ONT-10 / Pfizer - LARVOL DELTA

Oncothyreon: Clinical Trial Update (Oncothyreon) - “ONT-10 has been well tolerated at doses through 2000 μg administered weekly over an 8-week period and when administered once every 6 weeks for up to two years”; “Consistent with preclinical data, ONT-10 induces IgM and IgG anti-MUC1 response in the majority of patients, with titers frequently exceeding 1:50,000”; “IgG response dose and schedule dependent, with greatest response seen at 1000–2000 μg QW”; “Encouraging disease control in patients with heavily pretreated and incurable cancers, with > 70% of patients without progression by irRC at Week 12, and 11 patients to date without progression for > 6 months”

P1 data • Oncology

Oncothyreon: Clinical Trial Update (Oncothyreon) - “ONT-10 has been well tolerated at doses through 1000 μg administered Q2W or QW over an 8-week period and when administered every 6 weeks as maintenance therapy for up to 11 months”; “Consistent with preclinical data, ONT-10 induces IgM and IgG anti-MUC1 response in the majority of patients, with titers frequently exceeding 1: 50,000”; “The data support a schedule and dose response, with the greatest IgG response to date occurring at the highest weekly dose tested, 1000 μg QW”; “T cell response analysis is ongoing. Preliminary evidence of induction of a T cell response has been seen using CD28/CD49d-costimulation in the ELISPOT assay”; “Encouraging disease control has been seen in patients with heavily pretreated and incurable cancers, and greater than 50% of patients have enrolled in the maintenance study”

P1 data • Oncology

Study of ONT-10 and Varlilumab to Treat Advanced Ovarian or Breast Cancer (clinicaltrials.gov) - P1; N=42; Not yet recruiting; Sponsor: Oncothyreon Inc.

Clinical • New P1 trial

Study of ONT-10 and Varlilumab to Treat Advanced Ovarian or Breast Cancer (clinicaltrials.gov) - P1b; N=22; Completed; Sponsor: Cascadian Therapeutics Inc.; Active, not recruiting ➔ Completed; Phase classification: P1 ➔ P1b; N=42 ➔ 22; Trial primary completion date: Dec 2016 ➔ Jun 2016

Clinical • Enrollment change • Phase classification • Trial completion • Trial primary completion date

Study of ONT-10 and Varlilumab to Treat Advanced Ovarian or Breast Cancer (clinicaltrials.gov) - P1; N=42; Recruiting; Sponsor: Oncothyreon Inc.; Not yet recruiting ➔ Recruiting

Clinical • Enrollment open

Study of ONT-10 and Varlilumab to Treat Advanced Ovarian or Breast Cancer (clinicaltrials.gov) - P1; N=42; Active, not recruiting; Sponsor: Oncothyreon Inc.; Recruiting ➔ Active, not recruiting

Clinical • Enrollment closed