Category: Health

Biotech Companies to Benefit from AI Efficiencies and Analysis

Posted on by phoffman@channelchek.com

Enabling Better Drug Discovery Outcomes with Machine Learning

Can the long road to bring new medical treatments or therapies to market be shortened by introducing artificial intelligence? AI applied to the early stage of the discovery process, which often involves new insight into a disease or treatment mechanism, may soon provide researchers many more potential candidates or designs to evaluate. AI can also help in the sorting and evaluation of these candidates to improve the success rates of those that make it into the lab for further study.

Benefits AI Brings to Biotech Research

The cost of bringing a single drug to market in terms of time and money is substantial. Estimates are in the $2.8 billion range, and the average timeline for drug development exceeds a decade. On top of this, there is a low level of certainty of taking a promising molecule all the way to market. The success rate of translating preclinical research findings into effective clinical treatments is low; failure rates are estimated to be around 90%.

The refinement of digital sorting and calculating with advanced computational technologies, such as artificial intelligence (AI) and machine learning (ML), have the potential to revolutionize pharmaceutical research and development (R&D). Despite it still being a young technology, AI-enabled applications and algorithms are already making an impact in drug discovery and development processes.

One of the significant benefits of ML in drug development is its ability to recognize patterns and unveil insights that might be missed by conventional data analysis or take substantially less time to recognize. AI, and ML technologies can help a biotech company do precursory evaluation, accelerate the design and testing of molecules, streamline the testing processes, and provide a faster understanding along the way if the molecule will perform as expected. With improved clinical success and reduced costs throughout the development pipeline, AI may be shot in the arm the industry needs.

Adoption of AI in Biotechnology

While any full-scale adoption of AI in the pharmaceutical industry is still evolving and finding its place, implementation and investment are growing. Top global pharmaceutical companies have increased their R&D investment in AI by nearly 25% over the past three years – this indicates a recognition of the perceived benefits.

The interest and investment in AI drug discovery is fueled by several factors. As touched on earlier, a more efficient and cost-effective drug development process would be of great benefit. AI can significantly reduce both time and cost. And the sooner more effective treatments are available, the better. Chronic diseases, such as cancer, autoimmune problems, neurological disorders, and cardiovascular diseases, creates an ongoing demand for improved drugs and therapies. AI’s ability to analyze vast amounts of data, identify patterns, and then learn from the information at an accelerated rate can allow researchers to shorten timelines to final conclusions.  

Even more exciting is the growing availability of large datasets thanks to the rise of big data. With an increase in the volume, variety and velocity of data, and the AI-assisted ability to make sense of it, outcomes are expected to be improved. These datasets, obtained from various sources like electronic medical records and genomic databases, allow successful AI applications in drug discovery. Technological advancements, especially in ML algorithms, have been contributing to the growth of AI in medicine. And they are growing more sophisticated, allowing for accurate pattern identification in complex biological systems. Collaborations between academia, industry, and government agencies have further accelerated growth sharing knowledge and resources.

Trends in AI and ML Biotechnology

While considered a young technological field, AI-enabled drug discovery is being shaped by a number of new trends and technologies. Modern AI algorithms are now capable of analyzing intricate biological systems and foretelling the effects of medications on human cells and tissues. By detecting probable adverse effects early on in the development phase, the predictive ability helps prevent failures in the later stages.

By generating candidates that fit certain requirements, generative models can accelerate the design of completely new medications. But other technology is also now available to assist. By offering scalable processing resources, cloud computing dramatically cuts down on both time and expense. By simulating the interaction of hundreds of chemicals with disease targets, virtual drug screening enables the fast screening of drugs.

A higher understanding of disease biology and the discovery of new therapeutic targets is being made possible by integrative techniques that incorporate many data sources not available a short while ago.

Constraints on AI-Assisted Biotech Research

While AI can speed up certain aspects of drug discovery, it cannot replace most traditional lab testing. Hands-on experimentation and data collection on living organisms are expected to always be necessary, many of these processes during the clinical trial stages cannot be sped up.

Regulatory bodies, like the FDA, are also cautious about embracing AI fully, raising concerns about transparency and accountability in decision-making processes.

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Take Away

The near future of artificial intelligence and machine learning assuming a larger role in enabling drug discovery and more efficient R&D looks bright. The technology offers real promise for more efficient and cost-effective drug development processes – this would address the need for new therapies for chronic diseases.

The time-consuming process of testing on real subjects is not expected to be replaced or overly streamlined by technology, but finding subjects and evaluating results can also benefit from the new technology.

Paul Hoffman

Managing Editor, Channelchek

Sources

https://5058440.fs1.hubspotusercontent-na1.net/hubfs/5058440/cold%20outreach%20use%20case%20images/Pathways%20for%20Successful%20AI%20Adoption%20in%20Drug%20Development%20-%20VeriSIM%20Life.pdf

https://www.mckinsey.com/industries/life-sciences/our-insights/ai-in-biopharma-research-a-time-to-focus-and-scale

https://www.drugdiscoveryonline.com/doc/the-global-market-for-ai-in-drug-discovery-to-sextuple-by-0001

https://www.mckinsey.com/industries/life-sciences/our-insights/we-can-invent-new-biology-molly-gibson-on-the-power-of-ai

https://www.fda.gov/patients/learn-about-drug-and-device-approvals/drug-development-process

Baudax Bio (BXRX) – More Positive Top-Line Results From Phase II BX1000 Trial

Posted on by cpereira@noblefcm.com


Thursday, June 08, 2023

Baudax Bio is a pharmaceutical company focused on innovative products for acute care settings. ANJESO is the first and only 24-hour, intravenous (IV) COX-2 preferential non-steroidal anti-inflammatory (NSAID) for the management of moderate to severe pain. In addition to ANJESO, Baudax Bio has a pipeline of other innovative pharmaceutical assets including two novel neuromuscular blocking agents (NMBs) and a proprietary chemical reversal agent specific to these NMBs. For more information, please visit www.baudaxbio.com.

Gregory Aurand, Senior Vice President, Equity Research Analyst, Healthcare Services & Medical Devices, Noble Capital Markets, Inc.

Refer to the full report for the price target, fundamental analysis, and rating.

Deeper dive into the results.  The electomyography (EMG) detailed analysis confirmed the earlier top-line data released showing the highest dose of BX1000 was comparable to rocuronium (current standard). There was a clear dose response for BX1000 on maximum T1 suppression, with comparable results for the 1.5x ED95  dose of BX1000 and the 2x ED95 dose of rocuronium, strongly suggesting lower BX1000 dosing needed.

What is T1 suppression?  Train of Four (TOF) testing is a method of peripheral nerve stimulation, using electrodes placed along the nerve pathway. An electrical impulse will cause a contraction (twitch). With increased NMB dosing, the twitch response fades, with the fourth (T4) response lost first, then T3, then T2, and finally the first (T1). The number of twitches observed indicates the NMB level achieved, determining the minimum amount needed to achieve the desired effect, while reducing the likelihood of over-paralysis and prolonged muscle weakness. A T1 level of suppression (or one twitch) represents approximately 90% block, a level suitable for short term procedures including intubation. 


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This Company Sponsored Research is provided by Noble Capital Markets, Inc., a FINRA and S.E.C. registered broker-dealer (B/D).

*Analyst certification and important disclosures included in the full report. NOTE: investment decisions should not be based upon the content of this research summary. Proper due diligence is required before making any investment decision. 

Release – Tonix Pharmaceuticals Announces Data Presentations Involving TNX-1500 (anti-CD40L mAb) for the Prevention of Rejection in Kidney and Heart Allograft Transplantation in Animal Models at the 2023 American Transplant Congress

Posted on by aweinsoff@channelchek.com

Research News and Market Data on TNXP

June 07, 2023 7:00am EDT

Research Directed by Faculty of the Center for Transplantation Sciences, Massachusetts General Hospital

TNX-1500 is Expected to Enter Phase 1 Clinical Development in Third Quarter 2023

CHATHAM, N.J, June 07, 2023 (GLOBE NEWSWIRE) — Tonix Pharmaceuticals Holding Corp. (Nasdaq: TNXP) (Tonix or the Company), a clinical-stage biopharmaceutical company, today announced data from two oral presentations and one poster presentation at the 2023 American Transplant Congress (ATC) by faculty at the Center for Transplantation Sciences, Massachusetts General Hospital. The data involve studies of Tonix’s TNX-1500 (Fc-modified anti-CD40L monoclonal antibody) in development for the prevention of organ transplant rejection. The molecular target of TNX-1500 is CD40-ligand (CD40L), which is also known as CD154. Copies of the presentations are available on the Tonix Pharmaceuticals website at www.tonixpharma.com.

