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AGC Biologics to Prepare Late Phase and Commercial Runs for Immunocore

AGC Biologics

AGC Biologics, a leading global Biopharmaceutical Contract Development and Manufacturing Organization (CDMO), today announced a new late-stage clinical and process performance qualification (PPQ) project at its Heidelberg, Germany site with Immunocore Holdings Plc (Nasdaq: IMCR). Immunocore intends to use the Heidelberg site to complete late-stage manufacturing and prepare for commercialization for IMC-F106C, Immunocore’s PRAME-targeted bispecific therapy. Under the agreement, AGC Biologics will leverage its microbial fermentation and manufacturing experience to perform bench-scale qualification and process characterization, and other required studies to support phase III manufacturing, as well as PPQ runs. Pending a successful PPQ campaign and regulatory approvals, the Immunocore project is expected to move into commercial stages at the AGC Biologics Heidelberg site. This is the next step in the partnership for this candidate between the two companies, with AGC Biologics providing early-phase support for this same project. Immunocore and AGC Biologics previously worked together on commercial manufacturing readiness for KIMMTRAK® (tebentafusp-tebn) at the CDMO’s Copenhagen site. “This is a great example of the power of the AGC Biologics network and our ability to collaborate at our global sites to support important client projects,” said Dieter Kramer, General Manager, AGC Biologics Heidelberg. “I am extremely proud of our team here in Heidelberg and the work they’ve done to support this project. We are pleased Immunocore has agreed to work with us on these next important steps in their product’s lifecycle, as our team has the late-stage and commercial expertise to deliver what is needed.” AGC Biologics runs multiple cGMP microbial fermentation lines at its Heidelberg facility. The AGC Biologics Heidelberg site has produced biologics products for 40 years and has built a track record for navigating clients through the early clinical phases and into later stages to help prepare for commercial production. In addition to fermentation, the site serves as a center of excellence for plasmid DNA (pDNA) and messenger RNA (mRNA). To learn more about AGC Biologics’ microbial system-based biologics, plasmid DNA (pDNA) and messenger RNA (mRNA) manufacturing site in Heidelberg, visit www.agcbio.com/facilities/heidelberg. For more information on the company’s Protein Biologics, pDNA, Cell Therapy, Viral Vector and mRNA drug product services go to www.agcbio.com. About AGC Biologics AGC Biologics is a leading global biopharmaceutical Contract Development and Manufacturing Organization (CDMO) with a strong commitment to delivering the highest standard of service as we work side-by-side with our clients and partners, every step of the way. We provide world-class development and manufacture of mammalian and microbial-based therapeutic proteins, plasmid DNA (pDNA), messenger RNA (mRNA), viral vectors, and genetically engineered cells. Our global network spans the U.S., Europe, and Asia, with cGMP-compliant facilities in Seattle, Washington; Boulder and Longmont, Colorado; Copenhagen, Denmark; Heidelberg, Germany; Milan, Italy; and Chiba, Japan and we currently employ more than 2,500 employees worldwide. Our commitment to continuous innovation fosters the technical creativity to solve our clients’ most complex challenges, including specialization in fast-track projects and rare diseases. AGC Biologics is the partner of choice. To learn more, visit www.agcbio.com. Contact Details AGC Biologics Nick McDonald +1 425-419-3555 nmcdonald@agcbio.com

November 20, 2023 05:08 AM Eastern Standard Time

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Breaking ground in vision restoration: Kiora Pharmaceuticals reveals promising results with KIO-301

Kiora Pharmaceuticals

Kiora Pharmaceuticals CEO Brian Strem joined Steve Darling from Proactive to share news the company's plan to broaden the clinical development of KIO-301, a treatment designed for various inherited retinal diseases. The expansion includes initiating a Phase 2 trial which will be controlled, double-masked, randomized, and will involve an ascending dose. This trial is set to include up to 20 patients suffering from Retinitis Pigmentosa (RP), who will receive doses monthly over a span of 90 days. Strem explained that this move is propelled by encouraging topline results from a Phase I/II clinical trial, which indicated that KIO-301 is a first-in-class small molecule with significant potential to improve vision for patients with RP, even those with extremely low vision or complete blindness. Moreover, Kiora Pharmaceuticals has plans to engage with the FDA in the fourth quarter of 2023. The goal of this meeting is to achieve consensus regarding the study designs, endpoints, and additional requirements necessary to conduct further studies in the United States and Europe. These studies would not only target RP but also extend to other inherited retinal diseases such as Choroideremia (CHM) and Stargardt disease. Contact Details Proactive Investors +1 604-688-8158 na-editorial@proactiveinvestors.com

November 17, 2023 01:54 PM Eastern Standard Time

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MTL Cannabis road to success is based on flower first philosophy

