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Centre for Neuro Skills Study Finds Differences in Sleep Patterns Between Men and Women with Post-Traumatic Brain Injury

Centre for Neuro Skills

Centre for Neuro Skills (CNS), a premier provider of traumatic and acquired brain injury rehabilitation services, has shared findings from a study researching sleep-wake disturbances, published in Neurotrauma Reports on January 3, 2024. They found that sleep deficits are correlated with poorer brain injury patient outcomes (verbal skills, depression issues), as monitored by therapists and administrators at CNS. The study included data from 57 individuals between the ages of 18-70 who sustained traumatic brain injuries (TBIs). CNS collected the data between 2018-2020 at its in-house sleep centers in Dallas and Bakersfield. “Overall, we found that lack of REM sleep negatively impacts memory and learning for TBI patients,” says Dr. Stefanie Howell, a neuroscientist at CNS. “In research, we must also consider additional variables that may impact our results. This includes biological variables such as sex, as biological sex does impact sleep. Our research found that women achieve REM sleep far less than men. Additionally, a decrease in REM sleep was associated with poorer learning and memory task performance, indicating a potential impact on outcome and recovery.” In addition to biological sex, CNS evaluated several sleep medications to determine if their use impacted sleep for TBI patients. Howell said “medications do not seem to be impacting results between men and women; however, the use of melatonin was associated with improved REM sleep and may therefore be of potential short-term benefit to TBI patients. It is important to note that over-the-counter melatonin options are variable due to formula ingredients.” “Through research, we’ve found that while sleep supplements in the benzodiazepine family may cause someone to fall asleep, they suppress REM sleep, which is crucial for memory recollection and improved learning,” says Dr. Brent Masel, executive vice president of medical affairs at CNS. “Melatonin was found to help improve REM sleep in the short term, but it’s important to note that long-term use can be habit-forming. I cannot stress this enough – the best medication is no medication.” In 2021, CNS published two other studies regarding sleep-wake disturbances post-stroke. The first evaluated the incidence of obstructive sleep apnea (OSA) and the second study considered the anatomical location of the injury (stroke). *** About Centre for Neuro Skills Centre for Neuro Skills is an experienced and respected world leader in providing intensive rehabilitation and medical programs for those recovering from all types of brain injury. CNS covers a full spectrum of advanced care from residential and assisted living to outpatient/day treatment. Founded by Dr. Mark Ashley in 1980, CNS has seven locations in California and Texas. For more information about Centre for Neuro Skills, visit: www.neuroskills.com, Facebook, Twitter, LinkedIn, YouTube. Media, please note: Visual assets, including photos, are available. To request an interview with CNS leadership or clinical staff, please contact Robin Carr at 415.766.0927 or CNS@landispr.com. # # # Contact Details Landis Communications Inc. Robin Carr +1 415-766-0927 cns@landispr.com Company Website https://www.neuroskills.com/

March 04, 2024 08:01 AM Pacific Standard Time

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No More Jitters? Company Says Its Hydro-CaffeineTM Improves Your Morning Caffeine Fix’s Benefits By 400-500%

