NYC’s COVID-19 test and trace program can’t pinpoint 80% of cases

The Big Apple’s heavily touted coronavirus tracing program is having trouble tracking down sources of at least 80 percent of the COVID-19 infections in New York City, Mayor Bill de Blasio acknowledged Tuesday.

“People want firm, specific answers and, understandably, we would like for things to be clear and neat and that’s just not what the coronavirus usually gives us,” Hizzoner said during his daily briefing. “We just don’t have sites or activities that led to anywhere near the number of cases you would think.”

City health experts have said that roughly 10 percent of infections in the city can be traced back to travel outside of the area, while another 5 to 10 percent of cases can be linked back to individual sources and instances of infection.

But that leaves more than 80 percent of COVID-19 infections without a clear source, a startling new development that is complicating the city’s fight to stave off a second wave of the coronavirus pandemic that’s already sweeping across most other parts of the country.

“The challenge is how diffuse this is. And when it’s this diffuse it isn’t always as simple as, ‘oh, I went to a restaurant or I went to a gym’,” de Blasio added. “A lot of times there isn’t an obvious place because there’s a substantial amount of community spread.”

The city’s Test and Trace Corps employs more than 1,200 who are tasked with contacting and interviewing people who test positive for the dreadful disease in an effort to ascertain how they contracted it — and, just as importantly, who else they may have exposed.

City Hall’s effort to build the program from scratch after the pandemic exploded got off to a rocky start in the summertime.

Initially, just one-in-three New Yorkers provided contact information for people they may have exposed to the virus. And the program struggled to hire Yiddish speakers, a problem that exploded into view as the city’s tight-knit Orthodox communities were the center of a COVID outbreak in September.

Statistics published by the Test and Trace Corps show that of the nearly 93,000 New Yorkers contacted so far by the program, just 63 percent have completed their intake forms.

https://nypost.com/2020/11/17/nycs-covid-19-test-and-trace-program-cant-pinpoint-80-of-cases/

Sanofi rilzabrutinib Fast Track'd in U.S. for low platelet count

• FDA has granted Fast Track Designation to Sanofi's (NASDAQ:SNY) oral investigational Bruton’s tyrosine kinase inhibitor, rilzabrutinib, for the treatment of immune thrombocytopenia (low blood platelets).
• Fast Track status provides for more frequent interaction with the FDA review team and a rolling review of the marketing application.
• In addition, following positive Phase 1/2 study results, a Phase 3 study evaluating rilzabrutinib for ITP has been initiated.
• https://seekingalpha.com/news/3637353-sanofis-rilzabrutinib-fast-trackd-in-u-s-for-low-platelet-count
  

Pfizer and Vivet on go with mid-stage VTX-801 study in liver disorder

• Pfizer and privately held Vivet Therapeutics said the FDA has cleared Vivet’s Investigational New Drug (IND) application for the GATEWAY study, a Phase 1/2 clinical trial evaluating Vivet’s gene therapy vector, VTX-801, for the potential treatment of Wilson disease (WD), a rare and life-threatening liver disorder. The trial is expected to commence in early 2021.
• The GATEWAY trial will measure relevant biomarkers to evaluate physiological restoration of copper elimination and transport in patients.
• The primary endpoint is to assess the safety and tolerability of VTX-801 at 52 weeks after a single infusion.
• Vivet Therapeutics expects to enroll the first patient in early 2021.
• In March 2019, Pfizer acquired 15% ownership stake in Vivet and secured an exclusive option to acquire all outstanding shares.
• In September 2020, Vivet and Pfizer inked manufacturing agreement for the VTX-801.
• https://seekingalpha.com/news/3637354-pfizer-and-vivet-on-go-mid-stage-vtxminus-801-study-in-liver-disorder
  

Kazia jumps on positive paxalisib data in glioblastoma

• Kazia Therapeutics (NASDAQ:KZIA) soars 22% after-hours after announcing new paxalisib data which will presented at SNO Annual Meeting, held virtually from 19-21 November 2020.
• New interim analysis of paxalisib phase II study in glioblastoma is highly consistent with prior data.
• Median progression-free survival (PFS) of 8.4 months vs. 5.3 months for temozolomide, the existing standard of care.
• Median overall survival (OS) of 17.5 months reported, vs. 12.7 months for temozolomide.
• Phase 1 study in DIPG shows paediatric maximum tolerated dose (MTD) of 27 mg/m², with safety profile and pharmacokinetics similar to adult data.
• In terms of PFS, the proportion of patients alive and progression-free at six months was 96%, which compares favorably to an historical control of 58%.
• The company expects final data from both paxalisib phase II study and DIPG study in H1 2021.
• The paxalisib arm of the GBM AGILE study has moved into an operational phase, and first patient in is expected early in Q1 2021.
• Kazia will hold a conference call on November 18, 8pm ET to discuss the results further.
• https://seekingalpha.com/news/3637356-kazia-stockplus-22-on-positive-paxalisib-data-in-glioblastoma
  

