Novocure Lung Cancer Treating Electric Fields Up Survival, Stock Tumbles On Remaining Doubts

 

• Zai Lab Limited (NASDAQ: ZLAB) and Novocure Limited (NASDAQ: NVCR) presented results from the phase 3 LUNAR trial evaluating the use of Tumor Treating Fields (TTFields) therapy together with standard therapies for non-small cell lung cancer (NSCLC) at the 2023 American Society of Clinical Oncology Annual Meeting.

• The LUNAR trial met its primary endpoint with a statistically significant and clinically meaningful 3-month improvement in median overall survival (OS) when TTFields therapy was added to standard therapies.

• Patients randomized to receive TTFields therapy and standard therapies demonstrated a median OS of 13.2 months compared to 9.9 months in patients treated with standard therapies alone.

• Patients randomized to receive TTFields therapy and physician's choice immune checkpoint inhibitor demonstrated a median OS of 18.5 months versus a median OS of 10.8 months in patients treated with ICIs alone.

• Patients randomized to receive TTFields therapy and docetaxel had a positive survival trend with a median OS of 11.1 months vs. 8.7 months in patients treated with docetaxel alone.

• Median progression-free survival (PFS) for patients treated with TTFields therapy and standard therapies was 4.8 months versus 4.1 months in patients treated with standard therapies alone.

• Stat News noted that the data does not fit the current medical practice for lung cancer patients as 70% of the study participants did not receive initial immune checkpoint inhibitor treatment, such as Merck & Co Inc's (NYSE: MRK) Keytruda, which dominates current therapy.

https://finance.yahoo.com/news/novocures-cancer-treating-electric-fields-194012322.html

FDA Removes Expert with Ties to Eisai, Biogen from Leqembi Adcomm

 Monday, the FDA removed neurologist David Weisman from an upcoming Peripheral and Central Nervous System Drugs Advisory Committee meeting to discuss the full approval of Eisai’s and Biogen’s Alzheimer’s disease medicine Leqembi (lecanemab).

In April 2023, the regulator granted Weisman’s waiver, allowing him to participate in the meeting as a temporary voting member. The Peripheral and Central Nervous System Drugs Advisory Committee (PCNS) is set to convene on June 9.

The waiver document listed Weisman’s conflicts of interest, including his role as a site principal investigator for a clinical trial sponsored by Biogen. The patient population in this study also overlaps with the indication to be discussed in the upcoming PCNS meeting. Weisman receives between $5,000 and $15,000 per year for his involvement in this study.

Weisman is also a site principal investigator for an Eisai-sponsored Phase II study of lecanemab, though this study is not up for deliberation at the advisory committee meeting. In this role, Weisman receives up to $5,000 in yearly salary.

Despite these financial conflicts, the FDA initially allowed his participation in the PCNS, citing his “unique qualifications and specialized expertise.”

In 2008, Weisman founded the Clinical Trial Center of Abington Neurological Associates, his employer, and has since run several clinical trials in Alzheimer’s disease and mild cognitive impairment.

“Any potential for a conflict of interest is greatly outweighed by the strong need for Dr. Weisman’s expertise in this matter,” the FDA stated in its waiver document.

However, in a tweet posted Monday, Weisman revealed that he was no longer on the panel “for entirely unrelated reasons,” though he did not explain exactly why he was pulled from the meeting.

Aside from his financial conflicts, Weisman was one of dozens of signatories of a May 2023 open letter from the Alzheimer’s Association urging the PCNS to back the full approval of Leqembi.

Leqembi Faces Adcomm

Biogen and Eisai won the FDA’s accelerated approval for Leqembi in January 2023, making it the second Alzheimer’s treatment to hit the market.

Its approval was based on Phase II data, which showed that the therapeutic antibody could significantly lower the accumulation of amyloid-β plaques in the brain. To demonstrate Leqembi’s clinical benefit, the pharma partners ran the Phase III Clarity-AD study, whose results demonstrated slower disease progression and better cognitive and functional performance among treated patients.

Clarity-AD will also serve as Leqembi’s confirmatory trial—a regulatory requirement to convert its accelerated approval into a full one—and will be scrutinized in the upcoming PCNS meeting. The FDA is expected to decide on Leqembi’s traditional approval by July 6.

https://www.biospace.com/article/fda-pulls-expert-with-ties-to-eisai-biogen-from-leqembi-adcomm/

Merck Sues Biden Administration Over Drug Pricing Law

 Merck & Co. on Tuesday filed a lawsuit against the Biden administration in the U.S. District Court for the District of Columbia, challenging the constitutionality of the Inflation Reduction Act that deals with drug price negotiation.

