Stockwinners Market Radar for November 10, 2019 - Earnings, Upgrades downgrades, option trades, Best Stock Advisory Service

16:57 EST Facebook's Instagram to start hiding likes for U.S. audiences - Facebook subsidiary Instagram's CEO Adam Mosseri said in a Wired interview that Instagram will start hiding likes on the platform for U.S. audiences beginning next week, saying the goal is to"depressurize Instagram, make it less of a competition." Reference Link

16:35 EST Alibaba generates $12B in gross merchandise volume in first hour of 11/11 event - Alibaba Group Holding Limited kicked off the 2019 11.11 Global Shopping Festival at midnight in China. In the first minute and eight seconds, gross merchandise volume, or GMV, settled through Alipay reached $1.0B. In the first hour, GMV settled through Alipay reached $12.0B.

11:48 EST Mirati presents data from sitravatinib in combination with nivolumab trials - Mirati Therapeutics announced the presentation of initial data from its ongoing Phase 2 clinical trial of sitravatinib in combination with nivolumab in metastatic urothelial cancer patients with documented progression on a platinum-chemotherapy and checkpoint inhibitor. The data were presented in an oral presentation at the Society of Immunotherapy of Cancer 34th Annual Meeting. Preliminary results from the ongoing Phase 1 study of neoadjuvant sitravatinib combined with nivolumab in patients with resectable squamous cell carcinoma of the oral cavity, SNOW trial, were also presented in a poster session. The preliminary data suggest that the combination of neoadjuvant sitravatinib and nivolumab is safe and active in patients with squamous cell carcinoma of the oral cavity who are candidates for resection. Tumor reduction was observed in all eight patients who were eligible for evaluation, including one complete pathological response. All patients received postoperative radiation therapy, and none required postoperative chemotherapy. With a median follow-up of 31.4 weeks, all patients are alive with no disease recurrence to date. In most patients, treatment with sitravatinib led to a decrease in myeloid-derived suppressor cells and a shift towards M1-type macrophages in the tumor microenvironment, supporting previous preclinical findings. "Sitravatinib is a spectrum-selective kinase inhibitor that potently inhibits receptor tyrosine kinases, including TAM family receptors that has the potential to increase responsiveness in patients whose tumors are resistant to checkpoint inhibitors. The initial efficacy data from the Phase 2 clinical trial presented today in patients with checkpoint refractory mUC is promising and extends the clinical benefit data beyond what has already been demonstrated by sitravatinib combined with nivolumab in checkpoint refractory non-small cell lung cancer," said Charles Baum, M.D., CEO of Mirati. "In addition, we are evaluating sitravatinib in patients who have progressed on checkpoint therapy, including those with NSCLC and renal cell cancer, and we continue to expand development efforts of sitravatinib through our collaboration with BeiGene in multiple indications including NSCLC, renal cell cancer, hepatocellular cancer, ovarian cancer, and gastric cancer."

11:40 EST NextCure presents updated data from NC318 Phase 1/2 clinical trial - NextCure announced that updated clinical results from the Phase 1 portion of its ongoing trial with NC318, a monoclonal antibody targeting Siglec-15, or S15, were presented at the SITC annual meeting. S15 is a novel immunomodulatory protein that is expressed on highly immunosuppressive cells called M2 macrophages and on tumor cells. In addition, NextCure announced the initiation of the Phase 2 portion of its ongoing Phase 1/2 clinical trial of NC318. "NC318 has been well tolerated in the Phase 1 trial, and the only dose-limiting toxicity was a grade 3 pneumonitis in the 1,600 mg cohort," said Kevin Heller, M.D., NextCure's Chief Medical Officer. "It is encouraging to see single-agent activity among NSCLC patients refractory to PD-1 therapies, including a durable complete response and a durable partial response. Given what appears to be the non-overlapping expression of PD-L1 and S15, the results to date support the potential of NC318 to block S15-mediated immune suppression among a patient population unlikely to respond to PD-1/PD-L1-directed therapies."

11:36 EST Roche's Genentech announced Gazyva data that met primary, secondary endpoints - Genentech, a member of the Roche Group (RHHBY), announced data from the Phase II NOBILITY study, investigating the safety and efficacy of Gazyva for adults with proliferative lupus nephritis. The study met the primary endpoint with Gazyva, in combination with standard of care, demonstrating superiority compared to placebo plus standard of care. Gazyva additionally met key secondary efficacy endpoints showing improved overall renal response and serologic markers of disease activity as compared to placebo. No new safety signals were observed with Gazyva in the study at the time of this analysis. Through week 76, serious adverse events and serious infections were not increased with Gazyva. These data will be presented at the 2019 American College of Rheumatology Annual Meeting in Atlanta, Georgia, on November 10.

