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AI startup Leucine nets $7M to level up Pharma manufacturing compliance to keep pace with drug innovation

Leucine

Pharmaceutical manufacturing is the lynchpin to getting drug innovation to people. While compliance protocols are key to ensuring the smooth operation of the industry, they are beset by processes that are not fit for purpose and are hindering their ability to deliver life-saving drugs faster. Suffocated by paper-based records and legacy systems, the large-scale manufacturing of drugs is being hampered. It’s little wonder that a staggering 2 out of 3 FDA warnings are for non-compliance related to procedures not being followed appropriately, unclear work instructions of methods, failure to review equipment usage logs, and lack of shared procedures between Quality Assurance and production departments. These matters are often missed and go unnoticed because of the conventional paper-based systems in the pharmaceutical industry. Helping to make pharmaceutical manufacturing compliant, safer, and faster, tech startup Leucine is today announcing a $7M series A funding round led by Ecolab Inc., a strategic investor, to scale its Compliance Cloud platform globally. This round also saw participation from all existing investors, including Pravega Ventures, Axilor Ventures, Techstars, and angels. Vivek Gera, founder, and CEO of Leucine, commented: “Paper-based manufacturing records are the industry's achilles' heel, fueling not only regulatory nightmares but also ballooning production costs and inefficiencies. The legacy solutions are no better, with their extremely long implementation cycles and rigid, siloed applications that leave manufacturers in a lurch.” Leucine's Compliance Cloud serves as a digital twin of the pharma manufacturing shop floor, bringing real-time performance monitoring, compliance management, and actionable insights to the table. For pharma manufacturers, leveraging data can mean the difference between a successful batch and a costly recall. What differentiates Leucine from some of the legacy digitization tools is its AI-driven capabilities designed not only to digitize pharma manufacturing workflows faster but also to provide proactive insights that enable pharma companies to stay compliant and produce faster and in a cost-effective manner. Leucine's platform can be implemented in 8 weeks. This speed of implementation becomes possible because of the proprietary AI-enabled digital process builder based on Large Language Models (LLMs) that rapidly digitizes paper SOPs into execution-ready digital formats. "Our models are trained on a wealth of pharma data, which allows the platform to create custom workflows enriched with GxP compliance measures, enabling us to deliver unparalleled value at breakneck speed," added Vivek Gera. A batch execution procedure is the single most important document in pharma manufacturing. This rapid digitization capability reduces the digitization cycle of a batch record from 6-8 months to 3-5 days. Leucine is currently deployed at over 30 companies in over 300 pharma manufacturing facilities across 10 countries, including the US, India, Brazil, Mexico, UAE, and others. The company is today also announcing the beta launch of Leucine10x, a groundbreaking AI framework designed to serve as a co-pilot in pharmaceutical manufacturing processes. Leucine10x will revolutionize how decision-making is done in pharma manufacturing, enabling Production and Quality Assurance teams to achieve their organization goals with ease and confidence. Built on proprietary LLM technology, Leucine10x offers an army of AI co-pilots that perform highly specialized tasks such as digitizing paper-based SOPs, creating a digital twin of the shop floor, collaborating with Production Managers in creating dynamic production plans, thus ensuring on-time batch delivery. Most significant is their ability to speed up Root Cause Analysis (RCA) of deviations in the manufacturing process by quickly analyzing data, including text-based records, logs, and even staff interview transcripts, to identify potential issues or patterns that might not be readily apparent. Mustaq Singh Bijral, Co-founder and CPO of Leucine, said: "We're excited to share that Leucine10x is already operational in select customer facilities under a trusted tester agreement. The response has been incredibly positive, and due to high demand, we're currently enrolling new customers through a waitlist". The funding round will support Leucine in refining its AI capabilities and making its AI Co-pilot a trusted partner to the production and quality managers on the shop floor and in expanding its reach to more facilities and customers. “Vivek and Mustaq have been relentless in their mission to make pharma manufacturing safer. This latest funding round will enable Leucine to bring the power of LLMs and associated technologies to make significant advances in pharma manufacturing. We couldn’t be happier to support them in this quest” said Rohit Jain, Co-founder and Partner at Pravega Ventures. Pravega Ventures also invested in the Seed round of Leucine. Vivek Gera remarked: "We're just scratching the surface; our vision is to leverage AI and technology to bring safe medicine to patients across the world” About Leucine Leucine is at the forefront of digitizing pharmaceutical manufacturing, leveraging cutting-edge AI technologies to bring unprecedented efficiency and compliance to the shop floor. Our innovative solutions, from Batch Planning to Batch Release, aim to modernize traditional procedures, replacing paper-based records with a seamless, digital-first approach. Trusted by industry leaders, Leucine not only streamlines the manufacturing process but also delivers actionable insights through its AI-driven analytics dashboard, empowering pharma companies to produce safer and more effective medicines. Leucine is headquartered in New Jersey, United States. For more information, visit https://www.leucine.io/ About Pravega Ventures Pravega Ventures is an early stage Venture Capital fund that partners with passionate founders, who are leveraging technology to either disrupt existing markets or create new ones. Contact Details Leucine Sampada Bhootna +91 81458 07848 sampada.bhootna@leucinetech.com Company Website https://www.leucine.io/

