MUC16 x CD3

Event-free survival of investigational use of Libtayo® (cemiplimab) in neoadjuvant cutaneous squamous cell carcinoma (CSCC) from Phase 2 trial to be featured in oral presentation First data for the investigational combination of Libtayo and ubamatamab (MUC16xCD3) in recurrent ovarian cancer also to be presented Additional presentations on outcomes of Libtayo-based therapy in advanced non-small cell lung cancer, including PD-L1 expression and histology specific subgroups Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) today announced the latest clinical data in early- and late-stage cancers from its oncology pipeline will be presented at the European Society for Medical Oncology (ESMO) Congress 2023 from October 20 to 24 in Madrid, Spain. The presentations demonstrate the role of Libtayo® (cemiplimab) as both a monotherapy and a backbone of novel investigational combinations for various solid tumors. “Our data presentations at ESMO underscore Regeneron’s ability to apply a deep understanding of cancer biology, genetics and the immune system to advance the development of meaningful combinations for cancer types that have high unmet need,” said Israel Lowy, Senior Vice President, Translational and Clinical Oncology at Regeneron. “Notably, we are presenting the first survival data for neoadjuvant Libtayo therapy in cutaneous squamous cell carcinoma and the first results for Libtayo in combination with ubamatamab, our investigational MUC16xCD3 bispecific antibody, in recurrent ovarian cancer. Beyond ESMO, we are excited by recent progress across our oncology portfolio, including FDA Fast Track Designation for fianlimab (LAG-3) plus Libtayo in melanoma. We look forward to sharing more with the global oncology community as we deliver on our promise to improve the lives of those impacted by cancer.” Among Regeneron’s ESMO presentations is an oral highlighting one-year survival outcomes, including event-free survival, from a Phase 2 trial of Libtayo in neoadjuvant CSCC. The primary analysis was shared at last year’s ESMO meeting. Regeneron will also debut Phase 1 dose-escalation results for its investigational combination of Libtayo and ubamatamab in patients with heavily pretreated recurrent ovarian cancer in a poster session. A Phase 2 expansion portion of the study is underway. Ubamatamab is a CD3-targeting bispecific designed to bridge MUC16 on cancer cells with CD3-expressing T cells to facilitate local T-cell activation. Additional presentations at ESMO include subgroup analyses of Libtayo in advanced non-small cell lung cancer (NSCLC), focusing on such populations as squamous cell carcinoma and patients with varying levels of PD-L1 expression. About Regeneron in Cancer We aspire to turn revolutionary discoveries into medicines that can transform the lives of those impacted by cancer. Our team around the world is driven to solve the needs and challenges of those affected by one of the most serious diseases of our time. Backed by our legacy of scientific innovation and a deep understanding of biology, genetics and the immune system, we’re pursuing potential therapies across more than 30 types of solid tumors and blood cancers. Our cancer strategy is powered by cutting-edge technologies and therapies that can be flexibly combined to investigate potentially transformative treatments for patients. Oncology assets in clinical development comprise nearly half of Regeneron’s pipeline, and include checkpoint inhibitors, bispecific antibodies and costimulatory bispecific antibodies. Our approved PD-1 inhibitor Libtayo serves as the backbone of many of our investigational combinations. To complement our extensive in-house capabilities, we collaborate with patients, healthcare providers, governments, biopharma companies and each other to further our shared goals. Together, we are united in the mission to serve as a beacon of transformation in cancer care. About Libtayo Libtayo is a fully human monoclonal antibody targeting the immune checkpoint receptor PD-1 on T cells and was invented using Regeneron's proprietary VelocImmune® technology. By binding to PD-1, Libtayo has been shown to block cancer cells from using the PD-1 pathway to suppress T-cell activation. In the U.S. and other countries, Libtayo is indicated in certain patients with advanced basal cell carcinoma (BCC), advanced CSCC and advanced NSCLC, as well as in advanced cervical cancer in the European Union (EU), Canada and Brazil. As of July 1, 2022, Regeneron is responsible for the development and marketing of Libtayo globally. In the EU, Libtayo is currently marketed by Sanofi on Regeneron’s behalf over the course of a defined transition period. In the U.S., the generic name for Libtayo in its approved indications is cemiplimab-rwlc, with rwlc as the suffix designated in accordance with Nonproprietary Naming of Biological Products Guidance for Industry issued by the U.S. Food and Drug Administration (FDA). Outside of the U.S., the generic name of Libtayo in its approved indications is cemiplimab. The extensive clinical program for Libtayo is focused on difficult-to-treat cancers. Libtayo is currently being investigated in trials as a monotherapy, as well as in combination with either conventional or novel therapeutic approaches for other solid tumors and blood cancers. These potential uses are investigational, and their safety and efficacy have not been evaluated by any regulatory authority. About Regeneron's VelocImmune Technology Regeneron's VelocImmune technology utilizes a proprietary genetically engineered mouse platform endowed with a genetically humanized immune system to produce optimized fully human antibodies. When Regeneron's 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 envision making such a genetically humanized mouse, and Regeneron has spent decades inventing and developing VelocImmune and related VelociSuite® technologies. Dr. Yancopoulos and his team have used VelocImmune technology to create a substantial proportion of all original, FDA-approved or authorized fully human monoclonal antibodies. This includes REGEN-COV® (casirivimab and imdevimab), Dupixent® (dupilumab), Libtayo®, Praluent® (alirocumab), Kevzara® (sarilumab), Evkeeza® (evinacumab-dgnb), Inmazeb® (atoltivimab, maftivimab and odesivimab-ebgn) and Veopoz™ (pozelimab-bbfg). About Regeneron Regeneron is a leading biotechnology company that invents, develops and commercializes life-transforming medicines for people with serious diseases. Founded and led for 35 years by physician-scientists, our unique ability to repeatedly and consistently translate science into medicine has led to numerous FDA-approved treatments and numerous product candidates in development, almost all of which were homegrown in our laboratories. Our medicines and pipeline are designed to help patients with eye diseases, allergic and inflammatory diseases, cancer, cardiovascular and metabolic diseases, hematologic conditions, infectious diseases and rare diseases. Regeneron is accelerating and improving the traditional drug development process through our proprietary 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 is conducting one of the largest genetics sequencing efforts in the world. The content above comes from the network. if any infringement, please contact us to modify.

