Category: Health

Lundbeck to Acquire Longboard Pharmaceuticals in Strategic Deal to Boost Neuroscience Pipeline

Posted on by slightbourne@noblecapitalmarkets.com
Key Points:
– Lundbeck acquires Longboard Pharmaceuticals for $2.6 billion to strengthen its neuro-rare disease portfolio.
– Lead asset, bexicaserin, in late-stage trials, holds potential as a breakthrough treatment for epilepsy-related conditions.
– The acquisition aligns with Lundbeck’s strategy of expanding in rare neurological disorders and advancing its development pipeline.

H. Lundbeck A/S (Lundbeck), a global leader in brain health, has announced a landmark deal to acquire Longboard Pharmaceuticals, Inc., a clinical-stage biopharmaceutical company specializing in transformative treatments for neurological disorders. This $2.6 billion acquisition marks a pivotal moment for Lundbeck, reinforcing its commitment to building a strong portfolio in rare and complex neurological diseases.

The strategic deal will enable Lundbeck to further expand its reach in neuro-rare conditions, a field with high unmet medical needs. Longboard’s lead asset, bexicaserin, is being developed to treat Developmental and Epileptic Encephalopathies (DEEs), including Dravet syndrome, Lennox-Gastaut syndrome, and other severe epilepsy disorders. With this acquisition, Lundbeck gains access to a potential blockbuster drug that has shown encouraging results in both preclinical and clinical trials.

Bexicaserin is a next-generation superagonist specifically targeting 5-HT2C receptors. This innovative approach differentiates the drug from existing treatments for epilepsy, positioning it as a potential best-in-class therapy for patients suffering from these debilitating conditions. The drug is currently being evaluated in a global phase III trial under the DEEp SEA Study, involving approximately 480 patients with DEEs. If successful, bexicaserin could be a cornerstone in Lundbeck’s portfolio, with an estimated global peak sales potential of between $1.5 and $2 billion following its anticipated launch in 2028.

The acquisition aligns with Lundbeck’s Focused Innovator strategy, which seeks to invest in high-potential, cutting-edge treatments that address the most pressing needs in brain health. The transaction will not only enhance Lundbeck’s ability to provide innovative solutions for patients with neuro-rare disorders, but it will also bolster the company’s capabilities in treating complex neurological conditions.

Lundbeck’s CEO, Charl van Zyl, has emphasized that this acquisition represents a significant step in advancing the company’s mission of improving the lives of patients with severe brain disorders. “Bexicaserin addresses a critical unmet need for patients suffering from rare and severe epilepsies, for which there are very few treatment options. This acquisition will become a cornerstone in Lundbeck’s neuro-rare franchise and drive growth into the next decade,” van Zyl noted.

Longboard’s expertise and its leading asset, bexicaserin, will complement Lundbeck’s existing neuroscience portfolio, creating new opportunities for research and development in rare neurological disorders. This acquisition also adds valuable intellectual property and a broader reach into under-served markets, providing the potential for substantial growth in revenue and market share.

In terms of financial impact, the acquisition is expected to be funded through existing cash resources and bank financing, with integration costs projected at around $80 million in 2024. Lundbeck aims to leverage its financial strength to ensure that the acquisition delivers long-term value for shareholders.

With bexicaserin having already received Breakthrough Therapy Designation (BTD) from the U.S. FDA, the future looks promising for this cutting-edge treatment. Lundbeck’s integration of Longboard Pharmaceuticals and its innovative technologies is poised to reshape the landscape for rare epilepsy treatment and boost the company’s leadership in neurological disorders.

Take a moment to take a look at more emerging growth biotechnology companies by taking a look at Noble Capital Markets’ Research Analyst Robert LeBoyer’s coverage list.

Tonix Pharmaceuticals (TNXP) – A New Era For Tonix Begins With The Tonmya NDA Filing

Posted on by cpereira@noblefcm.com


Friday, October 11, 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.

We Expect The NDA Filing For Tonmya Approval To Be Submitted Shortly. We anticipate the NDA submission for Tonmya to be announced around the end of October 2024. This would start the FDA review process, which we expect to lead to marketing approval in mid-2025. In July, Tonmya received Fast Track Review, a designation that gives advantages in the regulatory pathway. With a pending NDA submission for a drug that could be used by millions of patients, we believe the company’s progress has not been reflected in the stock price.

Fast Track Review Is A Significant Distinction. The Fast Track Review designation from the FDA is awarded to drugs that can make significant impact on serious medical conditions. The designation provides important benefits including increased communications with the FDA, as well as eligibility for Accelerated Approval and Priority Review. We expect the application for Accelerated Approval to be filed shortly after the NDA is completed. This could shorten the FDA’s review period by up to 4 months.


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Release – Brendan Shanahan Appointed Chief Financial Officer of GoHealth, Bringing Decades of Leadership in Healthcare and Financial Strategy

Posted on by aweinsoff@channelchek.com

Research News and Market Data on GOCO

Oct 10, 2024 at 10:45 AM EDT

Brendan Shanahan Appointed Chief Financial Officer of GoHealth, Bringing Decades of Leadership in Healthcare and Financial Strategy

CHICAGO, October 10, 2024 /Globe Newswire/ — GoHealth, Inc. (NASDAQ: GOCO), a leading health insurance marketplace and Medicare-focused digital health company, today announced the appointment of Brendan Shanahan as Chief Financial Officer (CFO), effective October 14, following a comprehensive search process. Mr. Shanahan, a seasoned executive with over 30 years of financial leadership experience and over 20 years of expertise in the Medicare Advantage space, will oversee GoHealth’s financial strategy and operations, contributing to the company’s profitable growth and innovation efforts.

“Brendan’s extensive expertise in financial strategy, M&A, operational leadership, and deep knowledge of the Medicare Advantage market makes him the ideal choice to lead GoHealth’s financial organization,” said Vijay Kotte, CEO of GoHealth. “His track record of driving financial performance, operational efficiency, and long-term value aligns perfectly with our mission to deliver outstanding results for shareholders.”

Mr Shanahan, who was also a licensed insurance agent, will manage all financial aspects of GoHealth, including financial planning, analysis, reporting, investor relations, and capital structure optimization. Additionally, he will provide leadership in financial risk management, business analytics, budgeting, audit, and tax compliance, to ensure GoHealth achieves both its short- and long-term financial goals.

Throughout his career, Mr. Shanahan has built high-performing finance teams, implemented systems to streamline financial operations, and played key roles in mergers and acquisitions. His leadership in financial strategy, including P&L oversight, cost containment, and capital management, has consistently delivered tangible results.

