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Saturday, October 2, 2021

Underestimating COVID’s Age Discrimination

 In mid-September, King County, Washington, in which ­Seattle is located, released an eye-popping slide about vaccine efficacy and breakthrough prevalence: Vaccines had reduced the risk of infection from COVID sevenfold, county data showed, and reduced the risk of hospitalization and death 41-fold and 42-fold, respectively.

These ratios, though bigger than those found in other studies released in recent weeks, are nevertheless in line with an obvious emerging consensus in the data: Vaccines do clearly reduce transmission and dramatically reduce hospitalizations and deaths, making the threat of severe outcomes to the vaccinated much more like the risk associated with other, far more quotidian diseases. A recent Centers for Disease Control and Prevention study of Los Angeles found a 29-fold reduction in hospitalization from vaccines early this summer, for instance, and another quasi-national study suggested an average 11-fold reduction in mortality risk overall.

But in small type, King County included some other data that paint what seems at first blush like a very different picture: Fully 25 percent of deaths were among vaccinated people, the county reported. How can this be? If the vaccines are so effective that they reduce mortality 42 times over, how could the vaccinated account for such a large proportion of the deaths? The answer is actually quite simple: the overwhelming age skew of the disease, which — in the time of vaccines, breakthrough cases, and Delta — we are still, as a public, hugely underestimating and which is governing the post-vaccine pandemic landscape as clearly as it did the pre-vaccine landscape. To put it more bluntly: in assessing an individual’s risk of dying from COVID, age appears still as important — and maybe even more important — than vaccination status. And while encouraging further vaccination remains by far the best tool we have in fighting the pandemic to an endgame détente, we should also be clear along the way about the continuing risks to the vaccinated elderly and what might be done to protect them.

Most people know the pandemic has hit the elderly hardest — that is the meaning of the age skew, that the disease grows much more severe the older you are. But if they have seen a chart illustrating this, it probably looks like this gentle upward slope, from the UK’s NHS:

Graphic: Courtesy of the UK Coronavirus Dashboard

That is a logarithmic chart, which means that the y-axis scales exponentially — a change from one to ten looks to the untrained eye like a change from one to two). That means a huge variation is concealed by presenting mortality risk data in logarithmic form. A chart of the same British information presented linearly (the graphing format you remember from elementary school).

Graphic: Courtesy of the UK Coronavirus Dashboard

Viewed this way, the deaths from those under the age of 50 are more or less invisible. To scale the graph to make them visible — which would show that the risk slope from children to 50 year olds is about as dramatic as the slope from 50 year olds to 90 year olds — would require zooming in so close that the bars representing elderly outcomes would tower far above the top of your screen.

After 18 months of public-health guidance promoting universal vigilance, I think hardly any American has a clear view of just how dramatic these differentials are. All else being equal, an unvaccinated 66-year-old is about 30 times more likely to die, given a confirmed case, than an unvaccinated 36-year-old, and someone over 85 is over 10,000 times more at risk of dying than a child under 10. And although many infections still go undetected (complicating any attempt at a universal calculation of risk), your chances of dying from a confirmed case roughly double with every five to eight years of age, as countless data across multiple countries demonstrated last year — an effect larger than even the most significant comorbidities. The “exponential growth” of mortality risk by age is, in other words, another aspect of the pandemic we have processed only poorly.

Over the past nine months, vaccination has utterly transformed the shape of the pandemic in the places where it has penetrated the whole population. The effect isn’t just visible in countries like Portugal or Iceland — where the threat appears to be fast receding and which give an encouraging picture of our possible future — but in parts of the United States as well. But for all its transformative, liberating power, vaccination has not broken the basic age skew of the disease or offered anyone an exit ramp from it. Instead, in two profound ways, vaccination has confirmed the age skew: by producing severe breakthrough cases concentrated overwhelmingly in the elderly and by reducing the risk faced by individuals by an astonishing degree that is nevertheless smaller than the still more striking effect of age.

Although vaccines do substantially reduce the risk of infection, too, breakthrough cases are not terribly uncommon, accounting for perhaps as many as one-quarter of all new infections these days, as the CDC estimated in Los Angeles. But they are overwhelmingly mild, and in the rare cases when they do grow severe, they tend to be among the old and very old. According to the CDC, 70 percent of breakthrough cases resulting in hospitalizations and 87 percent of those resulting in death were in patients over 65. The median age of breakthrough deaths in England was 84; in King County, it was 79.

