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NEWPORT NEWS SPINE SURGEON PERFORMS FIRST TWO INTRACEPT® BASIVERTEBRAL NERVE ABLATIONS IN HAMPTON ROADS

Orthopaedic & Spine Center

Mark McFarland, DO, Performs Outpatient Procedure for Vertebrogenic Back Pain NEWPORT NEWS, VIRGINA / ThriveNewsWire / June 10, 2024 / On Thursday, Spine Surgeon Mark W. McFarland, DO, performed the first two Intraosseus Basivertebral Nerve Ablation procedures, using the Intracept® device by Relievant Medsystems, Inc., a subsidiary of Boston Scientific. The outpatient procedures were performed at Mercy Bon Secours Mary Immaculate Hospital in Newport News, Virginia and were a first for this region. The first procedure was performed on a 91year-old man with a history of chronic vertebrogenic back pain, on levels L3-S1. The second procedure was performed on a 53-year-old man who also had a long-standing history of vertebrogenic back pain, on levels L3-5. Both patients did very well during their procedures and were discharged to go home after spending a few hours in recovery. “With the Intracept Procedure, we are embarking on a paradigm shift in the treatment and diagnosis of vertebrogenic pain,” said Dr. McFarland, who practices at Orthopaedic and Spine Center in Newport News, Virginia. “Not only is the procedure proven to be safe and durable, but it also provides patients with the opportunity to get back to living without the burden of chronic low back pain.” Mark W. McFarland, DO, is a spine specialist who provides the most advanced treatments available for spinal deformities, disease and disorders, as well as arthritis. He is also known for his pioneering work as a consultant and innovator in developing new surgical techniques and instruments to improve spine surgery and the resulting outcomes for patients. Orthopaedic & Spine Center offers specialized Orthopaedic and Interventional Pain Management services, including spine care, sports medicine, arthroscopic surgery, total joint replacement, pain management and Workers’ Compensation Injury Management. They serve patients throughout the Hampton Roads area. Their physicians have full staff privileges at Coastal Virginia Surgery Center and Mercy Bon Secours Mary Immaculate Hospital. Orthopaedic & Spine Center is located at 250 Nat Turner Boulevard in Newport News, VA. For an appointment, call (757) 596-1900, and for more information on the practice and its physicians, visit www.osc-ortho.com. Contact Details Orthopaedic & Spine Center Shannon Bednarova – Director of Marketing 757-596-1900 sbednarova@osc-ortho.com Company Website https://www.osc-ortho.com/ Contact Details Orthopaedic & Spine Center Shannon Bednarova – Director of Marketing +1 757-596-1900 sbednarova@osc-ortho.com

June 10, 2024 03:25 PM Eastern Daylight Time

Elicio Therapeutics Unveils Promising Phase 1a Data For ELI-002 7P In mKRAS Tumors

