Daiichi Sankyo Company, Limited (hereafter, Daiichi Sankyo) and
Puma Biotechnology, Inc. (Nasdaq: PBYI) have announced a
preclinical research collaboration with Memorial Sloan Kettering
Cancer Center (MSK) to explore the combination of Daiichi Sankyo’s
investigational antibody drug conjugate DS-8201 and Puma
Biotechnology’s irreversible pan-HER tyrosine kinase inhibitor
neratinib (NERLYNX®) in HER2-mutated or HER2-positive solid
tumors.
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A team of scientists led by Maurizio Scaltriti, PhD, and in
collaboration with a team of clinical investigators led by
Bob Li, MD, will use isogenic models and established
patient-derived xenograft models to assess the susceptibility of
HER2-mutated or HER2-positive cancers to DS-8201, neratinib and
other HER2-targeting therapies, elucidate mechanisms of action and
resistance of these various tumor types, and evaluate the potential
for synergistic combinations. Daiichi Sankyo and Puma Biotechnology
will co-sponsor the research.
“Since early clinical data suggest that DS-8201 may have
activity beyond breast and gastric cancers, the archetype
HER2-driven tumors, we are interested in studying this asset on a
molecular level as well as in combination with other HER2-targeting
agents,” said Tom Held, Vice President, Global Head, Antibody Drug
Conjugate Task Force, Daiichi Sankyo. “In this collaboration, we
are examining whether combining DS-8201 and neratinib, with its
specific covalent binding to the HER2 receptor and associated
increased internalization, is a rational combination therapy
strategy to pursue. We are excited to join forces with Memorial
Sloan Kettering and Puma to advance the understanding of combining
HER2-targeted therapies to potentially treat various forms of
HER2-mutated cancer.”
“We are pleased to enter into this research collaboration with
Memorial Sloan Kettering and Daiichi Sankyo to explore the
combination of neratinib and DS-8201,” said Alan Auerbach, Puma’s
Chief Executive Officer and President. “Combination therapy with
agents that address different and complementary pathways, with
neratinib targeting the HER2 kinase and DS-8201 providing an
innovative targeted delivery of a potent cytotoxic, represents an
intriguing approach to the treatment of HER2 mutated tumors and
helps to maximize the potential for both agents in treating cancers
with a HER2 mutation.”
About DS-8201
DS-8201 is the lead product in the ADC Franchise of the Daiichi
Sankyo Cancer Enterprise. ADCs are targeted cancer medicines that
deliver cytotoxic chemotherapy (“payload”) to cancer cells via a
linker attached to a monoclonal antibody that binds to a specific
target expressed on cancer cells. Designed using Daiichi Sankyo’s
proprietary ADC technology, DS-8201 is a smart chemotherapy
comprised of a humanized HER2 antibody attached to a novel
topoisomerase I inhibitor payload by a tetrapeptide-based linker.
It is designed to target and deliver chemotherapy inside cancer
cells and reduce systemic exposure to the cytotoxic payload (or
chemotherapy) compared to the way chemotherapy is commonly
delivered.
DS-8201 is currently in phase 2 clinical development for
HER2-positive unresectable and/or metastatic breast cancer
resistant or refractory to T-DM1 (DESTINY-Breast01), phase 2
development for HER2-positive advanced gastric resistent or
refractory to trastuzumab (DESTINY-Gastric01) and phase 1
development for other HER2-expressing advanced/unresectable or
metastatic solid tumors.
DS-8201 has been granted Breakthrough Therapy designation for
the treatment of patients with HER2-positive, locally advanced or
metastatic breast cancer who have been treated with trastuzumab and
pertuzumab and have disease progression after ado-trastuzumab
emtansine (T-DM1), and Fast Track designation for the treatment of
HER2-positive unresectable and/or metastatic breast cancer in
patients who have progressed after prior treatment with
HER2-targeted therapies including T-DM1 by the U.S. Food and Drug
Administration (FDA). DS-8201 is an investigational agent that has
not been approved for any indication in any country. Safety and
efficacy have not been established.
About NERLYNX® (neratinib)
Neratinib was approved by the FDA in July 2017 for the extended
adjuvant treatment of adult patients with early stage HER2-positive
breast cancer following adjuvant trastuzumab-based therapy, and is
marketed in the United States as NERLYNX® (neratinib) tablets.
Important Safety Information (ISI)NERLYNX®
(neratinib) tablets, for oral use
INDICATIONS AND USAGE: NERLYNX is a kinase inhibitor
indicated for the extended adjuvant treatment of adult patients
with early-stage HER2 overexpressed/amplified breast cancer, to
follow adjuvant trastuzumab-based therapy.
