– First Preclinical Data for Pan-RAF Inhibitor DCC-3084 to be Presented; IND Filing Expected in Second Half of 2023 –
– New Preclinical Data Supports ULK inhibitor DCC-3116 in Combination with QINLOCK® in GIST and in Combination with Encorafenib and Cetuximab in Colorectal Cancer; Expects to Initiate Two New Combination Escalation Studies in Second Half of 2023 –
– New Pan-KIT Development Candidate DCC-3009 for GIST Demonstrates Potential Best-in-Class Profile with Broad Coverage of KIT Mutations with High Selectivity –
– Company Discloses New Research Programs Focused on Novel Integrated Stress Response Targets GCN2 and PERK –
– Company to Host Virtual Investor Event on Tuesday, April 18 at 6:30 PM ET –
Deciphera Pharmaceuticals, Inc. (NASDAQ: DCPH), a biopharmaceutical company focused on discovering, developing, and commercializing important new medicines to improve the lives of people with cancer, today announced the presentation of eight posters at the upcoming AACR Annual Meeting 2023, taking place in Orlando, Florida on April 14-19, 2023. The Company will also host a virtual investor event on Tuesday, April 18 at 6:30 PM ET.
“We are excited to share new preclinical data that demonstrate the breadth and depth of our research capabilities based on our proprietary switch-control kinase inhibitor platform and its ability to generate new opportunities for potential first- and best-in-class kinase inhibitors,” said Steve Hoerter, President and Chief Executive Officer of Deciphera. “At the upcoming AACR meeting, we look forward to presenting preclinical data supporting our next Investigational New Drug (IND) candidate, DCC-3084, a potential best-in-class pan-RAF inhibitor that broadly inhibits Class I, II, and III BRAF mutations, BRAF fusions, and BRAF/CRAF heterodimers. In addition, we will present preclinical data on our ULK inhibitor, DCC-3116, in combination with QINLOCK in gastrointestinal stromal tumor (GIST) and in combination with encorafenib and cetuximab in colorectal cancer that strongly support two new dose escalation combination studies that we expect to initiate in the second half of this year.”
Mr. Hoerter continued, “We continue to expand our leadership position in GIST with the addition of our newest development candidate, DCC-3009, a potential best-in-class pan-KIT inhibitor, which preclinically has demonstrated its ability to potently and very selectively inhibit the broad spectrum of known primary and secondary drug-resistant mutations in GIST, spanning KIT exons 9, 11, 13, 14, 17, and 18. Finally, we are excited to share initial preclinical data on two new programs, GCN2 and PERK, two novel targets focused on the integrated stress response, which is a major adaptive stress response pathway in cancer.”
Copies of the abstracts are available on AACR’s website. Presentation details are as follows:
Poster Number: 4872
Title: DCC-3116, a first-in-class selective inhibitor of ULK1/2 kinases and autophagy, in combination with the KIT inhibitor ripretinib induces complete regressions in GIST preclinical models
Presenter: Madhumita Bogdan, Ph.D., Senior Principal Investigator, Biological Sciences, Deciphera Pharmaceuticals
Session Date: Tuesday, April 18
Session Time: 1:30 – 5:00 PM ET
Poster Number: 1377
Title: DCC-3116, a first-in-class selective inhibitor of ULK1/2 kinases and autophagy, synergizes with encorafenib and cetuximab in BRAF V600E mutant colorectal cancer models
Presenter: Madhumita Bogdan, Ph.D., Senior Principal Investigator, Biological Sciences, Deciphera Pharmaceuticals
Session Date: Monday, April 17
Session Time: 9:00 AM – 12:30 PM ET
Poster Number: 4033
Title: Pan-exon mutant KIT inhibitor DCC-3009 demonstrates tumor regressions in preclinical gastrointestinal stromal tumor models
Presenter: Bryan Smith, Ph.D., Vice President, Biological Sciences, Deciphera Pharmaceuticals
Session Date: Tuesday, April 18
Session Time: 9:00 AM – 12:30 PM ET
Poster Number: 4045
Title: DCC-3084, a RAF dimer inhibitor, broadly inhibits BRAF class I, II, III, BRAF fusions, and RAS-driven solid tumors leading to tumor regression in preclinical models
Presenter: Stacie Bulfer, Ph.D., Senior Director, Biological Sciences, Deciphera Pharmaceuticals
Session Date: Tuesday, April 18
Session Time: 9:00 AM – 12:30 PM ET
Poster Number: 4938
Title: DP-9024, an investigational small molecule modulator of the Integrated Stress Response kinase GCN2, synergizes with asparaginase therapy in leukemic tumors
Presenter: Qi Groer, M.S., Scientist, Biological Sciences, Deciphera Pharmaceuticals
Session Date: Tuesday, April 18
Session Time: 1:30 – 5:00 PM ET
Poster Number: 1639
Title: DP-9149, an investigational small molecule modulator of the Integrated Stress Response kinase GCN2, pre-clinically causes solid tumor growth inhibition as a single agent and regression in combination with standard of care agents
Presenter: Gada Al-Ani, Ph.D., Senior Principal Investigator, Biological Sciences, Deciphera Pharmaceuticals
Session Date: Monday, April 17
