Advanced therapy CDMO roundup: Deals for WuXi, Resilience, Fujifilm

Resilience will make gene therapies for Opus; WuXi Advanced Therapies will make CAR-Ts for Chimeric; and Fujifilm will make RNA oncology candidates for Chimeron.

First up in our roundup of advanced therapy contract manufacturing deals this week is Opus Genetics, which has struck a deal with (National) Resilience to support its pipeline of adeno-associated viral (AAV) vector-based gene therapies for inherited retinal diseases.

The contract development and manufacturing organization (CDMO) will provide process and analytical development, quality control testing, and GMP manufacturing services for preclinical studies, and future clinical trials in the US.

Ben Yerxa, acting CEO of Opus, said: “Leveraging Resilience’s expertise puts Opus in the best position to efficiently advance our AAV-based gene therapies into the clinic and toward the patients who need them.”

Work will take place at Resilience’s facilities in Waltham, Massachusetts and Research Triangle Park, North Carolina – the latter being a lentiviral vector manufacturing facility acquired from Bluebird Bio last year.

Next up, Chimeric Therapeutics has selected WuXi Advanced Therapies for the manufacture of two of its autologous chimeric antigen receptor (CAR) T-cell therapies for solid tumours: CHM 2101 in late preclinical development for gastrointestinal cancers and CHM 1101, which is a Phase I trial for patients with recurrent or progressive glioblastoma.

“CHM 2101 will leverage WuXi ATU’s end-to-end closed loop CAR T process development, Good Manufacturing Practice (GMP) manufacturing and testing platform, aiming to accelerate development towards its planned first-in-human study,” the firm said in a statement.

“CHM 1101 will leverage WuXi ATU’s scalable manufacturing and analytical testing capacity to enable potential future expansion of the program to multiple additional clinical trial sites and additional solid tumour indications, including metastatic melanoma.”

Finally, RNA vaccine and therapeutic developer Chimeron Bio has selected Fujifilm Diosynth Biotechnologies for the transfer and scale up of its drug substance manufacturing process from its facility in College Station, Texas.

“We selected Fujifilm Diosynth Biotechnologies as our manufacturing partner because of their proven track record in the advanced therapies space,” said Jolly Mazumdar, CEO of Chimeron Bio. “FDB really understands our ChaESAR platform and pipeline potential, making them the best partner to scale up our processes and help bring our ground-breaking approach for the treatment of underserved patients closer to reality.”

Chimeron’s ChaESAR platform is a self-assembling biosynthetic non-lipid nanoparticle (NLNP) comprising a self-amplifying RNA genome encased within a capsid with a surface ligand of choice.