CONTRAINDICATIONS: None
WARNINGS AND PRECAUTIONS:
- Diarrhea: Aggressively manage
diarrhea occurring despite recommended prophylaxis with additional
antidiarrheals, fluids, and electrolytes as clinically indicated.
Withhold NERLYNX in patients experiencing severe and/or persistent
diarrhea. Permanently discontinue NERLYNX in patients experiencing
Grade 4 diarrhea or Grade ≥ 2 diarrhea that occurs after maximal
dose reduction.
- Hepatotoxicity: Monitor liver
function tests monthly for the first 3 months of treatment, then
every 3 months while on treatment and as clinically indicated.
Withhold NERLYNX in patients experiencing Grade 3 liver
abnormalities and permanently discontinue NERLYNX in patients
experiencing Grade 4 liver abnormalities.
- Embryo-Fetal Toxicity: NERLYNX
can cause fetal harm. Advise patients of potential risk to a fetus
and to use effective contraception.
ADVERSE REACTIONS: The most common adverse reactions (≥
5%) were diarrhea, nausea, abdominal pain, fatigue, vomiting, rash,
stomatitis, decreased appetite, muscle spasms, dyspepsia, AST or
ALT increase, nail disorder, dry skin, abdominal distention,
epistaxis, weight decreased and urinary tract infection.
To report SUSPECTED ADVERSE REACTIONS, contact Puma
Biotechnology, Inc. at 1-844-NERLYNX (1-844-637-5969) and
www.NERLYNX.com or FDA at 1-800-FDA-1088 or
www.fda.gov/medwatch.
DRUG INTERACTIONS:
- Gastric acid reducing agents: Avoid
concomitant use with proton pump inhibitors (PPI) and H2-receptor
antagonists. Separate NERLYNX by 3 hours after antacid dosing.
- Strong or moderate CYP3A4 inhibitors:
Avoid concomitant use.
- Strong or moderate CYP3A4 inducers:
Avoid concomitant use.
- P-glycoprotein (P-gp) substrates:
Monitor for adverse reactions of narrow therapeutic agents that are
P-gp substrates when used concomitantly with NERLYNX.
USE IN SPECIFIC POPULATIONS:
- Lactation: Advise women not to
breastfeed.
Please see Full Prescribing Information for
additional safety information.
The recommended dose of NERLYNX is 240 mg (six 40 mg tablets)
given orally once daily with food, continuously for one year.
Antidiarrheal prophylaxis should be initiated with the first dose
of NERLYNX and continued during the first 2 months (56 days) of
treatment and as needed thereafter.
To help ensure patients have access to NERLYNX, Puma has
implemented the Puma Patient Lynx support program to assist
patients and healthcare providers with reimbursement support and
referrals to resources that can help with financial assistance.
More information on the Puma Patient Lynx program can be found at
www.NERLYNX.com or 1-855-816-5421.
About Puma Biotechnology
Puma Biotechnology, Inc. is a biopharmaceutical company with a
focus on the development and commercialization of innovative
products to enhance cancer care. Puma in-licenses the global
development and commercialization rights to three drug candidates —
PB272 (neratinib (oral)), PB272 (neratinib (intravenous)) and
PB357. NERLYNX® (neratinib) is approved for commercial use by
prescription in the United States as extended adjuvant therapy for
early stage HER2-positive breast cancer following adjuvant
trastuzumab-based therapy and is marketed as NERLYNX. Neratinib is
a potent irreversible tyrosine kinase inhibitor that blocks signal
transduction through the epidermal growth factor receptors, HER1,
HER2 and HER4. Currently, Puma is primarily focused on the
commercialization of NERLYNX and the continued development of its
other advanced drug candidates directed at the treatment of
HER2-positive breast cancer. Puma believes that NERLYNX has
clinical application in the potential treatment of several other
cancers that over-express or have a mutation in HER2. Further
information about Puma Biotechnology can be found at
www.pumabiotechnology.com
About Daiichi Sankyo Cancer Enterprise
The vision of Daiichi Sankyo Cancer Enterprise is to leverage
our world-class, innovative science and push beyond traditional
thinking in order to create meaningful treatments for patients with
cancer. We are dedicated to transforming science into value for
patients, and this sense of obligation informs everything we do.
