Tag: Biopharmaceutical

Release – ZyVersa Therapeutics Announces Publication Reinforcing the Rationale for Inhibiting ASC with IC 100 to Potentially Attenuate Cardiac Comorbidities in Patients with Alzheimer’s Disease

Posted on by aweinsoff@channelchek.com

Research News and Market Data on ZVSA

Apr 29, 2024

  • This publication, authored by leading experts in inflammasome-mediated inflammation and neurology at University of Miami Miller School of Medicine, demonstrates that multiple inflammasome triggers (NLRP1 and pyrin) govern the inflammatory response in Alzheimer’s Disease (AD), and that release of inflammasome laden extracellular vesicles (EV) into the blood induce significant inflammation in cardiovascular cells.
  • ZyVersa is developing Inflammasome ASC Inhibitor IC 100 to inhibit multiple types of inflammasomes, including NLRP1 and pyrin, and their associated ASC specks that trigger damaging inflammation and its spread to surrounding tissues.
  • AD, a progressive neurodegenerative disease affecting 6.7 million people in the US, is associated with many comorbidities, especially heart disease and stroke, resulting in increased morbidity and mortality.

WESTON, Fla., April 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 acclaimed 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 journal, Frontiers in Molecular Neuroscience, highlighting how inflammasome-mediated inflammation in Alzheimer’s disease can trigger inflammation in the heart.

The paper titled, “Extracellular vesicles mediate inflammasome signaling in the brain and heart of Alzheimer’s disease mice,” summarizes research evaluating serum and tissue cultures from an AD mouse model, and experiments of adoptive transfer of EV from AD patients into cardiovascular cells. Following is a summary of key findings:

  • NLRP1, pyrin, caspase-1, and ASC were significantly elevated in the cortex of AD mice.
  • In AD mice, there was a heightened level of inflammatory proteins circulating in the body via EVs containing an inflammasome protein cargo.
  • Inflammasome activation was demonstrated in the heart of AD mice, associated with an increase in ASC oligomerization into specks.
  • In adoptive transfer experiments, EVs released from AD patients induced significant inflammation in cardiovascular cells when compared to EVs from healthy individuals.

“Our data provide evidence that there is a neural-cardiac axis mediated by EVs in AD. Therefore, inflammasomes may provide a novel therapeutic target for the treatment of cardiac comorbidities in AD and beyond,” said Juan Pablo de Rivero Vaccari, Associated Professor of Neurological Surgery and The Miami Project to Cure Paralysis at the University of Miami.

“This research reinforces the importance of attenuating activation of multiple types of inflammasomes that govern the inflammatory response in AD and mediating systemic inflammatory signals in EVs to control the spread of damaging inflammation to cardiovascular and other cells,” commented Stephen C. Glover, ZyVersa’s Co-founder, Chairman, CEO, and President. “ZyVersa’s Inflammasome ASC inhibitor IC 100 is designed to inhibit formation of multiple types of inflammasomes to attenuate initiation of the inflammatory cascade and to inhibit their associated ASC specks to reduce spread and perpetuation of damaging inflammation.”

To review a white paper summarizing the mechanism of action and preclinical data for IC 100, Click Here.

About Inflammasome ASC Inhibitor IC 100

IC 100 is a novel humanized IgG4 monoclonal antibody that inhibits the inflammasome adaptor protein ASC. IC 100 was designed to attenuate both initiation and perpetuation of the inflammatory response. It does so by binding to a specific region of the ASC component of multiple types of inflammasomes, including NLRP1, NLRP2, NLRP3, NLRC4, AIM2, 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.

About ZyVersa Therapeutics, Inc.

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

Cautionary Statement Regarding Forward-Looking Statements

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

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

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

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

Release – YS Biopharma Granted Phase I Clinical Trial License of Therapeutic Chronic Hepatitis B Virus Vaccine

Posted on by aweinsoff@channelchek.com

Research News and Market Data on YS

GAITHERSBURG, Md., April 18, 2024 /PRNewswire/ — YS Biopharma Co., Ltd. (Nasdaq: YS) (“YS Biopharma” or the “Company”), a global biopharmaceutical company dedicated to discovering, developing, manufacturing, and delivering new generations of vaccines and therapeutic biologics for infectious diseases and cancer, today announced that its YS-HBV-002 immunotherapeutic vaccine, designed to treat patients suffering from chronic hepatitis B virus (“HBV”) infection, has been granted clinical trial approval by the Philippine Food and Drug Administration (“PFDA”). In light of the approval, the Company is preparing to initiate a Phase I clinical trial for YS-HBV-002 in the Philippines, which is expected to begin in June 2024.

Chronic HBV infection is a major global health concern, with an estimated 254 million people suffering from the condition, with 1.2 million new infections each year, according to the World Health Organization (WHO). Those infected are at higher risk for cirrhosis, liver failure, and liver cancer, with between 15%-40% of chronic HBV patients afflicted with one or more of these conditions. In 2022, HBV infection resulted in an estimated 1.1 million deaths, mostly from cirrhosis and hepatocellular carcinoma (primary liver cancer). Chronic HBV infections occur in both developing and developed countries, constituting a significant unaddressed public health threat. At present, the efficacy of existing anti-viral treatment paradigms is limited, and no cure for chronic HBV has yet been developed. Despite the availability of preventive vaccines for hepatitis B infection, there remains an urgent need for effective therapies for individuals who are already infected and have progressed to chronic stages of infection.