October 16, 2023 09:00 AM Eastern Daylight Time

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Tiziana Life Sciences reports six-month PET scan results for MS patients

Tiziana Life Sciences PLC

Tiziana Life Sciences Ltd (NASDAQ:TLSA) chief medical officer and chief operating officer Matthew Davis speaks to Thomas Warner from Proactive after the clinical-stage biopharmaceutical company announced an update on the company's progress in treating non-active secondary progressive multiple sclerosis (MS). The latest six-month PET scan data reveals improvements in five out of six patients, echoing the positive results from the three-month scans. This breakthrough aligns with the drug's hypothesis, as published in the Proceedings of the National Academy of Science, which suggests the drug works by stabilising the brain's innate immunity. From a business perspective, Davis suggests the findings are significant. In the US, there's no FDA-approved treatment for this specific MS type, affecting approximately 200,000 patients. Tiziana Life Sciences is gearing up for its phase 2a programme, focusing on PET change as a primary endpoint. Davis also highlights that he addressed the importance of targeting neuroinflammation in MS and Alzheimer's during a keynote speech in Milan this week. Contact Details Proactive UK Ltd +44 20 7989 0813 uk@proactiveinvestors.com

October 16, 2023 08:00 AM Eastern Daylight Time

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Faron Pharmaceuticals CEO delighted with latest BEXMAB study findings

Faron Pharmaceuticals Oy

Faron Pharmaceuticals Limited (AIM:FARN, OTC:FPHAF) chief executive Dr Markku Jalkanen speaks to Thomas Warner from Proactive London after the clinical stage biopharmaceutical company revealed fresh data from the company's ongoing phase I/II trial. Its BEXMAB study is evaluating the efficacy of bexmarilimab in treating acute myeloid leukaemia (AML) and myelodysplastic syndromes (MDS). Jalkanen explains that the results show that bexmarilimab achieved a 50% remission rate among 22 patients who had relapsed or were refractory to standard treatments, including hypomethylating agents (HMAs). Of the 22 patients, eight achieved complete remission, indicating that their symptoms were entirely eradicated or significantly reduced. Looking forward, he says the results "mean that the program we have been planning to take the clinical development all the way to the marketing approval, and we have said that we could actually file the PLA in 2025. These results really support that view... I'm anticipating not to have really huge massive clinical trial size any more for this project - we're probably looking at 50-100 patients all in." Contact Details Proactive UK Ltd +44 20 7989 0813 uk@proactiveinvestors.com

October 16, 2023 06:15 AM Eastern Daylight Time

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Don't Let Osteoarthritis Hold You Back

