DCC-3009 / Ono Pharma - LARVOL DELTA

AN OPEN-LABEL PHASE 1/2 STUDY OF DCC-3009 MONOTHERAPY IN PATIENTS (PTS) WITH ADVANCED GASTROINTESTINAL STROMAL TUMOR (GIST) (CTOS 2025) - P1/2 | "For inclusion in the monotherapy dose escalation, adult pts must have histologically or cytologically confirmed advanced GIST with documented KIT or PDGFRA mutation, progression on or intolerance to ≥1 approved TKI regimen in the advanced setting (imatinib if KIT-mutant), ≥1 measurable lesion per modified Response Evaluation Criteria in Solid Tumors version 1.1 (mRECIST v1.1), and an Eastern Cooperative Oncology Group performance status of 0 or 1 at screening. N/A"

Clinical • Metastases • Monotherapy • P1/2 data • Stroma • Gastrointestinal Cancer • Gastrointestinal Stromal Tumor • Oncology • Sarcoma • Solid Tumor • DCC • KIT • PDGFRA

Deciphera Announces Multiple Data Presentations at the Connective Tissue Oncology Society (CTOS) Annual Meeting 2025 (Businesswire) - "Multiple presentations on vimseltinib for the treatment of Tenosynovial Giant Cell Tumor (TGCT), including encore data from the Phase 3 MOTION study presented in an oral session; Two posters on DCC-3009 in Gastrointestinal Stromal Tumor (GIST)."

Clinical data • Gastrointestinal Stromal Tumor • Tenosynovial Giant Cell Tumor

An open-label phase 1/2 study of DCC-3009 monotherapy in patients with advanced gastrointestinal stromal tumor. (ASCO 2025) - P1/2 | "For inclusion in the DCC-3009 monotherapy dose escalation, adult patients (≥18 years) must have histologically or cytologically confirmed advanced GIST with documented KIT or PDGFRA mutation and progression on or intolerance to at least 1 approved TKI regimen in the advanced setting (imatinib if KIT-mutant)...The primary outcome measures for monotherapy dose escalation include safety assessment. Secondary outcome measures include objective response rate, duration of response, and progression-free survival by mRECIST v1.1, as well as overall survival and pharmacokinetics."

Clinical • Metastases • Monotherapy • P1/2 data • Stroma • Gastrointestinal Cancer • Gastrointestinal Disorder • Gastrointestinal Stromal Tumor • Immunology • Oncology • Sarcoma • DCC • KIT • PDGFRA

A Master Protocol to Evaluate DCC-3009 in Gastrointestinal Stromal Tumor (GIST) (clinicaltrials.gov) - P1/2 | N=120 | Recruiting | Sponsor: Deciphera Pharmaceuticals, LLC | Not yet recruiting ➔ Recruiting

Enrollment open • Gastrointestinal Cancer • Gastrointestinal Disorder • Gastrointestinal Stromal Tumor • Oncology • Sarcoma

A Master Protocol to Evaluate DCC-3009 in Gastrointestinal Stromal Tumor (GIST) (clinicaltrials.gov) - P1/2 | N=120 | Not yet recruiting | Sponsor: Deciphera Pharmaceuticals, LLC

New P1/2 trial • Stroma • Gastrointestinal Cancer • Gastrointestinal Disorder • Gastrointestinal Stromal Tumor • Oncology • Sarcoma

Ono Announces Results of Tender Offer to Acquire Deciphera Pharmaceuticals and Completion of Acquisition of Deciphera (a Wholly Owned Subsidiary of Ono) (PRNewswire) - "Ono Pharmaceutical...today announced that it has successfully completed the tender offer, previously announced on April 30, 2024 to acquire all outstanding shares of common stock of a US biopharmaceutical company, Deciphera Pharmaceuticals, Inc...for US$25.60 per share (total amount of approximately US$2.4 billion) net to the seller in cash, without interest thereon and less any applicable withholding taxes, through its wholly owned subsidiary, Topaz Merger Sub, Inc...established in the State of Delaware, United States, solely for the purpose of engaging in the transactions contemplated in the Merger Agreement....'Through this acquisition, we will leverage Deciphera's excellent research and development capabilities in the oncology field and its sales power in Europe and the United States, and work to further accelerate the expansion of our pipeline and global expansion, which are part of our growth strategies.'"

M&A • Gastrointestinal Stromal Tumor • Graft versus Host Disease • Hematological Malignancies • Oncology • Sarcoma • Soft Tissue Sarcoma • Solid Tumor • Tenosynovial Giant Cell Tumor

Deciphera Pharmaceuticals Announces Planned 2024 Corporate Milestones Supporting Evolution to a Self-Sustaining, Multi-Product Company (Businesswire) - "DCC-3084: Initiate a Phase 1 study for DCC-3084, a potential best-in-class pan-RAF inhibitor, in the first half of 2024; DCC-3009: Submit an investigational new drug (IND) application with the FDA for DCC-3009...in the first half of 2024 and initiate a Phase 1 study in the second half of 2024."

