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AGC Biologics Completes Copenhagen Campus Expansion, Doubling Single-use Mammalian Bioreactor Capacity at Site

AGC Biologics

AGC Biologics, a leading global Biopharmaceutical Contract Development and Manufacturing Organization (CDMO), today announced at BIO International the completion of its new manufacturing building at the AGC Biologics Copenhagen campus. The completed work doubles the site’s single-use bioreactor capacity for mammalian services and allows it to produce 150 more batches of drug product each year. The expansion adds 19,000 m2 of space in an ultramodern building that houses a large manufacturing floor, expanded quality control and process development lab space, utilities to support all operations and prevent outages caused by natural disasters, and a fully dedicated warehouse to serve the entire AGC Biologics Copenhagen campus. The new AGC Biologics Copenhagen manufacturing building is already in production with its first customer, a phase II/III clinical product. AGC Biologics announced the planned expansion in November 2020, investing roughly $200 million into the work. One-of-a-kind single-use manufacturing offering The new manufacturing area offers 8 x 2,000 L single-use bioreactors with two seed trains, as well as two independent downstream suites – [CW1] more than doubling the existing capacity offered at this site for mammalian-based projects. AGC Biologics Copenhagen is now one of the only sites in the world with multiple single-use bioreactor systems of this magnitude capable of producing batches at high-levels of clinical and commercial production. Further, for developers needing to transfer in an existing process, AGC Biologics Copenhagen’s multiple single-use suites give the site greater flexibility to take on technical transfers and perform like-for-like process and knowledge activities for products entering the facility, eliminating lag time associated with onboarding a new CDMO. AGC Biologics has been a leader in single-use technology over the last decade, and it is one of the largest CDMO networks in the industry offering flexible and scalable single-use bioreactors systems. The news comes after AGC Biologics announced an end-to-end protein biologics drug product partnership with Dutch-based BioConnection in late May. The alliance provides a secure and full-service “gene-to-vial” offering for biopharma developers with drug substance development, manufacturing and aseptic fill and finish capabilities for drug products. “AGC Biologics Copenhagen site continues to be one of the most active in our network with all the necessary commercial approvals – FDA, EMA, HCA, PMDA, ANVISA etc. – and we are more than happy to offer the capacity and capabilities our current and future customers will look for with this completed expansion,” said Christoph Winterhalter, CBO, AGC Biologics. “The expansion, combined with our new drug product alliance, demonstrates AGC Biologics’ agility to meet all the needs developers may have, from pre-clinical through commercial.” AGC Biologics’ Copenhagen site core teams of scientists have more than 25 years of expertise in biopharmaceutical development and manufacturing, including seven commercial products brought to market. The site offers pre-clinical through commercial production for protein biologics services using mammalian and microbial systems. It has a gold EcoVadis Sustainability Rating for its environmental, health and sustainability practices. “I am extremely proud of the work and collaboration of everyone at our site over the last several years, it is truly remarkable to see what we can accomplish by working together. We are eager to offer more of the important capabilities the industry is looking for to support patients in need,” said Andrea C. Porchia, General Manager, AGC Biologics Copenhagen. To learn more about AGC Biologics Copenhagen, visit www.agcbio.com/facilities/copenhagen. For more information about AGC Biologics’ global CDMO 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. We currently employ more than 2,500 Team Members 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 a part of AGC Inc.’s Life Science Company. The Life Science company runs more than 10 global facilities focused on biopharmaceuticals, advanced therapies, small molecule active pharmaceutical ingredients, and agrochemicals. To learn more, visit www.agcbio.com. Contact Details Nick McDonald +1 425-419-3555 nmcdonald@agcbio.com Company Website https://www.agcbio.com/

