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Lilly and Incyte announce results from baricitinib’s COV-BARRIER study in hospitalized COVID-19 patients

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Lilly and Incyte announce results from baricitinib’s COV-BARRIER study in hospitalized COVID-19 patients

April 8, 2021: Eli Lilly and Company and Incyte announced results of COV-BARRIER, a Phase 3 study evaluating baricitinib 4 mg once daily plus standard of care (SoC) versus placebo plus SoC.

The trial did not meet statistical significance on the primary endpoint, which was defined as a difference in the proportion of participants progressing to the first occurrence of non-invasive ventilation including high flow oxygen or invasive mechanical ventilation including extracorporeal membrane oxygenation (ECMO) or death by Day 28.

Baricitinib-treated patients were 2.7 percent less likely than those receiving standard of care to progress to ventilation (non-invasive or mechanical) or death, a difference that was not statistically significant (odds ratio [OR]: 0.85; 95% CI 0.67, 1.08; p=0.1800). 


Related News: First JAK-Inhibitor Baricitinib Demonstrate for Hair Regrowth in Phase 3 Trial

In COV-BARRIER, treatment with baricitinib in addition to SoC (which included 79% receiving corticosteroids and 19% receiving remdesivir, with some receiving both) resulted in a significant reduction (nominal p-value=0.0018) in death from any cause by 38 percent (n/N: 62/764 [8.1%] baricitinib, 100/761 [13.1%] placebo; hazard ratio [HR]: 0.57; 95% CI: 0.41, 0.78) by Day 28.

A numerical reduction in mortality was observed for all baseline severity subgroups of baricitinib-treated patients and was most pronounced for patients receiving non-invasive mechanical ventilation at baseline (17.5% versus 29.4% for baricitinib plus SoC versus SoC; hazard ratio [HR]: 0.52; 95% CI: 0.33, 0.80; nominal p-value=0.0065).

A reduction in mortality was also seen for the pre-specified subgroups of patients being treated with or without corticosteroids at baseline. 

“There remains a driving unmet need for treatments with the potential to further decrease mortality for COVID-19 patients,” said co-primary investigator E. Wesley Ely, M.D., MPH, professor of medicine and co-director of the Critical Illness, Brain Dysfunction, and Survivorship (CIBS) Center at Vanderbilt University Medical Center.

“While COV-BARRIER did not hit the primary endpoint based on stages of disease progression, the data show that baricitinib meaningfully reduced the risk of mortality above and beyond the recommended standard of care, without additional safety risks.

These important findings advance our pursuit of treatment options to save lives in hospitalized COVID-19 patients.”

The frequency of adverse events and serious adverse events were generally similar in the baricitinib (44.5% and 14.7%, respectively) and placebo (44.4% and 18.0%, respectively) groups.

Serious infections and venous thromboembolism (VTE) occurred in 8.5 percent and 2.7 percent of patients treated with baricitinib, respectively, versus 9.8 percent and 2.5 percent of patients treated with placebo. No new safety signals potentially related to the use of baricitinib were identified.

Lilly intends to publish detailed results of this study in a peer-reviewed journal in the coming months. 

Lilly will share the data from COV-BARRIER with regulatory authorities in the U.S., European Union and other geographies to evaluate next steps for baricitinib for the treatment of hospitalized COVID-19 patients.

“Since the beginning of the pandemic, we have worked to expand the science behind COVID-19 therapies,” said Ilya Yuffa, senior vice president and president of Lilly Bio-Medicines.

“Even though the study did not show a statistically-significant benefit on the primary endpoint, this trial showed the largest effect reported to date for reduction in mortality observed for this patient population with COVID-19.

As there remains an urgent need to reduce COVID-related deaths in hospitalized patients, we hope these results will provide further understanding and support for baricitinib’s potential role in treatment on top of the current standard of care.”

COV-BARRIER (NCT04421027) is the first global, randomized, double-blind, placebo-controlled study to assess baricitinib versus placebo in patients hospitalized with COVID-19 receiving SoC which could include corticosteroids, antimalarials, antivirals, and/or azithromycin.

This Phase 3 study of 1,525 patients began in June 2020 and enrolled hospitalized patients who did not require supplemental oxygen (ordinal scale [OS] 4), required supplemental oxygen (OS 5) or high-flow oxygen/non-invasive ventilation (OS 6).

Patients were also required to have at least one increased marker of inflammation, an indicator of risk of disease progression.

All patients were treated with SoC per local clinical practice including 79 percent receiving corticosteroids (with 91% of those patients receiving dexamethasone) and 19 percent receiving remdesivir at baseline, with some receiving both.

Patients were randomized 1:1 to baricitinib 4 mg or placebo for up to 14 days or until discharge from the hospital.

The study was global and included diverse patients from several countries with high prevalence of COVID-19 hospitalizations – the U.S., Brazil, Mexico, Argentina, Russia, India, UK, Spain, Italy, Germany, Japan and Korea.

An addendum to the study was initiated in December 2020 to include mechanically ventilated (OS 7) patients at baseline and is currently enrolling.

The COV-BARRIER trial was designed to complement the Adaptive COVID-19 Treatment Trial (ACTT-2) sponsored by the National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health (NIH).

ACTT-2 began in May 2020 and has published results from 1,033 patients. Patients who received baricitinib in combination with remdesivir had a shorter median time to recovery compared to patients who received remdesivir alone.

In ACTT-2, there was a significant reduction in the proportion of patients progressing to noninvasive ventilation, invasive mechanical ventilation or death, in the baricitinib plus remdesivir group compared to remdesivir.

A numerical decrease in mortality risk through Day 29 was observed in patients treated with baricitinib plus remdesivir compared to remdesivir.

