Category: Health

Release – Eledon Provides Enrollment Update for Phase 2 BESTOW Trial Assessing Tegoprubart for the Prevention of Organ Rejection

Posted on by aweinsoff@channelchek.com

July 29, 2024

80 Participants (Two-thirds of Projected Recruitment) Enrolled

IRVINE, Calif., July 29, 2024 (GLOBE NEWSWIRE) — Eledon Pharmaceuticals, Inc. (“Eledon”) (NASDAQ: ELDN) today announced that it has enrolled the 80th participant in its ongoing Phase 2 BESTOW trial assessing tegoprubart for the prevention of rejection in kidney transplantation.

“As of this week, we have already enrolled two-thirds of the projected study participants across sites in the United States, Europe and Latin America,” said David-Alexandre C. Gros, M.D., Chief Executive Officer of Eledon. “We are grateful to the participants and their clinical teams, whose high level of interest enabled us to achieve this level of enrollment in our Phase 2 BESTOW trial. This progress underscores the urgency and need for innovative solutions in preventing kidney transplant rejection. We remain on track to complete enrollment by the end of the year.”

BESTOW, a multicenter, two-arm, active comparator clinical study, will enroll approximately 120 participants undergoing kidney transplantation in the United States, Europe and Latin America to evaluate the safety, pharmacokinetics, and efficacy of the anti-CD40 ligand antibody tegoprubart compared to the calcineurin inhibitor tacrolimus. The study’s primary objective is to assess graft function at 12 months post-transplant, as measured by estimated glomerular filtration rate (eGFR), in participants treated with tegoprubart compared to tacrolimus. Better graft function as assessed by eGFR has been associated with improved long-term patient and graft survival.

Eledon is currently conducting a Phase 2 trial (BESTOW; NCT05983770), a Phase 1b trial (NCT05027906), and a long-term safety and efficacy extension study (NCT06126380) to evaluate tegoprubart for the prevention of organ rejection in patients receiving a kidney transplant.

About Eledon Pharmaceuticals and tegoprubart

Eledon Pharmaceuticals, Inc. is a clinical stage biotechnology company that is developing immune-modulating therapies for the management and treatment of life-threatening conditions. The Company’s lead investigational product is tegoprubart, an anti-CD40L antibody with high affinity for the CD40 Ligand, a well-validated biological target that has broad therapeutic potential. The central role of CD40L signaling in both adaptive and innate immune cell activation and function positions it as an attractive target for non-lymphocyte depleting, immunomodulatory therapeutic intervention. The Company is building upon a deep historical knowledge of anti-CD40 Ligand biology to conduct preclinical and clinical studies in kidney allograft transplantation, xenotransplantation, and amyotrophic lateral sclerosis (ALS). Eledon is headquartered in Irvine, California. For more information, please visit the Company’s website at www.eledon.com.

Follow Eledon Pharmaceuticals on social media: LinkedIn; Twitter

Forward-Looking Statements

This press release contains forward-looking statements that involve substantial risks and uncertainties. Any statements about the company’s future expectations, plans and prospects, including statements about planned clinical trials, the development of product candidates, expected timing for initiation of future clinical trials, expected timing for receipt of data from clinical trials, expected or future results of tegoprubart trials and its ability to prevent rejection in connection with kidney transplantation, as well as other statements containing the words “believes,” “anticipates,” “plans,” “expects,” “estimates,” “intends,” “predicts,” “projects,” “targets,” “looks forward,” “could,” “may,” and similar expressions, constitute forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Forward-looking statements are inherently uncertain and are subject to numerous risks and uncertainties, including: risks relating to the safety and efficacy of our drug candidates; risks relating to clinical development timelines, including interactions with regulators and clinical sites, as well as patient enrollment; and risks relating to costs of clinical trials and the sufficiency of the company’s capital resources to fund planned clinical trials. Actual results may differ materially from those indicated by such forward-looking statements as a result of various factors. These risks and uncertainties, as well as other risks and uncertainties that could cause the company’s actual results to differ significantly from the forward-looking statements contained herein, are discussed in our quarterly 10-Q, annual 10-K, and other filings with the U.S. Securities and Exchange Commission, which can be found at www.sec.gov. Any forward-looking statements contained in this press release speak only as of the date hereof and not of any future date, and the company expressly disclaims any intent to update any forward-looking statements, whether as a result of new information, future events or otherwise.

Investor Contact:

Stephen Jasper
Gilmartin Group
(858) 525 2047
stephen@gilmartinir.com

Media Contact:

Jenna Urban
Berry & Company Public Relations
(212) 253 8881
jurban@berrypr.com

Source: Eledon Pharmaceuticals

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Source: Eledon Pharmaceuticals, Inc.

Release – ZyVersa Therapeutics Announces Published Data Demonstrating That Plasma Levels of Inflammasome ASC Show Promise as Biomarker of Early Cognitive Changes in Older Adults

Posted on by aweinsoff@channelchek.com

Research News and Market Data on ZVSA

Jul 29, 2024

PDF Version

  • This data supports the potential of plasma ASC levels as a biomarker for early stages of cognitive decline, based on elevated ASC levels in older adults (>60 years) who were cognitively normal at baseline but demonstrated cognitive decline one year later (NI) compared to ASC levels in those who:
    1. Were cognitively normal at both baseline and 1 year later (NN), and
    2. Were cognitively impaired at both baseline and one year later (II)
  • Inflammasome-induced neuroinflammation has been associated with early stages of cognitive decline in dementia associated with Alzheimer’s and Parkinson’s diseases.
  • Excessive inflammasome activation leads to cell death (pyroptosis) and systemic release of cell contents, including ASC that can be measured in the plasma.

WESTON, Fla., July 29, 2024 (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 that leading inflammasome researchers from the University of Miami Miller School of Medicine and inventors of Inflammasome ASC Inhibitor IC 100 have published a scientific paper in the peer-reviewed International Journal of Molecular Sciences demonstrating that plasma levels of inflammasome ASC show promise as a biomarker of early cognitive decline in older adults.

