New Immuno-Oncology Therapy Against Advanced Solid Tumors to Enter Phase 1 Clinical Studies

New Immuno-Oncology Therapy Against Advanced Solid Tumors to Enter Phase 1 Clinical Studies

An experimental immuno-oncology treatment will move into early phase clinical trials for patients with advanced solid tumors, under a collaboration agreement between Cancer Research UK and Biotecnol.

The therapy, called Tb535H, is a T-cell engager and the first to be developed by Biotecnol. Tb535H binds to 5T4, a protein found at the surface of tumor cells, and recruits the patient’s T-cells to engage and kill the targeted tumor cells.

5T4/WAIF1 is expressed on most solid tumors, including 40-80% of colorectal cancer, over 95% of renal cancer, 85-90% of breast cancer, 70% of ovarian cancer, 98% of mesothelioma, 50-70% of gastric cancer, over 99% of non-small cell lung cancer, over 80% of prostate cancer, and 86-90% of cervical cancer.

Expression of 5T4/WAIF1 on patient tumor cells is a negative prognostic factor in several malignancies and has been associated with the cancer stem cell phenotype. Because this protein is generally absent or has very low levels in normal tissues, it is a promising anti-cancer target.

Tb535H was developed using the Trisoma antibody development platform, which is commonly used to assemble, engineer, and test the company’s various Tribody molecules – a type of antibodies that recruit the patient’s T-cells and directs them to attack tumors. The approach uses patients’ own immune systems to fight cancer, and the company believes it may be more effective than traditional antibody-based therapies.

Initially, a Phase 1, two-center, open-label, dose-escalation trial will evaluate the therapy’s tolerability and safety against the 5T4/WAIF1 tumor protein, which is found on many different solid tumors and is thought to contribute to the spread of cancer cells.

The initial focus of this trial is to evaluate Tb535H’s potential against cancers with high unmet needs, including thoracic cancers, mesothelioma, small-cell lung cancer, and renal cell cancer.

The WAIF1 antigen was discovered by Cancer Research UK scientists at the Manchester Institute. Clinical trials of Tb535H will be partially supported by Cancer Research UK.

“We’re very proud to work with Cancer Research UK on the development of advanced clinical trial approaches in this competitive and highly promising field of immuno-oncology,” Pedro de Noronha Pissarra, chief executive officer of Biotecnol, said in a press release. “The collaboration is important for Biotecnol’s strategy of working with top cancer institutions in the immune-oncology field which will accelerate the development of cutting-edge therapeutic approaches to fight cancer.”

“It’s hugely exciting to be able to accelerate the development of a drug that could change outcomes for patients with many different types of cancer. In particular, we urgently need new ways to improve treatment for lung cancer, which causes more than one in five of all cancer deaths in the UK,” said Nigel Blackburn, from Cancer Research UK.

“Without this collaboration it might have been years before this treatment reached patients so we’re pleased to work with Biotecnol to elevate their novel drug development platform,” he added.