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Infographic – U.S. Venture Funding States Left Behind

Chart: States with fewest venture dollars

Click on image for full-size view (Crunchbase News)

20 Nov. 2021. If it seems Science & Enterprise reports a lot about venture funds for start-ups in California, New York, and Massachusetts, you’re right. As CB Insights notes, the metro areas in the U.S. attracting the most venture capital dollars and deals in the third quarter of 2021 are San Francisco/Silicon Valley, New York, Los Angeles, and Boston.

On Thursday, Crunchbase News reported on parts of the U.S. getting the fewest venture dollars, displayed in today’s infographic. In the past five years, start-ups in West Virginia attracted a total of $44 million in venture funding, with Mississippi companies receiving nearly $73 million in that time. By comparison, says Crunchbase, California businesses gained $120 million in venture financing in just the first three quarters of 2021 alone.

Crunchbase News talked to Tony James, CEO of a group promoting tech innovation in Mississippi, to learn what’s holding back venture funding in his region. James tells Crunchbase News, new tech companies may get started in Mississippi, only to move to places like San Francisco, to find venture money and talent, as well as live the Silicon Valley lifestyle. “The question becomes: Can companies effectively grow here,” says James. “That’s what this really will come down to.”

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Cell Therapy Start-Up Raises $6M in Seed Funds

Stem cells

Stem cells illustration (Public Domain Pictures)

19 Nov. 2021. A new company providing clinical development and commercialization for emerging cell therapies began operations and raised $6 million in seed funding. Cellevolve Bio in San Francisco also signed an agreement for manufacturing cell therapies with National Resilience Inc., known as Resilience, a one year-old biopharmaceutical production enterprise in San Diego and Boston.

Cellevolve Bio says it offers services to take promising cellular therapies from academic and commercial discovery labs to market. The company plans to collaborate with discovery labs on development and commercialization of early-stage cell therapies, then take those efforts through clinical trials and regulatory stages, as well as provide manufacturing and distribution of end products. Cellevolve says it seeks to build pipelines of treatments for cancer, central nervous system, and viral diseases from the estimated 2,000 cell therapies now in development.

For clinical trials, Cellevolve says it applies up-to-date recruitment and retention techniques, bringing in patients, clinicians, and regulators early in the planning process. Since many cell therapies use a patient’s own cells as raw material, that process is often designed one patient at a time. In addition, says the company, cell therapy clinical trials often require smaller numbers of participants, compared to conventional drugs.

“There is an abundance of promising new cell therapy innovations being developed around the world, with early data to support clinical efficacy,” says founder and CEO Derrell Porter in a Cellevolve Bio statement released through BusinessWire. “Our goal at Cellevolve is to build one of the largest cell therapy pipelines in the industry through partnerships with innovators, and deliver that breakthrough science to patients as commercially available therapies.”

Exclusive manufacturing partner

Cellevolve Bio is raising $6 million in its seed funding round, from a group including Chris Jeffers of Hibiscus BioVentures and and Marcus Whitney of Jumpstart Nova, taking part with Resilience. Jumpstart Nova says it’s the first Black health care venture fund in the U.S. Jeffers, Whitney, and a representative from Resilience are expected to join Cellevolve’s board. Also taking part in the seed round are Boxcar Partners, Catalytic Impact Fund, and several individual investors.

Cellevolve named Resilience its exclusive manufacturing partner. But the company is also expected to take part in selection of cell therapy assets, and has an option to provide manufacturing services in exchange for equity in future Cellevolve financing.

Science & Enterprise reported in November 2020 on Resilience’s initial operations and $800 million in two funding rounds. Resilience provides manufacturing and supply chain services for biotechnology companies and labs. The company says it offers a network of production and distribution facilities and services including manufacturing facilities that meet industry manufacturing practice standards aimed at fulfilling regulatory requirements, with supply chain elements and management all onshore.

“Manufacturing has been a critical barrier holding back cell therapies from reaching patients,” notes Resilience CEO Rahul Singhvi. “By working with Cellevolve to create new manufacturing processes, we aim to help them produce medicines that can be made quickly and at scale to meet the high demand from people in need.”

