Rapid development of a vaccine to prevent the global health crisis is a global imperative, and defining the stakes and potential hurdles is critical because regulatory and medical decisions are based on benefit/risk calculations.
The benefit of developing an effective vaccine is very high, and even greater if it can be deployed in time to prevent repeated or continuous epidemics.
A recent article in the NEW ENGLAND JOURNAL of Medicine said: “The need to rapidly develop a vaccine against SARS-CoV-2 comes at a time of explosion in basic scientific understanding, including in areas such as genomics and structural biology, that is supporting a new era in vaccine development.
Over the past decade, the scientific community and the vaccine industry have been asked to respond urgently to epidemics of H1N1 influenza, Ebola, Zika, and now SARS-CoV-2.
An H1N1 influenza vaccine was developed relatively rapidly, largely because influenza-vaccine technology was well developed and key regulators had previously decided that vaccines made using egg- and cell-based platforms could be licensed under the rules used for a strain change.
Although a monovalent H1N1 vaccine was not available before the pandemic peaked in the Northern Hemisphere, it was available soon afterward as a stand-alone vaccine and was ultimately incorporated into commercially available seasonal influenza vaccines.”
Active biotech companies with recent developments include: Hoth Therapeutics, Inc., Gilead Sciences, Inc., Inovio Pharmaceuticals, Inc., Sorrento Therapeutics, Inc., Vaxart, Inc.
The article continued: Multiple platforms are under development. Among those with the greatest potential for speed are DNA- and RNA-based platforms, followed by those for developing recombinant-subunit vaccines.
RNA and DNA vaccines can be made quickly because they require no culture or fermentation, instead using synthetic processes.
Developers’ and regulators’ experience with these platforms for personal oncology vaccines can facilitate rapid testing and release.
There are no approved RNA vaccines to date, but RNA vaccines have entered clinical trials, and regulators have experience in reviewing clinical trial applications and with associated manufacturing of the vaccines.
Hoth Therapeutics, Inc. BREAKING NEWS: Hoth Therapeutics Provides Shareholder Update on Therapeutics Pipeline – Management provides pipeline update for assets including its COVID-19 vaccine and peptide therapeutic
Hoth Therapeutics today is providing an update on its pipeline of therapeutics including six compounds in various stages of clinical development, targeting atopic dermatitis, lupus as well as a COVID-19 vaccine and peptide therapeutic.
“Hoth has assembled a unique and portfolio of therapeutics, that is each addressing significant unmet market needs globally.
We have partnered with some of the most renowned doctors, clinics, and scientific institutions as we strive to bring these innovative therapeutic solutions through the clinic.
We have several significant milestones upcoming throughout the rest of 2020 into next year including our human study for BioLexa, targeting the treatment of eczema in adolescents.
Management remains committed to developing, and bringing these novel treatments to market and improving the lives of those that require them,” stated Mr. Robb Knie, CEO of Hoth Therapeutics.
BioLexa Platform (Dermatological) – The BioLexa Platform is a proprietary antimicrobial therapy designed for the treatment of atopic dermatitis or eczema through a non-corticosteroid approach.
In January 2020, Hoth concluded its “In-life 28-day animal study”.
The BioLexa Platform has recorded positive results from its pilot project in 2019 and most recently obtained strong data from initial animal testing.
Additionally the Company is preparing to begin its first trial in humans later this year.
VNLG-152 (Dermatological) – Earlier this year, Hoth acquired the full licensing rights of VNLG-152 novel retinamides (Retinoic acid metabolism blocking agents, or RAMBAs) for the treatment of dermatological diseases.
The Company previously announced that pre-clinical work is underway at Weill Cornell Medicine to examine the efficacy of RAMBAs in blocking acne pathogenic gene expression and carcinogenesis in mice.
Currently, Hoth is exploring whether VNLG-152 is capable of blocking this inflammatory response.
Immediately after identifying an effective dose of VNLG-152, the researchers will conduct studies on mouse skin to determine if this drug is effective in blocking acne-like inflammation.