Rexis Biotech

By Meg Flippin, Benzinga It’s no secret that many people turn to chugging caffeine-induced drinks to get them through the day. But what they may not realize is too much caffeine can be a bad thing. Jitters, elevated heart rates and anxiety are just some of the side effects many consumers just learn to accept. But caffeine overload doesn’t have to be the foregone conclusion just to get your caffeine fix. Products like Rexis Biotech Inc.’s Hydro-Caffeine TM are revolutionizing the energy drink market. Thanks to its nanotechnology, the Delaware biotech firm says it has created a better caffeine that gives you energy without all the bad side effects. Quadruple The Effects For Less Hydro-Caffeine can be found in Rexis’s new groundbreaking energy drink Squared Energy, a product line extension to their already successful Squared brand which is available in over 2,000+ retailers in 10 states across the country. It is created using the company’s proprietary co-crystal that amplifies the effects by increasing the bioavailability of its caffeine co-crystal by four to five times. Rexis is taking it up a level with this drink by fusing Hydro-Caffeine with naturally occurring Hemp Delta-9 THC + broad-spectrum CBD to create a singular polymorph molecule in which all three work together for the ultimate entourage effect. That creates a unique experience for consumers highlighted by clear-headed, focused energy without any jitters or anxiety, according to Rexis. The first two flavors they’ll be bringing to market include a Raspberry Lemonade and their High Spirits Awards-winning Sparkling Grapefruit. Hydro-Caffeine could be a huge winner for both consumers and Rexis shareholders; caffeine is a very popular energy stimulant. Not only does caffeine give you energy but it can reduce the risk of cardiovascular disease and type 2 diabetes and improve longevity, which is why caffeine is so popular in the U.S. and abroad. While coffee and tea are the most common ways to get a caffeine fix, energy drinks, caffeine pills and supplements are also popular. In fact, the global energy drinks market is poised to reach $108.4 billion by 2031, growing at a CAGR of 8.2% from 2022 to 2031. In the U.S. 93% of Americans say they consume caffeine, with 75% partaking in it daily, according to the International Food Information Council. One-quarter of that group consumes caffeine three or more times a day. It is the latter group that worries doctors. Caffeine overdose is real and can lead to several issues including insomnia, jitters, anxiety, elevated heart rate and headaches. It tends to happen a lot since many Americans underestimate the safe amount of caffeine to consume and still remain healthy. Worse, the International Food Information Council found nearly 29% of consumers in the U.S. say they don’t know what the safe amount of caffeine is. The Secret Sauce Rexis says that with Squared Energy, you need not worry about getting too much or too little caffeine to reap the benefits. The secret behind it is the Hydro-Caffeine fibers which are absorbed more efficiently and rapidly through sublingual and buccal absorption in the cheeks and mouth. That differs from traditional energy drinks, which use a form of encapsulated caffeine in which the caffeine is coated with a sugar-type substance to eliminate bitter flavors. That process increases the time it takes to absorb, decreasing the portion introduced into circulation. The caffeine then must be processed by first-pass metabolism, which reduces efficacy even more. As a result, Rexis says you may receive as much as 25% less of the ingredient in your system than what is said on the packaging. “Shaking Up” The Market Rexis’s potentially game-changing Squared Energy drink isn’t the only way the biotech is shaking up the consumer markets. With its proprietary nanotechnology, it can improve the potency, taste and speed of effectiveness in everything from energy drinks to cannabis-infused beverages. The goal of Rexis Biotech is to be the Nvidia Corp. (NASDAQ: NVDA) or Intel Corp. (NASDAQ: INTC) of the consumer packaged goods industry. It envisions a world where brands license Rexis’s nanotechnology to enhance everything from drinks to food. To meet that end Rexis also manufactures and distributes products for companies including Hemp D9 beverages for 3Chi and functional mushrooms for First Person. It also licenses its technology to brands in the regulated cannabis market including Smokiez and Happy Valley. Caffeine will always be a preferred way to get a boost, but that doesn’t mean consumers have to accept the negative side effects. Jitters, headaches and elevated heart rates could become a thing of the past thanks to Rexis Biotech. Rexis Biotech is currently raising funds to support its growth. Click here to learn more about Rexis Biotech’s crowdfunding raise, and how to invest in the company the founders are modeling after Nvidia! Featured photo by Mark Daynes on Unsplash. Rexis is the industry leader and pioneer in developing Hydrophobic Molecule Delivery systems. Leading in the innovation, production and formulation of water based ingredients for use in the Pharmaceutical and Consumer Packaged goods industry. Established in 2022, Rexis is building a core mix of proprietary IP used to sustain strong sales models with pharmaceutical licensees, consumer packaged goods manufacturers and clinical research teams. This post contains sponsored content. This content is for informational purposes only and is not intended to be investing advice. Contact Details Ryan Erving ryan@rexissystems.com Company Website https://www.rexissystems.com

March 04, 2024 08:25 AM Eastern Standard Time

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Unlocking the Secrets to Global Impact - Dr. Christina Rahm's Entrepreneurial Triumph