June 04, 2024 12:00 AM Pacific Daylight Time

Mphasis and Classiq Partner to Drive Quantum Innovation

Classiq Technologies

Mphasis, (BSE: 526299; NSE: MPHASIS), an Information Technology (IT) solutions provider specializing in cloud and cognitive services, today announced its strategic partnership with Classiq, a leading quantum software company to demonstrate and commercialize industry solutions powered by Quantum. The strategic partnership aims to accelerate the adoption of quantum solutions for enterprises by integrating them into its operations. The collaboration is committed to fostering innovation and redefining technological boundaries and paving the way for a quantum-powered future. Classiq leads in quantum computing software and has developed a platform for faster and more efficient quantum algorithm design. Mphasis will focus on building industry solutions in sectors such as BFSI, Lifesciences, Healthcare, Supply Chain & Logistics, Chemistry, utilizing these advanced algorithms. By leveraging Classiq’s quantum platform, Mphasis will develop industry-specific intellectual properties (IPs) and will also jointly market and implement customer IPs, execute customer projects, and provide support for the commercialization of Classiq’s platform and IPs. Additionally, Mphasis’ Quantum Initiative, launched in 2020 within the Applied R&D division, NEXT Labs, aims to facilitate our client's transition to the quantum era. The adoption model comprises awareness-building, assessment, and consulting workshops, as well as the development and implementation of quantum solutions in key domains such as optimization, artificial intelligence, simulation, and cybersecurity. Within the realm of quantum computing, the company’s priorities include applied research, the creation of industry-specific solutions and intellectual properties, thought leadership dissemination, building robust partnerships, and leveraging a design thinking approach to drive adoption. “We are thrilled to announce our collaboration with Classiq and leveraging their expertise to unlock the vast potential of quantum computing. This partnership enables us to combine our industry knowledge with cutting-edge quantum technology, to innovative solutions tailored to our clients' needs. Together we hope to lead the way in initiating and implementing state-of-the-art quantum solutions that redefine the boundaries of our field," said Srikumar Ramanathan, Chief Solutions Officer, Mphasis. "Classiq is proud to be partnering with Mphasis to support scalable enterprise quantum computing software development. Together we combine depth of industry domain knowledge and quantum expertise with the technology needed to implement sophisticated optimized quantum computing programs for our clients," said Nir Minerbi, CEO and Co-Founder, Classiq Technologies. By synergizing Mphasis' domain expertise with Classiq's quantum computing acumen, the collaboration is poised to unlock newer possibilities and redefine industry benchmarks. Quantum computing's ability to tackle previously unsolvable problems opens doors for entirely new discoveries and innovations. National Institute of Standards and Technology’s report states that quantum computing could lead to breakthroughs in areas like materials science, drug discovery, and financial modelling. McKinsey & Company estimates a $106B potential quantum technology market size by 2040. The alliance between Mphasis and Classiq represents a fusion of expertise and innovation, with Classiq's cutting-edge quantum development platform complemented by Mphasis' extensive industry knowledge. Together, the companies aim to pioneer groundbreaking quantum solutions that will reshape sectors primed for transformative change. Classiq’s platform enables both beginner and expert designers to rapidly generate, analyze, and execute quantum circuits. The collaboration reflects the shared dedication of Mphasis and Classiq, showcasing a commitment to pioneering quantum computing applications across diverse industry sectors. Apart from this, in June 2021, Mphasis along with the Government of Alberta, and the University of Calgary signed an MoU to announce the launch of the world-leading Quantum City - Canada. The strategic partnerships were to accelerate talent development and the development of a quantum computing ecosystem in Calgary, driving R&D in the technology sector. In June 2022, Mphasis deepened its commitment to Canada by announcing a delivery center in Calgary, opening the center in Alberta for business. The Mphasis business ecosystem was positioned to reinforce the region's reputation as a leading hub for digital transformation, AI, quantum computing, and more, and contribute to Canada's growing digital sector. About Mphasis Mphasis’ purpose is to be the “Driver in Driverless Car” for Global Enterprises by applying next-generation design, architecture, and engineering services, to deliver scalable and sustainable software and technology solutions. Customer centricity is foundational to Mphasis, and is reflected in the Mphasis’ Front2Back ™ Transformation approach. Front2Back™ uses the exponential power of cloud and cognitive to provide hyper-personalized (C= X2C2TM =1) digital experience to clients and their end customers. Mphasis’ Service Transformation approach helps ‘shrink the core’ through the application of digital technologies across legacy environments within an enterprise, enabling businesses to stay ahead in a changing world. Mphasis’ core reference architectures and tools, speed and innovation with domain expertise and specialization, combined with an integrated sustainability and purpose-led approach across its operations and solutions are key to building strong relationships with marquee clients. Click here to know more. ( BSE: 526299; NSE: MPHASIS ) About Classiq Classiq Technologies, the leading quantum software company, provides an all-encompassing software platform (IDE, compiler and OS) with a single point of entry into quantum computing, from algorithm design to execution. Tailored to all levels of developer proficiency, Classiq aims to democratize access to quantum computing with software that equips customers to take full advantage of the quantum computing revolution. A low-code development environment that automates quantum programming ensures that a broader range of talents, including those with backgrounds in AI, ML and linear algebra, can harness quantum computing without requiring deep, specialized knowledge of how to program quantum computer hardware. Classiq also works closely with advanced computation hardware providers providing software for use with quantum computers, HPC and quantum simulators. Backed by powerful investors such as HPE, HSBC, Samsung, Intesa Sanpaolo and NTT, Classiq’s world-class team of scientists and engineers has distilled decades of quantum expertise into its groundbreaking software development platform. Follow Classiq on LinkedIn, X (formerly Twitter) or YouTube, join the Slack community, or try the Classiq platform. Contact Details Rainier Communications Michelle Allard McMahon +1 781-718-3248 classiqPR@rainierco.com Mphasis Corporate Communications Deepa Nagaraj +1 646-424-5160 deepa.nagaraj@mphasis.com Mphasis Corporate Communications Sumana Bhat +91 99029 80980 sumana.bhat@mphasis.com Company Website http://www.classiq.io/

June 04, 2024 02:04 AM Eastern Daylight Time

Candel Therapeutics (NASDAQ: CADL) Reports Positive Data From Phase 2 Trial Of CAN-2409 In Borderline Resectable Pancreatic Cancer

