Fra Artic analysen angående Fimavacc:
To date, more than 80 subjects have been included. Preliminary data has indicated initial clinical support of fimaVACC’s potential to enhance the cellular immune response at well-tolerated dose levels, as well as early responses and high response rates.
Interestingly and somewhat unexpectedly, best responses were found at the lowest fimaporfin dose that was tested. Therefore, the study needed additional expansion to include lower doses. This led to more subjects being recruited and a slight delay to the study timelines than originally planned. The study was initiated in 3Q16 and completion is expected in 2H18.
Strategic positioning To improve the immunogenicity of vaccines is of great importance for vaccine-based immunotherapeutics. Most vaccines are depending on enhancement by adjuvants, which boost uptake of antigens and immune response, but are still considered somewhat suboptimal. The development of better adjuvants has shown to be demanding, costly and time consuming. Therefore, PCI enhancement should be an interesting opportunity for companies developing cancer vaccines. Fimaporfin is stable in solution and at room temperature, with cost-effective synthesis and is used in combination with a user-friendly, disposable “band-aid-like” device for illumination at the vaccination site.
PCI Biotech reports it has previously attempted to out-license the technology on the back of preclinical data, but instead saw the opportunity for substantial upside by gaining quick clinical validation of concept, optimization of the protocol and confirmation of safety at relatively limited cost.
After completion of the phase I study, the company’s main strategy is to out-license the fimaVACC technology to vaccine companies, likely on a non-exclusive basis, in resemblance with adjuvants. The technology has a broad application, as it can be combined with peptide and protein antigens, as well as with particulate antigen formulations and prophylactic and therapeutic vaccination.
Due to PCIB’s strong patent situation and positioning, it could also decide to utilize the platform and develop vaccine candidates by itself. The strategy of non-exclusive out-licensing agreements could give PCI Biotech some revenue stream from late 2018 or early 2019. These types of deals are usually backend loaded and could be imagined to include lower single-digit upfront payments, sober development and regulatory milestones and lower single-digit royalties on sales.
The total global cancer vaccines market (preventative and therapeutic vaccines) was valued at some USD 4bn in 2016, mostly driven by prophylactic cancer vaccines. The market is projected to reach a value somewhere between USD 7.5 - 12.5bn by 2023, but includes a wide range of cancer vaccines and “affiliated” technologies, like CAR-T treatments that are expected to generate blockbuster revenues within that time period. Few therapeutic cancer vaccines have received clinical approval so far, but more than 120 vaccine assets are currently in clinical development, of which some 40 in combination with PD-1/L1 checkpoint inhibitors.
is worth noting that for vaccines already in clinical development, companies would need to start clinical development from scratch if combining with a new adjuvant and/or delivery technology. On the other hand, many companies are aware of their suboptimal technology platform and are shopping around to optimize efficacy of their approach.
Sales projections and considerations
After completion of the phase I study, PCIB’s main strategy is to out-license the fimaVACC technology to vaccine companies, likely on a non-exclusive basis. The technology has a broad application, and a substantial “rescue value” for vaccine technologies that now generate suboptimal efficacy, due to delivery challenges.
The strategy of non-exclusive out-licensing agreements could give PCI Biotech some revenue stream from late 2018 or early 2019. These types of deals are usually backend loaded and could be imagined to include lower single-digit upfront payments, sober development and regulatory milestones and lower single-digit royalties on sales.
We find it particularly challenging to estimate the potential revenue stream fimaVACC could generate and we therefore model revenue from 1-2 out licensing agreements per year between 2019-2025 to a total of ten deals, with the following assumptions:
Each deal is based on an upfront of some USD 0.5-1m, additional milestones of some USD 2.53m and royalties of some 2%. We assume slightly higher milestone based payments for later deals, as the platform may be validated by earlier deals by then
We assume 5 - 10,000 vaccines per year (peak sales) at USD 50,000 per vaccine per deal, which amounts to an average of USD 7.5m per deal per year in royalties for 7 years (note: gradual ramp up of peak sales in line with industry statistics)
We assume all vaccine are developed from pre-clinical to clinical assets, all are successful and all have meaningful market uptake and sales
We acknowledge our assumptions are highly speculative and only reflect one possible scenario for fimaVACC. We do however think the total value for out-licensing of fimaVACC could be realistic