Benzinga

By Kyle Anthony, Benzinga Elicio Therapeutics (NASDAQ: ELTX) has announced that preliminary data from their AMPLIFY-7P Phase 1a Study of ELI-002 7P in patients with mKRAS-driven solid tumors was well tolerated with T cell responses correlating with a reduction in tumor biomarkers at the recommended Phase 2 dose (“RP2D”). Elicio Therapeutics is a clinical-stage biotechnology company focused on developing innovative lymph node-targeted immunotherapies to treat aggressive cancers. Given the firm’s expertise in materials science, immunology and oncology, it plans to forge a new path forward for cancer treatment by utilizing its diverse capabilities to fulfill its mission of amplifying the potential of immunotherapies, empowering patients to fight cancer with full force. The initial findings from its study are encouraging, given that KRAS mutated cancers are difficult to target in part due to the number of diverse mutations and bypass resistance mechanisms. “We are encouraged by the first data from the ongoing AMPLIFY-7P trial, which demonstrate ELI-002 7P has a favorable safety profile and early antitumor effects that correlate with induction of T cells specific for multiple KRAS mutations potentially providing broader coverage for patients, said Craig E. Devoe, M.D., MHCM., chief of the Division of Medical Oncology & Hematology and the R.J. Zuckerberg Cancer Center, and scientific investigator at Northwell Health. Elicio Therapeutics Pipeline Elicio Therapeutics’ lead product candidate, ELI-002, is a structurally novel investigational Amphiphile (AMP) cancer vaccine that targets cancers that are driven by mutations in the mKRAS-gene — a prevalent driver of many human cancers. ELI-002 is comprised of two powerful components that are built with Elicio Therapeutics’ AMP technology, consisting of AMP-modified mutant KRAS peptide antigens and an AMP-modified CpG adjuvant that is available as an off-the-shelf subcutaneous administration. ELI-002 2P (2 peptide formulation) is currently being studied in an ongoing Phase 1 (AMPLIFY-201) trial in patients with high relapse risk mKRAS-driven solid tumors following surgery and chemotherapy. ELI-002 7P (7 peptide formulation) is being studied in a Phase 1/2 (AMPLIFY-7P) trial in patients with mKRAS-driven pancreatic cancer. The ELI-002 7P formulation is designed to provide immune response coverage against seven of the most common KRAS mutations(G12D, G12R, G12V, G12A, G12C, G12S and G13D) present in 25% of all solid tumors, thereby increasing the potential patient population for ELI-002. Compelling Results From The Ongoing AMPLIFY-7P Phase 1a Study The company reports that the efficacy of ELI-002 7P as a treatment solution was successful in several instances, demonstrating the versatility of the drug and its ability to provide a strong T cell response. The preliminary data findings from the ongoing AMPLIFY-7P Phase 1a Study of ELI-002 7P include: ELI-002 7P administered as a monotherapy was well tolerated and able to generate a ~100x mKRAS-specific expanded T cell response relative to baseline levels ELI-002 7P generated an mKRAS-specific T cell response in 100% of patients including responses targeting all mKRAS mutations enrolled (G12D, V, R and G13D) mKRAS-specific T cells were polyfunctional with 66.7% (4/6) of evaluable patients having both CD8+ and CD4+ responses at the 4.9 mg Phase 2 dose level Tumor biomarker reductions were observed in 5/7 (71%) of evaluable patients at the 4.9 mg Phase 2 dose level ELI-002 7P was shown to induce antigen-spreading with increased T cell responses targeting non-immunizing, personalized tumor neoantigens in 6/6 (100%) of evaluable patients at the 4.9 mg Phase 2 dose level In speaking about these findings, Christopher Haqq, MD, PhD, executive vice president, head of Research and Development and chief medical officer at Elicio Therapeutics, stated, “These early immunogenicity and biomarker response data from ELI-002 7P continue to provide encouraging results showing that our lymph node-targeted approach generates a robust and differentiated T cell response that strongly correlates with tumor biomarker reductions.” “Across two trials, ELI-002 has demonstrated an ability to generate a robust T cell response against all mKRAS mutations of enrolled patients as well as T cell responses against non-immunizing personalized tumor neoantigens. ELI-002’s broader KRAS mutation coverage and higher T cell responses with the 7-peptide vaccine at the Phase 2 dose holds promise for the high unmet need of patients with KRAS-mutated tumors,” Haqq said. The AMPLIFY-7P Phase 1a Study data findings of ELI-002 7P were presented at the American Society of Clinical Oncology (ASCO) Annual Meeting, held from May 31 to June 4, 2024, in Chicago, IL. The ASCO Annual Meeting is considered the premier international forum for presenting scientific research and state-of-the-art education in clinical oncology. The five-day event attracts 30,000 attendees from around the world. An Immunotherapeutics Company Founded as a spin-out from the Massachusetts Institute of Technology (MIT), Elicio Therapeutics leverages the research of Professor Darrell Irvine, a Howard Hughes Investigator and expert in biomedical engineering and immunology. The company's main innovation, the Amphiphile (AMP) platform, delivers immunotherapeutics directly to the body’s lymph nodes to enhance the immune system's cancer-fighting mechanisms. By delivering cancer immunotherapies to the center of the immune response, Elicio Therapeutics intends to optimize the natural ability of the lymph nodes to educate, activate, and amplify cancer-specific T cells. Elicio Therapeutics' mission is to give patients battling cancer the best possible outcome. The firm’s leadership and scientific advisory board are composed of determined and experienced individuals who are committed to engineering lymph node–targeted immunomodulators, adjuvants, and vaccines for an array of aggressive cancers. The Path Forward Elicio Therapeutics’ recent findings are encouraging news and a tailwind for the firm’s innovation activities. Given the applicability of ELI-002 7P in treating patients with differing cancers, this is a milestone moment for Elicio Therapeutics and an encouraging step forward in the firm’s research and development and eventual commercialization of its treatment offering. As such, the benefit that Elicio Therapeutics provides and the value proposition the firm espouses could continue to grow and have increased industry resonance. Featured photo by CDC 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

June 10, 2024 08:30 AM Eastern Daylight Time

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News Release

Willow Bioscience Announces 3 Million dollar Fundraising to Support Partnership with Laurus Labs

Willow Biosciences Inc.

