Regeneron’s clinical presentations will include new safety and activity results from a Phase 1 study of cemiplimab alone or in combination with REGN1979, as well as updated results from a Phase 1 study of REGN1979 monotherapy. Collectively, the two studies enrolled patients with B-cell non-Hodgkin lymphoma (B-NHL) or Hodgkin lymphoma (HL) previously treated with at least one prior therapy and for whom no standard-of-care options exist.
REGN1979 is an investigational bispecific monoclonal antibody that binds to CD3 on immune system T-cells and to CD20 on B-cell malignancies to help trigger tumor killing. Cemiplimab is an investigational human, monoclonal antibody targeting PD-1 (programmed cell death protein 1).
The studies will be presented as posters during the 2017 ASH Annual Meeting as follows:
Safety and Preliminary Antitumor Activity of the Anti-PD-1 Monoclonal Antibody REGN2810 Alone or in Combination with REGN1979, an Anti-CD20 x Anti-CD3 Bispecific Antibody, in Patients with B-Lymphoid Malignancies
Abstract # 1495
Saturday, December 9, 5:30 – 7:30 p.m. ET
Safety and Preliminary Clinical Activity of REGN1979, an Anti-CD20 x Anti- CD3 Bispecific Antibody, in Patients with B-NHL Previously Treated with CD20-Directed Antibody Therapy
Abstract # 1550
Saturday, December 9, 5:30 – 7:30 p.m. ET
The FDA granted orphan drug designation to REGN1979 for diffuse large B-cell lymphoma (DLBCL) and breakthrough therapy designation status to cemiplimab for metastatic or locally advanced and unresectable cutaneous squamous cell carcinoma (CSCC) earlier in 2017. Cemiplimab is being developed jointly with Sanofi under a global collaboration agreement.
REGN1979 and cemiplimab are currently under clinical development, and their safety and efficacy have not been evaluated by any regulatory authority.
Regeneron (REGN) is a leading biotechnology company that invents life-transforming medicines for people with serious diseases. Founded and led for nearly 30 years by physician-scientists, our unique ability to repeatedly and consistently translate science into medicine has led to six FDA-approved treatments and over a dozen product candidates in development, all of which were homegrown in our laboratories. Our medicines and pipeline are designed to help patients with eye disease, heart disease, allergic and inflammatory diseases, pain, cancer, infectious diseases and rare diseases.
Regeneron is accelerating and improving the traditional drug development process through our proprietary VelociSuite® technologies, including VelocImmune® to yield optimized fully-human antibodies, and ambitious initiatives such as the Regeneron Genetics Center, one of the largest genetics sequencing efforts in the world.
For additional information about the company, please visit www.regeneron.com or follow @Regeneron on Twitter.
Regeneron Forward-Looking Statements and Use of Digital Media
This news release includes forward-looking statements that involve risks and uncertainties relating to future events and the future performance of Regeneron Pharmaceuticals, Inc. (“Regeneron” or the “Company”), and actual events or results may differ materially from these forward-looking statements. Words such as “anticipate,” “expect,” “intend,” “plan,” “believe,” “seek,” “estimate,” variations of such words, and similar expressions are intended to identify such forward-looking statements, although not all forward-looking statements contain these identifying words. These statements concern, and these risks and uncertainties include, among others, the nature, timing, and possible success and therapeutic applications of Regeneron’s products, product candidates, and research and clinical programs now underway or planned, including without limitation cemiplimab (REGN2810) and REGN1979, either alone or as a combination therapy, for the treatment of patients with patients with B-cell non-Hodgkin lymphoma or Hodgkin lymphoma or other potential indications; unforeseen safety issues resulting from the administration of products and product candidates in patients, including serious complications or side effects in connection with the use of Regeneron’s product candidates in clinical trials, such as cemiplimab and REGN1979; determinations by regulatory and administrative governmental authorities which may delay or restrict Regeneron’s ability to continue to develop or commercialize Regeneron’s products and product candidates; the likelihood, timing, and scope of possible regulatory approval and commercial launch of Regeneron’s late-stage product candidates and new indications for marketed products, such as cemiplimab and REGN1979; the extent to which the results from the research and development programs conducted by Regeneron or its collaborators may be replicated in later studies and lead to therapeutic applications; ongoing regulatory obligations and oversight impacting Regeneron’s marketed products, research and clinical programs (such as the clinical programs relating to cemiplimab and REGN1979 referenced in this news release), and business, including those relating to patient privacy; competing drugs and product candidates that may be superior to Regeneron’s products and product candidates; uncertainty of market acceptance and commercial success of Regeneron’s products and product candidates and the impact of studies (whether conducted by Regeneron or others and whether mandated or voluntary) on the commercial success of Regeneron’s products and product candidates; the ability of Regeneron’s collaborators, suppliers, or other third parties to perform filling, finishing, packaging, labelling, distribution, and other steps related to Regeneron’s products and product candidates; coverage and reimbursement determinations by third-party payers, including Medicare and Medicaid; the ability of Regeneron to manufacture and manage supply chains for multiple products and product candidates; unanticipated expenses; the costs of developing, producing, and selling products; the ability of Regeneron to meet any of its sales or other financial projections or guidance and changes to the assumptions underlying those projections or guidance; the potential for any license or collaboration agreement, including Regeneron’s agreements with Sanofi, Bayer HealthCare LLC, and Teva Pharmaceutical Industries Ltd. (or their respective affiliated companies, as applicable), to be cancelled or terminated without any further product success; and risks associated with intellectual property of other parties and pending or future litigation relating thereto, including without limitation the patent litigation relating to Praluent®(alirocumab) Injection, the ultimate outcome of such litigation, and the impact any of the foregoing may have on Regeneron’s business, prospects, operating results, and financial condition. A more complete description of these and other material risks can be found in Regeneron’s filings with the United States Securities and Exchange Commission, including its Form 10-K for the year ended December 31, 2016 and its Form 10-Q for the quarterly period ended June 30, 2017. Any forward-looking statements are made based on management’s current beliefs and judgment, and the reader is cautioned not to rely on any forward-looking statements made by Regeneron. Regeneron does not undertake any obligation to update publicly any forward-looking statement, including without limitation any financial projection or guidance, whether as a result of new information, future events, or otherwise.