The company has initiated a novel TLR9 agonist project and announces a plan for a Phase I clinical trial.
Clinical data shows that intratumoral delivery of TLR agonists in combination with immune checkpoint inhibitors can effectively treat solid cancers, reports the company in their press release. And NanoZolid technology is suitable to provide sustained intratumoral release and minimize the need for repeated injections, the company continues. LIDDS has performed pre-clinical studies with promising results using a TLR9 agonist formulated with NanoZolid.
Toll-like receptors (TLR) are a key target for the pharmaceutical industry in the fight against cancer. TLRs are expressed on various immune cells, including dendritic cells, and they initiate the body’s immune response. TLR activation can lead to an immunologically active or inflamed tumor environment which then recruits the cytotoxic T-cells necessary for an anti-tumor response in immunotherapy.
“The NanoZolid technology addresses key issues in developing TLR agonists as repeated intratumoral injections are needed using standard formulations,” says Monica Wallter, CEO LIDDS. “We will be focusing our project on TLR9, one of the most promising targets for increasing response and reversing resistance to immunotherapies. TLR9 agonists have been shown to be most effective when injected directly into a tumor. A preclinical programme is ongoing to broaden the results obtained to date and we are now preparing for a Phase I clinical trial using NanoZolid combined with a TLR9 agonist. The first human study is planned to commence in 2020.”
Significant commercial potential
Preclinical studies have shown that activation of TLR pathways can lead to potent immunological effects that generate anti-tumor immunity and shrink tumors. Most importantly, these effects can act in synergy with immune checkpoint inhibitors.
“There is significant commercial potential in this area of research and drug development and the market for TLR agonists is expected to be worth hundreds of millions of dollars over the coming years,” says Wallter.
The most relevant target cancers for the TLR9 project are head and neck cancer, prostate cancer and lymphomas. These cancers are diagnosed in around 2 million patients each year.