Category: Health

Release – MustGrow Receives USDA Organic Approval for Biological Fertilizer and Soil Amendment Technology

Posted on by aweinsoff@channelchek.com

Research News and Market Data on MGROF

  • USDA National Organic Program (OMRI Listed®) has awarded MustGrow’s TerraSanteTM Crop Fertilizer and Soil Amendment technology with organic compliance.
  • TerraSanteTM is a mustard plant-based technolgy focused on soil and soil microbiome health, nutrient and water use efficiencies, and plant yields.
  • MustGrow plans to continue to advance its TerraSanteTM registration approval process in key U.S. states.

SASKATOON, Saskatchewan, Canada, October 31, 2023 – MustGrow Biologics Corp. (TSXV:MGRO) (OTC:MGROF) (FRA:0C0) (the “Company” or “MustGrow”) is pleased to announce receipt of organic compliance certification from the USDA National Organic Program for its TerraSanteTM crop fertilizer and soil amendment technology. TerraSanteTM is now OMRI Listed® in the following Generic Material Listing(s): NOP: Plant Extracts, Class: Crop Fertilizers and Soil Amendments.

The organic certification from Organic Materials Review Institute (“OMRI”) (www.omri.org) may provide an opportunity for farmers to reduce synthetic chemical and fertilizer use while meeting growing market demand for organic biological products. The OMRI approval process includes a strict review of product ingredient composition and observance of manufacturing compliance standards required in organic production. Pending final registration of product approval from U.S. state agencies, TerraSanteTM will be marketed with the legend “OMRI listed for organic use”.

“We believe that organic compliance is a major milestone towards commercializing TerraSanteTM” commented MustGrow’s COO, Colin Bletsky. “Agriculture needs new organic innovations to support food production and this organic certification further supports our belief that MustGrow’s technologies could be impactful. The key U.S. agricultural regions are under constant pressure to eliminate or reduce synthetic products, so natural, OMRI certified technologies, like TerraSanteTM, have great promise for commercial-scale adoption.”

MustGrow believes this soil amendment and biofertility initiative will complement its existing biocontrol programs in preplant soil fumigation, postharvest food preservation, and bioherbicide, which are currently under development with four global partners: Janssen PMP, Bayer, Sumitomo Corporation, and NexusBioAg. These four partnered programs continue to achieve performance milestones and expand globally in scope and investment.

TerraSanteTM for Soil and Ecological Health

MustGrow’s soil amendment and biofertility development programs will focus on soil and soil microbiome health, nutrient and water use efficiencies, and plant yields. Initially, the development work is anticipated to progress in Washington, Idaho, Oregon, California and Arizona, before expanding nationwide across the United States.

Soil is a farmer’s most valuable and precious asset, and MustGrow’s plant-based technologies are being developed with the intention to improve not only the health of the soil, but also the surrounding ecological environment.

As a soil amendment in mixable form, TerraSanteTM contains nutritious plant proteins and carbohydrates that feed soil microbes, potentionally improving beneficial microbial activity and ensuring long-term sustainable soil health. These targeted micro-communities have been shown to work to improve nutrient availability, which can potentially increase plant vigor and yields, while reducing plant stress. TerraSanteTM has the potential to improve crop nutrient uptake and, hence, overall crop performance. There are no artificial additives or preservatives used during its manufacturing.

MustGrow expects to initially pursue TerraSanteTM branded registrations in North America for soil amendment applications, followed by formulations and brands targeting the biofertility markets. The soil amendment and biofertility products will utilize multiple technologies derived from novel plant-based extracts from mustard and potentially other sources.

Soil Amendment and Biofertility Marketplace

The global fertilizer market is anticipated to reach US$242 billion by 2030, up from US$193 billion in 2021 (2.5% CAGR).(1) This aggregate fertilizer figure includes the following sub-markets, which MustGrow intends to target initially with TerraSanteTM and potentially other branded products:

  • Soil amendment: estimated market size in 2022 was US$3.5 billion and is expected to be US$8.0 billion by 2030 (11.0% CAGR).(2)
  • Biofertility: estimated market size in 2021 was US$2.7 billion and is estimated to be US$7.0 billion by 2030 (12.3% CAGR).(3)

Combined, these additional market segments have the potential to add over US$15 billion of target market opportunity globally for MustGrow by 2030, which is almost double from the initially targeted infield biocontrol market.(1)

Alternatives to Synthetic Fertilizers are Needed

With the world’s population expanding, agriculture production and global food security are increasingly important. Fertilizers continue to play a critical role in agriculture, yet plans to reduce their use have been amplified in recent years to minimize the negative consequences of climate change through emission reduction strategies. Canada, for example, has set a voluntary national fertilizer emissions reduction target of 30% below 2020 levels by 2030 to lower greenhouse gas emissions.(2) Sustainable, climate-friendly solutions may play a role in helping to offset this reduction while balancing the nation’s economic health. For example, Canada’s fertilizer industry directly and indirectly supports over 76,000 jobs and contributes nearly C$13 billion to Canadian GDP.(2)

The European Green Deal is targeting a 20% reduction in fertilizer use by 2030, while also ensuring no deterioration in soil fertility, as part of the European Commission’s aim to reduce nutrient losses by at least 50% by 2030.(3) Fertilizer reduction is a key element of the broader Green Deal target of a minimum 55% net reduction in greenhouse gas emissions by 2030.(4)

Soil amendment and biofertifility innovations, such as MustGrow’s TerraSanteTM technology, could provide a key agricultural solution to the combined effects of fertilizer reduction targets alongside the need to increase farm production, farm profitability, economic growth and global food security.

Source:
1. Statista, Fortune Business, Polaris Market Research.
2. https://fertilizercanada.ca/our-focus/stewardship/emissions-reduction-initiative/
3. https://agriculture.ec.europa.eu/system/files/2022-02/factsheet-farmtofork-comparison-table_en_0.pdf
4. https://commission.europa.eu/strategy-and-policy/priorities-2019-2024/european-green-deal_en

———

About MustGrow

MustGrow is an agriculture biotech company developing organic biocontrol, soil amendment and biofertility products by harnessing the natural defense mechanism and organic materials of the mustard plant to sustainably protect the global food supply and help farmers feed the world. MustGrow and its leading global partners — Janssen PMP (pharmaceutical division of Johnson & Johnson), Bayer, Sumitomo Corporation, and Univar Solutions’ NexusBioAg — are developing mustard-based organic solutions to potentially replace harmful synthetic chemicals. Concurrently, with new formulations derived from food-grade mustard, the Company is pursuing the adoption and use of its technology in the soil amendment and biofertily markets. Over 150 independent tests have been completed, validating MustGrow’s safe and effective approach to crop and food protection and yield enhancements.  Pending regulatory approval, MustGrow’s patented liquid technologies could be applied through injection, standard drip or spray equipment, improving functionality and performance features. Now a platform technology, MustGrow and its global partners are pursuing applications in several different industries from preplant soil treatment and weed control, to postharvest disease control and food preservation, to soil amendment and biofertility. MustGrow has approximately 50.1 million basic common shares issued and outstanding and 55.0 million shares fully diluted. For further details, please visit www.mustgrow.ca.

Contact Information

Corey Giasson
Director & CEO
Phone: +1-306-668-2652
info@mustgrow.ca

MustGrow Forward-Looking Statements

Certain statements included in this news release constitute “forward-looking statements” which involve known and unknown risks, uncertainties and other factors that may affect the results, performance or achievements of MustGrow.

