Synta Pharmaceuticals

Synta earns $25M milestone from GSK pact

John Carroll — Tue, 14 Oct 2008 11:32:18 -0400

Synta Pharmaceuticals has earned a $25 million pay out from GlaxoSmithKline. And it stands to earn another two $25 million checks as Glaxo advances the cancer drug elesclomol, which is in a late-stage study as a treatment for skin cancer. The therapy triggers apoptosis, or programmed cell death.

When Lexington, MA-based Synta signed up on its development pact with Glaxo a year ago, it outlined a set of milestones worth up to $585 million and gained $80 million up front. The deal calls for $145 million in milestones for melanoma and $440 million for other cancer indications. Synta was a 2007 Fierce 15 company.

- check out Synta's release
- read the AP report

Melanoma therapy produces positive mid-stage data

Tue, 20 May 2008 06:59:54 -0400

Researchers for GlaxoSmithKline and Synta Pharmaceuticals say a mid-stage study of elesclomol produced "statistically significant" data on progression-free survival of patients with metastatic melanoma.

"These data, combined with earlier clinical and pre-clinical data we have presented for elesclomol, support our belief that oxidative stress induction is a promising new approach to cancer therapy in melanoma and, potentially, other cancer types," said Eric Jacobson, M.D., Synta's CMO.

- here's the press release
- read the AFX report

Synta outlines cash flow from Glaxo pact

Tue, 13 Nov 2007 06:59:56 -0500

Synta Pharmaceuticals' new, $1 billion pact with GlaxoSmithKline for the cancer drug elesclomol (code named STA-4783) is expected to open a spigot of cash for the drug developer. In its quarterly report, Synta says that Glaxo is expected to hand over milestone payments of $40 million to $50 million next year as the therapy advances in clinical trials. That's on top of the $80 million upfront provided by Glaxo.

"At the start of this year, we set an ambitious agenda for Synta in 2007: complete an initial public offering; initiate a global, pivotal trial for elesclomol; sign a major partnership agreement; initiate a Phase 1 trial for our Hsp90 inhibitor, STA-9090; and continue to build support for our oncology programs in the scientific community, including presenting survival data from our Phase 2b trial for elesclomol as well as mechanism of action and combination activity results," said Safi Bahcall, Ph.D., CEO of the Lexington, MA-based Synta. "I am pleased to say that we have successfully achieved each of these goals."

- check out the release for more info

Related Articles:
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Synta therapy slows spread of melanoma. Report
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Synta trial hits endpoint. Report
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Synta scores $1.1B deal with GSK

Wed, 10 Oct 2007 06:59:58 -0400

Synta Pharmaceuticals broke the billion-dollar mark in its new licensing deal with GlaxoSmithKline. Glaxo has agreed to pay Synta $80 million up front and up to $1.1 billion in total for the deal covering STA-4783, which has demonstrated efficacy in improving median survival rates for melanoma patients in a mid-stage study. In Phase II volunteers taking the therapy in combination with chemotherapy had a median survival rate of 12 months compared to 5.6 months for patients receiving chemotherapy alone. Progression free survival at six months jumped from 15 percent to 35 percent. The therapy is about to be tested in a late-stage trial.

Synta, which we recognized as a Fierce 15 company in 2004, has been developing therapies that kill cancer cells by raising oxidative stress levels in cancer cells to the point they self destruct. Normal cells are not affected by the treatment. For Glaxo, the deal underscores its willingness to get out the check book in order to beef up its lineup of late-stage cancer therapies. Glaxo committed $135 million for regulatory approval, $450 million for other indications and $300 million for sales targets. Another $45 million could be invested in Synta stock.

- check out the release on the agreement
- here's the report from the Wall Street Journal

Related Articles:
Synta therapy slows spread of melanoma. Report
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GSK stakes claim to ASCO spotlight. Report

Read more on: Synta | GlaxoSmithKline

Synta therapy slows spread of melanoma

Thu, 27 Sep 2007 06:59:58 -0400

Lexington, MA-based Synta Pharmaceuticals caused quite a stir with a recent presentation on an early-stage cancer therapy that slowed the spread of aggressive skin cancer. In the Phase IIb trial, researchers said that cancer patients taking Synta's therapy survived 3.7 months without the appearance of new cancer lesions--compared to 1.8 months for patients taking standard therapy. The therapy adopts a new approach in cancer; killing cancer cells by overloading them with oxygen. Normal cells can adjust to higher oxygen levels. Advanced melanoma is a particularly lethal disease, killing 7 out of 10 patients in the first year. A bigger study involving 600 patients is being planned. Synta was a 2004 Fierce 15 Company.

