PD-1

Immunocore reports updated Phase 1 data of brenetafusp (IMC-F106C), an ImmTAC bispecific targeting PRAME, in immune checkpoint pre-treated cutaneous melanoma patients at ASCO 2024

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пятница, мая 31, 2024
PRAME, Bristol Myers Squibb, Patient, Infection, Rash, Progression-free survival, Immunocore, Research and development, Pembrolizumab, Transaminase, Gene expression, Translational research, PFS, Therapy, Neoplasm, RECIST, Cytokine release syndrome, ImmTAC, Event, PD-1, Cancer, ASCO, Research institute, OS, PR, Society, Immunohistochemistry, Melanoma, DCR, History, Autoimmune hepatitis, Nivolumab, Annual general meeting, CRS, Pharmaceutical industry

Brenetafusp was shown to be well tolerated, in monotherapy and in combination with anti-PD1, and demonstrated durable clinical benefit.

Key Points: 
  • Brenetafusp was shown to be well tolerated, in monotherapy and in combination with anti-PD1, and demonstrated durable clinical benefit.
  • “We expect brenetafusp PFS to be even higher in first-line based on our analysis of blood T cell fitness.
  • All monotherapy treated patients had received prior immune checkpoint inhibitors (100% anti-PD1, 81% anti-CTLA4).
  • Immunocore will host a conference call today, May 31, 2024 at 7:15 PM ET / 6:15 PM CT, to discuss the Phase 1 PRAME expansion data and Phase 3 registrational trial in cutaneous melanoma.

BriaCell Initiates Patient Enrollment in First-in-Human Study of Bria-OTS™ in Advanced Metastatic Breast Cancer

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четверг, мая 30, 2024
CTA, MPH, Patient, Tislelizumab, Investigational New Drug, FDA, IND, BCT, Safety, PD-1, Cancer, Immunotherapy, Institutional review board, TSX, Quality of life, IRB, Pharmaceutical industry

PHILADELPHIA and VANCOUVER, British Columbia, May 30, 2024 (GLOBE NEWSWIRE) -- BriaCell Therapeutics Corp. (NASDAQ: BCTX, BCTXW) (TSX: BCT) (“BriaCell” or the “Company”), a clinical-stage biotechnology company that develops novel immunotherapies to transform cancer care, announces initiation of a first-in-human, Phase 1/2 study evaluating safety and efficacy of Bria-OTS™, BriaCell’s personalized off-the-shelf next generation immunotherapy, as monotherapy and in combination with PD-1 inhibitor tislelizumab , in advanced metastatic breast cancer.

Key Points: 
  • PHILADELPHIA and VANCOUVER, British Columbia, May 30, 2024 (GLOBE NEWSWIRE) -- BriaCell Therapeutics Corp. (NASDAQ: BCTX, BCTXW) (TSX: BCT) (“BriaCell” or the “Company”), a clinical-stage biotechnology company that develops novel immunotherapies to transform cancer care, announces initiation of a first-in-human, Phase 1/2 study evaluating safety and efficacy of Bria-OTS™, BriaCell’s personalized off-the-shelf next generation immunotherapy, as monotherapy and in combination with PD-1 inhibitor tislelizumab , in advanced metastatic breast cancer.
  • “Advancing Bria-OTS™ as our second novel immunotherapy candidate into the clinic is a significant milestone for BriaCell.
  • We believe personalization through our Bria-OTS™ immunotherapy platform will produce more potent and long-lasting responses than previously observed, with potential synergistic effects with the immune check point inhibitor,” stated Dr. William V. Williams, BriaCell’s President & CEO.
  • Additionally, we expect the preferred safety profile of our personalized immunotherapy, Bria-OTS™, to improve the quality of life and add months and even years to the lives of these heavily pretreated patients, a distinctive combination of benefits in late-stage cancer care.”

 Ivonescimab in Combination with Chemotherapy Approved in China by NMPA for 2L+ EGFRm NSCLC based on HARMONi-A Clinical Trial: Positive Trend Observed in Overall Survival towards Ivonescimab Plus Chemotherapy

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суббота, июня 1, 2024
Science, Radiology, Biotechnology, Research, Pharmaceutical, Oncology, Health, Clinical Trials, SMMT, National Medical Products Administration, Patient, HKEX, TKI, Data, NMPA, PFS, EGFR, NSCLC, Neoplasm, PD-1

This is a clinical setting with a patient population where PD-1 monoclonal antibodies have previously been unsuccessful in Phase III global clinical trials.