Dr. David Shao, Director, President, and CEO of YS Biopharma, commented, “The approval of YS-HBV-002 by the Philippines FDA and Ethics Committee represents a significant milestone in our efforts to develop innovative therapies for chronic hepatitis B infection. At present, there is no effective vaccine treatment option for patients suffering from chronic HBV, leaving them at higher risk for other conditions affecting the liver and significantly hampering their quality of life. With our recent approval and upcoming clinical study, we hope to provide these patients with a safe and effective solution to combat this significant unaddressed public health threat. As always, we plan to conduct the clinical trial to the highest safety and ethical standards, and we are eager to take the next step towards delivering these much-needed treatment options to chronic HBV patients.”

The Phase I clinical trial for YS-HBV-002 will mark an important milestone in addressing this unmet medical need. This trial will employ a double-blind, randomized, placebo-controlled, dose-escalation approach, and aims to evaluate the safety, immunogenicity, and efficacy of YS-HBV-002 among adult patients diagnosed with chronic HBV infection. By targeting both humoral and cellular immune responses, YS-HBV-002 has the potential to disrupt immune tolerance mechanisms and facilitate the treatment of chronic HBV infection in patients.

About YS-HBV-002

YS-HBV-002 is a new generation of therapeutic HBV vaccine based on the proprietary technology and clinical results of YS-HBV-001, the first generation of HBV vaccine in the pipeline of YS Biopharma. YS-HBV-002 is formulated with several key components, including recombinant core and surface hepatitis B antigens, and YS Biopharma’s proprietary PIKA adjuvant. This carefully designed set of components has the potential to activate both innate and adaptive immune responses in patients, thereby generating a more robust and targeted response to the virus. The re-establishment of a desirable and comprehensive immune response is the first step towards the eradication of chronic HBV infection from the body.

About YS Biopharma

YS Biopharma is a global biopharmaceutical company dedicated to discovering, developing, manufacturing, and commercializing new generations of vaccines and therapeutic biologics for infectious diseases and cancer. It has developed a proprietary PIKA® immunomodulating technology platform and a series of preventive and therapeutic biologics with a potential for improved Rabies, Coronavirus, Hepatitis B, Influenza, and Shingles vaccines. YS Biopharma operates in China, the United States, Singapore and the Philippines, and is led by a management team that combines rich local expertise and global experience in the bio-pharmaceutical industry. For more information, please visit www.ysbiopharma.com.

Cautionary Statement Regarding Forward-Looking Statements

This press release contains “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. All statements other than statements of historical or current fact included in this press release are forward-looking statements, including but not limited to statements regarding the expected growth of YS Biopharma, the development progress of all product candidates, the progress and results of all clinical trials, YS Biopharma’s ability to source and retain talent, and the cash position of YS Biopharma. Forward-looking statements may be identified by the use of words such as “estimate,” “plan,” “project,” “forecast,” “intend,” “will,” “expect,” “anticipate,” “believe,” “seek,” “target” or other similar expressions that predict or indicate future events or trends or that are not statements of historical matters. These statements are based on various assumptions, whether identified in this press release, and on the current expectations of YS Biopharma’s management and are not predictions of actual performance.

YS Biopharma cannot assure you that the forward-looking statements in this press release will prove to be accurate. These forward-looking statements are subject to a number of risks and uncertainties, including those included under the heading “Risk Factors” in the Post-effective Amendment No. 2 to the Company’s Registration Statement on Form F-1 filed with the SEC on January 23, 2024, and other filings with the SEC. There may be additional risks that YS Biopharma does not presently know or that YS Biopharma currently believes are immaterial that could also cause actual results to differ from those contained in the forward-looking statements. In light of the significant uncertainties in these forward-looking statements, nothing in this press release should be regarded as a representation by any person that the forward-looking statements set forth herein will be achieved or that any of the contemplated results of such forward-looking statements will be achieved. The forward-looking statements in this press release represent the views of YS Biopharma as of the date of this press release. Subsequent events and developments may cause those views to change. However, while YS Biopharma may update these forward-looking statements in the future, there is no current intention to do so, except to the extent required by applicable law. You should, therefore, not rely on these forward-looking statements as representing the views of YS Biopharma as of any date subsequent to the date of this press release. Except as may be required by law, YS Biopharma does not undertake any duty to update these forward-looking statements.

Investor Relations Contact

Alyssa Li
Director of Investor Relations
Email: ir@yishengbio.com 

Robin Yang
Partner, ICR, LLC
Tel: +1 (212) 537-4035
Email: YSBiopharma.IR@icrinc.com 

View original content to download multimedia:https://www.prnewswire.com/news-releases/ys-biopharma-granted-phase-i-clinical-trial-license-of-therapeutic-chronic-hepatitis-b-virus-vaccine-302120805.html

SOURCE YS Biopharma Co., Ltd.

Benitec Biopharma Lands $40M Lifeline to Advance Gene Therapy Pipeline

Posted on by slightbourne@noblecapitalmarkets.com

In an oversubscribed private placement deal, clinical-stage biotech Benitec Biopharma (NASDAQ: BNTC) has secured $40 million in fresh capital to propel its lead gene therapy program into human trials. The financing provides an essential lifeline for the company as it aims to validate its novel “Silence and Replace” platform through clinical data readouts.

Benitec sold 5.7 million shares of its common stock at $4.80 per share, while also issuing 2.6 million pre-funded warrants in the transaction. The deal was led by healthcare investment firm Suvretta Capital Management, with participation from an investor syndicate including Adage Capital Partners, Nantahala Capital, multiple specialist healthcare funds, and a large mutual fund.

The $40 million gross proceeds dwarf Benitec’s $8.5 million cash balance exiting 2023 and strengthen the biotech’s financial runway considerably. Executives stated the capital will primarily fund development of BB-301, Benitec’s lead therapeutic candidate for Oculopharyngeal Muscular Dystrophy (OPMD).

