Vaxart to present new data from Phase 2 Challenge study of oral H1 Flu vaccine

Vaxart announced it will present new data from the Phase 2 Challenge Study of its H1 influenza oral tablet vaccine at IDWeek 2018 in San Francisco on Saturday, October 6, 2018. “These latest results show that our vaccine elicited a significant expansion of mucosal homing receptor alpha4beta7+ plasmablasts to approximately 60% of all activated B cells, while Fluzone only maintained baseline levels of 20%. We believe these beta7+ plasmablasts are a key indicator of a protective mucosal immune response and a unique feature of our oral recombinant vaccines,” said CSO Sean Tucker. “Further analysis of the data also confirm that, while our vaccine also generated protective hemagglutinin inhibition antibodies in serum like conventional injectable flu vaccines, it primarily protected through the mucosal mechanism, providing a robust 39% reduction in illness versus placebo overall. In contrast, Fluzone, the market-leading injectable quadrivalent influenza vaccine, only provided a 27% reduction in illness versus placebo, while protecting primarily through HAI antibodies.” Vaxart previously reported only 37% of study participants receiving the Vaxart vaccine developed influenza infection after challenge, compared to 44% of those receiving Fluzone and 71% of those receiving placebo. The new Phase 2 data to be presented at IDWeek 2018 showed that the Vaxart vaccine generated a strong increase in mucosal homing antibody secreting cells, or beta7+ plasmablasts. In protected study participants, the percentage of beta7+ plasmablasts in recipients of the Vaxart vaccine nearly doubled, whereas the percentage of beta7+ plasmablasts in Fluzone recipients remained unchanged. The Phase 2 study was completed with support from Biomedical Advanced Research and Development Authority. Vaxart received a $13.9M contract from BARDA in September 2015 to support the advanced development of more effective influenza vaccines to ultimately improve seasonal and pandemic influenza preparedness. The contract was increased to $15.7M in 2017.
https://thefly.com/landingPageNews.php?id=2799671

Amag Pharmaceuticals to present data on Intrarosa at NAMS

Amag Pharmaceutical and Endoceutics announced an oral presentation regarding the effect of time since menopause, age, and previous hormone therapy on treatment efficacy of intravaginal 6.5 mg prasterone at the Annual Meeting of The North American Menopause Society, or NAMS. David Archer and colleagues analyzed combined data obtained from two prospective, randomized, double-blind, placebo-controlled clinical trials to evaluate the effect of daily intravaginal 6.5 mg Intrarosa administered for 12 weeks to women who identified moderate to severe pain at sexual activity as their most bothersome symptom, or MBS, of vulvar and vaginal atrophy, or VVA. The goal of the analysis was to assess the potential influence of time since menopause, age and previous hormone therapy on the response to treatment. Overall, there were 406 women treated with 6.5 mg Intrarosa and 234 women who received placebo. Women were divided into subgroups based upon time since menopause, age and if they had ever taken hormone therapy. While age and prior hormone therapy did not influence the overall efficacy of Intrarosa, the greatest reduction of dyspareunia had a tendency to be observed in women who were 1-2 years post menopause, compared to 3-5 years and more than 6 years post menopause, although the difference did not reach statistical significance.
https://thefly.com/landingPageNews.php?id=2799681

Oramed enrolls first patient in clinical study for oral insulin in NASH

Oramed has enrolled the first patient in an exploratory clinical study of its oral insulin capsule, ORMD-0801, in the treatment of nonalcoholic steatohepatitis, or NASH. The three-month treatment study will assess the effectiveness of ORMD-0801 in reducing liver fat content, inflammation and fibrosis in patients with NASH. Data from preclinical studies and clinical studies of ORMD-0801 demonstrate Oramed’s oral insulin capsule has the potential to reduce inflammation of the liver.
https://thefly.com/landingPageNews.php?id=2799719

Becton Dickinson price target raised to $280 from $250 at Morgan Stanley

Morgan Stanley analyst David Lewis expects Becton Dickinson will guide FY19 revenue growth to 5%-6% during its upcoming Q4 earnings, which he believes “seems achievable if not conservative.” Management is also likely to introduce revenue synergy guidance which should be higher, Lewis predicted. However, he thinks Becton’s reported earnings guidance is likely to come in below the Street consensus. Lewis raised his price target on Becton Dickinson shares to $280 to reflect a roll forward to CY20 estimates and he keeps an Equal Weight rating on the stock.
https://thefly.com/landingPageNews.php?id=2799737

Titan Medical achieves Q3 milestones for SPORT Surgical System

Titan Medical announced that the company has achieved all of its publicly stated Q3 development milestones for the SPORT Surgical System. It completed the improved camera insertion tube engineering confidence build. Titan Medical also completed design enhancements of both the surgeon workstation and patient cart in anticipation of system engineering confidence build by year-end. The company completed and demonstrated full suite of simulation training software for beta testing and filed three Q-submissions containing detailed protocols for animal, cadaver and human confirmatory studies for review by the FDA, approximately one year ahead of plan.
https://thefly.com/landingPageNews.php?id=2799759

Halozyme’s PEGPH20 data featured in Clinical Cancer Research publication

Halozyme announced the publication of nonclinical data for PEGPH20 in Clinical Cancer Research, an American Association for Cancer Research journal. PEGPH20 is the PEGylated version of Halozyme’s proprietary recombinant human hyaluronidase enzyme, rHuPH20. The paper demonstrates an association with increased collagen content, high tumor interstitial pressure, vascular collapse, hypoxia, drug resistance and increased metastatic potential. Treatment with PEGPH20 at the human equivalent dose degraded HA in the TME reversing these changes, and also depleted an important proangiogenic growth factor, VEGF-A165, suggesting that treatment with PEGPH20 may diminish the angiogenic potential of the TME. The accumulation of HA is common in many cancers, particularly in pancreatic cancer. A Phase 3 study evaluating the ability of PEGPH20 plus Abraxane and gemcitabine to increase Progression Free Survival and Overall Survival versus Abraxane and gemcitabine alone in metastatic pancreatic ductal adenocarcinoma patients, is under way.
https://thefly.com/landingPageNews.php?id=2799783

Adamas Pharmaceuticals publishes Phase 3 Gocovri Parkinson’s data

Adamas Pharmaceuticals announced that pooled Phase 3 data of Gocovri extended release capsules were published online in Parkinsonism and Related Disorders. Results from pooled Phase 3 ADS-5102 clinical trials, concluded that dyskinesias in people with Parkinson’s disease can impact a patient’s activities of daily living, or ADLs, across multiple tasks and that treatment with Gocovri can help ameliorate the impairment. Gocovri is the first and only medicine approved by the FDA for the treatment of dyskinesia in patients with Parkinson’s disease receiving levodopa-based therapy, with or without concomitant dopaminergic medications. It is also the only drug approved by the FDA to treat dyskinesia in people with Parkinson’s disease on levodopa therapy, as well as demonstrate a secondary benefit in reducing off time in that population. In the pooled Phase 3 analysis, most adverse reactions were of mild to moderate intensity, and the most common adverse reactions were hallucination, dizziness, dry mouth, peripheral edema, constipation, falls, and orthostatic hypotension. https://thefly.com/landingPageNews.php?id=2799797