HPK1 therapy (Ryvu Therapeutics)

- Nimbus to receive $4 billion in upfront cash, and up to $2 billion in commercial milestone payments - - NDI-034858 has potential best-in-class pro new therapeutic class of selective allosteric TYK2 inhibitors for immune-mediated diseases - BOSTON--(BUSINESS WIRE)-- Nimbus Therapeutics, LLC (“Nimbus Therapeutics” or “Nimbus”), a clinical-stage company that designs and develops breakthrough medicines through its powerful computational drug discovery engine, today announced that it has signed a definitive agreement under which Takeda (TSE:4502/NYSE:TAK) will acquire Nimbus Lakshmi, Inc., a wholly-owned subsidiary of Nimbus Therapeutics, and its tyrosine kinase 2 (TYK2) inhibitor NDI-034858. NDI-034858 is an oral, selective allosteric TYK2 inhibitor being evaluated for the treatment of multiple autoimmune diseases following successful recent Phase 2b results in psoriasis. “Nimbus’ allosteric TYK2 inhibitor has the potential to be a best-in-class medicine in multiple disease areas, and we are confident that Takeda’s commitment and capabilities will enable NDI-034858 to reach its full value to patients,” said Jeb Keiper, M.S., MBA, Chief Executive Officer of Nimbus. “The proposed acquisition highlights Nimbus’ ability to discover and develop high-value investigational medicines leveraging our computational structure-based drug design and development engine. We will continue to advance other exciting target programs in our R&D pipeline — including our selective HPK1 inhibitor, currently in a Phase 1/2 study in patients with solid tumors — as we have done since our founding in 2009.” Under the terms of the agreement, Takeda will pay Nimbus Therapeutics $4 billion upfront, and sales-based milestone payments up to $2 billion. The transaction is expected to be finalized in the first half of 2023. Closing of the transaction is contingent on completion of review under antitrust laws, including the Hart-Scott-Rodino (HSR) Antitrust Improvements Act of 1976. Nimbus Therapeutics will retain ownership of its other research and development subsidiaries. Takeda will be solely responsible for future development and commercialization of NDI-034858 and other TYK2 inhibitors. J.P. Morgan Securities LLC is acting as exclusive financial advisor to Nimbus Therapeutics and Goodwin Procter LLP is serving as its legal advisor. About NDI-034858 NDI-034858 is an allosteric TYK2 inhibitor discovered and developed by Nimbus Therapeutics that is being evaluated for the treatment of multiple autoimmune diseases. In preclinical studies, NDI-034858 has demonstrated exceptional functional selectivity and wide therapeutic margins. In Phase 1 studies, NDI-034858 showed a good tolerability profile, a dose-dependent trend in exploratory clinical activity and a pharmacokinetic pro for once-daily solid oral dosing. Results from Nimbus’ Phase 2b clinical trial in patients with moderate-to-severe plaque psoriasis demonstrated a significantly greater proportion of patients in the study achieving the primary endpoint of PASI-75 (a 75% improvement in skin lesions as measured by the Psoriasis Area and Severity Index) compared to placebo after twelve weeks of treatment. Data from this trial will be presented at an upcoming medical conference. In addition to psoriasis, NDI-034858 is in an ongoing Phase 2b trial in active psoriatic arthritis (NCT05153148). About Nimbus Therapeutics Nimbus Therapeutics is a clinical-stage, structure-based drug discovery company developing novel small molecule medicines designed to act against well-validated but difficult-to-drug targets implicated in multiple human diseases. Nimbus combines leading-edge computational technologies with a tailored array of machine learning-based predictive modeling approaches. Nimbus’ pipeline includes clinical-stage programs targeting TYK2 and HPK1 (NCT05128487), as well as a diverse portfolio of preclinical programs focused on cancer, inflammatory and autoimmune conditions and metabolic diseases. Nimbus is headquartered in Boston, MA. To learn more about Nimbus, please visit .

NEW YORK, Dec. 9, 2022 /PRNewswire/ -- Treadwell Therapeutics, a clinical-stage biotechnology company developing novel medicines for highly aggressive cancers, today announced that data presented on the ongoing CFI-402257-CL-001 clinical study of the Company's CFI-402257 program in advanced solid tumors, continued to show a tolerable safety profile and demonstrated clinical benefit both as a monotherapy as well in combination with fulvestrant. Data were presented at the 2022 San Antonio Breast Cancer Symposium (SABCS) being held from December 6-10, 2022 at the Henry B. Gonzalez Convention Center in San Antonio, Texas. "CFI-402257 is well-tolerated and showed signs of anti-tumor activity either as a monotherapy or in combination with Fulvestrant, including some patients who were with durable disease control after progression on prior CDK4/6 inhibitor therapy" said Dr. Philippe Bedard, Study investigator and Associate Professor of Medicine at the University of Toronto and Staff Medical Oncologist at the Princess Margaret Cancer Centre, Toronto, Canada. "CFI-402257 continues to demonstrate an encouraging clinical profile, and we look forward to further developing the molecule for the treatment of ER+ breast cancer," added Dr. Michael Tusche, Treadwell co-CEO. 2022 SABCS Poster Presentations and Details: An Update to a Phase I Trial of CFI-402257, an oral TTK Inhibitor, in Patients with Advanced Solid Tumors with HER2-Negative Breast Cancer Expansion Cohorts Poster Number: P6-10-13 Date: December 9th, 7:00 am CT Data presented on CFI-402257, an oral, best-in-class TTK inhibitor, continue to show a tolerable safety profile at the recommended Phase 2 dose of 168 mg once daily with manageable, dose-dependent neutropenia being the primary toxicity. In this heavily pre-treated population (N=86), the overall response rate was 6% for monotherapy patients (4/66) and 10% for ER+/HER2- breast cancer patients treated in combination with fulvestrant (2/20). The clinical benefit rate (CR+PR+SD>6 months) for monotherapy and combination were 12% and 25%, respectively. Patients achieving stable disease or better stayed on treatment for a median of 242 days (range: 112 to 673). Significantly, several ER+ breast cancer patients who previously failed CDK4/6 inhibitors in the combination cohort remained on therapy for a year or more. The most common drug related toxicities of any grade, which occurred in greater than 10% of all patients, included fatigue (48%), nausea (48%), decreased appetite (34%), diarrhea (34%), vomiting (24%), constipation (21%) and headache (21%). About Treadwell Therapeutics Treadwell Therapeutics is a science driven, clinical-stage, multi-modality biotechnology company developing first-in-class and best-in-class medicines to address unmet needs in patients with cancer. The Company's internally developed clinical pipeline includes CFI-400945 (PLK4 inhibitor), CFI-402257 and CFI-402411 (HPK1 inhibitor). The company is also advancing a pre-clinical pipeline of first-in-class antibody and TCR-based cell therapy assets. For more information, please visit . Contact [email protected] SOURCE Treadwell Therapeutics