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Novo Nordisk Buys RNA Biotech in $3.3B Deal

Wall Street sign

(A. Kotok)

18 Nov. 2021. Global drug maker Novo Nordisk is acquiring biotechnology company Dicerna Pharmaceuticals Inc. in an all-cash deal valued at $3.3 billion. Under the agreement, Novo Nordisk, based in Bagsvaerd, Denmark, is paying stockholders $38.25 for each Dicerna share, a premium of 80 percent over yesterday’s closing share price of $21.28. So far today, as of 11:00 am ET, Novo Nordisk’s shares on the New York Stock Exchange fell 0.6 percent from their opening price to $114.59.

Dicerna Pharmaceuticals, in Lexington, Mass., is a biotechnology company that develops therapies blocking actions of disease-causing genes using a process known as RNA interference. Ribonucleic acid or RNA is produced by genes with instructions to cells coded from DNA to synthesize proteins. With RNA interference, or RNAi, those instructions are interrupted, preventing production of proteins from disease-causing genes, while limiting effects on other genes, RNA, and protein synthesis.

Dicerna’s technology known as GalXC silences disease-causing genes in the liver. The company’s process adds N-acetylgalactosamine, a sugar molecule, to Dicer enzymes that process double-stranded RNA. Dicerna says these engineered enzymes prevent messenger RNA, the part of RNA molecules with protein synthesis instructions, from reaching the target cells. The company says GalXC treatments are stable and can be delivered as injections under the skin, while targeting cells in the liver. Moreover, says Dicerna, the process is flexible enough to be applied to a range of target genes, addressing a number of disease types including viral infectious diseases, chronic liver disorders, cardiovascular conditions, and some rare diseases.

Extend RNAi through product pipeline

As reported by Science & Enterprise in September 2021, Dicerna is testing an experimental therapy for alcohol use disorder, also known as alcoholism, based on its RNAi technology. The treatment candidate, code-named DCR-AUD, is designed to silence expression of messenger RNA from aldehyde dehydrogenase 2 or ALDH2 genes in the liver. Mutations in ALDH2 genes block production of enzymes that result in unpleasant physiological reactions when exposed to alcohol, causing people with these mutations to stop drinking. The early-stage trial is testing DCR-AUD with healthy volunteers.

Novo Nordisk is a developer of treatments for diabetes and other chronic diseases associated with obesity and metabolic disruptions, founded in 1923. Dicerna began collaborating with Novo Nordisk in November 2019 on applying GalXC to therapies for diseases affecting the liver, such as non-alcoholic steatohepatitis or NASH, type 2 diabetes, obesity, and some rare diseases. Novo Nordisk says the first treatment candidate produced by the partnership is expected to begin a clinical trial sometime next year.

Novo Nordisk expects the acquisition to extend its application of RNAi throughout the company’s development pipeline. “We build on our successful collaboration,” says Novo Nordisk’s chief scientist Marcus Schindler in a statement, “and by combining Dicerna’s state-of-the-art RNAi drug engine and intracellular delivery with our deep capabilities in disease biology understanding and tissue targeting through peptides and proteins we have the potential to expand our pipeline and deliver life-changing precision medicines for people living with chronic diseases such as diabetes, obesity, cardiovascular disease and NASH, as well as rare diseases like endocrine disorders and bleeding disorders.”

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Synthetic Bio Milk Company Gains $13M in Seed Funds

Milk splashing

(Myriams-Fotos, Pixabay. https://pixabay.com/photos/milk-splash-drops-food-liquid-4755234/)

17 Nov. 2021. A start-up enterprise creating milk and dairy products with proteins derived from engineered microorganisms is raising $13 million in seed funds. Imagindairy Ltd. in Tel Aviv, Israel is based on research in synthetic biology by its co-founder and chief scientist Tamir Tuller, professor of biomedical engineering at Tel Aviv University.

Imagindairy says it developed a process for producing milk and dairy products that are indistinguishable from the original animal-based products. The company’s technology creates whey and casein proteins found in dairy products from genetically engineered plant microorganisms, in a process it calls precision fermentation. Imagindairy says the process generates these protein components at a scale and quality for producing milk and dairy products with identical taste, texture, and nutritional value as those made from cows. The company says precision fermentation also makes it possible to produce milk and dairy products for consumers needing low cholesterol or are lactose sensitive.

