Molecular Partners to Collaborate with AGC Biologics for Manufacturing of Anti-COVID-19 DARPin® Program
Zurich-Schlieren, Switzerland, July 9, 2020. Molecular Partners AG (SIX: MOLN), a clinical-stage biotech company that is developing a new class of custom-built proteins known as DARPin® therapeutics, today announced a collaboration with AGC Biologics, a global biopharmaceutical contract development and manufacturing organization (CDMO), to support development of the company’s tri-specific DARPin® anti-COVID-19 program. The company plans to initiate clinical studies for this program in the fourth quarter of 2020.
The parties will work together to deliver clinical and commercial-scale GMP manufacturing solutions at initial capacities of 100 liters and 1000 liters, a scale which Molecular Partners estimates is suitable for development and initial global supply of patients in need. This projection is based on established manufacturing properties of clinical-stage DARPin candidates, and the potency data produced to-date from the anti-COVID-19 program.
Preclinical testing supports a highly favorable target product profile, including a long half-life, high solubility, high temperature stability and ease of manufacturability via validated bacterial fermentation. This manufacturing approach is scalable and may bring a significant speed and cost advantage as other protein-based antiviral approaches, such as monoclonal antibodies, often require expensive, extensive manufacturing process development and optimization.
Molecular Partners’ DARPin platform constructs its protein therapeutics through the assembly of single, monospecific DARPin proteins into a multi-functional chain that can bind to several targets at once: a ‘multi-specific’ DARPin. In the case of its anti-COVID-19 program, Molecular Partners is focused on unique tri-specific modalities that can bind to three parts of the novel coronavirus simultaneously.
“Securing manufacturing capacity is a critical step in advancing our novel antiviral DARPin program to clinical readiness. We are moving this program quickly to patients, building upon our strong preclinical data that shows potential best in class potency in neutralizing live virus, and the wealth of our previous clinical experience with DARPin candidates,” said Patrick Amstutz, Chief Executive Officer of Molecular Partners. “We are greatly encouraged by the recent data supporting the potential of our unique tri-specific approach to target SARS-CoV-2, as we believe novel therapeutics will be an essential tool for addressing the global COVID-19 pandemic.”
“AGC Biologics is pleased to be working with Molecular Partners on such an essential and innovative program,” says AGC Biologics CBO Mark Womack. “We are very proud to work alongside Molecular Partners in the fight against COVID-19.”
Molecular Partners has selected a lead candidate (MP0420) and a variant molecule for preclinical development. Both are tri-specific multi-DARPin candidates that inhibit the virus in several assays to the lowest picomolar potency or the assay sensitivity limit. These data, in combination with the anticipated half-life, suggests that subcutaneous administration could potentially function as both a therapeutic for existing viral infection and a prophylactic.