The following 15 young Southeast biotech companies have either recently had a significant event or expect one or more in 2007. Some, such as Biolex, are rumored to be heading for an initial public offering of stock. Others recently landed substantial fundings or expect to raise substantial capital this year. Some are just getting started but have intriguing new models for drug discovery or development, such as Tau Therapeutics and InVasc.
This list is by no means comprehensive. It’s a sampling of the best and brightest in Southeast biotechnology companies. We asked the companies to fill out a questionnaire and some provided more detail to certain questions than others.
AGTC
Alachua, Florida
(a suburb of Gainsville).
Founded: 1999, by Nicholas Muzyczka, Ph.D., Barry Byrne, M.D., Ph.D., William Hauswirth, Ph.D., Terence Flotte, M.D., R. Jude Samulski, Ph.D.
Leadership:
Sue Washer, president and CEO of AGTC, is an experienced entrepreneur with a strong scientific and operational background. Washer has 10 years of pharmaceutical management and research experience from Abbott Labs and Eli Lilly as well as 11 years of senior management experience with entrepreneurial firms in the Gainesville area.
NIH or other grant support to date:
Phase I SBIR: $256,000. Phase I SBIR: $106,000.
Venture backing:
Seed Round: $6M, PrimeBioTech.
September 2001.
“A” Round: $20M, Interwest Partners (Dr. Arnold Oronsky), Intersouth Partners (Dr. Garheng Kong), MedImmune Ventures (Dr. Frank Top), Skyline Ventures (Dr. David Lowe). December 2003
NIH or other grant support:
AGTC is working with Genzyme to develop a product to treat diabetic retinopathy under a $1M, milestone-driven, grant from the Juvenile Diabetes Research Foundation.
Product:
AGTC’s lead product is a gene therapy product for the treatment of Alpha-1 Antitrypsin Deficiency (Alpha-1, a form of congenital emphysema). Currently, this product is in Phase I clinical trials. It is, like all of our products, based on the Adeno-Associated virus (AAV) vector. A key characteristic of AAV vectors is that they provide long-term expression of the genes they carry. AGTC is taking advantage of this by developing products to treat chronic illnesses such as Alpha-1. Patients with Alpha-1 are currently treated with bi-monthly infusions of a product derived from human serum, at a cost of $65,000 to $90,000 per year. A single treatment of AGTC’s product for Alpha-1 may replace the need for these infusions for years, potentially for life.
Other products in your pipeline:
Pre-clinical: Age-related Macular Degeneration (the leading cause of blindness in the developed world.
Diabetic Retinopathy (AMD and DR are both under collaborative development with Genzyme.
Pompe Disease (muscle weakness so severe that affected infants rarely survive past one year).
Leber’s Congenital Amaurosis (congenital blindness).
Research:
X-Linked Retinoschisis (severe vision loss/blindness)
Myotonic Dystrophy (muscle weakness/wasting, also eye and nervous system involvement).
Amount of venture backing you may be seeking now:
We plan to begin B Round fund raising in the third quarter, 2007, with a target of $25 million.
Web site: www.agtc.com
Advanced Liquid Logic
RTP, NC
Founded: 2004 by Vamsee Pamula and Michael Pollack.
NIH or other grant support to date:
Several NIH grants via SBIR and other grant programs totaling $5,000,000+
Venture backing:
One angel round of $1,000,000+
Lead product/technology:
Advances in engineering have made possible new approaches to liquid handling based on microscale phenomena which are suitable for miniaturization and automation in a “microfluidic chip”. Advanced Liquid Logic’s unique and patented digital microfluidic technology promises to transform this emerging field. It enables integrated, flexible, and portable lab-on-a-chip systems for miniaturizing and automating an enormous array of liquid-based laboratory, medical, and other analyses.
Other products in the pipeline:
The company’s first product will be a handheld or bench top multifunction analyzer. A handheld format allows testing to be performed at the point of sample collection with results available immediately. Current handheld analyzers generally perform only one type of test; they do not have the sophisticated liquid handling system that is required to perform multiple types of tests.
While channel-based microfluidics offers the promise of miniaturization and automation, it has been implemented only in the laboratory, and only in single-test roles. Instruments implemented at the point-of-care in medicine have very simple or passive liquid handling systems. The company envisions a very inexpensive multifunction analyzer that can take a single sample – as little as 1/1000th of a drop – and automatically process the sample to perform many types of tests, including clinical chemistry, immunoassays, PCR, and even genetic sequencing tests. A prototype is in development.
