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Tonix Pharmaceuticals Nears Market Entry with Tonmya for Fibromyalgia Management

Tonix Pharmaceuticals

Tonix Pharmaceuticals CEO Dr. Seth Lederman joined Steve Darling from Proactive to announce the completion of the initial phase of an assessment conducted by EVERSANA® Life Science Services, LLC on the U.S. market opportunity for Tonmya. Tonmya represents a potential groundbreaking first-line therapy for fibromyalgia management, positioning itself as a non-opioid, centrally-acting alternative in a market dominated by opioids. Lederman highlighted the concerning dominance of opioids in the fibromyalgia prescription market, despite well-documented risks of dependency. Tonmya aims to address this gap by offering a safer, non-addictive option for fibromyalgia patients. EVERSANA's primary market research indicates promising interest from physicians, with a median interest rating of 4.0 on a 5-point scale and an intended use of Tonmya in 40% of fibromyalgia patients upon approval. The analysis also noted that approximately 50% of fibromyalgia patients in the U.S. are on Medicare. The Inflation Reduction Act, effective in 2025, will cap out-of-pocket prescription drug costs for Medicare patients, which could improve access to Tonmya if approved. With the submission of the New Drug Application (NDA) for Tonmya slated for the second half of the year, Tonix Pharmaceuticals anticipates an FDA decision on approval by 2025. Contact Details Proactive Investors +1 604-688-8158 na-editorial@proactiveinvestors.com

June 11, 2024 10:26 AM Eastern Daylight Time

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NOVUS INK Advisors and Solidus Capital Group Team-up to Serve Growing Transatlantic Commercial Interests of Mid-Market Enterprises

NOVUS INK Advisors

NOVUS INK Advisors and Solidus Capital Group signed a services agreement today to provide integrated senior advisory and execution services to small-and mid-market enterprises amid thriving commercial interests between the United States and Europe. The two firms aim to accelerate client services by combining expertise and resources to support growth into new markets, encompassing management counsel, valuation, performance tracking, board advisory, marketing, communication, public and government affairs. The collaboration will enable NOVUS INK Advisors and Solidus Capital Group to meet the unique needs of global small-and mid-market enterprise clients operating across business-to-consumer, business-to-business, and business-to-government segments. The transatlantic economy is proving remarkably robust in the face of global economic and geopolitical disruptions. No two other regions in the world are as deeply integrated as the United States and Europe, according to the 2024 Transatlantic Economy Report from the U.S. Chamber of Commerce, AmCham EU, Johns Hopkins SAIS and the Transatlantic Leadership Network. The report states: "the $8.7 trillion transatlantic economy employs more than 16 million workers in mutually onshored jobs on both sides of the Atlantic. It is the largest and wealthiest market in the world, accounting for half of total global personal consumption and close to one-third of world GDP in purchasing power. Ties are solid in foreign direct investment, portfolio investment, banking claims, trade and affiliate sales in goods and services, digital links, energy, mutual R&D investment, patent cooperation, technology flows, and sales of knowledge-intensive services." The services agreement will be overseen by a committee chaired by Pia De Lima and Daniel Diaz, NOVUS INK Advisors' Managing Partners, and Andreas Dal Santo, Solidus Capital Group's Managing Director. NOVUS INK Advisors is based in Miami. Solidus Capital Group, affiliated with Atlantic Business Labs, is based in New York. NOVUS INK Advisors is a communication, public and government affairs lobbying firm. NOVUS INK Advisors' practice areas include Corporate, Band and Product Reputation, Business Strategy, Crisis and Reputation Risk, Financial Services, Investor Relations, Mergers & Acquisitions, Brand and Product Marketing Communications Strategy, and Public and Government Affairs. NOVUS INK Advisors is a registered lobbying firm. To learn more, visit: www.NovusInk.com. Solidus Capital Group specializes in management consulting, business valuation, and board advisory services for firms expanding into North America, Latin America, and Europe. It is spearheading an ecosystem of companies, consultants, and subject matter experts with experience from different industries and regions to support corporate and institutional clients' global strategies and growth into new markets. To learn more, visit www.solidus-capital.com. CONTACTS: NOVUS INK Advisors: client.services@NovusInk.com Solidus Capital Group: client.services@Solidus-Capital.com Contact Details NOVUS INK Advisors Client Services client.services@NovusInk.com Company Website https://www.novusink.com/about

June 11, 2024 09:30 AM Eastern Daylight Time

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Surging Biotech M&A Reaffirms Massive Opportunity In Rare Disease Drug Development