Willow Bioscience CEO Dr Chris Savile joined Steve Darling from Proactive to share the company's plans to raise approximately $3 million. This capital will be used to support Willow Bioscience's recent partnership announcement with Laurus Labs. Dr. Savile explained that the deal with Laurus is a multi-product development and licensing partnership with a leading research-driven pharmaceutical and biotechnology company. Laurus Labs, with a market cap of $3.9 billion, serves global pharmaceutical companies and offers Contract Development and Manufacturing Organization (CDMO) services. Since its inception, Laurus has commercialized over 80 products and operates nine manufacturing facilities, including those with fermentation capabilities. Willow Bioscience aims to leverage its AI-driven technology platform and extensive expertise in enzyme, strain, and process engineering to develop biobased processes for high-value Active Pharmaceutical Ingredients (APIs). This includes Willow’s BioOxi™-based corticosteroid processes, intended for large-scale manufacturing, sales, and distribution at Laurus Labs. The first programs from this partnership are expected to reach commercial manufacturing by 2025. The planned fundraising will provide the necessary capital to advance these initiatives, ensuring that Willow Bioscience can effectively collaborate with Laurus Labs to bring innovative biobased pharmaceutical solutions to the market. Contact Details Proactive Investors +1 604-688-8158 na-editorial@proactiveinvestors.com

June 07, 2024 12:27 PM Eastern Daylight Time

Video

Loneliness Crisis Being Faced by Older Americans: AmeriCorps Seniors Believes Volunteering Fosters Connections and Conquers Loneliness

YourUpdateTV

A video accompanying this announcement is available at: https://youtu.be/dcH7-VsQaYQ Older adults are especially vulnerable to loneliness and social isolation, which can have a serious effect on health, according to a recent report issued by the U.S. Surgeon General. Chronic loneliness (persistent feelings of isolation and/or a lack of companionship) can adversely affect mental, cognitive, and physical health, general well-being and even longevity. However, there are ways to overcome loneliness and volunteering might be the answer. AmeriCorps Seniors is helping older adults form connections in their community, provide purpose and improve their lives through volunteering. After two years of volunteering with AmeriCorps Seniors, 78% of those who reported more than five symptoms of depression at the beginning of the study said that they felt less depressed two years later. Of those who first described a lack of companionship, 88% said they felt less isolated after two years. AmeriCorps is the federal agency for national service and volunteerism. AmeriCorps Seniors focuses on engaging adults ages 55 and up in service in their local communities. Through three signature programs, RSVP, the Foster Grandparent Program and the Senior Companion Program, AmeriCorps Seniors provides a space for older adults to take charge of this moment in life and use their time in impactful ways. Each year, AmeriCorps Seniors matches more than 140,000 Americans with service opportunities. For example, Shelley Brosnan, a volunteer with AmeriCorps Seniors RSVP through Volunteer Fairfax, Fairfax, Va., said, “Giving back is so very important. I’ve been volunteering for most of my adult life. Volunteering allows me to connect with my community and make it a better place. I also love the social aspects and meeting people who share my interests. We have a chance to help others and form new relationships, which has grown my social circle.” RSVP offers flexible scheduling and a diverse mix of opportunities. The Foster Grandparent Program pairs volunteers with children and youth in mentoring and tutoring relationships. Lastly, the Senior Companion Program provides a helping hand to other older adults and those with disabilities. They also support caregivers through respite services. For more information and to find volunteer opportunities near you, visit AMERICORPS.GOV/YOURMOMENT. Contact Details YourUpdateTV +1 212-736-2727 yourupdatetv@gmail.com

June 07, 2024 12:06 PM Eastern Daylight Time

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Theriva Biologics Receives Fast Track Designation From FDA For VCN-01 For Treating Metastatic Pancreatic Cancer

