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Vial and syringe with a vaccine

Clover Biopharmaceuticals, a clinical-stage firm developing a Covid-19 vaccine with potential manufacturing and distribution advantages over other vaccine technologies, has raised $230 million as it prepares to advance its lead candidate into pivotal testing.

Chengdu, China-based Clover said Tuesday that it expects to start a global Phase 2/3 clinical trial for its vaccine candidate, SCB-2019, in the first half of this year. The company added that it has already started planning for the production of potentially hundreds of millions of vaccine doses.

The Clover Covid-19 vaccine is protein-based. SARS-CoV-2, the virus that causes Covid-19 infection, is an enveloped RNA virus—the outer coating is dotted with spike proteins that bind to a receptor on the host cell. These spikes are trimeric, meaning they’re formed by three proteins.

Using its Trimer-Tag technology, Clover developed a trimeric spike protein that resembles the one found on the outer envelope of the novel coronavirus. The vaccine uses an adjuvant, an ingredient that boosts immune response, supplied by Dynavax Technologies.

As a protein-based vaccine similar to many of the vaccines developed for influenza, shingles, and hepatitis B, Clover said production can use manufacturing processes that are already well established. The company added that this production can be rapidly scaled up to large quantities.

Another advantage of the Clover vaccines are the temperature requirements. The company said its vaccines and adjuvant should be stable for long periods at refrigerator temperatures of 2 to 8 degrees Celsius. At room temperature, Clover has said its vaccines are stable for at least two months. Those temperature and storage requirements stand in contrast to messenger RNA vaccines, which must be distributed frozen and stored at temperatures well below what medical-grade freezers can achieve. Last week, Pfizer and BioNTech asked the FDA to approve a change in the storage temperatures permitted once vaccines reach a vaccination site.

The new financing follows publication in The Lancet earlier this month of peer-reviewed results from an early-stage test of two Clover Covid-19 vaccine candidates. The 150-patient study showed that the vaccines were well tolerated and safe. Both vaccines also induced neutralizing antibodies at levels comparable to or higher than those found in the blood of those who have recovered from Covid-19.

Clover said that its research includes vaccines that could address multiple variants of the novel coronavirus. In addition to supporting its Covid-19 vaccines, Clover said the new capital will support plans to advance multiple programs into human testing later this year. Other vaccines in the Clover pipeline include programs for rabies and influenza. The company also said it plans to expand its manufacturing and capabilities.

GL Ventures and Temasek both led the Series C financing. Oceeanpine Capital, OrbiMed, and Delos Capital also invested. Clover said it has raised more than $400 million in the past year.

Clover also has financial support from the Coalition for Epidemic Preparedness Innovations (CEPI), which has committed to finance development of the company’s Covid-19 vaccine candidate up through licensure with a total investment of $328 million. Some of that cash will fund the global Phase 2/3 study. If the Clover vaccine is shown to be safe and effective, it would be distributed through Covid-19 Vaccines Global Access, or COVAX, the World Health Organization’s initiative to ensure equitable vaccine access throughout the world.

Public domain photo by Flickr user Alachua County

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Pfizer and BioNTech are asking the FDA to approve a change that would permit storage of their Covid-19 vaccine within a temperature range found in medical-grade freezers.

To be clear, this proposed change doesn’t eliminate the need for ultra-cold temperatures as the vaccine moves throughout the supply chain—temperatures that require specialized equipment. Those storage requirements are a barrier to its distribution because not all facilities have equipment that can achieve the required temperatures. What Pfizer and BioNTech are proposing is that when the vaccine reaches its destination, such as a hospital or pharmacy, it could be stored for up to two weeks at (relatively) warmer freezer temperatures.

The FDA granted emergency use authorization to the messenger RNA vaccine, named Comirnaty, last December. According to the product’s label, the vaccine must be stored in ultra-cold temperatures between minus 112 degrees and minus 76 degrees Fahrenheit (minus 80 degrees and minus 60 degrees Celsius). At those temperatures, the vaccine can last up to six months. Pfizer ships the vaccines in specially designed containers that can be refilled with dry ice every five days. Those containers can serve as temporary storage for up to 30 days.

The vaccine can be stored at refrigerator temperatures for up to five days. Pfizer and BioNTech are asking the FDA to approve an additional option to store the vaccine at minus 13 degrees to 5 degrees Fahrenheit (minus 25 degrees to minus 15 degrees Celsius) for two weeks. That range would put it closer to the storage requirements for the mRNA vaccine from Moderna. The temperature range Pfizer and BioNTech are proposing would be in addition to the five days at refrigerator temperatures that is currently permitted under the authorization.

“If approved, this new storage option would offer pharmacies and vaccination centers greater flexibility in how they manage their vaccine supply,” Pfizer CEO Albert Bourla said in a prepared statement.

