PD-L2

OSE Immunotherapeutics Presents First Positive Clinical Results With its anti-PD1 OSE-279 in Advanced Solid Tumors

Retrieved on: 
Monday, October 16, 2023
Biotechnology, Health, Pharmaceutical, Clinical Trials, Oncology, Ligand, Tumor microenvironment, Mnemos EP, Hepatocellular carcinoma, AACR, PD-L1, Communication, MTD, Preventive healthcare, Index, OSE, PD-L2, ISIN, Maxima and minima, Conference, Patient, Pharmaceutical industry

OSE Immunotherapeutics SA (ISIN: FR0012127173; Mnemo: OSE) presented the first Phase 1/2 positive clinical results with high affinity anti-PD1 monoclonal antibody OSE-279 in advanced solid tumors at the AACR-NCI-EORTC International Conference on Molecular Targets and Cancer Therapeutics , held in Boston, MA (October 11 – 15, 2023 - Abstract number 35371, Poster C063).

Key Points: 
  • OSE Immunotherapeutics SA (ISIN: FR0012127173; Mnemo: OSE) presented the first Phase 1/2 positive clinical results with high affinity anti-PD1 monoclonal antibody OSE-279 in advanced solid tumors at the AACR-NCI-EORTC International Conference on Molecular Targets and Cancer Therapeutics , held in Boston, MA (October 11 – 15, 2023 - Abstract number 35371, Poster C063).
  • Silvia Comis, Head of Clinical Development and Regulatory Affairs of OSE Immunotherapeutics, comments: “These first efficacy and safety positive results from clinical Phase 1/2 assessing the therapeutic potential of our proprietary anti-PD1 monoclonal antibody OSE-279 in advanced solid tumors are very promising.
  • These results encourage further clinical development of OSE-279 in the future as a monotherapy treatment in pre-identified cancer niche indications, with still high unmet medical needs.
  • This product will also be available for combination with other OSE drug candidates or with external assets opening new potential partnerships.”
    The communication reported on the first positive results from the Phase 1/2 clinical trial evaluating OSE-279 monotherapy in patients with advanced solid tumors, with no therapeutic option available.

OncoHost Collaborates with BGN Technologies to Predict Cancer Patient Response to Anti-PD-1 Treatment with IcAR Biosensing Tech

Retrieved on: 
Thursday, May 4, 2023
Faculty, ICIS, Partnership, Drug development, ICI, Ligand, Cancer, Henney Kilowatt, Biomarker, Immunotherapy, Oncology, Patient, Physician, Medicine, PD-L2, BGU, Diagnosis, Ben-Gurion University of the Negev, PD-1, PD-L1, Palladium, Pharmaceutical industry, Medical imaging

BEER-SHEVA, Israel and BINYAMINA, Israel, May 4, 2023 /PRNewswire/ -- OncoHost, a technology company transforming the approach to precision medicine for improved patient outcomes, today announced that it has signed an option agreement with BGN Technologies, the technology transfer company of Ben-Gurion University of the Negev (BGU), to receive a license for a novel biosensing technology called IcAR (Immuno-checkpoint Artificial Reporter). IcAR was developed by a team of researchers from BGU.

Key Points: 
  • With only 20-40% of cancer patients responding to immune checkpoint inhibitor (ICI) treatment, better biomarkers are desperately needed.
  • The IcAR biosensing technology measures the binding functionality of PD-1 ligands, PD-L1 and PD-L2, to their receptor, PD-1.
  • "IcAR technology is expected to be a game-changer in the world of cancer treatment diagnostics," said Prof. Elkabets.
  • In the future, this bioassay technology may help predict response to additional ICI therapies and could be used to tailor personalized treatment protocols.