MTL Cannabis

MTL Cannabis CEO Mike Perron joined Steve Darling from Proactive to to discuss the ethos and operations of their family-founded company, which places a high value on the quality and potential of the cannabis plant. The company's focus is primarily on flower-based products, including dry flower and pre-rolls. However, Perron notes that they are also venturing into hash production, leveraging their in-house knowledge and capabilities to broaden their product portfolio. Perron highlighted to Proactive the significant growth MTL Cannabis has experienced, attributing it to organic business development strategies. Remarkably, until January last year, the company's sales efforts were spearheaded by a single, highly dedicated sales representative. This individual not only worked with provincial boards but also took personal initiatives to promote the brand to dispensaries and budtenders during weekends. Furthermore, Perron provided insights into MTL Cannabis’s agreement with Canada House Wellness Group, a company deeply rooted in clinics and medical cannabis, originally established by veterans for veterans. The veteran community constitutes a crucial segment of their business, accounting for about 96% of their medical cannabis sales. Canada House operates 12 clinics across the country, including virtual ones, with a strategic presence near military bases to best serve the veteran population. Contact Details Proactive Investors +1 604-688-8158 na-editorial@proactiveinvestors.com

November 17, 2023 01:44 PM Eastern Standard Time

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Medicus Pharma sees appointment of Dr Huma Qamar as key to company’s future

Medicus Pharma

In an exclusive interview with Dr Huma Qamar, chief scientific officer for Medicus Pharma Ltd, exciting developments in skincare and oncology are discussed. Dr Qamar shares her passion for addressing unmet medical needs, particularly in the field of basal cell carcinoma. The focus is on SkinJet, a flagship company acquired by Medicus Pharma, utilizing revolutionary microarray needles. The needles, transdermally delivering the chemotherapeutic agent doxorubicin, show promising data in preventing relapse and remission of basal cell carcinoma. Looking ahead, Dr Qamar outlines the company's goals for 2024, emphasizing the resumption of clinical development activities and recruitment efforts. The aim is to complete the phase two trial and present promising data. Dr Qamar, driven by a dedication to oncology and patient well-being, discusses the emotional impact of cancer and the hope that Medicus Pharma's contributions will bring positive changes to the lives of patients. Contact Details Proactive Investors +1 604-688-8158 na-editorial@proactiveinvestors.com

November 17, 2023 01:21 PM Eastern Standard Time

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News Release

Xeris Biopharma CEO unveils game-changing drug innovations and record financial success

Xeris Biopharma Holdings

Xeris Biopharma CEO Paul Edick joined Steve Darling from Proactive to share insights on the company's focus on innovative drug formulation technology after reporting strong third-quarter results. With three growing products addressing severe hypoglycemia, Cushing's Syndrome, and periodic peripheral paralysis, the company's core lies in commercial success. Edick discussed a promising drug in development—levothyroxine—in a once-weekly subcutaneous injection format, targeting consistency and reduced side effects. Despite being in phase two, the drug could revolutionize current prescription norms. Additionally, partnerships with industry giants like Regeneron and Amgen are underway, emphasizing Xeris' position as a formulation leader. Financially robust, Xeris reported a record quarter and anticipates cash flow breakeven by the fourth quarter. Edick affirmed the company's self-sustainability and projected ending 2024 with ample cash. Despite market challenges, Xeris' growth and strategic focus signal confidence in its trajectory, positioning it as a force in biopharmaceutical innovation. Contact Details Proactive Investors +1 347-449-0879 na-editorial@proactiveinvestors.com

November 17, 2023 01:07 PM Eastern Standard Time

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Arecor Therapeutics takes major step with first commercial sale of AT220

Arecor Therapeutics PLC

Arecor Therapeutics PLC CEO Sarah Howell speaks to Thomas Warner from Proactive after the biopharmaceutical group announced the first commercial sale of a product that incorporates its proprietary Arestat technology, known as AT220. Part of a licence agreement with an unnamed global pharma partner initiated in 2017, the milestone has triggered a payment to Arecor. It will also receive royalties on sales. Howell explains the significance of the news, emphasising its importance for patients and the business. She says the achievement aligns with Arecor's vision of building a large, self-sustaining biopharmaceutical company focused on improving patient care. While the partner involved in this achievement remains undisclosed, Howell shed light on Arecor's appeal to pharmaceutical collaborators and says the Arestat technology enables the company to enhance biosimilar products, providing more benefits to patients and giving partners a competitive edge in a high-value market. She says the financial impact is significant, with the milestone triggering licensed payments and initiating recurring royalty streams for Arecor. As the year approaches its end, Howell hints at potential updates. The partnered portfolio shows promising progress, with recent announcements of licensed milestones and positive developments in clinical studies. Ongoing partnerships with pharmaceutical and biotech companies are expected to expand, contributing to Arecor's growth. The company is actively developing its proprietary products, focusing on specialty hospital medications and diabetes treatments. One of their lead diabetes products, AT278, targets patients with high insulin needs, presenting a disruptive solution in a growing market segment. Results from the clinical study are anticipated in Q1 2024. Contact Details Proactive UK Ltd +44 20 7989 0813 uk@proactiveinvestors.com