Candel Therapeutics

By Jeremy Golden, Benzinga Clinical-stage biopharmaceutical company Candel Therapeutics, Inc. (NASDAQ: CADL) reported updated survival data from its randomized phase 2 clinical trial of CAN-2409 in borderline resectable pancreatic cancer. Pancreatic cancer is the fourth leading cause of cancer-related death in the U.S. The disease accounts for approximately 3% of all cancers, with an estimated 64,050 patients diagnosed in 2023. The randomized, controlled clinical trial is specifically looking into the safety and efficacy of CAN-2409 plus valacyclovir (prodrug), together with standard of care (SoC) chemoradiation, followed by resection – if possible – in borderline resectable pancreatic ductal adenocarcinoma (PDAC). Very encouraging results were recently reported by the Needham, Massachusetts-based company. Patients reached an estimated median overall survival of 28.8 months after experimental treatment with CAN-2409 versus only 12.5 months in the control group in PDAC. At 24 months, the survival rate was 71.4% in CAN-2409 treated patients compared to only 16.7% in the control group after chemoradiation. Thus, prolonged and sustained survival was observed after experimental treatment with CAN-2409 in patients with borderline resectable PDAC. Importantly, 4 out of 7 patients who received CAN-2409 were still alive at the time of data cut-off, with 2 patients surviving more than 50.0 months from enrollment. Only 1 out of 6 patients in the randomized control SoC chemotherapy group remained alive at the data cut-off (50.6 months). No new safety signals were observed, providing further support that multiple injections of CAN-2409 are generally well tolerated. Additionally, there were no dose-limiting toxicities or cases of pancreatitis reported. Previous analysis of resected tumors showed dense aggregates of immune cells – including CD8+, cytotoxic tumor-infiltrating lymphocytes and dendritic cells – in PDAC tissue after CAN-2409 administration. This reinforces the potential of CAN-2409 to activate a robust antitumoral immune response in patients with cancer also in ‘cold’, immunosuppressive tumors like PDAC. “Given the frequent recurrence and short survival with SoC chemotherapy for non-metastatic PDAC, effective new treatment options are urgently needed,” said Garrett Nichols, MD, MS, Chief Medical Officer of Candel. “We are very encouraged by the improved survival associated with CAN-2409, which has been shown to be durable after prolonged follow-up based on the updated data in this randomized clinical trial. CAN-2409 was generally well tolerated without significant additional local or systemic toxicity when added to SoC chemoradiation.” Candel’s most advanced viral immunotherapy candidate, CAN-2409, is an investigational off-the-shelf, replication-defective adenovirus designed to induce an individualized, systemic immune response against the tumor. Because of its versatility, CAN-2409 has the potential to treat a broad range of solid tumors. More than 1,000 patients have been dosed with CAN-2409 to date, with a favorable reported tolerability profile and proof of concept in each indication that the company is currently pursuing. CAN-2409 is injected directly into the tumor or target tissue using a localized injection method that is akin to the standard approach for in situ vaccination to elicit an immune response against the injected tumor and uninjected metastases. Long-term survival data in PDAC was recently updated with eight months of further follow-up since the first analysis was presented at the 2023 Society for Immunotherapy (SITC) Annual Meeting. Based on the data presented at SITC, the U.S. Food and Drug Administration (FDA) granted Fast Track Designation to Candel Therapeutics for CAN-2409 in combination with valacyclovir for the treatment of patients with PDAC in December 2023. More recently, the FDA also granted Orphan Drug Designation. “The failure of conventional immunotherapy to improve outcomes in pancreatic cancer is attributed to the highly immunosuppressive tumor microenvironment, which is largely devoid of immune cells,” said Paul Peter Tak, MD, PhD, FMedSci, President and Chief Executive Officer of Candel. “The immunological changes induced by CAN-2409, evident in the pancreatic tissue and the peripheral blood after administration, suggest that CAN-2409 is able to change the balance between the tumor and the patient’s anti-tumor immune response, which can convert progressive cancer into a chronic disease associated with improved survival.” Featured photo by National Cancer Institute on Unsplash. Candel is a clinical stage biopharmaceutical company focused on developing off-the-shelf multimodal biological immunotherapies that elicit an individualized, systemic anti-tumor immune response to help patients fight cancer. Candel has established two clinical stage multimodal biological immunotherapy platforms based on novel, genetically modified adenovirus and herpes simplex virus (HSV) gene constructs, respectively. CAN-2409 is the lead product candidate from the adenovirus platform and is currently in ongoing clinical trials in non-small cell lung cancer (NSCLC) (phase 2), borderline resectable pancreatic cancer (phase 2), and localized, non-metastatic prostate cancer (phase 2 and phase 3). CAN-3110 is the lead product candidate from the HSV platform and is currently in an ongoing investigator-sponsored phase 1 clinical trial in recurrent high-grade glioma (HGG). Finally, Candel’s enLIGHTEN™ Discovery Platform is a systematic, iterative HSV-based discovery platform leveraging human biology and advanced analytics to create new viral immunotherapies for solid tumors. This article includes certain disclosures that contain “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995, as amended, including, without limitation, express or implied statements regarding the timing and advancement of development programs, including the timing and availability of additional data, key data readout milestones, including CAN-3110 in HGG; expectations regarding the potential benefits conferred by Fast Track Designation; expectations regarding the therapeutic benefit of its programs, including the potential for its programs to extend patient survival; and expectations regarding cash runway and expenditures. The words “may,” “will,” “could,” “would,” “should,” “expect,” “plan,” “anticipate,” “intend,” “believe,” “estimate,” “predict,” “project,” “potential,” “continue,” “target” and similar expressions are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words. Any forward-looking statements in this press release are based on management’s current expectations and beliefs and are subject to a number of risks, uncertainties and important factors that may cause actual events or results to differ materially from those expressed or implied by any forward-looking statements contained in this press release, including, without limitation, those risks and uncertainties related to the timing and advancement of development programs; expectations regarding the therapeutic benefit of the Company’s programs; that final data from our pre-clinical studies and completed clinical trials may differ materially from reported interim data from ongoing studies and trials; the Company’s ability to efficiently discover and develop product candidates; the Company’s ability to obtain and maintain regulatory approval of product candidates; the Company’s ability to maintain its intellectual property; the implementation of the Company’s business model, and strategic plans for the Company’s business and product candidates, and other risks identified in the Company’s SEC filings, including the Company’s most recent Quarterly Report on Form 10-Q filed with the SEC, and subsequent filings with the SEC. The Company cautions you not to place undue reliance on any forward-looking statements, which speak only as of the date they are made. The Company disclaims any obligation to publicly update or revise any such statements to reflect any change in expectations or in events, conditions or circumstances on which any such statements may be based, or that may affect the likelihood that actual results will differ from those set forth in the forward-looking statements. Any forward-looking statements contained in this press release represent the Company’s views only as of the date hereof and should not be relied upon as representing its views as of any subsequent date. This post contains sponsored content. This content is for informational purposes only and is not intended to be investing advice. Contact Details Aljanae Reynolds +1 617-916-5445 areynolds@wheelhouselsa.com Company Website https://www.candeltx.com/