“Elevations in plasma ASC in early cognitive decline reinforce the role of inflammasome-induced inflammation in the development of neurodegenerative conditions such as Alzheimer’s and Parkinson’s diseases,” stated Stephen C. Glover, ZyVersa’s Co-founder, Chairman, CEO, and President. “ZyVersa is developing Inflammasome ASC Inhibitor IC 100 to inhibit multiple types of inflammasomes and their associated ASC specks that trigger damaging inflammation pathogenic in neurological and other inflammatory diseases, such as obesity and its metabolic complications, our lead indication.”

The paper titled, The Inflammasome Adaptor Protein ASC in Plasma as a Biomarker of Early Cognitive Changes, summarizes biomarker assessments in older adults at baseline and at one-year follow-up. Following is a summary of key findings:

  • Plasma ASC levels were elevated in older adults (>60 years) who were cognitively normal at baseline but demonstrated cognitive decline one year later (NI) compared to ASC levels in those who remained cognitively normal one-year post-baseline assessment (NN). The increase in ASC levels was even higher in people who were 70 years or older.
  • Likewise, plasma ASC levels in the NI group were elevated compared to ASC levels in older adults who demonstrated cognitive impairment at both baseline and one year later (II), indicating that plasma ASC levels are increased in the early stages of cognitive decline. Again, the increase in ASC levels was even higher in people who were 70 years or older.
  • In the group over 70 years old, area under the curve (AUC) for plasma levels of ASC in group NI versus group NN was 0.81, indicating excellent ability to differentiate between people with cognitive decline at one year versus those who were cognitively normal both at baseline and at one year. AUC is used to determine the diagnostic power of a biomarker.

“Dementia affects 57 million people worldwide, and the incidence is expected to double by 2040. There is an unmet need to develop minimally invasive, reliable biomarkers to diagnose early brain impairments so that emerging interventions can be applied before brain degeneration,” said Dr. Juan Pablo de Rivero Vaccari, Associate Professor of Neurological Surgery and The Miami Project to Cure Paralysis and Distinguished Faculty of the Center for Cognitive Neuroscience and Aging at the University of Miami Miller School of Medicine. “Our data indicate that plasma levels of ASC are a strong early indicator of the eventual development of cognitive impairment, especially in persons older than 70 years.”

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, and 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. The lead indication for IC 100 is obesity and its associated metabolic complications. To review a white paper summarizing the mechanism of action and preclinical data for IC 100, Click Here.

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 inflammatory or kidney diseases with high unmet medical needs. We are well positioned in the rapidly emerging inflammasome space with a highly differentiated monoclonal antibody, Inflammasome ASC Inhibitor IC 100, and in kidney disease with phase 2 Cholesterol Efflux MediatorTM VAR 200. The lead indication for IC 100 is obesity and its associated metabolic complications, and for VAR 200, focal segmental glomerulosclerosis (FSGS). Each therapeutic area offers a “pipeline within a product,” with potential for numerous indications. The total accessible market is over $100 billion. 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, Media, and IR Contact:
Karen Cashmere
Chief Commercial Officer
kcashmere@zyversa.com
786-251-9641        

Release – Ocugen to Host Conference Call on Thursday, August 8 at 8:30 A.M. ET to Discuss Business Updates and Second Quarter 2024 Financial Results

Posted on by aweinsoff@channelchek.com

Research News and Market Data on OCGN

July 29, 2024

PDF Version

MALVERN, Pa., July 29, 2024 (GLOBE NEWSWIRE) — Ocugen, Inc. (Ocugen or the Company) (NASDAQ: OCGN), a biotechnology company focused on discovering, developing, and commercializing novel gene and cell therapies and vaccines, today announced that it will host a conference call and live webcast to discuss the Company’s second quarter 2024 financial results and provide a business update at 8:30 a.m. ET on Thursday, August 8, 2024.

Ocugen will issue a pre-market earnings announcement on the same day. Attendees are invited to participate on the call using the following details:

Dial-in Numbers: (800) 715-9871 for U.S. callers and (646) 307-1963 for international callers
Conference ID: 7453742
Webcast: Available on the events section of the Ocugen investor site

A replay of the call and archived webcast will be available for approximately 45 days following the event on the Ocugen investor site.

About Ocugen, Inc.
Ocugen, Inc. is a biotechnology company focused on discovering, developing, and commercializing novel gene and cell therapies 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 X 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, including, but not limited to, statements regarding qualitative assessments of available data, potential benefits, expectations for ongoing clinical trials, anticipated regulatory filings and anticipated development timelines, 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 Communications
Tiffany.Hamilton@ocugen.com

Tonix Pharmaceuticals (TNXP) – A Mid-Summer Month’s Progress: Tonmya Gets Fast Track Review and Antiviral Gets $34 Million Grant

Posted on by cpereira@noblefcm.com


Monday, July 29, 2024

Tonix is a clinical-stage biopharmaceutical company focused on discovering, licensing, acquiring and developing therapeutics and diagnostics to treat and prevent human disease and alleviate suffering. Tonix’s portfolio is composed of immunology, rare disease, infectious disease, and central nervous system (CNS) product candidates. Tonix’s immunology portfolio includes biologics to address organ transplant rejection, autoimmunity and cancer, including TNX-15001 which is a humanized monoclonal antibody targeting CD40-ligand being developed for the prevention of allograft and xenograft rejection and for the treatment of autoimmune diseases. A Phase 1 study of TNX-1500 is expected to be initiated in the second half of 2022. Tonix’s rare disease portfolio includes TNX-29002 for the treatment of Prader-Willi syndrome. TNX-2900 has been granted Orphan-Drug Designation by the FDA. Tonix’s infectious disease pipeline includes a vaccine in development to prevent smallpox and monkeypox called TNX-8013, next-generation vaccines to prevent COVID-19, and an antiviral to treat COVID-19. Tonix’s lead vaccine candidates for COVID-19 are TNX-1840 and TNX-18504, which are live virus vaccines based on Tonix’s recombinant pox vaccine (RPV) platform. TNX-35005 (sangivamycin, i.v. solution) is a small molecule antiviral drug to treat acute COVID-19 and is in the pre-IND stage of development. TNX-102 SL6, (cyclobenzaprine HCl sublingual tablets), is a small molecule drug being developed to treat Long COVID, a chronic post-acute COVID-19 condition. Tonix expects to initiate a Phase 2 study in Long COVID in the second quarter of 2022. The Company’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, is in mid-Phase 3 development for the management of fibromyalgia with a new Phase 3 study launched in the second quarter of 2022. Finally, TNX-13007 is a biologic designed to treat cocaine intoxication that is expected to start a Phase 2 trial in the second quarter of 2022. TNX-1300 has been granted Breakthrough Therapy Designation by the FDA.