Generally, forward-looking information can be identified by the use of forward-looking terminology such as “plans”, “expects”, “is expected”, “budget”, “estimates”, “intends”, “anticipates” or “does not anticipate”, or “believes”, or variations of such words and phrases or statements that certain actions, events or results “may”, “could”, “would”, “might”, “occur” or “be achieved”. Examples of forward-looking statements in this news release include, among others, statements MustGrow makes regarding: its plans to continue to advance its TerraSanteTM registration approval process in key U.S. states; the opportunity that being OMRI listed for organic use may provide to farmers to reduce synthetic chemical fertilizer use while meeting growing market demand for organic biological products; the potential outcome of pending final registration product approvals; the planned marketing of TerraSanteTM with the legend, “OMRI listed for organic use”; the relevance of organic compliance towards commercializing TerraSanteTM; MustGrow’s belief that TerraSanteTM will complement its existing biocontrol programs; the expected focus of MustGrow’s soil amendment and biofertility development programs on soil and soil microbiome health, nutrient and water use efficiencies, and plant yields; the anticipated progression of MustGrow’s development work in Washington, Idaho, Oregon, California and Arizona, before expanding nationwide across the United States; MustGrow’s expectation that it will initially pursue TerraSanteTM branded registrations in North America for soil amendment applications, followed by formulations and brands targeting the biofertility markets; and the opportunity that soil amendment and biofertility innovations, such as MustGrow’s TerraSanteTM technology, could provide a key agricultural solution to the combined effects of fertilizer reduction targets alongside the need to increase farm production, farm profitability, economic growth and global food security.

Forward-looking statements are subject to a number of risks and uncertainties that may cause the actual results of MustGrow to differ materially from those discussed in such forward-looking statements, and even if such actual results are realized or substantially realized, there can be no assurance that they will have the expected consequences to, or effects on, MustGrow. Important factors that could cause MustGrow’s actual results and financial condition to differ materially from those indicated in the forward-looking statements include market receptivity to investor relations activities as well as those risks described in more detail in MustGrow’s Annual Information Form for the year ended December 31, 2022 and other continuous disclosure documents filed by MustGrow with the applicable securities regulatory authorities which are available at www.sedar.com. Readers are referred to such documents for more detailed information about MustGrow, which is subject to the qualifications, assumptions and notes set forth therein.

This release does not constitute an offer for sale of, nor a solicitation for offers to buy, any securities in the United States.

Neither the TSXV, nor their Regulation Services Provider (as that term is defined in the policies of the TSXV), nor the OTC Markets has approved the contents of this release or accepts responsibility for the adequacy or accuracy of this release.

© 2023 MustGrow Biologics Corp. All rights reserved.

GeoVax Labs, Inc. (GOVX) – Clinical Trial Expansion Continues With A Stream Of Milestones

Posted on by cpereira@noblefcm.com


Tuesday, October 31, 2023

GeoVax Labs, Inc. is a clinical-stage biotechnology company developing novel therapies and vaccines for solid tumor cancers and many of the world’s most threatening infectious diseases. The company’s lead program in oncology is a novel oncolytic solid tumor gene-directed therapy, Gedeptin®, presently in a multicenter Phase 1/2 clinical trial for advanced head and neck cancers. GeoVax’s lead infectious disease candidate is GEO-CM04S1, a next-generation COVID-19 vaccine targeting high-risk immunocompromised patient populations. Currently in three Phase 2 clinical trials, GEO-CM04S1 is being evaluated as a primary vaccine for immunocompromised patients such as those suffering from hematologic cancers and other patient populations for whom the current authorized COVID-19 vaccines are insufficient, and as a booster vaccine in patients with chronic lymphocytic leukemia (CLL). In addition, GEO-CM04S1 is in a Phase 2 clinical trial evaluating the vaccine as a more robust, durable COVID-19 booster among healthy patients who previously received the mRNA vaccines. GeoVax has a leadership team who have driven significant value creation across multiple life science companies over the past several decades.

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.

Site Expansion Should Increase Rate Of Enrollment. GeoVax announced the additional of new clinical sites in the Phase 2 trial for CM04S1, its COVID-19 vaccine to protect patients who are immunocompromised due to treatment for hematological malignancies. Patients who receive treatments including allogenic/autologous stem cell transplant or CAR-T therapy have difficulty responding to the available COVID-19 vaccines, leaving them vulnerable.

Site Expansion Should Increase Speed of Enrollment.  The trial is designed to compare the safety and immunogenicity of CM04S1 directly against the mRNA vaccines from Pfizer and Moderna. The trial began at the City of Hope Medical center in California and will begin treating patients at Wake Forest Baptist Medical Center (North Carolina), University of Massachusetts Medical Center, and Fred Hutchinson Cancer Research (Washington). Patient enrollment at these sites should increase the enrollment rate and number of patients in the study, providing greater statistical significance with shortened time to results.


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Weight Loss Drugs Shake Up Pharma Stocks, But Wider Impact Remains Unclear

Posted on by slightbourne@noblecapitalmarkets.com

A new class of potent weight loss drugs has been shaking up the pharmaceutical sector, sending stocks of some major drug makers soaring. But the wider impact on other industries like food, retail, and medical devices remains uncertain amidst changing consumer behaviors.

Novo Nordisk and Eli Lilly have been riding high thanks to their injectable diabetes medications Ozempic and Mounjaro. Though only approved for diabetes, both drugs have shown dramatic weight loss potential in clinical trials.

Ozempic and Mounjaro belong to a drug class called GLP-1 agonists. They mimic a hormone that regulates appetite and food intake. Patients using the new drugs at high doses can lose up to a quarter of their body weight.

Predictions have emerged that these drugs could reshape industries from restaurants to airlines. But so far, the actual impact beyond pharma has been muted.

In the stock market, Novo Nordisk shares are up over 50% in the last year thanks to Ozempic. The drug’s sales hit $5.2 billion in the first 9 months of 2022. Mounjaro brought in $187 million for Lilly within just 2 months of its launch.

“The physiological benefits these treatments offer patients help address significant unmet needs,” said Josh Schimmer, senior analyst at Evercore ISI.

The market potential also has investors excited. If just 2% of obese Americans eventually use weight loss medications, it could swell into a $58 billion market according to Evercore forecasts.

Among other drug stocks involved, Amgen owns a portion of Mounjaro’s revenue due to a licensing deal with Lilly. Meanwhile, companies like Entera Bio and Novo Nordisk have oral pills in late stage testing that could expand the weight loss drug market substantially.

However, analysts caution growth depends on how insurers cover the drugs which can cost nearly $1,500 a month without insurance. Usage also remains low currently at around just 1% of the US population.

Beyond pharma, the impact is hazier. The consumer staples sector has been the worst performing segment of the S&P 500 this year as investors brace for potential fallout.

But so far, food and beverage leaders seem unfazed. PepsiCo, Hershey, and Constellation Brands recently reported strong quarters without seeing signs of slowing demand.

Retailers and restaurants have opportunities to adapt their offerings to court health-focused consumers. “Maybe the GLP-1 consumer looks very different three or five years from now,” said Goldman Sachs analyst Jason English.

Surprisingly, medical device makers also haven’t seen slowed growth yet either. In fact, continuous glucose monitoring usage grew right alongside Ozempic prescriptions, suggesting weight loss isn’t eliminating diabetes demand.

However, bariatric surgery has been slightly impacted according to comments from Johnson & Johnson’s CEO. Other discretionary categories like apparel and travel could eventually be impacted if behaviors change long term.

For now, the uncertainty leaves analysts split on whether these drugs are a fad or the beginning of a healthcare revolution. But Wall Street is clearly enamored with the weight loss leaders.

As more data emerges on usage and impact, it will determine whether stock declines are overdone for consumer staples beyond pharma. If wide adoption materializes, Novo and Lilly appear poised to dominate a blockbuster new drug market.

Breaking Boundaries: Lilly’s Investment in Base Editing for Heart Disease

Posted on by slightbourne@noblecapitalmarkets.com

Pharmaceutical giant Eli Lilly is expanding its efforts in cardiovascular disease research through a new deal with Beam Therapeutics and Verve Therapeutics worth up to $600 million. The deal centers around base editing, an emerging gene editing technology that Beam and Verve are pioneering for new precision genetic medicines.

Under the agreement announced today, Lilly will acquire Beam’s opt-in rights to co-develop and co-commercialize several of Verve’s base editing programs targeting cardiovascular disease. This includes lead programs focused on PCSK9 and ANGPTL3 – two high profile genes involved in cholesterol regulation and metabolism. A third undisclosed target related to liver-mediated cardiovascular disease is also included.

In exchange, Beam will receive a hefty $200 million upfront payment along with a $50 million equity investment from Lilly. Beam is further eligible for up to $350 million in future milestone payments as the programs advance through clinical trials and regulatory approvals.

