On August 10, 2015 Ignyta, Inc. (Nasdaq: RXDX), a precision oncology biotechnology company, reported company highlights and financial results for the second quarter ended June 30, 2015 (Press release, Ignyta, AUG 10, 2015, View Source [SID:1234507143]).
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"Since the beginning of the second quarter of 2015, we have continued to make important strides toward our goal of becoming a leading precision oncology biotechnology company that can provide compelling treatment options to cancer patients with unmet needs," said Jonathan Lim, M.D., Chairman and CEO of Ignyta. "We made strong progress on our lead product candidate, entrectinib, announcing promising data at ASCO (Free ASCO Whitepaper) from our two Phase I clinical trials, releasing our proprietary next-generation sequencing assay to support our potentially registration-enabling STARTRK-2 Phase 2 clinical trial, and kicking off a collaboration with UCSF to study entrectinib in melanoma. We are also starting to gain good momentum in advancing the former Teva assets we acquired only a quarter earlier, as exemplified by the FDA’s clearance of our IND for RXDX-107, for which we are preparing to initiate a Phase 1/1b clinical trial. We also strengthened our balance sheet by raising gross proceeds of approximately $75 million in an underwritten public offering of our common stock, and we continued to expand our team with incredibly talented people."
Company Highlights
Presentation of Entrectinib Clinical Data at ASCO (Free ASCO Whitepaper)
In June 2015, Ignyta announced that interim results from the company’s two Phase 1 clinical trials of entrectinib were presented at the 2015 Annual Meeting of the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) in Chicago, Illinois.
The clinical trials included the ALKA-372-001 study and the STARTRK-1 study, which is the first of the "Studies of Tumor Alterations Responsive to Targeting Receptor Kinases." Both trials were designed to determine the maximum tolerated dose (MTD) and/or recommended Phase 2 dose (RP2D), as well as preliminary anti-cancer activity, of single agent entrectinib in patients with solid tumors with the relevant molecular alterations: NTRK1 (encoding TrkA), ROS1 or ALK for ALKA-372-001 and NTRK1/2/3 (encoding TrkA/TrkB/TrkC), ROS1 or ALK for STARTRK-1.
As of the May 1, 2015, data cut-off for the presentation, the findings showed:
A total of 67 patients with a range of solid tumors had been dosed across both clinical trials;
Entrectinib was well tolerated to date, with no treatment-related serious adverse events. Other safety findings included:
In the ALKA-372-001 study, two Grade 3 treatment-related adverse events were observed: fatigue and muscle weakness, each of which subsided with dose reduction. The most frequent adverse events were paresthesia, nausea, myalgia, asthenia, dysgeusia, and vomiting;
In the STARTRK-1 study, three Grade 3 treatment-related adverse events were observed: neutropenia, which resolved with dose reduction, and two dose-limiting toxicities of reversible cognitive impairment and fatigue, both of which resolved upon study drug interruption. The most frequent adverse events were fatigue, dysgeusia, constipation, nausea, and paresthesia;
Pharmacokinetic measurements showed dose-proportional increases across the daily dosing regimens evaluated, with a half-life compatible with once-daily dosing;
The body surface area (BSA)-based recommended Phase 2 dose was determined to be 400 mg/m2 once per day (QD); both studies are continuing in order to determine a fixed daily dose regimen;
11 patients across both clinical trials met the company’s expected Phase 2 eligibility criteria, which include:
Presence of NTRK1/2/3, ROS1 or ALK fusions, as opposed to other types of molecular alterations (e.g., SNPs, amplifications, deletions);
ALK inhibitor and/or ROS1 inhibitor naïve; and
Treatment at or above the recommended Phase 2 dose of 400 mg/m2;
The response rate in the 11 patients that met these criteria across both studies was 91% (10 of 11 responses as assessed by the clinical sites), with 9 patients remaining on study treatment with durable responses of up to 16 treatment cycles. The responses included:
3 of 3 responses in patients with NTRK1/2/3 fusions, including patients with non-small cell lung cancer (NSCLC), colorectal cancer and acinic cell cancer;
5 of 6 responses, including one complete response, in patients with ROS1 fusions, all of which were in NSCLC; and
2 of 2 responses in patients with ALK fusions, including one NSCLC patient and one patient with another solid tumor.
