On April 8, 2021, Iterum Therapeutics plc (the “Company”) received notice from the U.S. Food and Drug Administration (“FDA”) that it needs more time to review materials that have been provided by the Company in support of the Company’s new drug application (“NDA”) for sulopenem etzadroxil/probenecid for the treatment of uncomplicated urinary tract infections in patients with a quinolone non-susceptible pathogen and therefore, the previously scheduled FDA Antimicrobial Drugs Advisory Committee (the “Panel”) on June 2, 2021 has been postponed. A new date for the Panel review of the Company’s NDA has not yet been confirmed and the Company continues to work closely with the FDA to facilitate its review.
Friday, April 9, 2021
Surface Oncology: Promising Preclinical Data for Lead Immunotherapy Product Candidates
Surface Oncology (Nasdaq: SURF), a clinical-stage immuno-oncology company developing next-generation immunotherapies that target the tumor microenvironment, will present preclinical findings supporting the company’s lead product programs, SRF388 (targeting IL-27) and SRF617 (targeting CD39). These data will be presented as part of the American Association for Cancer Research (AACR) 2021 Annual Meeting, which is being held virtually April 10-15 and May 17-21, 2021.
“These findings further support the biological rationale that both of our lead product candidates, SRF388 and SRF617, promote increased proinflammatory activity within the tumor microenvironment in the hopes of ultimately providing novel treatment options to patients with cancer,” said Vito Palombella, chief scientific officer. “We look forward to sharing data from the ongoing Phase 1 clinical trials for both programs this June.”
The e-poster website will be launched at 8:30 a.m. ET on Saturday, April 10, and will remain available for viewing through Monday, June 21. The two e-posters will also be viewable on the Surface Oncology website.
https://finance.yahoo.com/news/surface-oncology-presents-promising-preclinical-115300568.html
Iovance Updates Data for Lifileucel in Advanced Melanoma
Median Duration of Response Not Reached at 28.1 Months of Median Study Follow Up in Cohort 2 of C-144-01 Study
36.4% Overall Response Rate; Continued Deepening of Responses
Iovance Biotherapeutics, Inc. (NASDAQ: IOVA), a late-stage biotechnology company developing novel T cell-based cancer immunotherapies, today announced data from Cohort 2 in the C-144-01 study of lifileucel in advanced melanoma. These data will be part of an oral presentation in a Clinical Trials Plenary Session at the upcoming American Association for Cancer Research (AACR) 2021 Annual Meeting.
“We are very excited to report our latest Cohort 2 melanoma data in an oral presentation at AACR,” said Maria Fardis, Ph.D., President and Chief Executive Officer of Iovance Biotherapeutics. “The long term follow up data show that median duration of response was not reached at 28.1 months of median study follow up. Furthermore, overall response rate remained at 36.4 percent and we saw a continued deepening of response in 17 percent of the patients. The data continue to demonstrate durability and depth of our lifileucel TIL therapy response after a one-time treatment, in a difficult to treat patient population with advanced melanoma. We are honored that AACR has chosen our melanoma Cohort 2 data to be featured in a clinical trials plenary session.”
Jason Chesney, M.D., Ph.D., Director, James Graham Brown Cancer Center, University of Louisville and C-144-01 study investigator stated, “Melanoma patients who have progressed on immune checkpoint and BRAF/MEK inhibitors are among the most challenging patients for oncologists to treat. The updated results of the C-144-01 study continue to demonstrate that autologous tumor infiltrating lymphocytes (TILs; lifileucel) induce durable clinical responses in 36 percent of patients in the study. This study also creates opportunities for additional trials of TILs in many other cancer types and in combination with immunomodulatory agents.”
NYC Launches New Mobile Vaccination Effort, Expands Walk-In for Seniors
With the goal of making the vaccine more accessible to priority populations, Mayor Bill de Blasio today announced the launch of mobile vaccinations, with mobile vaccine vans and buses reaching some of the hardest-to-reach New Yorkers with COVID-19 vaccines. The City will also expand the number of walk-in vaccine sites for New Yorkers 75 and older at City-run vaccine sites citywide.
“We’re doing all we can to get as many shots in arms as possible,” said Mayor Bill de Blasio. “With over 4.6 million doses now administered, we’re going above and beyond to reach every New Yorker, deploying mobile vans and expanding walk-ins to help our city recover one dose at a time.”
Made possible by the Johnson & Johnson vaccine, the mobile vaccination effort will include a fleet of vaccine vehicles, including vans and buses equipped with four to six vaccinators each, delivering the COVID-19 vaccine directly to communities most in need, whether priority populations or neighborhoods identified by the City’s Task Force for Racial Inclusion and Equity as being hardest-hit by the virus and histories of socio-economic disparity.
At these locations, the van will offer approximately 200 vaccine doses per day, for a range of one to three days. Local community-based organizations will help New Yorkers schedule vaccination appointments with the vaccine fleet ahead of time. The fleet will also accept walk-up appointments when available.