The oral presentations titled, “Fc-Modified anti-CD154 Mab Induced Long Term Renal Allograft Survival without Thromboembolic Complications” by Dr. Ryo Otsuka et al. and “Efficacy of CD154 Blockade with TNX-1500 to prevent heart allograft immune injury” by Dr. Ikechukwu Ileka et al., and the poster presentation titled “anti-CD154 mAb (TNX-1500) Alone, or in Combination with Rapamycin, MMF, or anti-CD28 mAb (VEL-101) Prolongs Cynomolgus Cardiac Allograft Survival” by Dr. Kohei Kinoshita et al. include data demonstrating that TNX-1500 showed activity in preventing organ rejection and was well tolerated in non-human primates. Blockade of CD40L with TNX-1500 monotherapy consistently prevented pathologic alloimmunity in non-human primate kidney and cardiac allograft models without clinical thrombosis. Dr. Kinoshita was recognized with “Poster of Distinction” for his poster presentation.

“The animal studies found that TNX-1500 retains activity to prevent rejection and preserve graft function, which we believe provides strong rationale for us to pursue development of TNX-1500 to prevent rejection in human transplant,” said Seth Lederman, M.D., Chief Executive Officer of Tonix Pharmaceuticals. “We expect to begin a Phase 1 trial with TNX-1500 in the third quarter of 2023. There remains a significant need for new treatments with improved activity and tolerability to prevent organ transplant rejection. TNX-1500 is a third generation anti-CD40L mAb that has been designed by protein engineering to decrease FcγRII binding and to reduce the potential for thrombosis. We believe TNX-1500 has the potential for treating and preventing organ transplant rejection. Beyond transplantation, we believe TNX-1500 has potential for treating autoimmune conditions including systemic lupus erythematosus, Sjögren’s syndrome and multiple sclerosis.”

Tonix Pharmaceuticals Holding Corp.*

Tonix is a clinical-stage biopharmaceutical company focused on discovering, licensing, acquiring and developing therapeutics to treat and prevent human disease and alleviate suffering. Tonix’s portfolio is composed of central nervous system (CNS), rare disease, immunology and infectious disease product candidates. Tonix’s CNS portfolio includes both small molecules and biologics to treat pain, neurologic, psychiatric and addiction conditions. Tonix’s lead CNS candidate, TNX-102 SL (cyclobenzaprine HCl sublingual tablet), is in mid-Phase 3 development for the management of fibromyalgia with topline data expected in the fourth quarter of 2023. TNX-102 SL is also being developed to treat Long COVID, a chronic post-acute COVID-19 condition. Enrollment in a Phase 2 study has been completed, and topline results are expected in the third quarter of 2023. TNX-1900 (intranasal potentiated oxytocin), in development for chronic migraine, is currently enrolling with topline data expected in the fourth quarter of 2023. TNX-601 ER (tianeptine hemioxalate extended-release tablets), a once-daily formulation being developed as a treatment for major depressive disorder (MDD), is also currently enrolling with interim data expected in the fourth quarter of 2023. TNX-4300 (estianeptine) is a small molecule oral therapeutic in preclinical development to treat MDD, Alzheimer’s disease and Parkinson’s disease. TNX-1300 (cocaine esterase) is a biologic designed to treat cocaine intoxication and has been granted Breakthrough Therapy designation by the FDA. A Phase 2 study of TNX-1300 is expected to be initiated in the third quarter of 2023. Tonix’s rare disease portfolio includes TNX-2900 (intranasal potentiated oxytocin) for the treatment of Prader-Willi syndrome. TNX-2900 has been granted Orphan Drug designation by the FDA. Tonix’s immunology portfolio includes biologics to address organ transplant rejection, autoimmunity and cancer, including TNX-1500, which is a humanized monoclonal antibody targeting CD40-ligand (CD40L or CD154) being developed for the prevention of allograft rejection and for the treatment of autoimmune diseases. A Phase 1 study of TNX-1500 is expected to be initiated in the third quarter of 2023. Tonix’s infectious disease pipeline includes TNX-801, a vaccine in development to prevent smallpox and mpox, for which a Phase 1 study is expected to be initiated in the first quarter of 2024. TNX-801 also serves as the live virus vaccine platform or recombinant pox vaccine platform for other infectious diseases. The infectious disease portfolio also includes TNX-3900 and TNX-4000, classes of broad-spectrum small molecule oral antivirals.

*All of Tonix’s product candidates are investigational new drugs or biologics and have not been approved for any indication.

This press release and further information about Tonix can be found at www.tonixpharma.com.

Forward Looking Statements

Certain statements in this press release are forward-looking within the meaning of the Private Securities Litigation Reform Act of 1995. These statements may be identified by the use of forward-looking words such as “anticipate,” “believe,” “forecast,” “estimate,” “expect,” and “intend,” among others. These forward-looking statements are based on Tonix’s current expectations and actual results could differ materially. There are a number of factors that could cause actual events to differ materially from those indicated by such forward-looking statements. These factors include, but are not limited to, risks related to the failure to obtain FDA clearances or approvals and noncompliance with FDA regulations; delays and uncertainties caused by the global COVID-19 pandemic; risks related to the timing and progress of clinical development of our product candidates; our need for additional financing; uncertainties of patent protection and litigation; uncertainties of government or third party payor reimbursement; limited research and development efforts and dependence upon third parties; and substantial competition. As with any pharmaceutical under development, there are significant risks in the development, regulatory approval and commercialization of new products. Tonix does not undertake an obligation to update or revise any forward-looking statement. Investors should read the risk factors set forth in the Annual Report on Form 10-K for the year ended December 31, 2022, as filed with the Securities and Exchange Commission (the “SEC”) on March 13, 2023, and periodic reports filed with the SEC on or after the date thereof. All of Tonix’s forward-looking statements are expressly qualified by all such risk factors and other cautionary statements. The information set forth herein speaks only as of the date thereof.

Contacts

Jessica Morris (corporate)
Tonix Pharmaceuticals
investor.relations@tonixpharma.com
(862) 904-8182

Maddie Stabinski (media)
Russo Partners
Madeline.Stabinski@russopartnersllc.com
(212) 845-4273

Peter Vozzo (investors)
Westwicke/ICR
peter.vozzo@westwicke.com
(443) 213-0505

Source: Tonix Pharmaceuticals Holding Corp.

Released June 7, 2023

PDS Biotechnology Corp. (PDSB) – Phase 2 VERSATILE-002 Data Reviewed On Conference Call

Posted on by cpereira@noblefcm.com


Wednesday, June 07, 2023

PDS Biotech is a clinical-stage immunotherapy company developing a growing pipeline of molecularly targeted cancer and infectious disease immunotherapies based on the Company’s proprietary Versamune® and Infectimune™ T-cell activating technology platforms. Our Versamune®-based products have demonstrated the potential to overcome the limitations of current immunotherapy by inducing in vivo, large quantities of high-quality, highly potent polyfunctional tumor specific CD4+ helper and CD8+ killer T-cells. PDS Biotech has developed multiple therapies, based on combinations of Versamune® and disease-specific antigens, designed to train the immune system to better recognize diseased cells and effectively attack and destroy them. The Company’s pipeline products address various cancers including HPV16-associated cancers (anal, cervical, head and neck, penile, vaginal, vulvar) and breast, colon, lung, prostate and ovarian cancers.

Robert LeBoyer, Senior Vice President, Equity Research Analyst, Biotechnology, Noble Capital Markets, Inc.

Refer to the full report for the price target, fundamental analysis, and rating.

ASCO Presentation On Head and Neck Cancer Reviewed. PDS Biotechnology held a conference call to review data from the Phase 2 VERSATILE-002 trial that was presented at the annual ASCO meeting on Monday, June 5. Management also briefly commented on a misinterpretation posted on social media sites that caused a sharp price decline and a trading halt in the stock.

