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Coya Therapeutics Enters First-Of-Its-Kind Partnership With Multi-Billion Dollar Drug Company — Why This Is a Major Moment For Drug Development

Coya Therapeutics Inc.

By David Willey, Benzinga Houston-based Coya Therapeutics (NASDAQ: COYA) has entered into a partnership with Dr. Reddy’s Laboratories Ltd. (NYSE: RDY), a world-leading pharmaceutical company based in India. Through this partnership, Coya will license Dr. Reddy’s biosimilar product, Abatacept, allowing Coya to develop its combination product, COYA 302. This drug will combat various neurodegenerative diseases, including Amyotrophic Lateral Sclerosis (ALS). Through its one-time, non-refundable fee, Coya has an exclusive and royalty-bearing license to Abatacept for the development and commercialization of COYA 302. This license also gives Coya the right to sell the drug in the Americas, the EU, the United Kingdom, Japan and elsewhere, and Coya will owe royalties to Dr. Reddy for the sale of the product. In addition, Dr. Reddy’s will develop COYA 302 in its own territories and will owe royalties back to Coya upon the commercialization of COYA 302. COYA 302 is a dual biologic product that will provide a novel treatment for various neurodegenerative diseases. Using the components COYA 301 and CTLA4-Ig, the drug suppresses inflammation in the brain or spinal cord via the body’s immunomodulatory pathways. Coya expects to file an investigational new drug (IND) application with the Food and Drug Administration (FDA) in the second half of 2023, with a phase 1b/2 trial to follow. Why This Deal Matters For Future Drug Development This partnership, between a multi-billion generic drug company and a small biotech, is amongst the first of its kind. It could indicate a shift in how major drug companies are positioning their development pipeline, as they explore a biologic biosimilar’s ability to treat new indications, or symptoms, for major diseases. The global biosimilar market has seen recent growth, with North America making up the largest portion of the market. The market was worth $28.61 billion in 2021 and is predicted to reach $103 billion by 2028, growing by a compound annual growth rate (CAGR) of 25.6% during the forecast period of 2022-2028. There are already 33 FDA-approved biosimilars that are used in various treatments including for cancer and autoimmune diseases. As well as improving treatments, biosimilars have already helped bring the cost of medication down. Dr. Reddy is a leading player in the biosimilar market. The partnership it entered with Coya signals that Dr. Reddy is adopting a new and possibly transformative approach to biosimilars. By combining a biologic biosimilar with another drug product, it is adapting the potential of biosimilars so they can treat new symptoms of serious diseases. Coya is already developing a Treg-based therapy to deal with neurodegenerative diseases with its Coya-101 product. Now, through its partnership with Dr. Reddy, Coya is showcasing the exciting potential of collaborations between smaller biotech companies and billion-dollar pharmaceutical corporations. Coya already has compelling early data from its clinical trials for COYA 302, and it will be revealing the data at the Muscular Dystrophy Association (MDA) conference on March 21st. Other biologics companies include Eli Lilly and Company (NYSE: LLY), bluebird bio (NASDAQ: BLUE) and GeoVax, Inc. (NASDAQ: GOVX). This article was originally published on Benzinga here. About Coya Therapeutics, Inc.Headquartered in Houston, TX, Coya Therapeutics, Inc. (Nasdaq: COYA) is a clinical-stage biotechnology company developing proprietary treatments focused on the biology and potential therapeutic advantages of regulatory T cells (“Tregs”) to target systemic inflammation and neuroinflammation. Dysfunctional Tregs underlie numerous conditions including neurodegenerative, metabolic, and autoimmune diseases, and this cellular dysfunction may lead to a sustained inflammation and oxidative stress resulting in lack of homeostasis of the immune system. Coya’s investigational product candidate pipeline leverages multiple therapeutic modalities aimed at restoring the anti-inflammatory and immunomodulatory functions of Tregs. Coya’s therapeutic platforms include Treg-enhancing biologics, Treg-derived exosomes, and autologous Treg cell therapy. Coya’s 300 Series product candidates, COYA 301 and COYA 302, are biologic therapies intended to enhance Treg function and expand Treg numbers. COYA 301 is a cytokine biologic for subcutaneous administration intended to enhance Treg function and expand Treg numbers in vivo, and COYA 302 is a biologic combination for subcutaneous and/or intravenous administration intended to enhance Treg function while depleting T effector function and activated macrophages. These two mechanisms may be additive or synergistic in suppressing inflammation. This post contains sponsored advertising content. This content is for informational purposes only and is not intended to be investing advice Contact Details David S. Snyder David@coyatherapeutics.com Company Website https://coyatherapeutics.com/