The second confirmation follows from the first and explains why, even given the power of vaccines, there are still some number of severe breakthrough cases and deaths. That 11-fold reduction of risk found in the national CDC study, for instance? Enormous, of course, but it is an average across the observed population as a whole and represents only the equivalent of the ­difference between an unvaccinated 86-year-old man and a 61-year-old one, all else being equal. According to an analysis of British data by the Financial Times, a vaccinated 80-year-old has about the same mortality risk as an unvaccinated 50-year-old, and an unvaccinated 30-year-old has a lower risk than a vaccinated 45-year-old. Even a 42-fold reduction, as was found in King County, would only be the rough equivalent of the difference between an unvaccinated 85-year-old woman and an unvaccinated 50-year-old — the sort of person who was very worried last year before the arrival of vaccines and who may this year be worrying many of those around them by not getting one.

To be clear: They should get one since doing so reduces disease transmission significantly, thereby limiting the future course of the disease, and because it would reduce their own risk of death from COVID by such a dramatic degree that it doesn’t even make sense to call it a degree. But it’s a sign of just how large the age skew is to begin with that getting vaccinated doesn’t deliver you into an entirely new category of pandemic safety — safer and more protected than anyone who hasn’t gotten vaccinated — but simply pushes you down the slope of mortality risk by the equivalent of a few decades.

On the other end of the age spectrum, the same skew is more comforting. Recent data from the U.K. illustrate the phenomenon neatly: unvaccinated children are safer from COVID-19 death than vaccinated adults of any age:

According to that data, an unvaccinated 10-year-old, who may look like the very picture of COVID vulnerability heading into the school year, faces a lower mortality risk than a vaccinated 25-year-old, whom we might today regard as close to safe as can be. In England, the incidence of hospitalization among unvaccinated kids was lower than that of those vaccinated aged 18 to 29, and in recent weeks, the hospitalization rate among kids ages 5 to 14 has been only about one per 100,000. Over the course of the entire pandemic, which has killed more than 135,000 Brits, just one boy and seven girls between the ages of 5 and 9 have died; between the ages of 10 and 14, nine girls and five boys have died. These are all tragedies — and each means many more years of life lost than with a death among the elderly — but they are nevertheless relatively few in number. As schools reopened on the backslope of the U.K.’s Delta surge, there were about seven times as many British kids under age 5 hospitalized with the respiratory disease RSV as there were with COVID.

Of course, infectiousness matters too; the impact of a disease is a product of both how contagious it is and how severe it is for those who catch it. With COVID, death is not the only outcome of relevance either, and the age skew of COVID hospitalization is less dramatic than that for COVID mortality — with the very elderly, according to CDC data, only 15 times more likely to be hospitalized than those in their 20s. But while some recent studies suggest that hospitalization rates might not be as meaningful as we’ve thought, the effect of vaccines on serious-but-not-lethal infections is, if not sufficient to eliminate the risk, then nevertheless game-changingly large. As for worry about “long COVID,” there are growing indications that the phenomenon, while realmay be considerably less prevalent than many self-reporting surveys have indicated; as the BBC put it recently, long COVID in children is “nowhere near [the] scale feared.”

This is not to say that unvaccinated children face absolutely no risk from COVID, given that many millions of Americans under the age of 18 have gotten sick, and almost 500 have died, over the course of the pandemic. It’s just that the risk those 73 million minors do face is — relative to the risks faced by their parents and grand­parents — very, very small. (As I wrote a few months ago, though a better, clearer first line would have been not “The kids are safe,” full stop, but “The kids are safe, relatively speaking”). Precautions are still worthwhile for the unvaccinated young: regular testing, better ventilation in schools, perhaps mask-­wearing, too, when community transmission is high. But it is strange and perhaps unfortunate that in the ongoing, unnecessary, often ugly debate about the vaccines — their efficacy, the risk of breakthroughs, and what additional precautions among the vaccinated may be necessary or advisable — almost invariably the discussions describe two groups, the vaccinated and unvaccinated, as though they occupy two uniform and entirely different spheres of risk. Because while the vaccine culture wars are indeed largely binary, and the future of the pandemic in the U.S. largely a matter of how many unvaccinated will get vaccinated, when we discuss individual risk, it simply doesn’t makes sense to talk about vaccinated 15-year-olds and 95-year-olds in the same breath and unvaccinated 15-year-olds and unvaccinated 95-year-olds in a different breath. In fact, it distorts the picture of the pandemic as a whole when we regard risk as neatly divided by vaccination status. That’s because a vaccinated 95-year-old is still probably over a thousand times more at risk of death, all else being equal, than an unvaccinated 15-year-old. Which means we probably shouldn’t be giving those two groups the same advice about masks or social distancing or boosters.

