Ipilimumab

TriSalus Life Sciences Highlights Clinical Data from Phase 1b PERIO-02 Trial, Studying Delivery of Nelitolimod via Pressure-Enabled Drug Delivery in Patients with Hepatocellular Carcinoma or Intrahepatic Cholangiocarcinoma at 2024 ASCO Annual Meeting

Retrieved on: 
月曜日, 6月 3, 2024
Oncology, Health, Clinical Trials, Research, Science, Pharmaceutical, Biotechnology, FACS, Therapy, ASCO, Hepatocellular carcinoma, IDO, Plasma, TME, CD73, Patient, CD8, Cancer, Blood, Annual general meeting, Liver, Ipilimumab, HAI, Liver disease, Gene expression, Immunotherapy, Society, Publication, CD4, Cohort, NT5E, Region, PFS, IL-2R, Pressure, CXCL10, Neoplasm, HCC, Liver tumor, Tumor microenvironment, ICC, University, MD Anderson Cancer Center, Poster, Medical imaging

The PERIO-02 clinical trial is the hepatic arterial infusion (HAI) of nelitolimod with the PEDD method to enhance tumor response in combination with intravenous checkpoint inhibition in adults with Hepatocellular Carcinoma (HCC) or Intrahepatic Cholangiocarcinoma (ICC).

Key Points: 
  • The PERIO-02 clinical trial is the hepatic arterial infusion (HAI) of nelitolimod with the PEDD method to enhance tumor response in combination with intravenous checkpoint inhibition in adults with Hepatocellular Carcinoma (HCC) or Intrahepatic Cholangiocarcinoma (ICC).
  • PERIO-02 is an open-label phase 1 trial of nelitolimod given by the PEDD method in HCC and ICC.
  • Additionally, a copy of the poster will be available on the publications page of the TriSalus website.
  • Title: PERIO-02: Phase 1b Pressure Enabled Regional Immuno-oncology Trial of nelitolimod (SD-101), a Class C TLR9 agonist, delivered via hepatic artery infusion +/- checkpoint inhibition in intrahepatic cholangiocarcinoma and hepatocellular carcinoma

Bristol Myers Squibb Presents Multiple New Analyses at 2024 ASCO® Annual Meeting Highlighting Opdivo and Opdivo-based Combinations in Early and Advanced Stages of Non-Small Cell Lung Cancer

Retrieved on: 
月曜日, 6月 3, 2024
Biotechnology, Health, Pharmaceutical, Clinical Trials, Oncology, Collection, ASCO, Patient, Annual general meeting, European Medicines Agency, Checkmate, Immunotherapy, HR, Society, Hope, EFS, Docetaxel, BMY, OS, PFS, Disease, Abstract, Food, Bristol Myers Squibb, Lung cancer, Progression-free survival, Ipilimumab, Neoplasm, Survival, Research, Recurrence, Pharmaceutical industry

Data are being presented at the 2024 American Society of Clinical Oncology (ASCO®) Annual Meeting from May 31 to June 4, 2024, in Chicago, IL.

Key Points: 
  • Data are being presented at the 2024 American Society of Clinical Oncology (ASCO®) Annual Meeting from May 31 to June 4, 2024, in Chicago, IL.
  • No new safety signals were observed with Opdivo plus Yervoy with two cycles of chemotherapy with this extended follow-up.
  • Opdivo and Opdivo-based combinations are approved in four indications in NSCLC, including in neoadjuvant and metastatic treatment settings.
  • Bristol Myers Squibb thanks the patients and investigators participating in the CheckMate -816, CheckMate -77T and CheckMate -9LA clinical trials.

BioAtla Presenting Phase 1 Evalstotug Clinical Trial Data Demonstrating Clinical Benefit at the Upcoming 2024 American Society of Clinical Oncology (ASCO) Annual Meeting

Retrieved on: 
木曜日, 5月 23, 2024
Conditional, Patient, PFS, SAN, NSCLC, CAB, Ipilimumab, PD-1, ASCO, Poster, Carcinoma, Society, Observation, BRAF, Therapy, DLT, Nivolumab, Annual general meeting, Pharmaceutical industry

SAN DIEGO, May 23, 2024 (GLOBE NEWSWIRE) -- BioAtla, Inc. (Nasdaq: BCAB), a global clinical-stage biotechnology company focused on the development of Conditionally Active Biologic (CAB) antibody therapeutics for the treatment of solid tumors, today announced expanded data at an upcoming presentation entitled, “Phase 1 study of evalstotug (BA3071), an anti-CTLA-4 Conditionally Active Biologic, in combination with nivolumab in advanced solid tumors”, demonstrating confirmed responses with a potentially differentiated tolerability profile with the Company’s novel, conditionally active anti-CTLA-4 agent, evalstotug, in combination with anti-PD-1 therapy. The poster will be presented at the upcoming 2024 American Society of Clinical Oncology (ASCO) Annual Meeting at the McCormick Place Convention Center in Chicago, Illinois on Saturday, June 1, 2024.