Amount of venture backing you may be seeking now: around $1million.
Web site: www.liquid-logic.com
Aldagen
Durham, NC
Founded: 2000 by Dr. Nelson Chao, Director, Adult Bone Marrow Transplant Center, Duke University; Dr. Clay Smith, Director, Leukemia/BMT Program of British Columbia; Dr. Micheal Colvin, Director Emeritus, Duke Comprehensive Cancer Center.
Leadership:
W. Thomas Amick, chairman & CEO: Tom Amick has proven his executive leadership abilities through a consistent string of
successes during his 30-year career with Johnson & Johnson.
NIH or other grant support to date:
Aldagen has received one NIH grant to date.
Venture backing:
The Company has closed a Series A, B and C round of venture funding and has raised $30 million to date. The syndicate includes the most active life science investors in the Southeast, including: Intersouth Partners; Aurora Funds; BD Ventures; Harbert Venture Partners; The Trelys Fund ; Tall Oaks; Village Ventures; Piedmont Angel Network.
Lead product/technology:
Aldagen is a clinical-stage regenerative medicine company developing and commercializing products to treat vascular and degenerative diseases. The company’s proprietary products can identify and isolate potent, highly effective adult stem and progenitor cells which can be quickly administered to regenerate or repair tissue. The company’s lead product, Aldesort, is currently being tested at Texas Heart Institute and Duke University in three clinical studies for ischemic heart failure, critical limb ischemia and cord blood transplantation.
Other products in your pipeline:
In conjunction with the development of Aldesort, Aldagen is also developing the Aldesorter. Unlike currently available cell sorters that are large, complex research instruments, the aldesorter is specifically designed to address the needs of clinical cell sorting including: ultra-high speed sorting, completely sealed fluidic path for disposability and sterility, compact size, and ease-of use. When completed, the Aldesorter will be desk-top size and have the ability to sort therapeutic stem cell doses in one to three hours.
Market:
Aldagen’s use of adult cell populations for tissue regeneration offers revolutionary treatment of a broad range of serious diseases affecting millions of people. Aldagen’s initial clinical development programs focus on three indications where the total market exceeds $2 billion.
Chronic Heart Failure: The heart disease population in the United States includes nearly 5 million people with chronic heart failure, and adds approximately 550,000 new cases annually. The American Heart Association estimates annual healthcare expenditures of $27.9 billion for the patients over the age of 65 suffering from heart failure. Within chronic heart failure patients, there is a growing subgroup of Class II/IV heart failure patients that are not candidates for any further revascularization procedures. Aldagen’s initial cardiology trial will target this patient group. Cardiologists estimate that this patient population may represent 5% to 10% of coronary artery disease patients, or approximately 500,000 to 1,000,000 patients.
Critical Limb Ischemia: It is estimated between 8 to 12 million Americans suffer from peripheral artery disease. The severe cases of PAD, known as critical limb ischemia, can lead to gangrene or tissue death, often requiring amputation of the effected limb.
Genetic disorders and hematological cancers: There are currently approximately 1,000 cord blood transplants performed per year to treat primarily pediatric genetic diseases. The current cord blood transplant procedure involves risk of opportunistic infections, hospital readmissions and ultimately impact patient survival. A cord blood transplant procedure that could decrease engraftment times would significantly increase the market opportunity to 1,000s of pediatric patients and 10,000 adult patients that do not currently undergo a transplant due to the procedural risk. Premium pricing in these indications, particularly the genetic diseases, is possible given the “curative” nature of the therapy. Independent market research pegs this market opportunity at greater than $400 million annually.
Amount of venture backing you may be seeking now:
Aldagen recently announced a $17.3 million financing in December of 2006. This was the largest U.S. VC led round of any regenerative medicine/stem cell company in the past two years. We have not made any public announcements regarding any future financing plans.
Web site address:
www.aldagen.com
Argos Therapeutics
Durham, NC
Founded: 1997 by Duke University
scientists – Eli Gilboa, Clay Smith, Bruce Sullenger, Kim Lyerly.
Leadership:
John Bonfiglio president and CEO, joined Argos Therapeutics in January 2007. Before joining Argos, Bonfiglio was president and CEO of Immune Response Corporation, where he led that company’s business development strategy and oversaw multiple clinical trials, manufacturing and the development of biologic immuno-stimulatory therapeutic agents. Prior to joining Immune Response, he served as president and CEO of Peregrine Pharmaceuticals, as director of the strategic business unit at Baxter Healthcare Corp., and as director of business planning at Allergan.
