Novel Regeneron Bispecific Antibodies Show Encouraging Anti-tumor Activity in Two Advanced Solid Tumors | Antibody
Novel Regeneron bispecific antibodies show encouraging anti-tumor activity in two advanced solid tumors
Posted on Sunday September 11, 2022 10:49
First Phase 1 data presented at ESMO for ubamatamab (REGN4018; MUC16xCD3) in recurrent ovarian cancer and REGN5093 (METxMET) in advanced MET-altered non-small cell lung cancer
TARRYTOWN, NY, United States I September 10, 2022 I Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) today announced positive early data for two novel and investigational bispecific antibodies: ubamatamab (REGN4018; MUC16xCD3) in recurrent ovarian cancer and REGN5093 (METxMET) in non-small cell lung cancer (NSCLC). ) advanced altered by MET. The first safety and efficacy results come from the dose escalation portions of two Phase 1/2 trials and are being presented at the European Society for Medical Oncology (ESMO) Congress 2022 in Paris.
“Bispecific antibodies are an important part of our oncology pipeline because of their flexibility to potentially treat a variety of cancers,” said Israel Lowy, MD, Ph.D., Senior Vice President, Translational and Clinical Sciences, Oncology at Regeneron. “At ESMO, we are showing this flexibility with ubamatamab and REGN5093, two novel bispecific antibodies that are initially being studied as monotherapies for recurrent ovarian cancer and advanced MET-impaired lung cancer, respectively. They were among the first in our pipeline to progress into clinical trials for solid tumors, and we are encouraged to see both show anti-tumor activity in dose escalation. These first-class results give us confidence in our VelociBi® bispecific development platform, and we look forward to further study ubamatamab and REGN5093. »
As shared in a mini-oral at ESMO, ubamatamab is a CD3-targeting bispecific being studied for recurrent ovarian cancer and designed to link MUC16 on cancer cells with CD3-expressing T cells to facilitate local activation of T cells. Dose escalation results were presented for 78 patients with relapsed ovarian cancer who had received a median of 4.5 prior treatments, including platinum and a median duration of ubamatamab exposure of 12 weeks (range:
Safety was assessed in 78 patients treated with ubamatamab, with the most common adverse events (AEs) in ≥15% being cytokine release syndrome (74%, all ≤ grade 2), pain (87% ) and anemia (51%). Grade ≥ 3 AEs occurred in 65% of patients, including > 5%, including anemia (24%), pain (23%) and neutropenia (8%). There was one case of dose-limiting toxicity (neutropenia) and three deaths due to AEs, none of which were considered treatment-related based on the sponsor’s assessment. Based on these efficacy and safety data, the phase 2 trial is enrolling patients with platinum-resistant ovarian cancer to further study ubamatamab as monotherapy and in combination with ubamatamab. Regeneron Libtayo PD-1 Inhibitor® (cemiplimab).
Preliminary first-in-human results for REGN5093 have also been published in an ESMO Scientific Abstract, with updated data and additional response rates to be detailed in a poster session on Monday, September 12. . REGN5093 is a tumor-targeting bispecific designed to bind to the MET receptor at two locations and trigger rapid internalization of this complex in cancer cells to degrade the MET receptor and block its ability to support cell proliferation. As highlighted in the abstract, of the 36 patients with MET-impaired advanced NSCLC who received the highest dose tested to date, 6 experienced a partial response, with 5 of these responses occurring in patients who received prior anti-PD-1 therapy. Total treatment exposure was approximately 467 patient weeks.
Grade ≥ 3 AEs occurred in 25% (n=11) of REGN5093-treated patients, with pneumonia and pulmonary embolism each occurring in 2 patients. One patient discontinued treatment due to increased alanine aminotransferase and aspartate aminotransferase. No dose-limiting toxicities or treatment-related deaths were observed at the data cutoff date. These early efficacy and safety data support further dose extensions, and a separate Phase 1/2 trial is underway to investigate an antibody-drug conjugate format of REGN5093 (REGN5093-M114).
The potential uses of ubamatamab, Libtayo, REGN5093, and REGN5093-M114 described above are investigational, and their safety and effectiveness have not been evaluated by any regulatory authority.
About Regeneron in Oncology
At Regeneron, we apply more than three decades of scientific innovation to develop breakthrough therapies for cancer patients. Our oncology portfolio is built around two fundamental approaches – our approved PD-1 inhibitor Libtayo and investigational bispecific antibodies – which are being evaluated both as monotherapies and in combination with emerging therapeutic modalities. Together, they provide us with unique combinatorial flexibility to develop potentially synergistic treatments for a wide range of solid tumors and blood cancers.
About Regeneron VelocImmune® Technology
by Regeneron VelocImmune uses a proprietary platform of genetically engineered mice with a genetically humanized immune system to produce optimized fully human antibodies. When Regeneron co-founder, president and chief scientific officer George D. Yancopoulos was a graduate student with his mentor Frederick W. Alt in 1985, they were the first to consider to make such a genetically humanized mouse, and Regeneron has spent decades inventing and developing VelocImmune and related VelociSuite® technologies. Dr. Yancopoulos and his team used VelocImmune technology to create approximately one in five of all original, FDA-approved or cleared fully human monoclonal antibodies. This includes REGEN-COV® (casirivimab and imdevimab), Dupixent® (dupilumab), Libtayo® (cemiplimab-rwlc), Praluent® (alirocumab), Kevzara® (sarilumab), Evkeeza® (evinacumab-dgnb) and Inmazeb™ (atoltivimab, maftivimab and odesivimab-ebgn).
Regeneron (NASDAQ: REGN) is a leading biotechnology company that invents, develops and markets life-changing medicines for people with serious diseases. Founded and led for nearly 35 years by physician-scientists, our unique ability to repeatedly and consistently translate science into medicine has led to numerous FDA-approved treatments and product candidates in development, nearly all of which have been cultivated internally in our laboratories. Our drugs and our pipeline are designed to help patients suffering from eye diseases, allergic and inflammatory diseases, cancer, cardiovascular and metabolic diseases, pain, hematological disorders, infectious diseases and rare diseases.
Regeneron accelerates and improves the traditional drug development process with our proprietary technology VelociSuite® technologies, such as VelocImmune®which uses unique genetically humanized mice to produce optimized fully human antibodies and bispecific antibodies, and through ambitious research initiatives such as the Regeneron Genetics Center, which conducts one of the largest genetic sequencing efforts in the world.
For more information about the company, please visit www.regeneron.com or follow @Regeneron on Twitter.
THE SOURCE: Regeneron Pharmaceuticals