Tag: Biotechnology

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

Posted on by cpereira@noblefcm.com


Tuesday, October 31, 2023

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

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

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

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

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


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. 

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

Posted on by slightbourne@noblecapitalmarkets.com

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

Posted on by slightbourne@noblecapitalmarkets.com

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

Posted on by aweinsoff@channelchek.com

Research News and Market Data on GOVX

 

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

Designed to Protect Immunocompromised Patients Against Severe COVID-19

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

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

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

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

About GEO-CM04S1

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

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

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

About GeoVax

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

Forward-Looking Statements

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

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

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

Medical Device Company Laborie Acquires Urotronic for Innovative Prostate Treatment Technology

Posted on by slightbourne@noblecapitalmarkets.com

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

Release – GeoVax Update: Clinical and Operational Progress Toward Transformative Opportunities

Posted on by aweinsoff@channelchek.com

Research News and Market Data on GOVX

ATLANTA, GA, October 24, 2023 – GeoVax Labs, Inc. (Nasdaq: GOVX), a biotechnology company developing immunotherapies and vaccines against cancers and infectious diseases, today announced an update on key strategic initiatives.

“The third quarter marked advancements in our next-generation COVID-19 vaccine clinical programs and our cancer therapy program, along with advanced manufacturing developments, and new patents issued for our Ebola, Marburg, Malaria, and HIV vaccines. I look forward to sharing more details about these developments during our upcoming investor/analyst earnings call on November 8,” said David Dodd, GeoVax’s Chairman and CEO.

“We believe this is a defining moment for the Company, as we expand the full potential of a next-generation COVID-19 vaccine (GEO-CM04S1) currently in three Phase 2 clinical trials and the broad application of Gedeptin® against solid tumors. We are gearing up to announce initial data readouts from two of these trials, along with updates from our Gedeptin clinical trial against advanced head and neck cancer as well as other important corporate developments. We believe that these upcoming catalysts will have a profound impact on patients in need and all our stakeholders.”

Recent Company Highlights

GEO-CM04S1

  • Investigator-Initiated Clinical Trial Begins, “Randomized Observer-Blinded Phase 2 Trial of COVID-19 Booster with GEO-CM04S1 or Pfizer-BioNtech Bivalent Vaccine in Patients with Chronic Lymphocytic Leukemia.”

    • Trial is rapidly enrolling patients, progressing towards an interim data review.
  • Enrollment Target Completed for Phase 2 Clinical Trial Evaluating GEO-CM04S1 as a Booster for Healthy Patients Who Have Previously Received the Pfizer or Moderna mRNA Vaccine.
    • Initial data readout is expected soon.
  • GeoVax Next-Generation COVID-19 Vaccine (GEO-CM04S1) Demonstrated Potent Antibody and Cellular Immunity in Immunocompromised Patients.
    • The journal, Vaccines, publishes data (GEO-CM04S1 Publication) from GeoVax’s Phase 2 clinical trial evaluating the safety and immunogenicity of GEO-CM04S1 next-generation COVID-19 vaccine, compared to either the Pfizer/BioNTech or Moderna mRNA-based vaccine in patients who have previously received an allogeneic hematopoietic cell transplant, an autologous hematopoietic cell transplant or CAR-T cell therapy.
  • GeoVax Universal COVID-19 Vaccine Data Presented at Keystone Symposia Conference.
    • Abstract Title: MVA-vector multi-antigen COVID-19 vaccines induce protective immunity against SARS-CoV-2 variants spanning Alpha to Omicron in preclinical animal modes.
    • Data revealed: GEO-CM02 vaccine induced immune responses that were efficacious against the original Wuhan strain and BA.1 Omicron variant with a single dose.

Gedeptin®

  • Gedeptin® Clinical Data presented at the AACR-AHNS Head and Neck Cancer Conference
    • Abstract Title: Phase 1/2 study of Ad/PNB with Fludarabine for the Treatment of Head and Neck Squamous Cell Carcinoma (HNSCC).
    • Data revealed: FDA-funded study reveals that administration of Gedeptin® is safe and feasible.