KEYTRUDA Market Drug Insight and Market Forecast 2023-2032: Competition with other Emerging Therapies Heats Up - ResearchAndMarkets.com

Retrieved on: 
Tuesday, February 21, 2023
Health, Pharmaceutical, Clinical trial, MSI-H, Ligand, Pembrolizumab, Pancreatic cancer, Immune system, PD-1, Research, United Kingdom, FDA, PD-L1, PD-L2, Patient, EU4, SWOT, Neoplasm, Pharmaceutical industry, Palladium

The "KEYTRUDA Market Drug Insight and Market Forecast - 2032" report has been added to ResearchAndMarkets.com's offering.

Key Points: 
  • The "KEYTRUDA Market Drug Insight and Market Forecast - 2032" report has been added to ResearchAndMarkets.com's offering.
  • Further, it also consists of future market assessments inclusive of the KEYTRUDA market forecast analysis for pancreatic cancer in the 7MM, SWOT, analysts' views, comprehensive overview of market competitors, and brief about other emerging therapies in pancreatic cancer.
  • Other emerging products for pancreatic cancer are expected to give tough market competition to KEYTRUDA and launch of late-stage emerging therapies in the near future will significantly impact the market.
  • What are the other emerging products available and how are these giving competition to KEYTRUDA for pancreatic cancer?

Junshi Biosciences Receives NMPA Approval of sNDA for Toripalimab in Combination with Chemotherapy as First-Line Treatment for Advanced Non-squamous Non-Small Cell Lung Cancer

Retrieved on: 
Tuesday, September 20, 2022
OS, World, Safety, Lancet, ALK, PD-L2, Society, Shaukat Khanum Memorial Cancer Hospital and Research Centre, Patient, Hospital, Somatic mutation, Research, Death, EUA, COVID-19, HKEX, NSCLC, National Medical Products Administration, Program, Ligand, SSE, Microbiology, NMPA, Mortality, EGFR, Peking Union Medical College, Autoimmunity, Junshi, Risk, FDA, ASCO, Social responsibility, Severe acute respiratory syndrome coronavirus 2, Bamlanivimab/etesevimab, Medicine, Progression-free survival, GLOBE, Marketing, Platinum, HIV disease progression rates, Cancer, Development, Incidence, World Health Organization, American Society of Clinical Oncology, Lung cancer, Pemetrexed, Lung, HR, PD-L1, PD-1, Bamlanivimab, Lilly, PFS, Infection, Pharmaceutical industry, Chinese, Science

This is the sixth indication approved for toripalimab in China and will bring more treatment options to Chinese patients with advanced NSCLC.

Key Points: 
  • This is the sixth indication approved for toripalimab in China and will bring more treatment options to Chinese patients with advanced NSCLC.
  • Professor Jie Wang from the Cancer Hospital, Chinese Academy of Medical Sciences elaborated on toripalimabs performance in clinical trials.
  • In China, the number of lung cancer patients is massive and so is the demand for treatment.
  • Junshi Biosciences has more than 3,100 employees in the United States (San Francisco and Maryland) and China (Shanghai, Suzhou, Beijing, Guangzhou, etc).

Merck Provides Update on Phase 3 KEYNOTE-412 Trial in Unresected Locally Advanced Head and Neck Squamous Cell Carcinoma

Retrieved on: 
Wednesday, July 20, 2022
Oncology, Health, Clinical Trials, General Health, Pharmaceutical, Biotechnology, MSD, Cisplatin, Patient, Infection, Selection, Neoplasm, Peripheral tolerance, Fluorouracil, Creatinine, Diarrhea, MRK, Squamous cell carcinoma, Merck & Co., HPV, Pembrolizumab, TNBC, CRT, PD-L2, Tobacco, NYSE, PD-1, Radiation, Biomarker, Pneumonitis, Incidence, Larynx, Risk, CPS, Adult, Safety, Head, Cancer, HIV disease progression rates, Recurrence, PD-L1, Disease, FDA, Platinum, Fourth grade, EFS, Neck, Survival, Ligand, Death, Prednisone, Mouth, CHL, PD-1 and PD-L1 inhibitors, Nose, Pharmaceutical industry, Vaccine, HNSCC, Cytomegalovirus, Merck

KEYNOTE-412 is a randomized, double-blind Phase 3 trial (ClinicalTrials.gov, NCT03040999 ) evaluating KEYTRUDA with concurrent CRT, followed by KEYTRUDA as maintenance therapy for the treatment of patients with unresected locally advanced HNSCC.

