20220121
www.reuters.com/world/us/exclusive-us-opposes-plans-stren...
U.S. opposes plans to strengthen World Health Organization
Major funding reform supported by Europe, Africa, South Asia
White House proposes separate fund for health emergencies
Biden administration sceptical about WHO, sources say
BRUSSELS, Jan 21 (Reuters) - The United States, the World Health Organization's top donor, is resisting proposals to make the agency more independent, four officials involved in the talks said, raising doubts about the Biden administration's long-term support for the U.N. agency.
The proposal, made by the WHO's working group on sustainable financing, would increase each member state's standing annual contribution, according to a WHO document published online and dated Jan. 4.
The plan is part of a wider reform process galvanised by the COVID-19 pandemic, which has highlighted the limitations of the WHO's power to intervene early in a crisis.
But the U.S. government is opposing the reform because it has concerns about the WHO's ability to confront future threats, including from China, U.S. officials told Reuters.
It is pushing instead for the creation of a separate fund, directly controlled by donors, that would finance prevention and control of health emergencies.
Four European officials involved in the talks, who declined to be named because they were not authorised to speak to the media, confirmed the U.S. opposition. The U.S. government had no immediate comment.
The published proposal calls for member states' mandatory contributions to rise gradually from 2024 so they would account for half the agency's $2 billion core budget by 2028, compared to less than 20% now, the document said.
The WHO's core budget is aimed at fighting pandemics and strengthening healthcare systems across the world. It also raises an additional $1 billion or so a year to tackle specific global challenges such as tropical diseases and influenza.
Supporters say that the current reliance on voluntary funding from member states and from charities such as the Bill and Melinda Gates Foundation forces the WHO to focus on priorities set by the funders, and makes it less able to criticise members when things go wrong.
An independent panel on pandemics that was appointed to advise on the WHO reform had called for a much bigger increase in mandatory fees, to 75% of the core budget, deeming the current system "a major risk to the integrity and independence" of the WHO.
LONG-STANDING SCEPTICISM
The WHO itself responded to a query by saying that "only flexible and predictable funds can enable WHO to fully implement the priorities of the Member States".
Top European Union donors, including Germany, back the plan, along with most African, South Asian, South American and Arab countries, three of the European officials said.
The proposal is to be discussed at the WHO's executive board meeting next week but the divisions mean no agreement is expected, three of the officials said.
The WHO confirmed there was currently no consensus among member states, and said talks were likely to continue until the annual meeting in May of the World Health Assembly, the agency's top decision-making body.
European donors in particular favour empowering, rather than weakening, multilateral organisations including the WHO.
One European official said the U.S. plan "causes scepticism among many countries", and said the creation of a new structure controlled by donors, rather than by the WHO, would weaken the agency's ability to combat future pandemics.
Washington has been critical of the WHO for some time.
Former president Donald Trump pulled the United States out of the WHO after accusing it of defending China's initial delays in sharing information when COVID-19 emerged there in 2019.
The Biden administration rejoined soon after taking office, but officials told Reuters they think the WHO needs significant reform, and raised concerns about its governance, structure and ability to confront rising threats, not least from China.
One of the European officials said other big countries, including Japan and Brazil, were also hesitant about the published WHO proposal.
Two of the European officials said China had not yet made its position clear, while a third official listed Beijing among the critics of the proposal.
The governments of Japan, China and Brazil had no immediate comment.
finance.yahoo.com/news/sorrento-therapeutics-announces-co...
Sorrento Therapeutics Announces Covishield (Sti-9167), a Broad-Spectrum Neutralizing Antibody, Potently Neutralizes Omicron and Omicron (+R346k) Variants of Sars-Cov-2
COVISHIELD (STI-9167) neutralizing antibody (nAb) was discovered by scientists from the Icahn School of Medicine at Mount Sinai (“Icahn Mount Sinai”) and further optimized and engineered by Sorrento scientists.
A preprint manuscript is published online at biorxiv.org: biorxiv.org/cgi/content/short/2022.01.19.476998v1
Sorrento has obtained worldwide exclusive license rights from Icahn Mount Sinai as previously announced on March 9, 2021
Compared to available published literature and head-to-head experiments, STI-9167 nAb is a potentially “Best-in-Class” nAb against the Omicron variant of SARS-CoV-2 and the first reported nAb with high potency against Omicron (+R346K mutation) and has demonstrated highly potent neutralization activities in vitro (IC50 of 25 ng/mL for Omicron live virus, 14.8 ng/mL and 23.9 ng/mL for Omicron and Omicron (+R346K mutation) pseudovirus, respectively), in addition to potent neutralizing activities against the SARS-CoV-2 virus and all of its variants of concern (VOCs).