VERSATILE-002 Data Consistent With Previous Results. As discussed in our Research Note from May 30, the presentation updated the Phase 2 VERSATILE trial data presented at ASCO ’22. At that time, preliminary data from the first 17 patients to reach the 9-month evaluation post was presented. The update included data from 34 patients that had reached the 12-month evaluation point. 


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Equity Research is available at no cost to Registered users of Channelchek. Not a Member? Click ‘Join’ to join the Channelchek Community. There is no cost to register, and we never collect credit card information.

This Company Sponsored Research is provided by Noble Capital Markets, Inc., a FINRA and S.E.C. registered broker-dealer (B/D).

*Analyst certification and important disclosures included in the full report. NOTE: investment decisions should not be based upon the content of this research summary. Proper due diligence is required before making any investment decision. 

ChitogenX Inc. (CHNXF) – Non-Brokered Private Placement 2nd Tranche Closed; Clarification And Revision

Posted on by cpereira@noblefcm.com


Wednesday, June 07, 2023

Gregory Aurand, Senior Vice President, Equity Research Analyst, Healthcare Services & Medical Devices, Noble Capital Markets, Inc.

Refer to the full report for the price target, fundamental analysis, and rating.

2nd Tranche.  The Company announced Monday they had closed a 2nd tranche for $288,000 (currencies in Canadian $).  This tranche, on the back of the closed $3.86 million 1st tranche announced previously, consisted of gross cash proceeds of $41,250 and $241,141 in convertible debt conversions that had matured May 1, 2023.  In this 2nd tranche, 1.922608 million units at $0.15 per unit were issued.  Each unit consisted of one share of common and one purchase warrant exercisable at $0.35 per share.

Clarification To Company May 5, 2023 Press Release And Correction.  In the Company’s press release Monday June 5, 2023, it was clarified that the $3.86 million non-brokered 1st tranche placement, which closed early May, consisted of $1.267 million in gross cash proceeds and debt conversions of $2.589 million.  While the two tranches remove $2.84 million in liabilities, gross cash proceeds from the tranches totaled approximately $1.31 million. In our prior noted dated June 1, 2023, we indicated ChitogenX raised $5.3 million subsequent to its fiscal January 31, 2023 yearend. However, gross cash proceeds were approximately $3.0 million.


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Equity Research is available at no cost to Registered users of Channelchek. Not a Member? Click ‘Join’ to join the Channelchek Community. There is no cost to register, and we never collect credit card information.

This Company Sponsored Research is provided by Noble Capital Markets, Inc., a FINRA and S.E.C. registered broker-dealer (B/D).

*Analyst certification and important disclosures included in the full report. NOTE: investment decisions should not be based upon the content of this research summary. Proper due diligence is required before making any investment decision. 

Can an Inexpensive, Repurposed Therapy Treat Brain Cancer?

Posted on by phoffman@channelchek.com

Brain Tumors are Cognitive Parasites – How Brain Cancer Hijacks Neural Circuits and Causes Cognitive Decline

Researchers have long known that brain tumors, specifically a type of tumor called a glioma, can affect a person’s cognitive and physical function. Patients with glioblastoma, the most fatal type of brain tumor in adults, experience an especially drastic decline in quality of life. Glioblastomas are thought to impair normal brain functions by compressing and causing healthy tissue to swell, or competing with them for blood supply.

What exactly causes cognitive decline in brain tumor patients is still unknown. In our recently published research, we found that tumors can not only remodel neural circuits, but that brain activity itself can fuel tumor growth.

This article was republished with permission from The Conversation, a news site dedicated to sharing ideas from academic experts. It represents the research-based findings and thoughts of, Saritha Krishna, Postdoctoral Fellow in Neurological Surgery, University of California, San Francisco, and Shawn Hervey-Jumper, Associate Professor of Neurological Surgery, University of California, San Francisco.

We are a neuroscientist and neurosurgeon team at the University of California, San Francisco. Our work focuses on understanding how brain tumors remodel neuronal circuits and how these changes affect language, motor and cognitive function. We discovered a previously unknown mechanism brain tumors use to hijack and modify brain circuitry that causes cognitive decline in patients with glioma.

Brain Tumors in Dialogue with Surrounding Cells

When we started this study, scientists had recently found that a self-perpetuating positive feedback loop powers brain tumors. The cycle begins when cancer cells produce substances that can act as neurotransmitters, proteins that help neurons communicate with each other. This surplus of neurotransmitters triggers neurons to become hyperactive and secrete chemicals that stimulate and accelerate the proliferation and growth of the cancer cells.

We wondered how this feedback loop affects the behavior and cognition of people with brain cancer. To study how glioblastomas engage with neuronal circuits in the human brain, we recorded the real-time brain activity of patients with gliomas as they were shown pictures of common objects or animals and asked to name what they depicted while they were undergoing brain surgery to remove the tumor.

While the patients engaged in these tasks, the language networks in their brains were activated as expected. However, we found that the brain regions the tumors had infiltrated quite remote from known language zones of the brain were also activated during these tasks. This unexpected finding shows that tumors can hijack and restructure connections in the brain tissue surrounding them and increase their activity.

This may account for the cognitive decline frequently associated with the progression of gliomas. However, by directly recording the electrical activity of the brain using electrocorticography, we showed that despite being hyperactive, these remote brain regions had significantly reduced computational power. This was especially the case for processing more complex, less commonly used words, such as “rooster,” in comparison with simple, more commonly used words, such as “car.” This meant that brain cells entangled in the tumor are so compromised that they need to recruit additional cells to carry out tasks previously controlled by a smaller defined area.

We make an analogy to an orchestra. The musicians need to play in synchrony for the music to work. When you lose the cellos and the woodwinds, the remaining musicians can’t deliver the piece as effectively as when all players are present. Similarly, when brain tumors hijack the areas surrounding it, the brain is less able to effectively function.

Gabapentin as a Promising Drug for Glioblastoma

Now we understood that tumors can impair cognition by affecting neural connections. Next, we further examined their connections with each other and with healthy neurons using mouse models and brain organoids, which are clusters of brain cells grown in a Petri dish.

These experiments, led by one of us, Saritha Krishna, found that tumor cells secrete a protein called thrombospondin-1 that plays a key role in promoting the hyperactivity of brain cells. We wondered whether blocking this protein, which normally helps neurons form synapses, would halt tumor growth and extend the survival of mice with glioblastoma.

Glioma cells could potentially be treated by repurposing the anti-seizure drug gabapentin. Castro Lab, Michigan Medicine/NIH via Flickr, CC BY-NC

To test this hypothesis, we treated mice with a common anti-seizure drug called gabapentin that blocks thrombospondin-1. We found that gabapentin was able to keep the brain tumors from expanding for several months. These findings highlight the potential of repurposing this existing drug to control brain tumor growth.

Our study suggests that targeting the communication between healthy brain cells and cancer cells could offer another way to treat brain cancer. Combining gabapentin with other conventional therapies could complement existing treatments, helping mitigate cognitive decline and potentially improving survival. We are now exploring new ways to take advantage of this drug’s potential to halt tumor growth. Our goal is to ultimately translate the findings of our study to clinical trials in people.

MustGrow Biologics Corp. (MGROF) – Setting Up the Seeds to Sprout

Posted on by cpereira@noblefcm.com


Tuesday, June 06, 2023

Joe Gomes, Managing Director, Equity Research Analyst, Generalist , Noble Capital Markets, Inc.

Joshua Zoepfel, Research Associate, Noble Capital Markets, Inc.

Refer to the full report for the price target, fundamental analysis, and rating.

New Agreement. MustGrow announced the Company has agreed to a Contract Services Agreement with Bio Ag Product Strategies to develop and commercialize MustGrow’s soil amendment and biofertility technologies, including TerraSante. The agreement is a non-exclusive contract, enabling MustGrow to seek out additional commercial collaborations and funding partnerships. Neither the length of the agreement nor any financials were disclosed.

Who is Bio Ag? Bio Ag Product Strategies is a consulting firm that provides consultation to manufacturers of microbial products for agriculture and support products including biostimulants and prebiotics. According to MustGrow, Bio Ag Product Strategies has tremendous knowledge and a great track record of working with organizations to help develop, market, and target key retailers and farmers.