Release for Clinical Use of Proprietary NGS Clinical Trial Assay
In June 2015, the company announced the release for clinical use of its first clinical trial assay to support patient identification and enrollment into its STARTRK clinical development program for entrectinib. The proprietary assay was co-developed with ArcherDx and validated within Ignyta’s own CLIA-registered, QSR-compliant diagnostic lab in San Diego. This lab will utilize this assay in acting as the central testing lab for patient screening for the STARTRK-2 Phase 2 clinical study of entrectinib.
Entrectinib Collaboration with UCSF
In July 2015, the company announced a clinical collaboration with the University of California, San Francisco (UCSF), under which UCSF will study entrectinib in a proof-of-concept clinical trial in cancer patients with metastatic melanoma that is positive for activating alterations to NTRK1/2/3 (encoding TrkA/TrkB/TrkC) or ROS1.
The study is a multicenter, open label umbrella trial designed by UCSF to obtain proof-of-concept data in patients with metastatic melanoma that is positive for molecular alterations in specific tyrosine kinase receptors. UCSF will exclusively use entrectinib for patients enrolled in the clinical trial having activating molecular alterations to NTRK1/2/3 or ROS1.
Clearance of Investigational New Drug (IND) Application for RXDX-107
In July 2015, Ignyta announced that the U.S. Food and Drug Administration (FDA) cleared the IND for Ignyta’s new chemical entity RXDX-107, a next-generation alkyl ester of bendamustine encapsulated in human serum albumin (HSA) to form nanoparticles.
Under this IND, the company intends to initiate a new Phase 1/1b, multicenter, open-label clinical trial of RXDX-107 in adult patients. This dose-escalation study is designed to determine the MTD, RP2D, tolerability, pharmacokinetics and preliminary clinical activity of RXDX-107 in patients with locally advanced or metastatic solid tumors.
Financing
In June 2015, the company issued an aggregate of 4,285,714 shares of its common stock in an underwritten public offering at a purchase price of $17.50 per share, which resulted in aggregate gross proceeds of approximately $75 million.
Enhancement of Leadership Capacity
In July 2015, Ignyta announced that Bernard Parker joined the company as its Chief Commercial Officer, bringing to the company broad commercial oncology experience from a variety of senior roles spanning sales, marketing, reimbursement, global brand management and regional business unit leadership at several leading pharmaceutical companies. Mr. Parker’s previous experience includes serving as Head of the EMEA Pharmaceuticals Franchise for the Alcon division of Novartis; as Global Brand Director, Biopharmaceuticals Portfolio for the Sandoz division of Novartis; as a management consultant at Bain & Company; and in various marketing and sales roles at Amgen, Pfizer and Parke-Davis.
Second Quarter 2015 Financial Results
For the second quarter of 2015, net loss was $13.1 million, or $0.51 per share, compared with $5.4 million, or $0.28 per share, for the second quarter of 2014.
Ignyta did not record any revenue for the three months ended June 30, 2015. Ignyta recorded revenue of $150,000 for the three months ended June 30, 2014, which consisted of a one-time service fee for research services conducted in the second quarter of 2014.
Research and development expenses for the second quarter of 2015 were $8.8 million, compared with $3.6 million for the second quarter of 2014. The increase was primarily due to an increase in activities relating to development of entrectinib and the company’s other product candidates, including the assets acquired from Teva Pharmaceutical Industries Ltd. in March 2015. 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, facilities related expenses as a result of the expansion of the company’s leased facilities space and expenses incurred in connection with the Teva asset acquisition.
General and administrative expenses were $3.9 million for second quarter of 2015, compared with $2.0 million for second quarter of 2014. The increase was primarily caused by increases in personnel costs and investor relations, audit, legal and intellectual property costs.
At June 30, 2015, the company had cash, cash equivalents and available-for-sale securities totaling $166.4 million and current and long-term debt of approximately $21.0 million. At December 31, 2014, the company had cash, cash equivalents and available-for-sale securities totaling $76.6 million and current and long-term debt of approximately $21.0 million.