J&J, Legend to Face Adcomm for Carvykti’s Push as Earlier Line MM Treatment

 Legend Biotech announced in an SEC filing on Tuesday that the FDA will convene its Oncologic Drugs Advisory Committee to discuss the use of its Johnson & Johnson-partnered Carvykti (ciltacabtagene autoleucel) in earlier lines of treatment for multiple myeloma.

The panel of external experts will evaluate J&J and Legend’s data in the Phase III CARTITUDE-4 study, which positions Carvykti as a treatment option for patients with relapsed and lenalidomide-refractory multiple myeloma who had received at least one previous line of systemic therapy, including an immunomodulatory agent and a proteasome inhibitor.

Currently, Carvykti is indicated for patients with at least four prior lines of therapy.

The meeting’s schedule has yet to be determined but will be announced in the Federal Register, according to Legend’s SEC filing.

The European Medicines Agency’s Committee for Advanced Therapy will also hold a Scientific Advisory Group Oncology meeting to discuss Carvykti’s similar expansion into an earlier-line setting.

Carvykti is a CAR-T therapy targeting the BCMA protein and was approved in February 2022 for the treatment of heavily pretreated relapsed or refractory multiple myeloma. In June 2023, Legend and J&J submitted a supplemental Biologics License Application to the FDA, seeking to initiate Carvykti treatment earlier in a patient’s disease course, after at least one prior line of therapy.

Carvykti’s push to earlier-line settings has been marred by the FDA’s probe into the overall safety of CAR-T therapies. In November 2023, the regulator first announced that it was looking into reports of patients who had developed secondary T-cell malignancies after being treated with these medicines. At the time, the regulator said that patients who had received CAR-T treatment, including through clinical trials, “should be monitored life-long for new malignancies.”

Last week, the FDA wrote to the manufacturers of all six commercial CAR-T therapies—including J&J and Legend—that their products need to include a boxed warning reflecting their risk of secondary cancers. Carvykti’s label already reflects these risks.

Despite the regulatory hurdles, J&J appears to be confident in the commercial prospects of the CAR-T therapy—which raked in $500 million in sales last year—while announcing a manufacturing ramp-up on Tuesday during its fourth-quarter 2023 earnings report.

“We are already manufacturing the first batches of Carvykti for clinical use this month of January,” J&J CEO Joaquin Duato said during an investor call. “We have also contracted additional capacity … to scale up production and increase our ability moving forward that will start mid this year.”

“Overall, we feel good that we are progressing with Carvykti,” Duato continued, adding that the company is confident that it can deliver quarter-over-quarter growth this year.

https://www.biospace.com/article/j-and-j-legend-to-face-fda-adcomm-for-carvykti-s-push-as-earlier-line-mm-treatment/

Sirona Biochem Corporate Update

 Sirona Biochem Corp. (TSX-V: SBM) (FSE: ZSB) (OTC: SRBCF) (“Sirona”) provides the following update:

Dear shareholders,

We are pleased to provide an update on our recent milestones and strategic decisions shaping Sirona Biochem's path forward.

Trademark of TFC-1326 as GlycoProteMim

We recently trademarked TFC-1326 as GlycoProteMim^TM. This branding decision aims to distinguish our anti-aging active ingredient in a competitive market by giving it an easily recognizable identity, while also enhancing its marketability and positioning it as a sought-after solution in the beauty industry. With a diverse array of options for consumers to address visible signs of aging, our brand aims to be one that people can be educated about, understanding its benefits and easily identifying it in the marketplace.

Establishment of Sirona Laboratories

We are excited to introduce Sirona Laboratories^TM, a newly established entity dedicated to commercializing GlycoProteMim. This decision is rooted in our commitment to expedite the commercialization process and provide a streamlined avenue for market penetration.

Sirona Biochem will maintain majority ownership in the subsidiary. This will ensure a more streamlined and efficient commercialization process by eliminating the common delays associated with external partnerships. We are poised to bring this innovative skincare solution to market in the shortest time possible.

