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Infographic – Apple Leads in A.I. Acquistions

A.I. acquisitions chart

Click on image for full-size view (Statista)

11 July 2020. The race to lead in artificial intelligence is a matter of strategic importance to nations, but also to big technology companies. Among the tech giants, Apple is the most aggressive in acquiring start-ups developing A.I. applications over the past 10 years, according to a chart posted this week by business research company Statista.

The chart is based on data compiled by technology market intelligence company CB Insights, which shows from 2010 through September 2019, Apple bought out 20 A.I. developers. Google is next with 14 acquisitions since 2010, followed by Microsoft, Facebook, and Amazon with seven to 10 acquisitions each. But as noted in the CB Insights report, consolidation is rampant in the A.I. field with 635 acquisitions over the past decade. Thus the 59 businesses acquired by the big five tech companies account for less than 10 percent of the total.

The Covid-19 pandemic is likely slowing the pace of A.I. acquisitions in most parts of the world. As our links below indicate, however, technology developers are making good use of A.I. to find solutions.

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HBCUs Still Putting Blacks in STEM

– Science & Enterprise special feature –

Katherine Johnson

Katherine Johnson, one of the mathematicians portrayed in the film Hidden Figures, was a graduate of West Virginia State College, an historically Black institution. 1983 photo. (NASA, Wikimedia Commons)

Clinton Parks

10 July 2020. The book and eponymous movie “Hidden Figures” shed light on the African-American female mathematicians at NASA and its predecessor, NACA, during the 1940s and 1950s. These women, called the West Area (or Colored) Computers, received their degrees from historically black colleges and universities. The local HBCU, then known as Hampton Institute, had a special part in training the computers with its Engineering for Women training class.

This was no anomaly, but just one example of the role HBCUs have played in preparing Blacks for professions in science, technology, engineering and mathematics — or STEM. HBCUs were almost the only place Blacks could receive a postsecondary education in the United States before the passing of civil rights legislation that ended oppressive racial segregation laws in the mid-1960s. Numbering just 100 in all, historically black schools account for only about two percent of the nation’s more than 4,500 degree-granting institutions of higher learning. HBCUs are a diverse set of institutions, said Ivory Toldson, president and chief executive of the QEM Network, a nonprofit that helps minority-serving institutions secure federal funding. HBCUs include four-year colleges and universities, community colleges, public and private institutions, as well as a few medical and law schools.

In the past, Blacks who earned their bachelor’s degree at HBCUs tended to earn STEM doctorates at higher rates than those who attended traditionally white institutions, according to a 2010 Urban Institute meta-analysis report. But is that still the case? The short answer is yes. HBCUs still hand out more bachelor’s degrees in STEM fields to Blacks than traditionally white institutions. But HBCUs no longer produce the rates of STEM bachelors they once did, and federal support for these programs has waned, recently.

HBCUs have bolstered the self-confidence necessary for many scientists who were taught there to endure and thrive in their fields. That affirmation can be as simple as seeing another Black person teaching a STEM class, said Jeffrey Handy, an assistant professor of biology at his alma mater of Morehouse. “A Black chemistry professor would more likely believe in the abilities of a young Black student,” he says. While about three percent of the faculty across all disciplines at non-HBCUs are Black, about 55 percent of faculty at HBCUs are Black, Rankins says, citing NSF data from 2006.

But the relationship between HBCU faculty and students is more than superficial. Howard University math professor Abdul-Aziz Yakubu has found weaker connections between faculty and students when he has taught or visited non-HBCUs, including where he received his graduate degree — North Carolina State University. Teaching at Howard “is a little more personal,” said Yakubu, who is from Ghana. Students at HBCUs see their professors as mentors, Yakubu said, and it’s a relationship he doesn’t see when teaching at historically white schools.