Key Points: 
  • The poster will be presented at the upcoming 2024 American Society of Clinical Oncology (ASCO) Annual Meeting at the McCormick Place Convention Center in Chicago, Illinois on Saturday, June 1, 2024.
  • “Given the emerging clinical profile observed, we believe evalstotug has the potential to be best-in-class CTLA-4 antibody and holds the promise to be used as often as a PD-1 inhibitor,” said Jay M. Short, Ph.D., Chairman, Chief Executive Officer and co-founder of BioAtla, Inc. “Strikingly, we have observed prolonged PFS of greater than 10 months and confirmed responses at high doses (350 mg), of evalstotug, suggesting increased exposure of CTLA-4 blockade in combination with PD-1 inhibition drives clinical benefit.
  • We continue to enroll in the Phase 2 first-line melanoma and mutated NSCLC combination cohorts at the 700 mg flat dose and we anticipate moving to the 1 gram flat dose in June following clearance of the DLT observation period and remain on track for monotherapy and combination data readouts later this year.
  • We anticipate enabling a Phase 3 trial of evalstotug in first-line metastatic or unresectable BRAF-mutated melanoma in the second half of this year.

Anavex Life Sciences Announces Expansion of Leadership Team

Retrieved on: 
水曜日, 5月 22, 2024
Marketing, Drug, Gen-Probe, European Medicines Agency, FDA, Drug development, North Carolina State University, Senior, Rett syndrome, HCV, Therapy, Pharmacology, Clinical research, Ritonavir, MD, James Madison University, Ipilimumab, AbbVie, CNS, Clinical pharmacology, Bristol Myers Squibb, New Drug Application, Arena Pharmaceuticals, Nobel Prize, Schizophrenia, Nivolumab, Amylin Pharmaceuticals, Yale University, Molecular biology, Pharmacokinetics, Doctor of Philosophy, Acer, Rochester Institute of Technology, Research and development, University, Overalls, Pramlintide, Intercept Pharmaceuticals, DSM-IV codes, Assistant, EMA, DMPK, Roche, Development, Central nervous system, Pharmaceutical industry

“The most important part of building a long-term, commercially sustainable, growing business is putting the right players on the field,” said Christopher U. Missling, PhD, President and Chief Executive Officer of Anavex.

Key Points: 
  • “The most important part of building a long-term, commercially sustainable, growing business is putting the right players on the field,” said Christopher U. Missling, PhD, President and Chief Executive Officer of Anavex.
  • Prior to Anavex Dr. Lopez-Talavera held key leadership positions at Fractyl Health, Intercept Pharmaceuticals, AbbVie, Bristol Myers Squibb and Roche.
  • Dr. Edwards brings to Anavex 18 years of experience in various aspects of drug development including DMPK (drug metabolism and pharmacokinetics), Clinical Pharmacology, and Clinical Science.
  • Before joining Anavex, Dr. Edwards served as Vice President of Clinical Science at Acer Therapeutics, and positions of increasing responsibility at Madrigal Pharmaceuticals, Intercept Pharmaceuticals, Amylin Pharmaceuticals, and Arena Pharmaceuticals.

Bristol Myers Squibb Announces Updated Action Date by the U.S. Food and Drug Administration for Subcutaneous Nivolumab (nivolumab and hyaluronidase)

Retrieved on: 
火曜日, 5月 21, 2024
Oncology, FDA, Health, Clinical Trials, Pharmaceutical, Biotechnology, Bristol Myers Squibb, Food, BMY, Safety, PDUFA, Ipilimumab, PD-1, Biologics license application, BLA, Nivolumab, Checkmate, Pharmaceutical industry

Bristol Myers Squibb (NYSE: BMY) today announced that the U.S. Food and Drug Administration (FDA) has reassigned the previously announced Prescription Drug User Fee Act (PDUFA) goal date of the Biologics License Application (BLA) for the subcutaneous formulation of Opdivo® (nivolumab) co-formulated with Halozyme’s proprietary recombinant human hyaluronidase (rHuPH20) (herein referred to as “subcutaneous nivolumab”) across all previously approved adult, solid tumor Opdivo indications as monotherapy, monotherapy maintenance following completion of Opdivo plus Yervoy (ipilimumab) combination therapy, or in combination with chemotherapy or cabozantinib.

