Hemispherx and Antigenics' Vaccine Adjuvants: Indispensable for Vaccines

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®

HEMISPHERX (HEB)

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 (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 (AGEN)

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 (GSK), Wyeth-Lederle Vaccines, Aventis Pasteur, Progenics Pharmaceuticals and Elan Corporation (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.

Comments

[David White:]

Today HEB is down strongly again. This is almost getting to be a trend. Apparently Jim Cramer has been bad mouthing the stock. Admittedly they did file a $150M mixed shelf offering recently. This should cuase significant dilution of the stock. It will cause much less if the stock goes up on approval. Also it is a mixed shelf offering. HEB may be able to sell bonds soon if FDA approval comes through.The data presented in this article favor approval of ampligen for CFS, even though the flu virus work is not directly applicable. The FDA scientists are very bureaucratic. Ampligen has been proven to be at least reasonably effective against CFS. It does not seem to be unsafe. The only really valid reason for rejecting the NDA now is safety. What bureaucrat would want to be on record as rejecting as unsafe an orphan drug that is at least reasonable effective against CFS, when half the world may soon be taking ampligen to help fight off flu?

Jun 17 10:15 AM

[David White:]

I should have added that Barrons has done exposes on Jim Cramer's accuracy. They claim he makes more bad calls than good ones. I tend to think this is one of his bad ones.

In fairness I should add that I consider Jim Cramer to be educational. He does say a lot of good things. I just done agree with him on this.

Jun 17 10:18 AM

[David White:]

I should also have added that HEB has a whole slew of other uses for ampligen, including the use as a flu vaccine adjuvant. It will take money to prove all of these out. Still these applications do hold incredible future promise for HEB earnings. HEB does have something to do with the money they will derive from the mixed shelf registration. Of course, sometimes HEB does get "free" help such as the case above in which the Japanese Institute of Health is spearheading the research into ampligen use with flu vaccine.

Jun 17 11:45 AM

[baltbear:]

ampligen has "been around" looking for approval for something for 10 years.
the recent annual meeting's report of proposed dilution is in keeping with its business plan over the years.
many "biotechs" have gotten play so far this year as part of a mass promotion of the idea that somehow the reasons for failure to deliver were all based on "bush era" political decisions.
the time to 2 cents a share earnings for any of them? not much different than they were 8 years ago.
a lot of thse can be amusing to play with as trades, but trading is not investing.

Jun 24 09:02 PM

[czxqa:]

Haha, 15 years ago those clowns were in my office pitching their company and Ampligen as the next new Aids treatment. It was supposed to boost the effectiveness of AZT. Chronic Fatigue was mentioned as the next application. They own the rights to a compound that does nothing other than be a talking point for them to go around selling stock.

Jun 25 01:01 PM