Vaccine Lotteries Credited With Enticing Millions To Accept Jabs

 In the US, the first winners of the "vaccination lotteries" being adopted by a growing number of states - including West Virginia (which is offering guns, trucks & "piles of cash), California and a handful of others - are taking home life-changing money, all because they decided to get vaccinated.

And according to WSJ, the incentives that these programs create are already having a positive impact on the vaccination rate, which has finally eclipsed 50% of American adults. The program is also having some success in Hong Kong.

But while it's impossible to determine exactly how many people are getting vaccinated because of the potential monetary rewards created by the vaccination lotteries, the anecdotal evidence is clear, as the Toledo Blade showed in a recent story about one of Ohio's "Vax-a-Million" winners who happened to be a Toledo resident.

"I kept hemming and hawing about it, and I work all the time, and when the Vax-a-Million thing started I immediately went down there and got it. It pushed me over the edge," he said.

Mr. Carlyle said after he hung up with the governor, he then called his girlfriend to let his family know he had won.

"It’s overwhelming. I don't know what to do. I'm still dreaming,” he said.

In Ohio alone, 3.2MM people entered the drawing - all of whom hadn't been previously vaccinated despite being eligible for weeks or months. And Ohio's Gov. ike DeWine credited the lottery enticements for a recent spike in vaccinations in the Buckeye State.

More than 3.2 million Ohioans entered the drawing to win the $1 million prize, and nearly 133,000 Ohioans ages 12 to 17 entered the college scholarship drawing, according to the Ohio Department of Health and the Ohio Lottery. The entry period for the next Ohio Vax-a-Million drawing ends June 6, 2021 at 11:59:59 p.m.

Governor DeWine credited the lottery enticement for a spike in new vaccinations after his initial announcement, but the numbers show the rate has again leveled off.

WSJ's Mike Bird added that the efficacy shown so far is evidence that vaccination lotteries create benefits that far outweigh their costs.

It’s difficult to overstate just how small the lottery payouts are relative to the economies they cover. In Hong Kong’s case, a real-estate developer is offering an apartment valued at roughly $1.39 million. That prize, though highly valuable to the winner, is equivalent to 0.0004% of the city’s already-reduced 2020 GDP.

Faster vaccinations enable more rapid economic normalization, especially in places that still have significant international travel restrictions in place. That normalization is worth far more than any plausible prizes. One percentage point of GDP growth for Hong Kong would be equivalent to around 2,500 such apartments. The same is true for Ohio’s million-dollar payouts, in an economy with output in the hundreds of billions of dollars a year.

What's more, there's evidence from a study in Singapore showing financial incentives are effective at boosting vaccination rates.

But there is evidence that financial incentives work. Vouchers worth just 10-30 Singapore dollars ($7.56 to $22.69) could boost take-up of influenza vaccines by 4.5% to 9.2% in one study, with the strongest effect among elderly recipients. A review of the literature by the U.S. Community Preventive Services Task Force showed vaccination rates rising by a median of 8 percentage points in the studies assessed.

At the very least, using financial incentives is certainly more humane than coercing people by allowing employers to effectively require all new hires to be vaccinated, which risks excluding people who object to vaccination for religious or other reasons from the workforce.

https://www.zerohedge.com/covid-19/it-pushed-me-over-edge-vaccine-lotteries-credited-enticing-millions-accept-jabs

Protagonist, Janssen Win Breakthrough Therapy Designation for Oncology Candidates

 Shares of Protagonist Therapeutics climbed nearly 4% in premarket trading after the company announced its lead drug candidate rusfertide snagged Breakthrough Therapy Designation from the U.S. Food and Drug Administration.

California-based Protagonist is developing rusfertide as a potential treatment of patients with polycythemia vera (PV) for the reduction of erythrocytosis. Specifically, the drug candidate is being developed for those patients who no longer require additional treatment for thrombocytosis and/or leukocytosis.

Suneel Gupta, chief development officer at Protagonist, expressed excitement over winning the designation for rusfertide. Gupta said PV is a severe disease with unmet medical needs. Better treatment options are needed for those patients, Gupta said. PV is a rare type of blood cancer that causes the marrow to make too many red blood cells. The increase of red blood cells causes a thickening of the blood and can cause serious and life-threatening blood clots. 

“Rusfertide is a natural hormone mimetic and may stand out as the first non-cytoreductive therapeutic drug for PV. We look forward to working closely with FDA regulators to advance and complete all relevant clinical studies, both ongoing and planned, as quickly as possible,” Gupta said in a statement.