March 23, 2023 09:15 AM Eastern Daylight Time

SOFTWARE EFFECTIVE SOLUTIONS "MEDCANA" (OTC: SFWJ) RETAINS INTERNATIONAL MONETARY FOR INVESTOR RELATIONS, CAPITAL FORMATION, AND OTHER STRATEGIC SERVICES

Software Effective Solutions Corp.

McapMediaWire -- Software Effective Solutions, (OTC Pink: SFWJ ) (“The Company”, “SFWJ”) is pleased to announce it has entered into a formal agreement with International Monetary ( www.intlmonetary.com), a merchant bank based in Newport Beach, CA, who will assist Software Effective Solutions Corporation in identifying new business prospects and strategic partnerships, as well as source capital so the company can continue to expand. Jose Gabriel Diaz, The Company’s CEO states: “We are pleased to have signed an agreement with International Monetary and believe that this additional support will facilitate the Company’s access to an increased shareholder base, raising awareness of the company in the marketplace, and uncovering synergistic opportunities going forward.” International Monetary’s Managing Director, Mr. Blaine Riley added, “After discussing and reviewing the company objectives and opportunities, we immediately recognized the enormous potential for this SFWJ and its Medcana and are excited to be part of what I expect will be one of the most talked about emerging growth stories in its sector. On the investor relations side, we will direct a series of initiatives to enhance shareholder value and ensure liquidity, and through our investment banking and strategic advisory arm, we will also advise the company on matters such as capital resources, structured financing, mergers, and acquisitions, and advise the company’s management on other strategic decisions”. “We are very happy where we are today. We have done a phenomenal job with the companies that we have acquired to ensure we build an ecosystem that supports our operations and those of our clients.” adds Diaz. ABOUT SFWJ: Software Effective Solutions/MedCana is a global infrastructure and holding company in the cannabis industry. Currently, MedCana has five companies focused on pharmaceutical cannabis production, one software company focused on managing processes for plant-to-patient operations. The recent acquisition an irrigation and greenhouse technology company has rounded out MedCana’s portfolio of companies. MedCana's initial focus is on developing clients and companies in Latin America with an initial focus in Colombia and partnerships with laboratories, research facilities, and hospitals throughout the world. About International Monetary: Founded in 1997, IM recognized a need to provide investment banking services with the speed and precision that is required in the new internet and technology economy. IM focuses on turnaround situations and rapidly growing small companies, specializing in debt/equity financing of under $1 billion. IM is led by a team of Managing Directors that offer a number of strategic advisory services, including: sourcing capital sources, M&A consultation, int’l licensing/commercialization, product/service distribution, advertising and marketing, and shareholder enhancement services. To learn more about IM, go to: www.intlmonetary.com SAFE HARBOR STATEMENT This press release contains forward-looking statements that can be identified by terminology such as "believes," "expects," "potential," "plans," "suggests," "may," "should," "could," "intends," or similar expressions. Many forward-looking statements involve known and unknown risks, uncertainties and other factors that may cause actual results to be materially different from any future results implied by such statements. These factors include, but are not limited to, our ability to continue to enhance our products and systems to address industry changes, our ability to expand our customer base and retain existing customers, our ability to effectively compete in our market segment, the lack of public information on our company, our ability to raise sufficient capital to fund our business, operations, our ability to continue as a going concern, and a limited public market for our common stock, among other risks. Many factors are difficult to predict accurately and are generally beyond the company's control. Forward-looking statements speak only as to the date they are made, and we do not undertake to update forward-looking statements to reflect circumstances or events that occur after the date the forward-looking statements are made. Contact: Jose Gabriel Diaz, CEO www.medcana.net info@medcana.co Contact Details Jose Gabriel Diaz, CEO info@medcana.co Company Website https://www.medcana.net/