Deep Root Causes Ventures

Dr. Christina Rahm, a visionary entrepreneur, scientist, and philanthropist, is set to captivate audiences with her insights as a featured speaker at SXSW in Austin at the Grit Daily House on March 10. With over 30 years of experience, Dr. Rahm has emerged as a trailblazer in addressing global issues through her groundbreaking work in entrepreneurship and scientific innovation. Dr. Rahm, holding degrees in counseling, education, philosophy, and strategic sciences, stands as a well-rounded powerhouse committed to holistic well-being. Her roles as a scientist, inventor, artist, and philanthropist showcase her diverse skill set. Operating under DRC Ventures, Dr. Rahm leads 12 entities dedicated to humanity's betterment and aims to create positive global change. The Root Brands, Ella Pure Beauty, Rahm Roast, and her book " Cure the Causes: Live the Life You Want, Not the One Prescribed " exemplify her commitment to transformative ventures. The Root Brands products foster exceptional lifestyles, Ella Pure Beauty is an all-natural skincare line, and Rahm Roast is an all-natural clean coffee blend. Dr. Rahm is currently immersed in pioneering research in pharmaceutical, nutraceutical, biotechnology, and environmental sciences, contributing to global advancements. Dr. Rahm recently visited the Kennedy Center in Washington, D.C., where she shared her new book, “Roots of Military Science: Understanding the intersection of conflict, mental health and wellness”. Last winter, she was also on a European speaking tour, giving several presentations at prestigious events such as the World Economic Forum in Davos, Switzerland, and more. Dr. Rahm's speaking engagement at SXSW will continue to provide insights into her disruptive vision. Dr. Christina Rahm, Ph.D., is an internationally known scientific leader, spokesperson, and innovator in health and wellness whose approach revolves around dismantling root problems. A living embodiment of her motto, "the most important environment is yours," she travels the world presenting, lecturing, and educating the private and public sectors about the bold new world of nutraceuticals, wellness strategies, and environmental solutions, ultimately paving the way for the advancement of humanity. Contact Details R Public Relations Madison Baber +1 210-213-2426 madison@rprfirm.com Company Website https://www.drc-ventures.com/

February 29, 2024 03:44 PM Eastern Standard Time

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For The First Time The US Is Set To Hit 2 Million New Cancer Cases: Theriva Biologics Presents Novel Solutions To The Deadliest Cancers

Benzinga

By Faith Ashmore, Benzinga A recent cancer study showed that the incidence rates of early-onset cancer “increased substantially” from 2010 to 2019. Breast cancer had the highest number of incident cases, and gastrointestinal cancers had the fastest-growing incidence rates among all early-onset cancers. The National Cancer Institute reports that colorectal cancer has become the leading cause of cancer-related deaths for Americans aged 20 to 59 years old. Doctors are expecting that in 2024, there will be more than 2 million new cases of cancer; this would be the first year the U.S. would cross that threshold, marking almost 5,500 cancer diagnoses a day. The increasing cancer incidence, especially among young people, is a big cause for concern in the medical community. Specifically, there is an increase in pancreatic cancer, which is expected to become the second-highest cause of cancer-associated deaths in 2030 in the U.S. Fortunately, fatality rates from cancer have steadily been on the decline for the past 30 years. This is largely due to better detection systems and advancements in treatment. Theriva Biologics (AMEX: TOVX) is one of the biotech companies that is helping push the envelope in cancer treatment. The company specializes in developing oncolytic viruses that are unique and highly differentiated. These viruses have been optimized for systemic administration and are designed to treat various types of cancer and make other cancer therapies more effective. They are optimized to be administered in combination with chemotherapy and immunotherapies, increasing access to the tumor and exposing the tumor to the immune system. The company’s lead drug candidate is VCN-01, which is a uniquely engineered human adenovirus 5. VCN-01 also expresses a protein named hyaluronidase that degrades the dense matrix surrounding human tumors, and this helps the action of chemotherapy and immunotherapies. The phase 1 clinical trials of VCN-01 have shown promising results for the treatment of several additional indications such as pancreatic cancer, retinoblastoma, head and neck squamous cell carcinoma (HNSCC) and colorectal cancer (CRC) in combination with chemotherapy and immunotherapies. The company's innovative Albumin Shield™ platform and oncolytic virus discovery engine have enabled the development of a distinct product pipeline that holds promise in the fight against cancer. Currently, the company is conducting a phase 2b clinical trial of its VCN-01 in combination with standard-of-care chemotherapy for first-line metastatic pancreatic cancer. Theriva Biologics is on track to complete enrollment into the VIRAGE Study by the first half of 2024. In the first quarter of 2024, a Drug Monitoring Committee (DMC) conducted a thorough safety review of VCN-01, ensuring that the drug meets the necessary criteria for continued development. By the second half of 2024, Theriva Biologics aims to perform an interim analysis of the data obtained from the VIRAGE Study. Theriva Biologics And Its Potential Markets By The Numbers The pancreatic cancer market’s size was estimated at $2.2 billion in 2022, and it's expected to grow at a CAGR of 13.6% between 2023 and 2032, reaching approximately $7.91 billion by 2032. Theriva Biologics seems well-positioned to excel in this space with its innovative VCN-01 drug candidate, with the potential to also serve other multi-billion dollar markets – such as head and neck cancer drugs, set to surpass $2.99 billion by 2030. Theriva Biologics reported $31.6 million in cash and short-term investment for Q3 2023. The company also increased research expenses to $4 million from $2.6 million a year ago while decreasing general and administrative expenses by 91% y-o-y. The company narrowed its net loss for the quarter from $4.49 million in Q3 2022 to $3.3 million in Q3 2023, and the basic loss per share for the quarter was $0.19 compared to $0.3 a year ago. Theriva Biologics currently has a market capitalization of about $8 million. The clinical-stage company’s innovative drug research might present a novel solution to extend the lives of those suffering from the deadliest of cancers, providing patients with new hope and improved outcomes. 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

