BRIDGEWATER, N.J., June 15, 2020 /PRNewswire/ -- Preclinical
data for Sanofi's investigational compounds in breast, lung,
multiple myeloma and other cancers will be featured at the American
Academy of Cancer Research (AACR) Virtual Annual Meeting II on
June 22-24. The results that will be
presented underscore the Company's commitment to transforming
scientific knowledge and advances in innovative oncology
therapies.
"We believe the innovation and
efforts we are driving in oncology have the potential to make a
significant difference in the lives of people living with
cancer," said Yong Jun Liu,
Global Head of Research, Senior Vice President R&D
at Sanofi. "Preclinical data presented at this year's
AACR Virtual Meeting II showcase the depth of our pipeline and
support the continued exploration of our investigational assets
that reflect some of the most cutting-edge scientific technologies
and platforms in oncology."
Preclinical data show anti-tumor activity and support further
research across a range of solid tumors, including evolving
evidence in breast and lung cancers
Sanofi continues to embrace a variety of technological
approaches to address some of the hardest-to-treat forms of cancer,
including breast and lung cancer.
Abstract 3452: Pre-clinical development of next generation
Selective Estrogen Receptor Degrader – SAR439859 (Dr. Fangxian Sun, Sr.;
Tuesday, June 23: Virtual
Minisymposium Session, 10:20-10:30
AM)
SAR439859 (SERD '859) is a
oral endocrine backbone therapy in hormone receptor positive (HR+)
breast cancer that selectively binds to estrogen receptors in
breast cancer cells to block signaling and trigger their
degradation. Breast cancer is the second most common form of cancer
worldwide, with an estimated 70-80% of breast cancers being
HR+.
- Preclinical research from SERD '859 demonstrated anti-tumor
activity in HR+ breast cancer cell lines.
- SERD '859 showed significant anti-tumor activity against
endocrine-therapy-resistant, patient-derived tumor models that
correlated with pharmacokinetic (PK) exposure and pharmacodynamic
(PD) modulation in target tissue.
- Looking to potential combination therapies, researchers
observed strong synergistic activity between SERD '859 and
palbociclib, a CDK4/6 inhibitor
Abstract 561/16: Pre-clinical efficacy data for the
anti-CEACAM5-DM4 ADC SAR408701
supports further development in lung and gastro-intestinal
cancers (Dr. Stephanie Decary; Monday, June 22: Poster Display, 9:00 AM-6:00 PM)
SAR408701 (SAR '701) is Sanofi's
potential first-in-class antibody-drug conjugate targeting CEACAM5
(carcinoembryonic antigen-related cell adhesion molecule 5), a
cell-surface glycoprotein that is highly expressed in non-squamous
non-small cell lung cancers (NSCLC). Approximately 20-30% of lung
cancers have a high expression of CEACAM5.
- Results from patient-derived xenograft mouse studies of SAR
'701 in non-small cell lung cancer will be presented.
- Findings revealed a potential correlation between preclinical
activity of the compound and the expression of CEACAM5 in lung
tumors.
- Further exploration of SAR '701 clinical activity is also
ongoing across a number of CEACAM5-expressing solid tumors.
Abstract 1943/10: SHP2
inhibition as the backbone of targeted therapy combinations for the
treatment of cancers driven by oncogenic mutations in the RAS
pathway (Dr. Jacqueline Smith;
Monday, June 22: Poster Display,
9:00AM-6:00PM)
SAR442720 (RMC-4630) is an
investigational inhibitor of the cellular enzyme SHP2 developed jointly by Sanofi and Revolution
Medicines. Inhibitors of SHP2 are
designed to reduce cell growth signaling in the RAS-MAP kinase
pathway that is frequently overactive in human cancers, like
NSCLC.
- Results from preclinical combination studies showed
SAR442720 enhanced the anti-tumor
activity of EGFR-mutant or KRASG12C inhibitors.
Preclinical data add to growing body of evidence supporting
Sarclisa (isatuximab-irfc) in multiple myeloma and other blood
cancers
Sanofi is committed to investigating new treatments for patients
with multiple myeloma, a difficult-to-treat blood cancer, who often
need multiple lines of therapy. Despite available treatments,
multiple myeloma remains an incurable malignancy and is associated
with significant patient burden.
Abstract 5179/5: Isatuximab based combinations induce potent
tumor growth inhibition in pre-clinical models of multiple myeloma
and acute lymphocytic leukemia (Dr. Chen Zhu; Monday, June
22: Poster Display, 9:00 AM-6:00
PM)
Sarclisa is a monoclonal antibody that binds to the CD38
receptor on multiple myeloma cells. It is currently approved for
use in the U.S. and EU in combination with pomalidomide and
dexamethasone for the treatment of certain adults who have received
at least two prior therapies including lenalidomide and a
proteasome inhibitor.
- Results from a study using patient-derived mouse xenograft
models showed anti-tumor activity with Sarclisa in combination with
standard-of-care treatments in both multiple myeloma (pomalidomide,
lenalidomide, bortezomid, carfilzomib, melphalan) and acute
lymphocytic leukemia (vincristine, cytarabine, cyclophosphamide).