The company says its precision fermentation process is up to 20 times more efficient than animals in converting inputs such as feed into milk proteins. Moreover, the process is more environmentally friendly than conventional dairy farm agriculture, releasing fewer greenhouse gases and without harm to animals or surrounding ecosystems.

Imagindairy says it uses computational biology techniques to engineer the plant microorganisms in its precision fermentation process. Tuller’s research at Tel Aviv University studies computational models of gene expression, to construct algorithms for predicting and simulating different stages of gene expression. Tuller’s lab also designs methods for engineered gene expression used in biotechnology. Imagindairy says Tuller and co-founder Arie Abo, now the company’s chief technology officer, developed the company’s technology.

Collaborating with current dairy producers

“The market is eager to develop new dairy analogs based on our animal-free proteins,” says Imagindairy co-founder and CEO Eyal Afergan in a company statement released through Cision. “Once we reach commercialization, more consumers will be able to enjoy eating animal-free dairy products. It’s hard for people to make big changes, especially when it comes to the foods they enjoy, but when there’s an alternative with the same flavor and experience that is more aligned to their values, it becomes easy.”

Imagindairy is raising $13 million in seed funds from a group led by MoreVC, a venture capital investor specializing in early-stage Israeli technology companies. Joining the round are Strauss Group, Entrée Capital, S2G Ventures, Collaborative Fund, New Climate Ventures, Green Circle Foodtech Ventures, Emerald Technology Ventures, and Pierre Besnainou. Imagindairy also raised $1.5 million in pre-seed funds in June 2021, when the company began operations.

The company says it’s collaborating with dairy companies, to offer more sustainable sources of dairy proteins. “Imagindairy’s innovative technology,” notes MoreVC partner Glen Schwaber, “allows dairy companies to develop new products or reformulate existing products, without involving animals and with a dramatic reduction in carbon-footprint. They have the technology to produce the dairy products of the future that consumers want today.”

Imagindairy is not alone in developing animal-free milk products. Science & Enterprise reported in January 2020 that TurtleTree Labs, based in Singapore, raised seed funds to advance its process for producing milk directly from mammary cells in the lab, but without crops, animals, or farms.

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Small Biz Grant Funds Long-Term Spasticity Implant

Delpor implant device

Delpor implant device (Delpor Inc.)

16 Nov. 2021. A developer of treatments for neurological disorders received National Institutes of Health funding for an implant treating spasticity for up to six months. Delpor Inc. in Brisbane, California is receiving a $2.5 million award from National Institute of Neurological Disorders and Stroke, part of NIH, to continue development of its spasticity implant device through August 2022.

Delpor designed the device to treat spasticity, a chronic neuromotor condition where where muscles are continuously contracted, which interferes with normal speech and movements, and can be particularly harmful to growing children. Spasticity, marked by muscle tightness and involuntary movements, is a symptom of disorders including cerebral palsy, multiple sclerosis, traumatic brain injury, stroke, and spinal cord injury. According to Johns Hopkins University, some 12 million people worldwide have a form of spasticity, affecting as many as 80 percent of people with cerebral palsy or multiple sclerosis.

The company says two oral drugs, tizanidine and baclofen, are prescribed to treat spasticity, but both drugs work for short periods of time and require being given to patients three or four times a day. In addition, says Delpor, the drugs have unwelcome adverse effects at high plasma levels, such as muscle weakness, dizziness, and drowsiness. And while a surgically-implanted infusion pump can administer baclofen into the spinal canal, that surgery can take as long as three hours and require general anesthesia, as well as an overnight hospital stay.

10-minute outpatient procedure

Delpor develops long-term treatments for neurological conditions, with medications formulated into passive, non-mechanical reservoir implants that continuously administer the drugs for as long as 12 months. The small titanium devices — four to six millimeters in diameter, and four to five centimeters in length — are implanted under the skin of the abdomen in a 10-minute outpatient procedure using local anesthetics. The company says the procedures are reversible, if necessary, and the device is easily replaced after the drug runs out. Delpor’s lead product is an implant with the drug risperidone for 12-month schizophrenia maintenance therapy, now being evaluated in a clinical trial.