Mr. Shanahan holds an MBA in Banking and Finance from Hofstra University and a Bachelor of Science in Business Administration from The Citadel. He is also a Certified Public Accountant (CPA) (inactive) and a Chartered Global Management Accountant.

Mr. Shanahan expressed his excitement to join GoHealth, stating, “I’m thrilled to join GoHealth at such a pivotal time for the Medicare Advantage industry and the brokerage space. Having spent much of my career working to help individuals navigate their healthcare options, I am excited to continue that journey with GoHealth. The combination of GoHealth’s technology, deep expertise in Medicare, and commitment to empowering consumers is unparalleled. I look forward to working with Vijay and the team to capitalize on the significant opportunities ahead as we navigate this dynamic market and drive long-term value for shareholders.”

Katherine O’Halloran will remain as a key leader in the finance organization, continuing to serve as Chief Accounting Officer and reporting to the CFO. “We want to thank Katie for embracing with diligence her interim role as CFO and her commitment to managing GoHealth and the financial team through this transition. Katie is an extraordinary example of living our GoHealth values,” said Kotte.

About GoHealth, Inc.

GoHealth is a leading health insurance marketplace and Medicare-focused digital health company. Enrolling in a health insurance plan can be confusing for customers, and the seemingly small differences between plans can lead to significant out-of-pocket costs or lack of access to critical medicines and even providers. GoHealth combines cutting-edge technology, data science and deep industry expertise to build trusted relationships with consumers and match them with the healthcare policy and carrier that is right for them. Since its inception, GoHealth has enrolled millions of people in Medicare plans and individual and family plans. For more information, visit https://www.gohealth.com.

Media Inquiries 
pressinquiries@gohealth.com 
Investor Relations 
jshave@gohealth.com 
Forward-Looking Statements

This press release contains forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, (the “Securities Act”) and Section 21E of the Securities Exchange Act of 1934, as amended (the “Exchange Act”). These forward-looking statements are made in reliance upon the safe harbor provision of the Private Securities Litigation Reform Act of 1995. All statements other than statements of historical facts contained in this press release may be forward-looking statements. Statements regarding our future results of operations and financial position, business strategy and plans and objectives of management for future operations, including, among others, statements regarding our expected growth, future capital expenditures, debt service obligations and adoption and use of artificial intelligence technologies are forward-looking statements.

In some cases, you can identify forward-looking statements by terms such as “may,” “will,” “should,” “aims,” “expects,” “plans,” “anticipates,” “could,” “intends,” “targets,” “projects,” “contemplates,” “believes,” “estimates,” “predicts,” “potential,” “likely,” “future” or “continue” or the negative of these terms or other similar expressions. The forward-looking statements in this press release are only predictions, projections and other statements about future events that are based on current expectations and assumptions. Accordingly, we caution you that any such forward-looking statements are not guarantees of future performance and are subject to risks, assumptions and uncertainties that are difficult to predict. Although we believe that the expectations reflected in these forward-looking statements are reasonable as of the date made, actual results may prove to be materially different from the results expressed or implied by the forward-looking statements.

These forward-looking statements speak only as of the date of this press release and are subject to a number of important factors that could cause actual results to differ materially from those in the forward-looking statements, including the factors described in the sections titled “Summary Risk Factors,” “Risk Factors” and “Management’s Discussion and Analysis of Financial Condition and Results of Operations” in our Annual Report on Form 10-K for the fiscal year ended December 31, 2023 (“2023 Annual Report on Form 10-K”) and in our other filings with the Securities and Exchange Commission. The factors described in our 2023 Annual Report on Form 10-K should not be construed as exhaustive and should be read together with the other cautionary statements included in this press release, as well as the cautionary statements and other risk factors set forth in the Quarterly Report on Form 10-Q for the first fiscal quarter ended March 31, 2024, the forthcoming Quarterly Report on Form 10-Q for the second quarter ended June 30, 2024 and in our other filings with the Securities and Exchange Commission.

You should read this press release and the documents that we reference in this press release completely and with the understanding that our actual future results may be materially different from what we expect. We qualify all of our forward-looking statements by these cautionary statements. Except as required by applicable law, we do not plan to publicly update or revise any forward-looking statements contained herein, whether as a result of any new information, future events, changed circumstances or otherwise

Unicycive Therapeutics (UNCY) – Results From Phase 1 Trial Testing UNI-494 In Acute Kidney Injury Announced

Posted on by cpereira@noblefcm.com


Thursday, October 10, 2024

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.

Phase 1 Trial Tested Safety, Tolerability, and Pharmacokinetics At Multiple Doses. Unicycive announced completion of the Phase 1 trial testing UNI-494, its product in development for protecting against acute kidney injury. The study was designed to determine tolerability, safety, and pharmacokinetic data for the design of Phase 2. Unicycive plans to present the study at an upcoming scientific meeting.

UNI-494 Is In Development For Preventing Acute Kidney Injury. UNI-494 is a proprietary formulation of nicorandil to protect against the mitochondrial dysfunction and prevent pathways that lead to cell death in acute kidney injury. The proprietary formulation increases the half-life and makes it practical for administration, while maintaining its properties as a nicotinamide ester derivative and selective activator of the ATP-sensitive mitochondrial potassium channel.


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

Release – Unicycive Therapeutics Successfully Completes UNI-494 Phase 1 Study in Healthy Volunteers

Posted on by aweinsoff@channelchek.com

Research News and Market Data

October 09, 2024 7:03am EDT

UNI-494 was Well-Tolerated as a Single Dose up to 160 mg and in Multiple Doses at 40 mg Twice-a-Day

LOS ALTOS, Calif., Oct. 09, 2024 (GLOBE NEWSWIRE) — Unicycive Therapeutics, Inc. (Nasdaq: UNCY), a clinical-stage biotechnology company developing therapies for patients with kidney disease (the “Company” or “Unicycive”), today announced the successful completion of the UNI-494 Phase 1 study in healthy volunteers.

“We are pleased to announce the successful completion of the UNI-494 Phase 1 study that informs our next steps for advancement to a potential Phase 2 clinical trial in patients with acute kidney injury,” said Shalabh Gupta, MD, Chief Executive Officer of Unicycive. “This is an important milestone for the clinical development of UNI-494 as it provides the necessary dosing and tolerability data to progress the program. We plan to request a meeting with the U.S. Food and Drug Administration (FDA) before the end of the year to review these Phase 1 results and a potential Phase 2 study design. We would like to extend our gratitude to the trial investigator and participants who committed their time and effort to the study.”