Pfizer and BioNTech are proposing the additional temperature option based on new data about their vaccine’s stability. The data span from the earliest clinical trials up to batches currently in production.

Messenger RNA vaccines are a new technology that employ a snippet of genetic material from the novel coronavirus. This mRNA serve as a blueprint that a cell’s protein-making machinery use make the characteristic spike protein found on the surface of the novel coronavirus. That protein is what triggers an immune response and confers immunity.

Though mRNA vaccines are administered at room temperature, they must be kept at ultra-cold temperatures in the supply chain because mRNA is fragile. The extremely cold temperatures keep the components of the vaccine from breaking down. As mRNA companies study the storage data they have for vaccines, they are getting a better understanding of how long these vaccines can last at certain temperatures. Last November, Moderna released data that it said supported storage of its vaccine at refrigerator temperatures for up to 30 days.

Temperature requirements can be a barrier to the distribution of the vaccine to rural areas, which may not have facilities with appropriate freezers. In that regard, the Johnson & Johnson Covid-19 vaccine is seen as offering an advantage. In addition to requiring only a single shot (both authorized mRNA vaccines require two), the J&J vaccine can be stored at standard refrigerator temperatures. An FDA advisory committee is scheduled to hold a hearing about that vaccine on Feb. 26.

Photo by BioNTech

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Paula Soteropoulos

Gene therapy may offer potential cures, but its promise comes with a price. Some experimental approaches require a multi-step process to prepare stem cells for the procedure—a burden to a patient and to the healthcare system, according to Paula Soteropoulos, executive chair of startup Ensoma.

Soteropoulos’s company is proposing an alternative. The Boston-based biotech is developing technology that won’t require hospitalization in a specialized medical center. Furthermore, the Ensoma technology does its therapeutic work in vivo—inside the patient. These features could make genomic medicine more accessible, turning a lengthy hospital process into a single visit to a doctor’s office.

“Our hope with our technology is to be able to do it outpatient,” Soteropoulos said. “It’s an injection that can be done anywhere, it doesn’t require specialized centers.”

Ensoma emerged last week with details about its technology and $70 million in Series A financing. The company also revealed something unusual for a preclinical startup coming out of stealth: a research partnership with a large pharmaceutical company. Takeda Pharmaceutical is collaborating with Ensoma on up to five disease targets.

Soteropoulos, the former CEO of rare-disease drug developer Akcea Therapeutics, said Takeda and others that want to be in gene therapy are looking for in vivo innovations. Ex vivo approaches, in which a patient’s cells are removed and manipulated in a lab before being reintroduced, pose complexities and challenges for companies trying to commercialize them and to healthcare facilities that will provide them, she said.

Gene therapies reach target cells as cargo carried on engineered viruses. But these viruses come with limitations. Adeno-associated virus (AAV), a commonly used vector, can trigger an immune response. AAV also has limited capacity, which makes it hard to deliver a therapy consisting of a larger gene.

An alternative vector, lentivirus, has more capacity but is still limited in its ability to carry a big payload. This approach requires collecting a patient’s stem cells and engineering them outside the body. Before the stem cells are reintroduced, patients must undergo conditioning, comprised of chemotherapy. This step helps the stem cells carrying a therapeutic gene to be taken up by bone marrow, where they will proliferate. But conditioning can lead to side effects such as greater susceptibility to infection and bleeding. Avrobio and bluebird bio are among the biotechs developing lentiviral stem cell gene therapies that require patient  conditioning.

Soteropoulos describes Ensoma’s engineered adenoviruses as “gutless.” On the inside, they’re stripped of viral DNA or RNA that could trigger an immune response. On the outside, the viruses are engineered to specifically target hematopateic stem cells in the bone marrow. They can also target the cells that arise from these stem cells, such as T cells, B cells, and myeloid cells.

There’s another benefit to Ensoma’s gutless viruses. Removing their DNA or RNA creates more room for the genetic payload—more than three times as much as what the viruses used to deliver the current generation of gene therapies can carry. With that extra space, Ensoma’s vectors can carry larger genes as well as gene-editing tools, such as CRISPR or zinc finger nucleases.

“It allows us to do things that other gene therapies cannot,” Soteropoulos said.

Ensoma’s science is based on 20 years of research from the company’s scientific co-founders, Hans-Peter Kiem of the Fred Hutchinson Cancer Research Center, and André Lieber of the University of Washington School of Medicine. In the past five years, that research started forming the foundations of a company. In 2017, the scientists published research showing how their cells were taken up by the bone marrow in a monkey study. Last year, they published study results showing how their approach corrected two genetic disorders, beta thalassemia and sickle cell disease, in mice.