Continue reading HBCUs Still Putting Blacks in STEM

Cannabis Assessed for Pain in Real-World Trial

Cannabis plant

Cannabis plant (Michael Fischer, Pexels.com)

10 July 2020. A clinical trial in Canada is evaluating medical cannabis products as treatments for chronic pain with participants reporting their experiences online. The Medical Cannabis Real-World Evidence or MC-RWE study is conducted by Toronto General Hospital, part of University Health Network, and Canadian drug store chain Shoppers Drug Mart.

The opioid crisis is affecting Canada as well as the U.S., with much of the opioid abuse traced to addictions formed from prescription pain medications. Physicians in Canada and elsewhere hear from patients about pain relief offered by medical cannabis products, but little comprehensive, systematic, and detailed evidence has so far been collected. The MC-RWE study aims to provide data from patients prescribed cannabis-based pain treatments, with results tied to specific products and doses.

Hance Clarke, an anesthesiologist and director of pain services at Toronto General Hospital, is leading the project. “We need the evidence to help us in prescribing the appropriate validated product, at the right dose, for the right patient,” says Clarke in a University Health Network statement. “Ensuring quality standards will allow physicians and their patients to be confident about using medical cannabis to treat a wide range of pain-related ailments.”

In the study, patients report on cannabis-based pain treatments prescribed by their doctors and acquired through the online portal Medical Cannabis by Shoppers, a part of Shoppers Drug Mart. The study is enrolling 2,000 participants age 19 and older experiencing chronic pain, as well as sleep disorders, anxiety, or depression. This observational study has no control or comparison group.

Individuals are evaluated at the beginning of the study with several standard rating scales completed online assessing pain, sleep, anxiety, and depression, then after six, 12, and 24 weeks, receiving a nominal reward ($20) for taking part. Recreational cannabis users and people already registered with Medical Cannabis by Shoppers are excluded form the study.

Researchers expect participants will report on a wide range of cannabis-based products including dried flowers, oil extracts, edibles, and, topical treatments. Medical Cannabis by Shoppers, a funder of the project, says it can report on many aspects of items purchased through its portal, providing specific chemical and genetic details needed by the study team, with a system using blockchain to assure integrity of the data.

Ken Weisbrod, vice president for business development and cannabis strategy at Shoppers Drug Mart says, “Our development of a blockchain secured initiative, with TruTrace Technologies Inc., has now been integrated into an operational portal that will provide products with an immutable digital identity, that can capture everything from detailed chemistry down to its DNA.”

The MC-RWE team hopes the findings generate more systematic and rigorous evidence to provide more options for chronic pain patients. “The challenge with the medical use of cannabis,” notes Clarke, “is that physicians and patients are unsure of the quality of products being consumed. For the first time we will have a national repository of data that can provide answers about the effectiveness of these products, to test their claims.”

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Pharma Companies Form $1B Antibiotics Fund

Klebsiella pneumoniae

Klebsiella pneumoniae bacteria, among the microbes becoming resistant to antibiotics (CDC.gov)

9 July 2020. A group of 23 pharmaceutical companies are creating an investment fund to finance research and development of new drugs to combat antibiotic resistance. The AMR Action Fund — AMR stands for antimicrobial resistance — says it so far collected commitments approaching $1 billion to finance development of two to four new antibiotics by the year 2030.

Antimicrobial resistance occurs when bacteria or fungi mutate making current antibiotics ineffective in controlling their spread, leaving patients with fewer options in treating infections. The problem is compounded by overuse of antibiotics by humans or with animals, creating more opportunities for microbes to mutate and become resistant to current antibiotics.

As a result, a growing list of infectious diseases — including pneumonia, tuberculosis, blood poisoning, gonorrhea, and food-borne diseases — are becoming more difficult to treat. The AMR Action Fund cites data showing some 700,000 people worldwide die each year from antibiotic-resistant bacteria, with that number expected to rise to 10 million by 2050.

Compounding the problem further are the disappearing business incentives for companies to develop new antibiotics. In a December 2019 commentary, Science & Enterprise cites a New York Times story about antibiotic drug makers going bankrupt even as some products show promise against drug-resistant bacteria. And even with government contracting for these new antibiotics, venture investors remain reluctant to bankroll developers of these new drugs, preferring bigger payoffs from treatments for chronic disorders like cancer and heart disease.

