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Start-Up Developing Precision Antibiotics for Resistant Bacteria

Pseudomonas Aeruginosa bacteria

Pseudomonas Aeruginosa bacteria (Public Health Image Library, CDC)

14 Nov. 2023. A company formed earlier this year is developing precision treatments for bacteria resistant to conventional antibiotics, and raising £4.3 million ($US 5.4 million) in seed funds. Glox Therapeutics in Glasgow, Scotland, U.K. is spun-off from labs at University of Glasgow and University of Oxford studying engineered proteins to attack resistant microbes.

Glox Therapeutics designs new treatments for infections from gram-negative bacteria that mutate and are difficult to eradicate with today’s antibiotics. Antibiotic resistance is a continuing threat to public health worldwide, which according to the U.S. Centers for Disease Control and Prevention was responsible for 1.2 million deaths in 2019, citing data from The Lancet. Gram-negative bacteria, those with a protective outer membrane, are particularly difficult to control and more likely to become resistant. “Gram” refers to a classification where bacteria either keep (gram-positive) or shed (gram-negative) a test stain on their outer cell membranes.

The technology offered by Glox Therapeutics is based on research by its scientific founders Colin Kleanthous, professor of biochemistry at Oxford and microbiology professor Daniel Walker at University of Glasgow, now at University of Strathclyde, also in Glasgow. Kleinthous and Walker study protein interactions with bacteria, particularly protein molecules called bacteriocins, produced naturally by bacteria to ward off competing microbes. The company is developing synthetic bacteriocins targeting gram-negative bacterial species currently resistant to most antibiotics, but designed not to harm the human microbiome, communities of helpful microbes in the body.

Treatment for ventilator-associated pneumonia

Glox Therapeutics says its first products are addressing Pseudomonas aeruginosa or P. aeruginosa and Klebsiella pneumoniae bacteria that are on the World Health Organization’s list of critical drug-resistant bacteria. The company’s expects its lead product to be an intravenous formulation of bacteriocins to treat pneumonia that develops in the lungs of people on ventilators, where bacteria enter through the ventilator tube. And among the company’s bacterial targets are Escherichia coli or E. coli and Acinetobacter baumannii bacteria, also on the WHO critical drug-resistant bacteria list, with treatments for other types of pneumonia, sepsis, and lung infections in people with cystic fibrosis and chronic obstructive pulmonary disease or COPD.

“Our mission,” says Glox Therapeutics CEO James Clark in a company statement, “is to provide physicians and patients with highly potent, targeted antimicrobial therapies that can kill antibiotic-resistant bacteria for which there are diminishing options available for treatment.”

Glox Therapeutics is raising £4.3 million in seed funds, led by the venture investment arm of drug maker Boehringer Ingelheim and Scottish Enterprise that supports technology start-ups in Scotland. The biotechnology company plans to use the proceeds to establish labs in Glasgow and Oxford, and add key staff. “This will enable us to establish laboratories and attract top-tier talent,” adds Clark, “and I’m delighted to lead the team as we embark on our pioneering bacteriocin development program, with the first target being P. aeruginosa.”

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Antibody/Gene Therapy Biotech Gains $138 Million in Early Funds

Adeno-associated virus

Adeno-associated virus diagram (Lawrence Berkeley National Lab)

13 Nov. 2023. A developer of synthetic antibodies for neurodegenerative disorders delivered like gene therapies is raising €129 million ($US 138 million) in its first venture funding round. VectorY Therapeutics BV in Amsterdam, The Netherlands plans to initially use the proceeds to advance its lead program, a treatment to delay progression of amyotrophic lateral sclerosis or ALS.

VectorY Therapeutics is a three year-old biotechnology enterprise founded by the Dutch life science venture investor Forbion to advance gene therapies for degenerative nervous system diseases such as ALS. The company designs and delivers synthetic antibodies aimed at clearing specific toxic proteins or lipids in brain cells or elsewhere in the central nervous system. VectorY says its antibodies are fused with degrons, amino acid tags identifying unique protein degradation sequences that provide precise targeting.

The company delivers these payloads with adeno-associated viruses or AAVs, benign viruses with single strands of DNA that allow for adding genetic materials. AAVs have become delivery workhorses for gene therapies. However, VectorY Therapeutics alters the capsid or outer shell of its AAVs to help penetrate the blood-brain barrier, a normally protective mechanism in the brain that also limits the reach of many medications. In addition, the company says it built a manufacturing platform based on baculoviruses that in nature infect insects, but are engineered in this case to reliably produce large-scale quantities of AAV vectors.

