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CureVac’s COVID-19 vaccine candidate inches forward to Phase 2b/3 efficacy readout

CureVac (NSDQ:CVAC) has announced that its first-generation COVID-19 vaccine has passed its first interim analysis but has chosen not to share efficacy data until a statistically significant efficacy analysis is ready.

The Tübingen, Germany–headquartered company is developing two mRNA-based vaccines. The mRNA vaccines from Moderna (NSDQ:MRNA) and Pfizer (NYSE:PFE) are currently two of the most popular COVID-19 vaccines in the world.

The data and safety monitoring board also concluded that there were no safety concerns linked to the CVnCoV in the HERALD study.

The company’s second-generation vaccine is known as CV2CoV, which it is developing in collaboration with GSK.

CureVac and GSK announce promising preclinical data for next-gen COVID-19 vaccine

As CureVac (NSDQ:CVAC) awaits European authorization for its mRNA COVID-19 vaccine, it is conducting preclinical research on a second-generation vaccine candidate known as CV2CoV, which it is developing with GSK.

In a study involving rats, the new mRNA vaccine candidate yielded high levels of antigen and strong neutralizing antibody titers after the first vaccination.

Tübingen, Germany–based CureVac also said the vaccine candidate led to high levels of antibodies against several variants of concern, including B.1.1.298, B.1.1.7 and B.1.351.

“To successfully fight the COVID-19 pandemic in the long term, we will need different vaccines, and we need to be able to respond effectively to emerging variants,” GSK Global Vaccines President Roger Connor said in a statement.

CV2CoV uses a new mRNA platform than CureVac’s first COVID-19 vaccine candidate known as CVnCoV. The new platform intends to bolster intracellular mRNA stability and translation to y…

Which companies will likely produce the most COVID-19 vaccine in 2021?

Photo by Markus Spiske on Unsplash

Since the beginning of the pandemic, much of society has pinned its hopes on the availability of a vaccine. Now that several are available across the world, there is hope, said Dr. Anthony Fauci, chief medical advisor to President Joe Biden, in a recent JAMA interview. “There’s light at the end of the tunnel.”

One thing that will make the light at the end of the tunnel brighter as we head into the spring is the greater availability of vaccine doses. “The discordance between supply and demand will be diminished,” Fauci said.

The roster of companies producing vaccines is steadily increasing, making it possible to vaccinate a substantial portion of the world’s population this year. (Note: Most of the companies in this list have two-dose vaccines.)

Here’s a roundup of notable companies’ production targets for 2021:

AstraZeneca and Oxford University: Up to 3…

GSK and CureVac team up on COVID-19 vaccine to battle viral variants

Late last year, GlaxoSmithKline (NYSE:GSK) and Sanofi (NYSE:SNY) announced that their joint COVID-19 vaccine was delayed.

Now, GlaxoSmithKline is hooking up with Germany-headquartered CureVac (NSDQ:CVAC) to develop a COVID-19 vaccine that can target multiple variants of the virus simultaneously. GSK plans on spending €150 million on the project, paying the first half to CureVac initially and the latter half as a milestone payment.

For GSK, the project also entails a shift in viral platform. Its previous vaccine candidate was an adjuvanted recombinant protein-based COVID-19 vaccine.

The new project, however, will use the mRNA platform that Moderna (NSDQ:MRNA) and Pfizer (NYSE:PFE) have deployed in their vaccines, which were the first to win FDA authorization in the U.S.

The two companies plan to commercially launch an mRNA vaccine in 2022, pending regulatory approval.

GSK will also work with CureVac to produce up to 100 million doses of its …

MedTech 100 roundup: Stocks were practically unchanged last week

Despite plenty of ups and downs coming in the stock market for the medtech industry, there was hardly any movement from week to week.

MassDevice’s MedTech 100 Index — which includes stocks of the world’s largest medical device companies — sat at 89.6 points at the end of last week (Aug. 21). Overall, medtech stocks saw a -0.2% decrease from the 89.77-point total at the same time a week prior (Aug. 14).