Ensoma was founded about 18 months ago, backed by seed financing from 5AM Ventures, Soteropoulos said. The startup licensed technology from Fred Hutch and UW, then added to the research, building on the intellectual property surrounding it. She said the research reached the point where additional financing was needed to support the next step of selecting which diseases to pursue.

Along the way, the startup drew interest from larger companies that had followed the science of its founders, Soteropoulos said. One of those companies was Takeda. In addition to investing in Ensoma’s Series A financing, the Tokyo-based pharmaceutical giant is also a research partner. The collaboration grants Takeda an exclusive global license to Ensoma’s technology for up to five rare diseases. That alliance could lead to up to $100 million in upfront and preclinical research payments to Ensoma. If all five programs reach the market, Ensoma could receive as much as $1.25 billion in milestone payments plus royalties from sales.

The Ensoma technology offers the potential to go beyond rare diseases. Soteropoulos said that the in vivo approach does away with all the complexity of working with a therapy outside of the body, making these therapies simpler to manufacture and easier to administer. She added that the fact that these therapies won’t require conditioning or stem cell donors helps extend the reach of these genetic medicines to common diseases.

Ensoma is pursuing rare diseases first. The technology is new, so regulators will need time to understand it, Soteropoulos said. Takeda and Ensoma aren’t disclosing the disease targets they have in mind and Soteropoulos said it’s too soon to say when the technology will reach human testing. But she added that because Ensoma’s approach holds promise to address many diseases, there are plenty to choose from. The startup may look for other collaborators in the future but in the near term, the company will focus on developing its own therapies in addition to working with Takeda.

“There are some rare diseases where there is already validation from being able to make these modifications and cure,” Soteropoulos said. “We would be working off of that for our first indications and then see how we can explore other areas.”

5AM led Ensoma’s Series A financing. Besides Takeda, the new round of funding included the participation of F-Prime Capital, Viking Global Investors, Cormorant Asset Management, RIT Capital Partners, Symbiosis II, and Alexandria Venture Investments.

Photo by Ensoma

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Johnson & Johnson has formally asked the FDA to allow emergency use of its Covid-19 vaccine as the company seeks to add a third option to the U.S. lineup of vaccines for the novel coronavirus.

The application comes a week after J&J released preliminary data showing 66% overall efficacy in a Phase 3 clinical trial. Those results fall short of the efficacy marks of messenger RNA (mRNA) vaccines from Moderna and Pfizer. But the J&J jab offers advantages compared to those vaccines.

Unlike mRNA vaccines, which are given as two doses weeks apart, J&J’s vaccine is a single shot. Also, the J&J vaccine can be kept at refrigerator temperatures. Both the Moderna and Pfizer vaccines must be kept frozen—Pfizer’s at ultra-cold temperatures. They’re then thawed and temporarily stored at refrigerator temperatures before dosing.

J&J’s vaccine storage requirements are the same as those for most vaccines, making it an easier fit vaccine distribution channels already in place. The company said that if authorized, its vaccine will ship using the same cold chain technologies it uses for transporting other medicines. Of the vaccine candidates that have advanced to late-stage testing, J&J’s is the only one given as a single dose.

Before the FDA decides whether to grant emergency use authorization to the J&J vaccine, the pharma giant’s candidate must be evaluated by an independent advisory committee to the agency that will evaluate the clinical data and discuss the efficacy and safety risks of the shot. The vaccines from both Moderna and Pfizer went through the same step. The J&J meeting is scheduled for Feb. 26.

J&J’s vaccine, developed by the company’s Janssen division, employs a version of the virus that causes the common cold. That virus is modified so it does not cause illness. It’s used to deliver to cells a snippet of the genetic code for the spike protein, which is prominent on the surface of the novel coronavirus. The cells of the body read that genetic material and make copies of the spike protein. The immune system responds to those copies by making antibodies that protect against Covid-19.

AdVac is the same platform Janssen used to develop an Ebola vaccine that was approved by the FDA in 2019. The technology is also the foundation of experimental Zika, RSV, and HIV vaccines. J&J said that the safety profile observed with its Covid-19 vaccine was consistent with other experimental vaccines based on AdVac.

J&J evaluated its Covid-19 vaccine in a Phase 3 study enrolling 43,783 patients. The main goal was to show protection from moderate to severe disease. There were geographic differences in efficacy rates. The vaccine candidate was most protective in the U.S., where efficacy was 72%, the company said. In Latin America, efficacy was 66%; in South Africa, it was 57% effective. While those marks fell short of the efficacy rates demonstrated by the Moderna and Pfizer vaccines, cross trial comparisons are tricky. Also, the J&J studies were done when more variants of the novel coronavirus were circulating compared to when the Moderna and Pfizer vaccines were tested.

Paul Stoffels, J&J’s chief scientific officer, said in a prepared statement that the company has vaccines ready to ship immediately upon receiving emergency authorization.

