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QS-21 Stimulon® Adjuvant Pipeline
breaking news: RTS,S Malaria Vaccine Demonstrates Postive Results in Study of 6,000 African Children

QS-21 Stimulon® adjuvant* is designed to strengthen the body's immune response to a vaccine's antigen, thus making it more effective.

The New England Journal of Medicine has published results from a Phase 3 trial of GSK's malaria vaccine. This vaccine contains Agenus QS-21 Stimulon adjuvant as a key component.

Overview

QS-21 Stimulon adjuvant has become a critical component in the development of investigational preventive vaccine formulations across a wide variety of infectious diseases, and appears to be essential for several investigational therapeutic vaccines intended to treat cancer and degenerative disorders. Currently, QS-21 is being studied in clinical trials in approximately 17 vaccine indications, of which four are in Phase 3 studies. These include RTS,S for malaria, MAGE-A3 for non-small cell lung cancer, MAGE-A3 for melanoma and Zoster Herpes for shingles. In addition, a QS-21-containing vaccine candidate is in Phase 2 trials for the treatment of Alzheimer’s disease. Agenus' licensees include GlaxoSmithKline and Janssen Alzheimer Immunotherapy**. QS-21 represents the most clinically advanced adjuvant.

Therapeutic Applications

Through commercial licenses with leading pharmaceutical companies, research collaborations with academic institutions worldwide, and Agenus’ own internal programs, QS-21-based vaccines have been evaluated (including in ongoing studies) in more than 50 different indications.

To date, there have been over 40 Phase 2 trials conducted. QS-21 is currently being evaluated in approximately 17 vaccine candidates, four of which have Phase 3 trials ongoing in major indications.

Agenus has also developed product combinations to expand the scope of potential applications for QS-21. Agenus’ licensees are further developing and exploiting combinations in several vaccine products.

Availability

QS-21 represents a significant, near-term opportunity as a powerful adjuvant across a variety of diseases. Agenus currently has multiple partnerships for QS-21 and is capable of supplying significant quantities of QS-21.

With ongoing partnerships, QS-21 is currently being evaluated in multiple Phase 3 programs that are fully funded under our agreements. Pending successful results, we anticipate receiving QS-21 revenues in the next few years. As additional results from other late-stage clinical trials are produced, QS-21 has the potential to generate substantial revenue in the years to come.

Additionally, Agenus continues its internal development of QS-21 in combination with our vaccine candidates in infectious diseases and is exploring additional partnership opportunities.

*QS-21 Stimulon adjuvant and the related agreements, and HerpV are assets of Antigenics Inc., a wholly owned subsidiary of Agenus Inc.

**Janssen Alzheimer Immunotherapy, a wholly-owned subsidiary of Johnson & Johnson, has acquired substantially all of the assets and rights of Elan Corporation (“Elan”) related to its Alzheimer Immunotherapy Program. Elan was the original licensee of QS-21 for use in its Alzheimer’s disease vaccines.