Last update 21 Dec 2024
VRC-01
Last update 21 Dec 2024
Overview
Basic Info
Drug Type Monoclonal antibody |
Synonyms VRC-HIVMAB01060-00-AB, VRC 01 MRNA, VRC01 + [1] |
Mechanism HIV envelope protein gp120 inhibitors |
Therapeutic Areas |
Active Indication- |
Inactive Indication |
Originator Organization |
Active Organization- |
Drug Highest PhasePendingPhase 2 |
First Approval Date- |
Regulation- |
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Gene Sequence
Sequence Code 13383401L
Source: *****
Sequence Code 319922396H
Source: *****
Related
13
Clinical Trials associated with VRC-01ANTIRETROVIRAL ANALYTICAL TREATMENT INTERRUPTION (ATI) TO ASSESS IMMUNOLOGIC AND VIROLOGIC RESPONSES IN PARTICIPANTS WHO RECEIVED VRC01 OR PLACEBO AND BECAME HIV-INFECTED DURING HVTN 704/HPTN 085
Start Date15 Feb 2021 |
Sponsor / Collaborator- |
Phase I/II Multisite, Randomized, Controlled Study of Monoclonal Antibody VRC01 With Combination Antiretroviral Therapy to Promote Clearance of HIV-1-Infected Cells in Infants
The purpose of this study was to evaluate the safety and antiviral activity to promote clearance of HIV-1 infected cells of VRC01 in infants with HIV beginning combination antiretroviral therapy (cART).
Start Date06 Aug 2018 |
Sponsor / Collaborator |
A Phase 1 Clinical Trial to Evaluate the Safety, Pharmacokinetics, and Anti-Viral Activity of VRC-HIVMAB060-00-AB (VRC01) and VRC-HIVMAB080-00-AB (VRC01LS) in the Serum and Mucosa of Healthy, HIV-Uninfected Adult Participants
This study will evaluate the safety, pharmacokinetics, and antiviral activity of VRC-HIVMAB060-00-AB (VRC01) and VRC-HIVMAB080-00-AB (VRC01LS) in the serum and mucosa of healthy, HIV-uninfected adults.
Start Date01 Mar 2017 |
Sponsor / Collaborator |
100 Clinical Results associated with VRC-01
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100 Translational Medicine associated with VRC-01
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100 Patents (Medical) associated with VRC-01
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279
Literatures (Medical) associated with VRC-0101 Jan 2025·METABOLIC ENGINEERING
Flux balance analysis and peptide mapping elucidate the impact of bioreactor pH on Chinese hamster ovary (CHO) cell metabolism and N-linked glycosylation in the fab and Fc regions of the produced IgG
Article
Author: Ierapetritou, Marianthi ; Singh, Sumit Kumar ; Reddy, Jayanth Venkatarama ; Lee, Kelvin H ; Lee, Kelvin H. ; Papoutsakis, Eleftherios Terry ; Leibiger, Thomas
Culture conditions have a profound impact on therapeutic protein production and glycosylation, a critical therapeutic-quality attribute, especially for monoclonal antibodies (mAbs). While the critical culture parameter of pH has been known since the early 1990s to affect protein glycosylation and production, detailed glycan and metabolic characterization and mechanistic understanding are critically lacking. Here, Chinese Hamster Ovary (CHO) cells were grown in bioreactors at pH 6.75, 7, and 7.25 (± 0.03) to examine how pH affects cell metabolism and site-specific N-linked glycosylation of the produced broadly neutralizing anti-HIV IgG1 mAb. VRC01 has N-linked glycosylation sites in both the Fc region and the Fab region, a situation not previously examined with respect to mAb glycosylation as affected by culture conditions. Using parsimonious Flux Balance Analysis (pFBA) and Flux Variability Analysis (FVA), we dissect and quantitate the impact of pH on cell growth, glucose/lactate metabolism, accumulation of the toxic metabolite ammonia, IgG production rates, and nonessential amino acid metabolism. pFBA revealed that beyond the established mechanism of glutamine conversion to glutamate, ammonia is also produced by the reaction converting serine to pyruvate, especially in the later phases of culture. pFBA also provided insights into the switch from ammonia production to consumption, notably due to depletion of glutamine, and consumption of glutamate and aspartate. We document that culture duration and pH alter the complex bimodal patterns (production/uptake) of several essential and non-essential amino acids. Site-specific N-linked glycan analysis using glycopeptide mapping demonstrated that pH significantly affects the glycosylation profiles of the two IgG1 sites. Fc region glycans were completely fucosylated but did not contain any sialylation. The Fab region glycans were not completely fucosylated but contained sialylated glycans. Bioreactor pH affected both the fucosylation and sialylation indexes in the Fab region and the galactosylation index of the Fc region. However, fucosylation in the Fc region was unaffected thus demonstrating that the effect of pH on site-specific N-linked glycosylation is complex.