February 29, 2024 08:25 AM Eastern Standard Time

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MAIA Biotech Completes Enrollment For Phase 2 Trial Of Its Candidate THIO To Fight Non-Small Cell Lung Cancer

Benzinga

By Meg Flippin, Benzinga MAIA Biotechnology Inc. (AMEX: MAIA), the clinical-stage biopharmaceutical company developing targeted immunotherapies for cancer, completed enrollment for its phase 2 trial for THIO, its lead therapy to fight advanced non-small cell lung cancer or NSCLC. NSCLC is a disease in which cancer cells form in the tissues of the lung. It’s the most common form of lung cancer in the U.S., accounting for 81% of lung cancer diagnoses. The five-year survival rate for this type of cancer is 28%. THIO targets and compromises the function of telomeres, which play a key role in helping cancer cells live and spread. Telomeres are made from DNA sequences and proteins and sit at the end of chromosomes, capping and protecting them in the cell division progress. Telomeres can be regenerated with the support of telomerase, an enzyme present in the early stages of growth and development in humans and in very few cells of adults. Telomerase is present in nearly all cancers and is expressed in 80% of NSCLC tumors. Evaluating The Effectiveness THIO is recognized by telomerase, leading to the uncapping of telomeres and thus resulting in rapid tumor cell death. THIO induces telomerase-dependent telomeric DNA modification, DNA damage responses and selective cancer cell death. The phase 2 THIO-101 go-to-market clinical trial is designed to evaluate THIO sequenced with the immune checkpoint inhibitor cemiplimab (Libtayo®) in patients with NSCLC. In preclinical models in vivo, MAIA demonstrated that low doses of THIO followed by anti-PD-L1 or anti-PD1 therapy completely eliminated advanced tumors and produced cancer cell-specific memory to activate the immune system against the cancer cells after extended periods with no need for additional treatment. Enrollment Reached Ahead Of Schedule Earlier in February, the trial reached its enrollment target of 41 patients for the 180 mg dose. Initially, the trial was designed to test three dose levels but following the selection of 180 mg/cycle as the optimal dose in December all patients were enrolled at that dose level and trial enrollment was completed ahead of schedule, the company said in a press release. “Enrollment in our Phase 2 THIO-101 trial has been strong from the start. With excellent results across all doses and our selection of the optimal dose in December 2023, we enrolled the necessary number of patients in the Simon 2-stage design to achieve our trial endpoints earlier than expected,” said Vlad Vitoc, M.D., MAIA’s Chairman and Chief Executive Officer when announcing the enrollment results. “THIO-101 preliminary data has demonstrated unprecedented rates of disease control and response to date, and we look forward to the long-term efficacy results as we continue to monitor the enrolled patients in the upcoming months.” THIO Well Tolerated The main objectives of the trial are to evaluate the safety, tolerability and preliminary clinical efficacy of THIO in patients with advanced NSCLC who have experienced disease progression or relapse after initial treatments with an immune CPI alone or in combination with chemotherapy. THIO is currently being developed as a second or later line of treatment for NSCLC patients who have progressed beyond the standard-of-care regimen of existing checkpoint inhibitors. MAIA Biotechnology said treatment with THIO followed by cemiplimab (Libtayo®) followed by THIO has been generally well tolerated to date in a heavily pre-treated population. “As the only direct telomere targeting agent currently undergoing clinical development in the field of cancer, we believe THIO holds a time-to-market advantage and strong potential to become a new standard of care for NSCLC,” said Vitoc. While THIO is currently being tested for NSCLC, telomerase is present in 85% to 95% of human cancers and contributes to the proliferation and reproductive immortality of cancer cells. As a result, the company is studying THIO in models of several tumor types with active telomerase, including rate indications in liver, colorectal and brain cancers. That could result in further use cases for MAIA’s lead treatment. 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 not intended to be investing advice. Contact Details Benzinga +1 877-440-9464 info@benzinga.com Company Website http://www.benzinga.com