When I asked the CDC about the case fatality ratios implied by its quasi-national study — which suggested, during the observed period, vaccinated seniors were twice as likely to die, given a confirmed case, as unvaccinated people between the ages of 50 and 64 — the lead author suggested that it would be better to consider the incidence rate, which looks at how many people in a given time period suffer a particular adverse event. According to that measure, death among vaccinated seniors was two and a half times more common than death among unvaccinated people ages 18 to 49.

Over the past few months, as we first began hearing reports of breakthrough cases and even breakthrough hospitalizations and deaths, Americans have been treated to a fair amount of columnizing about how, as the vaccination rate grew, we shouldn’t be surprised that the share of serious outcomes among the vaccinated would grow, too — that we should expect it, in fact, and that it would be a sign of vaccine success, not vaccine failure, since it would signal the ongoing penetration of vaccine protection through the population. This is true, in principle, since in a country with 100 percent vaccination, all severe outcomes would be among the vaccinated. But it is also an implicit acknowledgment that some share of the vaccinated population will continue to be at risk. At least for now, plenty of people are still dying, most but not all of them unvaccinated.

And so to believe that the vaccinated elderly are now perfectly safe, as can be tempting to all of us who are desperate for the unvaccinated to get with the program, is to raise an uncomfortable set of questions about the way we have processed risk by universalizing it. If we want to believe, say, a vaccinated 75-year-old is safe, have we now simply normalized a higher level of individual risk than seemed moral to accept as recently as 12 months ago, given that they may not be any less in danger of dying than an unvaccinated 53-year-old? If we are now debating what we can do, in schools especially, to protect unvaccinated children, who are much safer still, should we not be discussing at the same time what measures can be taken, beyond boosters, to protect the vaccinated elderly? Mask wearing offers differential benefits, too: according to the much-applauded study in Bangladesh, cloth masks of the kind typically worn by children offer very little protection, and the strongest effects of surgical masks were observed among the elderly.

These are questions not just for individuals but also for communicators and public-health messaging. Is it now more important to emphasize the protections offered by vaccines in order to encourage further uptake? Or to emphasize the enduring risks faced by the most vulnerable, who might take additional precautions as a result? Because as long as the disease continues to circulate — in part because of frustratingly slow vaccine uptake — there will likely continue to be severe cases and deaths. That’s the brutal logic of the age skew and the vulnerability of the very old it describes. Even universal vaccination among the elderly can’t eliminate those risks, only reduce them. In fact, in several of the recent studies of vaccine efficacy, the effect is notably smaller among the old. (In King County, for instance, where vaccination was calculated to reduce the overall risk of death 42-fold, the effect among seniors was only eightfold.) These studies’ findings obscure confounding ­variables — that is the nature of epidemiological analysis in real time — but taken together, they suggest that, as long as the disease continues to circulate, even the vaccinated elderly will continue to be vulnerable to some extent.

To what extent? “Post-vax COVID,” as Katherine J. Wu called the “new disease” recently in the Atlantic, is much less lethal overall than the pre-vaxx or unvaxxed variety. But making COVID only as lethal as pneumonia or the flu would still mean, as long as the disease sticks around, probably tens of thousands of American deaths annually. Perhaps a young person can squint at that future and see something that still looks “normal.” But they probably wouldn’t want to tell their grandparents to be blasé about catching pneumonia or the flu, even if they’ve had their annual shot — and might hope that public-health policy focused a bit more on those vulnerabilities rather than simply accepting them.

