Michael Cross
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.
Fusion Pharma
William Crossman
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.
Phoenix PharmaLabs Inc.
President & CEOAlan Cullen
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
PresidentMaureen Cullum
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.
Cynvenio Biosystems, Inc.
CFOJeremy Curnock Cook
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.