Specifically, Benitec plans to kick off a natural history lead-in study and then initiate a Phase 1b/2a clinical trial evaluating BB-301 in OPMD patients. A portion will also support general operations as the company works to build out its pipeline leveraging the next-generation “Silence and Replace” platform.

For Benitec, scoring this level of financing commitment represents a major endorsement from the investment community. The company has been touting the promise of its dual RNA interference and gene therapy technology for years, but has leaned on equity injections and partnerships to keep the lights on.

Now, with $40 million from a blue-chip investor group, Benitec will have resources to prove its bold scientific vision can translate into real-world results for patients. Delivering clinical validation would be a game-changer in unlocking the plethora of therapeutic opportunities the “Silence and Replace” platform could potentially address.

As part of the deal terms, Benitec has agreed to consider adding Suvretta portfolio manager Kishen Mehta to its board of directors. Having greater oversight and alignment with the lead investor could tighten Benitec’s focus on prudent capital allocation and strategic execution going forward.

The financing did require issuing shares at a discount to the $4.80 prior closing price as well as warrant coverage for investors to get the deal done. But scoring that magnitude of capital from high-quality funds suggests belief in the innovative science and upcoming data milestones.

For a pre-revenue biotech still in clinical development stages, continual cash raises remain the norm. Yet this latest $40 million haul buys Benitec significant runway to produce human proof-of-concept results and hit major value-inflection points, without being forced to give away the farm through onerous dilution or a cut-rate M&A exit.

Of course, as is the case with all cutting-edge technologies, execution risk remains. Benitec and its investors are betting big on the “Silence and Replace” platform living up to its game-changing gene therapy potential. Success would be transformative, but fai lures are all too common in the high-risk, high-reward biotech realm.

With its coffers newly replenished, Benitec is approaching a make-or-break inflection point. This $40 million lifeline paves the way for the pioneering gene therapy firm to generate pivotal clinical data that could vindicate its ambitious “Silence and Replace” platform. The road ahead is unforgiving, with little margin for error against the high bar set for regulatory approval and commercial success in the cutthroat biotech sphere. But if Benitec can deliver validating evidence that its dual RNA interference and gene replacement approach translates into meaningful therapeutic benefits, it could spark a tectonic shift in how the industry tackles genetic diseases. Benitec is staring down its chance to forever change the landscape of modern medicine.

Take a moment to take a look at Noble Capital Markets’ Senior Research Analyst Robert LeBoyer’s coverage universe.

Release – YS Biopharma to Report First Nine Months of Fiscal Year 2024 Financial Results on April 19, 2024

Posted on by aweinsoff@channelchek.com

Research News and Market Data on YS

Download this Press Release

GAITHERSBURG, Md., April 16, 2024 /PRNewswire/ — YS Biopharma Co., Ltd. (NASDAQ: YS) (“YS Biopharma” or the “Company”), a global biopharmaceutical company dedicated to discovering, developing, manufacturing, and delivering new generations of vaccines and therapeutic biologics for infectious diseases and cancer, today announced that it plans to release its financial results for the first nine months of the fiscal year ended March 31, 2024, before the U.S. market opens on Friday, April 19, 2024.

(PRNewsfoto/YishengBio Co., Ltd)

   

The Company’s management will hold an earnings conference call at 8:00 A.M. Eastern Time on Friday, April 19, 2024 to discuss the financial results. Listeners may access the call by dialing the following numbers:

United States Toll Free:           1-888-346-8982
International:                             1-412-902-4272
Mainland China Toll Free:       4001-201203
Canada Toll Free:                   1-855-669-9657
Hong Kong:                               852-301-84992

Upon dialing-in, participants should ask to be joined into the YS Biopharma Co., Ltd. call.

The replay will be accessible through April 26, 2024 by dialing the following numbers:

United States Toll Free:             1-877-344-7529
International:                     1-412-317-0088
Canada Toll Free:                 1-855-669-9658
Access Code:                       2468327

A live and archived webcast of the conference call will also be available at the Company’s investor relations website at https://investor.ysbiopharm.com/.

About YS Biopharma 

YS Biopharma is a global biopharmaceutical company dedicated to discovering, developing, manufacturing, and commercializing new generations of vaccines and therapeutic biologics for infectious diseases and cancer. It has developed a proprietary PIKA® immunomodulating technology platform and a series of preventive and therapeutic biologics with a potential for improved Rabies, Coronavirus, Hepatitis B, Influenza, and Shingles vaccines. YS Biopharma operates in China, the United States, Singapore and the Philippines, and is led by a management team that combines rich local expertise and global experience in the bio-pharmaceutical industry. For more information, please visit www.ysbiopharma.com.

Investor Relations Contact

Alyssa Li
Director of Investor Relations
Email: ir@yishengbio.com 

Robin Yang
Partner, ICR, LLC
Tel: +1 (212) 537-4035
Email: YSBiopharma.IR@icrinc.com

Cision View original content to download multimedia:https://www.prnewswire.com/news-releases/ys-biopharma-to-report-first-nine-months-of-fiscal-year-2024-financial-results-on-april-19-2024-302118047.html

SOURCE YS Biopharma Co., Ltd.

Eliem Bets Big on Autoimmune Pipeline with $210M Tenet Buyout

Posted on by slightbourne@noblecapitalmarkets.com

The biotech deal scene is heating up, with Eliem Therapeutics becoming the latest to double down on an emerging pipeline through M&A. The clinical-stage company announced it is acquiring private biotech Tenet Medicines for $120 million in stock, while simultaneously raising $120 million in a private placement to fund Tenet’s lead autoimmune disease program.

The transaction allows Eliem to pivot from its previous focus on neurological disorders to prioritize TNT119 – an anti-CD19 antibody that Tenet was developing across multiple autoimmune indications like lupus, immune thrombocytopenia, and membranous nephropathy. With $210 million in projected cash reserves after closing, the combined company plans to rapidly advance TNT119 into Phase 2 studies for systemic lupus erythematosus and immune thrombocytopenia in the second half of 2024.

