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xCures to Contribute Data to Support Aetion®'s Collaboration with FDA

xCures

In a step forward for healthcare research, xCures is pleased to announce that it will support Aetion®'s collaboration with the US Food and Drug Administration (FDA) Oncology Center of Excellence (OCE). As part of this partnership, xCures will provide Aetion with data to support their research collaboration agreement with OCE which centers on using real-world data (RWD) to assess real-world oncology endpoints and measure and address health disparities. As part of the collaboration with OCE, Aetion’s comprehensive fit-for-purpose data assessment identified xCures’ real-time, regulatory-grade data platform to be an appropriate fit for this research study, particularly its ability to integrate clinical data with patient pathology, radiology reports, and imaging assessments. “Aetion is proud to embark on this partnership with xCures to help OCE conduct pivotal research to advance the use of real-world evidence, including in measuring and understanding vulnerable and underrepresented populations,” said Liz Garry, Head of Scientific Research, Aetion. “This work furthers our mission to power critical decisions in healthcare with data science-driven technology and brings us one step closer to achieving health equity.” xCures’ CEO, Mika Newton, explains, "Our platform's automated organization and structuring of aggregated, continuous data result in complete, source-verifiable, and fully longitudinal clinical data sets. This rich dataset can offer unprecedented insight into the real-world patient experience." The contribution of robust RWD from xCures will play an integral role in this endeavor, aiming to fill knowledge gaps and facilitate advancements in healthcare research. For more information about real-time, regulatory-grade clinical data, please visit www.xcures.com/solutions. About Aetion® Aetion is a healthcare analytics company that delivers real-world evidence for the manufacturers, purchasers, and regulators of medical treatments and technologies. Aetion Evidence Platform® analyzes data from the real world to produce transparent, rapid, and scientifically validated answers on safety, effectiveness, and value. Founded by Harvard Medical School faculty members with decades of experience in epidemiology and health outcomes research, Aetion informs healthcare’s most critical decisions—what works best, for whom, and when—to guide product development, commercialization, and payment innovation. Learn more at aetion.com and follow us on LinkedIn. About xCures xCures Inc. operates an AI-assisted platform that automatically retrieves medical records from all sites of care. The (unstructured) data is aggregated and organized into a powerful, always up-to-date care summary that helps cancer patients get the right therapy at the right time. The platform's portals, xINFORM for patients and xDECIDE for providers, facilitate treatment option decisions. The research portal, xUTILITY, generates Real-time, Regulatory-grade, Clinical data (RRC) for studies and decentralized trials. For more information, contact info@xcures.com or visit http://www.xcures.com. Contact Details xCures Inc Patrick van der Valk pvandervalk@xcures.com Company Website https://xcures.com

August 01, 2023 08:45 AM Eastern Daylight Time

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Proactive Analyst expects "some good news over the next 1-2 months" from Tiziana Life Sciences

Tiziana Life Sciences PLC

Proactive Research Analyst Robin Davidson talks to Thomas Warner about his new research note on Tiziana Life Sciences Ltd, which focuses on what he expects from the clinical-stage biopharmaceutical company over the next few months. He says Tiziana is approaching a significant milestone with the initiation of a planned study for its lead agent, Foralumab in non-active secondary progressive MS. Meanwhile, data from the existing expanded access protocol study of the same drug is expected to be revealed next month. Additionally, there's a possibility of scientific data being published at what he describes as the "main MS meeting globally" ECTRIMS scheduled to take place in Milan in October. He goes on to say that Foralumab is also in development for other indications, including Alzheimer's disease, where they are seeking grant funding from a philanthropic source to potentially conduct a study in 2024. Contact Details Proactive UK Ltd +44 20 7989 0813 uk@proactiveinvestors.com

August 01, 2023 08:00 AM Eastern Daylight Time

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MGC Pharmaceuticals receives permission to import psilocybin mushrooms into Europe

MGC Pharmaceuticals Ltd

MGC Pharmaceuticals Ltd (LSE:MXC, OTC:MGCLF, ASX:MXC) CEO and managing director Roby Zomer speaks to Thomas Warner from Proactive after the Europe-based plant-inspired medicine company announced it has secured permission to import 200g of psilocybin mushrooms into Slovenia for analysis. The news is significant because its the first time the company has been granted permission to import the naturally-occurring psychedelic compound into the country. Zomer explains that MGC Pharma has been contracted by a pharmaceutical company based in Southern Africa to import psilocybin mushrooms grown in the region to MGC's facility in Slovenia. As a certified pharmaceutical company in Europe, MGC Pharma will provide the necessary support and infrastructure to help their partner gather essential data for obtaining marketing approval for the product in other countries. Despite this new collaboration, Zoma emphasized that MGC Pharma's primary focus remains on their existing treatments for refractory epilepsy and immune modulation. However, they recognise the potential of psilocybin as an innovative medicine for the future, particularly in palliative care and post-traumatic treatments. MGC Pharma aims to stay at the forefront of this emerging sector and provide services to other companies interested in exploring psilocybin-based therapies. Looking ahead, MGC Pharmaceuticals awaits the arrival of the imported mushrooms in Slovenia with a view to commencing the testing and development processes. Additionally, updates are expected on their cannabinoid treatments in the UK, as well as their relations and expansion in America. Contact Details Proactive UK Ltd +44 20 7989 0813 uk@proactiveinvestors.com

