MAB

Dyadic Announces Publication of C1 Monoclonal Antibody in Nonhuman Primate Study in Nature Communications

Retrieved on: 
Tuesday, March 26, 2024
CHO, Science, Manuscript, C1, SARS-CoV-2, Infection, Clinical trial, Veterinary medicine, Safety, Vaccine, Nature Communications

The first trial using a C1 produced monoclonal antibody provides equivalent protection against SARS-CoV-2 in hamster and nonhuman primate models compared to monoclonal antibody produced in CHO.

Key Points: 
  • The first trial using a C1 produced monoclonal antibody provides equivalent protection against SARS-CoV-2 in hamster and nonhuman primate models compared to monoclonal antibody produced in CHO.
  • "The study characterized the in vitro activity of a monoclonal antibody (mAb) produced by C1 cells (designated "HuMab 87G7") and demonstrated its protective efficacy for both prophylactic and therapeutic applications in hamsters and non-human primates without causing antibody-mediated enhanced virus replication.
  • A mounting body of evidence, from both ourselves and an expanding community of scientists worldwide, supporting the use of Dyadic's C1 expression system as a versatile production platform.
  • To view the online publication of “Filamentous fungus-produced human monoclonal antibody provides protection against SARS-CoV-2 in hamster and nonhuman primate models”, please visit nature communications or follow the link below:

Antengene Presents Four Preclinical Posters at AACR 2024

Retrieved on: 
Saturday, April 6, 2024
PRMT5, AML, CDX, Risk, Weight loss, LILRB4, MTAP, Acute myeloid leukemia, CRS, Cancer, IND, AACR, PDX, Antibody, DDI, TCE, Immunohistochemistry, San Diego Convention Center, Cytokine release syndrome, Vaccine

SHANGHAI and HONG KONG, April 5, 2024 /PRNewswire/ -- Antengene Corporation Limited ("Antengene", SEHK: 6996.HK), a leading innovative, commercial-stage global biopharmaceutical company dedicated to discovering, developing and commercializing first-in-class and/or best-in-class medicines for cancer, today announced the presentation of four preclinical posters at the 2024 American Association for Cancer Research Annual Meeting (AACR 2024), taking place from April 5th to April 10th at the San Diego Convention Center in San Diego, California, the United States.

Key Points: 
  • SHANGHAI and HONG KONG, April 5, 2024 /PRNewswire/ -- Antengene Corporation Limited ("Antengene", SEHK: 6996.HK), a leading innovative, commercial-stage global biopharmaceutical company dedicated to discovering, developing and commercializing first-in-class and/or best-in-class medicines for cancer, today announced the presentation of four preclinical posters at the 2024 American Association for Cancer Research Annual Meeting (AACR 2024), taking place from April 5th to April 10th at the San Diego Convention Center in San Diego, California, the United States.
  • Study results showed that ATG-042 has the potential to elegantly target tumor cells while sparing healthy cells, with an attractive developability profile.
  • 12:00 AM - 3:30 AM, April 10, 2024 (Beijing Time)
    This preclinical study was designed to test the in vitro/in vivo efficacy, and preclinical pharmacokinetic (PK) properties of ATG-042.
  • This poster presents the discovery and validation of a novel, highly sensitive immunohistochemistry (IHC) antibody that selectively identifies CLDN18.2.

Bluejay Announces Receipt of PRIME Designation from European Medicines Agency (EMA) for BJT-778 for the Treatment of Chronic Hepatitis Delta Virus Infection

Retrieved on: 
Monday, March 25, 2024
Therapy, Patient, SAN, HDV, European Medicines Agency, PRIME, Hepatology, Immunoglobulin G, Blue jay, Disease, EMA

SAN MATEO, Calif., March 25, 2024 (GLOBE NEWSWIRE) -- Bluejay Therapeutics, Inc., a private clinical-stage biopharmaceutical company focused on viral and liver diseases, today announced the European Medicines Agency (EMA) has granted Priority Medicine (PRIME) designation to BJT-778 for the treatment of Chronic Hepatitis Delta Virus (HDV) infection.