“While the trend observed for the primary endpoint was not significant, the demonstration of a potential effect on mortality is a clinically important finding.

This effect on mortality was seen with or without corticosteroids and/or remdesivir at the time of enrollment,” said Vincent C. Marconi, M.D., professor of medicine and global health at Emory University School of Medicine and Emory’s Rollins School of Public Health, a co-principal investigator of COV-BARRIER and a co-investigator on the ACTT-2 study.

“These results – along with those from the NIAID-sponsored ACTT-2 study evaluating baricitinib in combination with remdesivir – add to the growing body of data supporting the use of baricitinib in certain hospitalized patients with COVID-19.”

Additional research is ongoing to further evaluate the potential role of baricitinib in COVID-19, including NIAID’s ACTT-4 trial (evaluating the efficacy and safety of baricitinib or dexamethasone in combination with remdesivir in hospitalized adults with COVID-19 on supplemental oxygen), the RECOVERY trial in the UK and several investigator-initiated trials. 

An emergency use authorization (EUA) was issued by the U.S. Food and Drug Administration (FDA) on Nov. 19, 2020 for baricitinib in combination with remdesivir in hospitalized patients with COVID-19 requiring supplemental oxygen, invasive mechanical ventilation, or ECMO.

Please see below for important warnings and information about the authorized use of baricitinib in the U.S.  More than 200,000 patients globally are estimated to have been treated with baricitinib for COVID-19.

Baricitinib, an oral JAK inhibitor, was discovered by Incyte and licensed to Lilly. It is approved and commercially available as OLUMIANT in the U.S. and more than 70 countries as a treatment for adults with moderate to severe active rheumatoid arthritis (RA) and in the European Union and Japan for the treatment of adult patients with moderate to severe atopic dermatitis (AD) who are candidates for systemic therapy.

Authorized Use Under the EUA and Important Safety Information for baricitinib (in the United States) for COVID-19
Baricitinib is authorized for use under an Emergency Use Authorization (EUA) in combination with remdesivir, for treatment of suspected or laboratory confirmed coronavirus disease 2019 (COVID-19) in hospitalized adults and pediatric patients 2 years of age or older, requiring supplemental oxygen, invasive mechanical ventilation, or extracorporeal membrane oxygenation (ECMO). 

Baricitinib has not been approved for the treatment of COVID-19, but has been authorized for emergency use by the FDA.

Baricitinib is authorized under an EUA only for the duration of the declaration that circumstances exist justifying the authorization of the EUA of baricitinib under Section 564(b)(1) of the Act, 21 U.S.C. § 360bbb-3(b)(1), unless the authorization is terminated or revoked sooner.  

For information on the authorized use of baricitinib and mandatory requirements under the EUA, please review the FDA Letter of Authorization, Fact Sheet for Healthcare Providers and Fact Sheet for Patients, Parents and Caregivers (English; Spanish). 

Important Safety Information about baricitinib for COVID-19 
The following provides essential safety information on the unapproved use of baricitinib under the Emergency Use Authorization. 

Warnings 

Serious Infections: Serious infections have occurred in patients receiving baricitinib. Avoid the use of baricitinib with known active tuberculosis.

Consider if the potential benefits outweigh the potential risks of baricitinib treatment in patients with active serious infections other than COVID-19 or chronic/recurrent infections. 

Thrombosis: In hospitalized patients with COVID-19, prophylaxis for venous thromboembolism is recommended unless contraindicated.

If clinical features of deep vein thrombosis or pulmonary embolism occur, patients should be evaluated promptly and treated appropriately. 

Abnormal Laboratory Values: Evaluate at baseline and thereafter according to local patient management practice.

Monitor closely when treating patients with abnormal baseline and post-baseline laboratory values.

Follow dose adjustments as recommended in the Fact Sheet for Healthcare Providers for patients with abnormal renal, hematological and hepatic laboratory values. Manage patients according to routine clinical guidelines. 

Hypersensitivity:If a serious hypersensitivity occurs, discontinue baricitinib while evaluating the potential causes of the reaction. 

See Warnings and Precautions in the FDA-approved full Prescribing Information for additional information on risks associated with longer-term treatment with baricitinib. 

Serious Side Effects: Serious venous thrombosis, including pulmonary embolism, and serious infections have been observed in COVID-19 patients treated with baricitinib and are known adverse drug reactions of baricitinib.” 

https://investor.lilly.com/news-releases/news-release-details/lilly-and-incyte-announce-results-phase-3-cov-barrier-study

BMS Announces Opdivo plus Yervoy in Esophageal Squamous Cell Carcinoma

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BMS Announces Opdivo plus Yervoy in Esophageal Squamous Cell Carcinoma

April 8, 2021: “Bristol Myers Squibb announced positive topline results from the Phase 3 CheckMate -648 trial evaluating treatment with Opdivo (nivolumab)plus chemotherapy or Opdivo plus Yervoy (ipilimumab) in patients with unresectable advanced or metastatic esophageal squamous cell carcinoma (ESCC).

In the study, Opdivo plus chemotherapy demonstrated a statistically significant and clinically meaningful benefit for the primary and secondary endpoints of overall survival (OS) in patients whose tumors express PD-L1 and in the all-randomized patient population at the pre-specified interim analysis.

Additionally, Opdivo plus chemotherapy demonstrated a statistically significant and clinically meaningful improvement in the primary endpoint of progression-free survival (PFS) by blinded independent central review (BICR) in patients whose tumors express PD-L1.

Opdivo plus Yervoy also met its primary and secondary endpoints by demonstrating statistically significant and clinically meaningful improvement in overall survival in patients whose tumors express PD-L1 and in the all-randomized population.