22 Oct 2024·JOURNAL OF VIROLOGY
Short CDRL1 in intermediate VRC01-like mAbs is not sufficient to overcome key glycan barriers on HIV-1 Env
Article
Author: Stamatatos, Leonidas ; Salladay, Kelsey R. ; Pancera, Marie ; MacCamy, Anna ; Knudsen, Maria L. ; Kher, Gargi M. ; Sanders, Rogier W. ; Bontjer, Ilja ; Kallur Siddaramaiah, Latha ; Stuart, Andrew B. ; Hurlburt, Nicholas K. ; Khechaduri, Arineh ; Gristick, Harry B. ; Bjorkman, Pamela J. ; Montefiori, David ; Agrawal, Parul ; Shen, Xiaoying
ABSTRACT:
VRC01-class broadly neutralizing antibodies (bnAbs) have been isolated from people with HIV-1, but they have not yet been elicited by vaccination. They are extensively somatically mutated and sometimes accumulate CDRL1 deletions. Such indels may allow VRC01-class antibodies to accommodate the glycans expressed on a conserved N276 N-linked glycosylation site in loop D of the gp120 subunit. These glycans constitute a major obstacle in the development of VRC01-class antibodies, as unmutated antibody forms are unable to accommodate them. Although immunizations of knock-in mice expressing human VRC01-class B-cell receptors (BCRs) with specifically designed Env-derived immunogens lead to the accumulation of somatic mutations in VRC01-class BCRs, CDRL1 deletions are rarely observed, and the elicited antibodies display narrow neutralizing activities. The lack of broad neutralizing potential could be due to the absence of deletions, the lack of appropriate somatic mutations, or both. To address this point, we modified our previously determined prime-boost immunization with a germline-targeting immunogen nanoparticle (426c.Mod.Core), followed by a heterologous core nanoparticle (HxB2.WT.Core), by adding a final boost with a cocktail of various stabilized soluble Env trimers. We isolated VRC01-like antibodies with extensive somatic mutations and, in one case, a seven-amino acid CDRL1 deletion. We generated chimeric antibodies that combine the vaccine-elicited somatic mutations with CDRL1 deletions present in human mature VRC01 bnAbs. We observed that CDRL1 indels did not improve the neutralizing antibody activities. Our study indicates that CDRL1 length by itself is not sufficient for the broadly neutralizing phenotype of this class of antibodies.
IMPORTANCE:
HIV-1 broadly neutralizing antibodies will be a key component of an effective HIV-1 vaccine, as they prevent viral acquisition. Over the past decade, numerous broadly neutralizing antibodies (bnAbs) have been isolated from people with HIV. Despite an in-depth knowledge of their structures, epitopes, ontogenies, and, in a few rare cases, their maturation pathways during infection, bnAbs have, so far, not been elicited by vaccination. This necessitates the identification of key obstacles that prevent their elicitation by immunization and overcoming them. Here we examined whether CDRL1 shortening is a prerequisite for the broadly neutralizing potential of VRC01-class bnAbs, which bind within the CD4 receptor binding site of Env. Our findings indicate that CDRL1 shortening by itself is important but not sufficient for the acquisition of neutralization breadth, and suggest that particular combinations of amino acid mutations, not elicited so far by vaccination, are most likely required for the development of such a feature.