FDA lifts clinical hold on Cellectis' early-stage UCARTCS1 study in multiple myeloma

• Cellectis announces that the FDA has lifted the clinical hold on the Phase 1 MELANI-01 trial evaluating the UCARTCS1 product candidate for the treatment of patients with relapsed or refractory multiple myeloma (MM).
• Cellectis worked closely with the FDA to address the agency’s requests, which include adjustments to the MELANI-01 clinical protocol designed to enhance patient safety.
• “The safety of patients enrolled in our clinical trials remains our priority, and we are committed to resuming the clinical development of this promising program,” said Carrie Brownstein, MD, Chief Medical Officer, Cellectis.
• Patient enrollment is ongoing in Cellectis’ two other Phase 1 dose escalation trials: AMELI-01 evaluating UCART123 in acute myeloid leukemia and BALLI-01 evaluating UCART22 in B-cell acute lymphobastic leukemia.
• https://seekingalpha.com/news/3637357-fda-lifts-clinical-hold-on-cellectis-early-stage-ucartcs1-study-in-multiple-myeloma
  

ViiV cabotegravir nabs accelerated review in U.S. for HIV prevention

• FDA grants Breakthrough Therapy Designation to ViiV Healthcare's long-acting, injectable cabotegravir for HIV pre-exposure prophylaxis (PrEP).
• Breakthrough Therapy status provides for more intensive guidance from the FDA on development, the involvement of more senior agency personnel and a rolling review of the marketing application.
• ViiV Healthcare is the HIV-focused joint venture between GlaxoSmithKline (NYSE:GSK), Pfizer (NYSE:PFE) and Shionogi (OTCPK:SGIOY).
• https://seekingalpha.com/news/3637361-viiv-healthcares-cabotegravir-nabs-accelerated-review-in-u-s-for-hiv-prevention
  

Sinovac: COVID-19 vaccine 'successful' in mid-stage trials

• Sinovac Biotech's (NASDAQ:SVA) experimental COVID-19 vaccine, CoronaVac triggered a quick immune response but low levels of antibodies when compared to the people who had recovered from the disease, source Reuters.
• While the early to mid-stage trials were not designed to assess the efficacy of CoronaVac, researchers said it could provide sufficient protection, based on their experience with other vaccines and data from preclinical studies with macaques.
• The announcement comes after European and U.S. vaccines reported successful data from large late-stage trials. Three vaccines, developed in the U.S., Germany and Russia, have all released data suggesting efficiency of more than 90%.
• Like the rest of the world, China is racing to develop a COVID-19 vaccine. CoronaVac and four other experimental vaccines have entered the third and final stage of clinical trials.
• Our findings show that CoronaVac is capable of inducing a quick antibody response within four weeks of immunisation by giving two doses of the vaccine at a 14-day interval,” Zhu Fengcai, one of the authors of the paper, said.
• "We believe that this makes the vaccine suitable for emergency use during the pandemic,” Zhu said in a statement published alongside the paper.
• The Sinovac findings, published in medical journal The Lancet Infectious Diseases, came from results in Phase I and Phase II clinical trials in China involving more than 700 participants.
• Sinovac is currently running three Phase III trials in Indonesia, Brazil and Turkey.
• CoronaVac is one of three COVID-19 vaccines China has been using to inoculate hundreds of thousands of people under an emergency use program.
• The two other vaccines in the program, both developed by institutes linked to Sinopharm, and another vaccine from CanSino Biologics, were also shown to be safe and triggered immune responses in early and mid-stage trials, according to peer-reviewed papers.
• Gang Zeng, a Sinovac researcher involved in the CoronaVac study, said the vaccine could be an attractive option because it can be stored at normal fridge temperatures of 2 to 8 degrees Celsius (36°-46°F) and may remain stable for up to three years.
• Trials of the Sinovac Biotech vaccine in Brazil were briefly halted last week but resumed after the reported death of a volunteer was found to have no links to the vaccine.
• CoronaVac is also being considered by Brazil and Indonesia for inoculations in the coming months.
• Over the past few days, there has been a string of promising vaccine news from around the world.
• Researchers behind all of the three vaccines developed by a German-U.S. Pfizer and BioNtech, U.S. company Moderna and a Russian Covid vaccine have released data from more advanced testing stages than the Chinese vaccine. However, Sinovac is conducting these same late-stage trials as well.
• Approval and mass production would be the next hurdles and which of those vaccines will be first rolled out still remains to be seen.
• https://seekingalpha.com/news/3637388-sinovacs-covidminus-19-vaccine-successful-in-mid-stage-trials