NIH or other grant support to date:
$1 million grant from Alliance for Lupus Research in 2004; In October 2006, received $21.5 million contract from NIH to develop a personalized HIV immunotherapy over a five year period.
Venture backing: Series A and B. $48 million. Investors include, TVM, Intersouth, Aurora, MDS Capital, GeneChem, ABN AMRO
Product:
A personalized dendritic cell-based immunotherapy for the treatment of virtually all cancers and infectious diseases. We are currently in clinical trials in HIV and two cancers (renal cell carcinoma and chronic lymphocytic leukemia.
Other products in your pipeline:
An antibody for the treatment of lupus (partnered with Novo Nordisk) and a soluble protein (CD83) for the treatment of autoimmune disorders and transplantation rejection.
Market:
Global sales of cancer agents in 2005 exceeded $20 billion; these sales are expected to double by 2011. These figures do not include products used for adjunct, supportive care treatments, which account for another $12.5 billion. Treatments for HIV presently represent a commercial market in excess of $5 billion. Argos’ focused strategy is to bring therapies for these selected diseases all the way to market.
Amount of venture backing you may be seeking now: $30 million Series C
Web site: www.argostherapeutics.com
AxoGen
Gainesville, FL
(moving headquarters to Alachua, FL ,by April 1st, 2007).
Founded: 2002 by Jamie M. Grooms and John P. Engels.
NIH or other grant support to date:
N/A Venture backing (number of rounds, total amount raised, VCs: two rounds (Series A & B), $8.5 million, De Novo Ventures, Accuitive Medical Ventures, Cardinal Health Partners.
NIH or other grant support: N/A
Product:
Every year, thousands of people suffer peripheral nerve injuries that impair their ability to perform simple daily tasks or to feel normal sensations. Restoring this function after an injury has been a significant challenge for surgeons. AxoGen was formed to address these needs and to advance the science of peripheral nerve repair.
Peripheral nerves branch out from the spinal cord to regulate all movement and sensation in the body. Each nerve consists of numerous tubes closely packed in protective sheaths. Scientists and surgeons have long known that nerve regrowth is severely impaired when the protective sheath is damaged. Researchers at the University of Florida’s McKnight Brain Institute discovered that a substance in these nerve sheaths actually inhibits nerve regeneration after an injury.
Using this amazing discovery, AxoGen has developed nerve grafts that foster regeneration over longer distances than possible in the past and with restored function. The processed nerve grafts will provide surgeons better options to repair peripheral nerve damage than ever before.
AxoGen’s first products focus on the repair of nerve injuries from trauma and from
surgical procedures such as prostate cancer where the removal of the cavernous nerves surrounding the prostate result in erectile dysfunction for the patient.
Other products in your pipeline: N/A
Amount of venture backing you may be seeking now: N/A
Web site: www.axogeninc.com
Biolex Therapeutics
Pittsboro, NC
Regional sources say Biolex is likely to file for an initial public offering of stock (IPO) in the coming year.
Founded: 1998. The technology came from NC State.
Leadership:
The company is currently led by a seasoned management team including: Jan Turek, president and CEO; David Spencer, Ph.D., COO and SVP, research and development; John Irick, CBO and senior vice president.
NIH or other grant support to date:
Only one from the NC Biotechnology Center.
Venture backing:
$70 million, seed rounds, Series A, Series B. VCs include: Intersouth Partners; Quaker BioVentures ; Johnson & Johnson Development Corporation; Polaris Venture Partners ; Mitsui & Co. Venture Partners; Kitty Hawk Capital; Wakefield Group; The Dow Chemical Company; Dogwood Equity; Trelys Venture Partners; Franklin Street Partners ; Tall Oaks Capital.
Lead product/technology:
Biolex Therapeutics is developing and commercializing therapeutic proteins based on its proprietary LEX System, an expression system that enables the production, development and commercialization of hard-to-make proteins and the optimization of monoclonal antibodies. The company is developing a proprietary pipeline of products that rely upon known mechanisms of action to provide a reduced risk profile while targeting large, proven pharmaceutical markets.
