Media Update: New data from Sanofi’s diverse, differentiated oncology pipeline and portfolio to be presented at ASCO 2023

June 2, 2023
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New data from Sanofi’s diverse, differentiated oncology pipeline and portfolio to be presented at ASCO 2023

  • Oral presentation to highlight results of a first-in-human study of an investigational trifunctional anti-CD123 NK cell engager SAR443579, which was recently granted Fast Track Designation by the U.S. FDA for the treatment of hematological malignancies
  • Sanofi continues to advance its research into potentially transformative therapies such as antibody drug conjugates, natural killer and T-cell therapeutics

Paris, June 2, 2023. Sanofi will present new data at the 2023 American Society of Clinical Oncology (ASCO) Annual Meeting from June 2-6, including an oral presentation where results will be shared for the first time of a first-in-human study of an investigational trifunctional anti-CD123 natural killer (NK) cell engager SAR443579 in relapsed or refractory acute myeloid leukemia, B-cell acute lymphoblastic leukemia or high risk-myelodysplasia.

Peter Adamson
Global Development Head, Oncology
The presentation of data at ASCO from our initial clinical trial of SAR443579, a novel NK cell engager, supports the potential of this investigational approach for patients with hematologic malignancies. At Sanofi, we are continuing to build our early oncology pipeline, which leverages leading-edge R&D platforms, to drive a range of investigational approaches for patients with difficult-to-treat cancers.”

The U.S. Food and Drug Administration (FDA) has granted Fast Track Designation for SAR443579 for the treatment of hematological malignancies. Fast Track Designation is an FDA process designed to facilitate the development, and expedite the review of, medicines to treat serious conditions and fill unmet medical need. The FDA created this process to help deliver important new drugs to patients earlier, and it covers a broad range of serious illnesses.

Olivier Nataf
Global Head, Oncology
“Having recently joined Sanofi as Global Head, Oncology, I am looking forward to coming together with the global oncology community at ASCO to discuss the future of cancer treatment and latest oncology research. This year, we are focused on highlighting our pipeline and exploring new opportunities that allow us to continue helping those living with cancer. Cancer is complex and we understand that innovation does not happen in isolation, so exploring strategic partnerships and collaborations that align science and technology with evolving medical needs is essential to our journey.

Sanofi’s oncology pipeline has doubled since 2019, and we are exploring the advancement of potentially transformative therapies and focusing research on areas of high unmet needs for those living with various types of cancer.

Other Sanofi data to be presented at ASCO include studies in several priority areas of focus, such as relapsed multiple myeloma, advanced solid tumors and non-small cell lung cancer.

Early data for SAR443579, an investigational trifunctional anti-CD123 NK cell engager*

Abstract #7005: A first-in-human study of CD123 NK Cell Engager SAR443579 in relapsed or refractory acute myeloid leukemia, B-cell acute lymphoblastic leukemia or high risk-myelodysplasia

Updated results of the Phase 3 IKEMA study of Sarclisa® (isatuximab) in relapsed multiple myeloma

Abstract #8029: Long-term outcomes with isatuximab-carfilzomib-dexamethasone (Isa-Kd) in relapsed multiple myeloma patients with 1q21+ status: updated results from the Phase 3 IKEMA study

Early safety results of investigational tusamitamab ravtansine in advanced solid tumors*

Abstract #e15003: Phase 1/2 study of tusamitamab ravtansine in patients with advanced solid tumors: pooled safety analysis of corneal adverse events

Analysis of extended adjuvant endocrine therapy in HR+/HER2- breast cancer

Abstract #e12509: Side effects and impacts of extended adjuvant endocrine therapy: A qualitative study among women with HR+/HER2- breast cancer

Click here to view these abstracts located in the ASCO Meeting Library.

*These assets are currently under investigation and their safety and efficacy has not been fully evaluated by any health authority.

About Sanofi
We are an innovative global healthcare company, driven by one purpose: we chase the miracles of science to improve people’s lives. Our team, across some 100 countries, is dedicated to transforming the practice of medicine by working to turn the impossible into the possible. We provide potentially life-changing treatment options and life-saving vaccine protection to millions of people globally, while putting sustainability and social responsibility at the center of our ambitions.

Sanofi is listed on EURONEXT: SAN and NASDAQ: SNY

Media Relations
Sandrine Guendoul | + 33 6 25 09 14 25 | sandrine.guendoul@sanofi.com
Sally Bain | + 1 617 834 6026 | sally.bain@sanofi.com
Victor Rouault | + 33 6 70 93 71 40 | victor.rouault@sanofi.com

Investor Relations
Eva Schaefer-Jansen | + 33 7 86 80 56 39 | eva.schaefer-jansen@sanofi.com
Arnaud Delépine | + 33 6 73 69 36 93 | arnaud.delepine@sanofi.com
Corentine Driancourt | + 33 6 40 56 92 21 | corentine.driancourt@sanofi.com
Felix Lauscher | + 1  908  612 7239 | felix.lauscher@sanofi.com
Tarik Elgoutni| + 1 617 710 3587 | tarik.elgoutni@sanofi.com
Nathalie Pham | + 33 7 85 93 30 17 | nathalie.pham@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 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 pandemics or other global crises may 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. 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, 2022. Other than as required by applicable law, Sanofi does not undertake any obligation to update or revise any forward-looking information or statements.

 

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