29 May 2023. It’s Memorial Day today in the U.S., a day to honor those who gave their lives in the service of this country. We’ll resume our editorial posting tomorrow.
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27 May 2023. A recent poll shows U.S. adults continue to favor vaccinations against the childhood diseases mumps, measles, and rubella, but show less support for Covid-19 vaccines. The Pew Research Center reported the findings last week from a survey conducted in March 2023. In three surveys since June 2016, Pew researchers find some nine in 10 Americans, 88 percent each time, say health benefits of the mumps, measles, and rubella or MMR vaccine outweigh the risks. In those same polls, between seven and eight in 10 Americans rate the MMR vaccine’s health benefits as high, while roughly two-thirds, between 64 and 69 percent, say the risks of that vaccine are low. But for the Covid-19 vaccine, opinion in the U.S. is more divided. Roughly six in 10 Americans (62%) say benefits of the Covid-19 vaccines outweigh the risks, while more than one-third (36%) believe risks of that vaccine outweigh the benefits. Likewise less than half of American adults (45%) say preventive health benefits of the Covid-19 vaccine are high, and nearly as many, 41 percent, say risks of side effects are low. While the American public is largely in favor of MMR vaccines for children, those not vaccinated against Covid-19 show less support. About three-quarters (74%) of respondents without a Covid-19 vaccine say MMR vaccine benefits outweigh the risks, compared to more than nine in 10 — 94 to 95 percent — of those with Covid-19 prime or booster shots. In addition, only about half of Americans without Covid-19 vaccines say MMR vaccines provide high health benefits, compared to roughly eight in 10 — 79 to 83 percent — of those with Covid-19 prime or booster vaccines. Pew Research Center conducted the survey online with 10,701 U.S. adults taking part in the Center’s American Trends Panel from 13 to 19 Mar. 2023. Participants are recruited through national random sampling of U.S. households, with results weighted to be representative of the U.S. adult population. More from Science & Enterprise:
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26 May 2023. Results of a small clinical trial show most patients with melanoma receiving a personalized therapeutic vaccine with an approved immunotherapy reduced at least some of their tumors. Evaxion Biotech A/S, a company in Copenhagen, Denmark and developer of the vaccine, plans to present the findings on 3 June at the upcoming American Society for Clinical Oncology or ASCO meeting in Chicago. Evaxion Biotech designs personalized therapies for cancer and infectious diseases, including treatments for bacterial infections becoming resistant to conventional antibiotics. The company says its technology uses generative prediction models from artificial intelligence to create precision medicine treatments that invoke the immune system. For cancer therapies, Evaxion says it starts with a tissue sample from a patient’s tumor biopsy to identify the cancer-causing mutation, then uses its A.I. models to determine the contents of neoantigens, unique sequences of amino acids or peptides on the surface of tumor cells that act as vaccine targets. Neoantigens represent not only properties of the tumor, but also characteristics of the patient’s personal chemistry. The company says its models can design vaccines with multiple targets where tumors are quickly mutating, and predict as well the likelihood of neoantigen targets to invoke T-cell responses from the immune system. Evaxion says it manufactures personalized cancer vaccines generating T-cell responses targeting those precise antigens, given with standard cancer treatments. The company says vaccines used in the reported clinical trial took eight weeks to produce. All participants show T-cell responsesThe early-stage clinical trial is recruiting patients in Italy with melanoma, an aggressive skin cancer that metastasized, or spread to the lymph nodes or to other parts of the body. Participants are given the approved immune checkpoint inhibitor drug pembrolizumab that blocks tumors from suppressing the immune system, as well as Evaxion’s experimental personal vaccine code-named EVX-01. The study team is evaluating participants for two years, looking for full or partial clinical responses to the treatments, immune system responses, and any adverse effects. The team is comparing participants’ responses to historical data of metastatic melanoma patients treated with pembrolizumab alone or going untreated. The study has no placebo or comparison group. At the ASCO meeting, Evaxion is reporting interim data from the trial that began in July 2022. All of the 12 patients enrolled, says the company, exhibit T-cell responses from the personalized neoantigens, with more than half (58%) of the