The FDA based its designation on data from an ongoing Phase II study of rusfertide in PV patients. The ongoing data was presented in December at the American Society of Hematology meeting. 

The data showed that most patients treated with rusfertide were able to eliminate therapeutic phlebotomies and maintain a target hematocrit level of less than 45%, Protagonist said. Additionally, data showed these patients were able to reverse their iron deficiency and also saw improvements in their PV symptoms. The company will present updated data from the ongoing Phase II study at the European Hematology Association next week. 

Breakthrough Therapy Designation is granted to experimental drugs that may demonstrate substantial improvement over existing therapies on one or more clinically significant endpoints. Drugs that receive this designation can also benefit from expedited development and regulatory reviews. 

Previously, the FDA granted orphan drug status and Fast Track Designation to rusfertide in this indication.

Protagonist isn’t the only company this week to be awarded Breakthrough Therapy Designation. Janssen’s multiple myeloma asset teclistamab was also given the designation. 

Teclistamab is an off-the-shelf, T-cell redirecting, bispecific antibody that targets both B-cell maturation antigen (BCMA) and CD3 receptors. The Breakthrough Therapy Designation followed PRIME (PRIority MEdicines) designation granted by the European Medicines Agency for teclistamab.

Peter Lebowitz, Global Therapeutic Area Head in Oncology at Janssen Research & Development, was pleased with both the FDA and EMA designations. He said the teclistamab program “exemplifies our commitment to advancing science for patients living with multiple myeloma.” 

Lebowitz also said the designations strengthen the company’s robust portfolio in oncology. The FDA designation for teclistamab marked the 11th such designation received by Janssen's Oncology Therapeutic Area.

The FDA awarded Breakthrough Therapy Designation for teclistamab based on data from the Phase I MajesTEC-1 study, which evaluated the oncology asset in adults with measurable multiple myeloma that is relapsed or refractory to established therapies or be intolerant of those established multiple myeloma therapies. 

Results from preclinical studies demonstrate that teclistamab kills myeloma cell lines and bone marrow-derived myeloma cells from heavily pretreated patients. Updated results from the MajesTEC-1 study will be presented at the 2021 American Society of Clinical Oncology Annual Meeting next week. 

Teclistamab is currently being evaluated in a Phase II clinical study for the treatment of relapsed or refractory multiple myeloma and is also being explored in combination studies. 

https://www.biospace.com/article/protagonist-janssen-win-breakthrough-therapy-designation-for-oncology-drugs/

States Are Passing Laws That Threaten Public Health: Report

 In the wake of the COVID-19 pandemic, states are passing laws that could endanger the public health, according to a report from the National Association of County and City Health Officials (NACCHO).

"In recent months, at least 15 state legislatures have passed or are considering measures to limit severely the legal authority of public health agencies, and other states may consider such legislation in the future, hindering the ability of health departments to do their jobs and putting wide swaths of the public at risk," the organization said in a statement last week when it released the report.

Examples of laws cited in the report include:

• Prohibiting requiring masks in any situation, including cases of active tuberculosis. In North Dakota, a new law would remove the authority of the state health office to require face masks or covering.

• Blocking the closure of businesses necessary to prevent the spread of disease, allowing for super-spreader venues. In Kansas, a new law removes the governor's ability to close businesses during a public health emergency.

• Banning the use of quarantine. In Montana, a new law prohibits local board of health emergency orders from separating those individuals who are not yet ill but are reasonably believed to be infected or exposed. Prohibition of quarantine orders undermines the basis of infection control and would make it impossible to stop outbreaks of deadly diseases that are spread by individuals who are not yet symptomatic.

• Blocking state hospitals and universities from requiring vaccinations for employees and students in dormitories to protect state residents. In Arizona, a new law prohibits requirements that a person receive a vaccination -- except in K-12 school settings -- and creates criminal penalties for violating the ban.

• Giving unilateral power to legislatures to stop public health actions. In Ohio, a new law will allow the legislature alone to rescind any order or action by the state health department or director of health to control or [stop] the spread of contagious or infectious disease. The governor, who vetoed the law, issued a statement saying that the law "strikes at the heart of local health departments' ability to move quickly to protect the public from the most serious emergencies Ohio could face." The governor's veto was overridden by the legislature, and the law will take effect on June 23.

NACCHO noted in its report that the introduction of these types of bills "appears to be coordinated, in part, [by] the American Legislative Exchange Council (ALEC)," a conservative-leaning organization that develops model bills for state legislatures, and whose membership includes one-quarter of state legislators.