Opdivo plus Yervoy did not meet its other primary endpoint of progression-free survival by BICR in patients whose tumors express PD-L1.

The safety profiles of Opdivo and the combination of Opdivo and Yervoy were consistent with those previously reported.

 “The results for these Opdivo-based combinations represent a significant advancement for patients with esophageal cancer who are often diagnosed after their disease has spread and would benefit from new therapeutic options,” said Ian M. Waxman, M.D., development lead, gastrointestinal cancers, Bristol Myers Squibb.

“This study further demonstrates our commitment to pursue combination strategies that improve outcomes for patients with high unmet need, such as those with gastrointestinal cancers.”

The data from CheckMate -648 build upon those from CheckMate -649, together making Opdivo the first and only PD-1/L1 inhibitor to demonstrate superior first-line survival in upper GI cancers across histologies and tumor locations (stomach, gastroesophageal junction, and esophagus).

They also add to the existing body of data demonstrating the clinical benefit of Opdivo in esophageal cancer, from the late-line metastatic setting to earlier stages of disease.

The company will complete an evaluation of the CheckMate -648 data and looks forward to sharing the results at an upcoming medical conference, as well as with health authorities.

Bristol Myers Squibb thanks the patients and investigators who were involved in the CheckMate -648 clinical trial.

Related News: BMS Opdivo plus Yervoy misses the mark in high-risk melanoma Patients

Opdivo Plus Yervoy Improves Overall Survival for Metastatic Non-Small Cell Lung Cancer

About CheckMate -648

CheckMate -648 is a randomized Phase 3 study evaluating Opdivo plus Yervoy or Opdivo plus fluorouracil and cisplatin against fluorouracil plus cisplatin alone in patients with unresectable advanced or metastatic esophageal squamous cell carcinoma.

The primary endpoints of the trial are overall survival (OS) and progression-free survival (PFS) by blinded independent central review (BICR) in patients whose tumors express PD-L1, for both Opdivo-based combinations versus chemotherapy.

Secondary endpoints of the trial include overall survival and progression-free survival by BICR in the all-randomized population.

In the Opdivo plus Yervoy arm, patients received treatment with Opdivo 3 mg/kg every 2 weeks and Yervoy 1 mg/kg every 6 weeks up to 24 months or until disease progression or unacceptable toxicity.

In the Opdivo plus chemotherapy arm, patients received treatment with Opdivo 240 mg on Day 1 and Day 15, fluorouracil 800 mg/m²/day on Day 1 through Day 5 (for 5 days), and cisplatin 80 mg/m² on Day 1 of four-week cycle.

Patients received Opdivo for up to 24 months or until disease progression or unacceptable toxicity, and chemotherapy until disease progression or unacceptable toxicity.”

https://news.bms.com/news/corporate-financial/2021/Bristol-Myers-Squibb-Announces-Opdivo-nivolumab-plus-Chemotherapy-and-Opdivo-plus-Yervoy-ipilimumab-Demonstrate-Superior-Survival-Benefit-Compared-to-Chemotherapy-in-Unresectable-Advanced-or-Metastatic-Esophageal-Squamous-Cell-Carcinoma/default.aspx

FDA Releases Action Plan for Reducing Exposure to Toxic Elements from Foods for Babies

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FDA Releases Action Plan for Reducing Exposure to Toxic Elements from Foods for Babies

April 08, 2021: “Protecting one of our most vulnerable populations, babies and young children, is among the U.S. Food and Drug Administration’s highest priorities.

We’re announcing a new action plan, Closer to Zero, that sets forth our approach to reducing exposure to toxic elements in foods commonly eaten by babies and young children to the lowest possible levels.

Although the FDA’s testing shows that children are not at an immediate health risk from exposure to toxic elements at the levels found in foods, we are starting the plan’s work immediately, with both short- and long-term goals for achieving continued improvements in reducing levels of toxic elements in these foods over time.

We recognize that Americans want zero toxic elements in the foods eaten by their babies and young children. In reality, because these elements occur in our air, water and soil, there are limits to how low these levels can be.

The FDA’s goal, therefore, is to reduce the levels of arsenic, lead, cadmium and mercury in these foods to the greatest extent possible.

We are also sensitive to the fact that requiring levels that are not currently feasible could result in significant reductions in the availability of nutritious, affordable foods that many families rely on for their children.

Our plan, therefore, outlines a multi-phase, science-based, iterative approach to achieving our goal of getting levels of toxic elements in foods closer to zero over time.  

Closer to Zero includes research and evaluation of changes in dietary exposures to toxic elements, setting action levels (recommended limits of toxic elements in foods that can be achieved by industry and progressively lowered as appropriate), encouraging adoption of best practices by industry, and monitoring progress.

Our action plan will occur in three phases. As part of the first phase, we’ll immediately begin our work setting action levels using a four-pronged approach:

  1. Evaluate the scientific basis for action levels. The cycle of continual improvement starts with the FDA evaluating existing data from routine testing of the food supply, research and data on chemical analytical methods, toxicological assays, exposure and risk assessments, and other relevant scientific information.

    Through a process that may include advisory committees, public workshops, and consultation with scientific experts, federal agency partners, and other stakeholders, the agency will establish interim reference levels (IRLs) for certain toxic elements as appropriate.

    An IRL is a measure of exposure from food that the FDA may use to determine if the amount of exposure to an individual element across foods could result in a specific health impact.  
  2. Propose action levels. The IRLs may be among the key factors that inform the development of the FDA’s proposed action levels for certain toxic elements in categories of baby foods (e.g., cereals, infant formula, pureed fruits and vegetables, etc.) and other foods commonly eaten by babies and young children.  
  3. Consult with stakeholders on proposed action levels, including the achievability and feasibility of action levels.