Benzinga

By Kyle Anthony, Benzinga Theriva™ Biologics (AMEX: TOVX) is an immuno-oncology company developing oncolytic viruses, otherwise known as cancer cell-infecting viruses, to overcome the protective barrier surrounding solid tumors and selectively kill tumor cells. As a company engaged in developing differentiated clinical-stage therapeutics, Theriva’s mission is to change patient outcomes by working to improve the current standard of care and transform the cancer therapy landscape. The firm’s management and scientific advisory board is comprised of determined and experienced leaders who are committed to offering patients with difficult-to-treat cancers the chance of a longer life. The company recently achieved a significant milestone as the U.S. FDA granted Fast Track Designation (FTD) to its candidate VCN-01 to improve progression-free survival and overall survival in patients with metastatic pancreatic adenocarcinoma. Previously, the FDA granted orphan drug designation to VCN-01 for treatment of pancreatic ductal adenocarcinoma (PDAC). Company Background Founded in 2001 and operating as Synthetic Biologics from 2012, the company was previously focused on developing biologic and drug candidates for various indications, including infectious diseases and gastrointestinal disorders. The company rebranded to Theriva Biologics in September 2022 to reflect its evolving focus on oncolytic viruses and cancer therapies. Regarding the impetus behind the firm’s rebranding, Steven A. Shallcross, Chief Executive Officer of Theriva Biologics, said, “The rebranding solidifies our strategic transformation and reflects our sharpened focus on advancing unique, oncolytic viruses optimized for IV administration. We continue to build on the incredible progress made to date and are diligently advancing our oncolytic adenovirus pipeline. This includes lead clinical-stage program VCN-01, designed to break down the tumor stroma, and preclinical-stage program VCN-11, leveraging our proprietary Albumin Shield Technology to protect systemically administered oncolytic viruses from the host immune system. These two differentiated programs are intended to improve the anti-tumor effect of the oncolytic virus, co-administered chemotherapies and/or immuno-oncology therapeutics. Together, VCN-01 and VCN-11 position Theriva at the forefront of oncolytic virus development. We are excited about Theriva’s path towards strategic growth, renewed corporate strategy and remain on track to deliver on upcoming value-driving milestones.” Theriva Biologics Pipeline As Steven A. Shallcross’s preceding quote suggests, Theriva Biologics' leading clinical-stage program, VCN-01, has displayed promise as a treatment solution. Presently, VCN-01 is part of an ongoing phase 2 clinical trial, entitled VIRAGE, where it is being tested in combination with standard-of-care chemotherapy for patients with pancreatic ductal adenocarcinoma (PDAC), the most common form of pancreatic cancer. VCN-01 was also administered with the checkpoint inhibitor durvalumab (an FDA-approved immunotherapy for cancer) in a phase 1 study in patients with head and neck cancers and is currently being evaluated in combination with huCART-meso cells – cells manufactured using a patient’s own white blood cells, which are modified to target cancer cells or cells that help cancer to grow – in an investigator-sponsored study in patients with either pancreatic cancer or ovarian cancer. Beyond VCN-01, Theriva Biologics is also developing SYN-004 (ribaxamase), which is aligned with the company’s oncology focus and seeks to mitigate adverse outcomes for patients who will undergo bone marrow transplant (allogeneic hematopoietic cell transplantation) to treat hematologic cancers. 80% to 90% of these patients will be treated with an intravenous β-lactam antibiotic, and this antibiotic treatment has been strongly associated with increased incidence and severity of acute graft-vs-host disease (aGVHD), vancomycin-resistant Enterococci (VRE) infection and Clostridioides difficile infection (CDI). Preventing one or all of these outcomes by SYN-004 co-administration may significantly improve treatment outcomes and reduce patient mortality. VCN-01 Receives Fast Track Designation By The U.S. FDA Theriva Biologics achieved a significant milestone as the FDA granted Fast Track Designation (FTD) to VCN-01. This designation, in combination with gemcitabine and nab-paclitaxel – standard-of-care chemotherapy drugs – is aimed at improving progression-free survival and overall survival in patients with metastatic pancreatic cancer. This recognition underscores Theriva Biologics' commitment to advancing cancer treatment and the potential of VCN-01 in this field. Pancreatic cancer is one of the leading causes of cancer death globally. The increasing incidence of this cancer across the U.S. and other parts of the world is one of the factors driving the need for drugs used in its treatment. According to research published by Fortune Business Insights, the global pancreatic cancer treatment market size was $2.86 billion in 2023 and is projected to grow from $3.30 billion in 2024 to $10.69 billion by 2032. Attaining FTD is a seminal achievement for pharmaceutical drug companies, as the designation is designed to help treatments reach patients faster by facilitating the development and expediting the review of therapies with the potential to treat serious conditions and fill an unmet medical need. Benefits of FTD to programs include early and frequent interactions with the FDA during the clinical development process, and if relevant criteria are met, the FDA may also review portions of a marketing application before the sponsor submits the complete application. Regarding Theriva Biologics receiving the FTD, Shallcross said, “The FDA’s decision to grant FTD to VCN-01 highlights the urgent need for new treatment options for PDAC, which accounts for the 4 th highest cause of cancer-associated deaths in the US and Europe. VIRAGE, our Phase 2b trial evaluating VCN-01 in metastatic PDAC continues to progress, with enrollment expected to be completed in the third quarter of 2024. FTD is an important step that furthers our ability to expedite the review of and build upon the compelling clinical data that underscores VCN-01’s multiple modes of action and therapeutic potential in combination with chemotherapy or immunotherapy. We will continue to deliver on our mission to advance new therapeutic options for these patients.” Based on the strength of the science and its relevance, VIRAGE was accepted for presentation as a trial-in-progress poster at the 2024 American Society of Clinical Oncology (ASCO) Annual Meeting, held in Chicago, IL, from May 31-June 4. The Path Forward Theriva Biologics' approach to cancer treatment differentiates it from its peers, potentially placing the company in a unique market position. As incidences of pancreatic cancer continue to rise globally, drug treatment options, such as VCN-01, will likely rise in demand. With VCN-01 receiving FTD from the U.S. FDA, this milestone speaks to the drug's efficacy and long-run potential. As such, the benefit that Theriva Biologics provides and the value proposition the firm espouses could continue to grow and have increased industry resonance. Featured photo by National Cancer Institute 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