Key Points: 
  • KEYNOTE-412 is a randomized, double-blind Phase 3 trial (ClinicalTrials.gov, NCT03040999 ) evaluating KEYTRUDA with concurrent CRT, followed by KEYTRUDA as maintenance therapy for the treatment of patients with unresected locally advanced HNSCC.
  • Most head and neck cancers are squamous cell carcinomas that begin in the flat, squamous cells that make up the thin surface layer of the structures in the head and neck.
  • KEYTRUDA is indicated for the treatment of adult and pediatric patients with recurrent locally advanced or metastatic Merkel cell carcinoma (MCC).
  • KEYTRUDA is indicated for the treatment of patients with recurrent or metastatic cutaneous squamous cell carcinoma (cSCC) or locally advanced cSCC that is not curable by surgery or radiation.

Junshi Biosciences and Coherus Announce FDA Acceptance of Resubmission of BLA for Toripalimab for the Treatment of Nasopharyngeal Carcinoma

Retrieved on: 
Wednesday, July 6, 2022
Patient, Nose, Biosimilar, GLOBE, Marketing, COVID-19, Biologics license application, Pharynx, PD-L2, Ranibizumab, Drug development, EUA, Primary tumor, Severe acute respiratory syndrome coronavirus 2, National Medical Products Administration, FDA, Bamlanivimab, Infection, Journal of Clinical Oncology, Skull, NMPA, Breakthrough therapy, Agency, Immunotherapy, Travel, Autoimmunity, SSE, CEO, Blas, NPC, Orphan drug, American Society of Clinical Oncology, Lilly, Nasopharyngeal carcinoma, Private Securities Litigation Reform Act, Social responsibility, HKEX, Review, Journal, Cisplatin, Bamlanivimab/etesevimab, Ligand, HIV disease progression rates, Nature Medicine, PD-1, U.S. Securities and Exchange Commission, United, PD-L1, Risk, Cancer, Radiation, PDUFA, Society, BLA, Medical device, Pharmaceutical industry, Science

SHANGHAI, China and REDWOOD CITY, Calif., July 06, 2022 (GLOBE NEWSWIRE) -- Shanghai Junshi Biosciences Co., Ltd. (“Junshi Biosciences”, HKEX: 1877; SSE: 688180) and Coherus BioSciences, Inc. (“Coherus”) announced today that the United States Food and Drug Administration ("FDA") has accepted for review the Biologics License Application (“BLA”) resubmission for toripalimab in combination with gemcitabine and cisplatin as first-line treatment for patients with advanced recurrent or metastatic nasopharyngeal carcinoma (“NPC”) and for toripalimab monotherapy for the second-line or later treatment of recurrent or metastatic NPC after platinum-containing chemotherapy.

Key Points: 
  • Over the next several months, we will work closely with the FDA to facilitate the review of this novel drug.
  • Toripalimab would address a critical unmet medical need for patients with nasopharyngeal carcinoma, an aggressive cancer for which there are currently no FDA-approved immunotherapy treatments.
  • We collaborated closely with our partner, Junshi Biosciences, to complete the quality process changes requested by the FDA and facilitate the rapid resubmission of the toripalimab BLA, said Dr. Theresa LaVallee, Chief Development Officer of Coherus.
  • The resubmission of the BLA for toripalimab for the treatment of NPC was accepted by the FDA in July 2022.