August 01, 2023 04:14 AM Eastern Daylight Time

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Proactive Research Analyst says Shield Therapeutics' commercialisation drive "going well"

Shield Therapeutics PLC

Proactive Research Analyst Robin Davison speaks to Thomas Warner after publishing a new research note on Shield Therapeutics PLC, following the release of new prescription data from the commercial-stage specialty pharmaceutical company for its iron deficiency treatment Accrufer/Feraccru. The key highlight from the analysis is the significant increase of 50% in prescriptions during the second quarter, specifically for Accrufer. The number of doctors prescribing the drug for the first time has also shown a positive trend, with a considerable proportion of those doctors continuing to prescribe it in the following quarter. Davison says that the company's efforts in commercialising the product are "going well", with more benefit expected to come following the expansion of their sales force in June. Contact Details Proactive UK Ltd +44 20 7989 0813 uk@proactiveinvestors.com

August 01, 2023 03:45 AM Eastern Daylight Time

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Syntekabio and Metaclipse sign MOU for Joint Research on Personalized Immunotherapy for Cancer

Syntekabio, Inc.

Syntekabio (KOSDAQ: 226330), an Artificial Intelligence (AI) based drug development company, announced that it has signed a MOU with Metaclipse Therapeutics, an Atlanata, GA USA based biotechnology company developing immunotherapies for cancer and vaccines for infectious disease, for joint research on development of a personalized immunotherapy for cancer. Through this MOU, Syntekabio plans to support Metaclipse in conducting research on neoantigen identification for its Membrex TM personalized cancer vaccine platform. Metaclipse’s Membrex™ vaccine is a personalized immunotherapy for solid tumors comprising a patient tumor antigen source combined with the company’s proprietary membrane-linked biological adjuvants. The company has received approval from US FDA to proceed with a phase 1 clinical trial and will work with Syntekabio to leverage its proprietary NEO-ARS® platform to identify neoantigen candidates that generate patient-specific anti-tumor immune responses. Michael Coleman, CEO of Metaclipse, said, “The TMV-based cancer vaccine has the advantage of presenting a broad array of potential neoantigens derived from the patient’s tumor, thereby providing a personalized immunotherapy for cancer. With this MOU agreement, we plan to identify neoantigen candidates, which play a critical role in activating the patient’s immune system and provide the potential for tailoring patient-specific booster doses and developing off-the-shelf Membrex TM therapies with broad application.” Jongsun Jung, CEO of Syntekabio, said, “We are delighted to conduct joint research with Metaclipse, a cancer vaccine specialist in the clinical development stage. We are open to collaboration with companies specializing in the development of cancer vaccines and immunotherapies and will contribute in various ways so that domestic and foreign vaccine manufacturers in clinical stages can achieve positive results.” The Phase 1 clinical trial is to verify the safety and immunological activity of Metaclipse’s tumor membrane vesicle-based vaccine, termed Membrex TM. Syntekabio will contribute to the clinical trial by analyzing genomic data from tumor sample of clinical trial subjects and identifying personalized cancer neoantigens using NEO-ARS®, a neoantigen prediction AI platform. Metaclipse's cancer vaccine incorporates a broad array of tumor antigens in the form of tumor membrane vesicles prepared from the patient's own tumor. This type of vaccine has the advantage of providing a broad array of antigen candidates minimizing selection bias that is present in some other approaches. Through the joint research, the two companies expect to be able to identify the most immunologically relevant antigens by utilizing Syntekabio's NEO-ARS® platform. After this agreement, the two companies plan to comprehensively analyze Syntekabio's neoantigen prediction results and Metaclipse's clinical trial results to evaluate the correlation between the neoantigen profile and treatment response and to conduct joint research to identify potent individual neoantigens that demonstrate high immunogenicity among the many antigens loaded in the Membrex TM vaccine. For more information about Syntekabio and its offering, please visit http://www.syntekabio.com/. Contact Details WMSG | Syntekabio USA +1 201-402-1400 wgroup@wmedical.org Company Website http://www.syntekabio.com/

July 31, 2023 02:58 PM Eastern Daylight Time

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News Release

Neural Therapeutics gets go-ahead from Peruvian Government to work with San Pedro Cactus

Neural Therapeutics Inc.