February 29, 2024 08:15 AM Eastern Standard Time

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Charges Dismissed Against Dr. Mohammad Faghihi, Farzaneh Modarresi, and Faezeh Faghihi

dr mohammad faghihi

In a significant legal victory, Dr. Mohammad Faghihi, alongside Farzaneh Modarresi and Faezeh Faghihi, have been exonerated of all previously held charges. This announcement marks the resolution of a prolonged legal examination, affirming their commitment to ethical and lawful conduct. The allegations, which pertained to purported violations of international sanctions, were rigorously investigated, leading to this unequivocal dismissal. This outcome substantiates the integrity of the individuals involved and dissolves any misgivings regarding their professional and personal endeavors. Dr. Faghihi, expressing relief and optimism for the future, stated, "We are immensely thankful that justice has prevailed, and we can now focus on our passion for medical science without the weight of these accusations. We extend our heartfelt appreciation to our legal team, family, and friends who have supported us through this challenging time." The dismissal allows these dedicated professionals to continue their valuable contributions to the medical field without the distraction of legal obstacles. About Dr. Mohammad Faghihi: Dr. Mohammad Faghihi is a revered figure in the field of medical genetics, renowned for his pioneering work on non-coding RNAs and their significant role in gene regulation and epigenetics. An alumnus of Shiraz University of Medical Sciences and the esteemed Karolinska Institute, where he earned his Ph.D., Dr. Faghihi has dedicated his career to unraveling the complexities of the human genome and its implications in neurological disorders. His extensive body of research, which has been published in numerous high-impact scientific journals, has not only advanced our understanding of genetic mechanisms but also opened up promising avenues for novel therapeutic strategies. As a committed educator and an innovative researcher, Dr. Faghihi continues to inspire and lead in the biomedical sciences, contributing to breakthroughs that could reshape the future of medical treatments and patient care. For further insight into his professional background, accolades, and contributions to medical science, you may explore his detailed research history and achievements. www.DrMohammadFaghihi.com Scholar Achievements on Google Citations: https://scholar.google.com/citations?user=VT2HrSkAAAAJ&hl=en&oi=ao For Press Inquiries please contact: ALPHABULL LLC Phone: +1 (800) 530-0142 Email: cs@alphabull.io Contact Details AlphaBull.IO PR AlphaBull Public Relations +1 800-530-0412 cs@alphabull.io Company Website https://www.drmohammadfaghihi.com/

February 28, 2024 04:27 PM Eastern Standard Time

Kadimastem Takes Another Step Towards Signing the Merger Agreement with Nasdaq Listed IMCC

