The move marked ValiRx’s first full in-licensing of a new asset - the initial indications of which are directly aligned with our therapeutic focuses on cancer and women’s health.

Triple negative breast cancer accounts for around 15% of breast cancers. It is usually more aggressive, harder to treat, and more likely to recur than many other cancers. New research into potential treatments is crucial.

CLX001 is a peptide in a nanoparticle formulation, developed for the treatment of triple negative breast cancer, with potential for expansion into ovarian cancer and other solid tumour cancers. It is designed for precision destruction of cancer cells using a novel mechanism of action which targets the tumour environment without requiring specific cell markers or gene mutations for activity.

But where and how did Cytolytix’s journey begin? And how has ValiRx taken this early stage, highly promising peptide through negotiation and evaluation, to the point where it is now ready for preclinical evaluation? We share Cytolytix’s story so far.

Peptide development

Work first started on the development of CLX001 in 2018, when Professor Martin Ulmschneider, a specialist in membrane protein folding, Professor of Computational Chemistry, and the new Head of Department of Chemistry at King’s College London, together with his PhD student Charles Chen, began investigating short peptides that have the ability to selectively perforate membranes of different cells.

Antimicrobial peptides are part of the innate immune response. Ubiquitous in nature, and found within all living things, they are selective, and only perforate invading bacteria, and not the body’s own cells. Researchers have identified that some of these peptides possess anti-cancer properties, but generally require very high - and therefore unsafe - concentrations. So, Martin’s team moved to focus on designing a new peptide that possesses selectivity towards cancer cells, and developed one from scratch.

CLX001 was a ‘classic discovery’, as Martin explains: “The remarkable thing about the candidate peptide was that every other variation we studied was less effective than CLX001 – so it really was like finding a needle in a haystack.”

Tech transfer

Armed with this new data, Martin reached out to the Intellectual Property (IP) and Licensing team at King's College London and informed them of his findings. The IP and licensing experts at King’s work closely with external partners and its academic innovators to ensure the commercialisation process is appropriate and timely.

The team immediately saw the potential in CLX001, and worked with Martin to file a patent application for the technology, shortly followed by the submission of an academic paper.

Once the patent application was filed, Martin and King’s IP & Licensing team opened discussions with potential licensees for the technology, as he explains: “As it was an early-stage project, I was seeking an organisation that was truly passionate about and convinced by the science behind the tech we’d developed, and ValiRx ticked all the boxes.”

Becoming Cytolytix

The first step was the negotiation of commercial terms, in which it was agreed that ValiRx would become the major shareholder in a newly formed subsidiary company called Cytolytix.

Cytolytix then signed an IP license agreement with King’s College London which would provide the necessary funding to progress the preclinical development of the technology.

Through Cytolytix, ValiRx leads the development of CLX001, with oversight provided by the Cytolytix board, which comprises representatives from ValiRx, King’s College London, and Martin Ulmschneider.

By agreeing heads of terms ahead of CLX001’s evaluation, King’s was able to work with ValiRx on a ‘no loss, further knowledge’ basis. This included the agreement that if the project was deemed unsuitable for any reason, ValiRx would provide King’s College London with the data generated during the evaluation, with no further commitment required from either side.

The project was evaluated to confirm the impact of the peptide drug candidate against triple negative breast cancer. Over nine months, ValiRx investigated the candidate peptide with a battery of in vitro and in vivo tests. In July 2022, it concluded there was good evidence of biological activity and a strong rationale for further development. In addition to triple negative breast cancer, the tests illustrated promising data against ovarian cancer cells, with the novel mechanism of action potentially allowing further expansion into other hard to treat cancer types.

Cytolytix is now moving onto the next step of its preclinical testing and evaluation, with the aim of preparing the drug candidate for early-stage clinical trials.

Accelerating academic innovation

Of his experience of working with ValiRx so far, Martin Ulmschneider says: "Working with ValiRx has been an incredible experience, and highlights the importance of finding great commercial partners that believe in translating new approaches from the laboratory towards clinical application for patient benefit.

“Suzy and the ValiRx team are highly positive, professional, and open to new and innovative ideas. They have drawn on their strong industry network and range of external partners to ensure the science behind CLX001 is sound. I am very excited about the ongoing journey with ValiRx.”

Dr Suzy Dilly, CEO of ValiRx, explains: “This project is the first output of the strategy we launched in 2020 to bring new academic, early-stage projects into our pipeline. It is an excellent example of the innovative science being carried out at UK universities. Expanding our portfolio with CLX001 is an important step towards diversifying our pipeline and ensuring innovative research and development remains the foundation of our company.”

Mark Treharne, Corporate Development Manager at ValiRx, adds: “Collaborating with academics is a key area of focus for ValiRx as the company continues to develop and move forward. Cytolytix is a prime example of how we can successfully work with universities on promising projects at the very earliest of stages. In our view, there is often no better person to work on a project with than the innovator themselves.”

Speaking about his advice to fellow academics seeking to expedite their innovation, Martin says: “The first step is to reach out to the IP and licensing team at your university to explore your options, and identify if the discovery is patentable. When pitching for a licensee for your project, be sure to present the main unique selling points of the science, and why it represents a major improvement on the current standard of care and/or technology. Importantly, find a team you click with, and that is as enthusiastic as you are about the science and its clinical potential.”

To find out more about Cytolytix, click here.

Connected innovation

ValiRx accelerates the development of treatments in cancer and women’s health to improve patient lives. We provide the scientific, financial, and commercial framework to enable the rapid translation of innovative science into clinical development.

With our extensive and proven experience in research and drug development, we select and incubate promising novel drug candidates and guide them through an optimised process of development, from pre-clinical studies to clinic and investor-ready assets.

If you’re an innovator interested in working with ValiRx, we’d love to hear from you. Please get in touch here.