
The Prototype: These Bacteria Can Generate Electricity
In this week's edition of The Prototype, we look at quantum computing for image recognition, a gene therapy using a patient's own skin cells, electricity-generating bacteria, using physics to cook perfect pasta and more. You can sign up to get The Prototype in your inbox here.
Years ago, scientists found that certain kinds of bacteria appear to breathe by generating electricity, rather than taking in oxygen, but how they did so was a mystery. A new study published in the journal Cell identifies how this happens: the microbes are using a group of chemicals called naphthoquinones in a manner similar to the way a battery discharges electricity. This is what enables bacteria to thrive in oxygen-deprived areas like deep sea vents.
Armed with this knowledge, it may be possible for scientists to adapt these bacteria for use in a wide variety of applications, such as wastewater treatment or developing bioelectronic sensors. It could even be used as a method to turn atmospheric carbon dioxide into useful chemicals–a sustainability twofer.
Stay tuned.
CEO Vishwas Seshdari
Abeona Therapeutics
Around 750 people in the United States have a rare genetic condition called recessive dystrophic epidermolysis bullosa (RDEB). People with this disease aren't able to correctly produce a particular type of collagen essential for the skin, causing excessive blistering and slowing the healing of wounds dramatically–if they heal at all.
Earlier this week, the FDA approved a new treatment for this condition called Zevaskyn, which was developed by gene therapy company Abeona Therapeutics. The product is manufactured using a patient's own skin cells, which have been genetically modified to produce the right kind of collagen. Those cells are then formed into sheets that can be grafted to a patient at the site of a wound.
In a clinical trial, 81% of the wounds treated with Zevaskyn showed significant healing after six months, compared to just 16% in patients using current therapies. What's more, the healing appears to be durable, showing long term improvements at follow-ups conducted years later. Patients getting the therapy also reported significantly less pain.
Abeona's CEO Vishwas Seshdari told me that with the approval, the company should be ready to start treating patients by July, starting with a manufacturing cadence of being able to treat about six patients a month. The price per treatment is $3.1 million, with patients expected to receive one or two in their lifetime, and Seshdari said that it's already working on reimbursement arrangements with payers to ensure those who need it can get it.
The company is also expanding its manufacturing capability with an eye to being able to treat 10 patients a month by the first half of next year. 'We can't wait to bring this therapy to patients,' he said.
Quantum software company BlueQubit has figured out how to use quantum computing to power image-classifying AI. Working with the Honda Research Institute, it developed three different ways to encode images so they can be manipulated by quantum computing hardware. They were then used both by regular computers using quantum algorithms as well as quantum computers manufactured by IBM. The company found that one of the encoding methods enabled quantum-powered AI to classify images with about 94% accuracy, which is comparable to what can be achieved by classical computers. That said, current methods of classifying images are still faster. But by developing a way to do image classifying on quantum hardware, this research sets the stage for this type of application to be used when quantum computers have scaled to the point where they're regularly out-performing regular computers.
On Monday morning, 27 satellites for Amazon's Project Kuiper were launched into orbit. CEO Andy Jassy confirmed on social media that day that all of them were operational. The company intends to eventually have over 3,200 satellites in orbit, with a goal of providing broadband internet access around the globe.
In my other newsletter, InnovationRx, Amy Feldman and I looked at a patent fight over the world's top-selling drug, new breakthroughs from the American Association for Cancer Research, a dataset to better understand Parkinson's, the relationship between microplastics and heart disease and more.
Waymo is partnering with Toyota to design a new platform for autonomous cars and trucks with an aim to develop them for personal use.
Scientists have discovered a massive, glowing molecular cloud just 300 light years from our solar system. This vast cloud of gas and dust, which has been dubbed Eos, is primarily composed of hydrogen and will evaporate in around 6 million years.
A team of researchers has developed a soft exoskeleton called the MyoStep, which is made of lightweight materials and can help kids with cerebral palsy walk and play.
Starbucks has 3D-printed its latest store, a 1400 square foot, drive-thru only facility in Brownsville, Texas.
A genetically modified probiotic could remove mercury from seafood after you eat it. The gut microbe was developed by researchers at UCLA and UC San Diego, and was shown to reduce the amount of mercury passing into the brain and fetuses of mice who were fed a diet of fish.
