SAN DIEGO, CA, USA I December 29, 2017 I Ignyta, Inc. (Nasdaq: RXDX), a biotechnology company focused on precision medicine in oncology, today announced that the U.S. Food and Drug Administration (FDA) has cleared its Investigational New Drug (IND) application for RXDX-106, a novel oral immunomodulatory agent and TAM inhibitor, in patients with solid tumors.
“This agent furthers our commitment to advancing new medicines to help patients in their fight against cancer. We look forward to commencing this Phase 1 study in early 2018.”
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Under this IND, the company intends to initiate the TITAN (Targeted Immunomodulatory TAM ANtagonist) study, a first-in-human, open label, multicenter, dose escalation study of RXDX-106 in patients with locally advanced or metastatic solid tumors. TITAN is designed to determine the safety, tolerability, pharmacokinetics, pharmacodynamics, and preliminary clinical activity of RXDX-106.
“RXDX-106 represents a new class of immuno-oncologic precision medicines that we are excited to advance to the clinic. In preclinical studies, RXDX-106 has demonstrated the potential to elicit and potentiate an immune response to cancer, by targeting the TAM family of receptors in the tumor microenvironment, both as a single agent and in combination with checkpoint inhibitors,” said Jonathan Lim, M.D., chairman and CEO of Ignyta. “This agent furthers our commitment to advancing new medicines to help patients in their fight against cancer. We look forward to commencing this Phase 1 study in early 2018.”
About RXDX-106
RXDX-106 is a novel oral immunomodulatory agent with potent nonclinical antitumor activity that appears to restore and enhance overall immune function by reversing immunosuppression of innate immune cells in the tumor microenvironment (TME) through inhibition of the receptor tyrosine kinases (RTKs) TYRO3, AXL, and MER (collectively, TAM). In the TME, TAM RTKs contribute to cancer cell evasion of the immune system and tumor progression by promoting anti-inflammatory and pro-tumorigenic activities. RXDX-106 is a potent and selective TAM inhibitor designed to reverse TAM RTK-mediated immunosuppression and inhibit tumor growth and progression.
About Ignyta
At Ignyta, we work tirelessly on behalf of patients with cancer to offer potentially life-saving, precisely targeted therapeutics (Rx) guided by diagnostic (Dx) tests. Our integrated Rx/Dx strategy allows us to enter uncharted territory, illuminating the molecular and immunological drivers of cancer and quickly advancing treatments to address them. This approach embraces even those patients with rare cancers, who have the highest unmet need and who may otherwise not have access to effective treatment options. With our pipeline of potentially first-in-class or best-in-class precision medicines, we are pursuing the ultimate goal of not just shrinking tumors, but eradicating cancer relapse and recurrence in precisely defined patient populations.
SOURCE: Ignyta
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SAN DIEGO, CA, USA I December 29, 2017 I Ignyta, Inc. (Nasdaq: RXDX), a biotechnology company focused on precision medicine in oncology, today announced that the U.S. Food and Drug Administration (FDA) has cleared its Investigational New Drug (IND) application for RXDX-106, a novel oral immunomodulatory agent and TAM inhibitor, in patients with solid tumors.
“This agent furthers our commitment to advancing new medicines to help patients in their fight against cancer. We look forward to commencing this Phase 1 study in early 2018.”
Tweet this
Under this IND, the company intends to initiate the TITAN (Targeted Immunomodulatory TAM ANtagonist) study, a first-in-human, open label, multicenter, dose escalation study of RXDX-106 in patients with locally advanced or metastatic solid tumors. TITAN is designed to determine the safety, tolerability, pharmacokinetics, pharmacodynamics, and preliminary clinical activity of RXDX-106.
“RXDX-106 represents a new class of immuno-oncologic precision medicines that we are excited to advance to the clinic. In preclinical studies, RXDX-106 has demonstrated the potential to elicit and potentiate an immune response to cancer, by targeting the TAM family of receptors in the tumor microenvironment, both as a single agent and in combination with checkpoint inhibitors,” said Jonathan Lim, M.D., chairman and CEO of Ignyta. “This agent furthers our commitment to advancing new medicines to help patients in their fight against cancer. We look forward to commencing this Phase 1 study in early 2018.”
About RXDX-106
RXDX-106 is a novel oral immunomodulatory agent with potent nonclinical antitumor activity that appears to restore and enhance overall immune function by reversing immunosuppression of innate immune cells in the tumor microenvironment (TME) through inhibition of the receptor tyrosine kinases (RTKs) TYRO3, AXL, and MER (collectively, TAM). In the TME, TAM RTKs contribute to cancer cell evasion of the immune system and tumor progression by promoting anti-inflammatory and pro-tumorigenic activities. RXDX-106 is a potent and selective TAM inhibitor designed to reverse TAM RTK-mediated immunosuppression and inhibit tumor growth and progression.
About Ignyta
At Ignyta, we work tirelessly on behalf of patients with cancer to offer potentially life-saving, precisely targeted therapeutics (Rx) guided by diagnostic (Dx) tests. Our integrated Rx/Dx strategy allows us to enter uncharted territory, illuminating the molecular and immunological drivers of cancer and quickly advancing treatments to address them. This approach embraces even those patients with rare cancers, who have the highest unmet need and who may otherwise not have access to effective treatment options. With our pipeline of potentially first-in-class or best-in-class precision medicines, we are pursuing the ultimate goal of not just shrinking tumors, but eradicating cancer relapse and recurrence in precisely defined patient populations.
SOURCE: Ignyta
Post Views: 20
