Oncophage®
Oncophage (vitespen; formerly HSPPC-96) is a patient-specific therapeutic cancer vaccine tested in over 800 patients in multiple cancers in more than 15 Phase 1, 2 and 3 clinical trials. Oncophage is approved in Russia for the adjuvant treatment of kidney cancer patients at intermediate-risk for disease recurrence. Oncophage contains the heat shock protein, gp96, and associated peptides which are purified from the patients’ own tumor tissue and has been the primary focus of Antigenics’ research and development efforts since the company’s founding. Treatment with Oncophage is designed to target only cancerous cells — not healthy normal cells. As a result, Oncophage is designed to limit the toxicities associated with traditional broad-acting cancer treatments.
Oncophage first entered the clinic in the 1990’s where it was studied in a number of different tumor types in advanced disease settings. The objectives of these early Phase 1/2 trials were to assess the feasibility of vaccine manufacture and corresponding logistics, safety and to identify signals of activity. The early findings supported the initiation and completion of two Phase 3 randomized trials in stage IV melanoma and adjuvant renal cell carcinoma (RCC).
The accumulated clinical data has revealed a pattern of findings that is entirely consistent with the biological premise:
- Oncophage is well tolerated and has demonstrated a very low toxicity profile
- Oncophage elicits tumor-specific T cell responses and innate immune response irrespective of tumor type
- Oncophage efficacy is most significant in patients with early-stage disease/ low tumor burden (patients with better prognostic features)
To make Oncophage, patients first have surgery to remove part or all of the cancerous tissue, and the tumor tissue is shipped frozen to Antigenics’ state-of-the-art GMP manufacturing facility in Massachusetts. The facility is capable of making vaccine for 10,000 patients with on site expansion to enable vaccine production for 100,000 patients. Using a proprietary, standardized, quality-controlled procedure, the product is isolated from the tumor in 8-10 hours. The product is sterile-filtered, packaged in vials, and shipped frozen back to the hospital pharmacy or clinician for use when the patient has recovered from surgery.
Oncophage is administered as a simple weekly or biweekly intradermal injection during an office visit.
Oncophage received fast track and orphan drug designations from the US Food and Drug Administration (FDA) for both kidney cancer and metastatic melanoma as well as orphan drug designation from the EMEA for kidney cancer. In 2009, Oncophage also received orphan drug designations from the FDA and EMEA for glioma. Antigenics has developed crucial management and logistics expertise in patient-specific vaccines.