Once again, the index nearly reached a high point during the COVID-19 pandemic, as on Aug. 18, it hit 90.4 points for the second time in as many weeks, a total that nearly poked past the previous mid-pandemic high (90.45), which came on Aug. 5.

The most recent high mark represents just a -2.1% dip from the Feb. 19 high point of 92.32, while the tally at the end of the week marks a -2.9% decrease from that pre-pandemic high.

Meanwhile, the S&P 500 Index saw a 0.72% increase from Aug. 14 to Aug. 21, having reached record highs on Aug. 18. Meanwhil…

DTW Podcast: Can Fractyl Labs and Cala Health go where only drugs have gone before?

DeviceTalks Weekly, powered by MassDevice

In this week’s episode of the DeviceTalks Weekly podcast, co-hosts Tom Salemi, editorial director of DeviceTalks, and Chris Newmarker, executive editor of life sciences, review this week’s Top 5 medtech stories, aka “Newmarker’s Newsmakers,” with news coming from CureVac, Avail Medsystems, ClearMask, Thermo Fisher and Bayer.

We also hear from two executives from Fractyl Laboratories — CEO Dr. Harith Rajagopalan and CFO Lisa Davidson — about its recent $55 million Series E round of financing and the strides they’re making in developing a device to treat diabetes.

In a second interview, bioelectronic device company Cala Health CEO Renee Ryan gives us an update on the Cala Trio’s clinical success in treating essential tremors and how the start-up is working through COVID-19.

Finally, Chris and Tom hint at an upcoming event for the DTW communit…

DTW Podcast: Can Fractyl Labs and Cala Health go where only drugs have gone before?

In this week’s DeviceTalks Weekly podcast, co-costs Tom Salemi and Chris Newmarker walk through this week’s “Newmarker’s Newsmakers,” the Top Five #medtech stories of the week with news coming from CureVac, Avail Medsystems, ClearMask, Thermo Fisher and Bayer.

We also hear from CEO Harith Rajagopalan, MD and CFO Lisa Davidson of Fractyl Laboratories, which is making great strides in developing a device to treat diabetes.

Cala Health CEO Renee Ryan returns to the podcast to give us an update on the Cala Trio’s clinical success in reducing essential tremors and how the start-up is working through COVID-19.

Finally, Chris and Tom hint at an upcoming event for the DTW community.

Subscribe today on Apple Podcasts, Spotify, and other players.

DeviceTalks by MassDevice · Can Fractyl Labs and Cala Health go where only drugs have gone before?

The top 5 MassDevice stories of the week — August 21, 2020

COVID-19 continues to dominate medical device industry news on MassDevice.

The pandemic is causing more major lawsuit settling — as well as efforts to offer more medtech to enable better management of the coronavirus.

Want to hear more about the week’s top news? Executive editor Chris Newmarker and Tom Salemi will discuss during our DeviceTalks Weekly podcast. Without further ado, here’s this week’s MassDevice Top Five:

5. CureVac raises more than $200M in IPO

CureVac (NSDQ:CVAC) — a Germany-based biotech outfit — is developing a COVID-19 vaccine with backing from the Bill and Melinda Gates Foundation. Read the full story.

4. This telemedicine system could get medtech sales reps back to ORs

Avail Medsystem’s telemedicine system could prove a more efficient way for sales reps to sit in on surgeries, especially as the COVID-19 pandemic continues to hinder access to hospitals. Read the full story.

3. FDA clears ClearMask transparent surgical mas…

CureVac stock soars after $213.3M IPO

Shares of CureVac (NSDQ:CVAC) continue to rise after the company reportedly raised $213.3 million in its initial public offering on Friday.

According to a report from MarketWatch, the Germany-based biotech outfit priced its IPO at $16 per share and sold more than 13.3 million shares to raise the $213.3 million. Currently, shares of CVAC are trading up 30.2% at $72.77.

Get the full story at our sister site, Drug Delivery Business News.