    For each toxic element—for every identified category of food—the FDA will gather data and other information through a process of consultation that could include workshops, scientific meetings, and collaboration with federal partners to assess, among other things, the achievability and feasibility of the proposed action levels and the timeframes for reaching them. 
  4. Finalize action levels. The FDA will use the information gathered from stakeholders, updated scientific research, and routine monitoring data to make any needed adjustments and finalize action levels.

Once the FDA has published final action levels, the agency will establish a timeframe for assessing industry’s progress toward meeting the action levels and recommence the cycle to determine if the scientific data support efforts to further adjust the action levels downward. 

Our action plan will start with prioritizing our work on those elements for which we have the most data and information – arsenic and lead – while research continues on other elements, progressing through each element over time across various categories of foods consumed by babies and young children.

During the plan’s first year (phase one), we will be proposing action levels for lead in categories of foods consumed by babies and young children, consulting with and gathering data from stakeholders and federal partners on issues such as the feasibility of meeting action levels for lead, and sharing resources with industry on best practices for reducing or preventing lead contamination.

We will also complete updated sampling assignments testing toxic element levels in baby foods and evaluate the science related to arsenic exposure from foods beyond infant rice cereal. Phases two, three and beyond are outlined in our plan. 

Through this plan, we’ll also take measures to ensure that limiting exposure to toxic elements in foods does not have unintended consequences—like limiting access to foods that have significant nutritional benefits by making them unavailable or unaffordable for many families, or unintentionally increasing the presence of one toxic element when foods are reformulated to reduce the presence of another.

In addition, our goal of moving closer to zero reflects the reality that fruits, vegetables, and grains do take up toxic elements in the environment as they grow.

With a cycle of continual improvement and collaboration, we aim to push the levels of toxic elements in these foods closer and closer to zero over time.

While our testing of toxic elements in foods has shown there have already been significant reductions of toxic elements found in foods, the FDA is confident that our new plan will help further advance our work in this area.

As part of our ongoing efforts to reduce exposure to toxic elements from foods, we’ll be continuing our research and collaborations on this topic, finalizing action levels for arsenic in apple juice and issuing draft action levels for lead in juices in the near future, evaluating the potential impact of new technologies, interventions, or mitigation controls to reduce exposure, and reevaluating risks based on declining levels of toxic elements in foods.

We view this work and our Closer to Zero plan as part of a larger effort to improve maternal and infant nutrition and health.

We plan to combine our efforts to reduce exposure to toxic elements in baby foods with other FDA initiatives to improve the health of mothers, infants, and children. 

Again, it’s important to note that the FDA’s testing shows that children are not at an immediate health risk from exposure to toxic elements at the levels found in foods.

However, we know that additional progress can be made and are confident that a science-driven, transparent and inclusive process will help lead to even further reductions in exposure to these toxic elements.

We look forward to providing additional updates on our plan as new data, information, progress updates and additional material are made available.

The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices.

The agency also is responsible for the safety and security of our nation’s food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.”

https://www.fda.gov/news-events/press-announcements/fda-releases-action-plan-reducing-exposure-toxic-elements-foods-babies-young-children

Sanofi completes Kymab acquisition

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Sanofi completes Kymab acquisition

April 09 2021: “Sanofi announced today the successful completion of its acquisition of Kymab Group Ltd., adding KY1005 to its pipeline, a fully human monoclonal antibody targeting key immune system regulator OX40L.

The acquisition continues to build on Sanofi’s leading presence in immunology aligned with the company’s strategy to pursue best-in-class treatments in defined areas.

Kymab’s pipeline also includes the oncology asset KY1044, an ICOS agonist monoclonal antibody, currently in early Phase1/2 development as monotherapy and in combination with an anti-PD-L1.”

https://www.sanofi.com/en/media-room/press-releases/2021/2021-04-09-07-00-00-2207173

Interim late-breaking clinical data validate not-alpha profile of THOR-707, Sanofi’s novel investigational IL-2

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Interim late-breaking clinical data validate not-alpha profile of THOR-707, Sanofi’s novel investigational IL-2

 April 9, 2021: “Interim data from a first-in-human trial evaluating the safety, therapeutic activity and maximum tolerable dose of THOR-707 (SAR444245), a highly differentiated not-alpha interleukin-2 (IL-2) candidate, as a monotherapy and in combination with anti-PD-1, will be presented Saturday, April 10 as a late-breaking poster presentation at the American Association for Cancer Research (AACR) Annual Meeting.

The Saturday late-breaking poster session will include additional updated data.

Interim safety, anti-tumor activity and biomarker data further validate the not-alpha IL-2 profile seen preclinically.

In both the combination and monotherapy settings, initial activity was observed, with three confirmed partial responses, which includes patients who have received prior anti-PD-1 therapeutics.

“THOR-707 has a potentially best-in-class profile and reinforces the promise of our Synthorin technology platform to overcome difficult targets with precision biology,” said John Reed, M.D. Ph.D., Global Head of Research & Development, Sanofi. 

“The activity observed both as single agent and with an anti-PD-1 further strengthens our belief that as a unique not-alpha IL-2, THOR-707 could become a backbone of future immuno-oncology therapies.

We will continue to explore the molecule’s potential for best-in-disease combinations.”

