Dactolisib

Please check out the biopharma industry coronavirus (COVID-19) stories that are trending for April 3, 2020. News information is not all-inclusive. Please check back for updates. FDA Actions Warning Letters: The FDA and FTC issued three warning letters for selling fraudulent COVID-19 products and providing misleading claims that its products can prevent, treat, diagnose or cure COVID-19. These companies include: Gaia’s Whole Health Essentials LLC. , Homeomart Indibuy and Health Mastery Systems DBA Pure Plant Essentials . Diagnostics Update : The FDA has worked with more than 240 test developers who plan to submit EUA requests to detect COVID-19. Also, 25 EUAs have been issued. The FDA has been notified that more than 125 laboratories have begun testing under the policies set forth in its COVID-19 Policy for Diagnostic Tests for Coronavirus Disease-2019 during the Public Health Emergency Guidance. On April 1 st , the FDA issued an EUA to Cellex Inc.’s qSARS-CoV-2 IgG/IgM Rapid Test. Blood Donor Eligibility : The FDA announced it is revising recommendations in several guidances including HIV, malaria and CJD/vCJD for immediate implementation. Additionally, the FDA is published a fourth guidance providing notice of alternatives for the duration of the COVID-19 pandemic. Diagnostics Aytu BioScience: Aytu BioScience announced it has begun shipping its Coronavirus Disease 2019 (“COVID-2019") IgG/IgM Rapid Test to U.S. customers. BD ( Becton, Dickinson and Company ) received Emergency Use Authorization from the U.S. Food and Drug Administration for a new diagnostic test that will enable hospitals to screen for COVID-19 on site and get results in under three hours. The test will be run on the BD MAX System, a molecular diagnostic platform already in use at hundreds of laboratories in nearly every state across the country. Each unit is capable of analyzing hundreds of samples per day. Mayo Clinic is reportedly to begin antibody testing on Monday, using an internally developed test. Beroni Group ’s SARS-CoV-2 IgG/IgM Antibody Detection Kit gets approval in Europe. It has also notified the FDA of its validated serology tests for its COVID-19 diagnostic test. Predictive Technology Group signed a deal between its subsidiary, Predictive Laboratories , and Wellgistics , for U.S. distribution of its Assurance AB COVID-19 IgM/IgG Rapid Antibody Test. Testing Therapies, Antivirals and Vaccines Novartis/Incyte: Novartis announced that, with Incyte , it is launching a Phase III clinical trial to determine if their cancer drug Jakavi (ruxolitinib) can be used to treat COVID-19. An experimental vaccine developed by the University of Pittsburgh is showing promise in the fight against COVID-19 . The vaccine produced a significant amount of antibodies in mice that could protect against the virus for up to one year. The researchers are seeking to move the vaccine into human trials. I-Mab: I-Mab announced the FDA has cleared the company’s Investigational New Drug (IND) application to initiate a clinical trial for TJM2. This trial will assess treatment for cytokine release syndrome (CRS) associated with severe illness caused by COVID-19. Cellex: The U.S. Food and Drug Administration approved the first blood test that looks for antibodies against the novel coronavirus that causes COVID-19. Research Triangle Park, North Carolina-based Cellex was granted an emergency use authorization (EUA) on its test yesterday. After screening for antibodies against COVID-19, South Korea’s Celltrion Group is moving its antiviral treatment into the next phase of clinical research . The first phase saw the securing of 300 different types of antibodies that bind to the antigen. The library of antibodies was created using the blood of recovered patients in Korea. Celltrion anticipates the candidate screening for the therapeutic monoclonal antibody will be complete by mid-April, sooner than originally expected. GlaxoSmithKline has teamed up with Innovax Corporation to evaluate that company’s recombinant protein-based coronavirus vaccine candidate COVID-19 XWG-03. The COVID-19 XWG-03 vaccine candidate technology is based on a series of truncated S (spike) proteins which will be screened during the pre-clinical testing and a lead candidate will be determined by immunogenicity data. GSK will provide Innovax with its pandemic adjuvant system for preclinical evaluation of the vaccine. Early indications of the adjuvant’s benefit have been reported in the first pre-clinical experiments by one of the collaborations. GSK expects data to be reported from the various collaborations over the next three months and these data will inform the next steps for clinical development of the candidate vaccines. FluGen and Bharat Biotech partnered with the University of Wisconsin at Madison to