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Byondis: Taking Precision Medicine To The Next Level

“We are further progressing in innovation, quality and scientific excellence.”
- Jacques Lemmens, Ph.D., Byondis Founder and Chairman of the Board

With a passion for outsmarting relentless cancers and autoimmune diseases, Byondis takes precision medicine to the next level. Located in the oldest city in the Netherlands, Nijmegen, this science-based, biopharmaceutical company is driven by one goal: providing novel treatments with an improved therapeutic window for patients with a high unmet medical need.

Beyond standard of care: Byondis’ differentiating technologies and pipeline

Many companies work in areas of unmet medical need. What differentiates Byondis is its focus on a broad spectrum of molecular concepts, ranging from small molecule chemistries to complex protein structures. The company produces small and large molecules and combines the two to target the right part of the body. This involves:

  • Next generation antibody-drug conjugate (ADC) technology, including proprietary linker-drug (LD) technology to generate multiple ADC candidates targeting different indications
  • Monoclonal antibody (mAb) technology
  • Expertise in developing highly selective, disease-targeting small molecules

Beyond the laboratory: clinical pipeline

Byondis takes its innovative portfolio beyond the laboratory, from discovery to clinical drug development, up to and including pivotal clinical studies. This relies on an up-to-date pipeline of new biological and chemical entities.

Byondis CEO Marco Timmers, Ph.D. explained, “We employ the latest insights in tumor biology and patient unmet needs in our search for and development of new mechanisms and new targets for monoclonal antibodies, ADCs and small molecule programs. Our aim is to have a solid pipeline with programs at different development stages.”

Byondis' oncology pipeline has two ADCs in clinical trials, and two in early development.

The lead program, [vic-]trastuzumab duocarmazine (SYD985), combines the anti-HER2 antibody trastuzumab with a synthetic duocarmycin prodrug. [Vic-]trastuzumab duocarmazine targets a broad range of HER2-expressing tumors such as metastatic breast, endometrial, gastric, and urothelial cancers.

"The duocarmycin derivative is delivered as a prodrug, activated only in the tumor, with a short half-life when it reaches the circulation. This reduces the chance of systemic toxicity, as circulating levels of the free payload are negligible in contrast to other ADC platforms,” said Timmers.

“In addition, as a DNA alkylator, rather than a tubulin-binding drug, [vic-]trastuzumab duocarmazine isn't reliant on the tumor cells dividing rapidly," said Timmers. "Uptake of the activated payload by neighboring tumor cells with lower HER2 expression may also improve the efficacy potential, the so-called bystander effect."

[VIC-]TRASTUZUMAB DUOCARMAZINE (SYD985) IS A HER2-TARGETING ANTIBODY-DRUG CONJUGATE (ADC) WITH A THREE WAY MECHANISM OF ACTION

Granted fast track designation from the U.S. Food & Drug Administration based on promising Phase I data from heavily pre-treated last-line HER2-positive metastatic breast cancer patients, [vic-]trastuzumab duocarmazine is in a pivotal Phase III clinical trial for locally advanced or metastatic breast cancer (TULIP®). It is also in two Phase II clinical trials for early-stage breast cancer (I-SPY 2 TRIAL™), and advanced or metastatic endometrial cancer, respectively. And it is undergoing a Phase I trial in combination with the PARP inhibitor niraparib in patients with solid tumors.

Byondis has also initiated a Phase I trial of its second most advanced ADC, SYD1875, that targets 5T4-expressing, locally advanced or metastatic solid tumors, another unmet need. SYD1875 builds on Byondis’ ADC technology with site-specific conjugation of the linker-drug, which results in enhanced in vivo antitumor activity, as demonstrated in preclinical models.

But Byondis is more than an ADC company. Its pipeline also includes an immuno-oncology monoclonal antibody, and a new chemical entity for autoimmune disease in early development.

Beyond the company: partnerships made easy

Byondis’ mission is supported by partnerships with global biotechnology and pharmaceutical companies. Timmers and his business development and licensing team ensure that partnership discussions with pharma, biotech and research institutions move forward as smoothly as possible.

Byondis at a glance

  1. Scientific excellence focussed on a broad spectrum of molecular concepts, ranging from small molecule chemistries to complex protein structures to create innovative precision medicines against relentless cancers and autoimmune diseases
  2. Oncology pipeline includes two ADCs in clinical trials. Two additional ADCs and an immuno-oncology mAb will enter the clinic in the coming two years. The most advanced ADC, [vic-]trastuzumab duocarmazine, is currently undergoing a pivotal Phase III clinical trial for locally advanced or metastatic breast cancer (TULIP®)
  3. Staff of more than 350 includes highly educated scientists and skilled technicians. In-house GMP manufacturing and conjugation facilities for both mAbs and ADCs.

Visit us on the web at www.byondis.com - Follow us on LinkedIn

“We can work with potential partners to create an agreement that is adapted to their needs, from a straightforward licensing deal in return for a fee and milestone payments, to a comprehensive package that includes early and clinical development, manufacturing and supply, IP (intellectual property) and regulatory support,” said Timmers.

Unlike many other mid-sized biopharma companies, Byondis has in-house GMP manufacturing and conjugation facilities for both mAbs and ADCs. The company can support partners by manufacturing quantities up to early commercial launch, either as part of a service for licensees that obtain Byondis’ linker-drug platform technology, or for partners that will commercialize the ADCs developed by Byondis.

Beyond science: making hope real

Byondis’ staff of more than 350 includes highly educated scientists and skilled technicians. “We are scientific and caring, nimble and thorough, independent and collaborative, said Timmers. “We create molecules that matter in the lives of patients – not just symptom-managing, but disease-modifying innovations. We call this ‘making hope real.’”

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