SYD-3521 is under clinical development by Byondis and currently in the Phase I in clinical pathway. The characteristics of the clinical trial as well as other attributes related to the drug, regulations, and company play a fundamental role in ensuring the likelihood of transition that the drug moves from its current development stage to next.

According to GlobalData, the latest event to affect SYD-3521’s likelihood of approval (LoA) and phase transition for Solid Tumor took place on 27 Jun 2022, which decreased the likelihood that the drug progresses to the next phase in its clinical pathway.

GlobalData uses proprietary data and analytics to provide a complete picture of this assessment in their SYD-3521 Likelihood of Approval (LoA) and Phase Transition Success Rate (PTSR) Report.

SYD-3521 overview

SYD-3521 is under development for the treatment of solid tumor, uveal melanoma, clear cell renal cell carcinoma (ccRCC), papillary renal cell carcinoma (PRCC) and head and neck squamous cell carcinoma. The therapeutic candidate is an antibody conjugated with member of the class duocarmycins (cytotoxic agent). It is developed based on antibody drug conjugate (ADC) platform. It is a new molecular entity.

Byondis overview

Byondis, formerly Synthon Biopharmaceuticals, focuses on the discovery and development of innovative precision medicines for the treatment of auto-immune diseases including cancer. The company offers biosimilar of trastuzumab, a monoclonal antibody indicated for the treatment of breast and stomach cancers. It is advancing its lead candidate: SYD985, a novel duocarmycin-based HER2-targeting antibody drug conjugate (ADC), and a portfolio of preclinical and clinical programs with an aim to provide novel treatments for solid tumours that overexpress HER2, uterine serous carcinoma and auto-immune diseases. It harnesses its proprietary linker-drug (LD) technology to generate ADCs targeting treatment for different indications. The company works in collaboration with pharmaceutical companies including Amgen, Allergan and Macrogenics; academic institutions; and medical communities worldwide. Byondis is headquartered in Nijmegen, Gelderland, the Netherlands.

Quick View SYD-3521 LOA Data

Report Segments
  • Innovator
Drug Name
  • SYD-3521
Administration Pathway
Therapeutic Areas
  • Oncology
Key Developers
Highest Development Stage
  • Phase I

GlobalData, the leading provider of industry intelligence, provided the underlying data, research, and analysis used to produce this article.

GlobalData’s Likelihood of Approval analytics tool dynamically assesses and predicts how likely a drug will move to the next stage in its clinical pathway (PTSR), as well as how likely the drug will be approved (LoA). This is based on a proprietary algorithm built from the drugs’ sales forecast, regulatory milestones, cost forecasts, WACC rate and other proprietary data sources found on GlobalData’s Pharmaceutical Intelligence Center.