YourUpdateTV

Do you or someone you know have pain in your joints or stiffness when doing daily activities? These symptoms may be related to a common condition called osteoarthritis and it affects more than 32.5 million adults in the U.S. Recently, Dr. Sherri Betz, PT, DPT, a physical therapist and spokesperson for the American Physical Therapy Association, conducted a satellite media tour to talk about how physical therapy can treat and help people manage the symptoms of osteoarthritis. A video accompanying this announcement is available at: https://youtu.be/7OIFKIUNuxA Osteoarthritis, or OA, is the most common form of arthritis. Some people call it degenerative joint disease or “wear and tear” arthritis. It occurs most frequently in the hands, hips, and knees. ( CDC ). The signs and symptoms of OA can vary, so the approach to care also will vary. Common symptoms include stiffness in joint(s), pain during activity, and cracking or creaking noise around the joint. Physical therapists work with their patients and clients to develop treatment plans specific to each person’s needs and goals. Although osteoarthritis cannot be reversed, osteoarthritis symptoms often can be effectively managed through conservative approaches like exercise and treatment by a physical therapist. Regular physical activity can help maintain and improve movement and function and reduce joint pain for people with arthritis. The knees are among the joints most commonly affected by osteoarthritis, with nearly 12.4 million people ages 65 or older having symptomatic knee OA. Some individuals may receive multiple steroid injections to treat their OA; however, research shows that physical therapy is an effective treatment option for OA of the knee. A new report just released by the American Physical Therapy Association found that, compared with injections, physical therapy for OA of the knee offers similar improvements sooner. The report also calculated the economic impact of choosing physical therapy for OA of the knee over steroid injections and found that doing so saves close to $14,000, including all the hidden costs of your time, pain, missed life events, and the dollars paid for services. For more information visit ChoosePT.com About Sherri Betz, PT, DPT APTA spokesperson Sherri Betz is a physical therapist and director of TheraPilates Physical Therapy in Louisiana, specializing in geriatrics and osteoporosis. Betz is devoted to improving awareness about geriatric exercise, bone health, and safe yoga and Pilates-based exercise through professional and consumer education as well as through the promotion of low-cost, on-site, and virtual community exercise programs for older adults. She serves on the Bone Health & Osteoporosis Foundation’s Exercise and Rehabilitation Activities Council as APTA’s liaison, as well as the American Bone Health’s Professional Education Committee. Betz also serves as chair of Pilates Method Alliance's Research Committee and is past chair of the PMA Certification Commission and board vice president. She is a graduate of Louisiana State University’s physical therapy program and received a Doctor of Physical Therapy degree from EIM Institute of Health Professions. She is a board-certified clinical specialist in geriatric physical therapy. She also is a nationally certified NPCP Pilates teacher and a certified exercise expert for aging adults. Betz is a recipient of both the PMA's Deborah Lessen award for her many years of dedicated service to PMA and the APTA Geriatrics' Lynn Phillippi Advocacy for Older Adults award. She has published numerous articles, authored book chapters, produced videos, and speaks internationally about exercise for osteoporosis. Contact Details YourUpdateTV +1 212-736-2727 yourupdatetv@gmail.com

October 12, 2023 11:46 AM Eastern Daylight Time

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The Promise Of Psilocybin When It Comes To Mental Health, And How COMPASS Pathways (NASDAQ: CMPS) Is Advancing It