"ALEC is advocating a slate of policy initiatives and model bills crafted to limit the authority of public health agencies and weaken their ability to protect the public's health ... Many of the bills that have been, or will be considered, in a majority of states are based on ALEC's model acts," the report said, adding that "in some cases, the legislation uses language that is almost verbatim to ALEC's model bill."

Asked to comment on the report, an ALEC spokesman said in an email: "The NACCHO report is incorrect in its assertion. ALEC does not have model bills or any public policy initiatives crafted to limit the authority of public health agencies." He added that "In fact, ALEC has no public health model policy of any sort on COVID-19. As a 501(c)(3), we don't advocate policy. We have, however, empowered legislators with fact-based CDC information, discussions on vaccine safety and touchless travel innovations."

The spokesman also gave a link to ALEC's model policy database.

Georges Benjamin, MD, executive director of the American Public Health Association, said he found the trend in the laws disturbing. "We've been looking at what one needs to do about this because this is a big issue," Benjamin said in a phone interview. "Governmental public health is the only entity in the community that has legal authority to protect your health ... The fact that this legal authority is being attacked, which we believe are for reasons that are unacceptable, concerns us."

As to why these laws are being passed, "we think they don't understand what they're doing in their zeal to rein in things," Benjamin said of the state legislators. "It's like telling a bunch of doctors, 'We don't like the fact that you take out appendixes, so we're going to take away your authority to do surgeries.' It's like going to a fire chief and saying, 'Hey, we don't want you to have authority to do inspections or close down a venue because it's a fire hazard.'

"They're taking away core authorities that public health needs to do its work ... and undermining the work of government employees who are just doing their job," Benjamin said.

This is especially concerning when it comes to any public health emergency, he added. "You don't run an emergency by committee; it doesn't work that way. That's why the fire department and the police department have a chain of command. If you undermine those efforts, you're going to find that people won't have the authority they need, and bad things will happen."

https://www.medpagetoday.com/publichealthpolicy/healthpolicy/92915

#ASCO21: Novartis gears up for CAR-T fight with Gilead in follicular lymphoma — safety may be crucial

 Since winning the first CAR-T approval in the US back in 2017, Novartis has been hard at work expanding the reach of its blockbuster cancer drug Kymriah. Gilead’s Yescarta beat it to the punch in follicular lymphoma (FL) back in March — but now, Novartis says it has new pivotal data that could give its old rival a run for its money.

Of 94 patients given Kymriah for relapsed or refractory FL, 86% responded, according to primary results released ahead of ASCO 2021. A total of 66% saw a complete response — which is just a bit higher than the 65% Novartis touted upon sharing interim results from the Phase II ELARA trial back in December.

These new efficacy results include nearly twice as many patients as the interim analysis, Novartis said. The overall response rate also saw a small bump, up from the 83% rate recorded in December. Median duration of response, progression free survival, and overall survival were not yet reached, according to Novartis.

Despite some familiar efficacy figures, Kymriah could set itself apart on the safety front. No patients experienced Grade 3 or 4 cytokine release syndrome, a well-documented side effect of CAR-T therapy. Those results top Yescarta’s ZUMA-5 data, which showed Grade 3 or higher CRS in 8% of patients.

Grade 1 or 2 CRS occurred in 49% of patients in ELARA, with 9% of patients experiencing Grade 1 or 2 neurological events. One patient experienced Grade 4 neurological events, but recovered. Three participants died from progressive disease, though none of the deaths were treatment-related, according to the Swiss pharma.

Novartis plans on running the new data to regulators “as quickly as possible,” according to Stefan Hendriks, the global head of Novartis Oncology’s cell and gene division. He confirmed in an email to Endpoints News that a submission for the new indication will come sometime this year.

FL is the second most common form of non-Hodgkin lymphoma, with a five-year survival rate of only 20% for patients in the third line and later. Patients with FL have malignant tumors that grow slowly and can become more aggressive over time, and efficacy of available treatments drops off rapidly in later lines. Patients in ELARA had a median of four prior treatments, though some had taken as many as 13.

Yescarta won approval as a third-line therapy back in March, becoming the first CAR-T approved for relapsed/refractory FL. The OK was based on results from the ZUMA-5 trial, in which 91% of patients saw a response, 60% of whom achieved a complete remission, according to Gilead. Median duration of response had not been reached.

“As you know, direct cross trial comparisons are methodically and statistically not appropriate due to differences in patient characteristics, efficacy outcome measures (timing) and in-patient vs. out-patient setting,” Hendriks said in an email. “Head-to-head studies have not been performed, and no comparison of safety and efficacy can be made.”

