LONDON (ShareCast) - (Sharecast News) - Avacta said on Thursday it had agreed the design of a pivotal US trial for its lead cancer therapy with the US Food and Drug Administration, while reporting further clinical data that it said strengthened the case for its preCISION oncology platform.
The AIM-traded clinical-stage biotechnology company said the FDA had agreed that a single pivotal study of faridoxorubicin, or AVA6000, in patients with salivary gland cancer could support a potential full approval, using progression-free survival as the sole primary endpoint.

The trial would include both first- and second-line patients across the most common forms of the disease, allowing the company to move directly into a pivotal study once Phase 1b data mature.

Avacta said the regulator had also previously agreed to remove the lifetime maximum dosing limit at US trial sites following the treatment's favourable safety profile.

Separately, Avacta reported updated Phase 1a/1b data showing four confirmed partial responses and eight confirmed minor responses among 32 salivary gland cancer patients in the population selected for the planned pivotal study.

Median progression-free survival had not yet been reached, while additional translational data suggested the treatment remained effective even in tumours with very low levels of fibroblast activation protein, supporting the broader applicability of its preCISION platform.

The company also said it had discontinued development of its AVA7100 Affimer drug conjugate programme after the latest findings reduced the need for the approach, while reaffirming that it intended to advance faridoxorubicin only with the support of a commercial partner.

At 1029 BST, shares in Avacta Group were up 2.07% at 74p.

Reporting by Josh White for Sharecast.com.

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