STI-9167 nAb demonstrated strong protection in vivo following Omicron virus challenge in a preclinical model of COVID-19, preventing weight loss and reducing virus titers in the lungs to levels below the limit of detection.
GMP drug product manufacturing in support of large clinical development is in place at Sorrento GMP facilities.
Sorrento is evaluating in-house GMP manufacturing and is in negotiations with major global CMOs for commercial scale manufacturing to secure capacity to manufacture and supply tens of millions of doses. Sorrento currently has in-hand sufficient cGMP drug substance for 100,000’s of doses at the projected intranasal dose of STI-9199, the intranasal formulation of STI-9167.
INDs to be submitted in the US, UK and Mexico within a month for use as either a small volume intravenous push or intranasal instillation.
(investors.sorrentotherapeutics.com/news-releases/news-rel...).
SAN DIEGO, Jan. 21, 2022 (GLOBE NEWSWIRE) -- Sorrento Therapeutics, Inc. (Nasdaq: SRNE, "Sorrento") today announced the release of new data on the Omicron variant neutralizing antibody (nAb) STI-9167, COVISHIELD, an advanced stage antibody discovered and developed for clinical trials in an ongoing collaboration between immunologists and virologists at Sorrento and the Icahn School of Medicine at Mount Sinai (“Icahn Mount Sinai”) in New York, NY.
Spike protein binding assays and neutralization assays using viruses representing all known SARS-CoV-2 variants of concern (VOCs) have been completed with STI-9167, and this nAb was observed to bind with high affinity and provide highly potent neutralizing activity (Omicron IC50 = 25 ng/ml). Of noted significance, STI-9167 is unique when compared to tests of EUA-approved SARS-CoV-2 nAbs in that binding and neutralization properties are maintained against the emerging Omicron and Omicron (+R346K) variant, an increasingly prevalent Omicron lineage variant that encodes an additional R346K Spike protein mutation. Additionally, STI-9167 administered at a low dose (5mg/kg) by either the intranasal or intravenous routes provided strong protection against the clinical signs of infection by the Omicron variant in the K18-hAce2 transgenic mouse model of COVID-19, preventing weight loss and reducing virus titers in the lungs to undetectable levels.
“The generation and characterization of the STI-9167 nAb demonstrates the great collaboration between the scientists of Mount Sinai and Sorrento to address a global health crisis,” said Domenico Tortorella, PhD, Professor of Microbiology at Icahn Mount Sinai.
“We selected antibody STI-9167 from large sets of diverse anti-SARS-CoV-2 spike neutralizing antibodies that we developed in our labs. It demonstrated the most effective cross-neutralization against all known SARS-CoV-2 isolates and variants of concerns, including the recent Omicron and Omicron (+R346K) variants,” commented J. Andrew Duty, PhD, Assistant Professor of Microbiology and Director of the Center for Therapeutic Antibody Development at Icahn Mount Sinai.
“The currently EUA-approved nAbs have markedly reduced or absent binding and neutralization activities against omicron/omicron (+R346K) making them inadequate to support current clinical needs,” stated Mike A. Royal, MD, JD, MBA, Chief Medical Officer at Sorrento. “Alternative nAbs are sorely needed in the near term, particularly for the pediatric population which appears to be at higher risk for severe omicron infection and hospitalization. Our intranasal COVIDROPS formulation delivers our nAbs to the upper airways where Omicron is most likely to target and flourish, and as a non-invasive, easy to administer treatment, it is ideal for children. We have already begun to treat children with COVIDROPS (with STI-2099) in Mexico where the delta variant is still prevalent. Through Phase 2 studies in the US, United Kingdom and Mexico, we have seen a benign safety profile for intranasal delivery of our nAbs and expect a similar outcome with COVIDROP (with STI-9167).”
“We now have had experience with bringing multiple COVID-19 therapeutics into the clinic and advancing several into Phase 2 and/or pivotal development,” says Mark Brunswick, PhD, SVP and Head of Regulatory Affairs and Quality at Sorrento. “We are well situated to rapidly bring forth COVISHIELD through the IND stage and into the clinic and expect to file this important IND in the next month.”
