An Update: Experimental EGFR/HER2 Tumor Vaccine Study

From Prof Mark Mamula

The following is an update (July 6, 2023) provided by Prof. Mamula and the EGFR/HER2 vaccine research team at Yale University and Therajan.

As many of you know, we recently expanded the number of hospitals that are participating in the vaccine study. While this is an exciting step in our pursuit of making this therapy more widely available, the number of pet owners seeking enrollment of their dogs in the study has far exceeded our current production capabilities. We are hopeful that the information below provides clarity about the study requirements and vaccine availability.

• This is a USDA-regulated scientific study with the goal of obtaining approval that will allow greater availability of the vaccine to treat more dogs. This study has specific criteria and requirements that are regulated by the USDA. It is imperative that we adhere to the protocol and obtain the required samples and data. Drs. Mamula and Doyle or Yale University do not qualify or approve individual patients for entry into the clinical trial. Eligibility is determined by individual clinical sites.

• At this time, we are limiting study enrollment to dogs with confirmed osteosarcoma, hemangiosarcoma, and transitional cell carcinoma. Dogs with other types of tumors already on a wait list may be eligible for enrollment.

• The vaccine is currently provided to the study sites and owner at no charge. As this is not a fully funded study, all costs associated with evaluation, testing, and vaccine administration are the responsibility of the owner. If the vaccine receives approval, it will no longer be provided at no cost.

Study Enrollment Criteria

• Histologically (biopsy) confirmed diagnosis of osteosarcoma, hemangiosarcoma, or transitional cell carcinoma. An exception may be made if the dog has a long bone (limb) lesion consistent with osteosarcoma and the owner has elected not to pursue amputation. If amputation is planned, the first dose of vaccine can be administered following the amputation.

• Anticipated survival of greater than 3 months as determined by the evaluating oncologist.

• While dogs with metastases may be enrolled in the study, this will be based on the extent/volume of the disease and prognosis.

• Dogs cannot be enrolled if they are receiving other immunotherapies or alternative therapies or are enrolled in another clinical study. Traditional chemotherapy and radiation therapy are allowed.

Required testing is listed below. All costs associated with evaluation and testing are the responsibility of the pet owner and are not covered by the study. You will be provided a cost estimate for all required and any additional recommended testing.

• Chest x-rays, CBC, biochemical profile, and urinalysis at baseline prior to vaccine administration. Testing completed within seven days will likely be acceptable.

• Chest x-rays must be repeated at 3, 6, and 9 months

• A blood sample will be collected at each visit (baseline, day 21, day 40-50, 3 months, 6 months, 9 months) for research purposes.

Strict adherence to the vaccine administration guidelines is required. A booster vaccine must be given 21 days following the initial dose. It is allowable to administer the booster 1 day early or up to 5 days late if necessary due to appointment availability or if the administration day falls on a weekend or holiday.

Due to the limited supply of the vaccine, hospitals are being asked to limit enrollment to 5 new dogs per week.

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We'll be continuing to provide updates on this page.

This vaccine is being made available to hundreds of dogs as part of a clinical study, thanks to your generous support.