For Lilly, this deal provides access to a promising new approach to treating cardiovascular disease, an area where the company already has a major presence. Lilly has been a leader in cholesterol drugs like statins for decades, and more recently entered the PCSK9 market through its ownership of Repatha. But despite effective medications, cardiovascular disease remains a top killer globally.

Base editing offers a way to precisely and permanently modify disease-causing genes in order to lower cholesterol and potentially deliver stronger treatment effects than current options. Early human trials have already shown base editing of PCSK9 can lower LDL cholesterol. Verve recently initiated a clinical trial using base editors to target both PCSK9 and ANGPTL3 simultaneously.

Take a moment to take a look at Ocugen (OCGN), a biotechnology company focused on discovering, developing, and commercializing novel gene and cell therapies and vaccines.

As a technology pioneer, Beam is widely considered the leader in base editing. The company has uncovered a series of natural enzymes that can be programmed to make single letter DNA changes at targeted sites without cutting the double strand like traditional CRISPR gene editing. This opens possibilities for more precise control while minimizing unintended effects.

Beam CEO John Evans highlighted base editing as a core strategic priority, and views creative partnerships as a key path to accelerate development. “Our initial collaboration with Verve and this new transaction with Lilly are exemplary of our execution of that strategy,” Evans said. “This deal provides meaningful upfront capital to advance our portfolio of clinical- and research-stage programs, with significant additional value achievable as the Verve programs advance.”

For Beam, the capital influx provides fuel to advance its broader base editing pipeline including programs in sickle cell disease, alpha-1 antitrypsin deficiency, and glycine encephalopathy. The company now expects its cash runway to extend into the second half of 2026.

Lilly’s history with Verve also preceded this acquisition. In 2021, Lilly led Verve’s $105 million Series B financing and took a stake in the company. That marked another early mover deal to tap into base editing. Verve CEO Sekar Kathiresan said “Lilly’s extensive capabilities in drug development and commercialization make them an ideal partner for Verve as we work together to advance base editing programs aimed at reducing CVD risk through genome editing.”

Beam and Verve join a short list of biotechs focused on realizing the promise of base editing. But Lilly’s involvement marks a huge vote of confidence from the pharma world. As base editing advances toward the clinic, deals like this suggest major players view the technology as more than just hype.

Lilly has been aggressively scouting the latest biotech innovations through both in-house R&D and external deals. The past year saw Lilly acquire hot companies like POINT Biopharma and Repare Therapeutics for large sums. Base editing adds a new tool in Lilly’s toolkit for next generation therapeutic approaches.

Cardiovascular disease also represents an attractive area for investment despite already having effective medications. Heart attacks, strokes and other complications remain a top cause of mortality globally. In the US alone, 1 in 4 deaths are attributable to heart disease each year. Even modest improvements in treatment can translate into major public health benefits.

The risk for Lilly and other major pharmaceutical companies is that base editing and gene editing fail to live up to their early promise in the clinic. However, most experts are optimistic the technology will usher in a new wave of therapies over the next decade. For a pharma giant like Lilly with over $28 billion in yearly revenue, the potential reward is well worth the investment risk to stay on the cutting edge.

Release – GeoVax Commences Site Expansion for Phase 2 Trial of Next-Generation COVID-19 Vaccine

Posted on by aweinsoff@channelchek.com

Research News and Market Data on GOVX

 

  • Last updated: 30 October 2023 13:48
  • Created: 30 October 2023 12:02
  • Hits: 28

Designed to Protect Immunocompromised Patients Against Severe COVID-19

ATLANTA, GA, October 30, 2023 – GeoVax Labs, Inc. (Nasdaq: GOVX), a biotechnology company developing immunotherapies and vaccines against cancers and infectious diseases, today announced that it has commenced the planned site expansion for the Phase 2 clinical trial investigating its next-generation SARS-CoV-2 vaccine, GEO-CM04S1, as a primary vaccine in immunocompromised patients. In addition to study enrollments completed at the City of Hope Medical Center (Duarte, California), the trial will be initiating enrollment of eligible patients at Wake Forest Baptist Medical Center (Winston Salem, North Carolina), the University of Massachusetts Medical Center (Worcester, Massachusetts), and Fred Hutchinson Cancer Research Center (Seattle, Washington).

The Phase 2 clinical trial (ClinicalTrials.gov Identifier: NCT04977024) is evaluating the safety and immunogenicity of GEO-CM04S1, compared to either the Pfizer/BioNTech or Moderna mRNA-based vaccine, in patients with hematologic malignancies who have received either an allogeneic hematopoietic stem cell transplant, an autologous hematopoietic stem cell transplant or chimeric antigen receptor (CAR) T cell therapy. Such patients often have difficulty mounting an adequate protective antibody response after receiving currently available COVID-19 vaccines.

David Dodd, GeoVax Chairman and CEO, commented, “We are pleased with these site activations to expand the scope and reach of this trial, which we expect will accelerate patient enrollment for this important study in one of the highest at-risk patient populations, currently underserved by available vaccines. We believe the unique properties of GEO-CM04S1 potentially offer a more robust, durable degree of protection than the current authorized COVID-19 vaccines, not only as a vaccine for highly vulnerable immunocompromised patients for whom the currently authorized mRNA vaccines may be inadequate, but also potentially for healthy patients as a universal booster vaccine to the mRNA vaccines. In the U.S., there are approximately 15 million individuals who, as a result of their compromised immune systems, often do not adequately respond to the current authorized vaccines. Worldwide, there are an estimated 240+ million such patients. Our hope is that GEO-CM04S1 provides robust, durable immune protection for such patients, while also providing a critically important alternative to COVID-19 booster vaccines for healthy individuals.”

A recent publication in Vaccines (https://doi.org/10.3390/vaccines11091492) from the open-label portion of the trial indicates that GEO-CM04S1 is highly immunogenic in these patients, inducing both antibody responses, including neutralizing antibodies, and T cell responses against ancestral as well as recently evolved SARS-CoV-2 virus strains. These data support the progression of the Phase 2 clinical study, which includes a direct comparison to currently approved mRNA vaccines.

About GEO-CM04S1

GEO-CM04S1 is based on GeoVax’s MVA viral vector platform, which supports the presentation of multiple vaccine antigens to the immune system in a single dose. GEO-CM04S1 encodes for both the spike (S) and nucleocapsid (N) antigens of SARS-CoV-2 and is specifically designed to induce both antibody and T cell responses to those parts of the virus less likely to mutate over time. The more broadly functional engagement of the immune system is designed to protect against severe disease caused by continually emerging variants of COVID-19. Vaccines of this format should not require frequent and repeated modification or updating.

In addition to this ongoing study, GEO-CM04S1 is being evaluated in two other Phase 2 clinical trials:

  • As a booster vaccine for healthy patients who have previously received the Pfizer or Moderna mRNA vaccine. gov Identifier: NCT04639466. GeoVax recently announced that this trial has fully enrolled.
  • As a booster vaccine in immunocompromised patients with chronic lymphocytic leukemia (CLL), a recognized high-risk group for whom current mRNA vaccines and monoclonal antibody (MAb) therapies appear inadequate relative to providing protective immunity. ClinicalTrials.gov Identifier: NCT05672355.

About GeoVax

GeoVax Labs, Inc. is a clinical-stage biotechnology company developing novel therapies and vaccines for solid tumor cancers and many of the world’s most threatening infectious diseases. The company’s lead program in oncology is a novel oncolytic solid tumor gene-directed therapy, Gedeptin®, presently in a multicenter Phase 1/2 clinical trial for advanced head and neck cancers. GeoVax’s lead infectious disease candidate is GEO-CM04S1, a next-generation COVID-19 vaccine targeting high-risk immunocompromised patient populations. Currently in three Phase 2 clinical trials, GEO-CM04S1 is being evaluated as a primary vaccine for immunocompromised patients such as those suffering from hematologic cancers and other patient populations for whom the current authorized COVID-19 vaccines are insufficient, and as a booster vaccine in patients with chronic lymphocytic leukemia (CLL). In addition, GEO-CM04S1 is in a Phase 2 clinical trial evaluating the vaccine as a more robust, durable COVID-19 booster among healthy patients who previously received the mRNA vaccines. GeoVax has a leadership team who have driven significant value creation across multiple life science companies over the past several decades. For more information, visit our website: www.geovax.com.