Session Time: 9:00 AM – 12:30 PM ET
Poster Number: 1640
Title: DP-9024, an investigational small molecule modulator of the Integrated Stress Response kinase PERK, causes B-cell cancer growth inhibition as single agent and in combination with standard-of-care agents
Presenter: Gada Al-Ani, Ph.D., Senior Principal Investigator, Deciphera Pharmaceuticals
Session Date: Monday, April 17
Session Time: 9:00 AM – 12:30 PM ET
Poster Number: 1613
Title: Dimerization-induced activation of the Integrated Stress Response kinase PERK by an investigational small molecule modulator, DP-9024
Presenter: Aaron Rudeen, Ph.D., Senior Scientist, Deciphera Pharmaceuticals
Session Date: Monday, April 17
Session Time: 9:00 AM – 12:30 PM ET
Conference Call and Webcast
Deciphera will host a virtual investor event on Tuesday, April 18 at 6:30 PM ET. The event may be accessed by registering at https://deciphera-2023-aacr-investor-event.open-exchange.net/. A webcast of the event will be available in the “Events and Presentations” page in the “Investors” section of the Company’s website at https://investors.deciphera.com/events-presentations. The archived webcast will be available on the Company’s website within 24 hours after the event and will be available for 30 days following the event.
About Deciphera Pharmaceuticals
Deciphera is a biopharmaceutical company focused on discovering, developing, and commercializing important new medicines to improve the lives of people with cancer. We are leveraging our proprietary switch-control kinase inhibitor platform and deep expertise in kinase biology to develop a broad portfolio of innovative medicines. In addition to advancing multiple product candidates from our platform in clinical studies, QINLOCK® is Deciphera’s switch-control inhibitor for the treatment of fourth-line GIST. QINLOCK is approved in Australia, Canada, China, the European Union, Hong Kong, Israel, Macau, New Zealand, Switzerland, Taiwan, the United Kingdom, and the United States. For more information, visit www.deciphera.com and follow us on LinkedIn and Twitter (@Deciphera).
Cautionary Note Regarding Forward-Looking Statements
This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, as amended, including, without limitation, our expectations and timing regarding the potential for our preclinical and/or clinical stage pipeline assets to be first-in-class and/or best-in-class treatments; plans to file an IND for DCC-3084 in the second half of 2023; plans to initiate two new combination escalation studies with DCC-3116 in the second half of 2023 in GIST and CRC; the potential for DCC-3009 to be a broad-spectrum KIT inhibitor in GIST. The words “may,” “will,” “could,” “would,” “should,” “expect,” “plan,” “anticipate,” “intend,” “believe,” “estimate,” “predict,” “project,” “potential,” “continue,” “seek,” “target” and similar expressions are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words. Any forward-looking statements in this press release are based on management’s current expectations and beliefs and are subject to a number of risks, uncertainties and important factors that may cause actual events or results to differ materially from those expressed or implied by any forward-looking statements contained in this press release, including, without limitation, our ability to successfully demonstrate the efficacy and safety of our drug or drug candidates and in additional indications for our existing drug, the preclinical or clinical results for our drug candidates, which may not support further development of such drug candidates, comments, feedback and actions of regulatory agencies, our ability to commercialize QINLOCK and execute on our marketing plans for any drugs or indications that may be approved in the future, the inherent uncertainty in estimates of patient populations, competition from other products, our ability to obtain and maintain reimbursement for any approved product and the extent to which patient assistance programs are utilized and other risks identified in our Securities and Exchange Commission (SEC) filings, including our Annual Report on Form 10-K for the year ended December 31, 2022, and subsequent filings with the SEC. We caution you not to place undue reliance on any forward-looking statements, which speak only as of the date they are made. We disclaim any obligation to publicly update or revise any such statements to reflect any change in expectations or in events, conditions or circumstances on which any such statements may be based, or that may affect the likelihood that actual results will differ from those set forth in the forward-looking statements.
Deciphera, the Deciphera logo, QINLOCK, and the QINLOCK logo are registered trademarks of Deciphera Pharmaceuticals, LLC.
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Contacts
Investor Relations:
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Argot Partners
Deciphera@argotpartners.com
212-600-1902
Media:
David Rosen
Argot Partners
david.rosen@argotpartners.com
212-600-1902