Cacio e pepe is a deceptively simple Italian dish with only three ingredients - pasta, black pepper and pecorino romano cheese, which combined make a rich and creamy dish. Or, if you're like me, a clumpy mess. But a team of physicists have figured out how to do it flawlessly every time, and published their results in the journal Physics of Fluids. The key is to add powdered starch to the water before cooking the pasta, which ensures there's enough of it to allow the cheese to blend. It's also important to make sure the water cools before you add the cheese, blending it in, then heating the resulting sauce slowly to avoid clumps. If you're looking for a dish to make this weekend, give it a try.
I've been greatly enjoying Guy Ritchie's series MobLand on Paramount+. It's an organized crime drama set in London that primarily follows Tom Hardy's Harra Da Souza, who works as chief enforcer for his boss, played by Pierce Brosnan. The show itself is well-executed and entertaining, but it's elevated by Helen Mirren clearly having a ball playing a Lady MacBeth-esque crime boss's wife. I definitely recommend it.
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Business Upturn
an hour ago
- Business Upturn
U.S. FDA approves third indication of darolutamide for patients with advanced prostate cancer
U.S. FDA approves third indication of darolutamide for patients with advanced prostate cancer Darolutamide is the first and only in the U.S. and FDA-approved androgen receptor inhibitor (ARi) for the treatment of patients with hormone-sensitive prostate cancer (mHSPC), in combination with androgen deprivation therapy (ADT), with or without chemotherapy. This third approval is based on positive results from the pivotal Phase III ARANOTE trial and broadens the indication profile of darolutamide in mHSPC, enabling its use in combination with ADT, with or without chemotherapy (docetaxel). Darolutamide plus ADT reinforces the established safety and tolerability profile of darolutamide for prostate cancer patients across all approved indications. Orion's collaboration partner Bayer announced today that the U.S. Food and Drug Administration (FDA) has approved the oral androgen receptor inhibitor (ARi) darolutamide in combination with androgen deprivation therapy (ADT) for use in patients with metastatic castration-sensitive prostate cancer (mCSPC), which is also known as metastatic hormone-sensitive prostate cancer (mHSPC). The approval is based on positive results from the pivotal Phase III ARANOTE trial, which showed that darolutamide plus ADT significantly reduced the risk of radiological progression or death by 46% compared to placebo plus ADT (HR 0.54; 95% CI 0.41–0.71; P<0.0001) in patients with mHSPC. With this approval, darolutamide plus ADT is indicated in the U.S. for the treatment of adult patients with mHSPC either with or without docetaxel. In addition, darolutamide is approved for the treatment of adult patients with non-metastatic castration-resistant prostate cancer (nmCRPC) who are at high risk of developing metastatic disease. Prostate cancer is the second most common cancer in men and the fifth most common cause of cancer death in men worldwide.1 In 2022, an estimated 1.5 million men were diagnosed with prostate cancer, and about 397,000 died from the disease worldwide.1 Prostate cancer diagnoses are projected to increase to 2.9 million by 2040.2 Darolutamide, under the brand name Nubeqa®, is already approved in mHSPC in combination with ADT and docetaxel in over 85 markets around the world. It's also approved in combination with ADT for the treatment of patients with non-metastatic castration-resistant prostate cancer (nmCRPC) who are at high risk of developing metastatic disease in more than 85 countries around the world. An approval process in the EU for the treatment of mHSPC in combination with ADT (without docetaxel) is already underway by Bayer. Nubeqa achieved blockbuster status in September 2024, with annual sales reported by Bayer reaching EUR 1.52 billion for the full year of 2024. Darolutamide is developed jointly by Orion and Bayer. About the ARANOTE trial The ARANOTE trial is a randomized, double-blind, placebo-controlled Phase III study designed to assess the efficacy and safety of darolutamide plus ADT in patients with mHSPC. 