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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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Manitoba Woman Beats Stage 4 Cancer with Breakthrough CAR T-Cell Therapy

MarketJar

Disseminated on behalf of CERo Therapeutics Holdings, Inc. Cancer treatments have come a long way over the years, but there is a newer treatment that is providing even stage four cancer patients with a new lease on life. The first CAR T-cell therapy was only approved in 2017, but it’s already having a significant impact in the cancer treatment market. The latest success story comes from Sandra Hajlo, who just became the first person in Manitoba to be declared cancer-free following CAR T-cell therapy. 1 Initially diagnosed with stage four B-cell lymphoma in 2015, Hajlo underwent successful chemotherapy. However, eight years later, her cancer returned, leading to another battle with the disease. After a misdiagnosis of scoliosis, a CT scan revealed her cancer had come back. Her oncologist recommended CAR T-cell therapy, a new treatment where T-cells are modified to target cancer cells, making her the first recipient of this therapy at CancerCare Manitoba. Dr. David Szwajcer, Manitoba Blood & Marrow Transplant Director at CancerCare Manitoba, explained that the CAR T-cells are collected, sent to a U.S. facility for modification, and then reintroduced to the patient. Hajlo described the procedure as quick and straightforward, taking only 20 minutes. After undergoing CAR T-cell therapy in December 2023, Hajlo learned in April 2024 that the treatment was successful, and she is cancer-free once again, expressing her gratitude for the second chance at life. CAR T-cell therapy does not guarantee survival, with about half of the patients not responding,but it has shown promising results in many cases. CERo Therapeutics Holdings (NASDAQ:CERO) is an innovative immunotherapy company seeking to advance the next generation of engineered T cell therapeutics. CERo Therapeutics is unrelated to CancerCare Manitoba and had no role in the CAR T-cell therapy described above. Nevertheless, CERo Therapeutics believes that the success of the CAR T-cell therapy in Manitoba may provide an indication of the potential for its proprietary CER-T (chimeric engulfment receptor) cell therapy. CAR-T cell treatment has a steep price tag and some potential serious side effects including secondary cancer developing 2 as well as cytokine release syndrome (CRS), 3 which causes your immune system to go into overdrive and is potentially life threatening. CER-T cell therapy may provide a more cost-effective alternative with fewer side effects. CERo Advances Innovative Cancer Immunotherapy CERo Therapeutics (NASDAQ:CERO) developed CER-T cells to enhance efficiency and reduce side effects compared to traditional therapies by leveraging the body's natural tumor-fighting mechanisms. CER-T cells achieve this through direct tumor killing and by amplifying the body's anti-tumor immune response, and additionally by presenting cancer cell fragments to other immune cells, drawing these cells to attack the tumor. Peer-reviewed data shows that CER-T cells have at least eight anticancer functions, offering potent, durable, and low-toxicity therapeutic benefits, with the capability to completely eliminate tumors. The company has validated these findings in 10 animal experiments, including a study on Acute Myeloid Leukemia (AML) published in March 2024. CERo Therapeutics believes CER-T cells offer greater therapeutic potential than currently approved chimeric antigen receptor (CAR-T) cell therapy, potentially targeting both hematological malignancies and solid tumors. The company plans to begin clinical trials for its lead product candidate, CER-1236, in 2024 for treating hematological malignancies. CERo has been diligently completing pre-clinical studies and documentation necessary to initiate clinical trials after gaining approval from the FDA for its Investigational New Drug (IND) Application. CERo Therapeutics Holdings, Inc., (NASDAQ:CERO) has successfully completed toxicity studies for CER-1236, a critical step before applying to the FDA for approval to begin human trials. With these studies showing that CER-1236 can be safely administered, the company is now focusing on ensuring safe manufacturing and finalizing its FDA application. Upon FDA acceptance, the company would be able to commence Phase 1 clinical trials, marking the start of the journey toward US approval and addressing unmet medical needs. CERo plans to update shareholders on their progress, including presentations at investor conferences, potential growth of their intellectual property portfolio, and advancements in other programs beyond AML. Click here for more information CERo Therapeutics Holdings, Inc., (NASDAQ:CERO). Footnotes: [1] https://globalnews.ca/news/10428035/manitobas-first-car-t-cell-therapy-patient-declared-cancer-free/ [2] https://jamanetwork.com/journals/jama/article-abstract/2815500 [3] https://www.pennmedicine.org/cancer/navigating-cancer-care/treatment-types/immunotherapy/what-is-car-t-therapy Disclosure: 1) The author of the Article, or members of the author’s immediate household or family, do not own any securities of the companies outlined in this Article. The author determined which companies would be included in this article based on research and understanding of the sector. 