John Manzello United States

Promosome is a synthetic biology company founded to commercialize the discoveries of the late Nobel Laureate, Dr. Gerald M. Edelman, and colleague Dr. Vincent P. Mauro of The Scripps Research Institute (TSRI) in La Jolla, CA. Leveraging Dr. Edelman’s and Mauro's unparalleled expertise in the area of mRNA translation and the resulting technologies they pioneered, Promosome offers technology licensing opportunities to biotherapeutic and bioindustrial companies seeking to dramatically improve efficiencies in expression, secretion, and potentially biotherapeutic safety and dose tolerance.

In March 2014, GEHC and Promosome executed an agreement to license a subset of Promosome’s initial technology suite in support of their mammalian cell line development ambitions.

Promosome operates a developmental center in the Torrey Pines section of San Diego which focuses on expanding its mRNA translation-based toolset as well as identifying and developing a pipeline of proprietary proteins which can be differentiated by their unique manufacturing attributes (higher yields, greater homogeneity, etc.) and quite possibly by their safety profile in clinical use.

Year Founded
2004
Biotech Phase of Development
Technology Overview
Ribosomal Engagement mRNA Translation
Alliance & Collaborations
GE Healthcare Life Sciences
Current Financing Needs
5-10M USD
Current Investors
HWI
IP Status
Varying from Provisional to Granted
Recent Milestones
Exclusive Mammalian to GEHC
Management Team Highlights
Proven & Expanding
Promosome LLC
President & CEO 

Dr Kurt Marek

The Office of Translational Alliances and Coordination (OTAC) at the National Heart, Lung, and Blood Institute supports the development of innovative biomedical products to address unmet medical needs in the heart, lung, blood and sleep fields.  OTAC is home to the NHLBI's small business programs (SBIR and STTR) and the NIH Centers for Accelerated Innovations.

The NHLBI's SBIR and STTR programs comprise one of the largest sources of early-stage capital for U.S. small business, acting as engines of innovation for developing and commercializing novel technologies and products that aid in the prevention, diagnosis, and treatment of heart, lung, blood, and sleep diseases and disorders. The NHLBI provides grant and contract funding opportunities and resources to support small businesses performing research and development on technologies related to the mission of NHLBI. With an annual budget of $85M, the NHLBI funds about 200 companies each year through the Institute's small business programs.

The NIH Centers for Accelerated Innovations accelerate translation of scientific discovery into commercial products that improve health for patients. This unique public-private partnership is changing the way discoveries with scientific and commercial potential are identified and developed.

Dr Kurt Marek
National Heart Lung and Blood Institute
LinkedIn logo Deputy Director OTAC 

Gifford Marzoni United States

DavosPharma’s corporate offering covers all the activities required to get a drug from conception to commercialization. DavosPharma has been filling this need since 1972, serving the pharmaceutical and life science market by providing discovery chemistry & biology, pre-clinical development, and all required CMC activities including custom synthesis of organic molecules, custom dosage formulation, and custom manufacturing of cGMP intermediates, APIs, and drug product. 

DavosPharma
Vice-President Global Pharmaceutical Development 

Yves Massicotte

Ropack, Inc.
President & CEO 

Nola Masterson

Science Futures Management is an investment firm based in California USA. In the Life Sciences the firm focuses on biotech therapeutics and diagnostics. The firm typically provides series A financing (equity) in the range of $25K to $5K. The firm is geographically agnostic but generally invests in companies based in the USA and Europe. The firm has no current mandate for the number of allocations it plans to make and will evaluate relevant opportunities as they surface.
Science Futures
Managing Director 

Gary Mathias United States

Year Founded
2011
Biotech Subsector
Biotech Phase of Development
Technology Overview

Thetis has discovered and is in the early stages of developing several compounds in the omega-3 arena that are quite differentiated from existing agents based on its proprietary HEALER Technology. 

  • TP-252 is an ionic derivative of eicosapentaenoic acid that delivers EPA with remarkable bioavailability in animal models. Unlike anything known in the omega-3 arena, TP-252 is a solid, stable, free-flowing drug substance that is suitable for tablet formulations and for potential use in fixed dose combination products with statins.
  • TP-113 (bis-metformin glutamate DHA) is a novel oral agent for treatment of T2DM as a 2nd generation metformin product with substantial differentiating pharmacological attributes and intellectual property protection. Its PPP targets significant HbA1c reduction as its primary clinical endpoint with enhanced pharmacological benefits that include insulin resistance resolution, multiple mechanistic effects on hepatic gluconeogenesis that could translate into lower metformin dosing requirements, and reduced serum triglyceride (TG) levels.
  • TP-352, an ionic derivative of docosahexaenoic acid that delivers DHA with remarkable bioavailability in animal models, has prospects for treatment of NASH based on the anti-fibrotic, metabolic and TG lowering effects of DHA.
  • TP-110 (bis-metformin glutamate EPA) has prospects as a first in class agent for treatment of PCOS based on the clinically established effects of its active moeties for ovulation restoration, reduced insulin resistance and enhanced anti-androgenic effects.  
Alliance & Collaborations
Marette Laboratory
Supporting Metrics or Evidence

HEALER Technology applied to already approved APIs with established safety records.

