Pfizer Venture Investments United States

Pfizer Venture Investments (PVI) is the corporate venture capital arm of Pfizer and was founded in 2004. PVI has an annual investments budget of $50 million and invests up to $10M per investing round. The firm focuses mainly on U.S. startups but has global reach. PVI attempts to allocate 80% of its funding to U.S. based companies and utilizes the remaining 20% for international ventures. PVI provides equity funding for private companies in need of seed, growth, or venture financing. Remaining opportunistic, PVI focuses entirely on high growth prospects in all sectors and all phases of development. The ideal candidate has a potential for high growth and returns. Additionally, PVI will seek to in-license products and buyout companies if the opportunity arises.

Barbara Dalton
Vice President 

Pharmatek United States

Pharmatek is a contract development & manufacturing company providing dosage form development & cGMP manufacturing of oral, injectable & topical products. Founded in 1999, our services focus on the rapid advancement of small molecule & peptide drug candidates from the bench to the clinic & include:

·         Formulation & Analytical Development

·         cGMP Manufacturing

·         Clinical Packaging, Labeling & Worldwide Distribution

 

Our experience includes first-in-man strategies, solutions for poorly soluble compounds, controlled release formulations & separate facilities for the handling of cytotoxic & potent compounds.  Pharmatek’s drug delivery technologies include:

·         Solid Dispersions

·         Particle Size Reduction

·         Lipid Delivery

·         Complexation

·         Lyophilization

·         Suspensions & Emulsions

Pharmatek’s 68,000 sq. ft. facility includes 9 class 100,000 cGMP manufacturing suites, formulation & analytical laboratories, & ICH stability storage.  Pharmatek has over 150 clients globally, ranging from virtual to large pharmaceutical companies. Having manufactured product for clinical trials in the North America, Europe & Asia; Pharmatek has successfully completed several large pharma quality, EH&S & QP audits.

Mr Tim Scott
Mr Tim Scott
LinkedIn logo President 

Phoenix PharmaLabs Inc. United States

Phoenix PharmaLabs, Inc. (PPL) is a privately held, preclinical drug discovery company focused on the development and commercialization of new potent, non-addictive treatments for pain and new therapies for the treatment of opiate addiction.

PPL has developed a novel family of New Molecular Entities (NMEs) with high binding affinity at all three opiate receptors: mu, kappa and delta.  These unique ligands, derived from opioid backbones using proprietary technology, have high binding affinity at all three opioid receptors (mu, delta and kappa) and more balanced receptor activity than morphine and other opioids, with partial agonist / antagonist activity at mu, somewhat higher, but not full, kappa agonist activity, and moderate delta activity.  This profile results in first-ever opiate analgesics that appear to be non-addicting and free of all significant dangerous side effects. 

Studies of the drugs have been conducted by prominent scientists at leading institutions including Lou Harris and colleagues at Virginia Commonwealth University (VCU), Jim Woods and colleagues at the University of Michigan, and Larry Toll and colleagues at SRI International and Torrey Pines Institute for Molecular Studies.  Study results in rodents and monkeys performed by the National Institutes of Health (NIH) / National Institute on Drug Abuse (NIDA) and SRI International Laboratories demonstrated the following:

  • Robust analgesic potency (10-20x stronger than morphine)
  • Little or no euphoric reward / abuse and addiction potential in rodents and monkeys (multiple studies)
  • No dysphoria in rodents and monkeys (multiple studies)
  • Only moderate signs of respiratory depression – even at 150x dosage
  • No death from overdose - even at 350x dosage
  • LD50 = 500x dosage
  • No physical dependence in naive rodents
  • No inhibition of GI transport - even at 350x dosage
  • No Long QT syndrome risk – hERG assay
  • No significant diuresis in rodents
  • Does not precipitate withdrawal in dependent monkeys

Since the drugs do not precipitate withdrawal, they offer very promising use for addiction therapy as a preferred substitute for methadone and buprenorphine, as well as for pain. 

The drugs are orally active and inexpensive to manufacture using PPL's patented manufacturing process.  A key patent on the lead molecule for Composition, Methods and Use will be issued in the US by January, 2015, and it is currently being internationalized.

The cost and risk of achieving a New Drug Approval (NDA) from the FDA is substantially lower than other NMEs with equivalent market potential.  Few drug classes have more longitudinal testing data than opioids for use as a predictor of success in trials.  Therefore, the risk of pharmaceutical product development is significantly reduced compared to the risk of developing less understood and potentially problematic drug classes.  As described above, the assets have been effectively de-risked in animal studies covering all risks that typically manifest themselves in opioids.