These potential uses of Sarclisa are investigational, and their
safety and efficacy have not been evaluated by any regulatory
authority.
Early science: new approaches in blood cancer
research
Abstract 2266/1: SAR442085, a
next generation anti-CD38 antibody with enhanced antibody-dependent
cellular cytotoxicity (ADCC) against multiple myeloma (Dr.
Angela Virone-Oddos; Monday, June 22:
Poster Display, 9:00 AM-6:00 PM)
Current anti-CD38 treatments in combination with standard
treatments represent a major advancement in the treatment of
patients with relapsed and refractory multiple myeloma, but unmet
needs remain. Sanofi scientists investigating a
next-generation anti-CD38 antibody SAR442085 for the treatment of multiple myeloma
will present preclinical data at the meeting.
- Findings from a study of SAR442085 include antibody-dependent cellular
cytotoxicity activity in vivo compared to currently available
anti-CD38 antibodies.
- SAR442085 demonstrated a higher
level of natural killer (NK) cell activation against primary plasma
cells in patient samples and potent in vivo single-agent activity
against tumor cells expressing human CD38 in a C57BL/6 mouse
model.
- SAR442085 is currently being
evaluated in Phase I clinical trials in patients with
relapsed/refractory multiple myeloma.
Abstract 5641/2: CD28 expression on multiple myeloma cells
enhances the cytotoxic activity of CD38/CD28xCD3 trispecific T-cell
engager (Dr. Nizar El-Murr;
Monday, June 22: Poster Display,
9:00 AM-6:00 PM)
Sanofi scientists are also investigating the trispecific T-cell
engager SAR442257 (CD38/CD28xCD3) as
a potential treatment for multiple myeloma.
- Preclinical data show that SAR442257 is active on CD38 in multiple myeloma
models.
- SAR442257 can also directly
target CD28, a T-cell activating protein expressed on tumor cells,
enhancing the protein's anti-tumor activity and allowing it to bind
to tumor cells when CD38 is occupied by other antibodies.
The clinical significance of the preclinical findings relating
to SERD '859, SAR '701, SAR442720, Sarclisa, SAR442085 and SAR442257 described above are currently
under investigation.
About Sarclisa
Sarclisa is a monoclonal antibody that binds to a specific
epitope on the CD38 receptor on MM cells. It is designed to work
through multiple mechanisms of action including programmed tumor
cell death (apoptosis) and immunomodulatory activity. CD38 is
highly and uniformly expressed on the surface of MM cells, making
it a potential target for antibody-based therapeutics such as
Sarclisa.
Sarclisa is approved in the EU, U.S., Switzerland, Canada and Australia in combination with pom-dex for the
treatment of certain adults with relapsed refractory MM. In the
U.S., the generic name for Sarclisa is isatuximab-irfc, with irfc
as the suffix designated in accordance with Nonproprietary Naming
of Biological Products Guidance for Industry issued by the U.S.
Food and Drug Administration.
Sarclisa continues to be evaluated in multiple ongoing Phase 3
clinical trials in combination with current standard treatments
across the MM treatment continuum. It is also under investigation
for the treatment of other hematologic malignancies and solid
tumors. The safety and efficacy of these additional uses have not
been evaluated by any regulatory authority.
For more information on Sarclisa clinical trials please visit
www.clinicaltrials.gov.
IMPORTANT SAFETY INFORMATION AND INDICATION FOR U.S.
PATIENTS
What is SARCLISA?
SARCLISA is a prescription medicine used in combination with
pomalidomide and dexamethasone to treat adults who have received at
least 2 prior therapies, including lenalidomide and a proteasome
inhibitor, to treat multiple myeloma.
It is not known if SARCLISA is safe and effective in
children.
Do not receive SARCLISA if you have a history of
severe allergic reaction to isatuximab-irfc or any of the
ingredients in SARCLISA (see the list of ingredients in full
Prescribing Information).
Before receiving SARCLISA, tell your healthcare provider
about all of your medical conditions, including if you:
- are pregnant or plan to become pregnant. SARCLISA may harm your
unborn baby. You should not receive SARCLISA during pregnancy.
- Females who are able to become pregnant should use an effective
method of birth control during treatment and for 5 months after
your last dose of SARCLISA. Talk to your healthcare provider about
birth control methods that you can use during this time.
Tell your healthcare provider right away if you think you are
pregnant or become pregnant during treatment with SARCLISA.
- are breastfeeding or plan to breastfeed. It is not known
if SARCLISA passes into your breast milk. You should not breastfeed
during treatment with SARCLISA.
Tell your healthcare provider about all the medicines you
take, including prescription and over-the-counter
medicines, vitamins, and herbal supplements.
How will I receive SARCLISA?
- SARCLISA will be given to you by your healthcare provider by
intravenous (IV) infusion into your vein.
- SARCLISA is given in treatment cycles of 28 days (4 weeks),
together with the medicines pomalidomide and dexamethasone.
- In cycle 1, SARCLISA is usually given weekly.
