TRACON Therapeutics (Private)

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September 24, 2012 Issue

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Developing the Next Generation Therapies, TRACON Therapeutics is addressing New Targets that have not been exploited commercially with Two Clinical-Stage Product Candidates for Cancer, each inhibiting a Unique Cellular Process that will complement Currently Available Therapies

Company Profile:
www.traconpharma.com
TRACON Pharmaceuticals develops targeted therapies for people with cancer and related diseases. The current pipeline has two clinical-stage product candidates, each addressing a unique cellular process, that are expected to complement currently available therapies.
 

TRACON aims to develop effective and well-tolerated treatments for underserved populations with the ultimate goal of enhancing survival and quality of life while maximizing shareholder value.

Charles P. Theuer, M.D., Ph.D.
President & CEO
Dr. Theuer joined TRACON as President, Chief Executive Officer, and a board member in July 2006. From 2004 to 2006, Dr. Theuer was Chief Medical Officer and Vice President of Clinical Development at TargeGen, Inc. where he led the development of small molecule kinase inhibitors in oncology, ophthalmology and cardiovascular disease. Dr. Theuer was a Director of Clinical Oncology at Pfizer, where he led the clinical development of Sutent® in kidney cancer; Sutent® was approved by the U.S. Food and Drug Administration in 2006 for the treatment of advanced kidney cancer. Dr. Theuer has also held senior positions at IDEC Pharmaceuticals and the National Cancer Institute where he was involved in the development of multiple small molecules and monoclonal antibody therapies. Dr. Theuer holds a B.S. from MIT, an M.D. from UC San Francisco, and a Ph.D. from UC Irvine. He completed a general surgery residency program at Harbor-UCLA Medical Center. Dr. Theuer has held academic positions at the National Cancer Institute and at the University of California, Irvine, where he was a member of the Division of Surgical Oncology. His previous research involved immunotoxin and cancer vaccine development, translational work in cancer patients, and gastrointestinal cancer epidemiology.

Healthcare
Cancer Related Diseases
(Private)

TRACON Therapeutics
San Diego, CA 92122
858/550-0780
www.traconpharma.com


 

Interview conducted by: Lynn Fosse, Senior Editor, CEOCFO Magazine, Published – September 24, 2012

CEOCFO: Dr. Theuer, would you tell us, what is the focus for TRACON?

Dr. Theuer: TRACON is a biotechnology company that is developing the next generation of cancer therapies. We are a group of people that came together from established companies in the San Diego area. We are developing two new compounds that are in clinical stage testing to improve the treatment options for cancer patients.

CEOCFO: How does it work?

Dr. Theuer: There are three stages of clinical testing before you can apply for market authorization—Phase 1, Phase 2, and Phase 3. Our lead product is an antibody that is in Phase 2 testing. It is an angiogenesis inhibitor, which is a class of treatments that have made a major impact in cancer care. Our particular antibody, called TRC-105, inhibits the new blood vessel growth that is essential for cancer growth and spread to other parts of the body. We inhibit angiogenesis by a mechanism that is currently unaddressed by any approved therapy. Our goal is to build upon what is approved, whether it is chemotherapy or targeted agents, to better inhibit angiogenesis.

CEOCFO: What is your compound doing that has not been done before?
Dr. Theuer: Cancer is the abnormal growth of cells that once were normal and have activated pathways that provide the ability to metastasize to different parts of the body. Once cancer metastasizes, it grows into lesions that need to recruit a new blood supply in order to continue growing. That new blood supply recruitment is called angiogenesis. There are approved drugs that inhibit angiogenesis by primarily inhibiting one pathway that is important for blood vessel growth. However, there are other pathways which are also important. A therapy that inhibits only a single pathway may work for a while but it is not going to work forever, as tumors develop escape pathways that overcome the drug effect. Therefore, if you can inhibit escape pathways that are also essential for angiogenesis, you may more completely inhibit that process and thereby delay tumor growth for a much longer period of time than is currently achievable.

CEOCFO: Was this tried in the past?
Dr. Theuer: Angiogenesis inhibition has been successful with respect to inhibiting the VEGF pathway. Unfortunately, patients on VEGF inhibitors will eventually fail that therapy. However, if we can inhibit a second pathway that may represent an escape pathway from VEGF inhibition, we can more fully inhibit the angiogenesis that is required for continued cancer growth.

