Wed, Oct. 7, 7:33 AM
- An interim analysis of six-month data from a Phase 2 clinical trial evaluating Genocea Biosciences' (NASDAQ:GNCA) lead product candidate GEN-003 for the treatment of genital herpes showed a 58% reduction from baseline in the viral shedding rate (p<0.0001), the primary endpoint. The results were generated by the best performing dose of 60 ug per protein/75 ug of Matrix-M2 adjuvant. The data will be presented this Friday at IDWeek 2015 in San Diego, CA.
- In a secondary analysis based on patient-reported lesion rates, GEN-003 demonstrated statistically significant reductions from baseline in five of six dose groups ranging from 43% to 69%. The proportion of patients who received GEN-003 who were lesion-free at six months post dosing ranged from 30% to 50%, which was comparable to trial results observed with other oral antivirals. Time-to-first recurrence ranged from 152 days to more than 180 days. GEN-003 was well tolerated with no serious adverse effects seen.
- 12-month efficacy data is expected in Q1. An end-of-Phase 2 meeting with the FDA should happen in late 2016 followed by the initiation of a Phase 3 study.
- GEN-003 is a T cell-directed immunotherapy (therapeutic vaccine) designed to elicit both a T cell and B cell (antibody) response to HSV-2. It licensed the Matrix-M2 adjuvant from Novavax (NASDAQ:NVAX). Genital herpes affects ~400M people worldwide.
- The company will host a conference call this morning at 9:00 am ET to discuss the data.
- Shares are up 21% premarket on light volume.
Wed, Sep. 30, 9:13 AM
Tue, Sep. 29, 5:51 PM
- From up heavily premarket to the day's worst biotech performer, Novavax (NASDAQ:NVAX) slid 21.4% today, with most of the decline coming in the last 90 minutes of trading.
- It's the stock's biggest decline in more than six years. Early this morning Novavax posted a success in trial results showing mothers vaccinated for respiratory syncytial virus (RSV) could pass protection to newborns.
- While positive, the effect was too muted to attract demand for the vaccine, says Piper Jaffray. Analyst Edward Tenthoff says the data are a proof of concept, but the concentration of antibodies in the blood seemed low. He's still bullish on the stock, however, with an Overweight rating.
- The stock has rebounded some after hours, up 5.2%.
Tue, Sep. 29, 8:07 AM
- Novavax (NASDAQ:NVAX) is up 9% premarket on light volume in response to its announcement of positive top-line results from a Phase 2 clinical trial evaluating its RSV F-protein recombinant nanoparticle vaccine candidate, RSV-F Vaccine, to protect infants via maternal immunization. The study's objective was to assess the safety and immunogenicity of the RSV-F Vaccine in 50 healthy pregnant women who were in their third trimesters.
- The blinded, placebo-controlled trial randomized the participants to receive either 120 mcg of RSV-F Vaccine adjuvanted with 0.4 mg of aluminum phosphate or placebo. They were followed through the remainder of their pregnancies and an additional 180 days postpartum. In addition to serum and cord blood samples taken from the mothers, serum samples were taken from the infants over the six-month period to provide a preliminary estimate of the half-life of the vaccine-induced maternal antibodies.
- Women in the vaccine arm showed a geometric mean 14-fold increase in anti-F IgG antibodies, a 29-fold increase in palivizumab-competing antibodies and a two-fold increase in microneutralization titers. Palivizumab is AstraZeneca's Synagis, which is a monoclonal antibody indicated for the prevention of RSV infection.
- Half-lives of the key antibodies in the infants ranged from 30 to 41 days.
- The Bill & Melinda Gates Foundation has awarded a grant to the company valued at up to $89M to support a Phase 3 study in pregnant women. The trial is expected to commence in Q1. There are no approved RSV vaccines currently available.
- Respiratory syncytial virus (RSV) is the leading cause of lower respiratory tract infections in infants and young children worldwide, striking 64M kids each year leading to 160K deaths.
Tue, Sep. 15, 6:30 PM
- Novavax (NASDAQ:NVAX) is up 3.2% after hours, adding on to a gain of 4.3% today, after a promising preclinical animal study came in for a candidate to vaccinate infants.
- Pregnant guinea pigs immunized with its RSV F-protein recombinant nanoparticle vaccine showed "robust transplacental antibody transfer," transmitting protection to their offspring against respiratory syncytial virus.
- Directly immunizing infants is complicated by their immature immune systems. “RSV is the leading cause of infant hospitalizations in the U.S. and a significant unmet need in full-term infants,” says Novavax's Gregory Glenn.
Tue, Sep. 15, 5:42 PM
Wed, Aug. 26, 6:57 PM
- Biotech analysts at Piper Jaffray say they are buyers on weakness of four biotech names - Vertex Pharma (NASDAQ:VRTX), Novavax (NASDAQ:NVAX), Alnylam Pharma (NASDAQ:ALNY) and Arrowhead Research (NASDAQ:ARWR) - that boast strong enough balance sheets to make it through upcoming value-driving events.
