Developing novel therapies to address unmet medical needs in the treatment of cancer and its consequences.

About QUE

The QUE Team

QUE Oncology is a virtual organization with a core team of contributors who have expertise in our areas of scientific research. We retain the services of key consultants with significant experience in pharmaceutical research and development, and leverage the infrastructure of partner universities. This staffing model allows flexible access to specialist resources.

Board of Directors

Dennis Liotta, Ph.D.

Over the past two and a half decades Dr. Dennis Liotta’s research has focused on the discovery and development of novel antiviral, anticancer and anti-inflammatory therapeutic agents. 0He is recognized as one of the premier discoverers of novel therapeutics, having been one of the inventors associated with ten FDA approved therapeutics including Epivir, Combivir, Trizivir, Epzicom, Epivir-HBV, Emtriva, Truvada, Atripla, Complera and Stribid. In addition, he is the inventor of record for several clinically important antivirals, including Epivir, Reverset, Racivir and Elvucitabine. He is also the lead inventor of Q-122 (formerly known as MSX-122), a safe, orally available clinical agent for controlling hot flashes in post-menopausal women. In the preclinical arena his research group has recently discovered the first potent, dual tropic (CCR5/CXCR4) HIV entry inhibitor. In addition, in his current role as Executive Director of the Emory Institute for Drug Development, Dennis oversaw the discovery and development of a novel nucleoside analogue, EIDD-2023, for treating hepatitis C infections.

Dennis has authored approximately 250 peer reviewed publications and is an inventor on 75 issued US patents. A company he founded, Pharmasset (acquired by Gilead Sciences) developed Sofosbuvir, which has become the first line therapy for treating (and perhaps curing) hepatitis C. In addition, he has founded numerous other companies including, inter alia: (a) Altiris (drugs for stem cell mobilization and as potential treatments for a variety of cancers); (b) Triangle Pharmaceuticals (developed emtricitabine and was subsequently acquired by Gilead Science); (c) NeurOp (therapies for treating ischemic conditions, such as stroke); (d) QUE Oncology, a joint venture owned by the University of Queensland and Emory, that is carrying out the Q-122 clinical trials (vide supra); and (h) DRIVE (Drug Innovation Ventures at Emory, a non-profit drug development company focused on the development of therapies for treating single stranded RNA virus infections, such as Dengue Fever, hepatitis C, influenza A and B, respiratory syncytial virus and various equine encephalitis viruses). DRIVE utilizes an innovative model that seeks to extract maximum value from therapeutic innovations discovered at Emory or elsewhere by efficiently advancing them into clinical trials.

Dean Moss, Ph.D.

Dean Moss has over 20 years' experience in science, academia, business, management and commercialisation in Australia, USA and the UK. He has been managing director or senior business development executive of several health and biotech companies worldwide, including Agen Biomedical, Launch Diagnostics, Amrad ICT, Amrad Biotech, and United Drug. He established his own start-up business in the UK, York Medical Technologies.

Prior to moving into the commercial world, Dean was principal R&D scientist at Agen Biomedical. He also worked as an NH&MRC research scientist at the Princess Alexandra Hospital, the Royal Brisbane Hospital and the Queensland Institute of Medical Research. He is a recipient of the Campion-Ma-Playoust Memorial Award for Medical Research.

Dean is a board member of Coridon Pty Ltd, Bio Energy Solutions Pty Ltd (Chairman), Dendright Pty Ltd (Chairman) and Q-Pharm Pty Ltd, and has contributed to raising more than $20m in venture capital investment.

Chris Nave, Ph.D., M.B.A.

Chris is a founding partner of Brandon Capital Partners and Principal Executive of the Medical Research Commercialisation Fund. In addition to OccuRx, Chris currently holds directorships with Spinifex Pharmaceuticals, Osprey Medical Inc., PolyActiva Pty Ltd, Global Kinetics Corporation and Otifex Therapeutics Pty Ltd. Chris previously was Director of Commercialisation at the Baker IDI Heart and Diabetes Institute, Melbourne, Australia. He was responsible for the commercialisation of technologies developed at the Baker and the Alfred Hospital, including the management of local and international spinout companies.

Prior to this, Chris was the Manager of the Biotechnology Team at Melbourne Ventures, the commercialisation company of the University of Melbourne. Concurrently during this period, he was an Investment Manager for, and on the investment committee of, Uniseed Pty Ltd, a $60 million pre-seed fund. Chris has international experience with Leiras Pharmaceuticals in Finland, a wholly owned subsidiary of Schering AG, working for their Business Development group. He successfully moved companies to the US, securing investment from US investors for these companies. Past directorships have seen Chris involved directly in the management, fundraising, and successful spinout of various companies in the life sciences industry. Chris was also Chairperson of Fibrotech Therapeutics at the time of its successful sale to Shire. In 2014, he was awarded the AusBiotech Johnson & Johnson Industry Leadership Award.

