HER2-Associated Cancers

ADXS-HER2 has received orphan drug designation from the FDA and EMA for the treatment of osteosarcoma. In April 2016 ADXS-HER2 was granted Fast Track Designation by the FDA for treatment of patients with newly diagnosed, non-metastatic, surgically-resectable osteosarcoma.

ADXS-HER2 is being evaluated in a first-in-human Phase 1b dose-escalation clinical study for the treatment of patients with metastatic HER2-expressing solid tumors. The dose escalation portion of the study will investigate the safety and tolerability of ADXS-HER2 as a monotherapy in patients diagnosed with metastatic HER2-expressing solid tumors. Results from the study will be used to determine the future clinical development program of ADXS-HER2.

Advaxis plans to conduct a pivotal trial in pediatric osteosarcoma in collaboration with Children’s Oncology Group (COG).

Advaxis has seen encouraging data in naturally occurring canine osteosarcoma, which is considered a proxy for human osteosarcoma. Osteosarcoma is the most common primary bone tumor in pet dogs, accounting for roughly 85 percent of tumors on the canine skeleton.¹ More than 10,000 dogs per year (predominately middle- to older-aged dogs and larger breeds) are diagnosed with osteosarcoma in the United States.^{1 2}

Advaxis has licensed ADXS-HER2 and three other immunotherapy constructs to Aratana Therapeutics, Inc. for the development of animal therapeutics.

Preliminary data have demonstrated ADXS-HER2, in combination with palliative radiation, delayed tumor progression and prolonged overall survival in pet dogs with treatment-naïve spontaneous Canine Osteosarcoma. Repeat doses of ADXS-HER2 were well tolerated with no systemic or cardiac toxicity.