Advanced Vaccine Manufacturing Process

  • GeoVax and ProBioGen announced the signing of a landmark commercial license agreement for ProBioGen’s groundbreaking AGE1.CR.pIX® suspension cell line. The agreement empowers GeoVax to enhance the manufacturing capabilities of its entire Modified Vaccinia Ankara (MVA)-based vaccine portfolio.

Intellectual Property Developments

  • GeoVax announced that the U.S. Patent and Trademark Office has issued a Notice of Allowance for Patent Application No. 17/584,231 titled patent titled “Replication Deficient Modified Vaccina Ankara (MVA) Expressing Marburg Virus Glycoprotein (GP) and Matrix Protein (VP40).”
  • GeoVax announced that the U.S Patent and Trademark Office has issued a Notice of Allowance for Patent Application No. 17/409,574 titled “Multivalent HIV Vaccine Boost Compositions and Methods of Use.”
  • GeoVax announced that the U.S. Patent and Trademark Office has issued a Notice of Allowance for Patent Application No. 17/726,254 titled “Compositions and Methods for Generating an Immune Response to Treat or Prevent Malaria.”
  • GeoVax announced that the U.S. Patent and Trademark Office has issued Patent No. 11,701,418 B2 to GeoVax, pursuant to the Company’s patent application No. 15/543,139 titled “Replication-Deficient Modified Vaccinia Ankara (MVA) and Matrix Protein (VP40).”

About GeoVax

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

Forward-Looking Statements

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

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

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

Release – PDS Biotech Announces Preliminary Biomarker Study Results in Subset of Advanced HPV-Positive Head and Neck Cancer Patients at ESMO

Posted on by aweinsoff@channelchek.com

Research News and Market Data on PDSB

  • Combination of PDS0101 and KEYTRUDA® appears to lead to changes towards a TH1 predominant cytokine profile reported to be associated with improved killer T cell activity
  • Lowered CD8 T cells in peripheral blood after treatment align with previously reported CD8 T cell targeting and accumulation in tumors1

PRINCETON, N.J., Oct. 23, 2023 (GLOBE NEWSWIRE) — PDS Biotechnology Corporation (Nasdaq: PDSB) (PDS Biotech or the Company), a clinical-stage immunotherapy company developing a growing pipeline of targeted cancer immunotherapies and infectious disease vaccines based on the Company’s proprietary T cell activating platforms, today announced immune response data from a preliminary analysis of a subset of patients in VERSATILE-002, the Phase 2 clinical trial evaluating the safety and efficacy of PDS0101 in combination with Merck’s anti-PD-1 therapy KEYTRUDA® (pembrolizumab) in patients with human papillomavirus (HPV)16-positive recurrent or metastatic head and neck squamous cell carcinoma (HNSCC). The data presented during the European Society for Medical Oncology Congress 2023 (ESMO Congress 2023) provided preliminary insight to the pre-existing immune responses in advanced HPV-positive HNSCC patients and potential changes to the immune profile after treatment.

“Generation of multifunctional, anti-tumor T cells with the relevant cytokine and chemokine profiles are necessary for effective long-term control of tumor growth and clinical outcomes. This initial study focused on understanding the immunological profile of advanced head and cancer patients in the blood,” said Kevin Harrington, PhD, Professor of Biological Cancer Therapies, The Royal Marsden. “This preliminary study suggests that PDS0101 may promote a TH1 predominant cytokine profile as well as induction of important T cell activating chemokines. Such studies could be helpful in providing further insight into how PDS0101 in combination with KEYTRUDA® alters T cell cytokine and chemokine profiles to promote improved clinical outcomes.”

The data presented at ESMO 2023 included 18 patients with a median age of 63 years (range 46-83) and all had confirmed HPV16-positive tumors. The immunological profiles were assessed at three timepoints: pre-treatment,12 (cycle 5), and 36 weeks (cycle 13) following four and five cycles of combination therapy, respectively.