“TNT119 represents a promising clinical asset across autoimmune diseases where there is a clear need for improved treatments,” said Andrew Levin, Eliem’s Executive Chairman. “This deal allows us to accelerate development of a potential best-in-class therapy while creating value for our shareholders.”

The acquisition continues the torrid pace of deal-making in biotech as companies look to revamp pipelines and build out emerging focus areas through M&A. Just in the first few months of 2024, over $30 billion in biotech acquisitions have been announced according to Bloomberg data.

Major deals included Vertex’s $4.9 billion buyout of Alpine Immune Sciences to gain a promising IgA nephropathy drug, Pfizer’s $43 billion acquisition of Seagen to bolster its oncology portfolio, and Amgen’s $27.8 billion deal for Horizon Therapeutics’ rare disease pipeline. Now Eliem is the latest to join the fray, making a significant bet on the autoimmune space.

“We believe TNT119 has best-in-class potential and could transform treatment for many autoimmune patients,” said Stephen Thomas, who will become interim CEO of the combined company after previously leading Tenet.

In addition to systemic lupus erythematosus and immune thrombocytopenia, TNT119 has also shown preliminary efficacy in treating membranous nephropathy – an autoimmune kidney disorder. By depleting B cells that produce autoantibodies driving the diseases, the therapy could provide a novel approach across this set of serious inflammatory conditions.

To fund TNT119’s ambitious development program, Eliem secured backing from a syndicate of major healthcare investors including RA Capital, Deep Track Capital, Boxer Capital and Janus Henderson in the $120 million private placement.

The wave of biotech deals has been driven by larger players looking to rebuild pipelines, while smaller companies seek resources to push programs forward amid a challenging economic environment and tight funding markets. With its Tenet acquisition, Eliem is aiming to thread that needle – gaining a promising clinical asset while raising enough capital to rapidly usher it through key studies.

For Eliem shareholders, the risky pivot to autoimmune therapies represents a major strategic shift. But if TNT119 can live up to its blockbuster aspirations, it could allow the company to go from an underdog in neurological disorders to a standout in the hot autoimmune space. That big “if” appears to be a gamble Eliem and its investors are willing to take amid biotech’s current deal-making renaissance.

Register Now to Attend the Noble Capital Markets Emerging Growth Virtual Healthcare Equity Conference

No Cost Attendee Registration

Vertex Banks on Autoimmune Therapy in $4.9 Billion Alpine Acquisition

Posted on by slightbourne@noblecapitalmarkets.com

Boston-based biotech giant Vertex Pharmaceuticals announced today that it has agreed to acquire Alpine Immune Sciences for $4.9 billion in cash, placing a major bet on the smaller company’s promising drug candidate for treating serious autoimmune diseases.

The crown jewel of the acquisition is Alpine’s lead molecule povetacicept, a dual antagonist of the BAFF and APRIL proteins that have been implicated in driving several autoimmune and inflammatory conditions. Through Phase 2 trials, povetacicept has demonstrated potentially best-in-class efficacy for treating IgA nephropathy (IgAN), a serious progressive kidney disease caused by autoimmune complexes.

IgAN is the most common cause of primary glomerulonephritis (inflammation of the kidney’s filtering units) worldwide, affecting approximately 130,000 people in the U.S. alone. The disease frequently leads to end-stage renal failure, yet there are currently no approved treatments that target the underlying causes of IgAN. Povetacicept is slated to enter pivotal Phase 3 clinical trials in the second half of 2024.

“Alpine is a compelling strategic fit that furthers our ambition of creating transformative medicines for serious diseases with high unmet need,” said Reshma Kewalramani, Vertex’s CEO and President. “We look forward to bringing povetacicept, a potential best-in-class treatment for IgAN, to patients faster.”

But Vertex is betting big that povetacicept’s impact could extend far beyond just IgAN. Due to its dual mechanism targeting BAFF and APRIL, the drug candidate holds promise as a potential “pipeline-in-a-product” for treating other autoimmune diseases affecting the kidneys like membranous nephropathy and lupus nephritis. Clinical trials are also evaluating povetacicept’s utility for autoimmune cytopenias that destroy blood cells.

The $4.9 billion acquisition allows Vertex, a leader in cystic fibrosis treatments, to expand into autoimmune and inflammatory diseases – one of the hottest areas of drug development. It also provides Vertex with Alpine’s protein engineering expertise that could unlock new therapeutic modalities.

“Povetacicept has demonstrated potential best-in-class attributes and has broad development potential across autoimmune conditions with significant unmet need,” said Mitchell Gold, Alpine’s CEO. “We’re excited for the opportunity to make a meaningful difference as part of Vertex.”

The deal is structured as an all-cash tender offer, with Vertex paying $65 per share for Alpine’s outstanding stock – a substantial 92% premium over Alpine’s closing price on April 9th. Vertex expects to finance the $4.6 billion net transaction cost through a combination of existing cash on hand and new debt financing.

The acquisition, which was unanimously approved by both companies’ boards, is expected to close in the second quarter of 2024 pending regulatory approval and other customary closing conditions. It marks Vertex’s second acquisition in the autoimmune disease space in recent years, having purchased protein therapeutics firm Semma Therapeutics in 2019 for $950 million.

With povetacicept’s promising data and Vertex’s resources behind it, the combined company will be well-positioned to rapidly advance a potentially transformative new class of autoimmune therapies. But at a lofty price tag nearing $5 billion, the deal places a major bet that the Alpine drug can live up to its blockbuster aspirations.