Today, the fleet launches with its first bus, taking vaccines on the road with a focus on reaching restaurant workers and delivery workers. Promobile Kitchen will operate this first bus, Daybreak Health will administer vaccine doses, and Relief Opportunities for All Restaurants (ROAR) will lead outreach efforts to restaurant workers, helping them sign up for appointments ahead of time and on site. Additionally, the City will assist with outreach to the community, helping to coordinate with local community-based organizations, elected officials, and industry groups to canvass and engage communities, post flyers, promote these opportunities, and fill these appointments. Vans will have live interpretation on site and vaccine materials in 12 languages.
Restaurant workers and restaurant delivery workers can schedule appointments by emailing vaccbus@roarnewyork.org, or by calling 1-833-ROAR-NYC (1-833-762-7692). Details about additional mobile vaccine sites, including hours and days of operation, will be announced in the coming weeks.
The City will expand its walk-up appointment pilot for New Yorkers over the age of 75 at City-run sites, with a full list below. Additional, site specific information can be found on nyc.gov/vaccinefinder:
Brooklyn
- Bushwick Educational Campus
- Canarsie HS
- Brooklyn Army Terminal
- Starrett City – Spring Creek Towers
- Teachers Prep
- Flatbush YMCA
- City Point
- Coney Island YMCA (opens 4/8)
Bronx
- South Bronx Educational Campus
- Bronx High School of Science
- Co-Op City
- Bathgate
- West Bronx Gymnasium
Queens
- Beach Channel Educational Campus
- Long Island City
- Korean Community Services
- CitiField
- Martin Van Buren Highschool
Staten Island
- Ocean Breeze Athletic
- Empire Outlets
Manhattan
- Essex Crossing
- City College
- Abyssinian Baptist Church
- Ford Foundation (opens 4/7)
- Yeshiva University (opens 4/7)
- Fulton Community Center (opens 4/7)
Humanigen: Positive Results From Phase 1 Glioblastoma Study
Phase 1 dose escalation and bioimaging study shows that ifabotuzumab demonstrates highly specific tumor targeting in patients with recurrent glioblastoma multiforme
Results to be presented as a virtual poster at American Association for Cancer Research (AACR) 2021 Annual Meeting
Humanigen, Inc. (Nasdaq:HGEN), a clinical-stage biopharmaceutical company focused on preventing and treating an immune hyper-response called ‘cytokine storm’ with its lead drug candidate, lenzilumab™, today announced positive results from the Phase 1 safety and bioimaging trial of its second Humaneered® antibody, ifabotuzumab, in patients with glioblastoma multiforme (GBM). In the study, ifabotuzumab demonstrated highly sensitive, specific, and reproducible targeting of the tumor and tumor microenvironment in all patients. The results will be presented as a poster at the AACR Annual Meeting 2021, held virtually from April 10-15, 2021, and remain available until June 21, 2021.
The Phase 1 study primarily sought to determine the safety and recommended Phase 2 dose of ifabotuzumab in patients with GBM, the most frequent and lethal primary brain neoplasm, with 5-year survival rates of 10%. It is estimated there are more than 18,000 deaths from Brian cancer annually in the United States.1 Ifabotuzumab is a non-fucosylated IgG1κ antibody targeting the EphA3 receptor. EphA3 is a tumor-restricted antigen expressed in the tumor vasculature and tumor stroma of various solid tumors including breast, colon, lung, prostate, melanoma, and GBM. The study showed that, at both doses, ifabotuzumab demonstrated highly sensitive, specific, and reproducible targeting of the tumor and tumor microenvironment in all patients. There were no dose-limiting toxicities observed and all adverse events were readily manageable. Additional studies are planned to evaluate ifabotuzumab as an antibody-drug conjugate in solid tumor patients.
https://finance.yahoo.com/news/humanigen-announces-positive-results-phase-110000848.html
CytoDyn’s COVID-19 Long-Hauler’s Trial Closed as Enrollment Exceeds Goals
CytoDyn Inc. (OTC.QB: CYDY), (“CytoDyn” or the “Company"), a late-stage biotechnology company developing leronlimab (PRO 140), a CCR5 antagonist with potential multiple therapeutic indications, announced today its COVID-19 long-haulers study (“CD15”) is now fully enrolled. Enrollment was faster than expected because of the high number of patients wanting to participate, which now includes 56 patients in the trial. This is a multicenter Phase 2, two-arm, randomized, double blind, placebo-controlled study to evaluate the safety and efficacy of Vyrologix™ (leronlimab) in the treatment of patients with prolonged COVID-19 symptoms, a condition now known as Post-Acute COVID Syndrome (PACS). Patients will be given eight (8) weekly doses of Vyrologix™ or placebo. The final treatment for the last enrolled patient will be in early June with results expected in July.
https://finance.yahoo.com/news/cytodyn-covid-19-long-hauler-214100593.html
Troubled Covid-19 Vaccine Rollout in Europe Nears Possible Turning Point
The European Union's economy and vaccination effort have been mired for months while the U.S. and U.K. race ahead toward recovery from the pandemic. But the EU's fortunes could change by midyear -- provided that mishaps stop hampering its vaccine supply.
