trial in pediatric patients, including patients with advanced cancer, TRK gene fusions and infantile fibrosarcoma. Larotrectinib has been granted Breakthrough Therapy Designation and Rare Pediatric Disease Designation by the FDA .

Disease:

Details: * On March 20, 2017, Loxo Oncology announced that it has entered into a collaboration agreement with Ventana Medical Systems, to develop and commercialize a pan-TRK immunohistochemistry (IHC) test as a companion diagnostic to identify patients across tumor types suitable for treatment with larotrectinib. Loxo Oncology and Roche will utilize an investigational assay piloted by Loxo Oncology that will be further developed by Roche using its flagship OptiView DAB detection technology. Initially, the parties will optimize and validate the assay to ensure it is sufficiently robust to withstand clinical and regulatory scrutiny. The parties plan to first globally commercialize an analytical assay and then develop a Class III assay for pre-market approval (PMA) from the FDA. FDA approval will be based on analyses of patient samples collected from ongoing larotrectinib clinical trials to support clinical claims referencing larotrectinib. Roche is responsible for developing, obtaining and maintaining regulatory approvals for the companion diagnostic test in the United States , specified countries in the European Union and other countries that recognize the CE/ in vitro diagnostic registration process, as mutually agreed.

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