- Starting in cycle 2, SARCLISA is usually given every 2
weeks.
Your healthcare provider will decide how long you should receive
SARCLISA.
- If you miss any appointments, call your healthcare provider as
soon as possible to reschedule your appointment.
- Your healthcare provider will give you medicines before each
dose of SARCLISA to help reduce the risk of infusion reactions
(make them less frequent and severe).
What are the possible side effects of SARCLISA?
SARCLISA may cause serious side effects, including:
- Infusion reactions. Infusion reactions are common
with SARCLISA and can sometimes be severe.
- Your healthcare provider will prescribe medicines before each
infusion of SARCLISA to help decrease your risk for infusion
reactions or to help make any infusion reaction less severe. You
will be monitored for infusion reactions during each dose of
SARCLISA.
- Your healthcare provider may slow down or stop your infusion,
or completely stop treatment with SARCLISA, if you have an infusion
reaction.
Tell your healthcare provider right away if you develop any
of the following symptoms of infusion reaction during or within 24
hours after an infusion of SARCLISA:
- feeling short of breath
- cough
- chills
- nausea
- Decreased white blood cell counts. Decreased white
blood cell counts are common with SARCLISA and certain white blood
cells can be severely decreased. You may have an increased risk of
getting certain infections, such as upper and lower respiratory
infections.
Your healthcare provider will check your blood cell counts
during treatment with SARCLISA. Your healthcare provider may
prescribe an antibiotic or antiviral medicine to help prevent
infection, or a medicine to help increase your white blood cell
counts during treatment with SARCLISA.
Tell your healthcare provider right away if you develop any
fever or symptoms of infection during treatment with
SARCLISA.
- Risk of new cancers. New cancers have happened in
people during treatment with SARCLISA. Your healthcare provider
will monitor you for new cancers during treatment with
SARCLISA.
- Change in blood tests. SARCLISA can affect the
results of blood tests to match your blood type. Your
healthcare provider will do blood tests to match your blood type
before you start treatment with SARCLISA. Tell all of your
healthcare providers that you are being treated with SARCLISA
before receiving blood transfusions.
The most common side
effects of SARCLISA include:
|
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-lung infection
(pneumonia)
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-upper respiratory
tract infection
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-decreased red blood
cell counts
(anemia)
-diarrhea
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-decreased platelet
counts (thrombocytopenia)
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These are not all the possible side effects of SARCLISA. For
more information, ask your healthcare provider or pharmacist.
Please see full Prescribing Information, including
Patient Information.
About Sanofi
Sanofi is dedicated to supporting people through their health
challenges. We are a global biopharmaceutical company focused on
human health. We prevent illness with vaccines, provide innovative
treatments to fight pain and ease suffering. We stand by the few
who suffer from rare diseases and the millions with long-term
chronic conditions.
With more than 100,000 people in 100 countries, Sanofi is
transforming scientific innovation into healthcare solutions around
the globe.
Sanofi, Empowering Life
Media
Relations Contact Sally
Bain Tel: +1 (781)
264-1097 mr@sanofi.com
|
Investor Relations
Contact Felix
Lauscher Tel.: +33 (0)1 53 77
45 45 ir@sanofi.com
|
Sanofi Forward-Looking Statements
This press release contains forward-looking statements as defined
in the Private Securities Litigation Reform Act of 1995, as
amended. Forward-looking statements are statements that are not
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predict and generally beyond the control of Sanofi, that could
cause actual results and developments to differ materially from
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among other things, the uncertainties inherent in research and
development, future clinical data and analysis, including post
marketing, decisions by regulatory authorities, such as the FDA or
the EMA, regarding whether and when to approve any drug, device or
biological application that may be filed for any such product
candidates as well as their decisions regarding labelling and other
matters that could affect the availability or commercial potential
of such product candidates, the fact that product candidates if
approved may not be commercially successful, the future approval
and commercial success of therapeutic alternatives, Sanofi's
ability to benefit from external growth opportunities, to complete
related transactions and/or obtain regulatory clearances, risks
associated with intellectual property and any related pending or
future litigation and the ultimate outcome of such
litigation, trends in exchange rates and prevailing interest
rates, volatile economic and market conditions, cost
containment initiatives and subsequent changes thereto, and
the impact that COVID-19 will have on us, our customers, suppliers,
vendors, and other business partners, and the financial condition
of any one of them, as well as on our employees and on the global
economy as a whole. Any material effect of COVID-19 on any of
the foregoing could also adversely impact us. This situation is
changing rapidly and additional impacts may arise of which we are
not currently aware and may exacerbate other previously identified
risks. The risks and uncertainties also include the uncertainties
discussed or identified in the public filings with the SEC and the
AMF made by Sanofi, including those listed under "Risk Factors" and
"Cautionary Statement Regarding Forward-Looking Statements" in
Sanofi's annual report on Form 20-F for the year ended December 31, 2019. Other than as required by
applicable law, Sanofi does not undertake any obligation to update
or revise any forward-looking information or statements.
Source: Sanofi (EURONEXT: SAN) (NASDAQ: SNY).
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