March 23, 2023 09:00 AM Eastern Daylight Time

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Kim Sledge of Sister Sledge, the recording artists behind the international hit song “We are Family” Urges Support for The American Center for Cures

The American Center for Cures

Kim Sledge of Grammy Award winning vocal group Sister Sledge, famed for its international hit song and platinum album, “We are Family,” advocated her support for The American Center for Cures (ACC), an audacious “moonshot” mission to prevent, treat or cure diseases that plague every American family, with a new song titled, “ Unity Strong.” Ms. Sledge also shared personal commentary in support of the ACC: “I’m Kim Sledge from the recording group Sister Sledge. We recorded the international hit song, ‘We Are Family.’ I write today in support of The American Center for Cures. Having had the privilege of traveling around the world and looking in the eyes of people of all colors, ages, and cultures, and having seen both healthy, as well as, unfortunately disease affected communities, I am in full support of an initiative I was introduced to by a very dear friend of our families, Mr. Lou Weisbach, CEO and Co-Founder of ACC. Lou, Ruthie, and their family have, over the years, shared in and supported some of my family’s great times and losses. To think that some of those sad times could have been avoided, but even more to know, now there’s a new hope, and soon other families won’t have to go through the despair of disease and loss. I am truly grateful and ecstatic to hear of the possibilities The American Center For Cures has planned. Its mission is awe inspiring and I believe it is divinely designated for such a time as this. Globally, we are in dire and imminent need of a fully funded mission to prevent, treat and cure the diseases that plague every American family. Today, I cry out for unity regarding the efforts of the ACC which can bring healing wholeness and perhaps a bond of peace. We are all diverse families sharing this small planet and we all want the same thing: healthy longevity. The ACC is unequivocally the right solution to confront the nation’s health crisis and the plan is already in place. Right now, we need only to act on it by uniting our hearts, hope, and hands in active support with quick fire momentum to result in an epic unified outcome. Let’s put these disease groups out of business. Too many families have been desperate for far too long. It’s time for prevention, cures, healing, and wholeness. Lou and Dr. Boxer have taken the position of warriors for this cause. In unity, let’s put our hands to the plow with them and burst open the doors for The American Center for Cures. I’ve often heard it said, ‘how good and pleasant it is for brothers to dwell together in unity.’ I see only one other place where we as families strive with greater unity, and that place is in love. We can do this, together. We are family. We are unity strong.” The ACC initiative was introduced by co-founders Lou Weisbach and Dr. Rick Boxer, who was recently appointed by President Joseph Biden to the National Cancer Advisory Board. Their tireless, exemplary, and passionate efforts will enable us to turn theory into practice and finally make the families of our nation and the world recipients of long-awaited prevention, treatments, and cures through fully funded mission-based entities in the private sector individually focused on major diseases with CEO’s that are accountable and responsible to finally get the job done. Former Secretary of Health Tom Price commented that, “when this plan is approved it will rival the greatest achievements in US history and offer the sense of urgency that all American families yearn for and deserve when battling disease.” Ms. Sledge, who is also an ordained minister, and the ACC CEO Lou Weisbach are available for interviews to personally discuss this bipartisan initiative and its mission to unite medicine, science, pharmaceuticals, business, and government to seek out new treatments and cures for Alzheimer’s, diabetes, Parkinson’s, mental diseases, many forms of cancer, and several others. You can listen to “Unity Strong,” Ms. Sledge’s new song dedicated to mission of the ACC, here. About American Center for Cures The American Center for Cures (ACC) initiative is a bipartisan mission to prevent, treat and cure diseases that plague every American family. The initiative will be funded by the sale of $750B bonds by the Federal Reserve, providing the capital needed to accelerate the current trajectory of medicine. Annual interest will be paid through the licensing of new compounds and drugs to pharmaceutical companies. The principal will be repaid by savings provided to the United States Government through successes in the areas of prevention and cures. The ACC business model will cost the government and taxpayers nothing, making this the single most impactful investment on behalf of the American people in the nation’s history. For more information, please visit https://theamericancenterforcures.org. Contact Details Jenna Beaucage +1 508-340-6851 jbeaucage@rainierco.com Company Website https://theamericancenterforcures.org

