“It will take longer than you expect — don’t give up.” Charles Cotropia of BioClonetics Immunotherapeutics
I had the pleasure of interviewing Charles Cotropia, CEO and co-founder of BioClonetics Immunotherapeutics, Inc. www.bioclonetics.com a Texas based biotech company.
Thank you so much for joining us! Can you tell us a story about what brought you to this specific career path?
My educational background is in Law and Aerospace Engineering. I practiced patent law for 43 years but during that time, I also worked closely with my brother, Dr. Joseph Cotropia, on his development of monoclonal antibodies to treat and provide a therapeutic cure for HIV as well as other infectious diseases. This partnership with my brother led to the beginning of our company BioClonetics.
Can you share your story of Grit and Success? First can you tell us a story about the hard times that you faced when you first started your journey?
The company has developed a unique method for producing fully human IgG1 monoclonal antibodies for treating infectious diseases. From this method, we have created cell lines that produce fully human monoclonal antibodies that target and neutralize infectious diseases including HIV, influenza, tetanus and diphtheria.
The primary focus of the company today is to complete the development of its anti-HIV monoclonal antibody for use in treating and providing a therapeutic cure for the 36 million people now infected with HIV.
The primary monoclonal antibody produced by the company (called Clone 3) has been successfully tested in 5 independent laboratories where it fully neutralized over 95% of the HIV isolates (strains) against which it was tested. Even though faced with a very limited budget, the company is progressing to the final development of this monoclonal antibody leading to animal and then clinical trials.
Development of a new therapy in the pharma industry faces many unexpected barriers. You would expect that a demonstrated technology that could successfully help 36 million people infected with HIV and that could possibly change the fate of over 1 million who die each year from the virus, would garner support from those in the industry. We have found this is not the case. If a therapy is “not invented here” and there is less than animal or clinical trial evidence (which costs millions of dollars) that removes all possible doubt about its success, very few will be interested. So, the difficulty is not only creating unbelievable technology, but once created, finding a meaningful partner or the huge sums of money needed to independently carry the technology to market.
Where did you get the drive to continue even though things were so hard?
Over 3000 people die each day from HIV. Over 300 of them will be children. Pause for a minute to contemplate that fact — namely since you and I had breakfast yesterday, over 300 children have died from HIV. That’s almost twice as many as who perish from cancer. And that same number will die each day thereafter. And over 3000 individuals will also die each day. This is in one day!
This thought comes to my mind every day. And I wonder if the money being spent by the government and big pharma are being applied to develop the most effective therapies. Are all the possible therapies being given a fair chance in the challenge to find a cure? As for myself, my drive comes from the need that exists and what I see as a lack of support for therapies that are promising — more promising than those that are supported by unlimited funding.
So, how are things going today? How did Grit lead to your eventual success?
Since the beginning, we have made great technological advances with limited funding. Specifically, our technology began with the creation of a parent cell line that produces a fully human monoclonal antibody that neutralizes HIV. This parent antibody has been tested in 5 international labs against multiple HIV isolates (strains of the virus) where it neutralized 41 of 43 (over 95%) of the clinical HIV-1 isolates against which it was tests. These tests were against the different strains of the virus found around the world, namely isolates (strains) in clades A, B, C, E and F.
Additionally, and significantly, our antibody targets an immutable site on the HIV virus (a site that remains constant in 98% of the over 6000 strains of the virus known to exist) and thus our expectation is that it will be effective in treating infected patients without experiencing what is known as “virus escape”. Virus escape occurs when the virus mutates around a particular therapy such as an antibody.
One has to recognize that there are currently over 6000 different strains of HIV thus far identified and a successful treatment, antibody or otherwise, must be able to defeat them all. To do this, in the case of an antibody, it must target a site on the HIV virus that does not mutate. Otherwise the virus mutates around the treatment and the treatment is ultimately ineffective. For example, the anti-HIV antibody VCR01 is a “neutralizing antibody” but tests have shown that the virus mutates around it before it can provide an effective therapy. Even in view of this fact, funding continues for this antibody and others with similar limitations. In our case, our antibody targets an immutable site on the HIV virus and expectedly will not suffer such failure.