Furthermore, a vast amount of opioid testing data is available concerning the transition of effects of pure opioid compounds from animals to humans.  Consequently, our scientific experts and advisors predict that the risk of problems in toxicology and safety pharmacology is very low.  The prediction correlation from animals to humans is very high, and thus there is a high level of confidence that the compounds will be safe, effective and beneficial for humans.   

Recently our drug family has also attracted attention for Animal Health applications, primarily due to the lack of respiratory depression and GI tract side effects as well as the likelihood that the drugs would likely be unscheduled (or at most scheduled as Class IV or V).

The strategic objective of our company is to enter into one or more license agreements with appropriate market leader(s) that have the resources and motivation to further develop, commercialize, and maximize the market potential of PPL’s family of drugs.  We are making steady progress towards the achievement of that objective. Following submission of a BAA grant proposal to the DoD, we were invited by the U.S. Army Medical Research and Material Command (USAMRMC) to submit a full application for a $3.6 million grant for the advancement of our PPL-103 compound for pain, and we are currently awaiting the results. In the meantime we are exploring other potential funding opportunities and strategic collaborations. 

Year Founded
2002
Biotech Subsector
Biotech Phase of Development
Technology Overview
PPL has developed a novel family of New Molecular Entities (NMEs) with high binding affinity at all three opiate receptors: mu, kappa and delta. These unique ligands, derived from opioid backbones using proprietary technology, have high binding affinity at all three opioid receptors (mu, delta and kappa) and more balanced receptor activity than morphine and other opioids, with partial agonist / antagonist activity at mu, somewhat higher, but not full, kappa agonist activity, and moderate delta activity. This profile results in first-ever opiate analgesics that appear to be non-addicting and free of all significant dangerous side effects. Studies of the drugs have been conducted by prominent scientists at leading institutions including Lou Harris and colleagues at Virginia Commonwealth University (VCU), Jim Woods and colleagues at the University of Michigan, and Larry Toll and colleagues at SRI International and Torrey Pines Institute for Molecular Studies. Study results in rodents and monkeys performed by the National Institutes of Health (NIH) / National Institute on Drug Abuse (NIDA) and SRI International Laboratories demonstrated the following: • Robust analgesic potency (10-20x stronger than morphine) • Little or no euphoric reward / abuse and addiction potential in rodents and monkeys (multiple studies) • No dysphoria in rodents and monkeys (multiple studies) • Only moderate signs of respiratory depression – even at 150x dosage • No death from overdose - even at 350x dosage • LD50 = 500x dosage • No physical dependence in naive rodents • No inhibition of GI transport - even at 350x dosage • No Long QT syndrome risk – hERG assay • No significant diuresis in rodents • Does not precipitate withdrawal in dependent monkeys. Since the drugs do not precipitate withdrawal, they offer very promising use for addiction therapy as a preferred substitute for methadone and buprenorphine, as well as for pain. The drugs are orally active and inexpensive to manufacture using PPL's patented manufacturing process. The cost and risk of achieving a New Drug Approval (NDA) from the FDA is substantially lower than other NMEs with equivalent market potential. Few drug classes have more longitudinal testing data than opioids for use as a predictor of success in trials. Therefore, the risk of pharmaceutical product development is significantly reduced compared to the risk of developing less understood and potentially problematic drug classes. As described above, the assets have been effectively de-risked in animal studies covering all risks that typically manifest themselves in opioids. Furthermore, a vast amount of opioid testing data is available concerning the transition of effects of pure opioid compounds from animals to humans. Consequently, our scientific experts and advisors predict that the risk of problems in toxicology and safety pharmacology is very low. The prediction correlation from animals to humans is very high, and thus there is a high level of confidence that the compounds will be safe, effective and beneficial for humans.
Alliance & Collaborations
Research alliances: SRI International, Torrey Pines Institute for Molecular Studies, Virginia Commonwealth University (VCU), the University of Michigan, The Rockefeller University, and BioDuro / PPD; Synthesis alliance: Mallinckrodt, Inc.; Preclinical toxicology alliance: Calvert Labs