For spasticity, Delpor designed its implant code-named DLP-208 to continuously dispense tizanidine for three to six months. In April 2019, the company received a $225,000 Small Business Innovation Research or SBIR grant to assess the technical feasibility of an implant device to treat spasticity. The award funded preclinical proof-of-concept lab and animal studies of the device.

The new SBIR grant, awarded in September 2021, continues the preclinical research on DLP-208. The grant funds the work needed for Delpor to file an investigational new drug or IND application with Food and Drug Administration. An IND filing officially seeks permission from FDA to ship new drug candidates across state lines to clinical trial sites, in effect requesting permission for an early-stage clinical trial.

This and other SBIR grants at the agency are made under NIH’s small business programs that set aside a part of the agency’s research funding for U.S.-based and owned companies. SBIR grants fund work by research companies in the U.S., and in most cases are made in two parts: a first phase to determine technical and commercial feasibility, and a second phase to develop and test a working prototype or prepare for clinical trials.

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Ultimate Guide to Managing Your Online Business

– Contributed content –

Home delivery

(Kindel Media, Pexels. https://www.pexels.com/photo/man-in-white-button-up-shirt-delivering-packages-6868556/)

16 Nov. 2021. Online business is the new frontier of enterprises. With the internet, you can reach customers in every country on the planet without needing to set foot outside your front door. The online world means that you have a vast potential customer base at your fingertips. This has created an exciting opportunity for entrepreneurs looking to start their businesses. However, there are many pitfalls that newcomers to e-commerce face when they decide to take the plunge into starting up their online store or blog.

Ensure you make an excellent first impression

Do you remember the first time you went to a shop or restaurant and immediately felt turned off by how unprofessional it all seemed? This doesn’t just apply to physical stores. Your website is your shop-front online, so you need to ensure that everything about its design screams professionalism! You don’t have much space to impress new visitors when they land on your site for the first time, so ensure that any images are of good quality and relevant to what your business does. Also, keep in mind fonts – if possible, use serifs (fonts with small lines sticking out) as these tend to look more formal than sans serif fonts (those without them).

Research your market with Google Analytics

Not only is Google Analytics free, but it’s also a potent tool. It provides you with a comprehensive analysis of your website traffic so that you can determine the best target markets for your business to focus on. Using this data will enable you to be smart about how much time and money you invest in marketing activities like social media outreach or PPC adverts. They’ll help bring more visitors who are likely to contribute to your bottom line (i.e., make sales). Additionally, you should consider using paid services like Moz to track your SEO performance and research specific industry-related keywords to create effective online content.

Ensure customer transactions are streamlined

Many consumers don’t purchase anything online because it’s too complicated. People like to know that they’re buying from a trustworthy source. Considering that most customer transactions are now made on mobile devices, this process needs to be simple if you want your visitors to convert into customers. Ensure that any form fields are relevant (i.e., asking for unnecessary information will decrease conversion rates), keep page load times below 100ms (speed is critical in today’s digital world), and ensure your business isn’t listed as a TMF; otherwise, you should try and find out how to get off match list, also make sure your “thank-you” pages tell users precisely what happens next after clicking order with clear instructions about how their goods will reach them or where they can provide feedback.

Create a robust online presence

You’ll find that most people turn to Google when they’re looking for information about a product or service. However, suppose you want your business to be found online. In that case, you must create an active presence on the internet with informative blogs and pages across social media platforms like Facebook, Twitter, Instagram, etc. This will help increase trust in your brand and provide new visitors who are searching for reviews of products similar to yours with valuable insights into what others think about the services you offer. Having an effective website is crucial if you want more traffic, resulting in sales; however, this isn’t all there is to consider.

Engage customers on Facebook ads

It’s essential to not only build an online presence but also engage with your target market. Social media platforms like Facebook can be used as a powerful sales tool, particularly when you utilize them in conjunction with targeted advertising campaigns that deliver messages to specific audiences based on their demographics and interests. This type of strategy is known as retargeting, and it works by placing cookies onto the browsers of users who have visited your website or even just seen one of your ads elsewhere (like Google). You’ll then start seeing this user popping up on other websites they visit across the web so that there’s constant exposure for what you’re offering, which can lead to more conversions than ordinary adverts do because people are familiar with the brand before clicking through.