RazorPitch CRDL NVO AZN SNY

Compared to their non-orphan counterparts, orphan drugs have consistently outpaced growth and have become a major part of pharma’s mainstream business. The U.S. FDA's orphan drug designation, established under the Orphan Drug Act of 1983, encourages the development of treatments for rare diseases affecting fewer than 200,000 people in the U.S. by providing incentives to offset the small market size. Last year, sales from orphan drugs soared to $168 billion, accounting for about 17% of the industry’s total and just shy of the entire oncology therapeutic category at $194 billion. This year, these drugs are on track to generate an impressive $185 billion and are projected to hit around $270 billion by 2028. For such a large cohort of drugs to still be growing at a double-digit pace is impressive and shows that continued investment into the unmet need of rare diseases is warranted. That explains why there has been a surge in M&A activity among orphan drug developers over the past couple of years. For instance, when novel cannabidiol-based drug Epidiolex successfully treated rare forms of child onset epilepsy, GW Pharmaceuticals more than doubled its market value. The 120-patient trial showed patients taking Epidiolex achieved a median reduction in monthly convulsive seizures of 39% compared with a reduction on placebo of 13%. GW Pharmaceuticals went on to be acquired by Jazz Pharmaceuticals for $7.2 billion in 2021, representing a premium of approximately 50% over GW's closing stock price at the time. Clearly, there is a significant opportunity in orphan drug development, which is why these four stocks have been generating substantial investor interest. Cardiol Therapeutics (NASDAQ:CRDL) is a Canadian biotech drug developer focused on developing their novel ultrapure cannabidiol formulation, CardiolRx™, for rare inflammatory heart diseases, specifically recurrent pericarditis and acute myocarditis. Pericarditis is characterized as inflammation of the pericardium, layers of tissue that surround the heart, that affects about 165,000 people in the U.S. annually and has no first-line FDA-approved treatment. Among those treated for acute pericarditis, 15% to 30% may experience recurrent pericarditis. Currently, anti-inflammatory drugs such as colchicine are prescribed for pericarditis treatment in cases of chronic or recurrent pericarditis. If the patient with pericarditis disease does not respond to anti-inflammatory medications, corticosteroids such as prednisone are prescribed. More recently, Kiniksa Pharmaceuticals’ ARCALYST® (rilonacept) became the first and only FDA-approved treatment indicated for the treatment of recurrent pericarditis and the reduction in risk of recurrence in adults and children 12 years and older. ARCALYST is a weekly subcutaneous injection, whereas CardiolRx™ is an oral drug taken twice daily which is a major advantage as the idea of weekly injections could not be as appealing to patients. Cardiol Therapeutics’ (NASDAQ:CRDL) pre-clinical models showed that by inhibiting activation of the NLRP3 inflammasome pathway, cannabidiol may help resolve the symptoms of pericarditis. This approach has already demonstrated incredible potential, as the company was granted Orphan Drug Designation (ODD) by the U.S. FDA for the treatment of pericarditis, which includes recurrent pericarditis. Cardiol Therapeutics followed this major achievement with completing enrollment in its Phase 2, open-label MAvERIC-Pilot study investigating the tolerance, safety, and effect of CardiolRx™ in patients with recurrent pericarditis. The primary endpoint of the trial is the change in patient-reported pericarditis pain using an 11-point numeric rating scale (NRS) from baseline to week 8 with topline results expected in early June. Not only that, Cardiol Therapeutics recently presented its concurrent Phase II ARCHER trial design at the annual congress of the Heart Failure Association of the European Society of Cardiology. This demonstrated the high level of interest from the cardiology community in novel approaches to treat acute myocarditis, for which there are currently no therapies approved by European and US regulatory authorities. The ARCHER trial is expected to enroll 100 patients at pre-eminent cardiovascular research centers in the United States, Canada, France, Brazil, and Israel. Patient recruitment has been accelerating due in large part to the growing global awareness of myocarditis, and ARCHER has already exceeded 85% of target enrollment. Cardiol Therapeutics (NASDAQ:CRDL) expects that results from the ARCHER trial will assist in furthering its understanding of the therapeutic potential of CardiolRx™ and will complement the more advanced MAvERIC-Pilot Phase II study in patients with recurrent pericarditis. Just to put the opportunity here in context, Future Market Insights expects that the worldwide pericarditis treatment market is likely to be worth $ 6 billion by 2032. ARCALYST’s sales further reaffirm this considering that the drug’s 2023 net revenue grew 90% year-over-year to $233.1 million. Several analysts have maintained their positive outlook on the company and have high hopes that the June data will further prove CardiolRx™ efficacy in treating recurrent pericarditis. In fact, Joe Gantoss of Chimera Research Group notes, “I won’t be surprised to see the price breaking out the 3-year high at $4.96 if the recurrent-pericarditis data show a clear success and open the path to move to the next stage with Phase-3 trial,” while analysts at H.C Wainwright & Co. issued a $9 price target for the stock. Novo Nordisk (NYSE:NVO) announced that it was buying Phase II-stage heart failure drug developer Cardior Pharmaceuticals (private) for up to $1.11 billion as it moves to strengthen its pipeline of drugs to treat cardiovascular disease and expand into areas outside of its core diabetes and weight-loss markets. The Denmark-based pharmaceutical giant is enjoying blockbuster success for its Wegovy and Ozempic obesity and diabetes treatments, which aren’t only proving highly effective at regulating blood