QUE Oncology Launches Phase II Trials in the United States

April 2, 2019 Off By BusinessWire

Biotech creating a new therapy for hot flashes in breast cancer
patients launches clinical trials across United States

ATLANTA–(BUSINESS WIRE)–Clinical stage biotechnology company QUE Oncology today announces the
launch of its Phase II trials which will see its novel non-hormonal
therapy, for women with breast cancer suffering hot flashes and night
sweats, tested at key sites in the United States.

QUE Oncology is developing drugs for large unmet medical needs and has
already advanced clinical development of its lead drug program Q-122,
through four Phase 1 trials.

QUE Oncology is now set to commence a placebo-controlled, double-blind
study to examine the efficacy of Q-122 at leading clinical sites across
the United States, including Brigham and Women’s Hospital, Boston, Johns
Hopkins Kimmel Cancer Center, Baltimore, and Indiana University,
Indiana. Additional clinical sites in other US states will follow,
subject to relevant ethics and regulatory approvals.

After a diagnosis of breast cancer, women are routinely prescribed drugs
such as tamoxifen or aromatase inhibitors (known as endocrine therapy)
which reduce or block the action of estrogen, a hormone known to
stimulate the growth of breast cancer. However, the side-effect of
reducing estrogen is an increased likelihood of moderate to severe hot
flashes and night sweats. These symptoms can severely impact a women’s
general wellbeing and often cause women to stop taking their breast
cancer treatment. QUE Oncology is looking to develop a therapy to
address these debilitating symptoms.

Previous trials with Q-122 have shown an excellent safety profile in
over 60 patients and healthy volunteers. In a previous Phase 1b trial in
women undergoing estrogen reduction therapy for breast cancer, 85% of
women showed a reduction in both the frequency and severity of their hot
flashes.

QUE Oncology Chief Executive Officer Dr Rob Crombie says, “Evidence
shows that up to 75% of women undergoing long-term preventative breast
cancer treatment suffer hot flashes and night sweats, with some facing
more than 20 events in one day. Through our Phase II trials we hope to
replicate the data that we have already seen in this patient group as we
develop a treatment to substantially improve the quality of life for
women on long-term endocrine therapy.”

Dr Hadine Joffe, Director of the Connors Center for Women’s Health and
Gender Biology at Brigham and Women’s Hospital, and the Paula A. Johnson
Associate Professor of Psychiatry in the Field of Women’s Health at
Harvard Medical School, a key investigator on the trial in the United
States says, “For women undergoing breast cancer treatment, hot flashes
can be debilitating, not only during the day but also at night,
impacting sleep quality. In extreme cases, these symptoms can make women
consider stopping their anti-cancer therapy. Trials in this area are
urgently needed to identify effective treatments to combat these side
effects.”

QUE Oncology’s products also have the potential to expand into related
conditions, such as hot flashes associated with menopause, and hot
flushes experienced by men undergoing prostate cancer treatment.

Women interested in further details about QUE Oncology’s clinical trials
should visit www.queoncology.com.

Notes to Editors:

For further information or to arrange an interview, please contact:

QUE Oncology: Andrew Hamilton, [email protected],
+61 420 447 669

About QUE Oncology, Inc.

QUE Oncology, Inc. is a global clinical stage biotechnology company
developing drugs for large unmet medical needs. The company’s lead drug
program, Q-122 is initially focused on the treatment of hot flashes in
breast cancer survivors undergoing hormone therapy. Several clinical
studies with Q-122 have shown the drug to be safely administered to over
60 patients and healthy volunteers.

QUE Oncology was jointly established by Emory
University (Atlanta, GA) and the University of Queensland’s main
commercialisation company, UniQuest Pty Ltd. QUE Oncology was jointly
established by Emory
University (Atlanta, GA) and the University of Queensland’s main
commercialisation company, UniQuest Pty Ltd. The Series A investment
round was led by the Medical Research Commercialisation Fund (MRCF),
alongside Uniseed.

Que Oncology has now commenced a placebo-controlled Phase 2 study in
breast cancer patients, with multiple sites across Australia and the
USA. Backed by a A$21.5M capital raise (June 2017) led by Australia’s
Medical Research Commercialisation Fund (MRCF) and Uniseed, QUE is well
funded to execute on its clinical development programs.

About Q-122

Q-122 is being developed for the treatment of hot flashes in women
diagnosed with breast cancer who are receiving hormonal therapy. Q-122
is an orally available small molecule that has been investigated in
several in vitro and in vivo pharmacology studies. The clinical results
have shown that Q-122 has an excellent safety profile and warrants the
needs for further clinical studies to assess the efficacy of the drug in
the treatment of hot flashes.

Clinical trials to date

To date Q-122 has been safely administered to a total of 62 participants
in 4 separate clinical trials as described briefly below.

Phase 1 – first-in-human (FIH) study: Examined the safety of Q-122 in
cancer patients with solid or haematological malignancies. In this
study, seven cancer patients received either 50 or 75 mg of Q-122
daily for up to 110 days. No maximum tolerated dose was identified,
and no trends in adverse events (AEs) noted.
Phase 1 Single Ascending Dose (SAD): In this study, 22 healthy
participants received single doses of 50 mg, 100 mg, 200 mg or 400 mg
Q-122. Q-122 was well tolerated with no serious adverse events (SAEs)
reported.
Phase 1b Initial Proof-of-Concept (Q-1001): This open-label study
enrolled breast cancer survivors taking endocrine therapy (tamoxifen
or an aromatase inhibitor) who were experiencing 49 or more moderate
to severe hot flashes per week. In this study, 21 participants
received daily doses of 100 mg (10 participants) or 200 mg (11
participants) Q-122 for up to 28 days. In this study, both the
frequency and severity of hot flashes were significantly reduced
following treatment with Q-122 as were menopausal symptoms assessed
using the Greene Climacteric Scale.
Phase 1 Pharmacokinetic (PK) Study (Q122-1002): A Phase 1 study was
conducted to determine the effect of food and dosing regimen on Q-122
pharmacokinetics. In Part 1, healthy volunteers were administered
Q-122 (200 mg) in either fed or fasted conditions. The results
demonstrated an increase in bioavailability of Q-122 under fed dosing
conditions. In Part 2, the same 12 participants were randomized to a
once daily (200 mg) versus twice daily (2 doses of 100 mg) to examine
the effect of the dosing regimen of Q-122.

Given these very encouraging study outcomes, QUE has accelerated
development of Q-122 as a treatment for vasomotor symptoms in breast
cancer survivors taking tamoxifen or an aromatase inhibitor.