The landmark approvals of CAR-T therapies have been heralded, but emerging supply chain hurdles catalyzed by the complex manufacturing process for the cellular therapies have pushed makers to look for ways to streamline and quicken the process to augment product volumes and shore up adoption. China’s Gracell is looking to capitalize on these technical wobbles, with its crop of new, low cost cell therapies, with the backing of storied investor Temasek.
On Monday, Gracell said it had scored $85 million in Series B funding, led by Temasek and featuring participation from Lilly Asia Ventures, Kington Capital, King Star Capital and Chengdu Miaoji, to shepherd its preclinical CAR-T products into human trials.
The company was established in 2017 by Wei (William) Cao — who previously founded and led Cellular Biomedicine Group $CBMG — and was initially supported by 6 Dimensions in a Series A round soon after the Suzhou-based firm’s formation.
“Immune cell gene therapy is expected to become a pillar of modern medicine, but the industry is still in its infancy. Challenges and opportunities coexist,” Cao said in a statement.
Gracell is itching to alleviate some of these constraints: high production costs, lengthy manufacturing process, a paucity of off-the-shelf products and a short duration of therapeutic effects, with its raft of early-stage CAR-T products. The notion is commendable, but there is a long road ahead.
Cell therapy manufacturing is convoluted. Essentially, the journey begins with the collection of cells from the patient (with their specific genetic background and medical history) and ends with the administration of the therapy to the same patient — but in between there are various processes that must take place before these cells are turned into a therapeutic, unlike a simple off-the-shelf traditional chemical drug.
These manufacturing challenges are the primary reason behind the tepid sales of Novartis’ $NVS CAR-T Kymriah — in the fourth quarter, the drug generated a paltry $28 million. However, the Swiss drugmaker is doing its best to shore up manufacturing, having bought cell and gene therapy manufacturer CellforCure.
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