sugar and helping patients lose weight, but are also yielding extra health benefits such as cutting the risk of stroke and heart attacks and slowing the progression of kidney disease. Based on these findings, the company recently unveiled plans to build a portfolio of therapies in areas like cardiovascular diseases and emerging-therapy areas while strengthening its progress in the rare-disease pipeline. CDR132L, Cardior’s lead compound, is designed to halt and reverse detrimental cardiac remodeling following myocardial infarction (MI) as the first-ever ncRNA-based therapy to enter clinical trials in heart disease. It is currently being investigated in the Phase 2 HF-REVERT clinical trial in 280 post-MI patients with cardiac dysfunction at more than 60 locations across Europe. AstraZeneca (NASDAQ:AZN) also announced that it has entered into a definitive agreement to acquire Amolyt Pharma, a clinical-stage biotechnology company focused on developing novel treatments for rare endocrine diseases for $800 million. The deal also features $250 million in milestones tied to a regulatory event. The proposed acquisition will bolster the Alexion, AstraZeneca Rare Disease late-stage pipeline and expand on its bone metabolism franchise with the notable addition of eneboparatide (AZP-3601), a Phase 3 investigational therapeutic peptide with a novel mechanism of action designed to treat hypoparathyroidism. In patients with hypoparathyroidism, a deficiency in parathyroid hormone (PTH) production results in significant dysregulation of calcium and phosphate, which can lead to life-altering symptoms and complications, including chronic kidney disease. It is one of the largest known rare diseases, affecting an estimated 115,000 people in the US and 107,000 people in the EU, approximately 80% of whom are women. Eneboparatide is designed to produce sustained and stable levels of calcium, which falls to low levels in patients with hypoparathyroidism, while preventing kidney disease and restoring bone turnover. Sanofi (NASDAQ:SNY) earlier this year agreed to buy the U.S. biotech Inhibrx Inc. for as much as $2.2 billion, giving the French drugmaker a potential therapy for a genetic disorder that affects the lungs and liver. Inhibrx shareholders will get $30 per share as part of the deal, along with the right to receive $5 in cash if the experimental drug meets a regulatory milestone. “The addition of INBRX-101 as a high potential asset to our rare disease portfolio reinforces our strategy to commit to differentiated and potential best-in-class products,” said Houman Ashrafian, Sanofi’s head of research and development. “With our expertise in rare diseases and growing presence in immune-mediated respiratory conditions, INBRX-101 will complement our approach to deploy R&D efforts in key areas of focus.” Disclaimers: RazorPitch Inc. "RazorPitch" is not operated by a licensed broker, a dealer, or a registered investment adviser. This content is for informational purposes only and is not intended to be investment advice. The Private Securities Litigation Reform Act of 1995 provides investors a safe harbor in regard to forward-looking statements. Any statements that express or involve discussions with respect to predictions, expectations, beliefs, plans, projections, objectives, goals, assumptions, or future events or performance are not statements of historical fact may be forward looking statements. Forward looking statements are based on expectations, estimates, and projections at the time the statements are made that involve a number of risks and uncertainties which could cause actual results or events to differ materially from those presently anticipated. Forward looking statements in this action may be identified through use of words such as projects, foresee, expects, will, anticipates, estimates, believes, understands, or that by statements indicating certain actions & quote; may, could, or might occur. Understand there is no guarantee past performance will be indicative of future results. Investing in micro-cap and growth securities is highly speculative and carries an extremely high degree of risk. It is possible that an investors investment may be lost or impaired due to the speculative nature of the companies profiled. RazorPitch has been retained and compensated by Cardiol Therapeutics to assist in the production and distribution of content related to CRDL. RazorPitch is responsible for the production and distribution of this content. It should be expressly understood that under no circumstances does any information published herein represent a recommendation to buy or sell a security. This content is for informational purposes only, you should not construe any such information or other material as legal, tax, investment, financial, or other advice. Nothing contained in this article constitutes a solicitation, recommendation, endorsement, or offer by RazorPitch or any third party service provider to buy or sell any securities or other financial instruments. All content in this article is information of a general nature and does not address the circumstances of any particular individual or entity. Nothing in this article constitutes professional and/or financial advice, nor does any information in the article constitute a comprehensive or complete statement of the matters discussed or the law relating thereto. RazorPitch is not a fiduciary by virtue of any persons use of or access to this content. Contact Details RazorPitch Inc Mark McKelvie +1 585-301-7700 mark@razorpitch.com Company Website http://razorpitch.com

June 11, 2024 06:00 AM 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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Room to Roam: ‎The Elephant’s Path to Climate Resilience

News Media Group, Inc.

Contact Details Karl Wayne +1 334-440-6397 karl@newsmg.com Company Website https://newsmg.com/

June 10, 2024 07:00 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

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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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