Supporting Metrics or Evidence
Opioid Receptor Binding Affinities of PPL-103 Ki (nM): Mu: 0.36 +/- 0.11; Delta: 2.47 +/- 0.105; Kappa: 0.29 +/- 0.03. Functional Activities of PPL-103 – EC50 (nM) and % Stimulation: Mu: 4.30 +/- 2.13 and 22.60% +/- 0.05%; Delta: 9.01 +/- 2.64 and 39.80% +/- 3.9%; Kappa: 2.99 +/- 0.92 and 41.7% +/- 5.0%. Antinociception of PPL-103: Compared to morphine's ED50 of 2.0 to 4.0 mg/kg, PPL-103's ED50 of 0.2 mg/kg was ten-fold to twenty-fold more potent than morphine. Several Self Administration studies as well as Conditioned Place Preference (CPP) and Conditioned Place Aversion (CPA), Physical Dependence and Drug Discrimination studies in rodents and monkeys have been conducted to assess the degree to which PPL’s novel opioid compounds elicit either euphoric reward (which can lead to abuse and addiction) or dysphoria. The results of all studies show no significant signs of either euphoric reward / abuse potential or dysphoria. Several Self Administration studies as well as Conditioned Place Preference (CPP) and Conditioned Place Aversion (CPA), Physical Dependence and Drug Discrimination studies in rodents and monkeys have been conducted to assess the degree to which PPL’s novel opioid compounds elicit either euphoric reward (which can lead to abuse and addiction) or dysphoria. The results of all studies show no significant signs of either euphoric reward / abuse potential or dysphoria. Studies showed no death from overdose at 350x dose and no constipation at 350x dose. LD50 = 500x dose.
Current Financing Needs
Approximately $3.6 million will be needed to complete preclinical studies, obtain IND and produce GMP material to support human clinical trials. (This may be funded by a USAMRMC grant.) Subsequently, approximately $3 million will be required to advance the compound through simultaneous Phase I / II trials in Australia to reach POC in humans prior to licensing.
Current Timeline
Completion of preclinical trials and IND approval in 2016. Completion of simultaneous Phase I / II trials in Australia to reach POC in humans in 2017.
Current Investors
Founders and angel investors
IP Status
For the lead molecule a Composition, Methods and Use patent application was filed in 2010 and will be issued in the US by January, 2015. It is currently being internationalized. Other Methods and Use patents on related molecules have been issued as well.
Recent Milestones
Completed de-risking studies of lead molecule; patent approval of Composition, Methods and Use patent of lead molecule
Management Team Highlights
Management Team & Board of Directors: John Lawson, Ph.D., Founder, Board Chairman and Chief Scientist - the primary developer of PPL’s intellectual property; formerly headed the Neurochemistry R&D Group at SRI International; William Crossman, President, CEO and Board Member - launched and developed numerous emerging technology companies; served as CEO, CFO and CDO of enterprises ranging from start-ups to Fortune 100 level companies; Timmy Chou, Vice President, CFO and Board Member - founding partner of Spectra Consulting Group; experience as CEO and CFO of numerous emerging companies, serves on the Boards of several public and private companies; Lawrence Toll, Ph.D., Chief Neuropharmacologist and Board Member; Director of the Neuropharmacology Department of Torrey Pines Institute for Molecular Studies and SRI International; co-discoverer of the nociceptin opioid peptide; Chris Tew, Vice President, Board Member - senior sales and marketing executive of bioscience companies including VP Sales for Protocol Systems (Welch Allyn); Theodore Stanley, M.D., Board Member - Chairman and Founder of ZARS Pharma; formerly Director of Research of the University of Utah. Board of Advisors: Louis Harris, Ph.D. - Harvey Professor at VCU; member of the Drug Evaluation Committee for the NIH; founding member of the Committee on Problems of Drug Dependence (CPDD) for the National Institute on Drug Abuse (NIDA); a preeminent researcher in behavioral testing of opioids in animal models; Anthony Fox, M.D., Ph.D. – a recognized expert in strategic clinical planning and the evaluation and selection of contract research organizations (CROs); President of EBD Group, a pharmaceutical consulting firm; Mary Jeanne Kreek, M.D., Senior Attending Physician and Patrick E. and Beatrice M. Haggerty Professor, Head of Laboratory of Biology of Addictive Diseases, The Rockefeller University; recipient of numerous professional awards; John Mendelson, M.D., Senior Scientist, California Pacific Medical Center Research Institute; specific expertise in the design and supervision of human clinical trials of controlled substances; Shayne Gad, Ph.D., Principle, Gad Consulting; recipient of the American College of Toxicology Lifetime Contribution Award; 35 years experience in toxicology, statistics and risk assessment; authored or edited 44 published books in the fields.
William Crossman
President & CEO 

