AVID100 / BMS - LARVOL DELTA

Novel anti-EGFR antibody-drug conjugate AVID100: A phase 2a trial in patients with EGFR-overexpressing advanced solid tumors (AACR-NCI-EORTC 2019) - P1a; "sqNSCLC and HNSCC patients with EGFR IHC of 3+ as well as mTNBC patients whose EGFR IHC shows 3+ intensity in ≥ 50% of tumor cells, or ≥ 2+ intensity in ≥ 75% of tumor cells, are eligible to enroll. Conclusions A significant proportion of retrospectively assessed sqNSCLC, HNSCC and TNBC patient samples were found to overexpress the EGFR. The prospective Phase 2a trial assessing AVID100, a novel growth factor receptor function-blocking anti-EGFR ADC, remains ongoing and updated results will be presented at the meeting."

Clinical • P2a data • Breast Cancer • Head and Neck Cancer • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • Squamous Cell Carcinoma of Head and Neck • Thoracic Cancer • Triple Negative Breast Cancer

A Phase Ia/IIa trial of AVID100, an anti-EGFR antibody-drug conjugate (AACR 2019) - "Prolonged disease stabilization was observed in 3 of these patients not selected for EGFR overexpression (colorectal, ovarian, cervical).ConclusionsAVID100 is a well-tolerated anti-EGFR-DM1 conjugate with evidence for exposure levels at or above those observed for cetuximab and ado-trastuzumab emtansine. Antitumor activity is currently being evaluated in EGFR-overexpressing patients in Phase IIa."

P1/2 data • Breast Cancer • Head and Neck Cancer • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Squamous Cell Carcinoma of Head and Neck • Thoracic Cancer • Triple Negative Breast Cancer

AVID100 in Advanced Epithelial Carcinomas (clinicaltrials.gov) - P1a; N=30; Recruiting; Sponsor: Formation Biologics

Clinical • New P1 trial • Breast Cancer • Head and Neck Cancer • Lung Cancer • Lung Non-Small Cell Squamous Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • Squamous Cell Carcinoma • Squamous Cell Carcinoma of Head and Neck • Triple Negative Breast Cancer • EGFR

AVID100 in Advanced Epithelial Carcinomas (clinicaltrials.gov) - P1a; N=90; Recruiting; Sponsor: Formation Biologics; N=30 ➔ 90; Trial completion date: Aug 2019 ➔ Jun 2020; Trial primary completion date: Apr 2019 ➔ Sep 2019

Clinical • Enrollment change • Trial completion date • Trial primary completion date • Breast Cancer • Head and Neck Cancer • Lung Cancer • Lung Non-Small Cell Squamous Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • Squamous Cell Carcinoma • Squamous Cell Carcinoma of Head and Neck • Thoracic Cancer • Triple Negative Breast Cancer • EGFR

AVID100 in Advanced Epithelial Carcinomas (clinicaltrials.gov) - P1a; N=90; Recruiting; Sponsor: Formation Biologics; Trial completion date: Jun 2020 ➔ Dec 2020; Trial primary completion date: Sep 2019 ➔ Sep 2020

Clinical • Trial completion date • Trial primary completion date • Breast Cancer • Head and Neck Cancer • Lung Cancer • Lung Non-Small Cell Squamous Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • Squamous Cell Carcinoma • Squamous Cell Carcinoma of Head and Neck • Thoracic Cancer • Triple Negative Breast Cancer • EGFR

AVID100 in Advanced Epithelial Carcinomas (clinicaltrials.gov) - P1a; N=49; Terminated; Sponsor: Formation Biologics; N=90 ➔ 49; Active, not recruiting ➔ Terminated; lack of efficacy

Clinical • Enrollment change • Trial termination • Breast Cancer • Head and Neck Cancer • Lung Cancer • Lung Non-Small Cell Squamous Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • Squamous Cell Carcinoma • Squamous Cell Carcinoma of Head and Neck • Triple Negative Breast Cancer • EGFR

AVID100 in Advanced Epithelial Carcinomas (clinicaltrials.gov) - P1a; N=90; Active, not recruiting; Sponsor: Formation Biologics; Recruiting ➔ Active, not recruiting

Clinical • Enrollment closed • Breast Cancer • Head and Neck Cancer • Lung Cancer • Lung Non-Small Cell Squamous Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • Squamous Cell Carcinoma • Squamous Cell Carcinoma of Head and Neck • Triple Negative Breast Cancer • EGFR

Newly added product (Forbius Press Release) - P2, Non Small Cell Lung Cancer, Squamous Cell Carcinoma of Head and Neck, Triple Negative Breast Cancer

Pipeline update • Breast Cancer • Non Small Cell Lung Cancer • Oncology • Squamous Cell Carcinoma of Head and Neck • Triple Negative Breast Cancer

Forbius: phase 2 clinical data with tumor-selective anti-EGFR ADC AVID100 featured at AACR-NCI-EORTC and World ADC San Diego (Businesswire) - “Forbius…will today present the first clinical data from its Phase 2 development program with novel, tumor-selective anti-EGFR ADC AVID100 at the 10th Annual World ADC in San Diego (Oct. 8 – 11). AVID100 clinical data will also be featured in an upcoming poster presentation at the AACR-NCI-EORTC meeting in Boston (Oct. 26 – 30).”

P2 data

Forbius announces first patient dosed in phase 2a EGFR-overexpressing triple negative breast cancer (TNBC) trial of AVID100, a novel, tumor-specific anti-EGFR ADC (Businesswire) - "Forbius...announced...that the first patient has been dosed in a Phase 2a triple negative breast cancer (TNBC) clinical trial with AVID100, a novel, tumor-specific anti-epidermal growth factor receptor (EGFR) antibody-drug conjugate (ADC)."

Enrollment open

AVID100 is an anti-EGFR ADC that promotes DM1-meditated cytotoxicity on cancer cells but not on normal cells (AACR 2019) - "AVID100 has completed a Phase 1 clinical trial with the recommended Phase 2 dose having been determined. The Phase 2 trial of AVID100 is ongoing."

Forbius’ AVID100, a novel anti-EGFR ADC, reports positive phase 1 data at AACR: Exceptionally high RP2D established, phase 2 in SCCHN and sqNSCLC ongoing (Businesswire) - "Forbius...announces today that it will report the results from its Phase 1 dose-finding trial with novel, tumor selective, anti-epidermal growth factor receptor (EGFR) antibody-drug conjugate (ADC) AVID100 at the AACR Annual Meeting 2019. An additional AACR poster presentation will feature preclinical data confirming AVID100’s novel mechanism of action, which potently targets tumor cells while sparing EGFR-expressing non-tumor cells."

P1 data • Preclinical

Forbius announces first patient dosed in phase 2a squamous cell carcinoma of the head and neck (SCCHN) trial of AVID100, a novel anti-EGFR ADC (Businesswire) - "Forbius, a clinical-stage company that develops novel biologics for the treatment of fibrosis and cancer, announced today that the first patient has been dosed in a Phase 2a squamous cell carcinoma of the head and neck (SCCHN) clinical trial."

Enrollment open