Key Points: 
  • This is a clinical setting with a patient population where PD-1 monoclonal antibodies have previously been unsuccessful in Phase III global clinical trials.
  • Median PFS for ivonescimab plus chemotherapy was 7.1 months (95% CI: 5.9 – 8.7), as compared to 4.8 months (95% CI: 4.2 – 5.6) for placebo plus chemotherapy.
  • Both overall survival curves appear to demonstrate clear separation between the two arms of the trial and show a trend in improvement of survival towards ivonescimab plus chemotherapy.
  • Overall response rate (ORR) was 50.6% (95% CI: 42.6% – 58.6%) for those receiving ivonescimab plus chemotherapy vs. 35.4% (95% CI: 28.0% - 43.3%) for those receiving chemotherapy alone.

Agendia Announces New Data Assessing the Immune Active State in HR+/HER2- Early-Stage Breast Cancer at 2024 ASCO

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пятница, мая 31, 2024
Biotechnology, Pharmaceutical, Health, Oncology, Patient, MP, MammaPrint, Transcriptome, University, Antigen presentation, Breast cancer, HR, MD, APC, Neoplasm, PD-1, Macrophage, Biomarker, ASCO, Division, Gene, Associate, B cell, Woman, Society, Classification, Immunotherapy, Kurt Cobain, PD-L1, Checkmate, SWOG, Medical imaging

Agendia®, Inc. today announced it will present new data characterizing the immune biology of MammaPrint High Risk tumors in an oral session at the 2024 Annual American Society of Clinical Oncology (ASCO) Meeting , taking place in Chicago, IL.

Key Points: 
  • Agendia®, Inc. today announced it will present new data characterizing the immune biology of MammaPrint High Risk tumors in an oral session at the 2024 Annual American Society of Clinical Oncology (ASCO) Meeting , taking place in Chicago, IL.
  • characterizes the underlying immune biology that mediates immune therapy response in early stage hormone receptor-positive (HR+), Human Epidermal Growth Factor Receptor negative (HER2-) breast cancer, categorized as MammaPrint High Risk 2 (MP H2) in patients enrolled in the prospective, observational FLEX Study ( NCT03053193 ).
  • The data from this study suggests that early stage HR+HER2- High-2 tumors might benefit from the addition of immunotherapy to their chemotherapy treatment regimens.
  • “There is a great need for biomarkers beyond PD-L1 and tumor mutational burden that may predict clinical benefit from immunotherapy-based treatments.

Ivonescimab Monotherapy Decisively Beats Pembrolizumab Monotherapy Head-to-Head, Achieves Statistically Significant Superiority in PFS in First-Line Treatment of Patients with PD-L1 Positive NSCLC in China

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четверг, мая 30, 2024
Biotechnology, Health, Pharmaceutical, Clinical Trials, Oncology, Partnership, SMMT, Patient, Progression-free survival, HKEX, Phase, Pembrolizumab, Therapy, PFS, Neoplasm, PD-1, Cancer, ASCO, Lung cancer, Data monitoring committee, Immunotherapy, Pharmaceutical industry

HARMONi-2 evaluated monotherapy ivonescimab against monotherapy pembrolizumab in patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) whose tumors have positive PD-L1 expression (PD-L1 TPS >1%).

Key Points: 
  • HARMONi-2 evaluated monotherapy ivonescimab against monotherapy pembrolizumab in patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) whose tumors have positive PD-L1 expression (PD-L1 TPS >1%).
  • HARMONi-2 is a single region, multi-center, double-blinded Phase III study conducted in China sponsored by Akeso, Inc. (Akeso, HKEX Code: 9926.HK) with data generated and analyzed by Akeso.
  • At a prespecified interim analysis conducted by an independent Data Monitoring Committee, ivonescimab demonstrated a statistically significant and clinically meaningful improvement in PFS by blinded independent central radiology review committee (BICR) compared to pembrolizumab.
  • There are no known Phase III clinical trials in NSCLC which have shown a statistically significant improvement compared to pembrolizumab in a head-to-head setting.

Anaveon announces IND approval of ANV600-001 (EXPAND) Phase I/II clinical study

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среда, мая 29, 2024
MSD, Merck & Co., Pembrolizumab, FDA, IND, Trial of the century, Safety, PD-1, Merck, Pharmaceutical industry

BASEL, Switzerland, May 29, 2024 (GLOBE NEWSWIRE) -- Anaveon, a clinical stage, immuno-oncology company, today announced that its Investigational New Drug (IND) application to conduct a Phase I/II study evaluating the safety and clinical activity of ANV600 has been accepted by the FDA. The Company will initiate the first two dose escalation cohorts with ANV600 monotherapy and combination with MSD’s (Merck & Co., Inc., Rahway, NJ., USA) anti-PD-1 therapy KEYTRUDA® (pembrolizumab) as part of a multi cohort study to evaluate the safety and efficacy of ANV600 in multiple cancer indications.