Biolex’s lead candidate, Locteron, is being developed as a best-in-class controlled-release interferon alfa for the treatment of hepatitis C. The company’s second product candidate, BLX-155, is a direct-acting thrombolytic, designed to break up clots in certain diseases such as acute peripheral arterial disease, catheter occlusion and deep vein thrombosis. In addition, the unique capabilities of the LEX System have led to collaborations with Centocor, Medarex and other leading pharmaceutical/biotech companies.
Other products in your pipeline:
Locteron for hepatitis C (phase 2).
BLX-155, a direct-acting thrombolytic
(preclinical).
Market:
Independent market research predicts that total interferon sales for the treatment of hepatitis C will exceed $5 billion by 2014. We do not have estimates available for BLX-155 at this time.
Amount of venture backing you may be seeking now:
Biolex is a private company with a strong shareholder group comprised of leading venture capital firms and corporate investors. We have not made any public announcements regarding any future financing plans.
Editor’s note: Don’t be surprised if Biolex files for an IPO this year.
Web site address:
www.biolex.com
CeNeRx BioPahrma
Cary, NC
Founders: Barry Brand (CEO); Mark Baric (President & CFO) and Jim Free (COO).
Leadership:
Barry Brand is CEO and a founding member of CeNeRx BioPharma; Brand brings 18 years of pharmaceutical experience with 12 years Neuroscience experience to CeNeRx. As VP, Global Commercial Strategy – Neuroscience, GlaxoSmithKline. Brand was responsible for commercial development of GSK’s Neuroscience clinical pipeline. Brand also oversaw global commercialization for marketed CNS products including such major global brands as Paxil /CR, Wellbutrin/XL, Zyban and Imitrex. As Paxil marketing director, Brand managed GSK’s largest asset achieving gross sales of $1.8 billion and was recognized as one of Advertising Age’s Top 100 Marketers.
Market:
CeNeRx is focused on developing and commercializing innovative treatments for diseases of the central nervous system ($95 billion global market). CeNeRx’s lead compound, TyRima, is in early phase clinical development for the treatment of depression and anxiety, a $20 billion global market. The National Institute of Mental Health reports that major depressive disorders affect approximately 14.8 million American adults in a given year.
Currently, major depressive disorder is the leading cause of disability in the U.S. for individuals aged 15-44. Many patients do not respond satisfactorily to current therapies, reinforcing the need for a range of safe and effective treatments. CeNeRx is also advancing drug candidates which could be effective in pain, epilepsy and obesity.
NIH or other grant support to date:
CeNeRx is a privately funded company.
Venture backing:
CeNeRx has raised approximately $25 million to fund development of the RIMA antidepressant series, including lead agent TyRima. Our Series A financing in October 2005 was led by Perseus-Soros BioPharmaceutical Fund, with participation from L Capital Partners, AM Pappas & Associates, and Wistar Morris. CeNeRx is considering a series B round of $20-25 million in late 2007/early 2008.
Product:
The portfolio is led by TyRima, CeNeRx’s new drug candidate with a triple mechanism of action for the treatment of depression and anxiety. TyRima is a member of a novel class of drugs known as reversible inhibitors of monoamine oxidase A, or RIMA. RIMA antidepressants elevate the levels of three key neurotransmitters that affect mood and anxiety in contrast to the leading antidepressants available today that affect the single neurotransmitter serotonin.
This triple mechanism has the potential for enhanced efficacy and an improved therapeutic index compared to current therapies. TyRima could be the first RIMA antidepressant available in the U.S. market, and it has patent protection beyond 2026. CeNeRx has worldwide rights to develop and commercialize TyRima in the $20 billion global antidepressant market.
Other products in the pipeline:
In addition to the RIMA antidepressant series, the CeNeRx pipeline has two additional series of compounds:
HPA-Axis Novel Neuromodulator – a series of clinical/pre-clinical stage novel
neuromodulators which act on the HPA-axis with potential utility in the treatment of mood/anxiety disorders and epilepsy. The lead candidate, CXB722 has a human safety database of 500+ patients and positive clinical trial data in epilepsy and stress-related disorders.
Cannabinoid Series – a series of discovery stage cannabinoids with varying selectivity for different receptors. The series include a variety of agents with efficacy demonstrated in preclinical models of pain and obesity.
Amount of venture backing you may be seeking now:
CeNeRx is exploring a series B round of $20-25 million in late 2007/ early 2008.
