Recent Articles in Cell & Gene Therapy

AbelZeta Pharma, a Maryland-Shanghai CAR-T company, reported positive results from a China Investigator-Initiated Trial of C-CAR031 in patients with heavily pretreated advanced hepatocellular carcinoma (HCC). The study showed early signs of efficacy in the patients and a manageable safety profile. C-CAR031 is an autologous, armored GPC3-targeting CAR-T therapy being developed in China, though it belongs to AstraZeneca and is based on Astra-Zeneca’s novel GPC3-targeting CAR-T platform. It is manufactured by AbelZeta in China, where it being co-developed by AbelZeta and AstraZeneca. More details....

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Shanghai HuidaGene Therapeutics, a company that develops CRISPR-based genomic medicines, partnered its high-fidelity Cas12 CRISPR nuclease (hfCas12Max) with Synthego of Redwood City, CA. HuidaGene granted Synthego non-exclusive manufacturing and commercialization rights for the hfCas12Max nuclease and optimized gRNA for research. Synthego will also have the right to sublicense the nuclease for therapeutic use. Synthego offers novel CRISPR solutions for developing cell and gene therapies. The companies said the partnership reflects the clinical utility of hfCas12Max and complements Synthego's focus on advanced GMP manufacturing. Terms of the agreement were not disclosed. More details....

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Nanjing IASO Bio announced that Science Immunology, a sub-journal of Science, published a single-cell analysis of its anti-BCMA CAR T cell therapy in patients with neuromyelitis optica spectrum disorder (NMOSD). NMOSD is an autoimmune disease that usually occurs in the optic nerve and spinal cord, though it can affect the brain. The disease, which occurs in flare-ups that can cause muscle weakness or blindness, is sometimes misdiagnosed as multiple myeloma. Last year, IASO and its partner, Innovent, were approved in China to launch Equecabtagene Autoleucel, an anti-BCMA CAR T drug, as a fourth-line therapy for multiple myeloma. More details....

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Shanghai Ribobay Pharma has built a cGMP-level oligonucleotide manufacturing center using Cytiva's first FlexFactory platform for oligo manufacturing. Ribobay, a spin-off of General Biol (Anhui), said the facility will be ready to start manufacturing oligo in June, with the ability to produce several hundred kilograms of pharmaceutical oligo per year. Cytiva, headquartered near Boston, is a division of Danaher. Cytiva’s FlexFactory offers one-stop integrated services, from factory design to equipment and technologies that enable cGMP manufacturing. More details....

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Chengdu WestGene Biopharma was approved to start US trials of its Epstein-Barr (EB) virus-related mRNA therapeutic cancer vaccine, the first mRNA candidate approved to start trials for the indication. The EB virus is correlated with more than ten malignancies. WestGene says WGc-043, its lead candidate, offers promising efficacy, low toxicity, broad applicability and efficient scalability at a cost-effective price. WGc-043 has already completed investigator-initiated trials in nasopharyngeal carcinoma and natural killer T-cell lymphoma, showing better safety and efficacy than other publicly available mRNA therapeutic cancer vaccines. More details.....

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