neoantigens inducing an immune response. Eight of the 12 patients, or two-thirds, exhibit at least some clinical improvement, with two of the eight participants showing a complete response, indicating disappearance of all known disease. Evaxion says any adverse events from the EVX01 treatments are rated mild or moderate. “EVX-01 was well tolerated,” says Evaxion Biotech CEO Per Norlén in a company statement, “and induced a higher objective response rate than previously reported for standard of care treatment.” Norlén adds that “EVX-01 induced a broad immune response that correlated with clinical outcome, which is very encouraging for the further development of Evaxion’s personalized cancer vaccine programs.” More from Science & Enterprise:
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25 May 2023. Interim results from a clinical trial show a drug given as a dissolvable oral film in a lower dose reduces agitation in people with bipolar disorder and schizophrenia. Findings from the trial were released by Bioxcel Therapeutics Inc., developer of the drug Igalmi, testing half of the approved dose in a clinical setting, in advance of the second part of the study testing the drug among patients at home. Bioxcel Therapeutics in New Haven, Connecticut discovers new applications of existing drugs with machine learning algorithms and analytics, which it says speeds development of new therapies at lower cost and with a greater likelihood of success. The company’s lead product, Igalmi, is an adaption of the drug dexmedetomidine first developed as a sedative in hospitals for intubation or mechanical ventilation. Bioxcel reformulates dexmedetomidine as a film dissolved under the tongue for individuals with mental health disorders who become overly agitated. The company says controlling agitation is difficult and can lead to aggression in some people if not addressed quickly. In April 2022, the Food and Drug Administration approved Igalmi as a treatment for people with agitation from schizophrenia and bipolar disorder types 1 and 2; bipolar disorder type 2 is associated with major depressive disorder. FDA’s approval covers two dosage levels, 120 and 180 micrograms, taken by the patients themselves but under the supervision of clinicians. Lower scores on agitation scaleThe new clinical trial is testing Igalmi in a lower dose, 60 micrograms — code-named BXCL501 — as an eventual treatment for agitation that can be taken at home, without supervision by trained staff. Bioxcel designed the late-stage trial in two parts: first in a clinical setting, then by patients at home. The entire trial will enroll 450 participants diagnosed with bipolar disorders type 1 and 2, schizophrenia, and related conditions at 16 sites in the U.S. Participants are randomly assigned to receive BXCL501 or a placebo, then assessed in the next few hours and tracked for 12 weeks. Bioxcel released results today of the study’s first phase — with 201 participants taking BXCL501 or placebo under clinical supervision — on its web site and are not yet peer-reviewed. Results show none of the BXCL501 recipients experienced severe adverse effects, with any adverse effects rated mild or moderate, and none requiring medical intervention or monitoring. The most common adverse effect was drowsiness or fatigue, experienced by 13 of the 101 BXCL501 recipients. The company says results of standard clinical assessments of agitation show lower scores among participants receiving BXCL501 than placebo recipients at two and four hours after taking the drug, compared to before the trial, but only the differences between the groups after four hours are large enough for statistical reliability. The number of participants responding to treatments, defined as a 40 percent or larger reduction on the same standard agitation assessment scale, is greater for BXCL501 than placebo recipients at two hours after taking the drug, compared to before the trial. “We believe these results have opened the therapeutic window for BXCL501’s potential use at home for bipolar- and schizophrenia-related agitation,” says Bioxcel Therapeutics’ chief medical officer for neuroscience Robert Risinger in a company statement. Company CEO Vimal Mehta adds, “Treatment in the early stages of agitation at home could significantly benefit patients, caregivers, and hospital systems by reducing the need for emergency room visits and associated treatment costs.” More from Science & Enterprise:
