Cell therapy weekly: Univercells and RoosterBio enter a strategic partnership to advance manufacturing of extracellular vesicles
This week: Univercells and RoosterBio enter strategic partnership to advance manufacturing of extracellular vesicles, FDA grants Nanjing Bioheng Biotech an orphan drug designation to CAR-T cell therapy for gastric cancer and Gamida Cell seeks strategic partners in preparation for its FDA submission of blood cancer treatment omidubicel.
The news highlights:
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- Univercells and RoosterBio enter strategic partnership to advance manufacturing of extracellular vesicles
- FDA grants Nanjing Bioheng Biotech an orphan drug designation to CAR-T cell therapy for gastric cancer
- Gamida Cell seeks strategic partners in preparation for its FDA submission of blood cancer treatment omidubicel
Univercells and RoosterBio enter strategic partnership to advance manufacturing of extracellular vesicles
Univercells (Charleroi, Belgium) and RoosterBio (MD, USA) have recently announced a strategic partnership with plans to streamline the manufacturing of extracellular vesicles using scalable and continuous bioprocessing technologies. The two companies aim to deliver solutions for exosome manufacture by utilizing Univercells’ scale-X hydro fixed-bed bioreactor, which features 2.4m² surface for cell growth, and RoosterBio’s human mesenchymal stem/stromal cells bioprocess and engineering media systems. The goal is to advance the commercialization of these therapies in order to deliver regenerative medicines to patients at faster timelines and lower costs.
“Together, Univercells and RoosterBio will leverage our novel technologies and expertise to accelerate our customers’ journey from preclinical development to commercialization, reducing complexity and costs to make these life-saving therapies accessible for all patients,” commented Tim Kelly, CEO of RoosterBio.
FDA grants Nanjing Bioheng Biotech an orphan drug designation to CAR-T cell therapy for gastric cancer
Nanjing Bioheng Biotech (Nanjing, China) have announced that its CAR-T cell therapy product, CTB001, has been granted orphan drug designation by the FDA. CTB001 is an autologous gene-edited CAR-T cell therapy that targets the claudin18.2 protein on cancer cells, a stomach-specific isoform that is highly expressed in several tumor types. The designation will allow manufacturers to qualify for incentives such as tax credits for qualified clinical trials.
The investigational cell therapy was developed using Bioheng Explored CAR-T platform to enhance CTB001’s antitumor efficacy – and clinical studies have demonstrated its efficacy and safety. “It is a very promising immunotherapy that can accurately, quickly and efficiently bring good benefits to [patients with] claudin18.2-positive cancer,” the company concluded in a statement.
Gamida Cell seeks strategic partners in preparation for its FDA submission of blood cancer treatment omidubicel
Gamida Cell (MA, USA), is seeking strategic partners for commercialization in preparation for its FDA submission for the blood cancer treatment termed omidubicel – an off-the-shelf bone marrow stem cell transplant. Omidubicel has demonstrated efficacy over the standard umbilical cord transplant, as well as a highly statistically significant reduction in time to neutrophil engraftment, which is paramount in bone marrow transplant recovery. The cell therapy company is initiating a rolling submission after the FDA asked for more data on its manufacturing facility before the submission could continue in November 2021.
Prior to submission, Gamida Cell is reducing operating expenses by cutting 10% of its staff – this is anticipated to extend cashflow to mid-2023 to meet the potential launch of omidubicel.
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