Soligenix: current focus and pipelines – interview with Dr. Christopher J. Schaber

Rebecca Aris interviews Dr Christopher J. Schaber

Soligenix

pharmaphorum speaks with Dr Christopher J. Schaber, the president and CEO of Soligenix, on its current pipeline, its vaccines for bioterrorism agents and what the future holds for the company.

Soligenix, Inc, a development stage biopharmaceutical company, develops drugs in the area of treating life-threatening side effects of cancer treatments and serious gastrointestinal diseases, in addition to vaccines for certain bioterrorism agents.

Dr Christopher Schaber, a scientist by training, is president and CEO of Soligenix and has over 23 years of experience in the pharmaceutical industry.

Here he speaks with pharmaphorum on Soligenix’s current pipeline, what the future holds for the company and what advances in the area of gastrointestinal disease he’s most excited about.

Interview summary

RA: Christopher, thank you for agreeing to take part in this interview could you please start by telling me more about Soligenix and your role within it.

CS: I am the Chairman, President and CEO of Soligenix.

We are a clinical stage biopharmaceutical company developing products to treat serious inflammatory diseases where there remains an unmet medical need, as well as developing several biodefense vaccines and therapeutics.

Soligenix has a unique business model in which we have two segments to our Business. A BioTherapeutics segment focused on small molecules for Supportive Cancer Care and GI inflammation and a Vaccines / BioDefense Segment funded entirely by government grants, focused on medical countermeasures for civilian and military use, including a thermostable ricin toxin vaccine called RiVax™, which has made the news recently with the unfortunate incident in Washington DC. We are a world leader in ricin vaccine development.

In fact across these two business segments, we have been fortunate enough to secure multiple grants from both FDA and NIH. This has afforded us the opportunity to build a robust pipeline with eight potential value drivers in development.

RA: For what reason was your treatment of Pediatric Crohn’s Disease fast-tracked by the FDA last year?

CS: Fast Track is granted by the FDA when a drug you are developing is in an area of unmet medical need. There are no first line drug therapies approved for pediatric Crohn’s disease at this time, therefore, there is a high unmet need here.

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“Fast Track is granted by the FDA when a drug you are developing is in an area of unmet medical need.”

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RA: What recent advances from your company in the area of GI diseases are you most excited about?

CS: There are several, our SGX203 program in pediatric Crohn’s disease, as I just spoke of. I feel that our drug therapy has great potential to make a difference in these sick children. I am also excited about two other drug candidates we have in areas of high unmet medical need where no drug is currently approved. These therapies are both treating the extremely debilitating effects of cancer treatment: 1) our SGX201 for acute radiation enteritis in colorectal cancer patients, and 2) SGX942 for oral mucositis in head and neck cancer patients. Both of these programs will be moving to Phase 2 clinical trials.

RA: What else is currently in your GI pipeline?

CS: Another interesting GI program is in the biodefense / vaccines segment of our business, and has received interest from the government in potentially funding its continued development. The program is GI acute radiation syndrome or GIARS. This program uses our OrbeShield™ product to protect the GI tract against potential lethal dose radiation exposure due to a catastrophic event / accident. By the way, this program has also received fast track designation from the FDA and is the subject of a contract proposal currently under review by BARDA.

RA: What impact do you anticipate these prospective treatments to have on patients with GI disorders?

CS: I believe our programs, if successful in their development, would have a significant and positive impact for the patients they would treat, as essentially all that I have noted are in area of high unmet medical need where there is currently no drug therapy approved in the specific patient population. As you can imagine, I as well as my team here at Soligenix, are very excited about our pipeline’s potential, along with our clinical investigators, and medical and scientific advisory boards.

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“I believe our programs, if successful in their development, would have a significant and positive impact for the patients they would treat…”

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RA: What do you think the future holds for Soligenix?

CS: I obviously believe Soligenix has significant potential and if we are fortunate enough to achieve that potential, the future is very bright for the company, the patients and our shareholders. We have a dedicated and experienced team at Soligenix that is working nonstop to move our robust pipeline forward. We are also working closely with the key government agencies, like the FDA. We anticipate a lot of potential activity in the coming months, assuming we continue to be successful in securing the funding necessary to move our programs forward. So please stay tuned!

RA: What does Soligenix look for in a partnership?

CS: We are very active on the business development front. We are always looking at new and creative ways to collaborate. In today’s economic environment, I think this is absolutely vital for growing small life science companies, like ours.

RA: Thank you for speaking with me today.

CS: Rebecca, thank you for your time today in learning more about Soligenix. I truly appreciate it. I hope that this discussion has sparked some interest for those reading this article and they take a closer look at the company. I think they will be impressed.

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About the interviewee:

Christopher J. Schaber, PhD has over 23 years experience in the pharmaceutical and biotechnology industry.

Dr. Schaber has been Soligenix’s President and Chief Executive Officer and a director since August 2006. He also serves on the board of directors for the Alliance for BioSecurity and BioNJ, and is a member of the corporate councils for both the National Organization for Rare Diseases (NORD) and the American Society for Blood and Marrow Transplantation (ASBMT). Prior to joining the company, Dr. Schaber served from 1998 to 2006 as Executive Vice President and Chief Operating Officer of Discovery Laboratories, Inc., where he was responsible for overall pipeline development and key areas of commercial operations, including regulatory affairs, quality control and assurance, manufacturing and distribution, preclinical and clinical research, and medical affairs, as well as coordination of commercial launch preparation activities. During his tenure at Discovery Laboratories, Inc., Dr. Schaber played a significant role in raising over $150 million through both public offerings and private placements. From 1996 to 1998, he was a co-founder of Acute Therapeutics, Inc., and served as its Vice President of Regulatory Compliance and Drug Development. From 1994 to 1996, he was employed by Ohmeda PPD, Inc., as Worldwide Director of Regulatory Affairs and Operations. From 1989 to 1994, Dr. Schaber held a variety of regulatory, development and operations positions with The Liposome Company, Inc., and Elkins-Sinn Inc., a division of Wyeth-Ayerst Laboratories. Dr. Schaber received his BA from Western Maryland College, his MS in Pharmaceutics from Temple University School of Pharmacy and his PhD in Pharmaceutical Sciences from the Union Graduate School.

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