Chris has a first-class Honours degree in Science and a PhD in Endocrinology and Physiology from the University of Melbourne and he has completed the Private Equity and Venture Capital Program at Harvard Business School, Boston, MA

John P. Richard, M.B.A.

John is Head of Corporate Development and a co-founder of Mereo BioPharma Group, plc.

He has significant corporate, operational and transactional experience, having served in various executive, director and advisory roles throughout his career. He is a board member of Aviragen, Phase4 Partners, QUE Oncology and Catalyst Biosciences.

Previously, he was Executive VP Business Development at SEQUUS, where he was responsible for negotiating SEQUUS’ acquisition by ALZA. John also headed business development for VIVUS and Genome Therapeutics; where he established numerous alliances.

John received his M.B.A. from Harvard Business School and his B.S. from Stanford University.

Leadership Team

Rob Crombie, Ph.D.

Dr Rob Crombie, Chief Executive Officer of Que Oncology Inc., has over 20 years of background in private and public markets in the UK and Australia with a strong business development and transactional focus.

Rob has founded and transitioned several start-up companies most recently as the inaugural CEO of ASX-listed cancer drug company Prescient Therapeutics (ASX:PTX). As former Head of Melbourne Operations for Arana Therapeutics (ASX:AAH), Rob played a key role in Arana's successful A$318M acquisition by Cephalon Incorporated (Teva Pharmaceuticals).

Rob has an academic background in Genetics from Trinity College Dublin, Ireland, a PhD in cancer research from The University of Glasgow, and a Howard Hughes post-doctoral fellowship from Baylor College of Medicine, Houston, Texas.

Wendy Painter, M.D.

Wendy Painter, MD, MPH, is Chief Medical Officer, QUE Oncology, Inc. Wendy has over 25 years’ experience in the pharmaceutical and biotechnology industries. Prior to joining QUE Oncology, Wendy served in roles as Chief Medical Officer at Chimerix, Inc. and Director at Glaxo Smith Kline. She has also maintained her own consulting business in the biotech industry where she has provided a range of research, development, and diligence services to more than 25 organizations.

Dr. Painter received a Master of Science degree in organic chemistry at Emory University, her Doctor of Medicine degree from The University of Miami School of Medicine, and a Master of Public Health degree in epidemiology from the School of Public Health at The University of North Carolina at Chapel Hill. She completed a Preventive Medicine fellowship at Duke University.

Alice T Robertson, Ph.D.

Alice Robertson, Ph.D. is the Head of Clinical Operations at QUE Oncology, Inc. Alice has over 20 years’ experience in preclinical and clinical drug development including positions at Becton Dickinson, Triangle Pharmaceuticals, King Pharmaceuticals, Inc. and Chimerix, Inc. In addition, she has worked at clinical contract research organizations managing multi-trial clinical programs and serving in executive leadership positions. Over her career, Alice has designed and managed clinical trials/programs ranging in size from small, single center Phase 1 studies to large, multi-center, Phase 3 global programs. Alice received her PhD in Microbiology/Molecular Biology from Va. Tech and an NCI fellowship for post-doctoral research at Louisiana State University Medical Center.

Scientific Collaborators

Maree Smith, Ph.D.

Education: Awarded a B Pharm (Hons) degree from UQ and undertook a PhD and initial postdoctoral training in clinical pharmacokinetics, bioanalysis and drug metabolism in the Department of Medicine at UQ. This was followed by postdoctoral training in the field of pain management.

Professor Maree Smith is the co-founder and Executive Director of the Centre for Integrated Preclinical Drug Development (CIPDD) and Professor of Pharmacy at The University of Queensland (UQ). She has considerable expertise and know-how in new drug development. To date, Professor Smith and her colleagues at the CIPDD have conducted more than 600 R&D contracts for 200+ organisations in the biopharmaceutical sector under the brand name ‘TetraQ’. Professor Smith has specialist capabilities in the discovery and development of novel analgesics with potential for human use. Two of Professor Smith’s inventions are being commercialized by the UQ spin-out companies, QRx Pharma Pty Ltd and Spinifex Pharmaceuticals Pty Ltd. Professor Smith has published more than 120 peer-reviewed publications and multiple patent families. She has advised/co-advised to completion 25 PhD students and 50 Honours students. In 2008, Professor Smith received the Women in Technology Biotech Outstanding Achievement Award and in 2009 she was awarded Honorary Fellowship of the Faculty of Pain Medicine, ANZCA. In 2011, she was elected Fellow of the Australian Academy of Technological Sciences and Engineering and in 2012 she was awarded the Life Sciences Queensland Industry Excellence Award jointly with Dr Jim Aylward. At the UQ top 5 Inventor and top 5 Innovator Awards in 2013, Professor Smith received awards in both categories and in 2013 she was also appointed ‘Innovation Champion’ at UQ.