2) The Article was issued on behalf of and sponsored by, CERo Therapeutics Holdings, Inc. Market Jar Media Inc. was paid $1,500 USD for the production and publishing of this article by CERo Therapeutics Holdings, Inc.’s Digital Marketing Agency of Record (Native Ads Inc.). Additional details relating to Market Jar Media Inc.’s engagement by CERo Therapeutics Holdings, Inc.’s Digital Marketing Agency of Record (Native Ads Inc.) are set out in https://pressreach.com/disclaimer-cero. 3) Statements and opinions expressed are the opinions of the author and not Market Jar Media Inc., its directors or officers. The author is wholly responsible for the validity of the statements. The author was not paid by Market Jar Media Inc. for this Article. Market Jar Media Inc. was not paid by the author to publish or syndicate this Article. Market Jar has not independently verified or otherwise investigated all such information. None of Market Jar or any of their respective affiliates, guarantee the accuracy or completeness of any such information. The information provided above is for informational purposes only and is not a recommendation to buy or sell any security. Market Jar Media Inc. requires contributing authors to disclose any shareholdings in, or economic relationships with, companies that they write about. Market Jar Media Inc. relies upon the authors to accurately provide this information and Market Jar Media Inc. has no means of verifying its accuracy. 4) The Article does not constitute investment advice. All investments carry risk and each reader is encouraged to consult with his or her individual financial professional. Any action a reader takes as a result of the information presented here is his or her own responsibility. By opening this page, each reader accepts and agrees to Market Jar Media Inc.'s terms of use and full legal disclaimer as set forth here. This Article is not a solicitation for investment. Market Jar Media Inc. does not render general or specific investment advice and the information on PressReach.com should not be considered a recommendation to buy or sell any security. Market Jar Media Inc. does not endorse or recommend the business, products, services or securities of any company mentioned on PressReach.com. 5) Market Jar Media Inc. and its respective directors, officers and employees hold no shares for any company mentioned in the Article. 6) This communication contains statements that are forward-looking and as such are not historical facts. This includes, without limitation, statements regarding the financial position, business strategy and the plans and objectives of management for future operations of CERo. These statements constitute projections, forecasts and forward-looking statements, and are not guarantees of performance. Such statements can be identified by the fact that they do not relate strictly to historical or current facts. When used in this communication, words such as “anticipate,” “believe,” “continue,” “could,” “estimate,” “expect,” “intend,” “may,” “might,” “plan,” “possible,” “potential,” “predict,” “project,” “should,” “strive,” “would” and similar expressions may identify forward-looking statements, but the absence of these words does not mean that a statement is not forward-looking. When CERo discusses its strategies or plans, it is making projections, forecasts or forward-looking statements. Such statements are based on the beliefs of, as well as assumptions made by and information currently available to, CERo’s management. Actual results could differ from those implied by the forward-looking statements in this communication. Certain risks that could cause actual results to differ are set forth in CERo’s filings with the Securities and Exchange Commission, including its Annual Report on Form 10-K, filed on April 2, 2024, and the documents incorporated by reference therein. The risks described in CERo’s filings with the Securities and Exchange Commission are not exhaustive. New risk factors emerge from time to time and it is not possible to predict all such risk factors, nor can CERo assess the impact of all such risk factors on its business, or the extent to which any factor or combination of factors may cause actual results to differ materially from those contained in any forward-looking statements. Forward-looking statements are not guarantees of performance. You should not put undue reliance on these statements, which speak only as of the date hereof. All forward-looking statements made by CERo or persons acting on its behalf are expressly qualified in their entirety by the foregoing cautionary statements. CERo undertakes no obligation to update or revise publicly any forward-looking statements, whether as a result of new information, future events or otherwise, except as required by law. 7) Any graphs, tables or other information demonstrating the historical performance or current or historical attributes of CERo Therapeutics Holdings, Inc. or any other entity contained in this document are intended only to illustrate historical performance or current or historical attributes of CERo Therapeutics Holdings, Inc. or such entities and are not necessarily indicative of future performance of CERo Therapeutics Holdings, Inc. or such entities. 8) Investing is risky. The information provided in this article should not be considered as a substitute for professional financial consultation. Users should be aware that investing in any form carries inherent risks, and as such, there is a possibility of losing some or all of their investment. The value of investments can fluctuate significantly within a short period, and investors must understand that past performance is not indicative of future results. Additionally, users should exercise caution as transactions involving investments may be irreversible, even in cases of fraud or accidental actions. It is crucial to acknowledge that rapidly evolving laws and technical issues can have adverse effects on the usability, transferability, exchangeability, and value of investments. Furthermore, users must be cognizant of potential security risks associated with their investment activities. Individuals are strongly encouraged to conduct thorough research, seek professional advice, and carefully evaluate their risk tolerance before engaging in any investment endeavors. Market Jar Media Inc. is neither an investment adviser nor a broker-dealer. The information presented on the website is provided for informative purposes only and is not to be treated as a recommendation to make any specific investment. No such information on PressReach.com constitutes advice or a recommendation. Contact Details James Young +1 800-340-9767 campaigns@pressreach.com Company Website https://pressreach.com

