Pfizer and BioNTech Initiate Phase 1/2 Study of First mRNA-based Shingles Vaccine Program

 Pfizer Inc. (NYSE: PFE) and BioNTech SE (Nasdaq: BNTX) today announced the start of a Phase 1/2 trial exploring the safety, tolerability, and immunogenicity of the companies’ mRNA vaccine candidates against shingles (also known as herpes zoster, or HZ), a debilitating disease caused by the varicella-zoster virus (VZV). Shingles affects millions of people around the world each year.2

The companies’ Phase 1/2 multicenter, randomized, controlled, dose-selection study (NCT05703607

 will evaluate the safety, tolerability, and immunogenicity of mRNA vaccine candidates against shingles. The study is aiming to enroll up to 900 healthy volunteers 50 through 69 years of age and is being conducted in the United States. Phase 1 will help select the optimal mRNA vaccine candidate, dose level, dosing schedule, and formulation for advancement to Phase 2. Participants in the study will be followed to determine how long protection may last.

While there are currently approved vaccines for shingles, Pfizer and BioNTech aim to utilize mRNA technology to potentially develop a vaccine that demonstrates high efficacy, is well tolerated, and is efficient to produce globally. The companies will leverage Pfizer's proprietary antigen technology and BioNTech's proprietary mRNA platform technology used in the companies’ COVID-19 vaccine. The mRNA shingles vaccine candidates encode different versions of glycoprotein E (gE) on the surface of the varicella zoster virus. The gE protein is important for viral replication and the cell-to-cell spread after reactivation of the virus in the nerve cells.3

Pfizer and BioNTech announced a shingles vaccine collaboration in January 2022. The companies are also working together on COVID-19 vaccines, and a COVID-19 and influenza combination vaccine program.

https://www.pfizer.com/news/announcements/pfizer-and-biontech-initiate-phase-12-study-first-mrna-based-shingles-vaccine

Dexcom Announces G7 Launch in Super Bowl Ad With Nick Jonas

 During this year’s Super Bowl, Dexcom will air a commercial starring pop star Nick Jonas, announcing the US launch of its latest continuous glucose monitor (CGM), the Dexcom G7. The device, perhaps the year’s most anticipated release in diabetes tech, promises to raise awareness about the power of CGM and Time in Range.

Dexcom announced this week that the long-anticipated US debut of its next generation continuous glucose monitor (CGM), Dexcom G7, will be featured in a Super Bowl ad starring pop star Nick Jonas. 

Over the past year, G7 has also been released in the United Kingdom, Ireland, Germany, Austria, and Hong Kong.

The ad will be viewed by approximately 4.8 million Americans with diabetes on insulin, along with millions more with personal connections to the diabetes community, displaying diabetes and the power of CGM on a global, mainstream level.

Two years ago, the company also used the Super Bowl to spotlight its previous CGM, Dexcom G6, in a commercial with Jonas. 

“At its core, the commercial is about representation for people with diabetes,” Kevin Sayer, Dexcom CEO, said about the latest ad. “When Dexcom launched its first Super Bowl ad in 2021, it was the first time diabetes was put on a stage like this. This year’s commercial aims to continue these efforts as part of a broader awareness campaign to highlight the ‘magic moments’ people with diabetes can experience with a little help from their Dexcom CGM.”

In the commercial, Jonas reveals the device using a magician’s sleight of hand and shows the simple device insertion and mobile app display – you can watch the ad below.

 

https://diatribe.org/dexcom-announces-g7-launch-super-bowl-ad-nick-jonas

Mineralys, in thawing IPO market, upsizes offering to $192M for race with AstraZeneca

 After a long winter, the first signs of spring have brought the return of the lesser spotted upsized biotech IPO. Days after Structure Therapeutics closed its upsized offering, Mineralys Therapeutics has revealed a $192 million haul that positions it to race AstraZeneca to a new uncontrolled hypertension opportunity. 

Mineralys filed to test the long-frosty IPO waters last month and updated its paperwork with its targeted offering figures last week. Now, the developer of a high blood pressure drug has revealed the fundraising is going better than expected. Having set out to sell 10 million shares for $14 to $16 each, the biotech is set to shift 12 million shares and hit the top end of its target range.

There could be more to come for Mineralys if it sells the overallotment of 1.8 million shares. Either way, the biotech will exit the IPO with the cash to cruise past upcoming data drops that could send its stock price up a notch.

In the first half of 2023, Mineralys plans to start a phase 2 clinical trial to evaluate its lead candidate, the aldosterone synthase inhibitor lorundrostat, as an add-on drug in patients with uncontrolled or resistant hypertension (uHTN/rHTN). It also expects to kick off another phase 2 trial of lorundrostat for the treatment of uHTN and rHTN in a chronic kidney disease population around the midpoint of the year.

Top-line data from both studies are due in the first half of next year and will shape confidence in a phase 3 program. Mineralys plans to start a phase 3 trial to test lorundrostat in around 1,000 adults in the second half of 2023. With phase 3 results due in mid-2025, the IPO money will run dry before the pivotal data drop, but the phase 2 trials give Mineralys chances to strengthen its hand for further fundraising.

Mineralys will need to pay Mitsubishi Tanabe Pharma if the drug makes it to market. Mitsubishi licensed the molecule to the biotech for $1 million upfront in 2020 in a deal that also features up to $9 million in development milestones and up to $155 million in commercial milestones. Mineralys picked up the drug candidate in the belief its inhibition of an enzyme will lower levels of a blood pressure hormone.