Take advantage of affordable accounting software 

One of the key reasons people fail in their online ventures is that they don’t keep track of all transactions and plan accordingly. Therefore, it’s essential to make sure you’re always taking advantage of tax benefits through your business, particularly by utilizing tools like Xero, which can streamline this process so that there are fewer mistakes when submitting returns or filing paperwork to HMRC (if necessary). You should also try and write a financial forecast at least once per year as part of any long-term planning process so that you know exactly what income will be coming in from sales during specific periods.

Offer clients superior customer service

As the saying goes, “the customer is always right,” and this couldn’t be truer when it comes to making sales online. There’s a reason why businesses like Zappos have become household names; they’ve built their reputation on providing superior service with things like free shipping both ways for customers who are unsure about sizing or want to make returns after taking possession of their orders. You should try and emulate these types of strategies by offering your visitors as much detail about products as possible to reduce queries through email support systems which can then save time spent on trying to find solutions yourself. A quick way of doing this is through videos, photos, product descriptions, showing people exactly what you’re selling instead of just expecting them to take a risk without much information.

There are many things to consider when it comes to running an online business. It’s crucial that you have a robust presence on the internet, engage with customers through social media and advertising campaigns, so they become familiar with your brand before committing themselves financially to increase conversions.

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New Company to Develop Synthetic Antibody Therapies

SARS-CoV-2 particle

Transmission electron micrograph of a SARS-CoV-2 virus particle, isolated from a patient. (NIAID, NIH)

15 Nov. 2021. A new business is underway to develop and commercialize treatments for Covid-19 and other diseases based on synthetic antibody proteins. Revelar Biotherapeutics Inc. is spun-off from synthetic DNA developer Twist Bioscience Corp. in South San Francisco, and staked to a $10 million seed investment from the founding company.

Twist Bioscience develops synthetic genetic materials on a silicon platform, patterned after semiconductors, instead of traditional plastic plates and receptacles. This process, says the company, overcomes conventional limitations and inefficiencies to design and construct genes, and from these synthetic genes, produce libraries of genetic variations. Twist Bio also created a subsidiary, Twist Biopharma, that applies the technology to create collections of synthetic antibodies the company says match genomic sequences occurring in the body.

As reported in Science & Enterprise in September 2021, these collections are made from phage display libraries, protein interactions derived from viruses that infect bacteria called bacteriophages, a tool used increasingly to discover immunotherapies. The Twist Biopharma subsidiary uses these collections of phage display libraries, or “library of libraries” as the company calls it, to identify therapeutic antibody candidates that match existing human genomic sequences.

Neutralizes all known variants of concern

Revelar Biotherapeutics is being formed as a separate company to take synthetic antibodies designed or discovered by Twist Bio into clinical development, through regulatory stages, and to the marketplace. “This transaction,” says Twist Bio CEO and co-founder Emily Leproust in a company statement, “allows Twist to participate in the rapid advancement of therapeutic antibodies while remaining focused on our current opportunities in our core business as well as our biopharma and DNA data storage verticals.” Leproust adds that they aim to have the company’s first discovered antibody enter clinical trials next year.

Revelar’s lead product is an antibody treatment for Covid-19 disease that Twist Bio says in preclinical studies neutralizes all known variants of concern of the SARS-CoV-2 virus. In September, three researchers from Twist Bio were among 75 authors of a paper in the journal Science identifying seven receptor binding domains on the SARS-CoV-2 virus. The authors from the Coronavirus Immunotherapeutic Consortium analyzed an initial pool of 269 synthetic antibodies, then sorted 186 of those antibodies into seven communities, addressing each of the receptor binding domain targets.

Twist Bio is providing Revelar a license for exclusive development and commercialization of a Covid-19 synthetic antibody treatment candidate based on this research, as well as a series of back-up antibodies. Revelar is also receiving $10 million in seed funding from Twist Bio. In addition to Covid-19, Revelar says it plans to develop treatments for other infectious diseases, as well as cancer and autoimmune disorders.