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.

Tonix Announced Two Significant Developments In Late July. Tonmya (TNX-102 SL) has received Fast Track Review designation from the FDA. This designation is awarded to products that can make significant impact on serious medical conditions. The designation provides important benefits for Tonmya including eligibility for Accelerated Approval and Priority Review Fast Track Review. The NDA application for approval is expected to be filed in 2H24.

Fast Track Review Is A Significant Distinction. The FDA awards Fast Track Review to drugs that treat serious conditions with unmet needs. It is given when the FDA believes the drug is either providing a therapy where none exists and/or has meaningful advantages over existing therapies. We have long believed the Tonmya Phase 3 data meets both requirements.


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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. 

Ocugen (OCGN) – Ocugen Completes Phase 1 Dosing For OCU410 In Dry AMD

Posted on by cpereira@noblefcm.com


Friday, July 26, 2024

Ocugen, Inc. is a biotechnology company focused on developing and commercializing novel gene therapies, biologicals, and vaccines. The lead product in its gene therapy program, OCU400, is in Phase 1/2 clinical trials for retinitis pigmentosa.

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.

Escalating Dose Stage Has Completed Dosing. Ocugen reported completion of the escalating dose stage of its Phase 1/2 ArMaDa trial testing OCU410 in Geographic Atrophy (GA), a late-stage complication of dry age-related macular degeneration (dry AMD). OCU410 uses Ocugen’s “master regulatory gene” approach, with a single injection to deliver the nuclear receptor gene RAR-related orphan receptor A (RORA). This gene regulates pathways that lead to dry age-related macular degeneration.

Next Stage In Phase 1/2 Trial Expected In 3Q24. The Phase 1/2 ArMaDa trial is testing OCU410 in geographic atrophy (GA), a lesion secondary to dry AMD at 14 retina surgical centers in the US. The first stage of the trial administered three escalating doses of OCU410. The second stage will randomize patients into three arms at a ratio of 1:1:1 to compare the medium and high dosage levels to a control group. Endpoints will be efficacy and safety.


Get the Full Report

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. 

Dexcom’s Stock Plummets: A Wake-Up Call for the Diabetes Management Giant

Posted on by slightbourne@noblecapitalmarkets.com
Key Points:
– Dexcom shares dropped over 40% in a single day, the worst in company history.
– Disappointing Q2 revenue and lowered full-year guidance shocked investors.
– Internal issues, not market changes, appear to be the primary cause of the downturn.

Dexcom, a leader in diabetes management technology, experienced a seismic shock on Friday, July 26, 2024, as its stock plunged more than 40% following a disappointing second-quarter earnings report. This dramatic fall, erasing approximately $18 billion in market capitalization, marks the company’s worst single-day performance since its 2005 IPO.

The catalyst for this financial tremor was Dexcom’s Q2 revenue report, which fell short of analyst expectations. Despite a 15% year-over-year increase to $1 billion, it missed the projected $1.04 billion target. More alarmingly, the company significantly lowered its full-year revenue guidance from $4.20-$4.35 billion to $4.00-$4.05 billion, a reduction that caught many investors off guard.

During the earnings call, CEO Kevin Sayer attributed the shortfall to several internal factors. A major restructuring of the sales team led to disruptions in customer relationships, particularly affecting the crucial durable medical equipment (DME) channel. The company also faced challenges with lower-than-expected new customer acquisition and reduced revenue per user, partly due to rebates offered for their new G7 continuous glucose monitor.

The magnitude of the guidance cut raised eyebrows among analysts. JPMorgan downgraded Dexcom’s stock, expressing shock at the level of disruption caused by internal reorganization. However, they and other analysts, including those from William Blair and Leerink, maintained that these issues are likely transient and should not significantly impact Dexcom’s long-term trajectory.

Interestingly, Dexcom’s woes do not appear to be linked to broader market trends, such as the rising popularity of GLP-1 weight loss treatments. Instead, the company’s stumbles seem largely self-inflicted, a fact that has both frustrated and perplexed market watchers.

Looking ahead, Dexcom is pinning hopes on its new over-the-counter continuous glucose monitor, Stelo, cleared by the FDA in March 2024 and set for an August launch. Designed for Type 2 diabetes patients who don’t use insulin, Stelo represents a significant expansion of Dexcom’s addressable market.

Despite the current turmoil, some analysts believe the market’s reaction may be overblown. Leerink analysts, in particular, argue that the magnitude of the sell-off is excessive given the likely temporary nature of Dexcom’s challenges.

Nevertheless, the incident serves as a stark reminder of the volatility inherent in the healthcare technology sector. It underscores the importance of effective execution, particularly in sales and customer relationship management, even for established market leaders.

As Dexcom works to right the ship, investors and industry observers will be watching closely. The company’s ability to overcome these short-term hurdles and leverage opportunities like the Stelo launch will be crucial in regaining market confidence.

While the road ahead may be bumpy, Dexcom’s strong market position and innovative product pipeline suggest that this may be a temporary setback rather than a long-term decline. However, the company will need to demonstrate improved execution and a clear path to recovery in the coming quarters to fully reassure investors and regain its market momentum.

Release – GoHealth to Announce Second Quarter 2024 Results on August 8, 2024

Posted on by aweinsoff@channelchek.com

Research News and Market Data on GOCO

Jul 25, 2024 at 8:00 AM EDT

CHICAGO, July 25, 2024 (GLOBE NEWSWIRE) — GoHealth, Inc. (GoHealth) (NASDAQ: GOCO), a leading health insurance marketplace and Medicare-focused digital health company, announced that the company will release its second quarter 2024 financial results on the morning of August 8, 2024.

