Amplia Therapeutics Ltd (ASX:ATX) and Cancer Research UK (CRUK) have negotiated an amendment to the Licence Agreement for the company’s focal adhesion kinase (FAK) asset AMP886.
CRUK has agreed to extend the deadline for filing an investigational new drug application (IND) or commencing a Phase 1 trial of AMP886 until December 31, 2023.
“Further preclinical studies”
Amplia CEO Dr John Lambert said: “We are extremely pleased that we have been able to obtain this extension from CRUK and are grateful for their support and collaboration on this matter.
“The additional time that has been made available will allow us to undertake further preclinical studies with this promising molecule which has a unique activity profile, and identify therapeutic indications for which it is best suited before we initiate formal development.
“Meanwhile, our efforts to push AMP945 onward into Phase 2 trials are proceeding in earnest.”
In the initial licence agreement signed in March 2018, the company and CRUK agreed to either file an IND or initiate a phase 1 clinical trial of AMP886 within three years.
In March 2021, CRUK agreed to extend the term allowed for initiation of these activities, subject to further negotiations with the company.
Amplia has also has been granted a trading halt by the ASX as it prepares to make a capital raising announcement.
The halt will remain in place until the start of regular trade on Monday, November 8, or until an announcement is released to the market, whichever occurs earliest.
Amplia Therapeutics has stormed ahead, shedding its ‘pre-clinical stage’ status to become a drug development company, with two potent candidates on the brink of two Phase 2 clinical studies for pancreatic cancer and pulmonary fibrosis.
The pipeline drugs were originally developed by the Cancer Therapeutics CRC, an Australian industry/academic collaboration that included leading cancer and medicinal chemistry researchers at Australia’s top cancer research institutes.
Amplia was established to advance these promising drugs into clinical development and commercialisation.
FAK is an increasingly important target in the field of cancer immunology and Amplia has a particular development focus in pancreatic and ovarian cancer. FAK also plays a significant role in a number of chronic diseases, such as idiopathic pulmonary fibrosis (IPF).