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MustGrow Biologics Gains California Approval for Organic Biofertility Product, TerraSante

MustGrow Biologics Corp

MustGrow Biologics Chief Operating Officer Colin Bletsky joined Steve Darling from Proactive to share regulatory achievements for the company. MustGrow has received approval from the California Department of Food and Agriculture for its mustard plant-based TerraSante™, an organic biofertility product. Additionally, TerraSante™ has been granted organic certification specific to California requirements, supplementing its existing Organic OMRI Listed® certifications in Oregon and Washington State. Bletsky announced that with these approvals, TerraSante™ sales can now begin in California. These developments are crucial to MustGrow's strategy for commercializing its soil amendment and biofertility technologies in partnership with BioAg Product Strategies. The company, which already holds certifications in Oregon and Washington, plans to pursue further state-level registrations across the U.S. TerraSante™ is part of MustGrow's broader suite of solutions, which includes biocontrol programs targeting preplant soil fumigation, postharvest food preservation, and bioherbicides. These initiatives are advancing in collaboration with global partners such as Bayer, Sumitomo Corporation, Janssen PMP, and NexusBioAg, underlining MustGrow's commitment to sustainable agricultural practices worldwide. Contact Details Proactive North America +1 604-688-8158 na-editorial@proactiveinvestors.com

May 09, 2024 01:16 PM Eastern Daylight Time

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Triomics automates oncology workflows with GenAI powered platform, raises $15M

