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Twist Bioscience and Astellas Pharma have entered a collaboration to help the latter to discover antibodies for immunotherapies. In May 2022, they signed a research partnership and exclusive option licence agreement for the development of antibodies to reduce tumour microenvironment-mediated immunosuppression.
Ildong Pharmaceutical will licence a suite of Twist Bioscience's VHH antibody libraries after the two companies entered a partnership agreement. Twist's VHH libraries, used for discovering and developing antibodies for use in immuno-oncology, will be licensed by Ildong for three years for research and development works. .
The FDAs decision was based on comprehensive data demonstrating biosimilarity between Avtozma and the reference product, Actemra. That was followed by a full approval for the same patient subset in December 2022, making it the first FDA-approved monoclonal antibody to treat COVID-19.
SK Bioscience has received marketing authorisation from the UK’s medicines and healthcare products regulatory agency (MHRA) for its Covid-19 vaccine, SKYCovion. It was granted based on data from the Phase III study, which demonstrated that the vaccine induced neutralising antibodies against the SARS-CoV-2 original strain.
In the last three years alone, there have been over 633,000 patents filed and granted in the pharmaceutical industry, according to GlobalData’s report on Immuno-oncology in Pharmaceuticals: Tumour antibody serum compositions. The production of antibodies in response to proteins expressed during cancer development serves as a biomarker.
The China National Medical Products Administration’s (NMPA) Center for Drug Evaluation (CDE) has granted clearance for Transcenta’s investigational new drug (IND) application for its TST003 to treat solid tumours. TST003 is a first-in-class Gremlin1 targeting humanised monoclonal antibody.
The antibody-drug conjugate (ADC) treatment is indicated for such patients who have previously received one to three systemic therapy regimens, irrespective of the usage of Avastin priorly. binding antibody, a cell-surface protein which is greatly expressed in ovarian cancer, as well as the maytansinoid payload DM4.
Rilzabrutinib joins a wave of innovative ITP therapies , including thrombopoietin-receptor agonists like eltrombopag and romiplostim, which boost platelet production. Rilzabrutinib works by targeting BTK, a protein involved in immune cell communication.
AbbVie is to begin clinical development of an antibody designed to neutralise the SARS-CoV-2 coronavirus after licensing the therapy in from Harbour BioMed and Utrecht University. AbbVie has begun a phase 1 clinical trial of the antibody, with clinical development beginning in the US and expanding into Europe.
The researchers found no differences in antibodyproduction, auto-antibodies, T cell profiles, or prior viral exposures, but found elevated levels of spike protein along with increased cytokines (consistent with innate inflammation) and increased troponin (indicating cardiac injury).
Confo Therapeutics and AbCellera have entered a research partnership to discover GPCR [specific G protein-coupled receptor ligand]-targeting antibody candidates. The collaboration will use Confo Therapeutics’ suite of ConfoBody-enabled antibody discovery technologies on two undisclosed GPCR targets.
The patent battle between Amgen and Sanofi over their cholesterol-lowering antibodies has divided big pharma in the past months. Both drugs are monoclonal antibodies that inhibit the protein PCSK9. But in this case, Amgen has a fully finished product, he adds. Amgen’s Repatha was greenlit a month later.
By growing high quality crystal structures of protein-based therapeutics under microgravity, researchers can gain better insights into their complex structures and stability. The proteins will be analyzed back on Earth using techniques such as X-ray diffraction and compared with crystals from the same biologics grown on Earth.
The introduction of new first-in-class biological therapies will further increase therapy options for SLE and LN patients, and it remains to be seen if any of these products will have superior efficacy and safety profiles to currently available Benlysta, Rituxan, Lupkynis and Saphnelo.
Ono Pharmaceutical and Monash University have entered an option and research collaboration for the discovery and development of antibodies that target G protein-coupled receptors (GPCRs).
Eli Lilly has bolstered its position the fast-emerging area of protein degrader drugs, agreeing a $1.6 Lilly has bought into Lycia’s lysosomal targeting chimera (LYTAC) protein degradation technology, developed by Bertozzi at Stanford University, with an initial focus on projects in immunological disease and pain.
Flow Eighteen38, a protein sciences division created to facilitate and accelerate antibody characterization and protein purification projects, has announced a â5m ($5.58m) investment into its proteinproduction and biophysical characterization capabilities and services from its parent company, CRO FairJourney Biologics S.A.
Clinical-stage biopharmaceutical firm Alentis Therapeutics has raised $105m in a Series C financing round for advancing transformational medicines targeting the CLAUDIN-1 protein. ALE.F02 is being developed for the treatment of advanced kidney, lung and liver fibrosis while ALE.C04 is a potential treatment to target CLDN1-positive tumours.
Biopharma companies are under pressure to do more with less in the production of monoclonal antibody (mAb) therapies. However, these processes can damage cells, resulting in more impurities in the downstream process to remove and decreasing the product quality. The first is to increase the specific productivity of the cells.
FibroGen has signed an exclusive licence agreement with Fortis Therapeutics for the FOR46 antibody-drug conjugate (ADC) that targets a new epitope on CD46, a protein-coding gene. FOR46 is currently being investigated in a Phase I trial as a potential treatment for metastatic castration-resistant prostate cancer (mCRPC).
The FDA has issued straight-to-final guidance that provides sponsors of monoclonal antibody and other therapeutic protein COVID-19 treatments with recommendations for potency assays to ensure consistent product quality. Source link.
Nuvaxovid is a protein-based vaccine created from the genetic sequence of the initial SARS-CoV-2 virus strain. Nuvaxovid demonstrated a significant antibody response when given as a booster dose after primary vaccination with other authorised Covid-19 doses in the COV-BOOST trial.
