Monoclonal Antibody: News & Recent Developments

Oct 24, 2024

Hope Medicine’s mAb HMI-115 shows promise in treating endometriosis pain. (Source)

Merck’s KEYTRUDA® (pembrolizumab) Receives 30th European Commission Approval, Expanding Treatment Options for Gynecologic Cancers. (Source)

Regeneron’s Dupixent Targets Chronic Urticaria with Monoclonal Antibody Therapy. (Source)

Oct 23, 2024

Calluna Pharma advances novel fibrotic and fibro-inflammatory therapy, CAL101, to Phase 2 trials after successful Phase 1 completion. Monoclonal antibody, idiopathic pulmonary fibrosis, systemic sclerosis (Source)

NImmune has acquired the Asia development and commercialization rights to Omilancor, a small molecule drug candidate for the treatment of ulcerative colitis and Crohn’s disease. (Source)

Johnson & Johnson‘s monoclonal antibody DARZALEX^® (daratumumab) receives European Commission approval for use in a multiple myeloma treatment regimen. (Source)

Oct 22, 2024

SIGA Technologies, Inc. Secures Exclusive Rights to Vanderbilt University‘s Pioneering Poxvirus Monoclonal Antibody Technology. (Source)

MacroGenics, Inc. and TerSera Therapeutics LLC have announced a global licensing agreement. Under the terms of the deal, TerSera will acquire the rights to MARGENZA® (margetuximab-cmkb), a cancer therapy developed by MacroGenics. It is an FDA-Approved, Fc-Engineered, HER2-targeted monoclonal antibody (mAb). (Source)

Otsuka reports positive phase 3 trial results for Sibeprenlimab in IgA nephropathy. Monoclonal antibody, IgA nephropathy, kidney disease (Source)

Annexon shares results from its Phase 2 clinical trial of ANX007 in patients with dry age-related macular degeneration (AMD) and less advanced geographic atrophy at the American Academy of Ophthalmology Annual Meeting in 2024. (Source)

UCB’s Bepranemab Phase 2a Study Results to be Featured at CTAD 2024. Alzheimer’s disease (Source)

Oct 21, 2024

Astellas’ VYLOY™ (zolbetuximab) has been approved by the U.S. FDA for treating advanced gastric and gastroesophageal junction (GEJ) cancers that are CLDN18.2 positive. VYLOY™ (zolbetuximab) is an anti-claudin 18.2 (CLDN18.2) monoclonal antibody. (Source)

Oct 18, 2024

Novo Nordisk’s Alhemo® (concizumab – a humanized monoclonal antibody) has been recommended for European approval as the first once-daily subcutaneous prophylactic treatment for individuals with hemophilia A or B who have developed inhibitors. (Source)

The FDA has partially halted the PRESERVE-003 Phase 3 trial for BioNTech and OncoC4’s gotistobart. Monoclonal antibody, lung cancer (Source)

Oct 17, 2024

Innovent Pharmaceuticals reports that its investigational drug, Picankibart (IBI112), has met the primary endpoint in a Phase 2 clinical trial involving Chinese patients with ulcerative colitis. (Source)

Merck’s Clesrovimab, an RSV preventative monoclonal antibody, effectively reduced RSV disease and hospitalization in infants. (Source)

Oct 15, 2024

AMGEN announces positive Phase 3 clinical trial data for UPLIZNA (inebilizumab-CDON) in the treatment of generalized myasthenia gravis at the American Academy of Neurology Annual Meeting 2024. Monoclonal antibody (Source)

Johnson & Johnson’s Nipocalimab shows promise in treating adolescent generalized myasthenia gravis in a Phase 2/3 study. (Source)

Oct 14, 2024

GSK has reported positive results from phase III trials for depemokimab, a potential treatment for chronic rhinosinusitis with nasal polyps. (Source)

Eli Lilly presents 1-year histology data from a Phase 3 trial comparing mirikizumab to ustekinumab in Crohn’s disease. (Source)

Jasper Therapeutics announces positive SPOTLIGHT trial results for briquilimab in chronic urticaria. (Source)

Oct 11, 2024

Junshi Biosciences‘ new drug, ongericimab injection (trade name: Junshida®), has been approved by the NMPA for treating high cholesterol. This approval marks the company’s fifth commercial product. (Source)

Pfizer secures FDA approval for Hympavzi, a monoclonal antibody, to treat hemophilia A and B. (Source)

South Korean pharmaceutical company Dong-A ST has gained FDA clearance for Imuldosa, a biosimilar version of J&J’s Stelara. plaque psoriasis, psoriatic arthritis, Crohn’s disease, ulcerative colitis, biosimilar (Source)

Cantargia announces promising biomarker and safety data from its Phase 1 clinical trial of the CAN10 antibody. psoriasis, hidradenitis suppurativa, systemic sclerosis (Source)

Oct 10, 2024

Johnson & Johnson’s recent FDA-approved monoclonal antibody, Tremfya, demonstrates promising results in a subgroup analysis of Phase 3 data for Crohn’s disease and ulcerative colitis. (Source)

Allakos releases Phase 1 data on AK007, a mast cell-inhibiting monoclonal antibody, demonstrating safety and bioavailability. chronic spontaneous urticaria, food allergy, asthma (Source)

XtalPi’s Ailux Biologics partners with Janssen Biotech (a Johnson & Johnson company), granting a license for its AI-powered biologics platform. Monoclonal antibody, drug discovery, AI (Source)

About Monoclonal Antibody

Monoclonal antibodies are proteins produced by immune cells that can specifically bind to a particular target molecule, such as a protein or a specific part of a cell. They have revolutionized biotechnology and drug development, offering a wide range of applications.

Key Characteristics:

• Specificity: Bind to a single, specific target molecule.
• Monoclonality: Produced from a single clone of immune cells, ensuring uniformity.
• High affinity: Bind to their targets with high affinity and specificity.

Applications in Biotechnology and Drug Development:

1. Therapeutic Agents:
   • Cancer treatment: Target cancer cells for destruction.
   • Autoimmune diseases: Suppress the immune system in autoimmune disorders.
   • Infectious diseases: Neutralize viruses or toxins.
2. Diagnostic Tools:
   • Immunohistochemistry: Used to identify specific proteins in tissues.
   • ELISA: Enzyme-linked immunosorbent assay for detecting and quantifying substances.
   • Flow cytometry: Analyzing cells based on their surface markers.
3. Research Tools:
   • Protein purification: Used to isolate specific proteins from complex mixtures.
   • Immunoprecipitation: Precipitating proteins from solution using antibodies.
   • Western blotting: Detecting and quantifying proteins in a sample.

Production Methods:

• Hybridoma technology: Fusing mouse B cells with myeloma cells to create immortal hybridomas that produce monoclonal antibodies.
• Recombinant DNA technology: Cloning antibody genes into expression systems like bacteria or mammalian cells.

Advantages of Monoclonal Antibodies:

• High specificity: Can target specific molecules without affecting other cells or tissues.
• High affinity: Bind to their targets with high affinity, ensuring effective therapeutic or diagnostic actions.
• Versatility: Can be used in a wide range of applications, from therapeutics to research.

Challenges and Limitations:

• Immunogenicity: Can sometimes induce an immune response in patients, leading to side effects.
• Cost: Production and manufacturing can be expensive.
• Delivery: Delivering monoclonal antibodies to their target tissues can be challenging, especially for intracellular targets.

Despite these challenges, monoclonal antibodies have become indispensable tools in biotechnology and drug development. Continued advancements in antibody engineering and production methods are expanding their potential applications and addressing limitations.