Register Now to Attend the Noble Capital Markets Emerging Growth Virtual Healthcare Equity Conference

No Cost Attendee Registration

Century Therapeutics Makes Bold Move in Autoimmune Disease and Cell Therapy

Posted on by slightbourne@noblecapitalmarkets.com

Century Therapeutics, a pioneering biotech company developing induced pluripotent stem cell (iPSC)-derived cell therapies, announced a transformative set of initiatives that could reshape the landscape of cell therapy in cancer and autoimmune diseases.

The centerpiece is an ambitious expansion of Century’s lead program CNTY-101, a novel CD19-targeting immune cell therapy, into multiple autoimmune indications beyond the previously planned systemic lupus erythematosus (SLE) trial. This strategic pivot is backed by a $60 million private financing round and bolstered by the acquisition of Clade Therapeutics.

CNTY-101 is an allogeneic, iPSC-derived natural killer (iNK) cell therapy that has shown promising potential in eradicating cancerous B-cells in early clinical trials. Century believes its unique design, including gene edits to enable repeat dosing without lymphodepletion, could make it an ideal therapy for autoimmune diseases driven by B-cell dysregulation.

“We’ve seen compelling translational data pointing to CNTY-101’s potential in diseases like lupus,” said Century CEO Brent Pfeiffenberger. “This financing allows us to aggressively pursue that opportunity across multiple autoimmune indications with high unmet need.”

While the SLE trial remains on track for 2024, Century plans additional regulatory filings for CNTY-101 in autoimmune diseases in the second half of this year, supported by the $60 million raise from investors like Bain Capital Life Sciences and Adage Capital.

But the company didn’t stop there. Century also acquired Clade Therapeutics and its innovative iPSC-derived alpha beta T-cell platform for $35 million upfront, with potential future milestones. The deal adds three promising preclinical cancer and autoimmune programs to Century’s pipeline.

More importantly, it provides Century with next-generation capabilities to manufacture highly-functional, engineered T-cell therapies from iPSCs, something the field has long sought after.

“Clade’s groundbreaking platform replicates the natural T-cell development process, overcoming key limitations of current therapies,” said Century R&D President Hy Levitsky, M.D. “Combined with our iPSC-derived NK and gamma delta T-cells, this gives us unparalleled ability to create potential cures across a wide range of diseases.”

The move establishes Century as a preeminent player in allogeneic, off-the-shelf iPSC cell therapy, with an arsenal of NK cells, alpha beta T-cells, and gamma delta T-cells for oncology and autoimmune diseases. It diversifies the pipeline with complementary assets while providing a renewable cell source to manufacture consistent, high-quality therapies.

While still in early stages, some analysts view this as an aggressive and smart play by Century to stay ahead of the competition in this rapidly evolving space. By expanding into autoimmune diseases, acquiring transformative technology, and putting significant capital behind it all, Century is cementing its position as an iPSC cell therapy leader looking to deliver on the modality’s long-awaited promise.

Register Now to Attend the Noble Capital Markets Emerging Growth Virtual Healthcare Equity Conference

No Cost Attendee Registration

Biotech Buzz: Adial and Skye Bioscience Deliver Promising Updates Amid Sector Momentum

Posted on by slightbourne@noblecapitalmarkets.com

The biotech and healthcare sectors have seen a flurry of activity in recent weeks, with companies making strides through drug developments, clinical trials, and corporate milestones. Two firms generating buzz today are Adial Pharmaceuticals (ADIL) and Skye Bioscience (SKYE), both reporting encouraging news that has fueled investor interest.

Adial Pharmaceuticals, a clinical-stage biopharmaceutical company focused on developing addiction therapies, announced the publication of a peer-reviewed article highlighting the promising safety data and high patient compliance observed with its lead investigational drug AD04 in a Phase 3 clinical trial for alcohol use disorder (AUD).

The study, published in the European Journal of Internal Medicine, comprehensively analyzed the liver safety profile of low-dose AD04 compared to a placebo in patients with AUD and a specific genetic profile. Notably, AD04 did not significantly impact biochemical markers of liver injury like ALT, AST, and bilirubin levels, underscoring its potential to address AUD while mitigating liver damage risks.

Moreover, AD04 demonstrated an impressive safety and tolerability profile, with low adverse event occurrence, high medication adherence, and minimal dropout rates – a rarity for AUD treatments. Adial’s CEO, Cary Claiborne, expressed enthusiasm about providing a precision treatment tailored to individuals with AUD, potentially offering a novel approach to managing alcohol consumption and liver harm.

Separately, Skye Bioscience (SKYE), a clinical-stage biotech focused on the endocannabinoid system, achieved a significant milestone by uplisting its common stock to the Nasdaq Global Market. Trading under the ticker “SKYE” is expected to commence on April 11th.

The Nasdaq uplisting is a testament to Skye’s recent accomplishments, including advancing its Phase 2 clinical programs, strengthening its financial position, and broadening its shareholder base. As CFO Kaitlyn Arsenault noted, the move aims to enhance visibility, liquidity, and ultimately drive long-term shareholder value.

Skye’s pipeline includes SBI-100 Ophthalmic Emulsion, a CB1 agonist being studied in a Phase 2 trial for glaucoma and ocular hypertension, with top-line data expected this quarter. Additionally, the company plans to launch a Phase 2 clinical trial in Q3 2024 for nimacimab, a peripheral CB1 inhibitor, targeting obesity through monotherapy and combination arms with a GLP-1R agonist.

These developments from Adial and Skye underscore the vibrant activity within the biotech and healthcare sectors, where companies are continuously striving to advance innovative therapies and achieve corporate milestones.