June 06, 2024 08:30 AM Eastern Daylight Time

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Culturelle® Probiotics and Re:wild Team Up to ‘Protect the Gut Microbiome’

YourUpdateTV

A new campaign from Culturelle® Probiotics and global conservation non-profit, Re:wild, is highlighting the similarities between endangered ecosystems on Earth and the endangered ecosystem within: the human gut microbiome. Recently, Dr. Robin Moore from Re:wild, participated in a nationwide satellite media tour to discuss the new initiative. A video accompanying this announcement is available at: https://youtu.be/JT_Nv2wpwrU Earth’s ecosystems are what sustain us. They are our first line of defense against emerging diseases and climate chaos, and they provide everything from clean air and water to food and medicines. But research shows that the populations of mammals, birds, reptiles, amphibians and fish have declined by nearly 70% since 1970. And a loss of biodiversity can significantly disrupt an ecosystem – lowering its productivity and quality. The gut microbiome – made up of trillions of living, breathing bacterial species – is also facing a loss of biodiversity and is under constant siege from a variety of modern-day stressors, like anxiety, lack of sleep, and poor eating habits, that can put it out of balance and hinder its ability to thrive. This led the Culturelle brand to make a poignant connection between the vulnerable state of our gut microbiome and the other ecosystems of the world. The gut is a critical ecosystem — and it's at risk. Culturelle Probiotics and Re:wild have teamed up to draw attention to the similarities between the endangered ecosystems of our world and the ecosystem within – the human gut microbiome – and raise awareness on the importance of protecting biodiversity in all ecosystems, both inside and out. To learn more about the campaign, visit ProtectTheGut.com. About Dr. Robin Moore Dr. Robin Moore blends his scientific training with his passion for photography and storytelling to connect a broad audience with the urgency and opportunity for saving endangered species and critical ecosystems. Recognizing the importance of communications for challenging perceptions and changing behaviors, Robin has spearheaded innovative campaigns to raise the profile of too-often overlooked species. The Search for Lost Frogs, a global quest to find species missing for decades, attracted significant media attention and inspired the book, In Search of Lost Frogs, which was named one of The Guardian’s best nature books of 2014. Robin is an award-winning photographer and Senior Fellow of the International League of Conservation Photographers. The Search for Lost Species, a signature initiative of Re:wild, builds on this success. About Culturelle® Probiotics For more than 25 years, Culturelle® Probiotics have helped individuals, children and families support their health. Covering digestive, immune, feminine, and pediatric health, Culturelle® product formulations are based on science, utilizing clinically studied probiotics to support the unique benefits of each product. Plus, the ingredients are proven effective and work in harmony with the human body.* About Re:wild Re:wild protects and restores the wild. They have a singular and powerful focus: the wild as the most effective solution to the interconnected climate, biodiversity and human wellbeing crises. Re:wild brings together Indigenous peoples, local communities, influential leaders, nongovernmental organizations, governments, companies and the public to protect and rewild at the scale and speed we need. Learn more at rewild.org. © 2024 dsm-firmenich group, Culturelle® is a trademark of the dsm-firmenich group. * The Food and Drug Administration has not evaluated these statements. This product is not intended to diagnose, treat, cure, or prevent any disease. Contact Details YourUpdateTV +1 212-736-2727 yourupdatetv@gmail.com