Dr. Henry Ji, Chairman and CEO of Sorrento, commented, “The work by the teams at Sorrento and Mount Sinai has yielded a remarkable antibody with unique and valuable protective properties against Omicron and all other SARS-CoV-2 VOCs. Our COVISHIELD neutralizing antibody is the best-in-class and the most advanced candidate for combatting the prevalent Omicron and emerging Omicron (+R346K) VOCs. We are working diligently to position this antibody for use in COVID patients and are confident that our approach will provide an efficacious clinical solution not only in the near term but also as the pandemic continues to evolve.”
A preprint manuscript is published online at biorxiv.org: biorxiv.org/cgi/content/short/2022.01.19.476998v1
The neutralizing antibody described was generated in the laboratories at Mount Sinai and exclusively licensed to Sorrento Therapeutics. Mount Sinai and Mount Sinai faculty members have a financial interest in Sorrento Therapeutics.
About STI-9167, COVISHIELD, Antibody
Initially isolated as a SARS-CoV-2 (WA-1 strain) nAb candidate following vaccination of transgenic mice, the STI-9167 antibody was optimized to maximize protein stability and minimize interactions with host Fc gamma receptors. Using established master cell banks, GMP drug product has been generated at Sorrento in preparation for anticipated Phase 1 through pivotal Phase 2/3 human clinical trials. Tech transfer of methods and GMP processes in support of commercial-scale GMP manufacturing is currently underway.
About STI-9167 Clinical Development Plans
Sorrento has demonstrated the protective effects of SARS-CoV-2 nAbs administered by either intravenous, IV, or intranasal, IN, routes in preclinical COVID-19 animal models and the safety of SARS-CoV-2 nAbs administered by IV and IN routes to human subjects. Current clinical study plans for STI-9167, pending feedback from regulatory agencies, call for evaluation of safety following antibody administration at single doses via the IV and IN routes in healthy normal adults or asymptomatic Omicron infected patients, followed by large Phase 2/3 clinical trials globally for newly infected COVID-19 patients.
20220121
www.reuters.com/world/us/exclusive-us-opposes-plans-stren...
U.S. opposes plans to strengthen World Health Organization
Major funding reform supported by Europe, Africa, South Asia
White House proposes separate fund for health emergencies
Biden administration sceptical about WHO, sources say
BRUSSELS, Jan 21 (Reuters) - The United States, the World Health Organization's top donor, is resisting proposals to make the agency more independent, four officials involved in the talks said, raising doubts about the Biden administration's long-term support for the U.N. agency.
The proposal, made by the WHO's working group on sustainable financing, would increase each member state's standing annual contribution, according to a WHO document published online and dated Jan. 4.
The plan is part of a wider reform process galvanised by the COVID-19 pandemic, which has highlighted the limitations of the WHO's power to intervene early in a crisis.
But the U.S. government is opposing the reform because it has concerns about the WHO's ability to confront future threats, including from China, U.S. officials told Reuters.
It is pushing instead for the creation of a separate fund, directly controlled by donors, that would finance prevention and control of health emergencies.
Four European officials involved in the talks, who declined to be named because they were not authorised to speak to the media, confirmed the U.S. opposition. The U.S. government had no immediate comment.
The published proposal calls for member states' mandatory contributions to rise gradually from 2024 so they would account for half the agency's $2 billion core budget by 2028, compared to less than 20% now, the document said.
The WHO's core budget is aimed at fighting pandemics and strengthening healthcare systems across the world. It also raises an additional $1 billion or so a year to tackle specific global challenges such as tropical diseases and influenza.
Supporters say that the current reliance on voluntary funding from member states and from charities such as the Bill and Melinda Gates Foundation forces the WHO to focus on priorities set by the funders, and makes it less able to criticise members when things go wrong.
An independent panel on pandemics that was appointed to advise on the WHO reform had called for a much bigger increase in mandatory fees, to 75% of the core budget, deeming the current system "a major risk to the integrity and independence" of the WHO.
LONG-STANDING SCEPTICISM
The WHO itself responded to a query by saying that "only flexible and predictable funds can enable WHO to fully implement the priorities of the Member States".
