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DREW BREES AND COPPER COMPRESSION TOUCHDOWN AT WALGREENS, REVOLUTIONIZING RECOVERY FROM ONLINE INTO AISLE

Copper Compression, LLC

In an exciting play for the recovery game, Copper Compression, the leading online health and wellness compression wear brand endorsed by football legend Drew Brees, announces today its expansion into over 1500 select Walgreens stores nationwide. This strategic partnership not only enhances Copper Compression’s accessibility, but also delivers new winning solutions for Walgreens’ health conscious consumers seeking premium wellness products not typically found at retail locations. “Partnering with one of the largest chain drug stores marks a significant milestone for Copper Compression and underscores the evolution of our brand,” says Super Bowl Champion, Drew Brees. “I’ve personally experienced faster recovery while using Copper Compression. Having these products available at Walgreens will be life-changing for people dealing with pain and in need of effective all-natural relief.” Walgreens will now carry a selection of six Copper Compression products featuring Brees including, the Recovery Shoulder Brace (an Amazon Best Seller), Calf Sleeves, a universal Finger Splint which features medical grade aluminum and the introduction of Coppervibe™, the latest innovation in wearable tech that combines Vibration and Heat for hands, back and knee relief. Copper Compression continues to garner recognition by millions of online fans for its lab-tested nylon compression all which is infused with the maximum copper advantage. Its full collection of products are also FDA approved and certified antimicrobial by the EPA; these standards lead to explosive growth, rave reviews and a loyal customer base which include celebrities Anna Wintour, DJ Khaled, Kid Rock and Kaley Cuoco. “The trend from online to inline continues to reflect a dynamic transformation in the retail landscape," adds Vincent Porpiglia, President of Hero Brands, “Fan favorite digital brands continue to emerge and prove themselves alongside legacy brands at brick-and-mortar. Copper Compression stands at the forefront of this movement, delivering its premium recovery solutions to your neighborhood Walgreens” About Copper Compression New York City-based Copper Compression is a health and wellness brand that designs, manufactures, and distributes the most diverse portfolio of cutting-edge copper-infused compression wearables tailored for pain relief and performance recovery. The company’s 100 unisex products include groundbreaking solutions for arthritis, tendonitis, and plantar fasciitis. Established in 2015, Copper Compression has served over 10 million satisfied customers and has been featured in Forbes, ESPN, Women’s World, US Weekly, and Sports Illustrated for its renowned commitment to effective, all-natural pain relief. Having amassed over 300,000+ authentic customer reviews from their online-first business model, Copper Compression swiftly expanded its success to over 10,000 national retail locations in less than 3 years, partnering with industry giants like Walmart, Walgreens, Publix, Ingles, and Harris Teeter. Copper Compression earned seven best seller badges on Amazon.com for its top-rated Half-Finger Arthritis Gloves and Arch Supports. Follow @CopperCompression on Instagram, TikTok and Facebook. Note to Editors: Photos available Here. Press Contacts: Nathan Lindsey NLindsey@adjmi.com 203.376.8154 Sarah Leheny SLeheny@adjmi.com 631.834.2815 Contact Details Copper Compression Joey Braha JBraha@adjmi.com Copper Compression Nathan Lindsey +1 203-376-8154 nlindsey@adjmi.com Copper Compression Sarah Leheny +1 631-834-2815 Company Website https://www.coppercompression.com/

March 19, 2024 08:30 AM Eastern Daylight Time

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Monogram Orthopaedics (NASDAQ: MGRM) Aims To Overcome Robot Shortcomings With Its Advanced Solution