Anchored by our Antibody Drug Conjugate (ADC) and Acute Myeloid
Leukemia (AML) Franchises, our cancer pipeline includes more than
20 small molecules, monoclonal antibodies and ADCs stemming from
our powerful research engines: our two laboratories for
biologic/immuno-oncology and small molecules in Japan, and
Plexxikon Inc., our small molecule structure-guided R&D center
in Berkeley, CA. Compounds in development include: quizartinib, an
oral FLT3 inhibitor, for newly-diagnosed and relapsed or refractory
AML with FLT3-ITD mutations; DS-8201, an ADC for HER2-expressing
breast and gastric cancer, and other HER2-expressing solid tumors;
and pexidartinib, an oral CSF-1R inhibitor, for tenosynovial giant
cell tumor (TGCT), which is also being explored in a range of solid
tumors in combination with the anti-PD1 immunotherapy
pembrolizumab. For more information, please visit:
www.DSCancerEnterprise.com.
About Daiichi Sankyo
Daiichi Sankyo Group is dedicated to the creation and supply of
innovative pharmaceutical products to address diversified, unmet
medical needs of patients in both mature and emerging markets. With
over 100 years of scientific expertise and a presence in more than
20 countries, Daiichi Sankyo and its 15,000 employees around the
world draw upon a rich legacy of innovation and a robust pipeline
of promising new medicines to help people. In addition to a strong
portfolio of medicines for hypertension and thrombotic disorders,
under the Group’s 2025 Vision to become a “Global Pharma Innovator
with Competitive Advantage in Oncology,” Daiichi Sankyo research
and development is primarily focused on bringing forth novel
therapies in oncology, including immuno-oncology, with additional
focus on new horizon areas, such as pain management,
neurodegenerative diseases, heart and kidney diseases, and other
rare diseases. For more information, please visit:
www.daiichisankyo.com. Daiichi Sankyo, Inc., headquartered in
Basking Ridge, New Jersey, is a member of the Daiichi Sankyo Group.
For more information on Daiichi Sankyo, Inc., please visit:
www.dsi.com.
Forward-Looking Statements
This press release contains forward-looking statements,
including statements regarding the benefits of a research
collaboration with Memorial Sloan Kettering and Daiichi Sankyo,
including whether a combination of neratinib and DS-8201 will be
successful or beneficial, the benefits of NERLYNX® and neratinib,
Puma’s clinical trials and the announcement of data relative to
those trials. All forward-looking statements included in this press
release involve risks and uncertainties that could cause Puma’s
actual results to differ materially from the anticipated results
and expectations expressed in these forward-looking statements.
These statements are based on current expectations, forecasts and
assumptions, and actual outcomes and results could differ
materially from these statements due to a number of factors, which
include, but are not limited to, the fact that Puma has only
recently commenced commercialization and shipment of its only FDA
approved product; Puma’s dependence upon the commercial success of
NERLYNX (neratinib); Puma’s history of operating losses and its
expectation that it will continue to incur losses for the
foreseeable future; risks and uncertainties related to Puma’s
ability to achieve or sustain profitability; Puma’s ability to
predict its future prospects and forecast its financial performance
and growth; failure to obtain sufficient capital to fund Puma’s
operations; the effectiveness of sales and marketing efforts;
Puma’s ability to obtain FDA approval or other regulatory approvals
in the United States or elsewhere for other indications for
neratinib or other product candidates; the challenges associated
with conducting and enrolling clinical trials; the risk that the
results of clinical trials may not support Puma’s drug candidate
claims; even if approved, the risk that physicians and patients may
not accept or use Puma’s products; Puma’s reliance on third parties
to conduct its clinical trials and to formulate and manufacture its
drug candidates; risks pertaining to securities class action,
derivative and defamation lawsuits; Puma’s dependence on licensed
intellectual property; and the other risk factors disclosed in the
periodic and current reports filed by Puma with the Securities and
Exchange Commission from time to time, including Puma’s Quarterly
Report on Form 10-Q for the quarter ended September 30, 2017.
Readers are cautioned not to place undue reliance on these
forward-looking statements, which speak only as of the date hereof.
Puma assumes no obligation to update these forward-looking
statements, except as required by law.
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version on businesswire.com: http://www.businesswire.com/news/home/20171212006311/en/
Daiichi Sankyo:Daiichi Sankyo, Inc.Jennifer Brennan+1 908
992 6631 (office)+1 201 709 9309 (mobile)jbrennan2@dsi.comorPuma
Biotechnology ContactPuma Biotechnology, Inc.Alan H. Auerbach,
+1 424 248
6500info@pumabiotechnology.comir@pumabiotechnology.comorPuma
Biotechnology, Inc.Alshad S. Lalani, PhD+1 424 248 6500 Ext. 3037
(office)+1 415 722 5234 (mobile)ALalani@pumabiotechnology.com
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