Encouraging Final Results from GALAXY-1 Trial Validate Selection of Chemosensitive Patient Population for Ongoing Phase 3 GALAXY-2 Trial
Ganetespib Included in Six Large, Randomized Clinical Trials
Webcast and Conference Call Today,
“The final results from the GALAXY-1 study in non-small cell lung
adenocarcinoma represent a significant addition to the collection of
encouraging data that our ganetespib development program has generated
in multiple cancer indications and confirms the choice of the
chemo-sensitive patient population for the GALAXY-2 Phase 3 trial,” said
First Quarter and Recent Updates
- Results From Final Analysis of GALAXY-1 Study. Synta announced today final results from the global, randomized, multi-center Phase 2b GALAXY-1 study comparing the combination of ganetespib and docetaxel to docetaxel alone for the second-line treatment of advanced non-small cell adenocarcinoma. The final results from this trial, in particular the encouraging overall survival results and tolerability profile in chemosensitive patients, validate the selection of the chemosensitive population for the pivotal Phase 3 GALAXY-2 trial.
- GALAXY-2 Clinical Trial on Track to Meet Data Readout Timelines. Synta announced today that the Company’s pivotal, Phase 3 GALAXY-2 trial of ganetespib and docetaxel vs. docetaxel alone for the second-line treatment of patients with advanced non-small cell adenocarcinoma remains on track to meet previously guided data readout timelines. With a target enrollment of approximately 850 patients, and based on current projections and statistical assumptions, Synta expects the two interim efficacy analyses of GALAXY-2 to be conducted by the independent Data Monitoring Committee (DMC) in the second half of 2015 and the final analysis to be conducted in the first half of 2016.
ENCHANT-1 Trial Meets Study Objectives; Shifting of Resources to
I-SPY 2 Breast Cancer Trial. In
March 2014, Synta announced interim results from the ENCHANT-1 trial, a single-arm multi-center Phase 2 proof-of-concept study designed to evaluate ganetespib administered as monotherapy for the treatment of metastatic breast cancer, at the European Breast Cancer Conference(EBCC). These results have confirmed early signals of activity of ganetespib in breast cancer patients, as well as positive results reported with other Hsp90 inhibitors in this tumor type. The strength of the scientific rationale and evidence of clinical activity have led to the selection of ganetespib into the I-SPY 2 program. In this randomized Phase 2 trial, safety and efficacy of ganetespib will be evaluated in combination with standard chemotherapy in patients with triple-negative breast cancer, and if positive, results from this trial will provide a robust proof of concept for ganetespib in this indication. In light of the inclusion of ganetespib in the I-SPY2 program, Synta is closing the ENCHANT-1 trial and directing its resources in breast cancer towards the I-SPY 2 trial.
Ganetespib Selected for the AML-LI-1, AML-18 and AML-19 Trials
in AML/MDS. In
January 2014, the Company announced three multicenter, randomized trials, supported by the Leukemia & Lymphoma Research Fundand Cancer Research UK, evaluating ganetespib in combination with chemotherapy in first-line treatment of patients with acute myeloid leukemia (AML) and high risk myelodysplastic syndrome (MDS). The trials are being conducted under the auspices of the UK National Cancer Research Institute Hematological Oncology Study Group, and under the sponsorship of Cardiff University. The AML-LI (Less Intensive)-1 Phase 2/3 trial, which is currently ongoing, evaluates the combination of ganetespib with low dose cytarabine (Ara-C) vs. low dose Ara-C alone in patients who are not eligible for intensive chemotherapy and are traditionally not included in most trials. An interim analysis will be conducted after 50 patients have been enrolled to evaluate whether to proceed with full Phase 3 enrollment. This interim analysis is expected to be conducted in mid-2014. The AML-18 and AML-19 Phase 2/3 studies are expected to begin enrolling patients in the first and second half of 2014, respectively.
Ganetespib Selected for the GANNET53 Trial in Ovarian Cancer. In
January 2014, the Company announced the initiation of GANNET53, a Seventh Framework Programme (FP7) research project funded by the European Commission, which is a pan-European randomized trial designed to evaluate the combination of ganetespib and paclitaxel vs. paclitaxel alone in over 200 patients with metastatic, predominantly p53 mutant, platinum-resistant ovarian cancer. The safety lead-in Phase 1 portion of GANNET53 is expected to begin enrollment in mid-2014.
Presented Preclinical Results for Hsp90 Inhibitor Drug
Conjugates (HDC). In February and March of 2014, Synta
reported on progress with lead compounds from its Hsp90-Inhibitor Drug
Conjugate platform at the IASLC 14th Annual Targeted
Therapies of the Treatment of Lung Cancer Meeting and the 12th
International Congress on Targeted Anticancer Therapies. The new compounds, consisting of an Hsp90-inhibitor conjugated with SN-38 (HDC SN-38) and an Hsp90-inhibitor conjugated with docetaxel (HDC docetaxel), demonstrated proof of principle in multiple preclinical cancer models. Notably, complete or near complete regressions of tumors were observed in models of NSCLC, small-cell lung cancer, breast cancer, pancreatic cancer, colon cancer, and skin cancer, including models that are generally resistant or show limited response to treatment with the unconjugated therapies.