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Equity Research is available at no cost to Registered users of Channelchek. Not a Member? Click ‘Join’ to join the Channelchek Community. There is no cost to register, and we never collect credit card information.

This Company Sponsored Research is provided by Noble Capital Markets, Inc., a FINRA and S.E.C. registered broker-dealer (B/D).

*Analyst certification and important disclosures included in the full report. NOTE: investment decisions should not be based upon the content of this research summary. Proper due diligence is required before making any investment decision. 

An Investor List of the Industries that Can be Improved With Blockchain Technology

Posted on by phoffman@channelchek.com

Blockchain Beyond Cryptocurrency: The Potential of Distributed Ledger Technology

Does blockchain have a future beyond crypto? Since its beginning as the underlying technology for Bitcoin (BTC) and later other cryptocurrencies, blockchain has been the necessary, behind-the-scenes, engine that allow these fintech currencies to function. Dogecoin (DOGE), Ethereum (ETH), and even the 18 G20 countries developing a central bank digital currency (CBDC) need blockchain to exist.  

But what non-finance industries are being impacted or will be disrupted by blockchain? It is not with exaggeration to say blockchain has the power to revolutionize various industries and redefine everyday transactions, manage data, and establish trust. Long-term investing requires knowledge of current trends and where the future may take them. Below we explore many of the possibilities of blockchain aside from cryptocurrency and delve into its promising future.

What is Blockchain?

At its core, blockchain is a decentralized (no single control) and immutable (unable to be changed) ledger that records activity across multiple computers. This distributed character replaces the need for institutional intermediaries to ensure transparency, security, and efficiency. A person or an entity can function, even across borders directly, without the need for a middleman. Verification of activity is recorded and remains a part of a blockchain ledger.

Uses beyond cryptocurrency, or the speculative investment that crypto and non-fungible tokens (NFT) have become, include health care, finance, voting, real estate titles, and smart communities.

Health Care

The HIPAA Privacy Rule sets national standards to protect individuals’ medical records and other identifiable health information. It applies to health plans, healthcare clearinghouses, and healthcare providers that conduct certain medical transactions electronically. The purpose is to keep data ownership from improperly being passed and to maintain privacy in the industry. Current centralized systems are not able to meet the many needs of patients, health service providers, insurance companies, and governmental agencies. Blockchain technology enables a decentralized system for access control of medical records where all stakeholders’ interests are protected.

Blockchain systems not only allow healthcare service providers to securely share patients’ medical records but patients may also track who has accessed their records and determine who is authorized to do so. If blockchain-driven, all transactions can become transparent to the patient.

And blockchain-powered interoperability can enable the seamless sharing of medical data between healthcare organizations, improving patient care, research, and drug development.

Supply Chain Management

Complex global supply chains involve numerous stakeholders, some sending, others receiving, and others verifying the source of food or products. Verifying the authenticity and improving traceability of products can be a challenging task. Blockchain’s ability to create an immutable record of every transaction and movement along the supply chain enables transparency and accountability. A company will be able to securely track the origin, manufacturing process, and movement of goods. Consumers can be equipped with verified information, among other benefits, this will increase trust and reduce the risk of receiving counterfeit products.

Storing information regarding movement on a blockchain improves integrity, accountability and traceability. For example, IBM’s Food Trust uses a blockchain system to track food items from the field to retailers. The participants in the food supply chain record transactions in the shared blockchain, which simplifies keeping track.

Entertainment Products

As technology has allowed greater reproduction and distribution, including music and art, blockchain may provide creators with more control over their work. The whole entertainment industry may undergo a significant transformation with blockchain technology. Artists can tokenize their efforts, creating a digital certificate of ownership that can be bought, sold, and shared on blockchain platforms. This will enable artists to have tight control over their intellectual property, receive fair compensation, and even establish a direct connection with their followers. Beyond ownership infringement, blockchain can facilitate transparent royalty distribution, this could ensure that artists receive their rightful earnings without an intermediary and the cost that comes with anyone getting in the middle of a transaction.

The Energy Sector

Blockchain is likely to play a transformative role in all forms of energy. As renewable energy sources continue their trend, blockchain can enable peer-to-peer energy trading. Individuals and organizations will be able to directly exchange surplus energy with those expecting an energy deficit. This could create a decentralized energy market.

Smart contracts executed on the blockchain can automatically verify and settle transactions, ensuring transparency. This democratization of energy, if broadly implemented, could accelerate the adoption of sustainable practices, provide energy where needed, and reduce waste.

Governments

While the government is often the intermediary that the blockchain makes less needed or unneeded, recognizing the potential of blockchain to enhance transparency and efficiency in public services may become its greatest use. Land registries, taxation, voting systems, and identity certainty can all be improved through blockchain’s tracking and tamper-resistant design. Immutable records of land ownership can reduce disputes and increase trust in property transactions. Digital identities stored on a blockchain can streamline processes such as passport verification and border control, making them more secure and efficient. Blockchain-based voting systems have the potential to eliminate voter fraud, ensuring fair and transparent elections.

Potential

Much of what is described above has either barely been implemented or has not been put to use. This is a period in any technological advancement when most long-term investors would like to be involved. Efficiencies and improved products are poised to help the industries mentioned, and pure blockchain companies, large and small, can benefit from developing uses for their technology.

Despite its potential, blockchain technology still faces challenges. Scalability, energy consumption, and regulatory frameworks require further development and refinement. However, ongoing research and collaborations among businesses, academia, industry, and policymakers are actively finding avenues around these concerns, driving the maturation of blockchain technology.

Take Away

Blockchain is still in its infancy, and industries are just becoming aware of its power to help them. As the paradigm shifts, it could become a technology businesses could not imagine doing without. Blockchain’s decentralized, transparent, and secure nature makes it a powerful tool for revolutionizing healthcare, supply chain management, entertainment, governing, and energy sectors. As the technology evolves, we can expect innovative use and widespread adoption of blockchain that serves to elevate trust, efficiency, and transparency. And maybe the now-developed cryptocurrencies will survive within these changes.

Paul Hoffman

Managing Editor, Channelchek

Sources

https://www.investopedia.com/tech/forget-bitcoin-blockchain-future/

https://www.hhs.gov/hipaa/for-professionals/privacy/index.html

https://www.ibm.com/products/supply-chain-intelligence-suite/food-trust

https://www.investopedia.com/10-biggest-blockchain-companies-5213784

Release – PDS Biotechnology Post-ASCO Conference Call Tomorrow, June 6, at 8 a.m. ET

Posted on by aweinsoff@channelchek.com

Research News and Market Data on PDSB

FLORHAM PARK, N.J., June 05, 2023 (GLOBE NEWSWIRE) — PDS Biotechnology Corporation (Nasdaq: PDSB), a clinical-stage immunotherapy company developing a growing pipeline of targeted immunotherapies for cancer and infectious disease, today announced that the Company will be hosting a conference call and webcast tomorrow, June 6, 2023, to discuss the promising interim data from the VERSATILE-002 (NCT04260126) Phase 2 clinical trial investigating PDS0101 in combination with Merck’s anti-PD-1 therapy, KEYTRUDA® (pembrolizumab), presented at the 2023 American Society for Clinical Oncology (ASCO) meeting.

During the call, management will provide an in-depth review of the 2023 ASCO interim data.

Conference Call Information:
PDS Biotech will host a conference call on Tuesday, June 6, at 8:00 a.m. ET to discuss the interim data being presented at the ASCO 2023 Annual Meeting. A live webcast of the event will be available online at PDS Biotech Post-ASCO Webcast. The event will be archived in the investor relations section of PDS Biotech’s website for six months.

Additionally, interested participants and investors may access the conference call by dialing either 877-407-3088 (US) or 201-389-0927 (International).