Benzinga

By Meg Flippin, Benzinga When it comes to robots in the operating room, they are falling short. Robots should save hospitals time and money and give patients better outcomes, but those benefits have yet to be seen. As it stands, the current robots decrease surgical throughput, add costs, and cannot achieve parity with manual procedures. Take total knee replacement surgeries as one example. The average time for a manual total knee arthroplasty (TKA) is 88.7 minutes. With a robot, it is 105.5 minutes. What’s more, robotic-assisted TKA is 10% more expensive than manual TKA. The robotic systems currently on the market also have a steep learning curve. Nevertheless, the demand for robots in the operating room is growing as more hospitals and surgeons adopt this approach to treatment and care. That’s particularly true in orthopedics, with some estimates predicting that 50% of all knee procedures will be robotic by 2027, up from 12% today. With almost 88% of knee surgeries still performed manually today, the long-term growth trajectory for robotics in orthopedic medicine could be impressive. It’s also growing from a large base. The addressable market for companies that can change the current economics of robotic surgery is significant. According to Fortune Business Insights, the orthopedic device market alone is forecast to grow by a CAGR of 4.5% through 2030, reaching $80.28 billion. Driving the growth is a rising prevalence of osteoporosis and musculoskeletal diseases, an aging population, and an increase in sports-related injuries. Mako Seems To Have A Lock On The Market … For Now Currently, the dominant player in robotic knee replacements is Mako, the unit of Stryker Corp. (NYSE: SYK) that makes robotic arm-assisted surgical equipment. It accounts for over 50% of Stryker’s surgical knee volume and 70% of the press-fit (also cementless) knees. Mako is unique in that it combines patient-specific CT-based planning with robot enabled saw cutting. This combination of personalized planning and efficient bone cutting has driven Mako’s popularity with doctors. But Mako has opportunities for improvement. The arm has only four joints, which appears to limit the workspace and potentially the ease of use for future applications. While Mako’s haptic constraints enhance safety over manual cutting, the virtual boundaries still require care and caution. Mako’s navigation also requires arrays rigidly fixed to bone with pins and manual point sampling. Navigation pins have been shown to introduce a risk of fracture and infection in some instances. New Player On The Scene Aiming For Dominance Monogram Orthopaedics Inc. (NASDAQ: MGRM) is taking a page from Mako, aiming to revolutionize orthopedic joint replacement surgery with its mBôs robotic technology that will aim to link 3D printing and robotics with advanced pre-operative imaging. Monogram’s mBôs is designed to enable precise virtual intraoperative assessment of patient specific laxity in order to plan where to make cuts for proper implant placement. These tools can dramatically simplify the complexity of joint reconstruction. With mVision, Monogram’s recently announced navigation solution, the goal is to increase the number of daily surgeries hospitals can perform, lower surgery costs, and minimize clinical risk. The robot is also designed for ease of use, aiming to minimize the learning curve and level of expertise needed. The company hopes that enhancements like these could help advance the standard of care in orthopedic robotics and hopefully make robots ubiquitous in the operating room. Monogram CEO Ben Sexson says the company’s ultimate vision is to combine a surgical robot that addresses economic and clinical pain points with more personalized implants. The company believes that the current generic, “one size fits none,” model is too costly and is not likely optimal for patients. Robotics could enable increased personalization of the implants. Monogram wants to get to a point where surgeons use 3D-printed implants that are designed based on the patient’s unique characteristics. The custom implants could enhance implant performance with, for example, improved coverage and minimized bone removal. The company believes custom implants could improve the initial stability of implants to facilitate bone ingrowth (which would reduce the need for bone cement to hold them in place). The vision is for the mBôs system to precisely cut the bone and put the custom implant in place. Sexson said the company is tracking to commercialize a robot that solves clinical and economic problems, while also enabling the next generation of 3D printed patient optimized implants. Promising Progress In preclinical trials that simulated cadaver surgeries with an mBôs prototype, Monogram reports that the robot was able to prepare the bone for implantation in approximately 40 minutes, which is significantly faster than the time it takes today. The company’s goal is to cut that down to 20 minutes. “The mBôs robot aims to combine safety, ease of use, streamlined cost, novel implant design, broad clinical functionality, and speed to help drive the next wave of robotic adoption in orthopedics,” Monogram says on its website. But it’s not only performing in trials. The company recently announced it delivered its first surgical robot to one of the world’s largest global robotics distributors. It marks the first sale for Monogram. “Delivering our first robot and realizing our first commercial revenues validates our technology and represents a pivotal milestone for our strategic roadmap,” Sexson said when announcing the milestone. “Our system is performing at an extremely high level. We now look forward to seeing how our robot competes and scales in the real world. We hope to see the mBôs robot contribute to advancing the standard of care for orthopedic patients worldwide.” The company has stated that its goal is to obtain FDA clearance as quickly and economically as possible. Further, they may have a strategy to exceed regulatory timeline expectations. "We have been exploring the technical feasibility of a semi-active system, and the results are promising," said Sexson. "A semi-active system could mitigate the possibility of a clinical trial and have distinct performance advantages over a fully autonomous system, such as cutting efficiency. We believe surgeons would be receptive to a robot with autonomous and semi-active modalities or a combination of both because of the distinct advantages of each system. This approach could theoretically be extremely favorable to our submission timeline." The company recently shared that it's on track with plans to submit its mBôs 510(k) for FDA clearance in the second half of 2024. The critical question is how long the company needs to obtain FDA clearance for its mBôs system. In its recently reported 10-K, it wrote, “Regulatory strategy can be dynamic as new facts and opportunities emerge. Our goal is to obtain FDA clearance as quickly and economically as possible. It is management’s interpretation of the FDA’s main cited technical differences of the “active” embodiment of our mBôs system with the predicate that could justify a clinical study to establish substantial equivalence, related primarily to foot pedal control of the system, i.e., hands-free active cutting. The company has been exploring the technical feasibility of a semi-active system (an embodiment that would not allow for remote operation) that we anticipate could minimize cited technical differences with our predicate and potentially obviate the need for clinical data with our 510(k) submission. Our preliminary market research suggests surgeons could be receptive to a robot with active and semi-active modalities. The company is exploring submitting a semi-active modality 510(k) first without clinical data and then submitting for the active modality after obtaining OUS clinical data. This approach is still under investigation but could theoretically be favorable to our commercialization timeline.” This interesting recent addition to the filing could be something to keep a very close eye on. Hospitals and surgeons are incentivized to find ways to more efficiently treat patients and ensure better outcomes. Robots are supposed to achieve that, but many on the market fall short. Monogram is focused on changing that with its mBôs robot. Featured photo courtesy of Monogram Orthopaedics. 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 not intended to be investing advice. Contact Details Benzinga +1 877-440-9464 info@benzinga.com Company Website http://www.benzinga.com