AMR Action Fund aims to create more incentives for the industry to develop new antibiotics. The fund plans to step in for venture capital investors by investing in small biotechnology companies developing new antibiotics, as well as provide technical expertise as needed from participating companies. In addition, AMR Action Fund expects to enlist support from foundations, development banks, and multilateral organizations to encourage governments to create better market conditions for new antibiotics.

The 23 participating companies in the AMR Action Fund so far are members of the International Federation of Pharmaceutical Manufacturers & Associations, or IFPMA, the group organizing the initiative. IFPMA, based in Geneva, Switzerland, says participating companies committed some $1 billion to the fund. The fund plans to begin operating in the fourth quarter of 2020.

“With the AMR Action Fund,” says David Ricks, CEO of Eli Lilly and Company and president of IFPMA in an organization statement, “the pharmaceutical industry is investing nearly $1 billion to sustain an antibiotic pipeline that is on the verge of collapse, a potentially devastating situation that could affect millions of people around the world.”

Ricks adds, “The AMR Action Fund will support innovative antibiotic candidates through the most challenging later stages of drug development, ultimately providing governments time to make the necessary policy reforms to enable a sustainable antibiotic pipeline.”

Companies taking part in the AMR Action fund so far are Almirall, Amgen, Bayer, Boehringer Ingelheim, Chugai, Daiichi Sankyo, Eisai, Eli Lilly and Company, GlaxoSmithKline, Johnson & Johnson, LEO Pharma, Lundbeck, Menarini, Merck, MSD, Novartis, Novo Nordisk, Pfizer, Roche, Shionogi, Takeda, Teva, and UCB, as well as the Novo Nordisk Foundation.

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Disclosure: The author owns shares in Johnson & Johnson and Pfizer.

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NIH Opens Covid-19 Clinical Trial Network

Network pointer

(Gerd Altmann, Pixabay)

9 July 2020. National Institutes of Health is organizing a collection of sites for late-stage clinical trials to test Covid-19 vaccines and antibody treatments. The Covid-19 Prevention Network, or CoVPN, is operated by National Institute of Allergy and Infectious Diseases, or NIAID, the agency in NIH most responsible for Covid-19 vaccines and therapies, and Fred Hutchinson Cancer Research Center in Seattle.

CoVPN will test Covid-19 vaccines and antibody treatments in late-stage clinical trials. Late-stage trials, also called phase 3 trials, usually enroll thousands, even tens of thousands, of participants, testing experimental drugs or medical devices against a placebo, current drugs, or other experimental vaccines or therapies. As the name implies, late-stage trials are conducted after an experimental therapy or vaccine is shown to be safe, establishes safe dose levels, and demonstrates some clinical benefits in early- and mid-stage trials.

The first drug tested in CoVPN is made by Moderna Inc. in Cambridge, Massachusetts, code-named mRNA-1273, developed with NIAID. The vaccine is given as two injections, 28 days apart. As reported by Science & Enterprise in May, the company says early-stage trials among healthy volunteers show mRNA-1273 is generally well tolerated with a few severe adverse effects experienced at its highest dose level after the second injection. Also, mRNA-1273 produced neutralizing antibodies in eight recipients, age 18 to 55. The company did not report findings from older age groups.

The network is being established from four current networks already operating to test drugs for HIV and other infectious diseases: HIV Vaccine Trials Network,  HIV Prevention Trials Network, Infectious Diseases Clinical Research Consortium, and AIDS Clinical Trials Group. Together, CoVPN is expected to have about 100 sites in the U.S. and some overseas locations.

In addition, CoVPN is using standard clinical trial plans and protocols designed by Accelerating Covid-19 Therapeutic Interventions and Vaccines, or ACTIV, a consortium of federal health agencies, European Medicines Agency, not-for-profit organizations, and pharmaceutical and biotechnology companies. ACTIV aims to streamline clinical trial execution as much as possible by offering standard protocols and avoiding duplicative efforts in preclinical studies and clinical trials.