COMPASS Pathways

By Faith Ashmore, Benzinga Recent advancements in understanding mental health and the brain have allowed us to identify possible commonalities between different mental health conditions. One of the shared experiences among patients with conditions like treatment-resistant depression (TRD), bipolar II disorder and PTSD is the inability to move on and the presence of repetitive thoughts or ruminations. These thoughts can be persistent, counterproductive and even self-destructive. Patients often describe feeling disconnected from the world including friends and family. Although our ability to measure brain activity in humans is limited, doctors can use magnetic resonance imaging (MRI) to observe blood flow, which is closely linked to brain activity. When there is an increase in blood flow in a specific area, it indicates increased local activity, particularly at synapses. The brain is a highly energy-demanding organ, and different parts of the brain tend to fire together as modules rather than operating as completely independent entities. These modules control various functions such as vision, sensory/motor control of movement, the emotions, attention and even a default mode network associated with rumination and internal dialogues. This default mode network is where patients may experience the persistent and intrusive self-critical voice in their minds. In a number of mental health conditions, these functional modules appear to be more connected within and less between each other compared to individuals without the condition. Understanding the commonalities revealed by human imaging studies across conditions offers valuable insights for rethinking treatment approaches and providing proper care, especially for patients with unmet needs. This is why the world of psychedelics is especially promising when it comes to mental health care. Drugs producing psychedelic experiences have shown promise in treating mental health conditions, perhaps by disrupting the connectivity of functional modules altered in depression, anxiety, and other conditions. For example, by reducing activity in the default mode network, it has been suggested that these drugs may also help individuals break negative thought patterns and ruminations. Animal studies suggest that they may help in promoting neuroplasticity and repairing neural circuits, which may lead to improved and sustained mental health outcomes in some patients. This potential is exciting and more research is needed to understand how psychedelics may be used. COMPASS Pathways’ (NASDAQ: CMPS) innovative approach has received FDA Breakthrough Therapy designation in the U.S. and Innovative Licensing and Access Pathway designation in the U.K. for their investigational COMP360 psilocybin in TRD. Moreover, in late 2021, COMPASS Pathways announced the completion of a randomized, controlled double-blind phase 2b study of investigational COMP360 psilocybin treatment involving 233 patients with TRD in 22 sites across Europe and North America. While the company is currently focusing on TRD, it is also researching PTSD and anorexia nervosa, in part because of neurological similarities. Companies like COMPASS Pathways are working to develop interventions that address these common factors and support patients on their path toward improved mental well-being. For patients who have found no relief with current medications, this would be meaningful progress. Company BioCOMPASS Pathways plc (Nasdaq: CMPS) is a mental health care company dedicated to accelerating patient access to evidence-based innovation in mental health. Our focus is on improving the lives of those who are suffering with mental health challenges and who are not helped by current treatments. We are pioneering the development of a new model of psilocybin therapy, in which our proprietary formulation of synthetic psilocybin, COMP360, is administered in conjunction with psychological support. COMP360 has been designated a Breakthrough Therapy by the U.S. Food and Drug Administration (FDA) and has received Innovative Licensing and Access Pathway (ILAP) designation in the UK for treatment-resistant depression (TRD). We have commenced a phase 3 clinical program of COMP 360 psilocybin therapy in TRD, the largest randomised, controlled, double-blind psilocybin therapy clinical program ever conducted. Previously, we completed a phase 2b study with top line data showing a statistically significant (p<0.001) and clinically relevant improvement in depressive symptom severity after three weeks for patients who received a single high dose of COMP360 psilocybin with psychological support. We are also conducting phase 2 clinical studies of COMP360 psilocybin therapy for post-traumatic stress disorder (PTSD) and anorexia nervosa. COMPASS is headquartered in London, UK, with offices in New York and San Francisco in the United States. Our vision is a world of mental wellbeing. This post contains sponsored content. This content is for informational purposes only and not intended to be investing advice. Contact Details Stephen Schultz stephen.schultz@compasspathways.com

October 12, 2023 09:15 AM Eastern Daylight Time

Josephine Antonellis and Julie Harris, Ph.D., Named to New Roles at Cure Alzheimer’s Fund