Chief Executive Officer, Vijay Kotte, and interim Chief Financial Officer, Katie O’Halloran, will host a conference call and live audio webcast on the day of the release at 8:00 a.m. (ET) to discuss the results.

A live audio webcast of the conference call will be available via GoHealth’s Investor Relations website, https://investors.gohealth.com/. A replay of the call will be available via webcast for on-demand listening shortly after the completion of the call.

About GoHealth, Inc.

GoHealth is a leading health insurance marketplace and Medicare-focused digital health company whose purpose is to compassionately ensure consumers’ peace of mind when making healthcare decisions so they can focus on living life. For many of these consumers, enrolling in a health insurance plan is confusing and difficult, and seemingly small differences between health plans may lead to significant out-of-pocket costs or lack of access to critical providers and medicines. GoHealth’s proprietary technology platform leverages modern machine-learning algorithms, powered by over two decades of insurance purchasing behavior, to reimagine the process of matching a health plan to a consumer’s specific needs. Its unbiased, technology-driven marketplace coupled with highly skilled licensed agents has facilitated the enrollment of millions of consumers in Medicare plans since GoHealth’s inception. For more information, visit https://www.gohealth.com.

Investor Relations
John Shave
jshave@gohealth.com

Media Relations
Pressinquiries@gohealth.com

Release – Tonix Pharmaceuticals Granted Fast Track Designation by FDA for Tonmya™ for Fibromyalgia

Posted on by aweinsoff@channelchek.com

Research News and Market Data on TNXP

July 25, 2024 8:00am EDT

Fast Track is designed to expedite FDA review of important new drugs to treat serious conditions and fill an unmet medical need

Fast Track designation for Tonmya recognizes fibromyalgia as a serious condition impacting more than 10 million U.S. adults

NDA submission on track for second half 2024

Tonmya has the potential to be the first new drug for treating fibromyalgia in more than 15 years

CHATHAM, N.J., July 25, 2024 (GLOBE NEWSWIRE) — Tonix Pharmaceuticals Holding Corp. (Nasdaq: TNXP) (Tonix or the Company), a fully-integrated biopharmaceutical company with marketed products and a pipeline of development candidates, today announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation to Tonmya™ (cyclobenzaprine HCl sublingual tablets) for the management of fibromyalgia. Tonmya is a non-opioid, centrally-acting analgesic drug under development for treating fibromyalgia, which is a common chronic pain condition affecting mostly women. The designation validates that fibromyalgia is a serious condition and that Tonmya has the potential to address this unmet medical need. Tonix previously announced alignment with the FDA regarding the content of its proposed NDA submission, following completion of the Company’s pre-NDA meetings. The Company reaffirms its guidance to submit the NDA for Tonmya to the FDA in the second half of 2024.

“The FDA’s decision to grant Tonmya Fast Track designation supports our goal of bringing this well tolerated, non-opioid analgesic treatment option to the market in 2025,” said Seth Lederman, M.D., Chief Executive Officer of Tonix Pharmaceuticals. “The designation underscores the importance of addressing the unmet needs of fibromyalgia patients, who report dissatisfaction with current treatment options. If approved by the FDA, we expect Tonmya to become the first new pharmacotherapy for fibromyalgia in over 15 years. The NDA being prepared supports Tonmya’s potential position as a first line therapy for fibromyalgia, indicated for long-term daily use at bedtime.”

The FDA’s Fast Track process is designed to facilitate development and expedite the review of therapies intended to treat serious conditions and address unmet medical needs to potentially bring important new medicines to patients sooner. Companies whose programs are granted Fast Track designation are eligible for more frequent interactions with the FDA during clinical development. Tonix plans to request Priority Review designation, and if granted, FDA may accelerate the review of the NDA. For more information on Fast Track designation, please visit the FDA’s website at www.fda.gov/patients/fast-track-breakthrough-therapy-accelerated-approval-priority-review/fast-track.

About Tonmya* (also known as TNX-102 SL)

Tonmya is a centrally acting, non-opioid, analgesic investigational drug for bedtime use. The tablet is a patented sublingual formulation of cyclobenzaprine hydrochloride developed for the management of fibromyalgia. In December 2023, the company announced highly statistically significant and clinically meaningful topline results in RESILIENT, the second pivotal Phase 3 clinical trial of Tonmya for the management of fibromyalgia. In the study, Tonmya met its pre-specified primary endpoint, significantly reducing daily pain compared to placebo (p=0.00005) in participants with fibromyalgia. Statistically significant and clinically meaningful results were also seen in all six key secondary endpoints related to improving sleep quality, reducing fatigue and improving overall fibromyalgia symptoms and function (all p≤0.001). RELIEF, the first statistically significant Phase 3 trial of Tonmya in fibromyalgia, was completed in December 2020. It met its pre-specified primary endpoint of daily pain reduction compared to placebo (p=0.010) and showed activity in key secondary endpoints. In both pivotal studies, the most common treatment-emergent adverse event was tongue or mouth numbness at the administration site, which was temporally-related to dosing, self-limited, never rated as severe, and rarely led to study discontinuation (one participant in each study). Tonix has announced the results of two positive pre-NDA meetings and alignment with FDA on nonclinical, clinical pharmacology, clinical and CMC features of the NDA submission.

About Fibromyalgia

Fibromyalgia is a common chronic pain disorder that is understood to result from amplified sensory and pain signaling within the central nervous system. Fibromyalgia afflicts an estimated 6 million to 12 million adults in the U.S., the majority of whom are women. Symptoms of fibromyalgia include chronic widespread pain, non-restorative sleep, fatigue, and brain fog (or cognitive dysfunction). Other associated symptoms include mood disturbances, including anxiety and depression, headaches, and abdominal pain or cramps. Individuals suffering from fibromyalgia struggle with their daily activities, have impaired quality of life, and frequently are disabled. Physicians and patients report common dissatisfaction with currently marketed products.

