On November 7, 2017 Ignyta, Inc. (Nasdaq: RXDX), a biotechnology company focused on precision medicine in oncology, reported company highlights and financial results for the third quarter ended September 30, 2017 (Press release, Ignyta, NOV 7, 2017, View Source [SID1234521678]). The company is issuing this press release in lieu of conducting a conference call.
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"In addition, during the quarter we continued to advance our pipeline of precision medicines targeted at the molecular and immunological drivers of cancer, and we strengthened our balance sheet through an equity offering that provides us with additional resources to continue developing meaningful new cancer therapies for patients."
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"We are pleased with the continued development and regulatory progress of our lead product candidate, entrectinib—an investigational, CNS-active, potent, and selective tyrosine kinase inhibitor being developed for tumors that harbor TRK or ROS1 fusions—as we approach the expected submission of two NDAs and a PMA in 2018," said Jonathan Lim, M.D., Chairman and CEO of Ignyta. "In addition, during the quarter we continued to advance our pipeline of precision medicines targeted at the molecular and immunological drivers of cancer, and we strengthened our balance sheet through an equity offering that provides us with additional resources to continue developing meaningful new cancer therapies for patients."
Company Highlights
Entrectinib
Regulatory Updates: Orphan Drug Designation and PRIME
In July 2017, we announced that FDA granted orphan drug designation to entrectinib for "treatment of NTRK fusion-positive solid tumors."
In October 2017, we announced that the European Medicines Agency (EMA) granted Priority Medicines (PRIME) designation for entrectinib in the treatment of NTRK fusion-positive, locally advanced or metastatic solid tumors in adult and pediatric patients who have either progressed following prior therapies or who have no acceptable standard therapy. Entrectinib is the only TRK inhibitor to have been granted PRIME designation, which is analogous to the Breakthrough Therapy Designation from the U.S. FDA that entrectinib received earlier in 2017.
Development and Clinical Data Updates Towards Dual TRK and ROS1 NDA Submissions
In September 2017, we announced completion of enrollment of the efficacy data sets for both the TRK tissue-agnostic (i.e., fusion-positive solid tumor) cohort and the ROS1 NSCLC cohort to support dual NDA submissions in 2018.
In October 2017, at the WCLC, we announced updated interim results from our clinical trials, including the STARTRK-2 trial, of entrectinib. In this interim analysis (based upon an enrollment cut-off of December 31, 2016 and data cut-off of September 13, 2017):
Entrectinib demonstrated a 78% confirmed objective response rate (ORR; by Investigator; 95% CI: 60.0, 90.7) and a 69% confirmed ORR (by Blinded Independent Central Review, or BICR; 95% CI: 50.0, 83.9) in 32 patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) that harbored ROS1 fusions;
Entrectinib demonstrated compelling durability in these patients, with a median duration of response (mDOR) of 28.6 months (by BICR; 95% CI: 6.8, 34.8; median follow-up of 12.9 months) and a median progression-free survival (mPFS) of 29.6 months (by BICR; 95% CI: 7.7, 36.6; median follow-up of 8.5 months); and
Of the patients evaluated, 11 had CNS metastases at baseline as assessed by investigator, and 83% (5 out of 6; by BICR) of the patients with BICR-confirmed measurable CNS metastases at presentation had confirmed intracranial RECIST responses to treatment with entrectinib.
Entrectinib remained well tolerated, with more than 200 patients treated at the recommended Phase 2 dose, with mostly Grade 1-2 reversible treatment-related adverse events. The program is tracking towards dual NDA submissions in TRK and ROS1 in 2018, if supported by clinical data, with an anticipated U.S. commercial launch in both indications in 2019.
RXDX-105
In September 2017, at the ESMO (Free ESMO Whitepaper) conference, we announced new Phase 1b clinical data on RXDX-105—an investigational, VEGFR-sparing, potent RET inhibitor—in which a preliminary ORR of 75 percent was observed in patients with non-KIF5B-RET fusions, with six of eight patients achieving a confirmed partial response. In contrast, those with KIF5B-RET fusions (14 patients) did not demonstrate RECIST responses. RXDX-105 continued to be well tolerated, with the most common treatment-related adverse events being Grade 1 or 2 and reversible with dose modifications. The most common Grade 3 treatment-related adverse events (> 5%) were rash (10%), hypophosphatemia (7%) and elevated ALT (7%).
RXDX-106
In October 2017, at the AACR (Free AACR Whitepaper) Tumor Immunology and Immunotherapy meeting, we presented new data highlighting the immuno-oncological efficacy of RXDX-106—a novel immunomodulatory agent with potent anti-tumor activity, alone and in combination with checkpoint inhibitors, that in preclinical models has demonstrated immunomodulatory effects in the tumor microenvironment (TME) through TYRO3, AXL, and MER (TAM) receptor tyrosine kinase (RTK) inhibition. The data presented demonstrated immune-mediated, single-agent anti-tumor activity of RXDX-106 in multiple tumor models. The anti-tumor effect was further enhanced by combination therapy with immune checkpoint inhibitors, potentially by reversing immunosuppression of innate immunity in the TME. The data also suggested that RXDX-106 has a novel mechanism of enhancing overall immune function by activating both innate and adaptive immunity, as observed by treatment-mediated changes in relevant cytokine levels and immune cell biomarkers, and regulating cross-talk between immune and cancer cells. These promising early findings support further development of RXDX-106 to potentially treat a wide variety of cancers.
Financing Transaction
In October 2017, the company raised aggregate gross proceeds of $160.0 million after issuing 10.0 million shares of its common stock in an underwritten public offering at a price to the public of $16.00 per share.
Third Quarter 2017 Financial Results
For the third quarter of 2017, net loss was $28.6 million, or $0.51 per share, compared with $23.3 million, or $0.56 per share, for the third quarter of 2016.
Ignyta did not record any revenue for the third quarter of 2017 or for the third quarter of 2016.
Research and development expenses for the third quarter of 2017 were $21.7 million, compared with $16.6 million for the third quarter of 2016. This increase was due to an increase in external clinical development costs and the chemistry, manufacturing and control costs associated with entrectinib and our other product candidates, and increased facilities costs of $1.1 million due to the expansion of our leased facilities space.
General and administrative expenses for the third quarter of 2017 were $6.5 million, compared with $6.1 million for the third quarter of 2016. This increase was due to an increase in our facilities costs, as described above, and an increase in outside services expenses, due to an increase in pre-launch commercial activities, which was partially offset by a reduction in depreciation expense.
At September 30, 2017, we had cash, cash equivalents and available-for-sale securities totaling $144.8 million—which does not include the $150 million of net proceeds from the October financing—and current and long-term debt of $32.0 million. At December 31, 2016, we had cash, cash equivalents and available-for-sale securities totaling $133.0 million and current and long-term debt of $32.0 million.