Ultimately, the creation of Sirona Laboratories stands as a strategic move that directly benefits our stakeholders. It not only safeguards shareholder interests but also positions GlycoProteMim as a valuable asset within a separate entity, presenting potential avenues for capitalization on its technology while preserving the integrity of Sirona Biochem.

In the aesthetic space brand acquisitions at high valuations are common and novel technology optimally capitalized when part of an established brand. Beauty brand M&A is predicted to be a growing market trend. https://www.beautyindependent.com/kearney-predicts-beauty-ma-activity-increase/.

Preparation for commercialization of GlycoProteMim

Final process development for the manufacturing of GlycoProteMim by Wuxi AppTec has been completed and they are ready to produce multi-kilogram orders upon request. Work is well underway on multiple other fronts necessary to produce a high quality consumer product. Further updates will be made near term regarding the team of experts we are assembling for this task.

It is our intention to launch our first consumer product containing GlycoProteMim in both Europe and North America through our subsidiary Sirona Laboratories, then expanding to other markets globally. With the necessary funding, we have set out a plan to launch our first product early in the 1^st quarter of 2024. The fundamental science is clinically proven, and safety established so the work needed is mainly to satisfy technical requirements of a new product and re-establish its effectiveness necessary to allow appropriate product claims.

TFC-1067 – Global Licensing Agreement with Allergan Aesthetics

Allergan continues to work toward integration of TFC-1067 into its pipeline. Once permissible, we will update our shareholders accordingly. Sirona’s management remains in regular communication with Allergan Anesthetic’s team.

Antiviral Library, Diabetes and other new R&D projects

TFChem's scientists at Sirona are actively involved in progressing the antiviral and SGLT 2 diabetic project. Despite this ongoing effort, these projects are not currently the top priority. The primary focus of the team is directed towards pioneering new developments within the aesthetic space. It's worth noting that certain aspects of their work are kept confidential until they reach a stage where intellectual property (IP) can be securely established.

Making Sirona Laboratories a Market Success

To materialize the success of GlycoProteMim, we will be securing strategic funding from private equity funds and investors. This infusion of substantial upfront capital is earmarked for crucial aspects such as inventory, retail infrastructure, and impactful marketing efforts, which will all contribute to a robust and successful product launch.

Envisioning beyond a single product, Sirona Biochem sees a future of diversified offerings with multiple products utilizing GlycoProteMim. Preserving shareholder value is a core principle in our strategy. By avoiding significant dilution and control issues, we ensure that our shareholders enjoy a substantial portion of the revenue stream generated by GlycoProteMim.

Other Profitable Markets

Beyond GlycoProteMim, we can continue to advance projects in areas such as Cellulite, Wound care, and Keloid treatments, underscoring our commitment to comprehensive skincare solutions. Sirona Laboratories is poised to bring to market not only GlycoProteMim but also new cosmeceuticals developed by TFChem. This collaboration enhances our ability to introduce a diverse and wide range of innovative skincare solutions.

By pursuing a quicker route to profitability, we reduce reliance on recurrent financing, ensuring stability and a sustainable growth trajectory for Sirona Biochem and its subsidiaries. Sirona Biochem's stable financial source paves the way for bringing numerous backlogged ideas from our scientific team into commercial reality. This proactive approach to innovation ensures that our pipeline remains dynamic and responsive to emerging skincare needs.

About Sirona Biochem Corp.

Sirona Biochem is a cosmetic ingredient and drug discovery company with proprietary platform technology. Sirona specializes in stabilizing carbohydrate molecules with the goal of improving efficacy and safety. New compounds are patented for maximum revenue potential.