Web site: www.cenerx.com
DiaKine Therapeutics
Charlottesville, VA
Product: DiaKine Therapeutics is an early stage drug discovery company focused on bringing novel therapies for type 1 and type 2 diabetes to market.
Market: 20.8 million people in the United States have diabetes. Of these, 14.6 have been diagnosed while another 6.2 million remain undiagnosed; 1.5 million new cases of diabetes were diagnosed in people over 20 years of age last year. Another staggering statistic: 41 million Americans are in a pre-diabetic condition. All of this adds up to a potential market opportunity in excess of $13 billion.
Leadership: Keith Ignotz, president & CEO. Ignotz has over 25 years of experience in the global healthcare market with 14 of those in diabetes. He joined DiaKine from SpectRx, a diabetes management company which he co-founded in 1993 and took public in 1997. Ignotz has extensive experience in venture, public, and grant financing of start-ups and development stage companies; he has raised more than $70 million in the last 10 years. Previously, he was president of Humphrey Instruments SmithKline Beckman (Japan), president of Humphrey Instruments (Germany), and senior vice president of Allergan Humphrey.
Venture backing: $1.5 million in financing.
Company is currently seeking Series A venture capital round.
Web site: www.diakine.com
Ion Healthcare Corporation
Midlothian, VA
Founded: 2005 by Stephen A. Burton, Ph.D.
Leadership:
Michael Rowe, CEO; Stephen Burton, PhD, President
Market:
Over $3 billion spent annually managing about 3 million patients diagnosed with sleep apnea. An additional 15 million patients with this disorder are undiagnosed. Apnea is serious cardio-respiratory disorder that wreaks havoc on a patient’s health and quality of life.
Untreated apnea has been proven to double a patient’s healthcare expenditures, short life up to 5-10 years, increase risk of stroke, hypertension and fatal heart attack. Strong reimbursement on initial contact when diagnosed and treatment initiated.
Excellent recurring revenues from managing the apnea patients, who require on-going support for balance of their life. Once on treatment patients live normal lives for decades.
NIH or other grant support to date: None.
Venture backing: Series A $5MM; closed July 2006.
Product:
Cost effective, vertically integrated, clinically proven turn-key disease management healthcare service for sleep apnea; Built on patented, FDA approved home diagnostic test for sleep apnea and HIPPA secure ASP that provides initial diagnostic confirmation within 10 minutes of home test completion and delivers digital medical record to healthcare service site automatically. Solves significant market pressure to address high volume, time sensitive sleep apnea risk assessment required in peri-surgical screening for procedures with general anesthesia.
Other products in your pipeline: Cardinal symptom for sleep apnea is chronic snoring (one in three snorers have sleep apnea). Company has license to use FDA approved device for internet delivery of snoring assessment that is clinically validated to predict success of snoring treatment. Device would interact with simple home PC, PDA, or cell phone. Device would allow Ion service to be delivered throughout the world on cost effective platform.
Amount of venture backing you may be seeking now: Unannounced at this time. Estimate a second $5 million round in 2008.
Web site address: www.ionhealthcare.com
InVasc Therapeutics, Atlanta, Georgia; research facility in Columbus, Ohio.
Founded: 2003 by Dr. Sampath Parthasarathy, chair; Dr. Bobby Khan, president; Dr. Sanjay Rajagopalan, executive vice president; Dr. Nadya Merchant, director of research operations.
Leadership: Dr. Bobby Khan, president.
Market:
Atherosclerosis (the process of hardening of the arteries) is systemic process and affects not only the coronary arteries but also the cerebral vessels, kidney arteries, arteries supplying the lower extremities and reproductive organs, resulting in strokes, hypertension, amputations and impotence.Thus the burden of atherosclerosis (and corresponding market) is not restricted to coronary heart disease.
It includes strokes (cerebrovascular disease), peripheral arterial disease and erectile dysfunction. Heart disease and stroke are the first and third leading causes of death in the United States, accounting for nearly 40 percent of all deaths.
Nearly 930,000 Americans die of cardiovascular diseases each year, which amounts to one death every 33 seconds. About 70 million Americans have some form of cardiovascular disease, which is responsible for more than 6 million hospitalizations each year.
In 2006, the cost of heart disease and stroke alone in the United States is projected to exceed $400 billion: $250 billion for health care expenditures and $150 billion for lost productivity from death and disability.
Peripheral arterial disease, another manifestation of atherosclerosis, affects over 5 million adults aged 40 years and older.