March 23, 2023 08:15 AM Eastern Daylight Time

CleverTap Gaming Unveiled at GDC 2023

CleverTap

CleverTap, the all-in-one customer engagement platform, today at Game Developers Conference 2023 unveiled CleverTap Gaming – soon to go live in the summer of 2023. Through full player management, the latest offering will help boost revenue from LiveOps, Lifecycle Marketing, and Remote Configuration by 3x with personalization across the entire player journey. The platform is powered by TesseractDB™, CleverTap's proprietary data engine, which is built for real time triggering & segmentation with high performance, low latency, and massive economies of scale. CleverTap Gaming brings holistic and sophisticated multi-channel campaigns inside and outside the in-game experience. With a simplified UI, it reduces the dependence on technical teams and increases operational efficiency. By leveraging CleverTap’s proprietary TesseractDB™, it offers rich granularity with unlimited data points and no restrictions on lookback period. Previously, the lack of these features could have been a limiting factor for game studios trying to maximize retention and lifetime value, but CleverTap Gaming unlocks these use cases enabling game studios to scale their personalization efforts to new heights. Also, given its versatility, CleverTap Gaming offers a vast array of benefits within various functions in typical game studios: LiveOps: With over 2000 unique player attributes (10x more than the industry average), LiveOps Managers can improve the relevance of their offers with much more granular insights into user behavior and preferences. Marketing: Consumers have vastly different preferences and a single journey does not fit each and every one of them. As such, conditional logic, advanced branching, and unified composition flow across all channels can help marketers plan campaigns with contingencies in mind. The advanced segmentation feature can also help marketers create better-targeted campaigns from the outset. Development: The ability to integrate with existing backend solutions lowers the barrier to transition for gaming studios with other solutions. Native Unity SDK means the platform can enhance developer productivity and shorten release cycles considerably. “Modern gaming is evolving. They are no longer static endpoints – and with features like LiveOps and Remote Configuration, developers are empowered to make changes in real-time without the constraints of approvals and a relaunch.” said Lawrence Hsieh, Principal Product Manager at MobilityWare. “CleverTap Gaming gives us an all-in-one cost-effective solution that ensures consistency and efficiency while not only developing but also promoting an update.” “With over 2.6 billion mobile game players globally, it is only a matter of time before the growth trajectory flattens out and retention becomes a bigger area of focus. We hope that CleverTap Gaming can accompany those studios looking to stay ahead of the curve by maximizing their pre-existing user base via personalized and relevant messaging,” said Sunil Thomas, Co-founder and Executive Chairman at CleverTap. “When we acquired Leanplum last year, we looked to strengthen our footprint within various verticals and geographies. CleverTap Gaming is another step in this direction, and we are confident that it will further accelerate our growth journey.” About CleverTap Gaming, powered by Leanplum CleverTap Gaming is powered by Leanplum and helps gaming studios achieve engagement and revenue goals by providing the tools and expertise to deliver more personalized player experiences at scale. Learn more about what CleverTap can do for your brand at clevertap.com. For a platform demo, visit clevertap.com/live-product-demo/ About CleverTap CleverTap is the all-in-one customer engagement platform that helps brands personalize and optimize all consumer touch points to improve user engagement, retention, and lifetime value. It's the only solution built to address the needs of retention and growth teams, with audience analytics, deep-segmentation, multi-channel engagement, product recommendations, and automation in one unified product. The platform is powered by TesseractDB™ – the world’s first purpose-built database for customer engagement, offering both speed and economies of scale. CleverTap is trusted by 2000 customers, including Electronic Arts, TiltingPoint, Gamebasics, Big Fish, MobilityWare, TED, English Premier League, TD Bank, Carousell, AirAsia, Papa Johns, and Tesco. Backed by leading investors such as Sequoia India, Tiger Global, Accel, and CDPQ the company is headquartered in Mountain View, California, with presence in San Francisco, New York, São Paulo, Bogota, London, Amsterdam, Sofia, Dubai, Mumbai, Singapore, and Jakarta. For more information, visit clevertap.com or follow on LinkedIn and Twitter. Forward-Looking Statements Some of the statements in this press release may represent CleverTap's belief in connection with future events and may be forward-looking statements, or statements of future expectations based on currently available information. CleverTap cautions that such statements are naturally subject to risks and uncertainties that could result in the actual outcome being absolutely different from the results anticipated by the statements mentioned in the press release. Factors such as the development of general economic conditions affecting our business, future market conditions, our ability to maintain cost advantages, uncertainty with respect to earnings, corporate actions, client concentration, reduced demand, liability or damages in our service contracts, unusual catastrophic loss events, war, political instability, changes in government policies or laws, legal restrictions impacting our business, impact of pandemic, epidemic, any natural calamity and other factors that are naturally beyond our control, changes in the capital markets and other circumstances may cause the actual events or results to be materially different, from those anticipated by such statements. CleverTap does not make any representation or warranty, express or implied, as to the accuracy, completeness or updated or revised status of such statements. Therefore, in no case whatsoever will CleverTap and its affiliate companies be liable to anyone for any decision made or action taken in conjunction. Contact Details Sony Shetty sony@clevertap.com Company Website https://clevertap.com/

