What does Highlight Therapeutics do?
The company is developing a drug that can combine with other immuno-oncology drugs to extend the benefits to patients that have not responded to treatment so far.
Immuno-oncology has revolutionised oncology in recent decades but even the most successful blockbuster drugs are not able to successfully treat every patient.
The chief function of immuno-oncology is to stop tumours evading the defensive cells of the body’s immune system but mut most types of cancerous tumour do not respond to single-therapy treatments of this sort.
Highlight Therapeutics’ lead drug candidate is BO-112. It works by activating a series of processes in tumour cells that stop them from evading detection by the body’s immune system, as well as helping activate the immune cells.
The company is confident that BO-112 can work in conjunction with most other types of cancer treatment, from radiology and chemotherapy to other immune-oncology treatments such as checkpoint inhibitors and adoptive cell therapies.
Is Highlight Therapeutics in clinical trials?
Early studies suggested BO-112 is very potent in making tumour cells visible to the immune system, using double-stranded messenger RNA.
“BO-112 turns ‘cold’ tumours ‘hot’ and so leads to the body’s immune cells attacking the tumour,” explains Highlight Therapeutics chief executive Marisol Quintero.
It is currently being tested in two Phase II clinical trials in collaboration with Merck & Co’s (MSD) Keytruda (pembrolizumab) therapy, a blockbuster checkpoint inhibitor that acts on a protein called PD-1.
BO-112 has been shown to reactivate PDL1 and also enhance the body’s immune system, which enables the checkpoint inhibitor drug to regain its efficacy on tumours that had become resistant.
One trial is in patients with melanoma who received a checkpoint inhibitor as part of their first-line treatment and are progressing. They will be eligible to receive Highlight’s drug in combination with pembrolizumab.
The other trial is in patients with select advanced-stage solid tumors that have metastasised, or spread, from their gut to their liver, with tumour types that are known to be very “cold” and have historically had indicative of a poor response to immunotherapy
What the CEO says
The gastro-intestinal trial typifies Quintero’s overall strategy: “The idea of the liver metastases is something that can be applied outside gastrointestinal tumours, and we intend to do that very soon.”
The initial readouts from these two Phase II trials this will define the strategy for the board, in terms of how to reach regulatory approval, she says.
Highlight is unlisted currently but has raised €45mln and Quintero says the board plans this year to properly assess a listing in London or elsewhere to finance the drug registration and trials.
The company is one of several focused on intratumoral therapy, including several pursuing melanoma, but as Quintero says, the only one that is working at two levels.
“On one side we are working to activating your immune system. But we are also modifying tumours to make them present more efficiently to the immune system and that’s unique from our mechanism of action.”