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Connect Biopharma’s Latest Dermatitis Drug Update Fails to Pump up Shares

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Loss-making Connect Biopharma says Phase 3 clinical trials of its CBP-201 drug for atopic dermatitis will begin in second half of this year
Connect Biopharma shares, which more than halved after its November release of initial Phase 2 clinical trial data, fell further after latest update

By Mia Shanley

China’s Connect Biopharma Holdings Ltd. (NASDAQ: CNTB) is just itching to bring in its first-ever revenue with a drug for moderate-to-severe atopic dermatitis that’s making steady progress in the clinical testing process. But it’s having a hard time winning over investors, even after releasing extra data last week from recent clinical trials. That included details on its plans to start Phase 3 trials – considered the final phase before seeking regulatory approval – later this year.

The new drug, CBP-201, could be a potential alternative to Regeneron’s (NASDAQ: REGN) and Sanofi’s (NASDAQ: SNY) blockbuster drug Dupixent, which brought in 3.5 billion euros ($4 billion) in 2020 and which the drug makers believe has the potential to reach peak annual sales of 10 billion euros. Other pharmaceutical giants like Eli Lilly(NYSE: LLY) and Pfizer (NYSE: PFE) are also in the race with their own treatments for dermatitis.

Connect Biopharma said in its Jan. 5 announcement that additional analysis from its Phase 2b clinical trials showed that CBP-201 could be safely administered at various dosing schedules. It touted one of its schedules in particular – 300 mg once every four weeks (Q4W) – as being a “more convenient” option to current treatments.

“We are very encouraged by the findings from the additional analyses and remain confident on the potential for a highly competitive efficacy and safety profile for CBP-201 coupled with a more convenient and differentiated Q4W dosing schedule,” said Zheng Wei, co-founder and CEO of Connect Biopharma, in the statement.

Despite that upbeat tone, investors were less impressed. The company’s stock fell 7% the day of the announcement last Wednesday, though it later clawed back most of those losses. Still, the shares have lost more than two-thirds of their value over the last 52 weeks as investors remain unimpressed about the new drug’s prospects.

Atopic dermatitis has an estimated lifetime prevalence of up to 20%, is on the rise internationally and is the most commonly diagnosed chronic inflammatory skin disorder. Beyond that market, Connect Biopharma also hopes its product can be used to treat asthma and chronic rhinosinusitis.

But the 10-year old company, which has a pipeline of four drug candidates but no revenues yet, must prove that CBP-201 – its lead product candidate – is at least as good as, or has an edge over, products already on the market. That appears to be the big sticking point for skeptical investors.

Sanofi is moving fast to maintain its dominant position. It has already secured green lights for Dupixent in new markets like China for adolescents suffering from atopic dermatitis and for use as an add-on treatment for patients with asthma by the U.S. Food and Drug Administration.

Connect Biopharma said on a call with analysts after the latest findings that discussions with Chinese authorities were ongoing and so far “positive” and “productive”.

Meanwhile, quarterly sales of Dupixent have nearly tripled in the last two years. Sanofi posted 1.4 billion euros in revenues from the drug in last year’s third quarter, a 55% increase on the same period a year ago, thanks to growth not just in the U.S. where it is dominant, but also in its home European market and also in Japan.

Crowded market

It’s looking increasingly difficult for Connect Biopharma, whose current market capitalization stands at a modest $283 million, to stand out in a sea of pharmaceutical giants. Perhaps reflecting that reality, the company’s shares lost more than half their value after it released initial data about its Phase 2 clinical trial for CBP-201 in November.

The updated findings this month have done little to support the shares, which closed Tuesday at $4.93, not far off an all-time low of $4.06 and just a fraction of the $17 IPO price when the company listed on the Nasdaq last March. Potentially adding to ongoing concerns, Connect Biopharma said it plans to begin phase 3 trials of the drug in the “second half of 2022”, which sounds like a potential slight delay over the expectation for “mid-2022” commencement used in its November statement.

But the bigger concern for investors appears to be the simpler issue of big competition. In December, Pfizer won approval from the European Commission for its abrocitinib drug to treat adults with moderate-to-severe atopic dermatitis. Eli Lilly also said last month its lebrikizumab demonstrated significant skin improvement and itch relief when combined with topical corticosteroids in people with atopic dermatitis in a third Phase 3 study.