As we head into the fall, debate over vaccine policy has coalesced around two anchors: the matter of juvenile vaccination and the matter of boosters. On September 22, the FDA authorized booster doses of the Pfizer vaccine for the elderly, high-risk individuals, and those with frequent exposure but not the population as a whole; later in the same week, the CDC director overruled internal advisers to make the same recommendation. To this point, much of the debate around boosters has focused on waning immunity — and it is clear now, in study after study, both that protection does wane and that boosters, already delivered abroad in more than a dozen countries, help significantly. The waning is most visible among the elderly, as many of the studies have shown. But just as important, and much less discussed, is what it would mean to restore that immunity to that group. Because of the age skew, the social impact of elevating protection among the most vulnerable by even a few percentage points would be absolutely enormous. That’s because if vulnerability is hundreds of times higher in one group than another, the impact of that boost is going to be much, much larger too.

That is one reason why a country like the U.K. — enthusiastically considering boosters for the elderly — is at the moment advising against vaccinating even the teenagers already eligible here in the U.S. Vaccines for kids are a reassuring prospect for worried parents and have often been described as an important milestone for school reopening, too (though, to date, less than half of eligible teenagers have been vaccinated, and the rates among younger kids may well turn out to be lower). But in terms of shrinking the country’s overall mortality risk, the enduring fact of the age skew suggests that boosting the immunity of the elderly would be much more ­consequential. Of course, the effect is not nearly as large as administering new first doses to the elderly in the developing world. Why hasn’t the White House committed to fully funding that effort, again?

https://nymag.com/intelligencer/2021/09/covid-19-vaccine-status-age-discrimination.html

Supreme Court denies NYC teachers' request to block vaccine mandate

 The Supreme Court on Friday rejected a request from a group of New York City public school teachers to block the city's coronavirus vaccine mandate.

The teachers, who refused to receive a COVID-19 inoculation, filed their request Thursday to Justice Sonia Sotomayor, who handles emergency matters arising from New York, after losing in the lower courts. 

Sotomayor denied their request unilaterally and without comment.

An attorney for the teachers did not immediately respond to a request for comment. 

The mandatory vaccine policy for employees at New York City public schools, the country’s largest school system, was set to take effect at 5 p.m. on Friday under an order first announced by city officials in August. 

The court’s denial of the New York-based request is at least the second challenge to a school vaccine mandate to be turned away by the Supreme Court.  

A request by a group of Indiana University students in August to block their school’s requirement was denied by Justice Amy Coney Barrett, who handles emergency matters from Indiana.

https://thehill.com/regulation/court-battles/574964-supreme-court-denies-new-york-city-teachers-request-to-block-vaccine

Union 'dues skim' from home health care workers will hurt the most vulnerable

 President Biden promised to be the most pro-union president in history. And he’s proving loyal to that commitment, but at the expense of the seriously ill and disabled.

Biden’s Department of Health and Human Services (DHS) proposed a new rule that would allow unions to skim dues from home health care workers. Under the proposed rule, DHS would permit diversion of Medicaid payments to third parties, including unions. While this may seem innocuous, it is anything but. In fact, this rule would reauthorize what is known as a “dues skim,” a scheme that has benefitted unions at the expense of vulnerable Medicaid recipients and their caregivers.

In 2011, the Mackinac Center was the first organization to discover the redirection of Medicaid payments to labor organizations. In Michigan, the Service Employees International Union’s (SEIU) local affiliate recognized it could obtain “dues” from home health care providers and worked with the state to force-unionize them. First, the SEIU lobbied the state to create an agency known as the Michigan Quality Community Care Council that would serve as the putative employer of home health care providers in Michigan. The SEIU then bargained with that “employer” to unionize these workers. This all happened even though fewer than 20 percent of the affected home health care providers voted for the union. Many were not even aware that a unionization election had occurred.

As a result, a portion of Medicaid payments meant for covering the costs of home health care providers  — often the family members of seriously ill or disabled individuals — was redirected to the SEIU. By 2012, the SEIU had successfully skimmed over $34 million in Michigan alone. After reforms were passed banning dues skim (and later reaffirmed in a ballot proposal), home health care providers overwhelmingly demonstrated they did not wish to be unionized. In less than a year, SEIU Healthcare Michigan’s membership fell 80 percent. In other words, when given the choice about whether to become a member of a union, only 20 percent of providers decided it was worthwhile. 