Trial Design: The Phase 1 study was a single center, double-blind, placebo-controlled, randomized single ascending dose (Part 1) and multiple ascending dose (Part 2) study in healthy volunteers conducted in the United Kingdom. Dosing in both arms was completed in a stepwise fashion. The objective of the study was to assess the safety, tolerability and pharmacokinetics of UNI-494.

Single Ascending Dose: Part 1 of the study enrolled 40 participants in 5 cohorts with 30 participants dosed with UNI-494 and 10 participants dosed with placebo. UNI-494 was well-tolerated in healthy participants as a single dose ranging from 10 mg to 160 mg. There were no serious adverse events (SAEs) or adverse events (AEs) leading to withdrawal. Headache was the most common adverse event reported. Most of the adverse events were mild, and all participants dosed with UNI-494 completed the study.

Multiple Ascending Dose: Part 2 of the study enrolled 19 participants in two cohorts with 15 participants dosed with UNI-494 and 4 dosed with placebo. In Cohort One (n=9), participants were dosed with 40 mg two times a day (BID) for 5 days with UNI-494 or matching placebo. In Cohort Two (n=10), participants were dosed with 80 mg BID for 5 days. There were no serious adverse events (SAEs) in Part 2 of the study, and UNI-494 was safe and well-tolerated at the 40 mg BID dose for 5 days. Most common adverse events reported included headache, nausea, and vomiting. In Cohort One, the majority of the adverse events reported were mild and all but one participant completed the study. In Cohort Two, UNI-494 was not well-tolerated with 4 participants withdrawing from the study due to adverse events.

Pharmacokinetics of UNI-494 were also evaluated in the study. The absorption of UNI-494 was fast, and UNI-494 was rapidly metabolized to release nicorandil and the linker as expected. Plasma concentration of nicorandil increased in a slightly greater than proportional manner as the dose increased.

Collectively, these results will help determine the dose and schedule of UNI-494 for a potential Phase 2 clinical trial in patients with acute kidney injury.

Unicycive intends to present additional details of the study at an upcoming scientific conference.

About UNI-494

UNI-494 is a novel nicotinamide ester derivative and a selective ATP-sensitive mitochondrial potassium channel activator. Mitochondrial dysfunction plays a critical role in the progression of acute kidney injury and chronic kidney disease. UNI-494 has a novel mechanism of action that restores mitochondrial function and may be beneficial for the treatment of several diseases including kidney disease. UNI-494 is protected by issued patent(s) in the U.S. and Europe and a wide range of patent applications worldwide. UNI-494 has been granted orphan drug designation (ODD) by the U.S. Food and Drug Administration (FDA) for the prevention of Delayed Graft Function (DGF) in kidney transplant patients. UNI-494 has completed a Phase 1 dose-ranging safety study in healthy volunteers.

About Acute Kidney Injury

Acute kidney injury (AKI) is defined as a sudden loss of kidney function that is determined based on increased serum creatinine levels and decreased urine output and is limited to a duration of 7 days. The primary causes of AKI include sepsis, ischemia, hypoxia, and drug-induced nephrotoxicity. Delayed Graft Function is a type of acute kidney injury that occurs in the first week after kidney transplantation. AKI is estimated to occur in 20-200 per million population in the community, 7-18% of patients in the hospital and approximately 50% of patients admitted to the intensive care unit. Importantly AKI is associated with morbidity and mortality; an estimated 2 million people die of AKI worldwide every year whereas survivors of AKI are at increased risk of chronic kidney disease, end stage renal disease.

About Unicycive Therapeutics

Unicycive Therapeutics is a biotechnology company developing novel treatments for kidney diseases. Unicycive’s lead drug candidate, oxylanthanum carbonate (OLC), is a novel investigational phosphate binding agent being developed for the treatment of hyperphosphatemia in chronic kidney disease patients on dialysis. UNI-494 is a patent-protected new chemical entity in clinical development for the treatment of conditions related to acute kidney injury. For more information, please visit Unicycive.com and follow us on LinkedIn, X, and YouTube.

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 using words such as “anticipate,” “believe,” “forecast,” “estimated” and “intend” or other similar terms or expressions that concern Unicycive’s expectations, strategy, plans or intentions. These forward-looking statements are based on Unicycive’s current expectations and actual results could differ materially. There are several 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, clinical trials involve a lengthy and expensive process with an uncertain outcome, and results of earlier studies and trials may not be predictive of future trial results; our clinical trials may be suspended or discontinued due to unexpected side effects or other safety risks that could preclude approval of our product candidates; risks related to business interruptions, which could seriously harm our financial condition and increase our costs and expenses; dependence on key personnel; substantial competition; uncertainties of patent protection and litigation; dependence upon third parties; and risks related to failure to obtain FDA clearances or approvals and noncompliance with FDA regulations. Actual results may differ materially from those indicated by such forward-looking statements as a result of various important factors, including: the uncertainties related to market conditions and other factors described more fully in the section entitled ‘Risk Factors’ in Unicycive’s Annual Report on Form 10-K for the year ended December 31, 2023, and other periodic reports filed with the Securities and Exchange Commission. Any forward-looking statements contained in this press release speak only as of the date hereof, and Unicycive specifically disclaims any obligation to update any forward-looking statement, whether as a result of new information, future events or otherwise.

Investor Contact:

ir@unicycive.com
(650) 543-5470

SOURCE: Unicycive Therapeutics, Inc.

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Source: Unicycive Therapeutics, Inc.

Released October 9, 2024

Release – Ocugen, Inc. Announces Removal of Clinical Hold on Investigational New Drug Application for OCU200 Phase 1 Clinical Trial

Posted on by aweinsoff@channelchek.com

Research News and Market Data on OCGN

October 9, 2024

PDF Version

MALVERN, Pa., Oct. 09, 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, biologics, and vaccines, today announced that the U.S. Food and Drug Administration (FDA) has lifted the clinical hold on the investigational new drug application for the Phase 1 clinical trial evaluating OCU200, a recombinant fusion protein consisting of tumstatin and transferrin, for treating diabetic macular edema (DME).

“We are excited to launch the Phase 1 clinical trial for OCU200, which is designed to treat patients with DME,” said Dr. Arun Upadhyay, Chief Scientific Officer and Head of Research & Development at Ocugen. “Approximately 30 to 40% of DME patients are refractive to current anti-VEGF therapies. OCU200 targets the underlying disease mechanisms through the integrin pathway and holds promise to provide benefits to all DME patients, including non-responders to currently approved therapy.”

