Byondis: A Passion for Patients and Precision Medicines
The name says it all. “Byondis, pronounced ‘beyond this,’ is about going beyond the standard of care to provide novel treatments with high efficacy and low systemic toxicity for patients with unmet medical needs.
Based in Nijmegen, the Netherlands, Byondis started in 2012 as a subsidiary of Dutch-based generics pharmaceutical company Synthon. After Synthon became a recognized global entity, its co-founder Jacques Lemmens, Ph.D., redirected his focus — from producing affordable versions of off-patent medicines, to creating next generation precision medicines to outsmart cancers and autoimmune diseases.
That was always Lemmens’ plan. The inventive entrepreneur and scientist, now Byondis Founder and Chairman, dreamed of creating “new molecules that matter, leading to medical breakthroughs.” Ten years later, the company, which separated from Synthon and rebranded as Byondis in 2020, has a broad development pipeline built on proprietary technologies, and comprising preclinical as well as early- and late-stage clinical development programs. This includes lead program [vic-]trastuzumab duocarmazine (SYD985), an antibody-drug conjugate (ADC) currently under U.S. regulatory review.
Byondis employs the latest insights in tumour biology and immunology to search for new molecular targets and develop new mechanisms for ADCs, monoclonal antibodies (mAbs) and small molecule programs.
The company’s next generation ADCs employ its proprietary duocarmazine linker-drug technology, ByonZine®. ByonZine is responsible for our ADCs’ high stability in circulation and ability to efficiently release the cytotoxin in the tumour.
In addition, Byondis’ site-specific antibody conjugation technology, ByonShieLD®, uses a controlled method of connecting the linker-drug to the antibody. This enhances the ADCs’ antitumor activity, while helping to streamline the manufacturing process.
With a dedicated team of about 400, including highly educated scientists and skilled technicians working in state-of-the-art R&D and Good Manufacturing Practice production facilities, Byondis creates both targeted and immuno-oncology [IO] therapies.
Byondis four-phased value creation strategy:
- Following positive results of the pivotal Phase III TULIP® study investigating SYD985 in HER2-positive metastatic breast cancer, Byondis submitted the Biologics License Application to the U.S. Food & Drug Administration and a Marketing Authorization Application to the European Medicines Agency. The company has also entered into a License and Collaboration Agreement and a Supply Agreement with Germany-based medac to commercialize SYD985 in Europe and the UK, pending regulatory approvals.
- The potential of SYD985 in other clinical indications is being explored. A Phase II trial is evaluating the safety and efficacy of SYD985 as a standalone therapy in HER2-expressing metastatic endometrial cancers.
- Three new programs are planned to enter clinical development, with preclinical data suggesting a promising therapeutic window in patients:
- BYON4228, a mAb, is the lead cancer immunotherapy from Byondis’ next generation IO program. The mAb targets SIRPα, which increases the tumour-killing capacity of the immune system.
- BYON3521 is an ADC that targets c-Met, which is widely overexpressed in various solid tumours.
- BYON4413 is an ADC directed against the molecular target CD123, which is expressed in many hemato-oncological malignancies.
- The company continues to identify research programs ensuring a sustainable R&D pipeline in the coming decade. In its early discovery pipeline, three new platforms were identified, including:
- A novel linker-drug technology to generate IO ADCs
- A linker-drug technology to generate ADCs with potential in both oncologic and other indications, such as autoimmune diseases
- A platform to increase the tumour-specificity of mAbs and ADCs
Byondis regularly collaborates with leading global biotechnology and pharmaceutical companies, as well as many academic research institutions. While uniquely positioned to take its innovative portfolio beyond the laboratory, up to and including pivotal clinical studies, the company welcomes partners and collaborators to help speed its medicines to those who need them.
We call this “making hope real.”
For more information, visit www.byondis.com.
Follow us on LinkedIn: https://www.linkedin.com/company/byondis/