THOR-707 is a precisely PEGylated version of IL-2, where the PEG chain is attached to a novel amino acid inserted at a location on IL-2 that prevents it from engaging the alpha-receptor and binding to immune receptors that cause drug toxicities (IL-2R-alpha, CD25). The engineered IL-2 retains near-native binding to the beta-gamma receptors that selectively expand tumor-killing T effector cells and Natural Killer (NK) cells without the alpha-mediated immunosuppressive effects of regulatory T cells or eosinophil-mediated vascular leak syndrome.

Interim results indicate a similar pattern where CD8+ T cells and NK cells increased after the first dose of THOR-707 and sustained throughout the entire cycle , with a dose escalating effect; this effect was enhanced when combined with KEYTRUDA® (pembrolizumab).

Related News: KEYTRUDA® plus LENVIMA® Combination Demonstrated Meaningful Tumor Response Rates in Unresectable Hepatocellular Carcinoma and Advanced Renal Cell Carcinoma

No significant increases in CD4+ regulatory T cells or eosinophils were observed, indicative of not-alpha IL-2 receptor selectivity.

No dose-limiting toxicities were observed for THOR-707 at reported doses, up to 24 μg/kg as monotherapy and 16 μg/kg in combination.

The most common treatment emergent adverse events (TEAEs) following the first dose included flu-like symptoms, fever, vomiting/nausea and chills.

Symptoms were transient and resolved with standard supportive care. Among G3-4 related toxicities was a transient decrease in lymphocyte count, which preceded T cell expansion.

No eosinophilia or vascular leak syndrome was reported at any doses tested.

IL-5 levels remained at or below the lowest level of detection, suggesting a rationale for the lack of IL-5 associated toxicity observed during treatment.

“Novel approaches, such as not-alpha IL-2, seek to activate this powerful immune pathway while mitigating current challenges with dosing and safety to potentially expand the patient population who could benefit from treatment,” said Filip Janku, M.D. Ph.D., Associate Professor, Department of Investigational Cancer Therapeutics, Division of Cancer Medicine, The University of Texas MD Anderson Cancer Center, Houston, TX.

“Preclinically, THOR-707 appeared to activate an anti-tumor immune response without an increased risk of alpha-mediated toxicities, such as eosinophilia or vascular leak syndrome.

While early, the interim clinical data at AACR align very closely to what we saw in preclinical research and suggest further study of this not-alpha IL-2 molecule is warranted, both alone and in combination with a synergistic treatment such as anti-PD-1.”

THOR-707 dose escalation has progressed beyond projected monotherapy RP2D of 24 μg/kg Q3W to 32 μg/kg Q3W to further characterize the upper bounds of the dose range.

In addition to testing THOR-707 in combination with KEYTRUDA, Sanofi is planning to evaluate the activity of this novel biologic in combination with other anti-PD-1 antibodies, including Libtayo®, (cemiplimab) anti-CD38 antibody Sarclisa® (isatuximab) and anti-EGFR.”

https://www.sanofi.com/en/media-room/press-releases/2021/2021-04-09-06-01-00-2207165

CDC Awards $3 Billion to Expand COVID-19 Vaccine Programs

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CDC Awards $3 Billion to Expand COVID-19 Vaccine Programs

April 6, 2021: The Centers for Disease Control and Prevention (CDC) has awarded funding to support local efforts to increase vaccine uptake by expanding COVID-19 vaccine programs and ensuring greater equity and access to vaccine by those disproportionately affected by SARS-CoV-2, the virus that causes COVID-19.

The awards are part of $3 billion in funding that CDC has granted to 64 jurisdictions to bolster broad-based vaccine distribution, access, and administration efforts. 

The funding was made available by the American Rescue Plan and the Coronavirus Response and Relief Supplemental Appropriations Act and will provide critical support through CDC’s existing immunization cooperative agreements in communities around the country.

“We are doing everything we can to expand access to vaccinations,” said CDC Director Rochelle P. Walensky, MD, MPH. “Millions of Americans are getting vaccinated every day, but we need to ensure that we are reaching those in the communities hit hardest by this pandemic.

This investment will support state and local health departments and community-based organizations as they work on the frontlines to increase vaccine access, acceptance, and uptake.”

To ensure health equity and expanded access to COVID-19 vaccines:

  • 75% of the total funding must focus on specific programs and initiatives intended to increase vaccine access, acceptance, and uptake among racial and ethnic minority communities; and,
  • 60% must go to support local health departments, community-based organizations, and community health centers.

For example, funds could be used to identify and train trusted members of the community to conduct door-to-door outreach to raise awareness about COVID-19 vaccines and help individuals sign up for appointments.

Funds may also be used to support hiring community health workers who perform culturally-competent bilingual health outreach so they can provide people who are receiving care with the information they need to get a free vaccination.

These awards are part of ongoing efforts by CDC and the U.S. Department of Health and Human Services (HHS) to increase public education, awareness, and access to COVID-19 vaccines and strengthen health equity.

  • Last week, HHS launchedexternal icon the COVID-19 Community Corpsexternal icon – a nationwide, grassroots network of community leaders people know and trust, to encourage Americans to get vaccinated.

    Community Corps members will receive weekly updates on the latest scientific and medical updates, talking points about the vaccine, social media suggestions, infographics, factsheets with timely and accurate information, and tools to help people get registered for an appointment and vaccinated.