Forward-Looking Statements

This release contains forward-looking statements regarding GeoVax’s business plans. The words “believe,” “look forward to,” “may,” “estimate,” “continue,” “anticipate,” “intend,” “should,” “plan,” “could,” “target,” “potential,” “is likely,” “will,” “expect” and similar expressions, as they relate to us, are intended to identify forward-looking statements. We have based these forward-looking statements largely on our current expectations and projections about future events and financial trends that we believe may affect our financial condition, results of operations, business strategy and financial needs. Actual results may differ materially from those included in these statements due to a variety of factors, including whether: GeoVax is able to obtain acceptable results from ongoing or future clinical trials of its investigational products, GeoVax’s immuno-oncology products and preventative vaccines can provoke the desired responses, and those products or vaccines can be used effectively, GeoVax’s viral vector technology adequately amplifies immune responses to cancer antigens, GeoVax can develop and manufacture its immuno-oncology products and preventative vaccines with the desired characteristics in a timely manner, GeoVax’s immuno-oncology products and preventative vaccines will be safe for human use, GeoVax’s vaccines will effectively prevent targeted infections in humans, GeoVax’s immuno-oncology products and preventative vaccines will receive regulatory approvals necessary to be licensed and marketed, GeoVax raises required capital to complete development, there is development of competitive products that may be more effective or easier to use than GeoVax’s products, GeoVax will be able to enter into favorable manufacturing and distribution agreements, and other factors, over which GeoVax has no control.

Further information on our risk factors is contained in our periodic reports on Form 10-Q and Form 10-K that we have filed and will file with the SEC. Any forward-looking statement made by us herein speaks only as of the date on which it is made. Factors or events that could cause our actual results to differ may emerge from time to time, and it is not possible for us to predict all of them. We undertake no obligation to publicly update any forward-looking statement, whether as a result of new information, future developments or otherwise, except as may be required by law. 

Company Contact:         Investor Relations Contact:         Media Contact:
info@geovax.com paige.kelly@sternir.com sr@roberts-communications.com
678-384-7220 212-698-8699 202-779-0929

Release – MAIA Biotechnology Reveals Higher Anticancer Potency of Telomere-Targeting Compounds Derived From THIO

Posted on by aweinsoff@channelchek.com

Research News and Market Data on MAIA

October 30, 2023 8:41am EDT

Study results warrant further in vivo in-depth investigation of THIO conjugates as second generation cancer therapies

CHICAGO–(BUSINESS WIRE)– MAIA Biotechnology, Inc. (NYSE American: MAIA), a clinical stage company developing telomere-targeting immunotherapies for cancer, today announced positive results from an investigational new drug-enabling study of the Company’s second-generation telomere-targeting agents derived from lipid-modified THIO molecules. MAIA’s second-generation telomere-targeting molecule program seeks to discover new compounds with improved specificity towards cancer cells relative to normal cells, potentially increased anticancer activity, and stronger chemistry manufacturing control characteristics.

“In this study we demonstrated broad-spectrum therapeutically-attractive opportunities for specific telomeric stress-inducing treatments. The results demonstrate an increase in innate sensing and adaptive antitumor immunity via the self-produced chemical modification of cancer cell telomeres by THIO,” said MAIA’s Chief Scientific Officer Sergei Gryaznov, Ph.D.

The new THIO prodrugs are lipid conjugated compounds derived from THIO. The prodrugs are pharmacologically inactive compounds that, after intake, are metabolized into a pharmacologically active drug. In vitro, these compounds were able to induce telomeric DNA damage responses that were similar or more profound than those for THIO, as assessed by quantitative Telomere Damage Induced Foci assays (TIF formation). Efficient formation of micronuclei structures was also observed. Initial in vivo evaluation of the anticancer activity, conducted in human xenografts and murine syngeneic models of colorectal cancer, demonstrated potent anticancer activity at relatively low dose levels for one of the lead lipid conjugates.

“Our findings from this study demonstrate the significance of telomeric DNA structural and functional integrity for cancer cell survival. The high potency of these THIO-like agents warrants further in vivo in-depth investigation as a potential next generation of telomerase-mediated telomere-targeting compounds,” said Vlad Vitoc, M.D., MAIA’s Chief Executive Officer.

The findings were presented by Dr. Gryaznov at the International Biochemistry Congress 2023, organized by the Turkish Biochemical Society and held in Turkey. The findings are detailed in the abstract available in the event website under Speakers, Sergei M. Gryaznov and Lecture Abstract sections.

The telomere-centric action of MAIA’s lead candidate THIO is being evaluated in Phase 2 clinical trials (THIO-101) in non-small-cell lung carcinoma (NSCLC) patients.

About THIO

THIO (6-thio-dG or 6-thio-2’-deoxyguanosine) is a first-in-class investigational telomere-targeting agent currently in clinical development to evaluate its activity in Non-Small Cell Lung Cancer (NSCLC). Telomeres, along with the enzyme telomerase, play a fundamental role in the survival of cancer cells and their resistance to current therapies. The modified nucleotide 6-thio-2’-deoxyguanosine (THIO) induces telomerase-dependent telomeric DNA modification, DNA damage responses, and selective cancer cell death. THIO-damaged telomeric fragments accumulate in cytosolic micronuclei and activates both innate (cGAS/STING) and adaptive (T-cell) immune responses. The sequential treatment with THIO followed by PD-(L)1 inhibitors resulted in profound and persistent tumor regression in advanced, in vivo cancer models by induction of cancer type–specific immune memory. THIO is presently developed as a second or later line of treatment for NSCLC for patients that have progressed beyond the standard-of-care regimen of existing checkpoint inhibitors.

About MAIA Biotechnology, Inc.

MAIA is a targeted therapy, immuno-oncology company focused on the development and commercialization of potential first-in-class drugs with novel mechanisms of action that are intended to meaningfully improve and extend the lives of people with cancer. Our lead program is THIO, a potential first-in-class cancer telomere targeting agent in clinical development for the treatment of NSCLC patients with telomerase-positive cancer cells. For more information, please visit www.maiabiotech.com.

Forward Looking Statements

MAIA cautions that all statements, other than statements of historical facts contained in this press release, are forward-looking statements. Forward-looking statements are subject to known and unknown risks, uncertainties, and other factors that may cause our or our industry’s actual results, levels or activity, performance or achievements to be materially different from those anticipated by such statements. The use of words such as “may,” “might,” “will,” “should,” “could,” “expect,” “plan,” “anticipate,” “believe,” “estimate,” “project,” “intend,” “future,” “potential,” or “continue,” and other similar expressions are intended to identify forward looking statements. However, the absence of these words does not mean that statements are not forward-looking. For example, all statements we make regarding (i) the initiation, timing, cost, progress and results of our preclinical and clinical studies and our research and development programs, (ii) our ability to advance product candidates into, and successfully complete, clinical studies, (iii) the timing or likelihood of regulatory filings and approvals, (iv) our ability to develop, manufacture and commercialize our product candidates and to improve the manufacturing process, (v) the rate and degree of market acceptance of our product candidates, (vi) the size and growth potential of the markets for our product candidates and our ability to serve those markets, and (vii) our expectations regarding our ability to obtain and maintain intellectual property protection for our product candidates, are forward looking. All forward-looking statements are based on current estimates, assumptions and expectations by our management that, although we believe to be reasonable, are inherently uncertain. Any forward-looking statement expressing an expectation or belief as to future events is expressed in good faith and believed to be reasonable at the time such forward-looking statement is made. However, these statements are not guarantees of future events and are subject to risks and uncertainties and other factors beyond our control that may cause actual results to differ materially from those expressed in any forward-looking statement. Any forward-looking statement speaks only as of the date on which it was made. We undertake no obligation to publicly update or revise any forward-looking statement, whether as a result of new information, future events or otherwise, except as required by law. In this release, unless the context requires otherwise, “MAIA,” “Company,” “we,” “our,” and “us” refers to MAIA Biotechnology, Inc. and its subsidiaries.

View source version on businesswire.com: https://www.businesswire.com/news/home/20231030253336/en/

Investor Inquiries
MAIA Biotechnology
Joseph McGuire
Chief Financial Officer
jmcguire@maiabiotech.com
904-228-2603

Investor Relations
ir@maiabiotech.com

Source: MAIA Biotechnology, Inc.