Metabolic syndrome, a major risk factor for atherosclerosis, represents a cluster of risk factors for diabetes and cardiovascular disease.
There is a huge market for pre-emptive drug therapy to prevent atherosclerosis related mortality and morbidity by targeting metabolic syndrome.
There is a tremendous need for drugs that effectively treat recurrent complications once atherosclerosis manifests.
NIH or other grant support to date: none.
Venture backing: $500,000.
Product:
InVasc has selected its initial products for development based on the following criteria: products with targeted action that meet pre-specified secret toxicity criteria which are safe and effective.
Meets the needs of large markets: particularly atherosclerosis, anti-aging and inflammatory conditions.
Ease of production and scale-up without technology risk.
Expedited path towards approval by regulatory bodies.
Enlistment of a scientific advisory team familiar with the science related to the the products and with specifics of drug development through Phase II clinical trials.
The company has short listed one lead candidate compound for further testing and development. This compound has already shown evidence of efficacy and limited safety in early testing. Further development, including pharmacokinetics, pharmacodynamics, carcinogenicity, and toxicity data will be generated for an IND application. We hope to move into Phase I clinical trials shortly thereafter.
InVasc then plans to complete the development of its initial applications with the support of its pharmaceutical partner(s) through licensing agreements. Relationships already exist with several leading prospective partner companies. Revenues from royalties and milestone payments will also be leveraged to bring additional products thorough clinical trials. It is expected that the company will develop the means to market or co-market many of these subsequent prescription pharmaceutical products itself, providing enormous long-term growth for InVasc.
Other products in your pipeline:
InVasc’s commercial pipieline consists of two promising pharmaceutical compounds based on our proprietary template strategy and one diagnostic assay. The latter is an assay for homocysteinemia, a risk marker of coronary and vascular disease. The lead compounds has already undergone limited pre-clinical testing and have demonstrated efficacy in atherosclerosis and reduction of blood pressure. Additional testing is currently underway in models of metabolic syndrome and atherosclerosis.
Amount of venture backing you may be seeking now: $4.1 million
Web site: www.invasc.net.
Metabolon Inc.
Durham, NC
Founded: 2000 by John Ryals, Ph.D., Chris Beecher, Ph.D., Rima Kaddurah-Daouk, Ph.D. and Paul Schimmel, PhD.
Leadership:
John Ryals, Ph.D. , president and CEO.
Market:
Metabolon, Inc. has developed and patented a proprietary methodology that detects and quantifies the repertoire of small molecules present in biological specimens. Because these small molecules represent the products of cellular metabolism, which change in response to disease and drug therapy, Metabolon is able to use its technology to improve the discovery of new drugs and diagnostic technologies. Over 90 studies with pharmaceutical, government, and academic investigators have validated Metabolon’s technology as a powerful tool for biomarker discovery in biological specimens.
NIH or other grant support to date: 13 grants totaling about $2.5 million.
Venture backing:
Since 2003, Metabolon has raised $17 million in equity financing in two rounds. Venture capital investors include Sevin Rosen Funds, Aurora Funds, Trelys Funds, and Harris & Harris Group.
Product:
Metabolon’s technology utilizes a global and unbiased view of the human metabolome. The result is the identification of hundreds of named metabolites that is analyzed for its impact on well known and documented biochemical pathways. Metabolon has filed pioneering methods patents on the use of metabolomics for drug discovery, disease treatment and diagnosis. Our first claim using this method was issued in 2006 in the field of ALS. More than twenty additional methods and biomarker patents have been filed and are various stages of prosecution.
Other products in your pipeline:
In 2006, Metabolon launched three solutions designed to enable biomarker discovery across the drug discovery pipeline.
These products, mSelect, mVivo, and mProveClinical allow researchers to cost-effectively evaluate compound effects in various models so that they can confidently select and advance most promising drug candidates. These products represent the first Metabolon solutions designed to enable our customers to maximize their return on their research investment.
Amount of venture backing you may be seeking now:
Metabolon intends to raise approximately $15 million in equity financing during 2007
Web site: www.metabolon.com
Metastatix
Tucker, Georgia
Founded: 2005 by Dennis Liotta PhD, Tony Shuker PhD, Mike Natchus PhD, Hyunsuk Shim PhD, Jim Snyder PhD.