Tonix Pharmaceuticals Holding Corp.**

Tonix is a fully-integrated biopharmaceutical company focused on developing, licensing and commercializing therapeutics to treat and prevent human disease and alleviate suffering. Tonix’s development portfolio is focused on central nervous system (CNS) disorders. Tonix’s priority is to submit a New Drug Application (NDA) to the FDA in the second half of 2024 for Tonmya, a product candidate for which two statistically significant Phase 3 studies have been completed for the management of fibromyalgia. TNX-102 SL is also being developed to treat acute stress reaction. Tonix’s CNS portfolio includes TNX-1300 (cocaine esterase), a biologic designed to treat cocaine intoxication that has Breakthrough Therapy designation. Tonix’s immunology development portfolio consists of 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. Tonix also has product candidates in development in the areas of rare disease and infectious disease. Tonix Medicines, our commercial subsidiary, markets Zembrace® SymTouch® (sumatriptan injection) 3 mg and Tosymra® (sumatriptan nasal spray) 10 mg for the treatment of acute migraine with or without aura in adults.

*Tonmya™ is conditionally accepted by the U.S. Food and Drug Administration as the tradename for TNX-102 SL for the management of fibromyalgia. Tonmya has not been approved for any indication.

**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. 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, 2023, as filed with the Securities and Exchange Commission (the “SEC”) on April 1, 2024, 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

Katie Dodge
LaVoieHealthScience
kdodge@lavoiehealthscience.com
(978) 360-3151

Primary Logo

Source: Tonix Pharmaceuticals Holding Corp.

Released July 25, 2024

Release – ZyVersa Therapeutics Selects Obesity and Related Metabolic Complications as Lead Indication for Inflammasome ASC Inhibitor IC 100

Posted on by aweinsoff@channelchek.com

Research News and Market Data on ZVSA

Jul 25, 2024

PDF Version

WESTON, Fla., July 25, 2024 (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 that obesity and its related metabolic complications has been selected as the lead indication for Inflammasome ASC Inhibitor IC 100.

“Obesity, a well-established risk factor for an array of different metabolic disorders, including insulin resistance, type 2 Diabetes, hypertension, cardiovascular disease, and cancer, has reached pandemic proportions, affecting up to two-thirds of the adult population in developed countries,” stated Stephen C. Glover, ZyVersa’s Co-founder, Chairman, CEO and President. “Published research demonstrating that inflammasome activation in fat tissue triggers cell death and systemic release of proinflammatory IL-1β, and ASC specks, which can perpetuate and spread inflammation leading to metabolic disturbances associated with obesity provides support for Inflammasome ASC Inhibitor IC 100 as a potential therapeutic option. We are excited about progressing our development program in this area of high unmet needs.”

Following is the rationale behind selection of obesity and related metabolic complications, and an overview of the development program.

Why Obesity and Related Metabolic Complications as an Indication?

  • Large Growing Market: The global obesity drug market reached nearly $24 billion in 2023, more than a sevenfold growth in just three years, and it is forecasted by IQVIA t to reach up to $131 Billion by 2028 (24 – 27% CAGR).
  • Significant Health and Economic Impact: Obesity, which now affects over 40% of Americans (CDC), is associated with multiple chronic medical conditions, including type 2 diabetes, heart disease, and some forms of cancer, at an annual cost and economic impact exceeding 1.4 trillion in the United States including healthcare expenditures, loss of productivity (Milken Institute).
  • Need for Alternative Mechanisms of Action to Complement GLP-1 agonists: While GLIP-1 drugs deliver meaningful weight loss, improve glucose control, and help to mitigate cardiovascular disease, they do not address the chronic tissue inflammation observed in adipose tissue, liver, muscle, and pancreatic islet cells that has emerged as a key feature of obesity. This chronic tissue inflammation, termed, “immunometabolism,” leads to insulin resistance, beta cell dysfunction, and development of type 2 diabetes and long-term inflammatory complications including microvascular disease (retinopathy, nephropathy, and neuropathy), macrovascular disease (stroke, myocardial infarction, and peripheral arterial disease), heart failure, and nonalcoholic fatty liver disease. As such, anti-inflammatory drugs have potential to provide additional benefits in obesity management (Immunity. 2022 Jan 11;55(1):31-55).

Rationale for Inflammasome Inhibitors as a Treatment for Obesity and Related Metabolic Complications

Inflammasomes, which are activated by nutrients, such as glucose and free fatty acids, trigger activation and stimulation of downstream inflammatory pathways, leading to chronic inflammation in obesity (Front Endocrinol (Lausanne). 2023 Aug 31;14:1232171).

  1. Nutrient overload triggers inflammasome-induced inflammation in the brain’s hypothalamus, causing increased appetite and food intake, increasing the number and size of fat cells associated with weight gain and obesity.
  2. The fat cells become hypoxic, resulting in cell death and macrophage recruitment. This leads to inflammasome activation, death of inflamed cells, and systemic release of proinflammatory cytokines, such as IL-1β, and ASC specks, spreading inflammation throughout the body. If unresolved, sustained inflammation leads to the metabolic complications of obesity.

Why Inflammasome ASC Inhibitor IC 100?

  • Multiple types of inflammasomes, not just NLRP3, are activated in obesity and related metabolic complications (NLRP1, NLRP3, NLRC4, and AIM2). Because IC 100 targets the inflammasome ASC component, it inhibits each of these inflammasomes, including NLRP3, with potential to better attenuate the damaging inflammation associated with obesity and its complications (Immunology. 2021 Aug;163(4):348-362).
  • Inflammation is spread and perpetuated by systemic release of proinflammatory IL-1β and ASC specks during death of inflamed cells, leading to obesity-related complications. IC 100 disrupts the structure and function of ASC specks, thereby attenuating spread and perpetuation of inflammation (Transl Res. 2022 Jul 3:S1931-5244(22)00150-5).

ZyVersa believes that inflammasome ASC Inhibitor IC 100 administered concurrently with GLIP-1 agonists will lead to incremental weight loss, and more importantly, attenuate the chronic tissue inflammation not addressed by GLIP-1 agonists to reduce the long-term micro- and macrovascular inflammatory complications.