Released October 30, 2023

Release – Schwazze Sets Third Quarter 2023 Conference Call for November 14, 2023 At 5:00 P.M. ET

Posted on by aweinsoff@channelchek.com

Research News and Market Data on SHWZ

October 30, 2023

PDF Version

DENVER, Oct. 30, 2023 /CNW/ – Medicine Man Technologies, Inc., operating as Schwazze, (OTCQX: SHWZ) (NEO: SHWZ) (“Schwazze” or the “Company”), will host a conference call on Tuesday, November 14, 2023 at 5:00 p.m. Eastern time to discuss its financial and operational results for the third quarter ended September 30, 2023. The Company’s results will be reported in a press release prior to the call.

   

The Schwazze management team will host the conference call, followed by a question-and-answer period. Interested parties may submit questions to the Company prior to the call by emailing ir@schwazze.com.

Date: Tuesday, November 14, 2023
Time: 5:00 p.m. Eastern time
Toll-free dial-in: (888) 664-6383
International dial-in: (416) 764-8650
Conference ID: 64450430
Webcast: SHWZ Q3 2023 Earnings Call

The conference call will also be broadcast live and available for replay on the investor relations section of the Company’s website at https://ir.schwazze.com.

Toll-free replay number: (888) 390-0541
International replay number: (416) 764-8677
Replay ID: 450430

If you have any difficulty registering or connecting with the conference call, please contact Elevate IR at (720) 330-2829.

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.

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.

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.

View original content to download multimedia:https://www.prnewswire.com/news-releases/schwazze-sets-third-quarter-2023-conference-call-for-november-14-2023-at-500-pm-et-301970632.html

SOURCE Schwazze

Release – Tonix Pharmaceuticals Announces New Data Involving TNX-1500 (Fc-modified dimeric anti-CD40L mAb) in Heart Xenotransplantation in Animal Models at the ACS Clinical Congress and IPITA-IXA-CTRMS Joint Congress

Posted on by aweinsoff@channelchek.com

Research News and Market Data on TNXP

October 30, 2023 7:00am EDTDownload as PDF

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

TNX-1500 is currently in Phase 1 Clinical Development

Tonix is Developing TNX-1500 for Prevention of Kidney Allograft Rejection as the First Indication; Multiple Other Indications, including Autoimmune Disorders, are Planned

CHATHAM, N.J., Oct. 30, 2023 (GLOBE NEWSWIRE) — Tonix Pharmaceuticals Holding Corp. (Nasdaq: TNXP) (Tonix or the Company), a biopharmaceutical company with marketed products and a pipeline of development candidates, today announced data from two oral presentations which were delivered recently at the American College of Surgeons (ACS) Clinical Congress 2023, and The International Pancreas and Islet Transplant Association (IPITA), the International Xenotransplantation Association (IXA), and the Cell Transplant and Regenerative Medicine Society (CTRMS) Joint Congress by faculty at the Center for Transplantation Sciences, Massachusetts General Hospital (MGH) in October 2023. The data involve Tonix’s TNX-1500 (Fc-modified dimeric anti-CD40L monoclonal antibody [mAb]) which is currently in Phase 1 development for the prevention of organ transplant rejection. Copies of the presentations are available under the Scientific Presentations tab of the Tonix Pharmaceuticals website at www.tonixpharma.com.

The oral presentations titled, “Pilot Evaluation of a Clinical Xeno Heart Transplant Regimen in a Preclinical Model” and “Extended Survival of 9- and 10-Gene Edited Pig Heart Xenografts with Ischemia Minimization and CD154 Costimulation Blockade-Based Immunosuppression” by Dr. Ikechukwu Ileka et al. include data demonstrating the use of TNX-1500 as maintenance therapy after xeno heart transplant in non-human primates. In both studies, genetically engineered (GE) pigs in baboon transplants were treated with cold-perfused ischemia minimization and a novel costimulation-based immunosuppressive regimen including TNX-1500. The multi-GE pigs were provided by eGenesis and Revivicor.

“The results of these preclinical studies are encouraging and demonstrate the potential of genetically engineered pig hearts in the context of a clinically applicable regimen,” said Seth Lederman, M.D., Chief Executive Officer of Tonix Pharmaceuticals. “Because anti-CD40L treatment is widely recognized as critical to the success of xeno organ transplant, no animals were transplanted without anti-CD40L treatment.”

“These and other data1,2,3 confirm the rationale for us to pursue development of TNX-1500 to prevent rejection in human transplantation,” said Dr. Lederman. “We are currently enrolling in a Phase 1 trial in healthy volunteers to support the development of TNX-1500 for the prevention of allograft rejection. However, long term we hope to develop TNX-1500 for xenotransplantation in which the donor organ comes from genetically engineered pigs.”

1Lassiter G., et al. Am. J. Transplant. 2023. https://doi.org/10.1016/j.ajt.2023.03.022

2Miura S., et al. Am. J. Transplant. 2023. https://doi.org/10.1016/j.ajt.2023.03.025

3Anand R.P., et al. Nature. 2023. 622, 393–401.

Tonix Pharmaceuticals Holding Corp.*

Tonix is a biopharmaceutical company focused on commercializing, developing, discovering and licensing therapeutics to treat and prevent human disease and alleviate suffering. Tonix Medicines, our commercial subsidiary, markets Zembrace® SymTouch® (sumatriptan injection) 3 mg and Tosymra® (sumatriptan nasal spray) 10 mg under a transition services agreement with Upsher-Smith Laboratories, LLC from whom the products were acquired on June 30, 2023. Zembrace SymTouch and Tosymra are each indicated for the treatment of acute migraine with or without aura in adults. Tonix’s development portfolio is composed of central nervous system (CNS), rare disease, immunology and infectious disease product candidates. Tonix’s CNS development portfolio includes both small molecules and biologics to treat pain, neurologic, psychiatric and addiction conditions. Tonix’s lead development CNS candidate, TNX-102 SL (cyclobenzaprine HCl sublingual tablet), is in mid-Phase 3 development for the management of fibromyalgia, having completed enrollment of a potentially confirmatory Phase 3 study in the third quarter of 2023, with topline data expected in late December 2023. TNX-102 SL is also being developed to treat fibromyalgia-type Long COVID, a chronic post-acute COVID-19 condition. Enrollment in a Phase 2 proof-of-concept study has been completed, and topline results were reported in the third quarter of 2023. TNX-601 ER (tianeptine hemioxalate extended-release tablets) is a once-daily oral formulation being developed as a treatment for major depressive disorder (MDD), that completed enrollment in a Phase 2 study in the third quarter of 2023, with topline results expected in early November of 2023. TNX-4300 (estianeptine) is a single isomer version of TNX-601, a small molecule oral therapeutic in preclinical development to treat MDD, Alzheimer’s disease and Parkinson’s disease. Relative to tianeptine, estianeptine lacks activity on the mu-opioid receptor while maintaining activity and the ability to activate PPAR-β/δ and neuroplasticity in tissue culture. TNX-1900 (intranasal potentiated oxytocin), is in development as a preventive treatment in chronic migraine, and the clinical phase of a Phase 2 proof-of-concept study is now completed with topline data expected in early December 2023. TNX-1900 is also being studied in binge eating disorder, pediatric obesity and social anxiety disorder by academic collaborators under investigator-initiated INDs. 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 fourth quarter of 2023. Tonix’s rare disease development 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 development 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 was initiated in the third quarter of 2023. Tonix’s infectious disease pipeline includes TNX-801, a vaccine in development to prevent smallpox and mpox. TNX-801 also serves as the live virus vaccine platform or recombinant pox vaccine platform for other infectious diseases, including TNX-1800, in development as a vaccine to protect against COVID-19. The infectious disease development portfolio also includes TNX-3900 and TNX-4000, which are classes of broad-spectrum small molecule oral antivirals.

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

Zembrace SymTouch and Tosymra are registered trademarks of Tonix Medicines. Intravail is a registered trademark of Aegis Therapeutics, LLC, a wholly owned subsidiary of Neurelis, Inc. All other marks are property of their respective owners.

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.