Sirona’s compounds are licensed to leading companies around the world in return for licensing fees, milestone fees, and ongoing royalty payments. Sirona’s laboratory, TFChem, is located an hour north of Paris, France, and is the recipient of multiple French national scientific awards and European Union and French government grants. For more information, please visit www.sironabiochem.com.

https://www.biospace.com/article/releases/sirona-biochem-corporate-update-january-2024/

'Britain's Labour aims to save billions of pounds with planned health reforms'

Britain's main opposition Labour Party said it would aim to save 10 billion pounds ($12.71 billion) by cutting waste and reforming the health service if in power, saying this could free up cash to spend on frontline care.

The state-run National Health Service (NHS) emerged from the COVID-19 pandemic in crisis, crippled by long waiting lists, ambulance delays and industrial action by staff over pay.

Prime Minister Rishi Sunak had pledged to cut waiting lists as one of his five priorities, but has blamed the strikes for missing that aim.

He expects to hold an election later this year, and Labour leads Sunak's governing Conservatives by around 20 points in opinion polls.

Labour's plans to reform rather than simply spend more on the NHS, a cherished national institution founded by a Labour government after World War Two, has prompted criticism from some unions.

But Labour health spokesperson Wes Streeting, who has vowed to face down those hostile to his reform agenda, said the plan would ultimately result in more money for frontline services.

"After 14 years of Conservative neglect of the NHS, we are paying more but getting less," he will say in a speech on Tuesday, according to extracts released by Labour.

"I am focusing on waste because I want to give the public hope that the NHS can be saved. The money that is wasted today can be used to get the NHS back on its feet tomorrow. Only Labour has a plan to reform the NHS."

Labour said it could save 3.5 billion pounds by ending payments to recruitment agencies to cover staffing shortfalls, as well as a further 1.7 billion pounds by freeing up hospital beds currently occupied by patients who can't be sent home due to a lack of available care in the community.

However, the NHS Confederation, which represents organisations across the healthcare sector, cautioned against budget cuts to a service that is already struggling due to underinvestment.

"Capital budgets are already being raided to plug rising deficits in the day-to-day NHS budget caused by strikes and other cost pressures," the NHS Confederation said, adding that the next government needed to boost capital funding to help address the backlog.

Labour has previously set out plans to integrate health and social care, and recruit and retain more carers.

The British government has responsibility for the NHS only in England as health is a devolved policy area in Scotland, Wales and Northern Ireland.

https://news.yahoo.com/britains-labour-aims-save-billions-223604837.html

Conspiracy Theorists Were Right About Climate Lockdowns

 by Bobbie Anne Flower Cox via The Brownstone Institute,

Well folks, I really hate to say this, but it’s another win for the conspiracy theorists. They can take off their tinfoil hats and take a deep bow. Yet another one of their outrageous “predictions” is coming true. For anyone keeping score, sadly the score card is rather one-sided. I think the count is something like Conspiracy Theorists = 1,000,000 wins vs. Logic & Normalcy = 0 wins. Boy how I wish we could win some on the “Logic & Normalcy” scale!

So, I acknowledge that I do have a rather dry sense of humor. I throw sarcasm in there a bunch. A couple of my friends tell me they cannot always tell when I’m being serious or if I’m joking. This makes me think that quite a few of you will be wondering, “Is she serious or is she joking with the title to her article?” To that I answer, I will tell you what I know, and then you decide. (You know how I love to promote critical thinking)…

Last week, our unfortunate Governor of New York, Kathy Hochul, issued a TRAVEL BAN for an entire county. You read that correctly. No, not a travel advisory, but a full on travel ban! Meaning, New Yorkers in Erie County were forbidden from going anywhere. What’s another name for that? Well, if you live in a rural or very suburban area (which most of New York State is), where driving on a road is the way you get from point A to point B, then I would say a synonym would be “lockdown.”