- The firm notes VRTX holds more than $1B in cash, and expects a dramatic increase in treatable cystic fibrosis patients with the newly approved Orkambi, which will help drive revenue growth and a return to near-term profitability.
- Jaffray says it has increased confidence in NVAX following positive Phase 2 data in its RSV-F in elderly subjects; the company ended the quarter with $315M in cash, which can fund "at least one" pivotal RSV trial.
- ALNY ended the recent quarter with $1.4B in cash, with key patisiran and revusiran Phase II in OLE updates expected in Q4.
- On ARWR, the firm looks to an expected September update of Phase IIa HEPARC 2001 data.
Tue, Aug. 11, 12:45 PM
Tue, Aug. 11, 9:16 AM
Tue, Aug. 11, 8:50 AM| Tue, Aug. 11, 8:50 AM | 6 Comments
Tue, Aug. 11, 8:05 AM
- Shares of Novavax (NASDAQ:NVAX) are up 12% premarket on light volume in response to its announcement that a Phase 2 clinical trial assessing its RSV (respiratory syncytial virus) vaccine candidate, RSV F, was successful in demonstrating efficacy in older adults aged 60+, a population that historically has been difficult to protect from RSV infection.
- The 1,600-subject, randomized, observer-blinded, placebo-controlled study was conducted at 10 sites in the U.S. It was designed to prospectively evaluate the incidence of all symptomatic respiratory illnesses associated with RSV in community-living older adults who were treated with placebo, the safety and immunogenicity of an unadjuvanted 135 mcg dose of RSV F versus placebo and to estimate the efficacy of RSV F in reducing the incidence of respiratory illness due to RSV.
- The trial was the first to demonstrate active RSV immunization in any clinical trial population, showing a statistically significant vaccine efficacy (44%) in preventing all symptomatic RSV disease and preventing RSV disease with symptoms of lower respiratory tract infection (46%) in older adults. RSV-F's efficacy in protecting against more severe RSV illness, defined by the presence of multiple lower respiratory tract symptoms associated with difficulty breathing, was 64% in several ad hoc analyses.
- The study also established a 4.9% attack rate for symptomatic RSV disease in older adults, 95% of which included lower respiratory track symptoms. The attack rate is a biostatistical measure of the frequency of morbidity, or speed of spread, in an at-risk population.
- As many as 2.4M older Americans are infected with RSV each year, leading to 900K medical interventions and 14K deaths.
- The company intends to proceed to Phase 3 development as soon as next quarter.
Mon, Aug. 10, 4:31 PM
Sun, Aug. 9, 5:35 PM| Sun, Aug. 9, 5:35 PM | 13 Comments
Thu, Jul. 30, 10:37 AM
- Novavax (NVAX +0.4%) bucks the market's bearishness with its announcement of positive top-line data from a Phase 2 clinical trial assessing Influenza VLP, its recombinant quadrivalent (four flu virus strains) seasonal influenza virus-like (VLP) vaccine candidate. The trial met its immunogenicity targets and showed potential to meet CBER's (FDA's Center for Biological Evaluation and Research) criteria for accelerated approval.
- The primary endpoint was safety and tolerability of Influenza VLP and qualified immune responses to each of the four influenza strains as measured by hemagglutination-inhibiting (HAI) antibody titers. The HAI responses in 400 healthy adult volunteers were 50% greater that those observed in a previous Phase 2 study.
- The company plans to review the data with program funder BARDA (Biomedical Advanced Research and Development Authority) to determine the next steps in development.
Tue, Jul. 21, 9:15 AM
Tue, Jul. 21, 8:53 AM
- Top-line data from a Phase 1 trial show Novavax's (NASDAQ:NVAX) Ebola glycoprotein (GP) recombinant nanoparticle vaccine candidate adjuvanted with the company's Matrix-M was well-tolerated and highly immunogenic in a group of 230 healthy adult volunteers. The results were presented during the World Health Organization's Fifth Teleconference on Ebola Vaccine Clinical Trials.
- Participants received either one or two intramuscular injections, with and without Matrix-M, ranging from 6.5 micrograms to 50 micrograms of antigen on study days 0 and 21. Immunogenicity was assessed at multiple times including days 28 and 35. The adjuvanted two-dose regimens induced Ebola anti-GP antibody increases of 500- to 750-fold over baseline at day 35. The adjuvanted single dose regimen induced increases of 21- to 27-fold over the same time frame.
- President & CEO Stanley Erck says, "These positive data represent the third time Novavax has leveraged the power of our platform technology to rapidly address an emerging threat. These Ebola GP Vaccine date, in combination with clinical data from our H7N9 VLP vaccine candidate and preclinical data from our vaccine candidate for Middle East Respiratory Syndrome coronavirus, provide additional validation of our nanoparticle vaccine platform."
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