Amid rising social and political pressure, and despite setbacks, including new safety fears over the vaccine made by AstraZeneca PLC, European policy makers and analysts are expressing cautious optimism that the summer could bring a turning point, when vaccine makers say production will accelerate sufficiently to reopen the economy before fall.
The hoped-for vaccination breakthrough that experts estimate could see over 50% of the EU's adult population inoculated by late July will depend on the seamless supply of shots from multiple manufacturers, as well as overcoming the logistical and administrative challenges that have so far plagued the rollout. The EU's vaccine problems in recent months have ranged from bureaucracy and the public's hesitancy to key suppliers slashing deliveries due to manufacturing issues.
The EU expects to receive 360 million doses of Covid-19 vaccines in the second quarter, a sharp improvement on the 107 million doses it received in the first quarter. The rising supply is coming mainly from the vaccine developed by Pfizer Inc. and BioNTech SE, which is becoming the mainstay of the EU's inoculation campaign. Nearly 68 million doses of the vaccine were delivered in the first quarter and 200 million are expected in the second quarter.
"The capacity is rapidly increasing," Thierry Breton, the European Commissioner overseeing the EU's vaccine strategy, said in a social-media post on Thursday. Vaccine production in Europe is more than doubling every month, he said, offering hope for an end to lockdowns. "I'm afraid we're nowhere near 'normal' yet, but I am confident that we will find some normality soon."
The U.K.'s experience shows how vaccinating vulnerable groups can rapidly reduce deaths and hospitalizations from Covid-19 and pave the way for economic reopening. The British government wants to lift restrictions gradually between April and June.
That prospect currently seems distant to continental Europeans suffering the misery of yet another round of lockdowns. France this week began its third nationwide lockdown of the pandemic while Germany is considering introducing one.
But an end to the EU's funk is coming into sight. "The gap between the EU and the U.K. will close, thanks to an impressive ramp-up of vaccinations in the EU," said Mujtaba Rahman, European head of risk consulting firm Eurasia Group.
"The political mood in the EU will turn quite quickly as well, just as it has done in the U.K. on the back of vaccinations," he said. "All everyone cares about is getting back to normal."
Economists believe the EU economy will probably rebound powerfully in the second half of this year. Data show much of Europe's manufacturing industry is recovering, while many service sectors have found a way to coexist with the persistent restrictions on daily life.
Europe's economic pain is increasingly concentrated in tourism, bars, restaurants and other activities that are currently shut or tightly restricted, but healthy household incomes and pent-up demand for entertainment mean even those sectors could start to revive by late summer.
The EU's official goal is to achieve herd immunity by the end of summer. Although some observers say that target is too optimistic, forecasters say even inoculating half of the adult population would probably be enough to reduce Covid deaths and allow for reopenings.
"Based on what is happening in the U.K., vaccinating roughly 50% of adults is the threshold you need to get to for governments to feel comfortable about lifting restrictions," said Andrew Kenningham, chief European economist at Capital Economics in London. "We expect it will be a phased process in July, August and September, depending on the country, the pace of vaccinations and the prevalence of the virus."
Still, the EU's vaccination delays probably doom Southern Europe's tourism-heavy economies such as Greece, Spain and Italy to another lost summer, Mr. Kenningham said--at least until late in the season.
The risks to a rosier outlook include the threat of mutant virus variants and further setbacks to vaccine supplies.
Public patience is also wearing thin in many countries after months of on-again, off-again lockdowns.
Germans' trust in their government's competence has fallen as Chancellor Angela Merkel has wrestled with the country's 16 states. Restrictions, loosened in March despite worsening Covid contagion, could now tighten again.
In France, public anger was roused by media reports of clandestine dinners among the social and political elites of Paris, in defiance of social-distancing rules. And in Italy, restaurateurs fought with police outside the national Parliament in Rome earlier this week amid growing frustration and hardship in the sector.
Unlike in spring 2020, when tough lockdowns eventually suppressed Covid infections in most of Europe, months of sacrifices since late last year have seemingly borne little fruit. Infections, hospitalizations and deaths have remained stubbornly high in the EU's major countries.
Health experts partly blame the spread of the more aggressive U.K. virus variant throughout Europe, dwindling compliance with social distancing rules by a weary public and the fact that many people continue to go to their workplaces in factories and offices.
A year ago, wild animals wandered the streets of deserted European cities. Now, traffic and commuters are back, albeit at lower levels than normal. Mobility data show rising movement despite restrictions.
Workplaces and schools are among the main sources of infection in Germany, according to the country's disease-control center, the Robert Koch Institute. Ms. Merkel's government has struggled to coax businesses to let their staff work from home.
In contrast, Nordic countries such as Norway and Finland have kept infection rates down thanks partly to widespread working from home. Denmark, whose fight against the virus has also benefited from one of Europe's most effective testing regimes, even began to reopen this week and plans to lift most restrictions by late May.
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