Highlights of the analysis include:

  • Combination of PDS0101 and KEYTRUDA® appears to lead to changes towards a TH1 predominant cytokine profile reported to be associated with improved killer T cell activity
  • Combination of PDS0101 and KEYTRUDA® resulted in increased polyfunctionality reflected in T cells expressing 5 or more cytokines. Increased polyfunctionality is typically associated with enhanced killing function and anti-tumor activity

“This analysis provides preliminary insights into how PDS0101 in combination with KEYTRUDA® may be impacting specific cytokines and chemokines in CD8 and CD4 T cell populations,” said Lauren V. Wood, MD, Chief Medical Officer of PDS Biotech. “The investigational combination appears to be promoting a predominant TH1 immunologic profile that is associated with decreases in CD8 T cells in peripheral blood. We are encouraged that these observations align with other Phase 2 studies reporting PDS0101-induced polyfunctional CD8 T cells traffic to tumors and we look forward to continued investigation in our VERSATILE-003 Phase 3 study.”

1 Klopp A, et al. 2022. IMMUNOCERV, an ongoing Phase II trial combining PDS0101, an HPV-specific T cell immunotherapy, with chemotherapy and radiation for treatment of locally advanced cervical cancers. Presented at: Society for Immunotherapy of Cancer; November 8-12, 2022. Boston, MA. Abstract: 674.

About PDS0101
PDS0101, PDS Biotech’s lead candidate, is a novel investigational human papillomavirus (HPV)-targeted immunotherapy that stimulates a potent targeted T cell attack against HPV-positive cancers. PDS0101 is given by subcutaneous injection alone or in combination with other immunotherapies and cancer treatments. In a Phase 1 study of PDS0101 in monotherapy, the treatment demonstrated the ability to generate multifunctional HPV16-targeted CD8 and CD4 T cells with minimal toxicity. Interim data suggests PDS0101 generates clinically active immune responses and the combination of PDS0101 with other treatments can demonstrate significant disease control by reducing or shrinking tumors, delaying disease progression, and/or prolonging survival. The combination of PDS0101 with other treatments does not appear to compound the toxicity of other agents.

About VERSATILE-002
VERSATILE-002 is a single-arm Phase 2 trial evaluating the safety and efficacy of PDS0101, an HPV16-targeted investigational T cell-activating immunotherapy that leverages PDS Biotech’s proprietary Versamune® technology, in combination with Merck’s anti-PD-1 therapy, KEYTRUDA® (pembrolizumab). The combination is being evaluated in immune checkpoint inhibitor (ICI)-naïve and ICI-refractory patients with recurrent/metastatic HPV16-positive head and neck squamous cell carcinoma (HNSCC) and was granted Fast Track designation by the Food and Drug Administration in June 2022.

