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Advanced Cancer Therapeutics |
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December 15, 2014 Issue |
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The Most Powerful Name In Corporate News and Information |
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Discovery and Early Development of Novel Cancer Therapeutics |
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President & CEO
Advanced Cancer Therapeutics http://www.advancedcancertherapeutics.com/
Interview conducted by: Lynn Fosse, Senior Editor, CEOCFO Magazine, Published – December 15, 2014
CEOCFO: Mr. Riggs, what is the idea behind Advanced Cancer Therapeutics? Mr. Riggs: Advanced Cancer Therapeutics was brought into existence to leverage existing and new breakthrough therapies in cancer that are discovered at the James Graham Brown Cancer Center (“Brown Cancer Center”). We then take those early-stage drugs/molecules under pre-set licensing terms that allows us to move quickly to make the drugs better and increase the strength of the patent position around those new molecules. Then we move those improved drugs into Phase I human clinical trials for the benefit of cancer patients. After Phase I trial, we then look to license or sell the asset to leading pharmaceutical companies that have more bandwidth and financial resources to do late-stage development and commercialization. Once we license the anti-cancer product to a third party, we continue to have a stake in the product(s) moving forward in terms of up-front license fees, clinical milestone payments and royalties on products sales. We use a lot of that money not only to pay back our investors, but also to bring back money to the Brown Cancer Center so that they can continue developing these much-needed breakthrough cancer therapies.
CEOCFO: Do you pick and choose, or do you take all the ideas and attempt to work with them? Mr. Riggs: We do choose. We select, and what we are looking for are things that have the potential to be breakthrough or transformational and have exhibited some in vivo animal efficacy studies. We can then take the compound or molecule and do what we call SAR, which is structure activity relationship or termed as medicinal chemistry. We make the compounds with better drug-like attributes for use in humans. In addition, you also perform SAR activities to improve the intellectual property strength of the asset. In our industry, intellectual property is a critical component because it costs so much to develop a drug. You have to have a very strong patent position to have exclusivity to develop and commercialize the therapeutic and provide an appropriate return on investment.
CEOCFO: At what point might the researcher say it is time to talk to you, or are you supervising the research and deciding when to get involved? Mr. Riggs: We do interact a lot with all the 80+ research scientists at the Brown Cancer Center. We are aligned with them not only from a partnership standpoint but also from an economical standpoint. They own a little over 30% of ACT, so when we do well, they do well. We have structured our business strategy this way because we are fitting into this niche when researchers make a discovery most of the time the stage of the asset is very early in the drug development process and the researcher needs someone else to take it through the valley of death. The valley of death as we refer to it in the pharmaceutical industry, are those promising early stage discoveries that have not yet entered human clinical trials. That is where ACT enters into the process. If the asset demonstrates good activity/efficacy in animals and the compound looks promising, we can license it from them and we will pay them an up-front license fee and clinical milestone payments and royalties on product sales. We can make the asset much more valuable by taking it through the pre-clinical research stage and advance it into humans where we see safety and clinical activity of the drug. At that point, the asset is very valuable because the pharmaceutical company understands that value proposition. It is a unique asset that addresses a specific disease, for example, for the treatment of breast, lung or prostate cancer. When we license or sell the asset, a lot of those proceeds will return to the Brown Cancer Center and benefit the inventors who initially discovered the product, as well as provide funds for the next potential breakthrough product.
CEOCFO: When you are looking at what projects to take on, are you looking for a particular mix or is each potential drug or discovery vetted on its own? Mr. Riggs: What I am looking for is a product that will address an unmet medical need in cancer that could have a big impact on cancer patients’ lives. For example, the first product we have advanced into Phase I human trials is a key cancer target that when you inhibit it, it prevents the tumor cells from using glucose as a fuel source to survive, grow and metastasize. This target mostly drives solid tumors like breast, lung, prostate and colon cancers. Inhibition of this target, called PFKFB3, prevents those tumors from using glucose as a key fuel source to grow and metastasize. Our drug, PFK-158, in Phase I human clinical trials, prevents many solid tumors from being able to use glucose as a key energy source to grow and wreak havoc on the human body. This is really a wonderful product, and if you think about some of our best products in cancer even today, one can see that in a drug like Avastin®, which makes over six billion in annual revenues and treats an assortment of solid tumors. Avastin® prevents tumors from gaining access to blood as a nutrient for survival, growth and metastasis. With PFK-158, ACT is using a similar strategy against tumors cells by preventing tumors from gaining access to glucose as a key energy source used by tumors to survive, grow and metastasize.