“With our submission to the FDA and our ongoing reviews with other health authorities around the world, we are working with great urgency to make our investigational vaccine available to the public as quickly as possible,” he said.

In addition to the submission to the FDA, J&J is seeking similar authorizations from health agencies in other countries. The company said an application to the European Medicines Agency will be submitted in coming weeks.

Photo: Teka77, Getty Images

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For decades, scientists have known that viruses can kill cancer cells. The challenge has been harnessing that power safely and effectively.

Buoyed by advances in immunotherapy and drug discovery, a new wave of researchers and companies is poised to make a run at that challenge over the next few years with a class of therapies known as oncolytic viruses.

“We’re just on the brink of some really exciting developments in our field,” said Charlotte Casebourne, CEO of Theolytics. Based in Oxford, England, the company hopes to move its lead oncolytic virus candidate into clinical trials over the next two to three years.

The field is based on a relatively simple premise. A virus is injected into tumor cells; the virus replicates and blows up – or lyses – the tumor cells; the immune system recognizes the remaining tumor cells and clears them out.

The premise was discovered decades ago in patients who came down with viruses alongside cancer. The viruses attacked the cancer but they also could harm patients.

Early research focused on attenuated viruses, which generally proved too weak to do much. Recent advances are solving that challenge while addressing new ones, such as preventing the immune system from turning on the virus.

“Right now, it’s about finding that Goldilocks, that perfect happy medium,” said Greg Delgoffe, a cancer immunologist and associate professor at the University of Pittsburgh.

The field got a shot in the arm in 2015 when Amgen won approval from the U.S. Food and Drug Administration for an oncolytic virus therapy called T-VEC. Based on a genetically modified herpes simplex virus and marketed as Imlygic, it is used to treat melanomas that cannot be surgically removed.

“We have this example which provides us with really nice clinical proof of concept that efficacy is possible with oncolytic viruses as a technical approach,” Casebourne said in a Zoom interview.

T-VEC, however, is injected directly into a tumor. Some of the newer therapies are designed to be injected intravenously, allowing them to move through the body to clear cancer.

Theolytics’ lead candidate is TheoAd281, an adenovirus-based therapy that targets ovarian cancer. Clinical trials will focus on its safety and efficacy as a monotherapy, delivered intravenously, before delving into its potential in combination with other therapies, Casebourne said.

The company was founded in 2017 by Casebourne and researchers Margaret Duffy, Kerry Fisher and Len Seymour. It raised $6.8 million in a Series A round in early 2021 led by Epidarex Capital and Taiho Ventures, with participation from existing investor Oxford Sciences Innovation.

In addition to Amgen’s approved therapy, the field has benefited from advances in drug discovery and gene sequencing, Casebourne noted. Theolytics uses a proprietary phenotypic platform to figure out which virus variants might be effective against particular tumors, Casebourne said. The platform speeds up the discovery process to between 12 and 18 months, she added.

Valo Therapeutics also is banking on a platform approach. Its platform incorporates peptides to create oncolytic viruses that do not linger in the body after they turn the immune system against tumor cells. Its lead candidate, PeptiCRAd 1, is expected to enter phase 1 trials this year, most likely for treating melanoma and non-small cell lung cancer, according to Paul Higham, CEO of Valo, which is based in Oxford, England.

The use of peptides is based on research by Vincenzo Cerullo, a professor and head of the drug research program at Helsinki University in Finland.

“Because it’s actually a simple process to attach peptides on the surface of the oncolytic virus, we can be extremely flexible in terms of what we attach to the viruses,” Higham said. “We can select all different kinds of peptides to stimulate all different kinds of immune responses.”

Different tumors may require different peptides, he said. “The most effective therapies in the future are going to be those that are most specific to the patient being treated, and our platform really allows to do that.”

Another contender in the space is CG Oncology, based in Irvine, California. In December, the company raised $47 million in a Series D round led by Kissei Pharmaceutical Co. Ltd. CG’s main oncolytic virus candidate, CG0070, is being examined in several clinical trials.

A phase 3 trial is testing the candidate as monotherapy for a form of bladder cancer. A phase 2 trial is studying CG0070 for the same indication but in combination with Merck’s Keytruda, a checkpoint inhibitor. The candidate is injected directly into the tumor.

Checkpoint inhibitors release the brakes on the immune system while the oncolytic virus strengthens the immune response, said Arthur Kuan, CG’s CEO. “I think oncolytic viruses will continue to emerge as one of the best combination partners with checkpoint inhibitors.”

The company is planning to move into other cancers this year, Kuan said in a phone interview. He and others expect that future oncologists will have a range of viruses to choose from based on a range of factors, including the type and location of the cancer.

It may be years before therapies win approval, Kuan said. But he believes the oncolytic virus field is coming into its own.