About PDS Biotechnology
PDS Biotech is a clinical-stage immunotherapy company developing a growing pipeline of targeted cancer and infectious disease immunotherapies based on our proprietary Versamune®, Versamune® plus PDS0301, and Infectimune™ T cell-activating platforms. We believe our targeted immunotherapies have the potential to overcome the limitations of current immunotherapy approaches through the activation of the right type, quantity and potency of T cells. To date, our lead Versamune® clinical candidate, PDS0101, has demonstrated the ability to reduce and shrink tumors and stabilize disease in combination with approved and investigational therapeutics in patients with a broad range of HPV16-associated cancers in multiple Phase 2 clinical trials and will be advancing into a Phase 3 clinical trial in combination with KEYTRUDA® for the treatment of recurrent/metastatic HPV16-positive head and neck cancer in 2023. Our Infectimune™ based vaccines have also demonstrated the potential to induce not only robust and durable neutralizing antibody responses, but also powerful T cell responses, including long-lasting memory T cell responses in pre-clinical studies to date. To learn more, please visit www.pdsbiotech.com or follow us on Twitter at @PDSBiotech. 

Investor Relations:
Deanne Randolph
PDS Biotech
Phone: +1 (908) 517-3613
Email: drandolph@pdsbiotech.com

Rich Cockrell
CG Capital
Phone: +1 (404) 736-3838
Email: pdsb@cg.capital

Media Contacts:
Tiberend Strategic Advisors, Inc.
Dave Schemelia
Phone: +1 (609) 468-9325
dschemelia@tiberend.com

Bill Borden
Phone: +1 (732) 910-1620
bborden@tiberend.com

Release – Schwazze Completes Acquisiton to Manage Assets of New Mexico Cannabis Operator, Everest Apothecary, Inc.

Posted on by aweinsoff@channelchek.com

Research News and Market Data on SHWZ

June 5, 2023

NEO: SHWZ 
OTCQX: SHWZ

Acquisition Increases Schwazze’s New Mexico Retail Store Count to 32 and 
Provides Expanded Coverage Throughout State

DENVER, June 5, 2023 /CNW/ – Medicine Man Technologies, Inc., operating as Schwazze, (OTCQX: SHWZ) (NEO: SHWZ) (“Schwazze” or the “Company”), announced it has acquired certain assets of Sucellus, LLC, pursuant to which the Company will manage Everest Apothecary, Inc. (“Everest“), a New Mexico not-for-profit corporation. The transaction includes retail dispensaries, cultivation, and manufacturing facilities.  

The acquisition of Everest increases the Company’s retail consumer base and furthers Schwazze’s growth strategy in the New Mexico market. Upon closing, Schwazze’s New Mexico operations will include 32 dispensaries, four cultivations, two manufacturing facilities and over 400 employees statewide.

The Everest brand complements Schwazze’s existing retail brand in New Mexico, R. Greenleaf.  Each serves a unique demographic, and both retail banners will continue to operate in the state.  

“This acquisition fits well within our growing portfolio of retail brands alongside R.Greenleaf, and firmly positions us as a top operator in the New Mexico market,” said Nirup Krishnamurthy, President of Schwazze.

“Collaborating on Schwazze’s operating playbook, we look forward to working with the Everest team members to continue to support the Everest customers with outstanding service and an even wider selection of quality products throughout the entire state. These really are two great teams coming together as one,” said Ken Diehl, New Mexico Division President of Schwazze.   

Established in 2016, Everest is a New-Mexico-based licensed medical and recreational cannabis provider that consists of 14 dispensaries, one cultivation facility and one manufacturing plant. The dispensaries are in Albuquerque, Santa Fe, Las Cruces, Los Lunas, Sunland Park, Belen, and Texico. Everest’s cultivation and manufacturing facilities are both located in Albuquerque.

Since April 2020, Schwazze has acquired, opened, or announced the planned acquisition of 60 cannabis retail dispensaries (bannered as Star Buds, Emerald Fields, R. Greenleaf, Standing Akimbo, and Everest) as well as six operating cultivation facilities and three manufacturing plants across Colorado and New Mexico. In May 2021, Schwazze announced its Biosciences division, and in August 2021, it commenced home delivery services in Colorado.

ABOUT SCHWAZZE

Schwazze (OTCQX: SHWZ) (NEO: SHWZ) is building a premier vertically integrated regional cannabis company with assets in Colorado and New Mexico and will continue to take its operating system to other states where it can develop a differentiated regional leadership position. Schwazze is the parent company of a portfolio of leading cannabis businesses and brands spanning seed to sale. The Company is committed to unlocking the full potential of the cannabis plant to improve the human condition.

Schwazze is anchored by a high-performance culture that combines customer-centric thinking and data science to test, measure, and drive decisions and outcomes. The Company’s leadership team has deep expertise in retailing, wholesaling, and building consumer brands at Fortune 500 companies as well as in the cannabis sector. Schwazze is passionate about making a difference in our communities, promoting diversity and inclusion, and doing our part to incorporate climate-conscious best practices.

Medicine Man Technologies, Inc. was Schwazze’s former operating trade name. The corporate entity continues to be named Medicine Man Technologies, Inc. Schwazze derives its name from the pruning technique of a cannabis plant to enhance plant structure and promote healthy growth. To learn more about Schwazze, visit www.Schwazze.com.

Forward-Looking Statements

This press release contains “forward-looking statements.” Such statements may be preceded by the words “may,” “will,” “could,” “would,” “should,” “expect,” “intends,” “plans,” “strategy,” “prospects,” “anticipate,” “believe,” “approximately,” “estimate,” “predict,” “project,” “potential,” “continue,” “ongoing,” or the negative of these terms or other words of similar meaning in connection with a discussion of future events or future operating or financial performance, although the absence of these words does not necessarily mean that a statement is not forward-looking. Forward-looking statements are not guarantees of future events or performance, are based on certain assumptions, and are subject to various known and unknown risks and uncertainties, many of which are beyond the Company’s control and cannot be predicted or quantified. Consequently, actual events and results may differ materially from those expressed or implied by such forward-looking statements. Such risks and uncertainties include, without limitation, risks and uncertainties associated with (i) regulatory limitations on our products and services and the uncertainty in the application of federal, state, and local laws to our business, and any changes in such laws; (ii) our ability to manufacture our products and product candidates on a commercial scale on our own or in collaboration with third parties; (iii) our ability to identify, consummate, and integrate anticipated acquisitions; (iv) general industry and economic conditions; (v) our ability to access adequate capital upon terms and conditions that are acceptable to us; (vi) our ability to pay interest and principal on outstanding debt when due; (vii) volatility in credit and market conditions; (viii) the loss of one or more key executives or other key employees; and (ix) other risks and uncertainties related to the cannabis market and our business strategy. More detailed information about the Company and the risk factors that may affect the realization of forward-looking statements is set forth in the Company’s filings with the Securities and Exchange Commission (SEC), including the Company’s Annual Report on Form 10-K and its Quarterly Reports on Form 10-Q. Investors and security holders are urged to read these documents free of charge on the SEC’s website at http://www.sec.gov. The Company assumes no obligation to publicly update or revise its forward-looking statements because of new information, future events or otherwise except as required by law.

View original content to download multimedia:https://www.prnewswire.com/news-releases/schwazze-completes-acquisition-to-manage-assets-of-new-mexico-cannabis-operator-everest-apothecary-inc-301842392.html

SOURCE Medicine Man Technologies, Inc.

Release – Onconova Therapeutics Announces Poster Presentation At The American Society Of Clinical Oncology Annual Meeting

Posted on by aweinsoff@channelchek.com

Research News and Market Data on ONTX


Jun 05, 2023

Trial in Progress poster detailed design of Phase 2 program evaluating rigosertib monotherapy in advanced squamous cell carcinoma complicating recessive dystrophic epidermolysis bullosa

NEWTOWN, Pa., June 05, 2023 (GLOBE NEWSWIRE) — Onconova Therapeutics, Inc. (NASDAQ: ONTX), (“Onconova”), a clinical-stage biopharmaceutical company focused on discovering and developing novel products for patients with cancer, today announced the presentation of a Trials in Progress poster at the American Society of Clinical Oncology (ASCO) Annual Meeting, which is taking place June 2 – 6, 2023 in Chicago, Illinois and online.