Coherus and Junshi Biosciences Announce FDA Acceptance of Resubmission of BLA for Toripalimab for the Treatment of Nasopharyngeal Carcinoma

Retrieved on: 
Wednesday, July 6, 2022
Patient, Nose, Biosimilar, GLOBE, Marketing, COVID-19, Biologics license application, Pharynx, PD-L2, Ranibizumab, Drug development, EUA, Primary tumor, Severe acute respiratory syndrome coronavirus 2, National Medical Products Administration, FDA, Bamlanivimab, Infection, Journal of Clinical Oncology, Skull, NMPA, Breakthrough therapy, Agency, Immunotherapy, CHRS, Travel, Autoimmunity, SSE, CEO, Blas, NPC, Orphan drug, American Society of Clinical Oncology, Lilly, Nasopharyngeal carcinoma, Private Securities Litigation Reform Act, Social responsibility, HKEX, Review, Journal, Cisplatin, Bamlanivimab/etesevimab, Ligand, HIV disease progression rates, Nature Medicine, PD-1, U.S. Securities and Exchange Commission, United, PD-L1, Risk, Cancer, Radiation, PDUFA, Society, BLA, Medical device, Pharmaceutical industry, Science

REDWOOD CITY, Calif., and SHANGHAI, China, July 06, 2022 (GLOBE NEWSWIRE) -- Coherus BioSciences, Inc. (“Coherus”, Nasdaq: CHRS) and Shanghai Junshi Biosciences Co., Ltd. (“Junshi Biosciences”, HKEX: 1877; SSE: 688180) announced today that the United States Food and Drug Administration ("FDA") has accepted for review the Biologics License Application (“BLA”) resubmission for toripalimab in combination with gemcitabine and cisplatin as first-line treatment for patients with advanced recurrent or metastatic nasopharyngeal carcinoma (“NPC”) and for toripalimab monotherapy for the second-line or later treatment of recurrent or metastatic NPC after platinum-containing chemotherapy.

Key Points: 
  • Toripalimab would address a critical unmet medical need for patients with nasopharyngeal carcinoma, an aggressive cancer for which there are currently no FDA-approved immunotherapy treatments.
  • We collaborated closely with our partner, Junshi Biosciences, to complete the quality process changes requested by the FDA and facilitate the rapid resubmission of the toripalimab BLA, said Dr. Theresa LaVallee, Chief Development Officer of Coherus.
  • Over the next several months, we will work closely with the FDA to facilitate the review of this novel drug.
  • The resubmission of the BLA for toripalimab for the treatment of NPC was accepted by the FDA in July 2022.

European Commission Approves KEYTRUDA® (pembrolizumab) as Adjuvant Treatment for Adult and Adolescent Patients (≥12 Years of Age) With Stage IIB or IIC Melanoma Following Complete Resection

Retrieved on: 
Friday, June 24, 2022
FDA, Health, Clinical Trials, General Health, Pharmaceutical, Biotechnology, MSD, Patient, Research, IIIC, Peripheral tolerance, EC, Fourth grade, Marketing, Growth, Cancer, Pneumonitis, Skin cancer, Royal commission, Princess, Incidence, PD-L2, Recurrence, Melanoma, IIC, Pembrolizumab, MRK, Population, Ageing, CHL, NYSE, Diarrhea, RFS, III, Death, Infection, European Commission, Survival, Adult, Creatinine, Merck & Co., Ligand, Adolescence, Biomarker, IIB, Prednisone, Disease, PD-1, PD-1 and PD-L1 inhibitors, Prognosis, PD-L1, Risk, Selection, Toxicity, TNBC, Safety, Vaccine, Pharmaceutical industry, Medical imaging, Medical device, Merck, EU, Cytomegalovirus

Additionally, the EC approved expanding the indications for KEYTRUDA in advanced (unresectable or metastatic) melanoma and stage III melanoma (as adjuvant treatment following complete resection) to include adolescent patients aged 12 years and older.

Key Points: 
  • Additionally, the EC approved expanding the indications for KEYTRUDA in advanced (unresectable or metastatic) melanoma and stage III melanoma (as adjuvant treatment following complete resection) to include adolescent patients aged 12 years and older.
  • In the EU, KEYTRUDA was previously approved for the treatment of adult patients with advanced (unresectable or metastatic) melanoma and for the adjuvant treatment of adult patients with stage III melanoma and lymph node involvement who have undergone complete resection.
  • Selected KEYTRUDA (pembrolizumab) Indications in the U.S.
    KEYTRUDA is indicated for the treatment of patients with unresectable or metastatic melanoma.
  • KEYTRUDA is indicated for the adjuvant treatment of adult and pediatric (12 years and older) patients with stage IIB, IIC, or III melanoma following complete resection.

