Date: 2014-08-04
Type of information: Licensing agreement
Compound: RXDX-103, RXDX-104
Company: Ignyta (USA - CA) Nerviano Medical Sciences (Italy)
Therapeutic area: Cancer - Oncology
Type agreement: licensing agreement
Action mechanism: RXDX-103, and RXDX-104 are two kinase inhibitors. RXDX-103 is an inhibitor of the cell division cycle 7-related (Cdc7) protein kinase. Loss of cell cycle control is a hallmark of cancer, and interfering with the DNA replication process is a proven strategy for cancer therapy. Cdc7 is a serine/threonine protein kinase essential for the initiation step of DNA replication during the synthesis (S) phase. Ignyta and Nerviano believe that inhibiting the initiation step rather than the elongation step of DNA replication by targeting Cdc7 could offer a more targeted therapeutic strategy for disrupting DNA replication. For example, inhibition of Cdc7 has been demonstrated to selectively kill tumor cells in a P53-independent manner, while sparing non-cancerous cells. RXDX-104 is a program to identify a highly selective inhibitor of the rearranged during transfection (RET) tyrosine kinase. The RET proto-oncogene is a receptor tyrosine kinase prone to gene rearrangements and other mutations, which can become oncogenic drivers in cancers such as non-small cell lung cancer and medullary thyroid cancer. While some marketed and development stage multi-kinase inhibitors induce non-selective RET inhibition that confers anti-tumor efficacy in cancer patients with RET rearrangements, such compounds often have limiting toxicities from their other mechanistic effects, such as VEGF inhibition. Each of these programs is in preclinical development for the potential treatment of multiple cancers.
Disease: multiple cancers
Details: * On August 4, 2014, Ignyta, an oncology precision medicine biotechnology company, and Nerviano Medical Sciences, a leading oncology discovery organization, announced that they have signed a license agreement that grants Ignyta exclusive global development and commercialization rights to two new drug development programs, which Ignyta will refer to as RXDX-103 and RXDX-104. RXDX-103 is an inhibitor of the cell division cycle 7-related (Cdc7) protein kinase, and RXDX-104 is a program to identify a highly selective inhibitor of the rearranged during transfection (RET) tyrosine kinase. Each of these programs is in preclinical development for the potential treatment of multiple cancers. Ignyta previously licensed exclusive rights to its RXDX-101 product candidate and its RXDX-102 back-up product candidate from Nerviano.
Under the terms of the license agreement, Ignyta will assume sole responsibility for global development and commercialization of the RXDX-103 product candidate immediately, and for the RXDX-104 program upon the earlier of December 31, 2014 or the identification of a lead development candidate.
Financial terms: Nerviano will receive an upfront payment of $3.5 million, as well as development- and regulatory-based milestone payments and tiered royalty payments on future net sales of RXDX-103 or RXDX-104.
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