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

Forward Looking Statements
This communication contains forward-looking statements (including within the meaning of Section 21E of the United States Securities Exchange Act of 1934, as amended, and Section 27A of the United States Securities Act of 1933, as amended) concerning PDS Biotechnology Corporation (the “Company”) and other matters. These statements may discuss goals, intentions and expectations as to future plans, trends, events, results of operations or financial condition, or otherwise, based on current beliefs of the Company’s management, as well as assumptions made by, and information currently available to, management. Forward-looking statements generally include statements that are predictive in nature and depend upon or refer to future events or conditions, and include words such as “may,” “will,” “should,” “would,” “expect,” “anticipate,” “plan,” “likely,” “believe,” “estimate,” “project,” “intend,” “forecast,” “guidance”, “outlook” and other similar expressions among others. Forward-looking statements are based on current beliefs and assumptions that are subject to risks and uncertainties and are not guarantees of future performance. Actual results could differ materially from those contained in any forward-looking statement as a result of various factors, including, without limitation: the Company’s ability to protect its intellectual property rights; the Company’s anticipated capital requirements, including the Company’s anticipated cash runway and the Company’s current expectations regarding its plans for future equity financings; the Company’s dependence on additional financing to fund its operations and complete the development and commercialization of its product candidates, and the risks that raising such additional capital may restrict the Company’s operations or require the Company to relinquish rights to the Company’s technologies or product candidates; the Company’s limited operating history in the Company’s current line of business, which makes it difficult to evaluate the Company’s prospects, the Company’s business plan or the likelihood of the Company’s successful implementation of such business plan; the timing for the Company or its partners to initiate the planned clinical trials for PDS0101, PDS0203 and other Versamune® and Infectimune® based product candidates; the future success of such trials; the successful implementation of the Company’s research and development programs and collaborations, including any collaboration studies concerning PDS0101, PDS0203 and other Versamune® and Infectimune® based product candidates and the Company’s interpretation of the results and findings of such programs and collaborations and whether such results are sufficient to support the future success of the Company’s product candidates; the success, timing and cost of the Company’s ongoing clinical trials and anticipated clinical trials for the Company’s current product candidates, including statements regarding the timing of initiation, pace of enrollment and completion of the trials (including the Company’s ability to fully fund its disclosed clinical trials, which assumes no material changes to the Company’s currently projected expenses), futility analyses, presentations at conferences and data reported in an abstract, and receipt of interim or preliminary results (including, without limitation, any preclinical results or data), which are not necessarily indicative of the final results of the Company’s ongoing clinical trials; any Company statements about its understanding of product candidates mechanisms of action and interpretation of preclinical and early clinical results from its clinical development programs and any collaboration studies; and other factors, including legislative, regulatory, political and economic developments not within the Company’s control. The foregoing review of important factors that could cause actual events to differ from expectations should not be construed as exhaustive and should be read in conjunction with statements that are included herein and elsewhere, including the other risks, uncertainties, and other factors described under “Risk Factors,” “Management’s Discussion and Analysis of Financial Condition and Results of Operations” and elsewhere in the documents we file with the U.S. Securities and Exchange Commission. The forward-looking statements are made only as of the date of this press release and, except as required by applicable law, the Company undertakes no obligation to revise or update any forward-looking statement, or to make any other forward-looking statements, whether as a result of new information, future events or otherwise. 

Versamune® and Infectimune® are registered trademarks of PDS Biotechnology Corporation. KEYTRUDA® is a registered trademark of Merck Sharp and Dohme LLC, a subsidiary of Merck & Co., Inc., Rahway, N.J., USA.

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

Media Contact:
Gina Cestari
6 Degrees
Phone: +1 (917) 797-7904
Email: gcestari@6degreespr.com

Release – Eledon Pharmaceuticals Strengthens Leadership Team with Appointment of Eliezer Katz, M.D., FACS as Chief Medical Officer

Posted on by aweinsoff@channelchek.com

Research News and Market Data on ELDN

IRVINE, Calif., Oct. 23, 2023 (GLOBE NEWSWIRE) — Eledon Pharmaceuticals, Inc. (“Eledon”) (NASDAQ: ELDN) today announced the appointment of Eliezer Katz, M.D., FACS as Chief Medical Officer with responsibility for leading the company’s clinical development programs.

“We are pleased to welcome Dr. Katz to the Eledon team,” said David-Alexandre C. Gros, M.D., Eledon Chief Executive Officer. “Dr. Katz brings a wealth of knowledge in the surgical transplantation field together with extensive experience designing and overseeing clinical trials for immunosuppressive treatments. We look forward to his leadership and contributions as we continue to advance tegoprubart for the prevention of rejection in patients undergoing transplantation procedures.”