June 03, 2024 08:30 AM Eastern Daylight Time

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News Release

Sector Spotlight: Orphan Drug Developers With Significant Upside

RazorPitch CRDL, KNSA

The biotech sector is finally beginning to recover following a two year stretch of underperformance that was largely driven by rising interest rates and other macro factors. Biotech has a track record of strong recoveries, with the sector typically seeing double-digit gains after a downturn. This is something investors shouldn’t ignore. This recent turnaround can be credited to a robust increase in fundraising efforts and an uptick in IPOs, reaching levels not seen since the peak of the mid-pandemic market boom. According to the Financial Times, drug developers raised $6 billion in equity capital markets in January, the largest total since February 2021 – a period when biotech stocks hit their all-time high. Moreover, the SPDR S&P Biotech ETF (XBI) returned 28.7% over the past six months alone, clearly illustrating investors' rising confidence in the biotech rebound. Identifying biotech stocks with the potential to deliver superior returns is no easy feat. There are specific milestones that companies can achieve to signal positive momentum to investors. For example, smaller biotech companies may have received the nod from regulatory authorities such as the FDA, or new breakthroughs from clinical trials, to offer a compelling investment opportunity. With that in mind, two stocks that investors should consider looking at are Cardiol Therapeutics (NASDAQ:CRDL) (TSX:CRDL) and Kiniksa Pharmaceuticals (NASDAQ:KNSA). Cardiol Therapeutics lead product is CardiolRx™, a small molecule therapy that appears on track to bring major disruption to the pericarditis market. CardiolRx™ received a vote of confidence as it was granted Orphan Drug Designation (ODD) by the FDA for the treatment of pericarditis back in February, illustrating the potential of the drug. Apart from providing a seven-year term of market exclusivity upon final FDA approval, the ODD also positions Cardiol Therapeutics (NASDAQ:CRDL) (TSX:CRDL) to be able to leverage a wide range of financial and regulatory benefits, including government grants for conducting clinical trials, waiver of expensive FDA user fees, and certain tax credits. The U.S. Orphan Drug Act is intended to assist and encourage companies to develop safe and effective therapies for the treatment of rare diseases and disorders, defined as one that affects fewer than 200,000 people in the U.S. There are approximately 160,000 cases of recurrent pericarditis in the U.S. annually, which includes 38,000 cases with a recurrence. Having secured FDA approval, Cardiol Therapeutics is an exemplary company likely to attract biotech investors seeking assurance in smaller firms. While the stock had a significant rally on the backdrop of this news and continues to show strength, we believe that there is still potential for further upside. Cardiol Therapeutics (NASDAQ:CRDL) (TSX:CRDL) is expected to release topline data in June for its Phase 2 MAvERIC-Pilot clinical trial, which if positive, could unlock significant shareholder value. Several analysts have already indicated that they are highly optimistic that the data could be a catalyst, with one analyst noting that “CardiolRx’s potential to be a safe, new approach to RP (recurrent pericarditis) treatment is underappreciated.” CardiolRx™ stands out when compared to the only FDA-approved therapy because it is administered orally and expected to be offered as a first-line therapy for pericarditis, opening it up to an even bigger opportunity as it could be prescribed at the first occurrence. Orphan drugs have become lucrative business opportunities because these drugs command premium drug pricing, with the average price for an orphan drug at $32,000 per year per patient according to a 2021 study published in the journal Rare Diseases & Journal of Orphan Drugs. That could explain why analysts who have been tracking CRDL are so bullish on the stock. For instance, Joe Gantoss of Chimera Research Group says he won’t be surprised to see Cardiol’s price break past the 3-year high at $4.96, while analyst Vernon Bernardino of H.C. Wainwright & Co. reiterated their Buy rating and issued a $9.00 price target. That would imply that Cardiol Therapeutics (NASDAQ:CRDL) (TSX:CRDL) has a potential upside of about 300% from its current share price. Kiniksa Pharmaceuticals (NASDAQ:KNSA) offers some insight into the revenue potential of an orphan drug that treats recurrent pericarditis. So far, KNSA has had a great run, gaining about 36% over the past year and trading at about $18.00 per share despite challenges in the sector. It is currently valued at $1.3 billion. Kiniksa’s portfolio of assets includes ARCALYST®, the first and only FDA-approved therapy for recurrent pericarditis. For some context, the FDA granted Breakthrough Therapy designation to ARCALYST® for recurrent pericarditis in 2019; the FDA granted Orphan Drug exclusivity to ARCALYST® in March 2021 for the treatment of recurrent pericarditis and a reduction in the risk of recurrence in adults and pediatric patients 12 years of age and older. The European Commission granted Orphan Drug Designation to ARCALYST for the treatment of idiopathic pericarditis in 2021. Sales of ARCALYST® were $38.5 million in 2021; $122.5 million in 2022; $233.2 million in 2023 further reaffirming the massive revenue potential for treating recurrent pericarditis. For the first quarter of 2024, ARCALYST® sales were $78.9 million representing 85% year-over-year growth. Furthermore, since its launch in April 2021, approximately 2,000 prescribers have written ARCALYST® prescriptions for recurrent pericarditis, illustrating the massive demand for effective recurrent pericarditis therapies. Going forward, Kiniksa anticipates that it will bring in between $370 million and $390 million in 2024, up from the earlier guidance of $360 million to $380 million. The revised outlook represents roughly 63% year-over-year growth at the midpoint. Disclaimers: RazorPitch Inc. "RazorPitch" is not operated by a licensed broker, a dealer, or a registered investment adviser. This content is for informational purposes only and is not intended to be investment advice. 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, objectives, goals, assumptions, or 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 & quote; may, could, or might occur. Understand there is no guarantee past performance will be indicative of future results. Investing in micro-cap and growth securities is highly speculative and carries an extremely high degree of risk. It is possible that an investors investment may be lost or impaired due to the speculative nature of the companies profiled. RazorPitch has been retained and compensated by Cardiol Therapeutics to assist in the production and distribution of content related to CRDL. RazorPitch is responsible for the production and distribution of this content. It should be expressly understood that under no circumstances does any information published herein represent a recommendation to buy or sell a security. This content is for informational purposes only, you should not construe any such information or other material as legal, tax, investment, financial, or other advice. Nothing contained in this article constitutes a solicitation, recommendation, endorsement, or offer by RazorPitch or any third party service provider to buy or sell any securities or other financial instruments. 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. RazorPitch is not a fiduciary by virtue of any persons use of or access to this content. Contact Details RazorPitch Inc Mark McKelvie +1 585-301-7700 Mark@razorpitch.com Company Website http://razorpitch.com

