RE:RE:RE:Biotech industry readies for " Pharma M&A Spree" A growing emphasis on using synthetic control arms (SCA), which are derived from historical real-world evidence (RWE) using advanced statistical methods are becoming adopted by the regulatory bodies and CROs, like GCAR, who will be conducting ONCY's Phase 2/3 pancreatic cancer clinical trial. Implementing an SCA eliminates the need for enrolling placebo groups in certain clinical trials, which can improve retention rates because patients are guaranteed to receive the experimental therapy. With this approach, researchers can increase their trial’s generalizability with more diverse populations being represented in the data.
As stated this approach is being increasingly accepted by the regulatory bodies because it reduces the necessity for large patients enrollment numbers for a particular clinical trials, like those which trial treatments for unment medical needs.
This change in clinical trial pateint enrollment numbers is particularly critical for Big Pharma companies as they push to plug patent-loss gaps in an M&A environment that has left fewer late-stage biotechs, with treatments for unmet medical needs, available for them to scoop up. The present paucity of late-stage biotech companies and their focused assets for Big Pharma to acquire, are have those late-stage clinical development companies acquired at significant M&A premiums, especially if those companies and assets align with the Big Pharma's acquirers' core product pipeline and key assets. And any late-stage biotech company with a platform technology and a pipeline of late-stage clinical drug assets will now be able to develope those assets at a more rapid pace than has been historically seen.
As we know, ONCY is a late-stage clinical development company, with a platform technology and a clinical development pipeline of clinical targets, in which the company has been advancing the clinical development of pelareorep for the treatment of varius cancers with unmet medical treatment needs.
As outlined in numerous posts here, ONCY's pelareorep can both enhance the effectiveness of many Big Pharma currently marketed blockbuster products, as well as being able to extend their marketing exclusivity beyond their patent expirations, if combined with pelareorep and creating new I/O therapy, due to the FDA's 13 years of market exclusivity for novel biologic drugs that have not been previously approved, such as those like ONCY's pelareorep
ONCY has currently pursued treatment in 5 cancers involving 7 treatment modalities - from the use of pelareorep as a monotherapy to that in combination with other cancer agents.