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24 May 2023. A global drug maker is acquiring access to a biotechnology company’s precise genome editing techniques to develop new therapies for rare and cardiometabolic disorders. The agreement with Novo Nordisk A/S in Bagsværd, Denmark could bring Life Edit Therapeutics Inc. in Durham, North Carolina and its parent company ElevateBio more than $2 billion if all terms of the deal are fulfilled. Life Edit Therapeutics discovers new treatments for disease with the genome editing process similar to Crispr, short for clustered, regularly interspaced short palindromic repeats, adapted from a bacterial process for protecting against attacks by viruses. Crispr uses RNA to find the exact location in a genome to edit malfunctioning genes responsible for disease, with enzymes that perform the edits. Life Edit says it extends the Crispr approach with new types of nucleases or enzymes that perform a wider range of genome editing functions. The company says its genome editing enzymes are derived from natural microbial sources provided by its partner company AgBiome Inc. Among Life Edit’s extended genome-altering techniques is base editing for fixing more granular errors in the genome. Base editing seeks to change errors called point mutations where one base pair in a single DNA strand is replaced by another base pair. The human genome is made up of some 3 billion base pairs — adenine (A)/thymine (T), and cytosine (C)/guanine (G) — and each pair joining with sugar and phosphate molecules to form a nucleotide. The sequence of those nucleotides in strands of DNA make up a person’s genome. Limit off-target edits and adverse effectsLife Edit says it achieves base editing precision with its highly accurate enzymes designed to cut only a single DNA strand at the specific base-pair location. This level of precision, says the company, is needed to address mutations responsible for rare diseases and limit off-target edits and adverse effects. Novo Nordisk is a global drug maker and developer of branded drugs for obesity, diabetes, heart disease, and genetic disorders such as hemophilia. The agreement with Life Edit Therapeutics calls for the two companies to collaborate on base editing applied to seven disease targets, including rare genetic diseases and cardiometabolic disorders, where metabolic conditions such as insulin resistance are combined with cardiovascular diseases like hypertension. Under the deal, Novo Nordisk is responsible for all research and development expenses and Life Edit receives an undisclosed up-front payment. The agreement makes Life Edit eligible for development, regulatory, and commercial milestone payments of up to $335 million for each of the first two therapy programs, and up to $225 million for each of the following five treatments. Life Edit is also eligible for royalties on future sales of therapies. In addition, Novo Nordisk is taking part in the latest venture funding round of ElevateBio, the parent company of Life Edit Therapeutics, a gene and cell therapy holding company in Waltham, Mass. Science & Enterprise reported on ElevateBio’s previous funding round in Mar. 2021. “The advancements we’ve made,” says Life Edit CEO Mitchell Finer in a statement, “to our next-generation gene editing platform and base editing capabilities are opening the next frontier of treating disease through DNA editing.” Marcus Schindler, executive vice-president and chief scientist at Novo Nordisk adds that his company is “continuously building and leveraging technology platforms that open up new opportunities across our therapeutic areas to deliver potentially curative treatment options to people living with serious chronic diseases.” More from Science & Enterprise:
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23 May 2023. A venture investment fund and university bioengineering center are creating a laboratory to design more sustainable alternative materials to help address the climate crisis. The Collaborative Fund, based in New York is contributing $15 million to start the Laboratory for Sustainable Materials Research and Innovation, under the Wyss Institute for Biologically Inspired Engineering at Harvard University. The new lab is expected to study and develop new types of materials that protect and conserve the environment with technologies such as synthetic biology and bio-manufacturing. Researchers at the lab, says the Wyss Institute, will investigate techniques for replacing fossil fuels in producing materials and substances used in textiles and plastics, but also found in food and energy products. A separate initiative in the lab plans to study processes for accelerating lab discoveries into commercial-scale solutions, which historically are under-funded and often not recognized among scientists or business people. Donald Ingber, founding director of the Wyss Institute, says in a statement that the Laboratory for Sustainable Materials Research and Innovation shows the bioengineering center recognizes the need to look beyond its usual medical and health studies. “We see this as a call-to-arms for our researchers and entrepreneurs working on problems in sustainability,” notes Ingber, “as well as a stimulus for other members of our community who are currently working in medical areas to pivot and apply their know-how in entirely new ways to meet this monumental