Triomics

Currently, oncology staff must manually search thousands of patient health records to find the right trials or care pathways for their patients. Triomics is today announcing it has raised $15M to help cancer centers streamline these workflows and process oncology data at scale by applying their framework to build, institution-tuned large language models (OncoLLM™) and use case-specific software. The company has raised from several Silicon Valley firms making pioneering investments in generative AI and healthcare, including Lightspeed, Nexus Venture Partners, General Catalyst and Y Combinator. Manual chart review can take hours per patient, and many health systems face significant backlogs in completing key oncology-related workflows for thousands of patients. This workload leads to clinical delays, such as patients missing out on clinical trials or biomarker-driven treatments, lagging quality reporting, and provider dissatisfaction and turnover. Triomics co-founders Sarim Khan (CEO) and Hrituraj Singh (CTO) were college friends who later worked as an MIT biotech researcher and Adobe AI researcher, respectively. They knew software existed to quickly analyze the ~20% of medical data that is stored in a uniform, structured manner, like a patient’s demographics or laboratory values. However, they realized recent advances in generative AI created the possibility of similarly analyzing the ~80% of medical data that exists in an unstructured format, like a doctor’s free-text note. “Hrituraj and I decided to partner to build solutions leveraging the advances in the field of generative AI and LLMs to help hospital staff,” said Sarim Khan, CEO of Triomicss. “We want our solutions to reason and sound like experts in oncology.” After developing an OncoLLM™ with Medical College of Wisconsin researchers, Triomics found that, in just minutes, it found 90% of eligible patients for clinical trials, which would have taken days or weeks for qualified nurses. It also extracted structured data points from unstructured notes at similar or higher accuracy to proprietary models like GPT4 or Claude while being 40 times cheaper. Triomics recently also published the results of its information retrieval engine for oncology, which they found to be 1.5-2 times better than other state-of-the-art retrieval models. “Most of the solutions on the market today claim they use GenAI, but many lack published evidence. Triomics is setting themselves apart by taking a truly collaborative approach to co-developing these models,” said Bradley Taylor, Chief Research Informatics Officer at the Medical College of Wisconsin and Director of the CTSI Center for Biomedical Informatics. Anai Kothari, a surgical oncologist at the Medical College of Wisconsin Cancer Center added: “The ability to quickly and accurately convert complex cancer data into a format that can be used to improve patient care is crucial. Triomics has been a great partner in integrating our suggestions and rigorously studying their approach to ensure safety.” OncoLLM™ powers proprietary Triomics software that integrates with health system EHRs to complete specific clinical and administrative tasks. For example, Triomics Prism aids in patient-trial matching by prescreening oncology patients with upcoming appointments to find relevant clinical trials. Triomics Harmony curates EHR data to support quality reporting, cohort analysis and precision oncology. Hrituraj Singh, CTO at Triomics, commented: “Our investments in our core areas of focus have been deliberate. We have successfully merged expertise in two complex functional areas: our AI researchers, who are specialized in customizing language models to specific domains, and our clinical staff, who have decades of oncology-specific experience. As a result, our software can complement the strengths of these advanced models while also proactively addressing potential flaws, all with the intricacies of cancer research and care in mind.” Given the heightened importance of accuracy for oncology data, Triomics partners with leading academic cancer centers and researchers to develop generative AI performance and safety benchmarks and best practices. Partners include the Collaboration for Oncology-focused LLM Training (COLT), a consortium of leaders from a dozen NCI-designated cancer centers, and the Cancer Informatics for Cancer Centers (CI4CC) Society. “We differentiate ourselves by building tailored models specifically for oncology and pairing them with GenAI native workflows,” said Sarim Khan. “While other solutions address some of the use cases we’re working on, like patient-trial matching, they are broad based solutions that use or modify legacy technologies that have proven not to have the scalability or ROI the industry is requesting.” Triomics next plans to publish additional data on OncoLLM efficacy across a diversity of settings and patient populations, and develop software that powers additional use cases. “Triomics is leveraging existing healthcare datasets and Generative AI to empower hospital staff to automate clinical trials and streamline cancer center workflows,” said Dev Khare, partner at Lightspeed. “We are excited to back Triomics in this important mission.” “With robust early results for their proprietary oncology specific LLMs and partnerships with leading cancer care and research centers, Triomics is well poised to deliver significant value to cancer care providers and patients in the U.S. and globally,” said Jishnu Bhattacharjee, managing director at Nexus Venture Partners. “We are thrilled to partner with Sarim and Hrituraj to help build a remarkably impactful company!" About Triomics Triomics uses generative AI to streamline workflows for cancer centers. Its oncology specialized generative AI model (OncoLLMTM) and use case-specific software help cancer providers process free-text health record data at scale, match patients to clinical trials, improve quality of care operations, deliver precision oncology and more. Based in San Francisco, the company has raised $15 million from leading VC investors. About Lightspeed Lightspeed is a global multi-stage venture capital firm focused on accelerating disruptive innovations and trends in the Enterprise, Consumer, Health, and Fintech sectors. Over the past two decades, the Lightspeed team has backed hundreds of entrepreneurs and helped build more than 500 companies globally including Affirm, Acceldata, Carta, Cato Networks, Darwinbox Epic Games, Faire, Innovaccer, Guardant Health, Mulesoft, Navan, Netskope, Nutanix, Rubrik, Sharechat, Snap, OYO Ultima Genomics and more. Lightspeed and its global team currently manage $25B in AUM across the Lightspeed platform, with investment professionals and advisors in the U.S., Europe, India, Israel, and Southeast Asia. About Nexus Venture Partners Nexus Venture Partners is a leading early-stage venture capital firm partnering with extraordinary entrepreneurs to build product-first companies. With $2.6 billion under management, Nexus operates as one team across the US and India. Nexus portfolio includes Apollo.io, Aryaka, Clover Health, Delhivery, Druva, FingerprintJS, Hasura, H2O.ai, Infra Market, Kaltura, Mezi, MinIO, Observe.ai, Postman, Pubmatic, Quizizz, Rancher, Sibros, Snapdeal, TileDB, Turtlemint, Unacademy, and Zomato. Contact Details Triomics Bilal Mahmood +44 7714 007257 b.mahmood@stockwoodstrategy.com Company Website https://www.triomics.com/

May 09, 2024 01:16 PM Eastern Daylight Time

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6.7 Million Americans Live With Alzheimer’s – IGC Pharma Believes They Deserve Treatment Options Without Black Box Warnings