OCU200 possesses unique features that potentially enable it to treat vascular complications of DME. Tumstatin is the active component of OCU200 and binds to integrin receptors, which play a crucial role in disease pathogenesis. Transferrin is expected to facilitate the targeted delivery of tumstatin into the retina and choroid and potentially help increase the interaction between tumstatin and integrin receptors.

“I look forward to bringing OCU200 into the clinic and advancing this important candidate in Ocugen’s portfolio for treating blindness diseases,” said Dr. Huma Qamar, Chief Medical Officer at Ocugen. “DME is becoming more prevalent as the number of people with diabetes in the U.S. rises, making the condition even more imperative to address.”

This is a multicenter, open-label, dose-ranging study with 3 cohorts in the dose-escalation portion assessing safety of OCU200 and in the fourth cohort a combination of OCU200 (MTD) with anti-VEGF following sequential intravitreal administration.

DME is one of the most common vision-threatening diseases occurring in people with diabetes and includes blurriness in vision and progressive vision loss as the disease progresses. Approximately 746,000 people in the United States are affected with DME.

The Company intends to pursue additional indications for OCU200 to potentially treat diabetic retinopathy and wet age-related macular degeneration, which combined affect nearly nine million Americans.

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

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, strategy, business plans and objectives for Ocugen’s clinical programs, plans and timelines for the preclinical and clinical development of Ocugen’s product candidates, including the therapeutic potential, clinical benefits and safety thereof, expectations regarding timing, success and data announcements of current ongoing preclinical and clinical trials, the ability to initiate new clinical programs; 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 annual and 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

Traws Pharma (TRAW) – Phase 1 Study In Influenza Shows Positive Data With Plans To Move To Phase 2

Posted on by cpereira@noblefcm.com


Wednesday, October 09, 2024

Onconova Therapeutics is a clinical-stage biopharmaceutical company focused on discovering and developing novel products for patients with cancer. The Company has proprietary targeted anti-cancer agents designed to disrupt specific cellular pathways that are important for cancer cell proliferation. Onconova’s novel, proprietary multi-kinase inhibitor narazaciclib (formerly ON 123300) is being evaluated in a combination trial with estrogen blockade in advanced endometrial cancer. Based on preclinical and clinical studies of CDK 4/6 inhibitors, Onconova is also evaluating opportunities for combination studies with narazaciclib in additional indications. Onconova’s product candidate rigosertib is being studied in multiple investigator-sponsored studies. These studies include a dose-escalation and expansion Phase 1/2a study of oral rigosertib in combination with nivolumab in patients with KRAS+ non-small cell lung cancer, a Phase 2 program evaluating rigosertib monotherapy in advanced squamous cell carcinoma complicating recessive dystrophic epidermolysis bullosa (RDEB-associated SCC), and a Phase 2 trial evaluating rigosertib in combination with pembrolizumab in patients with metastatic melanoma.

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.

Positive Results Announced From Tivoxavir Marboxil Study. Positive data was announced from the Phase 1 clinical trial testing safety and pharmacokinetics of Tivoxavir Marboxil, Traw’s drug in development for seasonal and pandemic influenza. The study showed tolerability and bloodstream levels within the expected range, supporting use as a one-time treatment for flu. The dose for Phase 2 has been selected with the trial planned to begin in 1H2025.

Tivoxavir Inhibitor A Protease Needed For Viral Replication. Tivoxavir acts through inhibition of CAP-dependent endonucleases (CEN), a highly conserved influenza protein needed for the synthesis of its viral mRNA. Tivoxavir was designed for use across a broad range of flu viruses including the H5N1 bird flu virus. Preclinical studies have shown potent inhibition of drug-resistant influenza viruses.


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

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

Release – Tonix Pharmaceuticals Announces AI Collaboration with X-Chem to Develop Broad-Spectrum Antivirals

Posted on by aweinsoff@channelchek.com

Research News and Market Data on TNXP

October 08, 2024 8:30am EDT

AI (Artificial Intelligence) and ML (Machine Learning) drug discovery collaboration will accelerate the development of small molecules as orally available host-targeted broad-spectrum medical countermeasures

Host-directed antiviral drugs have the potential to enhance the immune response to viruses from a range of viral families

Tonix was awarded a contract with the U.S. Department of Defense for up to $34 million for the accelerated development of its host-directed broad-spectrum antiviral program TNX-4200

CHATHAM, N.J., Oct. 08, 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 it has entered into an AI and ML research collaboration with X-Chem, Inc. (X-Chem), a leader in small molecule drug discovery, to accelerate development of Tonix’s oral broad-spectrum antivirals.

Tonix’s TNX-4200 antiviral program focuses on the development of oral CD45 phosphatase inhibitors, with broad-spectrum activity against a range of viral families. As previously disclosed, Tonix entered into a contract with the U.S. Department of Defense’s Defense Threat Reduction Agency (DTRA) for up to $34 million to advance the development of Tonix’s TNX-4200 broad-spectrum oral antiviral program for medical countermeasures, including an Investigational New Drug (IND) submission and a first-in-human Phase 1 clinical study.

“We are excited to enter into this research collaboration with X-Chem, which we believe will expand our capabilities, and deepen our understanding of host-targeted small molecule therapeutics for a variety of targets,” said Seth Lederman, M.D., Chief Executive Officer of Tonix Pharmaceuticals. “With the support of X-Chem’s drug discovery AI/ML technology, we expect to optimize the physicochemical properties, pharmacokinetics, and safety attributes of our drug candidates.”

“We are excited to partner with Tonix in their pursuit of such important programs in human health, at the intersection of laboratory and in silico technology. This collaboration highlights how integrative work continues to leverage the creation of target-specific high-quality data to drive AI drug discovery,” said Erin Davis, Ph.D., Chief Technology Officer of X-Chem.”

The DTRA contract awarded to Tonix is expected to help fund and accelerate the development of the Company’s lead oral host-directed TNX-4200 broad-spectrum antiviral program. The TNX-4200 program aims to reduce viral load and to allow the adaptive immune system to alert the other arms of the immune system to mount a protective response. Tonix plans to leverage previous research on phosphatase inhibitors to optimize lead compounds for therapeutic intervention of biothreat agents.

For the oral broad-spectrum antiviral programs, including TNX-4200, Tonix is utilizing its 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 (RDC) located in Frederick, Md., as well as experienced personnel in-house. The RDC is located in Maryland’s ‘I-270 biotech corridor’ and is close to the center of the U.S. biodefense research community.

About X-Chem, Inc.