As the Weill Cornell lab reopens later this month Hoth has intentions to finalize results of its preclinical work.
WEG-232 (Dermatological) – Last year Hoth entered into a research agreement with the George Washington University (GW) to explore the potential use of WEG-232 for topical and/or systemic therapy to counter the dermatological related side-effects of Erlotinib therapy in cancer patients.
Erlotinib is a drug that is used to combat various cancers and has been known to cause varying degrees of skin rashes, lesions, hair loss and nail changes to patient.
A recent research study suggested the topical application of WEG-232 could be very effective in suppressing erlotinib induced-facial rash/hair loss with approximate 71% reduction.
It concluded that WEG-232 may be used as an effective intervention to prevent EGFR-TKI-induced cutaneous toxicity.
Hoth looks forward to filing a pre-IND with the FDA this year to receive guidance and begin its human trial.
VaxCelerate (COVID-19) – VaxCelerate is self-assembling vaccine (SAV) platform designed to protect patients at risk of Coronavirus (COVID-19) infection.
VaxCelerate is believed to offer unique advantages over other compounds in combination therapy.
In infectious applications, it allows rapid development against viruses and other pathogens.
The vaccine focuses on both DNA and internal / external mutated proteins providing the immune system with more potential targets to attack.
VaxCelerate is currently in animal trials and will share those results as the testing completes.
Novel Peptide Therapeutic (COVID-19) – The Company recently licensed technology and intellectual property exclusively from Virginia Commonwealth University (“VCU”) for a novel peptide therapeutic to prevent spike protein binding, a potential leading cause of COVID-19.
This treatment could be a breakthrough in slowing the transmission of the virus.
Current research is being led by inventor, Michael H. Peters, Ph.D., Professor, Department of Chemical and Life Science Engineering at VCU, College of Engineering.
The work is being aided, in part, by powerful supercomputers as part of the COVID-19 High Performance Computing Consortium through a virtual system that scientists can use to interactively share computing resources known as the Extreme Science and Engineering Discovery Environment.
Hoth hopes to have an update as to further collaboration with VCU in the month ahead.
AEA loaded into Z-pods™ (Lupus) – Developed in partnership with Zylö Therapeutics, Hoth’s AEZ-loaded Z-pods™ are currently being tested for approval in the treatment of Cutaneous Lupus Erythematosus (CLE).
Scientists have demonstrated that topical administration with AEA-loaded nanoparticles significantly prevents the development of CLE in an established animal model of lupus.
Exon Skipping Approach (Allergic Disease) – During Q4 of 2019, Hoth entered into a licensing agreement with North Carolina State University (NC State) to study NC State’s Exon Skipping Approach for Treating Allergic Diseases.
This Exon Skipping Approach was developed by Dr. Glenn Cruse, Principal Investigator and Assistant Professor in the Department of Molecular Biomedical Sciences at the NC State College of Veterinary Medicine.
During Dr. Cruse’s research, a new approach for the technique of antisense oligonucleotide-mediated exon skipping to specifically target and down-regulate IgE receptor expression in mast cells was identified.
Through this collaborative project, NCSU looks to establish the most effective approach for targeting genes that regulate surface expression of FcεRI in mast cells that mediate allergic airway inflammation.
Other industry developments from around the markets include:
Gilead Sciences, Inc. recently announced topline results from the Phase 3 SIMPLE trial in hospitalized patients with moderate COVID-19 pneumonia.
This open-label study evaluated 5-day and 10-day courses of the investigational antiviral remdesivir plus standard of care, versus standard of care alone.
The study demonstrated that patients in the 5-day remdesivir treatment group were 65 percent more likely to have clinical improvement at Day 11 compared with those in the standard of care group (OR 1.65 [95% CI 1.09-2.48]; p=0.017).
The odds of improvement in clinical status with the 10-day treatment course of remdesivir versus standard of care were also favorable, trending toward but not reaching statistical significance (OR 1.31 [95% CI 0.88-1.95]; p=0.18).
