TCR² Therapeutics has established manufacturing capacity in the US, as it looks to Phase II trials for its solid tumor candidate TC-210.

ElevateBio will provide manufacturing and technical expertise for TC-210, a cell therapy that is currently in Phase I/II trials and being prepared to enter Phase II.

The production will take place at ElevateBio’s BaseCamp, a 140,000-square-foot cell and gene therapy manufacturing facility based in Waltham, US.

Image: iStock/cbies

ElevateBio secured the funding for the site and its operations last year, with the organization offering a centralized model that provides R&D and manufacturing capabilities to partnered companies.

Earlier this year, the organization closed a further $170 million (€143 million) in a Series B financing to complete the build-out of BaseCamp.

A spokesperson for TCR² told Bioprocess Insider that the partnership was attractive as an ‘interim step’ for its build out in the US, while the company looks to establish a commercial scale manufacturing facility in the country.

TCR² is headquartered in Cambridge, Massachusetts, but possesses a current good manufacturing practice (cGMP) facility in Stevenage, UK, that provides enough manufacturing capacity for Phase I and II trials, after establishing a partnership with the UK’s Cell and Gene Therapy Catapult.

In terms of what attracted TCR² to partner with ElevateBio, the spokesperson mentioned an existing link between the two organizations in the form of Mitchell Finer, who is the co-founder and CSO of ElevateBio.

“Finer, a consultant to TCR² and former TCR² board member who helped develop our manufacturing process, has valuable insights into cell manufacturing and developed bluebird bio’s manufacturing from the ground up as their former chief scientific officer,” the spokesperson explained.

The potential therapy at the heart of the agreement is TC-210, which is currently in the dose escalation portion of a Phase I/II clinical trial, targeting mesothelin-expressing solid tumours.

TCR² is expecting an interim update on the trial in the fourth quarter of 2020, while the company’s next step is to determine the Phase II dosage before shifting into an expansion portion of the clinical trial, the spokesperson said.

The next stage of trials will feature four cohorts, specifically, non-small cell lung cancer (NSCLC), ovarian cancer, mesothelioma and cholangiocarcinoma. In addition, there will be a further NSCLC cohort where TC-210 will be studied alongside an anti-PD-1 antibody.