Top European Union donors, including Germany, back the plan, along with most African, South Asian, South American and Arab countries, three of the European officials said.
The proposal is to be discussed at the WHO's executive board meeting next week but the divisions mean no agreement is expected, three of the officials said.
The WHO confirmed there was currently no consensus among member states, and said talks were likely to continue until the annual meeting in May of the World Health Assembly, the agency's top decision-making body.
European donors in particular favour empowering, rather than weakening, multilateral organisations including the WHO.
One European official said the U.S. plan "causes scepticism among many countries", and said the creation of a new structure controlled by donors, rather than by the WHO, would weaken the agency's ability to combat future pandemics.
Washington has been critical of the WHO for some time.
Former president Donald Trump pulled the United States out of the WHO after accusing it of defending China's initial delays in sharing information when COVID-19 emerged there in 2019.
The Biden administration rejoined soon after taking office, but officials told Reuters they think the WHO needs significant reform, and raised concerns about its governance, structure and ability to confront rising threats, not least from China.
One of the European officials said other big countries, including Japan and Brazil, were also hesitant about the published WHO proposal.
Two of the European officials said China had not yet made its position clear, while a third official listed Beijing among the critics of the proposal.
The governments of Japan, China and Brazil had no immediate comment.
finance.yahoo.com/news/sorrento-therapeutics-announces-co...
Sorrento Therapeutics Announces Covishield (Sti-9167), a Broad-Spectrum Neutralizing Antibody, Potently Neutralizes Omicron and Omicron (+R346k) Variants of Sars-Cov-2
COVISHIELD (STI-9167) neutralizing antibody (nAb) was discovered by scientists from the Icahn School of Medicine at Mount Sinai (“Icahn Mount Sinai”) and further optimized and engineered by Sorrento scientists.
A preprint manuscript is published online at biorxiv.org: biorxiv.org/cgi/content/short/2022.01.19.476998v1
Sorrento has obtained worldwide exclusive license rights from Icahn Mount Sinai as previously announced on March 9, 2021
Compared to available published literature and head-to-head experiments, STI-9167 nAb is a potentially “Best-in-Class” nAb against the Omicron variant of SARS-CoV-2 and the first reported nAb with high potency against Omicron (+R346K mutation) and has demonstrated highly potent neutralization activities in vitro (IC50 of 25 ng/mL for Omicron live virus, 14.8 ng/mL and 23.9 ng/mL for Omicron and Omicron (+R346K mutation) pseudovirus, respectively), in addition to potent neutralizing activities against the SARS-CoV-2 virus and all of its variants of concern (VOCs).
STI-9167 nAb demonstrated strong protection in vivo following Omicron virus challenge in a preclinical model of COVID-19, preventing weight loss and reducing virus titers in the lungs to levels below the limit of detection.
GMP drug product manufacturing in support of large clinical development is in place at Sorrento GMP facilities.
Sorrento is evaluating in-house GMP manufacturing and is in negotiations with major global CMOs for commercial scale manufacturing to secure capacity to manufacture and supply tens of millions of doses. Sorrento currently has in-hand sufficient cGMP drug substance for 100,000’s of doses at the projected intranasal dose of STI-9199, the intranasal formulation of STI-9167.
INDs to be submitted in the US, UK and Mexico within a month for use as either a small volume intravenous push or intranasal instillation.
(investors.sorrentotherapeutics.com/news-releases/news-rel...).
SAN DIEGO, Jan. 21, 2022 (GLOBE NEWSWIRE) -- Sorrento Therapeutics, Inc. (Nasdaq: SRNE, "Sorrento") today announced the release of new data on the Omicron variant neutralizing antibody (nAb) STI-9167, COVISHIELD, an advanced stage antibody discovered and developed for clinical trials in an ongoing collaboration between immunologists and virologists at Sorrento and the Icahn School of Medicine at Mount Sinai (“Icahn Mount Sinai”) in New York, NY.
Spike protein binding assays and neutralization assays using viruses representing all known SARS-CoV-2 variants of concern (VOCs) have been completed with STI-9167, and this nAb was observed to bind with high affinity and provide highly potent neutralizing activity (Omicron IC50 = 25 ng/ml). Of noted significance, STI-9167 is unique when compared to tests of EUA-approved SARS-CoV-2 nAbs in that binding and neutralization properties are maintained against the emerging Omicron and Omicron (+R346K) variant, an increasingly prevalent Omicron lineage variant that encodes an additional R346K Spike protein mutation. Additionally, STI-9167 administered at a low dose (5mg/kg) by either the intranasal or intravenous routes provided strong protection against the clinical signs of infection by the Omicron variant in the K18-hAce2 transgenic mouse model of COVID-19, preventing weight loss and reducing virus titers in the lungs to undetectable levels.
