2024-13-020 + 2021-08-011 + 2020-07-012 - Compound H/pro-H 03 - Novel pre-clinical candidates for immune-oncology (compound H and pro-H)
Contacts
AO
CH
DZ
Acronim & Gínjol codes
Compound H/pro-H 03
2024-13-020 + 2021-08-011 + 2020-07-012
Main technology offer
2 small molecule TGF-beta receptor inhibitors: compound H and its prodrug (pro-H), with clear innovation potential. Clear advantage in efficacy and toxicity over competitors.
Ownership
Barcelona, Spain
2005
Institut de Recerca Biomèdica (IRB Barcelona)
Public Partners
Readiness Level
3-4 Experimental PoC /
5 Prototype /
6-7 MVP /
8 Industrialization /
9 Commercialization
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Impact: ESG & SDG Goals
IRB Barcelona adheres to the 3 pillars of ESG, environmental, social and governance, to perform all of their projects with the highest standards.
UN Goals for sustainable development (GDS): This project will contribute to Goal 3: ‘Ensure healthy lives and promote well-being for all at all ages’ of the UN sustainable development goals. Specifically: Reduce by one third mortality rate attributed to cardiovascular disease, cancer, diabetes or chronic respiratory disease.
Market Data
Problem: TGFβ signaling is involved in cancer, where promotes invasion, immunosuppression, metastasis formation and drug resistance. Recently, TGFβ inhibition has been shown to block metastasis initiation and to activate anti-tumour immune responses potentiating other immunotherapies in experimental models of cancer (Tauriello et al., Nature 2018; Mariathasan et al., Nature 2018). Clinical trials with TGFβ inhibitors are ongoing for a variety of cancers, but clinical exploitation has been hampered by toxicity issues. Solution: our new TGFBRI inhibitors outperform competitors since they are efficacius at a tolerable dose.
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Our fist approach is the creation of a spin-off company to develop our compound until firs-in-human trials, and then licence the asset to a big pharmaceutical company, but we are open to collaboration and licensing opportunities.
CRC is the third most-diagnosed cancer in EU and USA. Diagnosed prevalent cases in 2018 were 2,741 million being stage III and IV of the disease 45% of all cases and expected to reach 3,152 million by 2025. According to Globaldata, the CRC market size in 2018 in the 8MM was 8,552 USD million with a CAGR of 0.03% (2015- 2025). Not only for CRC, but novel therapies targeting TGFβ signaling are in clinical trials for a variety of cancers.
The global colorectal cancer (CRC) market was estimated to be €14.5 billion in 2022 and is expected to grow at a CAGR of 2.63% to reach €20.3 billion by 2035. The current market in addition to surgery and radiation therapy consists of several therapeutic approaches such as targeted drugs (Cetuximab, Ramucirumab), chemotherapy (5-Fluorouracil, Capecitbine, Oxaliplatin), Immunotherapy (Nivolumab, Pembrolizumab). Over 45% of CRC diagnosed patients develop metastatic CRC20 where options such as resection (surgery) are usually ineffective. These patients are treated with the standard of care, yet around 90% do not respond to treatment due to specific traits associated with metastatic CRC, and succumb to the disease. With so few available treatment options, this creates a large market opportunity for a unique therapeutic drug targeting a TGFβ receptor, that is highly efficacious, easy to administer and less expensive than biologicals.
Funding
We have calculated a need of 1.850.000 € for the accomplishment of the Regulatory, CMC, DMPK and Toxicology analysis, in order to have our product ready for first in human trials
Investors and/or pharmaceutical companies willing to enter into co-development/licensing agreements
1) CMC production 2) DMPK and Tox 3) Submission of a Clinical Trial Application (CTA)
Technology Status
We have generated two small molecule TGF-beta receptor type 1 (TGFBRI (ALK5)) inhibitors: compound H and its prodrug (pro-H), with clear innovation potential over competitors under development, since they are efficacious at a tolerable dose.
Clinical trials with TGFβ inhibitors are ongoing for a variety of cancers, but clinical exploitation has been hampered by toxicity issues. Safer and more effective TGFβRI inhibitors are expected to have an enormous market potential either alone or in combination with immune checkpoint inhibitors (ICIs).
BUSINESS ROADMAP: 1) Establishment of a spin-off company/licensing/codevelopment agreement. 2) Submit Clinical Trial Application. TECHNICAL ROADMAP: 3) cGMP batch production for lead Compound H. 4) Completion of CTA enabling studies for lead Compound H.
Patent Protected. National Phases: The patent has been granted in Japan. Furthermore, we are actively addressing the official actions required to secure patent protection of Compound H in Europe, the United States, Canada, and China.
Patent protected. Open to collaborations and licensing opportunities, investment for spin-off creation.
Know-how and expertise of the scientific team in CRC.
Quality Management
We are planning to produce Compound H under GLPs.