Nivolumab

Eight-Year Data for Opdivo (nivolumab) Plus Yervoy (ipilimumab) Continue to Demonstrate Longest Survival Benefit vs. Sunitinib Reported in Patients with Previously Untreated Advanced or Metastatic Renal Cell Carcinoma

Retrieved on: 
Monday, January 22, 2024

Patients treated with Opdivo plus Yervoy maintained superior survival and more durable response benefits compared to those who received sunitinib in both patients with intermediate- and poor-risk prognostic factors and across all randomized patients.

Key Points: 
  • Patients treated with Opdivo plus Yervoy maintained superior survival and more durable response benefits compared to those who received sunitinib in both patients with intermediate- and poor-risk prognostic factors and across all randomized patients.
  • DOR: Median DOR was 82.8 months for patients treated with Opdivo plus Yervoy compared to 19.8 months with sunitinib.
  • ORR: ORR benefits were maintained with Opdivo plus Yervoy compared to sunitinib (42% vs. 27%).
  • DOR: For patients treated with Opdivo plus Yervoy, median DOR was 76.2 months compared to 25.1 months with sunitinib.

Opdivo (nivolumab) Plus Yervoy (ipilimumab) Reduced the Risk of Disease Progression or Death by 79% Versus Chemotherapy in Patients with Microsatellite Instability-High or Mismatch Repair Deficient Metastatic Colorectal Cancer in CheckMate -8HW Trial

Retrieved on: 
Saturday, January 20, 2024

Median PFS was not yet reached in the Opdivo plus Yervoy arm (95% CI: 38.4-NE) vs. 5.9 months in the chemotherapy arm (95% CI: 4.4-7.8).

Key Points: 
  • Median PFS was not yet reached in the Opdivo plus Yervoy arm (95% CI: 38.4-NE) vs. 5.9 months in the chemotherapy arm (95% CI: 4.4-7.8).
  • Grade 3/4 treatment-related adverse events (TRAEs) occurred in 23% of patients in the Opdivo plus Yervoy arm and 48% of patients in the chemotherapy arm.
  • Any grade TRAE-related discontinuation was 17% in the Opdivo plus Yervoy arm and 32% in the chemotherapy arm.
  • Bristol Myers Squibb thanks the patients and investigators involved in the CheckMate -8HW clinical trial.

OSE Immunotherapeutics Highlights Clinical Portfolio Advancements and Provides 2024 Outlook

Retrieved on: 
Friday, January 19, 2024

OSE Immunotherapeutics SA (ISIN: FR0012127173; Mnemo: OSE) updates on its clinical portfolio advancements and provides 2024 outlook.

Key Points: 
  • OSE Immunotherapeutics SA (ISIN: FR0012127173; Mnemo: OSE) updates on its clinical portfolio advancements and provides 2024 outlook.
  • Nicolas Poirier, Chief Executive Officer of OSE Immunotherapeutics, comments: “The Company has a broad portfolio of 5 products in clinical development with significant advances reached in 2023 and key milestones expected in 2024.
  • Our shared ambition at OSE is to create value by leading our two advanced assets in phase 2 and phase 3 to a clinical inflection point allowing a structuring agreement.
  • Thus, from Q1 2024, the Company could have validated doses and therapeutic regimens to consider the implementation of possible other clinical trials.

ClearNote Health Announces New Proprietary Approach for Predicting Immunotherapy Treatment Response in Non-Small Cell Lung Cancer Using Only Blood

Retrieved on: 
Tuesday, January 16, 2024

The article, “ Plasma Cell-Free DNA Hydroxymethylation Profiling Reveals Anti-PD-1 Treatment Response and Resistance Biology in Non-Small Cell Lung Cancer ,” was published in the online issue of The Journal for ImmunoTherapy of Cancer, the official journal of the Society for Immunotherapy of Cancer (SITC) .

Key Points: 
  • The article, “ Plasma Cell-Free DNA Hydroxymethylation Profiling Reveals Anti-PD-1 Treatment Response and Resistance Biology in Non-Small Cell Lung Cancer ,” was published in the online issue of The Journal for ImmunoTherapy of Cancer, the official journal of the Society for Immunotherapy of Cancer (SITC) .
  • The comparison of plasma-derived cfDNA 5-hmC profiles revealed differences that distinguish patients responding to therapy from those not responding before and throughout treatment.
  • This underscores the value of 5hmC analysis for the measurement of treatment response biomarkers without the need for an invasive and potentially deadly tissue biopsy.
  • A recently published study in Cancer Research, “ The 5-Hydroxymethylcytosine Landscape of Prostate Cancer ,” showed the utility of ClearNote Health’s platform in marking epigenetic activation in prostate cancer and identifying hallmarks of prostate cancer progression.

Arbutus Announces 2024 Corporate Objectives and Provides Financial Update

Retrieved on: 
Monday, January 8, 2024

Arbutus plans to announce end-of-treatment data from this trial in the first half of 2024.

Key Points: 
  • Arbutus plans to announce end-of-treatment data from this trial in the first half of 2024.
  • Arbutus plans to announce end-of-treatment data from this portion of the trial in the first half of 2024.
  • Arbutus expects to report preliminary data from the healthy subject portion of this clinical trial, including target engagement and receptor occupancy data, in the first half of 2024.
  • With respect to the Moderna lawsuit, fact discovery is currently on-going with the claim construction hearing scheduled for February 8, 2024.