The poster, which was presented on Saturday, June 3, 2023, during the “Melanoma/Skin Cancers” session, detailed the design of an investigator-sponsored Phase 2 program evaluating rigosertib monotherapy in advanced squamous cell carcinoma complicating recessive dystrophic epidermolysis bullosa (RDEB-associated SCC). A copy of the poster, titled “A pilot, open study to assess efficacy and safety of ON-01910 (rigosertib) in patients with recessive dystrophic epidermolysis bullosa associated locally advanced/metastatic squamous cell carcinoma,” is available on the “Scientific Presentations” section of the Onconova website.

About RDEB-associated SCC

RDEB is caused by insufficient expression of normal type VII collagen protein, which is responsible for anchoring the skin’s inner layer to its outer layer. This leads to extreme skin fragility as well as chronic blistering and wound formation with recurrent infections in RDEB patients, many of whom go on to develop metastatic squamous cell carcinoma driven by overexpression of polo like kinase 1 (PLK-1). RDEB-associated SCC tumors show a highly aggressive and early metastasizing course that makes them the primary cause of death for these patients, with a cumulative risk of death of 70% and 78.7% by ages 45 and 55, respectively1,2. RDEB-associated SCC can appear in pediatric patients or in young adults. Currently available treatments such as targeted therapies and conventional chemo- and/or radiotherapy have demonstrated limited response rates and poor durability in RDEB-associated SCC1,3.

About Onconova Therapeutics, Inc.

Onconova Therapeutics is a clinical-stage biopharmaceutical company focused on discovering and developing novel products for patients with cancer. The Company has proprietary targeted anti-cancer agents designed to disrupt specific cellular pathways that are important for cancer cell proliferation.

Onconova’s novel, proprietary multi-kinase inhibitor narazaciclib (formerly ON 123300) is being evaluated in a combination trial with estrogen blockade in advanced endometrial cancer. Based on preclinical and clinical studies of CDK 4/6 inhibitors, Onconova is also evaluating opportunities for combination studies with narazaciclib in additional indications.

Onconova’s product candidate rigosertib is being studied in multiple investigator-sponsored studies. These studies include a dose-escalation and expansion Phase 1/2a study of oral rigosertib in combination with nivolumab in patients with KRAS+ non-small cell lung cancer, a Phase 2 program evaluating rigosertib monotherapy in advanced squamous cell carcinoma complicating recessive dystrophic epidermolysis bullosa (RDEB-associated SCC), and a Phase 2 trial evaluating rigosertib in combination with pembrolizumab metastatic melanoma.

For more information, please visit www.onconova.com.

References

  1. Mellerio et al. Br J Dermatol. 2016 Jan; 174(1):56-67. doi: 10.1111/bjd.14104.
  2. Fine et al. J Am Acad Dermatol. 2009 Feb; 60(2):203-11. doi: 10.1016/j.jaad.2008.09.035.
  3. Stratigos et al. Eur J Cancer. 2020 Mar;128:83-102. doi: 10.1016/j.ejca.2020.01.008.

Forward-Looking Statements

Some of the statements in this release are forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, Section 21E of the Securities Exchange Act of 1934, as amended, and the Private Securities Litigation Reform Act of 1995, and involve risks and uncertainties. These statements relate to Onconova’s expectations regarding its clinical development and trials, its product candidates, its business and financial position. Onconova has attempted to identify forward-looking statements by terminology including “believes,” “estimates,” “anticipates,” “expects,” “plans,” “intends,” “may,” “could,” “might,” “will,” “should,” “preliminary,” “encouraging,” “approximately” or other words that convey uncertainty of future events or outcomes. Although Onconova believes that the expectations reflected in such forward-looking statements are reasonable as of the date made, expectations may prove to have been materially different from the results expressed or implied by such forward-looking statements. These statements are only predictions and involve known and unknown risks, uncertainties, and other factors, including the success and timing of Onconova’s clinical trials, investigator-initiated trials and regulatory agency and institutional review board approvals of protocols, Onconova’s collaborations, market conditions and those discussed under the heading “Risk Factors” in Onconova’s most recent Annual Report on Form 10-K and quarterly reports on Form 10-Q. Any forward-looking statements contained in this release speak only as of its date. Onconova undertakes no obligation to update any forward-looking statements contained in this release to reflect events or circumstances occurring after its date or to reflect the occurrence of unanticipated events.

Company Contact:
Mark Guerin
Onconova Therapeutics, Inc.
267-759-3680
ir@onconova.us
https://www.onconova.com/contact/

Investor Contact:
Bruce Mackle
LifeSci Advisors, LLC
646-889-1200
bmackle@lifesciadvisors.com

Release – Tonix Pharmaceuticals Announces Presentation of Data Supporting Development of Racemic and Single (S)-Isomer Tianeptine, Plastogen Anti-Depressants, at the American Society of Clinical Psychopharmacology Meeting

Posted on by aweinsoff@channelchek.com

Research News and Market Data on TNXP

June 05, 2023 7:00am EDT

Tianeptine’s Mechanism of Restoring Neuroplasticity and Neurogenesis by Dual PPAR-β/δ and PPAR-γ Agonism Supports Development as a First-in-Class Oral Therapy for Psychiatric and Neurodegenerative Diseases

Racemic Tianeptine, or TNX-601 ER, is Enrolling in a Potentially Pivotal Phase 2 Study for the Treatment of Major Depressive Disorder; Results from Interim Analysis Expected Fourth Quarter 2023

Single (S)-Isomer of Tianeptine, or TNX-4300, is Free from µ-Opioid Receptor Activity Associated with the (R)-Isomer

TNX-4300 is in Preclinical Development for Depression, Bipolar Disorder, Alzheimer’s Disease and Parkinson’s Disease

CHATHAM, N.J., June 05, 2023 (GLOBE NEWSWIRE) — Tonix Pharmaceuticals Holding Corp. (Nasdaq: TNXP) (Tonix or the Company), a clinical-stage biopharmaceutical company, today announced the presentation of data detailing the mechanism of action and pharmacokinetics of TNX-601 ER (tianeptine hemioxalate extended release) and TNX-4300 (estianeptine) at the American Society of Clinical Psychopharmacology (ASCP) meeting in Miami, Fla. TNX-601 ER is being tested in a potentially pivotal Phase 2 trial for the treatment of major depressive disorder (MDD) for which results of a preplanned interim analysis are expected in the fourth quarter of 2023. TNX-4300 is in preclinical development for mood disorders, Alzheimer’s disease and Parkinson’s disease. The active ingredient of both products is the (S)-isomer of tianeptine.1 The (S)-isomer of tianeptine activates PPAR-β/δ, restores neuroplasticity in neuronal tissue culture and lacks µ-opioid liability. In contrast, the (R)-isomer of tianeptine lacks PPAR-β/δ activity and is an agonist at the µ-opioid receptor. The poster presentation is available on Tonix’s website: www.tonixpharma.com.

Tonix recently announced that the plastogen anti-depressant tianeptine, a drug marketed outside the U.S. for more than 30 years, acts on nuclear PPAR-β/δ and PPAR-γ in neurons and glia to restore neuronal connectivity in depression.2 The understanding that tianeptine bypasses the synapse and acts on the nucleus to exert its effects on restoring neuroplasticity and neurogenesis has direct applicability in a number of neurodegenerative diseases in which neuronal connections are atrophying.2 The newly reported mechanism also provides clarity on why tianeptine is not associated with sexual dysfunction, weight gain or several other treatment-limiting toxicities, which are associated with the antidepressants currently marketed in the U.S. for long-term use.

“Restoring atrophied neuronal connections in psychiatric and neurodegenerative diseases has the potential to achieve better and more durable outcomes,” said Seth Lederman, M.D., Chief Executive Officer of Tonix Pharmaceuticals. “The tianeptine marketed outside the U.S. for treating depression is a 1:1 racemic mixture of two mirror image isomers. Our team of scientists isolated and characterized the (S)-isomer of tianeptine, which is free from µ-opioid receptor activity and is now under development as TNX-4300 for treating psychiatric and neurodegenerative diseases. The (S)-isomer of tianeptine is responsible for tianeptine’s activity on PPAR-β/δ and restoring neuroplasticity and neurogenesis, while the (R)-isomer is responsible for any off-target activity on the µ-opioid receptor.”