CEOCFO: Why does the glucose work?
Mr. Riggs:
This target
is highly expressed in tumor cells, not in healthy cells, so it will be
selective for a variety of solid and hematological tumors. Tumors have an
inefficient nucleus and an insatiable desire to quickly multiply or
proliferate. That is how cancer ends up wreaking havoc on cancer patients
and can lead to a patient’s death. Tumors use glucose as a key fuel source
to survive, grow and metastasize. This concept is well known within the
pharmaceutical industry. In fact, back in the early 1930s, a German doctor
named Dr. Warburg. Dr. Warburg professed that many cancers have an
insatiable demand for glucose uptake as a key fuel source for survival and
growth. While this idea for treating a variety of cancers has been around
for some time, not much work in this area has been accomplished with the
exception of our first-in-man, first-in-class glucose inhibitor, PFK-158. We
are the first company to enter into human clinical trials to address this
unique cancer target with the novel drug, PFK-158, that inhibits glucose
uptake in tumor cells. Mr. Riggs: I think they have been paying attention. We are in discussions with several leading pharmaceutical companies, and just last week I presented PFK-158 in Boston, Massachusetts at TAP, which is the Therapeutic Area Partnerships. TAP is sponsored by Informa and Kantar Health. We were one of the Top Ten Oncology Drugs to watch in 2014 and PFK-158 was selected by an independent panel of oncology experts. I believe we are being noticed, and I think this is important because we make significant breakthroughs when we try to attack cancer from a novel mechanism perspective. It is very difficult to make those types leaps or breakthroughs when you do follow-on or copycat products. We seek novel mechanisms that not only would have a profound impact on the cancer as a stand-alone treatment, but also in combination with currently available cytotoxic and targeted anti-cancer therapies. For example, we have demonstrated that PFK-158 has synergistic activity with Cisplatin in animal studies with resistant ovarian cancer. Cisplatin is a common drug used for treating ovarian cancer patients. Treating difficult cancers with a combination of drugs is the way most oncologists treat cancer patients today. Oncologists use a combination of products that hit the cancer at multiple areas of critical importance with the goal to stop or delay disease progression.
CEOCFO: Where does gut feeling come in along with the science? Mr. Riggs: I believe in our industry the people who have been successful must have a mixture of gut instinct, passion and perseverance. I evaluate the asset from an objective standpoint but also from a gut instinct. However, at the end of the day you have to have passion and perseverance in this challenging industry that has many ups and downs. You will have obstacles thrown at you that you cannot imagine, and they will really put you on your knees, but if you have that core passion for your product, you can call upon that to help you persevere during the down times and continue moving forward.
CEOCFO: What is next on the agenda? Mr. Riggs: We are looking to complete the Phase I human clinical trial in the first half of 2015. Currently, we have two clinical sites: the University of Louisville Hospital, Georgetown Medical in Washington D.C. Recently, we signed on M.D. Anderson in Houston, Texas, which is one of the best cancer centers in the world, and the University of Texas Medical Center in San Antonio, Texas, which is also a very respected oncology center. I believe engaging all four of these reputable medical centers with our Phase I trial speaks volumes to the asset quality of the PFK-158 program. We intend to complete treating patients in our Phase I trial, then we will look to partner or sell PFK-158 to a leading pharmaceutical company to generate revenue that will be used to develop the next potential breakthrough treatment. We plan to keep repeating this process again and again. The Brown Cancer Center has 80+ researchers ACT can leverage upon that are focused on discovering breakthrough treatments for oncology. While they own a little over 30 percent of ACT, ACT does not pay their salaries, facilities, equipment, employee benefits, etc., which allows ACT to remain productive and lean. If I were a conventional biotech company, my annual expenses would be much greater than it is under ACT’s current business structure. We have been operating like this since 2007 and it works very well for both ACT and the Brown Cancer Center, and we believe it will continue to work well for many years to come.