June 03, 2024 07:00 AM Eastern Daylight Time

From Pets To Humans, Telomir Pharmaceuticals (NASDAQ: TELO) Holds The Key To Extending Life, Reversing Aging

Benzinga

By Meg Flippin, Benzinga Whoever said you can’t turn back time hasn’t heard of telomere gene therapy. A potentially game-changing field in anti-aging treatment, telomere regeneration involves repairing telomeres or the DNA structures that protect the ends of our chromosomes, similar to caps or shoelaces. Numerous studies have shown that fixing them can extend a person’s biological age and even turn back the clock on certain diseases. As we age, our telomeres become shorter, making us more susceptible to age-related diseases such as osteoporosis, arthritis, heart disease, dementia, Alzheimer's and Parkinson's. Telomeres also affect our appearance. Typically, the longer the telomeres, the younger you look. Reversing Aging One Telomere At A Time Repairing Telomeres could prove to be the holy grail of anti-aging treatments, which is why it's a big opportunity. After all, if you could reverse age-related diseases, the benefits could be endless. That’s what Telomir Pharmaceuticals Inc. (NASDAQ: TELO) is hoping proves true with Telomir-1, its potential treatment for age-related conditions. The company says Telomir-1 is the first novel small molecule to lengthen the DNA’s protective telomere caps in order to potentially reverse age-related conditions. The novel molecule – which Telomir is currently testing in mice and dogs, with human clinical trials to come later – binds to critical metals that wear down telomeres. By limiting the availability of metals and interrupting the enzyme function, Telomir-1 seeks to restore cellular metal homeostasis and reverse a person’s biological age. The non-toxic oral therapy provides what the company says is a safe and effective alternative to existing treatments with minimal side effects. Total Addressable Market and investment Opportunity That alone is a big market opportunity for Telomir Pharmaceuticals. The longevity and anti-senescence therapy market is valued at $27.11 billion and is projected to reach $44.92 billion by 2031, growing at a CAGR of 6.8% over 2024-2031. Then there’s Alzheimer's, where telomere length has also received attention as a biomarker. Nearly seven million Americans suffer from this disease that attacks memory and cognitive functions. By 2050, that’s forecast to reach close to 13 million. And let's not forget cancer, another area Telomir-1 could prove effective in fighting. The global oncology market size is projected to reach $521.60 billion by 2033, growing at a CAGR of 8.9% from now until then. Positive Preclinical Studies & Effectiveness So far, Telomir is making progress in proving its effectiveness, with early preclinical studies and collaborations with InSilicoTrials indicating Telomir-1's potential efficacy in telomere elongation and age reversal. Positive outcomes in its animal studies include improvements in mobility and cognitive functions, which sets the stage for the company to achieve what it says are significant milestones. Telomir also points to the results of rat and dog studies to be released later this year, which are expected to show Telomir-1’s efficacy and safety profile. That may boost investor confidence as it gets one step closer to human trials. In March, the company presented a scientific poster at the National University Health System of Singapore (NUHS) Centre for Healthy Longevity Conference 2024 with data showing Telomir-1 lengthed three human cell lines: MRC-5 fetal lung fibroblasts, human umbilical endothelial cells and mesenchymal stem cells. A subsequent poster presentation at the Global Longevity Federation Conference in Las Vegas further demonstrated that total telomere length was augmented following various Telomir-1 treatments. “While more research is needed, these preliminary findings open up the possibility that many diseases long considered inevitable consequences of aging could become avoidable,” said Dr. Michael Roizen, special advisor to Telomir. “This study further demonstrates our belief that Telomir-1 may have the effect of reversing age through telomere regeneration, enabling the production of more stem cells, essentially allowing an individual to repair oneself.” Canine Opportunity Too Telomir is focused on bringing its novel telomere therapy to humans, but it is also going after the canine market, aiming to reverse the aging of America’s best friend. Positive preclinical trials have shown that Telomir-1 may have many applications in the veterinary market. That, too, is a big opportunity for Telomir, given that Americans are poised to spend $156 billion on their pets by the end of this year – with dogs being the most popular pets. The world is getting older, but not necessarily healthier. With age-related diseases exploding, finding ways to reverse the impact of time on our bodies is reaching a fever pitch. Telomir may hold the key to anti-aging with Telomir-1. “It will be a powerful, revolutionary change. Every country in the world would want to use this product,” said Telomir CEO Chris Chapman, if it works on humans. “If we can stop the aging process we can stop age-related diseases.” Featured photo by digitale.de on Unsplash. Benzinga is a leading financial media and data provider, known for delivering accurate, timely, and actionable financial information to empower investors and traders. This post contains sponsored content. This content is for informational purposes only and is not intended to be investing advice. Contact Details Benzinga +1 877-440-9464 info@benzinga.com Company Website http://www.benzinga.com