    The Community Corps launched on Thursday, April 1 with over 275 founding members, and as of Friday, April 2, more than 3,000 had already signed up.
  • CDC plans to award more than $250 million to community-based organizations serving minority or underserved communities to support their COVID-19 outreach efforts, including connecting members of the community with health services and vaccinations.
  • The HHS Office of Minority Health is also investing $250 million to encourage COVID-19 safety and vaccination among underserved populations in minority communities.
  • HHS, through the Health Resources and Services Administration (HRSA), will invest more than $6 billion from the American Rescue Plan into Community Health Centers nationwide to expand COVID-19 vaccinations, testing, and treatment for vulnerable populations.
  • CDC announced a plan to invest $2.25 billion to address COVID-19-related health disparities and advance health equity among high-risk and underserved populations through grants to public health departments.
  • CDC also plans to provide $300 million to jurisdictions for community health worker services to support COVID-19 prevention and control and address disparities in access to COVID-19 related services, such as testing, contact tracing, and vaccinations, as well as an additional $32 million for training, technical assistance, and evaluation.

    https://www.cdc.gov/media/releases/2021/p0407-covid-19-vaccine-programs.html

Artios Pharma and Novartis to Create Next Generation DDR Cancer Therapies

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Artios Pharma and Novartis to Create Next Generation DDR Cancer Therapies

April 7, 2021: “Artios Pharma Limited (Artios), a leading DNA Damage Response (DDR) company exploiting synthetic lethality to develop a broad pipeline of precision medicines for the treatment of cancer announced a global research collaboration with Novartis to discover and validate next generation DDR targets to enhance Novartis’ Radioligand Therapies (RLT).

Under the three-year collaboration, Artios and Novartis will perform target discovery and validation, and Novartis will select up to three exclusive DDR targets, and receive worldwide rights on these targets to be utilized with its RLT’s.

Dr. Niall Martin, Chief Executive Officer at Artios Pharma, said: “This collaboration expands the reach of our discovery platform, leveraging our DDR expertise and target knowledge to enhance the potential of radioligand therapies.

We are thrilled to work with Novartis, and this combined with our recent collaboration with Merck KGaA, provides important validation of the power of the internal discovery capabilities at Artios.

From a strategic perspective, this collaboration is an ideal fit which maximizes the application of our platform to areas beyond our current focus as we independently advance our pipeline of novel DDR candidates.

We look forward to continued momentum as a clinical-stage precision medicine company, building upon our recently initiated Phase 1 study of ART0380, our potential best-in-class ATR inhibitor, with the expected entry of our first-in-class Pol Theta program into the clinic before year end.”

Under the terms of the agreement, Novartis will make an up-front payment of US$20 million and provide near term research funding to support the collaboration.

Artios will be eligible to receive discovery, development, regulatory and sales-based milestones, in addition to royalty payments on net sales of products commercialized by Novartis.

The collaboration does not include Artios’ lead programs, ART0380, which is currently in clinical development, or ART4215, a first-in-class Pol Theta inhibitor.

Novartis’ RLT delivers targeted radiation to a specific subset of cancer cells, with minimal effect on surrounding healthy cells.

RLT has been shown to improve overall survival and quality of life, particularly in the setting of cancers with bone metastases.”

https://www.artiospharma.com/2021/04/07/artios-pharma-announces-collaboration-with-novartis-to-create-next-generation-ddr-cancer-therapies/

FDA Issues Emergency Use Authorization for the Symbiotica COVID-19 Self-Collected Antibody Test System

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FDA Issues Emergency Use Authorization for the Symbiotica COVID-19 Self-Collected Antibody Test System

April 06, 2021: The U.S. Food and Drug Administration announced it has issued an emergency use authorization (EUA) for the Symbiotica COVID-19 Self-Collected Antibody Test System, the first antibody test authorized for use with home collected dried blood spot samples.

Samples collected at home are then sent to a Symbiotica, Inc. laboratory for analysis.

“The authorization of the first prescription use, home collection antibody test will play an important role in helping health care professionals identify individuals who have developed an adaptive immune response from a recent or prior COVID-19 infection,” said Jeff Shuren, M.D., J.D., director of the FDA’s Center for Devices and Radiological Health.

“The FDA will continue to authorize COVID-19 tests that will give more Americans access to greater testing flexibility and options.”

The COVID-19 Self-Collected Antibody Test System is authorized for prescription use with a fingerstick dried blood sample that is self-collected by an individual age 18 years or older or collected by an adult from an individual 5 years of age and older. The test is intended to aid in identifying individuals with an adaptive immune response to SARS-CoV-2, indicating recent or prior infection.

The COVID-19 Self-Collected Antibody Test System should not be used to diagnose or exclude acute SARS-CoV-2 infection.

At this time, it is unknown how long antibodies persist following infection and if the presence of antibodies confers protective immunity.

Antibody tests, also known as serology tests, detect antibodies present in the blood when the body is responding to a specific infection, as with SARS-CoV-2.

COVID-19 antibody tests can help identify people who may have had a prior infection or who may have recovered from COVID-19.

However, these tests cannot detect the presence of the SARS-CoV-2 virus to diagnose COVID-19.

The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices.

The agency also is responsible for the safety and security of our nation’s food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.”

https://www.fda.gov/news-events/press-announcements/coronavirus-covid-19-update-fda-issues-emergency-use-authorization-symbiotica-covid-19-self

New study suggests vegan diet could control blood sugar for people with, or at risk of, type 2 diabetes

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New study suggests vegan diet could control blood sugar for people with, or at risk of, type 2 diabetes

April 06, 2021: “A study into the effects of a vegan diet in people with or at risk of developing type 2 diabetes has found that a plant-based lifestyle may help control blood glucose levels.

The study is supported by the NIHR Leicester Biomedical Research Centre (BRC) and NIHR Applied Research Collaboration East Midlands (ARC EM).

TMAO (or trimethylamine N-oxide) is a molecule produced when food, particularly from animal sources, is broken down in the gut.

Its presence is associated with an increased risk of heart disease, which is often linked to type 2 diabetes.