Inflammasome ASC Inhibitor IC 100 Development Plans for Obesity and Related Complications

  • IC 100’s preclinical program is nearing completion, with a planned Investigational New Drug (IND) submission Q4-2024, and Phase 1 clinical trial initiation shortly thereafter.
  • Preclinical scientific collaboration to assess IC 100 as a potential treatment for atherosclerosis, a common obesity-related metabolic complication, is expected to conclude H2-2024.
  • Preclinical scientific collaboration with University of Miami Miller School of Medicine to assess IC 100 as a potential treatment for obesity and metabolic syndrome is expected to begin H2-2024, with a second study looking at concomitant treatment with IC 100 and a GLIP-1 agonist to begin shortly thereafter.
  • ZyVersa has recruited six top-tiered experts in obesity and related metabolic complications for a scientific advisory board to guide clinical development plans for IC 100, which will be announced in the next few weeks.

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, and 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. The lead indication for IC 100 is obesity and its associated metabolic complications. To review a white paper summarizing the mechanism of action and preclinical data for IC 100, Click Here.

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 inflammatory or kidney diseases with high unmet medical needs. We are well positioned in the rapidly emerging inflammasome space with a highly differentiated monoclonal antibody, Inflammasome ASC Inhibitor IC 100, and in kidney disease with phase 2 Cholesterol Efflux MediatorTM VAR 200. The lead indication for IC 100 is obesity and its associated metabolic complications, and for VAR 200, focal segmental glomerulosclerosis (FSGS). Each therapeutic area offers a “pipeline within a product,” with potential for numerous indications. The total accessible market is over $100 billion. 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, Media, and IR Contact:
Karen Cashmere
Chief Commercial Officer
kcashmere@zyversa.com
786-251-9641

Release – Ocugen, Inc. Announces Completion of Dosing In Subjects With Geographic Atrophy Secondary To dAMD In High-Dose Cohort Of Phase 1/2 ArMaDa Clinical Trial Of OCU410—A Novel Modifier Gene Therapy

Posted on by aweinsoff@channelchek.com

Research News and Market Data on OCGN

July 25, 2024

PDF Version

• Initiated Phase 2 clinical trial

MALVERN, Pa., July 25, 2024 (GLOBE NEWSWIRE) — Ocugen, Inc. (“Ocugen” or the “Company”) (NASDAQ: OCGN), a biotechnology company focused on discovering, developing, and commercializing novel gene and cell therapies and vaccines, today announced that dosing is complete in the third cohort of its Phase 1/2 ArMaDa clinical trial for OCU410 (AAV-hRORA)—a novel modifier gene therapy candidate being developed for geographic atrophy (GA), an advanced stage of dry age-related macular degeneration (dAMD). GA affects approximately 1 million people in the United States.

“Currently, there are two FDA approved anti-complement therapies for GA, which targets only one pathway for a disease that has a multifactorial and complex etiology,” said Majda Hadziahmetovic, MD, Associate Professor of Ophthalmology, Vitreoretinal Diseases and Surgery, Duke University Eye Center, and the lead investigator for the OCU410 Phase 1/2 trial. “Though these treatments are a significant milestone, they provide limited benefits and involve a continuous regimen of multiple intravitreal injections over several years. This modifier gene therapy could potentially transform the landscape of GA treatment.”

Three subjects received a single subretinal administration of the highest dose (200 µL of 1.5×1011 vg/mL) being tested, which completed the dosing for the Phase 1 stage of the trial. The ArMaDa clinical trial for OCU410 is being performed at 14 leading retinal surgery centers across the United States.

“We are very encouraged about the potential of OCU410 as a one-time treatment option for GA,” said Dr. Huma Qamar, Chief Medical Officer of Ocugen.

We have initiated a Phase 2 clinical trial that will assess the safety and efficacy of OCU410 in a larger group of patients who will be randomized into either of two treatment groups (medium- or high-dose) or a control group.

The Company will continue to provide clinical updates on a periodic basis.

About the Phase 1/2 ArMaDa clinical trial
The ArMaDa Phase 1/2 clinical trial will assess the safety of unilateral subretinal administration of OCU410 in subjects with geographic atrophy and will be conducted in two phases. Phase 1 is a multicenter, open-label, dose-escalation study consisting of three dose levels [low dose (2.5×1010 vg/mL), medium dose (5×1010 vg/mL), and high dose (1.5 ×1011 vg/mL)]. Phase 2 is a randomized, outcome accessor-blinded, dose-expansion study in which subjects will be randomized in a 1:1:1 ratio to either one of two OCU410 treatment groups or to an untreated control group.

About dry age-related macular degeneration (dAMD) and geographic atrophy (GA)
Dry age-related macular degeneration (dAMD) affects approximately 10 million Americans and more than 266 million people worldwide. It is characterized by the thinning of the macula, the portion of the retina responsible for clear vision in one’s direct line of sight. dAMD involves the slow deterioration of the retina with submacular drusen (small white or yellow dots on the retina), atrophy, loss of macular function, and central vision impairment. dAMD accounts for 85-90% of all AMD cases.

About OCU410
OCU410 utilizes an adeno-associated virus (AAV) platform for the retinal delivery of the RORA (ROR Related Orphan Receptor A) gene. The RORA protein plays an important role in lipid metabolism, reducing lipofuscin deposits and oxidative stress, and demonstrates an anti-inflammatory role as well as inhibiting the complement system in both in vitro and in vivo (animal model) studies. These results demonstrate the ability of OCU410 to target multiple pathways linked with dAMD pathophysiology. Ocugen is developing AAV-RORA as a one-time gene therapy for the treatment of geographic atrophy.

About Ocugen, Inc.
Ocugen, Inc. is a biotechnology company focused on discovering, developing, and commercializing novel gene and cell therapies and vaccines that improve health and offer hope for patients across the globe. We are making an impact on patients’ 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 X and LinkedIn.