30 Aug 2024·Science Immunology
Immunization with germ line–targeting SOSIP trimers elicits broadly neutralizing antibody precursors in infant macaques
Article
Author: Derking, Ronald ; Weinbaum, Carolyn ; Yasmeen, Anila ; Sanders, Rogier W. ; Eudailey, Joshua ; Zhang, Shiyu ; Villinger, Francois ; Hudgens, Michael G. ; Ward, Andrew B. ; Cronin, Kenneth ; Isaac, John ; De Paris, Kristina ; Cupo, Albert ; Nelson, Ashley N. ; Davis, Dominique ; Chutkan, Suni ; Stanfield-Oakley, Sherry ; Berendam, Stella ; Wiehe, Kevin ; Chen, Yue ; Byrd, Alliyah ; Klasse, Per Johan ; Dennis, Maria ; Gao, Hongmei ; Williams, Wilton B. ; Milligan, Emma ; Cross, Kaitlyn A. ; Sewall, Leigh M. ; Moore, John P. ; Permar, Sallie R. ; Rogers, Kenneth ; van Schooten, Jelle ; Ferrari, Guido ; Van Rompay, Koen K. A. ; Shirreff, Lisa ; Vekatayogi, Sravani ; Alam, S. ; LaBranche, Celia C. ; Ozorowski, Gabriel ; Montefiori, David C. ; Shen, Xiaoying ; Memon, Saad
Adolescents are a growing population of people living with HIV. The period between weaning and sexual debut presents a low-risk window for HIV acquisition, making early childhood an ideal time for implementing an immunization regimen. Because the elicitation of broadly neutralizing antibodies (bnAbs) is critical for an effective HIV vaccine, our goal was to assess the ability of a bnAb B cell lineage–designed HIV envelope SOSIP (protein stabilized by a disulfide bond between gp120-gp41—named “SOS”—and an isoleucine-to-proline point mutation—named “IP”—at residue 559) to induce precursor CD4 binding site (CD4bs)–targeting bnAbs in early life. Infant rhesus macaques received either a BG505 SOSIP, based on the infant BG505 transmitted/founder virus, or the CD4bs germ line–targeting BG505 SOSIP GT1.1 (
n
= 5 per group). Although both strategies induced durable, high-magnitude plasma autologous virus neutralization responses, only GT1.1-immunized infants (
n
= 3 of 5) exhibited VRC01-like CD4bs bnAb precursor development. Thus, a multidose immunization regimen with bnAb lineage–designed SOSIPs shows promise for inducing early B cell responses with the potential to mature into protective HIV bnAbs before sexual debut.
5
News (Medical) associated with VRC-0102 Jul 2024
A major challenge in developing a vaccine for HIV is that the virus mutates fast -- very fast. Although a person initially becomes infected with one or a few HIV strains, the virus replicates and mutates quickly, resulting in a 'swarm' of viral strains existing in a single body.
A major challenge in developing a vaccine for HIV is that the virus mutates fast -- very fast. Although a person initially becomes infected with one or a few HIV strains, the virus replicates and mutates quickly, resulting in a "swarm" of viral strains existing in a single body. But scientists at Scripps Research; IAVI; the Ragon Institute of Mass General, MIT, and Harvard; La Jolla Institute for Immunology; and additional institutions have conducted a series of preclinical trials indicating that they're potentially closer to an immunization regimen than ever before -- one that could produce rare antibodies that would be effective against a wide range of HIV strains.
Published in Science, Science Immunology, and Science Translation Medicine on May 16, 2024, the findings are outlined in four individual papers and build on a 2022 phase I clinical trial conducted by the nonprofit scientific research organization IAVI. The findings represent a key step forward in an immunization strategy that could protect against the virus.
"All in all, these studies show that we have a good chance at creating an effective HIV vaccine -- we just need to keep iterating and build on these findings in future clinical trials," says co-senior author of all four studies, William Schief, PhD, who is also a Scripps Research professor; vice president for antigen design and selection, Infectious Disease Research, at Moderna, Inc.; and executive director of vaccine design at IAVI's Neutralizing Antibody Center.
The HIV vaccine strategy involves stimulating the body to produce mature broadly neutralizing antibodies (bnAbs). bnAbs are among the immune system's key players in fighting HIV, since they can block many variants of the virus. The problem is that bnAbs produced by the human body are rare. The IAVI trial, spearheaded in part by Schief, focused on inducing the immune cells that could eventually evolve into the right bnAbs -- ones that could protect host cells from multiple HIV strains. These precursor immune cells, known as B cells, were stimulated with the help of a priming immunogen -- a customized molecule to "prime" the immune system and elicit responses from the correct precursor cells.
But the primer also requires additional "booster" immunogens to coax the immune system into producing not just precursor cells, but coveted VRC01-class bnAbs -- a rare and specific class of antibodies known to neutralize more than 90 percent of diverse HIV strains. Boosters are also needed for the production of BG18 -- another important bnAb class that binds to sugars on the HIV spike protein. That's where the new studies come in: Researchers developed immunization regimens that could prime either VRC01 or BG18 precursors, and subsequently boost those precursors further down the path toward becoming bnAbs.
"The results contained in these papers are deeply exciting and further support the germline-targeting strategy to HIV vaccine development that IAVI and our partners are pursuing," says Mark Feinberg, MD, PhD, president and CEO of IAVI. "We look forward to continuing our collaboration with Scripps Research and partners to advance further research building on these promising findings."
This groundbreaking science is enabled by collaboration between scientific institutions and funding partners. Without the ongoing, critical support of the Scripps Consortium for HIV/AIDS Vaccine Development (CHAVD), the Collaboration for AIDS Vaccine Discovery (CAVD), the Bill & Melinda Gates Foundation, and Moderna (the manufacturer of the mRNA used in these studies), this research would not have been possible.