The consequences of dues skim become even worse on a national scale. From 2000 to 2017, unions successfully diverted approximately $1.4 billion in Medicaid payments. 

There is little justification for these payments. Although DHS claims that allowing these diversionary payments would benefit caregivers through better training and education, it has presented no evidence to support this claim. What evidence does exist suggests that such arguments are meritless

The position is also logically inconsistent. If unions had training opportunities that would benefit home health care providers, nothing stops them from offering those trainings for a fee. Providers could then decide whether to spend the funds they receive from Medicaid to enhance their skills by attending these training sessions. This arrangement would be consistent both with the law  and market incentives. Instead, DHS has opted for an arrangement that favors coercion and potential fraud.

The practical consequences of permitting dues skimming cannot be understated. The providers from whom payments would be diverted are often the family members of those with serious illnesses or disabilities. Without this care, the ill and disabled would be forced into an institution, likely at greater taxpayer expense. These family members sacrifice their time and energy and are lightly compensated primarily through Medicaid payments. 

Despite this, some unions have used dues skim to divert payments while providing little, if any, tangible benefits to providers or Medicaid recipients. But in this situation, unions have little to offer either party, since home health care providers are not employed by an outside agency, but rather, their patients. They work from either their own homes or the homes of their ill and disabled relatives. They manage their own working conditions and hours, based on the needs of their patient. Unions play no representational role in these areas — the traditional purpose of collective bargaining. 

DHS should not reinstate dues skim through administrative fiat. Doing so would reduce the funds available to help the sick and disabled, increase the shortage of home health care workers and direct Medicaid payments away from their intended purpose. Funds paid to caregivers should be used to support their efforts to care for the sick and disabled, not for favored political causes. 

Steve Delie is the director of labor policy at the Mackinac Center for Public Policy in Midland, Mich.

https://thehill.com/opinion/finance/574821-a-union-dues-skim-from-home-health-care-workers-will-hurt-the-most-vulnerable

OraSure Awarded $109M to Manufacture Rapid Antigen Self-Tests

 OraSure Technologies Inc., Bethlehem, Pennsylvania, was awarded a $109,000,000 firm-fixed-price contract for the increased domestic manufacturing capability of rapid antigen self-tests for home care testing. This contract provides for the retrofit of a production facility and a new additional facility with machinery to increase domestic COVID-19 rapid test production capacity. Work will be performed in Bethlehem, Pennsylvania, and is expected to be completed by March 31, 2024. This award is the result of a COVID-19 Joint Acquisition Task Force Commercial Solution Opening. Fiscal 2021 American Rescue Plan Act, Department of Health and Human Services other funds in the amount of $109,000,000 are being obligated at the time of award. There is known congressional interest in this action. Air Force Life Cycle Management Center, Hanscom Air Force Base, Massachusetts, is the contracting activity (FA8730-21-S-C001). (Awarded Sept. 30, 2021)

https://news.clearancejobs.com/2021/10/01/orasure-technologies-awarded-109m-to-manufacture-rapid-antigen-self-tests/

Friday, October 1, 2021

7 Public Cell Therapy Companies Deliver Opportunities for Investors, Patients

 Cell therapies have grown to become a prevailing field dominating new medical breakthroughs with the promise of treatments and cures for multiple diseases. The biopharma hubs of Philadelphia and Maryland have emerged as important drivers of this new wave of medicine, build on the foundation of renowned research institutes, universities, and a number of successful cell therapy companies who have paved the way forward in this field. 

Successful advances made by these cell therapy-focused companies have drawn the eyes of venture capitalists and other investors who provide significant amounts of capital to advance these cutting-edge modalities. Earlier this year, Allied Market Research predicted the global cell therapy industry will be valued at $48.11 billion by 2027. That’s a significant growth trajectory from an estimated value of 7.75 Billion in 2019. With that kind of expected growth, it is no wonder that investors are closely looking at cell therapy companies exploring a potential move toward becoming a publicly traded company.

Philadelphia, now known as Cellicon Valley because it has become a hub for cell and gene therapies, has established a vibrant ecosystem to support the rapid growth of this field that offers multiple advantages over other regions. Home to industry pioneers in the field, including Dr. Carl June and Dr. Jim Wilson at the University of Pennsylvania, and other leading experts out of Children’s Hospital of Philadelphia, Jefferson Health, and the 30 cell and gene therapy companies, the city is stacked with a renowned pool of leaders in cell and gene therapy.