X-Chem, Inc. is a leader in small molecule drug discovery services for pharmaceutical and biotech companies. As pioneers of DNA-encoded chemical library (DEL) technology and its integration with proprietary AI technology and computational sciences, X-Chem can accelerate all steps in the discovery process. The company leverages its unique AI/ML approach, market-leading DEL platform, and computationally-driven medicinal chemistry expertise to discover novel small molecule leads against challenging, high-value therapeutic targets. Integrated with X-Chem’s extensive chemistry and computational technologies, project teams can deliver clinical candidates with unmatched speed. X-Chem also provides libraries, reagents, and informatic tools to allow DEL operators to get the most of their DEL platform. X-Chem empowers its partners to effectively build drug pipelines from target to clinical candidate, enhanced with AI and extensive data packages.

Further information about X-Chem can be found at www.x-chemrx.com.

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 priority is to submit a New Drug Application (NDA) to the FDA in October of 2024 for TNX-102 SL, a product candidate for which two statistically significant Phase 3 studies have been completed for the management of fibromyalgia. TNX-102 SL was generally well tolerated in the Phase 3 program. The FDA has granted Fast Track designation to TNX-102 SL for the management of fibromyalgia. TNX-102 SL is also being developed to treat acute stress reaction. Tonix recently announced the U.S. Department of Defense (DoD), Defense Threat Reduction Agency (DTRA) awarded it a contract for up to $34 million over five years to develop TNX-4200 small molecule broad-spectrum antiviral agents targeting CD45 for the prevention or treatment of infections to improve the medical readiness of military personnel in biological threat environments. Tonix owns and operates a state-of-the art infectious disease research facility in Frederick, MD. The company’s Good Manufacturing Practice (GMP)-capable advanced manufacturing facility in Dartmouth, MA was purpose-built to manufacture TNX-801 and the GMP suites are ready to be reactivated in case of a national or international emergency. Tonix’s development portfolio is focused on central nervous system (CNS) disorders. Tonix’s CNS portfolio includes TNX-1300 (cocaine esterase), a biologic in Phase 2 development 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.

* Tonix’s product development candidates are investigational new drugs or biologics; their efficacy and safety have not been established 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

Ray Jordan
Putnam Insights
ray@putnaminsights.com
(949) 245-5432

Primary Logo

Source: Tonix Pharmaceuticals Holding Corp.

Released October 8, 2024

Release – Traws Pharma Announces Positive Topline Phase 1 Data for Flu Candidate, Tivoxavir Marboxil

Posted on by aweinsoff@channelchek.com

Research News and Market Data on TRAW

Oct 08, 2024

PDF Version

Investigational agent in development as a one dose treatment or prevention of seasonal and pandemic influenza

A dose ranging, Phase 1 study in healthy volunteers demonstrated positive tolerability results and plasma levels in the predicted therapeutic window, enabling selection of Phase 2 dose

Preclinical data showed potent inhibition of drug-resistant and bird influenza viruses

Phase 2 study expected to begin in H1 2025

Improved therapy is an important need for both seasonal and pandemic flu

NEWTOWN, Pa., Oct. 08, 2024 (GLOBE NEWSWIRE) — Traws Pharma, Inc. (NASDAQ: TRAW) (“Traws Pharma”, “Traws” or “the Company”), a clinical-stage biopharmaceutical company developing oral small molecule therapies for the treatment of respiratory viral diseases, today announced positive topline Phase 1 safety and pharmacokinetic results for its investigational one-dose influenza (flu) therapy, tivoxavir marboxil (tivoxavir). Tivoxavir was designed as a potential best-in-class inhibitor of the highly-conserved influenza protein, CAP-dependent endonuclease (CEN), intended for use across a broad range of flu viruses.

“Topline data from the Phase 1 healthy volunteer study showed good overall tolerability and a pharmacokinetic profile that appears to support tivoxavir’s potential use as a one-time treatment for flu, including pandemic flu. We are especially pleased with data showing that a single dose of tivoxavir maintained plasma drug levels above the EC90 for greater than 5 days1,” said Werner Cautreels, PhD, Chief Executive Officer of Traws Pharma. “In addition, preclinical data show that tivoxavir is a potent inhibitor of drug-resistant influenza and bird flu viruses1. Together, these initial results suggest that tivoxavir has the potential to be developed as a best-in-class agent for influenza. With these data, we plan to advance the program to a Phase 2 study in H1 2025.”

“Influenza is a substantial public health burden in the US2, with a disproportionate impact on older adults and vulnerable populations. Data from the last influenza season showed that flu-related hospitalizations3 and mortality4 were highest, by approximately three times, among people 65 years of age or older5. Recent bird flu outbreaks, and the risk that this highly pathogenic virus (H5N1) poses for evolving into a pandemic outbreak6, also signal the need for new antiviral treatments,” said Robert R. Redfield, MD, Chief Medical Officer for Traws Pharma and former Director of the U.S. Centers for Disease Control and Prevention (CDC). “Our enthusiasm for tivoxavir is based on the data announced today and the need for novel therapeutics, especially as valuable resources in case of an avian flu outbreak or a pandemic, and for potential use to prevent virus spread in households and congregant settings.”

“We selected CEN as the target for our flu program because it is conserved among human and avian influenza viruses, including the highly pathogenic H5N1. As a result, we believe tivoxavir has the potential to suppress a wide range of viruses. We are very pleased that tivoxavir demonstrated broad activity in laboratory studies against drug-resistant viruses and highly pathogenic strains such as avian flu1. In addition, we believe that preferential uptake in the lung is another important feature of a candidate agent. Preclinical data indicate that a single dose of tivoxavir has more than 15X higher accumulation in the lung compared to plasma1,” said C. David Pauza, PhD, Chief Science Officer for Traws Pharma. “Positive Phase 1 data showing that tivoxavir achieved plasma blood levels in healthy subjects that are consistently above the EC90 and within the predicted therapeutic window for more than five days lead to the identification of our Phase 2 dose, supporting further development of the program.”

Topline Phase 1 Results
The Phase 1 trial was a randomized, double-blind, placebo-controlled study to assess the safety, tolerability, pharmacokinetics (PK) and pharmacodynamics (PD) of ascending doses of one-time tivoxavir marboxil treatment in healthy, influenza-negative, adult volunteers.  

At the identified Phase 2 dose, no treatment related adverse events were reported during the Phase 1 study. Topline data from this study showed that a single dose of tivoxavir marboxil maintained plasma drug levels consistently above the EC90 for more than five days and within the predicted therapeutic window. Preclinical studies showed that tivoxavir marboxil demonstrated potent inhibition of drug-resistant influenza viruses, as well as potent inhibition of highly pathogenic bird flu viruses1.