Targeting toxic proteins in brain cells

The lead product at VectorY Therapeutics, code-named VTx-002, applies the company process to address ALS, also known as Lou Gehrig’s disease that occurs when motor neurons in the central nervous system begin wasting away. People with ALS lose their ability to first control voluntary movements, such as standing and walking, then often progresses to walking, chewing, and swallowing, and eventually breathing. VTx-002 targets misfolded TAR DNA-binding protein 43 or TDP-43 in neurons associated with ALS, to clear accumulations of toxic misfolded TDP-43 and allow normal TDP-43 to form in its place. Company representatives presented preclinical lab evidence of this process at a scientific meeting in Dec. 2022.

VectorY Therapeutics is raising €129 million in its first venture financing round, called series A, led by life science investors Forbion in Narden, The Netherlands that founded the company and EQT Life Sciences in Amsterdam. Joining the round are MRL Ventures Fund, the corporate venture arm of drug maker Merck, ALS Investment Fund, BioGeneration Ventures, and others. According to Crunchbase, VectorY raised €31 million ($US 38 million) in seed funds in June 2021.

The company plans to first apply the proceeds for advancing VTx-002. “The investment,” says VectorY Therapeutics CEO Sander van Deventer in a company statement, “will enable us to advance our lead program VTx-002, a potentially disease-modifying therapy for ALS, into clinical development. Our program is uniquely positioned to address TDP-43 pathology, which underlies the disease in the vast majority of ALS patients. The series A will also support advancement of additional pipeline programs targeting proteinopathies in neurodegenerative diseases demonstrating the broad potential of our platform.”

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Infographic – Digital Health Funding Continues Slide

Bar chart: Digital health venture funding by quarter, 2019 through 2023

Click on image for full-size view (CB Insights)

11 Nov. 2023. Venture funding for digital health start-ups continued heading down in the third quarter of 2023, reaching low levels not seen in almost a decade.  The technology intelligence company CB Insights describes the data for this sector in a report issued in late October (registration required).

CB Insights says companies worldwide developing digital health solutions raised $3 billion in 247 deals from July through Sept. 2023, declines of 14 percent in investment dollars and 33 percent in deal numbers from the previous three months. Moreover, says CB Insights, the $3 billion in investments is the lowest quarterly total since 2016 and the 247 transactions is the fewest number of deals in a quarter since 2014.

Start-ups providing digital care delivery and navigation raised $1.3 billion, nearly half of the total dollars invested by this sector, in 105 deals in Q3 2023. Developers of monitoring, imaging, and diagnostics technologies raised $700 million, while drug R&D start-ups attracted $500 million in the third quarter. The continued downward trend for digital health start-ups runs counter to venture funding overall and in life science start-ups that show gains in Q3 from the previous quarter; see the links below.

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Peanut Allergy Toothpaste Shown Safe in Trial

A woman brushing her teeth

(Martin Slavoljubovski, Pixabay. https://pixabay.com/photos/teeth-brushing-teeth-dentist-4818757/)

10 Nov. 2023. Results of a clinical trial show a peanut allergy treatment formulated as a toothpaste can safely deliver immunotherapy to raise recipients’ peanut tolerance. A representative of Intrommune Therapeutics Inc. in New York, developer of the experimental peanut allergy therapy, is scheduled to present the findings tomorrow at a meeting of the American College of Allergy, Asthma and Immunology in Anaheim, California.

Peanut allergies are among the most common food allergies, where the immune system reacts to proteins in peanuts as a pathogen, with symptoms ranging from runny nose and skin irritation to life-threatening anaphylaxis. The prevalence of peanut allergy is increasing in Europe and North America, reaching 1.4 to 2.0 percent of the population. In Feb. 2020, as reported by Science & Enterprise, the Food and Drug Administration approved the first peanut allergy treatment for children that exposes recipients to increasing amounts of peanut allergens for six months to desensitize the immune system. Otherwise, people with peanut allergies need to take special care not to ingest food made with even a small amount of peanuts.

Intrommune Therapeutics takes a different approach to build peanut tolerance called oral mucosal immunotherapy or OMIT that the biotechnology company says uses mucous membranes in the oral cavity to desensitize the immune system. Intrommune’s lead product, code-named INT301, is formulated as a toothpaste to deliver peanut immunotherapy as part of a person’s daily tooth-brushing routine. INT301, says the company, is designed as a fully-functioning toothpaste with immunotherapy that transfers through the mouth lining to gradually increases users’ peanut allergen threshold, to where symptoms are no longer triggered by accidental exposure.