- see Synta's release on the data

Related Articles:
Synta gets fast track for cancer therapy. Report
Synta trial hits endpoint. Report
Synta Pharmaceuticals Files For $115 IPO. Report

Synta Pharmaceuticals

Maureen Martino — Fri, 20 Jul 2007 14:39:27 -0400

Synta Pharmaceuticals
Based: Lexington, MA
Founded: Spun off in 2002
www.syntapharma.com

Why It's Fierce: In two years Synta has gone from a subsidiary of a Japanese firm to an aggressive, independent up-and-comer with promising drugs in clinical trials and a growing list of top executives. The company has two cancer drugs in development, including multiple Phase II trials of HSP70-Inducer and three candidates for immune disorders. The core scientific team, led by CEO Safi Bahcall, has been operating together for 10 years and new talent is streaming in. Three months ago, Matthew Sherman signed on as chief medical officer coming from Wyeth's research wing. New additions to the company's scientific advisory board have brought in some of the top academic talent from Harvard and King's College.

What to look for: Clinical data to back up its high hopes.

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Synta files $115M IPO

Tue, 21 Nov 2006 19:01:34 -0500

Perhaps buoyed by a string of positive data, 2004 Fierce 15 winner Synta Pharmaceuticals is filing a $115 million IPO despite the risky biotech IPO climate. The Lexington, MA biotech has yet to determine the number of shares to be offered and the price range for the offering. Earlier this month the FDA granted Synta fast-track status for its lead oncology drug candidate, STA-4783. Synta is developing small molecule drugs for a number of indications, including cancer and chronic inflammatory diseases.

- see the company press release

Related Articles:
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Synta trial hits endpoint. Report
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SPOTLIGHT: Synta gets fast track for cancer therapy

Tue, 14 Nov 2006 19:01:33 -0500

The FDA has granted Synta Pharmaceuticals fast-track status for its lead oncology drug candidate, STA-4783. In a recently completed, Phase IIb clinical trial in patients with Stage IV metastatic malignant melanoma, treatment with STA-4783 plus paclitaxel achieved the primary endpoint of increasing progression-free survival. Synta was a 2004 Fierce 15 company. Release

Press Release: Synta Pharmaceuticals gets FDA Fast Track Designation for STA-4783

Maureen Martino — Tue, 14 Nov 2006 11:48:22 -0500

Synta Pharmaceuticals Announces FDA Fast Track Designation for STA-4783 in Metastatic Melanoma

-- Designation Follows Announcement of Positive Phase 2b Clinical Data for Novel Compound --

LEXINGTON, Mass.--(BUSINESS WIRE)--Synta Pharmaceuticals Corp., a biopharmaceutical company focused on discovering, developing, and commercializing small molecule drugs to treat severe medical conditions, announced today that its lead oncology drug candidate, STA-4783, has been granted Fast Track designation by the U.S. Food and Drug Administration (FDA) for the treatment of metastatic melanoma, a serious type of skin cancer. In a recently completed, Phase 2b double-blind, randomized, controlled clinical trial in patients with Stage IV metastatic malignant melanoma, treatment with STA-4783 plus paclitaxel achieved the primary endpoint of increasing progression-free survival.

“We are very pleased to have received Fast Track designation for STA-4783. This is an important milestone for the program that will help the development and regulatory process,” said Safi Bahcall, President and Chief Executive Officer of Synta. “Metastatic melanoma is a disease with very limited treatment options for patients and a high mortality rate. We look forward to a productive collaboration with the FDA as we seek to realize the potential of STA-4783 to benefit these patients.”

