Cancer Vaccine

[RandyW]

Fighting Cancer: Startup Pique Therapeutics’ Lead Drug Candidate Shows Promise as a Vaccine

Special To LTW

Editor’s note: This is the fifth in a series of profiles featuring companies presenting at the Council for Entrepreneurial Development’s annual venture capital conference in Pine Hurst. The conference opens Tuesday afternoon and concludes Wednesday.

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DURHAM – Pique Therapeutics, a biotech startup capitalizing on the research of a physician at the University of Miami, just may be developing a potent weapon in the never-ending war against cancer.

Pique, which has received initial funding from Golden Pine Ventures, is developing a cancer vaccine with an initial target of non-small cell lung cancer, or NSCLC. In Phase 1 trials, the drug known as PT 107 improved the life span of advanced-stage lung cancer patients to 11 months from an average of 4-6 months.

“To the company’s knowledge, this exceptional level of patient improvement has not been seen before in clinical studies,” Pique’s management told WRAL Local Tech Wire in a Q&A. “Currently marketed drugs for NSCLC only improve the survival of patients by a couple of months.”

Pique was founded based on the work of Eckhard Podack, an MD and PhD, who is chair of the Department of Immunology and Microbiology at the University of Miami. He also acts as chief scientific director of Pique. The company’s current president is Christopher Meldrum, who also is managing director of Golden Pine Ventures.

Pique executives are seeking Series A financing in order to conduct further trials of its lead compound and to fill out its management team.

The Q&A:

What's your "elevator pitch"?

The lead product of Pique Therapeutics is a first-in-class therapeutic vaccine (PT 107) for the treatment of non-small cell lung cancer (NSCLC). PT 107 has completed Phase 1 clinical trials, was well-tolerated, and had an excellent safety profile in cancer patients. Although Phase 1 trials are primarily designed to explore safety, PT 107 showed very strong efficacy, with a 134 percent improvement in median survival (11 months) for patients with late-stage NSCLC, as compared with the expected 4 to 6 months median survival. To the company’s knowledge, this exceptional level of patient improvement has not been seen before in clinical studies. Currently marketed drugs for NSCLC only improve the survival of patients by a couple of months.

What makes your company unique? Do you have a proprietary and/or a patented technology? Please explain why it is unique and what the status is of any patent filings.

Pique Therapeutics’ novel therapeutic vaccine technology yields multiple products in the area of oncology by stimulating the patient’s immune system response. The company’s is developing therapeutic vaccines to a number of other important cancers, including pancreatic, colorectal, and head and neck cancer.

The company has a strong intellectual property portfolio of patent applications covering composition of matter for PT 107 and its other therapeutic vaccines, as well as methods of use for the treatment of lung cancer and other cancers. Additional patent applications cover the manufacturing process of the company’s therapeutic vaccines, and formulation patents covering the optimal dose-range.

What makes your product(s) and/or services unique vs. your competition?

Traditional first-line therapies for non-small cell lung cancer are cytotoxic, and extend survival only one to two months, even when given in combination. These drugs show significant adverse effects, due to their general cytotoxic nature.

Even Tarceva, a recent success story for cancer therapeutics, only extended median survival of late-stage NSCLC patients from 4.7 months to 6.7 months. This benefit of an additional two months is quite modest, particularly when compared against Pique’s lead product, PT 107, which extended median survival to 11 months.

What is your target market? What is the size of that market in terms of dollars? What share of that market do you believe you can win?

The market for PT 107, the company’s lead product for non-small cell lung cancer, is quite large, as it is the most common form of lung cancer, accounting for over 80 percent of the disease. There are about a million new cases of NSCLC diagnosed each year worldwide, with almost 200,000 of those cases being in the United States alone. Late-stage non-small cell lung cancer is a major unmet medical need, because patients at this stage of disease generally have an average life expectancy of four to six months.

NSCLC is the No. 1 cancer killer in the United States, causing more deaths than colon, breast, and prostate cancer combined. It is a particularly aggressive cancer. Indeed, the five-year survival for late-stage NSCLC is less than 5 percent, despite surgical intervention, radiation therapy, and chemotherapy. The U.S. sales potential of a new therapeutic in this area would exceed $1 billion per year.

What will you do with the invested funds? What is the timeline for product delivery? If you have existing products and services, how will additional funding help you expand your company, if that is the intention, or will you develop new products?

Net proceeds from the Series A financing will be used to fund:

# Pique Therapeutics’ proposed 300-patient, pivotal Phase 2 clinical trial for PT 107 in non-small cell lung cancer. If the strong efficacy data shown in the Phase 1 study are reproduced in this Phase 2 trial, the FDA could approve PT 107 off of this single pivotal study, as they have done in the past with many drugs in oncology.

# The further development of the other preclinical products in Pique’s pipeline. The Company intends to leverage its strong platform and initiate a number of further therapeutic vaccine trials in non-immunogenic tumors such as pancreatic, colon, and head & neck cancer.

# The recruitment of key executives to the company. The company will identify, attract, and recruit a seasoned management team, including a chief executive officer, a chief financial officer, a vice president of research and development, as well as additional individuals with expertise in clinical, regulatory, and manufacturing of therapeutic vaccines.