Alzheimer’s Disease Research Foundation

Cure Alzheimer’s Fund announces Josephine (Jo) Antonellis has been named Chief Financial Officer (CFO) and Julie Harris, Ph.D., has been named Executive Vice President, Research Management for the nonprofit organization. As CFO, Antonellis will be responsible for the financial management of the nonprofit organization, including leadership of the accounting and financial teams. She will be a member of the management committee and report directly to Meg Smith, Chief Executive Officer. “We are fortunate to have a person with Jo’s depth and breadth of experience to lead our financial operations,” said Smith. “Jo has played a key role as our Controller and I expect she will move seamlessly into the CFO role, ensuring continuity of all our financial operations.” Antonellis joined Cure Alzheimer’s Fund in 2021 as Controller. She came to the organization with more than 25 years of diverse accounting experience, including responsibility for accounting operations and human resource functions. She started her career as an auditor for Arthur Andersen, where she became a licensed CPA. She holds a B.S. in accounting from Bentley University. Harris will be responsible for research management and funding for Cure Alzheimer’s Fund in her new role. She will bring new ideas and perspectives to managing the research portfolio, and partner with the scientific community to further the nonprofit’s mission to eradicate Alzheimer’s disease. “When we hired Julie, I knew that her deep experience as a scientist and as the central leader of large scientific teams and projects meant that she would be an immediate contributor to our research program,” said Smith. “Julie has also shown us all that she is a natural ambassador for our science, our scientists and our organization.” Prior to joining CureAlz, Harris was vice president of preclinical biology at Cajal Neuroscience, a biotech startup focused on identifying novel therapies for neurodegenerative diseases. Before that, she spent 10 years at the Allen Institute for Brain Science, where her team was responsible for employing whole brain microscopy and transcriptomics in Alzheimer’s mouse models to characterize molecular, cellular and circuit patterns of disease. Harris received a B.S. in zoology from Michigan State University and a Ph.D. in neurobiology and behavior from the University of Washington. She trained as a postdoctoral fellow at the Gladstone Institute of Neurological Disease in San Francisco. Since its founding in 2004, Cure Alzheimer’s Fund has provided grants to more than 750 of the world’s leading researchers and contributed more than $175 million to research. Its funded initiatives have been responsible for many key breakthroughs in understanding the causes and pathology of Alzheimer’s disease. Cure Alzheimer’s Fund has received a 4-star rating for 12 consecutive years from Charity Navigator. With 100% of funds raised going to support research, Cure Alzheimer’s Fund has been able to provide grants to many of the best scientific minds in the field of Alzheimer’s research. For more information, please visit https://www.CureAlz.org/. Contact Details Cure Alzheimer's Fund Barbara Chambers +1 978-417-9890 bchambers@curealz.org

October 12, 2023 06:53 AM Eastern Daylight Time

News Release

Vivos Therapeutics secures Middle East-North Africa distribution deal and Stanford study

Vivos Therapeutics

Vivos Therapeutics CEO Kirk Huntsman joined Steve Darling from Proactive to share an exciting development for the company. Vivos has just entered into an exclusive distribution agreement with NOUM DMCC, a Dubai-based company with a strong focus on diagnostic testing and the distribution of treatment products for healthcare providers and hospital networks specializing in obstructive sleep apnea patients across the Middle East-North Africa (MENA) region. Huntsman elaborated on the significance of this partnership, highlighting how it addresses the growing demand for effective treatment alternatives to Continuous Positive Airway Pressure (CPAP) for individuals suffering from obstructive sleep apnea. With this agreement, NOUM has been granted exclusive distribution rights for Vivos' innovative products and services in several key countries in the MENA region. This list includes Saudi Arabia, the United Arab Emirates, Qatar, Kuwait, Bahrain, Oman, Jordan, Lebanon, and Palestine. A noteworthy aspect of this collaboration is that NOUM will promptly initiate the process of seeking regulatory approvals for Vivos' medical devices within the respective countries. These approval timelines are expected to vary, ranging from a few weeks to several months, contingent upon the specific regulatory requirements of each nation. Huntsman also revealed to Proactive that the company's flagship daytime-nighttime appliance or DNA will undergo a clinical trial at Stanford Medicine. The trial's protocol has been finalized, and participant enrollment is slated to commence in early 2024. In this clinical trial, individuals diagnosed with moderate to severe obstructive sleep apnea will be randomly assigned to one of two groups for treatment: either using Vivos' innovative DNA appliance or a traditional CPAP machine. The trial will closely monitor and assess the participants' condition through sleep studies conducted before and after the treatment course, using in-lab polysomnography to measure changes in the patients' apnea-hypopnea index. This clinical trial represents a significant milestone for Huntsman and Vivos as it provides an opportunity to validate the efficacy of their DNA appliance in addressing OSA, a serious and widespread sleep disorder. Contact Details Proactive Investors +1 347-449-0879 na-editorial@proactiveinvestors.com

