About

KOSBIO, a biotech startup, tackles challenges posed by Friedreich’s ataxia (FRDA) and other rare diseases. We aim to transform understanding and treatment using personalized medicine, including stem cell-derived organoids and AI. FRDA, affecting 25,000 globally, stems from Frataxin gene mutations, disrupting cellular functions. Symptoms include balance issues, speech challenges, heart failure, and diabetes. Manifesting in periadolescence, FRDA leads to severe neurological and cardiac dysfunction, wheelchair dependence within a decade, and a life expectancy of 15-25 years. FRDA's human-specific nature and slow progression hinder monitoring and therapy development. KOSBIO is committed to innovative solutions, bringing hope and improving the lives of FRDA patients and families facing rare diseases' complexities.

Solution & Product

KOSBIO has discovered a unique G-protein coupled receptor (GPCR) signaling pathway active during sensory neuron and cardiomyocyte embryogenesis. This developmental mechanism orchestrates a metabolic rewiring that circumvents the energy deficits induced by FRDA. KOSBIO's breakthrough approach entails the therapeutic reactivation of the pathway through regular injections of KB-001, an FDA-approved repurposed drug. In addition, ongoing efforts involve developing novel, more potent molecules (KB002-KB021), reflecting a commitment to refine treatment options. Moreover, KOSBIO is developing Idolyon, a proprietary, induced pluripotent stem cell (iPS)-based, rare diseases drug-screening platform for conducting "Clinical-Trials-in-a-Dish" in patient-specific, disease-relevant organoids. Idolyon's revolutionary approach ensures accurate disease representation, in a non-invasive, cost-effective manner, thereby expediting the translation of scientific discoveries into effective new therapies.

Innovation & Scalability

KOSBIO's distinctive value proposition is fortified by a multitude of innovations and competitive advantages: A. Innovative Technologies: 1. Novel therapeutic strategy: •KOSBIO's breakthrough involves discovering a developmental GPCR signaling pathway that alleviates the energy and growth deficit in FRDA. •Pharmacologic stimulation of the pathway represents a pioneering therapeutic approach. 2. Repurposed (KB-001) and Novel Molecules (KB002-KB021): •KOSBIO’s most valuable product, KB-001, repurposes an FDA-approved GPCR ligand. •Ongoing development of novel, patented ligands (KB002-KB021) reflects KOSBIO's commitment to enhancing treatment options and refining therapeutic approaches. 3. Idolyon Drug-Screening Platform: •Idolyon, KOSBIO's proprietary iPS-based drug-screening platform, provides unlimited access to patient-specific, disease-relevant organoids, offering a transformative, personalized medicine solution to the limitations of current approaches. B. Innovative Business Model: 1. Patient-Centric Approach: •KOSBIO's business model is anchored in patient-specificity, recognizing the unique challenges of FRDA and rare diseases. 2. Cost-Effectiveness and Competitive Pricing: •The strategic repurposing of an existing FDA-approved drug significantly diminishes the time and cost associated with new drug development, ensuring cost-effectiveness and competitive pricing. 3. IP and Licensing Arrangements: •IP and licensing for KB001-KB021 ensure market exclusivity

Traction & achievements

KOSBIO has achieved significant milestones in product development, particularly with KB-001 and KB002-KB021, along with the validation of its proprietary Idolyon technology. Idolyon, an iPS-based organoids technology, has reached Technology Readiness Level 5 (TRL-5), indicating a high degree of validation. KB-001, a repurposed drug, stands at TRL-4, with successful laboratory validation. Licensing negotiations for its commercialization are underway, marking a substantial step forward. KB002-KB021, demonstrating functional viability at TRL-3, have undergone synthesis and validation in animal and cellular models. The company has secured US and international patents, with licensing negotiations in progress for broader commercialization. In summary, KOSBIO's rigorous validation processes, patent acquisitions, and licensing agreements signify substantial progress in advancing its technology and therapeutic strategy.

Team & Why Us

KOSBIO is fueled by a personal commitment to cure Friedreich's Ataxia (FRDA), as two of the co-founders have family connections to the condition. Key team members include: 1. Kostas Chatzistergos, PhD: Co-Founder and CEO– Associate Professor of Developmental Biology at AUTH, co-inventor of KOSBIO’s IP. 2. Nick Ioannou, PhD: Co-founder, COO- Serial entrepreneur and former tech sector CEO, bringing extensive business expertise. 3. Vassilios Karatzias, LLM, MBA: Co-Founder, Secretary- Legal Military Advisor, HEFAA president and Euroataxia board member. 4. Josh Hare, MD: BOD President- Professor of Medicine at UM, co-inventor of KOSBIO’s IP. 5. Theofilos Kolettis, MD, PhD: Chief Medical Officer- Professor of Cardiology at the University of Ioannina. 6. Kristi Valasaki, MSc: BOD Vice President and Head of Manufacturing. This diverse team, with backgrounds in science, entrepreneurship, law, and medicine, reflects KOSBIO's holistic approach to advancing scientific knowledge and innovative solutions. Our growth strategy entails (I) Securing Orphan Drug Designation for KB-001 in the EU and the U.S; (ii), Conducting a Phase III Pediatric Clinical Trial; (iii), secure market exclusivity and reach a 15% market penetration by year 8 of operations. Expansion avenues include: Diversifying KB001 usage and the Idolyon Biobank for broader medical conditions; Forming strategic partnerships and collaborations for accelerated research; Developing blockbuster drugs (KB002-KB021) beyond KB001.

Funding Needs

Our funding needs are estimated at 5.5M Euros over the next 5 years and include the following milestones: 1. Complete Preclinical testing of KB-001 repurposing on Idolyon organoids and a mouse model of FRDA (years 0-2, budget=500K euros) 2. Conduct KB-001 Ph2/3 pediatric clinical trial (years 2-3, budget=2.5M euros) 3. KB-001 market authorization (years 3-5, budget=2.5M euros)