March 23, 2023 04:45 AM Eastern Daylight Time

News Release

1606 Corp discusses how latest acquisition of Brio Nutrition shapes new opportunity for growth

1606 Corp.

1606 Corp CEO Greg Lambrecht joins Proactive's Natalie Stoberman to discuss the company's growth since its latest acquisition of Brio Nutrition. 1606 Corp is an acquisition-based CBD distribution company with over 45 individual retail products. The company is aggressively acquiring established CBD companies to capture sufficient revenue to list on the NASDAQ stock exchange within the next 24 months. Contact Details Proactive Canada +1 604-688-8158 na-editorial@proactiveinvestors.com

March 22, 2023 03:03 PM Eastern Daylight Time

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News Release

1933 Industries looking to build off strong start in 2023 with more revenue growth strategies

1933 Industries Inc.

1933 Industries CEO Paul Rosen joined Steve Darling from Proactive to talk more about the company that specializes in the cultivation and manufacturing of cannabis for consumer-branded goods. Rosen also discussed a significant turnaround that saw the company posting the highest quarterly revenue in its history for the first quarter of 2023. Contact Details Proactive Canada +1 604-688-8158 na-editorial@proactiveinvestors.com

March 22, 2023 02:31 PM Eastern Daylight Time

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Detecting Early Signs of Heart Disease