Regeneron's revised R&D road map includes the study of the bispecific as a monotherapy. Regeneron is rethinking development of its prostate cancer bispecific after two patients died in a clinical trial. The deaths prompted the Big Biotech to stop enrolling patients to receive REGN5678 and a full dose of its checkpoint inhibitor, but a reshaped bispecific development program is continuing.  REGN5678 is designed to bind to CD28 on cytotoxic T-lymphocytes (CTLs) and PSMA on tumor cells. By binding to the costimulatory T-cell-specific surface glycoprotein and tumor-associated antigen, the drug candidate could activate CTLs and direct them to attack cancer cells. Regeneron identified the targeting of CD28 on previously activated T cells as a way to reduce toxicity compared to CD3 bispecifics.  The candidate, which may synergize with anti-PD-1/L1 checkpoint inhibitors, came through the release of preliminary phase 1/2 data unscathed. But safety concerns have since come to light and prompted a shift in the R&D strategy. In its second-quarter results statement, Regeneron reported two immune-mediated deaths in a cohort of patients who received REGN5678 in combination with Libtayo, the company’s checkpoint inhibitor. The deaths drove Regeneron to stop enrolling patients to receive REGN5678 and a full dose of Libtayo. Regeneron is sticking with the candidate, though. The revised R&D road map includes the study of the bispecific as a monotherapy and in combination with lower doses of Libtayo and other immunotherapy modalities. Regeneron’s other costimulatory bispecific development programs, which include candidates against EGFR, MUC16 and CD22, are unaffected and are still making their way through dose escalation.  Even so, the removal of the option to pair REGN5678 with a full dose of Libtayo is a blow. Regeneron took the bispecific into the clinic in the belief the combination may be able to overcome the resistance of metastatic castration-resistant prostate cancer to PD-1 inhibition. Overcoming resistance could bring the benefits of checkpoint inhibitors to prostate cancer, a setting in which the drugs have had little impact. CD28 has a troubled history as a cancer target. The CD28 superagonist TGN1412 caused critical illnesses linked to cytokine storms in a phase 1 clinical trial in 2006. In recent years, companies including Johnson & Johnson and Sanofi have invested in candidates against the target, but fresh concerns emerged last year, when two deaths stopped trials of Alpine Immune Sciences’ conditional costimulator of CD28.

Phalguni Deswal The single-arm, multicentre, open-label, dose expansion Phase I clinical trial would aim to evaluate the safety and efficacy of LBL-034 in patients with r/r multiple myeloma who have received prior treatment. Image Credit: Nemes Laszlo / Shutterstock. US Food and Drug Administration (FDA) and China’s National Medical Products Administration (NMPA) have approved the Investigational New Drug (IND) applications for Nanjing Leads Biolabs’ LBL-034 bispecific antibody for treating relapsed/refractory (R/R) multiple myeloma. LBL-034 is an IgG1 bispecific antibody that targets G protein-coupled receptor, class C, group 5, member D (GPRC5D) transmembrane receptor protein and cluster of differentiation 3 (CD3) T cell co-receptor protein. It induces T-cell-mediated cell lysis of GPRC5D expressing myeloma cells by redirecting CD3+ T-cells. Nanjing Leads Biolabs chief medical officer Dr Charles Cai said in a press release : “LBL-034 adopts a unique molecular design, which enables the drug to specifically bind to GPRC5D-expressing tumour cells with high affinity and reduces the risk of non-specific activation of T-cells, thereby enhancing anti-tumour efficacy and reducing the potential risk of immunotoxicity.” “LBL-034 demonstrated robust anti-tumour activities and good safety profile in pre-clinical studies.” The single-arm, multicentre, open-label, dose-expansion Phase I clinical trial would aim to evaluate the safety and efficacy of LBL-034 in patients with R/R multiple myeloma who have received prior treatment. The additional aim of the first-in-human study is to determine the Phase II recommended dose. In May 2023, AstraZeneca and LaNova Medicines signed a licence deal for a GPRC5D monoclonal antibody (LM-305) for R/R multiple myeloma. LM-305 has IND approval from UD FDA and China’s NMPA. Johnson & Johnson is also developing an anti-GPRC5D/CD3 bispecific antibody , talquetamab, for R/R multiple myeloma, with positive overall response data from the Phase I trial (NCT03399799). Other drugs in the Leads Biolabs’ pipeline include LBL-007, a monoclonal antibody developed in partnership with Chime Biologics and BeiGene to treat solid tumours, LBL-015, a bispecific antibody for treating solid tumours, and LBL-003, a monoclonal antibody in Phase I for the treatment of haematological and solid tumours. Three antibody drugs are in Phase I/II – LBL-019 (tumour necrosis factor receptor-2 targeting monoclonal antibody) for treating haematological and solid tumours, LBL-033 (bispecific antibody for anti-mucin 16 and CD3) for solid tumours especially ovarian cancer, and LBL-024 (bispecific antibody for PDL1 and CD137) for treating haematological and solid tumours.