Cemiplimab

Sensei Biotherapeutics Reports Full Year 2023 Financial Results and Recent Business Highlights

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Wednesday, February 28, 2024
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BOSTON, Feb. 28, 2024 (GLOBE NEWSWIRE) -- Sensei Biotherapeutics, Inc. (Nasdaq: SNSE), a clinical stage immuno-oncology company focused on the discovery and development of next-generation therapeutics for cancer patients, today reported financial results for the full year 2023, and provided corporate updates.

Key Points: 
  • “2023 saw the entry of our differentiated anti-VISTA antibody, SNS-101, into clinical development,” said John Celebi, President and Chief Executive Officer.
  • Recent updates include:
    A total of 33 patients have been treated with SNS-101 +/- Libtayo in the dose escalation phase of this study.
  • On October 23, 2023 , Sensei presented a trial-in-progress poster from the Phase 1/2 clinical trial for SNS-101 at the European Society for Medical Oncology Congress (ESMO) 2023.
  • On November 1, 2023, Sensei announced the appointment of Stephanie Krebs, MS, MBA, as Chief Business Officer.

GENESIS Pharma Announces an Exclusive Distribution Agreement With Regeneron Pharmaceuticals to Commercialize cemiplimab in Greece, Cyprus and Malta

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Friday, March 1, 2024
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GENESIS Pharma, a regional biopharma company specialized in the commercialization of innovative medicines targeting severe and rare diseases in Central and Eastern Europe, announces an exclusive distribution agreement for the cancer medicine cemiplimab in Greece, Cyprus and Malta with Regeneron Ireland DAC.

Key Points: 
  • GENESIS Pharma, a regional biopharma company specialized in the commercialization of innovative medicines targeting severe and rare diseases in Central and Eastern Europe, announces an exclusive distribution agreement for the cancer medicine cemiplimab in Greece, Cyprus and Malta with Regeneron Ireland DAC.
  • Regeneron Ireland DAC is a wholly owned subsidiary of Regeneron, a leading biotechnology company that invents, develops and commercializes life-transforming medicines for people with serious diseases.
  • Cemiplimab 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.
  • The two companies will work to seamlessly complete the transition of all relevant commercialization activities by the second quarter of 2024.

Libtayo® (cemiplimab) Neoadjuvant Treatment Demonstrates Encouraging Event-Free Survival in Patients with Resectable Cutaneous Squamous Cell Carcinoma (CSCC)

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Saturday, October 21, 2023
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TARRYTOWN, N.Y., Oct. 21, 2023 (GLOBE NEWSWIRE) -- Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) today announced the first presentation of key secondary endpoints for an investigational regimen of PD-1 inhibitor Libtayo® (cemiplimab) as a neoadjuvant monotherapy in stage II to IV resectable cutaneous squamous cell carcinoma (CSCC). The results from an international Phase 2 trial were presented in an oral session at the European Society for Medical Oncology (ESMO) Congress 2023 and concurrently published in The Lancet Oncology.

Key Points: 
  • “Advanced, resectable cutaneous squamous cell carcinoma can lead to reduced patient function and quality of life following the cumulative effects of treatment, typically surgery and radiation.
  • “Results from both the single-institution pilot trial and the multi-center Phase 2 trial found neoadjuvant cemiplimab was highly active in patients with resectable cutaneous squamous cell carcinoma.
  • These robust responses were durable, translating into event-free survival for the vast majority of patients at one and two years.”
    The multicenter, single-arm Phase 2 trial included two parts.
  • In Part 1, patients (n=79) received Libtayo 350 mg every three weeks for up to four doses, followed by curative-intent surgery.

Regeneron to Showcase Progress from Innovative Oncology Portfolio in Several Difficult-to-Treat Cancers at ESMO

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Sunday, October 15, 2023
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TARRYTOWN, N.Y., Oct. 15, 2023 (GLOBE NEWSWIRE) -- 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.

Key Points: 
  • The presentations demonstrate the role of Libtayo® (cemiplimab) as both a monotherapy and a backbone of novel investigational combinations for various solid tumors.
  • 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.
  • 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.
  • Ubamatamab is a CD3-targeting bispecific designed to bridge MUC16 on cancer cells with CD3-expressing T cells to facilitate local T-cell activation.