June 07, 2024 08:45 AM Eastern Daylight Time

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Candel Therapeutics’ (NASDAQ: CADL) Lead Candidate CAN-2409 Combats Lung, Pancreatic And Prostate Cancers With Fast Track Designation For Three Cancers

Candel Therapeutics

By Jeremy Golden, Benzinga Immunotherapy has transformed the way cancer is treated, but just 20% to 40% of patients typically respond to FDA-approved immune checkpoint inhibitor (ICI) treatments. Poor ICI treatment response has been linked to the tumor’s ability to disguise antigen presentation and generate an immunosuppressive microenvironment. In addition, most conventional immunotherapies are not designed to educate the patient’s immune system on how to recognize a variety of tumor antigens and neoantigens. Amid this landscape, a clinical-stage biopharmaceutical company has developed a new multimodal biological approach that leverages the ability of viral gene constructs to activate cancer-killing mechanisms, exposing multiple tumor antigens to the immune system, resulting in vaccination against the tumor while inhibiting the immunosuppressive tumor microenvironment. Candel Therapeutics, Inc. (NASDAQ: CADL) is developing a product candidate that is being studied in lung, pancreatic and prostate cancers. 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 patient’s own tumor. Part of the company’s adenovirus platform, CAN-2409 is injected directly into the tumor or target tissue using a localized injection, akin to the standard approach for vaccination. CAN-2409's adenoviral construct serves as a vector to transport the HSV-thymidine kinase gene into tumor cells at the site of injection. These tumor cells can then express HSV-thymidine kinase, which converts generic, FDA-approved anti-herpes drugs – such as ganciclovir, acyclovir and valacyclovir – into a toxic nucleotide analog that blocks DNA synthesis in dividing cells. Cancer cells exposed to the toxic nucleotide analog in the tumor microenvironment have been observed to undergo immunogenic cell death. Simultaneously, the adenoviral serotype 5 capsid protein elicits a strong pro-inflammatory signal in the tumor microenvironment, creating the optimal conditions to induce a specific CD8+ T cell-mediated response against the injected tumor and uninjected distant metastases for broad and systemic anti-tumor activity. CAN-2409 is currently being studied in an open-label, phase 2 clinical trial in non-small cell lung cancer (NSCLC) and in randomized, controlled, blinded phase 2b and phase 3 clinical trials in prostate cancer. The company has recently released very encouraging data for CAN-2409’s ability to improve overall survival in non-metastatic pancreatic cancer, with topline overall survival data in non-small cell lung cancer planned for this quarter (Q2 2024) and results from the prostate clinical trials later this year (Q4 2024). When it comes to NSCLC, the company previously presented data from the phase 2 clinical trial in which patients received two administrations of CAN-2409 plus prodrug. Those patients demonstrated the following: 1) Increased infiltration of CD8+ cytotoxic T cells in the tumor microenvironment, systemic expansion of effector T cells and increased soluble granzyme B levels in peripheral blood; 2) Favorable changes in the trajectory of tumor progression; 3) Decreased tumor size of target lesions in most patients; and 4) Reduced size of uninjected tumor lesions. The CAN-2409 immunotherapy antitumor strategy aims to increase the number of long survivors beyond 10 to 13 months. As previous work has shown that progressive disease could be converted into stable disease in most patients with non-small cell lung cancer after CAN-2409 treatment, the hypothesis is that this will translate into improved survival. When it comes to pancreatic cancer, the company reported notable improvements in patients with borderline resectable pancreatic ductal adenocarcinoma (PDAC) after experimental treatment with CAN-2409. The estimated overall survival rate was 71.4% at 24 months in CAN-2409-treated patients versus only 16.7% in the control arm after chemoradiation. In 2023, CAN-2409 received Fast Track Designation for both non-small cell lung cancer and pancreatic cancer, a validation from the FDA on its potential. CAN-2409 plus valacyclovir in combination with continued PD-1/PD-L1 agents is being evaluated in an ongoing, open-label phase 2 clinical trial in patients with late-stage NSCLC and an inadequate response to anti-PD(L)-1 therapy. In 2024, CAN-2409 also received Orphan Drug Designation from the FDA for CAN-2409 in borderline resectable pancreatic cancer. In the upcoming year, Candel plans to announce data readouts for the following: 1) Phase 2 topline overall survival (OS) data for CAN-2409 in NSCLC, expected in Q2 2024; 2) Phase 2 topline data for CAN-2409 in low-to-intermediate-risk, localized, non-metastatic prostate cancer, expected in Q4 2024; 3) Phase 3 topline data for CAN-2409 in localized intermediate/high-risk prostate cancer, expected in Q4 2024. 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 07, 2024 08:30 AM Eastern Daylight Time