develop a COVID-19 vaccine candidate, dubbed CoroFlu. The intranasal vaccine will be based on FluGen’s flu vaccine candidate M2SR. Researchers at the university will add SARS-CoV-2 gene sequences into M2SR to create a vaccine that could generate immunity against the novel coronavirus, according to reports . Australian researchers at Flinders University and Vaxine are testing a vaccine candidate against SARS-COV-2 leverage Oracle for technical collaboration. Company Actions resTORbio: resTORbio announced it will postpone enrollment in the fifth cohort of its ongoing Parkinson’s Phase Ib/IIa clinical trial of RTB101 in New Zealand. The delay is due to a COVID-19 level 4 alert. Novartis: Novartis and the Novartis US Foundation have established a US COVID-19 Community Response Fund totaling $5 million for immediate response and recovery efforts. Capricor Therapeutics: Capricor Therapeutics announced it will provide CAP-1002, its novel cell therapy to patients with advanced COVID-19 under the compassionate use pathway. Global Blood Therapeutics (GBT): GBT announced a newly created GBT Community Fund that will commit $250,000 to support the sickle cell disease community during the COVID-19 pandemic. Other Industry News Comparison: 2003 SARS Pandemic vs. 2020 COVID-19 Pandemic . When COVID-19 first appeared in the news, scientists took note and began to prepare for a widespread outbreak. The general population, however, wasn’t concerned. Many assumed it would be like the SARS pandemic, affecting relatively few people and, aside from a few cities or regions, not disrupting daily life. As the world continues to adjust to the new paradigm of self-quarantine due to COVID-19, Sanofi Chief Executive Officer Paul Hudson predicts the ways of working that many companies have adapted will become more permanent features. In an interview with the Wall Street Journal , Hudson predicted one-meeting trips will begin to disappear in favor of digital options like Zoom. Larger, multi-day meetings will remain a staple for networking purposes. Regarding the company’s efforts to develop a vaccine and therapeutic for COVID-19, Hudson predicted the company could have a vaccine ready to go by the second quarter of 2021. BIG NEWS! The BIO International Convention , like numerous other conferences and conventions, is moving to a virtual format for its June 8-12 convention, which they are dubbing BIO Digital 2020. They are offering a variety of offerings—it is, after all, one of the largest industry gatherings in the world—including Virtual BIO One-on-One Partnering, Online Education, and On-Demand Company Presentations. The Organization notes: “Nothing Stops Innovation. We’ll get beyond this health crisis together. Developing treatments and solutions to the world’s most urgent challenges and complicated problems is what we do.”

A number of companies reported clinical trial data last week. Here’s a look. A number of companies reported clinical trial data last week. Here’s a look. Takeda Pharmaceutical ’s VISIBLE 2 Phase III clinical trial in Crohn’s disease hit its primary endpoints. The trial evaluated Entyvio (vedolizumab) as a maintenance therapy in moderately or severely active Crohn’s disease. The primary endpoint was statistically significant percentage of patients who achieved clinical remission at 52 weeks compared to placebo. The company reported results on its VISIBLE 1 trial in May, where a subcutaneous version of Entyvio created a 46.2% clinical remission rate in ulcerative colitis patients at week 52, compared to 14.3% in patients receiving placebo. Intec Pharma announced top-line data from its Phase III trial, ACCORDANCE, of its Accordion Pill, carbidopa/levodopa (AP-CD/LD) compared with immediate release CD/LD (IR-CD/LD), Sinemet) for symptoms of advanced Parkinson’s disease. The trial did not show statistical superiority to Sinemet on the primary endpoint of reduction in daily OFF time. Intec noted that in some subsets of patients the treatment was very effective, so they plan to continue to analyze the full data set as they move forward. HAMLET Pharma reported that Alpha1H in bladder cancer was successful in the Phase I/II clinical trial. Alpha1H triggered significant shedding of cells in all cancer patients who received the treatment. The compound, Human Alpha-lactalbumin Made Lethal (HAMLET) also triggered the excretion of whole tumor fragments into the urine. The trial evaluated 40 patients, 20 receiving placebo and 20 who received six transfusions of Alpha1H over 22 days. Resolve Therapeutics announced it had completed enrollment in its Phase IIa trial of RSLV-132 for Systemic Lupus Erythematosis (SLE). It is a double-blind, placebo-controlled trial in 64 lupus patients in 20 centers in the U.S. It is looking to determine the efficacy and safety of