CEOCFO: There are many companies in your industry for people to look at. Put it together. Why Advanced Cancer Therapeutics? Mr. Riggs: I believe people should be paying attention today because of our close and symbiotic relationship with the Brown Cancer Center that focuses on leading edge discoveries in oncology. Historically, if you look where most of the really big discoveries originated, it has been from academic and medical institutions. In fact, many pharmaceutical companies are reducing their early-stage drug discovery activities because they continue to see declining productivity in innovation within their organizations. Innovation appears to be more prolific within small biotech or academic institutions. At ACT, we combine the best of both worlds – the commercial biotech company, ACT, which has very experienced people with over 20 years of experience doing early-stage discovery / development working with leading medical institutions like the Brown Cancer Center to capitalize on those breakthrough treatments. You never know where the next breakthrough treatment will come from, but we have our hands on the pulse very closely. I should also note that while we have a close relationship with the Brown Cancer Center, we are not only exclusive to the Brown Cancer Center. We have several other institutions approaching us with new discoveries for evaluation because of what we have been able to accomplish with the Brown Cancer Center. Therefore, we not only get the best opportunities from the Brown Cancer Center, we are also fortunate to evaluate new potential breakthrough products from other institutions. I believe some of these institutions approach us because they may see us as an attractive path forward to advance their early discoveries through the valley of death that may lead to a better asset value proposition for pharmaceutical companies. |
“We seek novel mechanisms that not only would have a profound impact on the cancer as a stand-alone treatment, but also in combination with currently available cytotoxic and targeted anti-cancer therapies.” - Randall B. Riggs
Advanced Cancer Therapeutics http://www.advancedcancertherapeutics.com/
Randall B. Riggs (502) 589-6404
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New Cancer Therapies, Advanced Cancer Therapeutics, Healthcare Companies, CEO Interviews 2014, Randall B. Riggs, Discovery and Early Development of Novel Cancer Therapeutics, first-in-man, first-in-class glucose inhibitor, PFK-158, in Phase I human trials for a key cancer target PFKFB3, that when you inhibit it, it prevents the tumor cells from using glucose as a fuel source to survive, grow and metastasize, PFKFB3 mostly drives solid tumors like breast, lung, prostate and colon cancers, sugar and cancer, Recent CEO Interviews, cancer therapies discovered at the James Graham Brown Cancer Center (“Brown Cancer Center”), tumors use glucose as a key fuel source to survive, grow and metastasize, this concept is well known within the pharmaceutical industry, Inhibition of this target, called PFKFB3, prevents those tumors from using glucose as a key fuel source to grow and metastasize, our drug, PFK-158, in Phase I human clinical trials, prevents many solid tumors from being able to use glucose as a key energy source to grow and wreak havoc on the human body, tumors have an inefficient nucleus and an insatiable desire to quickly multiply or proliferate, which is how cancer ends up wreaking havoc on cancer patients and can lead to a patient’s death, in the early 1930s Dr. Warburg professed that many cancers have an insatiable demand for glucose uptake as a key fuel source for survival and growth, our. We are the first company to enter into human clinical trials to address this unique cancer target with the novel drug, PFK-158, that inhibits glucose uptake in tumor cells, how does cancer metastasize?, does sugar play a role in tumor growth, does cancer feed on sugar, is sugar an energy source for cancer, drugs that inhibit or block sugar from going to a cancer cell, Advanced Cancer Therapeutics Press Releases, News, Companies looking for venture capital, Angel Investors, private companies looking for investors, healthcare companies seeking investors, cancer therapeutic companies needing investment capital |
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Randall
B. Riggs