May 31, 2024 09:30 AM Eastern Daylight Time

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CURE ALZHEIMER’S FUND PRESENTS THE JEFFREY L. MORBY PRIZE FOR EXCEPTIONAL RESEARCH

Alzheimer’s Disease Research Foundation

Cure Alzheimer’s Fund, a nonprofit dedicated to funding the most promising research to prevent, slow or reverse Alzheimer’s disease, has announced the recipients of the inaugural Jeffrey L. Morby Prize. Senior author David M. Holtzman, M.D., and first author Xiaoying Chen, Ph.D., both of Washington University School of Medicine in St. Louis, were selected by their peers for their paper “Microglia-Mediated T Cell Infiltration Drives Neurodegeneration in Tauopathy,” published in Nature in March 2023. The Morby Prize is named in honor of the late Co-Founder of Cure Alzheimer’s Fund, Jeffrey L. Morby, who inspired the nonprofit’s mission 20 years ago to fund research as a path to ending Alzheimer’s disease. Mr. Morby passed away in September 2023. Established this year, the Morby prize will be awarded annually to the senior and first authors of a recent scientific publication that transforms the fundamental understanding of Alzheimer’s disease and opens new paths to translate scientific results into effective ways to prevent, diagnose or treat the disease. This year’s award included $200,000 for the senior author’s lab for Alzheimer’s disease-related research. “Recognizing researchers for a paper selected by peer scientists for breakthrough thinking and benefit to the Alzheimer’s community befits Jeff’s wonderful legacy of empowering scientists to achieve rigorous and innovative science,” said Meg Smith, CEO of Cure Alzheimer’s Fund. “The many extraordinary CureAlz-funded projects that resulted in published papers in 2022 and 2023 made the competition for this award fierce, and the endorsement of this paper by their peers speaks to the importance of the work of Drs. Holtzman and Chen and their co-authors. Their compelling data challenge the old paradigm that the adaptive immune system has little role in neurodegenerative disease, and by doing so opens new avenues to explore for effective intervention in Alzheimer’s disease.” Added Dr. Holtzman: ”Both Xiaoying Chen and I and our many outstanding co-authors are very honored to receive recognition for the work in our recently published paper. There remain many unanswered questions about the exact role of the adaptive immune response in the pathogenesis of Alzheimer’s disease. I think this work along with work from others in the field is pushing us to understand how important adaptive immunity is in Alzheimer’s disease and other tauopathies, as well as whether targeting it will ultimately be therapeutically beneficial to people.” About The Holtzman Lab David M. Holtzman, Ph.D. is a neurologist and neuroscientist who has focused much of his efforts over the past 30 years on trying to better understand mechanisms underlying neurodegeneration, particularly as they are relevant to Alzheimer’s disease (AD). Xiaoying Chen, Ph.D., was a postdoc research associate in the Holtzman Lab and is first author of the winning paper. The Holtzman Lab at Washington University School of Medicine in St. Louis has published extensively on the neurobiology of apoE as it relates to the innate immune system and how apoE and other factors such as neuronal activity and sleep influence Aβ and tau metabolism, their accumulation, and their effects in the brain. For more information, visit HoltzmanLab.Wustl.edu. About Cure Alzheimer's Fund Cure Alzheimer’s Fund is a nonprofit dedicated to funding the most promising research to prevent, slow or reverse Alzheimer’s disease. Since its founding in 2004, Cure Alzheimer’s Fund has provided 848 grants to more than 300 of the world’s leading researchers and contributed $202 million to research. Its funded initiatives have been responsible for many key breakthroughs in understanding the causes and pathology of Alzheimer’s disease. Cure Alzheimer’s Fund has received a 4-star rating for more than 12 consecutive years from Charity Navigator. Our Board of Directors, Trustees and a core group of other donors direct their donations to CureAlz overhead expenses so that 100% of general donations go to our research program. For more information, visit CureAlz.org. To learn about the impact of Alzheimer’s on women and women working toward a cure, visit WomenandAlzheimers.org. Contact Details Barbara Chambers +1 978-417-9890 BChambers@CureAlz.org Company Website https://curealz.org