Barinthus Bio Provides a Financial Update and Announces Anticipated 2024 Corporate Milestones

Retrieved on: 
Friday, January 5, 2024

OXFORD, United Kingdom, Jan. 05, 2024 (GLOBE NEWSWIRE) -- Barinthus Biotherapeutics plc (NASDAQ: BRNS), formerly Vaccitech plc, today provided a preliminary financial update and announced its 2024 corporate objectives.

Key Points: 
  • OXFORD, United Kingdom, Jan. 05, 2024 (GLOBE NEWSWIRE) -- Barinthus Biotherapeutics plc (NASDAQ: BRNS), formerly Vaccitech plc, today provided a preliminary financial update and announced its 2024 corporate objectives.
  • Barinthus Bio is a clinical-stage biopharmaceutical company developing novel T cell immunotherapeutic candidates designed to guide the immune system to overcome chronic infectious diseases, autoimmunity, and cancer.
  • “2024 promises to be another exciting year for Barinthus Bio, with multiple data readouts expected across our hepatitis B virus (HBV) infection, human papillomavirus (HPV) infection and prostate cancer programs, as well as the planned initiation of the first in human study of our SNAP platform-based candidate VTP-1000 in Celiac Disease,” said Gemma Brown, Chief Financial Officer of Barinthus Bio.
  • * Barinthus Bio has worldwide rights for all product candidates.

Immunocore announces strategic priorities and pipeline expansion ahead of 42nd Annual J.P. Morgan Healthcare Conference presentation

Retrieved on: 
Friday, January 5, 2024

The Company is expanding its platform into autoimmune with two first in class new bispecific candidates entering the Company’s pipeline.

Key Points: 
  • The Company is expanding its platform into autoimmune with two first in class new bispecific candidates entering the Company’s pipeline.
  • The Company has updated its corporate presentation to reflect these business and strategic updates.
  • Additionally, the Immunocore management team will discuss these updates during a live and webcast presentation at the 42nd Annual J.P. Morgan Healthcare Conference, on Wednesday January 10, 2024, at 9:00 a.m. Pacific Standard Time (PST).
  • The presentation and webcast will be available in the ‘Investors/Media’ section of Immunocore’s website at www.immunocore.com.

SELLAS Provides Corporate Updates and Highlights Key Upcoming Milestones

Retrieved on: 
Wednesday, January 3, 2024

NEW YORK, Jan. 03, 2024 (GLOBE NEWSWIRE) -- SELLAS Life Sciences Group, Inc. (NASDAQ: SLS) (“SELLAS” or the “Company”), a late-stage clinical biopharmaceutical company focused on the development of novel therapies for a broad range of cancer indications, today provided a business update and will host a corporate webinar at 8:30 am ET.

Key Points: 
  • “2023 was a very productive year for SELLAS,” said Angelos Stergiou, MD, ScD h.c., President and Chief Executive Officer of SELLAS.
  • Dr. Stergiou continued: “We hope to build on this excellent progress and look forward to multiple clinical milestones that have the potential to create significant value for our shareholders.
  • Meaningful cell killing activity, defined as ≥50% reduction in blasts in the bone marrow, was observed at several dose levels.
  • This study is fully funded by the Company’s partner for SLS009, GenFleet Therapeutics (Shanghai), Inc. and is being conducted in China.

SELLAS Life Sciences Reports Positive Follow-Up Immune Response and Survival Data in Completed Phase 1 Study of Galinpepimut-S Combined with Opdivo® in Advanced Malignant Pleural Mesothelioma

Retrieved on: 
Wednesday, December 27, 2023

NEW YORK, Dec. 27, 2023 (GLOBE NEWSWIRE) -- SELLAS Life Sciences Group, Inc. (NASDAQ: SLS) (“SELLAS” or the “Company”), a late-stage clinical biopharmaceutical company focused on developing novel therapies for a broad range of cancer indications, today announced follow-up clinical/immune-response data from a Phase 1 investigator-sponsored clinical trial of its lead clinical candidate, galinpepimut-S (GPS), combined with the checkpoint inhibitor nivolumab (Opdivo®) in patients with refractory/relapsed malignant pleural mesothelioma (MPM).

Key Points: 
  • Nine out of ten patients (90%) had sufficient samples collected to be analyzed for GPS-specific immune response.
  • All enrolled patients had either received and progressed with or were refractory to frontline pemetrexed-based chemotherapy.
  • Additional analyses for the correlation of immune response and survival benefit were performed.
  • Among the nine evaluable patients, four patients had a CD4+ immune response (44.4%) and three patients had a CD8+ immune response (33.3%) to GPS.

Purple Biotech Completes Patient Enrollment in Phase 2 Pancreatic Cancer Trial

Retrieved on: 
Thursday, December 14, 2023

REHOVOT, Israel, Dec. 14, 2023 (GLOBE NEWSWIRE) --  Purple Biotech Ltd. ("Purple Biotech" or "the Company") (NASDAQ/TASE: PPBT), a clinical-stage company developing first-in-class therapies that harness the power of the tumor microenvironment to overcome tumor immune evasion and drug resistance, today announced it has completed patient enrollment in a Phase 2 study of CM24, a multi-functional immune checkpoint inhibitor, for the treatment of pancreatic ductal adenocarcinoma (PDAC).

Key Points: 
  • “Having completed patient enrollment, we now look forward to reporting overall survival results in 2024.
  • Survival rates in pancreatic cancer are unfortunately very low and with CM24’s novel CEACAM1 target, we believe we may have a positive impact on extending survival,” stated Purple Biotech CEO, Gil Efron.
  • An estimated 60,000 people are diagnosed with pancreatic cancer in the U.S. alone with a 5-year survival rate of only 12%.
  • In patients treated with chemotherapy as a 2nd line treatment, the 5-year survival drops to 3%.