Nivolumab

Immunocore announces clinical trial collaboration and supply agreement with Bristol Myers Squibb to evaluate IMC-F106C (PRAME HLA-A02) in combination with nivolumab in its registrational Phase 3 first-line advanced cutaneous melanoma trial

Retrieved on: 
Giovedì, Febbraio 22, 2024
BMY, Nivolumab, Bristol Myers Squibb, PRAME, Patient, Clinical trial, TCR, Infection, Immunocore, Relatlimab, Cancer, Pharmaceutical industry

IMC-F106C is Immunocore’s first-in-class bispecific TCR ImmTAC candidate targeting PRAME HLA-A02; nivolumab is manufactured by Bristol Myers Squibb

Key Points: 
  • IMC-F106C is Immunocore’s first-in-class bispecific TCR ImmTAC candidate targeting PRAME HLA-A02; nivolumab is manufactured by Bristol Myers Squibb
    The clinical trial collaboration relates to Immunocore’s PRISM-MEL-301 registrational Phase 3 clinical trial in first-line advanced cutaneous melanoma, evaluating IMC-F106C in combination with nivolumab versus a control arm of either nivolumab or the fixed-dose combination of nivolumab and relatlimab
    (OXFORDSHIRE, England & CONSHOHOCKEN, Penn.
  • Under the terms of the collaboration, Immunocore will sponsor and fund the registrational Phase 3 clinical trial of IMC-F106C in combination with nivolumab in first-line advanced cutaneous melanoma (PRISM-MEL-301), and Bristol Myers Squibb will provide nivolumab.
  • The PRISM-MEL-301 trial will randomize HLA-A*02:01+ first-line advanced cutaneous melanoma patients to IMC-F106C + nivolumab versus a control arm of either nivolumab or the fixed-dose combination of nivolumab and relatlimab, depending on the country where the patient is enrolled.
  • Immunocore plans to randomize the first patient in this trial in the first quarter of 2024.

MaaT Pharma indicates completion of Patient Recruitment for the Phase 2a Investigator-Sponsored Randomized Clinical Trial Evaluating MaaT013 in Combination with Immune Checkpoint Inhibitors in Metastatic Melanoma

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Martedì, Marzo 5, 2024
Oncology, Health, Clinical Trials, Research, Science, Pharmaceutical, Biotechnology, PICASSO, Week, Directorate, Neoplasm, Institut Gustave Roussy, PHRC, Ipilimumab, Nivolumab, ICI, National Cancer Institute, INRAE, Safety, MET, Patient, Survival, Cancer, Pharmaceutical industry

A total of 70 patients have been enrolled in 5 different centers in France in the randomized controlled Phase 2a PICASSO trial, which started in April 2022.

Key Points: 
  • A total of 70 patients have been enrolled in 5 different centers in France in the randomized controlled Phase 2a PICASSO trial, which started in April 2022.
  • The Company provided MaaT013 drug candidate and placebo and will contribute to the microbiome profiling of patients using its proprietary gutPrint® research engine.
  • The unblinding will be done at Week 27 (W27) to assess the primary endpoint which is safety.
  • Having reached this key recruitment milestone, the first publication will be submitted at the end of 2024 or in the first quarter of 2025.

Zai Lab Announces Full-Year 2023 Financial Results and Recent Corporate Updates

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Martedì, Febbraio 27, 2024
Oncology, Mental Health, Health, Infectious Diseases, Neurology, Pharmaceutical, Biotechnology, NSCLC, TED, Blood pressure, Cervical cancer, Psoriasis, Cetuximab, Infection, New Drug Application, SCLC, MAA, National Medical Products Administration, PMA, CIDP, NTRK, FDA, Nivolumab, Food, GEJ, Shanda, Schizophrenia, PDUFA, CRC, Bristol Myers Squibb, BMS, ADP, Safety, Mirati, TPS, Disease, HKT, Patient, Clinical trial, METIS, Fusion, Pancreatic cancer, NDA, NMPA, Pharmaceutical industry

The New Drug Application (NDA) that Zai Lab submitted to the NMPA for this indication is under priority review.