Kadimastem

In accordance with the MOU, Kadimastem will provide IMCC a loan of up to $650,000, which will be used by IMCC to restructure its current operations for sale allow Kadimastem to enter the public platform on the NASDAQ Kadimastem Ltd. (TASE: KDST), a leading cell therapy company in the clinical development stages of breakthrough products for the treatment of ALS and diabetes, has completed another step on the way to signing a merger with the U.S. NASDAQ listed company IMCC; IM Cannabis Corp (“IMCC”), (which is also listed in Canada on the CNSX) as reported several weeks ago, thus becoming a Nasdaq-listed company. The Company signed a loan agreement with IMCC, in accordance with their MOU. The loan amounts up to about $650,000 with the goal of organizing the current IMCC operations and preparing it for sale under a contingent value right (CVR) to be distributed to IMCC record shareholders prior to the consummation of the merger with Kadimastem', hence allowing Kadimastem to enter into IMCC’s public platform on the NASDAQ without taking ownership of IMCC’s current operations. Once and subject to the completion of the merger transaction and signing of the definitive documentation, pursuant to the MOU Kadimastem shareholders are expected to hold 88% of the shares of the combined company post -merger upon which Kadimastem will no longer be trading on the Tel Aviv Stock Exchange. The MOU is in line with the Company's strategic plan, to approach the target markets of its field of activity and the US capital markets. As part of the terms of the MOU, Kadimastem undertook to have approximately $5 million in funds, including capital raised simultaneously with the completion of the transaction and the commencement of trading from existing shareholders and additional investors. Ronen Twito, Executive Chairman of the Board said, "We are moving one step further towards a merger deal with IMCC that is planned to enable us to trade on the NASDAQ. This will assist Kadimastem’s development in the US capital markets especially in view of FDA approval to start a phase IIa multi-site clinical trial in the US for the ALS product candidate, as well as our development plans for additional product candidates, and especially the diabetes product candidate. I believe that together with IMCC’s professional management we will be able to promote the transaction quickly and professionally and generate significant value to our shareholders upon completion of the transaction." Kadimastem (TASE:KDST) is a clinical stage biotechnology company, with a unique platform for cell therapy that enables the production of off-the-shelf cell-based products for the treatment of unmet medical needs. Kadimastem was founded in 2009 based on patent protected technology that was developed at Prof. Michel Revel’s laboratory at the Weizmann Institute of Science. Forward Looking Statement This document may include forward-looking information as defined in the Securities Law, 5728 – 1968. Forward-looking information is uncertain and mostly is not under the Company's control and the realization or non-realization of forward-looking information will be affected, among other things, by the risk factors characterizing the Company's activity, as well as developments in the general environment and external factors affecting the Company's activity. The Company's results and achievements in the future may differ materially from any presented herein and the Company makes no undertaking to update or revise such projection or estimate and does not undertake to update this document. This document does not constitute a proposal to purchase the Company's securities or an invitation to receive such offers. Investment in securities in general and in the Company in particular bears risks. One should consider that past performance does not necessarily indicate performance in the future. Contact Details Kadimastem Sarah Bazak +972 73-797-1613 s.bazak@kadimastem.com Company Website https://www.kadimastem.com/

February 28, 2024 09:00 AM Eastern Standard Time

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Moving Fast: Candel’s (NASDAQ: CADL) CAN-3110 Granted FDA Fast Track Designation For Recurrent High-Grade Glioma Following Fast Track Designation For CAN-2409 In Pancreatic Cancer