November 17, 2023 12:47 PM Eastern Standard Time

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NRx Pharmaceuticals founder unveils potential treatment for suicidal thoughts and depression

NRx Pharmaceuticals Inc

NRx Pharmaceuticals founder and chief scientist Dr Jonathan Javitt joined Steve Darling from Proactive to discuss groundbreaking developments in treating suicidal ideation and depression. NRx focuses on targeting the NMDA (N-methyl-D-aspartate) receptor in the brain, identified as crucial for turning off suicidal thoughts. Traditional antidepressants, which target the serotonin axis, often increase suicide risk, highlighting the need for a new approach. Javitt told Proactive the company is approaching the clinical trial enrollment goals for its partnered product NRX-101, while opening new clinical initiatives in chronic pain, urinary tract infection, and NRX-100 for suicidal depression. The company said the trial is near completion of enrollment of the originally-targeted 70 participants in the Phase 2b/3 trial of NRX-101. Top-line data from this cohort of patients is expected shortly after the last patient visit. Javitt told Proactive chronic pain affects more than 50 million American adults, compared to the approximately 3 million who report thoughts of suicide on an annual basis. There has been no new non-opioid class of drugs to treat nociceptive pain in the past two decades and NRX-101 has the potential to be the first NMDA-antagonist drug to seek approval for this indication. Contact Details Proactive Investors +1 604-688-8158 na-editorial@proactiveinvestors.com

November 16, 2023 02:07 PM Eastern Standard Time

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Navigating Open Enrollment

YourUpdateTV

Open Enrollment season is underway, and as we look ahead to 2024, now is the time to assess health care coverage options and select the plan that is best for you and your budget. Recently, Rhonda Randall, the Chief Medical Officer of UnitedHealthcare Employer and Individual participated in a nationwide satellite media tour to share tips for navigating the Open Enrollment season. A video accompanying this announcement is available at: https://youtu.be/mhpkMs2vBGk Enrollment periods aren’t the same for everyone, so there are key dates to keep in mind depending on your circumstances. Many employers set aside a 2- to 3-week period between September and December when employees can select health benefits for the following year. But just as millions of Americans prepare to choose health insurance for next year, a recent survey revealed that 1 in 3 people (36%) spend less than 1 hour reviewing their benefits options. For most people, not making an enrollment decision means you may be locked into your current plan for the upcoming year. If anything has changed this year – either with your current plan, health status or budget – that decision to do nothing could lead to unpleasant surprises or missed cost-savings in 2024. Because everyone has unique health and budget needs, and there is no one-size-fits-all approach to selecting a health plan, it’s important to stay informed before making these decisions. When choosing a health plan, here are a handful of tips that will hopefully lead to better health and cost savings: Take your time and consider all of your options Learn the language Help prevent financial surprises Check for mental health coverage Don’t forget about specialty benefits Look into wellness programs Explore virtual care services Visit UHCOpenEnrollment.com for tips, resources and information on plans in your area About Rhonda Randall Rhonda L. Randall, D.O., is the Chief Medical Officer of UnitedHealthcare Employer & Individual, the nation’s largest business serving the health coverage and well-being needs of nearly 28 million Americans. Dr. Randall collaborates with U.S. employers who are looking for quality, cost-effective, long-term solutions to health benefits for their employees and retirees. She also leads the clinical strategy development for these businesses to improve quality outcomes, ensure affordability and improve health and well-being. Contact Details YourUpdateTV +1 212-736-2727 yourupdatetv@gmail.com

November 16, 2023 11:00 AM Eastern Standard Time

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Thrive Precision Health, Inc. (OTC:CNER) Taking Steps To Serve Diabetic Health Sector