May 30, 2024 06:00 AM Eastern Daylight Time

Nevis Brands Expands Major Brand with Launch of Gummies in Washington State

Nevis Brands

Nevis Brands CEO John Kueber joined Steve Darling from Proactive to announce the exciting expansion of the Major brand from beverages to gummies. Major Gummies will be offered in 100mg packages, containing ten 10mg gummies per package. Notably, these gummies are the only ones in the Washington market to utilize SoRSE emulsion, the same innovative ingredient used in Major beverages, which allows for improved taste and rapid onset. The flavors of Major Gummies will be consistent with the beverage line and will initially be available in Orange Mango and Blue Raspberry. Kueber explained that Nevis' licensee for Major in Washington State has completed its initial round of production, with initial sales set to begin in the first week of June. This timely launch positions Major Gummies to make a significant impact on Q3 financial results. According to the Imarc Group, a research firm, the cannabis edibles market is estimated to be approximately $3.4 billion, indicating substantial market potential for Major Gummies. The introduction of gummies represents a strategic expansion for the Major brand, leveraging the success and consumer trust built through its beverage line. The use of SoRSE emulsion ensures that the gummies will deliver a consistent, high-quality experience with a rapid onset, a key differentiator in the competitive cannabis edibles market. Kueber emphasized that the new product aligns with Nevis Brands' commitment to innovation and quality. By maintaining the flavor profiles and effective delivery system that customers expect from Major beverages, the company aims to capture a significant share of the growing edibles market. The initial focus on Orange Mango and Blue Raspberry flavors highlights the brand's strategy to offer familiar and popular tastes to its consumers. Looking ahead, Nevis Brands plans to expand the distribution of Major Gummies beyond Washington State, exploring opportunities in other markets to further enhance its footprint in the cannabis industry. The successful launch and anticipated positive reception of Major Gummies could pave the way for additional product lines and continued growth. Contact Details Proactive North America +1 604-688-8158 NA-editorial@proactiveinvestors.com

May 29, 2024 12:25 PM Eastern Daylight Time

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PathAI Expands Portfolio of AI-Powered Products, Announcing PathExplore™ IOP and IHC Explore™ Ahead of ASCO 2024

PathAI

PathAI, a global leader in AI-powered pathology, unveiled two novel AI products, PathExplore™ Immuno-Oncology Profiling (IOP) and IHC Explore 1 ™ to empower cancer drug developers and clinical researchers with AI-powered insights. The product pairing provides unprecedented single-cell and spatial resolution of the tumor microenvironment from routine pathology samples to facilitate biomarker discovery and deeper understanding of treatment response for the next generation of cancer therapeutics. The expansion of the Explore™ portfolio comes at a time when AI-pathology is experiencing accelerated large-scale adoption across the diagnostic and biopharma industries. “As cancer rates continue to rise, the demand for advanced precision medicine tools that provide accurate biological insights has never been greater. Our mission to make a difference in patient lives is unwavering, and these new products showcase our commitment to providing researchers with the tools they need to make meaningful advancements in cancer research, treatment and care,” said Andy Beck, PathAI CEO. “We're thrilled to introduce these two groundbreaking products ahead of the American Society of Clinical Oncology annual meeting.” PathExplore IOP: H&E-Based Immune Phenotyping The composition of the tumor immune microenvironment plays a crucial role in characterizing tumors likely to respond to immunotherapy. PathExplore IOP expedites characterization of immune phenotypes by quantifying tumor infiltrating lymphocytes (TILs) and their spatial distribution using routine hematoxylin and eosin (H&E) samples. With this new product, researchers have the ability to quantify TIL spatial arrangements within tumor core and periphery, and gain insights around the sample’s immune inflamed, desert, or excluded characteristics. PathExplore IOP was designed specifically to quantify patterns of immune infiltration characteristic of a strong immune response, and ultimately improved patient survival. Immune infiltration has been previously shown to be prognostic of positive outcomes, however; standardized and scalable approaches for investigating these phenotypes remained elusive. “PathExplore IOP illustrates the power of AI by visually interrogating the dynamics between cancer cells and immune cells with unparalleled resolution for highly accurate and efficient immune phenotype classification,” said Benjamin Glass, VP of Product & Translational Research. “Researchers can now access insights at scale to better inform biomarker strategies for patient stratification and mechanisms of response and resistance.” PathExplore IOP will be featured in a poster presentation at the upcoming ASCO 2024 meeting, demonstrating the product’s application for stratification of patient response to checkpoint inhibitors in non-small cell lung cancer. IHC Explore™: AI-Powered Biomarker Quantification Immunohistochemistry (IHC) is a widely utilized approach for identifying biomarkers unique to certain cancers, informing treatment strategies, measuring prognosis, and patient classification for clinical trials. IHC scoring in the early clinical settings can be time-consuming, subjective, and low-resolution. Especially in early stage biomarker development, defining an optimal scoring system for a novel IHC assay can be complex. IHC Explore™ fills a need for spatial quantification of IHC biomarkers in single-cell resolution with broad target compatibility. IHC Explore provides a panel of standardized and structured features that quantify IHC stain abundance within and around cells of the tumor microenvironment, enabling drug developers to build biomarker scoring strategies from scratch for most IHC stains – and to precisely find those patients most responsive to treatment. PathAI’s partnership with Roche streamlines the translation of these AI insights and scoring strategies into companion diagnostic development. “Drawing on our advanced computational pathology expertise, we're extending the impact of our Explore product suite, which enables us to seamlessly support AI-powered assay development,” said Hisani Madison, VP of Precision Medicine and Medical Device Development. “This advancement is poised to revolutionize biomarker-based drug development for new immunotherapies, antibody drug conjugates, and paving the way for the analysis of the next generation of targeted cancer therapies.” Accepted Abstracts at ASCO 2024 PathAI will be attending and presenting abstracts at the upcoming ASCO event in Chicago, IL. Visit PathAI’s booth in the Innovation Hub (IH18) May 31- June 4, 2024 to meet our team, learn more about AI-powered pathology, and engage with our scientists and collaborators at their respective posters. Footnotes 1 PathExplore™ IOP and IHC Explore™ are for research use only. Not for use in diagnostic procedures. About PathAI PathAI is the leading precision pathology company providing software and AI-enabled solutions to all pathologist stakeholders including laboratories, research institutions, and the biopharma industry. Developed with the input of hundreds of pathologists, PathAI’s digital pathology Image Management System, AISight, is the solution of choice for laboratories transitioning to digital workflows. 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. 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/