While Kymriah beat Yescarta out the gate back in 2017, Yescarta has the upper hand in sales, at least in Q1 of this year. The Gilead drug pulled in $160 million last quarter, while Kymriah made Novartis $151 million.

https://endpts.com/asco21-novartis-gears-up-for-car-t-fight-with-gilead-in-follicular-lymphoma-and-safety-could-define-the-battle/

BARDA looks to get jump on next pandemic with VC arm targeting 'transformative' tech

 Five years after Congress first called for it — and a year and a half after a pandemic broke out — BARDA, the US’s top pandemic preparedness agency, is launching its own VC fund.

The new fund will invest in technologies that could be deployed against future outbreaks or other public health emergencies. It follows a similar model to other public health VCs, such as the Gates Foundation’s fund, giving capital to early-stage companies with promising platform technologies in exchange for assurances they use it partly for infectious diseases that might not have a significant market.

Sandeep Patel, director of BARDA’s division of Research, Innovation and Ventures, name-checked mRNA vaccines, a technology that was being developed in large part for cancer before Covid-19, but which another branch of the government — DARPA — invested in as a pandemic preparedness tool.

It’s “looking at what’s potentially transformative,”  he told Endpoints News. “mRNA represented a kind of new class of vaccines. What’s the equivalent of that we can invest in for the future, either in vaccines, treatments or diagnostics? Or even things that cut across those areas.”

Fittingly for a long-overlooked government agency dependent on Congress for cash, the fund is for now modest. BARDA has committed only $10 million this year and $50 million over the next five years to the VC, although Patel said that they hope to raise that up to $500 million over the next decade. He noted that President Joe Biden’s new budget includes $50 million for year one of the effort, should it be passed.

They also plan to match their own investments with private capital. Congress authorized the VC fund in 2016 as part of the 21st Century Cures Act, but Patel said they needed time to figure out its model. After soliciting bids in the fall, the agency announced it will team with GHIC, a Gates-funded non-profit that will look to marshal more conventional VCs to burnish BARDA’s efforts.

Despite its pre-pandemic history, the new fund fits into a broader push to develop technologies, infrastructure and other capabilities to prevent the next pandemic, joining government and academic efforts to develop pan-viral vaccines and industry efforts to reimagine biologics manufacturing, so any future pandemic vaccine or treatment could be rapidly scaled.

It’s a departure from where BARDA has spent much of the funds in the past, when it directed tens of millions of dollars to get individual products — often antibiotics without an immediate commercial market — through late-stage studies.

Patel said they’ll invest in companies — around five to nine per year — that have clearer commercial applications outside of public health emergencies, so it will be sustainable without heavy public funding and ready if a crisis strikes. As with other non-profit venture efforts, any returns from those investments would be funneled back into the fund to be re-invested. He compared it to In-Q-Tel, the CIA’s VC arm.

What could those technologies or companies be? Patel wouldn’t dive into too many specifics, but he threw out needle-free vaccines, which BARDA has already modestly invested in,  and new methods for rapidly scaling manufacturing — anything that could turned around faster for Covid-28, or whatever strikes next.

“There’s a lot, there’s a long list here, we’re in the process of setting priorities,” Patel said. “Clearly Covid-19 has showed us some lessons.”

https://endpts.com/barda-looks-to-get-the-jump-on-next-pandemic-with-vc-arm-targeting-transformative-tech/

Breast-Cancer Pill Reduced Recurrence, Death in Early-Stage Patients: Study

 A drug sold by AstraZeneca PLC and Merck & Co. reduced the recurrence of breast cancer in women with an early but aggressive form of the disease, a long-running international study found.

The finding, which on Thursday was published online by the New England Journal of Medicine and released at a major cancer-research meeting, marked the latest advance in cancer treatments targeting the genetic traits of tumors. It could expand the arsenal of weapons against a hereditary form of breast cancer.

The result also helps validate the pharmaceutical industry's investment in a pricey new class of drugs that target cancer cells, known as PARP inhibitors.

AstraZeneca's pill, named Lynparza, has become one of the company's top sellers, generating $1.8 billion in sales last year. Rival GlaxoSmithKline PLC paid more than $5 billion in 2019 to acquire the maker of another PARP inhibitor, Tesaro.

Lynparza carries a U.S. list price of about $14,449 per patient monthly.

AstraZeneca plans to submit the data to regulators and request regulatory approval of the use of Lynparza for early-stage BRCA breast cancer, said David Fredrickson, executive vice president of AstraZeneca's oncology unit.

PARP inhibitors work by blocking cancer cells from relying on a survival tactic: the ability to repair their own DNA after their DNA is damaged naturally or by other drug treatments. This, in turn, contributes to cancer-cell death.