June 05, 2024 03:46 PM Eastern Daylight Time

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Mainz Biomed (NASDAQ: MYNZ) Announces Positive Topline Results From Cancer Detection Studies, Including 92% Sensitivity Rate

Benzinga

By James Blacker, Benzinga Mainz Biomed NV (NASDAQ: MYNZ), a company that specializes in the early detection of cancer, recently shared encouraging topline results from a clinical study designed to test the next-generation version of its colorectal cancer screening tool, ColoAlert®. The company recently unveiled compelling findings from its most expansive group to date at the 2024 Annual Meeting of the American Society of Clinical Oncology (ASCO) in Chicago, Illinois, as well as virtually. The comprehensive examination consisted of 690 participants from 30 reputable gastroenterology facilities in Europe and the United States, and introduced previously unexplored and unreported specimens. The results underscored the effectiveness of Mainz Biomed's multimodal screening test, marking significant advancements in colorectal cancer detection. Notable figures include a sensitivity of 92.3% for colorectal cancer, a specificity of 90.1%, a sensitivity rate of 82.2% for advanced precancerous lesions, and an impressive high-grade dysplasia detection rate of 95.8%. With the success of this study, Mainz Biomed now plans to move forward with a major clinical trial in the U.S., which will involve up to 15,000 participants. If this next trial produces positive results, the company says its next-generation tool has the potential to disrupt the at-home colorectal cancer screening market by becoming a new gold standard. “The new data read-out demonstrates that our next generation product candidate for early-stage CRC detection utilizing mRNA biomarkers, a FIT test and a proprietary AI algorithm has consistently delivered high sensitivity and specificity for both advanced adenomas and colorectal cancer,” said Guido Baechler, CEO of Mainz Biomed, “These results represent a critical milestone on our path to launching our FDA PMA pivotal study ReconAAsense, which is planned to recruit up to 15,000 patients.” Why Early Detection Matters According to the American Cancer Society’s latest publication, the incidence of colorectal cancer has increased alarmingly since the mid-1990s, continuing to rise between 1% and 2% each year in people under the age of 55. Since the mid-2000s, the mortality rate among young people has increased at a similar rate. Colorectal cancer is the third most common cancer worldwide and the second leading cause of cancer-related deaths worldwide. However, it is also the most preventable, with early detection leading to survival rates above 90 %. About Mainz Biomed Founded in Germany, Mainz Biomed is becoming a leading global provider of easy-to-use diagnostic solutions for patients and healthcare providers everywhere. The company develops market-ready molecular genetic diagnostic solutions for life-threatening conditions. It is involved in the commercializing of its product portfolio in Europe, the United States and the rest of the world, and develops innovative products to quickly and reliably identify the early onset of several leading deadly conditions – such as pancreatic cancer and colorectal cancer. The company reports that its CE-IVD-cleared flagship product, ColoAlert, is the first DNA-based screening test for colorectal cancer in Europe, and that it is developing proprietary genetic testing methods for pancreatic cancer. For 2023, the company earned revenues of $895,479, which compared to revenues of $529,877 in 2022. What Sets ColoAlert Apart In a market with established players such as Cologuard from Exact Sciences Corporation (NASDAQ: EXAS), ColoAlert stands out as an innovative product that addresses the need for a convenient and user-friendly test. Mainz Biomed claims that ColoAlert is not only more effective than traditional blood tests at detecting precancerous polyps early but also detects more cases of colorectal cancer than other stool tests. As Mainz Biomed plans its upcoming major trial in the U.S., the company could be one to watch as a force in the fight against cancer. More information about the company can be found at mainzbiomed.com. Featured photo by Gerd Altmann on Pixabay. 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 05, 2024 08:30 AM Eastern Daylight Time

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OncoCyte's Innovative Approach: Potential in Precision Diagnostics