Conducting clinical trials during the Covid-19 pandemic has also posed its own challenges, and Connect Biopharma noted that it had a higher patient discontinuation rate during trials. Indeed, the company said on the analyst call that as many as one in five patients had dropped out of parts of its global study as restrictions on movement were implemented.

The company said it expects its retention rate to improve as it pushes into Phase 3 trials and as the pandemic eases.

With investors still on the fence about the prospects for Connect Biopharma’s lead product, the company’s shares are likely to remain under pressure. It has three other drugs in the pipeline – one also in phase 2 trials that targets ulcerative colitis and Crohn’s Disease, and two others that are in earlier stages.

Meanwhile, the bleeding of money will continue. Connect Biopharma, with headquarters in China and operations in the U.S. and Australia, posted an operating loss of 268.4 million yuan ($42.1 million) in the first half of 2021, up sharply from a 62.5 million yuan loss in the same period the previous year, on rising R&D costs related to clinical trials, personnel and lab expenses.

But after raising $204.5 million in its 2021 IPO the company had 2 billion yuan in cash and cash equivalents at the end of the first half of 2021, meaning it has plenty of cash remaining before it would need to raise more.

That may buy the company just enough time until it can start generating its first revenues, which are unlikely to arrive for at least a year or more. Until then, investors will want to see that Phase 3 clinical trials are firmly on track, hopefully showing its dermatitis drug is as good as or more of a standout than what is already on the market.

The company currently trades at a lowly price-to-book (P/B) ratio of just 0.76. That’s less than the P/B of 1.25 for the similarly revenue-less cancer treatment specialist JW Therapeutics (2126.HK), and far less than a P/B of 4.85 for another cancer specialist I-Mab (NASDAQ: IMAB), which has begun to receive revenue through partnerships but has yet to get any from actual drug sales.

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Source Here: benzinga.com

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WHO Recommends Glaxo, Eli Lilly Drugs for COVID-19 Treatment Amid Omicron Surge

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An expert panel at the World Health Organization (WHO) recommended the use of treatments developed by Eli Lilly And Co (NYSE: LLY) and GlaxoSmithKline Plc (NYSE: GSK) / Vir Biotechnology Inc (NASDAQ: VIR) for COVID-19 patients.

In its guidelines published in the British Medical Journal, the panel has recommended Lilly’s baricitinib (Olumiant), a Janus kinase (JAK) inhibitor, combined with corticosteroids for severe COVID-19 patients.
The panel also conditionally recommended sotrovimab, a monoclonal antibody developed by GSK / Vir, for patients with non-severe COVID-19 at the highest risk of hospitalization.
Related:WHO Recommends IL-6 Drugs From Sanofi, Roche For Critically-Ill COVID-19 Patients.
While the global body has already approved the monoclonal antibodies casirivimab with Imdevimab from Regeneron Pharmaceuticals Inc (NASDAQ: REGN), it has found insufficient data to recommend one treatment over another from that class of medications.
The panel also noted that the activity of these drugs against new variants of the virus, such as Omicron remained uncertain and said it would update the guidelines once new data are available.
Price Action: GSK shares are up 0.88% at $45.46, VIR shares are down 2.87% at $36.57, and LLY stock is down 1.59% at $245.69 during the market session on the last check Friday.

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Posted-In: Briefs COVID-19 CoronavirusBiotech Government News Health Care General

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Source: benzinga.com

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ST Imaging’s ViewScan 4 Microfilm Scanner Wins 2022 Platinum Modern Library Award

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Northbrook, IL, Jan. 14, 2022 (GLOBE NEWSWIRE) — For an eighth straight year, ST Imaging’s ViewScan 4 microfilm scanner has been recognized for a Platinum Modern Library Awards (MLAs) from LibraryWorks. ST Imaging, a Digital Check brand, is a worldwide leader in the design and manufacturing of digital microfilm viewer/scanners, and the only microfilm scanner manufacturer to have continuously received the Platinum MLA for all eight years.

“We are thrilled to be recognized again as a leading microfilm scanner in the library market by librarians,” says Matt Anderson, Vice President of Sales and Marketing for ST Imaging. “We are dedicated to continue to develop and enhance the user experience of the ViewScan 4 and PerfectView software.”

When designing the ViewScan 4 and PerfectView software, we received direct feedback from the industry on how to implement those features and how to make them easy to use. The result is a simplified, color-coded, streamlined user experience that makes working with microfilm fast and fun. While older reader/printers and other microfilm scanners can be difficult to use, the ViewScan makes loading and scanning film quick, fun, and easy. The ViewScan also allows users to share their discoveries like never before.