Why will investors be impressed with your management team?

The company was founded on the research of Eckhard R. Podack, M.D., Ph.D., Chair of the Department of Immunology and Microbiology at the University of Miami. Dr. Podack serves as Chief Scientific Director of Pique Therapeutics. In addition to Dr. Podack, the management team includes Christopher Meldrum, who serves as the company’s president. Meldrum is the managing director at Golden Pine Ventures.

The company has assembled a strong Board of Directors to lead its initial development efforts, including Dennis Langer, M.D., J.D., managing partner with Phoenix IP Ventures and a former senior vice president at GlaxoSmithKline, and Keith Dionne, Ph.D., CEO and president of Alantos Pharmaceuticals, and formerly Vice President at Millennium Pharmaceuticals.

What is the exit strategy for the investor from your company? Are there potential strategic alliances with larger companies? Do you wish to take the company public? Or do you wish to grow the company and either sell it or acquire other companies?

A relationship with a large pharmaceutical or biotechnology partner could certainly be attractive as the company’s therapeutic vaccine products continue to develop, as this may position the Company attractively for exit via a merger or acquisition. Alternatively, and subject to appropriate market conditions, the company would be positioned well for an Initial Public Offering (IPO), which would finance the majority of the cost to build a sales and marketing infrastructure.

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FACT BOX: Pique Therapeutics, Inc.

MISSION STATEMENT: Pique Therapeutics, Inc. is a development-stage biotechnology company with a vision to become the leading therapeutic vaccine company, focused initially on the treatment of cancer. The company also intends to pursue other major market opportunities in the area of rheumatoid arthritis, asthma, and other autoimmune disorders.

TYPE OF COMPANY: Biotechnology

ADDRESS: 2530 Meridian Parkway, Suite 200, Durham, NC 27713

PHONE NUMBER: (919) 287-2566

WEB SITE: www.piquetherapeutics.com

MANAGEMENT TEAM MEMBERS:

Christopher S. Meldrum, president, is managing director of Golden Pine Ventures. Over his career, he has worked extensively with development-stage biotechnology and medical device companies, helping to secure initial financing for multiple start-up ventures. Before coming to Golden Pine Ventures, Meldrum held the position of Director, Corporate Alliances, at Paradigm Genetics, a publicly-traded biotechnology company, where he led business development efforts for both the healthcare and agriculture businesses. During his time at Paradigm, he negotiated to completion 7 revenue-generating collaborations with potential deal values totaling over $30 million. Meldrum received his MBA from the Carlson School of Management at the University of Minnesota, and his B.A. in Chemistry from the University of Utah.

Eckhard R. Podack, M.D., Ph.D. Chief Scientific Director: Dr. Podack is professor and chairman of the Department of Immunology and Microbiology at the University of Miami, and the Associate Director of the Sylvester Comprehensive Cancer Center at the University of Miami School of Medicine. Podack is the author of over 200 peer-reviewed publications and over 50 invited reviews. Over the course of his career, he has received significant grant support, including 18 grants from the NIH. He also has previous clinical experience in the LAK trial (Roche’s IND for IL-2). Podack received his Ph.D. in 1972 from the University of Göttingen, Germany, and his M.D. in 1968 from the University of Frankfurt, Germany.

BOARD MEMBERS:

Keith E. Dionne, Ph.D., has been the CEO and President of Alantos Pharmaceuticals since February 2004. Prior to joining Alantos, he was with Millennium Pharmaceuticals, where he held a number of senior management positions including: Vice President Research and Development Strategy; Vice President Business Development; and General Manager: Technology Business. In the latter role, he built Millennium’s technology solutions business into a $100 million per year division. Dr. Dionne holds a Ph.D. in Chemical Engineering and an M.S. in Technology and Public Policy from Massachusetts Institute of Technology (MIT).

Dennis H. Langer, M.D., J.D., is managing partner at Phoenix IP Ventures, a venture capital firm in Philadelphia. Prior to joining Phoenix IPV, he was most recently President, North America, of Dr. Reddy’s Laboratories, an emerging global pharmaceutical company. Previously, Dr. Langer was with GlaxoSmithKline (GSK) for nine years. His last position with GSK was as a member of the R&D Executive Team and as Senior Vice President, Project and Portfolio Management. In addition, he was also responsible for Alliance Management. He also held senior management positions with major pharmaceutical companies such as Searle, Abbott and Eli Lilly. Dr. Langer currently serves on the Boards of other biotechnology companies such as Myriad Genetics, Sirna Therapeutics, and Cytogen. Dr. Langer earned an M.D. from Georgetown University School of Medicine, a J.D. (**WORD NOT ALLOWED** laude) from Harvard Law School, and a B.A. in Biology from Columbia University.

INVESTORS: Seed capital provided by Golden Pine Ventures.

REVENUES: No revenues.

YEAR ESTABLISHED: 2005

NUMBER OF EMPLOYEES: 2

[karen335]

Thanks Randy,

Sounds promising.

Karen