Reducing the cost, time, and ethical burden of preclinical research in the pharmaceutical industry

Periodic Reporting for period 3 - GENBIO (Reducing the cost, time, and ethical burden of preclinical research in the pharmaceutical industry)

Período documentado: 2020-09-01 hasta 2021-08-31

Modern drug discovery is an inefficient, expensive and risky process. The average cost of a successful drug introduction now exceeds $3bn, with a time to market in excess of 10 years. The consumption of patent life during R&D has a profound financial impact with the decreasing economic life of an approved drug leading to increased market costs. The key bottleneck and attrition point in drug discovery is the hit to lead transition from early hits identified by multiple approaches (including genomics, proteomics, high throughput screening, AI) and in vivo proof of target.

The inefficiencies in drug discovery and validation do not only impact the bottom line of Pharmaceutical and Biotechnological Companies but also translate into higher prices of medicines for patients and outstanding unmet need in many disease areas. Last but not least, the preclinical research imposes high ethical burden on animals as many need to be sacrificed in the process of drug validation.

Our AI-driven Drug-Disease matching platform works in concert with the patented multi-disease modeling technology facilitating more efficient and ethical drug development and positioning. The toolkit reduces the time to prepare animal models, and the cost of drug discovery and pre-clinical trials, by an order of magnitude. The impact of this is cheaper, more rapidly developed drugs, with a greater target to market success rate.

With this in mind, the overall SME Instrument Phase 2 project objectives are as follows:

1) Enhance the prototype platform technology by refining methodology and target drug/disease roadmap
2) Validate technology through commercial trials with key industry partners
3) Develop commercialization and marketing strategy and prepare for the next scale-up phase

The work performed from the beginning of our SME Instrument Phase 2 grant has significantly progressed our platform technologies across several dimensions:

1) Commercial Trials: Established commercial trials, data has been analysed and prepared for dissemination. Several publications and white papers that describe trials results are published or under preparation.
2) Platform Enhancement: Platform has been enhanced technologically through optimization of technical protocols and assays. New drug candidates have been discovered through the platform and are planned to be further developed through preclinical and clinical studies.
3) Strategy: Commercial and communication strategy has been executed with all KPIs achieved. Several partnerships and collaborations have been established and GenBio is now pursuing exploitation activities to support the future growth of the company.

The work covered in the last, third year of the SME Instrument Phase 2 grant has led to full industrialization of the GenBio Platform per aim of reaching TRL7 . In particular:

4) Commercial Trials:
a. All commercial trials have been executed, data has been analysed and disseminated with 10+ publications (including research papers, white papers, newsletters and press releases).
5) Platform Validation:
a. Platform validation has been completed.
b. New drug candidates have been discovered and validated through the platform and are now planned to be further developed through preclinical and clinical studies.
6) Commercial and Communication Strategy:
a. Commercial and communication strategy has been executed with major KPIs achieved.
b. Formal research collaboration agreement has been signed with Astra Zeneca (research collaboration focusing on identification of drivers of cardiac regeneration and recovery) and Origenis (research collaboration focusing on co-development of New Chemical Entity (NCE) for indications in Cardiotoxicity / Cardioprotection)
c. Patent portfolio has been expanded to now include 10 ongoing patents with 1 patent fully granted in US (patent number: 10851388)
d. Genome Biologics is recipient of multiple awards such as: Top 100 Fastest Growing German Startup – BusinessInsider.de; Global Top 5 AI-Driven Drug Discovery Startup – StartUs-Insights.com; Top 10 AI and Drug Discovery Company in Europe – Labiotech.eu (“The TechCrunch for Biotech”)

We foresee a significant impact of our proposed solution on European Healthcare Landscape across three main dimensions:

Economic Impact:
• 8x reduced drug development time
• 10x reduced drug development cost
• Increased patent value
• Increased return on investment

Ethical Impact
• Up to 100x reduced animal usage
• Removed the need to breed and propagate animals
• Reduced animal pain & suffering
• Complete replacement of animals for certain tests, with the implementation of our cardiac organoid platform

Environmental Impact
• Large reduction in no. of animals used & disposed of
• Cut down in time to prepare animal models
• Reduced the impact of power, feed & waste disposal

Genome Biologics’ preclinical drug discovery and validation platform

Genome Biologics’ preclinical drug discovery and validation platform.

Genome Biologics’ preclinical drug discovery and validation platform

Periodic Reporting for period 3 - GENBIO (Reducing the cost, time, and ethical burden of preclinical research in the pharmaceutical industry)

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