Sanofi’s emerging oncology pipeline highlighted at the AACR Virtual Annual Meeting II

• Preclinical data show anti-tumor activity in Sanofi’s investigational compounds, including an oral selective estrogen receptor degrader (SERD) and an anti-CEACAM5 antibody-drug conjugate
• Data reinforce Sanofi’s commitment to multiple myeloma; include new preclinical findings for Sarclisa® (isatuximab-irfc), and anti-CD38 antibody and CD38/CD28xCD3 trispecific T-cell engager
• More than 20 presentations from Sanofi Oncology Research supporting additional investigation of priority compounds in breast, lung and blood cancers

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 KRAS^G12C 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.

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

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 historical facts. These statements include projections and estimates and their underlying assumptions, statements regarding plans, objectives, intentions and expectations with respect to future financial results, events, operations, services, product development and potential, and statements regarding future performance. Forward-looking statements are generally identified by the words “expects”, “anticipates”, “believes”, “intends”, “estimates”, “plans” and similar expressions. Although Sanofi’s management believes that the expectations reflected in such forward-looking statements are reasonable, investors are cautioned that forward-looking information and statements are subject to various risks and uncertainties, many of which are difficult to predict and generally beyond the control of Sanofi, that could cause actual results and developments to differ materially from those expressed in, or implied or projected by, the forward-looking information and statements. These risks and uncertainties include 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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Company Codes: NASDAQ-NMS:SNY, EuronextParis:SAN