We have one other product, a small molecule called TRC-102. The intent of TRC-102 is to make chemotherapy better. Chemotherapy is still the class of agents that is most commonly used to treat cancer across the board. When the use of chemotherapy first began, single agents were used. However, people quickly realized that tumors had the ability to escape single agent therapy. Currently, multiple chemotherapy agents are used simultaneously in order to delay the emergence of resistance. While that does work better, eventually most cancer progress despite treatment with multiple chemotherapy agents. TRC-102 is designed to reverse resistance to chemotherapy by inhibiting a certain pathway that cancer cells use to escape the effects of chemotherapy.  By reversing chemotherapy resistance, we hope to make chemotherapy much more active in certain cancer types, including lung cancer and brain cancer.

CEOCFO: Where are you in the process?

Dr. Theuer: TRC-102 has finished Phase 1 testing and we are in the process of moving it forward into Phase 2 testing in combination with Temodar® chemotherapy, which is a standard agent used for brain cancer, and in combination with Alimta chemotherapy, which is a standard agent used in lung cancer.

CEOCFO: Are you looking to do partnerships and joint ventures or will you continue to develop on your own?

Dr. Theuer: Currently we do not have a partner, but we remain very interested in partnering. Partnering has the advantage in that it allows access to additional capital. Even though we have a broad development program for TRC-105, for example, there is strong interest by key opinion leaders to advance that program into more trials. We could do that more easily with a partner and it is something that we are actively considering. With respect to TRC-102, that program could be developed in more indications than lung cancer and brain cancer, and a partnership would allow us to advance our program into other tumor types.

CEOCFO: I am looking at your website, www.traconpharma.com. I see with TRC-105 that many types of cancers are covered. Do you see that as universal?

Dr. Theuer: The unique aspect of TRC-105 is that almost every solid tumor needs to recruit a new blood supply as it grows, whether it started in the ovary, breast, colon or the brain. If you inhibit the process of angiogenesis, you have the potential to be broadly active and the potential to be effective in multiple solid tumor types. That said, we are testing TRC-105 in a number of types because it is likely that certain tumor types will be more sensitive than others regardless of the potential broad activity. We want to carefully define what tumor types will be most susceptible to our therapy.

CEOCFO: Are there any side effects that you have seen so far?

Dr. Theuer: The approved angiogenesis inhibitors have characteristic side-effects. For example, Avastin, which is the most commercially successful angiogenesis inhibitor, causes high blood pressure and allows protein to filter through the kidneys into the urine. Other inhibitors of angiogenesis cause rashes and pain in the hands and feet. Fortunately, we have not seen those side effects with our drug. That is exciting for us, because one of our prime goals is to combine our drug with these commercially successful and approved angiogenesis inhibitors. We have seen some side effects; most prominent with our drug has been a mild anemia with dosing that can be remedied with reducing the dose slightly. Fortunately we have not seen anything that would prohibit us from combining with the established therapies that are used to treat angiogenesis currently.

CEOCFO: What is the financial picture like for you today?

Dr. Theuer: We have been fortunate to have backing by a venture capital syndicate that has supported us since 2011 and includes JAFCO, Nextech Invest, Arcus Ventures, BHP, and Brookline Investments. Solid financial backing is essential for the success of any young biotech company. It is clearly a tougher environment since 2008.  Securing committed investors is critical to the success of any company that is in the developmental stage.

CEOCFO: Our readers are primarily investors and there are many companies in your general category, why should people choose TRACON?

Dr. Theuer: It is the people and the development-stage products. We have an incredibly committed group of people, who have experience with drug approvals at other companies. They have taken drugs from the development stage through to approval and I think that is important. In other words, the managers of this company have been there before. We are leveraging that experience and developing next generation therapeutics. Some biotech companies will develop primarily what are called “me-too” drugs, meaning they are very similar to a drug that is already approved with a slight variation on theme. TRACON develops the next generation therapies that address new targets that heretofore have not been exploited to make a commercial product. That is where the real excitement is in biotech development. That is also where the breakthroughs come that will generate returns for investors. Those are the unique aspects of TRACON, the unique people and the unique set of products.

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TRACON develops the next generation therapies that address new targets that heretofore have not been exploited to make a commercial product. That is where the real excitement is in biotech development. That is also where the breakthroughs come that will generate returns for investors. Those are the unique aspects of TRACON, the unique people and the unique set of products. - Charles P. Theuer, M.D., Ph.D.