ThirtyFiveBio Awarded Innovate UK Biomedical Catalyst Grant to Advance GPR35 Inhibitor Program with Initial Focus on Inflammatory Gastrointestinal Disease Ulcerative Colitis

Second Prestigious BMC Grant in Under a Year will Enable Creation and Validation of Biomarker-Driven Process for Precisely Selecting Patients Most Likely to Respond to GPR35 Inhibition

Company Narrows Initial Therapeutic Focus to Ulcerative Colitis with Precision Medicine Strategy for Clinical Development

Validating Non-Dilutive Grant Funding Supports Ongoing Fundraising Efforts as Company Continues on Path Toward Clinic

OXFORD, United Kingdom, July 2, 2024 /PRNewswire/ -- ThirtyFiveBio Limited, a biotechnology company developing first-in-class small molecule inhibitors of G protein-coupled receptor 35 (GPR35) for the treatment of gastrointestinal (GI) disease, today announced that the company, along with its long-standing academic collaborator, Nicole Kaneider, Ph.D., of the University of Cambridge, have been awarded a highly competitive Biomedical Catalyst (BMC) grant from Innovate UK, the UK's innovation agency. The grant, for a total of £643,371 (~$817,000), will fund preclinical research designed to enable the company to pursue a precision medicine approach to patient selection for the clinical development of its first-in-class GPR35 inhibitors. While the company's unique approach to GPR35 inhibition has potential application broadly across GI disease and cancers, ThirtyFiveBio is focusing its initial development activities on inflammatory GI conditions driven by epithelial dysfunction such as ulcerative colitis.

For this research project, ThirtyFiveBio and Dr. Kaneider will work collaboratively to identify subsets of patients who are enriched for GPR35 inhibitor responsiveness based on their unique genetic signatures. This will involve the deployment of bioinformatics and multi-omics to analyze clinical datasets and cross-reference those with preclinical data generated with relevant cell line and unique disease model platforms. Once this blueprint for GPR35 inhibitor responsiveness is created, the researchers will work to validate the genetic signature in additional preclinical studies, thus providing the company with biomarkers that can be used for precision patient selection in planned clinical trials.

"Receiving a second BMC grant from Innovate UK in less than a year is incredibly validating for the ThirtyFiveBio team and the pioneering work we are undertaking on GPR35 inhibition. As we continue to advance our preclinical program in this area, we learn more about the key role that GPR35 plays within the upstream causal biology of inflammatory GI diseases. It is this opportunity to engage at the source of disease activity that has driven our decision to elevate conditions such as ulcerative colitis to the top of our target indication list," said James Westcott, Ph.D., chief executive officer of ThirtyFiveBio. "We look forward to continuing to collaborate with Dr. Kaneider on this latest project and benefiting from her significant expertise on the biological function of GPR35 in GI disease. This work will be instrumental in supporting both the advancement of our GPR35 inhibitor program toward the clinic, as well as our ongoing fundraising efforts."

The role of GPR35 in GI diseases is genetically validated and provides a differentiated approach to disease treatment by focusing on underlying and unresolved epithelial and myeloid cell dysfunction, rather than directly addressing inflammation. Several drug developers are advancing programs designed to address the target, though to date, virtually all these efforts have been focused on increasing the activity of GPR35 with targeted agonists. However, important recent scientific findings, including key insights from the ThirtyFiveBio team, support the hypothesis that GPR35 antagonism may represent a more appropriate therapeutic approach by blocking unwanted GPR35 signaling. Based on this evolved scientific perspective, supported by the company's work with several world-leading, academic GPR35 specialists, ThirtyFiveBio is uniquely pursuing antagonism of the target with first-in-class small molecule GPR35 inhibitors.

Supporting the company's focus on GPR35 inhibition is a collection of pre-clinical data generated by its scientists that highlights the association between GPR35 mutations and GI diseases. This includes research showing that GPR35 variants are linked to inflammatory bowel disease, and that GPR35 expression is upregulated in GI cancers. The company and Dr. Kaneider have also shown that pathogenic mutations of GPR35 drive its increased expression and function. Furthermore, study results have demonstrated that commonly dysregulated GI-cancer genes can be reversed by knocking out GPR35 in cancer cells. Taken together, these findings provide compelling evidence that hyperactive genetic mutations within GPR35 contribute to a range of GI disease processes, and that inhibiting GPR35 activity may have therapeutic utility in these diseases.

About ThirtyFiveBio

ThirtyFiveBio Limited is a biotechnology company developing first-in-class small molecule inhibitors of G protein-coupled receptor 35 (GPR35) for the treatment of gastrointestinal (GI) disease. The company has built scientific thought leadership in the biology of GPR35 and the role that it plays in GI disease, including digestive tract colitis and cancers. ThirtyFiveBio has leveraged its fully enabled drug discovery platform to identify multiple unique families of first-in-class small-molecule GPR35 inhibitors that it is advancing through lead optimization activities. Created by M:M Bio and Canaan Partners, the company has raised $20 million in seed financing to date. ThirtyFiveBio is headquartered at the Innovation Centre on Milton Park, a key science precinct south of Oxford, UK. For more information, please visit: www.thirtyfivebio.com

About Innovate UK

Innovate UK drives productivity and economic growth by supporting businesses to develop and realise the potential of new ideas. We connect businesses to the partners, customers and investors that can help them turn ideas into commercially successful products and services and business growth. We fund business and research collaborations to accelerate innovation and drive business investment into R&D. Our support is available to businesses across all economic sectors, value chains and UK regions. Innovate UK is part of UK Research and Innovation. For more information visit https://www.ukri.org/councils/innovate-uk/

Contacts:
ThirtyFiveBio
James Westcott
Chief Executive Officer
P: +44 (0)1235 644980
[email protected]

Vida Strategic Partners (on behalf of ThirtyFiveBio)
Tim Brons (Media)
415-675-7402
[email protected]

SOURCE ThirtyFiveBio