669 patients were randomized 2:1 to receive 600 mg of darolutamide twice daily or matching placebo in addition to ADT. The primary endpoint of this study is rPFS, measured as time from randomization to date of first documented radiological progressive disease or death due to any cause, whichever occurs first. Secondary endpoints include overall survival (time to death from any cause), time to first castration resistant event, time to initiation of subsequent anti-cancer therapy, time to prostate-specific antigen (PSA) progression, PSA undetectable rates, time to pain progression, and safety assessments. Results from the Phase III ARANOTE trial presented at ESMO 2024 and published in The Journal of Clinical Oncology showed that darolutamide plus ADT significantly reduced the risk of radiological progression or death by 46% compared to placebo plus ADT (HR 0.54; 95% CI 0.41–0.71; P<0.0001), in patients with mHSPC. Consistent benefits in radiological progression-free survival (rPFS) were observed across prespecified subgroups, including patients with high-volume (HR 0.60, 95% CI: 0.44-0.80) and low-volume (HR 0.30, 95% CI: 0.15-0.60) mHSPC. The incidence of adverse events in the treatment group with darolutamide plus ADT in the ARANOTE study was comparable to placebo plus ADT. Darolutamide plus ADT was generally well tolerated and showed lower discontinuation rates due to adverse events compared to placebo plus ADT. About darolutamide Darolutamide is an oral ARi with a unique chemical structure that binds with high affinity to the androgen receptor and exhibits a strong antagonistic effect against the androgen receptor inhibiting the receptor function and the growth of prostate cancer cells. Additionally, preclinical models and neuroimaging data in healthy humans support darolutamide's low potential for blood-brain barrier penetration. Darolutamide (plus ADT or plus ADT and docetaxel) demonstrated a side effect profile in both registrational studies in mHSPC where the incidences of adverse events were roughly similar to the respective comparator arm. Darolutamide is a treatment option for doctors and patients, considering its tolerability and low risk of drug interaction. A robust clinical development program is underway investigating darolutamide across various stages of prostate cancer. The program includes the Phase III ARASTEP trial evaluating darolutamide plus ADT compared to ADT alone in hormone-sensitive high-risk biochemical recurrence (BCR) prostate cancer, who have no evidence of metastatic disease by conventional imaging and a positive PSMA PET/CT at baseline. Furthermore, darolutamide is also being investigated by Bayer in the collaborative Phase III DASL-HiCaP (ANZUP1801) trial led by the Australian and New Zealand Urogenital and Prostate Cancer Trials Group (ANZUP). The study evaluates darolutamide as an adjuvant treatment for localized prostate cancer with very high risk of recurrence. About metastatic hormone-sensitive prostate cancer At the time of diagnosis, most men have localized prostate cancer, meaning their cancer is confined to the prostate gland and can be treated with curative surgery or radiotherapy. mHSPC is a stage in the disease where the cancer has spread outside of the prostate to other parts of the body. Up to 10% of men will present with mHSPC when first diagnosed.3,4,5 For patients with mHSPC, ADT is the cornerstone of treatment, in combination with chemotherapy docetaxel and/or an androgen receptor inhibitor (ARi). Despite treatment, most men with mHSPC will eventually progress to castration-resistant prostate cancer (CRPC), a condition with limited survival. Contact person: Tuukka Hirvonen, Investor Relations tel. +358 10 426 2721 References Bray F et al. Global cancer statistics 2022: GLOBOCAN estimates of incidence and mortality worldwide for 36 cancers in 185 countries. Accessed: September 2024. James ND et al. Lancet 2024; 403: 1683–722. Piombino C et al. Cancers (Basel). 2023 Oct 11;15(20):4945. Helgstrand JT et al. Cancer. 2018;124(14):2931-2938. Buzzoni C et al. Eur. Urol. 2015;68:885–890. Publisher:Orion CorporationCommunicationsOrionintie 1A, FI-02200 Espoo, Finland Orion is a globally operating Nordic pharmaceutical company – a builder of well-being for over a hundred years. We develop, manufacture and market human and veterinary pharmaceuticals and active pharmaceutical ingredients. Orion has an extensive portfolio of proprietary and generic medicines and consumer health products. The core therapy areas of our pharmaceutical R&D are oncology and pain. Proprietary products developed by Orion are used to treat cancer, neurological diseases and respiratory diseases, among others. In 2024 Orion's net sales amounted to EUR 1,542 million and the company employed about 3,700 professionals worldwide, dedicated to building well-being. Orion's A and B shares are listed on Nasdaq Helsinki. Disclaimer: The above press release comes to you under an arrangement with GlobeNewswire. Business Upturn takes no editorial responsibility for the same. GlobeNewswire provides press release distribution services globally, with substantial operations in North America and Europe.