Key Points: 
  • Bristol Myers Squibb (NYSE: BMY) today announced that the U.S. Food and Drug Administration (FDA) has reassigned the previously announced Prescription Drug User Fee Act (PDUFA) goal date of the Biologics License Application (BLA) for the subcutaneous formulation of Opdivo® (nivolumab) co-formulated with Halozyme’s proprietary recombinant human hyaluronidase (rHuPH20) (herein referred to as “subcutaneous nivolumab”) across all previously approved adult, solid tumor Opdivo indications as monotherapy, monotherapy maintenance following completion of Opdivo plus Yervoy (ipilimumab) combination therapy, or in combination with chemotherapy or cabozantinib.
  • The updated goal date is December 29, 2024.
  • The application is based on results from CheckMate -67T, the first Phase 3 trial of the subcutaneous formulation of nivolumab to evaluate and demonstrate noninferior pharmacokinetics, efficacy and consistent safety vs. its intravenous formulation.
  • If approved, subcutaneous nivolumab has the potential to be the first and only subcutaneously administered PD-1 inhibitor.

Bristol Myers Squibb Provides Update on Phase 3 CheckMate -73L Trial

Retrieved on: 
金曜日, 5月 10, 2024
Oncology, Health, FDA, General Health, Clinical Trials, Pharmaceutical, Biotechnology, Bristol Myers Squibb, Patient, Progression-free survival, Lung cancer, BMY, PFS, Drug development, CCRT, NSCLC, Ipilimumab, Chemoradiotherapy, Immunotherapy, Checkmate, Pharmaceutical industry

Bristol Myers Squibb (NYSE: BMY) today announced the Phase 3 CheckMate -73L trial did not meet its primary endpoint of progression-free survival (PFS) in unresectable, locally advanced stage III non-small cell lung cancer (NSCLC).

Key Points: 
  • Bristol Myers Squibb (NYSE: BMY) today announced the Phase 3 CheckMate -73L trial did not meet its primary endpoint of progression-free survival (PFS) in unresectable, locally advanced stage III non-small cell lung cancer (NSCLC).
  • CheckMate -73L evaluated Opdivo® (nivolumab) with concurrent chemoradiotherapy (CCRT) followed by Opdivo plus Yervoy® (ipilimumab) versus CCRT followed by durvalumab in patients with unresectable stage III NSCLC.
  • “Unfortunately, adding immunotherapy concurrently with definitive chemoradiation did not improve PFS outcomes in this setting,” said Joseph Fiore, vice president, global program lead, thoracic cancers, Bristol Myers Squibb.
  • Opdivo and Opdivo-based combinations have shown positive outcomes and are approved treatment options for eligible patients with resectable or metastatic NSCLC.

Corvus Pharmaceuticals Provides Business Update and Reports First Quarter 2024 Financial Results

Retrieved on: 
月曜日, 5月 6, 2024
FDA, Total, ITK, Research, PTCL, PR, Doctor of Philosophy, Webcast, Fungal infection, Atopic dermatitis, RCC, Lymphoma, Vanderbilt University Medical Center, Lung cancer, Conference call, Kidney cancer, Conference, CRS, Peripheral, Assistant, PRS, NSCLC, Patient, Safety, Pembrolizumab, Modified, CTCL, Time management, Clinical trial, Division, Sale, A2A, Adenosine, HNSCC, T-cell lymphoma, Nivolumab, Ipilimumab, B-cell lymphoma, Disease, ALCL, Physician, Head, PTCL-NOS, Pharmaceutical industry

BURLINGAME, Calif., May 06, 2024 (GLOBE NEWSWIRE) -- Corvus Pharmaceuticals, Inc. (Corvus or the Company) (Nasdaq: CRVS) (GLOBAL NEWSWIRE), a clinical-stage biopharmaceutical company, today provided a business update and reported financial results for the first quarter ended March 31, 2024.

Key Points: 
  • ET / 1:30 p.m. PT
    BURLINGAME, Calif., May 06, 2024 (GLOBE NEWSWIRE) -- Corvus Pharmaceuticals, Inc. (Corvus or the Company) (Nasdaq: CRVS) (GLOBAL NEWSWIRE), a clinical-stage biopharmaceutical company, today provided a business update and reported financial results for the first quarter ended March 31, 2024.
  • Corvus anticipates initiating a registrational Phase 3 clinical trial of soquelitinib in patients with relapsed PTCL in the third quarter of 2024.
  • Corvus will host a conference call and webcast today, Monday, May 6, 2024, at 4:30 p.m.
  • ET (1:30 p.m. PT), during which time management will provide a business update and discuss the first quarter 2024 financial results.