The findings reported at the meeting show how the pharmacokinetics of oral TNX-601 ER in humans differ from intraperitoneal (i.p.) tianeptine in mice. In humans, after an oral dose of TNX-601 ER the half-life of tianeptine in the blood is approximately 5-7 hours. In contrast, in mice after an i.p. dose of tianeptine the half-life of tianeptine in the blood has been reported to be less than approximately 30 minutes and the behavioral effects appear dominated by the longer-lasting MC5 metabolite, which maintains µ-opioid receptor activity.3 The data Tonix presented also show that the (R)-isomer of tianeptine is responsible for the decrease in immobility in the mouse forced swim test after i.p. administration, which is consistent with previous reports that the effect of tianeptine on the forced swim test is a µ-opioid receptor-dependent phenomenon.3

Gregory Sullivan, M.D., Chief Medical Officer of Tonix Pharmaceuticals, said, “From our clinical studies on volunteers, after oral dosing with TNX-601 ER, the extended pharmacokinetics of parent tianeptine is consistent with tianeptine exerting activity on PPAR-β/δ and resulting in neurorestorative effects. In contrast, after i.p. dosing of tianeptine in mice, the exposure of tianeptine is brief and the behavioral effects appear dominated by the MC5 metabolite.3 While tianeptine’s MC5 metabolite has been reported to maintain µ-opioid receptor activity3, we found that MC5 metabolite lacks activity on either PPAR-β/δ or PPAR-γ in culture. Together, we believe these findings support the interpretation that the parent tianeptine and specifically, the (S)-isomer of tianeptine exert antidepressant effects in humans by interacting with PPAR-β/δ and PPAR-γ.”

Dr. Sullivan continued, “Our ongoing work on racemic tianeptine in depression is expected to inform and potentially accelerate the development of TNX-4300. The dose of tianeptine for treating depression is well-established from racemic studies, so we plan to test single isomer TNX-4300 at a dose equivalent to 50% of the racemic dose, which is expected to provide equivalent exposure of (S)-tianeptine as racemic tianeptine. Subsequently, we plan to test higher doses of (S)-tianeptine, because TNX-4300 lacks µ-opioid receptor activity, but such studies will require additional non-clinical studies.”

Key experiments were performed by scientists at Tonix’s Research and Development Center (RDC) in Frederick, Maryland.

* TNX-601 and TNX-4300 are investigational new drugs and are not approved for any indication
1Tonix press release, May 23, 2023 https:// ir.tonixpharma.com/news-events/press-releases/detail/1392/tonix-pharmaceuticals-announces-the-isolation-and
2Tonix press release, May 17, 2023 https://ir.tonixpharma.com/news-events/press-releases/detail/1389/tonix-pharmaceuticals-announces-pharmacology-and-medicinal
3 Samuels et al., Neuropsychopharmacology. 2017, 42(10):2052-2063

About Tianeptine

Racemic tianeptine sodium (amorphous) immediate release (dosed 3 times daily) was first marketed for depression in France in 1989 and has been available for decades in Europe, Russia, Asia, and Latin America for the treatment of depression. Tianeptine sodium has an established safety profile from decades of use in these jurisdictions. Currently no tianeptine-containing product is approved in the U.S. and no extended-release tianeptine product is approved in any jurisdiction. In animal models, tianeptine restores dendritic arborization of pyramidal neurons in the CA3 region of hippocampus and in the dentate gyrus region promotes new neuron formation and integration into hippocampal networks.1 Tianeptine’s enhancement of neuroplasticity in animal models of stress is believed to be mediated by activation of PPAR isoforms PPAR-β/δ and PPAR-γ, which makes its properties distinct from traditional monoaminergic antidepressants in the U.S. and contributes to its potential for clinical indications beyond MDD and stress disorders. Tianeptine and its MC5 metabolite are also weak mu-opioid receptor (MOR) agonists that present a potential abuse liability if illicitly misused in large quantities (typically abused at 8-80 times the therapeutic dose on a daily basis).2 In patients who were prescribed tianeptine for depression, the French Transparency Committee found an incidence of misuse of approximately 1 case per 1,000 patients treated3 suggesting low abuse liability when used at the antidepressant dose in patients prescribed tianeptine for depression. Clinical trials have shown that cessation of a therapeutic course of tianeptine does not appear to result in dependence or withdrawal symptoms following 6-weeks4-8, 3-months9, or 12-months10 of treatment. (S)-tianeptine mimics naturally occurring polyunsaturated fatty acid ligands in binding PPAR-β/δ and PPAR-γ. (S)-tianeptine’s activation of nuclear PPAR-β/δ and PPAR-γ receptors appears to be a more direct mechanism to achieve the goal of restoring neuronal connectivity than current therapies. Its proposed mechanism as a plastogen is consistent with its clinical effects in promoting cognition in Alzheimer’s disease and bipolar disorder11,12 in addition to posttraumatic stress disorder (PTSD) and corticosteroid-induced cognitive dysfunction. The PPAR-β/δ target is validated by prior work on agonists treating animal models of neurodegenerative and autoimmune diseases of the central nervous system13 and the concept that Alzheimer’s can be considered a form of diabetes that affects the CNS, or type-III diabetes.”14 Tianeptine’s reported pro-cognitive and anxiolytic effects as well as its ability to attenuate the neuropathological effects of excessive stress responses suggest that it may also be used to treat posttraumatic stress disorder (PTSD), and neurocognitive dysfunction associated with corticosteroid use.

1 McEwen, B. S., et al. Mol. Psychiatry 2010, 15 (3), 237–249.
2 Lauhan, R., et al. Psychosomatics 2018, 59 (6), 547–53.
3 Haute Authorite de Sante; Transparency Committee Opinion. Stablon 12.5 Mg, Coated Tablet, Re- Assessment of Actual Benefit at the Request of the Transparency Committee. December 5, 2012.
4 Emsley, R., et al. J. Clin. Psychiatry 2018, 79 (4)
5 Bonierbale M, et al. Curr Med Res Opin 2003, 19(2):114-124.
6 Guelfi, J. D., et al. Neuropsychobiology 1989, 22 (1), 41–48.
7 Invernizzi, G. et al., Neuropsychobiology 1994, 30 (2–3), 85–93.
8 Lepine, J. P., et al. Hum. Psychopharmacol. 2001, 16 (3), 219–227.
9 Guelfi, J. D. et al., Neuropsychobiology 1992, 25 (3), 140–148.
10 Lôo, H. et al., Br. J. Psychiatry. Suppl. 1992, 15, 61–65.
11 García-Alberca JM, et al. J Alzheimer’s Dis 2022, 88 (2), 707-720.
12 Kauer-Sant’Anna M, et al. J Psychopharmacol 2019, 33 (4), 502-510.
13 Kahremany S et al. Br J Pharmacol 2015, 172(3):754-70
14 Nguyen et al., Int J Mol Sci. 2010, 21(9):3165

Tonix Pharmaceuticals Holding Corp.*

Tonix is a clinical-stage biopharmaceutical company focused on discovering, licensing, acquiring and developing therapeutics to treat and prevent human disease and alleviate suffering. Tonix’s portfolio is composed of central nervous system (CNS), rare disease, immunology and infectious disease product candidates. Tonix’s CNS portfolio includes both small molecules and biologics to treat pain, neurologic, psychiatric and addiction conditions. Tonix’s lead CNS candidate, TNX-102 SL (cyclobenzaprine HCl sublingual tablet), is in mid-Phase 3 development for the management of fibromyalgia with topline data expected in the fourth quarter of 2023. TNX-102 SL is also being developed to treat Long COVID, a chronic post-acute COVID-19 condition. Enrollment in a Phase 2 study has been completed, and topline results are expected in the third quarter of 2023. TNX-1900 (intranasal potentiated oxytocin), in development for chronic migraine, is currently enrolling with topline data expected in the fourth quarter of 2023. TNX-601 ER (tianeptine hemioxalate extended-release tablets), a once-daily formulation being developed as a treatment for major depressive disorder (MDD), is also currently enrolling with interim data expected in the fourth quarter of 2023. TNX-4300 (estianeptine) is a small molecule oral therapeutic in preclinical development to treat MDD, Alzheimer’s disease and Parkinson’s disease. TNX-1300 (cocaine esterase) is a biologic designed to treat cocaine intoxication and has been granted Breakthrough Therapy designation by the FDA. A Phase 2 study of TNX-1300 is expected to be initiated in the third quarter of 2023. Tonix’s rare disease portfolio includes TNX-2900 (intranasal potentiated oxytocin) for the treatment of Prader-Willi syndrome. TNX-2900 has been granted Orphan Drug designation by the FDA. Tonix’s immunology portfolio includes biologics to address organ transplant rejection, autoimmunity and cancer, including TNX-1500, which is a humanized monoclonal antibody targeting CD40-ligand (CD40L or CD154) being developed for the prevention of allograft rejection and for the treatment of autoimmune diseases. A Phase 1 study of TNX-1500 is expected to be initiated in the third quarter of 2023. Tonix’s infectious disease pipeline includes TNX-801, a vaccine in development to prevent smallpox and mpox, for which a Phase 1 study is expected to be initiated in the second half of 2023. TNX-801 also serves as the live virus vaccine platform or recombinant pox vaccine platform for other infectious diseases. The infectious disease portfolio also includes TNX-3900 and TNX-4000, classes of broad-spectrum small molecule oral antivirals.