For years, Maryland has been blazing a trail in cell and gene therapies with advancements coming from companies, government facilities such as the National Institutes of Health’s National Cancer Institute, and academic research institutions, like Johns Hopkins University and University of Maryland. It’s that atmosphere that compelled TCR2 to select Rockville, Maryland for its commercial cell therapy manufacturing facility earlier this year. These seven publicly traded cell therapy companies that are making a significant impact on the market for investors and patients. One company, Kite, has multiple approved products on the market, as well as another company, MaxCyte, whose platform has been licensed by 14 different drug developers across the globe, in addition to being used to advance its own product pipeline of cell therapies.

Kite Pharma, a division of Gilead Sciences, was the second company to win FDA approval for a CAR-T cell therapy, Yescarta (axicabtagene ciloleucel), which was approved in 2017 for hematological malignancies. Last year, Kite was awarded FDA approval for Tecartus (brexucabtagene autoleucel), the first CAR-T cell therapy for relapsed or refractory mantle cell lymphoma.

Located in Frederick Maryland, Kite’s commercial cell therapy manufacturing facility is rapidly expanding to meet the patient needs for their cell therapies and is hiring over 100 new employees to meet that demand.

Like Kite, Adaptimmune and Autolus are both developing CAR-T therapies. Both companies have assets in various stages of development. Cabaletta Bio, a spin-out of the University of Pennsylvania, is also developing T-cell therapies as are NexImmune and NextCure.

There are certainly other cell therapy companies in the area that are poised to make breakthrough therapeutics, and are being followed closely by analysts and investors. For example, American Gene Technologies, which has developed a proprietary lentiviral platform capable of broad applications, and has banked thousands of lentiviral vectors that can be adapted to the specific needs of new target diseases. Earlier this year, the company dosed its first patient with AGT103-T, a genetically modified cell therapy for HIV. The hope from the Rockville-based company is that the Gag-specific AGT103-T will be able to restore a patient’s immune system to a point where it can remove HIV-infected cells on its own, and decrease or eliminate the need for lifelong antiretroviral treatment – a functional cure.

In July, AGT and the National Institute of Allergy and Infectious Diseases (NIAID) co-authored an article in Molecular Therapy that highlighted the capabilities of AGT103-T. AGT and NIAD researchers confirmed the process for large-scale production of HIV-specific CD4 T cells, also called helper T cellsIt is expected the number of HIV-specific immune cells protected and returned to the participants will be nearly 2000 times the number that was achieved in previous efforts.

AGT Chief Executive Officer Jeff Galvin expressed hope that when the Phase I study is complete, not only will the company be able to assess the safety of the therapy, but also determine if patients will be functionally cured, meaning they no longer demonstrate disease symptoms and cannot transmit the virus to others.

“I am exceedingly optimistic about the future of this cell therapy and AGT’s eventual contribution to the treatment of HIV,” Galvin said.

In addition to its HIV cell therapy, AGT is developing a cell therapy program for cancer. Through its ImmunoTox viral vector platform, AGT is reprogramming tumor cells to become potent gamma delta (γδ) T cells. When activated the T cells are able to eliminate the tumor cells and have the potential to attack additional tumors or metastases that are found within the body.

7 Publicly Traded Cell Therapy Companies

Autolus

IPO: Autolus (Nasdaq: AUTL) raised $150 million in its 2018 IPO

Current Price: $7.35 with 2021 high of $9.28 on Jan. 8

Market Cap: $521 million

Location: London, UK and Rockville, Maryland, U.S.

Approved Products: To date, Autolus has no approved products. Its lead cell therapy, obecabtagene autoleuce, Obe-cel) is an investigational CD19 CAR T cell therapy designed to overcome safety and activity limitations of current CD19 CAR T cell therapies. Obe-cel is in Ib testing for acute lymphoid leukemia.

Adaptimmune Therapeutics

IPO: Adaptimmune (Nasdaq: ADAP) raised $191 million in its 2015 IPO

Current Price: $6.37 with 2021 high of $6.83 on Feb. 8

Market Cap: $950 million

Location: Abingdon, UK and Philadelphia, Pennsylvania, U.S.