Precision NanoSystems Canada

Precision NanoSystems Inc. (“PNI”) has developed proprietary technology (NanoAssemblr) and companion Reagent Kits (SUB9KITS) that enable the simple manufacture of novel nanoparticles that are used to delivery genetic and small molecule medicines (nanomedicines). Nanomedicines are the "FedEx" of the health-care industry and are used for cell-specific delivery of research tools, diagnostic imaging agents and drugs to study, diagnose and treat disease. PNI's products are commercialized and in high demand from many of leading RNA and small molecule therapeutic biotechnology and pharmaceutical companies.  http://www.precisionnanosystems.com/products/

Year Founded
2010
Biotech Phase of Development
Current Financing Needs
PNI is currently raising Series A financing.
Recent Milestones
PNI launched its flagship NanoAssemblr Benchtop and SUB9KIT products in H2 2013. Since that time, PNI has seen significant latent demand for its products and is rapid expanding product manufacturing to satisfy market need. Additionally, PNI has achieved important technical milestones in it's large-scale nanomedicine platform and SUB9KIT products.
Management Team Highlights
PNI’s management, directors & advisors have collectively contributed to over 100 patents and 500 papers, started over 20 biotech companies, raised over $1B in financing/deals and have brought 4 drugs to market. PNI’s CEO, Dr. James Taylor has over 10 years of experience in commercializing biotech and has lead PNI since invention. PNI’s COO, Dr. Euan Ramsay, has 13 years commercializing biotech, has secured over $40M in leveraged financing, and has developed nanomedicines to clinical trials.
James Taylor
CEO 
Euan Ramsay
COO 

Prediction BioSciences United States

Website:
www.predict.net
Year Founded
2010
Biotech Subsector
Biotech Phase of Development
Technology Overview
Assay to predict bleeding; paired with various cardiovascular drugs, also developed by the company, to displace existing therapeutics from a safety perspective
Alliance & Collaborations
Glycotope GmbH, Cellonic SA, Qualigen Inc.
Supporting Metrics or Evidence
7 published papers on c-Fn predicting bleeding in various neurological indications
Current Financing Needs
$1.5M
Current Timeline
on-market 2018
Current Investors
NACP, Private Offices
IP Status
3 granted patents on main technology; several more in various WW phases
Recent Milestones
Private investment of more than $1Mio to progress first therapeutic/companion Dx assay to market
Management Team Highlights
Divestment of oncology Dx business
Cornelius Diamond
Founder & CEO 

Prize4Life

Prize4Life is a non-profit organization founded in 2006 in Cambridge, MA focused on accelerating therapy development for amyotrophic lateral sclerosis (ALS, aka Lou Gehrig's disease). Prize4Life uses incentive prizes to attract new minds and drive innovation in ALS drug development. The organization is running the $1M Avi Kremer ALS Treatment Prize4Life challenge for preclinical validation of a novel ALS therapeutic in an ALS mouse model, and submissions to this prize will be accepted until June 6th 2015. In addition to prizes, Prize4Life also runs infrastructure programs to support the ALS research community, such as the ALS FORUM, an online portal of cutting edge research and drug development news in ALS (www.researchals.org).

Sara Shnider
Executive Director 

Prolog Ventures United States

Prolog Ventures is a venture capital firm based out of St. Louis Missouri that was founded in 2001. The firm is currently making investments out of its vintage 2013 4th fund of approximately $100 million. The firm is looking to make equity investments in companies ranging from $500,000 to $3 million. The firm will invest in companies across the United States and plans to make approximately 3-4 investments over the next 6-9 months.

Brian Clevinger
Managing Director 

RDD Pharma Israel

RDD Pharma, a clinical stage company with programs in:
1. Fecal incontinence (Phase 2a)
2. Chronic anal fissure (Phase 3 ready).
3. Pruritus Ani - preclinical development
4. Radiation Colitis - animal studies

- All rograms utilize a 505(b)2 strategy .
- Anal Fissure IP goes out to 2030.
Year Founded
2009
Biotech Subsector
Biotech Phase of Development
Medtech Phase of Development
Technology Overview

Company focused on ano-rectal diseases

Experienced management team

Lead product targets $600M market with poorly
addressed needs

Follow on product targets a $3B US market

Pipeline - Three clinical stage products:

  • PHASE III READY – ANAL FISSURE
  • PHASE IIa – FECAL INCONTINENCE ONGOING
  • PHASE II READY – PRURITUS ANI

De-risked 505(b)2 regulatory path

Supporting Metrics or Evidence

Fecal Incontinence - P1 Proof of Concecpt + Phase 2a Ongoing

Chronic Anal Fissure - completed two (2) Phase II studies evaluating Nifedipine in CAF.

