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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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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

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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News Release

Perimeter Medical Imaging AI shortlisted for grant funding under Biden Cancer Moonshot initiative

Perimeter Medical Imaging AI

Perimeter Medical Imaging AI CEO Adrian Mendes joined Proactive's Stephen Gunnion with news that the company has been shortlisted in a grant funding process sponsored by the Advanced Research Projects Agency for Health (ARPA-H) as part of its Precision Surgical Interventions (PSI) program. Mendes explained that the initiative aims to provide groundbreaking tools for surgeons to effectively remove cancer in a single operation. Perimeter's technology aligns perfectly with this goal, as they have been working on it for the past decade. Perimeter Medical Imaging AI utilizes a technology called OCT, which has been around for 30 years. However, it has developed wide-field OCT, enabling larger image capture crucial for examining excised tumors. The company's current S series device is already in use in several operating rooms, gathering user feedback. It is also conducting clinical trials for its next-gen B series device, integrating AI technology to enhance surgeon workflow. While the base OCT technology isn't new, the company's innovations and AI integration represent the latest advancements. Contact Details Proactive Investors +1 604-688-8158 na-editorial@proactiveinvestors.com

October 11, 2023 01:02 PM Eastern Daylight Time

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PathAI Announces Research Presentations at AACR-NCI-EORTC International Conference on Molecular Targets and Cancer Therapeutics

PathAI

PathAI, a global leader in AI-powered pathology, today announced it will present research on advances in artificial intelligence (AI) approaches through three posters at the AACR-NCI-EORTC International Conference on Molecular Targets and Cancer Therapeutics on October 11-15 in Boston, Massachusetts, including one poster to be presented in partnership with Flare Therapeutics. The posters showcase how AI may improve the utility of complex and specialized modalities such as multiplexed immunohistochemistry and may enhance the utility of routine modalities, such as augmenting cellular resolution from H&E-stained images. The presentations underline the significant strides in AI that can enhance translational and clinical research applications. Spatially-resolved prediction of gene expression signatures in H&E whole slide images using additive multiple instance learning models (Poster B010) In this research, PathAI demonstrates the prediction of TGFβ-CAF gene expression signature levels in breast cancer from H&E images and links these levels to tumor microenvironment features using PathExplore, PathAI’s recently launched structured, standardized and scalable panel of human interpretable features (HIFs) offering unprecedented resolution of the tumor microenvironment (TME) from H&E whole-slide images. H&E staining is routine for cancer diagnosis but does not provide molecular information. This potentially limits its utility for molecular-targeted therapy development and selection. AI models augment the information that can be extracted from H&E staining, enhancing resolution of H&E data and increasing other applications such as associating spatial TME features with gene expression signatures. End-to-end additive multiple instance learning (aMIL) models developed and deployed by PathAI performed well at predicting TGFβ-CAF levels. Importantly, aMIL models link PathExplore HIFs to specific sub-regions within the TME, which allows for granular understanding of specific cellular contributions to various molecular predictions from H&E WSI. This poster adds to a series of PathAI achievements in predicting molecular phenotypes from digital pathology images, providing a means to harness complex biological signatures as clinical biomarkers for precision medicine. It will be presented by Chintan Parmar, manager of AI research at PathAI, on October 13 from 12:30-4 p.m. ET. Artificial intelligence (AI) analysis of histological images accurately identifies luminal subtype Urothelial Carcinomas characterized by high Peroxisome Proliferator-Activated Receptor Gamma (PPARG) expression (Poster B016) This research was completed in collaboration with Flare Therapeutics and highlights an AI-based model that identifies luminal subtype in Urothelial Carcinoma as a novel biomarker approach for its first-in-class clinical candidate FX-909. The poster will be presented by Stefan Kirov from Flare Therapeutics on October 13 from 12:30-4 p.m. ET. Machine-learning enabled quantification of colocalized multiplex IHC signals with spectral overlap (Poster B008) This poster demonstrates novel imaging and AI technology to accurately detect and quantify up to four co-localized antigens or stains from a single multiplex IHC slide. Multi-spectral imaging addresses the challenge of how to separate markers exhibiting both spectral and spatial overlap. Expression or staining of individual markers is identified in spectrally unmixed images and combined with information across all separate marker channels to create a “super annotation” co-expression map that is then used to train AI models. PathAI’s model utilizing super annotation demonstrated a significantly lower error rate in detecting co-expression of several markers such as ER, PR, and Ki67 compared to an commercially available method, which was consistent on two different scanners, Leica At2 and 3DHistech. These results may facilitate clinical utilization of higher-plex biomarkers, which could enable faster and more accurate co-expression measurement of various markers, promising cost and time savings by consolidating biomarker measurement to a single slide with automated scoring to assist pathologists. This poster will be presented by Waleed Tahir, pathology AI research scientist at PathAI, on October 13 from 12:30-4 p.m. ET. Learn More PathAI representatives will be on site at the conference for the poster presentations: Poster B008 October 13, 12:30-4:00 p.m. ET Presenter: Waleed Tahir, PathAI Poster B010 October 13, 12:30-4:00 p.m. ET Presenter: Chintan Parmar, PathAI Poster B016 (In partnership with Flare Therapeutics) October 13, 12:30-4:00 p.m. ET Presenter: Stefan Kirov, Flare Therapeutics If interested in meeting the PathAI team during or after the conference, contact the team via email at BD@pathai.com. About PathAI PathAI is the only AI-focused technology company to provide comprehensive precision pathology solutions from wet lab services to algorithm deployment for clinical trials and laboratory use. Rigorously trained and validated with data from more than 15 million annotations, its AI-powered models can be leveraged to optimize the analysis of pathology samples to improve efficiency and accuracy of pathology interpretation, as well as to better gauge therapeutic efficacy and accelerate drug development for complex diseases. PathAI, which is headquartered in Boston, MA, and operates a CAP/CLIA-certified laboratory in Memphis, TN, is proud to have a team of 600+ innovative thinkers from around the globe. For more information, please visit www.pathai.com. Contact Details SVM Public Relations and Marketing Communications Maggie Naples +1 401-490-9700 pathai@svmpr.com Company Website https://www.pathai.com/

October 11, 2023 10:00 AM Eastern Daylight Time

Immunic "super excited" about latest PMS trial data

Immunic Inc

Immunic Inc (NASDAQ:IMUX) President and CEO Dr Daniel Vitt speaks to Thomas Warner from Proactive after the biotechnology company announced encouraging interim data from its phase II CALLIPER trial assessing the potential of its treatment for progressive multiple sclerosis (PMS). Dr. Vitt expresses says he's "super excited" about the data, which he believes exceeded expectations. He adds that given the limited treatment options available for progressive MS, the company's findings are particularly significant. Immunic has observed a 22.4% reduction in the neurofilament light chain (NFL) biomarker, which correlates with better outcomes in preventing disability worsening in MS patients. This result was achieved with patients treated with 45 milligrams of their drug. The company has enrolled 467 patients in this 120-week phase two study, with final data expected around April 2025. Dr. Vitt also hints at upcoming updates from other programs as well as more news to come on a phase three clinical study. Contact Details Proactive United States +1 347-449-0879 action@proactiveinvestors.com

October 11, 2023 05:15 AM Eastern Daylight Time

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