The company argued that the program would force biopharma companies to negotiate prices below market value for drugs covered by Medicare, thereby violating the First and Fifth Amendments. Merck contended that the Fifth Amendment, in part, requires just compensation from the government for the public use of private property and that by forcing companies to acknowledge that prices are fair, the drug price negotiation program flies in the face of the First Amendment’s protections of free speech.

Merck is seeking an injunction to the newly enacted requirement. “Because this statute unlawfully impairs our core purpose of engaging in innovative research that saves and improves lives, Merck intends to litigate this matter all the way to the U.S. Supreme Court if necessary,” Robert Josephson, a Merck spokesperson, said in a statement, according to Politico.

President Biden signed the Inflation Reduction Act (IRA) into law last August. It aims to reduce the costs of drugs by $25 billion annually over the next eight years, starting this September when the Centers for Medicare & Medicaid Services (CMS) will announce the 10 drugs that cost the government agency the most money. In the lawsuit, Merck noted that its diabetes drug Januvia is expected to be on the list. Last year, Januvia brought in $2.8 billion.

Newly negotiated prices for these first 10 drugs will go into effect in 2026 and are projected to cut industry profits by $4.8 billion in the first year, Reuters reported. The biopharma industry has argued that the program will result in slowed drug development as a result of these profit losses.

In subsequent rounds, Merck expects that more of its drugs will be subject to negotiation. These include its blockbuster cancer immunotherapy Keytruda, which earned the company $21 billion last year (35% of the company’s total revenue), and its other diabetes drug Janumet, which brought in $1.7 billion.

The company’s lawsuit, specifically filed against the U.S. Department of Health & Human Services (HHS) and CMS, as well as the two agencies’ leaders, stated that “the IRA uses severe penalties to requisition medicines while refusing to pay their fair value—and then coerces manufacturers to smile, play along, and pretend it is all part of a ‘fair’ and voluntary exchange. This is political Kabuki theater.”

According to Endpoints News, claims of First Amendment violations successfully overturned a previous drug pricing rule from the HHS. In 2019, a federal court blocked a requirement for pricing disclosure in direct-to-consumer advertisements.

https://www.biospace.com/article/merck-sues-biden-administration-over-drug-pricing-law/

Eisai is latest pharma to suffer ransomware attack

 Japanese pharma group Eisai says it is battling a ransomware attack that was launched last weekend and has resulted in some of its servers becoming encrypted.

The attack has affected servers both within and outside Japan, and resulted in some of the group’s IT functions, including logistics systems, being taken off line. For now, it says the corporate websites and email services remain operational, and there’s no clear indication yet whether sensitive data has been leaked.

At the time of writing, it’s not clear if the attack is linked to another data theft hack that has affected a growing number of organisations around the world, including the BBC, UK payroll and human resources company Zellis, British Airways, and Aer Lingus.

Security specialist Bleeping Computer has said that the Clop ransomware gang has claimed responsibility for that attack, which has resulted in personal data and possibly bank details being stolen. No ransom demands have been made public as yet, likely because the gang is still sifting through the data to find information that could give it leverage.

The Clop attack exploited a vulnerability in MOVEit Transfer Tool, software designed to securely move files marketed by Progress Software.

Eisai said in a statement that it has set up a company-wide task force to mitigate the situation, and is working on recovery with its cybersecurity partners, as well as talking to law enforcement.

“Any potential impact of this incident on the consolidated earnings forecast of this fiscal year is currently under careful examination,” it said. “If determined that revisions are necessary, an announcement will be made as soon as possible.”

The most notorious ransomware attack on a pharma group is arguably the 2017 case involving Merck & Co, which has been estimated to have cost the company upwards of $1 billion to remedy.

Last year, Merck won a lengthy dispute with insurers who refused to pay a $1.4 billion claim by the drugmaker, claiming they were exempt because it was effectively an act of war, coming in the wake of Russia’s military intervention in Ukraine which started in 2014.

Merck won its case, arguing successfully that exclusion clauses in its policies covered armed conflict and not cyber warfare.