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

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

Media Contact
Ben Shannon
ICR Westwicke
ben.shannon@westwicke.com
443-213-0495

Source: Tonix Pharmaceuticals Holding Corp.

Released October 30, 2023

Medical Device Company Laborie Acquires Urotronic for Innovative Prostate Treatment Technology

Posted on by slightbourne@noblecapitalmarkets.com

Portsmouth, New Hampshire-based medical device manufacturer Laborie Medical Technologies announced it has acquired Minnesota company Urotronic in a deal worth up to $600 million. The acquisition provides Laborie entry into the interventional urology market and adds Urotronic’s novel Optilume drug-coated balloon technology to its product portfolio.

The definitive agreement was signed on September 6, 2023 with an upfront payment of $255 million in cash to close the deal. Up to $345 million more is payable based on certain commercial and reimbursement milestones being achieved.

Optilume is a minimally invasive surgical therapy (MIST) that combines mechanical dilation with delivery of the chemotherapy drug paclitaxel to treat urinary tract conditions like urethral strictures and benign prostatic hyperplasia (BPH), also known as enlarged prostate.

BPH affects over 40 million men in the United States alone and the global market for BPH treatment is valued at over $4 billion. Current surgical interventions for BPH like transurethral resection of the prostate (TURP) or laser procedures can have side effects and long recovery times.

Optilume has already gained FDA approval and CE Mark in Europe for treating BPH. This regulatory clearance, along with positive clinical data showing good safety and efficacy, were key factors in Laborie’s decision to acquire Urotronic.

The Optilume technology represents a paradigm shift in how urologists can treat patients suffering from BPH and urethral strictures. Rather than invasive surgery or permanent implants, the drug-coated balloon can be inserted cystoscopically and then inflated to dilate the urethra and deliver the paclitaxel to the tissue. The minimally invasive approach leads to fast patient recovery compared to other options.

Take a moment to take a look at Noble Capital Markets’ Medical Device Research Analyst Gregory Aurand’s coverage list.

According to Laborie Medical President and CEO Michael Frazzette, “There has never been a minimally invasive, combination drug-device therapy like Optilume before, leading to a highly disruptive, paradigm change for physicians treating urethral strictures and BPH.”

Urotronic CEO David Perry likewise noted that “Backed by positive clinical data, the Optilume BPH therapy is truly groundbreaking as the only MIST option that doesn’t require cutting, burning, steaming or a permanent implant.”

The Urotronic acquisition represents a strategic move for Laborie Medical Technologies to push further into the global urology market. Laborie is focused on high-growth segments including urology, gastroenterology, gynecology, and obstetrics.

According to Patricia Industries, which owns Laborie, the deal furthers Laborie’s long-term growth strategy by adding an innovative product with strong potential to its portfolio. Urotronic’s employees and assets will be fully integrated into Laborie Medical after the acquisition.

Laborie itself was acquired by Patricia Industries in 2017 for an estimated $2.4 billion and has gone through a period of rapid growth since then. The company manufactures a range of diagnostic equipment like urodynamic systems as well as therapy products such as electrodes for pelvic floor stimulation.

The global medical device market has seen a surge of M&A activity in recent years. Strategic mergers and acquisitions allow companies to expand their product lines, access new technology, enter new geographic markets, and consolidate to gain economies of scale.

Medtech titan Boston Scientific for example has made 10 acquisitions in the past 5 years totaling over $10 billion to become a leading player in less invasive device treatments. Teleflex likewise acquired Neotract and its novel UroLift system for treating BPH in a $1 billion purchase in 2017.

The closing of the Urotronic acquisition provides another growth milestone for Laborie Medical as it executes its strategy of providing innovative therapeutic solutions to physicians and hospitals involved in urological procedures. Adding Optilume’s promising technology gives it a differentiated offering in the nonsurgical treatment of enlarged prostate and strengthens Laborie’s portfolio for continued expansion in the urology device sector.

Release – Tonix Pharmaceuticals Completes Clinical Stage of Phase 2 PREVENTION Study of TNX-1900 for the Prevention of Migraine Headaches in Chronic Migraineurs

Posted on by aweinsoff@channelchek.com

Research News and Market Data on TNXP

October 26, 2023 7:00am EDTDownload as PDF

Topline results expected early December 2023

Novel formulation of intranasal oxytocin contains magnesium (Mg2+), shown to potentiate the analgesic
effects of oxytocin on the oxytocin receptor in animal models

TNX-1900 blocks release of CGRP, a key peptide in the pathogenesis of migraine, from trigeminal ganglia
neurons while limiting systemic exposure

CHATHAM, N.J., Oct. 26, 2023 (GLOBE NEWSWIRE) — Tonix Pharmaceuticals Holding Corp. (Nasdaq: TNXP), a biopharmaceutical company with marketed products and a pipeline of development candidates, today announced the completion of the clinical phase of the Phase 2 proof-of-concept, double-blind, randomized, placebo-controlled PREVENTION1 study of TNX-19002 (intranasal potentiated oxytocin) as a potential treatment for the prevention of migraine headaches in chronic migraineurs. A total of 88 patients were enrolled in this multi-site study in the U.S. Topline results are expected in early December 2023.

TNX-1900 is a proprietary formulation of oxytocin that contains magnesium, which Tonix has shown in animal models potentiates the action of oxytocin at oxytocin receptors and potentially improves the consistency of treatment by reducing paradoxical high-dose inhibition. Its unique, multimodal mechanism of action includes an ability to inhibit the release of the trigeminal neuropeptide calcitonin gene-related peptide (CGRP) in blood vessels within the brain, its lining and the brainstem, and to suppress signaling in pain neurons. Tonix believes that by engaging and activating oxytocin receptors in the trigeminal ganglia, TNX-1900 has the potential to help those suffering from chronic migraine.

“TNX-1900 is being developed as a novel, non-CGRP antagonist approach to treatment for chronic migraineurs,” said Seth Lederman, M.D., Chief Executive Officer of Tonix Pharmaceuticals. “There are an estimated four million individuals in the U.S. suffering from this debilitating condition, and despite several classes of migraine preventives available, there remains an unmet need for novel approaches.”

“With the last patient now treated, we look forward to analysis of the results of this proof-of-concept study, which will help to inform our plans as we discuss next steps with the U.S. Food and Drug Administration (FDA),” said Gregory Sullivan, M.D., Chief Medical Officer of Tonix Pharmaceuticals. “We would like to thank the participants, their families, and all the investigators and researchers who have been an important part of this journey so far.”

1Clinical Trials.gov I.D. NCT05679908
2TNX-1900 is an investigational new drug and is not approved for any indication.

About the Phase 2 PREVENTION Study
The Phase 2 PREVENTION study is a double-blind, randomized, multicenter, placebo-controlled study to evaluate the efficacy and safety of TNX-1900 taken prophylactically on a daily basis to prevent chronic migraine. There are three arms: two treatment regimens of TNX-1900 and one placebo in a 1:1:1 ratio in a total of 88 participants across approximately 26 U.S. sites. After a four-week Run-In phase to confirm chronic migraine criteria are met, there are 12-weeks of a double-blind Treatment phase with study drug, followed by a 2-week safety Follow-Up phase. The primary efficacy endpoint is mean change in the number of migraine headache days between the 28-day Run-In phase and the last 28-days of the Treatment phase. Key secondary efficacy endpoints include proportion of patients experiencing a ≥ 50% reduction in the number of migraine headache days, mean change in the number of days using migraine abortive medications, and mean change in a migraine-specific quality of life measure.

For more information, see ClinicalTrials.gov Identifier: NCT05679908.

About Migraine
Migraine is a neurological condition that typically manifests in a throbbing moderate to severe headache which lasts at least four hours, often on one side of the head and aggravated by routine physical activity. It can also be accompanied by nausea, vomiting, visual disturbances, and sensitivity to bright light and loud noises1. Epidemiological studies indicate that globally, approximately 1.2 billion individuals suffer from migraines annually2. In the U.S., approximately 39 million Americans suffer from migraines and among these individuals, approximately four million experience chronic migraines (15 or more headache days per month, at least eight of which are migraines)2. The current FDA approved drugs for migraine prevention in chronic migraine include Botox® (onabotulinumtoxinA), and the anti-CGRP/CGRP-R monoclonal antibodies Aimovig® (erenumab), Vyepti® (eptinezumab), Ajovy® (fremanezumab) and Emgality® (galcanezumab).

