Biden admin eyes vaccine mandate for businesses with under 100 employees

 The Occupational Safety and Health Administration (OSHA) says it is "seeking comment" about whether businesses with fewer than 100 employees should be subject to the COVID-19 vaccine and testing mandate it is implementing on big businesses. 

OSHA's requirement will force businesses with more than 100 employees to mandate vaccines or else their employees will need to wear masks and be tested for COVID-19 weekly. It will go into effect Jan. 4. 

But according to a summary released by OSHA, it appears to be considering implementing the rule for small businesses as well. 

"OSHA is confident that employers with 100 or more employees have the administrative capacity to implement the standard’s requirements promptly, but is less confident that smaller employers can do so without undue disruption," the summary says. "OSHA needs additional time to assess the capacity of smaller employers, and is seeking comment to help the agency make that determination."

The same language is included in the Federal Register page for the vaccine rule.

A Department of Labor spokesperson told FOX Business Friday that it is indeed considering whether to extend the vaccine or mask and testing mandate to businesses with fewer than 100 workers. 

"OSHA chose a 100-employees threshold at this time because the agency is confident that employers with 100 or more employees have the administrative capacity to implement the standard’s requirements promptly," the spokesperson said. "Because the emergency situation required OSHA to act quickly, the information immediately available to the agency did not allow it to confidently assess the impact on smaller firms."

The spokesperson added: "OSHA will consider whether to extend the rule to smaller firms in the public rulemaking that begins with the publication of this emergency rule."

https://www.foxbusiness.com/politics/biden-admin-considering-vaccine-mandate-small-businesses-fewer-than-100-employees

Pfizer stock jumps, Moderna, Merck tumble

 Pfizer dialed up the vaccine wars on Friday after disclosing its oral pill for COVID-19 is 89% effective in preventing hospitalization. 

Shares are on track for the largest percent increase since March of 2009, as tracked by Dow Jones Market Group. Roughly $30 billion in market value has been created for the pharma maker just today on the promise of the treatment. 

Pfizer CEO Albert Bourla tould FOX Business' Neil Cavuto the medical tool is a "game-changer" for COVID-19 patients. 

Pfizer's news comes after the Biden administration ordered businesses with over 100 workers to institute vaccine mandates set to begin on Jan. 4, 2022.

As Pfizer makes strides, other vaccine players are losing ground. 

Rival Merck, which has a competing COVID-19 treatment, is on pace for the biggest one-day decline since January of 2005. 

Moderna earlier this week cut its full fiscal year 2021 forecast for COVID-19 vaccine deliveries. Shares remained under pressure. 

"Key variables impacting output include longer delivery lead times for international shipments and exports that may shift deliveries to early 2022, temporary impact from expansion of fill/finish capacity and ramp-up of product release to market," Moderna said in its third-quarter earnings release. 

Regeneron, which produces a COVID-19 antibody cocktail, also saw its shares drop. 

https://www.foxbusiness.com/markets/pfizer-stock-trading-vaccine-moderna-merck-regeneron

Codexis, Nestlé Health Science Initiate Phase 1 Trial for Exocrine Pancreatic Insufficiency

 Codexis, Inc. (NASDAQ: CDXS), a leading protein engineering company and developer of novel biotherapeutics, and Nestlé Health Science, a globally recognized leader in the field of nutritional science, announced today the dosing of the first subject in a Phase 1 study to investigate the safety, tolerability, pharmacokinetics (PK), and pharmacodynamics of CDX-7108.

CDX-7108 is a lipase variant specifically engineered to overcome the limitations of traditional pancreatic enzyme replacement therapy (PERT) deficiencies. PERT is the main treatment for exocrine pancreatic insufficiency (EPI), a debilitating condition of the GI-tract that is caused by conditions that impair pancreatic function, such as pancreatitis, pancreatic cancer, Crohn’s disease, celiac disease, and cystic fibrosis. CDX-7108 was engineered to be highly stable to the acidic conditions in the stomach and resistant to proteases in the upper intestines.

The integrated, three-part Phase 1a/1b study comprises a randomized, double-blind, placebo-controlled dose escalation to investigate the safety, tolerability, immunogenicity, and PK of CDX-7108 after single (part A) and multiple (part B) oral dose administration in healthy adult subjects. Part C is a randomized, double-blind, placebo-controlled, single-dose, 2-way crossover study to assess proof-of-concept of CDX-7108 for pharmacodynamics, safety, tolerability, and immunogenicity in subjects with EPI.

