OncoOne Company Profile

Background

OncoOne, established in 2018, is a biotechnology company dedicated to developing precision medicines targeting chronic inflammation and cancer. The company's mission is to create targeted therapies with curative potential to significantly improve patient outcomes and quality of life. By focusing on the oxidized macrophage migration inhibitory factor (oxMIF), a disease-related isoform of MIF, OncoOne aims to revolutionize treatment strategies for solid tumors and inflammatory conditions.

Key Strategic Focus

OncoOne's strategic focus centers on the development of innovative therapeutics targeting oxMIF. The company is advancing two proprietary platforms:

Anti-oxMIF Platform: This platform involves the creation of therapeutic antibodies that specifically target oxMIF, enabling precise treatment of chronic inflammatory diseases and various solid tumors.

PreTarg-it® Platform: A modular approach utilizing bispecific antibodies for pre-targeted radioimmunotherapy, designed to treat hard-to-treat cancers by ensuring optimal tumor penetration and retention, thereby enhancing site-restricted payload delivery.

These platforms are directed towards addressing significant unmet medical needs in oncology and chronic inflammation.

Financials and Funding

In March 2020, OncoOne secured a €13 million Series A financing round. The funding was provided by the Austrian Research Promotion Agency (FFG), Austria Wirtschaftsservice Gesellschaft (AWS), and two family offices. This capital is intended to advance the development of multiple drug modalities targeting oxMIF, with the goal of rapidly entering clinical trials for pancreatic, colorectal, lung, and ovarian cancers.

Pipeline Development

OncoOne's pipeline includes several key candidates:

ON203: A therapeutic monoclonal antibody targeting oxMIF, aimed at treating solid tumors such as colorectal, lung, pancreatic, and ovarian cancers.

ON102: A companion radio-labeled diagnostic antibody designed to precisely detect and target oxMIF-expressing tumors.

ON104: A monoclonal antibody targeting oxMIF for the treatment of chronic inflammatory diseases, including rheumatoid arthritis, inflammatory bowel disease, asthma, and nephritis.

The company plans to initiate Phase I clinical trials for ON203 and ON102 in 2023.

Technological Platform and Innovation

OncoOne's innovation is anchored in its two proprietary platforms:

Anti-oxMIF Platform: This platform is based on the discovery that oxMIF is generated exclusively in the oxidative environment at sites of inflammation and cancer. The company develops therapeutic antibodies with high specificity and selectivity for oxMIF, ensuring minimal interference with non-pathological MIF and enabling targeted treatment of diseased tissues.

PreTarg-it® Platform: This modular platform employs bispecific antibodies for pre-targeted radioimmunotherapy. The strategy involves a two-step process where a bispecific antibody targets a specific tumor marker, followed by the administration of a radiolabeled molecule that binds to the antibody within the tumor. This approach enhances tumor-to-non-tumor ratios and reduces radiation exposure to healthy tissues.

Leadership Team

OncoOne's leadership comprises seasoned professionals with extensive experience in drug discovery and development:

Randolf Kerschbaumer, PhD: Co-Founder & Chief Executive Officer. With over 25 years in academia and pharmaceutical R&D, Dr. Kerschbaumer has held senior positions at Baxter BioScience, Baxalta, and Shire, focusing on therapeutics for cancer, inflammation, and hematologic disorders.

Michael Thiele, PhD: Co-Founder & Chief Scientific Officer. Dr. Thiele brings over two decades of expertise in immunology, tumor biology, and biologics development. He previously led the Department of Cell Biology in Oncology Research at Shire and has been instrumental in advancing anti-oxMIF antibody development.

Alexander Schinagl, PhD: Co-Founder & Chief Technology Officer. Dr. Schinagl has over 15 years of experience in antibody engineering and drug discovery, having held leadership roles at Shire, Baxter BioScience, and Baxalta.

Christine Landlinger-Schubert, PhD: Vice President Preclinical and Translational R&D. Dr. Landlinger-Schubert joined OncoOne in 2021, bringing nearly 15 years of experience in drug discovery and non-clinical development, with previous roles at PhagoMed and AFFiRiS.

Friedmund Bachmann: Vice President CMC.

Maria Reitzinger, BA: Head of Finance and Administration.

Leadership Changes

In March 2024, OncoOne announced the formation of a Clinical Advisory Board to support the development of ON104 for chronic inflammatory diseases. The board includes distinguished experts such as Dr. Richard Bucala, Chief of Rheumatology, Allergy & Immunology at the Yale Institute for Global Health, and Dr. Daniel Aletaha, Professor and Head of the Clinical Department of Rheumatology at the Medical University of Vienna.

Competitor Profile

Market Insights and Dynamics

The global oncology and chronic inflammation therapeutics market is experiencing significant growth, driven by increasing prevalence of cancer and inflammatory diseases, advancements in biotechnology, and a growing emphasis on precision medicine. The demand for targeted therapies that offer improved efficacy and reduced side effects continues to rise, presenting substantial opportunities for companies like OncoOne.

Competitor Analysis

OncoOne operates in a competitive landscape with several key players focusing on targeted therapies for cancer and inflammatory diseases. Competitors include biotechnology firms developing monoclonal antibodies, bispecific antibodies, and other biologics aimed at similar indications. Notable competitors are companies specializing in immuno-oncology and inflammation, leveraging proprietary platforms to develop precision medicines.

Strategic Collaborations and Partnerships

OncoOne has established significant collaborations to advance its pipeline:

GenScript ProBio: In November 2021, OncoOne entered into an agreement with GenScript ProBio for the manufacturing of therapeutic and diagnostic monoclonal antibodies targeting oxMIF. This partnership encompasses cell line development, drug substance, and drug product manufacturing, aiming to bring OncoOne's lead candidates into clinical trials.

University of Catania: OncoOne collaborates with the University of Catania, leveraging the institution's extensive research capabilities to support the development of its therapeutic programs.

Operational Insights

OncoOne's strategic positioning is bolstered by its focus on oxMIF, a novel and specific target in oncology and inflammation. The company's proprietary platforms, Anti-oxMIF and PreTarg-it®, provide distinct competitive advantages by enabling targeted and site-restricted therapies, potentially reducing off-target effects and improving patient outcomes. Collaborations with academic institutions and industry partners further enhance OncoOne's capabilities in drug development and manufacturing.

Strategic Opportunities and Future Directions

OncoOne is poised to capitalize on several strategic opportunities:

Advancement of Clinical Programs: Initiating Phase I clinical trials for ON203 and ON102 in 2023 represents a critical milestone in validating the therapeutic potential of targeting oxMIF.

Expansion of Pipeline: Further development of ON104 for chronic inflammatory diseases and exploration of additional indications for oxMIF-targeted therapies.

Strategic Partnerships: Pursuing additional collaborations to accelerate clinical development, leverage partner expertise, and explore licensing or commercialization opportunities.

Investment Opportunities: Seeking investors for Series A+/B financing to support the progression of its pipeline into clinical stages and expand research initiatives.