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New Clinical Data Reveals MAIA Biotechnology's THIO Achieves High Efficacy In Advanced Non-Small Cell Lung Cancer Treatment

Benzinga

By Mangeet Kaur Bouns Lung cancer remains the top cause of cancer-related deaths in the U.S., accounting for approximately 20% of all cancer fatalities. The American Cancer Society's projections for 2024 highlight the gravity of this issue, with an estimated 234,580 new lung cancer cases and about 125,070 deaths anticipated in the U.S. Of these, nearly 80% to 85% are non-small cell lung cancer (NSCLC) cases, highlighting the urgent need for effective treatments. MAIA Biotechnology, Inc. (AMEX: MAIA), a clinical-stage biopharmaceutical company focused on developing telomere-targeting immunotherapies for cancer treatment, has unveiled promising new clinical data showcasing the efficacy of its lead product candidate, THIO, in treating NSCLC. This data emerges from a phase 2 clinical trial evaluating THIO in combination with the immune checkpoint inhibitor (CPI) cemiplimab (Libtayo®), targeting patients with advanced NSCLC who have not responded to at least two standard-of-care therapies. In the context of NSCLC, where traditional treatments often fall short, THIO's potential as a first-in-class telomere-targeting agent raises hope. Its ability to disrupt cancer cell telomeres and stimulate immune responses marks a significant advancement in the fight against this devastating disease. MAIA’s Lead Candidate: THIO THIO is a groundbreaking telomere-targeting agent, currently undergoing phase 2 clinical trials aimed at treating NSCLC with telomerase-positive cancer cells. Telomerase, present in over 85% of human cancers, plays a crucial role in the immortality and proliferation of cancer cells. THIO integrates into telomeres within these cells, disrupting their structure and function – leading to rapid tumor cell death. By inducing telomerase-dependent DNA modification and damage, THIO triggers selective cancer cell death. This process accumulates telomeric damage in cytosolic micronuclei, which then activates both innate (cGAS/STING) and adaptive (T-cell) immune responses. In in vivo cancer models, sequential treatment with THIO followed by PD-(L)1 inhibitors resulted in significant and sustained tumor regression, fostering cancer-specific immune memory. Key Findings From The Phase 2 THIO-101 Clinical Trial The phase 2 THIO-101 trial primarily focuses on assessing the safety and tolerability of THIO both as an anticancer agent and as an immune system activator, alongside evaluating its clinical efficacy through overall response rate (ORR). The trial results are noteworthy. The disease control rate (DCR) for THIO in combination with CPI was 85%, far exceeding the 25-35% DCR typically seen with chemotherapy in third-line treatments. Additionally, 65% of patients surpassed the 5.8-month overall survival (OS) threshold, and 85% exceeded the 2.5-month progression-free survival (PFS) threshold, demonstrating significant clinical benefits. The median survival follow-up time stood at 9.1 months for the cohort of 20 patients. Optimal dose selection yielded even more impressive outcomes. Patients in third-line receiving 180mg of THIO exhibited a median PFS of 5.5 months, a 75% OS rate at six months and an ORR of 38%, compared to the standard 6-10% ORR for chemotherapy. Notably, 75% of these patients crossed the 5.8-month OS threshold and 88% surpassed the 2.5-month PFS threshold, with a median survival follow-up time of 9.1 months among the eight patients assessed. Implications And Future Directions Dr. Vlad Vitoc, chairman and CEO of MAIA, expressed enthusiasm about the trial outcomes, noting, "All exceptional measures of efficacy in our trial to date have exceeded our own expectations and outperformed standard-of-care treatments." He emphasized THIO’s potential as a robust, safe and highly effective alternative for patients who have not benefited from chemotherapy and other treatments. The THIO-101 trial, which completed enrollment ahead of schedule in February, reached its target of 41 patients for the 180 mg dose. This data, which indicates promising disease control and overall response rates, paves the way for further investigation and potential redefinition of cancer treatment protocols. As THIO-101 data continues to demonstrate favorable disease control and response rates, with full efficacy data anticipated in the latter half of this year, MAIA Biotechnology stands poised to redefine cancer treatment. THIO’s promise to transform the standard of care in oncology offers new hope to patients with advanced NSCLC, potentially establishing a new benchmark in cancer therapy. Featured photo by CI Photos at Shutterstock. 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