Key Points: 
  • The New Drug Application (NDA) that Zai Lab submitted to the NMPA for this indication is under priority review.
  • Zai Lab has joined the global Phase 3 FORTITUDE-102 study of bemarituzumab in combination with nivolumab and chemotherapy in first-line gastric or GEJ cancer in Greater China.
  • Zai Lab to submit an sBLA to the NMPA for efgartigimod SC in CIDP in the first half of 2024.
  • Zai Lab to complete patient enrollment in the China bridging study in schizophrenia in the fourth quarter of 2024.

Replimune Reports Fiscal Third Quarter 2024 Financial Results and Provides Corporate Update

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Giovedì, Febbraio 8, 2024
Carcinoma, Neoplasm, Melanoma, NMSC, Merkel-cell carcinoma, REPL, Angiosarcoma, SITC, PFS, Clinical trial, Research, RECIST, Society, Hercules, Patient, CSCC, Type, FDA, Marketing, Investment, RP1, Food, MCC, Immunotherapy, Skin, Nivolumab, Uveal melanoma, Annual general meeting, BLA, RP2, Pharmaceutical industry

WOBURN, Mass., Feb. 08, 2024 (GLOBE NEWSWIRE) -- Replimune Group, Inc. (Nasdaq: REPL), a clinical stage biotechnology company pioneering the development of a novel class of oncolytic immunotherapies, today announced financial results for the fiscal third quarter ended December 31, 2023, and provided a business update.

Key Points: 
  • WOBURN, Mass., Feb. 08, 2024 (GLOBE NEWSWIRE) -- Replimune Group, Inc. (Nasdaq: REPL), a clinical stage biotechnology company pioneering the development of a novel class of oncolytic immunotherapies, today announced financial results for the fiscal third quarter ended December 31, 2023, and provided a business update.
  • We plan to submit a BLA for the treatment of patients with anti-PD1 failed melanoma in 2H 2024.
  • Selling, general and administrative expenses included $4.5 million in stock-based compensation expenses for the third quarter ended December 31, 2023.
  • Net Loss: Net loss was $51.1 million for the third quarter ended December 31, 2023, as compared to a net loss of $39.7 million for the third quarter ended December 31, 2022.

SMC Laboratories Reveals Innovative STAM™-HCC/IO+ Mouse for Identifying and Developing Novel Therapeutic Drugs for Liver Cancer, Blazing a Trail in the Immuno-Oncology Field

Retrieved on: 
Martedì, Febbraio 6, 2024
Inflammation, Growth, Liver cancer, Immunity, Immunotherapy, Research, JACC, Therapy, Prevalence, Tan, Metabolic syndrome, PNAS, MOA, JAMA Oncology, Sorafenib, Fibrosis, Bevacizumab, Immunogenic cell death, Laboratory, ICIS, Metabolism, Pembrolizumab, Neoplasm, MASH, Nivolumab, Hepatology, Liver, Cancer

The STAM™-HCC/IO+ mouse is a model that allows stable evaluation of the growth of multiple target lesions originating from the liver over a certain period.

Key Points: 
  • The STAM™-HCC/IO+ mouse is a model that allows stable evaluation of the growth of multiple target lesions originating from the liver over a certain period.
  • Furthermore, it can be used for testing molecular target drugs and immune checkpoint inhibitors, and for other therapeutic targets while performing stable drug efficacy evaluations.
  • As the prevalence of liver cancer increases, it is anticipated that SMC Laboratories' STAM™-HCC/IO+ mouse will greatly contribute to the development of therapeutic drugs for liver cancer in the future.
  • Liver cancer is the fourth most common type of cancer in the world (Huang DQ et al, Nature Reviews Gastroenterology & Hepatology, 18, 223-238, 2021).

SMC Laboratories Reveals Innovative STAM™-HCC/IO+ Mouse for Identifying and Developing Novel Therapeutic Drugs for Liver Cancer, Blazing a Trail in the Immuno-Oncology Field

Retrieved on: 
Martedì, Febbraio 6, 2024
Inflammation, Growth, Liver cancer, Immunity, Immunotherapy, Research, JACC, Therapy, Prevalence, Tan, Metabolic syndrome, PNAS, MOA, JAMA Oncology, Sorafenib, Fibrosis, Bevacizumab, Immunogenic cell death, Laboratory, ICIS, Metabolism, Pembrolizumab, Neoplasm, MASH, Nivolumab, Hepatology, Liver, Cancer

The STAM™-HCC/IO+ mouse is a model that allows stable evaluation of the growth of multiple target lesions originating from the liver over a certain period.