Multiple other drug developers have latched onto the same idea. Boehringer Ingelheim has studied the mechanism, and AstraZeneca is entering the space through its $1.8 billion takeover of CinCor Pharma. A phase 2 trial of CinCor’s challenger missed its primary endpoint last year, but AstraZeneca has kept the faith in a candidate that could enter phase 3 around the same time as Mineralys’ lorundrostat.

https://www.fiercebiotech.com/biotech/mineralys-amid-signs-thawing-ipo-market-upsizes-offering-raise-192m-race-astrazeneca

Pfizer gets OK for atopic dermatitis med for teens

 Pfizer Inc. (NYSE: PFE) announced today that the United States (U.S.) Food and Drug Administration (FDA) approved its supplemental New Drug Application (sNDA) for CIBINQO® (abrocitinib), expanding its indication to include adolescents (12 to <18 years) with refractory, moderate-to-severe atopic dermatitis (AD) whose disease is not adequately controlled with other systemic drug products, including biologics, or when use of those therapies is inadvisable. CIBINQO was previously approved only for the treatment of adults 18 years and older.

https://finance.yahoo.com/news/fda-approves-pfizers-supplemental-drug-170900988.html

Fed’s Waller calls crypto ‘nothing more than a speculative asset’

 Federal Reserve Governor Christopher Waller said Friday he views crypto as a speculative asset that's worth whatever the next person is willing to pay for it and says he, personally, wouldn't hold it.

"To me, a crypto-asset is nothing more than a speculative asset, like a baseball card," Waller said in a speech at a crypto conference at the Global Interdependence Center in La Jolla, California.

"If people want to hold such an asset, then go for it," Waller said. "I wouldn't do it, but I don't collect baseball cards, either. However, if you buy crypto-assets and the price goes to zero at some point, please don’t be surprised and don’t expect taxpayers to socialize your losses."

Waller said it's critical to make sure that the risks associated with crypto are mitigated, but that regulators shouldn't "unduly limit" the development and potential future uses of any positive features of crypto.

Waller said any bank engaging with crypto customers would have to be very clear about the customers' business models, risk-management systems, and corporate governance structures to ensure that the bank is not left holding the bag if there is a crypto meltdown.

WASHINGTON, DC - FEBRUARY 13: Christopher Waller testifies before the Senate Banking, Housing and Urban Affairs Committee during a hearing on their nomination to be member-designate on the Federal Reserve Board of Governors on February 13, 2020 in Washington, DC. (Photo by Sarah Silbiger/Getty Images)

Waller's comments come after the SEC on Thursday reached a settlement with crypto exchange Kraken over its staking program which will see Kraken pay a $30 million fine and shutter its crypto staking service for U.S. customers.

They come after the Fed denied Wyoming-based crypto bank Custodia's application to become a member of the Fed's system, noting the bank's focus on crypto created significant safety and soundness risks and therefore didn’t meet requirements under the law.

The Fed also issued a policy statement on crypto last month, making clear that uninsured and insured banks regulated by the Fed will be subject to the same limits on activities, including crypto.

Banks would be allowed to provide safekeeping services, custody, for crypto-assets if done in a way the Fed views a safe and sound manner and in compliance with consumer and anti-money laundering laws.

https://finance.yahoo.com/news/feds-waller-calls-crypto-nothing-more-than-a-speculative-asset-173516465.html

Conformis sees business disruption in 2023

 2023 Outlook:

• Conformis expects Q1 2023 product revenue to be in the range of $12M - $13M.

• This range reflects the disruption related to the transition to our new business model and continued manufacturing and supply chain challenges.

• On January 23, 2023 we received a favorable appellate court ruling in our ongoing litigation against Aetna and intend to continue pursuit of these claims.

• On February 8, 2023 we launched our new media campaign

• https://conformis.wistia.com/medias/uegxhwukio

Conference Call and Webcast – March 1, 2023 – 4:30 pm ET

As previously announced, Mark Augusti, CEO, and Bob Howe, CFO, will host an earnings webcast and conference call, Wednesday, March 1, 2023, at 4:30 p.m. Eastern Time.

The webcast of the earnings call will be live at: Link Directly to Webcast

To attend by telephone, please use the information below for dial-in access.

• Date and Time: March 1, 2023 – 4:30 p.m. Eastern Time

• Please register for the call. You can register any time starting now through the call.

• Link to register: Registration Link

• Registration in advance is encouraged. As part of the registration process, you can choose to be provided with the dial-in and PIN or to use the automated “Call Me” feature.

Please visit the Investor Relations website at ir.conformis.com on March 1, 2023, to view the earnings release prior to the webcast and conference call.

The online archive of the webcast will be available on the company’s website at ir.conformis.com for 30 days.

https://finance.yahoo.com/news/conformis-provides-business-reports-preliminary-120000502.html

As FDA spins new tune in CKD anemia with GSK nod, others in class may hope to play along

 With the U.S. FDA go-ahead Feb. 2 for GSK plc’s oral daprodustat for anemia in patients with chronic kidney disease (CKD), the picture brightened for would-be competitors in the hypoxia-inducible factor prolyl hydroxylase (HIF-PHI) inhibitor space, including high-profile Akebia Therapeutics Inc., which has appealed last spring’s the complete response letter from gatekeepers with regard to vadadustat.

https://www.bioworld.com/articles/693998-hif-phi-delity-as-fda-spins-new-tune-in-ckd-anemia-with-gsk-nod-others-in-class-may-hope-to-play-along