Researchers on the ‘Plant Your Health’ study looked at whether a vegan diet could reduce the production of TMAO as well as improve blood sugar control in the body, and therefore reduce the risk of symptoms of type 2 diabetes.

The study followed 23 individuals who either had or were at risk of developing type 2 diabetes, or whose weight was defined as clinically obese. Participants were given a full health check, including TMAO, blood sugar and cholesterol levels.

They were then asked to swap their regular meals with vegan equivalents over a period of eight weeks and encouraged to keep their physical activity the same.

The researchers found that on average TMAO levels in participants almost halved after just one week, and remained relatively steady at eight weeks.

However, when participants switched back to their regular diets at the end of the study, TMAO levels had gone back to their original levels four weeks later.

Professor Tom Yates, a professor at the University of Leicester, and co-author on the study, said: “Recent research into the causes of type 2 diabetes has found a strong association between a molecule in the blood called TMAO and increased risk of heart disease. 

“Research has found that TMAO is particularly linked to animal products in the diet such as red meat, eggs and dairy.

Due to the increased risk of patients with type 2 diabetes also developing heart disease, research suggests that there is a connection between diet, type 2 diabetes and heart functioning.” 

Dr Stavroula Argyridou, a registered dietitian who conducted the research, said: “Our findings suggest that a vegan diet could be an effective strategy for reducing TMAO and blood sugar levels in individuals with or at high risk of type 2 diabetes.” 

https://www.nihr.ac.uk/news/new-study-suggests-vegan-diet-could-control-blood-sugar-for-people-with-or-at-risk-of-type-2-diabetes/27413

Sanofi expands its social commitments, creates nonprofit unit to provide poorest countries with access to essential medicines

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Sanofi expands its social commitments, creates nonprofit unit to provide poorest countries with access to essential medicines

April 07 2021:  “In an open letter, Sanofi Chief Executive Officer Paul Hudson today outlined several key projects that the company will implement to increase the impact of its Corporate Social Responsibility (CSR) strategy.

Embedded in Sanofi’s long-term strategy, the company’s commitment is based on four essential pillars in which Sanofi is uniquely positioned to make a difference: access to medicines, support for vulnerable communities, preservation of the environment, and inclusion and diversity of its employees.

“The pandemic has forced us to question nearly every aspect of our lives: how we live and work, and how we connect with our communities and the planet. Yet as challenging as 2020 was, it also brought us –Sanofi and the pharmaceutical industry– closer to our purpose than at any other time in living memory,” said Hudson.

“This unique context led us to elevate our ambition for our Corporate Social Responsibility strategy and embed it even more into our mission to transform lives and our vision for a better future.”

Sanofi Global Health, pillar of access to essential medicines
A cornerstone of Sanofi’s CSR strategy, Sanofi Global Health is a newly formed nonprofit unit within the company.

Leveraging the company’s diverse and large portfolio of medicines and global footprint, Sanofi Global Health is dedicated to increasing access to medicines considered essential by the World Health Organization (WHO) for patients in 40 lower income countries. 

Thirty of Sanofi’s medicines will be provided across a wide range of therapeutic areas, including cardiovascular disease, diabetes, tuberculosis, malaria and cancer. 

Sanofi Global Health will also fund the training of healthcare professionals or the set up and development of sustainable care systems for those who suffer from chronic diseases and require complex care.

Sanofi Global Health is the first global initiative to provide access to such a broad portfolio of medicines, in so many countries and across several therapeutic areas, while funding local support programs.

Additionally, Sanofi is committed to helping 1,000 patients living with rare diseases who have no access to treatments and will donate 100,000 vials of medicine for their treatments each year. This continues Sanofi’s 30-year commitment to patients suffering from rare diseases, such as Fabry, Gaucher or Pompe diseases, for which access to treatment is often limited.

Leveraging R&D efforts to address crucial treatment gaps
Sanofi continues to support vulnerable communities and commits to developing innovative medicines for pediatric cancer, with the ultimate ambition of eliminating cancer deaths in children.

In low- to middle-income countries, a child is four times more likely to die of pediatric cancers than children living in high-income countries.

Sanofi also continues its efforts to fight polio and sleeping sickness, two of its historical programs that address global health issues.

In December 2020, Sanofi announced it had renewed its five-year partnership with WHO to fight neglected tropical diseases that affect approximately one billion people.

In this context, Sanofi, the only pharmaceutical company that keeps developing and supplying treatments for African trypanosomiasis or sleeping sickness, has committed itself alongside the WHO to eliminate this neglected tropical disease in humans by 2030.

For 40 years, Sanofi has supplied billions of polio vaccine doses, including hundreds of millions of donated doses to support the global polio eradication effort.

Zero plastic packaging for vaccines and ecodesign of products
For several years, Sanofi has been implementing a global environmental protection program, Planet Mobilization.

Today, the company is amplifying its actions to further improve the environmental footprint of its products and activities.

To reduce its greenhouse gas emissions by 55% by 2030 and contribute to better resource conservation, Sanofi plans to remove all pre-formed plastic packaging (blister packs) for its vaccines by 2027.

The company is also committed to ecodesigning all its new products by 2025. In terms of energy management, all Sanofi sites will use 100% renewable electricity and the company has set a target of a carbon-neutral car fleet, both by 2030.

Pushing to build more diverse and inclusive workforce
As a global company, Sanofi is committed to ensuring that its leaders reflect the communities and patients it serves.

The company is committed to building an organization where all employees have equal opportunities to reach positions of responsibility within the company.

Sanofi will continue to build a workforce that is fully reflective of the communities employees live in and the patients the company serves.

This element of the social impact strategy will be integrated into the career development of Sanofi leaders worldwide, ensuring a mindset that fosters diversity and inclusion throughout the company.
            