Fox News
2 hours ago
- Fox News
Cannabis
Cannabis is a drug that comes from the dried leaves, flowers, stems, and seeds of a cannabis sativa plant. Cannabis is commonly referred to as weed or marijuana, though marijuana refers to a specific part of the cannabis plant that contains high amounts of the psychoactive compound THC (tetrahydrocannabinol), which has mind-altering effects. CBD (cannabidiol) is another compound found in cannabis. In a single year, 52.5 million people in the United States use cannabis at least once, according to 2021 data from the Centers for Disease Control and Prevention (CDC). Cannabis has a direct effect on the brain, specifically the parts used for learning, decision-making, emotion, memory, reaction time, coordination, and attention, the CDC states. Marijuana is commonly smoked for recreational purposes. There are few prescription cannabis drugs approved by the Food and Drug Administration (FDA) for medicinal purposes. One example is Epidiolex, which is used to treat seizures. The legalization of marijuana is a varying issue on a state-by-state basis. Some states have legalized marijuana for medicinal purposes, while in others marijuana is legal for both recreational and medicinal purposes. Idaho, Kansas, South Carolina and Wyoming are the only states where marijuana is fully illegal.
Yahoo
3 hours ago
- Yahoo
Ascletis Announces Phase III Trial of Denifanstat (ASC40), a First-in-Class, Once-Daily Oral FASN Inhibitor for Acne, Meets All Endpoints
Denifanstat (ASC40), a once-daily oral fatty acid synthase (FASN) inhibitor, demonstrated statistically significant and clinically meaningful improvement compared to placebo in all primary, key secondary, and secondary endpoints Denifanstat demonstrated a favorable safety and tolerability profile Denifanstat was 98% and 178% more effective than U.S. Food and Drug Administration (FDA)-approved sarecycline and doxycycline with regard to placebo-adjusted percent treatment success, respectively, 18.6% for denifanstat versus 9.4% for sarecycline, 18.6% versus 6.7% for doxycycline Denifanstat was 60% more effective than FDA-approved clascoterone cream with regard to placebo-adjusted percent treatment success, 18.6% for denifanstat versus 11.6% for clascoterone cream, respectively The exceptional efficacy of denifanstat coupled with its favorable safety profile in the Phase III trial provides a potential major break-through for the treatment of acne HONG KONG, June 3, 2025 /PRNewswire/ -- Ascletis Pharma Inc. (HKEX: 1672, "Ascletis") announces today that denifanstat (ASC40), a first-in-class, once-daily oral small molecule fatty acid synthase (FASN) inhibitor, meets all primary, key secondary, and secondary endpoints in the Phase III clinical trial for the treatment of moderate to severe acne vulgaris (NCT06192264). The Phase III clinical trial was a randomized, double-blind, placebo-controlled, multicenter clinical trial in China to evaluate the safety and efficacy of denifanstat once-daily oral tablet in 480 patients with moderate to severe acne vulgaris. Patients were enrolled and randomized into one active treatment arm and one placebo control arm at the ratio of 1:1 to receive 50 mg denifanstat oral tablet once daily or matching placebo for 12 weeks. Baseline characteristics were well balanced between denifanstat and placebo arms. Table 1 summarizes some of baseline characteristics. Primary, key secondary, and secondary endpoints can be found in Table 2. Primary endpoints included the percent treatment success (defined as an Investigator's Global Assessment (IGA) score of 0 (clear) or 1 (almost clear) with at least a 2-point decrease in IGA from baseline at week 12), the percent reduction from baseline in total lesion count, and the percent reduction from baseline in inflammatory lesion count. At week 12, percent treatment success was 33.2% compared to 14.6% for placebo, p<0.0001, percent reduction from baseline in total lesion count was 57.4% compared to 35.4% for placebo, p<0.0001, and percent reduction from baseline in inflammatory lesion count was 63.5% compared to 43.2% for placebo, p<0.0001. The key secondary endpoint, percent reduction from baseline in non-inflammatory lesion