IGC Pharma, Inc. (IGC)

By Faith Ashmore, Benzinga Over 6.7 million Americans aged 65 and older are living with Alzheimer’s disease (AD) and this number is predicted to grow to 13.8 million by 2060. AD is the sixth leading cause of death in the U.S. and in 2023, it was projected to cost the U.S. $345 billion. Alzheimer's disease is characterized by a gradual decline in memory, thinking, behavior and social skills; however, a lesser-known subsection of Alzheimer’s patients – despite a prevalence of 40%-80% in the patient population – suffer from Agitation in Alzheimer’s Disease (AAD). AAD is associated with higher admission rates to assisted living facilities, higher use of medications, higher rates of long-term hospitalizations and higher mortality rates for Alzheimer’s patients. This brings a significant emotional and financial cost to patients and caregivers. Currently, there is no perfect treatment for AD or ADD. Otsuka’s (OTC: OSUKF) Rexulti is one of the major medications currently being explored as a potential treatment for Alzheimer's disease. It was originally developed as an atypical antipsychotic to help treat mental health illnesses, and it is believed to work by affecting the activity of certain neurotransmitters in the brain. Due to this, ongoing research is investigating its potential to address the behavioral and psychological symptoms often associated with the condition, such as agitation and aggression, but some concerns are yet to be addressed. One of the major criticisms of Rexulti is that it carries a black box warning regarding the increased risk of death in elderly patients with dementia-related psychosis. Patients have reported adverse events associated with the drug like restlessness, weight gain and sleepiness. IGC Pharma (AMEX: IGC) is looking to an alternative to existing drugs with its drug, IGC-AD1, which has been specifically designed to target the underlying causes of AAD and aims to fill the gap for a safe and effective therapy. IGC Pharma began developing IGC-AD1 in 2017, and it was approved by the FDA as an investigational new drug in 2019. IGC-AD1 is designed to target neuroinflammation and dysfunction of the CB1 receptor. This investigational drug contains THC as one of two active pharmaceutical agents. THC is the primary psychoactive compound found in the cannabis plant. IGC-AD1 is undergoing extensive clinical trials to evaluate its effectiveness and safety in treating Alzheimer's disease. After a successful phase 1 clinical trial that resulted in patent protection in the U.S., the company has moved on to phase 2 trials. The phase 2 clinical trial, begun in 2023, encompasses 20 sites across the United States and Canada. With a target of 146 participants, this trial focuses on determining the efficacy of IGC-AD1 in alleviating agitation in Alzheimer's patients. The company has just announced the results of an interim analysis of its ongoing phase 2 trial. The main objective of the study is to evaluate the change in AAD over six weeks, utilizing the Cohen Mansfield Agitation Inventory (CMAI). According to IGC Pharma, the study showed that patients who were given IGC-AD1 had a more significant reduction in agitation levels compared to those who were given a placebo, with positive effects being observed as early as week two of the trial. At the six-week mark, the difference in agitation levels between the IGC-AD1 group and the placebo group was quite noticeable, with an effect size of 0.66 according to Cohen's d measure. The mean difference in the CMAI scores between the active treatment and placebo was -10.45, which indicates a meaningful contrast. Additionally, at the two-week mark, a secondary evaluation showed a positive effect size of 0.79 for IGC-AD1 compared to the placebo. If IGC-AD1 continues to perform well in clinical trials, it could be an effective, simpler and faster treatment option for patients – and importantly, the company is aiming to deliver a product with full approval from the FDA without major black box warnings. The formula as an oral liquid solution also caters to the older population. For millions of Americans who have family members with AD or are worried about developing AD later in life, this drug could provide hope. Featured photo by Cristina Gottardi on Unsplash. IGC Pharma Inc. (IGC) is at the forefront of the fight against Alzheimer's disease, developing innovative solutions to address this devastating illness. The company's mission is to transform the landscape of Alzheimer's treatment with a robust pipeline of five promising drug candidates. IGC-AD1 and LMP target the hallmarks of Alzheimer's disease, including neuroinflammation, Aβ plaques, and neurofibrillary tangles. IGC-AD1 is currently undergoing a Phase 2b clinical trial for agitation in dementia associated with Alzheimer's (clinicaltrials.gov, CT05543681). TGR-63 disrupts the progression of Alzheimer's by targeting Aβ plaques. IGC-M3, currently in preclinical development, aims to inhibit the aggregation of Aβ plaques, potentially impacting early-stage Alzheimer's. IGC-1C, also in preclinical stages, targets tau protein and neurofibrillary tangles, representing a forward-thinking approach to Alzheimer's therapy. In addition to its drug development pipeline, IGC Pharma is actively leveraging Artificial Intelligence (AI) for Alzheimer's research. Their AI projects encompass various areas, including clinical trial optimization and early detection of Alzheimer's. These forward-looking statements are based largely on IGC Pharma’s expectations and are subject to several risks and uncertainties, certain of which are beyond IGC Pharma’s control. Actual results could differ materially from these forward-looking statements as a result of, among other factors, the Company’s failure or inability to commercialize one or more of the Company’s products or technologies, including the products or formulations described in this release, or failure to obtain regulatory approval for the products or formulations, where required, or government regulations affecting AI or the AI algorithms not working as intended or producing accurate predictions; general economic conditions that are less favorable than expected; the FDA’s general position regarding cannabis- and hemp-based products; and other factors, many of which are discussed in IGC Pharma’s U.S. Securities and Exchange Commission ("SEC") filings. IGC Pharma incorporates by reference the human trial disclosures and Risk Factors identified in its Annual Report on Form 10-K filed with the SEC on July 7, 2023, and Quarterly Report on Form 10-Q filed with the SEC on February 14, 2024, as if fully incorporated and restated herein. Considering these risks and uncertainties, there can be no assurance that the forward-looking information contained in this release will occur. This post contains sponsored content. This content is for informational purposes only and not intended to be investing advice. Contact Details Rosalyn Christian rchristian@imsinvestorrelations.com Company Website https://igcpharma.com/