About Tivoxavir Marboxil
Seasonal influenza is estimated to represent a multi-billion antiviral market opportunity, largely driven by global health organizations, practice guidelines and government tenders1, with upside potential from pandemic flu outbreaks. Tivoxavir marboxil (also known as 27-5116 or TRX-100) was designed as an inhibitor of the highly conserved influenza protein, CAP-dependent endonuclease (CEN). It has demonstrated potent in vitro activity against a range of influenza strains, including the highly pathogenic avian flu, in preclinical studies. The drug candidate’s Phase 1 pharmacokinetic (PK) profile in healthy subjects, including the ability to achieve plasma levels that are consistently above the EC90 (as determined in laboratory studies), for more than five days and within the predicted therapeutic window, may enable a single dose treatment regimen. These data, combined with good overall tolerability results in healthy subjects, support further development of tivoxavir marboxil as a one-time treatment for influenza.

Source information:

  1. TRAW data on file
  2. Flu is burdensome
  3. Flu hospitalizations
  4. Flu mortality
  5. Flu in older adults
  6. Avian flu

About Traws Pharma, Inc.
Traws Pharma is a clinical stage biopharmaceutical company developing potential oral small molecule therapies for the treatment of respiratory viral diseases and cancer. The viral respiratory disease program includes two oral, novel, Phase 1, potentially best-in-class, small molecule drug candidates: tivoxavir marboxil, in development for flu and pandemic flu, targeting the influenza cap-dependent endonuclease (CEN); and ratutrelvir, in development as a COVID treatment, targeting the Mpro (3CL protease), without the need for co-administration of ritonavir.

In the cancer program, Traws is utilizing a partnering strategy, supported by investigator sponsored studies, to advance two novel proprietary multi-kinase inhibitors, narazaciclib, targeting CDK4+, and rigosertib, targeting cell cycle proteins including PLK-1.

Traws is committed to delivering novel compounds for unmet medical needs using state-of-the-art drug development technology. With a focus on product safety and a commitment to patients in need or that are specifically vulnerable, we aim to build solutions for important medical challenges and alleviate the burden of viral infections.

Forward-Looking Statements

Some of the statements in this release are forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, Section 21E of the Securities Exchange Act of 1934, as amended, and the Private Securities Litigation Reform Act of 1995, and involve risks and uncertainties including statements regarding the Company, its business and product candidates, including the potential opportunity, benefits and the regulatory plans for tivoxavir marboxil. The Company has attempted to identify forward-looking statements by terminology including “believes”, “estimates”, “anticipates”, “expects”, “plans”, “intends”, “may”, “could”, “might”, “will”, “should”, “preliminary”, “encouraging”, “approximately” or other words that convey uncertainty of future events or outcomes. Although Traws believes that the expectations reflected in such forward-looking statements are reasonable as of the date made, expectations may prove to have been materially different from the results expressed or implied by such forward looking statements. These statements are only predictions and involve known and unknown risks, uncertainties, and other factors, including the success and timing of Traws’ clinical trials, collaborations, market conditions and those discussed under the heading “Risk Factors” in Traws’ filings with the U.S. Securities and Exchange Commission (SEC). Any forward-looking statements contained in this release speak only as of its date. Traws undertakes no obligation to update any forward-looking statements contained in this release to reflect events or circumstances occurring after its date or to reflect the occurrence of unanticipated events.

Traws Pharma Contacts:

Mark Guerin
Traws Pharma, Inc.
267-759-3680
www.trawspharma.com

Investor Contact:

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

Bio-Path Surges on Expansion into Obesity Market

Posted on by cpatches
Key Points:
– Stock Surge: Bio-Path Holdings’ stock rose 30% after announcing BP1001-A, its new obesity treatment program, with trading volume significantly higher than average.
– New Focus: The company plans preclinical studies for BP1001-A by Q4 2024, marking its first use of DNAbilize technology for non-cancer applications.
– Market Opportunity: A September report projects the obesity treatment market could reach $200 billion by 2031, with up to 16 new drugs expected by 2029, presenting a lucrative opportunity for Bio-Path.

Shares of Bio-Path Holdings (NASDAQ: BPTH) surged by 30% as of 11 a.m. Tuesday, driven by significantly increased trading volume of 57 million shares, far exceeding its average volume of 329,000. The rally follows the company’s announcement of a new therapeutic program aimed at addressing obesity and related metabolic diseases using its DNAbilize® technology. This marks the company’s first foray into non-cancer applications, potentially opening the door to a new growth avenue for the biotech firm.

Bio-Path initiated the development of BP1001-A, targeting insulin sensitivity to treat obesity and type 2 diabetes, with plans to begin preclinical studies as soon as the fourth quarter of 2024. In a statement, Bio-Path’s President and CEO, Peter Nielsen, expressed enthusiasm about the expansion into obesity treatments, citing the growing epidemic as a critical health issue. “Developing BP1001-A for the treatment of obesity should have a high probability of success as its mechanism of action has the potential to treat insulin resistance, which is the underpinning of obesity, Type 2 diabetes, and other related diseases,” Nielsen said.

The company’s announcement also coincided with the completion of patient enrollment in the third dosing cohort of its ongoing Phase 1 clinical trial for BP1002, a treatment for acute myeloid leukemia (AML).

In a September report from analysts at Morningstar and Pitchbook, the obesity treatment market was forecast to see as many as 16 new drugs by 2029, vying for a slice of this lucrative and rapidly expanding market, currently dominated by industry giants Novo Nordisk and Eli Lilly. The same report projected that the global market for obesity treatments could balloon to $200 billion by 2031, highlighting the significant commercial potential in addressing obesity and related metabolic diseases.

Bio-Path Holdings is primarily known for its DNAbilize® technology, which uses RNAi nanoparticle drugs that can be administered via simple intravenous infusion. The company’s lead product candidate, prexigebersen (BP1001), is currently in a Phase 2 trial for blood cancers, while BP1001-A is being studied for solid tumors in a Phase 1 trial.

As Bio-Path explores the obesity space, this expansion could represent a major opportunity for growth, particularly as the market for obesity treatments continues to evolve at a rapid pace.

Release – ZyVersa Therapeutics Forms New Scientific Advisory Board to Support Development of Inflammasome ASC Inhibitor IC 100 for Obesity with Metabolic Complications

Posted on by aweinsoff@channelchek.com

Research News and Market Data on ZVSA

Oct 7, 2024

PDF Version

  • New Scientific Advisory Board (SAB) comprised of five leading experts in the areas of obesity and metabolic diseases, and four leading inflammasome experts and inventors of IC 100 from University of Miami Miller School of Medicine who have provided ongoing scientific advisory support for IC 100 since its license.

