INVESTORS & MEDIA
News Release
Regeneron to Report Results from CD20xCD3 and BCMAxCD3 Bispecifics and C5 Antibody Programs at ASH Annual meeting
Among the accepted abstracts are the first clinical data for REGN5458 (BCMAxCD3) in relapsed/refractory (R/R) multiple myeloma, as well as updated data for REGN1979 (CD20xCD3) in R/R B-cell non-Hodgkin lymphoma (B-
"The ASH presentations highlight Regeneron's growing portfolio in blood cancer and rare diseases, including data from two of our six bispecific antibodies currently in clinical development," said
"We continue to make important progress with REGN1979 and are currently enrolling a potentially registrational Phase 2 trial. At ASH, we plan to share new data with additional patients and longer duration of follow-up, with about 20 patients at effective dose levels for each cohort of follicular lymphoma and diffuse large B-cell lymphoma," said
The abstracts published today reflect older data; presentations with updated data will be shared at ASH as follows:
REGN1979
- Oral presentation: Clinical Activity of REGN1979, a Bispecific Human, Anti-CD20xAnti-CD3 Antibody, in Patients with Relapsed/Refractory (R/R) B-cell Non-Hodgkin Lymphoma (B-NHL) (Abstract 762;
Rajat Bannerji , M.D., Ph.D.:Monday, December 9 ,2:45-4:15 PM ET ) - Poster presentation: A Phase 2 Study of REGN1979, an Anti-CD20xAnti-CD3 Bispecific Antibody (Ab), in Patients with Relapsed/Refractory (R/R) B-Cell Non-Hodgkin Lymphoma (B-NHL) (Abstract 4007,
Max S. Topp , M.D.:Monday, December 9 ,6:00-8:00 PM ET )
REGN5458
- Poster presentation: Safety and Preliminary Clinical Activity of REGN5458, an Anti-BCMAxAnti-CD3 Bispecific Antibody, in Patients with Relapsed/Refractory (R/R) Multiple Myeloma (Abstract 3176;
Dennis Cooper , M.D.:Sunday, December 8 ,6:00-8:00 PM ET )
Pozelimab/PNH
- Oral presentation: A Novel Patient Reported Outcome Instrument Assessing the Symptoms of Paroxysmal Nocturnal Hemoglobinuria (Abstract 385; R Paola Daly:
Sunday, December 8 ,7:30-9:00 AM ET ) - Poster presentation: Pozelimab, a Human Antibody Against Complement Factor C5, Demonstrates Robust Inhibition of Alternative Complement Activity Both in Normal Human Serum and in
Phase I Normal Healthy Volunteers (Abstract 2278; Kishor Devalaraja-Narashimha, Ph.D., DVM:Sunday, December 8 ,6:00-8:00 PM ET ) - Poster presentation: Epidemiology of PNH and Real-World Treatment Patterns Following Incident PNH Diagnosis in the U.S. (Abstract 3407; Jessica J Jalbert, Ph.D.:
Sunday, December 8 ,6:00-8:00 PM ET )
About the Regeneron Bispecific Antibody Platform
All of Regeneron's bispecific antibodies are designed to closely resemble natural human antibodies. They are derived from a next-generation version of Regeneron's proprietary VelocImmune® technology and created using the company's VelociBi™ platform.
There are six Regeneron investigational bispecific antibodies currently in ongoing clinical trials for multiple blood cancers and solid tumors. These bispecifics fall into three categories:
- CD3 bispecifics are designed to bridge T-cells and tumor cells. At the tumor site, they activate T-cells via their CD3 receptors and promote T-cell killing of the cancer cells. Investigational candidates include:
- CD20xCD3 (REGN1979) for non-Hodgkin B-cell lymphomas;
- Two distinct BCMAxCD3s (REGN5458 and REGN5459) for multiple myeloma;
- MUC16xCD3 (REGN4018) for ovarian cancer.
- CD28 costimulatory bispecifics are also designed to bridge T-cells and tumor cells. At the tumor site, they costimulate T-cells via their CD28 receptors and may synergize with PD-1 inhibitors and/or CD3 bispecifics. Investigational candidates include:
- PSMAxCD28 (REGN5678) in combination with Libtayo® (cemiplimab) for prostate cancer.
- Tumor-targeted bispecifics are designed to target proteins only on the cancer cell. In this way, they may affect various signaling pathways to hamper the cancer cells' ability to survive and proliferate. Investigational candidates include:
- METxMET (REGN5093) for non-small cell lung cancer that is driven by MET mutations and/or amplifications. REGN5093 targets two different parts of the MET receptor on cancer cells to degrade the receptor and block its ability to trigger cell proliferation.
Regulatory Status of Programs
REGN1979, REGN5458, REGN5459, REGN4018, REGN5678, REGN5093, pozelimab and Libtayo are currently under clinical development for the diseases noted in this press release, and their safety and efficacy have not been evaluated by any regulatory authority for these diseases. As part of a global collaboration agreement, Regeneron and
Libtayo is approved in the U.S. for the treatment of patients with metastatic cutaneous squamous cell carcinoma (CSCC) or locally advanced CSCC who are not candidates for curative surgery or curative radiation, and in other countries for similar indications. In the U.S., the generic name for Libtayo is cemiplimab-rwlc, with rwlc as the suffix designated in accordance with Nonproprietary Naming of Biological Products Guidance for Industry issued by the
About
Regeneron (NASDAQ: REGN) is a leading biotechnology company that invents life-transforming medicines for people with serious diseases. Founded and led for 30 years by physician-scientists, our unique ability to repeatedly and consistently translate science into medicine has led to seven
Regeneron is accelerating and improving the traditional drug development process through our proprietary VelociSuite® technologies, such as VelocImmune®, which uses a unique genetically-humanized mouse to produce optimized fully-human antibodies and bispecific antibodies, and through ambitious research initiatives such as the Regeneron Genetics Center, which is conducting 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.
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This press release includes forward-looking statements that involve risks and uncertainties relating to future events and the future performance of
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