Key Points: 
  • SAN MATEO, Calif., March 25, 2024 (GLOBE NEWSWIRE) -- Bluejay Therapeutics, Inc., a private clinical-stage biopharmaceutical company focused on viral and liver diseases, today announced the European Medicines Agency (EMA) has granted Priority Medicine (PRIME) designation to BJT-778 for the treatment of Chronic Hepatitis Delta Virus (HDV) infection.
  • BJT-778 is a high-potency, fully human immunoglobulin G1 (IgG1) mAb that acts as an anti-viral to HDV by neutralizing and facilitating the clearance of HDV virions.
  • The application for PRIME designation was bolstered by compelling data from non-clinical studies, along with interim results from the company's Phase 1/2 study that included subjects with chronic HDV.
  • “We eagerly anticipate our continued collaboration with the EMA and other regulatory agencies to expedite the availability of this promising treatment for patients.”

Apogee Therapeutics Announces First Participants Dosed in Phase 1 Trial of APG808, its Novel Half-life Extended IL-4Rα Antibody for the Treatment of Chronic Obstructive Pulmonary Disease (COPD) and Other Inflammatory Diseases

Retrieved on: 
Monday, March 25, 2024
I&I, TARC, Atopic dermatitis, Disease, Half-life, Patient, SAN, Heel, IND, Respiratory disease, Asthma, SQ, Clinical trial, Therapy, Safety, Pharmacokinetics, Engineering, Pharmaceutical industry

SAN FRANCISCO and WALTHAM, Mass., March 25, 2024 (GLOBE NEWSWIRE) -- Apogee Therapeutics, Inc. (Nasdaq: APGE), a clinical-stage biotechnology company advancing differentiated biologics for the treatment of atopic dermatitis (AD), COPD, asthma and other inflammatory and immunology (I&I) indications, today announced that it has initiated dosing of healthy volunteers in its first clinical trial for APG808, a novel subcutaneous (SQ) extended half-life monoclonal antibody (mAb) targeting IL-4Rα, which is being developed as a treatment for people living with moderate-to-severe COPD, asthma and other I&I diseases.

Key Points: 
  • COPD is a progressive respiratory disease that is estimated to affect approximately 10 percent of the global population 40 years of age and older.
  • Despite recent advancements in COPD treatment, a significant number of people continue to suffer and die from the disease.
  • The APG808 Phase 1 trial is designed as a double-blind, placebo-controlled, first-in-human, single-ascending dose trial in healthy volunteers.
  • Importantly, this points to potentially less frequent dosing for patients with COPD, which could significantly improve quality of life.”

Invivyd Announces Interim Exploratory Data on VYD222 from Ongoing CANOPY Clinical Trial

Retrieved on: 
Friday, March 22, 2024
Science, Risk, COVID-19, Patient, SARS-CoV-2, RT-PCR, Clinical trial, Vaccination, Safety, Collection, Vaccine

Exploratory data such as provided in today’s update are important for broad reflection as they represent some of the first data from a clinical trial conducted with a monoclonal antibody in a population that has acquired prior immune exposure from either vaccination or natural infection.

Key Points: 
  • Exploratory data such as provided in today’s update are important for broad reflection as they represent some of the first data from a clinical trial conducted with a monoclonal antibody in a population that has acquired prior immune exposure from either vaccination or natural infection.
  • Symptomatic COVID-19 event collection in the CANOPY clinical trial is a secondary exploratory endpoint designed to allow Invivyd to contemplate further discovery and development work only.
  • The CANOPY clinical trial enrolled participants in two cohorts.
  • Invivyd is now providing an update on the clinical cases of confirmed symptomatic COVID-19 through Day 90.