Researchers are also investigating blood-based biomarkers to bolster efforts to find Alzheimer’s drugs that go beyond targeting the amyloid protein, so new targets can be tackled, potentially widening the pool of patients who may respond to a therapy. Lecanemab is an amyloid antibody that targets oligomers and protofibrils of amyloid.
The multi-year investment, covering the development of drug substances as well as drug products, will be implemented across the current locations of the company in Switzerland, Austria and Slovenia. For this purpose, the company will create a completely integrated scientific environment.
The treatment is an investigational first-in-class monoclonal anti-human complement factor C5a antibody. It has been designed for controlling the complement factor C5a, which is a protein that plays an important and harmful role in the immune response of the body.
China’s National Medical Products Administration (NMPA) has granted approval for AstraZeneca’s Soliris (eculizumab) to treat refractory generalised myasthenia gravis (gMG) in adult patients. Soliris is a first-in-class C5 complement inhibitor indicated for patients who are anti-acetylcholine receptor (AChR) antibody-positive.
Researchers are also investigating blood-based biomarkers to bolster efforts to find Alzheimer’s drugs that go beyond targeting the amyloid protein, so new targets can be tackled, potentially widening the pool of patients who may respond to a therapy. Lecanemab is an amyloid antibody that targets oligomers and protofibrils of amyloid.
It is a monoclonal antibody conjugate that acts by targeting f olate receptor alpha (FolR alpha). The company develops its pipeline products through the Xpress CF and XpressCF+ platform, a biochemical protein synthesis system that develops therapeutic proteins and discovers drugs for the treatment and prevention of diseases.
A study conducted by a consortium of Brazilian researchers has demonstrated that a hyperimmune serum consisting of purified antibody fragments produced in horses may be an efficient approach to combat COVID-19. The scientists are confident of the efficiency of the new product. 1 (Gamma) and P.2 2 variants. .
Pfizer and BioNTech Advance COVID-19 Vaccine Strategy With Study Start of Next-Generation Vaccine Candidate Based on Enhanced Spike Protein Design. Pfizer and BioNTech Advance COVID-19 Vaccine Strategy With Study Start of Next-Generation Vaccine Candidate Based on Enhanced Spike Protein Design. deliesschef. Tue, 07/26/2022 - 17:41.
The European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) has recommended granting expanded conditional marketing authorization (CMA) for Novavax ’s Covid-19 vaccine, Nuvaxovid (NVX-CoV2373), as a booster in adults aged 18 years and above.
Approved as the first and only long-acting C5 complement inhibitor, Ultomiris is indicated to treat adults with anti-aquaporin-4 (AQP4) antibody-positive (Ab+) NMOSD in the European Union (EU). It inhibits the C5 protein in the terminal complement cascade, part of the body’s immune system.
It comprises messenger ribonucleic acid (mRNA) that encodes for the initial spike protein of SARS-CoV-2 along with mRNA that encodes for Omicron BA.4/BA.5 5 variant spike protein. According to pre-clinical findings, a booster dose of this vaccine elicited a robust neutralising antibody response against the variants Omicron BA.1,
Its scope includes Syngene providing integrated drug discovery and development solutions in discovery chemistry and biology, peptide chemistry, antibody and protein reagents, pharmacokinetics and drug metabolism, and pharmaceutical development. until 2026. Syngene’s collaboration with Zoetis started in 2011.
NI006 is an antibody that binds to the misfolded forms of the transthyretin protein that form the fibrils, and cause them to be cleared away by immune cells like macrophages. Tafamidis is thought to work by stabilising the misfolded proteins.
The European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) has recommended marketing authorisation for AstraZeneca ’s Ultomiris (ravulizumab) to treat neuromyelitis optica spectrum disorder (NMOSD) in adult patients.
The human monoclonal antibody denosumab has been designed to bind to osteoclasts activator, RANKL protein. It decreases the osteoclast’s production and activity by attaching to and inhibiting RANKL. This results in bone loss reduction and the likelihood of fractures and other serious conditions related to bones.
In the partnership’s discovery phase, RAVEN, an artificial intelligence (AI) platform of Evaxion will be leveraged for designing a next-generation vaccine candidate that induces cellular as well as humoral/antibody responses. Using ExpreS 2 ion’s ExpreS2 platform, the company will manufacture the antigen constructs obtained from RAVEN.
The technique has been used to generate a high-affinity antibody against Arginase 2, an enzyme implicated in major human diseases.
Therefore, the enzyme is a target for inhibitory therapeutic antibodies that could help restore immune function against cancer cells, the researchers note.
Genmab, a trailblazer in the field of antibody therapeutics, celebrates this milestone by reflecting on its impressive journey from a small-scale startup to a global leader in cancer treatment and beyond. Since then, innovative science has been at Genmab’s core, as we harness the power of human antibodies to improve the lives of patients.
Dr Laura Moriarty, senior marketing manager at Bio-Rad, looks at the impressive immuno-therapeutic potential of bispecific antibodies (bsAbs). Though their bispecific nature complicates large-scale production and purification workflows, with challenges such as antibody chain mispairing, bsAbs have come a long way since first developed.
Harbour BioMed (HBM) announced with Utrecht University on Monday that they have licensed their fully human SARS-CoV-2 neutralizing antibody, 47D11, and its program to AbbVie. The product is designed for the prevention and treatment of COVID-19, along with related coronaviruses. before expanding it into Europe.
“It is programmed and coded for the production of the full-length spike protein of the coronavirus. It then elicits an immune response against that spike protein. You have a response with immunoglobulins type G (antibodies) and robust cellular response with both CD4 and CD8 T-cells being activated,” Morgon states.
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