Ipilimumab

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: 
torsdag, maj 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

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onsdag, maj 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: 
tisdag, maj 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: 
fredag, maj 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

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måndag, maj 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: 
måndag, maj 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: 
måndag, maj 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: 
onsdag, april 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.

Corvus Pharmaceuticals Provides Business Update and Reports Fourth Quarter and Full Year 2023 Financial Results

Retrieved on: 
tisdag, mars 19, 2024
Atopic dermatitis, Head, T helper cell, HNSCC, Patient, PTCL, Lung cancer, Ipilimumab, Asthma, CTCL, ALCL, Fungal infection, Pulmonary fibrosis, Lymphocyte, RCC, Clinical trial, CRS, Marketing, B-cell lymphoma, Research, PR, PTCL-NOS, Psoriasis, T-cell lymphoma, ASH, Webcast, Immunomodulation, Pembrolizumab, PRS, Exposition, Cancer, Nivolumab, Safety, Scleroderma, Food, NSCLC, Teva Pharmaceuticals, Modified, Lymphoma, Knowledge, Allergy, Immunodeficiency, Time management, Peripheral, Poster, FDA, ITK, Conference call, Kidney cancer, T helper 17 cell, Society, Preprint, BioRxiv, Autoimmunity, Physician, Total, Pharmaceutical industry

BURLINGAME, Calif., March 19, 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 fourth quarter and year ended December 31, 2023.

Key Points: 
  • ET / 1:30 p.m. PT
    BURLINGAME, Calif., March 19, 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 fourth quarter and year ended December 31, 2023.
  • We have several exciting opportunities in immunology, including plans for a randomized, placebo controlled clinical trial of soquelitinib in atopic dermatitis.
  • Mr. Arcara previously served as senior vice president, head global marketing & portfolio and strategy for the innovative medicines and biosimilars business at Teva Pharmaceuticals.
  • ET (1:30 p.m. PT), during which time management will provide a business update and discuss the fourth quarter and full year 2023 financial results.

MaaT Pharma Announces 2023 Annual Results and Provides a Business Overview

Retrieved on: 
torsdag, mars 28, 2024
Biotechnology, Pharmaceutical, Finance, Oncology, Health, FDA, Professional Services, Clinical Trials, AP-HP, Bone marrow, Survival, Immunotherapy, Patient, Innovation, IND, Ipilimumab, European Medicines Agency, Therapy, Artificial intelligence, Charcot disease, ASH, EMA, Head, MET, Investigational New Drug, Nivolumab, Safety, SITC, Microbiome, Food, ODD, Development, Acceleration, Maat, ARES, Cancer, AACR, DSMB, Haematopoietic system, Annual general meeting, OS, EUR, Physician, CIMON, CGMP, EAP, EBMT, ICI, Society, Randomized controlled trial, Symantec Endpoint Protection, Pharmaceutical industry

MaaT Pharma (EURONEXT: MAAT – the “Company”), a clinical-stage biotechnology company and a leader in the development of Microbiome Ecosystem TherapiesTM (MET) dedicated to enhancing survival of patients with cancer, today reported the full-year 2023 annual results and provided a business overview.

Key Points: 
  • MaaT Pharma (EURONEXT: MAAT – the “Company”), a clinical-stage biotechnology company and a leader in the development of Microbiome Ecosystem TherapiesTM (MET) dedicated to enhancing survival of patients with cancer, today reported the full-year 2023 annual results and provided a business overview.
  • In December 2023 , the Company presented positive results from the Early Access Program (EAP) in Europe involving 111 patients with aGvHD treated with MaaT013, at the 2023 American Society of Hematology (ASH) Annual Meeting.
  • In April 2023 , data from the Phase 1b study (CIMON) with MaaT033, previously communicated during the 64th annual ASH meeting, were also presented at the EBMT 2023 conference.
  • During 2023 and Q1 2024, MaaT Pharma reinforced its board of directors, executive team, and key functions:
    Karim Dabbagh as Chairman and Nadia Kamal as Director, both independent.