10:58 EST Akebia announces 'positive' data from two Phase 3 vadadustat studies - Akebia Therapeutics announced that MTPC, Akebia's development and commercialization collaboration partner in Japan for vadadustat, presented positive 24-week and 52-week data from two Phase 3 active-controlled pivotal studies evaluating the efficacy and safety of vadadustat, an investigational oral hypoxia-inducible factor prolyl hydroxylase inhibitor, in Japanese patients with anemia due to chronic kidney disease, at ASN Kidney Week 2019. Each study met its primary endpoint based on mean hemoglobin level at weeks 20 and 24, and showed vadadustat's effect on hemoglobin was sustained through to 52 weeks in each study.

10:51 EST Pieris presents data from phase 1 dose-escalation monotherapy study of PRS-343 - Pieris Pharmaceuticals announced the presentation of data from the phase 1 dose-escalation monotherapy study of PRS-343, a 4-1BB/HER2 bispecific for the treatment of HER2-positive solid tumors, in a late-breaking oral presentation at the Society for Immunotherapy of Cancer Annual Meeting. PRS-343 demonstrated single-agent anti-tumor activity, including partial responses, in heavily pre-treated patients across multiple HER2-positive tumors. Beyond demonstrating clinical benefit, PRS-343 showed a potent increase in CD8+ T cell numbers and proliferative index in the tumor microenvironment of responders, indicative of 4-1BB agonism on T cells. PRS-343 was safe and well tolerated at all doses and schedules tested. "The data presented today demonstrate PRS-343's potential to make a meaningful difference for patients with tumors that are difficult to treat with currently-available therapies," said Geoffrey Ku, medical oncologist at Memorial Sloan Kettering and the principal investigator for the PRS-343 monotherapy trial. "Beyond today's presentation, I look forward to sharing some of these case studies at Pieris' upcoming R&D day alongside emerging data from the study of PRS-343 in combination with atezolizumab."

10:48 EST Genocea presents data demonstrating potential of ATLAS platform - Genocea Biosciences presented clinical and preclinical data demonstrating the potential of Genocea's unique, biology-driven ATLAS platform to select neoantigens for inclusion in anti-tumor immunotherapies. The company said, "Striking clinical evidence shows that the presence of inhibitory neoantigens in an otherwise protective therapeutic vaccine completely suppressed anti-tumor immune responses and promoted tumor growth in pre-clinical models." These data were presented at the 34th Annual Meeting of the Society for Immunotherapy of Cancer. "These results point to the true power and utility of ATLAS," said Jessica Baker Flechtner, Chief Scientific Officer of Genocea. "Our findings confirm that responses to inhibitory neoantigens can undermine a cancer immunotherapy, even if it also contains stimulatory neoantigens. ATLAS is the only technology able to identify these inhibitory peptides, offering further proof of its potential to identify the targets that matter most."

10:42 EST Autolus Therapeutics reports 'encouraging' pre-clinical results for AUTO6NG - Autolus Therapeutics presented pre-clinical data on AUTO6NG, the company's next generation GD2-targeting CAR T cell therapy, at the 34th Annual Meeting of the Society for Immunotherapy of Cancer being held November 6-10, in Washington, D.C. "Autolus' growing set of programming modules addresses a range of inhibitory factors within the highly complex and dynamic solid tumor microenvironment. This presentation demonstrates the utility of three modules added to the clinically active and validated AUTO6 GD-2 targeting CAR that not only improve CAR T persistence but also combat the immunosuppressive environment," said Dr. Christian Itin, CEO of Autolus. "Based on these encouraging pre-clinical results, which demonstrate the activity of AUTO6NG, we plan on initiating a clinical study in patients with GD2 positive tumors including refractory/relapsed neuroblastoma in the second half of next year."

10:38 EST Great Panther Silver reports fatal accident at mine in Mexico - Great Panther reported that a fatal accident involving a contractor's employee occurred in the afternoon of November 8 due to an isolated rock fall at the San Ignacio underground mine, which forms part of the Guanajuato Mine Complex in Mexico. The company said that safety procedures are being reviewed and reinforced to ensure safety remains the top priority across all operations.