Invivyd Announces FDA Authorization for Emergency Use of PEMGARDA™ (Formerly VYD222) for Pre-exposure Prophylaxis (PrEP) of COVID-19

Retrieved on: 
Friday, March 22, 2024
Diphenhydramine, Anaphylaxis, Hook effect, Pre-exposure prophylaxis, Half-life, Risk, Bone marrow, COVID-19, Patient, Metoprolol, Adrenaline, Epitope, DSM-IV codes, SARS-CoV-2, Death, Adolescence, Bank statement, Post-exposure prophylaxis, Clinical trial, CDC, Antibody, Vaccination, Safety, Immunodeficiency, Vaccine, FDA, Food, Medicine

Recipients should not be currently infected with or have had a known recent exposure to an individual infected with SARS-CoV-2.

Key Points: 
  • Recipients should not be currently infected with or have had a known recent exposure to an individual infected with SARS-CoV-2.
  • “The PEMGARDA EUA marks a transformational moment for Invivyd and for the many moderately to severely immunocompromised people who are vulnerable to COVID-19 disease in the U.S.
  • It was developed using INVYMAB™, the company’s platform approach which combines state-of-the-art viral surveillance and predictive modeling with advanced antibody engineering.
  • The severity of the reactions was generally mild (17/27) or moderate (8/27), but two reactions were life-threatening.

Sino Biological Announces Services Partnership with Rapid Novor

Retrieved on: 
Thursday, March 14, 2024
ChiNext, Drug discovery, Partnership, Research, Protein, Antibody, De novo, Vaccine

BEIJING, China, March 14, 2024 (GLOBE NEWSWIRE) -- via NewMediaWire — Sino Biological, Inc. (“Sino Biological” or the “Company”), a biotechnology company listed on the Shenzhen stock exchange subsidiary ChiNext (SZSE: 301047), which provides biological research reagents and related technical contract research services, is pleased to announce the formation of a services partnership with Toronto, Canada-based Rapid Novor, Inc. (“Rapid Novor”).  Under the terms of this agreement, Sino Biological will market Rapid Novor’s proprietary de novo REmAb monoclonal antibody (mAb) sequencing service in combination with its custom mAb development and production services.  Geographic areas covered under this partnership include China, Singapore, Thailand, Malaysia, Indonesia, Vietnam, Philippines, Japan and South Korea.

Key Points: 
  • BEIJING, China, March 14, 2024 (GLOBE NEWSWIRE) -- via NewMediaWire — Sino Biological, Inc. (“Sino Biological” or the “Company”), a biotechnology company listed on the Shenzhen stock exchange subsidiary ChiNext (SZSE: 301047), which provides biological research reagents and related technical contract research services , is pleased to announce the formation of a services partnership with Toronto, Canada-based Rapid Novor, Inc. (“Rapid Novor”).
  • Under the terms of this agreement, Sino Biological will market Rapid Novor’s proprietary de novo REmAb monoclonal antibody (mAb) sequencing service in combination with its custom mAb development and production services.
  • Headquartered in Beijing, China, Sino Biological is the world’s leading provider of mammalian cell-based recombinant proteins, antibodies, and related contract research services.
  • Rob Burgess, Sino Biological’s Chief Business Officer, stated, “Rapid Novor’s REmAb monoclonal antibody sequencing capabilities perfectly complement Sino Biological’s antibody development and manufacturing services.

Takeda Announces Positive Topline Results from Phase 2 Study Evaluating Mezagitamab (TAK-079), a Potential Best-in-Class Anti-CD38 Monoclonal Antibody, for Primary Immune Thrombocytopenia

Retrieved on: 
Wednesday, March 13, 2024
Neurology, Biotechnology, Pharmaceutical, Oncology, General Health, Health, FDA, Clinical Trials, Fast track (FDA), Psoriasis, Cell, Disease, Risk, Patient, Megakaryocyte, Immunoglobulin G, ITP, B cell, Quality of life, Platelet, Autoantibody, Gastrointestinal tract, CD38, Bleeding, Safety, Dravet syndrome, Blood, Lennox–Gastaut syndrome, Fatigue, Fiscal, Food, Autoimmune disease, Pharmaceutical industry

Takeda ( TSE:4502/NYSE:TAK ) today announced positive topline results from a Phase 2, randomized, double-blind, placebo-controlled study evaluating the safety, tolerability and efficacy of mezagitamab (TAK-079) in patients with persistent or chronic primary immune thrombocytopenia (ITP).