Ability to ingest peanut protein

The early-stage clinical trial enrolled 32 adults with peanut allergies at two sites in New Jersey. Participants were randomly assigned on a 3-to-1 basis to use INT301 in escalating doses or a placebo toothpaste over 48 weeks. The study team from Intrommune looked mainly for tolerance and adverse effects from using INT301 as well as adherence to the daily tooth-brushing regimen, finding the maximum tolerated dose and exploratory immunoglobulin biomarkers indicating an immune response. In a subset of participants, the team also tested the ability of participants to ingest 300 milligrams of peanut protein, equivalent to 1 to 1.5 peanuts, at the beginning and end of the 48-week test period.

The researchers report all participants were able to tolerate use of INT301 up to the highest dose of the treatment. Participants reported no more than mild temporary adverse reactions, mainly itching around the mouth. Nearly all (97%) adhered to the treatments, with no dropouts from the study. And the team says initial biomarker measures indicate an immune response among INT301 recipients. In addition, the company reports all of those in the small group using INT301 could ingest 300 milligrams of peanut protein at the end of the study, compared to half of those using the placebo.

William Berger, an allergist and consultant to Intrommune Therapeutics who led the study and is presenting the findings, says in a company statement, “OMIT appeared to be a safe and convenient option for adults with food allergies.” Michael Nelson, CEO of Intrommune adds that the company is designing a mid-stage clinical trial to test INT301 among children.

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Challenge Seeks Transformative Human/A.I. Research Tech

Illustration: Artificial intelligence with a human face

(Gerd Altmann, Pixabay. https://pixabay.com/illustrations/artificial-intelligence-brain-think-4694502/)

9 Nov. 2023. A new challenge competition with $1 million in prizes seeks novel techniques for conducting biomedical research with data on human physiology and artificial intelligence. The Complement ARIE challenge — Complement ARIE stands for Complement Animal Research In Experimentation — is sponsored by the NIH Common Fund and conducted for National Institutes of Health by the crowdsourcing company HeroX. Initial submissions are due by 11 Jan. 2024.

With this competition, NIH aims to generate fresh ideas for conducting research on health that takes advantage of rapidly advancing computational technologies such as artificial intelligence and proliferation of detailed data on human physiology. NIH’s Common Fund, the vehicle for financing initiatives that cut across the agency’s institute boundaries, calls these novel ideas New Approach Methodologies or NAMs. The Common Fund hopes the competition can reveal tools for complementing or replacing conventional research models, such as tests with lab animals, to provide precise answers to complex questions about human biology.

The Complement ARIE challenge asks individuals and teams to propose human-based NAMs that can transform the conduct of basic and clinical research. Participants are expected to provide NAMs as detailed solutions that cut across conventional scientific and engineering disciplines to harness computational techniques and microphysiological data to better understand the complexities of human health. In addition, NAMs proposed by participants should be validated with the goal of acceptance by regulatory bodies. The Common Fund expects to use NAMs generated by the competition for its strategic planning, and to model human health and disease across diverse populations.

Up to 20 top solutions receive prizes

The challenge has an accelerated submission and judging schedule that first asks participants to submit a 15-page white paper by 11 Jan. 2024. Proposals should outline new ideas for NAMs covering in-vitro or lab culture studies, as well as computer simulations called in-silico techniques, and studies of molecular interactions in cell-free environments known as in-chemico methods. In addition, participants need to demonstrate the integration of these NAMs, particularly using A.I. for outcomes such as predictive models, real-time data analysis, and population-level or individual patient digital twins.

The challenge guidelines provide details for the format and content of white papers, participation requirements, and judging criteria, plus full eligibility rules. After submission of white papers on 11 Jan. 2024, judges will review proposals through mid-February. Up to 20 top solutions, each receiving $50,000, are expected to be announced later in February.

“NAMs research is at a critical point,” says Douglas Sheeley, acting director of the Office of Strategic Coordination that oversees the NIH Common Fund, in a HeroX statement released through Cision, “where investment and collaboration between multiple sectors could help to enable widespread development and expansion in use of these new technologies.” Sheeley adds, “NAMs fit well as an area for Common Fund investment because they have the possibility to create advancements across broad swaths of biomedical research.”

HeroX is providing the crowdsourcing platform for the Complement ARIE competition. The 10 year-old company provides the mechanisms for conducting idea-generating exercises, such as challenge competitions, for companies and organizations needing crowdsourced solutions for identified problems or issues. In Sept. 2023, Science & Enterprise reported on HeroX providing part of the process for an NIH-sponsored challenge seeking early indicators of Alzheimer’s disease and related dementias using analytics powered by artificial intelligence.