“We’re definitely in a rising-tide environment with many catalysts coming up in the next 12 to 18 months,” he said.

The field’s challenges over the years have made investors somewhat leery, said Dr. Mark McCamish, CEO of San Diego-based IconOVir Bio.

For its part, IconOVir was able to overcome investor skepticism by explaining how the field has overcome some of its earlier challenges, McCamish said. Those challenges have included creating an oncolytic virus that could escape detection by the immune system and confer lasting immunity against a tumor. IconOVir Bio raised $77 million earlier this year in Series A funding to advance its platform for creating oncolytic virus therapies. The platform is based on more than a decade of research by company co-founder Clodagh O’Shea of the Salk Institute for Biological Sciences.

“It’s data-driven. It’s not just a story,” said McCamish, who previously led immune-oncology company Forty Seven before it was bought last year by Gilead Sciences.

IconOVir is hoping to start clinical trials of its lead candidate, IOV-1042, in the first half of 2022. Derived from the common cold virus, IOV-1042 has been shown in preclinical research to infect and kill a range of tumor cells, including head and neck, bladder, lung and breast.

“I think it’s an exciting field and an exciting time,” said McCamish. “And if the science comes to fruition, it’s a great opportunity.”

Photo: Main_sail, Getty Images

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When he worked part-time one summer in a Brooklyn pharmacy, Rahul Kavuru made occasional sweeps of the store’s inventory to find nearly expired drugs and dispose of them.

The high school student suspected the drugs could have been put to better use. Conversations with his peers reinforced the notion and eventually prompted action on what is, in fact, a costly problem for pharmaceutical companies.

In early 2020, Kavuru, his sister and a friend started a nonprofit, Altrui Rx, and built a technology platform to match drug companies with nonprofits that help patients in need.

“The biggest problem is that it costs money to destroy the medication and it costs money to hold the product,” said Kavuru, a junior at St. Paul’s School in New Hampshire. His co-founders are his sister, Shreya Kavuru, a senior at St. Paul’s, and Sourish Jasti, a freshman at The Wharton School at the University of Pennsylvania.

Their research into the problem led them to conclude that roughly $5 billion worth of medication is destroyed each year at a cost of between $1 and $3 per pound, Rahul Kavuru said in a phone interview.

Drug companies often collaborate with charities to distribute medications they might otherwise destroy. But it is hard for manufacturers to work with more than a handful of charities, said Jasti, who plans to pursue studies in entrepreneurship and innovation.

Altrui’s platform makes it easier to find charities and learn what they need, Jasti said. Drug companies sign in, upload inventory that is near expiration and then pick from a list of organizations where they can send it. The charities are all vetted by Altrui.

Drug companies can then download packing slips and tracking numbers to send their products to the selected charities.

“We are an intermediary in the process,” Kavuru said. “The goal is to bring out more impact and create an accessible portal for these medications.”

Within a few months after its founding, Altrui had redirected nearly $12.3 million worth of medication. Its pharmacy partners include Aurobindo Pharma, Ingenus Pharmaceuticals and Rising Pharmaceuticals, where Altrui’s founders had an inside connection through a neighbor in their hometown of Holmdel, New Jersey. Rahul and Shreya now live in Rumson, New Jersey.

The founders initially spent their own money to build and host their website. But they have gotten subsequent funding from Aurobindo, the New Jersey Health Foundation and the BEN Health Innovation Summit, which is sponsored by Rutgers University. BEN stands for Biomedical Entrepreneurship Network.

They also have started a companion nonprofit, Altrui Education. It provides college counseling services to disadvantaged students. The two charities are staffed by a team of 15 volunteers.

In addition to their work at Altrui, Jasti and Rahul Kavuru run a blog called CompanyRoots, which interviews business experts and entrepreneurs about their experiences.

Altrui’s founders have impressed Paul Moore II, president and CEO of CitiHope Relief and Development in Margaretville, New York.

Over the past three decades, CitiHope has delivered more than $1.5 billion worth of donated medication to people and organizations around the world. The nonprofit has existing relationships with drug companies, but decided to give Altrui a try, Moore said in a phone interview.

This led CitiHope to get connected to new donors using Altrui’s platform. Moore, whose own philanthropic career began when he was a teenager, was heartened to find that the founders of the nascent startup have worked hard to learn more about this charitable niche.  

“Every interaction I’ve had with them has been, ‘Can we do this better? How have you managed this in the past?’” Moore said.

Photo: cagkansayin, Getty Images

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A major hurdle to quick and efficient vaccine distribution could be the proliferation of “pharmacy deserts” across the country.

There are 56,802 local and chain pharmacies, which evens out to about 1.83 pharmacies per 10,000 people on average, according to a new report from GoodRx. But these facilities are unevenly distributed leaving many residents in “pharmacy deserts.” These are areas where people have to drive a long distance to reach the closest pharmacy or areas with too many people sharing the same pharmacy.