Merck Receives Positive EU CHMP Opinion for KEYTRUDA® (pembrolizumab) as Adjuvant Treatment for Adult and Adolescent (≥12 Years of Age) Patients With Stage IIB or IIC Melanoma Following Complete Resection

Retrieved on: 
Friday, May 20, 2022
Biotechnology, Health, Pharmaceutical, Clinical Trials, Oncology, MSD, Royal commission, Cancer, MRK, PD-1 and PD-L1 inhibitors, IIB, Risk, Creatinine, Death, Disease, Ageing, Annual general meeting, PD-L2, Survival, Fourth grade, Ligand, Incidence, Adolescence, Abstract, Infection, European Commission, Patient, IIIC, PD-1, Pneumonitis, Skin cancer, Society, TNBC, American Society of Clinical Oncology, Adult, Peripheral tolerance, CHL, Research, PD-L1, Pembrolizumab, Recurrence, CHMP, European Medicines Agency, Prednisone, III, Selection, Union, ASCO, Biomarker, Growth, European Directive on Traditional Herbal Medicinal Products, Diarrhea, IIC, NYSE, Merck & Co., Melanoma, Vaccine, Pharmaceutical industry, Medical imaging, Medical device, Cytomegalovirus, Merck

Additionally, the CHMP recommended expanding the indications for KEYTRUDA in advanced (unresectable or metastatic) melanoma and stage III melanoma (as adjuvant treatment following complete resection) to include adolescent patients aged 12 years and older.

Key Points: 
  • Additionally, the CHMP recommended expanding the indications for KEYTRUDA in advanced (unresectable or metastatic) melanoma and stage III melanoma (as adjuvant treatment following complete resection) to include adolescent patients aged 12 years and older.
  • 0.00658) in patients 12 years and older with stage IIB and IIC melanoma following complete resection.
  • KEYTRUDA is indicated for the adjuvant treatment of adult and pediatric (12 years and older) patients with stage IIB, IIC, or III melanoma following complete resection.
  • Pneumonitis occurred in 8% (31/389) of adult patients with cHL receiving KEYTRUDA as a single agent, including Grades 3-4 in 2.3% of patients.

OSE Immunotherapeutics Receives First Notice of Allowance for a US Patent Covering Anti-PD1 Monoclonal Antibody OSE-279 And its Use in Cancer Treatment

Retrieved on: 
Monday, March 21, 2022
IL-7, Mnemos EP, United States Patent and Trademark Office, Epitope, Inflammation, Degenerative disease, Partnership, Patent, Ligand, Cancer, Transplant, Immunotherapy, PD-L2, Clinical trial, IND, Tumor microenvironment, Ulcerative colitis, Mab, Fortification, USPTO, Tissue, PD-1, Autoimmune disease, ISIN, Immune system, Boehringer Ingelheim, OSE, COVID-19, GLOBE, Nivolumab, PD-L1, Patient, Pancreatic cancer, Large-cell lung carcinoma, Fine chemical, Pharmaceutical industry, Vaccine

This patent will strengthen the global intellectual property of OSE-279 and will provide the product protection until 2039.

Key Points: 
  • This patent will strengthen the global intellectual property of OSE-279 and will provide the product protection until 2039.
  • OSE-279 is a humanized anti-PD1 monoclonal antibody blocking PD-L1 and PD-L2, the ligands of PD1 overexpressed by tumor cells.
  • Upregulation of PD-L1 and PD-L2 on tumor cells and other cell types of the tumor microenvironment is a proposed mechanism of tumor immune escape.
  • OSE Immunotherapeutics is an integrated biotechnology company focused on developing and partnering therapies to control the immune system for immuno-oncology and autoimmune diseases.