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Life Science Incubator Gains $100M in Start-Up Funds

Raven in a tree

Raven (arbyreed, Flickr. https://flic.kr/p/yHVbGg)

8 Nov. 2023. A new-business accelerator program, begun earlier this year to advance and commercialize biomedical research discoveries from academic labs, is receiving a $100 million founding grant. Blackbird Labs in Baltimore, Maryland is collaborating with life science researchers at local institutions including Johns Hopkins University and Lieber Institute for Brain Development, located on the Johns Hopkins campus, as well as University of Maryland in Baltimore.

Blackbird Labs says it aims to close the gap between research breakthroughs in university labs and the marketplace. The organization says it’s identifying new discoveries with market potential, then connecting researchers with life science industry experts to guide their solutions through further development and business creation. Blackbird plans to reduce risks of further development of these discoveries, encourage public-private partnerships, form start-up companies, and provide early capital.

The group says it will initially support research advances in cancer, neurological and genetic diseases, and inflammation and immune disorders. Blackbird, which formed in Jan. 2023, has already started collaborations on an oral drug for Crohn’s disease and colitis, cell-specific gene therapies, a multi-modal treatment for schizophrenia, and a digital technology to ease clinical trial participation by patients.

“Groundwork for the biotech companies of the future”

“We look forward,” says Blackbird Labs CEO Matt Tremblay in an organization statement released through Cision, “to utilizing our collective expertise in academic translation, company creation, and drug development, and leveraging our academic partnerships to lay the groundwork for the biotech companies of the future.” Tremblay was previously chief operating officer at Scripps Research Institute and Calibr, the institute’s drug discovery division.

The Stephen and Renee Bisciotti Foundation is providing a $100 million start-up grant for Blackbird Labs. Steve Bisciotti is owner of the Baltimore Ravens, the city’s NFL franchise, and the foundation’s address is M&T Stadium where the team plays. In March 2023, the foundation’s translational fund awarded seed grants to researchers at Johns Hopkins University for development of a messenger RNA or mRNA gene-therapy booster to address protein deficiencies, chimeric antigen receptor or CAR T-cell therapies for autoimmune diseases, and a vaccine that invokes T-cell responses in the immune system to protect against a range of coronavirus infections.

Christy Wyskiel, executive director of Johns Hopkins Technology Ventures, the university’s technology transfer arm, calls Blackbird Labs, “a unique resource for funding and expertise to help bring Johns Hopkins technologies to market. Its focus on therapeutic assets, one of our strengths, and on Baltimore-based start-ups is well-aligned with our mission.” Wyskiel also advises the university president on innovation and entrepreneurship.

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Home V.R. Therapy Shown to Reduce Back Pain

Man in pain holding lower back

(NIH.gov)

7 Nov. 2023. A virtual reality program conducted at home is shown in a clinical trial to relieve chronic lower back pain intensity and improve daily living more than a sham V.R. program. Findings from the nationwide clinical trial assessing the therapy designed by the company AppliedVR appear in the 24 Oct. 2023 issue of Mayo Clinic Proceedings: Digital Health.

AppliedVR in Los Angeles applies virtual reality to therapeutics for conditions such as chronic pain, as well as behavioral and mental health disorders. The lead product from the eight year-old company is RelieVRx, a V.R. treatment for chronic lower back pain, performed by the patient at home, once a day for eight weeks. The company says its cognitive behavioral therapy combines diaphragmatic breathing, mindfulness, cognition and emotion regulation with pain education into daily immersive exercises. In addition, the V.R. headset uses a built-in microphone to capture audio of the user’s exhaling patterns as part of biofeedback in the program.

RelieVRx is available by prescription, and cleared by the Food and Drug Administration. The treatments are coded for reimbursement by Centers for Medicare and Medicaid Services and part of the Department of Veterans Affairs’ federal supply schedule.

The authors note that chronic lower back pain is the most prevalent pain condition worldwide, but opioid pain relievers are now too dangerous, resulting in fewer options for patients with the condition. And conventional behavioral therapies require a therapist, which reduces the availability of pain treatments without drugs.

Measures of pain intensity and interference

The clinical trial sampled 1,067 adults, age 18 to 85, with chronic lower back pain in the U.S., recruited by clinics, chronic pain organizations, and online advertisements. The sample was mainly women (72%) with an average age of 51. Participants were all given the same V.R. headsets, but randomly assigned to receive the RelieVRx program or a sham V.R. experience, consisting of non-immersive content such as two-dimensional nature videos and relaxing music. Data were collected directly from participants through online surveys through the Curebase clinical trial platform.