Dr. Katz is an experienced transplant surgeon with significant clinical development experience. Most recently, he was Chief Medical Officer at eGenesis where he helped lead the clinical development of eGenesis’ xenotransplantation programs. Prior to eGenesis, Dr. Katz was Vice President of Clinical Development first at Viela Bio and then at Horizon Therapeutics following its acquisition of Vielo Bio. At Horizon and Viela Bio, Dr. Katz led the clinical development of inebilizumab in multiple autoimmune indications and oversaw the regulatory submission and approval of UPLIZNA®(inebilizumab) to treat neuromyelitis optica spectrum disorder in adults.

Prior to Viela Bio, Dr. Katz served as Senior Director of Clinical Development at MedImmune Inc. where he oversaw the clinical development of three different biologics. Prior to MedImmune, Dr. Katz served as Senior Director of Transplantation with the Medicine Development Group at Pfizer. At Pfizer, he oversaw multiple research programs with rapamycin, an anti-rejection drug, and was instrumental in the regulatory submission and FDA approval of rapamycin as a treatment for lymphangioleiomyomatosis (LAM), a rare and fatal lung disease.

Before joining industry, Dr. Katz spent two decades as a transplant surgeon. He was director of the abdominal transplantation division at Integris Baptist Medical Center in Oklahoma City, and an associate professor of surgery and the director of the liver transplantation division at the University of Massachusetts Medical Center, Worcester, MA. Dr. Katz spearheaded liver transplantation advances at these institutions and was actively involved with policy making in organ donation and allocation. Dr. Katz earned his M.D. at Hadassah Hebrew University Medical School in Jerusalem.

“With tegoprubart, Eledon is well positioned to meet the critical need for innovative transplantation immunosuppressant therapies,” said Dr. Katz. “I’m excited to join Eledon as the company continues to realize its vision to significantly improve the functional life of transplanted organs and address the side effects of current immunosuppressive treatments.”

About Eledon Pharmaceuticals and tegoprubart

Eledon Pharmaceuticals is a clinical stage biotechnology company with immunology expertise that is developing therapies to protect and prevent rejection of transplanted organs, as well as to treat amyotrophic lateral sclerosis (ALS). The Company’s lead compound in development is tegoprubart, an anti-CD40L antibody with high affinity for CD40 Ligand, a well-validated biological target with broad therapeutic potential. Eledon is headquartered in Irvine, California. For more information, please visit the company’s website at www.eledon.com.

Follow Eledon Pharmaceuticals on social media: LinkedIn; Twitter

Investor Contact:

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

Media Contact:

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

Source: Eledon Pharmaceuticals

Release – Baudax Bio Announces Corporate Update

Posted on by aweinsoff@channelchek.com

Research News and Market Data on BXRX

October 18, 2023 8:00am EDT

Company Poised to Initiate TI-168 Clinical Development Following Recent Shareholder Approval of Corporate Actions Related to TeraImmune Acquisition

Phase 1/2a Clinical Study of TI-168 In Hemophilia A with FVIII Inhibitors Projected to Begin Q1 2024

MALVERN, Pa., Oct. 18, 2023 (GLOBE NEWSWIRE) — Baudax Bio, Inc. (the “Company” or “Baudax Bio”) (NASDAQ: BXRX), a biotechnology company focused on developing T cell receptor (“TCR”) therapies utilizing human regulatory T cells (“Tregs”), as well as a portfolio of clinical stage Neuromuscular Blocking Agents (“NMBs”) and an associated reversal agent, today announced that following recent shareholder approval of corporate actions related to its June 29 2023 acquisition of TeraImmune, the Company is now poised to initiate clinical development of TI-168, the Company’s next-generation, FVIII specific Treg therapy designed to reliably and effectively address Hemophilia A patients with FVIII inhibitors. The Company anticipates initiating its Phase 1/2a clinical study of TI-168 in Hemophilia A patients with FVIII inhibitors with a modest initial budget in Q1 of 2024.

