Image Source: IVX Presentation, dated 9 November 2021
- Latest PoC study outcomes have highlighted a compelling rationale for the use of Invion’s API, INV043, with immune checkpoint inhibitors (ICI).
- The combination therapy exhibited more efficiency compared to ICI monotherapy with circa 65% decline in tumour size and considerably smaller tumours.
- The results open new partnership opportunities for Invion as INV043 might hold good potential for large pharmaceutical companies with ICI drugs facing patent expiries.
- ICI, which had an estimated global market of US$29.8 billion in 2020, is projected to grow at a CAGR of 16.8% by 2030.
Marking a major headway, Invion Limited (ASX:IVX) has announced encouraging results from the third Proof-of-Concept (PoC) study conducted by its research partner, Hudson Institute of Medical Research.
The study was designed to assess the effect of combining INV043 with immune checkpoint inhibitors (ICI) targeting PD-1 to improve outcomes in mice with triple negative breast cancer (TNBC).
The outcome of the third PoC gives Invion an additional path to commercialising the technolgy in the multi-billion dollar ICI market that did not exist before.
Importantly, the patents on a number of blockbuster ICI drugs owned by Big Pharma are about to expire in the next few years and INV043 could provide them an opportunity to extend their patents (more on this later).
INV043 is the latest Active Pharmaceutical Ingredient (API) developed by Invion and uses PhotosoftTM technology.
The results demonstrated a 65% decline in tumour size, tumour stabilisation, regression and remarkably smaller tumours, providing some convincing foundations for using the combination therapy.
Unlike previous PoCs, the administration of INV043 in the latest study was limited to a small portion of the tumour to specifically probe the combination approach and immune-mediated changes following therapy in an animal model.
The results provide compelling rationale for use of INV043 in combination with ICI therapies.
Data source: IVX update
Despite its widespread clinical use, ICI as a monotherapy has limited effectiveness against different types of cancer. Combining INV043 with ICI could improve clinical response in “cold” tumours, a tumour that is not likely to initiate a strong immune response, like TNBC.
Large and rapidly growing ICI market - Immune checkpoint inhibition (ICI) is a major part of the immunotherapy space and a very hot topic in biotech. The global ICI market, which was valued at around US$29.8 billion in 2020, is projected to grow at a compound annual growth rate (CAGR) of 16.8% to US$141 billion by 2030.
These findings suggest new growth avenues for IVX to access the vast and growing commercial space of ICI.
Strategic collaboration opportunities – INV043 may provide the potential for pharmaceutical companies with ICI drugs to improve clinical outcomes, develop new intellectual property, and extend the patent life of their ICI therapies, as per Invion.
It is to be noted that the key patents for Merck’s ICI drug “Keytruda” will expire in 2028, exposing the drugmaker to competition from generic drugs. Keytruda accounted for 30% of Merck’s global revenue in 2020.
Similarly, Bistrol, a global pharmaceutical company, is due to see the patent expiry for its ICI drug Opdivo in 2028.
There are new opportunities for the Company to collaborate on combination therapies and develop new IP to extend patent life of ICI’s.
The road ahead
Data analysis is ongoing to identify the main features of induced immunity following treatment with INV043 and the effect of combining the API with anti PD-1.
As Invion progresses towards clinical trials, specific biomarkers to evaluate treatment response will also be identified to guide clinical decision-making around treatment protocols.
IVX shares were trading at AU$0.012 midday on 30 May 2022.
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