May 09, 2024 08:45 AM Eastern Daylight Time

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Genflow Biosciences advances three major programs in fight against ageing diseases

Genflow Biosciences PLC

Genflow Biosciences PLC CE Dr Eric Leire tells Proactive's Stephen Gunnion the company had a successful year in 2023, allowing it to expand its research and development pipeline. Leire highlighted three main programs during an interview. The first focuses on MASH (Metabolic Dysfunction-Associated Steatohepatitis), soon progressing to clinical trials, indicating a strong move towards addressing liver diseases. The second program deals with Werner Syndrome, a progeria-related condition, where Genflow is innovating with synthetic organoids to mimic human organ function for better clinical trial predictions. The third program targets sarcopenia in collaboration with Revatis SA, aiming to combat muscle loss associated with ageing. The company has also engaged with regulatory agencies in Europe and the US, receiving positive feedback on its approach, particularly with its MASH program. It is awaiting further feedback from the FDA to decide the trial's location. In addition to a recent £715,000 fundraise, Genflow's financial strategy relies heavily on grants, with recent significant funding from the Wallonia Region in Belgium, which Leire believes positions it well to continue its work without heavy reliance on venture capital. Contact Details Proactive UK Ltd +44 20 7989 0813 uk@proactiveinvestors.com

May 09, 2024 07:37 AM Eastern Daylight Time

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Immunic CEO Dr Daniel Vitt discusses key Q1 advances and upcoming milestones