RazorPitch OCX

Chronic conditions such as organ transplant rejection and cancer represent significant challenges in modern healthcare, demanding precise diagnostic tools for effective management and treatment. For organ transplant patients, the risk of graft rejection remains a persistent threat, necessitating continuous monitoring to ensure long-term success. Similarly, the complexity of cancer requires advanced diagnostics to tailor treatments to individual patients, optimizing therapeutic efficacy while minimizing adverse effects. Amidst these challenges, OncoCyte Corporation (NASDAQ: OCX ) has emerged as an innovative player in the precision diagnostics market. The company's tests enhance clinical outcomes for patients undergoing organ transplants and cancer treatments. With recent strategic partnerships and regulatory advancements, OncoCyte has spearheaded transformative advancements in the field. OCX’s product portfolio includes VitaGraft, a clinical blood-based test for monitoring solid organ transplants, and GraftAssure, a research-use-only test for the same purpose. Additionally, DetermaIO and DetermaCNI are designed for oncology applications, predicting responses to immunotherapies and monitoring therapeutic efficacy, respectively. Partnerships In April 2024, OCX partnered with Bio-Rad Laboratories (NYSE: BIO) to commercialize the GraftAssure assay. This agreement leverages Bio-Rad's extensive reach and expertise in the life sciences sector, facilitating the co-marketing of GraftAssure in the U.S. and Germany. Bio-Rad holds exclusive global distribution rights outside these regions. This collaboration is pivotal for scaling OncoCyte's operations and meeting the growing demand for transplant diagnostics. The partnership also includes an option for Bio-Rad to acquire IVD commercial rights upon FDA clearance, subject to specific milestones. This option comes with a second equity investment into OncoCyte, reflecting Bio-Rad's confidence in the product's market potential. Riggs noted, "The QX600 ddPCR platform, along with their expertise in the life science market, makes Bio-Rad a natural partner for our transplant technology." Financial Performance OncoCyte's Q1 2024 financial results indicate a strategic focus on commercialization and cost-efficiency. The company reported gross proceeds of $15.8 million from an equity private placement, including a significant investment from Bio-Rad. This funding is crucial for advancing OncoCyte's product pipeline and expanding its market presence. Operational efficiency is evident, with OncoCyte reducing its cash burn to $3.9 million, reflecting a capital-efficient business model. The collaboration with Bio-Rad and the anticipated commercial launch of GraftAssure RUO test kits in Asia, the U.S., and the EU are expected to drive revenue growth and broaden the company's market reach. Riggs remarked, "The collaboration with Bio-Rad is pivotal for the upcoming launch of our GraftAssure RUO transplant rejection diagnostic test kit and central to our mission of developing accessible point-of-care diagnostics and continuous innovation in transplant rejection monitoring." Publication in New England Journal of Medicine OCX announced a significant milestone on May 30, 2024, with the publication of promising data on VitaGraft Kidney in the New England Journal of Medicine. This phase 2 study highlights VitaGraft Kidney’s potential to revolutionize kidney transplant care by accurately monitoring graft health through measuring donor-derived cell-free DNA (dd-cfDNA). For investors, this development signals substantial market potential. VitaGraft Kidney's ability to monitor therapeutic efficacy and detect disease recurrence opens new revenue streams. This test could become a standard in post-transplant care, driving repeated testing and long-term revenue. VitaGraft Kidney addresses a critical unmet need. Up to 20.2% of kidney transplant patients develop antibody-mediated rejection (AMR) within 10 years, with no FDA-approved drugs currently available for AMR management. The combination of VitaGraft testing and felzartamab therapy offers a promising solution, potentially improving patient outcomes and healthcare efficiency. OCX CEO Josh Riggs emphasized the breakthrough nature of this study, stating, “This positions VitaGraft Kidney as a crucial tool in managing transplant health. Our recent partnership with Bio-Rad expands our capacity to deliver these innovative solutions globally.” Riggs highlighted the test’s competitive edge in detecting AMR up to 10 months earlier than current protocols, enhancing patient care, and strengthening OncoCyte’s market position. The findings will be presented at the 2024 American Transplant Congress on June 3, 2024. This presentation is expected to further validate VitaGraft Kidney’s clinical value and could act as a catalyst for broader market adoption. OncoCyte’s latest publication not only validates VitaGraft Kidney’s clinical potential but also strengthens the company’s market position. As OCX continues to innovate and expand its market reach, investors can anticipate significant growth opportunities in the precision diagnostics sector. 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 PCG Advisory Inc. to assist in the production and distribution of this content. 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 05, 2024 07:00 AM Eastern Daylight Time

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