March 19, 2024 08:10 AM Eastern Daylight Time

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NCMA's Announces New Members to their National Committee

National Contract Management Association

At the National Contract Management Association (NCMA), the focus on providing high-quality resources— events, professional certifications, local networking, and the ANSI-approved Contract Management Standard™ —that positively advance and expand the contract management profession remains the top priority. To help to continue strengthen the association’s strategic direction and growth, NCMA is excited to announce its new National Committee Members, who bring a wealth of experience and expertise to guide their endeavors forward. “Our National Committee Members are essential in providing a platform for meaningful planning and growth for our members and association,” said NCMA’s Board-Chair Elect, Heather Gerczak. “They will be instrumental in inspiring innovation and refining our strategy. I am thrilled to welcome our new members and am excited to collaborate in Program Year 2025.” The National Committee members are seasoned professionals with impressive track records in their respective fields. NCMA welcomes: Joann Campbell-Maher, CPCM, CFCM, CCCM, Director of Contracts, SRC Inc., Chapter: Leatherstocking Chapter Will Cannon, Director of Business Operations, General Atomics Chapter: San Diego Jim Doss, Fellow, CPCM, CFCM, Director of Contracts, BlueHalo, Chapter: Tysons Derek Ebona, CPCM, Chief of the Contracting Office, Program and System Support for Contracting and Procurement Office, Defense Counterintelligence and Security Agency, Chapter: Tysons Jessica Johnson, CPCM, CFCM, VP, Services Contracts at Red River Technology, Chapter: Dulles Corridor Wanda Wallace, CPCM, CFCM, Senior Contracts Manager at Magellan Federal, Chapter: Jacksonville This year’s National Committees Members were elected through a competitive application and voting process. These members make a lasting impact on NCMA. The Committees are made up of five groups including audit and risk, governance and ethics, member engagement, professional development and certification, and strategic planning. All who have served have played an instrumental role in helping to shape the associations’ strategy and direction. The National Contract Management Association (NCMA) – www.ncmahq.org – has grown as a professional society whose mission is to collaborate towards a globally recognized contract management profession that strengthens its nexus with related acquisition communities. Serving approximately 20,000 members in both the public and private sectors, NCMA propels the growth, advancement, and impact of practitioners through a steadfast commitment to serve through the open exchange of ideas in neutral forums. Contact Details Holly DeHesa +1 281-865-3296 holly.dehesa@ncmahq.org Company Website https://www.ncmahq.org

March 19, 2024 05:00 AM Eastern Daylight Time

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AGC Biologics to Manufacture First-ever FDA Approved Gene Therapy for Early-onset Metachromatic Leukodystrophy, Orchard Therapeutics’ Lenmeldy™ (atidarsagene autotemcel)