Both the RelieVRx and sham V.R. programs lasted eight weeks, with participants tracked for another 24 months. The study team looked primarily at scores on a standard Brief Pain Inventory questionnaire that measures participants’ evaluations of pain intensity, and pain interference or practical effects of pain on their daily lifestyles, such as mood, walking ability, work, sleep, and relations with others. Researchers also captured other survey data on disability, sleep, anxiety, and depression.

Results show after eight weeks RelieVRx participants record less pain intensity with average scores of two points lower on a 10-point scale than sham V.R. program participants. Likewise, RelieVRx participants report less pain interference after eight weeks than sham V.R. users by an average of 2.3 points on a 10-point scale. In both cases, the differences are large enough for statistical reliability. On the secondary measures, RelieVRx participants say they experience less sleep disturbance, depression, and disability than sham V.R. users. Adverse effects were reported by no more than five percent of RelieVRx or sham V.R. participants, mainly dizziness, vertigo, or nausea.

Beth Darnall, a pain specialist at Stanford University medical school and co-author of the paper who advises AppliedVR, says in a company statement released through Cision that “traditional clinical guidelines have over-relied on medications or surgical procedures, which can be costly and ineffective over the long term.” Darnall adds that the new study, “builds on our previous research at a much larger scale and demonstrates that RelieVRx can be a powerful tool in providers’ tool belts for treating people experiencing chronic low back pain.”

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Electric Pulses Induce Lung Cancer Immune Response

Lung cancer illustration

(NIH.gov)

6 Nov. 2023. Results of a clinical trial show a lung cancer therapy using highly focused pulses with electrical energy show signs of immune responses that can treat the patients’ tumors. A team from the medical device company Galvanize Therapeutics Inc. in San Carlos, California reported the findings on Friday at a meeting of the Society for Immunotherapy of Cancer in San Diego.

Galvanize Therapeutics develops therapies for chronic bronchitis, atrial fibrillation, and solid tumor cancers with short high-voltage electrical pulses delivered to the disease site. The company says the electric pulses create an electric field that destabilizes the target cells leading to cell death. Because the technology does not use heat, says Galvanize, the treatments do not harm the extracellular matrix, supportive material around cells, and limits inflammation in the targeted tissue. The company says its treatments deliver the electric pulses with dose levels and electrodes designed for the targeted organs and tissue.

The clinical trial is an early- and mid-stage study testing the Galvanize Therapeutics treatment for non-small cell lung cancer that accounts for 80 to 85 percent of all lung cancer cases. The company says its system, called Aliya PEF for pulsed electic field, is cleared by the Food and Drug Administration and used by surgeons to ablate or burn off tumor cells and tissue with an electrical field. At the same time, says Galvanize, early evidence suggests the Aliya treatments also release antigens that activate the immune system, adding to their therapeutic benefits. The study aims to assess immune responses to the Aliya treatments.

Higher proportions of immune-system cells

The trial enrolled 42 participants at sites in Spain, the Netherlands, and Hong Kong diagnosed with early-stage non-small cell lung cancer, of which 34 agreed to have their tumors resected with the Aliya treatment. The other eight patients served as a control group. The study team initially sought to track adverse effects from the treatments for 30 days following surgery, and note the ability of surgeons to access he tumor sites and deliver the electrical pulses. Earlier trial results, says Galvanize, show the treatments are safe and feasible for surgeons.

In this paper, the authors report on test results of blood, lung tissue, and tumor samples from treated and untreated patients, taken before and after surgery. RNA sequencing indicates several types of immune signals in treated patients that result in higher proportions of innate immune-system B-cells, T-cells, and neutrophils in patients receiving Aliya therapy. The authors also report flow cytometry, a technique analyzing laser light patterns through cells, indicates treated patients have higher levels of circulating B-cells and memory T-cells, suggesting an adaptive immune response. And the supportive microenvironments in lung tumors among treated patients show higher numbers of cancer-killing T-cells and B-cells, with tumor cells expressing more antigen genes for triggering further immune responses.

In a company statement released through Cision, founder and CEO of Galvanize Therapeutics Jonathan Waldstreicher says the clinical trial data underscore “the potential of Aliya PEF as a transformative approach in the fight against cancer. By harnessing the body’s own immune system, we are moving closer to offering patients a personalized and potentially more effective treatment option.”

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Keeping Conversations Positive with Precision Moderation

– Sponsored content –

Colorful phone screen

(Fancycrave, Pexels.com)

27 Oct. 2023.

Sponsored content removed due to non-payment.

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Taking a Break

Suitcase in airport

(Michal Parzuchowski, Unsplash)

23 Oct. 2023. We’re traveling for the next two weeks, and will resume our editorial posts on Monday 6 Nov. 2023.

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