At ST Imaging, we understand that most customers are not experts in the field of digital image capture. Our system describes our camera size as we expect most of our customers to understand it, as you would for a cellphone or digital camera. The ViewScan 4 is equipped with a native 18-megapixel image sensor. That means there are 18 million pixels capturing the focused light providing an image instantly to the monitor. Competitive scanners may use a different definition for their camera. Be sure you have accurate information of the image sensor on the camera in your microfilm scanner and if you have any doubt, request a side-by-side comparison.

Jenny Newman, publisher and MLA program manager said, “It’s great to see ST Imaging and their ViewScan 4 be recognized year after year as a leading microfilm scanner in the library market.”

The MLAs were created to recognize top products in the library industry in a truly unbiased format. Products were submitted by companies, collected by LibraryWorks which distributes them to their database of more than 80,000 librarians at public, K-12, academic, and special libraries. Only customers who have had experience with these products in their facilities were permitted to judge the products, resulting in a truly unbiased score.

About ST Imaging

ST Imaging is a leading worldwide manufacturer and distributor of micrographic equipment and other collection scanning solutions. Founded in 1989, the company was acquired in 1999 by Digital Check Corp. In 2004, ST Imaging introduced the revolutionary ST200 digital film scanner, changing the way library customers view film.

The company’s flagship product, the ViewScan film scanner set the standard for making film scanning easy and assessable to the public. ViewScan systems incorporate the latest technology to improve viewing, scanning, editing, and sharing of microfilm within libraries, schools, government, business, and other collections.

The ST Imaging headquarters and manufacturing are in Meridian, ID. Scanners are available through a worldwide network of authorized resellers and are supported by ST Imaging’s comprehensive fulfillment, training, support, warranty, and repair services.

About LibraryWorks

LibraryWorks helps administrators to make informed decisions about library technology, automation and software, collection development and management, facilities and furnishings, staffing, purchasing, and other areas that drive effective strategic planning and day-to-day operations. Our family of resources can enable you to identify best practices, monitor trends, evaluate new products and services, apply for grants and funding, post or find a job, and even enjoy some library humor.

About the Modern Library Awards program

The Modern Library Awards (MLAs) is a program designed to recognize elite products and services in the library market which can help library management personnel enhance the quality-of-experience for the library user and increase the performance of their library systems.

ViewScan 4 Microfilm Reader
Modern Library Awards

Matt Anderson
ST Imaging
208-514-4000
manderson@stimaging.com
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Original Article: benzinga.com

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Vermont Lawmakers File Drug Decriminalization Bill, Here’s What’s in It

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It seems that Vermont is on its way to decriminalizing all drugs, as the state’s Democratic and Progressive lawmakers filed a new bill this week to decriminalize their possession.

Reps. Logan Nicoll (D) and Selene Colburn (P) introduced the legislation, which is seen as a harm reduction tool that can also help address racial disparities in enforcement, Marijuana Moment reported.

What’s In The New Bill?

The measure would make possession and distribution of personal-use amounts of currently illicit drugs punishable by a $50 fine – without a threat of a prison sentence or being subject to a substance use screening and health service.

In addition, if the amount of the drug in question is under a “benchmark personal use” threshold – previously set by a new Drug Use Standards Advisory Board – people would face a civil penalty once the bill amends the state statute on drug possession and distribution.

According to the new policy, the board would include “experts in the fields of general and behavioral health care, substance use disorder treatment, and drug user communities.”

Moreover, criminal penalties for sharing small amounts of currently illicit drugs without compensation would be removed.

So far, nearly one-third of the Vermont House, or 40 initial cosponsors, support the proposal.

Colburn told Marijuana Moment in an interview this week that the goal is to streamline the process of legalization in a way that lawmakers in other states have, citing Maine as an example.

The legislator said that she’s been “talking with a lot of frontline folks, a lot of people with lived experience, and the vast majority of those folks will share that justice system involvement has been a hurdle and a barrier in their recovery, or even just their access to life-saving medication or to harm reduction tools.”

Colburn added that in their discussions, she and her colleagues are trying to be clear that the vast majority of people who are drug users are not struggling with substance use disorder. “So this is definitely a civil liberties issue as well. But for folks who [do have substance misuse disorders], the impacts of criminalization have caused, and continue to cause, so much harm.”

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Photo: Courtesy of Colin Davis on Unsplash

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Source: benzinga.com

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