In exchange, Twist Bio gains a minority ownership stake in Revelar. Moreover, Twist Bio may receive up to $100 million in development, regulatory, and commercial milestone payments, as well as royalties on future sales. Revelar has an option of licensing up to five more antibody therapy candidates over the next four years, subject to similar milestone and royalty payments.

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Infographic – Unvaccinated Driving New Covid-19 Cases

Covid-19 vaccination rates

Click on image for full-size view (Statista)

13 Nov. 2021. Data released by the U.S. Centers for Disease Control and Prevention show new Covid-19 infections are concentrated largely among unvaccinated people. The CDC’s data, compiled from 14 states and two cities in the U.S., were displayed in chart form on Wednesday by the business research company Statista.

The data and chart show since June, rates of new Covid-19 infections per 100,000 persons age 12 and over have risen more sharply among those not yet vaccinated, while for vaccinated individuals, cases are climbing more slowly. CDC says since August, unvaccinated people are six to 10 times more likely to become infected with Covid-19 than unvaccinated persons.

Data also show the unvaccinated are much more likely to be hospitalized with Covid-19 infections. In fact, the difference in hospitalization rates between vaccinated and unvaccinated are greater than infections rates. Older unvaccinated individuals, those age 65 and over, are nine times more likely to be hospitalized than their vaccinated peers, with the difference rising to 14 times between unvaccinated and vaccinated people age 18 to 49.

Persons age 65 and over are somewhat more vulnerable to so-called breakthrough infections when fully vaccinated. But with 86 percent of this age group vaccinated, says CDC, they are still much less likely to be hospitalized.

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Targeted Immunotherapy Shown to Shrink, Stop Tumors

T-cells and cancer cells

Killer T-cells surround a cancer cell (NICHD, Flickr)

12 Nov. 2021. Results from tests with lab mice show an experimental targeted cancer therapy invoking the immune system shrinks tumors and prevents their recurrence. Findings from the study are scheduled for presentation today by researchers from biotechnology company Asher Biotherapeutics at the Society for Immunotherapy of Cancer or SITC annual meeting in Washington, D.C.

Asher Bio in South San Francisco designs immunotherapies that address a continuing problem from pleiotropy, a condition where changes in a single gene can affect multiple human traits. In cancer immunotherapies, pleiotropy can cause unintended changes in cells and tissue other than the tumors, when the treatment’s cancer targets are attacked. Asher Bio’s technology, called cis-targeting, addresses receptor proteins at two sites on surfaces of a single immune system cell, the therapeutic antigen target and a separate receptor that simulates immune responses, called an immunomodulator.

The company says it applies computational techniques to screen immune system cells and sub-types for therapeutic benefits, but also for possible unintended toxicities or reverse effects that block the therapy. Asher Bio then engineers selected immune system cells to produce cytokine enzymes that bind only on specific tumor targets and boost their potency.

Asher Bio’s lead product, code-named AB248, is an engineered protein that addresses receptor pathways for cancer-killing CD8+ T-cells in the immune system for interleukin-2 or IL-2 cytokines. Various IL-2 forms are already approved for treating some metastatic solid tumor cancers, but because of pleiotropy, IL-2 can also stimulate other unintended immune system cell types. And, because of its short active lifetime, IL-2 is needed in high doses, which can be toxic, causing heart and blood damage.

Tumor rejections and complete responses

In an oral presentation at the SITC meeting, a team led by Asher Bio’s scientific founder Robert Schreiber, an immunologist at Washington University in St. Louis, reported on tests of CD8-IL2, an AB248 surrogate, in lab mice induced with advanced sarcoma, or soft-tissue cancer. The results show one dose of CD8-IL2 causes rejection of tumors in 90 percent of recipient mice, defined as complete regression of tumors and without recurrence.

Mice receiving CD8-IL2 also show increased production of T-cells activated and targeted to attack the tumors. Plus, say the researchers, a similar set of cancer-induced mice show little, if any, response to high doses of IL-2 cytokines alone. In addition, mice receiving CD8-IL2 do not show weight loss, an indicator of tolerating the treatment.