YourUpdateTV

One in five people worldwide have inherited high lipoprotein(a) and most don’t know it. Because high Lp(a) isn’t screened for, often the first sign of this condition can be a heart attack or stroke. There are more than 60 million people in the United States at high risk for a heart attack or stroke because they were born with high lipoprotein(a). Recently, Katherine Wilemon, founder and CEO of the Family Heart Foundation, teamed up with preventive cardiologist Dr. Seth Baum, chief scientific officer of Flourish Research, on a nationwide satellite media tour to raise awareness and encourage people to get screened. A video accompanying this announcement is available at: https://youtu.be/NGQBZxqF-GI Lp(a) is a cholesterol-like substance that is unrelated to the food you eat or how you live. People inherit Lp(a) levels from their parents and high levels of Lp(a) significantly increase your likelihood of having a heart attack or stroke. High Lp(a) is a "triple threat" as it can clog your arteries like LDL cholesterol but it also promotes inflammation and increases the risk of your blood clotting. If you have heart disease or have had a stroke, or someone in your family has experienced cardiovascular disease, it is important to get screened for high Lp(a). In addition, if your LDL cholesterol is very high — over 190 mg/dL —you should also have your Lp(a) tested. Research from the Family Heart Foundation revealed that fewer than 1% of Americans had ever had their lipoprotein(a) tested – and it’s a simple blood test. “The truth is with 20% of the population affected, and heart disease continuing to be the single biggest threat to one’s ability to live a long healthy life, everyone should be screened,” said Dr. Baum. The Family Heart Foundation declared March 24 Lp(a) Awareness Day to raise awareness worldwide. In its second year, this day draws attention to high Lp(a) as an under-recognized cause of premature heart disease and stroke. “March 24 is a perfect time for everyone to think about their family history, be screened for high Lp(a) and maybe change the future for millions of Americans,” said Wilemon. For more information, visit FamilyHeart.org. The Family Heart Foundation’s Care Navigation team can answer questions and connect you to a healthcare provider near you. About Katherine Wilemon On the month she turned 39 years old, Katherine Wilemon’s world was rocked by a heart attack caused by a complete artery blockage. It was the importance of family that drove Katherine to investigate the deeper physiological issues that contributed to her cardiac event. She learned that she had familial hypercholesterolemia (FH), and, years later, that she also had elevated levels of lipoprotein(a). The more Katherine advocated for herself, the more she encountered an inadequate understanding of genetic conditions such as FH. Always an entrepreneur, she founded the Family Heart Foundation in 2011 to increase early diagnosis and treatment. Over the years the Foundation has helped create a national research registry for FH, established diagnostic codes and consensus statements for care, and provided a community for those living with inherited cholesterol disorders. Now, the organization has expanded to drive awareness and scientific understanding of Lp(a) so that others with high levels can better protect themselves and their families. About Seth Baum, MD, FACC, FACPM, FAHA, FNLA, FASPC Dr. Seth J. Baum is Chief Scientific Officer at Flourish Research, and clinical affiliate professor of Cardiology at FAU Medical School. He actively consults in Clinical Lipidology and Cardiovascular Disease Prevention and continues to offer lipoprotein apheresis for patients in southeast and central Florida. Dr. Baum has practiced Preventive Cardiology and Clinical Lipidology since 2000. He is a fellow of the American College of Cardiology, the American Heart Association, the American College of Preventive Medicine, the National Lipid Association, and the American Society for Preventive Cardiology. Dr. Baum is a past President of the American Society for Preventive Cardiology (ASPC). He currently serves on both the ASPC and Family Heart Foundation Advisory Boards. He has published over 100 peer reviewed papers and abstracts as well as two books. In 2013, he was awarded Cleveland Heart Lab’s “Heart Award” for lifelong dedication to Preventive Medicine. In 2019, Dr. Baum received Mended Hearts’ biennial Dwight Emary Harken Award. Dr. Baum is the Founder of Excel Medical Clinical Trials, LLC, a consortium of clinicians dedicated to the safe and professional conduct of high-level scientific trials. He has served as Principal Investigator in over 100 clinical trials covering a broad range of disease states. Dr. Baum is the Chief Scientific Officer of Flourish Research, a leading national clinical research company. Dr. Baum is a graduate of Columbia College and Columbia College of Physicians and Surgeons, and completed training in Internal Medicine, Cardiology, Interventional Cardiology, and Electrophysiology. Contact Details YourUpdateTV +1 212-736-2727 yourupdatetv@gmail.com

March 22, 2023 09:19 AM Eastern Daylight Time

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What Is Autologous Cell-Based Therapy, The Treatment Revolutionizing Regenerative Medicine That Could Be Set To Explode Over The Next Few Years?

BioRestorative Therapies, Inc.