“Our partnership with Nestlé Health Science aims at leveraging the CodeEvolver® protein engineering platform to create novel orally administered enzyme therapies for patients. We are excited to advance the first candidate from this partnership, CDX-7108, into clinical development”, according to John Nicols, Codexis’ President and CEO. “The complementarity of Nestlé Health Science’s gastrointestinal experience and Codexis’ proven ability to discover and develop differentiated enzymes, has led to the rapid advancement of CDX-7108 into the clinic”, Gjalt Huisman, Senior Vice-President, Codexis Biotherapeutics added.

https://finance.yahoo.com/news/codexis-nestl-health-science-initiate-200500442.html

Can IDO/PD-L1 combo work? Novo-backed IO spells out how in IPO filing

 Add another biotech to the horde of companies aiming to make their Nasdaq debuts before the calendar turns to 2022.

Copenhagen’s IO Biotech filed its SEC paperwork late last week, penciling in $100 million for its initial offering. The move comes about nine months after the Novo Seeds-backed company pulled in a $154.5 million Series B in January to advance its immune-modulating IDO and PD-L1 cancer vaccines.

IO Biotech has pinned its hopes and dreams on a rebound in IDO, and so far private investors appear to like what they’re seeing. In a previous interview with Endpoints News, Novo Seeds managing partner Søren Møller tied the company’s quick rise to an “inflection point” after IO launched a Phase II study in non-small cell lung cancer in May 2019.

The FDA has also taken notice of the biotech, granting IO researchers a BTD in unresectable or metastatic melanoma for combining its lead asset with Merck’s Keytruda. The program combines two candidates, IO102 and IO103, that work to direct T cells against IDO and PD-L1, respectively.

This approach is designed to attack the tumor microenvironments with the hope of eliminating them altogether, but IDO and checkpoint combinations are something with which biopharmas have struggled previously. Incyte’s effort to match epacadostat with Keytruda in melanoma whiffed in April 2018 while NewLink Genetics scrapped a Phase III trial for its own IDO program.

Where IO Biotech hopes to succeed is by deriving peptides from IDO and PD-L1 in their experimental drugs, activating that microenvironment-killing immune response, Møller said.

IO Biotech did not spell out how big its investors’ stakes are in the company, though Novo Holdings sits atop the list. The company has also seen funding from Lundbeck, Sunstone’s third life sciences fund, HBM and Vivo Capital.

As for the IPO funds themselves, IO Biotech plans to use the majority to fund a Phase III trial in first-line advanced melanoma, expected to launch by the end of the year. There will also be cash set aside for a “basket” of Phase II trials and a Phase I/II study for a second program in combination with the lead.

Biotech’s IPO market has awoken from its summer hibernation, with nearly a dozen biotechs having filed for Nasdaq in the last few weeks. The industry recently surpassed $14 billion raised across almost 90 newly public biotechs, per the Endpoints tally, figures that remain on pace to surpass 2020’s record sums of $16.5 billion from 91 companies.

https://endpts.com/can-an-ido-pd-l1-combo-ever-work-novo-backed-company-spells-out-how-in-biotechs-latest-ipo-filing/

Chinook Therapeutics Highlights Nephrology Candidate Presentations

 

• Additional data to be presented from the ongoing phase 1/2 study of BION-1301 in patients with IgA nephropathy, including biomarker and proteinuria reductions

• Several presentations on the atrasentan clinical program, including translational research demonstrating ETA activation is associated with clinical progression in IgA nephropathy

• Chinook to host investor conference call and webcast on November 4, 2021 to review abstracts and provide updates on the company’s pipeline

Investor Conference Call Details
To access the call, please dial (844) 309-0604 (domestic) or (574) 990-9932 (international) and provide the Conference ID 1381696 to the operator.

To access the live webcast and subsequent archived recording of this and other company presentations, please visit the Investors section of Chinook’s website. The archived webcast will remain available for replay on Chinook’s website for 90 days.

https://finance.yahoo.com/news/chinook-therapeutics-announces-upcoming-data-200500385.html

Ontrak Announces 2021 Third Quarter, Guidance

 

• Q3 Revenue of $18.6 million

• Ontrak Raises Annual Guidance to $82-$86 million

• Sales Pipeline Accelerating and Advancing with 3 of Nation’s Larger Health Plans

• Company in Advanced Discussions with 4 Employer Organizations and Several Providers

• Current National Plan Customer Signs Contract to Expand Ontrak Program to Include Mobile Care Solution