Pharmacy deserts may have dire implications for the Covid-19 vaccine rollout, according to a report from GoodRx, which tracks U.S. prescription drug prices and provides free discount coupons. Since pharmacies are playing a key role in administering the vaccine, living in a pharmacy desert may prevent Americans from getting vaccinated in a timely manner.

Two vaccines have been approved in the U.S., one developed by Pfizer and BioNTech, and the other by Moderna. Both are two-dose vaccines. So far, the rollout has been characterized by missteps and is moving slowly, with only 17 million vaccine doses administered out of nearly 38 million distributed as of Thursday, according to data from the Centers for Disease Prevention and Control. But President Joe Biden has promised to speed up the process — vowing to administer 100 million Covid-19 vaccine shots in the first 100 days of his administration.

GoodRx examined pharmacy deserts using information from the National Council for Prescription Drug Program’s DataQ and the GoodRx databases. Researchers also used data from the American Community Survey to calculate population per county.

Both rural and urban areas can have pharmacy deserts, according to the report.

Pharmacy deserts in rural counties are more likely to be characterized by a lack of pharmacy resources. About 177 U.S. counties have zero pharmacies, leaving 635,000 residents with no choice but to drive a long distance to access one.

On the other hand, pharmacy density is a bigger issue for Urban Americans, the report shows. For example, there are 10 million people living in Los Angeles County in California, but there are only 1.61 pharmacies per 10,000 residents. Cook County in Illinois, which has 5.2 million residents, has only 1.50 pharmacies per 10,000 residents. Both fall below the national average of 1.83 pharmacies per 10,000 residents.

Many pharmacy deserts are also vaccination deserts, the report states.

For instance, assuming the promised 100 million vaccines are distributed, only 11.2% of the population in San Mateo County, California, will receive both doses of the Covid-19 vaccine, researchers estimate, as the county only has 1.06 pharmacies per 10,000 residents.

Other similar vaccine deserts include Shelby County, Tennessee, El Paso County, Texas and Pinal County, Arizona.

The researchers conclude that administering the Covid-19 vaccine through pharmacies alone “is not going to cut it.” Additional mass vaccination sites are going to be needed as well as support services in more rural counties, like transportation or in-home vaccinations.

Biden’s administration has already heeded the call for more vaccination sites. The president’s vaccine distribution plan, unveiled in a speech last week, includes plans to mobilize the Federal Emergency Management Agency and the National Guard to ramp up distribution, according to STAT News.

Photo: LarisaBozhikova, Getty Images

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The Covid-19 pandemic may fade but some of the changes it has wrought in the life sciences may – or should – endure, according to two prominent pharma CEOs who spoke during a session Friday at the J.P. Morgan Healthcare Conference.

For starters, the pandemic has shown how quickly companies and regulators can bring products to market, with tests, vaccines and therapies being studied and approved at record speeds, according to the CEOs, Paul Hudson of Sanofi and Tom Polen of BD.

Companies also have collaborated in ways they would not have contemplated previously. Hudson cited Sanofi’s work with GSK to develop a Covid-19 vaccine. The partnership might once have taken a year to come together but took only 12 days, Hudson said.

“So many times, it was a race against the virus, not a race against each other,” said Hudson, who became Paris-based Sanofi’s CEO in fall 2019 after leaving Novartis.

Regulators have moved at similar speeds, delivering answers in minutes rather than months, Hudson said.

The fast pace stems from the pressure of Covid-19, which has killed two million people around the world and is continuing to spread and mutate. But the sense of urgency could be applied in the future to tackle other diseases, like childhood cancers.

“I think the industry is at its best when it’s purpose-driven with a singular focus,” Hudson said during the JPM session, which was moderated by managing directors at Boston Consulting Group.

Large pharma companies, meanwhile, showed that they could pivot and innovate quickly, despite stereotypes to the contrary. Polen cited BD’s effort to develop a rapid-antigen test for Covid-19. It went from launch to monthly production of 10 million units within six months, said Polen. It normally would take three years.

The speed was a function of setting a clear mandate and a deadline but also doing things differently inside the company, Polen said. While the test was a life science project, for example, BD plucked talent from across the organization to lead the charge.

Another key was empowering and supporting employees so that they were not afraid of taking risks. Early on, the team found a promising antibody, one that is now used in the test, Polen said. The normal progression would be to order a small batch, wait to see if it works and then start ordering batches for commercial production. BD executives assured employees they were OK with ordering the commercial batches up front despite the risk and cost.

“That ended up being a tremendous part of the success equation,” Polen said

The pandemic was not the only force reshaping the industry in 2020. Hudson and Polen discussed the lasting impact they hope to see from the racial justice protests that followed the death last year of George Floyd, an African American, at the hands of Minneapolis police officers.