RSLV-132 compared to placebo. RSLV-132 is a novel, targeted biologic designed to remove pro-inflammatory nucleic acids from patients’ circulation. ViiV Healthcare , the HIV-focused joint venture of GlaxoSmithKline, Pfizer and Shinogi Ltd., reported that its Phase III BRIGHTE trial hits its 96-week endpoints in heavily treatment-experienced adults with HIV-1 infection. The trial analyzed fostemsavir, a first-in-class attachment inhibitor, in combination with optimized background treatment (OBT) in this population. At 92 weeks, 60% of the fostemsavir plus OBT cohort achieved virologic suppression, a 6% increase over the 48-week result. Also at 96 weeks, the patients on fostemsavir showed an increase in CD4+ T-cell counts, a mean change from baseline of +205 cells per microliter. ACADIA Pharmaceuticals announced top-line results from its Phase III ENHANCE clinical trial of Parkinson’s drug Nuplazid (pimavanserin), which though it showed improvement in schizophrenia treatment, failed to hit statistical significance for its primary endpoint. In the trial, 396 patients moderate-to-severe psychotic symptoms related to adult schizophrenia received either Nuplazid or placebo added to their current antipsychotic treatment. The patients receiving Nuplazid showed a consistent trend in symptom improvement but did not hit statistical significance on the primary endpoint, which was the Positive and Negative Syndrome Scale (PANSS) total score. The company also indicates that there was a positive trend on a key secondary endpoint, the Clinical Global Impression-Severity (CGI-S) score. Actinium Pharmaceuticals announced that the 75 th patients had been treated in its Phase III SEIRRA trial of lomab-B for elderly relapsed/refractory acute myeloid leukemia. This is the midpoint of the trial. Lomab-B is an antibody radiation-conjugate (ARC) made up of the anti-CD45 antibody apamistamab and the radioisotope I-131. To date the trial has shown promising preliminary feasibility and safety data. resTORbio completed patient enrollment of its Phase III PROTECTOR 1 trial ahead of its clinical timeline. It has 1,024 patients. It is the first of two global Phase III trials looking at RTB101 to improve the immune function of patients aged 65 or older to decrease the incidence of respiratory tract infections (RTIs). RTB101 is an oral, selective, and potent TORC1 inhibitor. Chiasma reported top-line results from its Phase III CHIASMA OPTIMAL clinical trial. The trial is evaluating octreotide capsules for the maintenance treatment of adults with acromegaly. The trial met primary and all secondary endpoints with no new or unexpected safety signals. In the trial, 58% of patients on octreotide capsules maintained their IGF-1 response compared to 19% of patients on placebo. SCYNEXIS announced it had reached an agreement with the FDA under a Special Protocol Assessment (SPA) on the design, trial population, endpoints and statistical analysis of its Phase III CANDLE clinical trial. The trial will evaluate oral ibrexafungerp for the prevention of recurrent vulvovaginal candidiasis (VVC), otherwise known as a vaginal yeast infection. The primary endpoint is efficacy measured by the percentage of patients with no recurrences of VVC up through an evaluation at week 24. Arena Pharmaceuticals dosed its first patient in the Phase II CAPTIVATE trial of olorinab for visceral pain associated with gastrointestinal disorders. The trial is studying the efficacy and safety of three doses of olorinab for 12 weeks in about 240 patients experiencing abdominal pain associated with irritable bowel syndrome (IBS), including IBS with constipation (IBS-C) or IBS with diarrhea (IBS-D). Innovent Biologics dosed its first patient in its ORIENT-31 trial to evaluate Tyvyt (sintilimab injection) co-developed with Eli Lilly and Company, and IBI305, in combination with chemotherapy in patients with EGFR-mutant non-squamous non-small cell lung cancer (NSCLC) who have progressed from prior treatment with epidermal growth factor receptor tyrosine kinase inhibitor (EGFR-TKI). The Phase III trial is being conducted in China to evaluate the safety and efficacy of Tyvyt and IBI305 with chemotherapy in this patient population. 480 patients will be enrolled in the trial. Janssen Pharmaceutical , a Johnson & Johnson company’s Phase III OPTIMUM clinical trial of its ponesimod met its primary and most secondary endpoint s for relapsing’s forms of multiple sclerosis. The drug, a selective sphingosine-1-phosphate receptor 1 (S1P1) modulator, was compared in a head-to-head trial to Sanofi ’s Aubagio (teriflunomide) in adults with relapsing MS. The primary endpoint was annualized relapse rate (ARR) up to the end of the study, with a key secondary endpoint the change from baseline to week 108 in fatigue-related symptoms.