Key Points: 
  • The STAM™-HCC/IO+ mouse is a model that allows stable evaluation of the growth of multiple target lesions originating from the liver over a certain period.
  • Furthermore, it can be used for testing molecular target drugs and immune checkpoint inhibitors, and for other therapeutic targets while performing stable drug efficacy evaluations.
  • As the prevalence of liver cancer increases, it is anticipated that SMC Laboratories' STAM™-HCC/IO+ mouse will greatly contribute to the development of therapeutic drugs for liver cancer in the future.
  • Liver cancer is the fourth most common type of cancer in the world (Huang DQ et al, Nature Reviews Gastroenterology & Hepatology, 18, 223-238, 2021).

MiNK’s AgenT-797 Offers New Hope in Overcoming ICI Resistance in PD-1 Refractory Gastric Cancer - Published in Oncogene

Retrieved on: 
Martedì, Gennaio 30, 2024
PD-L1, FOLFOX, Immune system, Division, Clinical trial, RECIST, Patient, Stomach, Therapy, ICIS, Pembrolizumab, Brown University, Nivolumab, Associate, Stomach cancer, Mink, Cancer, Clinical research, Malignancy

“Novel therapeutic approaches, like allogeneic iNKT cells, are urgently needed to overcome resistance to immune checkpoint inhibitors in gastric cancers and other refractory solid tumors.

Key Points: 
  • “Novel therapeutic approaches, like allogeneic iNKT cells, are urgently needed to overcome resistance to immune checkpoint inhibitors in gastric cancers and other refractory solid tumors.
  • The activity, tolerability, and ease of off-the-shelf administration of iNKT-based cell therapies position them as an attractive approach for overcoming cancer resistance.”
    Gastric cancer, the fifth most common malignancy globally, is incurable with only 12% responsive to ICIs1,2.
  • This phase study (NCT05108623) was designed to evaluate agenT-797, an unmodified iNKT cell therapy, in solid tumors refractory to ICIs.
  • Kono K, Nakajima S, Mimura K. Current status of immune checkpoint inhibitors for gastric cancer.

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

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Lunedì, Gennaio 22, 2024
Biotechnology, Health, Pharmaceutical, Clinical Trials, Oncology, Bristol Myers Squibb, Death, Checkmate, Patient, Progression-free survival, OS, RCC, ASCO, Survival, Nivolumab, Ipilimumab, IRRC, Society, Risk, Immunotherapy, MD Anderson Cancer Center, Division, PFS, Abstract, Safety, Confidence interval, University, BMY, Sunitinib, IMDC, ITT

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: 
Sabato, Gennaio 20, 2024
Oncology, FDA, Health, Clinical Trials, Pharmaceutical, Biotechnology, Bristol Myers Squibb, Death, Checkmate, Patient, Progression-free survival, MSI-H, Nivolumab, Bevacizumab, Ipilimumab, Cetuximab, Immunotherapy, Risk, PFS, Confidence interval, BMY, FOLFIRI

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

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Venerdì, Gennaio 19, 2024
Biotechnology, Pharmaceutical, Health, Clinical Trials, Journal of Immunology, HCC, ICI, CD47, Cancer, EMA, Journal, Pembrolizumab, IL-7, Kidney transplantation, Acute lymphoblastic leukemia, Annals of Oncology, Nivolumab, Fortification, ESMO, Hepatocellular carcinoma, Safety, Inflammation, Ulcerative colitis, Patent, Ovarian cancer, Failure, Survival, Immunotherapy, Boehringer Ingelheim, Committee, Myelocyte, Oncology, Patient, European Medicines Agency, ALL, Partnership, Lung cancer, Head, Pancreatic cancer, Phase II, FDA, Clinical trial, FOLFIRI, Pharmaceutical industry

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.