Approved Products: Adaptimmune has yet to win FDA approval for its T-cell therapies. Its lead asset is afamitresgene autoleucel currently in Phase II/III development for synovial sarcoma and head and neck cancers.

Cabaletta Bio

IPO: Cabaletta Bio (Nasdaq: CABA), a spin-out of the University of Pennsylvania, raised $74.8 million in its 2019 IPO.

Current Price: $10.88 with 2021 high of $14.53 on Jan. 12

Market Cap: $269 million

Location: Philadelphia, PA

Approved Products: Cabaletta has no approved therapies at this time. The company is developing T-cell therapies for B cell–mediated autoimmune diseases. Its lead asset is DSG-CAART, a Phase I program for mucosal pemphigus vulgaris.

Kite

IPO: Kite raised $128 million in a 2014 IPO.

Current Price: N/A Kite was acquired by Gilead Sciences (NASDAQ: GILD) for $12 billion in 2017.

Market Cap: $88.7 billion (Gilead Sciences)

Location: Santa Monica, California and Frederick, Maryland

Approved Products: Kite is focused on chimeric antigen receptor and T cell receptor engineered cell therapies. Kite has two FDA approved cell therapies. In 2017, two months after it was acquired by Gilead Sciences, the company won approval for Yescarta, the second CAR-T treatment approved by the FDA. Yescarta (axicabtagene ciloleucel) has been approved for non-Hodgkin lymphoma, acute lymphoblastic leukemia, mantle cell lymphoma, and other indications. In 2020, the company won approval for Tecartus (brexucabtagene autoleucel) for relapsed or refractory mantle cell lymphoma.

MaxCyte

IPO: MaxCyte (Nasdaq: MXCT) raised $175 million when it listed on the Nasdaq in July.

Current Price: $16.96 with a 2021 high of $17 on July 30.

Market Cap: $1.7 billion

Location: Gaithersburg, Maryland

Approved Products: MaxCyte’s Flow Electroporation technology and ExPERT platform is employed by 14 different drug developers across the globe, as well as numerous biotechnology companies and academic translational centers. MaxCyte’s technologies are used to advance innovative cell-based research and next-generation cell therapies.

NexImmune

IPO: NexImmune (Nasdaq: NEXI) raised $126.5 million in its February 2021 IPO.

Current Price: $14.58 with a 2021 high of $25.91 on Feb. 26.

Market Cap: $325 million

Location: Gaithersburg, Maryland

Approved Products: NexImmune has two T-cell products in Phase I/II development, one patient-derived and one donor-derived. They are being developed for acute myeloid leukemia and multiple myeloma. The company also has a cell therapy for solid tumors in preclinical development.

NextCure, Inc.

IPO: NexCure (Nasdaq: NXTC) raised $86.25 million in a 2019 IPO.

Current Price: $7.64 with a 2021 high of $13.87 on Feb. 10.

Market Cap: $205 million

Location: Beltsville, Maryland

Approved Products: No approved products yet, but the company is in Phase II development for two oncology assets that harness the power of the company’s FIND-IO platform, which is used to understand targets and structural components of immune cells and their functional impact in order to develop immune-medicines.

https://biobuzz.io/seven-public-cell-therapy-companies-delivering-opportunities-for-investors-and-patients/

Pfizer Launches Final Study For COVID Drug Suspiciously Similar To 'Horse Paste'

 Another piece US anti-Ivermectin puzzle may have emerged. On Monday, Pfizer announced that it's launching an accelerated Phase 2/3 trial for a COVID prophylactic pill designed to ward off COVID in those may have come in contact with the disease.

Coincidentally (or not), Pfizer's drug shares at least one mechanism of action as Ivermectin - an anti-parasitic used in humans for decades, which functions as a protease inhibitor against Covid-19, which researchers speculate "could be the biophysical basis behind its antiviral efficiency."

Lo and behold, Pfizer's new drug - which some have jokingly dubbed "Pfizermectin," is described by the pharmaceutical giant as a "potent protease inhibitor."

As Zero Hedge readers might recognize, that's exactly what ivermectin, the prophylactic used for a number of reasons in both humans and animals, does. And unlike Pfizer's experimental drug, ivermectin already may have saved hundreds of thousands of lives from India to Brazil.