“We are very pleased with the broad support received in last week’s special shareholder meeting, during which shareholders approved all remaining issues related to our acquisition of TeraImmune,” said Gerri Henwood, President and Chief Executive Officer of Baudax Bio. “We believe this combination, which brings together TeraImmune’s research expertise with Baudax’s drug development experience for the initiation of clinical development of TI-168, represents the best path forward to create shareholder value. With shareholder support now secured, we can finalize our preparations for initiating a Phase 1/2a clinical study of TI-168 in Hemophilia A patients in Q1 of 2024.”

Stewart Mc Callum, MD, Consulting Chief Medical Officer for Baudax, added, “TI-168 is a TCR Treg designed to eliminate autoantibodies to Factor VIII in Hemophilia A patients, which significantly complicates the management of Hemophilia A. This product candidate previously had an IND filed seeking to treat human subjects that received regulatory clearance, and has also recently been granted Orphan Drug Designation by the FDA. Since our trial has an open label design, we anticipate early visibility on tolerability and initial efficacy data.”

“This trial represents the first time that TCR Tregs will be in a human clinical trial, and will seek to establish a dose where TI-168 eliminates T-cell and B cell mediated production of autoantibodies, demonstrating the potential of TI-168 to make Hemophilia A much less complicated for patients with inhibitors to manage. We are very excited for the opportunity to work toward this potential improvement to patient quality of life, and to deliver enhanced value for our shareholders and other stakeholders,” concluded Ms. Henwood.

About Baudax Bio

Baudax Bio is a biotech company focused on innovative products for certain auto-immune conditions, of which many but not all, are orphan drug conditions as well as acute care and related settings. The combined company will further the development of Treg therapy specific to HA (pipeline candidate TI-168). TI-168 is a next-generation, FVIII specific Treg therapy designed to reliably and effectively address Hemophilia A patients with FVIII inhibitor. By combining the patented Treg culture method and TeraImmune designed FVIII-specific TCR, the Company has successfully demonstrated the therapeutic concept of FVIII TCR-Treg therapy in controlling of FVIII ADA in a hemophilic animal model. The lead program TI-168 has shown encouraging pre-clinical data and the FDA has cleared an IND to commence a Phase 1/2a clinical trial for the treatment of Hemophilia A with inhibitors.

In addition, over time, the combined company will advance the development of TeraImmune’s innovative immune-cell therapies, leveraging a dual Treg manufacturing platform consisting of both natural regulatory Tregs isolated from patients and induced Tregs converted from a patient’s T-effector (“Teff”) cells. This Treg platform technology is designed for conditions that suppress unwanted immune reactions and includes the allogenic, or off-the-shelf, Tregs obtained from Umbilical Cord Blood for the treatment of skin diseases such as Atopic Dermatitis. For more information, please visit www.baudaxbio.com.

Forward Looking Statements

This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Such forward-looking statements reflect Baudax Bio’s expectations about its future performance and opportunities that involve substantial risks and uncertainties. When used herein, the words “anticipate,” “believe,” “estimate,” “may,” “upcoming,” “plan,” “target,” “goal,” “intend,” and “expect,” and similar expressions, as they relate to Baudax Bio, are intended to identify such forward-looking statements. Forward-looking statements are neither historical facts nor assurances of future performance. Instead, they are based on Baudax Bio’s current beliefs, expectations and assumptions regarding the future of its business, future plans and strategies, clinical results and other future conditions. Such forward-looking statements are subject to a number of material risks and uncertainties including but not limited to those set forth under the caption “Risk Factors” in Baudax Bio’s most recent Annual Report on Form 10-K filed with the SEC and its subsequent filings with the SEC. Any forward-looking statement speaks only as of the date on which it was made. Neither Baudax Bio, nor any of its affiliates, advisors or representatives, undertake any obligation to publicly update or revise any forward-looking statement, whether as result of new information, future events or otherwise, except as required by law. These forward-looking statements should not be relied upon as representing Baudax Bio’s views as of any date subsequent to the date hereof.