By Julian Richard, Benzinga Successful Autologous Cell-Based Therapies The global CAR-T cell therapy market is growing continuously due to novel clinical and commercial developments in this therapy. As a result, the Global CAR-T cell therapy market is expected to be worth USD 4.36 billion by 2028 from 2.31 billion in 2023, growing with a healthy CAGR of 13.5% during the forecast period. Companies like Pfizer (NYSE: PFE) Johnson & Johnson (NYSE: JNJ, Bristol-Meyers Squibb (NYSE: BMY) as well as Gilead Sciences (NASDAQ: GILD) all are focusing on this innovative CAR-T cell therapy. Autologous cell based therapies are personalized therapies using your own cells to target a disease or disorder. Personalized therapies targeting cancer such CAR-T cell therapies have generated impressive clinical results with complete remission rates in B-acute lymphoblastic leukemia in over >80% of patients. One of the reasons this therapy has been successful is because it is autologous. In 2017, the U.S. FDA approved the first two CAR-T cell therapies: Novartis’ Kymriah ® for treatment of acute lymphoblastic leukemia (ALL) and Gilead subsidiary Kite Pharma’s Yescarta ® for certain types of large B-cell lymphomas, a type of non-Hodgkin lymphoma. These autologous therapies are patient-specific where the therapeutic CAR-T cells are created from a patient’s own cells. The Value of Autologous Stem-Cell Therapies Autologous stem-cell therapy is a novel medical technology that is revolutionizing the way the medical community approaches the treatment of metabolic, autoimmune and degenerative diseases. Additionally, this technique has been used successfully to develop skin grafts for wound care, treat burns and bedsores and speed up recovery after surgery. The method involves extracting stem cells from a patient’s body and culturing them in laboratory conditions before reintroducing them into the patient. Stem cells are a unique type of cell that can develop into any other cell in the body. These “supercharged” cells can be used for tissue regeneration and repair, making stem cells a potent tool in modern personalized medicine. Stratified medicine simply cannot compete with this customization, precision, and safety profile. The main benefit of using autologous cells is that these cells come from your own body and therefore do not trigger any immunological rejection reactions. They also minimize the risk of infection from non-patient sources. This allows autologous cell therapy to be used safely over a longer term, ensuring that the patient can access consistent and reliable treatment without risk of rejection or complications due to incompatibility. In 2021, the autologous cell therapy market was valued at $4.3 billion and was projected to skyrocket to $29.1 billion by 2031—marking a compounded annual growth rate (CAGR) of 21% from 2022-2031. Although the market is still nascent, it is expected to eventually create a new healthcare sector with revenue similar to that of the pharmaceutical, biotechnological, and medical devices industries. An Autologous Stem Cell-Based Approach to treat Disc Pain BioRestorative Therapies Inc (NASDAQ: BRTX) focuses on innovative “home-grown” autologous stem-cell therapies to address unmet needs in patients with common yet serious diseases. It was founded by medical doctors, scientists and world-renowned stem-cell researchers committed to developing novel stem-cell therapies. The lead candidate in BioRestorative’s musculoskeletal stem-cell platform is BRTX-100, administered as a minimally-invasive single intradiscal injection. BRTX-100 is currently being evaluated in an FDA gold standard phase 2 double-blind, controlled, randomized study in those with chronic lumbar disc disease (cLDD). Chronic lumbar disc disease affects over 500 million individuals globally and is currently only treatable with opioids and surgery. Despite being the most commonly prescribed drug for cLLD, no clinical data supports the use of opioids in cLLD, which only serves to increase the opioid crisis in the USA. Surgery for cLLD carries many disadvantages and limitations. The cost of surgery can be high. While surgical intervention may reduce pain in some cases, it often fails to restore previous levels of function or mobility. Revision or reoperation rates for surgical intervention in the spine can be upwards of 20-30% of the cases performed. Furthermore, a more extended recovery period is associated with an increased risk of mechanical instability of the spine and potentially increased failure rates compared to non-surgical treatments. It would appear a bright future awaits BioRestorative Therapies and the autologous cell therapy market in general as patients increasingly look at personalized alternatives to surgery and conventional medicine. BRTX-100 is an innovative and minimally-invasive technology set to revolutionize lower back pain treatment. Visit https://www.biorestorative.com for more information on the company and its product candidates. This article was originally published on Benzinga here. BioRestorative Therapies was founded by scientists and researchers committed to developing stem cell therapies to address unmet needs in patients with highly prevalent conditions.Our advances in stem cell biology and delivery protocols harbor great promise in conditioning our bodies’ own regenerative potential to treat major diseases more effectively than current interventions.Today, BioRestorative is actively developing programs that aim to dramatically increase quality of care for both (i) chronic back pain caused by disc degeneration, as well as (ii) metabolic disorders including obesity and diabetes. This post contains sponsored advertising content. This content is for informational purposes only and is not intended to be investing advice. Contact Details Investor Relations ir@biorestorative.com Company Website https://www.biorestorative.com/

March 22, 2023 09:15 AM Eastern Daylight Time

Coya Therapeutics’ COYA 302 Treating ALS Proves Effective In Proof-Of-Concept Academic Clinical Study

Coya Therapeutics Inc.