Because the parent cell line (as it usually the case) does not produce a sufficient amount of antibody to treat the 36 million people infected with HIV, it was necessary to produce what is called a “recombinant” form of the antibody by using a fast-producing cell line. This is required so that sufficient quantities of the antibody could be made available for clinical trials and patient therapy. We have succeeded in creating such recombinant forms of our antibody — a highly challenging feat — on a very limited budget. When we first undertook this effort several years ago, the projected cost to produce the recombinant form of our parent antibody was several million dollars. With the advancement of technology, we have just succeeded in completing this step at a fraction of this cost.
Our initial tests of these recombinant forms of our antibody have shown that the recombinants are significantly more potent than the parent antibody! As we further test these recombinant antibodies, we are also planning animal trials.
Can you share a story about the funniest mistake you made when you were first starting? Can you tell us what lesson you learned from that?
In attempting to raise funding for our development, I was not aware that to convince one investor to invest in your idea, you have to actually reach out to thousands, if not hundreds of thousands, of potential investors. The difficulty in successfully disseminating one’s idea is tremendous and it takes a great deal of effort and perseverance.
What do you think makes your company stand out? Can you share a story?
Our anti-HIV monoclonal antibody is one of only a few that target the HIV virus at a site that does not mutate. While other antibodies being examined have initial efficacy, most target a site that on the virus that changes with time. In other words, the virus structure changes so that the antibody is no longer effective. This ability of a virus to mutate is not new news — the flu virus and all others, do it every year. Otherwise there would be no need to re-engineer the flu virus each year.
Use of a monoclonal antibody to treat the HIV virus offers another unvoiced benefit. Today, HIV patients are treated with antiretroviral drugs — which is chemotherapy. These drugs extend life but over time can impart significant damage to vital organs. Moreover, of the 36 million individuals who have HIV, only 46% have access to this treatment. That means 20 million infected patients have no treatment. Use of monoclonal antibodies would not require lifelong treatment but would be effective if administered for a limited time. And the antibody can be produced for pennies a dose. Thus, their impact on worldwide health could be remarkable.
Which tips would you recommend to your colleagues in your industry to help them to thrive and not “burn out”?
Keep improving your product and service. As you get closer to your objective, you will continue to persevere.
None of us are able to achieve success without some help along the way. Is there a particular person who you are grateful towards who helped get you to where you are? Can you share a story?
We are blessed to have associations with many labs with whom we have cooperated and contracted to advance our technology. We are very appreciative of labs who have taken an interest in what we have achieved and who are willing to work with us to move forward. Companies such as Genscript Labs, STC Biologics, Rapid Novor and Scripps Research have been most gracious in their willingness to work with us to move our technology forward.
How have you used your success to bring goodness to the world?
We haven’t accomplished this yet. If our technology can assist any of the 36 million individuals with HIV, or any of the 2 million who will become infected each year, then we will have succeeded.
What are your “5 things I wish someone told me before I started my company” and why. Please share a story or example for each.
1. Make as many contacts in your field as possible — their expertise can be of assistance.
2. Develop in as many different ways as you can — if one focus does not work, another might.
3. It will take longer than you expect — don’t give up.
4. Pick your primary shareholders carefully — you will be with them for a long time.
5. Pick people who have contacts in your field — their knowledge will be invaluable.
You are a person of great influence. If you could start a movement that would bring the most amount of good to the most amount of people, what would that be? You never know what your idea can trigger. :-)
My one greatest desire is to bring our therapy for treating and curing HIV to those who need it.
How can our readers follow you on social media?
Follow us on facebook at www.facebook.com/bioclonetics.
This was very inspiring. Thank you so much for joining us!
