Biopharma Begins Dosing in Study on Cancer Candidate

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https://finance.yahoo.com/news/deciphera-dcph-begins-dosing-study-143202390.html​

Deciphera (DCPH) Begins Dosing in Study on Cancer Candidate​

Zacks Equity Research
Thu, July 1, 2021, 10:32 PM·3 min read

 

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Deciphera Pharmaceuticals, Inc. DCPH announced that it has dosed the first patient in a phase I study which is evaluating its investigational ULK kinase inhibitor, DCC-3116, for the treatment of patients with advanced/metastatic tumors driven by mutations in RAS/RAF genes.

Notably, the open-label, first-in-human study is investigating DCC-3116 as a single agent and also in combination with Mekinist (trametinib), an FDA-approved MEK inhibitor for treating advanced/metastatic tumors with a mutant RAS/RAF gene.

If data from this study is found to be positive, Deciphera plans to begin combination expansion cohorts which will evaluate DCC-3116 + Mekinist in patients with advanced/metastatic pancreatic ductal adenocarcinoma with KRAS or BRAF mutations; non-small cell lung cancer with KRAS, NRAS, or BRAF mutations; colorectal cancer with KRAS, NRAS, or BRAF mutations; and melanoma with NRAS or BRAF mutations.


Shares of Deciphera have plunged 35.8% so far this year against the industry’s increase of 1.2%.

 

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Per the company, nearly one third of all cancers are driven by mutations in RAS/RAF genes. Hence, if successfully developed and upon potential approval, DCC-3116 can serve an area of high unmet medical need in the days ahead.

We remind investors that, Deciphera’s first commercial product, Qinlock (ripretinib), was approved by the FDA in May 2020, for the treatment of adult patients with advanced gastrointestinal stromal tumor (“GIST”) who have received prior treatment with three or more kinase inhibitors, including Novartis’ NVS Gleevec (imatinib).

The company is also working to expand the label of Qinlock for the larger commercial opportunity in second-line GIST.

The phase III INTRIGUE study is evaluating the efficacy and safety of Qinlock compared to Pfizer’s PFE Sutent (sunitinib) in patients with second-line GIST. Top-line data from the same is expected in the fourth quarter of 2021.

 

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About Deciphera Pharmaceuticals Inc​

Deciphera Pharmaceuticals, Inc. is a clinical-stage biopharmaceutical company. The Company is developing drugs to improve the lives of cancer patients. Its drug candidate includes DCC-2618, DCC-3014 and Rebastinib. Its proprietary kinase switch control inhibitor platform, inhibit the activation of kinases. DCC-2618, an orally administered kinase switch control inhibitor, for the treatment of gastrointestinal stromal tumors (GIST), advanced systemic mastocytosis (ASM), gliomas, including glioblastoma multiforme (GBM), and other solid tumors driven by pan-KIT or PDGFR alpha. DCC-3014 is an orally administered, potent and highly selective inhibitor of colony stimulating factor receptor 1 (CSF1R). Rebastinib is an orally administered, potent and selective inhibitor of the TIE2 immunokinase. Rebastinib binds potently into the switch pocket of TIE2, stabilizing the inhibitory switch and displacing the activation switch to block TIE2 signaling.

https://www.reuters.com/companies/DCPH.O

 

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Dosing Studies​

Dosing studies carried out in rodents can use a variety of dosing techniques, including oral dosing, inhalation, percutaneous absorption, intravenous (iv) injection, or iv infusion.

https://www.sciencedirect.com/topic...ogy-and-pharmaceutical-science/dosing-studies

 

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A dose-ranging study is a clinical trial where different doses of an agent (e.g. a drug) are tested against each other to establish which dose works best and/or is least harmful. Dose-ranging is usually a phase I or early phase II clinical trial.

Dose-ranging study - Wikipedia​

https://en.wikipedia.org › wiki › Dose-ranging_study