WESTON, Fla., Oct. 07, 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 a new SAB to support advancement of Inflammasome ASC Inhibitor IC 100 for obesity with metabolic complications. Based on its mechanism of action, IC 100, in combination with incretin therapy, is anticipated to augment weight loss, but more importantly, to attenuate the chronic systemic inflammation leading to metabolic complications and other inflammatory comorbidities of obesity.

“We are honored to work with such an accomplished and esteemed group of experts,” stated Stephen C. Glover, ZyVersa’s Co-founder, Chairman, CEO, and President. “Our advisors’ combined expertise and insights in the areas of obesity, metabolic diseases, and inflammasomes will be invaluable as we design IC 100’s clinical development program for obesity and metabolic complications.”

Members of ZyVersa’s Obesity, Metabolic and Inflammatory Diseases SAB are listed below. Full biographies are available on ZyVersa’s Website.

Caroline M. Apovian, MD, FACP, FTOS, DABOM

  • Co-Director, Center for Weight Management and Wellness, Division of Endocrinology, Diabetes, and Hypertension at Brigham and Women’s Hospital
  • Professor of Medicine, Harvard Medical School

Harold Bays, MD, MFOMA, FTOS, FACC, FACE, FNLA, FASPC

  • Medical Director and President, Louisville Metabolic and Atherosclerosis Research Center
  • Clinical Associate Professor, Endocrinology, University of Louisville School of Medicine
  • Chief Science Officer of the Obesity Medicine Association

Helen Bramlett, PhD

  • Professor, Department of Neurological Surgery, University of Miami Miller School of Medicine
  • The Miami Project to Cure Paralysis, University of Miami Miller School of Medicine

Marc-Andre Cornier, MD

  • Professor of Medicine, Medical University of South Carolina
  • Director, Division of Endocrinology, Diabetes and Metabolic Diseases, Medical University of South Carolina

Juan Pablo de Rivero Vaccari, PhD

  • Associate Professor, Department of Neurological Surgery, University of Miami Miller School of Medicine
  • The Miami Project to Cure Paralysis, University of Miami Miller School of Medicine
  • Distinguished Faculty Member, the Center for Cognitive Neuroscience and Aging, University of Miami Miller School of Medicine

W. Dalton Dietrich, III, PhD

  • Kinetic Concepts Distinguished Chair in Neurosurgery, and Scientific Director,
  • The Miami Project to Cure Paralysis, University of Miami Miller School of Medicine
  • Senior Associate Dean for Discovery Science and Co-Director, the Institute for Neural Engineering, University of Miami Miller School of Medicine
  • Professor, Neurological Surgery, Neurology, Biomedical Engineering, and Cell Biology, University of Miami Miller School of Medicine

Robert W. Keane, PhD

  • Professor, Physiology and Biophysics, Neurological Surgery and Microbiology, and Immunology, University of Miami Miller School of Medicine
  • The Miami Project to Cure Paralysis. University of Miami Miller School of Medicine

Samuel Klein, MD

  • William H. Danforth Professor of Medicine, Washington University School of Medicine
  • Director, Center for Human Nutrition, Washington University School of Medicine
  • Chief, Division of Nutritional Science and Obesity Medicine, Washington University School of Medicine

Suneil Koliwad, MD, PhD

  • Chief, Division of Endocrinology and Metabolism, UCSF Health
  • Gerold Grodsky Professor of Diabetes Research, UCSF
  • Mount Zion Health Fund Distinguished Professor of Endocrinology, UCSF

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 spread of inflammation 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 with 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 Mediator™ VAR 200. The lead indication for IC 100 is obesity with 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

PDS Biotechnology (PDSB) – Clinical Trial in Cervical Cancer Shows Improved Survival and Supports Use In Other Tumors

Posted on by cpereira@noblefcm.com


Monday, October 07, 2024

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

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

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

Interim Data From Phase 2 Cervical Cancer Trial Presented. An interim analysis from the Phase 2 ImmunoCerv Trial in locally advanced cervical cancer was presented at the American Society For Radiation Oncology (ASTRO) annual meeting on October 1, 2024. Overall survival (OS) and progression free survival (PFS) showed clinically meaningful improvements over published studies. We believe this supports the efficacy of Versamune HPV in cervical cancer as well as other HPV16+ tumors in other tissues.

Study Design. The ImmunoCerv study was an investigator-initiated trial (ITT) conducted at MD Anderson Cancer Center in Houston, Texas. The study enrolled 17 patients with newly diagnosed high-risk HPV-related cervical tumors at least 5 cm in size. Patients received up to 5 doses of Versamune HPV along with standard of care chemotherapy and radiation.


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

Release – Zomedica Announces Expansion of Exclusive Equine Distribution Agreement with Grovet in Europe

Posted on by aweinsoff@channelchek.com

Research News and Market Data on ZOM

Expansion adds new countries to Grovet’s existing PulseVet distribution coverage and enables launch of the TRUFORMA® equine platform in Europe

ANN ARBOR, MI / ACCESSWIRE / October 3, 2024 / Zomedica Corp. (NYSE American:ZOM) (“Zomedica” or the “Company”), a veterinary health company offering point-of-care diagnostics and therapeutic products for equine and companion animals, today announced the expansion of its distribution partnership in Europe with Grovet, a leading equine-focused veterinary distributor.

The terms of the updated agreement offer Grovet equine distribution rights for Zomedica’s equine PulseVet® and TRUFORMA product platforms throughout most of Europe. Grovet will exclusively distribute these equine products in 27 countries, including Austria, Belgium, Bulgaria, Croatia, Cyprus, Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Ireland, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, and Switzerland, and will distribute these products on anon-exclusive basis in Italy and the UK.

In addition to expanding the distribution of PulseVet products to equine veterinarians into additional European countries, this agreement also expands their product offerings to include the TRUFORMA platform as well as the Company’s current equine assays for eACTH and Cortisol, and equine Insulin when it launches later this year.

“We are very pleased to expand our relationship with Grovet for all of Zomedica’ s equine products in Europe,” stated Kevin Klass, Zomedica’s Senior Vice President of Sales. “Grovet has been a terrific partner since inception. Having them lead the way for us in equine by introducing the TRUFORMA equine product line to the market in 29 countries is a natural recipe for success,” continued Klass.

“Working with Zomedica and selling the PulseVet device has been a great experience for us,” stated Koen Schmitz-Managing Director of Grovet. “We only partner with companies whose products are rooted in scientific studies, and all of Zomedica’s products we are carrying are exactly just that, rooted in science and steeped in research,” continued Schmitz.