Fianlimab (LAG-3 inhibitor) Combined with Libtayo® (cemiplimab) Shows Clinically Meaningful and Durable Tumor Responses Across Key Advanced Melanoma Patient Populations

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Thursday, May 25, 2023
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TARRYTOWN, N.Y., May 25, 2023 (GLOBE NEWSWIRE) -- Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) today announced positive data from three independent cohorts evaluating an investigational combination of LAG-3 inhibitor fianlimab and PD-1 inhibitor Libtayo® (cemiplimab) in adults with advanced melanoma. The early clinical trial results, which demonstrated the combination led to clinically meaningful and durable results across multiple clinical settings, will be shared in an oral session at the 2023 American Society of Clinical Oncology (ASCO) Annual Meeting in Chicago on Monday, June 5 at 3:00 PM CT.

Key Points: 
  • “These updated and independent expansion cohort results reinforce the potential of the fianlimab and cemiplimab (Libtayo) combination to deliver clinically meaningful and durable responses in diverse clinical settings and patient populations, with an acceptable safety profile.
  • Adverse events (AEs) occurred in 94% of patients, with 44% being ≥Grade 3 and 30% considered serious.
  • “Fianlimab in combination with Libtayo has now demonstrated robust response rates in three independent advanced melanoma cohorts – each with unique patient populations,” said Israel Lowy, M.D., Ph.D., Senior Vice President, Translational and Clinical Sciences, Oncology at Regeneron.
  • “These positive results support the clinical potential of fianlimab in combination with Libtayo.

Regeneron to Highlight New and Updated Clinical Data at ASCO Showcasing Breadth of Cancer Research

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Tuesday, May 2, 2023
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TARRYTOWN, N.Y., May 02, 2023 (GLOBE NEWSWIRE) -- Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) today announced the presentation of new and updated data from its diverse oncology and hematology pipeline at the 2023 American Society of Clinical Oncology (ASCO) Annual Meeting, taking place from June 2-6 in Chicago, IL. Data presentations from 10 abstracts will include insights on four approved or investigational treatment regimens, showcasing the expanding potential of Regeneron’s portfolio and commitment to harnessing combination approaches to address the unmet need of patients with difficult-to-treat cancers.

Key Points: 
  • Data presentations from 10 abstracts will include insights on four approved or investigational treatment regimens, showcasing the expanding potential of Regeneron’s portfolio and commitment to harnessing combination approaches to address the unmet need of patients with difficult-to-treat cancers.
  • “Our clinical data at ASCO showcases our progress in addressing difficult-to-treat cancers with two foundational and synergistic approaches – PD-1 inhibition with Libtayo and our investigational bispecific antibodies,” said George D. Yancopoulos, M.D., Ph.D., Co-Founder, President and Chief Scientific Officer at Regeneron.
  • The linvoseltamab presentation will include more mature data from the pivotal Phase 2 trial in heavily pre-treated patients with relapsed/refractory multiple myeloma.
  • Additional ASCO presentations will share updated clinical results for Libtayo as monotherapy for advanced stages of cutaneous squamous cell carcinoma and non-small cell lung cancer, and in advanced HPV16-positive oropharyngeal cancer.

Libtayo® (cemiplimab) in Combination with Chemotherapy Approved by European Commission for the First-line Treatment of Advanced PD-L1 Positive Non-small Cell Lung Cancer (NSCLC)

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Wednesday, March 29, 2023
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TARRYTOWN, N.Y., March 29, 2023 (GLOBE NEWSWIRE) -- Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) today announced that the European Commission (EC) approved Libtayo® (cemiplimab) in combination with platinum-based chemotherapy for the first-line treatment of adult patients with advanced non-small cell lung cancer (NSCLC) with ≥1% PD-L1 expression. This includes patients that have no EGFR, ALK or ROS1 aberrations and whose tumors are metastatic or locally advanced and not candidates for definitive chemoradiation.