May 29, 2024 10:00 AM Eastern Daylight Time

Oncotelic Therapeutics (OTC: OTLC) Inks Deal With Mosaic ImmunoEngineering To Sell Clinical-Stage Necroptosis Cancer Therapy Assets

Benzinga

By Faith Ashmore, Benzinga The global retinoblastoma treatment market size was estimated to be $2.62 billion in 2023 and is expected to reach $4.20 billion by 2034 with a CAGR of 4.38% over 2024-2034. Rising incidence of retinoblastoma, early diagnosis and treatment, increasing healthcare expenditure, growing awareness of retinoblastoma treatment options, development of new treatments and government initiatives will drive the market’s growth. Recently, the FDA granted accelerated approval to Iovance Biotherapeutics’ (NASDAQ: IOVA) lifileucel (Amtagvi) to treat inoperable or metastatic melanoma, making it the first and only one-time tumor-infiltrating lymphocyte (TIL) therapy to be greenlighted for solid tumors. Lifileucel is manufactured by collecting and expanding a patient’s unique T cells from part of their tumor and then infusing them into that patient to fight the cancer. Oncotelic Therapeutics (OTCQB: OTLC) is looking to develop similar treatment therapies for ocular cancers, including retinoblastoma and uveal melanoma. The technology is named necroptosis therapies. Oncotelic and Mosaic ImmunoEngineering, Inc. (OTC: CPMV) are developers of necroptosis therapies. The recent approval of TIL cell therapy demonstrates how to manipulate patient immunity against cancer for a lasting cure. However, TIL cell therapy is costly, time-consuming and technologically challenging. Instead of driving TIL cells externally, Necroptosis Cancer Therapies drive innate TILs to the tumor. The key step is the induction of necrotic cell death and activation of death genes, exposing tumor-reactive antigens to initiate an immune response, activating antigen-presenting cells to achieve large-scale antigen presentation, activating T-cells, inducing strong and sustained cytotoxic T lymphocyte responses, and ultimately triggering a TIL antitumor immune effect. Necroptosis Cancer Therapies can use vascular disrupting agents (“VDA”), in combination with CheckPoint Inhibitors and other IO agents to drive TIL cells to the tumor. Oncotelic Therapeutics recently announced a binding term-sheet agreement with Mosaic ImmunoEngineering. Under this arrangement, Mosaic will acquire the rights to Oncotelic's clinical-stage necroptosis cancer therapies. These innovative therapeutics disrupt tumor blood flow, leading to immunogenic tumor cell death through the activation of "death receptors" – ultimately triggering a potent anti-cancer immune response. As part of the deal, Mosaic will also gain access to Oncotelic's AI technologies for identifying immunotherapy combinations. "We are very pleased to have this opportunity to bring these clinical stage assets that have promise for the treatment of multiple types of cancer into Mosaic. We anticipate that the initial application of the technology will be in areas with high unmet medical need such as uveal melanoma and retinoblastoma. We look forward to working with the Oncotelic team to advance the program," said Steven King, President and CEO of Mosaic. As outlined in the binding term sheet, Mosaic will issue $15 million in CPMV shares to Oncotelic upon the execution of the definitive purchase agreement. Additional milestones will enable Oncotelic to earn up to an extra $15 million in CPMV shares. The experienced Mosaic team, with a collective background encompassing more than 30 FDA and worldwide product approvals, will spearhead the advancement of these technologies. Both companies will collaborate closely to ensure the smooth transfer of technologies from Oncotelic to Mosaic, with Oncotelic providing short-term financial support for the program while working together toward achieving short-term and long-term financing goals. "This will be the second transaction for capitalizing on our assets and building shareholder value. The first being the successful transition of OT-101 to our joint venture (“JV”) with Dragon Capital Overseas, Limited. The JV is expected to list for an IPO and has been expanding its R&D including the completion of its research and manufacturing facility headquartered in San Diego, California." shared Dr. Vuong Trieu, CEO of Oncotelic. Pipeline – What More To Expect From Oncotelic Oncotelic has multiple drugs in its pipeline, such as ArtiVeda/ArtiShield, a COVID drug that aims to inhibit the spread of the virus; OT-101 for the treatment of solid tumors with a focus on brain cancer in adults and diffuse intrinsic pontine glioma in children; CA4P, which is intended to be used with Ipilimumab for the treatment of solid tumors with focus on melanoma; Oxi4503 for the treatment of liquid tumors with focus on childhood leukemia; and AL-101, an intranasal drug for the treatment of Parkinson Disease that also targets Erectile Dysfunction and Female Sexual Dysfunction. Oncotelic is looking to develop these drugs using a similar JV structure, which should enhance shareholder values. With an encouraging recent announcement and an extensive pipeline, Oncotelic may be a company to watch as it continues its endeavors to provide patients with more efficient treatments – with fewer side effects. Featured photo by Olga Kononenko on Unsplash. Benzinga is a leading financial media and data provider, known for delivering accurate, timely, and actionable financial information to empower investors and traders. This post contains sponsored content. This content is for informational purposes only and is not intended to be investing advice. Contact Details Benzinga +1 877-440-9464 info@benzinga.com Company Website http://www.benzinga.com

May 29, 2024 08:30 AM Eastern Daylight Time

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