November 20, 2017
DCC-2618 shows encouraging clinical signal in a patient with glioblastoma multiforme (GBM)
WALTHAM, Mass., Nov. 20, 2017 (GLOBE NEWSWIRE) -- Deciphera Pharmaceuticals, Inc. (NASDAQ:DCPH) a clinical-stage biopharmaceutical company focused on addressing key mechanisms of tumor drug resistance, today announced the presentation of data from its ongoing Phase 1 clinical trial of DCC-2618, the Company’s pan-KIT and PDGFRα inhibitor, in patients with malignant gliomas. The data were presented as a poster at the 22nd Annual Scientific Meeting and Education Day of the Society for Neuro-Oncology on November 18, 2017 in San Francisco, CA, USA. Out of four evaluable patients diagnosed with glioblastoma multiforme (GBM), one achieved a durable partial response per Response Assessment in Neuro-Oncology (RANO) criteria and sustained 94% tumor reduction after 84 weeks (cycle 23, day 1) on therapy.
“With fewer than 5% of patients surviving five years beyond diagnosis, GBM represents a disease where new treatments are urgently needed,” said Michael D. Taylor, Ph.D., President and Chief Executive Officer of Deciphera Pharmaceuticals. “We are encouraged by the dramatic response observed in one patient with a malignant glioma treated with DCC-2618, and are committed to understanding how other patients suffering with these cancers may benefit from DCC-2618.”
“DCC-2618 continues to demonstrate good tolerability and encouraging clinical activity,” said Oliver Rosen, M.D., Chief Medical Officer of Deciphera Pharmaceuticals. “The exceptional response in this single patient warrants further evaluation of DCC-2618 in patients with KIT and PDGFRα driven gliomas, and we have opened an expansion cohort in the Phase 1 clinical trial to facilitate the evaluation of DCC-2618 in this heterogenous population.”
The poster, titled “DCC-2618, a novel pan-KIT and PDGFRα kinase switch control inhibitor, shows encouraging signal in a patient with glioblastoma (GBM)”, was presented by Professor John de Groot, Department of Neuro-Oncology at The University of Texas MD Anderson Cancer Center. Of the eight patients diagnosed with malignant gliomas treated with DCC-2618, five patients were evaluable, and four of those patients had GBM. The data showed:
- Out of the four evaluable GBM patients, DCC-2618 achieved an encouraging partial response in one patient with triple amplification of PDGFRα, KIT and VEGFR-2 (4q12 amplicon) with a 94% tumor reduction per RANO after 84 weeks (cycle 23, day 1).
- Across the safety population studied (n=70), as of the data cut-off of July 28, 2017, DCC-2618 was generally well-tolerated at all dose levels evaluated and three DLT events were determined to be not clinically significant (two G3 lipase elevations and one G4 CPK elevation). An expansion cohort of the Phase 1 clinical trial is now open to facilitate further evaluation in this patient population.
A copy of the poster presentation will be available on the Science section of the Deciphera website under “Presentations and Publications” at www.deciphera.com.
DCC-2618 is currently in a first-in-human Phase 1 clinical trial. DCC-2618 is a pan-KIT and PDGFRα kinase switch control inhibitor in clinical development for the treatment of KIT and/or PDGFRα-driven cancers, including gastrointestinal stromal tumors, glioblastoma multiforme and systemic mastocytosis.
About Deciphera Pharmaceuticals
Deciphera Pharmaceuticals is a clinical-stage biopharmaceutical company focused on improving the lives of cancer patients by tackling key mechanisms of drug resistance that limit the rate and/or durability of response to existing cancer therapies. Our small molecule drug candidates are directed against an important family of enzymes called kinases, known to be directly involved in the growth and spread of many cancers. We use our deep understanding of kinase biology together with a proprietary chemistry library to purposefully design compounds that maintain kinases in a “switched off” or inactivated conformation. These investigational therapies comprise tumor-targeted agents designed to address therapeutic resistance causing mutations and immuno-targeted agents designed to control the activation of immunokinases that suppress critical immune system regulators, such as macrophages. We have used our platform to develop a diverse pipeline of tumor-targeted and immuno-targeted drug candidates designed to improve outcomes for patients with cancer by improving the quality, rate and/or durability of their responses to treatment.
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Cautionary Note Regarding Forward-Looking Statements
Various statements in this release concerning Deciphera Pharmaceuticals’ future expectations, plans and prospects, including without limitation, Deciphera Pharmaceuticals’ expectations regarding the timing, progress and results of preclinical studies and clinical trials for Deciphera Pharmaceuticals’ product candidates and any future product candidates may constitute forward-looking statements for the purposes of the safe harbor provisions under The Private Securities Litigation Reform Act of 1995 and other federal securities laws and are subject to substantial risks, uncertainties and assumptions. You should not place reliance on these forward-looking statements, which often include words such as “anticipate,” “estimate,” “expect,” “intend,” “may,” “on track,” “plan,” “predict,” “target,” “potential” or similar terms, variations of such terms or the negative of those terms. Although the Company believes that the expectations reflected in the forward-looking statements are reasonable, the Company cannot guarantee such outcomes. Actual results may differ materially from those indicated by these forward-looking statements as a result of various important factors, as well as those risks more fully discussed in the section entitled “Risk Factors” in Deciphera Pharmaceuticals’ most recent quarterly report on Form 10-Q, as well as discussions of potential risks, uncertainties, and other important factors in Deciphera Pharmaceuticals’ subsequent filings with the U.S. Securities and Exchange Commission. All such statements speak only as of the date made, and the Company undertakes no obligation to update or revise publicly any forward-looking statements, whether as a result of new information, future events or otherwise.
Gina Nugent, The Yates Network
Laura Perry or Sam Martin, Argot Partners
Laura@argotpartners.com or Sam@argotpartners.com
Christopher J. Morl, Chief Business Officer
Deciphera Pharmaceuticals, LLC
Source: Deciphera Pharmaceuticals, Inc.