Neural Therapeutics CEO Ian Campbell joined Steve Darling from Proactive to share the news that after 11 months of rigorous review, the company has received permission from Peru's Ministry of Agriculture to access genetic resources and their derivatives for the evaluation of the mescaline-containing cactus species of the Echinopsis genus, commonly known as San Pedro or Huachuma, for possible medicinal purposes. The company's plan is to develop intellectual property that will pave the way for drug development using mescaline. Mescaline is a chemical compound classified as a psychedelic and has shown potential medicinal and therapeutic applications. It is derived from the Peyote and San Pedro cacti. Neural Therapeutics is committed to sustainable practices throughout its exploration and development of mescaline-containing cacti. This includes replanting, donating samples for genetic preservation, and publishing biomarker data to aid in the preservation of wild stands of these cacti species. The access to genetic resources and derivatives of the San Pedro cactus will enable Neural Therapeutics to further explore the potential medicinal benefits of mescaline. The company's efforts could lead to the development of novel therapeutic options and potentially expand treatment options for various medical conditions. As the research progresses, Neural Therapeutics aims to ensure responsible and sustainable practices to safeguard the preservation of these valuable plant species. This approach aligns with the growing interest in harnessing the potential of natural compounds for therapeutic purposes while respecting the environment and preserving biodiversity. Contact Details Proactive Investors +1 604-688-8158 na-editorial@proactiveinvestors.com

July 31, 2023 11:29 AM Eastern Daylight Time

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Osteopore "chasing the holy grail of tissue regeneration”

Osteopore Ltd

Osteopore Ltd (ASX:OSX) Chairman Mark Leong speaks to Thomas Warner from Proactive London about the Australian-Singaporean medical technology company's pursuit of what he calls the "holy grail of tissue regeneration." Leong explains that aiming to commercialise products designed to enable natural bone healing across multiple therapeutic areas, including both hard and soft tissue. Initially focused on bone regeneration, Osteopore has received major regulatory approvals for their implants. However, their technology also holds promise for soft tissue regeneration, including shoulder rotator cuff tendon repair and cartilage regeneration. Looking ahead, the company aims to enter the "huge" Chinese market and is actively researching ways to accelerate tissue regeneration, potentially reducing healing time significantly. He says "In the next half a year or so you'll see us breaking some new ground into entering the Chinese market... and on the technology front we will be putting more effort into developing the soft tissue part because that's a whole new area of therapeutic treatment... we are chasing the holy grail of tissue regeneration which is to speed up tissue regeneration." Contact Details Proactive Australia Pty Ltd Proactive Australia Pty Ltd +61 431 597 771 action.australia@proactiveinvestors.com

July 27, 2023 06:00 PM Eastern Daylight Time

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4GLOBAL "very pleased" with final results and looking to the future

4GLOBAL PLC

4GLOBAL PLC (AIM:4GBL) CEO Eloy Mazon speaks to Thomas Warner from Proactive London following the release of audited final results for the year ended 31 March 2023. Mazon gives his highlights from the news release, saying that "all in all we are very pleased with the year", which was the company's first as a listed entity. Group revenues for the year ending 31 March 2023, grew by 53% to £5.6mln, with basic earnings per share closing at 2.4p compared to losses of 7.1p in 2022. Mazon says that strong demand from international markets played a significant role in the results and aligning with the company's growth strategy. Looking ahead, Mazon says 4GLOBAL PLC is focusing on capitalising on the strong demand, particularly in the North American market, where they have established key relationships and commercial partnerships. He explains that commercial partnerships, like the recent one with Jonas Fitness in the US, provide a valuable route to market and complement their product offerings and client onboarding capabilities. As the market shifts towards valuing data and insights, 4GLOBAL PLC aims to leverage its extensive database and technology for cleansing and transforming data into actionable insights. They also have plans to explore AI integration with a view to providing more valuable insights to their customers. Contact Details Proactive UK Ltd +44 20 7989 0813 uk@proactiveinvestors.com

July 27, 2023 10:43 AM Eastern Daylight Time

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Oxford Cannabinoid Technologies "officially on the way" after first dosing

Oxford Cannabinoid Technologies Holdings PLC

Oxford Cannabinoid Technologies Holdings PLC (LSE:OCTP, OTCQB:OCTHF) Clarissa Sowemimo-Coker speaks to Thomas Warner from Proactive London after announcing that the company has commenced its phase I clinical trial for the lead drug candidate, OCT461201, marking the administration of the first human dose. Researchers will assess the pain relief treatment's safety, tolerability, and pharmacokinetic profile (how it interacts with the body). Sowemimo-Coker says its "so important to have that significant milestone of finally getting that first dose into a healthy volunteer, so we can officially say we're on the way and looking forward to getting those results over time." The trial holds promise for patients suffering from chemotherapy-induced peripheral neuropathy (CIPN), a condition affecting 60% of chemotherapy recipients, causing severe pain and sensitivity in extremities. Sowemimo-Coker also highlights the recent addition to the team of Dr. Farquhar Smith, who runs the only CIPN clinic in the UK at the Royal Marsden. Contact Details Proactive UK Ltd +44 20 7989 0813 uk@proactiveinvestors.com

July 27, 2023 10:39 AM Eastern Daylight Time

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