Varsity Pharma in-licenses Pol-Theta inhibitor novobiocin - The Pharma Letter

UK biopharma company Varsity Pharmaceuticals has secured exclusive rights from Dana-Farber Cancer Institute (DFCI), a world-leading cancer treatment and research institute, to develop and commercialize novobiocin, a potential first-in-class DNA polymerase theta inhibitor for the treatment of homologous recombination (HR) deficient cancers.

Homologous recombination deficiency is where the body is unable to repair double strand breaks in DNA due to mutations in genes such as BRCA1 and BRCA2. Pol-Theta is an enzyme that can repair double strand breaks that recently emerged as a new cancer specific DNA Damage Response target that compensates for the loss of HR function in HR deficient cancers such as ovarian, breast, pancreatic and prostate cancer. Whilst PARP enzyme inhibitors have seen some success in the treatment of HR deficient cancers, PARP inhibitor drug resistance is emerging as a significant barrier to their effectiveness.

Research led by Professor Alan D'Andrea and published in Nature Cancer (Zhou et al. 2021) demonstrated that novobiocin, a drug previously used as an antibiotic, is a potent Pol-Theta enzyme inhibitor that can be used alone or in combination with PARP inhibitors to treat HR-deficient tumors, even after they have become resistant to PARP inhibitor therapy.

Could be a new treatment option

More than 50% of primary ovarian cancers, 25% of breast cancers, and approximately 5% of pancreatic and prostate cancers are associated with HR deficiency. If development is successful, the Pol-Theta inhibitor novobiocin could be a new treatment option for more than a 100,000 newly-diagnosed cancer patients per year in the USA alone. Varsity plans to start the first in-patient clinical studies of novobiocin in 2022.

Steve Fuller, chief executive of Varsity Pharma, commented: "Our exclusive license with Dana-Faber Cancer Institute reflects the core aims of Varsity to develop new therapies for hard to treat cancers. Varsity works with leading cancer research institutions to identify new targets for small molecules with clinical history that can be used in combination to greatly improve patient outcomes. This strategy accelerates clinical development and ensures the fastest route between discovery and new potentially life-saving treatments for cancer patients."

Varsity adds novobiocin to a pipeline of small molecule candidates under development as new therapies for treatment resistant cancers.

Varsity Pharmaceuticals was founded in Cambridge, UK, in 2020 as an oncology focused sister company to the rare disease focused Cycle Pharmaceuticals. Both Varsity and Cycle are 100% owned subsidiaries of Cycle Group Holdings. Varsity partners with leading oncology academics in Cambridge, and globally, to identify new targets to address drug resistance and develop new small molecule therapies for several resistant cancers. Varsity works to transform these novel discoveries into new therapies for patients by supporting the clinical development work needed for their eventual regulatory approval and distribution.

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