And what was Dictator Hochul’s, I mean Governor Hochul’s, reason for this lockdown of close to one million New Yorkers that live in Erie County? Wait for it. Ready? It was going to SNOW! For anyone who does not live in New York, or who has never been to Western New York in the winter, that area of our state gets a lot of snow. Often. And yet, the governor thinks (all of a sudden, out of nowhere) everyone living there is so ignorant, they must be confined to their homes until she says it’s safe for them to rejoin the world again. Either that, or she’s just testing you to see how far she can take her totalitarian desires. Or both.

For all the keyboard critics who love to jump in and twist my words, I’ll cut you off at the pass and say that I am not admonishing a governor’s desire to keep people safe in the wake of a storm. That’s not at all what I am saying. If a natural disaster is approaching, people should be warned, emergency services ready to roll, and help made readily available. Encourage people to stock up, stay home, and hunker down? For sure! Forbid people from leaving their homes? NO.

There is a big difference between caring about New Yorkers’ safety, and wanting to control people. Huge.

And in fact, Hochul was banning people from leaving their homes even if it was NOT snowing! Sound unbelievable? It sure does. But remember in my article last week, I cited an ancient Greek philosopher, Heraclitus, who fittingly said, “The truth often evades being recognized due to its utter incredibility.” 

Put another way, when something is so outrageous, it is often cast aside as untrue. Well, here’s what comrade Kathy posted on her Twitter:

She went on to post several other times about the snow and her travel ban. I was actually encouraged to read that most of the comments she received were negative, logical rebuttals to her power grab.

Here are a few…

Ok, so digging a bit into travel bans, you’ll recognize that there have been travel bans based on big storms in the past here in New York. However, those are issued by the local government (i.e. County Executive), after a state of emergency is declared. They are not issued by the Governor, nor are they issued without an emergency declaration.

Does anyone see the correlation here between government overreach, their quest for “centralized” power, and their fear-mongering? It’s the same thing the Governor and her DOH have been doing with their hideous “quarantine camp” regulation that I have been fighting in court for nearly two years now! The name of that case is Borrello v. Hochul, and you can read the details and case history here. Connecting the dots to the analysis at hand, you will note that the quarantine camp regulation tried to take the power from (elected) judges (in keeping with our law) who have the authority to temporarily quarantine sick, dangerous people, and shift that power to unelected, statewide, DOH employees and appointees who have zero accountability to We the People.

Under their quarantine camp reg, the Governor and her DOH would have centralized control over 19 million New Yorkers, to force you to lock down in your home, or they could force you (with the use of police) to go to a quarantine center/ facility/ camp (pick your noun), without any proof you are sick, indefinitely, with no procedure by which you can regain your freedom, and with no declared state of emergency! The fear factor used to try to justify the authoritarian power grab here is the threat of death…If we don’t lock people up who are possibly exposed to a disease, then you might die. Swap out “possibly exposed to a disease” and put in its stead “unclean.” What does that make you think of?

My next question: do you see any similarities here to Hochul’s probably illegal climate lockdown? 

I say “probably illegal” because I couldn’t find the supposed legal authority that she’s relying upon to prohibit people from driving. If you know what she is relying upon, feel free to post it in the Substack comment section below.

Before you draw your own final conclusion about all this, I will add one last thing for you to consider.

In December, a month before Hochul issued this Erie County travel ban, the (Democrat) County Executive, Mark Poloncarz, set up an online portal so residents could check and see if they would be deemed “essential workers” and thus exempt from any futuristic travel bans. Oh, and he coordinated with their “partners” in the federal government to come up with the list!

Sound familiar, folks?!

Remember Governor Cuomo’s C19 lockdown (“Just 2 weeks to flatten the curve”), which lasted for months, and all the “essential workers” that he exempted? Here’s an article about Erie’s coincidentally-just-in-time-for-a-travel-ban portal, “Erie County’s new online portal will identify essential workers exempt from travel bans.”