“Having a safe and effective medical countermeasure to prevent Covid-19 would enable us to not only save lives but also help end the global pandemic,” says NIAID director Anthony Fauci in an NIH statement. “Centralizing our clinical research efforts into a single trials network will expand the resources and expertise needed to efficiently identify safe and effective vaccines and other prevention strategies against Covid-19.”

A key challenge for CoVPN is recruitment of thousands of volunteers representing the diverse populations affected by Covid-19 to test vaccines and antibody treatments. NIH says CoVPN has a community engagement function for this purpose built into the process. Database systems company Oracle in Redwood Shores, California provides the data collection platform for CoVPN that includes a secure clinical trial registry for online enrollment.

“Each of the phase 3 clinical trials that the CoVPN will conduct will require thousands of volunteers,” notes NIH director Francis Collins. “Community engagement, particularly with the communities most vulnerable to Covid-19’s severe outcomes, will be critical to the success of this research endeavor.”

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EC, France Fund Universal Covid-19, Flu Vaccines

SARS-Cov-2 viruses

Scanning electron microscope image showing SARS-CoV-2 viruses, in yellow. (NIAID, NIH)

8 July 2020. A biotechnology company is receiving European Commission and French government funds to develop vaccines that protect against all strains of Covid-19 and flu viruses. Osivax in Lyon, France is expected to receive €32.6 million ($US 37 million) to advance its work on its experimental universal flu vaccine, and apply the technology to a similar vaccine preventing infections from the SARS-CoV-2 virus responsible for Covid-19.

Osivax designs vaccines that protect against infectious diseases, with its lead product code-named OVX836, a vaccine protecting against all known influenza strains, now in clinical trials. The company’s technology uses virus-like particles, fragments of viruses assembled into pieces resembling viruses to invoke a response from the immune system, but without infecting cells. Added to these particles are peptide supplements that encourage uptake by dendritic, or antigen-presenting cells in the immune system.

The result, says Osivax, is vaccines that generate a strong response from CD8 T-cells, considered the workhorse T-cells in the immune system. Osivax vaccines also target a component in viruses called the nucleoprotein, responsible for viral transcription and replication but also much less likely to mutate. A study published in the journal npj Vaccines in January 2019 shows OVX836 protects lab mice against three sub-types of influenza A.

European Innovation Council, the science-commercialization agency of the European Commission, is providing Osivax with an accelerator grant of €2.5 million and €15 million in equity financing to complete its mid-stage clinical trial of OVX836, and begin discovery of a universal coronavirus vaccine. That trial, conducted in Belgium, is enrolling 300 healthy volunteers testing OVX836 for safety and immune response. The equity investment likewise funds a large-scale study of OVX836, enrolling some 3,500 participants, and further development of a universal SARS-CoV-2 vaccine.

In addition, Osivax is receiving €15.1 million from Bpifrance, a public agency that provides equity and grant financing for French start-ups, as well as entrepreneurial training and export financing. In this case, the funds, from a Bpifrance research and development grant program, support lab analysis of human samples, and early- and mid-stage clinical trials of a universal SARS-CoV-2 vaccine.

“Similar to influenza, which leads to regular global outbreaks, Covid-19 has the potential to mutate.,” says Alexandre Le Verte, CEO and co-founder of Osivax, in a company statement. “Our commitment to cutting time and costs associated with vaccine production while providing comprehensive protection has never been more critical than in the face of the Covid-19 pandemic which continues to profoundly threaten global health.”

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Univ. Lab Discovers, Licenses Citrus Disease Treatment

Australian finger lime

Australian finger lime (Zaaera, Wikimedia Commons)

8 July 2020. Plant scientists in California discovered a natural peptide that stops bacteria from causing citrus greening, a disease destroying citrus crops worldwide. University of California in Riverside, site of the lab led by geneticist Hailing Jin that discovered the peptide, is licensing the discovery to agricultural technology start-up, Invaio Sciences Inc. in Cambridge, Massachusetts for development into commercial products.

