Announces Initiation of AML-18 Trial
Webcast and Conference Call Today,
“Since joining Synta two months ago, I have been working closely with
the Board and management team to develop a strategy for leveraging the
talent within Synta along with external partnerships to realize the
tremendous value-potential in ganetespib, our HDC platform and other
pipeline assets,” said
Ms. Whitaker concluded: “Our strategy, which we look forward to outlining in the months ahead, will be designed to support our goal of becoming a leading pharmaceutical company focused on the discovery, development and commercialization of medicines that make a difference for patients with few treatment options.”
Third Quarter and Recent Updates
Initiation of AML-18 Trial of Ganetespib in Acute Myeloid
Leukemia (AML) and High Risk Myelodysplastic Syndrome (MDS).
The Company announced that the AML-18 trial, which will
evaluate the combination of ganetespib with standard DA (daunorubin
and Ara-C) in patients with AML and high risk MDS over 60 years old
who can tolerate intensive chemotherapy versus treatment with standard
DA alone, has initiated and is expected to begin enrolling patients in
the ganetespib arm in the fourth quarter of 2014. AML-18 is the second
of three multicenter, randomized trials supported by the
Leukemia & Lymphoma Research Fundand Cancer Research UKthat will evaluate ganetespib in combination with chemotherapy in first-line treatment of patients with AML and high risk MDS. Up to 300 patients are expected to be enrolled in the ganetespib arm. Results from a pilot study conducted in the UKunder the auspices of the Cardiff Experimental Cancer Medicine Centre in 2012 confirmed the feasibility and safety of combining ganetespib with intensive chemotherapy in older patients with AML.
ODAC Pediatric Subcommittee to Review Ganetespib in Pediatric
Sarcoma. Earlier this week, Synta announced that
U.S. Food and Drug Administration( FDA) has invited the Company to participate in a meeting of the Oncologic Drugs Advisory Committee’s (ODAC) Pediatric Subcommittee on December 11, 2014to inform the FDAas to whether there is sufficient interest in the pediatric investigator community to warrant the FDAissuing a Pediatric Written Request to Synta. An additional six months of exclusivity will be granted to ganetespib if the FDAissues a Pediatric Written Request and Synta fulfills its requirements. The Pediatric Subcommittee of ODAC will review the design of SARC 023, an open label Phase 1/2 trial of ganetespib in combination with the mTOR inhibitor sirolimus in patients with refractory sarcomas, including malignant peripheral nerve sheath tumors (MPNSTs), as well as pre-clinical data demonstrating the scientific rationale for studying this combination in a clinical trial. The ongoing SARC 023 study is sponsored by the Sarcoma Alliance for Researchthrough Collaboration (SARC).
Initiation of I-SPY 2 TRIAL of Ganetespib in Breast Cancer. In
October 2014, the Company announced the initiation of the I-SPY 2 TRIAL (Investigation of Serial Studies to Predict Your Therapeutic Response with Imaging And moLecular Analysis 2) arm evaluating ganetespib, the Company’s Hsp90 inhibitor, as a neoadjuvant therapy for patients with breast cancer. I-SPY 2 is a standing Phase 2 randomized, controlled, multicenter trial for women with newly diagnosed, locally advanced breast cancer (Stage 2 or higher) that is designed to test whether adding investigational drugs to standard chemotherapy is better than standard chemotherapy alone in the neoadjuvant setting. The trial is sponsored by QuantumLeap Healthcare Collaborative, a 501(c)(3) non-profit organization dedicated to accelerating healthcare solutions, and shares a unique partnership with the Foundation for the National Institutes of Health Biomarkers Consortium.
Anne Whitaker Named President and Chief Executive Officer. In
September 2014, Anne Whitakerjoined Synta as President, Chief Executive Officer and a member of the Company’s Board of Directors. Ms. Whitaker has more than 20 years of experience in the pharmaceutical industry, principally at GlaxoSmithKline and Sanofi including, most recently, the role of President, North America Pharmaceuticals, at Sanofi.
Third Quarter 2014 Financial Results
There were no revenues recognized in the third quarters of 2014 and 2013.
Research and development expenses were
The Company reported a net loss of
In the third quarter of 2014, the Company raised an aggregate of
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 its current operating levels, the Company expects its cash
resources of approximately
Synta will host a conference call at
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 FDA for second-line treatment of non-small cell lung adenocarcinoma in combination with docetaxel.
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 over 40 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.
Synta Pharmaceuticals Corp. is a biopharmaceutical company focused on discovering, developing, and commercializing small molecule drugs to extend and enhance the lives of patients with severe medical conditions, including cancer and chronic inflammatory diseases. Synta has a unique chemical compound library, an integrated discovery engine, and a diverse pipeline of clinical- and preclinical-stage drug candidates with distinct mechanisms of action and novel chemical structures. All Synta drug candidates were invented by Synta scientists using its compound library and discovery capabilities. For more information, please visit www.syntapharma.com.
Safe Harbor Statement
This media release may contain forward-looking statements about Synta
Pharmaceuticals Corp. Such forward-looking statements can be identified
by the use of forward-looking terminology such as "will", "would",
"should", "expects", "anticipates", "intends", "plans", "believes",
"may", "estimates", "predicts", “continues”, "projects", or similar
expressions intended to identify forward-looking statements. Such
statements, including statements relating to the potential outcomes of
the ODAC Pediatric Subcommittee meeting on
Synta Pharmaceuticals Corp.
Three Months Ended
Nine Months Ended
|Research and development||16,208||17,623||52,552||51,879|
|General and administrative||3,241||4,171||11,505||12,236|
|Total operating expenses||19,449||21,794||64,057||64,115|
|Loss from operations||(19,449||)||(21,794||)||(64,057||)||(64,115||)|
|Interest expense, net||(517||)||(721||)||(1,752||)||(1,915||)|
Basic and diluted net loss per common
Basic and diluted weighted average number
Synta Pharmaceuticals Corp.
|Cash, cash equivalents and marketable securities||$||119,280||$||91,476|
|Other current assets||2,911||765|
|Property, plant and equipment, net||1,134||1,553|
|Other non-current assets||331||1,409|
|Liabilities and Equity|
Total liabilities and
Synta Pharmaceuticals Corp.
Daniel Cole, 781-541-7250
Andrea Rabney, 212-600-1494
Eliza Schleifstein, 917-763-8106