“Grovet has been a great partner to Zomedica for the equine PulseVet product line over the last several years, and they were the perfect partner to help expand the reach of our TRUFORMA equine platform within Europe,” stated Brandon Marino, Senior Director of Global Channels for Zomedica.

“PPID, or Cushing’s disease, is one of the most common endocrine disorders in horses and ponies. Left undiagnosed and untreated, quality of life for these animals will rapidly decline and their life expectancy will shorten. The TRUFORMA eACTH assay for equine plasma offers equine veterinarians the ability to diagnose and screen for PPID as well as monitor patients during treatment, in minutes in their own labs or stall-side. The equine Cortisol assay provides critical data to veterinarians treating foals, and the upcoming equine insulin assay will be of benefit for assessing insulin issues commonly faced by horses. The compact, easy to use, and durable TRUFORMA device offers reference lab accuracy with point of care convenience, making it a great fit for the unique challenges that face equine practitioners,” concluded Marino.

For more information on these products or any of Zomedica’s other products please visit, wwww.zomedica.com.

About Grovet – Equine health company
Grovet has been supporting equine veterinarians with high-quality products for over 25 years. Our team consists of people who are passionate about horses, which is why horse health is at the heart of everything we do.

With our extensive experience and knowledge, we offer a wide range of innovative products, including instruments, medicines, MedTech and supplements to support equine veterinarians. We are committed to continuously improving and expanding our product line to meet the evolving needs of equine practitioners. By working closely with veterinarians and industry experts, we stay up to date on the latest trends and challenges, allowing us to provide effective solutions that help vets deliver the best care possible.

A key example of our ongoing commitment to innovation is our successful collaboration with Zomedica. This partnership has allowed us to expand our product offerings with the PulseVet and now the TRUFORMA equine line of products. PulseVet products are highly regarded by our clients and fit seamlessly into Grovet’s existing range and customer base. Our clients are pleased to have access to these products through a European distributor, making it easier than ever to incorporate them into their veterinary practices.

For more information about our products or to explore partnership opportunities, please visit www.grovet.com or contact us directly.

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About Zomedica

Zomedica is a leading equine and companion animal healthcare company dedicated to improving animal health by providing veterinarians innovative therapeutic and diagnostic solutions. Our gold standard PulseVet® shock wave system, which accelerates healing in musculoskeletal conditions, has transformed veterinary therapeutics. Our suite of products also includes the Assisi® Loop line of therapeutic devices and the TRUFORMA® diagnostic platform, the TRUVIEW™ digital cytology system, and the VetGuardian® no-touch monitoring system, all designed to empower veterinarians to provide top-tier care. In the aggregate, their total addressable market in the U.S. exceeds $2 billion. Headquartered in Michigan, Zomedica employs approximately 150 people and manufactures and distributes its products from its world-class facilities in Georgia and Minnesota. An NYSE American company, Zomedica grew revenue 33% in 2023 to $25 million and maintains a strong balance sheet with approximately $83 million in liquidity as of June 30, 2024. Zomedica is advancing its product offerings, leveraging strategic acquisitions, and expanding internationally as we work to enhance the quality of care for pets, increase pet parent satisfaction, and improve the workflow, cash flow and profitability of veterinary practices. For more information visit www.zomedica.com.

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Cautionary Note Regarding Forward-Looking Statements

Except for statements of historical fact, this news release contains certain “forward-looking information” or “forward-looking statements” (collectively, “forward-looking information”) within the meaning of applicable securities law. Forward-looking information is frequently characterized by words such as “plan”, “expect”, “project”, “intend”, “believe”, “anticipate”, “estimate” and other similar words, or statements that certain events or conditions “may” or “will” occur and include statements relating to our expectations regarding future results. Although we believe that the expectations reflected in the forward-looking information are reasonable, there can be no assurance that such expectations will prove to be correct. We cannot guarantee future results, performance, or achievements. Consequently, there is no representation that the actual results achieved will be the same, in whole or in part, as those set out in the forward-looking information.

Forward-looking information is based on the opinions and estimates of management at the date the statements are made, including assumptions with respect to economic growth, demand for the Company’s products, the Company’s ability to produce and sell its products, sufficiency of our budgeted capital and operating expenditures, the satisfaction by our strategic partners of their obligations under our commercial agreements, our ability to realize upon our business plans and cost control efforts and the impact of COVID-19 on our business, results and financial condition.

Our forward-looking information is subject to a variety of risks and uncertainties and other factors that could cause actual events or results to differ materially from those anticipated in the forward-looking information. Some of the risks and other factors that could cause the results to differ materially from those expressed in the forward-looking information include, but are not limited to: the outcome of clinical studies, the application of generally accepted accounting principles, which are highly complex and involve many subjective assumptions, estimates, and judgments, uncertainty as to whether our strategies and business plans will yield the expected benefits; uncertainty as to the timing and results of development work and verification and validation studies; uncertainty as to the timing and results of commercialization efforts, as well as the cost of commercialization efforts, including the cost to develop an internal sales force and manage our growth; uncertainty as to our ability to successfully integrate acquisitions; uncertainty as to our ability to supply products in response to customer demand; uncertainty as to the likelihood and timing of any required regulatory approvals, and the availability and cost of capital; the ability to identify and develop and achieve commercial success for new products and technologies; veterinary acceptance of our products, including acceptance of the TRUFORMA platform by veterinarians in Europe; competition from related products; the level of expenditures necessary to maintain and improve the quality of products and services; changes in technology and changes in laws and regulations; our ability to secure and maintain strategic relationships; performance by our strategic partners of their obligations under our commercial agreements, including meeting distribution obligations; risks pertaining to permits and licensing, intellectual property infringement risks, risks relating to any required clinical trials and regulatory approvals, risks relating to the safety and efficacy of our products, the use of our products, intellectual property protection, risks related to the COVID-19 pandemic and its impact upon our business operations generally, including our ability to develop and commercialize our products, and the other risk factors disclosed in our filings with the SEC and under our profile on SEDAR+ at www.sedarplus.com. Readers are cautioned that this list of risk factors should not be construed as exhaustive.

The forward-looking information contained in this news release is expressly qualified by this cautionary statement. We undertake no duty to update any of the forward-looking information to conform such information to actual results or to changes in our expectations except as otherwise required by applicable securities legislation. Readers are cautioned not to place undue reliance on forward-looking information.

Investor Relations Contact:

Zomedica Investor Relations
investors@zomedica.com
1-734-369-2555

SOURCE: Zomedica Corp.