Anocca AB raised €25 million (US$26.5 million) in venture debt financing from the European Investment Bank to maintain its progress toward the clinic. “We’re quickly moving towards regulatory filings next year,” CEO and co-founder Reagan Jarvis told BioWorld. The company aims to start its first clinical trial in 2024.
As largely expected, Mirati Therapeutics Inc.’s adagrasib gained U.S. FDA accelerated approval ahead of its Dec. 14 PDUFA date, cleared for second-line use in patients with non-small-cell lung cancer (NSCLC) harboring the KRAS G12C mutation, in which it will go up ahead Amgen Inc.’s Lumakras (sotorasib), which has the advantage of a year and a half head start.
Elevatebio LLC and Affini-T Therapeutics Inc. have entered into a partnership to advance Affini-T's engineered T-cell therapies focused on KRAS, an oncogenic driver mutation in solid tumor cancers.
In its first oncology licensing collaboration, Hookipa Pharma Inc. is partnering with Roche Holding AG to develop an arenaviral for treating KRAS-mutated cancers. Roche will pay $25 million up front to Hookipa, which could ultimately bring in about $930 million in milestone-based payments as part of the deal.
Biomea Fusion Inc. has received IND clearance from the FDA to begin a phase I/Ib trial of BMF-219, a selective, covalent menin inhibitor in patients with unresectable, locally advanced, or metastatic non-small-cell lung cancer (NSCLC), colorectal cancer, or pancreatic ductal adenocarcinoma with an activating KRAS mutation.
Nested Therapeutics Inc. emerged from stealth, revealing $125 million in equity funding and plans to bring precision oncology to the next level by probing the genomics and structural biology of key cancer targets more deeply than before, in an ambitious bid to find new driver mutations, new druggable pockets, and new chemistry that will expand the current arsenal of targeted therapies.
Sibylla Biotech Srl raised €23 million (US$22.9 million) in series A funding to progress its two lead programs in targeted protein degradation, to broaden its pipeline, and to enhance its computationally intensive discovery platform. The company is expanding the druggable proteome in a highly original fashion. It applies mathematical techniques originally developed in theoretical physics to simulating the intermediate folding states of target proteins that have no obvious drug-binding pockets. These may well have transient structures that a small molecule can bind. So instead of drugging the native, biologically active molecule, it aims to develop small-molecule drugs that lock them into an intermediate state. They are then eliminated by the usual protein degradation pathways that operate within cells.
Following epigenetic STING (stimulator of interferon genes) derepression, inhibition of the MPS1 kinase strongly reactivated cGAS-STING signaling in mutations in both the oncogene KRAS and the tumor suppressor kinase LKB/STK11. Exploiting these findings could lead to a new therapeutic strategy to target treatment-refractory tumors with mutations in KL tumors, which have mutations in both KRAS and LKB1/STK11.
Data presented Sept. 9 at the European Society of Medical Oncology 2022 Congress showed impressive effects for KRAS inhibitors. But they also illustrated their limitations. Earlier-stage trials and researcher presentations, meanwhile, suggested ways those limitations might be addressed. Results from the Codebreak 200 study, presented in the day’s Presidential Symposium, were typical of the best that targeted therapies have to offer: large effects for brief time periods.
Mirati Therapeutics Inc. posted new data for its highly anticipated KRAS cancer fighter, adagrasib (MRTX-849), showing mixed results compared to its already-marketed competition, Lumakras (sotorasib) from Amgen Inc. The new data came from a cohort of patients with KRAS-G12C non-small-cell lung cancer enrolled in Mirati’s registration-enabling phase II Krystal-1 study. Each had received at least one prior systemic therapy, most with a PD-1/L1 inhibitor following or in combination with chemotherapy.