“This year brought a whole new and very much-needed focus on this issue for us as BD,” said Polen, who became CEO of the Franklin Lakes, New Jersey-based company in January 2020.

The company’s leaders have worked to create an environment where employees feel comfortable broaching difficult topics around race, Polen said. “That was a big change this year.”

Harris noted the need to improve diversity among patients in clinical trials but also among the investigators.

For 2021, Harris and Polen expect a sharper competition for talent in the life sciences.

“I think it’s going to escalate after we get out of Covid,” Polen said. But some of the workplace changes wrought by the pandemic could prove useful in the competition. Employees that once might have had to move for a promotion or a new job now can stay where they are and work remotely, an option that could help dual-income families.

Polen and Harris also discussed the growing role in health care for big tech companies like Amazon, Apple and Google. The CEOs painted the tech giants as potential partners rather than rivals. Not only can tech companies help bring products to patients, they also tools to transform pharma’s internal operations.

The challenge ahead lies in preserving the energy, purpose and speed that animated the industry in 2020, Hudson added. “People can quickly fall back into the old routines.”

Photo: Dmitrii_Guzhanin, Getty Images

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 Cancer care is changing for the better. Advanced cancers that were once considered incurable only seven or eight years ago are now looked upon in a new light thanks to researchers, biotech and pharma companies introducing advanced treatment modalities to the market. Today, clinicians are armed with different treatment options, including targeted therapies and immunotherapies in addition to the more traditional chemotherapy, radiation and surgery approaches.

These new treatments have, in fact, reduced the cancer death rate by 27% over the past 25 years and given the average cancer patient hope for survival. Unfortunately, there are still an estimated 600,000 U.S. citizens who succumb to cancer each year according to the U.S. Cancer Society. This can be attributed to most patients being treated with a ‘one-size-fits-all’ mindset, and a general lack of appropriate predictive biomarkers to guide and personalize cancer treatment.

In recent years, the concept of personalized medicine, or “precision medicine,” has come to the forefront of advanced healthcare systems across the globe. This approach attempts to tailor medical treatment to the individual biologic characteristics of each patient, helping physicians provide optimal care and improve patient outcomes. Within the cancer care community, precision medicine is an integral component of immunotherapy, a new approach that harnesses the power of a patient’s immune system to identify and control diseases such as cancer, boosting the body’s natural defenses to fight the disease. While immunotherapy has made a vital reform in cancer care, the challenge of understanding which patient will benefit from immunotherapy is still an obstacle. In 2019, the American Society of Clinical Oncology (ASCO) defined this challenge as one of the top nine research priorities.

According to research published by JAMA, an estimated 43.63% of U.S. cancer patients are eligible for checkpoint inhibitor immunotherapy, yet only 12.46% (on average) are estimated to respond. This limited response rate can be attributed to the lack of understanding of how patients will react to a given immunotherapy treatment. One of the top questions facing researchers in the field today is “who will respond best to immunotherapy?”

Enter Host Response Profiling
Many studies have focused on tumor-related factors, including driver mutations and cell components in the tumor mass as the basis of resistance. However, in recent years, new studies have indicated that the host (patient) response to almost any type of anti-cancer therapy plays a pivotal role in determining and affecting the response to treatment. Now, if we consider the complexity of the ‘biologic universe’ that is the human body, this understanding of the role of the host should not come as a surprise. In many cases, our own body can even ‘team up’ with the invasive tumor to negate the effects of cancer treatment, resulting in further tumor growth rather than elimination. Shockingly, this phenomenon remained hidden from us for many years.

With advanced AI and machine learning tools, new solutions are now being made available to physicians that allow them to profile patients early in the immunotherapy treatment process to better characterize, analyze and predict host response – or see how the patient will respond to the treatment.

Host response can be identified by proteomic profiling, which involves analyzing a broad range of select proteins in a series of patient blood samples, with the first collected prior to treatment and the next collected after the first dose of treatment. The tracked changes in the select series of proteins between the samples can then be used to serve as a predictive tool to determine the likelihood of the treatment’s success and further guide physicians in tailoring treatment plans for individual patients. With this approach, physicians can better predict which immunotherapy treatment will work for each individual patient, optimizing patient care outcomes while reducing treatment costs and minimizing potential adverse treatment side effects.

Host Response Profiling Waiting In The Wings
I recently came across a patient story of a 62-year-old woman who was admitted into the hospital who had a severe cough and blood in her sputum. The woman, who was a heavy smoker, was diagnosed with non-small-cell lung carcinoma (NSCLC), with the primary cancer located in her lungs and traces of metastasis in her liver and brain. In order to choose the treatment protocol – and as part of the pre-treatment work up – PD-1 levels were measured in the tumor, and the patient’s tumor demonstrated a high expression of PD-1 (a protein that serves as an approved biomarker to guide treatment decision). Usually, this is considered to be good news, since the first line of treatment for tumors with a high expression of PD-1 is a drug that is directed against PD-1, such as Merck’s Keytruda.

