Pleco Therapeutics BV Company Profile

Background

Pleco Therapeutics BV is a clinical-stage specialty biopharmaceutical company headquartered in Nijmegen, the Netherlands, with a U.S. subsidiary, Pleco Therapeutics USA Inc., based in Newark, New Jersey. The company's mission is to extend the lifespan and enhance the quality of life for patients by developing novel Plecoid™ therapies designed to dramatically increase the effectiveness of current cancer treatments.

Key Strategic Focus

Pleco Therapeutics focuses on developing innovative treatments that detoxify the cancer microenvironment, thereby improving the efficacy of existing chemotherapy regimens. Their primary area of specialization is in the treatment of orphan cancers, with a current emphasis on Acute Myeloid Leukaemia (AML) and Small-Cell Lung Cancer (SCLC). The company's proprietary Plecoid™ therapies aim to positively change the balance of protein expression within the cancer microenvironment by removing the burden of toxic metals within the cell.

Financials and Funding

In September 2022, Pleco Therapeutics announced the final close of its Series A financing, raising a total of €17.3 million. The funding included €3.6 million in new equity from Oost NL and private investors, €5 million in government funding from the Netherlands Enterprise Agency (RVO), and €8.7 million in equity and R&D project financing from Hyloris Pharmaceuticals SA. These funds are intended to complete the development and commercialization of the company's lead Plecoid™ product, PTX-061, for AML treatment.

Pipeline Development

Pleco Therapeutics' pipeline includes:

PTX-061: A fixed-dose combination (FDC) for AML treatment, currently in development with plans for regulatory submission to the FDA and EMA as early as 2024.

PTX-252: A novel molecular entity developed to increase the sensitivity of cancer cells to chemotherapy. In January 2024, PTX-252 received Orphan Drug Designation from the FDA for the treatment of AML.

PTX-062: A candidate in preclinical testing for the treatment of SCLC.

Technological Platform and Innovation

Pleco Therapeutics' proprietary Plecoid™ therapies are innovative treatments that include chelating agents with distinct properties. These agents aim to rebalance metal ions within the cancer microenvironment, thereby improving the effectiveness of existing chemotherapy. The company's approach involves:

Proprietary Technologies: Development of fixed-dose combination therapies that incorporate chelating agents to detoxify the cancer microenvironment.

Scientific Methodologies: Utilization of metal-binding amino acids to alter protein expression and reduce toxic metal burden within cancer cells.

Leadership Team

Ivo Timmermans, MD MBA: Co-Chief Executive Officer. Dr. Timmermans brings extensive experience in pharmaceutical and biotech industries, leading the company's strategic direction and operations.

Rudi Jansen: Co-Chief Executive Officer. Mr. Jansen co-leads the company, focusing on financial and operational management.

Dr. Henno Welgemoed: Chief Medical Officer. Appointed in September 2023, Dr. Welgemoed oversees clinical development activities, including the implementation of clinical studies for PTX-252. He has over 15 years of clinical expertise and two decades of pharmaceutical experience.

Dan Gelvan, PhD: Chief Research & Development Officer. Dr. Gelvan leads the company's R&D efforts, focusing on the development of Plecoid™ therapies.

Gerben de Rijk, LLM: Chief Legal Officer. Mr. de Rijk manages legal affairs, ensuring compliance and supporting corporate governance.

Michael Stalhamer: President of Pleco Therapeutics USA, Inc. Appointed in July 2022, Mr. Stalhamer brings over 25 years of experience in pharmaceutical and biotechnology sectors, overseeing U.S. operations and regulatory affairs.

Julie Powell: Corporate Development Director. Ms. Powell focuses on strategic partnerships and business development initiatives.

Tamara Kokaz: Operational Director. Ms. Kokaz manages operational activities, ensuring efficient execution of company strategies.

Leadership Changes

Dr. Henno Welgemoed: Appointed as Chief Medical Officer in September 2023, bringing extensive experience in haematology-oncology and rare diseases.

Michael Stalhamer: Appointed as President of Pleco Therapeutics USA, Inc. in July 2022, leading U.S. operations and regulatory affairs.

Competitor Profile

Market Insights and Dynamics

The global market for AML and SCLC treatments is characterized by a high unmet medical need due to the aggressive nature of these cancers and limited treatment options. The development of therapies that enhance the efficacy of existing treatments presents significant growth potential.

Competitor Analysis

Key competitors in the oncology therapeutics space include:

Roche: Developed Tecentriq, a monoclonal antibody approved for the treatment of advanced-stage SCLC in combination with chemotherapy. Tecentriq works by binding to PD-L1, preventing it from interacting with PD-1 and B7.1 receptors, thereby activating T cells to kill cancerous cells.

Hyloris Pharmaceuticals SA: A specialty biopharma company focused on innovating and optimizing existing medications. Hyloris has partnered with Pleco Therapeutics to co-develop and commercialize Plecoid™ agents for AML and SCLC.

Strategic Collaborations and Partnerships

Hyloris Pharmaceuticals SA: In November 2021, Pleco Therapeutics entered into a strategic partnership with Hyloris to co-develop and commercialize Plecoid™ agents for AML and SCLC. Hyloris committed €1 million in initial funding, with potential additional funding of up to €7.7 million for predefined R&D activities.

The University of Texas MD Anderson Cancer Center: Pleco Therapeutics has initiated a sponsored research program based on intellectual property developed at MD Anderson.