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Founders’ story: Libera Bio

In an interview with MedCity News, the founder and CSO of Spanish biotech startup Libera Bio talked about her company's ambitions to apply its precision medicine technologies for the treatment of different types of cancer.

Maria Jose Alonso, Libera Bio Founder and CSO

Why did you start this company?

My main motivation as a pharmaceutical scientist has always been to solve problems of drugs, notably biological drugs, in order to upgrade their exploitation for treating severe diseases.
Ten years ago, I conceived the idea of a nanoformulation design that would further enhance the value of cancer therapies based on monoclonal antibodies. A significant milestone was when the European Technology Platform on Nanomedicine (ETPN) through the ENATRANS program recognized the idea as one with a great valorization potential. Subsequently, the government of our province (Xunta de Galicia) offered us a “bridge valorization award” with the objective of converting our idea into a startup.
My expectations in Libera Bio are to further develop our lead candidate, MPN-anti-KRAS, a nanoformulated monoclonal antibody, to a stage that will enable defining plans for regulatory approval and, hence, attracting lead investors and alliances with pharma companies. I am fully committed to this stage of development as it will exemplify the real value of our research efforts.

What specific need/problem are you seeking to address in healthcare?

Among the most aggressive cancers, lung and pancreatic carcinomas are those with alarmingly low survival rates. These cancers, among others, are characterized for expressing mutated “Kirsten Rat Sarcoma Viral Oncogene Homologue” (KRAS) intracellular oncoproteins (100% of pancreatic ductal adenocarcinoma (PDAC) and 30% of lung adenocarcinoma (LAC)), which so far could not be targeted (known as “undruggable” targets).
Efforts focused in small molecule inhibitors of the KRAS gene and signaling pathways have failed to provide the expected outcome in pre-clinical and clinical phases. Alternatively, the use of monoclonal antibodies (mAb)-based therapies to target intracellular oncoproteins has been disregarded due to their inability to cross the cell membrane. In fact, all mAb-based therapies marketed so far are intended to reach extracellular targets.

What does your product do? How does it work?

Leveraging our patented technology, we are creating a paradigmatic change in the use of mAb-based treatments by providing these complex molecular entities with the capacity to cross the cell membrane and reach intracellular targets. Our strategy has relied on the hypothesis that a conveniently designed nanotechnology would enable the protection of mAb molecules and their targeted delivery inside the tumor and metastatic cells, following IV administration.
We have validated this hypothesis with our platform, identified as Multifunctional Polymeric Nanocapsules (MPN Technology®), for an Anti-KRAS mAb, among others. The results of the proof of concept (PoC) studies performed in various laboratories, using different animal models are very promising. From the pharmaceutical development standpoint, the technology is robust and scalable.

Is this your first healthcare startup? What’s your background in healthcare?

I have been part of several biotechnology startups already. In addition, I have coordinated multiple consortia financed by the WHO, the Bill & Melinda Gates Foundation, and the European Commission.
My credentials in healthcare include:
  • Full professorship at the University of Santiago de Compostela, Spain, and Vice-rector of Research & Innovation (2006-2010)
  • Recently recognized as a top 20 global biopharma influencer
  • High level scientific track record: over 281 scientific contributions with >29,300 cites (H Index 90)
  • Member of the U.S. National Academy of Medicine and 3 Academies in Spain, fellow of the American Institute Medical and Biomedical Engineering (AIMBE) and the Controlled Release Society (CRS)
  • President of the Controlled Release Society
  • Translational vision: inventor of 21 patent families, most of them licensed-out to pharma companies.
  • International network: extensive collaboration with academic and industrial sectors around the world.

What is your company’s business model?

Our strength is to develop precision medicine technologies for actively targeted delivery of cancer drugs. We intend to continue expanding the range of our patents on delivery technologies and to start the development of products treating a variety of intracellular cancer targets, either as a single or as a combination therapy.
Late stage development and commercialization will be better done by large pharmaceutical companies that have the necessary experience, means, scale and global reach. Therefore, our model is to license each asset as early as possible (typically after a successful Phase 1/2a of clinical trials and proof of concept in humans), so that we may proceed with a new asset offering a different solution for another set of patients.

Who is your customer? How do you generate revenue?

In this model, our customer will be pharmaceutical companies purchasing the asset or acquiring a commercialization license (classically involving an upfront payment, milestone payments and royalty fees during commercialization).
Their clients are healthcare systems and practitioners that will buy and use the products. The ultimate beneficiaries will be cancer patients, especially those for whom no treatment or few options exist today.

Do you have clinical validation for your product?

We have extensive pre-clinical validation in a variety of cancer models. We are preparing the dossier for regulatory approval to enter clinical phase on our lead candidate, a MPN-anti-KRAS compound.

At what stage of development is your lead product?

Our lead compound is at pre-clinical stage, on its way to enabling studies to obtain Clinical Trial Authorization (CTA).
Picture: Getty Images


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