A mutual interest in mutants

Novartis taps Invivoscribe for test to identify FLT3- positive AML patients

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SAN DIEGO—Invivoscribe Technologies Inc. has entered into a collaboration agreement with Novartis to develop and commercialize a companion diagnostic test to identify FLT3-positive acute myeloid leukemia (AML) patients for specific use in connection with the Novartis development compound, midostaurin (PKC412).

Midostaurin, a targeted small-molecule inhibitor of FLT3 tyrosine kinase, is currently in Phase III clinical development for newly diagnosed patients with FLT3 mutated AML who are receiving midostaurin or a placebo in combination with chemotherapy (NCT00651261). PKC412 is an oral multi-targeted kinase inhibitor that works via multiple signal transduction pathways. It is an inhibitor of a spectrum of FLT-3 receptor tyrosine kinase mutants. FLT3 is mutated in approximately one-third of patients with AML and is associated with poor prognosis.

PKC412 is also an inhibitor of c-KIT, which is mutated in 80 percent of patients with aggressive systemic mastocytosis (ASM). It also inhibits multiple other molecular targets including VEGFR-2, PDGFR and the Pgp-mediated multidrug resistance gene MDR. In addition, PKC412 inhibits multiple isoforms of the serine/ threonine protein kinase C (PKC). The compound is currently being investigated in RATIFY, a multinational phase III trial in newly diagnosed AML with FLT-3 mutations and a Phase II trial in aggressive systemic mastocytosis (ASM).

Determination of FLT3 mutation status has become a standard of care for patients diagnosed with AML. Both the American Society of Clinical Oncology and the National Comprehensive Cancer Network recommend testing for the FLT3 mutation in all patients diagnosed with AML. The Laboratory for Personalized Molecular Medicine (LabPMM), a subsidiary of Invivoscribe, is currently the only clinical laboratory with an exclusive license to the patents required to generate a FLT3 result that can be used toward regulatory approval of a companion diagnostic.

"Developing an FDA-approved FLT3 companion diagnostic for midostaurin will be a significant milestone for our companies, Invivoscribe and LabPMM," says Dr. Jeffrey E. Miller, founder, chief scientific officer and CEO of Invivoscribe and LabPMM. "We are delighted to collaborate with one of the world's leading healthcare companies in a manner that enables us to leverage our expertise in both molecular diagnostic product development and personalized molecular medicine."

Invivoscribe and LabPMM will develop, manufacture and work with the Novartis Molecular Diagnostics (MDx) unit to obtain regulatory approval for the companion diagnostic. Invivoscribe and Novartis MDx will then work together to make the companion diagnostic for treatment of AML available throughout the world. Invivoscribe manufactures its products in San Diego at its GMP facility. Exclusive licensed patents protect the majority of the company's products. IVS products are currently sold in more than 50 countries to clinical laboratories directly from Invivoscribe and Invivoscribe SARL, as well as through a network of distributors worldwide.

Invivoscribe describes itself as "a debt-free, privately held, international corporation. This year marks our fifteenth year in business. We have been profitable for more than a decade and have enjoyed revenue growth of at least 20 percent during each of the last 10 years. Currently, we provide the majority of all molecular reagents and products for leukemia and lymphoma testing. Invivoscribe's products are used to identify, classify and monitor leukemias, lymphomas and other lymph proliferative diseases."

Invivoscribe's wholly owned subsidiaries, Invivoscribe SARL, LabPMM LLC, LabPMM GmbH and LabFlow, are partnerships, the company states. Though they are flow-through entities, they are expected to become independently profitable within 18 months of inception and achieve substantive revenue growth each year.

The company says it "has diligently refrained from accepting any outside investment that might interfere with our long-term strategic vision and focus. While we appreciate learning of new licensing opportunities and we are always amenable to hearing of new scientific and business collaborations, we are likely to refrain from moving forward if the terms are not consistent with our successful, time-validated business model. Individuals, institutions and companies that become our licensing or business partners enjoy our ongoing assistance in intellectual property prosecution and enforcement. This is a substantive value-added skill set that is enjoyed by our partners."

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