DCC-3084 / Ono Pharma - LARVOL DELTA

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

DCC-3084-01-001: Study of DCC-3084 in Participants With Advanced Malignancies Driven by the Mitogen-Activated Protein Kinase (MAPK) Pathway (clinicaltrials.gov) - P1/2 | N=140 | Recruiting | Sponsor: Deciphera Pharmaceuticals LLC | Not yet recruiting ➔ Recruiting

Combination therapy • Enrollment open • Metastases • Monotherapy • Gastrointestinal Cancer • Hepatology • Lung Cancer • Melanoma • Non Small Cell Lung Cancer • Oncology • Pancreatic Cancer • Solid Tumor

DCC-3084, a brain penetrant RAF dimer inhibitor, broadly inhibits BRAF class I, II, and III alterations leading to growth inhibition of intracranially implanted tumors in preclinical models (AACR 2024) - "The switch-control inhibitor DCC-3084 broadly inhibits Class I, II and III BRAF mutations, BRAF fusions, and BRAF/CRAF heterodimers leading to tumor regression in preclinical models. DCC-3084 CNS penetration enables potential for further research in brain metastases or primary brain cancer."

Preclinical • Brain Cancer • Oncology • Solid Tumor • BRAF

Study of DCC-3084 in Participants With Advanced Malignancies Driven by the Mitogen-Activated Protein Kinase (MAPK) Pathway (clinicaltrials.gov) - P1/2 | N=140 | Not yet recruiting | Sponsor: Deciphera Pharmaceuticals LLC

New P1/2 trial • Gastrointestinal Cancer • Hepatology • Lung Cancer • Melanoma • Non Small Cell Lung Cancer • Oncology • Pancreatic Cancer • Solid 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

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 (AACR 2023) - "The Switch Control inhibitor DCC-3084 broadly inhibits Class I, II and III BRAF mutations, BRAF fusions, and BRAF/CRAF heterodimers leading to tumor regression in preclinical models. The overall preclinical profile of DCC-3084 supports IND-enabling activities towards clinical development in a key area of unmet medical need in RAS and RAF mutant cancers."

Preclinical • Oncology • Solid Tumor • BRAF • KRAS

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

Deciphera Pharmaceuticals Announces Planned 2023 Corporate Milestones to Support Continued Evolution to Multi-Product Company (Businesswire) - "Business updates and planned 2023 corporate milestones include: DCC-3084: (i) Submit an investigational new drug (IND) application with the FDA for DCC-3084, a potential best-in-class pan-RAF inhibitor, in the second half of 2023; (ii) Present in vitro and in vivo data demonstrating a preclinical profile as a potent and selective inhibitor of BRAF/CRAF kinases, with optimized pharmaceutical properties for development in both single-agent and combination opportunities, in the first half of 2023."

IND • Preclinical • Oncology