Netherlands-based Synthon Biopharmaceuticals, a biopharmaceutical research, and development company creating innovative precision medicines including the anti-HER2 investigational antibody-drug conjugate (ADC) [vic-]trastuzumab duocarmazine, previously known as SYD985 for the treatment breast cancer, has been relaunched as Byondis.

Byondis is creating safe and effective precision medicines based on its proprietary technologies, targeting intractable cancers and auto-immune diseases, which aim to improve the standard of care for patients.

Trastuzumab duocarmazine
Trastuzumab duocarmazine is an ADC composed of the recombinant humanized anti-epidermal growth factor receptor 2 (HER2) monoclonal antibody trastuzumab linked, via a cleavable linker, to the duocarmycin prodrug seco-duocarmycin-hydroxybenzamide-azaindole, also known as seco-DUBA.

The investigational agent is part of a wave of HER2 directed antibody-drug conjugates under clinical investigation and recently improved agents, including trastuzumab deruxtecan (Enhertu®; Daiichi Sankyo/AstraZeneca) for HER2 amplified but also HER2 expressing but not amplified breast tumors. [1][2] In addition, these novel ADCs have demonstrated to offer activity in low HER2-expressing tumors.

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Furthermore, in contrast to trastuzumab emtansine (T-DM1; Kadcyla®; Genentech/Roche), an ADC approved for the treatment of HER2 positive breast cancer, trastuzumab duocarmazine demonstrated that the resistance to seen with trastuzumab emtansine can be overcome with an improved design.[3]

Byondis is expecting results from its pivotal TULIP® Phase III trial (NCT03262935) in the second half of 2020. The study compares trastuzumab duocarmazine to physician’s choice treatment in patients with HER2-positive unresectable locally advanced or metastatic breast cancer. Submission of a Biological License Application (BLA) is scheduled before the end of 2020.

New development programs
The company, in a statement, confirmed that it anticipates entering the clinic with four additional programs in the course of 2020/2021. After progressing to clinical proof of concept, the company intends to enter into partnerships for late-stage development and commercialization.

Byondis, established as Synthon Biopharmaceuticals 2007 as a part of Synthon, became a separate biopharmaceutical subsidiary in 2012, quickly building a promising pipeline of innovative R&D programs. In November 2019, following the acquisition of Synthon International Holding by BC Partners, Jacques Lemmens, MD, the company’s founder, decided that the company should continue as an independent biopharmaceutical company, with its own management team and state-of-the-art facilities. This company relaunched as Byondis.

“Our relaunch as Byondis is an exciting moment for the Company,” Lemmens said. “Building on our heritage, while preserving our company culture, we are further progressing in innovation, quality, and scientific excellence.”

“Now is the time to step up as an independent biopharmaceutical company, with our exceptional people, unique technologies, and a well-established development pipeline, including trastuzumab duocarmazine. I am very proud of how [we have] grown and evolved. The company’s new name, Byondis, represents the next chapter and embodies our entrepreneurial spirit and ambition to create innovative precision medicines to outsmart cancers and auto-immune diseases,” Lemmens added.

Experience and Expertese
The Byondis management team has a wealth of scientific, clinical, and operational experience, and is well networked within the pharmaceutical industry. Marco Timmers, Ph/D., the company’s Chief Executive Officer, and others in the senior team have collaborated for many years as part of Synthon. During this time, they created a company driven by science and innovation, with unique technologies and significant validation deals, include out-licensing a trastuzumab biosimilar (trastuzumab-anns; Kanjinti™) in a global partnership agreement with Amgen in 2012.

“As Byondis, we can now showcase our strong business and scientific proposition,” Timmers added. “We have generated a portfolio of preclinical and clinical programs with the potential to deliver completely novel treatments for cancer and auto-immune diseases. We have unique technologies with differentiating potential, state-of-the-art facilities including our own GMP manufacturing, and broad licensing expertise that makes us an attractive partner for out-licensing. This is a really exciting time for Byondis and our team.”

Byondis is based in Nijmegen, the Netherlands, with over 350 highly qualified employees working in state-of-the-art research and development and GMP manufacturing facilities. The company has established long-term worldwide partnerships with global biotech and pharma companies and works in close collaboration with national and international academic research institutions.

Clinical trials
SYD985 vs. Physician’s Choice in Participants With HER2-positive Locally Advanced or Metastatic Breast Cancer (TULIP) – NCT03262935
First-in-human Study With the Antibody-drug Conjugate SYD985 to Evaluate Safety and Efficacy in Cancer Patients – NCT02277717
Phase I Study of SYD985 With Niraparib in Patients With Solid Tumors – NCT04235101
SYD985 in Patients With HER2-expressing Recurrent, Advanced or Metastatic Endometrial Carcinoma – NCT04205630

[1] Rinnerthaler G, Gampenrieder SP, Greil R. HER2 Directed Antibody-Drug-Conjugates beyond T-DM1 in Breast Cancer. Int J Mol Sci. 2019 Mar 5;20(5). pii: E1115. doi: 10.3390/ijms20051115.
[2] Xu Z, Guo D, Jiang Z, et al. Novel HER2-Targeting Antibody-Drug Conjugates of Trastuzumab Beyond T-DM1 in Breast Cancer: Trastuzumab Deruxtecan(DS-8201a) and (Vic-)Trastuzumab Duocarmazine (SYD985). Eur J Med Chem. 2019;183:111682. doi:10.1016/j.ejmech.2019.111682
[3] Nadal-Serrano M, Morancho B, Escrivá-de-Romaní S, et al. The Second Generation Antibody-Drug Conjugate SYD985 Overcomes Resistances to T-DM1. Cancers (Basel). 2020;12(3):670. Published 2020 Mar 13. doi:10.3390/cancers12030670

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