Contributing to the sector’s momentum is the upcoming Noble Capital Markets Emerging Growth Virtual Healthcare Equity Conference, taking place on April 17-18. This premier event will bring together industry leaders, investors, and emerging companies, providing a platform to showcase groundbreaking research, discuss market trends, and explore potential partnerships and collaborations.

With the biotech and healthcare industries consistently evolving, such conferences play a crucial role in fostering collaboration, facilitating knowledge-sharing, and driving progress towards improving patient outcomes and advancing healthcare solutions.

As companies like Adial and Skye continue to make strides, the broader biotech and healthcare sectors remain vibrant and poised for growth, fueled by scientific advancements, regulatory approvals, and investor confidence. The upcoming Noble Capital Markets Virtual Healthcare Conference promises to further catalyze innovation and propel the industry forward.

Click here to register for the Emerging Growth Virtual Healthcare Equity Conference.

Release – Cadrenal Therapeutics Receives FDAOrphan Drug Designation For Tecarfarin For Prevention Of Thromboembolism And Thrombosis In Patients With LVADs, RVADs, Biventricular Assist Devices, And Total Artificial Hearts

Posted on by aweinsoff@channelchek.com

Research News and Market Data on CVKD

FDA designation provides potentially seven years of market exclusivity after approval and expanded partnering opportunities for tecarfarin

PONTE VEDRA, Fla., April 9, 2024 — Cadrenal Therapeutics, Inc. (Nasdaq: CVKD), a biopharmaceutical company developing tecarfarin, a late-stage novel oral and reversible anticoagulant (blood thinner) designed to prevent heart attacks, strokes, and deaths due to blood clots in patients with rare cardiovascular conditions, announced today that the United States Food and Drug Administration (FDA) has granted tecarfarin Orphan Drug Designation (ODD) for the prevention of thromboembolism and thrombosis in patients with an implanted mechanical circulatory support device (left ventricular assist device (LVAD), right ventricular assist device (RVAD), collectively known as ventricular assist devices (VADs), biventricular assist device, and total artificial heart).



“This second orphan drug designation highlights the expanded need for tecarfarin where existing anticoagulation therapies are inadequate,” said Quang Pham, Founder, Chairman and Chief Executive Officer of Cadrenal Therapeutics. “We are dedicated to advancing tecarfarin through clinical development options as swiftly as possible.”

The FDA’s ODD program provides incentives to sponsor organizations for the development of innovative treatments for rare diseases that affect fewer than 200,000 people in the U.S. Since its adoption in 1983, the Orphan Drug Act has helped countless individuals living with these conditions gain access to life-enhancing and life-saving therapies. ODD also provides certain benefits to drug developers, including assistance in the drug development process, tax credits for certain clinical research, and a waiver of the New Drug Application user fee. The designation is made to promote safe and efficacious products for the treatment of rare conditions.

All patients with VADs require chronic anticoagulation to prevent the formation of thrombus (clot) which can cause the device to fail or can result in a clot breaking off (embolizing), resulting in a stroke or other vascular catastrophe.

The current market-leading direct oral anticoagulants (DOACs), such as Eliquis, are not indicated for patients with VADs due to a lack of evidence of benefit. Moreover, a recent study revealed that the level of anticoagulation achieved with warfarin, the only currently available Vitamin K Antagonist (VKA), is maintained in the target range only 56% of the time which has been shown to increase the risk of clotting and bleeding complications.

ABOUT CADRENAL THERAPEUTICS, INC.

Cadrenal Therapeutics is developing tecarfarin for unmet needs in anticoagulation therapy. Tecarfarin is a late-stage novel oral and reversible anticoagulant (blood thinner) to prevent heart attacks, strokes, and deaths due to blood clots in patients with rare cardiovascular conditions. Tecarfarin has orphan drug and fast-track designations from the FDA for the prevention of systemic thromboembolism (blood clots) of cardiac origin in patients with end-stage kidney disease (ESKD) and atrial fibrillation (AFib) and just received orphan drug designation for the prevention of thrombosis and thromboembolism in patients with ventricular assist devices (VADs). Cadrenal is also pursuing additional regulatory strategies for unmet needs in anticoagulation therapy for patients with thrombotic antiphospholipid syndrome (APS). Tecarfarin is specifically designed to leverage a different metabolism pathway than the oldest and most commonly prescribed Vitamin K Antagonist (warfarin). Tecarfarin has been evaluated in eleven (11) human clinical trials and more than 1,000 individuals. In Phase 1, Phase 2, and Phase 2/3 clinical trials, tecarfarin has generally been well-tolerated in both healthy adult subjects and patients with chronic kidney disease. For more information, please visit www.cadrenal.com.

Safe Harbor Statement

Any statements contained in this press release about future expectations, plans, and prospects, as well as any other statements regarding matters that are not historical facts, may constitute “forward-looking statements.” These statements include statements regarding tecarfarin addressing unmet needs in anticoagulation therapy and the ability to derive the anticipated and potential benefits from the recent Orphan Drug Designation for tecarfarin, including seven years of market exclusivity, and the expanded development and commercial partnering for tecarfarin as a result of the Orphan Drug Designation. The words “anticipate,” “believe,” “continue,” “could,” “estimate,” “expect,” “intend,” “may,” “plan,” “potential,” “predict,” “project,” “should,” “target,” “will,” “would” and similar expressions are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words. Actual results may differ materially from those indicated by such forward-looking statements as a result of various important factors, including the Company’s ability to derive the anticipated benefits from the recent Orphan Drug Designation for tecarfarin and the other risk factors described in the Company’s Annual Report on Form 10-K for the year ended December 31, 2023, and the Company’s filings with the Securities and Exchange Commission, including periodic reports on Quarterly Reports on Form 10-Q and Current Reports on Form 8-K. Any forward-looking statements contained in this press release speak only as of the date hereof and, except as required by federal securities laws, the Company specifically disclaims any obligation to update any forward-looking statement, whether as a result of new information, future events, or otherwise.

