Hemispherx and Antigenics' Vaccine Adjuvants: Indispensable for Vaccines

Includes: AGEN, HEB
by: Prohost Biotech

Finally, there is general agreement that preventive vaccines (and therapeutic vaccines) are indispensable, especially when we are living an evolution when viral strains that used to infect species other than humans have begun to infect humans. These strains have severe symptoms and are, indeed, life-threatening. More important is that the strains mutate and we have to be prepared. Recent experiences came at the hands of H5N1 and swine flu viruses, which brought the fear that they might become pandemic as they acquire the ability for human-to-human transmission. The only way of prevention is effective vaccines.

Adjuvants are substance added to vaccines and other immunotherapies to enhance the body’s immune response to the antigen contained within the vaccine or treatment. Currently developed Adjuvants are playing a major role in the success of vaccines in boosting the immune system to prevent and cure infectious diseases and other diseases, including cancers. Here are some firms developing adjuvants. We begin with those that are currently put in the spotlight.

Promising Adjuvants:

1. Ampligen®


The innate immune system recognizes viral infection by identifying viral components, including double stranded (ds) RNA. Antiviral immune response is triggered in the mucosa of air passages.

Ampligen® (poly I:poly C12U) is a new class of specifically-configured ribonucleic acid (NASDAQ:RNA) compounds developed by Hemispherx. It is a synthetic specifically configured double-stranded RNA containing regularly occurring regions of mismatching. Ampligen® and Oragens® experimental nucleic acids are being developed for the potential treatment of globally important viral diseases and disorders of the immune system including Chronic Fatigue Syndrome/Myalgic Encephalomyelitis (CFS/ME), HIV, Hepatitis B, Hepatitis C, HPV, influenza and cancers including, kidney cancer and metastatic malignant melanoma.

Together with Defense R&D Canada, the National Institute of Infectious Diseases in Tokyo, the Princess Margaret Hospital in Hong Kong and the National Institutes of Health in the United States Hemispherx is conducting broad-based experimental studies to assess the efficacy of Ampligen®, Alferon N Injection® and Alferon LDO® as adjuvant single agent antiviral.

To date, >75,000 doses of Ampligen have been administered to humans, at an average dose of 400 mg, and it has been generally well tolerated

The intranasal inoculation with both the trivalent inactivated influenza vaccine + Ampligen(r) induced cross-protection mucosal immunity to H5N1 influenza virus in mice. Intranasal inoculation with both the annual influenza vaccine and Ampligen(r) may thus represent a strategy to generate protective mucosal immunity against newly emerging and highly pathogenic avian influenza viruses in humans.

Challenging trials clearly demonstrated that vaccine plus Ampligen adjuvant have been most effective versus all other treatment options. It is important to know that Ampligen may be used as an adjuvant for any other future influenza outbreak, not just Swine Flu.

Comments: A new peer reviewed publication titled "Development of mucosal adjuvants for intranasal vaccine for H5N1 influenza viruses" was published in Therapeutics and Clinical Risk Management 2009:5 125-132. The article summarizes ongoing research in which researchers conclude that Ampligen(r) is the "most promising adjuvant candidate for mucosal vaccines and produced cross-protection against variant influenza viruses not seen with the vaccines given alone.

Is this not the adjuvant task? Indeed it is and Ampligen has done it at best. We need adjuvants and Ampligen is among those whom we really need to have available to infectious disease and oncology specialists.

2. QS-21 Stimulon Adjuvant


Antigenics’ QS-21 Stimulon adjuvant is used in various vaccines under development in trials for diseases, such as hepatitis, human immunodeficiency virus, influenza, cancer, Alzheimer’s disease, malaria, and tuberculosis;

QS-21 Stimulon is one of the world’s most widely studied adjuvants. Research has shown that when added to a vaccine, QS-21 has the potential ability to increase total vaccine-specific antibody response and T-cell response. In addition, QS-21 seems to increase potency of the vaccine with relatively small quantities of antigen and to exhibit synergy with other adjuvants.

Because of the ability of QS-21 to improve the body’s immune response to very low doses of antigen, vaccine antigen may be ‘spared,’ which could significantly decrease the amount of antigen required for a given dose and make vaccine production more economical.

Antigenics’ QS-21 is an integral part of experimental vaccines and treatments for conditions such as melanoma, malaria, HIV and other infectious diseases. Antigenics’ partners include GlaxoSmithKline (NYSE:GSK), Wyeth-Lederle Vaccines, Aventis Pasteur, Progenics Pharmaceuticals and Elan Corporation (NYSE:ELN).

Comments: We expects results from some vaccines developed by Antigenics’ partners to be positive and sales to begin with royalties paid to Antigenics for the use of its adjuvant. This good news is besides the good news about the firm’s therapeutic vaccine Oncophage for cancers, whose results were very promising. This cancer vaccine is approved in Russia and is waiting for approval to come from the E.U. to be followed by a U.S. approval.

Disclosure: No positions.