Michael Cross Canada

Fusion Pharmaceuticals is a clinical stage company committed to developing next generation precision radiopharmaceuticals for the diagnosis and treatment of human cancers with unmet medical needs.  The Company’s lead product, FPX-01, combines an alpha radionuclide with the precise targeting of an antibody to cause selective cytotoxicity of tumor cells.  FPX-01 will be entering Phase 2 clinical development in H2, 2015.

Year Founded
2014
Biotech Phase of Development
Technology Overview
The FPX-01 program represents a true theranostic approach. By leveraging its expertise in radiochemistry and biology, and utilizing different isotopes, Fusion has produced variants of FPX-01 that act as either diagnostic or therapeutic agents. For human proof-of-concept, Fusion initiated a Phase I imaging trial in Canada. Using Iodine-124 as a probe, this trial was designed to confirm that FPX-01 binds and internalizes to solid tumors expressing the receptor target as determined through PET/CT imaging. Initial results from this trial demonstrate that FPX-01 can identify metastatic lesions not previously identified through other imaging techniques. These data corroborate previous preclinical in vivo data which indicated that the radioactivity-associated with FPX-01 accumulated within tumours over several days. Following the completion of the Phase 1 imaging trial and additional preclinical studies planned for H1 2015, Fusion will file an IND in H2 2015 that will be designed to achieve breakthrough status in NSCLC. For therapy, FPX-01 will be radiolabeled with an alpha-emitting isotope. Preclinical xenograph studies, using only a single administration of isotope demonstrated tumor regression, with minimal toxicity at any dose level. It is expected that the IND-opening trial will be a Phase I/II therapeutic study in approximately 100 patients with non-small cell lung cancer (NSCLC), addressing a major unmet medical need.
Alliance & Collaborations
Ontario Institute for Cancer Research
Supporting Metrics or Evidence
Clinical and pre-clinical data.
Current Financing Needs
Series A $15M
Current Timeline
H2 2015: Phase 2 IND
Current Investors
Centre for Probe Development and Commercialization
IP Status
The FPX-01 antibody is protected worldwide via multiple granted patents. Additional combinations of delivery vehicles, conjugation/chelation technologies and radioisotope variation are routinely considered and evaluated for their proprietary nature and if appropriate, patent applications are filed. Regulatory exclusivity will extend FPX-01 protection in the US market.
Management Team Highlights
Frank Gleeson, CEO. Founding CEO of Fusion Pharma, DVLR Therapeutics, Verio Therapeutics (sold to Fate Therapeutics in 2010) and former Partner with MDS Capital Corp. Mr. Gleeson has raised over $200M in syndicated financings.
Fusion Pharma

William Crossman 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.
Phoenix PharmaLabs Inc.
President & CEO 

Alan Cullen United States

Westwood & Wilshire is a premier provider of executive search services to the Pharmaceutical, Biotechnology, Medical Devices and Diagnostics sectors.  Services include:

-Direct Hire Executive Search
-Interim Executive Search and Consultant Placement
-Board of Director and Advisory Group Development

Our clients range from Venture Capital-backed portfolio start ups to Fortune 500 Big Pharma. Our success encompasses executive level placements across Clinical, Medical, Regulatory, R&D, Quality and Commercial.

Westwood & Wilshire LLC
President 

Maureen Cullum United States

Cynvenio has developed a new LiquidBiopsy technology to sequence the DNA of tumor cells isolated from peripheral blood. Key applications include longitudinal patient monitoring throughout the cancer care cycle, the detection of resistance mutations, and providing physicians with accurate molecular evidence to select the best targeted therapy for a given patient.

Cynvenio's technology can be accessed as a CLIA lab service, or  can be installed and operated inside hospital labs and cancer research centers. Cynvenio's lab has been CLIA certified since 2013 and LiquidBiopsy system deployments began in the second half of 2014.

Website:
www.cynvenio.com
Year Founded
2008
Biotech Subsector
Medtech Subsector
Biotech Phase of Development
Technology Overview
Sequencing tumor cells from whole blood
Alliance & Collaborations
Yes, US and International
Supporting Metrics or Evidence
CLIA/CAP accreditation, validations completed, generating revenue
Current Financing Needs
$15M
Current Timeline
Series C raise to scale commercial
Current Investors
Privately funded
IP Status
Core IP has issued
Recent Milestones
4 US deployments, 2 strategics
Management Team Highlights
Amgen, Nortel, Harvard, UCLA, McKinsey
Cynvenio Biosystems, Inc.
CFO 

Jeremy Curnock Cook Australia

BioScience Managers is a venture capital life science investment firm headquartered in Melbourne, Australia. The group makes equity investments from $3M-5M and anticipates about 6 new investments this year. BioScience Managers invests globally. 

BioScience Managers will invest in companies across the life science space, including therapeutics, diagnostics and medical technology. The group does not invest in service providers. BioScience Managers considers all subsectors and indications, including orphan indications. The group will consider technology either in or prepared for human clinical trials and is open to all classes of devices. BioScience Managers seeks investments in novel technology and is not looking to gain share of an existing market. 

Investor Type
Biotech Phase of Development
Medtech Phase of Development
Capital Structure Preference
Investment Stage Preference
BioScience Managers
Managing Director 

Charles Cywin

NINDS
Scientific Project Manager