Citrus greening, also known as huanglongbing or HLB, is a bacterial disease that according to U.S. Department of Agriculture, destroyed more than three-quarters of citrus crops in Florida. Citrus greening already devastated citrus crops in Asia and South America, and also appears in citrus-producing states of Texas and California. Up to now, no cures nor resistant varieties for citrus greening were available.

The disease is caused by the bacterium Canidatus Liberbacter asiaticus and spread by the Asian citrus psyllid when feeding on new shoots. Early detection and removal of diseased trees are essential for controlling citrus greening, but many infected trees do not display symptoms for months, making it difficult to control its spread.

Jin’s lab studies plant immunity and pathogens, seeking environmentally-friendly solutions to plant diseases, focusing on instructions to cells in RNA transcribed from a plant’s DNA or genetic code. A team from the lab analyzed RNA profiles and corresponding gene expression of citrus varieties that tolerate citrus greening. Their screening method isolated genes in Australian finger limes, a popular edible fruit, that allow those plants to withstand citrus greening bacteria. The lab’s investigation revealed a peptide — a short chain of amino acids — that silences receptive proteins in Australian finger limes, providing the plants with immunity against the disease.

Tests by Jin and colleagues over two years confirmed the peptide’s effectiveness. “You can see the bacteria drastically reduced,” says Jin in a university statement, “and the leaves appear healthy again only a few months after treatment.”

The peptide is also more stable and able to withstand high temperatures than many agricultural antibiotics. “Most antibiotics are temperature sensitive, so their effects are largely reduced when applied in the hot weather,” notes Jin. “By contrast, this peptide is stable even when used in 130-degree heat.” Because of the peptide’s stability, the researchers believe it needs to be applied only a few times a year, either as a treatment or a type of vaccine for younger plants.

The company Invaio Sciences is acquiring the peptide from UC-Riverside to develop it for citrus growers. The deal gives Invaio Sciences an exclusive global license to the peptide, but financial details of the agreement were not disclosed.

Invaio is a two year-old company developing technologies from natural sources for agriculture that replace chemicals harmful to farm workers and the environment. Among its products are delivery systems for packaging bioactive molecules for safe transmission and their precise injection into plants’ vascular networks. These delivery methods, says Invaio, are more effective than sprays and do not harm the plants.

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Improve Efficiency in Your Construction Company

– Contributed content –

(Paul Brennan, Pixabay)

7 July 2020. All business owners want long-term success for their companies and to see them grow. For construction companies, planning for long-term success is particularly important, as this is a crowded industry with many competitors vying for the same contracts.

A crucial part of achieving sustained success involves improving your business’s efficiency. Ensuring that your business operation is as efficient as possible will help you to maximize your profits by reducing waste and making sure that every aspect of your company is performing at an optimum level. Examining each area of your business and assessing whether it is functioning to its full potential will help you to improve efficiency throughout your construction company. Here are some points to consider when trying to improve business efficiency:

Reduce downtime

Downtime is wasted time for your company, so reducing downtime is essential for boosting productivity. Using work time efficiently will increase productivity levels and should see work rate soar. Downtime can have serious knock-on effects in your business and could mean that a project is completed late. Downtime is not always in your control, but there are many ways that you can help to minimize the chances of it occurring.

Keeping your site equipment well-maintained is vital to reducing downtime. When your equipment and machinery is working at its best, it will help your employees be more productive and work efficiently. Choosing high-quality products to power your equipment is essential to keep it running. Using products such as anti-freeze and heavy-duty oil from producers such as www.peakhd.com will help your equipment to keep running whatever the weather conditions, meaning less downtime.

Stick to a plan

Construction projects can have a habit of dragging on for longer than they should; this is not only frustrating for your clients, but also means that your time and resources are tied up in work that should already have been completed. These delays can be extremely costly both to your bottom line and your company’s reputation. Falling behind deadlines can result in time penalties for your business and even the loss of future contracts from your client. Building strong relationships with your clients and completing the work when you say you will not only make your business operation more efficient, it also reinforces your reputation as a reliable contractor.