U.S. Food and Drug Administration Accepts Bristol Myers Squibb’s Application for Subcutaneous Nivolumab (nivolumab and hyaluronidase)

Retrieved on: 
月曜日, 5月 6, 2024
Oncology, FDA, Health, Clinical Trials, Pharmaceutical, Biotechnology, Cancer, BMY, Safety, Pharmacokinetics, Food, Ipilimumab, Research, Biologics license application, PD-1, ASCO, PDUFA, Checkmate, Patient, Society, Physician, Serum, BLA, Bristol Myers Squibb, File, Pharmaceutical industry

The FDA assigned a Prescription Drug User Fee Act (PDUFA) goal date of February 28, 2025.

Key Points: 
  • The FDA assigned a Prescription Drug User Fee Act (PDUFA) goal date of February 28, 2025.
  • “We believe subcutaneous nivolumab has the potential to make a significant difference in the lives of patients, which is reinforced by the FDA’s acceptance of our application,” said Gina Fusaro, Ph.D., vice president, global program lead, Bristol Myers Squibb.
  • Additionally, subcutaneous nivolumab showed noninferiority of the key powered secondary endpoint of objective response rate (ORR) as assessed by Blinded Independent Central Review (BICR) vs. IV Opdivo.
  • The safety profile of subcutaneous nivolumab was consistent with the IV formulation.

European Medicines Agency Validates Bristol Myers Squibb’s Application for Opdivo (nivolumab) Plus Yervoy (ipilimumab) for the First-Line Treatment of Adult Patients with Microsatellite...

Retrieved on: 
月曜日, 5月 6, 2024
Science, Biotechnology, Research, Pharmaceutical, Oncology, Health, FDA, Clinical Trials, Type 2, PFS, Cancer, BMY, Nivolumab, MSI-H, Ipilimumab, Progression-free survival, Immunotherapy, ASCO, Checkmate, Patient, Society, EMA, Bristol Myers Squibb, European Medicines Agency, Pharmaceutical industry

Bristol Myers Squibb (NYSE: BMY) today announced that the European Medicines Agency (EMA) has validated its Type II variation application for Opdivo® (nivolumab) plus Yervoy® (ipilimumab) for the first-line treatment of adult patients with microsatellite instability–high (MSI-H) or mismatch repair deficient (dMMR) metastatic colorectal cancer (mCRC).

Key Points: 
  • Bristol Myers Squibb (NYSE: BMY) today announced that the European Medicines Agency (EMA) has validated its Type II variation application for Opdivo® (nivolumab) plus Yervoy® (ipilimumab) for the first-line treatment of adult patients with microsatellite instability–high (MSI-H) or mismatch repair deficient (dMMR) metastatic colorectal cancer (mCRC).
  • The EMA’s validation of the application confirms the submission is complete and begins the EMA’s centralized review process.
  • The study is ongoing to assess the other dual primary endpoint of PFS in patients receiving Opdivo plus Yervoy compared to Opdivo alone, as well as secondary endpoints.
  • Bristol Myers Squibb thanks the patients and investigators involved in the CheckMate -8HW clinical trial.

Immunocore announces upcoming presentation and posters at ASCO 2024

Retrieved on: 
水曜日, 4月 24, 2024
ImmTAC, Cancer, Nivolumab, Ipilimumab, Infection, Webcast, Immunocore, PRAME, ASCO, Patient, Society, Annual general meeting, Communications satellite

ET

Key Points: 
  • ET
    Session: Poster Session – Melanoma/Skin Cancers, Saturday 1 June 2024, 1:30-4:30 p.m. CT / 12:30-3:30 p.m.
  • ET
    Session: Poster Session – Melanoma/Skin Cancers, Saturday 1 June 2024, 1:30-4:30 p.m. CT / 12:30-3:30 p.m.
  • ET
    Session: Poster Session – Melanoma/Skin Cancers, Saturday 1 June 2024, 1:30-4:30 p.m. CT / 12:30-3:30 p.m.
  • ET
    Session: Poster Session – Melanoma/Skin Cancers, Saturday 1 June 2024, 1:30-4:30 p.m. CT / 12:30-3:30 p.m.