NuCana Release: Acelarin Achieves Very High Disease Control Rates In Patients With Advanced Gynaecological Cancers In A Phase I/II Setting

CHICAGO--(BUSINESS WIRE)--NuCana, a clinical stage biopharmaceutical company developing and commercialising a portfolio of novel anti-cancer medicines, today presented ground-breaking clinical results in gynaecological cancers for its first-in-class, Phase III-ready, anti-cancer agent, Acelarin® at the 51^st Annual Meeting of the American Society of Clinical Oncology (ASCO) in Chicago.

“Resistance to chemotherapy severely limits patient survival. The clinical outcomes achieved with Acelarin are very encouraging especially in patients with relapsed gynaecological cancers where few effective treatment options exist.”

Results from the Phase I/II study showed that Acelarin, the first anti-cancer ProTide, achieved an exceptional 93% disease control rate in patients with advanced progressive gynaecological tumours relapsed or refractory to all standard therapies.

Of the fourteen evaluable patients enrolled 14% achieved a Partial Response and 79% Stable Disease, for an overall disease control rate of 93%. Moreover, this disease control was durable with a progression free survival of 8.2 months ongoing. Acelarin was well tolerated with no unexpected adverse events. The study reached its primary objective, having established the recommended Phase II dose.

Hugh Griffith, NuCana’s Chief Executive Officer, said: “Acelarin has achieved exceptional levels of durable disease control across a range of advanced gynaecological cancers. We are committed to expediting the development of this important new medicine through Phase III studies and beyond so that as many patients as possible can benefit from this medical advance.”

Acelarin is the first in a new class of anti-cancer agents, ProTides. These new medicines are specifically designed to overcome the key cancer resistance mechanisms that dramatically reduce the action of many widely prescribed anti-cancer drugs and thereby currently limit patient survival.

Dr Sarah Blagden, Associate professor of Experimental Cancer Medicine at Oxford University and Chief Investigator on the Phase I/II study, commented: “Resistance to chemotherapy severely limits patient survival. The clinical outcomes achieved with Acelarin are very encouraging especially in patients with relapsed gynaecological cancers where few effective treatment options exist.”

Acelarin has entered into a Phase I/II combination study with carboplatin to assess the safety and clinical activity in patients with ovarian cancers. This approach may facilitate the introduction of Acelarin at a much earlier stage of treatment to improve patient survival. In addition Phase III global studies are planned in ovarian cancer.

Poster information at ASCO 2015

First in human Phase I/II study of NUC-1031 in patients with advanced gynaecological cancers

Abstract No: 2547

Poster Board Number: Board #263

Time: Saturday May 30, 8:00 AM to 11:30 AM

Location: S Hall A

About NuCana

NuCana^® is a rapidly growing, clinical stage biopharmaceutical company with a broad development portfolio of novel anti-cancer medicines. The Company’s proprietary ProTide technology has the potential to set new benchmarks in efficacy and safety with its treatments that are specifically designed to overcome key cancer resistance mechanisms. Acelarin^® is NuCana’s lead medicine and was the first ProTide to enter the clinic in October 2010. Acelarin achieved exceptional levels of disease control in a broad range of patients with advanced, rapidly progressing solid tumours. Global Phase III studies with Acelarin are currently being planned in ovarian, biliary and pancreatic cancers. Privately held, NuCana, which raised $57 million in a Series B financing in April 2014, is backed by world-leading investors including Sofinnova Partners, Sofinnova Ventures, Morningside Ventures, Alida Capital International and the Scottish Investment Bank.

For more information, please visit: www.nucana.com

About ProTides

ProTides are first in class pre-activated anti-cancer agents, with a protective phosphoramidate group that allows the medicine to bypass the key tumour resistance mechanisms that limit the activity of many current chemotherapy drugs. Acelarin is the first ProTide in oncology to be brought to the clinic. The innovative ProTide chemistry is a technology platform that can be applied to all nucleoside analogues. Gilead’s ProTide, Sovaldi^®, has shown the potential of this new class of medicines for anti-viral therapy.