October 11, 2023 01:47 PM Eastern Daylight Time

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News Release

BioHarvest Sciences announces Health Canada has approved VINIA Sales in Canada

BioHarvest Sciences Inc.

BioHarvest Sciences CEO Ilan Sobel joined Steve Darling from Proactive to share news Health Canada has granted BioHarvest Sciences a Canadian product license through Health Canada's Natural and Non-Prescription Health Products Directorate. Sobel explained that this newly acquired license now authorizes the company to sell VINIA in Canada, a pivotal step in their growth plan. VINIA stands as a groundbreaking product developed using BioHarvest's innovative Botanical Synthesis platform. It contains a rich assortment of polyphenols, including Piceid Resveratrol, with each daily 400mg capsule equivalent to the polyphenol content found in 1,000 grapes. VINIA is a potent nutraceutical, and its clinical efficacy has been demonstrated in significantly increasing arterial dilation. Following the launch in Canada, BioHarvest Sciences has ambitious expansion plans, with a keen eye on the immense potential of the Chinese health supplement market, which is valued at a staggering US$40 billion. This move into the Chinese market represents a significant opportunity for the company to further establish its presence and offer the benefits of VINIA to a broader global audience. In summary, the Canadian product license from Health Canada marks a crucial milestone for BioHarvest Sciences, enabling them to introduce their innovative product, VINIA, to the Canadian market and beyond. This achievement aligns seamlessly with the company's growth strategy, offering the potential for improved health and well-being to a wider consumer base, while also paving the way for expansion into one of the world's largest health supplement markets in China. Contact Details Proactive Investors Canada +1 604-688-8158 na-editorial@proactiveinvestors.com

October 11, 2023 01:37 PM Eastern Daylight Time

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Cardiol Therapeutics releases positive study results of subcutaneously administered cannabidiol

Cardiol Therapeutics

Cardiol Therapeutics CEO David Elsley joined Steve Darling from Proactive with news the company has unveiled highly promising study results from international research, which showcased the remarkable potential of subcutaneously administered cannabidiol, the active pharmaceutical ingredient found in Cardiol's groundbreaking CRD-38 subcutaneous formulation. In this study, it was revealed that the application of subcutaneous cannabidiol effectively curtailed the upward trajectory of both body weight and heart weight, while also preventing undesirable increases in crucial cardiac inflammatory and remodelling markers. This research was conducted in a meticulously designed model of heart failure with preserved ejection fraction, noteworthy for its ability to accurately replicate the comorbidities commonly associated with this condition, such as hypertension, obesity, and metabolic dysfunction. Elsley emphasized the profound significance of these study findings, particularly focusing on the unique pre-clinical model employed. This model, meticulously crafted to mimic the conditions experienced by patients suffering from heart failure with preserved ejection fraction, serves as an essential tool in understanding the complex interplay of factors contributing to the disease. The results, which illuminated the multiple cardioprotective effects of subcutaneously administered cannabidiol, serve as a pivotal stepping stone towards the development and potential approval of CRD-38 as a groundbreaking treatment for heart failure. The collective body of evidence generated by this research provides strong support for the advancement of Cardiol Therapeutics' innovative therapeutic approach in combating this debilitating condition, offering hope and potential relief to countless individuals affected by heart failure with preserved ejection fraction. Contact Details Proactive Canada +1 604-688-8158 na-editorial@proactiveinvestors.com

October 11, 2023 01:05 PM Eastern Daylight Time

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