Commit Biologics achieves proof-of-concept for novel Complement Engager platform in non-human primates

• Novel approach harnessing the power of the complement system to drive potent cell depletion
• Single-dose study shows rapid and sustained immune cell depletion
  in blood and tissues
  with a very favourable safety profile
• Commit Biologics’ CEO Mikkel Wandahl Pedersen
  to present data at PEGS Europe summit, November 11-13, 2025 in Lisbon, Portugal

AARHUS, Denmark, Nov. 11, 2025 /PRNewswire/ — Commit Biologics (“Commit”), today announced positive results from a non-human primate (NHP) study demonstrating proof-of-concept for its proprietary Complement Engager (BiCE™) platform. The study evaluated a Complement Engager candidate targeting a B-cell antigen. Results showed:

• Rapid and deep depletion of B cells in blood and tissues following a single dose
• Sustained B cell depletion for more than four weeks
• Favourable safety profile – no adverse clinical observations and no cytokine release
• Unique mechanism of action, demonstrating the power of complement as primary driver of cell killing

The NHP study confirms earlier findings from human whole blood showing effective B cell depletion. In these studies, the Complement Engager achieved superior B cell depletion compared with a clinically approved T cell engager and an ADCC enhanced antibody. Importantly, and as verified in the NHP study, complement mediated B cell depletion comes without cytokine release – a key challenge associated with T cell engagers and ADCC enhanced antibodies. 

“The positive NHP results represent a major milestone for Commit Biologics. Not only do they validate that the complement system can be used to safely and effectively deplete cells of interest in a highly relevant model they also demonstrate the ability of our platform to generate novel therapeutics with a unique mechanism of action that can be applied across many different indications,”said Mikkel Wandahl Pedersen, Chief Executive Officer of Commit Biologics. “We are pleased to share these findings at PEGS Europe.”

Platform Proof-of-Concept

Commit’s Complement Engager technology is designed to redirect and amplify the power of the complement system, a so far underutilized part of the immune system, to selectively kill cells of choice. By combining a conventional antibody with our proprietary complement engager technology, we can generate a highly potent complement activating compound with superior cell depletion capacity. The NHP study establishes critical platform proof-of-concept, showing that complement-driven activity can be harnessed safely and effectively to achieve deep and durable depletion of target cells.

Unlocking New Possibilities in Drug Development

With these results, Commit Biologics has significantly de-risked the BiCE™ modality and opened new possibilities for the development of therapies across multiple indications including immune-mediated and malignant diseases. The company is currently building a pipeline of exciting first in class therapeutics and aim to disclose a first development candidate in 2026.

“Our Complement Engager platform is highly modular, scalable, and has the potential to be truly transformative,” added Mikkel Wandahl Pedersen. “The NHP results support the emergence of an entirely new class of complement-based therapeutics and lay the foundation for a first-in-class pipeline with the potential to improve the lives of patients worldwide.”

Presentation details

Title: Bispecific Complement Engagers (BiCEs): Harnessing Complement Activation for Enhanced Antibody Therapy

Speaker: Mikkel Wandahl Pedersen, PhD, CEO & CSO, Commit Biologics ApS

Location: PEGS Europe, Lisbon Congress Centre, Libson, Portugal

Date & time: Wednesday November 12^th 2025, 17:45 GMT

About Commit Biologics

Commit Biologics is a pioneer in guiding the complement system to specifically kill target cells, with applications in autoimmune diseases and cancer. Spun out of Aarhus University, and building on more than three decades of research, Commit’s Complement Engager (BiCE™) platform can supercharge a conventional monoclonal antibody to activate the complement system more effectively. Commit is backed by major investors including Novo Holdings, Bioqube Ventures and Korys.

About the complement system

The complement system is a key component of the innate immune system, acting as one of the body’s first lines of defense against infection and disease. It consists of a network of plasma proteins that, once activated, work in concert to recognize, tag, and eliminate pathogens or damaged cells. Beyond its role in host defense, the complement system also influences inflammation, immune regulation, and tissue homeostasis. Harnessing complement activity therefore represents a powerful therapeutic approach with broad potential across autoimmune, inflammatory, and malignant diseases.

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SOURCE Commit Biologics

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