The US Food and Drug Administration (FDA) has granted clearance for Aston Sci.’s Investigational New Drug (IND) application for a Phase II clinical trial of its therapeutic cancer vaccine AST-301 (HER2-hICD vaccine).

Named CornerStone-001, the placebo-controlled, randomised, multiregional trial will analyse AST-301 (pNGVL3-hICD) to treat HER2- 1+/2+ breast cancer patients.

After Australia and the Taiwan regions, the trial will be launched in the US.

In the trial, subjects will be given the vaccine along with standard therapies, such as Capecitabine or Pembrolizumab, in high recurrence patients after a curative surgical procedure. 

A total of 146 participants will be enrolled and receive three intradermal injections every three weeks, along with a standard therapy regimen. 

In addition, these subjects will be given a booster dose as per the direction of the investigator.

This trial also has the same subject group and design as the Phase III trials. 

The company plans to expand the pivotal cohort to generate corroborative clinical findings in the Phase II trial, based on the initial data. 

The safety/tolerability, immunogenicity, and survival rate offered by AST-301 were validated in the Phase I clinical trial, as well as a follow-up study of over a decade on HER2-expressing breast cancer patients. 

This vaccine is also anticipated to have a key role in cancer recurrence prevention following surgery. 

AST-301 could be potentially used to treat advanced cancer as it leads to some adverse reactions and has a long-term immunological memory compared to current anti-cancer therapies.

Aston Sci. regulatory affairs director Dr Choi said: “It is a remarkable milestone that is definitely a leap forward for us in the cancer vaccine clinical development field. 

“Based on the significant regulatory value of the Phase I clinical trial, including more than ten years of long-term survival data, we have reinforced regulatory-required data, which complies to the latest guidelines of therapeutic cancer vaccine, and the US FDA has fully reviewed and approved it.”