AGC Biologics

AGC Biologics, a leading global Biopharmaceutical Contract Development and Manufacturing Organization (CDMO), today announced that the U.S. Food and Drug Administration (FDA) has cleared its Milan site to begin commercial manufacturing for the lentiviral vector and genetically modified cell drug product (DP) of Orchard Therapeutics’ Lenmeldy™ (atidarsagene autotemcel), a hematopoietic stem cell (HSC) gene therapy for the treatment of pre-symptomatic late infantile, pre-symptomatic early juvenile and early symptomatic early juvenile metachromatic leukodystrophy (MLD). Lenmeldy received approval by the FDA on Monday, March 18. “It is wonderful to see Orchard Therapeutics reach this goal. This accomplishment is a strong proof point of our commitment at AGC Biologics to collaborating directly with developers to meet rigorous regulatory standards and achieve the best possible results for our partners,” says Patricio Massera, CEO of AGC Biologics. Lenmeldy is the first therapy to receive U.S. FDA approval for MLD. With this announcement, AGC Biologics Milan becomes the only global CDMO site to receive the regulatory agency’s clearance to produce this treatment for patients in the U.S. commercially. The FDA approval is the culmination of a partnership that started in 2018 with Orchard Therapeutics, which also includes guiding the product through commercial approval by the European Commission (EC) in 2021. AGC Biologics’ Milan site is uniquely connected to this product’s full lifecycle, as the facility and its scientific teams partnered with each company that owned this treatment’s IP over the last 20 years to help advance it from research and development stages to this DP commercial milestone. “We congratulate Orchard for reaching this important stage. Our team has had the privilege of supplying every clinical milestone for Lenmeldy and are glad to see it reach FDA approval,” said Luca Alberici, General Manager of AGC Biologics Milan. “I am proud of the work of the Milan team. This demonstrates our unique ability to collaborate on technical processes to deliver groundbreaking treatments to patients worldwide. This approval makes our site one of the rare few in the viral vector and genetically modified cells field that has commercial manufacturing authorization from two of the world’s leading regulatory authorities." "AGC Biologics has played a pivotal role as a strategic partner throughout the clinical development and commercial scale-up of atidarsagene autotemcel, which helped facilitate regulatory approvals in Europe and the U.S.," said Nicoletta Loggia, Ph.D., chief technical officer of Orchard Therapeutics. "Utilizing our best-in-class commercial HSC gene therapy manufacturing platform, we have consistently met the demands for drug product production since the European launch in early 2021. This has enabled us to provide treatment to patients from three continents, including Europe on a commercial basis, the Middle East through treatment abroad programs, and the U.S., under compassionate use. With the recent U.S. approval, we are excited to further expand access to this vital therapy for eligible children with early-onset MLD. The AGC Biologics Milan location has 30 years of experience in the cell and gene field and expertise with complex advanced cell therapy projects. The core team has guided three cell therapy products from development to commercial stages and has manufactured hundreds of batches of cell therapies for clinical and commercial usage. The site serves as the AGC Biologics’ Global Cell and Gene Center of Excellence for AGC Biologics. The team has a track record for helping developers meet regulatory guidelines and achieve quality performance metrics, and experience with navigating the unique complexities of technology transfers and scaling up and scaling out manufacturing within the cell and gene space. To learn more about AGC Biologics’ global cell therapy services, visit: www.agcbio.com/capabilities/cell-therapy, go to www.agcbio.com/capabilities/viral-vector and learn more about the CDMO’s viral vector offerings. Lenmeldy™ (atidarsagene autotemcel) is a trademark of Orchard Therapeutics. 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 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 a part of AGC Inc.’s Life Science Company. The Life Science company runs ten different facilities focused on biopharmaceuticals, advanced therapies, small molecule active pharmaceutical ingredients, and agrochemicals. To learn more, visit www.agcbio.com. Contact Details AGC Biologics Nick McDonald +1 425-419-3555 nmcdonald@agcbio.com Company Website https://www.agcbio.com/