Immunic Inc

Immunic Inc (NASDAQ:IMUX) CEO Dr Daniel Vitt takes Proactive's Stephen Gunnion through the company's first-quarter achievements and upcoming milestones for its clinical pipeline of orally administered, small molecule therapies for chronic inflammatory and autoimmune diseases. Vitt said the quarter was notable for Immunic's successful fundraising efforts, raising up to $240 million in a three-tranche private placement aimed at furthering its Multiple Sclerosis (MS) and gastrointestinal treatments. He also highlighted the importance of the recent allowance of a fourth US patent for vidofludimus calcium, enhancing its intellectual property portfolio around MS treatments and ensuring long-term commercial exclusivity. Vitt gave an update on the status of ongoing clinical trials, including the advanced Phase 2 CALLIPER trial for MS, with significant results expected in April next year. Moreover, he touched on Immunic's gastrointestinal disorder programs, particularly for celiac disease, with the IMU-856 program showing promising results in restoring gut wall functions. The interview also covered upcoming milestones, focusing on executing current clinical trials and preparing for future phases. Contact Details Proactive North America +1 604-688-8158 NA-editorial@proactiveinvestors.com

May 09, 2024 06:58 AM Eastern Daylight Time

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Fusion Antibodies reports second-half rebound as new commercial strategy pays off

Fusion Antibodies PLC

Fusion Antibodies PLC (AIM:FAB) CEO Adrian Kinkaid joined Proactive's Stephen Gunnion with more on the company that specialises in various stages of antibody development, excluding GMP production for clinical trials. He described Fusion Antibodies as a collaborative research organisation that engages deeply with clients to develop therapeutic antibodies, one of the most complex scientific endeavours. Its client base includes small VC-funded biotechs and has expanded to include large organisations like the National Cancer Institute. Fusion Antibodies also explores adjacent markets such as diagnostics, family medicine, and veterinary medicine. Recently, the company faced economic challenges, particularly a decrease in venture capital for biotechs, impacting its core business. However, it responded with strategic diversifications and cost management, leading to a 47% increase in fourth-quarter 2024 sales compared to the first quarter. The order pipeline at the year's end was significantly stronger at £750,000, promising a solid foundation for future growth. Kinkaid noted that Fusion Antibodies has secured various agreements, including a notable collaboration with the National Cancer Institute to employ their OptiMAL technology platform for discovering human antibodies. This platform could potentially lead to multiple licensing opportunities due to its vast diversity. Additionally, the company raised about £1.37 million, which will fund growth initiatives, including expanding its commercial team to better reach its primary market in the USA. Contact Details Proactive UK Proactive UK +44 20 7989 0813 UKEditorial@proactiveinvestors.com

May 09, 2024 06:41 AM Eastern Daylight Time

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Centre for Neuro Skills Promotes Dr. Omesh Singh to Associate Chief Medical Officer

Centre for Neuro Skills

Centre for Neuro Skills (CNS), a leader in traumatic brain injury and stroke rehabilitation services, today announced the promotion of Dr. Omesh Singh, D.O. FACOI, to associate chief medical officer. “Dr. Singh’s extensive knowledge and expertise has been a major asset to us. I’m excited to work in lockstep with him to deliver on our promise to give patients the best rehabilitative care science can offer,” said Dr. Matthew Ashley, chief medical officer of Centre for Neuro Skills. Since joining CNS in 2015, Singh has served as medical director overseeing CNS’ Dallas and Fort Worth clinics. A specialist in internal medicine and post-stroke treatment, Singh treats a wide range of patients recovering from traumatic and acquired brain injury. As associate chief medical officer, Singh will retain his current responsibilities and his oversight will expand from two to all seven clinics. Singh will report directly to Dr. Matthew Ashley, working closely to treat complex cases, oversee the standard of care and manage all medical operations. Singh received his Doctor of Osteopathic Medicine degree from the Lake Erie College of Osteopathic Medicine. He is a certified Fellow of the American College of Osteopathic Internists. He completed his Internal Medicine Residency training at Plaza Medical Center (Medical City Fort Worth), where he is an associate professor of internal medicine. Singh has served as an internal medicine physician in the Dallas-Fort Worth Metroplex for nearly a decade. The CNS Dallas clinic is a state-of-the-art 40,000 sq. ft. rehabilitation facility located in Irving, Texas. The Fort Worth clinic also offers patient-centered rehabilitation through advanced technology and skilled therapists. CNS has two other clinics in Texas (Houston and Austin) and three California clinics in Bakersfield, San Francisco and Los Angeles. *** About Centre for Neuro Skills Centre for Neuro Skills is an experienced and respected world leader in providing intensive rehabilitation and medical programs for those recovering from all types of brain injury. CNS covers a full spectrum of advanced care from residential and assisted living to outpatient/day treatment. Founded by Dr. Mark Ashley in 1980, CNS has seven locations in California and Texas. For more information about Centre for Neuro Skills, visit: www.neuroskills.com, Facebook, X (formerly known as Twitter), LinkedIn, YouTube. Media, please note: Visual assets, including photos, are available. To request an interview with CNS leadership or clinical staff, please contact Robin Carr at 415.766.0927 or CNS@landispr.com. # # # Contact Details Landis Communications Inc. Robin Carr +1 415-766-0927 cns@landispr.com Company Website https://www.neuroskills.com/