Key Points: 
  • TARRYTOWN, N.Y., March 29, 2023 (GLOBE NEWSWIRE) -- Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) today announced that the European Commission (EC) approved Libtayo® (cemiplimab) in combination with platinum-based chemotherapy for the first-line treatment of adult patients with advanced non-small cell lung cancer (NSCLC) with ≥1% PD-L1 expression.
  • This marks the fifth approval for Libtayo in Europe.”
    Lung cancer is the leading cause of cancer death worldwide.
  • “This approval highlights continued progress in first-line treatment options for people impacted by advanced lung cancer in Europe.”
    Libtayo is currently approved in the EU and other countries for the treatment of certain patients with advanced basal cell carcinoma (BCC), advanced cutaneous squamous cell carcinoma (CSCC), advanced NSCLC and advanced cervical cancer.
  • The Libtayo combination was also approved by the U.S. Food and Drug Administration (FDA) for advanced NSCLC regardless of PD-L1 expression in November 2022.

Immuneering Appoints Harold E. Brakewood as Chief Business Officer

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Tuesday, March 28, 2023
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CAMBRIDGE, Mass., March 28, 2023 (GLOBE NEWSWIRE) -- Immuneering Corporation (Nasdaq: IMRX), a clinical-stage oncology company developing medicines for broad populations of cancer patients with an initial aim to develop a universal-RAS therapy, announced today that it has appointed Harold E. Brakewood (“E.B.”) as its Chief Business Officer.

Key Points: 
  • CAMBRIDGE, Mass., March 28, 2023 (GLOBE NEWSWIRE) -- Immuneering Corporation (Nasdaq: IMRX), a clinical-stage oncology company developing medicines for broad populations of cancer patients with an initial aim to develop a universal-RAS therapy, announced today that it has appointed Harold E. Brakewood (“E.B.”) as its Chief Business Officer.
  • Mr. Brakewood, who has more than 25 years of experience as a senior executive in the biotechnology and pharmaceutical industry, will be responsible for corporate and business development, new product planning, and commercial strategy.
  • join Immuneering’s senior leadership team as we continue to advance our oncology pipeline, including IMM-1-104, our clinical-stage universal-RAS program,” said Ben Zeskind, Ph.D., MBA, Co-founder, and Chief Executive Officer of Immuneering.
  • He joins Immuneering from Regeneron Pharmaceuticals where he most recently served as Vice President, Business Unit Head for oncology, Covid-19, and new product planning.

Roche receives FDA approval of label expansion for VENTANA PD-L1 (SP263) Assay to identify patients with locally advanced and metastatic non-small cell lung cancer eligible for Libtayo

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Monday, March 6, 2023
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This additional approval will allow more patients with locally advanced and metastatic NSCLC broader access to the immunotherapy Libtayo.

Key Points: 
  • This additional approval will allow more patients with locally advanced and metastatic NSCLC broader access to the immunotherapy Libtayo.
  • PD-L1 testing provides clinicians with essential information that helps guide clinical decision making and improve patient outcomes.
  • "This approval helps physicians make more confident treatment decisions by  identifying patients with tumours that may respond to the immunotherapy Libtayo."
  • Every year, more than 2.2 million people are diagnosed with lung cancer globally and up to 85 percent of these cases are NSCLC.3,4

Libtayo® (cemiplimab) in Combination with Chemotherapy Receives Positive CHMP Opinion for the Treatment of Advanced PD-L1 Positive Non-small Cell Lung Cancer (NSCLC)

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Friday, February 24, 2023
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Specifically, the CHMP recommended the Libtayo combination be approved in the European Union (EU) for first-line treatment of adult patients with advanced non-small cell lung cancer (NSCLC) with ≥1% PD-L1 expression.

Key Points: 
  • Specifically, the CHMP recommended the Libtayo combination be approved in the European Union (EU) for first-line treatment of adult patients with advanced non-small cell lung cancer (NSCLC) with ≥1% PD-L1 expression.
  • This includes patients that have no EGFR, ALK or ROS1 aberrations and whose tumors are metastatic or locally advanced and not candidates for definitive chemoradiation.
  • In November 2022, the Libtayo combination was approved by the U.S. Food and Drug Administration (FDA) for advanced NSCLC regardless of PD-L1 expression.
  • Libtayo is currently approved in the EU and other countries for the treatment of certain patients with advanced basal cell carcinoma (BCC), advanced cutaneous squamous cell carcinoma (CSCC), advanced NSCLC and advanced cervical cancer.