Forward-Looking Statements
This press release contains forward-looking statements within the meaning of The Private Securities Litigation Reform Act of 1995, including, but not limited to, statements regarding qualitative assessments of available data, potential benefits, expectations for ongoing clinical trials, anticipated regulatory filings and anticipated development timelines, 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, including, but not limited to, the risks that preliminary, interim and top-line clinical trial results may not be indicative of, and may differ from, final clinical data; that unfavorable new clinical trial data may emerge in ongoing clinical trials or through further analyses of existing clinical trial data; that earlier non-clinical and clinical data and testing of may not be predictive of the results or success of later clinical trials; and that that clinical trial data are subject to differing interpretations and assessments, including by regulatory authorities. 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 Communications
Tiffany.Hamilton@ocugen.com

Viking’s Surprise Move in the $150 Billion Weight Loss Race

Posted on by slightbourne@noblecapitalmarkets.com
Key Points:
– Viking Therapeutics stock surges 20% after announcing early advancement to late-stage trials for weight loss drug
– Company’s experimental injection VK2735 shows promising results, potentially rivaling industry giants
– Decision to skip additional mid-stage trial could accelerate drug’s market entry by a year
– Viking also developing a convenient monthly injection and oral version of the drug

In a stunning turn of events, the relatively unknown biotech company Viking Therapeutics has suddenly become the talk of Wall Street. The San Diego-based firm saw its stock price soar by over 20% on Thursday, following a game-changing announcement that has investors and health enthusiasts alike sitting up and taking notice.

The catalyst for this dramatic surge? Viking Therapeutics revealed its plans to fast-track its experimental weight loss injection, VK2735, directly into late-stage trials. This bold move, which comes earlier than expected, has positioned the company as a potential dark horse in the fiercely competitive GLP-1 market, currently dominated by pharmaceutical giants Novo Nordisk and Eli Lilly.

The GLP-1 market, projected to balloon to a staggering $150 billion by the end of the decade, has been a battlefield for drug companies seeking to capitalize on the growing demand for effective weight loss solutions. Viking’s unexpected leap forward has not only caught the attention of investors but also sent ripples through the industry, with shares of both Novo Nordisk and Eli Lilly dipping more than 1% in response.

What makes Viking’s VK2735 so promising? In a phase two trial, patients receiving weekly doses of the injection lost up to 14.7% of their body weight over just 13 weeks – an impressive figure that puts it in the same league as its more established competitors. But Viking isn’t stopping there. The company is also developing a monthly injection version of VK2735, which could offer a more convenient option for patients compared to the weekly regimens of current market leaders.

Adding another layer of intrigue, Viking is simultaneously working on an oral version of VK2735. In early-stage trials, this pill form demonstrated a 3.3% weight loss compared to placebo, opening up the possibility of a non-injectable alternative in the future.

The decision to skip an additional mid-stage trial and move directly to phase three could shave off a significant amount of time from Viking’s development timeline. Analysts now estimate that this strategic move could accelerate the drug’s market entry by as much as a year, potentially launching in 2028 instead of the previously projected 2029.

Viking’s CEO, Brian Lian, expressed confidence in the company’s direction during a recent earnings call, citing positive feedback from the Food and Drug Administration as a key factor in their decision to expedite the development process. The company is now preparing for a crucial meeting with the FDA in the fourth quarter to discuss the design and timing of the phase three trial.

As Viking Therapeutics gears up for this next critical phase, the biotech world watches with bated breath. Could this underdog company be on the verge of disrupting the weight loss drug market? With its promising results and aggressive development strategy, Viking is certainly positioning itself as a formidable contender in the race to capture a slice of the lucrative GLP-1 pie.

For investors and health-conscious individuals alike, the message is clear: keep a close eye on Viking Therapeutics. This small biotech firm might just be holding the key to the next big breakthrough in weight loss treatment.

Release – Beyond “One Bug, One Drug” – Tonix Pharmaceuticals Secures Up To $34 Million In Funding From The U.S. Department Of Defense To Develop a Broad-Spectrum Antiviral

Posted on by aweinsoff@channelchek.com

Research News and Market Data on TNXP

July 24, 2024 7:45am EDT

CHATHAM, NJ / ACCESSWIRE / July 24, 2024 / From anthrax to the plague, biological warfare is a real threat to U.S. forces and civilians, so much so the Pentagon budgeted about $2 billion for the country’s biological defense for the coming fiscal year. It’s also why the U.S. Department of Defense is seeking broad-spectrum antiviral drugs and teaming up with the biotech companies developing them.

That’s the case with Tonix Pharmaceuticals Holding Corp. (NASDAQ:TNXP), a fully integrated biopharmaceutical company. The DoD’s Defense Threat Reduction Agency (DTRA) recently inked a five-year deal with Tonix Pharmaceuticals to develop small molecule broad-spectrum antiviral agents for the prevention or treatment of infections to improve the medical readiness of military personnel in biological threat environments. Through the Other Transaction Agreement (OTA) contracting vehicle, Tonix could get as much as $34 million in funding over five years.

“Through our agreement with DTRA, our broad-spectrum antiviral research program will address the DoD’s goal of protecting U.S. forces in the event biological weapons are introduced onto the battlefield,” said Seth Lederman, M.D., President and Chief Executive Officer of Tonix. “This funding provides important validation for our ongoing research and current in-house capabilities and will enable Tonix to advance its antiviral discovery program.”

Stop Viruses In Their Tracks

Antiviral drugs are designed to stop a virus in its tracks by either attacking it or preventing it from spreading. In the case of Tonix’s program, the goal is to fortify the immune system so that it can protect against a range of viruses. Demand for antiviral drugs is rising along with the concerns about viruses on the battlefield. Viruses are changing, jumping back and forth between humans and animals and there’s the new risk that synthetic biology can be used maliciously, to make new viruses or to make existing viruses more virulent in what’s called “gain of function”. On the battlefield, the DoD is looking for antiviral drugs that can protect soldiers regardless of the agent. It is pouring money into different initiatives designed to react in the event of a biological attack.

Take DTRA’s Chemical and Biological Technologies Department which is sponsoring Tonix’s research. The department, which is funded out of DTRA’s approximately $1.9 billion budget for fiscal 2024, invests in medical countermeasure projects to fulfill its mission to anticipate future threats and equip the warfighter to survive, fight and win in chemical and biological contested environments.

Across the U.S. government, chemical and biological countermeasures programs have approximately $1.26 billion budgeted for fiscal 2024 and includes programs to reduce the risks to both U.S. troops and the global community from bacteria or viruses. The need to slow the spread of viruses and protect troops from biowarfare is just part of an over-all antiviral market estimated to reach $74.75 billion by 2028, growing at a CAGR of 6.19%.