Candel Therapeutics

By Jeremy Golden, Benzinga A clinical-stage biopharmaceutical company has been granted Fast Track Designation by the FDA for a first-in-class drug candidate. Focused on developing multimodal biological immunotherapies to help patients fight cancer, Candel Therapeutics, Inc. (NASDAQ: CADL) was granted the designation for CAN-3110, a replication-competent herpes simplex virus-1 (HSV-1) oncolytic viral immunotherapy candidate for patients with recurrent high-grade glioma (HGG). The Needham, Mass.-based company hopes CAN-3110 will improve overall survival in this patient population. A phase 1b clinical trial of CAN-3110 in recurrent HGG, led by E. Antonio Chiocca, MD, PhD, Head of the Department of Neurosurgery at Brigham & Women’s Hospital and Professor at Harvard Medical School, is ongoing. Candel Therapeutics plans to report additional data, including the potential benefits from multiple injections of CAN-3110, from the clinical trial in the second half of 2024. Designed to facilitate the development and expedite the review of medicines that can treat serious conditions, Fast Track Designation offers an investigational medicine eligibility for more frequent interactions with the FDA to discuss the candidate’s development plan. The medicine may be eligible for priority review if relevant criteria are met. “Receiving FDA Fast Track Designation for CAN-3110 reinforces the critical need to find effective treatment options for patients with recurrent HGG and further supports the potential of CAN-3110 to address the challenges that the standard of care and conventional therapies have failed to meet,” said Paul Peter Tak, MD, PhD, FMedSci, President and CEO of Candel. “A strong local and systemic anti-tumoral response and improved survival in patients with recurrent HGG was observed following a single injection of CAN-3110 in the Phase 1b trial.” Additionally, Candel and academic collaborators at the Brigham and Women’s Hospital published results from the ongoing phase 1b clinical trial in the high-impact journal Nature, demonstrating that CAN-3110 was well tolerated with no dose-limiting toxicity reported. The investigators observed a near-doubling of the expected median overall survival (mOS) after a single CAN-3110 injection, achieving a mOS of about 12 months, compared to historical reports of less than 6 to 9 months in this therapy-resistant condition. Positive HSV-1 serology was a predictor of response and was associated with improved survival; the mOS in this population reached 14 months. 50 to 80% of American adults have oral herpes (HSV-1), which causes cold sores or fever blisters near or in the mouth. Caused by HSV-1 or HSV-2, genital herpes affects one out of every six people in the U.S. aged 14 to 49. Furthermore, increased infiltrating immune cells in the tumor microenvironment and expansion of the T cell repertoire after administration were also associated with improved survival, suggesting that CAN-3110 can elicit both a local and systemic antitumoral response. “Recurrent HGG is one of the most aggressive malignancies for which there is no cure, representing a significant and urgent unmet need,” Chiocca, the study director, said. “With Fast Track Designation, I look forward to the potential of accelerating the development of CAN-3110 and the possibility of bringing this differentiated therapy to patients with recurrent high-grade glioma as we strive to improve outcomes and provide hope for patients and their families.” In December 2023, Candel Therapeutics also received Fast Track Designation for both non-small cell lung cancer (NSCLC) and pancreatic cancer, a validation from the FDA on the potential of CAN-2409, its most advanced product candidate. An investigational viral immunotherapy, CAN-2409 is designed to stimulate an individualized, systemic immune response to the patient’s specific tumor. 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. Featured photo by Hush Naidoo Jade Photography 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/

February 28, 2024 08:15 AM Eastern Standard Time

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Tonix Pharmaceuticals drug TNX-102 SL gets FDA ok for US Department of Defense funded trial

Tonix Pharmaceuticals

Tonix Pharmaceuticals CEO Dr. Seth Lederman joined Steve Darling from Proactive to share significant news regarding the company's latest development: the clearance of the Investigational New Drug application by the U.S. Food and Drug Administration for the Phase 2 investigator-initiated OASIS trial. This trial aims to evaluate the efficacy of TNX-102 SL in reducing the severity of acute stress reaction and the frequency of acute stress disorder and post traumatic stress disorder. Dr. Lederman explained that the trial is sponsored by The University of North Carolina Institute for Trauma Recovery and is supported by a substantial 3 million dollar grant from the U.S. Department of Defense. The primary objective of the trial is to assess the safety and efficacy of TNX-102 SL in mitigating adverse posttraumatic neuropsychiatric effects among patients who present to the emergency department following a motor vehicle collision. The trial is expected to enroll approximately 180 trauma survivors across various emergency department study sites throughout the United States. Participants will be randomly assigned to receive either TNX-102 SL 5.6 mg or a placebo for a two-week course. Notably, there is currently a lack of medication available at or near the point-of-care to effectively address the needs of patients suffering from traumatic events and support their long-term health. This development underscores Tonix Pharmaceuticals' commitment to addressing unmet medical needs in the field of trauma recovery and psychiatric disorders. With the initiation of the OASIS trial, the company aims to contribute to the advancement of treatment options for individuals experiencing acute stress reactions and related neuropsychiatric sequelae following traumatic events. Contact Details Proactive Investors +1 604-688-8158 na-editorial@proactiveinvestors.com

February 28, 2024 06:56 AM Eastern Standard Time

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