Ensuring that every project has a strict schedule for the work and that the project manager reinforces it is crucial. Your business will never be as profitable as it could be if you fall behind on each project.

Employee training

Training is an often overlooked aspect of improving business efficiency. Having employees that are confident in what they are doing and feel capable of completing their tasks to a high standard will help you to increase productivity and ensure that jobs get completed on time. Setting aside the time to train your employees thoroughly so that they can complete tasks quickly and to the highest standard will significantly boost efficiency in your business, and help to reduce any errors.

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BARDA to Buy $2B in Covid-19 Vaccines, Therapies

Syringe, pills, capsules

(Arek Socha, Pixabay)

7 July 2020. The federal health preparedness agency is spending more than $2 billion for developers to produce Covid-19 vaccines and treatments now in clinical trials. The Biomedical Advanced Research and Development Authority, or BARDA, with the U.S. Department of Defense, are contracting with Novavax Inc. in Gaithersburg, Maryland to complete clinical trials and produce large quantities of its Covid-19 vaccine, and Regeneron Pharmaceuticals Inc. in Tarrytown, New York, for production of its dual-antibody cocktail treatment for Covid-19 infections.

BARDA, an agency of the U.S. Department of Health and Human Services, invests in vaccines, therapies, and diagnostics to prepare for and respond to health security threats, including pandemics like Covid-19. The agency is contracting with Novavax in a deal valued at $1.6 billion for manufacturing, storage, and distribution, of 100 million doses of its vaccine code-named NVX-CoV2373 to protect against Covid-19 infections. The contract also funds late-stage clinical trials of NVX-CoV2373, enrolling some 30,000 participants, which if successful, would trigger the production phases of the contract.

Novavax creates vaccines protecting against infectious diseases with nanoscale particles of synthetic proteins designed specifically against the genetic code of their targets. The company says it infects cells from reproductive systems of the fall armyworm, a tropical insect, with engineered viruses that grow only in those cells. The engineered viruses are designed to express surface proteins that trigger an immune response, which make up the nanoscale particles in their vaccines. The company says NVX-CoV2373 creates antibodies that prevent binding of the virus’s characteristic spike protein with human receptors, thus preventing infections, and generates antibodies that neutralize the SARS-CoV-2 virus.

NVX-CoV2373 is in an early- and mid-stage clinical trial in Australia, testing the vaccine for safety and immune response among 131 participants age 18 to 59. The vaccine is being tested with and without Matrix-M, an adjuvant also made by Novavax. The company says Matrix-M boosts the immune response, allowing for lower doses of the primary vaccine.

“The pandemic has caused an unprecedented public health crisis,” says Stanley Erck, Novavax’s CEO in a company statement, “making it more important than ever that industry, government, and funding entities join forces to defeat the novel coronavirus together.”

BARDA says the doses produced for vaccination in this deal would be available to U.S. citizens at no cost, with insurers picking up the costs of administration by health care providers. As reported by Science & Enterprise in May, Novavax received a $384 million grant from Coalition for Epidemic Preparedness Innovations, or CEPI, to support early development of NVX-CoV2373, which follows World Health Organization’s guidelines for equitable global production and distribution of Covid-19 therapeutics and vaccines.

Regeneron double-antibody treatment

In a separate agreement, Regeneron is receiving $450 million from BARDA for manufacturing the company’s Covid-19 treatment code-named REGN-COV2, a dual-antibody formulation. Regeneron uses a combination of two antibodies for neutralizing the SARS-CoV-2 virus, each targeting a separate region of the characteristic protein found on the surface of the coronavirus spike, which penetrates and binds to receptor proteins in cells, beginning the infection process. Regeneron says the two antibodies in REGN-COV2 work in tandem, one antibody to start neutralizing the spike protein, with the second antibody blocking mutated forms of the virus that can form and escape after the initial attack.