Attacking The CD45 Protein

Tonix Pharmaceuticals’ program will focus on optimizing and developing TNX-4200, the company’s oral CD45 antagonist program, which is designed to have broad-spectrum efficacy against a range of viral pathogens. This broad-spectrum capability is a move beyond the previous “one bug, one drug” approach and seeks to target a broad range of deadly agents through just a single drug. Reduction of CD45 activity, a protein tyrosine phosphatase, protects animals against many viruses, including the Ebola virus. Through this funding, Tonix expects to establish the treatment’s biological activity and safety in animals and then submit an Investigational New Drug application (IND) to conduct a first-in-human phase 1 clinical study.

Tonix said it plans to leverage previous research on phosphatase inhibitors – specifically compounds that target CD45 – to optimize compounds for therapeutic intervention of biothreat agents and provide the government with a broad-spectrum medical countermeasure. The idea behind Tonix’s compound is that partial inhibition of CD45 will provide optimal antiviral protection with an acceptable safety profile. The $34 million, five-year contract will help bankroll and accelerate the development of Tonix’s host-directed antivirals which have the potential to reduce viral load and allow the adaptive immune system to alert the other arms of the immune system to mount a protective response, reports the company.

Leveraging R&D Capabilities

To develop its program, Tonix plans to rely on what it says are state-of-the-art research laboratory capabilities, including a Biosafety Level 3 (BSL-3) lab and an Animal Biosafety Level 3 (ABSL-3) facility at its research and development center in Frederick, Maryland. The research center is located in Maryland’s I-270 biotech corridor and is close to the center of the U.S. biodefense research community. The research facilities will help to accelerate the development of vaccines and antiviral drugs against infectious diseases.

The threat of viruses, pandemics and biochemical attacks is increasing, driving demand for antivirals that can stop pathogens in their tracks. Tonix is betting it can deliver a single remedy to cover several viruses – and has up to $34 million to prove it.

Featured photo by api.army.mil.

Click here for more information on Tonix Pharmaceuticals: https://redingtonvirtual.com/tnxp-aw-24072/

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

Important notice, please read: Certain statements in this document 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, 2023, as filed with the Securities and Exchange Commission (the “SEC”) on April 1, 2024, and periodic reports filed with the SEC on or after the date thereof. All 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. This is not a solicitation of any offer to buy or sell. Redington, Inc. is paid by Tonix Pharmaceuticals Holding Corp. for investor relations services, and its employees or members of their families may from time to time own an equity interest in companies mentioned herein.

SOURCE: Tonix Pharmaceuticals Holding Corp.

View the original press release on accesswire.com

Released July 24, 2024

Release – MAIA Biotechnology Announces New Updates From Phase 2 Trial Of Novel Cancer Treatment Agent

Posted on by aweinsoff@channelchek.com

Research News and Market Data on MAIA

July 23, 2024 4:11am EDT

  • THIO followed by cemiplimab shown to be well tolerated throughout trial, with far lower toxicity compared to standard of care treatments
  • 6 patients on trial regimen for more than 12 months have completed up to 21 cycles, with treatment ongoing

CHICAGO–(BUSINESS WIRE)– MAIA Biotechnology, Inc., (NYSE American: MAIA) (“MAIA”, the “Company”), a clinical-stage biopharmaceutical company developing targeted immunotherapies for cancer, today announces positive treatment updates from its Phase 2 clinical trial, THIO-101, evaluating THIO sequenced with the immune checkpoint inhibitor (CPI) cemiplimab (Libtayo®) in patients with advanced non-small cell lung cancer (NSCLC) who failed two or more standard-of-care therapy regimens.

The trial’s therapeutic regimen is cycled every 3 weeks, with THIO 180mg administered in 60mg incremental doses on days 1, 2 and 3, followed by immune activation on day 4 (no dosing), and cemiplimab 350mg administered on day 5. As of the latest clinical cutoff date, June 12, 2024:

  • 6 patients remain on treatment following at least 12 months of therapy.
  • Treatment with THIO followed by cemiplimab has been well tolerated throughout the trial, with much lower toxicity compared to standard-of care treatments.
  • Continuing treatment past 12 months demonstrates safety, efficacy and ongoing benefit from MAIA’s novel telomere targeting NSCLC therapy.

“Our longest treated patient so far has completed 21 cycles of THIO sequenced with a CPI, and 6 patients who have crossed the 12-month survival follow-up are continuing the treatment,” said Vlad Vitoc, M.D., Chairman and Chief Executive Officer of MAIA. “With current therapies, second-line patients’ treatment duration is usually around 3-4 months1 and third-line is even lower than that. It is very encouraging to see that our patients can remain on treatment for much longer. The ongoing benefits of THIO in longer-term patients are particularly notable, signifying THIO’s potential as a durable and efficacious treatment for advanced NSCLC patients faced with limited options.”

  1. https://www.sciencedirect.com/science/article/pii/S0169500217304373

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 THIO-101, a Phase 2 Clinical Trial

THIO-101 is a multicenter, open-label, dose finding Phase 2 clinical trial. It is the first trial designed to evaluate THIO’s anti-tumor activity when followed by PD-(L)1 inhibition. The trial is testing the hypothesis that low doses of THIO administered prior to cemiplimab (Libtayo®) will enhance and prolong immune response in patients with advanced NSCLC who previously did not respond or developed resistance and progressed after first-line treatment regimen containing another checkpoint inhibitor. The trial design has two primary objectives: (1) to evaluate the safety and tolerability of THIO administered as an anticancer compound and a priming immune activator (2) to assess the clinical efficacy of THIO using Overall Response Rate (ORR) as the primary clinical endpoint. Treatment with cemiplimab (Libtayo®) followed by THIO has been generally well-tolerated to date in a heavily pre-treated population. For more information on this Phase II trial, please visit ClinicalTrials.gov using the identifier NCT05208944.

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.

Investor Relations Contact
+1 (872) 270-3518
ir@maiabiotech.com

Source: MAIA Biotechnology, Inc.

Released July 23, 2024