challenge head-on.” Out of the lab and into the marketplaceThe Collaborative Fund is a network of venture capital managers that seeks out investment opportunities that combine both favorable returns and achieve a social good. In Aug. 2022, Collaborative Fund began its Collab SOS program, a $200 million fund to invest in the sustainable economy. Collab SOS expects to support start-ups developing environmentally-friendly materials, ingredients, and energy products as well as supply chains for these products. The fund plans to finance new companies in their first two full venture rounds, called series A and B, but also provide advice on moving their products and services out of the lab and into the marketplace. In a Collaborative Fund blog post, the fund says it plans to support synthetic biology applied to materials science in its Wyss Institute partnership, particularly in consumer goods and heavy industry, considered major contributors to greenhouse gas emissions. And as in the case of Collab SOS, the fund expects to share its insights into moving ideas from the lab into the marketplace. “We want to help accelerate the shift from research to real-world impact,” says Collaborative Fund partner Sophie Bakalar adding, “When it comes to climate change, there’s no time to waste.” The Wyss Institute’s technology translation director Angelika Fretzen will share oversight of the new lab with Bakalar, also receiving an institute appointment as visiting scholar. The Institute says technology transfer from its research has so far resulted in 55 new start-up companies, 115 licensing deals, and more than 4,000 patent filings. More from Science & Enterprise:
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![]() Psilocybin mushrooms (Workman, Wikimedia Commons. https://commons.wikimedia.org/wiki/File:Psilocybe.tampanensis.two.jpg) 22 May 2023. A biotechnology company says it identified engineered precursors of a psychedelic compound that in lab animals produce safe and intended therapeutic effects. Researchers from Enveric Biosciences Inc. in Naples, Florida and University of Calgary in Alberta, Canada posted their findings on 18 May, on the BioRxiv preprint server, which are not yet peer-reviewed. Enveric Biosciences is a three year-old enterprise developing treatments for mental health disorders such as anxiety, depression, and addictions. The company says it maintains a library of synthetic chemical drug candidates, numbering in the hundreds, with properties shown to produce a response in the nervous system. This drug candidate collection, says Enveric Bio, includes synthetic analogs of the compound psilocybin, a chemical found in so-called magic mushrooms known to produce psychedelic effects, from euphoria to undesired outcomes such as panic, anxiety, and hallucinations. The company says it engineered nine types of prodrugs or chemical precursors of psilocin, a key psychoactive component of psilocybin. Prodrugs on their own have few, if any, chemical effects, but produce a chemical reaction similar to drugs when they react to enzymes in the body. Enveric Bio says it’s producing a series of mental health treatments based on these psilocin prodrugs designed to act in the body like small molecule or low molecular weight drugs. The company says its drug candidates can be delivered as nasal sprays, oral drugs, or injections, with fast access to the brain, and in lower doses to reduce adverse effects. Therapeutically relevant levels of the psychoactive agent“Psilocybin has shown therapeutic benefit for the treatment of numerous psychiatric diseases,” says Peter Facchini, biochemistry professor at University of Calgary and chief innovation officer of Enveric Biosciences in a company statement, “however, due to the high intensity and duration of the psychedelic experience, there is a significant barrier to its widespread therapeutic application. To address this issue, we designed a series of novel psilocin prodrug derivatives that are able to release therapeutically relevant levels of the psychoactive agent psilocin, with improved pharmacokinetic concentration and profiles.” The authors of the research paper, led by Facchini, note that clinical studies show psilocybin-assisted therapies can help treat people with treatment-resistant depression and mental distress among cancer patients. However, say the authors, people receiving those treatments also report psychoactive episodes lasting as long as six hours, with elevated psilocin levels in blood plasma for up to 24 hours. In the paper, the team started with a set of 28 prodrugs derived from psilocin, and screened the compounds in lab cultures and mice, to reveal activity in target cells and chemical effects in the body. The researchers narrowed the prodrug list to 15 candidates to test intended metabolic activity, as well as a head-twitching responses in healthy mice indicating psychoactive responses. Notably, say