Leadership:
Tony Shuker, Ph.D, president and CEO. Shuker is experienced in the science and the business of drug discovery and has seen the highs and lows of both. His career as a synthetic and medicinal chemist has yielded numerous patents in the United States and abroad, as well as several molecules in clinical development. And his work as an advocate of the biotechnology industry has helped to establish a number of independent research and development companies.
Dr. Shuker was formerly a senior scientist at Eli Lilly and Company in Indianapolis, where he had responsibility for leading several major drug discovery and development projects that resulted in multiple clinical candidates. While at Lilly, he led a team that brought a compound to clinical trial in 210 days, the fastest “time to trial” for a compound in the company’s history.
Following his pharmaceutical career, Dr. Shuker has been involved in a number of entrepreneurial ventures and served as president of the privately held NuTec Life Sciences and EmTech Bioscience. Prior to founding Metastatix, he was most recently part of the executive management team of Somatocor Pharmaceuticals and founded Prism Therapeutics. Dr. Shuker serves on the Board a number of not-for-profit organizations including the Georgia Biomedical Partnership and BioSouth. Because of his dual perspective as both scientist and entrepreneur, Shuker has been in high demand as a speaker, addressing dozens of conferences and organizations.
In his free time, Dr. Shuker is an avid rock guitarist and songwriter and is a long-suffering follower of English sports.
Market: Novel, oral drugs for cancer, HIV and inflammation each represents $800
million markets
NIH or other grant support to date: $100,000 from the Georgia Research Alliance.
Venture backing: $ 4 million raised ( seed round and Series A) since August 2005 from the following: H.I.G. (lead Investor); The Aurora Funds, SR. One; MedImmune Ventures; CM Capital; Georgia Venture Partners; Centrosome Ventures and the State of Georgia.
Product: A novel, orally available and non-toxic small molecule drug that is targeted for solid tumors such as breast cancer and small-cell lung cancer along with leukemia. The drug works by blocking a cell surface receptor called CXCR4
Other products in your pipeline: Novel drugs for the prevention of HIV infection and the effective treatment of inflammation.
Amount of venture backing you may be seeking now: The company is seeking a Series B financing in 2007.
Web site: www.metastatix.com
Regado Biosciences
Durham, North Carolina
Founded: 2001 by Bruce Sullenger, Ph.D. and Chris Rusconi, Ph.D.
Leadership:
Doug Gooding, CEO. Gooding led the founding investment in Regado as a Principal with The Aurora Funds, an early stage venture capital fund based in Durham, NC. As a Principal at Aurora, Doug also led investments in, and served on the Board of Directors, of Tissue Informatics (NASDAQ:CLDA). Prior to joining Aurora, Doug served as Director of Business Development of Icoria (NASDAQ:CLDA), a systems biology company located in Research Triangle Park, NC. Prior to his involvement with Icoria, Doug was a Manager in the Genomic Production Group at Incyte Pharmaceuticals (NASDAQ:INCY) in Palo Alto, CA. Doug began his career at Stratagne Corp. (NASDAQ:STGN) in La Jolla, CA. Doug received his Bachelor’s in Biology with a minor in Chemistry from the University of San Diego and his MBA from the Kenan-Flagler Business School at the University of North Carolina.
Market: Regado is looking to revolutionize antithrombotic therapy. Regado’s products target a multi-billion market segment of injectable antithrombotics.
NIH or other grant support to date:
Approximately $100K as an SBIR from NHLBI.
Venture backing:
The company has raised $25.6M to date. Investors include Domain Associates (Princeton, NJ), Quaker Bioventures (Philadelphia, PA), The Aurora Funds (Durham, NC), and individual investors.
Product:
Regado’s lead program REG1, which is an anticoagulation system comprised of two parts, RB006, which is an aptamer that inhibits Factor IX, and RB007, which is an oligonucleotide antidote, which directly reverses the activity of RB006. The concept of antidote-controlled aptamers was discovered and put into practice by the Sullenger lab in the Department of Surgery at the Duke University Medical Center.
Other products in your pipeline:
The company has an active discovery group working on the discovery and development of antidote-controlled antithrombotics.
Amount of venture backing you may be seeking now: Not currently raising capital.
Web site: www.regadobiosciences.com
Tau Therapeutics
Charlottesville, VA
Founded: 2003 by Andrew Krouse, Dr. Lloyd Gray, M.D., and Dr. Timothy Macdonald, Ph.D.