Other recent cases involving pharma companies included an attack on Novartis a year ago, which resulted in the theft of R&D information that was up for sale on the Dark Web. Charles River Laboratories, Bayer, and Fresenius have also been hit in the last few years.

The Eisai case serves as another reminder that, as pharmaceutical companies move towards greater digitalisation and the storage of more valuable data, digital security practices become more mission critical.

https://pharmaphorum.com/news/eisai-latest-pharma-suffer-ransomware-attack

Akero suggests the limits of GLP-1s in Nash

 Adding efruxifermin to background GLP-1 therapy cut nonalcoholic steatohepatitis patients’ liver fat, Akero said today. But the implication is not so much that efruxifermin might be a contender in Nash as that GLP-1s alone might not. The data come from the small expansion cohort of Akero’s mid-stage Symmetry Nash trial, comprising patients with both liver fibrosis caused by Nash and type 2 diabetes, who were already taking a GLP-1 for the latter condition. The significant improvement in liver fat among those given Akero’s FGF21 analogue versus the placebo group suggests that the GLP-1s the patients were on were doing little to improve the condition of their livers. Novo Nordisk’s juggernaut semaglutide hit in phase 2 in Nash but failed to resolve fibrosis, and a phase 3 Nash trial, Essence, is ongoing. Another important finding from Symmetry was that efruxifermin plus the GLP-1 was generally safe; since many Nash patients are also diabetic or obese any additional toxicity could have limited Akero’s market. Perhaps GLP-1/glucagon co-agonists can do better in Nash than GLP-1s. Several are in trials in Nash or the milder condition nonalcoholic fatty liver disease, including Lilly’s Mounjaro. Meanwhile full Symmetry data should come later this year. 

Data from cohort D of Ph2b Symmetry trial (NCT05039450)
Drug and dose	Efruxifermin 50mg	Placebo	P value
N	16	10	-
Mean change from baseline in hepatic fat fraction* (%)	-65	-10	<0.001
Proportion of patients achieving a reduction in liver fat of at least 50% (%)	88	0	<0.001
Proportion of patients whose liver fat normalised to 5% or less (%)	88	10	<0.001
*Assessed by MRI-PDFF. All patients on background GLP-1 therapy. Source: company release.

 

Selected incretins in development for Nash/Nafld
Company	Project	Mechanism	Trial details
Novo Nordisk	Wegovy/Ozempic (sc semaglutide)	GLP-1 agonist	Essence, Ph3 in Nash, could report 2028
Hanmi	Efinopegdutide	GLP-1/glucagon agonist	Data from Ph2a in Nafld due at Easl, Jun 2023
Boehringer Ingelheim	BI 456906	GLP-1/glucagon agonist	Ph2 in Nash and fibrosis could report late 2023
Lilly	Mounjaro	GLP-1/GIP agonist	Synergy-Nash, Ph2 in Nash, could report 2024
Hanmi/Merck	Efocipegtrutide (HM15211/ LAPS Triple Agonist)	GIP/GLP-1/glucagon agonist	Ph2 in Nash could report 2025
Altimmune	Pemvidutide	GLP-1/glucagon agonist	Data from Ph1 in Nafld due at Easl, Jun 2023
Source: Evaluate Pharma, clinicaltrials.gov. https://www.evaluate.com/vantage/articles/news/trial-results-snippets/akero-suggests-limits-glp-1s-nash

WHO Body Calls For 'Simulation' To Prep For Next Global Health Crisis

 by Kevin Stocklin via The Epoch Times (emphasis ours),

As 194 nations continue to work through drafts of pandemic agreements that would grant more authority to the World Health Organization (WHO), the Global Preparedness Monitoring Board (GPMB), a body convened by the WHO, has called for a worldwide pandemic simulation to be carried out by the end of this year to test the effectiveness of the new terms before member nations sign them in 2024.

“We feel very strongly that we cannot wait for the next emergency to find out how well the pandemic accord and the IHR amendments will work; we need to know now,” Joy Phumaphi, co-chair of the GPMB, stated on May 22. “We therefore suggest that Member States, together with other key stakeholders, carry out a simulation exercise based on the draft accord and draft IHR amendments later this year, before they are finalized and adopted.”