As part of a clinical trial, the patient underwent host response analysis to monitor the dynamics of her biological processes in response to her cancer treatment method. Upon receiving the results of the analysis, it was discovered that despite the high PD-1 levels that were measured, the response probability for that specific patient was very low (less than 2%) given the treatment protocol that was chosen for her. Her proteomic analysis also revealed that there were several potential treatment combinations that might have given her a much higher chance of success. The host response analysis tool used for this patient was still in development while this patient was undergoing care, and her physicians were not allowed to implement these added insights. Unfortunately, she passed away three months later.

Putting The Odds In Our Favor
Physicians face incredibly difficult decisions every single day. When patients respond well to treatment, the choice to stay on the course is a relatively simple one. When patients are not responding and cancer growth continues, albeit at a slower rate, physicians need to decide whether to continue with the same treatment modality or attempt an alternate course of care. This decision is made even more problematic as cancer patients are fighting against the clock, not to mention that these treatments can cause uncomfortable and sometimes serious adverse side effects for the patients receiving them.

The more we learn about cancer, the more we understand just how unpredictable, distinct and deadly this disease can be. While cancer is not a one-size-fits-all disease, the treatment currently is, and this needs to change. It is imperative that our physicians be empowered with advanced patient information before and during treatment regimens so that they can provide precise medical treatments for each patient’s specific diagnosis and biological needs. If we can help physicians expedite proper, individualized treatment as quickly as possible, we can help them give their patients a fighting chance.

Photo: mathisworks via Getty Images

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The next generation of antibody testing for Covid-19 is beginning to take shape.

Initial tests determined whether someone had or did not have antibodies to the virus’s signature spike protein. A new crop promises to quantify the antibodies, an advance that could be crucial as researchers seek to understand longer-term immunity from the virus, whether acquired through vaccines or natural infection. But that is not the only question out there.

“There’s still a lot to be learned,” said Michael Haydock, a senior director at Informa Pharma Intelligence in London.

For example, he said, researchers don’t know if there is a threshold number of antibodies a person needs to maintain immunity, Haydock said. Quantitative tests could help pinpoint a threshold and track whether antibodies fall below it, potentially necessitating a booster vaccine.

“Measuring that is going to be very important,” Haydock said in a phone interview. Tests also may be able to quantify differences in immune response based on age, race and other factors.

In addition, quantitative tests can be used to assess people who have recovered from Covid-19 and want to donate plasma for use in convalescent plasma therapy, a treatment for the virus. Researchers also may be interested in understanding the response to Covid-19 vaccines among those who are already on therapies that modify their immune systems.

“That’s the nature of this pandemic, that you’re trying to move forward when you have more questions than you have answers. Antibody testing can help answer those questions,” said Sara Barrington, chief commercial officer for Kantaro Biosciences.

The New York-based company offers a quantitative antibody test for Covid-19 using technology developed at Mount Sinai Health System early in the pandemic. Kantaro is a joint venture between Mount Sinai and RenalytixAI, a diagnostics company based in the United Kingdom.

Complicating the issue is the lack of an agreed-upon standard for measuring antibodies. However, clarity is on the horizon.

The World Health Organization is expected to set standards soon, Barrington said in a phone interview.

“With an international standard, you’d be able to compare the results across different tests,” said Erik Lium, Kantaro’s chairman and the chief commercial innovation officer at Mount Sinai.

In November, the Food and Drug Administration approved Kantaro’s test for emergency use. But the approval comes with a qualification: the test, called COVID-SeroKlir, is considered semi-quantitative.

The FDA appears to be waiting for the international standard to be set before declaring tests fully quantitative, Barrington said. However, European regulators are not waiting. They cleared COVID-SeroKlir for use as a fully quantitative test.

Other tests also have won clearance. One was developed by drug maker Roche, based in Basel, Switzerland. Its test – the Elecsys Anti-SARS-CoV-2 S – is being used in a partnership with Covid-19 vaccine maker Moderna to trace antibody responses in vaccine-trial participants. Like Kantaro’s, the Roche test was approved for emergency use as a semi-quantitative test.

Some are looking beyond Covid-19 to other infections.

A group of researchers from Linnaeus University and bioanalysis company Attana, both in Sweden, is developing a quantitative test for Covid-19, as well as the bacteria that causes tetanus.

“Our vision is a general diagnostics platform that is relevant not just at present, during the ongoing pandemic, but one that will also serve a greater, broader purpose in the future” Teodor Aastrup, Attana’s CEO, said in a statement.

Photo: sorbetto, Getty Images

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