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Sanofi presents new data at AACR 2018 highlighting advances in early-stage oncology portfolio

•  Building on strong oncology heritage, Sanofi is pursuing a multifaceted R&D strategy, including – but not limited to – immuno-oncology (I-O)

•  Emerging investigational pipeline includes intratumoral cytokine mRNAs, TGF-beta inhibitor, small molecule inhibitor of VEGFR3, and Selective Estrogen Receptor Degrader (SERD) 

Friday, April 6, 2018 10:24 am EDT

Dateline:

Bridgewater, NJ

Sanofi today announced it will present nine abstracts at the American Association for Cancer Research (AACR) Annual Meeting in Chicago from April 14-18. Building on its strong heritage in oncology, the company will share new, early-stage studies highlighting an emerging and dynamic portfolio that encompasses diverse strategies, including immuno-oncology (I-O).

Sanofi’s abstracts at AACR will include a late-breaking pre-clinical presentation in partnership with BioNTech highlighting the potential impact of combination treatment with intratumoral cytokine mRNAs, an emerging class of immunotherapy medication. Additionally, results on overcoming resistance to an already-established type of immunotherapy, PD-1 (programmed cell death protein 1) inhibitors, will be presented. Notably, these data will feature Sanofi’s TGF-beta candidate, SAR439459, along with a joint presentation with Evotec on the investigational candidate EVT801, a small molecule inhibitor of VEGFR3 to target myeloid derived suppressor cells (MDSCs) in the tumor microenvironment.

Sanofi is also advancing SAR439859, a SERD (selective estrogen receptor degrader) in estrogen-receptor-positive breast cancer, and will have a number of presentations on this candidate. 

“Sanofi is excited to share a broad range of promising early-stage science in oncology at AACR 2018,” said Yong-Jun Liu, M.D., Ph.D., Head of Research, Global R&D at Sanofi. “By strengthening our internal research capabilities, and by collaborating with the key therapeutic leaders in this field, we are now able to demonstrate the emerging strength and depth of our oncology pipeline at Sanofi.”

The company is pursuing a breadth of approaches and new technologies to shape its early-stage oncology pipeline, including small molecule therapeutics, next-generation biologics such as antibody drug conjugates, and multi-targeting therapies.

AACR 2018 Data Presentations

Sanofi’s presentations at AACR 2018 can be accessed via the AACR website, and are summarized below.

Late breaking presentation

  • Combinatorial treatment with intratumoral cytokine mRNAs results in high frequency of tumor rejection and development of anti-tumor immunity across a range of preclinical cancer models (Session LBPO.IM01 - Late-Breaking Research: Immunology 1, Section 45, April 16, 2018, 8:00 AM - 12:00 PM)

Oral presentation

  • SAR439859, an orally bioavailable selective estrogen receptor degrader (SERD) that demonstrates robust antitumor efficacy and limited cross-resistance in ER+ breast cancer (Session MS.EN01.01 - Novel Roles of Steroid Hormone Receptors, Room S504 - McCormick Place South (Level 5), April 15, 2018, 3:05 PM - 3:20 PM)

Sanofi presentation with Evotec

  • Translation to the clinic of EVT801: A novel immune-oncology agent for addressing innate-driven immunosuppression into the tumor microenvironment and expanding patient population responding to immune checkpoint therapies (PO.IM02.03 - Immune Mechanisms Invoked by Therapies 1, Section 33, April 16, 2018, 1:00 PM - 5:00 PM) 

Poster presentations

  • Pre-clinical development of a novel CD3-CD123 bispecific T-cell engager using Cross-Over-Dual-Variable-Domain (CODV) format for the treatment of acute myeloid leukemia (AML) (Session PO.IM02.10 - Therapeutic Antibodies, Including Engineered Antibodies 1, Section 34, April 16, 2018, 8:00 AM - 12:00 PM)

  • Sensitivity of liver cancer cell lines to B-catenin knock-down correlates with pathway activation (Session PO.MCB03.03 - Nuclear Oncoproteins and Tumor Suppressor Genes, Section 21, April 16, 2018, 1:00 PM - 5:00 PM)

  • The anti-TGFβ neutralizing antibody, SAR439459, blocks the immunosuppressive effects of TGFβ and inhibits the growth of syngeneic tumors in combination with anti-PD1 (Session PO.IM02.11 - Therapeutic Antibodies, Including Engineered Antibodies 2, Section 34, April 16, 2018, 1:00 PM - 5:00 PM)

  • Identification of SAR439859, an orally bioavailable selective estrogen receptor degrader (SERD) that has strong anti-tumor activity in wild-type and mutant ER+ breast cancer models. (Session PO.ET06.10 - Canonical Targets 2, Section 36, April 18, 2018 8:00 AM - 12:00 PM)

  • Basal-like breast cancer subtype is characterized by deregulated glutamine metabolism and is sensitive to GLS inhibition (Session PO.MCB08.03 - Targets Affecting Metabolism Section 21, April 18, 2018, 8:00 AM - 12:00 PM)

  • Translational biomarkers for SAR439459, an anti-TGFβ antibody for cancer immunotherapy (PO.CL06.08 - Immunomodulatory Agents and Interventions 3, Section 25, April 18, 2018, 8:00 AM - 12:00 PM)

The agents identified above are under investigation only; their safety and efficacy have not been evaluated by any regulatory authority.

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 absence of guarantee that the product candidates if approved will be commercially successful, the future approval and commercial success of therapeutic alternatives, Sanofi's ability to benefit from external growth opportunities 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 conditions, the impact of cost containment initiatives and subsequent changes thereto, the average number of shares outstanding as well as those 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, 2017. Other than as required by applicable law, Sanofi does not undertake any obligation to update or revise any forward-looking information or statements.

Contact:

Media Relations Contact
Ashleigh Koss
Tel.: +1 (908) 981-8745
ashleigh.koss@sanofi.com

Investor Relations Contact
George Grofik
Tel.: +33 (0)1 53 77 45 45
ir@sanofi.com

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