• Company to Host Conference Call at 4:30 pm ET Today

Conference Call & Webcast Details

The Company will host a conference call/webcast today at 4:30 pm ET/1:30 pm PT. Investors, analysts, employees and the general public can access the call by dialing (833) 519-1269 for U.S. participants or (914) 800-3841 for international participants and referencing conference ID #5477522. A live and archived webcast of the event will be available at: https://ontrakhealth.com/investors/presentations-events.

https://finance.yahoo.com/news/ontrak-announces-2021-third-quarter-200500167.html

Emergent CEO: Why we’re ending pandemic manufacturing partnership with U.S. government

 This week, the U.S. Department of Health and Human Services agreed to Emergent BioSolution’s request to end our 9-year pandemic manufacturing partnership that began after the 2009 H1N1 “swine flu” pandemic. We did not come to this decision easily.

Emergent was founded to help respond to and prepare for public health threats. And even though we’re ending this manufacturing partnership with the government, our Bayview facility will continue producing COVID-19 vaccines and treatments for our private sector partners, and we will continue to supply the U.S. government with other needed medical countermeasures. We’re proud of what our hundreds of employees have been able to accomplish right here in Baltimore. As the country looks ahead to preparing for the next pandemic, I want to share with you our experience and what we learned, so the country is better prepared for the future.

The original intent of this partnership was to create a facility that could produce 50 million dose-equivalents of influenza vaccine drug substance in four months in the event of a pandemic. Facility expansion was only a first step. To build and maintain a state of readiness, continued investment is a necessity. The government maintained that they would provide us with the necessary drug development work to build and maintain those capabilities. That didn’t happen.

Fast forward to the emergence of COVID-19. The federal government sought domestic manufacturing capacity as pharmaceutical companies began trials on dozens of vaccine candidates. Despite the eight years and over $200 million of additional Emergent investment, our Bayview facility was still developing clinical-stage drug substance material, with fewer than 100 employees, and had never been tested by the government for influenza, much less a new virus. Ultimately, Emergent would hire and train more than 300 new employees and deploy never-before-tested processes and technologies to manufacture not one, but two, novel coronavirus vaccine candidates.

We had already committed to Johnson & Johnson to manufacture their vaccine candidate when the U.S. government, through the Center for Innovation in Advanced Development and Manufacturing (CIADM) program, reserved the remaining capacity at Bayview to be used at their discretion. They directed us to work with AstraZeneca. No one at the time knew which vaccine candidates would succeed. So, even though the U.S. government, we and our partners understood the risks of producing two viral-vector vaccines in the same facility, we took on the challenge.

Then, in March of this year, a single batch of the J&J vaccine was cross contaminated with the AstraZeneca vaccine. Emergent has taken full responsibility for this incident and addressed the conditions that caused it. And, thanks to the dedicated work of our employees alongside J&J, manufacturing of the vaccine resumed in late July. Despite the setback, there are approximately 100 million people in the world who are safer because of vaccine made at Bayview, with more batches still under review. We are proud of this accomplishment. As of today, except for Emergent, none of the companies selected by the Biomedical Advanced Research and Development Authority to create CIADMs have yet produced usable vaccine.

As we prepare for future pandemics, there are a few key lessons we need to take from this experience. First, we shouldn’t assume the next pandemic will be just like this one. The investment in our Bayview facility was born out of a review of the 2009 influenza pandemic. We need to take an expansive view of potential public health threats and create the capabilities to respond.

Second, we need to approach manufacturing with a military readiness mentality. Proactively producing a variety of drug substances will allow us to develop the technologies, processes, and worker expertise to manufacture whatever is needed to defeat the next pandemic.

Third, we need to invest in the jobs and training to prepare for the next pandemic. That means investing now in the people and training to manufacture the next therapeutic or vaccine that will lead us out of a future pandemic.

Many companies stepped up to help fight this pandemic, often attempting to do things that had never been done before. Not everything went perfectly. We know that firsthand at Emergent. But if you want companies to engage, you need to be willing to stand by them through both challenge and achievement. As difficult as that is, it’s essential to America’s success in combating the public health threats of the future.

Robert Kramer (ceo@ebsi.com) is president and chief executive officer of Emergent BioSolutions, in Gaithersburg, Md.

https://www.baltimoresun.com/opinion/op-ed/bs-ed-op-1105-emergent-government-partnership-end-20211104-ooalp5sb4zbczog4b3ryol5leu-story.html