We aren't the only ones to have put this together, as twitter users have commented on the similarities. The timing - which coincides with the whole "horse dewormer" smear campaign - just seems odd.

The similarity between Pfizer's upcoming offering and Ivermectin has not gone unnoticed.

But Pfizer, Moderna and their executives have already shown the world with their actions that they see COVID as "manna from heaven" - to quote legendary defense attorney Johnny Cochran -  a new 'profit center' that will keep shareholders in butter brickle, especially since the companies have quietly raised prices on their vaccines.

But since a large portion of the American market has rejected the vaccines, Pfizer needs another medication that can be used to treat them as well (otherwise, the company is missing out on nearly one-third of the American market).

According to Reuters, Pfizer said on Monday it has "started a large study testing its investigational oral antiviral drug for the prevention of COVID-19 infection among those who have been exposed to the virus."

Pfizer isn't the only drugmaker hoping to develop a prophylactic treatment for COVID exposure (especially since variants raise the possibility that vaccinations just might not be enough). Merck and Swiss rival Roche have been racing to develop an easy-to-administer antiviral pill of their own - so the clock is ticking for Pfizer.

Reuters explains that the mid-to-late-stage study will test the Pfizer drug's - known as PF-07321332 ability to prevent COVID symptoms in up to 2,660 healthy adult participants aged 18 and older who live in the same household as an individual with a confirmed symptomatic COVID infection.

The drug, designed to block the activity of a key enzyme needed for the coronavirus to multiply inside the human body, will be administered along with a low dose of ritonavir, an older medication widely used in combination treatments for HIV infection.

At present, Gilead's much-hyped but not-all-that-effective IV drug remdesivir is the only approved antiviral treatment for COVID in the US. Several antibody cocktails have also been widely tested and trials are ongoing - including Merck and partner Ridgeback Biotherapeutics, which recently launched a late-stage trial for experimental COVID prophylactic, molnupiravir.

In the mean time, concerned citizens should keep an eye out for any new information about Ivermectin - if you can find it.

https://www.zerohedge.com/covid-19/pfizer-launches-final-study-covid-drug-thats-suspiciously-similar-ivermectin

Oxford Nanopore makes stellar debut on UK stock market

 Shares in DNA sequencing specialist Oxford Nanopore rocketed after the company made its debut on the London Stock Exchange yesterday, rising nearly 50% to propel its valuation up towards the £5 billion ($6.7 billion) mark.

The Oxford University spinout saw its share price rise from an opening of 425p to 612p by close of trading with further gains this morning.

Oxford Nanopore has risen to prominence during the COVID-19 pandemic as its technology has been used to track SARS-CoV-2 variants, reported to be used in a fifth of all coronavirus sequencing efforts globally.

It also won a £113 million contract to provide rapid saliva-based COVID-19 testing services to the NHS, although that was ended early by the UK government in the summer as demand fell due to vaccinations.

The successful IPO lends further weight to a biotech boom in the UK in 2021, with record levels of cash flowing into the sector included a £195 million fundraising round for Oxford Nanopore in May that helped the industry-wide tally in the second quarter reach a record £1.6 billion.

The debut – raising upwards of £350 million from new shares – is the largest IPO for a UK biotech company since allergy drug specialist Circassia in 2014.

It has made Oxford Nanopore’s chief executive and cofounder Gordon Sanghera an on-paper fortune of £63 million, while another cofounder – chief business development officer Spike Willcocks – is now worth £30 million. Chief technology officer Clive Brown is also sitting on a £10 million stake.

Sanghera said in a statement that the world is “living on the cusp of the genomic era”, adding that the company’s technology “will open up many new possibilities for positive impact, both through enabling new discoveries in scientific research, and through more accessible, faster, richer biological insights in health, agriculture, food and understanding environments.”

In its prospectus, Oxford Nanopore said the proceeds from the IPO would be used to increase R&D investment, double its commercial team within the next 18 months, and build up its manufacturing and business development capacity.

It may also use the cash injection for “in-licensing opportunities and potential acquisitions”, according to the document.

https://pharmaphorum.com/news/oxford-nanopore-makes-stellar-debut-on-uk-stock-market/