Leadership:
Andrew Krouse, Founder, President and CEO. Sixteen years senior university leadership including vice president of the Darden School of Business. Formerly, a consultant, Goldman Sachs, NYC. Graduate Maryland Business School (honors); Master’s Degree, Georgetown University; the executive program, The Darden School, University of Virginia. Selected to participate in the Washington Metro-area Mindshare 2005 for the hottest emerging companies in the region.
Market:
Tau views the development of its repositioned compound for certain orphan drug indications, a market that could be worth $300 million annually, as a gateway to the much larger cancer market, which eclipses $1 billion. Tau’s scientific founders have identified a universal, developmentally regulated, proliferation-producing mechanism dependent on a particular calcium T channel, a protein also known as Cav3.2. Recently a number of scientific journal articles have been published on this technology in cancer, pain, and epilepsy for which Tau holds patents.
NIH or other grant support: None.
Venture backing: Tau recently raised $500,000 from individual investors.
Product:
The company is focused on the development, repositioning and commercialization of calcium T-channel therapy agents that are designed to halt the growth of tumors. Tau’s founders have identified drugs that block this important new mechanism of action and have named this target, Cytostatic Checkpoint Therapy. Tau’s first Cytostatic Checkpoint Therapy product, a calcium T-channel blocker with a broad-spectrum of anti-cancer tumor potential, is a drug that was licensed by the U.S. FDA for the management of hypertension, and was safely used by thousand of patients.
Tau’s near term goal is to reposition this drug and obtain Orphan Drug status for certain indications. Repositioning offers the lowest risk and quickest return on investment in drug development. Within the next 12 months, Tau will validate the target and conduct significant pre-clinical tests on the repositioned drug and several other possible drug candidates, including TTL-1177. This milestone will allow the company to follow-on with a larger financing round to advance the repositioned drug to a combined Phase I/II Clinical Trial or another compound to an IND/Phase I Clinical Trial.
Other products in the pipeline:
In addition to Tau’s repositioning strategy, Tau researchers patented a diagnostic test, and two libraries, with two more libraries on the way, of small molecule compounds. Tau has and has currently synthesized and tested over 400 compounds in its first library. Tau conducted significant pre-clinical tests on over 100 of these compounds and has identified several viable lead compounds for development. Tau is also investigating the use of its novel calcium t-channel blockers for other validated targets such as pain and hypertension.
Amount of venture backing sought now: Tau is seeking a Series A round of $7 million to $10 million by late summer or fall 2007.
Web site: www.tautherapeutics.com.
Tigris Pharmaceuticals
Bonita Springs, FL
Founded: 2005 by Edmundo Muniz,
Anne White, Joshua Kazam, David Tanen,
Peter Kash.
Leadership: Edmundo Muniz, MD, PhD – President and CEO
Market: Developing drugs for the treatment and prevention of cancer
NIH or other grant support to date: $2.3 Million grant from NCI SBIR division for development of lead molecule A007
Venture backing: Two rounds completed: Series A of $11.6 million and Series B of $16 million. Series B included NGN Capital LLC, Wexford Capital, LLC, Bushido Capital Partners, L.P. and other institutional investors. Riverbank Capital Securities, Inc. acted as placement agent
Product:
A-007 (4,4′-dihydroxybenzophenone-2, 4- dinitrophenylhydrazine) is an aryl
hydrazone that is currently under development for the treatment of high-grade cervical and anal intraepithelial neoplasia. A Phase II multi-center, double-blind clinical trial with A-007 in 250 patients with high-grade cervical intraepithelial neoplasia (CIN) is ongoing.
The primary objective of this Phase II study is to determine the pathological response of A-007, a self-administered intravaginal gel, as compared to placebo in the treatment of high-grade CIN. Secondary objectives are evaluation of safety, human papillomavirus (HPV) eradication assessed via polymerase chain reaction (PCR) and Hybrid Capture II, and measurement of immunologic parameters. The trial is being conducted at 35 research centers in the United States. Two registration directed Phase II studies in patients with high-grade CIN are underway in Mexico. A Phase I/II study of safety and efficacy of
A-007 in patients with anal high-grade squamous intraepithelial lesions (HSIL) is also underway at several cancer treatment centers in the U.S.
Other products in your pipeline:
Tigris’ pipeline consists of novel agents
targeting key pathways in cancer growth such as p53/apoptosis, angiogenesis, Rho GTPases as well as PI3K/Akt and survivin.
Amount of venture backing you may be seeking now: None
Web site: www.tigrispharma.com
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