*All of Tonix’s product candidates are investigational new drugs or biologics and have not been approved for any indication.

This press release and further information about Tonix can be found at www.tonixpharma.com.

Forward Looking Statements

Certain statements in this press release are forward-looking within the meaning of the Private Securities Litigation Reform Act of 1995. These statements may be identified by the use of forward-looking words such as “anticipate,” “believe,” “forecast,” “estimate,” “expect,” and “intend,” among others. These forward-looking statements are based on Tonix’s current expectations and actual results could differ materially. There are a number of factors that could cause actual events to differ materially from those indicated by such forward-looking statements. These factors include, but are not limited to, risks related to the failure to obtain FDA clearances or approvals and noncompliance with FDA regulations; delays and uncertainties caused by the global COVID-19 pandemic; risks related to the timing and progress of clinical development of our product candidates; our need for additional financing; uncertainties of patent protection and litigation; uncertainties of government or third party payor reimbursement; limited research and development efforts and dependence upon third parties; and substantial competition. As with any pharmaceutical under development, there are significant risks in the development, regulatory approval and commercialization of new products. Tonix does not undertake an obligation to update or revise any forward-looking statement. Investors should read the risk factors set forth in the Annual Report on Form 10-K for the year ended December 31, 2022, as filed with the Securities and Exchange Commission (the “SEC”) on March 13, 2023, and periodic reports filed with the SEC on or after the date thereof. All of Tonix’s forward-looking statements are expressly qualified by all such risk factors and other cautionary statements. The information set forth herein speaks only as of the date thereof.

Contacts

Jessica Morris (corporate)
Tonix Pharmaceuticals
investor.relations@tonixpharma.com
(862) 904-8182

Maddie Stabinski (media)
Russo Partners
Madeline.Stabinski@russopartnersllc.com
(212) 845-4273

Peter Vozzo (investors)
Westwicke/ICR
peter.vozzo@westwicke.com
(443) 213-0505

Source: Tonix Pharmaceuticals Holding Corp.

Released June 5, 2023

Release – Ocugen, Inc. Announces Business Advisory Board

Posted on by aweinsoff@channelchek.com

Research News and Market Data on OCGN

June 5, 2023

MALVERN, Pa., June 05, 2023 (GLOBE NEWSWIRE) — Ocugen, Inc. (Ocugen or the Company) (NASDAQ: OCGN), a biotechnology company focused on discovering, developing, and commercializing novel gene and cell therapies, biologics, and vaccines, today announced that the Company has established a Business Advisory Board to assist in driving public/private partnerships with governments around the world; pursuing business collaborations, partnerships, and licensing opportunities; creating awareness of the Company’s differentiated capabilities; and promoting access to the Company’s therapies around the world.

“I am delighted to welcome this notable group of advisors to Ocugen,” said Dr. Shankar Musunuri, Chairman, CEO and Co-founder of Ocugen. “At this stage in the Company’s growth, it is critical to foster collaborations—among industry and with government agencies—to continue driving our clinical programs and maximizing value for our shareholders and patients. The Business Advisory Board will provide new insight to our business strategy, while expanding our reach to execute the strategy.”

Ocugen’s Business Advisory Board members have been selected based on their extensive professional backgrounds and proven track record of creating partnerships among the public and private sector. Members include:

Ambassador Joseph W. Westphal, PhD, Global Senior Fellow at the Joseph H. Lauder Institute of Management and International Studies at The Wharton School of The University of Pennsylvania. Dr. Westphal was the U.S. Ambassador to the Kingdom of Saudi Arabia from March 2014 to January 2017. He also held the positions of Assistant Secretary of the Army (Head of the Army Corps of Engineers) from 1998 to 2000 and Acting Secretary of the Army in 2001.

Pat Toomey, U.S. Senator who represented Pennsylvania from 2011 to 2023. As a senior member of the Senate Finance Committee, Senator Toomey helped to develop and pass the 2017 tax reform—the most sweeping reform in over 30 years. He previously served in the U.S. House of Representatives from 1999-2005. In addition to his public service, the senator has also worked in the financial services industry, trading and managing a portfolio of fixed income derivatives first for Chemical Bank and later for Morgan Grenfell.

Dennis Carey, PhD, Vice Chairman of Korn Ferry, where he recruits Board Directors, CEOs, and their direct reports. He has placed and assessed some of the most successful CEOs and directors for over 75 leading companies in the Fortune 500. Dr. Carey founded several forums for Chairmen, CEOs, and C-Suite executives. He has published seven books, his three most recent being, Talent Strategy Risk, Boards that Lead, and Talent Wins. In addition to his books, he has published over 50 refereed journal articles. Dr. Carey also teaches Corporate Governance at The Wharton School of The University of Pennsylvania.

“As the world faces critical challenges to public health from viruses and diseases, the research and development by Ocugen through cell and gene therapies and vaccines is an important effort to address these growing and impactful contributions to world health,” said Ambassador Westphal.

“I look forward to helping advance Ocugen—a leading Pennsylvania Biotech,” said Senator Toomey. “I will always be committed to driving economic growth in the state and this role is an extension of my many years in public office.”

“I’ve watched Ocugen evolve over the last few years as a business consultant and am now honored to join the Business Advisory Board,” said Dr. Carey. “Now is the right time to bring this group together, as there are several transformative milestones ahead in the near term.”

The Business Advisory Board will work alongside the Executive Leadership Team to offer guidance, perspective, and insight to enable the Company to fulfill its mission and achieve its short- and long-term strategy.

About Ocugen, Inc.
Ocugen, Inc. is a biotechnology company focused on discovering, developing, and commercializing novel gene and cell therapies, biologics, and vaccines that improve health and offer hope for patients across the globe. We are making an impact on patient’s lives through courageous innovation—forging new scientific paths that harness our unique intellectual and human capital. Our breakthrough modifier gene therapy platform has the potential to treat multiple retinal diseases with a single product, and we are advancing research in infectious diseases to support public health and orthopedic diseases to address unmet medical needs. Discover more at www.ocugen.com and follow us on Twitter and LinkedIn.

Cautionary Note on Forward-Looking Statements
This press release contains forward-looking statements within the meaning of The Private Securities Litigation Reform Act of 1995, which are subject to risks and uncertainties. We may, in some cases, use terms such as “predicts,” “believes,” “potential,” “proposed,” “continue,” “estimates,” “anticipates,” “expects,” “plans,” “intends,” “may,” “could,” “might,” “will,” “should,” or other words that convey uncertainty of future events or outcomes to identify these forward-looking statements. Such statements are subject to numerous important factors, risks, and uncertainties that may cause actual events or results to differ materially from our current expectations. These and other risks and uncertainties are more fully described in our periodic filings with the Securities and Exchange Commission (SEC), including the risk factors described in the section entitled “Risk Factors” in the quarterly and annual reports that we file with the SEC. Any forward-looking statements that we make in this press release speak only as of the date of this press release. Except as required by law, we assume no obligation to update forward-looking statements contained in this press release whether as a result of new information, future events, or otherwise, after the date of this press release.

Contact:
Tiffany Hamilton
Head of Corporate Communications
Tiffany.Hamilton@ocugen.com