count at week 12, was 51.9% compared to 28.9% for placebo, p<0.0001. Denifanstat demonstrated a favorable safety and tolerability profile following 12 weeks of once-daily oral administration at 50 mg. The incidence rates of treatment-emergent adverse events (TEAEs) were comparable between denifanstat and placebo. No incidence rates of TEAEs related to study drug in any category exceeded 10%. Only two categories of TEAEs had an incidence rate of more than 5% (6.3% dry skin in denifanstat-treated patients versus 2.9% in the placebo group; 5.9% dry eye in denifanstat-treated patients versus 3.8% in the placebo group). All denifanstat-related adverse events (AEs) were mild or moderate. There were no denifanstat-related grade 3 or 4 AEs and no denifanstat-related serious AEs (SAEs). No deaths were reported. The mechanisms of action of denifanstat for the treatment of acne are (1) direct inhibition of facial sebum production, through inhibition of de novo lipogenesis (DNL) in human sebocytes; and (2) inhibition of inflammation, through decreasing cytokine secretion and Th17 differentiation. Denifanstat's unique mechanism of action directly reduces one of the main underlying causes of acne which is the overproduction of sebum. This makes denifanstat unique as most other acne treatments do not treat the underlying cause of the condition. "We are extremely pleased with the topline results of our Phase III trial. Denifanstat tablets demonstrated impressive efficacy beyond treatment success, showing significant reductions in total lesion count, inflammatory lesion count, and non-inflammatory lesion count. We are excited to be submitting this innovative treatment with the China National Medical Products Administration (NMPA) soon." said Jinzi Jason Wu, Ph.D., Founder, Chairman and CEO of Ascletis. Table 3 highlights the excellent efficacy of denifanstat in a non-head-to-head comparison to other commonly used oral and topical acne treatments. Denifanstat demonstrated its exceptional efficacy across multiple key metrics compared to sarecycline, doxycycline and clascoterone cream. With regard to the placebo-adjusted percent treatment success and the placebo-adjusted percent reduction from baseline in inflammatory lesion count, denifanstat was 98% and 30% more effective than sarecycline, respectively, 178% and 178% more effective than doxycycline, respectively, and 60% and 59% more effective than clascoterone cream, respectively. With regard to the placebo-adjusted percent reduction from baseline in total lesion count, denifanstat was 189% and 85% more effective than doxycycline and clascoterone cream, respectively. With regard to the placebo-adjusted percent reduction from baseline in non-inflammatory lesion count, denifanstat was 411% and 102% more effective than sarecycline and clascoterone cream, respectively. Denifanstat has the potential to be a first-in-class, once-daily, oral acne therapeutic, potentially offering both exceptional efficacy and patient compliance with a favorable safety and tolerability profile. Compared to other oral acne treatments, denifanstat provides outstanding efficacy with excellent safety. There is no potential for antibiotic resistance or off target effects which can occur with tetracycline derivatives and no reported denifanstat-related severe AEs such as hepatotoxicity, hearing impairment and depression which are seen with isotretinoin. Denifanstat should also provide better adherence to treatment compared to topical therapies: an estimated 30% to 40% of patients do not adhere to their topical treatments[1]. Denifanstat is licensed from Sagimet Biosciences Inc. (Nasdaq: SGMT) for exclusive rights in Greater China. "The Phase III clinical trial results for denifanstat are highly encouraging. The data demonstrate statistically significant improvements in treatment outcomes for moderate-to-severe acne patients, with percent treatment success of 33.2%, total lesion count reduction of 57.4% from baseline, inflammatory and non-inflammatory lesion counts decreasing by 63.5% and 51.9%, respectively, while maintaining a favorable safety and tolerability profile. Denifanstat's first-in-class mechanism targeting FASN directly addresses a key cause for acne, establishing it as a groundbreaking therapeutic approach in acne treatment." said Prof. Leihong Xiang, Chief Physician of Dermatological Department, Huashan Hospital, Fudan University, Executive Deputy Director of Institute of Dermatology, Fudan University, Deputy Director of Dermatology Division of Chinese Medical Doctor Association and principal investigator of denifanstat Phase III trial for moderate to severe acne. [1] Purvis CG, Balogh EA, Feldman SR. Clascoterone: How the Novel Androgen Receptor Inhibitor Fits Into the Acne Treatment Paradigm. Ann Pharmacother. 