  • RDD Study 104 - 20 Patients
  • RDD Study 112 - 33 Patients
Current Financing Needs

OrbiMed Israel (invested $4M in 2012) is a lead investor and has committed to $3M of a $15M Series B.

Current Timeline

Anal Fissure  - Phase 3 to commence 1Q2015

Fecal Incontinence - Phase 2a data read March/April 2015

Current Investors

OrbiMed

Ofakim Hi-Tech Ventures

Corporate Finance Holding GmbH

Mor Research

IP Status

Nifedipine Capository™ - Device for Treating the Anal Sphincter

–      Japan                         Granted (new)

–      Australia                   Granted

–      Korea          Allowed (new)

–      Israel           Allowed (new)

–      USA            Granted

–      Canada                     Allowed

Fecal Incontinence

–      US – National Phase

Radiation Colitis

–      Methods for Treating and Ameliorating Radiation-induced Gastrointestinal Tract Injury

Pruritus Ani

–      Method of Treating Anal Pruritus and Other Perianal Disorders

–      USA-issued patent: April 1, 2014

Recent Milestones

Chronic Anal Fissure - completed two (2) Phase II studies evaluating Nifedipine in CAF.

  • RDD Study 104 - 20 Patients
  • RDD Study 112 - 33 Patients
Management Team Highlights

Jason Laufer CEO 

•       Over 25 years in healthcare clinical and commercial operations

•       Global BD & Licensing at URL Pharma (acquired by Takeda for $800M), Managing Director at CELLGRO® (acquired by Corning , and CEO at Elutex

Nir Barak, MD CMO and Founder

•       More than 10 years as internal medicine physician

•       Career integrating R&D and clinical medicine

•       Formerly CSO/Founder of OBEcure Ltd.

 

Robert Niecestro PhD Regulatory Affairs

  • Over 25 years of experience in the healthcare industry
  • Managing Director of Accelapharm, VP Reg. of Axsome Rx and EVP of Clinical & Reg. Affairs at TG Rx
  • VP Clinical & Reg. Affairs at Keryx Biopharma

 

Monil Shah, PharmD MBA Clinical Advisor

  • VP, Clinical Affairs at Ventrus Biosciences
  • Over 15 years in clinical management roles at BMS, Celgene, Amgen, and Novartis

Jason Laufer
CEO 

Recardio Austria

RECARDIO is a virtual, private, clinical stage life science company founded in 2011 focusing on drug based regenerative therapeutic modalities for the treatment of cardiovascular diseases.

The company started product development mid-stage by taking advantage of >$100m of previously invested capital in the licensed lead compound, Dutogliptin. Safety has been established in more than 1000 subjects and all non-clinical studies have been completed to the highest standards, including 2 year carcinogenicity, resulting in a de-risked clinical development program from the safety perspective and overall reduction in total program costs.

 After completion of limited preclinical studies clinical trials will commence in early 2015 in patients with acute myocardial infarction.



After establishing proof-of-principle in vivo and completion of the preclinical development, it has entered clinical stage and is developing multiple therapeutic leads as the future regenerative medication for patients with various cardiovascular diseases, with the potential of improving their cardiac function, quality of life and survival.

Website:
www.recardio.eu
Year Founded
2011
Biotech Subsector
Medtech Subsector
Indication
Biotech Phase of Development
Medtech Phase of Development
Current Financing Needs
Series A in process
Current Timeline
Phase 2b starting in 2015
Current Investors
Private
IP Status
Issued use and composition of matter patents
Recent Milestones
Positive FDA advice in 12.2014
Roman Schenk
CEO 

Recursion Pharmaceuticals United States

The Problem: Pharmaceutical development has traditionally focused on intense study of an explicit molecular target related to a specific disease of interest. This strategy is costly and inefficient.

 

The Solution: We have developed technology that can be scaled to quickly, precisely, reliably, and simultaneously model thousands of genetic diseases in human cells and evaluate the effect of thousands of individual drugs on those disease models. We've built a computational platform that recognizes structural changes in millions of diseased cells and then identifies drugs that return those diseased cells to a healthy state.

 

Proof of Concept: We have already used an early version of this platform to discover a potential treatment for one genetic disease. We have IP for this drug, and have already been approached about licensing.  We are scaling our platform now to enable us to achieve our goal of discovering and partnering to bring to market treatments for at least 100 genetic diseases in 10 years.

Dr Chris Gibson
LinkedIn logo CEO, Recursion Pharmaceuticals