By David Willey, Benzinga Coya Therapeutics, Inc. (NASDAQ: COYA) recently reported 48-week clinical data for its proof-of-concept open-label study in 4 ALS patients indicating that treatment with COYA 302 appeared to significantly ameliorate disease progression (stopping progression in all patients at 24 weeks with minimal decline at 48 weeks.) This was in a patient cohort who was declining prior to entry into the study. Four ALS patients with a mean decline of -1.1 points/month in the Revised ALS Functional Rating Scale (ALSFRS-R) score prior to study initiation, were treated for 48 consecutive weeks with COYA 302 and were evaluated for safety and tolerability, Treg suppressive function, serum biomarkers of oxidative stress and inflammation, and clinical functioning as measured by the ALSFRS-R scale. Following the administration of COYA 302 for 48 weeks, patients were evaluated over an 8-week washout period. During the 48-week treatment period, COYA 302 appeared to be well tolerated. The most common adverse event was mild injection-site reactions. No patient discontinued the study, and no deaths or other serious adverse events were reported. Preliminary efficacy of COYA 302 was measured by the ALSFRS-R scale, a validated rating tool for monitoring the progression of disability in patients with ALS. The mean (±SD) ALSFRS-R scores at week 24 (33.75 ±3.3) and week 48 (32 ±7.8) after initiation of treatment with COYA 302 were not statistically different compared to the ALSFRS-R score at baseline (33.5 ±5.9), indicating significant amelioration in the progression of the disease over the 48-week treatment period. Treg suppressive function, expressed as percentage of inhibition of proinflammatory T cell proliferation, showed a statistically significant increase over the course of the treatment period and was significantly reduced at the end of the 8-week washout post-treatment period. Treg suppressive function at 24 weeks (79.9±9.6) and 48 weeks (89.5±4.1) were significantly higher compared to baseline (62.1±8.1) (p<0.01), suggesting enhanced and durable Treg suppressive function over the course of treatment. In contrast, Treg suppressive function (mean ±SD) was significantly decreased at the end of the 8-week washout period compared to end-of-treatment at week 48 (70.3±8.1 vs. 89.5±4.1, p <0.05). The study also evaluated serum biomarkers of inflammation, oxidative stress, and lipid peroxides. The available data up to 16 weeks after initiation of treatment suggest a decrease of these biomarker levels, which is consistent with the observed enhancement of Treg function. The evaluation of the full biomarker data is ongoing. This article was originally published on Benzinga here. About Coya Therapeutics, Inc.Headquartered in Houston, TX, Coya Therapeutics, Inc. (Nasdaq: COYA) is a clinical-stage biotechnology company developing proprietary treatments focused on the biology and potential therapeutic advantages of regulatory T cells (“Tregs”) to target systemic inflammation and neuroinflammation. Dysfunctional Tregs underlie numerous conditions including neurodegenerative, metabolic, and autoimmune diseases, and this cellular dysfunction may lead to a sustained inflammation and oxidative stress resulting in lack of homeostasis of the immune system. Coya’s investigational product candidate pipeline leverages multiple therapeutic modalities aimed at restoring the anti-inflammatory and immunomodulatory functions of Tregs. Coya’s therapeutic platforms include Treg-enhancing biologics, Treg-derived exosomes, and autologous Treg cell therapy. Coya’s 300 Series product candidates, COYA 301 and COYA 302, are biologic therapies intended to enhance Treg function and expand Treg numbers. COYA 301 is a cytokine biologic for subcutaneous administration intended to enhance Treg function and expand Treg numbers in vivo, and COYA 302 is a biologic combination for subcutaneous and/or intravenous administration intended to enhance Treg function while depleting T effector function and activated macrophages. These two mechanisms may be additive or synergistic in suppressing inflammation. This post contains sponsored advertising content. This content is for informational purposes only and is not intended to be investing advice Contact Details David S. Snyder David@coyatherapeutics.com Company Website https://coyatherapeutics.com/

March 22, 2023 09:15 AM Eastern Daylight Time

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