Immunology and Biotherapies

TMB-355(Ibalizumab) is a humanized monoclonal antibody (mAb) and a member of an emerging class of HIV therapies known as viral-entry inhibitors. This drug candidate is distinct from other entry inhibitors in that it binds to the CD4 molecule, the primary receptor for HIV infection, thereby interfering with the penetration of the virus into the cell. It is the first entry-blocking humanized mAb to treat HIV/AIDS. TMB-355 caught the attention of the scientific community in February 2003, when results from the phase-1, single-dose clinical trial showed a transient but clinically significant reduction in the patients’ viral load. Moreover, it was well tolerated with no evidence of adverse effects on CD4 T-cells of treated subjects unlike the majority of approved drugs for HIV. The U.S. FDA granted TMB-355 fast track status in October 2003. The phase-2a clinical trial was successfully completed in 2006, with the results showing a clean safety profile and clear antiviral activity (10-fold reduction in viral load).  The Phase-2b clinical trial was also successfully completed in 2011. TaiMed Biologics is concurrently developing a subcutaneous injection dosage form and a phase 1 human pharmacokinetics bridging study is completed in 2012. Currently, TMB is developing a phase I/II study for HIV-negative and new HIV-positive subjects to begin by the end of 2012.

Via Krishan Maggon

The U.S. Food and Drug Administration today approved Bexsero, a vaccine to prevent invasive meningococcal disease caused by Neisseria meningitidis serogroup B in individuals 10 through 25 years of age.

 

Bexsero is the second vaccine approved by the FDA in the past three months to prevent this disease. The agency approved the first meningococcal serogroup B vaccine in October 2014. Before these approvals, existing approved meningococcal vaccines in the U.S. covered only four of the five main serogroups of N. meningitidis bacteria that cause meningococcal disease: A, C, Y and W.

 

Meningococcal disease is a life-threatening illness caused by bacteria that can infect the bloodstream (sepsis) and the lining that surrounds the brain and spinal cord (meningitis). N. meningitidis is a leading cause of bacterial meningitis. The bacteria are transmitted from person to person through respiratory or throat secretions (e.g., by coughing, kissing or sharing eating utensils). According to the Centers for Disease Control and Prevention, about 500 total cases of meningococcal disease were reported in the U.S. in 2012, of which 160 were caused by serogroup B.

 

Three studies evaluating Bexsero’s effectiveness were conducted in Canada, Australia, Chile, and the United Kingdom in approximately 2,600 adolescents and young adults. Among study participants who received two doses of Bexsero, after vaccination, 62 to 88 percent had antibodies in their blood that killed three different N. meningitidis serogroup B strains in tests carried out in a laboratory, compared with 0 to 23 percent before vaccination. These three strains are representative of strains that cause serogroup B meningococcal disease in the U.S.

The safety of Bexsero was assessed in approximately 5,000 participants who received the vaccine in studies conducted in the U.S. and abroad. The most commonly reported side effects by those who received Bexsero were pain and swelling at the injection site, headache, diarrhea, muscle pain, joint pain, fatigue, and chills. In addition, safety was monitored in more than 15,000 individuals who received Bexsero prior to approval in response to two university outbreaks of serogroup B meningococcal disease in the U.S. 

 

 

Via Krishan Maggon