AVA39966 Jan 2022 11:38
We are also due news on AVA3996 progress to clinical development. Unclear why we didn't see an update on this before the end of 2021 as AS seemed very positive on this in recent interviews. Detail below from 30th Sept interims as a reminder.
The next most advanced pre|CISION™ pro-drug is AVA3996, a FAP-activated analogue of Velcade, Takeda's proteasome inhibitor which comes off patent in 2022. The global proteasome inhibitors market size is expected to be worth $1.7 billion by 2023 (source) and Velcade represents just over half of that market. As with all chemotherapies the benefit of these drugs is limited by toxicities and tolerability for patients. In the case of Velcade, there are significant side effects such as peripheral neuropathy which has limited its approval, principally to multiple myeloma. A potentially safer proteasome inhibitor, such as AVA3996, could win significant market share for the treatment of multiple myeloma and also be used to treat solid tumours, such as pancreatic cancer. Pancreatic cancer also exhibits the highest level of FAP activity of any solid tumour and therefore a FAP activated pro-drug could have significant potential in this area of high unmet need.
Excellent progress has been made in the AVA3996 programme which remains on track for clinical development candidate selection by the end of 2021. A number of in-vivo studies aimed at de-risking the pre-clinical and clinical development of AVA3996 have been completed. A contract manufacturing organisation for the drug substance and drug product has been identified and the Company is investigating potential fast-track approval options.