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 

PhysioCue United States

PhysioCue is a medical device company that has developed an anti-hypertension medical device, clinically shown to immediately reduce the high blood pressure of hypertensive patients. This device is non-invasive and works by controlled cold therapy with the carotid artery baroreceptor reflex. Unlike drug treatments, our PhysioCue therapy device is efficient, safe, easy to use, non-invasive, and has none of the side effects associated with anti-hypertensive drugs. We also develop mobile Health device.

PhysioCue’s Mechanism of Action is the body’s natural baroreflexive system which provides important monitoring and feedback for blood flow throughout the body. It activates baroreceptors in the wall of the carotid artery which stimulate the afferent and efferent pathways of the automatic nervous system. To lower excessive blood pressure the brain responds by modulating efferent pathways, which relaxes the blood vessels, slows the heart rate and reduces fluid in the body. These actions reduce the afterload on the heart by decreasing arterial resistance, which improves the heart’s ability to pump blood to the tissues. The increase in parasympathetic tone and decrease in sympathetic drive results in the restoration of sympathetic-vagal balance which reduces excessive blood pressure and improves cardiac structure and function.

PhysioCue’s video has been published on YouTube http://youtu.be/A1bMjg5a3MY ,

Year Founded
2013
Main Sector
Indication
Biotech Phase of Development
Medtech Phase of Development
Technology Overview
anti-hypertension medical device
Supporting Metrics or Evidence
baroreflexive system
Current Financing Needs
$3M
Current Investors
Danen Ventures, TEEC Angels, Nextplay Ventures
IP Status
Issued IPs
Simon Yi
LinkedIn logo CEO 
BIO

Mr. Simon is a Silicon Valley veteran with nearly 20 years of experience in start-up manufacturing in the lubrication, bio sensory, and medical device industries. Most recently, Simon is a founder and CEO of PhysioCue, consumer medical device company at Silicon Valley and a co-founder of VORA OIL, a chemical engineering company dedicated to bringing highest performing industrial lubricants to the market, without causing disturbance to the environment and he is a founder and CEO at AcuTend, a medical device company that helps hypertension patients lower their high blood pressure to safe levels without the use of drugs. Simon was the Vice President of Technology and a co-founder at NeuroSky, which focused on the manufacturing and R&D of bio sensor for EEG, and EOG signals. He was a vice president at OpticLayer which focused on the manufacture optical filters, wires, and wireless combine telecommunication filter system with fully integrated electronics. Simon enjoyed and has hands on experienced in building revenue companies from scratch. Simon’s career began at HOYA Corporation, U.S.A.

PlantForm Canada

PlantForm Corporation is a Canadian company formed in 2008 to commercialize a low-cost, plant-based manufacturing platform for monoclonal antibodies, protein drugs and vaccines for cancer and other critical illnesses.

The company’s technology platform provides several advantages over mammalian cell culture and other fermentation systems used to produce most biologic drugs on the market today: it’s fast, efficient, highly versatile (for new product development) and easily scalable. Best of all, it’s capable of reducing manufacturing costs for life-saving drugs by up to 90 per cent.

PlantForm licenses its technology from the University of Guelph, where it was developed by Dr. J. Christopher Hall, a PlantForm founder and the company’s Chief Scientific Officer. Dr. Hall held the Canada Research Chair in Recombinant Antibody Technology from 2002 to 2014 and is a leading authority in the field. All relevant intellectual property is protected by patent filings.

PlantForm’s pipeline features both innovator and biosimilar products, including:

• biosimilar trastuzumab, a plant-produced version of the $6-billion breast cancer drug Herceptin® (animal studies successfully completed, human clinical trials scheduled for 2014, market entry anticipated 2017)

• biosimilar versions of two additional oncology drugs with combined annual global sales of $11.4 billion (2010)

• innovator antibodies for HIV/AIDS, funded by the Government of Canada and the Bill & Melinda Gates Foundation

• recombinant butyrylcholinesterase (rBuChE), an enzyme used as preventative medicine for people vulnerable to attack by nerve agents, organophosphates or other stimulants ($1.8-million contract with the U.S. Defense Advanced Research Projects Agency and $800,00 contract with Defence Canada)

Year Founded
2008
Biotech Phase of Development
Technology Overview
Plant based disruptive platform technology enabling us to produce ultra-low cost drugs
Alliance & Collaborations
JV in Brazil
Current Financing Needs
Series A Round - $10 million
Current Timeline
pre-clinical and moving into clinical
Current Investors
Angels, Founders, Atlantic Asset Trust
IP Status
4 families of patents
Recent Milestones
Mfg. of material for Phase 1 clinical trial
Management Team Highlights
Experienced Industry and Business Professionals
David Cayea
David Cayea
COO 
Don Stewart
CEO 

Plug and Play Tech Center United States

Plug and Play Ventures (a successor fund to Amidzad Partners) is a private/family investment vehicle based in Silicon Valley, CA. The fund is a structured organization for making angel investments in pre-seed or seed rounds. Investments are in the form of equity; in the next 6 months Plug and Play Ventures expects to make about 5-10 seed investments of $50,000-100,000 and an additional 40 pre-seed investments of $25,000, and is hoping to increase their allocations in the healthcare sector. Plug and Play also provides a three-month accelerator program. The firm will consider investing in companies worldwide.

Plug and Play Ventures is interested in investing in medical technology, and invests in subsectors in which the firm can apply expertise; typically this means products that have a significant software component. Healthcare IT, biosensors, wearables and health monitoring devices are of interest. While the firm is open to investing in any indication, Plug and Play is particularly interested in diabetes & blood glucose monitoring, personal fitness, and mental/behavioral disorders. In the healthcare IT sector, Plug and Play Ventures is interested in both consumer applications and enterprise software, but is not interested in diagnostic software such as genomic, proteomic, or molecular diagnostic algorithms; however, optimization and data analysis software for hospitals and diagnostic laboratories is of interest.

Phillip Vincent
Corporate Partnerships Manager 

Plug and Play Ventures United States

Plug and Play Ventures (a successor fund to Amidzad Partners) is a private/family investment vehicle based in Silicon Valley, CA. The fund is a structured organization for making angel investments in pre-seed or seed rounds. Investments are in the form of equity; in the next 6 months Plug and Play Ventures expects to make about 5-10 seed investments of $50,000-100,000 and an additional 40 pre-seed investments of $25,000, and is hoping to increase their allocations in the healthcare sector. Plug and Play also provides a three-month accelerator program. The firm will consider investing in companies worldwide.  

Plug and Play Ventures is interested in investing in medical technology, and invests in subsectors in which the firm can apply expertise; typically this means products that have a significant software component. Healthcare IT, biosensors, wearables and health monitoring devices are of interest. While the firm is open to investing in any indication, Plug and Play is particularly interested in diabetes & blood glucose monitoring, personal fitness, and mental/behavioral disorders. In the healthcare IT sector, Plug and Play Ventures is interested in both consumer applications and enterprise software, but is not interested in diagnostic software such as genomic, proteomic, or molecular diagnostic algorithms; however, optimization and data analysis software for hospitals and diagnostic laboratories is of interest.


Neda Amidi
Investment Associate 

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 

Promosome LLC 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
John Manzello
President & CEO