March 18, 2024 11:30 PM Pacific Daylight Time

AGBOOST SCALES AI-ENABLED GENETIC DATA ANALYSIS SOFTWARE FOR CATTLE PRODUCERS

AgBoost

After years of product development and field testing, AgBoost announced the global commercial expansion of its cloud-based data analysis platform that helps cattle producers interpret genomic data for selective breeding, health, market value and nutrition management. Despite a 65% increase in U.S. beef herd productivity over five decades, according to United Stated Department of Agriculture (USDA), rising demand for sustainably produced meat and shrinking profit margins underscore the importance of genetic data for herd efficiency. "Too often, cattle producers invest in DNA technology without unlocking its full potential," said Sean Akadiri, founder and CEO of AgBoost, at the 2024 Animal AgTech Innovation Summit and World Agri-Tech Innovation Summit. "Our platform revolutionizes decision-making, empowering ranchers with faster, more precise choices. By putting genetics at their fingertips, we're reducing the average $2,000 loss per calf during breeding and development, giving ranchers a decisive advantage over the competition.” Traditionally, breeding decisions rely on visual appraisals and multi-generation written records of estimated genetic merit. AgBoost's software combines genomic and production data, including live birth weight and diverse phenotypic information, for individual animals. Users can track animals individually or group them, such as in replacement heifer groups. By selecting specific traits, producers gain a comprehensive view to inform feeding, animal health, and marketing decisions effectively. “Genomic testing data can feel like deciphering hieroglyphics to most producers. But AgBoost transforms complexity into simplicity, presenting data in a visual wheel that sparks meaningful conversations. Now, we can swiftly identify the top bulls with complementary traits for desired calves,” said Nick Jorgensen, CEO and CFO of Jorgensen Land and Cattle, who not only licenses the platform for its large seed stock operation but also invested in the company. Seedstock cattle producers depend on analytics for marketing in bull and production sales. AgBoost visually showcases genetic value and identifies DNA-linked traits, like production, maternal, and carcass traits, aiding in sorting and selecting specific characteristics. The tool also allows for scenario planning, including establishing keep/cull lines to distinguish the top and bottom of the gene pool. Poised for Rapid Expansion into New Geographies and Livestock Introduced to U.S. cattle producers in 2018, AgBoost now holds millions of genomic data records for individual cows. With recent patent approvals, the company aims to expand into top-producing markets like Brazil, Canada, China, and the United Kingdom. The global beef market, valued at $526.50 billion in 2023, is projected to grow at a 4.2 percent CAGR by 2030. Currently, AgBoost supports all sizes of seedstock and commercial cow/calf producers, regardless of breed association, with an interactive pedigree and sire link, with a breeding suggestion calculator coming in late 2024. As pioneers in the market, the company intends to broaden individual producer subscriptions, enterprise licensing agreements, and tailor the platform for additional livestock and related industries to meet current demand. For more information, visit www.Ag-Boost.com. About AgBoost Established in 2013 by engineers and cattle producers as a subsidiary of the animal agtech leader, Agric-Bioformatics, Inc., AgBoost pioneers affordable, user-friendly genetic management tools for livestock producers worldwide. Our comprehensive software streamlines the entire process—from ordering tests to interpreting data for actionable insights and creating effective marketing tools. At AgBoost, our mission is clear: to prioritize producers by empowering them to own and comprehend their data, unlocking maximum growth potential for the future. To learn more or request a demo, visit www.Ag-Boost.com. Contact Details AgTech PR for AgBoost Jennifer Goldston jennifer@agtechpr.com

March 18, 2024 12:17 PM Central Daylight Time

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Abingdon Health CEO discusses strong interim results, robust pipeline and growth strategy

Abingdon Health PLC

Abingdon Health PLC (AIM:ABDX) CEO and co-founder Chris Yates discusses the company's interim results and business operations in an interview with Proactive's Stephen Gunnion. Abingdon Health is a lateral flow, contract development, and manufacturing organisation (CDMO), supporting customers from product ideation to commercial success. It offers services including development, scale-up manufacturing, regulatory and analytical laboratory provision, and packaging. Yates said a 117% revenue increase to £2.4 million during the interim period was primarily driven by its CDMO division. This growth was attributed to increases in development, operational revenues, and the emergence of regulatory area revenues. Despite an inflationary environment, Abingdon Health managed to maintain stable operating costs, resulting in improved gross margins to over 50%. The company has a robust opportunity pipeline with 29 ongoing projects, emphasizing its fully integrated solution's appeal to customers. Yates also highlighted a good start to the second half of the year, with revenues expected to grow significantly while controlling costs to enhance operating profit performance. Contact Details Proactive UK Proactive UK +44 20 7989 0813 UKEditorial@proactiveinvestors.com

