Sermonix Pharmaceuticals to Collaborate With Eli Lilly and Company in Studying Combination of Lasofoxifene and Lilly’s CDK ...
July 08 2020 - 10:00AM
Sermonix Pharmaceuticals Inc., a privately held biopharmaceutical
company focused on the development of female oncology products in
the precision medicine metastatic breast cancer arena, today
announced a collaboration with Eli Lilly and Company to study
Sermonix’s lead investigational drug, lasofoxifene, in combination
with Lilly’s FDA-approved CDK 4 and 6 inhibitor, abemaciclib.
The open-label, multi-center Phase 2 clinical trial, which is
projected to begin enrollment in the third quarter of 2020, will
evaluate the safety of lasofoxifene in combination with abemaciclib
for the treatment of pre- and postmenopausal women with locally
advanced metastatic estrogen receptor-positive (ER+)/HER2- breast
cancer and an ESR1 mutation. It marks Sermonix’s second
Evaluation of
Lasofoxifene in
ESR1 Mutations (ELAINE) study and will be known as
ELAINE 2.
“Sermonix is pleased to begin studying our lead compound,
lasofoxifene, in collaboration with Lilly for pretreated patients
with advanced breast cancer harboring an ESR1 mutation,” said Dr.
David Portman, founder and chief executive officer of Sermonix
Pharmaceuticals. “We look forward to learning more about the safety
of this combination to further support a larger study.”
Preclinical models of invasive breast cancer at the University
of Chicago have identified synergy between lasofoxifene, a
selective estrogen receptor modulator (SERM), and a CDK 4 and 6
inhibitor, palbocicilib, in the presence of ESR1 mutations.
“It is exciting to see this Sermonix combination study with
Lilly’s abemaciclib, as it will investigate lasofoxifene paired
with an already-approved therapy used widely to treat patients with
metastatic breast cancer,” said Dr. Geoffrey Greene, Ph.D., chair
of the Ben May Department for Cancer Research at the University of
Chicago and a member of Sermonix’s Oncology Steering Committee. “We
recently presented preclinical data at the American Association for
Cancer Research, demonstrating lasofoxifene synergy with a CDK 4
and 6 inhibitor, palbocicilib. The ELAINE 2 study is an important
first step in looking at a combination in the clinic.”
ELAINE 1, which is currently enrolling patients, is a Phase 2
clinical trial assessing the efficacy of oral lasofoxifene versus
intramuscular fulvestrant for the treatment of postmenopausal women
with locally advanced or metastatic ER+/HER2- breast cancer with an
ESR1 mutation as identified by a liquid biopsy and progression-free
survival as the primary endpoint. The open-label, randomized,
multi-center study (NCT03781063) is being conducted at multiple
sites in the U.S., Canada and Israel.
“Endocrine therapy is the backbone of combination therapies in
ER+/HER2- breast cancer, and as a well-characterized compound,
lasofoxifene may offer patients a potentially well-tolerated oral
option alone and in combination in an area of significant unmet
need,” said Sermonix Board Chairman Dr. Anthony Wild. “We look
forward to embarking on ELAINE 2 and executing on this important
trial.”
About Lasofoxifene
Lasofoxifene is an investigational, nonsteroidal selective estrogen
receptor modulator (SERM), which Sermonix licensed globally from
Ligand Pharmaceuticals Inc. (NASDAQ: LGND) and has been studied in
previous comprehensive Phase 1-3 non-oncology clinical trials in
more than 15,000 postmenopausal women worldwide. Lasofoxifene’s
bioavailability and activity in mutations of the estrogen receptor
could potentially hold promise for patients who have acquired
endocrine resistance due to ESR1 mutations, a common finding in the
metastatic setting and an area of high unmet medical need.
Lasofoxifene’s novel activity in ESR1 mutations was discovered at
Duke University and Sermonix has exclusive rights to develop and
commercialize the product in this area. Lasofoxifene, a potent,
oral SERM could, if approved, play a critical role in the targeted
precision medicine treatment of advanced ER+ breast cancer.
About
AbemaciclibAbemaciclib (trade name Verzenio®) is a CDK4
and 6 inhibitor and the first and only oral tablet of its kind that
can be taken every day for the treatment of HR+, HER2– metastatic
breast cancer. It is indicated for the treatment of HR+, HER2-
advanced or metastatic breast cancer, in combination with an
aromatase inhibitor for postmenopausal women as initial
endocrine-based therapy; in combination with fulvestrant for women
with disease progression following endocrine therapy; or as a
single agent for adult patients with disease progression following
endocrine therapy and prior chemotherapy in the metastatic
setting.
About
SermonixSermonix Pharmaceuticals Inc. is a privately held
biopharmaceutical company focused on the development of
female-specific oncology products and is currently undertaking a
Phase 2 clinical study of lasofoxifene, its lead investigational
drug. Sermonix Pharmaceuticals was founded in 2014 by David
Portman, M.D., a leading clinical researcher and expert in women’s
health, menopause and selective estrogen receptor modulator (SERM)
therapy. The Sermonix management team, led by Dr. Portman, has
significant experience in all stages of the drug development and
regulatory process. Paul Plourde, M.D., vice president of oncology
clinical development, has many decades of experience in the
oncology drug development arena. Barry Komm, Ph.D., chief
scientific officer, is recognized for his expertise in SERM
biology. Elizabeth Attias, M.M.Sc., Sc.D., chief strategy and
development officer, has extensive experience in pharmaceutical
drug commercialization. Simon Jenkins, Ph.D. vice president of
operations, has over 30 years of experience in global drug
development leadership. Sermonix non-executive chairman of the
board is Anthony Wild, Ph.D., former president of both Parke-Davis
Pharmaceuticals and Warner-Lambert’s Pharmaceutical Division. Learn
more at https://sermonixpharma.com/.
Contact:David Portman, MDCEO and Founder, Sermonix
Pharmaceuticalsdportman@sermonixpharma.com614-582-6849
Ligand Pharmaceuticals (NASDAQ:LGND)
Historical Stock Chart
From Mar 2024 to Apr 2024
Ligand Pharmaceuticals (NASDAQ:LGND)
Historical Stock Chart
From Apr 2023 to Apr 2024