For more information, please contact:

Cadrenal Therapeutics:
Matthew Szot, CFO
858-337-0766
press@cadrenal.com

Investors:
Lytham Partners, LLC
Robert Blum, Managing Partner
602-889-9700
CVKD@lythampartners.com

View original content to download multimedia:https://www.prnewswire.com/news-releases/cadrenal-therapeutics-receives-fda-orphan-drug-designation-for-tecarfarin-for-prevention-of-thromboembolism-and-thrombosis-in-patients-with-lvads-rvads-biventricular-assist-devices-and-total-artificial-hearts-302111758.html

SOURCE Cadrenal Therapeutics, Inc.

Johnson & Johnson Flexes Its M&A Muscle with $12.5 Billion Shockwave Medical Buy

Posted on by slightbourne@noblecapitalmarkets.com

Healthcare giant Johnson & Johnson announced on Friday that it is acquiring Shockwave Medical for a whopping $12.5 billion in cash, in a move that further bolsters its cardiovascular device portfolio. The deal allows J&J to add Shockwave’s innovative intravascular lithotripsy (IVL) system to its offerings.

IVL is a minimally invasive technique that uses sonic pressure waves to crack calcified plaque in arteries prior to inserting stents – similar in concept to how shockwaves are used to break up kidney stones. This novel approach helps improve outcomes for certain challenging arterial calcification cases that traditional treatment can struggle with.

Under the terms of the agreement, J&J will pay $335 per share for Shockwave, representing a 17% premium over the company’s stock price in late March when acquisition rumors first surfaced. The total enterprise value of the transaction is approximately $13.1 billion when including the cash on Shockwave’s balance sheet.

The acquisition comes hot on the heels of J&J’s $16.6 billion purchase of heart pump maker Abiomed last year, as the company doubles down on expanding its cardiovascular capabilities. Analysts see significant opportunity in this space, with RBC estimating the total addressable market for IVL and similar calcified plaque treatments at around $10 billion annually.

For Shockwave, being acquired by the deep-pocketed J&J provides the resources to ramp up commercialization of its breakthrough IVL system, which generated $730 million in sales last year. Meanwhile, the deal aligns with J&J’s strategic efforts to augment its medical device segment amid increasing competitive pressures in its pharmaceutical arm.

The Shockwave acquisition exemplifies a broader trend of large healthcare conglomerates snapping up promising smaller companies and technologies to drive future growth. With organic drug pipelines drying up and patent expirations looming, “big pharma” players are turning to M&A to inject innovation into their product portfolios.

Just last week, pharma giant AbbieVie announced multi-million dollar buyouts of smaller biotech firm Landos. Earlier this year, AstraZeneca shelled out $2.4 billion for oncology innovator Fusion Pharmaceuticals.

For investors interested in identifying the next potential M&A targets in healthcare’s hot growth areas, one upcoming event to mark on the calendar is the Noble Capital Markets Emerging Growth Virtual Healthcare Conference on April 17-18. This two-day virtual investor conference will feature presentations from emerging public and private healthcare companies spanning biotech, medical devices, healthcare IT and services. You can register at no cost for this event here.

The Noble virtual conference provides an ideal opportunity for institutional investors, financial advisors and independent investors alike to gain insights into cutting-edge healthcare innovations that could be tomorrow’s M&A prizes for industry titans like J&J. Presenting companies will span an array of therapeutic areas including oncology, neurology, xenotransplantation and more.

As the Shockwave deal demonstrates, big pharma isn’t shying away from spending big to stay ahead of the healthcare innovation curve. For investors, uncovering the next game-changing therapies and technologies could uncover lucrative future buyout candidates.

Release – Zyversa Therapeutics Highlights Published Data Demonstrating NLRP3 Inflammasome Inhibition Has Potential To Decrease Atherosclerotic Lesions In Patients With Diabetes

Posted on by aweinsoff@channelchek.com

Research News and Market Data on ZVSA

Apr 4, 2024

PDF Version

  • Atherosclerosis (AS) and its sequelae are the most common cause of death in diabetic patients and one of the reasons why diabetes has entered the top 10 causes of death worldwide.
  • The published data show that inhibiting the NLRP3 inflammasome pathway significantly reduces atherosclerotic lesions and improves hyperglycemic-induced plaque instability.
  • ZyVersa is developing IC 100, a monoclonal antibody targeting inflammasome ASC and ASC specks from multiple types of inflammasomes, including NLRP3, to block initiation and perpetuation of damaging inflammation that promotes atherosclerosis and its progression, among numerous other inflammatory diseases.

WESTON, Fla., April 04, 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, highlights data from a peer-reviewed article published in Biochemical and Biophysical Research Communications. This article demonstrates that NLRP3 inhibition results in improved glucose tolerance and markedly smaller and more stable atherosclerotic lesions in a diabetic mouse model.

In the paper titled, “High glucose levels accelerate atherosclerosis via NLRP3-IL/ MAPK/ NF-κB-related inflammation pathways,” the authors evaluated serum and coronary artery tissues from patients with coronary artery disease (CAD), with and without diabetes and they conducted a study in diabetic mouse models. Key findings include:

  • Patients with comorbid CAD and diabetes had higher serum levels and expression of NLRP3 in their coronary arteries, and increased serum levels of IL-1β and IL-6 than those with CAD only.
  • Diabetic mouse models showed a significantly higher atherosclerotic plaque/vessel area ratio than non-diabetic mice, which was markedly reduced with NLRP3 inhibition and the resulting reduction in levels of proinflammatory cytokines and inflammation.