International negotiations to centralize pandemic-related action within the WHO have been ongoing throughout this spring. They include a “zero draft” WHO pandemic accord and amendments to International Health Regulations (IHRs), as well as discussions among various WHO subcommittees, U.N. organizations, and finance arms like the World Bank. The current round of negotiations on the pandemic accord and IHR amendments have gone on behind closed doors in Geneva, but statements from some of the ancillary groups like the GPMB may shed light on the tone of the discussions.

Phumaphi said that the GPMB’s “Manifesto for Preparedness” includes three “tests” for the treaty and IHR amendments. These are whether the treaty and IHR amendments are “sufficiently powerful,” whether they “deliver equity and coherence,” and whether they “have robust mechanisms for monitoring and accountability.”

Ambassador Pamela Hamamoto is currently negotiating terms of the WHO pandemic accord on behalf of the United States. While the language of the accord and IHR revisions is often opaque and bureaucratic, analysts say the ultimate goal of the reforms is to vest more pandemic authority within the WHO and have this authority extend beyond pandemic emergencies.

“The trajectory is about centralizing power over health emergencies,” David Bell, a public health physician and former WHO staffer specializing in epidemic policy, told The Epoch Times. “It will centralize authority within the WHO, particularly in the director general, and it will broaden the scope to what they call One Health.”

Negotiations Proceed in Secret

In April, delegates from the United States agreed with a Chinese proposal that new IHR drafts would not be shared with the public. Hamamoto stated that “at this stage, I have some concern about sharing the draft to all stakeholders given where we are in the process.”

In response, several nonprofit organizations and health experts wrote a letter to Health and Human Services Secretary Xavier Becerra and Secretary of State Antony Blinken protesting the secrecy of the negotiations.

“The attempt to create a veil of secrecy now surrounding the substantive and technical text-based negotiations on the WHO pandemic treaty sets a dangerous precedent for norm-setting at the multilateral level,” they wrote. “It also undermines trust in the process at a time when attacks on the WHO and on the pandemic accord are increasing.”

The GPMB’s Manifesto for Preparedness states that “the success of these reforms will largely be dependent on the adoption of a coordinated, One Health approach to PPPR that involves all countries, international and regional organizations, financial institutions, and the private sector.”

PPPR is the WHO acronym for pandemic prevention, preparedness, and response. “One Health” refers to the broadening of pandemic response to potentially include things like farming, poverty, and climate change, which could either cause or exacerbate outbreaks, or impair peoples’ health in other ways.

“One Health is anything in the biosphere that affects human well-being in its current definition,” Bell said. Current terms being negotiated, he said, would not only broaden the scope of the WHO’s mandate but would also grant it authority to act when a pandemic “threat” is perceived, as opposed to an actual pandemic emergency.

https://www.zerohedge.com/medical/who-body-calls-simulation-prep-next-global-health-crisis

Novavax exec says its new COVID shot should work against variants on the rise

 Novavax Inc's head of research and development on Monday said an updated COVID-19 vaccine the company is already producing is likely to be protective against other fast-growing coronavirus variants circulating in the U.S.

Protein-based vaccines like Novavax's take longer to produce than the messenger RNA-based (mRNA) versions made by Moderna and Pfizer/BioNTech.

Because of that, the company said earlier this year it had begun producing a version of the vaccine to target the currently dominant XBB.1.5 variant of the virus at commercial scale.

A panel of outside advisers to the U.S. Food and Drug Administration is scheduled to meet on June 15 to discuss strain selection for this year's COVID-19 booster shots, and regulators are expected to make their decision shortly afterward.

Novavax R&D chief Filip Dubovsky in an interview made the case for the XBB.1.5-targeting vaccine, saying it was a good approach that should also provide protection against related variants on the rise, such as XBB.2.3.

"You'd want the 1.5 more than likely" if your aim was to target newly circulating variants, he said. "The XBB.2.3 is a little bit closer to 1.5."

The company has a lot riding on its updated COVID booster.

With an underused COVID-19 as vaccine its lone product, Novavax said earlier this year it may not be able to stay solvent and is relying on a successful launch of an updated shot in time for a booster campaign this fall to improve its prospects.

Dubovsky said the company has also started work on vaccines that target the XBB.1.16 and XBB.2.3 variants, but that those are at an earlier stage of development.

A meeting of international regulators last month chaired by the U.S. Food and Drug Administration's top vaccine regulator, Peter Marks, concluded that an XBB strain of the virus was an "adequate candidate" for the vaccine update.

https://news.yahoo.com/novavax-exec-says-covid-shot-223133572.html