1The International Classification of Headache Disorders, 3rd Edition. Cephalalgia. 2018. 38(1):1-211.

2Burch et al., Migraine: Epidemiology, Burden, and Comorbidity. Neurol Clin. 2019. 631–649.

About TNX-1900
TNX-1900 (intranasal potentiated oxytocin) is a proprietary formulation of oxytocin in development as a candidate for prevention in chronic migraine and other conditions. In 2020, TNX-1900 was acquired from Trigemina, Inc. who had licensed the technology underlying the composition and method from Stanford University. TNX-1900 is a drug-device combination product, based on an intranasal actuator device that delivers oxytocin into the nasal cavity. Oxytocin is a naturally occurring human peptide hormone that also acts as a neurotransmitter in the brain. Oxytocin has no recognized addiction potential. It has been observed that low oxytocin levels in the body are associated with increases in migraine headache frequency, and that increased oxytocin levels are associated with fewer migraine headaches. Certain other chronic pain conditions are also associated with decreased oxytocin levels. Migraine attacks are caused, in part, by the activity of pain-sensing trigeminal neurons which, when activated, release of calcitonin gene-related peptide (CGRP) which binds to receptors on other nerve cells and starts a cascade of events that is believed to result in headache. Oxytocin, when delivered via the nasal route, concentrates in the trigeminal system1 resulting in binding of oxytocin to receptors on neurons in the trigeminal system, inhibiting the release of CGRP and transmission of pain signals returning from the site of CGRP release2. Blocking CGRP release is a distinct mechanism compared with CGRP antagonist and anti-CGRP antibody drugs, which block the binding of CGRP to its receptor. With TNX-1900, the addition of magnesium to the oxytocin formulation enhances oxytocin receptor binding3 as well as its inhibitory effects on trigeminal neurons and resultant craniofacial analgesic effects, as demonstrated in animal models4. Intranasal oxytocin has been shown to be well tolerated in several clinical trials in both adults and children5. Targeted nasal delivery results in low systemic exposure and lower risk of non-nervous system, off-target effects, which could potentially occur with systemic CGRP antagonists such as anti-CGRP antibodies6. For example, CGRP has roles in dilating blood vessels in response to ischemia, including in the heart. The Company believes nasally targeted delivery of oxytocin could translate into selective blockade of CGRP release from neurons in the trigeminal ganglion and not throughout the body, which could be a potential safety advantage over systemic CGRP inhibition. In addition, daily dosing is more rapidly reversible, in contrast to monthly or quarterly dosing, as is the case with anti-CGRP antibodies, giving physicians and their patients greater control. In addition to chronic migraine, TNX-1900 will be developed for treatment of episodic migraine, binge eating disorder, craniofacial pain conditions, and insulin resistance. Tonix also has a license with the University of Geneva to use TNX-1900 for the treatment of insulin resistance and related conditions.

1Yeomans DC, et al. Transl Psychiatry. 2021. 11(1):388.

2Tzabazis A, et al. Cephalalgia. 2016. 36(10):943-50.

3Antoni FA and Chadio SE. Biochem J. 1989. 257(2):611-4.

4Cai Q, et al., Psychiatry Clin Neurosci. 2018. 72(3):140-151.

5Yeomans, DC et al. 2017. US patent US2017368095.

6MaassenVanDenBrink A, et al. Trends Pharmacol Sci. 2016. 37(9):779-788.

Tonix Pharmaceuticals Holding Corp.*
Tonix is a biopharmaceutical company focused on commercializing, developing, discovering and licensing therapeutics to treat and prevent human disease and alleviate suffering. Tonix Medicines, our commercial subsidiary, markets Zembrace® SymTouch® (sumatriptan injection) 3 mg and Tosymra® (sumatriptan nasal spray) 10 mg under a transition services agreement with Upsher-Smith Laboratories, LLC from whom the products were acquired on June 30, 2023. Zembrace SymTouch and Tosymra are each indicated for the treatment of acute migraine with or without aura in adults. Tonix’s development portfolio is composed of central nervous system (CNS), rare disease, immunology and infectious disease product candidates. Tonix’s CNS development portfolio includes both small molecules and biologics to treat pain, neurologic, psychiatric and addiction conditions. Tonix’s lead development CNS candidate, TNX-102 SL (cyclobenzaprine HCl sublingual tablet), is in mid-Phase 3 development for the management of fibromyalgia, having completed enrollment of a potentially confirmatory Phase 3 study in the third quarter of 2023, with topline data expected in late December 2023. TNX-102 SL is also being developed to treat fibromyalgia-type Long COVID, a chronic post-acute COVID-19 condition. Enrollment in a Phase 2 proof-of-concept study has been completed, and topline results were reported in the third quarter of 2023. TNX-601 ER (tianeptine hemioxalate extended-release tablets) is a once-daily oral formulation being developed as a treatment for major depressive disorder (MDD), that completed enrollment in a Phase 2 study in the third quarter of 2023, with topline results expected in early November of 2023. TNX-4300 (estianeptine) is a single isomer version of TNX-601, a small molecule oral therapeutic in preclinical development to treat MDD, Alzheimer’s disease and Parkinson’s disease. Relative to tianeptine, estianeptine lacks activity on the mu-opioid receptor while maintaining activity and the ability to activate PPAR-β/δ and neuroplasticity in tissue culture. TNX-1900 (intranasal potentiated oxytocin), is in development as a preventive treatment in chronic migraine, and the clinical phase of a Phase 2 proof-of-concept study is now completed with topline data expected in early December 2023. TNX-1900 is also being studied in binge eating disorder, pediatric obesity and social anxiety disorder by academic collaborators under investigator-initiated INDs. 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 fourth quarter of 2023. Tonix’s rare disease development 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 development 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 was initiated in the third quarter of 2023. Tonix’s infectious disease pipeline includes TNX-801, a vaccine in development to prevent smallpox and mpox. TNX-801 also serves as the live virus vaccine platform or recombinant pox vaccine platform for other infectious diseases, including TNX-1800, in development as a vaccine to protect against COVID-19. The infectious disease development portfolio also includes TNX-3900 and TNX-4000, which are classes of broad-spectrum small molecule oral antivirals.

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

Zembrace SymTouch and Tosymra are registered trademarks of Tonix Medicines. Intravail is a registered trademark of Aegis Therapeutics, LLC, a wholly owned subsidiary of Neurelis, Inc. All other marks are property of their respective owners.

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; risks related to the failure to successfully market any of our products; 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.

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

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

Media Contact
Ben Shannon
ICR Westwicke
ben.shannon@westwicke.com
443-213-0495

Source: Tonix Pharmaceuticals Holding Corp.

Released October 26, 2023

Eledon Pharmaceuticals (ELDN) – C-Suite Interview With Eledon CEO Available On ChannelChek

Posted on by cpereira@noblefcm.com


Thursday, October 26, 2023

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

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Our Discussion Included Eledon’s Science, Markets, and Company Strategy.  We recently spoke with the Eledon CEO, Dr. DA Gros, as part of our C-Suite Interview Series. Our interview included the scientific principles on which tegoprubart is based, the unmet need in kidney transplantation, and the current clinical trials. Dr. Gros also discussed additional tegoprubart indications, company finances, and future milestones.

Eledon Is Pursuing An Unmet Need In Kidney Transplantation. Dr. Gros described how tegoprubart blocks a step in the immune response that has applications in many immune disorders. The first application in development is for prevention of kidney transplant rejection, where the current standard of care drugs are effective but have toxic side effects that lead to organ failure after 10 to 12 years. Tegoprubart is currently in two clinical trials for this indication.


