FDA nods phase II clinical trials for Aston Sci’s cancer vaccine

By Sakina Raj  | Date: 2022-08-25

FDA nods phase II clinical trials for Aston Sci’s cancer vaccine

Aston Science has reportedly announced that it has obtained approval from the U.S. FDA (Food and Drug Administration) for the phase II clinical trials of AST-301, its therapeutic cancer vaccine, on patients who have been diagnosed with TNBC (triple-negative breast cancer).

The clinical stage biopharmaceutical company also confirmed the immunogenicity, excellent safety, and survival rate of AST-301 by publishing the results of phase I at the ASCO (American Society for Clinical Oncology) last year. The results also comprised a follow-up study of more than a decade on breast cancer patients who have HER2 expression.

It has been revealed that this new drug is anticipated to play a crucial role in preventing the recurrence of cancer after surgery and treatment of progressive cancer since its side effects are few compared to the existing anticancer treatments. It also maintains a long-term immune memory.

In phase II clinical trial, combinations with Xeloda or Keytruda were administered, a standard treatment in patients who have a high chance with recurrence of cancer, after a low-expression HER2 breast cancer surgery.

In addition, both the phase II and phase III clinical trials use the same design and patient group.

 According to CMO Joung Eun-kyo, although there are different side effects of chemotherapy, like fear of recurrence and social problems, the company still hopes that its cancer vaccine will prevent its recurrence and improve the quality of life for cancer survivors. 

Based on the interim results, the company would open discussion on the authorization of BLA (biological license application) or expansion of the pivotal cohort to generate corroborative clinical data during the phase II clinical trials.

It compared this data to the rapid licensing strategy of the MSD, utilizing the results from the Keytruda clinical phase I study, adding that this strategy will allow it to recruit patients faster by completing the approval of IND in the U.S., following Taiwan and Australia.

Source: http://www.koreabiomed.com/news/articleView.html?idxno=14457

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Sakina Raj     aeresearch.net

Sakina Raj

Armed with a degree in English Literature, Sakina chose to explore the world of content writing and pursue it as a career. Sakina has been playing with words for over five years now and currently pens down articles relating to diverse domains for BonafideNews and vari...

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