Investor Relations Contact:

Mike Moyer
LifeSci Advisors
mmoyer@lifesciadvisors.com

Source: Baudax Bio

Released October 18, 2023

Gilead Partnership Provides Boost to Assembly Bio’s Antiviral Pipeline

Posted on by slightbourne@noblecapitalmarkets.com

Clinical-stage biotech Assembly Biosciences gained a powerful ally in developing next-generation antivirals through a new collaboration with pharma giant Gilead Sciences. The deal provides Gilead access to Assembly Bio’s portfolio of early-stage assets while giving Assembly funding and expertise to advance its programs.

Under the 12-year partnership announced Monday, Gilead will provide $100 million upfront, including an equity investment at a premium. Assembly Bio gains potential milestone payments, royalties, and profit-sharing as programs progress.

For investors, the collaboration validates Assembly Bio’s antiviral pipeline and represents significant long-term revenue potential. The deal also propels Assembly closer to becoming a fully integrated biotech firm.

Assembly’s current clinical assets target major viral diseases like hepatitis B virus (HBV) and herpes simplex virus (HSV). Its preclinical pipeline holds promise against hepatitis D virus (HDV), human cytomegalovirus, and more.

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

Gilead brings extensive experience developing and commercializing leading antiviral drugs in HIV and hepatitis C. The pharma giant now doubles down on virology via Assembly’s early-stage assets.

Opting into a program after proof-of-concept could cost Gilead at least $45 million, signaling confidence in Assembly’s science. The biotech leads R&D initially, with Gilead taking over once assets transition to late-stage trials and commercialization.

For Assembly investors, this deal structure provides valuable de-risking of the pipeline. The company secures funding to advance programs while sharing in the upside if Gilead opts in to lucrative late-stage development and sales.

Assembly is eligible for up to $330 million per program in milestones post opt-in. Royalties range from high single digits to high teens. The biotech can also opt into U.S. profit-sharing.

These economics help offset the risk of clinical failure for Assembly’s shareholders. Meanwhile, Gilead pays for the privilege of accessing Assembly’s innovating antiviral pipelines.

The partnership enhances Assembly’s financial position and extends its operating runway. This enables advancing other preclinical programs beyond the leads Gilead can opt into.

For example, Assembly recently unveiled a promising pan-herpesvirus asset that could treat multiple herpes infections from one oral pill. Such follow-on compounds ensure future revenue potential.

Meanwhile, major progress by Gilead with Assembly’s lead assets could generate substantial royalties and profit-sharing income. Upside from the deal should become clearer as Gilead opts to license drugs entering late-stage testing over the 12-year term.

With a strengthened balance sheet and veteran partner at its side, Assembly Bio seems poised for a breakthrough as a developmental biotech focused on next-gen antivirals.

The Gilead deal provides third-party validation of Assembly’s science and a critical launchpad toward integrated status combining R&D, late-stage trials, and commercialization.

For Assembly investors, these benefits significantly de-risk the journey to having approved antiviral products on the market. If clinical programs pan out as hoped, the payoff from this partnership could be huge.

Eledon Pharmaceuticals (ELDN) – Journal Publishes Study On Tissue Engineering For Xenotransplantation Surgery

Posted on by cpereira@noblefcm.com


Monday, October 16, 2023

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.

Potential Breakthroughs In Xenotransplantation. The journal Nature has published a preclinical study by Eledon’s research collaborator detailing genetic changes to porcine (pig) cells and the results of their transplantation to monkeys. In September, the second successful transplant of an engineered pig heart to a human patient used Eledon’s tegoprubart for immune suppression. Both developments have overcome many technological barriers and could make trans-species organ transplantation a clinical reality.

Publication Details Some Of The Changes To Make Xenotransplants Compatible.  Transplanting organs from a non-human species has many additional challenges than transplantation from one human to another (allografts). The Nature article, from Eledon’s collaborator eGenesis, describes the design, creation, and function of kidney grafts from a genetically engineered porcine transplant into a cynomolgus monkey model. The article describes 69 genomic edits to the donor tissue, addition of 7 human genes, and inactivation of endogenous retroviruses. The transplanted monkeys survived up to 758 days (108 weeks).