William Denny, Ph.D.

Bill Denny is a graduate of Auckland University, and trained at Auckland and Oxford Universities as a medicinal chemist. He is currently Director of the Auckland Cancer Society Research Centre in the University of Auckland’s School of Medical Sciences, where he has been closely involved in the development of 14 drugs from the Centre into clinical trials, in collaboration with different industrial partners. He is a principal investigator in the Maurice Wilkins Centre (one of the national Centres of Research Excellence), and is co-chair of the University’s Biopharma Research Initiative. He is a scientific co-founder of the biotech companies Proacta Inc and Pathway Therapeutics, and a scientific advisory board member of the Australian Research Centre for Cancer Therapeutics. He is a co-author of 650 scientific papers and 100 patent applications in the area of drug design and development. He is a Rutherford Medallist of the Royal Society of NZ, and an Officer of the NZ Order of Merit. He is an Adrien Albert Medallist of the UK Royal Society of Chemistry, a Royal Australian Chemical Institute Adrien Albert Award winner, and received the 2014 Medicinal Chemistry Award of the American Chemical Society (the first such award in 30 years given outside the US).

Bill leads the Medicinal Chemistry Group at the Auckland Cancer Society Research Centre. The 14 drugs developed to clinical trial by the Centre include topoisomerase inhibitors, protein and lipid kinase inhibitors, vascular disrupting agents and hypoxia-activated prodrugs for cancer, as well as antibacterial drugs for tuberculosis and leishmaniasis.

Trent M. Woodruff, Ph.D.

A/Prof. Woodruff earned his Ph.D at the University of Queensland in 2003 on the pharmacological development of a potent class of novel cyclic peptide C5a receptor antagonists. Subsequently, he joined the biotechnology UQ-spin off company, Promics Ltd, from 2003-2007, working to commercialize these antagonists for human clinical use. He drove the scientific development of these compounds, which saw them complete three Phase I clinical trials, before sale to Peptech and Cephalon Inc. He returned to Academia in 2008 as a Research Fellow, and in 2010, Dr Woodruff started his own group and independent laboratory in the School of Biomedical Sciences.

Despite his early-career statues, Dr. Woodruff has authored or co-authored over 68 research papers and book chapters, and over 95 Conference abstracts. He also is lead inventor on 4 granted International patents, and 1 Provisional patent. He has been awarded numerous accolades for his research, including the Queensland Premier’s Medal for Health and Medical Research (2008), the Denis Wade Johnson and Johnson New Investigator Award (2008), the Royal Society’s Edgeworth David Medal (2012), the Queensland Health and Medical Senior Research Award (2013), and the International Young Investigator in Complement Award (2014). He also has received several prestigious research fellowships including a Bill-Gole post-doctoral fellowship, a National Health and Medical Research Council Biomedical Career Development Award, and an Australian Research Council Future Fellowship. He has advised/co-advised to completion 8 PhD students and 27 Honours students.

His current directions of research include the development of new classes of complement therapeutic agents, and their use in a wide variety of diseases including cancer and Parkinson’s disease. He is an executive board member of the International Complement Society (ICS), and member of the Australian Health and Medical Research Society (ASMR), the Australian Neuroscience Society (ANS), and the Australasian Society of Clinical and Experimental Pharmacologists and Toxicologists.

Greg Monteith, Ph.D.

Following his PhD at the University of Sydney, Greg spent two years at the University of Maryland at Baltimore (USA) in the Department of Physiology, developing novel techniques for the assessment of calcium (Ca2+) in sub-cellular organelles. Since his appointment at the University of Queensland, Greg has established a research program with research funding via NHMRC, Queensland Cancer Fund, Society of biomolecular Screening (USA) and other grants and collaboration with Pharmaceutical companies. His interests are signal transduction in disease, calcium transporters as drug targets and biomolecular screening. In 2006 he received a UQ Foundation research excellence award. His work on calcium channels and pumps in breast cancer has been published in leading journals including Cell, Oncogene, Molecular Cancer Therapeutics, Journal of Biological Chemistry and Nature Reviews Cancer.

