Ignyta reported company highlights and financial results for the second quarter ended June 30.
"Since the beginning of the second quarter, we have continued to make solid progress toward our goal of becoming a leading precision medicine biotechnology company by developing targeted therapeutics for cancer patients," said Jonathan Lim, M.D., Chairman and CEO of Ignyta. "We initiated our STARTRK-1 clinical trial of RXDX-101, in which leading cancer centers in the U.S., Europe and Asia will utilize a continuous daily dosing regimen in treating patients with advanced, metastatic solid tumors, and we bolstered our pipeline with the addition of our RXDX-103 and RXDX-104 development programs. We also announced promising data at ASCO from our ongoing, Italy- based ALKA-372-001 Phase I clinical trial of RXDX-101, and we continued to expand our team with incredibly talented people."
According to a release from the company, in August 2014, it announced that it entered into a license agreement with Nerviano Medical Sciences S.r.l. that grants Ignyta exclusive global development and commercialization rights to RXDX-103 and RXDX-104, two new drug development programs. RXDX-103 is a development candidate stage inhibitor of the cell division cycle 7-related (Cdc7) protein kinase, and RXDX-104 is a lead optimization stage program to identify a highly selective inhibitor of the rearranged during transfection (RET) tyrosine kinase. Each of these programs is in development for the potential treatment of multiple cancers.
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, or the identification of a lead development candidate. 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.
In August 2014, Ignyta announced that Adrian Senderowicz, M.D., joined the company as its Chief Medical Officer and Senior Vice President, Clinical Development and Regulatory Affairs. In May 2014, the company announced that Jacob Chacko, M.D., was appointed as Chief Financial Officer, assuming responsibility for the role from Zachary Hornby, who was appointed to the newly-created role of Chief Operating Officer.
In July 2014, the company announced the multicenter initiation of its global Phase I/IIa clinical trial of RXDX-101, the company's proprietary oral tyrosine kinase inhibitor targeting multiple solid tumor indications. This clinical trial is called STARTRK-1, which stands for Study Targeting ALK, ROS1 or TRKA/B/C, and is a Phase I/ IIa, multicenter, single-arm, open-label clinical trial of continuous daily dosing of oral RXDX-101 in adult patients with locally advanced or metastatic cancer confirmed to be positive for relevant molecular alterations. The trial will involve multiple clinical sites in the U.S., Europe and Asia.
In May 2014, interim results from the first-in-human ALKA-372- 001 Phase I clinical trial of RXDX-101 were presented in an oral presentation at the 2014 Annual Meeting of the American Society of Clinical Oncology (ASCO). This dose escalation study was designed to determine the maximum tolerated dose (MTD) and recommended Phase II dose, as well as preliminary anti-cancer activity of single agent RXDX-101 in patients with solid tumors with molecular alterations in the TrkA, ROS1 or ALK tyrosine kinase receptors. For each of the first three weeks of each 28-day dosing cycle, patients received RXDX-101 for four consecutive days, followed by three days without dosing. During the fourth week of each 28-day dosing cycle, patients were not dosed.
At the time of the May 2014 data cut-off for the ASCO presentation, 20 patients had been enrolled, with 19 having been dosed in the six dose cohorts. The interim findings showed:
-no dose-limiting toxicities had been observed, no drug-related serious adverse events had been observed and no patients were discontinued from the study due to adverse events;
-six patients remained on active treatment (four patients with partial responses and two patients with prolonged stable disease), with three patients having received 12 to 16 cycles of treatment;
-RXDX-101 demonstrated partial responses in patients with three different cancer histologies (colorectal cancer, non-small cell lung cancer and neuroblastoma), and in patients with each of TrkA, ROS1 and ALK alterations; and
-a patient with TrkA positive metastatic colorectal cancer had a partial response, with this patient representing what the company believes to be the first reported case of a patient with a TrkA positive tumor to be treated with a TrkA inhibitor.
For the second quarter of 2014, net loss was $5.4 million, or $0.28 per share, compared with $1.1 million, or $0.84 per share, for the second quarter of 2013.
Ignyta recorded revenue of $150,000 for the three months ended June 30. The company did not record any revenue for the three months ended June 30, 2013. The increase was due to a one-time service fee for research services conducted in the second quarter of 2014.
Research and development expenses for the second quarter of 2014 were $3.6 million, compared with $0.6 million for the second quarter of 2013. The increase was primarily due to an increase in activities relating to the development of RXDX-101. The increase between periods was also due to personnel expenses related to hiring and engaging additional employees and consultants to help advance the company's product candidates and facilities related expenses as a result of the expansion of the company's leased facilities space.
General and administrative expenses were $2.0 million for second quarter of 2014, compared with $0.5 million for second quarter of 2013. The increase was primarily caused by increases in personnel, audit, legal and intellectual property costs, some of which resulted from activities relating to operating as a public company, and facilities related expenses as a result of the expansion of the company's leased facilities space.
At June 30, the company had cash, cash equivalents and marketable securities totaling $95.1 million and current and long-term debt of $10.0 million. At March 31, the company had cash, cash equivalents and marketable securities totaling $100.4 million and current and long-term debt of $10.0 million. At December 31, 2013, the company had cash and cash equivalents totaling $51.8 million and current and long-term debt of $10.0 million.
Ignyta is a biotechnology company developing precision medicine with integrated Rx/Dx solutions for cancer patients.
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