2021;55(10):1297-1299. doi:10.1177/1060028021992055. Table 1. Baseline characteristics of Phase III trial of denifanstat Baseline characteristics 50 mg denifanstat, oral, oncedaily (n=240) Placebo, oral, once daily (n=240) Total lesion count 102.2 102.1 Inflammatory lesion count 42.1 43.1 IGA=3 (moderate), % 85.8 85.8 IGA=4 (severe), % 14.2 14.2 Table 2. Efficacy endpoints of 50 mg denifanstat oral, once daily at week 12 versus placebo (intent-to-treat, ITT, analysis) Efficacy endpoints (1) 50 mg denifanstat, oral, once daily (n=240) Placebo, oral,once daily (n=240) Placebo adjusted p value Percent treatment success (2) (primary endpoint) 33.2 14.6 18.6 <0.0001 Percent reduction from baseline in total lesion count (primary endpoint) 57.4 35.4 22.0 <0.0001 Percent reduction from baseline ininflammatory lesion count (primary endpoint) 63.5 43.2 20.3 <0.0001 Percent reduction from baseline in non-inflammatory lesion count (key secondary endpoint) 51.9 28.9 23.0 <0.0001 Absolute reduction from baseline intotal lesion count (secondary endpoint) 58.3 36.2 22.1 <0.0001 Absolute reduction from baseline in inflammatory lesion count (secondaryendpoint) 26.6 18.4 8.2 <0.0001 Notes: (1) All efficacy endpoints are least square means.(2) Treatment success is defined as an Investigator's Global Assessment (IGA) score of 0 (clear) or 1 (almost clear) with at least a 2-point decrease in IGA from baseline at week 12. Table 3. Denifanstat compared to other commonly used acne treatments (not head-to-head comparison) Category Denifanstat (n=240) Sarecycline(1) (n=1002) Doxycycline(2) (n=216) Clascoterone cream(3) (n=722) Baseline characteristics Total lesion count 102.2 72.4 71.7 103.6 Inflammatory lesion count 42.1 30.0 33.6 42.7 IGA=3 (moderate), % 85.8 85.2 93.5 82.7 IGA=4 (severe), % 14.2 14.9 6.5 17.3 Efficacy endpoints at week 12 Placebo-adjusted percenttreatment success 18.6 9.4 6.7 11.6 Placebo-adjusted percent reductionfrom baseline in total lesion count 22.0 NA 7.6 11.9 Placebo-adjusted percent reductionfrom baseline in inflammatorylesion count 20.3 15.6 7.3 12.8 Placebo-adjusted percent reduction from baseline in non-inflammatorylesion count 23.0 4.5 NA 11.4 Notes: (1) The sarecycline data represent an analysis of its two Phase III clinical trials, with values expressed as means. The data are from Moore, A., et al., J Drugs Dermatol 2018 Vol. 17 Issue 9 Pages 987-996. The non- inflammatory lesion count data are from FDA ( The doxycycline data at week 16 are from Moore, A., et al., J Drugs Dermatol 2015 Vol. 14 Issue 6 Pages 581-6.(3) The clascoterone cream (1%) data represent an analysis of its two Phase III clinical trials, with values expressed as means. The data are from Hebert. A, et al., JAMA Dermatology 2020 Vol. 156 Issue 6, DOI: 10.1001/jamadermatol.2020.0465. About Ascletis Pharma Inc. Ascletis is an innovative R&D driven biotech listed on the Hong Kong Stock Exchange ( covering the entire value chain from discovery and development to GMP manufacturing. Led by a management team with deep expertise and a proven track record, Ascletis is focused on metabolic diseases by addressing unmet medical needs from a global perspective. Ascletis has multiple clinical stage drug candidates in its metabolic disease pipeline. For more information, please visit Contact: Peter VozzoICR Healthcare443-231-0505 (U.S.) Ascletis Pharma Inc. PR and IR teams+86-181-0650-9129 (China)pr@ ir@ View original content: SOURCE Ascletis Pharma Inc. Error in retrieving data Sign in to access your portfolio Error in retrieving data Error in retrieving data Error in retrieving data Error in retrieving data