New regulations tighten regulatory oversight of China’s investigator-initiated trials (IITs) but legitimize the pathway that will be open to other modalities beyond cell and gene therapies.

Immuneering Corp. reported a median overall survival of 17.3 months in first-line metastatic pancreatic cancer patients treated with its MEK inhibitor atebimetinib (IMM-1-104) plus modified gemcitabine/nab-paclitaxel in a phase IIa trial. Mizuho analyst Graig Suvannavejh called the results “astounding … easily beating current standard-of-care treatments.”

As generic versions of its blockbuster drug Ofev (nintedanib) start to hit the market, Boehringer Ingelheim GmbH looks to have swerved the patent cliff, with European and Japanese regulators both approving a potential replacement, Jascayd (nerandomilast), this week. At its monthly meeting, the EMA’s Committee for Medicinal Products for Human Use also recommended Novartis AG’s Vijoice (alpelisib) be given conditional approval in the treatment of PIK3CA-related overgrowth spectrum disorders.

The evolution of cancer diagnostics continues with the FDA’s May 20 approval of Guardant Health Inc.’s Guardant360 Liquid cDx. The new blood-based comprehensive genomic test assesses a 100-times wider genomic footprint than the previously approved Guardant360 cDx to deliver comprehensive tumor profiling results, according to the company. It noted that the seven companion diagnostic indications already approved for the older test will transfer to the new one.

The recent multibillion-dollar licensing alliance between Bristol Myers Squibb Co. and Jiangsu Hengrui Pharmaceuticals Co. Ltd is not an outlier, but rather the clearest sign yet that China’s biotech industry has entered a new phase of global influence.

There are real world demonstrations of how autonomous artificial intelligence agents are poised to disrupt biomedical research, according to two papers published May 19 in Nature. Each describes an AI system that assists across the piece, from generating hypotheses to designing experiments, analyzing the data and refining hypotheses in the light of new data.

Create Medicines Inc. closed a $122 million series B financing round to support its pipeline of therapies that use mRNAs delivered via liquid nanoparticles to express chimeric antigen receptors (CARs) in T cells, NK cells and myeloid cells inside the body of patients. The Cambridge, Mass.-based company estimates the capital will last through 2028, providing the opportunity for multiple clinical readouts of its various products.

Showing a significant efficacy signal in a phase II trial, Relay Therapeutics Inc.’s zovegalisib (RLY-2608) achieved a 60% volumetric response in patients with PIK3CA-driven vascular anomalies (VAs). The isoform-selective PI3Ka inhibitor is in late-stage clinical trials with various combinations for P13Ka-mutated, HR+/HER2- advanced breast cancer, with VAs representing a second indication for which Leerink Partners analyst Andrew Berens forecasts $2.8 billion in peak revenues.

Degron Therapeutics Inc. closed a $40 million series A extension round that will see the company advance its molecular glue degraders targeting previously undruggable or insufficiently drugged proteins.

Directed evolution has become a central pillar in gene therapy. This engineering strategy enables the generation of more efficient variants of genetic editors and delivery vectors. Molecular diversification methods are increasingly sophisticated and are now accelerated by machine learning and AI tools, as showcased at the 29th Annual Meeting of the American Society of Gene and Cell Therapy (ASGCT) held in Boston this week.