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. 

Baudax Bio (BXRX) – Shareholders Approve Merger-Related Preferred Stock Conversion

Posted on by cpereira@noblefcm.com


Monday, October 16, 2023

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

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

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

Meeting Held October 12, 2023.  In an October 13th filing, Baudax Bio reported that proposals submitted to shareholders for a Special Meeting of Shareholders passed.  In particular, the Series X convertible preferred stock conversion to common shares was approved. The preferred shares were issued in conjunction with the TeraImmune merger announcement in June. In the merger agreement, Baudax Bio issued 1.212 million shares of common stock, and 27,089.719 shares of Series X convertible preferred to TeraImmune shareholders, with each preferred share convertible into 1,000 shares of common stock.  

Amended and Restated Articles of Incorporation Approved.  Shareholders also approved an amendment to effect a reverse stock split to be determined by the Board of Directors at any time in the next year, at the Board’s discretion.  The Board can set the reverse split within a range of 1:10 to 1:40.


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. 

Alzheimer’s Specialist Prothena Surges on Sale Speculation

Posted on by slightbourne@noblecapitalmarkets.com

Shares of clinical-stage biotech Prothena Corp skyrocketed over 20% on Monday amid reports the company is exploring strategic options including a potential sale. Prothena specializes in developing therapies for neurodegenerative diseases like Alzheimer’s, making it a hot target for larger pharmaceutical firms hungry for new assets in this space.

Based in Ireland and spun off from Elan Corp in 2012, Prothena focuses on protein misfolding disorders. Its pipeline features several promising programs targeting proteins believed to play a key role in Alzheimer’s and other neurological conditions with high unmet need.

Prothena’s lead candidate is birtamimab, an antibody-based therapy for AL amyloidosis in late-stage studies. Results expected later this year or in early 2024 could support regulatory filings. Beyond amyloidosis, the company is going all-in on Alzheimer’s research.

The most advanced Alzheimer’s asset is PRX012, an antibody targeting amyloid beta proteins thought to drive disease progression. Prothena is also developing a dual vaccine dubbed PRX012/PRX123 against amyloid beta and tau proteins. Reducing both proteins simultaneously may provide better clinical benefit.

These programs have already attracted partnership interest. Prothena has neuroscience collaborations with pharmaceutical giants Bristol Myers Squibb, Roche, and Novo Nordisk. Just this month, Bristol Myers exercised an option to license PRX005, Prothena’s anti-tau antibody, for nearly $60 million upfront.

But Prothena may seek an acquirer willing to buy the entire company outright. The potential payoff from Alzheimer’s success is massive given the huge unmet need. With late-stage data upcoming, now may be the optimal time for a sale.

Any acquirer would gain full access to Prothena’s Alzheimer’s pipeline, along with its programs for Parkinson’s disease and other neurodegenerative disorders. Adding these diverse assets to an existing neuroscience portfolio could create exciting synergistic opportunities.

Prothena’s small size also makes it financially digestible for big pharma buyers. The company’s market cap sits around $2.5 billion, presenting a worthwhile gamble for majors like Roche or Bristol Myers with scores of billions in annual revenue.

News of the company exploring strategic options sent Prothena shares surging 25% on nearly 6x normal volume. Investors are betting a buyout could be announced in coming months. Prothena’s pipeline progress makes it an alluring target.

Upcoming clinical results will prove whether Prothena’s Alzheimer’s bet pays off scientifically. But from a business perspective, the stars may be aligning for a near-term acquisition. Cash-rich pharmas need new prospects to bolster aging portfolios, and Prothena boasts some of the most exciting neurological assets out there.

If Prothena’s Alzheimer’s programs demonstrate strong efficacy, bidding wars could drive the buyout price sky-high. With biotech valuations rebounding from lows, management may see now as the perfect time to capitalize on these assets. Whether via sale, partnership or remaining independent, Prothena’s future direction should become clearer soon.