Regeneron is testing REGN-COV2 in adaptive, multi-stage clinical studies enrolling patients with Covid-19 infections, both in and out of the hospital. In the trials’ early stages, the study teams are looking for signs of adverse effects from REGN-COV2 as well as indicators that it generates an immune response. The second stages will test REGN-COV2 for immune response and clinical benefits among infected Covid-19 patients.

As reported yesterday in Science & Enterprise, the company says results show, and an independent monitoring committee concurs, REGN-COV2 is safe to continue to the trial’s later stages, although detailed findings were not disclosed. Also reported yesterday, the early-stage safety results, says Regeneron, make possible a separate trial testing REGN-COV2 to protect uninfected people against Covid-19 infections. The new trial is enrolling some 2,000 participants at 100 sites in the U.S.

The BARDA agreement calls for Regeneron to produce between 70,000 and 300,000 treatment doses or 420,000 to 1.3 million prevention doses of REGN-COV2. The number and type of doses will be determined in part by results of the ongoing clinical trials. The company says it began gearing up on its own for large-scale production of REGN-COV2 in anticipation of favorable trial outcomes and emergency use authorization from Food and Drug Administration.

“We made the decision early on to begin large-scale manufacturing at our own risk,” says Regeneron president Leonard Schleifer in a company statement, “in order to ensure that product would be available immediately if our clinical trials prove successful and an emergency use authorization is granted.”

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FDA Halts Off-the-Shelf Engineered T-Cell Trial

Stop sign

(dimitrisvetsikas1969, Pixabay)

7 July 2020. A company designing gene-edited T-cells as cancer therapies stopped its clinical trial of a treatment for multiple myeloma when a patient in the trial died. Cellectis S.A. in New York and Paris says the Food and Drug Administration put a hold on the early-stage trial testing the safety of its engineered T-cell therapy.

Cellectis develops cancer treatments that harness the immune system by breaking down defenses tumors create to prevent the body’s immune system from fighting the disease. The company’s platform builds on recent developments that take T-cells, white blood cells from the immune system, and reprogram the cells through genetic engineering to find and kill cancer cells. The engineered T-cells become hunter cells, containing proteins known as chimeric antigen receptors that act like antibodies. These modified chimeric antigen receptor or CAR T-cells are infused into the patient, seeking out and binding to proteins associated with the cancer.

Most current CAR T-cell methods genetically engineer a patient’s own T-cells, then re-infuse the altered T-cells back into the individual. Cellectis’s process is designed to produce off-the-shelf CAR T-cell treatments, it calls Universal CAR T-cells, or UCARTs. These treatments use T-cells from healthy donors, rather than a patient’s own T-cells, then are genetically engineered to match the attributes of specific cancer types. In November 2019, Science & Enterprise reported on preclinical tests that show UCARTS accumulate on lymphoma cells in mice and generate cancer-killing proteins.

The clinical trial is testing Cellectis’s treatment for multiple myeloma code-named UCARTCS1. The early-stage study is enrolling 18 participants at three sites in the U.S. with relapsing or stubborn multiple myeloma, looking primarily for adverse effects among the patients. The company plans to test multiple dosage levels of the treatments, seeking the maximum tolerated dose.

Cellectis says a participant in the trial who had not responded to previous treatments for multiple myeloma suffered cardiac arrest after receiving UCARTCS1 and died. While the company says its investigation is continuing, the participant received one of the higher doses of the therapy. Cellectis says it earlier decided to expand the number of recipients at the treatment’s lower dose.

Carrie Brownstein, Cellectis’s chief medical officer, says the company is working with FDA to resolve the clinical hold, including changes to the design of the trial. “The safety of patients enrolled in our clinical trials is our utmost priority,” says Brownstein in a company statement, “and we at Cellectis remain committed to safely resuming the clinical development of UCART product candidate targeting CS1 for patients with multiple myeloma and unmet medical need.”

Cellectis has two other early-stage clinical trials underway testing UCARTs that are not affected by FDA’s hold, for acute myeloid leukemia and B-cell acute lymphoblastic leukemia. Both of the studies are testing UCARTs at various dosage levels.

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