June 07, 2024 08:15 AM Eastern Daylight Time

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BioHarvest Sciences Hits Major Sales Milestone with VINIA seeing sales records

BioHarvest Sciences Inc

BioHarvest Sciences CEO Ilan Sobel joined Steve Darling from Proactive to announce a significant achievement: VINIA®, the first commercialized product developed on the Botanical Synthesis platform, set a new record for monthly sales orders in May, reaching 1.98 million. This represents a remarkable 101% increase compared to May 2023. During the interview, Sobel explained that the sales growth in BioHarvest's Products division was primarily driven by strong subscription rates for VINIA. The company's core nutraceutical capsule business saw significant growth, bolstered by additional "VINIA Inside" products, such as VINIA Superfood Coffee, part of the Hot Beverage lineup. This impressive sales performance underscores BioHarvest's successful Direct-to-Consumer sales strategy, which has consistently increased both the number of new customers and total subscribers. Looking ahead, the company is planning several new marketing programs set to launch in early June. These initiatives, combined with additional VINIA products in the near-term pipeline and the ramp-up of its CDMO Services Business Unit, position BioHarvest for a robust second quarter in 2024. Revenue for this period is projected to be in the range of $5.7-6.0 million. Sobel expressed confidence in the company's growth trajectory, highlighting the expansion of their product offerings and the ongoing success of their strategic marketing efforts. Furthermore, BioHarvest's investment in research and development continues to yield promising results, with new product innovations expected to further drive revenue and market penetration. The company's commitment to leveraging its unique Botanical Synthesis technology positions it as a leader in the nutraceutical space, offering high-quality, scientifically-backed products to a growing consumer base. Sobel also touched on the importance of sustainability and environmental responsibility in BioHarvest's operations. The company's production methods are designed to be eco-friendly, minimizing waste and reducing the carbon footprint, aligning with the increasing consumer demand for sustainable and ethically produced products. Contact Details Proactive North America +1 604-688-8158 NA-editorial@proactiveinvestors.com

June 06, 2024 12:02 PM Eastern Daylight Time

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This One Company Is Working On A Breakthrough Approach To Revolutionize Pain Management

Autonomix Medical, Inc.

