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 

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 

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 

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 

River Cities Capital Funds United States

River Cities Capital Fund is a private equity firm founded in 1994 and based in Cincinnati, Ohio. The firm manages approximately $500 million under management and is currently investing out of its 2014 vintage $200 fund. The firm looks to make investments of $5-$15 million initially up to $20 million over the investments lifetime. The firm is willing to invest throughout the United States and is looking to make approximately 4-6 equity investments over the next 6 to 9 months.

Rik Vandevenne
Director 

RiverVest Venture Partners United States

RiverVest Venture Partners is a venture capital firm that was founded in 2000 and is based in St. Louis, Missouri with additional office in Cleveland, Ohio. The firm currently has managed over $208 million of total assets. RiverVest has raised two investment funds with total committed capital of $165 million since inception. The recent fund closed at $75 million. RiverVest typically makes equity investments into global companies, and has no specific geographic preferences. The firm will consider making investments at all the stages, and focuses on investments in seed, early-stage and select later-stage companies. The typical investment size is around $6 million, though the firm can invest more or less, depending on the opportunity. 

RiverVest is extremely opportunistic when it comes to investments in the life sciences space; with that being said RiverVests specified sectors and sub sectors of interest may or may not be an area in which RiverVest is currently looking to allocate capital to. The firm invests in companies in the biotech therapeutics and diagnostics, as well the medical technology space. 

Some of the firms investments have included companies developing biotech therapeutics and diagnostics targeting diseases of the blood and blood forming organs, neoplasms, cancer, and oncology, skin and subcutaneous tissue, cardiovascular diseases, diseases of the ear, and infectious diseases. The firm has also invested in companies developing anti-body based therapeutics. The firm has also invested in firms developing medical technologies such as therapeutic radiation devices, active implantable devices, non active implantable devices, hospital hardware, and imaging devices.

Year Founded
2000
Investor Type
Medtech Phase of Development
Capital Structure Preference
Investment Stage Preference
Karen Spilizewski
VP 

Safeguard Scientifics

Safeguard Scientifics is a publicly traded capital deployment firm founded in 1953 and is based in Wayne PA. The firm makes deployments from an evergreen fund and is actively seeking new investments in the healthcare sector. Initial equity placements are typically of $5-1m with the potential for a total allocation of $2-25m over the life of an investment. The firm focuses on North America with a concentration in the Mid-Atlantic and San Francisco Bay Area regions. Deployments are made at a range of stages from early-stage to growth expansion and recapitalization. Safeguard Scientifics prefers to be a sizable minority investor.
Gary Kurtzman
Managing Director 

Sand Hill Angels

Sand Hill Angels is an angel group that was founded in 2 and is headquartered in Sunnyvale California. The group focuses on investments in early-stage (from seed to series C) companies in the Life Sciences IT Internet and Clean Tech sectors. The group prefers to make equity and convertible notes investments and the typical investment size ranges from $.1million to $.5million. The group will consider syndicating with other investors for larger investments. The group will consider companies across the US.
Stephen Pollitt
Board Member Membership Chair