March 18, 2024 07:10 AM Eastern Daylight Time

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Faron Pharmaceuticals reports promising phase 1 results from BEXMAB study

Faron Pharmaceuticals Oy

Faron Pharmaceuticals Limited (AIM:FARN) chief executive Dr Markku Jalkanen joins Proactive's Stephen Gunnion with additional positive data from the Phase 1 study of the ongoing bexmarilimab (BEXMAB) trial that has moved into Phase 2 for higher-risk (HR) myelodysplastic syndrome (MDS) patients failed on previous hypomethylating agent (HMA). Dr Jalkanen said the study demonstrated promising results in reducing cancer cells and extending life expectancy in patients. He highlighted the durability and effectiveness of the treatment, particularly in patients with a severe form of myeloid leukemia called MDS, where current treatment options are limited. Dr Jalkanen said the Phase 1 results showed a high overall response rate and an extended overall survival rate among patients, which could lead to a new treatment option for an underserved patient population. He emphasized the importance of continuing the study and engaging with regulators to bring the treatment to market as swiftly as possible. He also noted the potential for increased interest from other pharmaceutical companies based on the positive data released. Faron Pharmaceuticals has moved to the Phase 2 part of the study, focusing on finalising dosing and drug levels as per FDA guidance. The goal is to establish a clear pathway to market approval. Contact Details Proactive UK Ltd +44 20 7989 0813 uk@proactiveinvestors.com

March 18, 2024 07:02 AM Eastern Daylight Time

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Candel Therapeutics (NASDAQ: CADL) Lead Product Candidate CAN-3110 Demonstrates Promise To Treat Deadly Brain Tumors

Candel Therapeutics

By Jeremy Golden, Benzinga Among brain tumors, high-grade gliomas are the most frequently diagnosed and fatal. Most of the patients with high-grade glioma will have glioblastoma, a more aggressive form of the cancer. The global burden of high-grade gliomas, which have a median overall survival of less than 15 months, cannot be understated, especially given the lack of available treatments to date. The unmet need is even greater in patients with recurrent high-grade glioma, where the expected median overall survival is less than 6 to 9 months. A leader in the development of therapies to treat this field of rare tumors, clinical-stage biopharmaceutical company Candel Therapeutics, Inc. (NASDAQ: CADL), is developing CAN-3110 – a first-in-class drug candidate – to help patients combat these deadly tumors. Candel Therapeutics leverages the ability of viral gene constructs to activate cancer-killing mechanisms, exposing multiple tumor antigens and inhibiting the immunosuppressive tumor microenvironment. The company reports that this tactic has been shown to produce an individualized immune response specific to the patient and their cancer. The company’s viral immunotherapy approach utilizes intratumoral administration of genetically engineered viruses to selectively induce tumor cell death. This elicits an innate and adaptive systemic immune response against the injected tumor and uninjected distant metastases. Best of all, local delivery enables Candel to achieve these results while aiming to minimize systemic toxicity. The lead product candidate in Candel Therapeutics’ HSV platform, CAN-3110, is a replication-competent herpes simplex virus-1 (HSV-1) engineered to enhance the selective killing of cancer cells while sparing healthy neighboring cells. Designed with dual activity for oncolysis and immune activation in a single therapeutic, CAN-3110’s activity is designed to be conditional to the expression of Nestin in cancer cells. CAN-3110 is being evaluated in a phase 1b investigator-sponsored clinical trial in patients with recurrent high-grade glioma. The results from this ongoing clinical trial were recently published in Nature. Investigators discovered that the drug candidate was well tolerated with no dose-limiting toxicity reported, and CAN-3110 was associated with improved survival. Pre-existing anti-HSV-1 immunity increased infiltrating immune cells in the tumor microenvironment and expansion of the T cell repertoire after treatment were all associated with improved survival. “Single-timepoint intralesional injection of rHGG with CAN-3110 enriches the tumor microenvironment with tumor infiltrating lymphocytes, inducing defined changes in peripheral and tumor T cell repertoires and tumor transcriptomic signatures,” investigators wrote in the report. “These changes are particularly evident in patients who are seropositive for HSV1 and are associated with improved survival in this otherwise therapy-refractory cancer. These findings therefore provide human immunological and biological evidence supporting the ability of CAN-3110 to convert the immunosuppressive one immunosuppressive tumor microenvironment characteristic of many solid cancers into a one that is more favorable to immunologic rejection of the tumor.” In the CAN-3110 clinical trial, Candel Therapeutics reports that a near-doubling of the expected median overall survival was observed after a single CAN-3110 injection, compared to historical reports of less than 6 to 9 months in this therapy-resistant condition. The company’s scientists and academic collaborators are currently evaluating the effects of multiple CAN-3110 injections in recurrent high-grade glioma, supported by the Break Through Cancer Foundation. Fresh off receiving FDA Fast Track Designation for the treatment of recurrent high-grade glioma, Candel Therapeutics plans to announce a data readout for the multiple injection cohort in CAN-3110’s phase 1 trial in 2H 2024. They expect initial results in the second half of 2024. How Does CAN-3110 Work? The off-the-shelf drug candidate is engineered for selective replication by placing ICP34.5 – the gene controlling HSV replication – under the control of the Nestin promoter. Nestin is highly expressed in high-grade glioma cells but absent in healthy adult brain cells, which could explain why dose-limiting toxicity was not observed in a study of a single injection of CAN-3110 into the brain tumor in patients with recurrent high-grade glioma. Nestin expression has also been detected in aggressive tumors other than high-grade glioma, broadening the potential reach of CAN-3110 into other indications outside the brain – creating a future pipeline-in-a-product. For more information on Candel Therapeutics, visit candeltx.com. 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/

