US-based biotechnology firm Advaxis is planning to start a clinical development programme with an immunotherapy, ADXS-cHER2, to treat paediatric osteosarcoma.

The company’s product candidate, ADXS-cHER2 targets the HER2 oncogene, which is overexpressed in certain solid-tumour cancers, including paediatric bone cancer and breast cancer.

In a veterinarian clinical trial, pet dogs with naturally occurring osteosarcoma treated with ADXS-cHER2 after the standard of care showed a statistically significant prolonged overall survival benefit compared with dogs that received standard of care without ADXS-cHER2.

The company said that both veterinary and human osteosarcoma specialists consider canine osteosarcoma to be the best model for human osteosarcoma.

Based on this data, the company intends to start a clinical development programme in paediatric patients with osteosarcoma.

In the US, an estimated 400 children and teenagers are affected by paediatric osteosarcoma every year, representing a small but significant unmet medical need.

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The disease may qualify for regulatory incentives including, but not limited to, orphan drug designation, patent term extension, market exclusivity, and development grants.

Advaxis chief scientific officer Robert Petit said the clinical activity seen with ADXS-cHER2 in preventing recurrence of osteosarcoma in pet dogs provides a strong rationale that this treatment has the potential to benefit paediatric osteosarcoma.

“We intend to move forward with the clinical development of ADXS-cHER2 for the treatment of pediatric osteosarcoma as expeditiously as possible.”

“We are grateful to the Sarcoma Foundation of America for this opportunity to present these data in canine osteosarcoma and look forward to working with them as we translate what we have learned from the canine study into developing ADXS-cHER2 for the treatment of osteosarcoma in pediatric patients,” Petit said.

Currently, the company is carrying out the required pre-IND activities to support the development of ADXS-cHER2 in HER2 overexpressing cancers.

Advaxis CEO Daniel O’Connor said the parallel between canine and paediatric bone cancer, along with company’s data in pet dogs, strongly supports its decision to pursue a clinical programme with ADXS-cHER2 in paediatric osteosarcoma.

“Success with ADXS-cHER2 in osteosarcoma will provide Advaxis with a high-degree of confidence to rapidly pursue larger markets in HER2 overexpressing cancers,” O’Connor said.

“We intend to move forward with the clinical development of ADXS-cHER2 for the treatment of pediatric osteosarcoma as expeditiously as possible.

“Osteosarcoma in children is a small and tragically underserved market in which Advaxis immunotherapy could provide a significant advancement.”

Osteosarcoma is the most common type of bone cancer in children and young adults. It usually develops in areas where the bone is growing quickly, such as near the ends of the long bones.

Image: High-magnification micrograph of a high-grade osteosarcoma. Photo: courtesy of Nephron.