No new safety signals were identified with remdesivir across either treatment group. Gilead plans to submit the full data for publication in a peer-reviewed journal in the coming weeks.
“Our understanding of the spectrum of SARS-CoV-2 infection severity and presentations of COVID-19 continues to evolve.
These study results offer additional encouraging data for remdesivir, showing that if we can intervene earlier in the disease process with a 5-day treatment course, we can significantly improve clinical outcomes for these patients,” said Francisco Marty, MD, an infectious diseases physician at Brigham and Women’s Hospital, and associate professor of medicine at Harvard Medical School.
Inovio Pharmaceuticals, Inc. recently announced the publication of the preclinical study data for IN0-4800, its COVID-19 DNA vaccine, demonstrating robust neutralizing antibody and T cell immune responses against coronavirus SARS-CoV-2.
The study was published in the peer-reviewed journal Nature Communications titled, “Immunogenicity of a DNA vaccine candidate for COVID-19” by INOVIO scientists and collaborators from The Wistar Institute, the University of Texas, Public Health England, Fudan University, and Advaccine.
Dr. Kate Broderick, INOVIO’s Senior Vice President of R&D and the Team Lead for COVID-19 vaccine development, said, “These positive preclinical results from our COVID-19 DNA vaccine (INO-4800) not only highlight the potency of our DNA medicines platform.
Also build on our previously reported positive Phase 1/2a data from our vaccine against the coronavirus that causes MERS, which demonstrated near-100% seroconversion and neutralization from a similarly designed vaccine INO-4700.
The potent neutralizing antibody and T cell immune responses generated in multiple animal models are supportive of our currently on-going INO-4800 clinical trials.”
Sorrento Therapeutics, Inc. recently announced it has received clearance from the U.S. Food and Drug Administration (FDA) for its investigational new drug (IND) application for STI-6129, a CD38-targeting antibody drug conjugate (ADC).
STI-6129 utilizes several technology platforms that are under development by Sorrento Therapeutics, including a CD38 specific antibody identified from its fully human G-MAB™ antibody library, its proprietary drug payload Duostatin 5 and its site-specific C-LOCK conjugation technology.
“That the FDA cleared our STI-6129 IND application to proceed to human trials is another important milestone for Sorrento.
Together with our CD38 CAR-T program, this has the potential to provide additional therapeutic options for patients in need.
We are looking forward to further evaluating the safety and efficacy of STI-6129 in clinical trials,” stated Dr. Henry Ji, Chairman and CEO of Sorrento Therapeutics.
Vaxart, Inc. a clinical-stage biotechnology company developing oral recombinant vaccines that are administered by tablet rather than by injection, recently announced that it has selected its lead COVID-19 vaccine candidate and has contracted with KindredBio to manufacture bulk vaccine under cGMP to complement the manufacturing capacity of partner Emergent BioSolutions.
“All our COVID-19 vaccine constructs were highly immunogenic in preclinical testing, and we are taking the candidate forward that is expected to generate the broadest immune response in humans.
In a phase 2 efficacy study that was recently published in the Lancet Infectious Diseases, we have demonstrated that our oral H1 flu tablet vaccine protected against influenza infection after just one dose.
Based on these results, we believe our vaccines are ideal to protect against mucosal respiratory viruses such as SARS-CoV-2, the virus that causes COVID-19,” said Sean Tucker, Ph.D., chief scientific officer of Vaxart.
In January 2020, Vaxart initiated a program to develop a COVID-19 vaccine based on its VAAST™ oral vaccines platform.
The Company evaluated multiple vaccine candidates in its preclinical models and has chosen the lead candidate for cGMP manufacturing and clinical testing based on the magnitude and the breadth of the immune response.
Vaxart has contracted with Emergent BioSolutions (“Emergent”) and Kindred Biosciences, Inc. (“KindredBio”) to produce bulk vaccine under cGMP for upcoming clinical trials.
The vaccine tablets will be manufactured at Vaxart.
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