“Throughout this pandemic, public authorities, scientists, and industry have worked closely together to discover and produce vaccines at a pace that has defied historical precedent.

We now have to apply this same sense of urgency to other pressing threats, such as climate change, and issues that the pandemic has sharply put into focus, including widening racial and healthcare inequalities.

Let’s always remember that crises do not just neatly follow one after the other, they stack up. At Sanofi, we know we can do more,” said Hudson.”

https://www.sanofi.com/en/media-room/press-releases/2021/2021-04-07-09-03-41-2205543

CDC Issues Updated Guidance on Travel for Fully Vaccinated People

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CDC Issues Updated Guidance on Travel for Fully Vaccinated People

April 2, 2021: “The Centers for Disease Control and Prevention (CDC) updated its travel guidance for fully vaccinated people to reflect the latest evidence and science. Given recent studies evaluating the real-world effects of vaccination, CDC recommends that fully vaccinated people can travel at low risk to themselves.

A person is considered fully vaccinated two weeks after receiving the last recommended dose of vaccine.

Fully vaccinated people can travel within the United States and do not need COVID-19 testing or post-travel self-quarantine as long as they continue to take COVID-19 precautions while traveling – wearing a mask, avoiding crowds, socially distancing, and washing hands frequently.

“With millions of Americans getting vaccinated every day, it is important to update the public on the latest science about what fully vaccinated people can do safely, now including guidance on safe travel,” said CDC Director Dr. Rochelle Walensky. 

“We continue to encourage every American to get vaccinated as soon as it’s their turn, so we can begin to safely take steps back to our everyday lives.

Vaccines can help us return to the things we love about life, so we encourage every American to get vaccinated as soon as they have the opportunity.”

Because of the potential introduction and spread of new SARS-CoV-2 variants, differences in disease burden and vaccines, and vaccine coverage around the world, CDC is providing the following guidance related to international travel:

  • Fully vaccinated people can travel internationally without getting a COVID-19 test before travel unless it is required by the international destination.
  • Fully vaccinated people do not need to self-quarantine after returning to the United States, unless required by a state or local jurisdiction.
  • Fully vaccinated people must still have a negative COVID-19 test result before they board a flight to the United States and get a COVID-19 test 3 to 5 days after returning from international travel.
  • Fully vaccinated people should continue to take COVID-19 precautions while traveling internationally.

The guidance issued today does not change the agency’s existing guidance for people who are not fully vaccinated. Unvaccinated travelers should still get tested 1-3 days before domestic travel and again 3-5 days after travel.

They should stay home and self-quarantine for 7 days after travel or 10 days if they don’t get tested at the conclusion of travel.  CDC discourages non-essential domestic travel by those who are not fully vaccinated.

Due to the large number of Americans who remain unvaccinated and the current state of the pandemic, CDC recommends that fully vaccinated people continue to take COVID-19 precautions, such as wearing a mask, social distancing, washing hands frequently and avoiding crowds when in public, when visiting with unvaccinated people from multiple other households, and when around unvaccinated people who are at high risk of getting severely ill from COVID-19.”

https://www.cdc.gov/media/releases/2021/p0402-travel-guidance-vaccinated-people.html

FDA Makes Two Revisions to Moderna COVID-19 Vaccine Emergency Use Authorization

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FDA Makes Two Revisions to Moderna COVID-19 Vaccine Emergency Use Authorization

April 01, 2021: “The U.S. FDA announced two revisions regarding the number of doses per vial available for the Moderna COVID-19 Vaccine.

The first revision clarifies the number of doses per vial for the vials that are currently available, in that the maximum number of extractable doses is 11, with a range of 10-11 doses.

The second revision authorizes the availability of an additional multi-dose vial in which each vial contains a maximum of 15 doses, with a range of 13-15 doses that can potentially be extracted.

“Both of these revisions positively impact the supply of Moderna COVID-19 Vaccine, which will help provide more vaccine doses to communities and allow shots to get into arms more quickly.

Ultimately, more vaccines getting to the public in a timely manner should help bring an end to the pandemic more rapidly,” said Peter Marks, M.D., Ph.D., director of the FDA’s Center for Biologics Evaluation and Research.

Depending on the type of syringes and needles used to extract each dose, there may not be sufficient volume to extract more than 10 doses from the vial containing a maximum of 11 doses or more than 13 doses from the vial containing a maximum of 15 doses.

To support these changes to the emergency use authorization, the FDA evaluated data showing the number of doses that could be extracted from the vials and on the fill volumes for both vials that were submitted by ModernaTX, Inc. 

The Fact Sheet for Healthcare Providers Administering Vaccine (Vaccination Providers) and Prescribing Information have been revised to reflect the new information and are intended to help frontline workers administering COVID-19 vaccines understand the number of doses that can potentially be extracted per vial.

Because the Moderna COVID-19 Vaccine does not contain preservative, any further remaining product that does not constitute a full dose should not be pooled from multiple vials to create one full dose.

If one vial becomes contaminated during use, pooling doses from multiple vials can spread contamination to other vials. Use of contaminated vials may cause serious bacterial infections in vaccinated individuals.

The updated information in the revised Fact Sheet for Vaccination Providers and Prescribing Information provides instructions to not pool vaccine from multiple vials.

The dosing regimen remains unchanged; the vaccine is administered as a two-dose series, 0.5 mL each dose, one month apart.

The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices.

The agency also is responsible for the safety and security of our nation’s food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.”

https://www.fda.gov/news-events/press-announcements/coronavirus-covid-19-update-fda-makes-two-revisions-moderna-covid-19-vaccine-emergency-use

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