The patient is waiting

Every meaningful step forward is a welcome advancement for patients. That's why we're collaborating with world-class clinicians to better understand where the Prophage Series cancer vaccine candidates will have the greatest impact and can be most rapidly commercialized. The first product in the R-Series (R-100, registered in Russia as Oncophage® vaccine), represents the only approved treatment for adjuvant or non-metastatic kidney cancer patients at intermediate risk for disease recurrence.

Introduction

The Prophage Series vaccines describe our portfolio of patient-specific therapeutic cancer vaccine candidates, which have been tested in more than 850 patients in multiple cancers in more than 15 Phase 1, 2, and 3 clinical trials. Included in the Prophage Series are the R-Series candidates in renal cell carcinoma (RCC), M-Series candidates in melanoma, G-Series candidates in glioma, and NP-Series candidate in pediatric neurological tumors.

Vaccine candidates in the Prophage Series contain the heat shock protein, gp96 and associated peptides that are purified from the patients’ own tumor tissue. It has been the primary focus of Agenus’ research and development efforts since the company’s founding.

Treatment with the Prophage Series cancer vaccine candidates is designed to target only cancerous cells — not healthy normal cells. As a result, Prophage Series candidates are designed to limit the toxicities associated with traditional broad-acting cancer treatments.

Prophage Series candidates are administered as a simple weekly or biweekly intradermal injection.

Agenus and NewVac LLC (a subsidiary of ChemRar High Tech Center and resident of the Skolkovo Innovation Center in Russia), a company focused on the development of innovative technology for cancer immunotherapy, have formed a license, development and manufacturing technology transfer agreement for Agenus’ Oncophage® (HSPPC-96 ; vitespen) vaccine. Oncophage is approved in Russia for the treatment of renal cell carcinoma ("RCC”; kidney cancer) in patients at intermediate risk of recurrence. Under the agreement, Agenus has granted NewVac an exclusive license to manufacture, market and sell Oncophage as well as pursue a development program of Oncophage in combination with NewVac’s co-adjuvant technology in the Russian Federation and CIS countries.

Progress

Prophage Series R-100 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 2008, R-100 was approved, as Oncophage® vaccine, an adjuvant treatment for patients with renal cell carcinoma who are at intermediate risk for recurrence. In 2009, Prophage Series G-100 received orphan drug designations from the FDA and EMEA for glioma. Agenus has developed crucial management and logistics expertise in patient-specific vaccines.

History

Prophage Series vaccine candidates entered the clinic in the 1990s where they were 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 and 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).

Clinical Trial Results

The accumulated clinical trial data have revealed a pattern of findings that is consistent with the biological premise:

  • Vaccine candidates in the Prophage Series are well tolerated and has demonstrated a very low toxicity profile
  • Vaccine candidates in the Prophage Series elicit tumor-specific T cell responses and innate immune response irrespective of tumor type
  • Efficacy of vaccine candidates in the Prophage Series appears most significant in patients with early-stage disease/low tumor burden (patients with better prognostic features)
  • 15 phase 1/2 and 3 clinical trials have been completed with our Prophage Series vaccine candidates, consistently generating signals of anti-tumor activity.

Production

To make a Prophage Series vaccine, patients first have surgery to remove part or all of the cancerous tissue, and the tumor tissue is shipped frozen to Agenus’ state-of-the-art GMP manufacturing facility in Massachusetts.

The facility is capable of providing commercial vaccine supply.

Using a proprietary, standardized, quality-controlled procedure, the product is isolated from the tumor in 8-10 hours.

The product is sterile-filtered, filled into vials, and shipped frozen back to the hospital pharmacy or clinician for use when the patient has recovered from surgery.