Avacta to start trialling second drug after FDA clearance
By Josh White
Date: Wednesday 21 Jan 2026
(Sharecast News) - Avacta Therapeutics said on Wednesday that it has received clearance from the US Food and Drug Administration for the investigational new drug application for 'FAP-Exatecan', or AVA6103, marking the transition of its second 'preCISION' medicine from preclinical development into human trials.
The AIM-traded biopharmaceutical company said the clearance allowed it to begin a phase one clinical study of FAP-Exd later in the first quarter.
It said the trial would assess the safety and potential efficacy of the programme and aim to determine an appropriate dose for further development in patients with pancreatic, cervical and gastric cancers, as well as small cell lung cancer.
Avacta said the tumour types were selected using an AI-driven approach examining sensitivity markers for topoisomerase I inhibitors alongside FAP expression, as part of its strategic collaboration with Tempus AI.
The phase one study would enrol adult patients in a dose-escalation design with two parallel treatment schedules, administering the drug every two weeks and every three weeks.
Avacta said preliminary data from the trial were expected in the second half of 2026.
"Taking FAP-Exd into the clinic is a critical milestone for the preCISION platform and for the company," said chief executive Christina Coughlin.
"In moving the FAP-Exd program forward from inception to a cleared IND in just 24 months, our team has exceeded industry standard timelines.
"The sustained release mechanism of FAP-Exd, invented by Avacta, is expected to enable greater efficacy in the clinic while limiting the toxicities that were observed with exatecan in its original clinical development.
"We are very excited to move this program forward for patients and shareholders alike."
Chief medical officer David Liebowitz said the programme would help validate the broader applicability of the preCISION platform.
"Our FAP-Exd program in the clinic will very soon provide a greater understanding of the new chemistry of the preCISION platform and also validate the potential to move forward with varied payloads based on our novel capping group and linker technologies," he said, adding that it would support Avacta's ability to "design molecules that maximize the exposure of our payloads in the tumor in patients."
Alexander Spira, co-director of the Virginia Cancer Specialists Research Institute and chief scientific officer of NEXT Oncology, said: "I am thrilled to work with Avacta on this exciting new drug.
"The ability to concentrate a potent topoisomerase I inhibitor directly in the tumor while protecting normal tissues from harmful effects is the next stage of how we should be treating cancer."
At 1212 GMT, shares in Avacta Group were up 7.45% at 56.95p.
Reporting by Josh White for Sharecast.com.
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