The Future of Clone 3

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1966

Left Field by Patricia Nell Warren

All Good Things
Are we nearer the day when the promise of a vaccine will outweigh profits & politics?
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There’s an old saying, “All good things must come to an end.” Writing this column for A&U has been a good thing for a decade and a half now. I’ve had the opportunity to explore the ins and outs of AIDS politics, not only in the U.S. but other countries as well. But other priorities are calling, and I need to make room for them in my life.

Over the years, I’ve met some extraordinary people through the column—including giants of activism like the late José Fernando Colón and his surviving partner Anselmo Fonseca, who founded Pacientes de SIDA Pro Política Sana in order to battle corruption in the AIDS delivery system in Puerto Rico. Most notably, the column brought me into contact with Texas scientist Joseph Cotropia, MD, co-founder with his attorney brother Charles Cotropia of BioClonetics Immunotherapeutics, Inc., a privately held biotech. I also met their CFO, Paul Fellegy.

Connecting with BioClonetics was a six-degrees-of-separation thing. Around six years ago, an HIV-positive gay male friend of theirs was sitting in his doctor’s waiting room and picked up a copy of A&U from the coffee table there. Flipping the pages, he ran across a Left Field. As an admirer of my novels, he was surprised to see that I had taken up nonfiction reporting. After his appointment, he raced to tell Dr. Cotropia and Paul, “Guess who’s writing about AIDS vaccines!”

Next thing, Paul called me on the phone. This was the first of many calls, and eventually meetings, as he and Dr. Cotropia told me the strange story of their frustrating (so far) search for financing of clinical trials. After many years of research, Cotropia had discovered a human monoclonal antibody that has a powerful potential for neutralizing HIV strains in a vaccine.

To put it simply, Cotropia discovered a human cell line producing a specific human antibody that targets a genetic sequence designated KLIC on the surface of HIV’s outer envelope. Dr. Cotropia named it Clone 3. This antibody can lock onto the KLIC epitope (the epitope is a key spot on the envelope where the virus is vulnerable to antibody action) in such a way that the virus is unable to reproduce, and ultimately cannot infect a human cell. Cotropia patented his discovery in 1989.

My column had already been reporting on vaccine research…and on the mounting record of failures. Most spectacular, back in 2003, was the furor around VaxGen and its AIDSVAX. This vaccine was supposedly designed to spark antibodies to gp120, a protein found in the surface of HIV viruses. Previous research along this line had not looked promising. But VaxGen pulled political strings and the AIDSVAX trial got funded, including a healthy grant by the CDC. And indeed, in early 2003, the first clinical reports revealed that AIDSVAX was a dud.

Since that first call from Fellegy, I’ve had ample opportunity to look at the science around Clone 3, as well as observe the political antics around it. Though NIH had funded one of the initial studies of Clone 3, in 2004 the agency said no to funding a Phase I clinical trial. “Lack of innovation,” the NIH reviewers sniffed.

Stranger still—in 1999, the government had made a patent application that overlapped an area covered by Dr. Cotropia’s 1989 patents. The government listed NIAID director Anthony Fauci and others as the “inventors.” In the affidavit required by the filing process, Fauci, et al., declared under oath that the neutralizing technology in question had “utility” and “commercial value.” But the U.S. Patent Examiner threw out the government’s bid to own the key area covering Clone 3. He pointed out that Dr. Cotropia and BioClonetics had a prior claim.

So if Clone 3 had “commercial value” according to Fauci himself, why was the discovery viewed by others as lacking “innovation?” Talking heads in the AIDS industry, including Fauci himself, have said that the best way to end the AIDS epidemic is an effective AIDS vaccine. Just recently, Fauci discussed the current effort to intensify conventional drug treatment globally, but wrote in conclusion, “An effective HIV vaccine would get us to an AIDS-free generation faster and, more important, help sustain that accomplishment.” Other antibodies, and other vaccine approaches, have been granted their chance at clinical trials. So far, all have failed to deliver real promise.

Then, in August 2010, came another landmark for Clone 3. The U.S. government’s Los Alamos HIV Clinical Database published a review of Clone 3 antibody’s capacity to bind directly with the 2,229 (then) known strains of HIV around the world. By searching the surface (amino acid) composition of these 2,229 HIV isolates, Los Alamos found that ninety-eight percent of them have an exact match—or conservative amino-acid substitution—for the minimal essential “core” epitope KLIC to which the CLONE 3 antibody binds. In other words, Clone 3 epitope KLIC has the potential to elicit, in active vaccination, a protective antibody (“CLONE 3”) that broadly neutralizes ninety-eight percent of all known HIV strains. This is more than any other vaccine candidate whose study results have been published.

Clearly this 2010 government data should have put the Clone 3 KLIC epitope at the front of the pack. But it didn’t—not even today, when HIV strains now total 4,009. Yet Clone 3 still holds its ninety-eight percent position.

Later in September 2010, I wrote a Left Field expressing my bafflement, followed by a longer piece posted at Bilerico Project in October. I had concluded that Dr. Cotropia’s discovery was being viewed as a “disruptive technology.” Humanist-sounding statements by the AIDS industry notwithstanding, a cost-effective vaccine that saves millions of people from being infected would eliminate the industry’s golden chance to sell many years of ARV drug treatments to these millions (or to their governments, or their insurance providers) after they get infected.

And, as I commented in the Bilerico piece: “The U.S. government is anxious to protect its own vested interest in ARV cash-flow. The FDA collects millions in user fees from pharmaceutical companies. The Dept. of Treasury collects additional taxes on pharmaceuticals. Plus there are royalties from medical inventions created by government scientists.”

So I wonder what the government would have done with Cotropia’s patent—if anything—if they had won their 1999 legal battle.

Dr. Cotropia and Fellegy have asked me if I would accept a commission to write a nonfiction book about their story. I said yes. It’s a huge story—one that deserves to be told. The story is still happening, and I’m still hoping that someone will show up who gives a damn about humanity and has the $500 million that is needed to bring this pharma product through clinical trials to market.

Meanwhile, every year that there’s still no AIDS vaccine on the global market, nearly 2 million people a year around the world—children, women and men—die needlessly of AIDS. Somebody will have to explain to me why 2 million deaths a year is an acceptable trade-off for the profits being made on ARVs.

So herewith my disclosure that I’m taking sides with a particular approach to the science and medicine of ending AIDS—and that I will be accepting payment for my professional book-author skills. I’m doing this because I’m convinced of Clone 3’s possible future.

Indeed, BioClonetics is aiming for broader development. The CLONE 3 antibody also has potential as a passive immunotherapy, to treat those infected with HIV/AIDS without the toxicity dangers presented by ARV drugs. Moreover, Dr. Cotropia tells me that the 1989 discovery has possible applications for diseases caused by other retroviruses as well, in both humans and animals. All in all, this could be an important horizon in medical history—I’d like to be there as that horizon is crossed.

Meanwhile—many thanks to publisher David Waggoner for the opportunity to publish in these pages. Thanks also to the A&U staff for their publishing know-how and TLC, especially managing editor Chael Needle and art director Timothy J. Haines. Last but not least, thanks to all you A&U readers who have hung in there with me for so many years, through so many twists and turns of other AIDS stories that needed to be told.

Author of fiction bestsellers and provocative commentary, Patricia Nell Warren has her writings archived at www.patricianellwarren.com. Reach her by e-mail at [email protected]

Copyright © 2013 by Patricia Nell Warren. All rights reserved.