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Release – ZyVersa Therapeutics Announces Research Published in the Peer-Reviewed Journal Diabetes Reinforcing IC 100’s Rationale for Inhibiting ASC to Attenuate Damaging Inflammation Associated with Serious Conditions Such as Obesity-related Heart Disease

Posted on by aweinsoff@channelchek.com

Research News and Market Data on ZVSA

Oct 25, 2023

PDF Version

  • Paper reports that obesity exacerbates scarring of the heart’s muscular tissue (myocardial fibrosis) through recruitment of inflammasome ASC to the heart’s mitochondria, facilitating NLRP3 inflammasome assembly and activation leading to damaging inflammation
  • Obesity, which affects over 650 million adults, is a known risk factor for myocardial fibrosis which is associated with almost all heart diseases
  • ZyVersa is developing Inflammasome ASC Inhibitor IC 100, designed to inhibit formation of multiple types of inflammasomes and their associated ASC specks to attenuate initiation and perpetuation of damaging inflammation

WESTON, Fla., Oct. 25, 2023 (GLOBE NEWSWIRE) — ZyVersa Therapeutics, Inc. (Nasdaq: ZVSA, or “ZyVersa”), a clinical stage specialty biopharmaceutical company developing first-in-class drugs for treatment of inflammatory and renal diseases, announces a publication in the peer-reviewed journal, Diabetes, demonstrating the role of ASC in myocardial fibrosis induced by obesity. ASC is an inflammasome adaptor protein that has a critical role in inflammasome activation.

In the paper titled, “Obesity enables NLRP3 activation and induces myocardial fibrosis via hyperacetylation of HADHa,” the authors performed MRIs on obese and lean people and evaluated their plasma. They also studied an animal model of obesity, with and without induced myocardial injury. Data indicate that:

  • Activated NLRP3 inflammasomes leading to increased levels of proinflammatory IL-1β and IL-18 contribute to obesity-related myocardial fibrosis in obese humans and mice.
  • Inflammasome ASC localized in the heart’s mitochondria participates in NLRP3 inflammasome formation and activation based on mouse data.
  • Inhibition of NLRP3 activation or removal of IL-1β and IL-18 abated the adverse effects on cardiac fibrosis and function in mice.

The authors concluded that these results provide new evidence for the involvement of mitochondria-localized ASC in obesity-induced cardiac fibrosis. To read the article, Click Here.

“Obesity, a well-established risk factor for cardiovascular disease, has reached pandemic proportions, and may affect up to two-thirds of the adult population in developed countries,” stated Stephen C. Glover, ZyVersa’s Co-founder, Chairman, CEO and President. “The research published in Diabetes demonstrates that ASC in the heart’s mitochondria facilitates NLRP3 inflammasome assembly and activation leading to damaging inflammation and myocardial fibrosis associated with obesity. This provides support for Inflammasome ASC Inhibitor IC 100 as a potential therapeutic option. By inhibiting ASC, IC 100 blocks formation of NLRP3 and other types of inflammasomes to block initiation of the inflammatory cascade. Likewise, IC 100 uniquely inhibits ASC specks to attenuate perpetuation of damaging inflammation.” To review a white paper summarizing the mechanism of action and preclinical data for IC 100, Click Here.

About Inflammasome ASC Inhibitor IC 100

IC 100 is a novel humanized IgG4 monoclonal antibody that inhibits the inflammasome adaptor protein ASC. IC 100 was designed to attenuate both initiation and perpetuation of the inflammatory response. It does so by binding to a specific region of the ASC component of multiple types of inflammasomes, including NLRP1, NLRP2, NLRP3, NLRC4, AIM2, Pyrin. Intracellularly, IC 100 binds to ASC monomers, inhibiting inflammasome formation, thereby blocking activation of IL-1β early in the inflammatory cascade. IC 100 also binds to ASC in ASC Specks, both intracellularly and extracellularly, further blocking activation of IL-1β and the perpetuation of the inflammatory response that is pathogenic in inflammatory diseases. Because active cytokines amplify adaptive immunity through various mechanisms, IC 100, by attenuating cytokine activation, also attenuates the adaptive immune response.

About ZyVersa Therapeutics, Inc.

ZyVersa (Nasdaq: ZVSA) is a clinical stage specialty biopharmaceutical company leveraging advanced, proprietary technologies to develop first-in-class drugs for patients with renal and inflammatory diseases who have significant unmet medical needs. The Company is currently advancing a therapeutic development pipeline with multiple programs built around its two proprietary technologies – Cholesterol Efflux Mediator™ VAR 200 for treatment of kidney diseases, and Inflammasome ASC Inhibitor IC 100, targeting damaging inflammation associated with numerous CNS and other inflammatory diseases. For more information, please visit www.zyversa.com.

Cautionary Statement Regarding Forward-Looking Statements

Certain statements contained in this press release regarding matters that are not historical facts, are forward-looking statements within the meaning of Section 21E of the Securities Exchange Act of 1934, as amended, and the Private Securities Litigation Reform Act of 1995. These include statements regarding management’s intentions, plans, beliefs, expectations, or forecasts for the future, and, therefore, you are cautioned not to place undue reliance on them. No forward-looking statement can be guaranteed, and actual results may differ materially from those projected. ZyVersa Therapeutics, Inc (“ZyVersa”) uses words such as “anticipates,” “believes,” “plans,” “expects,” “projects,” “future,” “intends,” “may,” “will,” “should,” “could,” “estimates,” “predicts,” “potential,” “continue,” “guidance,” and similar expressions to identify these forward-looking statements that are intended to be covered by the safe-harbor provisions. Such forward-looking statements are based on ZyVersa’s expectations and involve risks and uncertainties; consequently, actual results may differ materially from those expressed or implied in the statements due to a number of factors, including ZyVersa’s plans to develop and commercialize its product candidates, the timing of initiation of ZyVersa’s planned preclinical and clinical trials; the timing of the availability of data from ZyVersa’s preclinical and clinical trials; the timing of any planned investigational new drug application or new drug application; ZyVersa’s plans to research, develop, and commercialize its current and future product candidates; the clinical utility, potential benefits and market acceptance of ZyVersa’s product candidates; ZyVersa’s commercialization, marketing and manufacturing capabilities and strategy; ZyVersa’s ability to protect its intellectual property position; and ZyVersa’s estimates regarding future revenue, expenses, capital requirements and need for additional financing.

New factors emerge from time-to-time, and it is not possible for ZyVersa to predict all such factors, nor can ZyVersa assess the impact of each such factor on the business or the extent to which any factor, or combination of factors, may cause actual results to differ materially from those contained in any forward-looking statements. Forward-looking statements included in this press release are based on information available to ZyVersa as of the date of this press release. ZyVersa disclaims any obligation to update such forward-looking statements to reflect events or circumstances after the date of this press release, except as required by applicable law.

This press release does not constitute an offer to sell, or the solicitation of an offer to buy, any securities.

Corporate and IR Contact:
Karen Cashmere
Chief Commercial Officer
kcashmere@zyversa.com
786-251-9641

Media Contacts
Tiberend Strategic Advisors, Inc.
Casey McDonald
cmcdonald@tiberend.com
646-577-8520

Dave Schemelia
dschemelia@tiberend.com
609-468-9325

MAIA Biotechnology (MAIA) – THIO-101 Data Update Shows Improved Disease Control Rates

Posted on by cpereira@noblefcm.com


Wednesday, October 25, 2023

MAIA is a targeted therapy, immuno-oncology company focused on the development and commercialization of potential first-in-class drugs with novel mechanisms of action that are intended to meaningfully improve and extend the lives of people with cancer. Our lead program is THIO, a potential first-in-class cancer telomere targeting agent in clinical development for the treatment of NSCLC patients with telomerase-positive cancer cells. For more information, please visit www.maiabiotech.com.

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

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ESMO Data Shows Unusually High Survival Rates. MAIA Biotechnology presented preliminary data from the THIO-101 trial in non-small cell lung cancer (NSCLC) at the European Society for Medical Oncology conference. The disease control rate (DCR) reached 100% in second line patients compared with about 53% to 64%  for standard of care therapies. DCR for third line patients reached 88%, compared with about 30% expected. We see these results as extremely strong, and believe DCR could correlate with overall survival (OS), a primary endpoint of the trial.

Preliminary Data Shows Strong Response. The results showed a disease control rate (DCR, consisting of complete responses, partial responses, or stable disease) of 100% or 19 out of 19 patients in second line therapy and 88% or 14 out of 16 patients in third line. Published data from 74 clinical trials with standard of care therapies show 53% to 64% DCR in second line and about 30% in third line. We see this as a substantial improvement over results from standard of care therapies.


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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.