Key Points: 
  • BASEL, Switzerland, May 29, 2024 (GLOBE NEWSWIRE) -- Anaveon, a clinical stage, immuno-oncology company, today announced that its Investigational New Drug (IND) application to conduct a Phase I/II study evaluating the safety and clinical activity of ANV600 has been accepted by the FDA.
  • ANV600 uses a non-blocking anti-PD-1 antibody to target a powerful IL-2Rβ/γ selective IL-2 agonist to tumor-specific T cells, resulting in their proliferation and increase of tumor-killing potential.
  • “Approval to start our first-in-human clinical study of ANV600 represents an important step towards validation of our approach,” said Eduard Gasal, M.D., Chief Medical Officer of Anaveon.
  • KEYTRUDA® is a registered trademark of Merck Sharp & Dohme LLC, a subsidiary of Merck & Co., Inc., Rahway, NJ, USA.

SOTIO Announces First Patient Dosed in Phase 1 Clinical Study of SOT201 for Patients with Solid Tumors

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вторник, мая 28, 2024
Research, Clinical Trials, Other Health, Biotechnology, General Health, Pharmaceutical, Health, Science, Oncology, Other Science, Patient, MD Anderson Cancer Center, University, Ageing, Safety, PD-1, Therapy, PPF (company), Pharmaceutical industry

The VICTORIA-01 study will evaluate the safety, tolerability and initial efficacy of SOT201 monotherapy for the treatment of advanced solid tumors.

Key Points: 
  • The VICTORIA-01 study will evaluate the safety, tolerability and initial efficacy of SOT201 monotherapy for the treatment of advanced solid tumors.
  • “While anti-PD-1 therapeutics have been a great advance in cancer medicine, still only a minority of patients respond to them.
  • The VICTORIA-01 study is a Phase 1, open-label, dose escalation study of SOT201 which will assess its safety, tolerability, and preliminary efficacy as a monotherapy for patients aged 18 years or above with advanced unresectable or metastatic solid tumors ( NCT06163391 ).
  • Additional clinical sites across Europe – including in Belgium, Czech Republic and Spain – will initiate enrollment in the coming months.

Global Oncolytic Virus Immunotherapy Market Opportunity & Clinical Trials Insight to 2030 - Regulatory Approvals and Pharmaceutical Investments Driving Market Growth - ResearchAndMarkets.com

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понедельник, мая 27, 2024
FDA, Pharmaceutical, Health, Oncology, Pembrolizumab, Patient, Nanoparticle, Oncolytic virus, Immunotherapy, Astellas Pharma, NRG, Laboratory, Glioma, Investment, Candel, H101, Immune system, Bristol Myers Squibb, Therapy, Government, Head, Snow, Breast cancer, Optimism, Genelux Corporation, Growth, PD-1, Cancer, Potyvirus, Irinotecan, Pancreatic cancer, EMA, Melanoma, Research, Fast Track, Attention, Merck, Oncos, Gastrointestinal cancer, OH2, Roche, Indication, Virus, PD-L1, Antibody, Quality of life, Vaccine

The "Global Oncolytic Virus Immunotherapy Market Opportunity & Clinical Trials Insight 2030" report has been added to ResearchAndMarkets.com's offering.

Key Points: 
  • The "Global Oncolytic Virus Immunotherapy Market Opportunity & Clinical Trials Insight 2030" report has been added to ResearchAndMarkets.com's offering.
  • As the global medical community continues to advance targeted cancer therapies, oncolytic virus immunotherapy has emerged as a seminal player in this dynamic field.
  • Global Oncolytic Virus Immunotherapy Therapy Market Opportunity: > USD 1.50 Billion by 2030
    Oncolytic Viruses Immunotherapies Clinical Trials by Company, Indication & Phase
    Comprehensive Insight on Oncolytic Virus Immunotherapies in Clinical Trials: > 180 Therapies
    Cancer endures to be a relentless adversary, challenging both patients and the medical community across the world.
  • Continuous research, innovation, and collaboration are essential to sustaining this growth and realizing the full potential of oncolytic virus immunotherapy.