Health regulators have approved these types of drugs in recent years to treat ovarian, breast, prostate and pancreatic cancers.

The drugs have been found to be particularly useful against cancers associated with harmful mutations in genes known as BRCA1 and BRCA2. Women with these hereditary mutations have a higher risk of developing breast cancer, and often at a younger age than is typical.

The BRCA mutations account for about 5% of the estimated 281,000 cases of breast cancer diagnosed annually in the U.S.

Overall, breast cancer is the second leading cause of cancer death in women, causing about 43,600 deaths in the U.S. annually, according to the American Cancer Society.

The Food and Drug Administration cleared Lynparza, in 2018, to treat advanced-stage BRCA-mutated breast cancer.

The new study tested Lynparza in women at earlier stages of breast cancer, at a time when it is potentially curable. AstraZeneca sponsored the study and collaborated with Merck and various research groups that run breast-cancer clinical trials.

Starting in 2014, researchers in the U.S. and 22 other countries enrolled 1,836 women with early-stage BRCA1 or BRCA2 breast cancer.

Before enrolling in the study, the women had undergone surgery to remove tumors, and had received chemotherapy before or after surgery aimed at preventing a recurrence of the tumor. They were at high risk of recurrence based on the size of their tumors or presence of cancer in lymph nodes.

The women also tested negative for the HER2 gene that is present in some breast cancers.

Half of the women in the study were randomly assigned to take Lynparza tablets daily for one year, while the other half got a placebo.

At a median follow-up period of 2 1/2 years after the start of treatment, Lynparza reduced the combined risk of recurrence of cancer or death from any cause by 42% compared with a placebo, the researchers found.

Researchers estimated that three years after the start of treatment, 85.9% of the women who received Lynparza were living without disease recurrence, compared with 77.1% of women who received a placebo.

Lynparza also improved other measures of benefit, including the time from the start of treatment until the development of tumors distant from the original site in the breasts.

There were fewer deaths among the Lynparza patients than among women who received the placebo, 59 versus 86, but the difference didn't meet the study's criteria for statistical significance at the time of follow-up.

Researchers said it may be possible at future dates to demonstrate a statistically significant improvement in overall survival.

"The early results are very encouraging that these therapies may indeed result in increased cures for patients who develop cancers with these mutations," said Dr. Charles Geyer, deputy director of the Houston Methodist Cancer Center and one of the study's leaders.

The presence of BRCA mutations can be detected with a blood test. "This further highlights the importance of genetic testing in appropriate patients, so that we know which patients will benefit from this therapy, " ASCO President Dr. Lori J. Pierce said in an online briefing with reporters.

Patients receiving Lynparza had higher rates of certain adverse events including nausea, fatigue and anemia, compared with those who received placebo, the study found. Researchers said this was consistent with the safety profile of the drug for other uses.

AstraZeneca had previously disclosed in February that the study was positive but didn't report the full results until Thursday, ahead of being presented at the annual meeting of the American Society of Clinical Oncology. The New England Journal of Medicine also simultaneously published the results online.

AstraZeneca initially developed the drug. In 2017, it formed a partnership with Merck to further develop and co-market the drug.

https://www.marketscreener.com/quote/stock/ASTRAZENECA-PLC-4000930/news/Breast-Cancer-Pill-Reduced-Recurrence-Death-in-Early-Stage-Patients-Study-Finds-35515273/

Abbott Labs Plans Restructuring Due to Changes in Covid-19 Testing Demand

 Abbott Laboratories on Thursday said it approved a restructuring plan last month "to align its manufacturing network for Covid-19 diagnostic tests with recent changes in projected testing demand."

In a filing with the U.S. Securities and Exchange Commission, the company said the changes in projected testing demand have been driven by several factors, including reductions in cases in the U.S. and other major developed countries and accelerated rollout of Covid-19 vaccines globally.

The company also said it estimates pretax costs to implement its plan to be about $550 million to $700 million. "The costs are expected to be incurred during the remainder of 2021 with the majority of the costs expected to be recorded in the second quarter of 2021," Abbott said, adding "The costs will be treated as specified items."

Earlier this month, Abbott updated to its financial outlook for the full year. At that time, Robert B. Ford, the company's president and chief executive, said "We've recently seen a rapid decline in Covid-19 testing demand and anticipate this trend will continue, which led us to adjust our full-year guidance."

https://www.marketscreener.com/quote/stock/ABBOTT-LABORATORIES-11506/news/Abbott-Labs-Plans-Restructuring-Due-to-Changes-in-Covid-19-Testing-Demand-35515301/