May 08, 2024 08:00 AM Pacific Daylight Time

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Poolbeg Pharma's POLB 001 immuno-modulator II receives fully-granted patent from US Patent Office

Poolbeg Pharma PLC

Poolbeg Pharma PLC (AIM:POLB, OTCQB:POLBF) chief legal officer John McEvoy joins Proactive's Stephen Gunnion with news that POLB 001's Immuno-modulator II has received the fully granted patent from the US Patent Office. McEvoy explained the patent encompasses a class of drugs for treating and preventing hypercytokinemia (cytokine storms) in patients triggered by an immune response, applicable across multiple disease indications. The granted patent further solidifies Poolbeg Pharma's robust intellectual property portfolio for POLB 001, potentially increasing the asset's value and making it more attractive to potential partners. McEvoy highlighted the company's ongoing efforts to strengthen and expand their IP portfolio, noting existing patents covering p38 MAP kinase inhibitors for influenza treatment and hypercytokinemia. Additional patents have been filed, particularly focusing on cancer immunotherapy applications of POLB 001. The company has also applied for patents concerning dosage regimens based on results from their recent LPs trial, aiming to protect innovations and maintain a competitive edge in the pharmaceutical market. This strategic IP protection is crucial for safeguarding the company's products and ensuring shareholder value, particularly as they seek partnerships to further develop POLB 001. Contact Details Proactive UK Ltd +44 20 7989 0813 uk@proactiveinvestors.com

May 08, 2024 08:32 AM Eastern Daylight Time

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Faron Pharmaceuticals' new CEO Dr Juho Jalkanen sets bold vision for 2024

Faron Pharmaceuticals Oy

Faron Pharmaceuticals Limited (AIM:FARN) new CEO Dr Juho Jalkanen joined Proactive's Stephen Gunnion with his vision for the company. The founding member and former chief operating officer of Faron said one of his priorities is to meet with the US Food & Drug Administration earlier than planned in the hope of fast-tracking its lead drug, bexmarilimab, which has shown huge promise in treating a type of rare blood cancer. The move follows promising data from the phase I trials involving patients with myelodysplastic syndrome (MDS) who were unresponsive to a class of drugs called hypomethylating agents (HMAs). Jalkanen highlighted the company's ongoing phase 2 trial targeting relapsed refractory MDS, emphasising the strategic goal of securing non-dilutive funding and considering future mergers and acquisitions as the drug shows promise. Jalkanen also discussed the potential of the lead drug candidate in treating specific macrophage-driven cancers, indicating an optimistic outlook for the near term, including significant milestones expected in 2024. These milestones include more phase 2 data, expected by late May, and subsequent FDA feedback, pivotal for future planning. The CEO expressed confidence in the company's position and its appeal to investors, especially given the biotech sector's recovery from a period he referred to as a "nuclear winter." Contact Details Proactive UK Ltd +44 20 7989 0813 uk@proactiveinvestors.com

May 08, 2024 08:19 AM Eastern Daylight Time

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