the authors, the mice show no measurable psilocin levels in blood samples after 24 hours. The screening process narrowed the candidate list to five, then three, psilocin prodrugs that in tests with mice induced to express chronic stress, reduce anxiety-like behaviors comparable to psilocybin. Two of the prodrug candidates, say the authors, reduce the anxiety behaviors for seven days. Enveric Bio says from this study it identified a lead product to advance further in development. “Our lead product candidate, EB-373,” says company CEO Joseph Tucker, “which was derived from this important work, offers the potential to elicit a more rapid onset of action, more controlled therapeutic effect, and reduced side-effects, which we believe differentiates it from other drugs as a potential novel treatment for anxiety disorders.” More from Science & Enterprise:
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20 May 2023. When we last looked in March, venture funding for artificial intelligence start-ups showed a glimmer of hope as investment dollars turned up in the fourth quarter of 2022. Those hopes are now all but dashed as a new report from technology intelligence company CB Insights (subscription required) indicates a sharp downturn in venture funds for this sector. The report shows global investment dollars for A.I. start-ups fell from $9.5 billion in Q4 2022 to $5.4 billion in the first three months of 2023, a 43 percent decline. In addition, the number of venture transactions fell from 622 to 554 in Q1 2023, a drop of 11 percent from the previous quarter. Both the total investment dollars and number of venture deals in Q1 2023 are the lowest single quarter totals since 2019. In the U.S., total venture dollars for A.I. start-ups reflected the worldwide totals for Q1 2023, falling 27 percent to $3.7 billion from $5.1 billion in Q4 2022. The only sprinkling of sugar on this otherwise sour report is an uptick in investment dollars for A.I. in Silicon Valley, which rose to $2.4 billion in Q1, from $1.7 billion in the previous quarter. Plus, mergers and acquisitions of A.I. start-ups also rose to 75 in the first quarter of 2023, continuing an upward trend from 45 in the third quarter of 2022. However, A.I. start-ups going public almost disappeared in Q1, with only two IPOs and no SPAC mergers at all. More from Science & Enterprise:
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19 May 2023. A new challenge competition seeks biomarkers, models, and clinical tests of the factors behind responses to stress conditions in human aging that can stave off frailty or death. The Dynamic Resilience challenge, conducted by Wellcome Leap, has a total prize purse of $60 million, but also a short timetable with initial proposals due on 25 May 2023. The competition, says Wellcome Leap, aims to build a better understanding of human biological resilience that enables some people to respond to medical stresses as they get older, such as serious diseases, falls, or surgery. This ability to bounce back from adverse events, says the organization, results from complex physiological processes and mechanisms that enable individuals to continue functioning and maintain a stable equilibrium in their lives. Wellcome Leap cites data showing about half of adults over 65 experience at least two long-term health conditions, with that percentage rising to about 80 percent by the time they reach their 80s. Moreover, says the group, the ability to deal with these stresses diminishes as we get older, making older people more susceptible to serious illness or injury, a state in clinical terms called frailty. Other data cited by Wellcome Leap show about half of individuals age 65 or older becoming or already reaching a frail condition, resulting in less of people’s lifetimes spent in good health. Clinical trials among at-risk populationsThe challenge asks participants from labs worldwide in universities, research institutes, not-for-profit organizations, government agencies, and companies of all sizes to identify and integrate biomarkers or molecular indicators of resilience into mechanisms related to aging that promote or impair a return to equilibrium and functioning after a health stress event. Those biomarkers need to identify and predict a response to medical stress before the event with more than 85 percent true-positive sensitivity and 90 percent true-negative specificity. The challenge also asks participants to validate their models or interventions in targeted clinical trials among at-risk populations, demonstrating at least those same sensitivity and specificity levels, as well as a 25 percent or greater reduction in patients progressing toward frailty. Winning entries will receive funding for work covering three years, with an option for a one-year extension. The organization says up to $60 million will be awarded, but there are no pre-set number of awards, and specific funding