The FDA’s Fast Track program is designed to facilitate the development and expedite the review of new drug candidates that are intended to treat serious or life-threatening diseases and that demonstrate the potential to address unmet medical needs. Fast Track designation allows a company to file a New Drug Application (NDA) on a rolling basis as data become available. This permits the FDA to review the filing as it is received, rather than waiting for the entire document prior to commencing the review process. Fast Track designation may facilitate more frequent interactions with the FDA and may lead to a priority review, which could decrease the typical review period. However, Fast Track designation has no impact on the standard of review or on whether the FDA ultimately approves the drug for marketing.

About STA-4783

STA-4783 is an investigational, novel, small molecule drug candidate that induces a stress response in a wide variety of cancer cell types. This stress response results in two changes that may be important to the role of STA-4783 in tumor cell killing in combination with taxanes: a dramatic increase in the production of Hsp70 and other heat shock and stress-related proteins, which can enhance immune-mediated killing of tumor cells, and the alteration of certain signal transduction pathways in tumor cells, which can affect cell proliferation and induce programmed cell death, or apoptosis. In preclinical studies, STA-4783 combined with taxanes has shown activity against a broad range of cancers, including breast, lung, colon, lymphomas, and melanoma. To date, STA-4783 has been administered to a total of approximately 300 patients across multiple studies.

STA-4783 was tested in a Phase 2b double-blind, randomized, controlled clinical trial in patients with Stage IV metastatic melanoma at 21 clinical sites in the United States. A total of 81 patients were enrolled in this trial, which compared the effects of treatment with STA-4783 plus paclitaxel to treatment with paclitaxel alone. The primary endpoint of this trial was progression-free survival, which is the time from randomization until death or objective tumor progression, as defined by the industry standard RECIST criteria (Response Evaluation Criteria in Solid Tumors). In the intent-to-treat analysis, which includes all 81 patients, treatment improved the median progression-free survival from 1.84 months for patients receiving paclitaxel alone to 3.68 months for those receiving paclitaxel plus STA-4783 (p=0.035). In this analysis, the hazard ratio, an estimate of the risk of progression in the combination arm relative to the control arm, was 0.50. In the per-protocol analysis, which includes the 77 patients who were evaluable for efficacy as specified in the protocol, treatment improved progression-free survival from 1.84 months for paclitaxel alone to 4.40 months for paclitaxel plus STA-4783 (p=0.017). The hazard ratio in this analysis was 0.42.

STA-4783 was generally well tolerated in this study; adverse events were typical of those expected for paclitaxel alone. The most common adverse events in the STA-4783 plus paclitaxel group included fatigue, alopecia, constipation, nausea, hypoaesthesia, arthralgia, insomnia, diarrhea, and anemia. Certain adverse events including hypoaesthesia, neutropenia, stomatitis, arthralgia, and fatigue – all expected from paclitaxel treatment alone – occurred with higher incidence in the STA-4783 plus paclitaxel group, which may be partially attributable to the longer duration of paclitaxel treatment in this study group due to longer progression-free survival. The incidences of adverse events (including Grade 3 and above) were generally comparable between the two groups.

About Metastatic Melanoma

Melanoma, the most deadly form of skin cancer, arises from melanocytes, the pigment-producing cells of the skin. According to the American Cancer Society, melanoma accounts for approximately five percent of all skin cancers but causes about 75% of all skin cancer-related deaths. An estimated 60,000 people will be diagnosed and nearly 8,000 people will die from melanoma this year in the U.S. alone. If diagnosed and surgically removed while localized in the outermost skin layer, melanoma is potentially curable; however, for patients with deeper lesions or metastatic disease, the prognosis is poor, with limited available treatments and an expected survival of only six to nine months. The incidence of melanoma has increased more rapidly than any other cancer during the past ten years. The FDA has not approved a novel, small molecule drug for the treatment of metastatic melanoma in over 30 years.

About Synta Pharmaceuticals

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 discovered and developed internally. For more information, please see www.syntapharma.com

SPOTLIGHT: Synta trial hits endpoint

Thu, 14 Sep 2006 20:01:33 -0400

Synta Pharmaceuticals says that a Phase IIb clinical trial of STA-4783 doubled the progression free survival time of volunteers with metastatic melanoma in the study, hitting the study's primary endpoint for statistical significance. Median PFS for patients receiving STA-4783 plus paclitaxel was 112 days versus 56 days for those receiving paclitaxel alone. Report

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