IND • New P1 trial • Oncology • Solid Tumor

Deciphera Pharmaceuticals Announces Third Quarter 2023 Financial Results (Businesswire) - "DCC-3084: Expects to submit an Investigational New Drug (IND) application to the FDA for its pan-RAF inhibitor, DCC-3084, by year end 2023. DCC-3009: Expects to submit an IND application to the FDA for its pan-KIT inhibitor, DCC-3009, in the first half of 2024....Total revenue for the third quarter of 2023 was $43.3 million, which includes $41.8 million of net product revenue of QINLOCK and $1.5 million of collaboration revenue compared to $36.0 million of total revenue, including $32.3 million of net product revenue of QINLOCK and $3.7 million of collaboration revenue, for the same period in 2022....Research and development expenses for the third quarter of 2023 were $62.5 million, compared to $47.5 million for the same period in 2022. The increase was primarily due to an increase in clinical study costs for QINLOCK and clinical study costs related to the Phase 1/2 study of DCC-3116."

Commercial • IND • Sales • Gastrointestinal Cancer • Gastrointestinal Stromal Tumor • Oncology • Sarcoma • Soft Tissue Sarcoma • Solid Tumor

Deciphera Pharmaceuticals Announces Second Quarter 2023 Financial Results (Businesswire) - "Expects to announce top-line results from the MOTION pivotal Phase 3 study of vimseltinib, an investigational, orally administered, potent, and highly selective switch-control kinase inhibitor of CSF1R for the potential treatment of tenosynovial giant cell tumor (TGCT) in the fourth quarter of 2023. Expects to present updated data from the Phase 1/2 study of vimseltinib in the fourth quarter of 2023....Expects to submit an investigational new drug (IND) application to the U.S. Food and Drug Administration (FDA) for DCC-3084 in the fourth quarter of 2023....Expects to submit an IND to the FDA for DCC-3009 in the first half of 2024.... Research and development expenses for the second quarter of 2023 were $58.3 million, compared to $44.9 million for the same period in 2022. The increase was primarily due to an increase in clinical study costs related to the Phase 1/2 study of DCC-3116, the MOTION Phase 3 study and Phase 1 /2 study of vimseltinib, and clinical study costs for QINLOCK."

Commercial • IND • P1/2 data • P3 data: top line • Oncology • Solid Tumor

Deciphera Pharmaceuticals Announces First Quarter 2023 Financial Results (Businesswire) - "Expects to initiate new combination escalation studies evaluating DCC-3116 in combination with ripretinib in patients with GIST and in combination with encorafenib and cetuximab in patients with CRC in the second half of 2023....Expects to initiate one or more expansion cohorts in the ongoing Phase 1/2 study of DCC-3116 in the second half of 2023 in combination with the MEK inhibitors trametinib or binimetinib, or the KRAS G12C inhibitor sotorasib....Expects to submit an investigational new drug (IND) application to the FDA for DCC-3084 in the second half of 2023....Expects to submit an IND to the FDA for DCC-3009 in the first half of 2024."

IND • New trial • Trial status • Colorectal Cancer • Gastrointestinal Cancer • Gastrointestinal Stromal Tumor • Lung Cancer • Melanoma • Non Small Cell Lung Cancer • Oncology • Pancreatic Cancer • Pancreatic Ductal Adenocarcinoma • Skin Cancer • Solid Tumor

Pan-exon mutant KIT inhibitor DCC-3009 demonstrates tumor regressions in preclinical gastrointestinal stromal tumor models (AACR 2023) - "Heterogeneous drug-resistant secondary mutations arise in patients treated with FDA approved KIT inhibitors, including imatinib and sunitinib...Ripretinib has been FDA approved as a 4th line treatment for GIST and has broad activity against KIT mutations, including clinical potency in patients with mutations in KIT exons 11, 17, or 18...The pan-mutant KIT profile of DCC-3009 was shown in vitro to be superior to 2nd and 3rd line standard of care therapies sunitinib and regorafenib... DCC-3009 is a pan-exon mutant KIT inhibitor exhibiting high potency in KIT mutants in pre-clinical models spanning exons 9, 11, 13, 14, 17 and 18. In vivo, DCC-3009 exhibited efficacy in drug-resistant models with KIT exon 9/13, 11/13 or 11/17 mutations. Based on this profile, DCC-3009 has entered formal preclinical development."

Preclinical • Stroma • Gastrointestinal Cancer • Gastrointestinal Stromal Tumor • Oncology • Sarcoma

Deciphera Pharmaceuticals Announces Eight Presentations Highlighting Discovery Research Programs at the American Association for Cancer Research (AACR) Annual Meeting 2023 (Businesswire) - "...'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'....'We are excited to share initial preclinical data on two new programs, GCN2 and PERK, two novel targets focused on the integrated stress response'...New pan-kit development candidate DCC-3009 for GIST demonstrates potential best-in-class profile with broad coverage of KIT mutations with high selectivity."

New trial • Preclinical • Colorectal Cancer • Gastrointestinal Cancer • Gastrointestinal Stromal Tumor • Oncology • Sarcoma • Soft Tissue Sarcoma • Solid Tumor