Singapore-based CellVec will manufacture clinical-grade lentivirus – the first critical step in making LGR5 CAR-T cells for a first-in-human clinical trial for patients with advanced colorectal (bowel) cancer in late 2022.
Lentiviruses are widely used as a tool to deliver genes of interest to cells. In this case, the lentivirus transduces (or inserts) a group of genes to a patient’s T cells (immune cells), which turn the T cells into cancer-killing CAR-T cells targeting LGR5, a cancer stem cell marker found on colorectal cancer and other cancers.
Professor Simon Barry, Carina’s Vice President of Cell Therapy Manufacturing, said: “We are delighted to be working with CellVec because of their outstanding track record and expertise. Their flexibility and willingness to incorporate Carina’s proprietary manufacturing process was an important consideration in the selection of CellVec as our service provider.”
“The partnership with Carina Biotech marks a significant milestone for us to facilitate the furtherance of gene therapies. We look forward to supporting Carina in the successful development of its LGR5 CAR-T cells,” said Dr Ang Peng Tiam, Chairman of CellVec and Medical Director of Parkway Cancer Centre.
Carina’s LGR5 CAR-T cells are targeted at LGR5, a cancer stem cell marker that is highly expressed on colorectal cancer (and other cancers). Colorectal (bowel) cancer is the deadliest cancer for Australians aged 25-34 and Australia’s second deadliest cancer overall.
Young-onset colorectal cancer is often diagnosed at later stages, which have a much poorer prognosis.
Carina Biotech CEO, Dr Deborah Rathjen, said:
“We are continuing to see impressive results with our LGR5 CAR-T cell in pre-clinical testing. After our recent successful capital raise and welcoming new impact investors to our company, we are on track for a pre-IND submission in Q2 of 2022 and an IND submission to the FDA in the second half of 2022. These are important milestones towards the initiation of a Phase I/II clinical trial in patients with advanced colorectal cancer.”
LGR5 is a cancer stem cell marker that is highly expressed on advanced colorectal cancer and some other cancers. In colorectal cancer patients, LGR5+ expression has been correlated with a particularly poor prognosis.
Cancer stem cells are a small sub-population of cells within a tumour with the ability to self-renew, differentiate into the many cell types of a tumour, initiate new tumours, and resist chemotherapy and radiotherapy (leading to relapses).
By targeting cancer stem cells, it is hoped that this therapy will reduce the tumour’s ability to generate new cancer cells, resulting in durable tumour suppression and preventing the relapses that are very common in patients with colorectal cancer.
Carina’s pre-clinical studies of the LGR5-targeted CAR-T cell have shown highly promising results with complete tumour regression and no tumour recurrence. They have also demonstrated impressive tumour access and prolonged CAR-T cell survival.
There are five approved CAR-T therapies available in the US today – all for blood cancers. One of these has been approved for use in Australia (Kymriah for the treatment of relapsed/refractory B cell acute lymphoblastic leukemia and large B cell lymphoma).
All five CAR-T therapies are generating transformational outcomes for patients with blood cancers that have failed multiple prior lines of therapy.
CellVec is the first CDMO in Southeast Asia GMP-certified for the production of viral vectors for gene therapy as an active pharmaceutical ingredient. Its manufacturing facility is built to comply with PIC/S, US FDA and EU GMP specifications for viral vectors, upholding quality standards of viral vector production. Specialising in lentiviral vectors, CellVec is a specialist provider of custom viral vectors for pre-clinical and clinical applications. In its commitment towards innovating for patient benefit, CellVec also offers end-to-end project management support to see therapeutics ideas from bench to bedside. For more information, visit www.cellvec.com
Image credit: from CellVec website