Key Points: 
  • Takeda ( TSE:4502/NYSE:TAK ) today announced positive topline results from a Phase 2, randomized, double-blind, placebo-controlled study evaluating the safety, tolerability and efficacy of mezagitamab (TAK-079) in patients with persistent or chronic primary immune thrombocytopenia (ITP).
  • An interim analysis of the ongoing Phase 2 study demonstrated positive safety and efficacy results.
  • Based on these positive results, and following consultation with global health authorities, Takeda plans to initiate a global Phase 3 trial of mezagitamab in ITP in fiscal year 2024.
  • Results from the Phase 2 trial have no impact on the full year consolidated reported forecast for the fiscal year ending March 31, 2024 (Fiscal Year 2023).

PureTech Receives Orphan Drug Designation for LYT-200 in Acute Myeloid Leukemia

Retrieved on: 
Wednesday, March 13, 2024
Oncology, FDA, Health, Clinical Trials, Pharmaceutical, Biotechnology, Diagnosis, Head, Survival, Massachusetts General Hospital, AML, Patient, Doctor of Philosophy, MD, PRTC, HMA, Hospital, Bone marrow, MDS, Immunoglobulin G, Food, Person, Pharmaceutical industry

PureTech Health plc (Nasdaq: PRTC, LSE: PRTC) ("PureTech" or the "Company"), a clinical-stage biotherapeutics company dedicated to changing the lives of patients with devastating diseases, today announced that the U.S. Food and Drug Administration (FDA) has granted orphan drug designation to LYT-200 for the treatment of AML.

Key Points: 
  • PureTech Health plc (Nasdaq: PRTC, LSE: PRTC) ("PureTech" or the "Company"), a clinical-stage biotherapeutics company dedicated to changing the lives of patients with devastating diseases, today announced that the U.S. Food and Drug Administration (FDA) has granted orphan drug designation to LYT-200 for the treatment of AML.
  • LYT-200 is a fully human IgG4 monoclonal antibody (mAb) targeting galectin-9, a potent oncogenic driver in leukemia cells and an immunosuppressive protein.
  • “Orphan drug designation from the FDA validates our belief that targeting galectin-9 with LYT-200 is a novel, promising approach that may offer patients a better tolerated, more effective treatment,” notes Aleksandra Filipovic, MD, PhD, Head of Oncology at PureTech.
  • The FDA grants orphan drug designation to novel drug and biologic products for the treatment, diagnosis, or prevention of conditions affecting fewer than 200,000 persons in the U.S. Orphan drug designation qualifies PureTech for incentives under the Orphan Drug Act, including tax credits for some clinical trials and eligibility for seven years of market exclusivity in the U.S., if the drug is approved for AML.

Domain Therapeutics and Chime Biologics announce manufacturing agreement to advance novel anti-CCR8 antibody for cancer immunotherapy

Retrieved on: 
Tuesday, March 12, 2024
GPCR, CLD, CDMO, Organization, Partnership, Patient, CGMP, Research, Cutaneous T-cell lymphoma, Cancer, G protein-coupled receptor, CTCL, Gq alpha subunit, Therapy, CCR8, Vaccine

Under the terms of the agreement, Chime Biologics will ensure stable cell line development (CLD) and DT-7012 candidate manufacturing to support clinical trials in strategic countries.

Key Points: 
  • Under the terms of the agreement, Chime Biologics will ensure stable cell line development (CLD) and DT-7012 candidate manufacturing to support clinical trials in strategic countries.
  • Chime Biologics' first global modular facility with single-use bioprocessing technology meets international cGMP standards with proven audit track records.
  • Stephan Schann, Chief Scientific Officer of Domain Therapeutics, said: "We're thrilled to collaborate with Chime Biologics, a great scientific and manufacturing expert, to advance DT-7012, our leading anti-CCR8 candidate, to the next development stage.
  • At Domain, we prioritize precision research and innovation and embrace new partnerships with organizations that share our vision and passion to advance immuno-oncology".