March 15, 2024 08:15 AM Eastern Daylight Time

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How Theriva Biologics Is Using An Adenovirus To Develop A Novel Treatment For Pancreatic Cancer, As Well As Other Cancers With An Unmet Need

Benzinga

By Faith Ashmore, Benzinga Pancreatic cancer has, unfortunately, been in the news lately due to the rising rates of early-onset cancer, especially in young people. The gastrointestinal cancer, which has a 12% five-year survival rate, is expected to become the second-highest cause of cancer-associated deaths in 2030 in the U.S. In 2024, it is projected that 64,440 Americans will be diagnosed with pancreatic cancer. The global market size for pancreatic cancer was valued at $2.22 billion in 2022, and it is expected to be worth around $7.91 billion by 2032. Despite the multi-billion dollar market size, the industry is expected to grow at 13.6% through 2032, and pancreatic cancer still needs more therapeutic options – especially for advanced cases or when existing treatments don’t yield the desired results. Theriva Biologics (AMEX: TOVX) is a biotech company that is looking to use adenoviruses to help treat pancreatic cancer. Adenoviruses are a class of viruses with an established safety profile. They are highly prevalent in the environment, making them ideal candidates for therapeutic use in the cancer field. Theriva Biologics' lead product candidate, VCN-01, is a uniquely modified human adenovirus designed for systemic delivery to treat different types of cancer. Theriva Biologics reports that phase 1 clinical trials of VCN-01 have shown promising results for the treatment of several additional indications apart from pancreatic cancer, such as retinoblastoma, head and neck squamous cell carcinoma (HNSCC) and colorectal cancer (CRC) in combination with chemotherapy and immunotherapies. Currently, the company is conducting a phase 2b clinical trial of VCN-01 in combination with standard-of-care chemotherapy for first-line metastatic pancreatic cancer. It is on track to complete enrollment into the VIRAGE Study by the first half of 2024. In the first quarter of 2024, a Drug Monitoring Committee (DMC) conducted a thorough safety review of VCN-01, and found that the VCN-01 safety profile permitted the VIRAGE study to continue without modification. By the second half of 2024, Theriva Biologics aims to perform an interim analysis of the data obtained from the VIRAGE Study. Pancreatic cancer presents several unique challenges that contribute to its high mortality rate and the difficulty in managing the disease. One major challenge is the aggressive nature of pancreatic cancer, which often spreads to other organs before being diagnosed. Approximately 50% of patients are diagnosed when the cancer has already metastasized, resulting in advanced-stage disease. Pancreatic cancer is also known for causing nonspecific symptoms, making it challenging to detect in its early stages. VCN-01 has a systemic delivery approach, which means it can target both the main tumor and distant metastases, which makes it a promising therapeutic option for advanced and difficult-to-treat cancers like pancreatic cancer. If the company can successfully harness the benefits of adenoviruses, it will present suffering patients around the globe with a novel solution to extend their lives. 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

March 14, 2024 08:20 AM Eastern Daylight Time

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