First quarter 2014 financial results
There were no revenues recognized in the first quarters of 2014 and 2013.
Research and development expenses were
The Company reported a net loss of
During March and
This press release shall not constitute an offer to sell or the solicitation of an offer to buy the securities discussed herein, nor shall there be any offer, solicitation, or sale of the securities in any state in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such state.
More detailed financial information and analysis may be found in the
Company's Quarterly Report on Form 10-Q, which was filed with the
Based on our current operating levels the Company expects its cash
resources of approximately
Synta will host a conference call at
A slide set summarizing the GALAXY-1 results announced this morning can be found on the Synta website. These slides will be referred to during the Company’s first quarter 2014 results conference call this morning.
The conference call can be accessed by dialing (877) 407-8035 (U.S.) or
(201) 689-8035 (International). For those unable to join the live call,
a replay will be available from
The live webcast
can be accessed by visiting the Investor
Relations section of the
Ganetespib, an investigational drug candidate, is a selective inhibitor
of heat shock protein 90 (Hsp90), a molecular chaperone which controls
the folding and activation of a number of client proteins that drive
tumor development and progression. Many solid and hematologic tumors are
dependent on Hsp90 client proteins including proteins involved in
“oncogene addiction” (ALK, HER2, mutant BRAF and EGFR, androgen
receptor, estrogen receptor, and JAK2); proteins involved in resistance
to chemotherapy and radiation therapy (ATR, BCL2, BRCA1/2, CDK1/4, CHK1,
survivin, and WEE1); proteins involved in angiogenesis (HIF-1alpha,
VEGFR, PDFGR, and VEGF); and proteins involved in metastasis (MET, RAF,
AKT, MMPs, HIF-1alpha, and IGF-1R). In preclinical models, inhibition of
Hsp90 by ganetespib results in the inactivation, destabilization, and
eventual degradation of these cancer-promoting proteins. Ganetespib is
being evaluated in trials in lung cancer, breast cancer, and other tumor
types. The most common adverse event seen to date has been transient,
mild or moderate diarrhea, which has been manageable with standard
supportive care. Information on these trials can be found at www.clinicaltrials.gov.
Ganetespib has received Fast Track designation from
About Hsp90 inhibitor Drug Conjugates (HDC)
HDCs are small-molecule drugs consisting of an Hsp90 inhibitor (targeting moiety) joined to an anti-cancer agent (payload) via a cleavable chemical linker optimized for controlled release of payload drug inside cancer cells. They exploit the preferential retention of Hsp90 inhibitors in tumors to selectively deliver anti-cancer payloads. HDCs represent a promising new therapeutic class with the potential to enhance the safety and efficacy of a wide range of small molecule anti-cancer drugs.
Synta has established proof of concept for HDC lead candidates in preclinical studies and has developed HDCs using a range of Hsp90 inhibitor moieties, cleavable linkers, and anti-cancer payloads. The latter include cytotoxic chemotherapeutics, kinase inhibitors, hormone therapies, immunomodulators, and epigenetic modifiers, creating the potential for next-generation compounds in each of these categories. Synta has filed worldwide patent applications that include comprehensive claims covering the HDC platform, compositions of matter, methods for identifying therapeutically effective compounds, and methods of use of such compounds against a wide range of diseases and conditions.
Safe Harbor Statement
This media release may contain forward-looking statements about
Synta Pharmaceuticals Corp.
Condensed Consolidated Statements of Operations
(in thousands, except share and per share amounts)
Three Months Ended
|Research and development||17,583||16,380|
|General and administrative||5,324||3,878|
|Total operating expenses||22,907||20,258|
|Loss from operations||(22,907||)||(20,258||)|
|Interest expense, net||(650||)||(470||)|
|Basic and diluted net loss per common share||$||(0.28||)||$||(0.30||)|
|Basic and diluted weighted average number of common shares outstanding||85,438,127||68,991,371|
Synta Pharmaceuticals Corp.
Condensed Consolidated Balance Sheets Data
|Cash, cash equivalents and marketable securities||$||78,787||$||91,476|
|Other current assets||1,605||765|
|Property, plant and equipment, net||1,408||1,553|
|Other non-current assets||384||1,409|
|Liabilities and Equity|
Total liabilities and
Synta Pharmaceuticals Corp.
Steven Bernitz, 781-541-7250
Senior Vice President, Corporate Development
Andrea Rabney, 212-600-1494
Argot Partners, 917-763-8106