NuCana readies suite of PhIII cancer trials after rounding up mid-phase data

NuCana is set to start a Phase III trial of Acelarin in patients with pancreatic cancer this month, kicking off a surge into late-stage studies that will see it work on ovarian and biliary programs later this year. The Sofinnova Ventures-backed biotech is initiating the multi-front advance on the strength of Phase I/II data, details of which were presented at ASCO.

NuCana CEO Hugh Griffith

Edinburgh, United Kingdom-based NuCana published two abstracts at the cancer conference. The posters detailed data from a pair of Phase I/II trials, one of which dosed patients with advanced, progressive gynecological cancers with Acelarin. The other study gave the same drug--a reworking of Eli Lilly's ($LLY) Gemzar--to patients with solid tumors. Both trials triggered high disease control rates--78% in the solid malignancies and 93% in the gynecological tumors--in patients who had previously been treated with other therapeutics.

The disease control rates--most of which were accounted for by patients with stable disease--were high enough given the patients had relapsed or refractory cancers for NuCana to consider the studies successes. With that data in the bag, NuCana is set to start a Phase III trial in patients with pancreatic cancer this month. The pursuit of the indication pits NuCana against Lilly's Gemzar, Celgene's ($CELG) Abraxane and a clutch of other late-phase hopefuls, including Halozyme Therapeutics' ($HALO) PEGPH20 and Threshold Pharmaceuticals' ($THLD) evofosfamide.

NuCana is looking to the technology underlying Acelarin to give it an edge, particularly in patients who are resistant to existing therapies. The idea is to add increase the quantity of the active ingredient inside cancer cells by attaching a phosphoramidate moiety to an existing nucleoside analogue, such as Gemzar. Pharmasset used the same method to create Sovaldi, the hepatitis C drug that attracted an $11.2 billion (€10.3 billion) buyout from Gilead Sciences ($GILD) before going on to become one of the biggest selling and most talked about drugs on the market.

NuCana has an exclusive license to apply the approach in cancer, an asset that helped it snag $57 million in Series B fundraising from Sofinnova Ventures, Morningside Ventures and others in 2014. And the team running the company has a track record of building and selling biotechs, with several members of the NuCana management team having guided Bioenvision to its--somewhat contentious--takeover by Genzyme for $345 million in 2007.

- read the solid tumor release and abstract
- here's the gynecological release and abstract