QUE Drug Candidate

Q-122 for the treatment of hot flashes in breast cancer patients

QUE Oncology’s lead asset is Q-122, being developed for the treatment of hot flashes in women with a history of breast cancer who are receiving anti-estrogen therapy.

Q-122 is an orally available small molecule that has been investigated in a number of in vitro and in vivo pharmacology studies, and activity has been seen in models of inflammation.

Approximately 70% of breast cancer patients are estrogen receptor positive (ER+) or progesterone receptor positive (PR+) indicating that the growth and behavior of the tumor is influenced by estrogen and/or progesterone. Treatment modalities used to manage hormone sensitive breast cancer may result in the long term suppression of estrogen to control disease. The significant to total suppression of estrogen in these patients, in a short time frame, results in a state of induced menopause. Significant menopausal symptoms, including debilitating hot flashes, may occur. The use of hormone replacement therapy to manage vasomotor symptoms, including hot flashes, is contraindicated in patients with hormone sensitive tumors because of the increased risk of disease recurrence or progression. Although a recently approved non-hormonal therapy for treatment of hot flashes is available, it should not be used in patients on tamoxifen therapy because of a potential for interference with tamoxifen metabolism. A non-hormonal treatment for hot flashes resulting from breast cancer therapy is needed.

Two clinical studies of Q-122 have previously been conducted in healthy volunteers and cancer patients. A Phase 1b clinical study is currently being conducted.

Study Q-1001 is a two sequential dose escalation study to evaluate the safety, tolerability, pharmacokinetics, and effect on vasomotor symptoms of Q-122 in female subjects with breast cancer and receiving an aromatase inhibitor or Tamoxifen. The study is open-label, and is being conducted at a single site in the US.

QUE Research

Cancer is a leading cause of death. In 2012, an estimated 14.1 million cancer cases occurred worldwide. By 2035, it is estimated that 24 million cancer cases will occur on an annual basis. Although advances in the management of cancer occur frequently, there are still a number of types of cancer for which there is no, or minimally, effective therapy. Also, side effects from cancer treatment often affect the utility of the treatment or the patient’s quality of life. At QUE Oncology, research is directed toward understanding the mechanisms of cancer formation, growth, and metastasis. New pharmaceutical approaches targeting vulnerabilities common to several forms of cancer are being sought. QUE Oncology has assets that are designed to address several unmet medical needs in cancer therapy. These program areas include prostate cancer, breast cancer, multiple myeloma, metastatic melanoma, and neuropathic cancer pain.

  • Q102 - Prostate Cancer
  • Q201 - Neuropathic Cancer Pain
  • Q202 - Breast Cancer
  • Q204 - Metastatic Melanoma

Q-102 for Prostate Cancer

Prostate cancer is the most common cancer and the second leading cause of cancer-related death in males with an estimated 28,200 deaths in the US in 2012. Prostate cancer is generally a tumor type that affects older men, and as such, is often slowly progressive. When localized, the disease is often curable. However, in some patients, prostate cancer is rapidly growing and requires specific treatment such as surgery (radical prostatectomy), radiation or ultrasound therapy, drug therapy, or combination therapy.

Prostate tumors can be hormone dependent, being responsive to reduction in circulating testosterone levels. In these tumors, use of LRHR agonist or antagonist or surgical orchiectomy are normally used as first line therapy. Often, hormone dependent tumors become refractory after one to 3 years. In refractory tumor cases, and in castrate resistant prostate cancer, antimitotic therapy is normally used. However, significant toxicity limits the utility of antimitotic therapy in many patients. There remains unmet medical need for hormone refractory prostate cancer patients.

Q-102 is from a series of orally available sphingolipid modulator analogues. Sphingolipids, key components of cell membanes, are important in intracellular signaling. Sphingolipids and sphingolipid metabolites regulate important cellular processes related to growth, migration, differentiation, and apoptosis; regulation of cell division is an important target in cancer. Sphingoid bases, including sphinganine and sphingosine, are cytotoxic to cancer cells, but when phosphorylated to sphingosine 1-phosphate, become anti-apoptotic (inhibiting natural cell death). The Q-102 compounds have a sphingosine-like backbone, but cannot be phosphorylated; cell division is limited. Since this effect is not dependent on hormone regulation, this potential therapy may be important for castrate resistant and hormone resistant prostate cancer treatment.

Q-102 exhibits potent in vivo anticancer activity in models of colon and prostate cancer, and demonstrate excellent oral bioavailability in non-clinical studies.

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