amounts will depend on the type and scope of work proposed. Wellcome Leap has a short timetable for the competition. Initial abstract proposals from individuals or teams are due on Thursday 25 May. The organization will review the abstracts and provide feedback, including a recommendation to submit a full proposal by 9 June. Those full proposals of 25 pages are due by 10 July. Reviewers will then select those proposals for funding and alert the winning participants by 9 August. Full program details and instructions are on the Wellcome Leap web site. Wellcome Leap is a not-for-profit organization in Los Angeles that sponsors high-impact health research seeking medical breakthroughs on an accelerated schedule, spun-off in 2018 from the Wellcome Trust research foundation in the U.K. The group says it’s modeled after Defense Advanced Research Projects Agency or Darpa that supports R&D breakthroughs for defense applications, often by bringing together stakeholders and providing financial incentives. Science & Enterprise has reported on several Wellcome Leap programs, most recently in March 2023 seeking applications of quantum computing in the life sciences. More from Science & Enterprise:
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18 May 2023. A company creating brain-computer interface devices to help people with disabling communications impairments is raising $33 million in its first venture round. In addition, says Paradromics Inc. in Austin, Texas, the Food and Drug Administration designated its Connexus DDI system, the company’s lead product, as a “breakthrough device” that provides for an expedited review by the agency. Paradromics, founded in 2015, is developing technology to enable high-volume electronic data transfers linking signals from neurons or nerve cells in the brain to computer devices for people with severe neurological disorders such as ALS and stroke or spinal cord injuries. The company says its first systems are designed as assistive devices for people with disabling conditions preventing their abilities to speak or type, thus converting brain signals into text or synthesized speech. Paradromics says its systems capture and transfer data with more brain neurons and at higher volumes than other lab-developed brain-computer interfaces. As reported in Science & Enterprise in Oct. 2021, Paradromics is developing its Connexus Direct Data Interface or DDI system with funding in part from National Institute of Mental Health, a division of National Institutes of Health, under a three-year $3.2 million award. The company says its system uses a small low-power array of electrodes that captures data from some 1,600 neurons, implanted 1.5 millimeters into the brain’s cerebral cortex. The cerebral cortex that makes up the outer layer of the brain under the skull controls a person’s motor and sensory functions and conscious thought. The electrode array transfers the captured data to a receiving device implanted under the skin in the chest, which relays the data wirelessly in real time to external systems for processing and interpretation. Advance the system to a clinical trialParadromics says beyond assisting people with communication disabilities, its technology can be adapted to help treat mental health disorders resistant to conventional drugs, addiction, and chronic pain. The company says FDA designated the Connexus DDI a breakthrough device, a program to encourage more effective medical devices addressing life-threatening or irreversible debilitating conditions. The breakthrough device designation provides companies greater access and more interaction with FDA staff during development and an expedited review. “This designation,” says Paradromics CEO Matt Angle in a company statement released through Cision, “recognizes the transformative promise of our device, and we look forward to continued coordination with the FDA to accelerate its availability.” Paradromics is raising $33 million in its first venture funding round, which the company plans to use for advancing Connexus DDI to a clinical trial. The financing is led by Prime Movers Lab in Jackson, Wyoming, an investor in science-based start-ups covering a wide range of technologies including a category it calls human augmentation. Joining the round are Westcott Investment Group, Dolby Family Ventures, and Green Sands Equity. According to Crunchbase, Prime Movers Lab provided some $8.9 million to Paradromics in Sept. 2022. Dakin Sloss, founder and general partner at Prime Movers Lab notes, “I think it’s no longer a question of whether brain-computer interfaces will become the standard treatment for many neurological problems,” and adds, “We’re seeing only a couple of companies emerge as real contenders in the space, and I believe Paradromics will be the one that moves into successful human trials.” More from Science & Enterprise:
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