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

• Trial will evaluate the efficacy of AVID100 in TNBC patients with
  EGFR-overexpression
• 20% of TNBC patients highly overexpress EGFR; there is no approved
  targeted therapy
• AVID100 is the most advanced, broadly active anti-EGFR ADC in clinical
  development, targeting both wild-type and mutant forms of EGFR

AUSTIN, Texas & MONTREAL–(BUSINESS WIRE)–lt;a href="https://twitter.com/hashtag/AVID100?src=hash" target="_blank"gt;#AVID100lt;/agt;–Forbius, a clinical-stage company that develops novel biologics for the
treatment of cancer and fibrosis, announced today 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).

Approximately 20% of patients with TNBC have tumors that highly
overexpress EGFR. No targeted therapy is approved for
EGFR-overexpressing TNBC.

The multicenter, dose-expansion, Phase 2a trial (AVID100-01; NCT03094169)
will evaluate the efficacy, safety, and tolerability of AVID100 in
patients with advanced, EGFR-overexpressing, TNBC (IHC 2+/3+). This is
the third cohort launched and follows the previously announced cohorts
evaluating AVID100 in patients with advanced
squamous non-small cell lung cancer (sqNSCLC) and squamous
cell carcinoma of the head and neck (SCCHN). In total, approximately
100 patients will be evaluated across three EGFR-overexpressing tumor
types: sqNSCLC, SCCHN, and TNBC.

About AVID100 and the AVID100-01 Trial

AVID100 is a highly potent EGFR-targeting antibody-drug conjugate (ADC)
engineered to achieve enhanced anti-tumor efficacy without a
corresponding increase in toxicity against skin and other
EGFR-expressing normal tissues. In preclinical studies, AVID100
demonstrated significant anti-cancer activity in EGFR-overexpressing
tumor models resistant to marketed EGFR inhibitors. AVID100 is the most
advanced, broadly active anti-EGFR ADC in clinical development and
targets both wild-type and mutant forms of EGFR.

A recommended Phase 2 dose (RP2D) of 220 mg/m² (~6mg/kg) was
established for AVID100 in a completed Phase 1 study. This RP2D is
expected to be in the therapeutically active range based on preclinical
efficacy studies. The majority of treatment related adverse events in
the Phase 1 trial at RP2D were well-tolerated and grade 1 or 2 in
severity.

AVID100-01 (NCT03094169)
is an open label, multicenter, dose-expansion study to evaluate the
efficacy, safety, and tolerability of AVID100 in patients with confirmed
EGFR-overexpressing sqNSCLC (IHC 3+), SCCHN (IHC 3+), and TNBC (IHC
2+/3+) (more than 50% of cells with EGFR 3+ or more than 75% of cells
with EGFR 2+ staining).

About Forbius: Targeting TGF-beta and EGFR Pathways in Fibrosis and
Cancer

Forbius is a clinical-stage protein engineering company that designs and
develops novel biologics for the treatment of fibrosis and cancer. Our
current focus is on the development of agents that target the
transforming growth factor-beta (TGF-beta) and the epidermal growth
factor receptor (EGFR) pathways. For more information, please
visit www.forbius.com.

Contacts

Ilia A. Tikhomirov
[email protected]