BioNxt Solutions Inc. has announced the integration of its research, development, and commercialization activities with Gen-Plus GmbH & Co. KG, a Contract Research and Development Organization (CRDO) based in Munich, Germany. This strategic move positions the bioscience company to enhance its R&D capabilities and accelerate innovation within one of Europe's premier biotech hubs.
The Canadian-based company, which specializes in advanced drug delivery systems, will leverage Gen-Plus's sophisticated infrastructure, including a 1,000-square-meter laboratory equipped for handling high-potency active pharmaceutical ingredients and GMP-compliant processes. This facility offers specialized equipment for developing solid and semi-solid dosage forms, with particular capabilities in drug printing technology.
Advancing Multiple Sclerosis Treatment
In the immediate term, BioNxt and Gen-Plus will focus on the development and commercialization of BNT23001, the company's lead product candidate. This sublingual thin-film formulation of Cladribine targets multiple sclerosis (MS), a chronic autoimmune disease affecting approximately 2.8 million people worldwide.
Preparation for upcoming human bioequivalence studies is already underway, with activities including placebo trials, product and technology transfer, manufacturing scale-up, and analytical validation of the active pharmaceutical ingredient.
"This integration represents a significant advancement in our development capabilities," said Hugh Rogers, Co-Founder, CEO and Director of BioNxt. "Access to Gen-Plus's state-of-the-art facilities will accelerate our path to bringing innovative drug delivery solutions to patients, particularly those suffering from multiple sclerosis."
Enhanced Technological Capabilities
The collaboration provides BioNxt with access to cutting-edge technologies that align with its proprietary drug delivery platforms. Gen-Plus specializes in technologies critical to BioNxt's development pipeline, including:
- Hot-melt extrusion
- Drug printing
- Amorphization of active pharmaceutical ingredients
- Transdermal patch development
- Oral thin film formulation
These capabilities are particularly relevant to BioNxt's three proprietary platforms: Sublingual (Thin-Film), Transdermal (Skin Patch), and Oral (Enteric-Coated Tablets).
Strategic European Positioning
The Munich laboratory provides BioNxt with a strategic European base as the company advances its regulatory approvals and commercialization efforts, which are primarily focused on European markets. Gen-Plus brings over 25 years of experience in pharmaceutical formulation and development, along with established relationships with leading European research institutions and biotech companies.
This positioning is particularly advantageous as BioNxt targets therapeutic areas including autoimmune diseases, neurological disorders, and longevity-related conditions—all fields with significant research activity in the European biotech ecosystem.
Comprehensive Development Capabilities
The Gen-Plus facility offers end-to-end services from feasibility studies to clinical trial supply production. The laboratory is licensed for GMP-compliant production, including narcotics, providing BioNxt with comprehensive development capabilities under one roof.
For BioNxt, which maintains research and development operations in both North America and Europe, this centralization represents an opportunity to streamline development processes and potentially accelerate time-to-market for its pipeline products.
Market Context
BioNxt Solutions is publicly traded on the Canadian Securities Exchange under the symbol BNXT, on OTC Markets as BNXTF, and in Germany under WKN: A3D1K3. The company's focus on next-generation drug delivery technologies positions it in a growing market segment, with particular potential in the multiple sclerosis space.
The global multiple sclerosis therapeutics market was valued at approximately $23 billion in 2020 and is projected to grow significantly in the coming years, driven by increasing disease prevalence and demand for more convenient administration methods—precisely the area where BioNxt's thin-film technology aims to make an impact.
Future Outlook
As BioNxt and Gen-Plus collaborate on the development of BNT23001, the companies anticipate that the enhanced R&D capabilities will accelerate the advancement of BioNxt's broader pipeline of drug delivery technologies and therapeutic candidates.
The integration of operations in Munich represents a significant step in BioNxt's strategy to deliver patient-centric solutions that enhance treatment outcomes across its target therapeutic areas.
