Advaxis has received orphan drug designation (ODD) from the US Food and Drug Administration’s (FDA) Office of Orphan Products Development for its ADXS-cHER2, indicated for treatment of osteosarcoma.
ADXS-cHER2 immunotherapy is being developed by Advaxis to target the HER2 receptor that is overexpressed in certain solid-tumour cancers, including pediatric bone cancer, breast cancer and gastric cancer.
The company is developing ADXS-cHER2 for both human and animal health.
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Based on interim findings in an ongoing clinical study in canine osteosarcoma, the company is planning to begin a clinical development programme with ADXS-cHER2 in pediatric patients with osteosarcoma.
Advaxis CEO Daniel J O’Connor said that the orphan drug designation for ADXS-cHER2 in osteosarcoma is a key value driver for the company and will facilitate its ability to conduct clinical trials to more fully understand the potential for ADXS-cHER2 in osteosarcoma populations.
"The osteosarcoma ODD follows the recent ODD of ADXS-HPV in invasive cervical cancer," O’Connor said.
"These designations highlight the potential of our proprietary immunotherapy platform and the opportunity that it may offer in the treatment of several underserved cancer indications.
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By GlobalData"Looking ahead, Advaxis is now planning to initiate a clinical development programme in pediatric osteosarcoma with ADXS-cHER2.
"Given the limited availability of new treatment options for pediatric osteosarcoma, we believe that, subject to regulatory approval and upon completion of successful clinical trials, the potential to be on the market may be accelerated."
Until now, safety and efficacy of ADXS-cHER2 have been assessed in an ongoing veterinary clinical study in client-owned (pet) dogs with osteosarcoma.
This clinical study showed that dogs treated with ADXS-cHER2 immunotherapy after the standard of care (amputation and follow up chemotherapy) had a statistically significant prolonged overall survival rate compared with dogs that received standard of care without ADXS-cHER2.
Image: X-ray of osteosarcoma of the distal femur in a dog. Photo: courtesy of Joelmills.