The authors concluded, “Our research offers new understanding of the pathological mechanisms of diabetes-accelerated AS and provide a novel and promising target for treating diabetes-accelerated AS.” To review the publication, Click Here.

“We are excited about the data published in Biochemical and Biophysical Research Communications demonstrating that inhibiting inflammasome NLPR3 pathways has potential to attenuate the development and progression of AS in patients with diabetes, a leading cause of morbidity and mortality,” commented Stephen C. Glover, ZyVersa’s Co-founder, Chairman, CEO, and President. “We look forward to seeing our preclinical data with Inflammasome ASC Inhibitor IC 100 in an animal model of atherosclerosis in the first half of this year. We believe that by inhibiting multiple types of inflammasomes and disrupting the structure and function of their associated ASC specks to attenuate initiation and perpetuation of inflammation, that IC 100 has promise to effectively control AS development and progression.” To review a white paper summarizing the mechanism of action and preclinical data for IC 100, Click Here.

About Inflammasome ASC Inhibitor IC 100

IC 100 is a novel humanized IgG4 monoclonal antibody that inhibits the inflammasome adaptor protein ASC. IC 100 was designed to attenuate both initiation and perpetuation of the inflammatory response. It does so by binding to a specific region of the ASC component of multiple types of inflammasomes, including NLRP1, NLRP2, NLRP3, NLRC4, AIM2, 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.

About ZyVersa Therapeutics, Inc.

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

Cautionary Statement Regarding Forward-Looking Statements

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

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

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

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

Onconova Therapeutics (ONTX) – Transaction Forms A New Company In Virology and Oncology

Posted on by cpereira@noblefcm.com


Wednesday, April 03, 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.

Onconova Merges With Trawsfynydd Therapeutics To Form Traws Pharma, Inc. Onconova announced a business combination with Trawsfynydd Therapeutics, a private company developing products for influenza and COVID-19. The new company will be called Traws Pharma Inc, and will add antivirals to narazaciclib and rigosertib. Upon completion, it will raise $14 million in a private placement to bring its cash balance to about $28 million.

Combination Brings New Drugs With Several Near Term Milestones. Trawsfynydd brings antiviral drugs for influenza and COVID-19. TRX100 (viroksavir) inhibits the cap-dependent endonuclease required by the influenza virus for replication. Preclinical studies have shown efficacy against wild-type virus and strains that have resistance to current drugs. It has completed Phase 1, with data showing safety, tolerability, and pharmacokinetics that have potential dosing advantages. A dose-extension study will evaluate two increased doses. Following dose selection, Phase 2 is expected to begin in 2H24.


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. 

Biotechs Onconova and Trawsfynydd Merge to Create Traws Pharma

Posted on by slightbourne@noblecapitalmarkets.com

In a deal uniting two biotech companies from opposite coasts, Onconova Therapeutics and Trawsfynydd Therapeutics announced they are combining forces through an all-stock merger. The newly created entity, dubbed Traws Pharma, will have a deep pipeline spanning virology and oncology when it begins trading on the Nasdaq as “TRAW” this Wednesday.

Traws is being launched with an approximately $28 million cash balance after a $14 million private placement investment led by elite life sciences funds OrbiMed and Torrey Pines. The cash provides ample runway as Traws prepares for multiple clinical catalysts in 2024 across its three lead programs.

The combined company will be led by an executive team blending leadership from the previous organizations. Incoming CEO Werner Cautreels, Ph.D., previously headed Trawsfynydd, while Onconova’s Steven Fruchtman, M.D., will serve as President and Chief Scientific Officer of Oncology for Traws.

On the virology side, Traws inherits Trawsfynydd’s advancing pipeline of antiviral candidates for influenza and COVID-19. Viroksavir, a novel cap-dependent endonuclease inhibitor, has completed Phase 1 testing for influenza and is slated to begin Phase 2 trials in the second half of this year. Early data could read out by the first half of 2025.

Travaltrelvir is Trawsfynydd’s oral protease inhibitor targeting COVID-19. A first-in-human Phase 1 study initiated screening in the first quarter, with topline data expected in the second half of 2024. If positive, Traws plans to rapidly advance travaltrelvir into a Phase 2 trial in the second half of 2024 enrolling moderate to severe COVID-19 patients.

From Onconova, Traws gains narazaciclib, a next-generation CDK4/6 inhibitor being evaluated in a Phase 1/2 trial for low-grade endometrioid endometrial cancer (LGEEC). Preclinical data suggests narazaciclib could offer an improved therapeutic window over approved CDK4/6 drugs like palbociclib with potentially fewer bone marrow and GI toxicities.

The merger deal terms entail Trawsfynydd shareholders receiving 75.7% ownership in the combined Traws entity, with Onconova shareholders getting 13.7% and the OrbiMed/Torrey Pines investors getting 10.6%. A key piece allows current Onconova investors to retain a contingent value right (CVR) entitling them to potential future proceeds from narazaciclib.

Traws’ board will blend representation as well, co-led by Executive Chairman Iain Dukes, DPhil from OrbiMed and Nikolay Savchuk, Ph.D. of Torrey Pines, along with continuing Onconova directors.

While delivering upside potential from a fresh pipeline spanning anti-infectives and cancer, the Traws merger does come with a degree of complexity and deal risk. The share issuances require a shareholder vote, which could potentially disrupt the closing if there are any hiccups.

But if the transaction goes through as anticipated, Traws Pharma will emerge as a unique hybrid biotech play. Bolstered by crossover financing, it will seek to advance multiple clinical candidates toward key data inflections that could help unlock their full therapeutic and commercial potential across areas of significant unmet medical need.

Take a moment to take a look at more biotech companies by taking a look at Noble Capital Market’s Senior Research Analyst Robert Leboyer’s coverage list.