Current Financing Needs

$25 million to fund TP-113 through Phase IIa

Current Timeline

INDs can be opened on lead candidates within 12 months due to non-clinical safety efficiencies based on prototype candidate already vetted by FDA

Current Investors

Connecticut Innovations and Angel Investors

IP Status

Issued patents (US8765811, US8993124, US8901107) and non-provisional patent applications under petition to make special 

Recent Milestones
  • TP-113 preclinical studies in mice showing PDX formation
  • IND allowance establishing non-clinical safety of Thetis compounds
  • Extensive rodent pharmacokinetic studies demonstrating unique PK properties
  • Pre-formulation feasibility studies completed on lead candidates
  • Issued composition of matter patents on metformin compounds (TP-113/110)
Management Team Highlights

Frank Sciavolino, PhD, Chief Scientific Officer

  • former Pfizer R&D executive (Zithromax) and in-licensing (Celebrex)
  • PhD, Organic Chemistry, University of Michigan
  • Over 30 issued patents

Gary Mathias, MBA, Chief Financial Officer

  • Over 25 years as healthcare investment banking and entrepreneur
  • Former SVP, GE Equity, Healthcare
  • MBA, Yale University; BA Economics, Harvard College

Alexander Fleming, MD, Senior Clinical & Regulatory Officer

  • Former supervisory physician, DMEP, FDA
  • Expert in metabolic disease
  • MD, Board Certified, Endocrinology, Emory University

Andre Marette, PhD, Lead Investigator and Scientific Advisor

  • Professor of Medicine, Institute for Heart & Lung Research, Laval University
  • Pfizer Research Chair, Pathogenesis of Insulin Resistance and CVD
  • Recent publication on PDX effect on insulin resistance (Nat. Med. 5/11/2014)

Michael Van Zandt, PhD, Director, Discovery Chemistry

  • Former Director, Institute for Pharmaceutical Discovery (1996-2012)
  • PhD, Organic Chemistry, Wayne State University

Robert Lipper, PhD, Technical Consultant, Formulation

  • VP, Biopharmaceutics, BMS (1984-2008)
  • PhD, Pharmaceutical Chemistry, University of Michigan

Mehar Manku, PhD, Scientific Advisory

  • former Chief Scientific Officer, Amarin Corp.
  • Executive editor, PLEFAs
  • Inventory on 61 patents in polyunsaturated fatty acids
Thetis Pharmaceutcals
CFO 

Robert Maurer United States

IR2Dx Company Overview:

IR2Dx has developed a proprietary, breakthrough analysis and reporting system for multi-marker diagnostic test panels, to provide highly personalized treatment strategies for patients with Type 2 diabetes.  While control of glucose levels remains an important factor in the treatment of the disease, the IR2Dx platform evaluates the individual disease pathways for each patient, providing critical information regarding multiple markers and their overall pattern, all of which contribute to management of underlying disease.  This information can then be used by physicians to guide treatment decisions to deliver precision medicine in diabetes. 

Today, there are approximately 382 million people with diabetes in the world, and this number is expected to grow to 592 million by 2035.  The worldwide available market for early detection and drug response diabetes diagnostics is greater than $20 billion.  IR2Dx can enter the market within the current reimbursement and regulatory environments, and is ready to launch its first products in H1 2015 through commercial laboratories.

The IR2Dx platform provides personalized treatment information and recommendations to physicians based on a proprietary decision tree algorithm, greatly enhancing the clinical utility of a laboratory report.  Existing reimbursement levels for the panel markers in the U.S. and key international markets adequately cover the addition of the IR2Dx analysis and reporting. 

The platform is a software-based decision analysis tool. The analysis is performed on results from commercially available diagnostic tests run using standard laboratory bench top systems, requiring no tailored equipment, no custom design of the test system itself, and no capital investment.  Lab technicians upload the multi-marker panel testing results to the IR2Dx proprietary web portal to access the company’s decision support tool analysis product. In the initial commercialization phase, each laboratory will have a specific customized software product, and will pay for each report on a per-use basis. 

In the current U.S. regulatory environment for such products, with “health management IT functionalities”, such as the IR2Dx analysis and reporting system, near-term requirements for premarket review are unlikely, though the FDA may give additional guidance at any time. The IR2Dx platform is protected by a strong and broad intellectual property portfolio combining substantial data and know-how with issued patents in the U.S. and Europe. The company’s issued patents carry claims for use of its analysis platform and combination of markers for treatment guidance “with all glucose lowering drugs.”

 The company anticipates launch of the proprietary IR2Dx platform in H1 2015, introducing its first clinical decision support products through commercial laboratories. 