So… after taking in all that, is it 1,000,000 to 1… or is it 1,000,001 to 0?

https://www.zerohedge.com/political/conspiracy-theorists-were-right-about-climate-lockdowns

7 In 10 French Citizens Opposed To Solving Demographic Decline With Immigration

 Via ReMix News,

At a time when France is experiencing a spectacular demographic decline, an overwhelming majority of French citizens are not in favor of using immigration as a lever to boost the birth rate, recent polling showed.

According to a CSA survey conducted for CNews, Europe 1, and Le Journal du Dimanche, 69 percent of respondents rejected using replacement through immigration as a means of injecting fresh blood into the French economy.

Upon further analysis, women (71 percent) were slightly more opposed to mass immigration than men (67 percent), and while every age group rejected the idea, elderly respondents were more firmly opposed.

A total of 56 percent of 18-24-year-olds were against using immigration to counter the declining birth rate, while 74 percent of those aged 35-49 and 70 percent of over-65s were opposed to it.

In a socio-economic breakdown, 65 percent of the most highly educated respondents were opposed, compared to 76 percent of those less qualified academically.

Supporters of Jordan Bardella’s National Rally were the most opposed at 94 percent, closely followed by voters of Éric Zemmour’s conservative Reconquest party at 92 percent.

For the Republicans, this opposition is slightly less pronounced but remains in the majority at 84 percent. On the Renaissance side, 62 percent of those polled were also against.

Conversely, on the left of the political spectrum, supporters of all parties are in favor of the proposal. Supporters of La France Insoumise (56 percent), the Greens (58 percent), and the Socialist Party (60 percent) are in favor of using immigration as a solution to the country’s demographic decline.

The number of births in France has not been at such a low level since the end of World War II. According to Insee data, the year 2023 saw just 678,000 babies born, a 6.6 percent drop from the previous year.

Faced with this demographic challenge, some politicians are proposing more immigration to counter the population decline.

https://www.zerohedge.com/geopolitical/7-10-french-citizens-opposed-solving-demographic-decline-immigration

Heron: FDA OKs ZYNRELEF® Indication Expansion

 Heron Therapeutics Inc. (Nasdaq: HRTX), a commercial-stage biotechnology company, today announced that the U.S. Food and Drug Administration (the "FDA") has approved its supplemental New Drug Application ("NDA") for ZYNRELEF^® (bupivacaine and meloxicam) extended-release solution to expand the indication for soft tissue and orthopedic surgical procedures including foot and ankle, and other procedures in which direct exposure to articular cartilage is avoided. ZYNRELEF was previously approved for foot and ankle, small-to-medium open abdominal, and lower extremity total joint arthroplasty surgical procedures in adults.

This expanded indication for ZYNRELEF will now cover an estimated 13 million procedures annually, an estimated increase of 86% over prior indicated procedures. To obtain this labeling expansion, Heron successfully conducted studies for cesarean section, spinal surgery, augmentation mammoplasty, and total shoulder arthroplasty. No unique safety issues were identified from the new clinical trials, and the bupivacaine and meloxicam blood concentrations were consistent with previous experience following ZYNRELEF administration.

https://www.biospace.com/article/releases/heron-therapeutics-announces-fda-approval-of-zynrelef-indication-expansion-to-include-additional-orthopedic-and-soft-tissue-procedures/

Lilly Unit: Positive Phase 1/2 Data for Investigational Gene Therapy for Genetic Hearing Loss

 Hearing restoration was observed within 30 days of a single administration of AK-OTOF in the initial AK-OTOF-101 study participant, the first to receive gene therapy in the United States for a genetic form of hearing loss

AK-OTOF is a gene therapy being developed for the treatment of sensorineural hearing loss due to mutations in the otoferlin gene (OTOF)

https://www.biospace.com/article/releases/positive-phase-1-2-clinical-trial-data-for-an-investigational-gene-therapy-for-genetic-hearing-loss-to-be-presented-at-the-association-for-research-in-otolaryngology-2024-midwinter-meeting/