Datopotamab deruxtecan showed clinically meaningful overall survival improvement vs. chemotherapy in patients with advanced nonsquamous non-small cell lung cancer in TROPION-Lung01 Phase III trial

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понедельник, мая 27, 2024
Science, Cardiology, Biotechnology, Research, Pharmaceutical, General Health, Health, Clinical Trials, Biopharmaceutical, Docetaxel, Congress, Lung, Lung cancer, World Health Organization, DXD, Survival, ADC, MD, Cleavage, PD-1, Medicine, OS, Immunotherapy, Statistics, Immunology, Safety, NSCLC, Cancer, Patient, Incidence, Sapporo Medical University, Metabolism, AstraZeneca, Gefitinib, Observational study, Progression-free survival, Immunoglobulin G, Treatment, PFS, Pircher, Death, Triple-negative breast cancer, Pharmacotherapy, Social media, Daiichi Sankyo, ESMO, Pemetrexed, American Cancer Society, Oncology, Pharmaceutical industry

In the prespecified subgroup of patients with nonsquamous NSCLC, datopotamab deruxtecan showed a clinically meaningful improvement in OS compared to docetaxel, the current standard-of-care chemotherapy.

Key Points: 
  • In the prespecified subgroup of patients with nonsquamous NSCLC, datopotamab deruxtecan showed a clinically meaningful improvement in OS compared to docetaxel, the current standard-of-care chemotherapy.
  • Patients without known actionable genomic alterations were previously treated, concurrently or sequentially, with platinum-based chemotherapy and a PD-1 or PD-L1 inhibitor.
  • Datopotamab deruxtecan (Dato-DXd) vs doxetaxel in previously treated advanced/metastatic (adv/met) non-small cell lung cancer (NSCLC): results of the randomized phase 3 study TROPION-Lung01.
  • Pemetrexed plus platinum with or without pembrolizumab in patients with previously untreated metastatic nonsquamous NSCLC: protocol-specified final analysis from KEYNOTE-189.

HUTCHMED Highlights Presentations at the 2024 ASCO Annual Meeting

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пятница, мая 24, 2024
Patient, Tislelizumab, Survival, Osteosarcoma, Liver, HER2, Colorectal cancer, SOX, Safety, Sarcoma, Neoadjuvant therapy, University Challenge 2013–14, Trial of the century, PD-1, LARC, FRU, CAPOX, Capecitabine, Sintilimab, MSS, Pharmaceutical industry

Stereotactic ablative radiotherapy combined with fruquintinib and tislelizumab in metastatic colorectal cancer: updated findings from a single-arm, prospective phase II trial (RIFLE)

Key Points: 
  • Stereotactic ablative radiotherapy combined with fruquintinib and tislelizumab in metastatic colorectal cancer: updated findings from a single-arm, prospective phase II trial (RIFLE)
    A propensity score matched comparison of fruquintinib (FRU) versus FRU combined with PD-1 inhibitors for microsatellite stability (MSS) metastatic colorectal cancer: real-world data
    Efficacy and safety of fruquintinib plus trifluridine/tipiracil (TAS-102) as third-line treatment in patients with metastatic colorectal adenocarcinoma: Results from a single arm, phase 2, multicenter study
    A phase II study to evaluate the efficacy and safety of fruquintinib combined with tislelizumab and Hepatic arteryinfusion chemotherapy (HAIC) for advanced colorectal cancer liver metastases: An updated analysis of survival
    Fruquintinib combined with sintilimab and SOX as conversion therapy for unresectable locally advanced or metastatic gastric/gastroesophageal junction adenocarcinoma (GC/GEJC): A single-arm, open-label, phase 2 clinical trial
    Short-course radiotherapy (SCRT) followed by fruquintinib plus adebrelimab and CAPOX in the total neoadjuvant therapy of locally advanced rectal cancer (LARC): a multicenter, single-arm, open-label, phase II study
    Fruquintinib plus capecitabine versus capecitabine as first-line maintenance treatment of metastatic colorectal cancer (mCRC): Update results from the randomized, controlled, phase Ib/II study
    Efficacy and safety of fruquintinib plus investigator's choice of chemotherapy as second-line therapy in metastatic colorectal cancer: updated results of a multicenter, single-arm, phase 2 trial
    Efficacy and safety of fruquintinib-based treatment in patients with refractory bone and soft tissue sarcomas after developing resistance to several TKIs: A multi-centered retrospective study
    Disitamab vedotin combined with fruquintinib in patients with HER2-expressing or HER2 mutation/amplified metastatic colorectal cancer refractory to at least two standard regimens: A prospective, exploratory, single-arm study
    Surufatinib combined with TAS-102 in third- or later-line therapy of patients with metastatic pancreatic cancer (mPDAC): an open-Label, single-Arm, phase II Study
    Phase II study to evaluate surufatinib in patients with osteosarcoma and soft tissue sarcoma who have failed in standard chemotherapy: updated analysis