BYON3521 / Byondis - LARVOL DELTA

Understanding the Chemical Characteristics of Payloads and the Expression of Tumor-Associated Antigens of ADCs in Clinical Development. (PubMed, ACS Omega) - "Regarding the conjugation type, only trastuzumab deruxtecan, labetuzumab govitecan, sacituzumab govitecan, BYON3521, and SYD1875 used homogeneous conjugation. An interesting observation was that for some ADCs, TAA expression was higher in normal tissue than in the tumor. In summary, our analysis highlights that only a limited number of ADCs incorporate payloads with favorable physicochemical properties and that several ADCs currently under development target TAAs with higher expression in normal tissues than in the corresponding tumors."

Journal • Review • Oncology • EGFR • FOLR1 • HER-2

BYON3521.001: A First-in-human Dose-escalation and Expansion Study With the Antibody-drug Conjugate BYON3521 (clinicaltrials.gov) - P1 | N=31 | Completed | Sponsor: Byondis B.V. | Active, not recruiting ➔ Completed

Trial completion • Endometrial Cancer • Lung Cancer • Lung Non-Squamous Non-Small Cell Cancer • Melanoma • Non Small Cell Lung Cancer • Ovarian Cancer • Solid Tumor • MET

BYON3521.001: A First-in-human Dose-escalation and Expansion Study With the Antibody-drug Conjugate BYON3521 (clinicaltrials.gov) - P1 | N=31 | Active, not recruiting | Sponsor: Byondis B.V. | Recruiting ➔ Active, not recruiting | N=120 ➔ 31 | Trial completion date: Mar 2025 ➔ Jul 2024 | Trial primary completion date: Jan 2025 ➔ Jul 2024

Enrollment change • Enrollment closed • Metastases • Trial completion date • Trial primary completion date • Endometrial Cancer • Gastrointestinal Cancer • Lung Cancer • Lung Non-Squamous Non-Small Cell Cancer • Melanoma • Non Small Cell Lung Cancer • Oncology • Ovarian Cancer • Solid Tumor • MET

Translational Pharmacology of a Novel Site-Specifically Conjugated Anti-c MET Antibody Drug Conjugate BYON3521 (ADC-USA 2023) - "Discussing how BYON3521 has demonstrated potent and selective killing of c-MET expressing tumor cells in preclinical models, even at low c-MET expression levels; Describing how the ongoing dose-escalation part of the first-in-human (FiH) clinical study showed that the human PK was in line with the predicted preclinical in vivo PK.; Outlining the initial FiH study data which indicates that BYON3521 is well-tolerated up to 4.8 mg/kg"

Oncology • MET

First in human dose-escalation trial with the c-MET targeting antibody-drug conjugate BYON3521 (AACR 2023) - P1 | "To date, BYON3521 is well-tolerated with no DLTs at the investigated dose levels. Patient enrollment is ongoing and updated safety, efficacy and pharmacokinetic data will be presented. After the dose-escalation phase the trial will continue with expanded cohorts of patients with specific c-MET expressing cancer types."

P1 data • Colorectal Cancer • Esophageal Cancer • Gastrointestinal Cancer • Genito-urinary Cancer • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Pancreatic Cancer • Renal Cell Carcinoma • Solid Tumor • MET

Preclinical profile of BYON3521 predicts an effective and safe c-MET-antibody-drug conjugate. (PubMed, Mol Cancer Ther) - P1 | "In all, our nonclinical data suggests that BYON3521 is a safe ADC with potential for clinical benefit in patients. A first-in-human dose escalation study is currently ongoing to determine the maximum tolerated dose and recommended dose for expansion (NCT05323045)."

Journal • Preclinical • Oncology • Solid Tumor • HGF • MET

Preclinical Data on the Potential of Byondis ADC BYON3521 Published in Molecular Cancer Therapeutics (PRNewswire) - "Byondis B.V...announced that Molecular Cancer Therapeutics (an American Association for Cancer Research journal) has published encouraging preclinical data on its investigational, next generation antibody-drug conjugate (ADC) BYON3521....The data from in vitro and in vivo studies showed that BYON3521 potently and selectively kills tumor cells expressing c-MET, even at low c-MET-expressing levels. In addition, the nonclinical safety evaluation showed that BYON3521 is well tolerated, predicting a substantial clinical therapeutic window."

Preclinical • Oncology • Solid Tumor

Byondis Initiates Phase I Study of Next Generation Antibody-Drug Conjugate BYON3521 (PRNewswire) - "Byondis B.V....announced that the first cancer patients have been dosed with its investigational antibody-drug conjugate (ADC) BYON3521. The 'First-in-Human Dose-Escalation and Expansion Trial With the Antibody-Drug Conjugate BYON3521 to Evaluate the Safety, Pharmacokinetics and Efficacy in Patients with c-MET-Expressing Locally Advanced or Metastatic Solid Tumors' (BYON3521.001/NCT05323045) is currently enrolling patients in leading oncology centers in Belgium, Italy, the Netherlands and the U.K."

Trial status • Oncology • Solid Tumor

A First-in-human Dose-escalation and Expansion Study With the Antibody-drug Conjugate BYON3521 (clinicaltrials.gov) - P1 | N=120 | Recruiting | Sponsor: Byondis B.V.

New P1 trial • Head and Neck Cancer • Melanoma • Oncology • Renal Cell Carcinoma • Solid Tumor • Squamous Cell Carcinoma of Head and Neck • MET

[VIRTUAL] BYON3521, a novel effective and safe c-Met targeting antibody-drug conjugate (AACR 2021) - "In all, BYON3521 was deemed a safe ADC with potential for clinical benefit in patients. Preparations are ongoing to start clinical Phase I in 2021."

Oncology • Solid Tumor • MET