A separate poster presentation at SITC offers results from another preclinical test, by a team led by Asher Bio’s AB248 program chief Kelly Moynihan. Those findings show a majority of lab mice induced with colorectal cancer have a complete response — where no cancer is detected — to a single CD8-IL2 treatment, more responses than a form of IL-2 cytokine alone given to similar cancer-induced mice.

And say the authors, a combination of CD8-IL2 and anti-PD1 checkpoint inhibitor treatments result in complete responses for all mice induced with melanoma. Moreover, CD8-IL2 treatments invoke a selective expansion of CD8+ T-cells in tumor regions and peripheral blood in mice and lab monkeys. And like the companion study, mice in these tests show no weight loss, while the raw IL-2 recipient mice lose more than 10 percent of their body weight.

“We are encouraged by the preclinical results presented at SITC,” says Asher Bio co-founder and chief scientist Ivana Djuretic in a company statement, “which demonstrate the potential for AB248 to deliver both enhanced anti-tumor efficacy and improved safety, and reinforce our confidence in AB248’s potential as a best-in-class IL-2 immunotherapy. We look forward to advancing AB248 into clinical studies across multiple solid tumor types next year.”

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Trial Identifies Biomarkers for Quick Concussion Test

Brain activity graphic

(Gordon Johnson, Pixabay)

11 Nov. 2021. A clinical trial reveals glycan compounds found in saliva and urine as indicators of traumatic brain injury, helping create a quick diagnostic for the condition. Results of the trial conducted by Medicortex Finland Oy in Turku, Finland appear Tuesday in the journal Brain Sciences.

Traumatic brain injuries or TBIs such as concussions, result from blows to the head, including those from contact sports, or penetrations of the skull that disrupt normal brain functions. Military service members in combat are particularly vulnerable to TBIs, which often result from improvised explosive devices, such as road-side bombs experienced by U.S. troops and their allies in Iraq and Afghanistan. According to Department of Defense statistics, some 384,000 service members were diagnosed with TBIs since 2000, with more than 8 in 10 (82%) TBIs rated as mild, and the bulk of those injuries suffered by Army soldiers.

As reported by Science & Enterprise in July 2019, Medicortex Finland received DoD funding to develop a prototype test kit to diagnose TBIs. The company’s technology aims to quickly detect biomarkers, or biological indicators, of TBIs in accessible bodily fluids, like saliva or urine. The company says impacts to the head cause changes in the brain’s chemistry. As a result, the trauma also breaks down the blood-brain barrier, allowing characteristic proteins and enzymes indicating brain cell damage to enter the blood stream.

The clinical trial, conducted at Turku University Hospital assessed 23 adult participants, 11 individuals diagnosed with TBI and 12 healthy persons for comparison, mainly hospital staff. All participants provided blood, saliva, and urine samples, while those with suspected head trauma also received computed tomography or CT scans to confirm the extent of their injuries. The authors from Medicortex Finland and Turku Hospital point out that participants with head trauma were primarily men and with an average age of 64, older than the working-age healthy participants.

Glycans released from brain tissue

Researchers analyzed the samples for compounds binding to lectins, natural plant proteins with an affinity for carbohydrates. In this case, the team focused on glycans, a type of carbohydrate in proteins that ranges from simple to complex in structure. Glycans, say the authors, are released from nerve tissue in the brain when a patient suffers a TBI, and the blood–brain barrier is damaged.

Of the 11 participants with head trauma, nine individuals were diagnosed with mild injuries and two with severe injuries. Among those with head trauma, saliva samples show higher concentrations of one glycan compound than non-injured participants, while urine samples indicate higher concentrations of another glycan and lower rates for two separate glycans. At the same time, blood samples show lower concentrations of two other glycan compounds in plasma among those with head trauma, compared to healthy participants.

The higher rates of identifiable glycans in saliva and urine, say the researchers, can help speed development of a quick diagnostic test for TBI, particularly mild cases such as concussions that may otherwise go undetected. The authors note a rapid TBI test …

facilitates decision making when the test results are easily available with a low cost. It gives additional value and strengthens the validity of the clinical assessment. If the test is sensitive enough, it may diminish the need for a head CT scan. Such examinations are only available in big clinical centers and may require time-consuming travel and costly procedures.

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