Year Founded
2008
Biotech Subsector
Medtech Subsector
Biotech Phase of Development
Medtech Phase of Development
Technology Overview

In 2002, IR2Dx company founders observed that anti-diabetic therapies reduced adverse cardiology events across multiple drug classes, while at the same time, cardiovascular drugs were reducing diabetes conversions. Further, it has long been recognized that cardiovascular disease is a comorbidity of diabetes. IR2Dx founders concluded that cardiovascular disease and Type 2 diabetes are manifestations of the same underlying conditions, and by analyzing information on relevant markers, treating physicians could be provided with information to help guide drug selection and assess drug response, making improved treatment possible. The research identified pathway biomarkers that significantly elucidate the evolution, and optimal treatment, of the disease while continuing to provide glucose control, throughout the treatment process with a patient. These biomarkers are: high-sensitivity C-reactive protein (hsCRP), intact proinsulin, insulin, adiponectin and C-peptide. Through the IR2Dx patented methods and systems of evaluating the baseline and subsequent levels of these markers, the physician is given a previously unavailable, cost effective window into the pathways and causes of his/her patient’s specific disease, with the opportunity to intervene therapeutically before the disease state progresses further. Specifically, the IR2Dx platform, for the first time in diabetes, provides physicians with easily accessible clinical information to aid in: • Assessment of the current state of a patient’s metabolic pathways; • Determination of the likely further progression of disease; and, • Determination of optimal treatment strategies for the patient.

Alliance & Collaborations
Discussions are underway with commercial laboratory and kit development partners.
Supporting Metrics or Evidence

To date, the IR2Dx diagnostic panel markers have been used prospectively on over 14,000 patients across 35 clinical trials, with over 40 publications. These studies validated the use of the panel markers, and covered patients at all stages of disease including prediabetes, across the range of anti-diabetic drug- classes. These studies demonstrated improvements in group mean HbA1c levels, the present standard for clinical success in the diabetes field.

Current Financing Needs

$12 million, can be staged to support commercial laboratory rollout and kit development ($5 million), and further clinical studies ($7 million).

Current Timeline

At commercialization

Current Investors

Friends & Family, Founders, Physicians

IP Status

Patents issued in US and Europe

Management Team Highlights

Highly Experienced Team. CEO has over 40 years in the diagnostics field (including 17 years at Abbott Diagnostics), and all management team members have over 30 years in biotech. Many of our key advisors are well recognized world leaders in diagnostics, diabetes and cancer.

IR2Dx
CEO 

Allan May

Life Science Angels Inc was founded in 2004 and is based in Sunnyvale CA. The group makes early-stage equity investments in a wide range of life science companies. Life Science Angels invests primarily in California but is open to investing out of state provided a round is being syndicated with a local angel group. Life Science Angels does not rule out investing outside the USA but has yet to do so. The group invests as individuals and allocation sizes are therefore highly varied but are usually of about $2-$6, Life Science Angels usually invests in rounds seeking $3 million or less. The group is interested in syndicating rounds with other angel groups.

Investor Type
Biotech Phase of Development
Medtech Phase of Development
Capital Structure Preference
Investment Stage Preference
Life Science Angels
Founder 

Ian McBeath Canada

Naegis, based in Vancouver, British Columbia, is developing novel, small-molecule leukotirene synthesis inhibitors (LTSIs) for serious inflammatory conditions.  The Company is currently focused on two proprietary programs: 

topical and oral therapy for Uveitis, a condition that is responsible for 10% of legal blindness in the US and for which there are limited therapeutic options. 

o oral therapy for Chronic Obstructive Pulmonary Disease (COPD),  a serious lung disease with increasing rates of mortality.

Naegis has developed a large library of LTSIs that are potent inhibitors of either 5-LO or LTA4H.  The Company is currently identifying a lead compound for selection for futher development for ocular disease, in particular Uveitis.

The Company is also advancing a series of compounds that are novel structures and highly selective and potent inhibitors of LTA4H, which are expected to be developed as new therpaies for COPD

Naegis is seeking pharmaceutical partners and capital investment to advance more rapidly their novel programs.

Year Founded
2010
Biotech Subsector
Biotech Phase of Development
Technology Overview
Leukotrienes are key inflammatory mediators implicated in many diseases. There is growing evidence of their central role in Uveitis. 5-LO inhibitors have been shown to reduce the clinical signs of uveitis in animal models. Naegis is developing potent 5-LO inhibitors that are both topically and orally active, with unique structures that are not expected to have the limitations of earlier 5-LO inhibitors. In COPD recent evidence has demonstrated the critical role for LTA4H in the progression and persistence of the disease. However it has recently been shown that LTA4H has a dual role and functions as both a pro and anti-inflammatory. Thus it is necessary to identify compounds that are active only against the pro-inflammatory function of the enzyme, whilst sparing its anti-inflammatory effects. Naegis is developing highly specific inhibitors of LTA4H that inhibit only the anti-inflammatory activity of LTA4H.
Alliance & Collaborations
In discussion
Current Financing Needs
$500,000 - $1,000,000
Current Timeline
Lead
Current Investors
Private.
IP Status
Proprietary compounds
Management Team Highlights
CEO - Dr. David Burgoyne an experienced medicinal chemist who has developed compounds that are in current human clinical trials. Also on the Board are Dr. Philip Davies, formerly Executive Director of Research and Area Head of Immunology at Merck, New Jersey. Also Dr Julia Levy, founder of QLT and developer of the first effective therapy for macular degeneration.
Ian McBeath
Naegis Pharmaceuticals Inc.
Corporate Development