Company |
Product |
Description |
Indication |
Status |
Date |
Chimerix Inc. (Durham, N.C.) |
CMX001 |
Brincidofovir; oral nucleotide analog lipid-conjugate |
Hematopoietic cell transplant recipients with early adenovirus infection |
Phase II data showed it demonstrated activity against all pathogenic families of double-stranded DNA viruses, including herpesviruses, adenoviruses and polyomaviruses |
9/12/13 |
Durata Therapeutics Inc. (Chicago) |
Dalbavancin |
Second-generation, semi-synthetic lipoglycopeptide |
Acute bacterial skin and skin structure infections |
Phase II data showed it was non-inferior to the comparator regimen, vancomycin with an option to switch to oral linezolid |
9/12/13 |
Genocea Biosciences Inc. (Cambridge, Mass.) |
GEN-003 |
A first-in-class protein subunit vaccine |
Genital herpes |
Phase I/IIa data showed that patients who received three doses had reductions in the frequency of viral shedding of up to 51% |
9/16/13 |
Gilead Sciences Inc. (Foster City, Calif.) |
TAF |
Once-daily single tablet regimen containing tenofovir alafenamide |
HIV-1 infection |
Phase II data showed it was similar to Stribild based on the percentage of patients with HIV RNA levels less than 50 copies/mL, and was associated with more favorable renal and bone safety markers |
9/16/13 |
Novavax Inc. (Rockville, Md.) |
Vaccine |
Respiratory syncytial virus F-protein nanoparticle vaccine |
Respiratory syncytial virus |
Phase I data showed the vaccine was compatible with co-administration of influenza vaccine; it also was well tolerated, and yielded increases in antibodies |
9/12/13 |
Sangamo Biosciences Inc. (Richmond, Calif.) |
SB-728-T |
ZFP therapy |
HIV/AIDS |
Phase II data demonstrated functional control of the virus at or below the limit of detection in CCR5 delta-32 heterozygote HIV-infected subjects |
9/16/13 |
Theraclone Sciences Inc. (Seattle) |
TCN-202 |
A recombinant fully human monoclonal antibody |
Cytomegalo-virus |
Phase I data showed it was well tolerated, with no dose-limiting toxicities or serious adverse events, and had a favorable immunogenicity profile |
9/12/13 |
Viiv Healthcare Inc. (London) |
Tivicay |
Dolutegravir |
HIV |
Phase IIIb/IV data demonstrated noninferiority to darunavir |
9/16/13 |
Notes: Public biotech company stock symbols can be found in the stock report located on the last two pages of this issue. The date indicated refers to the BioWorld Today issue in which the news item can be found. |