By Austin DeNoce, Benzinga Autonomix Medical (NASDAQ: AMIX) is a medical device company dedicated to transforming the diagnosis and treatment of diseases or disorders related to the nervous system. At the core of Autonomix's innovative approach is a first-in-class technology platform featuring a catheter-based microchip sensing array. This technology boasts an unprecedented ability to detect and differentiate neural signals with up to 3,000 times greater sensitivity than existing technologies. This breakthrough has paved the way for transvascular diagnosis and treatment of nervous system diseases virtually anywhere in the body, offering a new horizon of medical possibilities and market opportunities. Clinical Studies In Pancreatic Cancer Pain Autonomix has initiated its first clinical study targeting pancreatic cancer pain, marking a significant milestone in its ongoing medical innovation. Pancreatic cancer represents a considerable unmet medical need, particularly concerning pain management. Effective solutions in this area are critically needed, as current relief options for pancreatic diseases are limited to drugs like opioids. In light of that, the initiation of these clinical studies represents a crucial step toward addressing this substantial healthcare challenge for suffering patients. Market Opportunities In addition to addressing the pain relief needs of patients, Autonomix’s technology presents significant market opportunities across various medical fields. By accurately targeting the nervous system, Autonomix aims to address unmet needs and improve treatments for a wide range of conditions including but not limited to: Pancreatic Cancer Pain: The successful application of Autonomix's technology in pancreatic cancer pain management would not only help pancreatic cancer patients find relief from pain but also unlocks significant market potential. Pancreatic cancer pain management is part of a $2.2 billion market for pancreatic cancer treatment. Chronic Pain: This market presents a significant opportunity estimated at $75 billion. Conditions such as lower back pain, pelvic pain, urinary tract pain, digestive disorders and other tumor-related pain are prevalent and often inadequately managed with current therapies, particularly opioids. Autonomix's technology offers the potential to significantly reduce or eliminate the dependence on opioids, providing a safer and more effective solution for chronic pain management. Cardiovascular Diseases: With a market opportunity estimated at $23 billion, Autonomix's technology could revolutionize the treatment of conditions like hypertension and cardiovascular disease. By targeting the nervous system's role in these diseases, more precise and effective treatments could be developed. Pulmonary Diseases: Chronic obstructive pulmonary disease (COPD) is another area where Autonomix's technology could have a substantial impact. The market for COPD treatments is estimated to be around $18 billion with considerable growth ahead, driven by the need for more effective and less side-effect-prone therapies. Autonomix's approach could provide a new paradigm in managing this debilitating condition. Meeting Unmet Needs with Innovative Solutions Current drug therapies for many of these conditions often come with significant side effects and do not adequately address the underlying issues. Autonomix's technology offers a promising alternative by providing targeted, nerve-based treatments that could improve patient outcomes and quality of life. This innovative approach aligns with Autonomix's mission to dramatically enhance the lives of millions by enabling precise and effective nerve-targeted treatments. In doing so, Autonomix can both detect and ablate malfunctioning nerves in one simple procedure, effectively opening new treatment options in the field of electrophysiology. The Full Opportunity Autonomix Medical sits at the forefront of a potential revolution in medical treatment for diseases driven by the nervous system. The company’s advanced technology platform not only offers hope for better management of pancreatic cancer pain, but also opens the door to addressing numerous other conditions with significant unmet need. By providing physicians with powerful new tools for diagnosis and treatment, Autonomix is poised to make a profound impact on the future of healthcare. Featured photo by Irwan on Unsplash. Autonomix is a medical device company focused on advancing innovative technologies to revolutionize how diseases involving the nervous system are diagnosed and treated. The Company’s first-in-class technology platform includes a catheter-based microchip sensing array that has the ability to detect and differentiate neural signals with approximately 3,000 times greater sensitivity than currently available technologies. We believe this will enable, for the first time ever, transvascular diagnosis and treatment of diseases involving the peripheral nervous system virtually anywhere in the body.We are initially developing our technology for pancreatic cancer pain, a condition that can cause debilitating pain and needs an effective solution. However, our technology constitutes a platform with the potential to address dozens of indications, including in cardiology, renal denervation and chronic pain management across a wide disease spectrum. Some of the statements in this release are “forward-looking statements,” which involve risks and uncertainties. Forward-looking statements in this press release include, without limitation, the timing of the completion of patient enrollment in the trial and the Company’s ability to successfully meet the milestones set forth in this press release on a timely basis, if at all. Such forward-looking statements can be identified by the use of words such as ‘should,’ ‘may,’ ‘intends,’ ‘anticipates,’ ‘believes,’ ‘estimates,’ ‘projects,’ ‘forecasts,’ ‘expects,’ ‘plans,’ and ‘proposes.’Although Autonomix Medical, Inc. (or Autonomix) believes that the expectations reflected in these forward-looking statements are based on reasonable assumptions, there are a number of risks and uncertainties that could cause actual results to differ materially from such forward-looking statements. You are urged to carefully review and consider any cautionary statements and other disclosures, including the statements made under the heading “Risk Factors” and elsewhere in the offering circular filed with the U.S. Securities and Exchange Commission (“SEC”) on January 26, 2024. Forward-looking statements speak only as of the date of the document in which they are contained and Autonomix does not undertake any duty to update any forward-looking statements except as may be required by law. This post contains sponsored content. This content is for informational purposes only and not intended to be investing advice. Contact Details JTC Team, LLC autonomix@jtcir.com Company Website https://autonomix.com/

June 06, 2024 09:00 AM Eastern Daylight Time

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