China New Energy Group Co

In the world of healthcare investments, the diabetes care market emerges as a compelling arena ripe with opportunities. Several important factors that may attract some investors are driving the sector's growth. At the heart of this surge is the continual development of efficient insulin delivery devices. Technological advancements in healthcare are steering manufacturers to innovate in this crucial area. Projections indicate a substantial uptick in the global diabetes care devices market, from $28,942.1 million in 2022 to an anticipated $42,119.3 million by 2028, reflecting a noteworthy compound annual growth rate (CAGR) of 6.4%. The World Health Organization's recognition of diabetes as a significant global health challenge underscores the urgency for solutions. With over 420 million people affected worldwide, the market demands innovative approaches to address this widespread concern. The insulin market, valued at $21.11 billion in 2022, signifies a substantial financial domain within the broader diabetes care landscape. Predictions hint at its growth to $25 billion by 2030, with North America playing a prominent role, commanding a considerable 38.91% market revenue share in 2022. On a domestic scale, the United States presents a vivid picture of the diabetes epidemic. A staggering 37.3 million Americans are diagnosed with diabetes, while an additional 96 million grapple with pre-diabetes. This prevalence is particularly pronounced in the aging population, where 48.8% of those aged 65 or older face the challenges of this health condition. Looking forward, Global Market Insights anticipates a robust compound annual growth rate of 10% for the diabetes care device market. This projection positions the market to evolve into an $88 billion industry by 2030, offering investors a compelling narrative for potential opportunities in this evolving healthcare landscape. Among the growing landscape of the diabetes care market, one potential hidden gem poised for prominence is Thrive Precision Health, Inc. (OTC: CNER). Thrive Precision Health Inc. is carving its niche as a global diabetes care powerhouse. Trading under the symbol CNER, the company is revitalizing established healthcare clinics specializing in diabetes care. Their unique approach integrates cutting-edge technologies, aiming to create a seamless digital experience for patients worldwide, offering personalized healthcare through the application of AI and quantum biosensors. The company marked a significant milestone on October 5, 2023, by completing a name change to Thrive Precision Health, Inc. This strategic move accompanied the establishment of two wholly-owned subsidiaries, Thrive Testing and Biosafety Inc. and Thrive Precision Health (USA), Inc., signaling a commitment to precision health and a broader global vision. Thrive Precision Health's expansion strategy takes center stage with a recent press release announcing a binding letter of intent to acquire two diabetes clinics in Arizona. The pending acquisition of True Diabetes Neuropathy and Wounds Solutions AZ, LLC, marks the initiation of their strategy to infuse advanced technology into diabetes care. The company is diligently developing a standardized clinical footprint designed for scalability across the nation and internationally. Each clinic is expected to offer a range of services, including wound care, IV therapies, neuropathy treatment, and complementary protocols. With up to 20 IV stations and five wound care treatment rooms per clinic, Thrive envisions generating $5–6 million in total revenues per location, aiming for an impressive 35% EBITDA within each clinic. Guy Zajonc, CEO and Chairman of Thrive Precision Health, is a prime example of the company's leadership, which places a strong emphasis on precision health and personalized medicine. The CEO of True Diabetes, Dr. Jason Mulder, draws attention to the urgent need in Arizona alone, where millions of people suffer from diabetes and there is a severe shortage of treatment resources. In the context of a burgeoning diabetes care market, Thrive Precision Health, Inc. (OTC: CNER) emerges as a compelling player with a vision to transform healthcare delivery. Their strategic acquisitions, commitment to precision health, and innovative approach position them as an intriguing opportunity within a sector poised for significant growth. As the demand for personalized diabetes care rises, CNER stands out as a potential cornerstone in this evolving narrative. Disclaimers: The Private Securities Litigation Reform Act of 1995 provides investors a safe harbor in regard to forward-looking statements. Any statements that express or involve discussions with respect to predictions, expectations, beliefs, plans, projections, assumptions, objectives, goals, or assumptions of future events or performance are not statements of historical fact may be forward looking statements. Forward looking statements are based on expectations, estimates, and projections at the time the statements are made that involve a number of risks and uncertainties which could cause actual results or events to differ materially from those presently anticipated. Forward looking statements in this action may be identified through use of words such as projects, foresee, expects, will, anticipates, estimates, believes, understands, or that by statements, indicating certain actions & quotes; may, could or might occur Understand there is no guarantee past performance is indicative of future results. Investing in micro-cap or growth securities is highly speculative and carries an extremely high degree of risk. It is possible that an investor's investment may be lost or due to the speculative nature of the companies profiled. Capital Gains Report (CGR) is responsible for the production and distribution of this content. CGR is not operated by a licensed broker, a dealer, or a registered investment advisor. It should be expressly understood that under no circumstances does any information published herein represent a recommendation to buy or sell a security. CGR has been retained by ACN LLC to produce and distribute this content related to CGER. As part of that content, readers, subscribers, and webs are expected to read the full disclaimers and financial disclosure statement that can be found on our website capitalgainsreport.com All content in this article is information of a general nature and does not address the circumstances of any particular individual or entity. Nothing in this article constitutes professional and/or financial advice, nor does any information in the article constitute a comprehensive or complete statement of the matters discussed or the law relating thereto. CGR is not a fiduciary by virtue of any persons use of or access to this content. Contact Details Capital Gains Report Mark McKelvie +1 585-301-7700 markrmckelvie@gmail.com Company Website http://CapitalGainsReport.com

November 16, 2023 10:00 AM Eastern Standard Time