“The generation and characterization of the STI-9167 nAb demonstrates the great collaboration between the scientists of Mount Sinai and Sorrento to address a global health crisis,” said Domenico Tortorella, PhD, Professor of Microbiology at Icahn Mount Sinai.
“We selected antibody STI-9167 from large sets of diverse anti-SARS-CoV-2 spike neutralizing antibodies that we developed in our labs. It demonstrated the most effective cross-neutralization against all known SARS-CoV-2 isolates and variants of concerns, including the recent Omicron and Omicron (+R346K) variants,” commented J. Andrew Duty, PhD, Assistant Professor of Microbiology and Director of the Center for Therapeutic Antibody Development at Icahn Mount Sinai.
“The currently EUA-approved nAbs have markedly reduced or absent binding and neutralization activities against omicron/omicron (+R346K) making them inadequate to support current clinical needs,” stated Mike A. Royal, MD, JD, MBA, Chief Medical Officer at Sorrento. “Alternative nAbs are sorely needed in the near term, particularly for the pediatric population which appears to be at higher risk for severe omicron infection and hospitalization. Our intranasal COVIDROPS formulation delivers our nAbs to the upper airways where Omicron is most likely to target and flourish, and as a non-invasive, easy to administer treatment, it is ideal for children. We have already begun to treat children with COVIDROPS (with STI-2099) in Mexico where the delta variant is still prevalent. Through Phase 2 studies in the US, United Kingdom and Mexico, we have seen a benign safety profile for intranasal delivery of our nAbs and expect a similar outcome with COVIDROP (with STI-9167).”
“We now have had experience with bringing multiple COVID-19 therapeutics into the clinic and advancing several into Phase 2 and/or pivotal development,” says Mark Brunswick, PhD, SVP and Head of Regulatory Affairs and Quality at Sorrento. “We are well situated to rapidly bring forth COVISHIELD through the IND stage and into the clinic and expect to file this important IND in the next month.”
Dr. Henry Ji, Chairman and CEO of Sorrento, commented, “The work by the teams at Sorrento and Mount Sinai has yielded a remarkable antibody with unique and valuable protective properties against Omicron and all other SARS-CoV-2 VOCs. Our COVISHIELD neutralizing antibody is the best-in-class and the most advanced candidate for combatting the prevalent Omicron and emerging Omicron (+R346K) VOCs. We are working diligently to position this antibody for use in COVID patients and are confident that our approach will provide an efficacious clinical solution not only in the near term but also as the pandemic continues to evolve.”
A preprint manuscript is published online at biorxiv.org: biorxiv.org/cgi/content/short/2022.01.19.476998v1
The neutralizing antibody described was generated in the laboratories at Mount Sinai and exclusively licensed to Sorrento Therapeutics. Mount Sinai and Mount Sinai faculty members have a financial interest in Sorrento Therapeutics.
About STI-9167, COVISHIELD, Antibody
Initially isolated as a SARS-CoV-2 (WA-1 strain) nAb candidate following vaccination of transgenic mice, the STI-9167 antibody was optimized to maximize protein stability and minimize interactions with host Fc gamma receptors. Using established master cell banks, GMP drug product has been generated at Sorrento in preparation for anticipated Phase 1 through pivotal Phase 2/3 human clinical trials. Tech transfer of methods and GMP processes in support of commercial-scale GMP manufacturing is currently underway.
About STI-9167 Clinical Development Plans
Sorrento has demonstrated the protective effects of SARS-CoV-2 nAbs administered by either intravenous, IV, or intranasal, IN, routes in preclinical COVID-19 animal models and the safety of SARS-CoV-2 nAbs administered by IV and IN routes to human subjects. Current clinical study plans for STI-9167, pending feedback from regulatory agencies, call for evaluation of safety following antibody administration at single doses via the IV and IN routes in healthy normal adults or asymptomatic Omicron infected patients, followed by large Phase 2/3 clinical trials globally for newly infected COVID-19 patients.