Priming rare antibodies
In the first study, which focused on BG18, Scripps Research scientists collaborated with co-senior authors Shane Crotty, PhD, chief scientific officer at La Jolla Institute for Immunology, and Devin Sok, PhD, former vice president, discovery and innovation at IAVI. Using a priming immunogen, they consistently primed exceptionally rare BG18 precursors in a wild-type animal model.
To confirm they were able to prime the correct precursors, the researchers then teamed up with Andrew Ward, PhD, Scripps Research integrative structural and computational biology professor and co-senior author of the study. Using cryo-EM structural analysis, they validated that the antibodies were indeed part of the BG18 class.
"The fact that priming worked well in macaques suggests that it has a good chance of succeeding in humans," says co-first author, Jon Steichen, PhD, an institute investigator in the Department of Immunology and Microbiology at Scripps Research.
Steichen was also co-first author on a second study, in which mice were modified to produce a low frequency of BG18 precursors. Scripps Research and IAVI scientists, along with the team of co-senior author Facundo Batista, PhD, associate director and scientific director of the Ragon Institute of MGH, MIT, and Harvard, used priming methods similar to the ones used in the first paper. However, a key difference was that this time, they also administered one of two boost immunogens using RNA technology. This resulted in boosting the primed B cells to adapt to recognize more native-like versions of HIV.
"This study showed that we can start to walk the B cells along toward bnAb development," Steichen explains.
Supercharging the immune system into action
For the third study, Schief and his team worked with IAVI scientists, wherein they primed a mouse model with the same immunogen used in the 2022 IAVI clinical trial. This resulted in mice that produced VRC01-class precursor B cells similar to those found in people. But the researchers also designed a new booster immunogen to drive the antibody response toward becoming matured bnAbs -- the next vital step in a sequential immunization series that could effectively fight HIV. The results: a "prime-boost" regimen that can drive VRC01-class B cells toward bnAb development.
"The findings demonstrate that we are able to make the antibody responses go in the right direction using this heterologous booster, which administers a different version of the vaccine than was given previously," says Christopher Cottrell, PhD, a senior staff scientist at Scripps Research who was the first co-author on this study.
Understanding the immunology
In the fourth and final study, on which Cottrell was also a co-first author, the team worked again with Batista's team at the Ragon Institute and used the same immunogens -- but in a different mouse model where his team could control the frequency of bnAb precursors that were modified to be similar to those found in humans. This allowed the researchers to take a deeper dive into the immunology associated with HIV vaccination by examining the germinal centers -- specialized microstructures in the body that protect against viral reinfection. Germinal centers provide B cells with a space to rapidly increase and mutate their antibody genes, ultimately helping the immune system fight off viral strains.
In addition, the researchers examined how germinal centers accumulate HIV mutations over time. They found that a prime-boost regimen increased precursor B-cell activity in germinal centers across different lineages, which could eventually lead to an increase in matured VRC01-class bnAbs.
What's next
Overall, all four papers confirm that the priming step to turn on the right bnAb precursors is possible when it comes to developing an HIV vaccine. Three of those papers specifically demonstrate that it's also possible to guide antibody precursors toward becoming bnAbs that can fight HIV.
"Taken together, the findings give us more confidence that we're able to prime precursors from multiple bnAb targets, and they also show that we're starting to learn the rules for how to advance precursor maturation through heterologous boosting," Schief added.
Following these results, the researchers are advancing phase 1, experimental medicine trials for both the VRC01 and BG18 projects. Vaccines aiming to prime and boost VRC01-class antibodies are being further evaluated in two clinical trials run by IAVI, IAVI G002 and IAVI G003, and a vaccine to prime BG18-class responses is being evaluated in HVTN144. These studies use both adjuvanted protein immunizations (IAVI G001 and HVTN144) and mRNA delivery (IAVI G002 and G003).
The results of these studies will guide the critical next steps on the discovery path to an HIV vaccine.
VaccineImmunotherapyPhase 1Clinical Result
30 May 2024
Using a combination of cutting-edge immunologic technologies, researchers have successfully stimulated animals' immune systems to induce rare precursor B cells of a class of HIV broadly neutralizing antibodies (bNAbs). The findings are an encouraging, incremental step in developing a preventive HIV vaccine.
Using a combination of cutting-edge immunologic technologies, researchers have successfully stimulated animals' immune systems to induce rare precursor B cells of a class of HIV broadly neutralizing antibodies (bNAbs). The findings, published in Nature Immunology, are an encouraging, incremental step in developing a preventive HIV vaccine.
HIV is genetically diverse making the virus difficult to target with a vaccine, but bNAbs may overcome that hurdle because they bind to parts of the virus that remain constant even when it mutates. Germline targeting is an immune system-stimulating approach that guides naïve (precursor) B cells to develop into mature B cells that can produce bNAbs. A class of bNAbs called 10E8 is a priority for HIV vaccine development because it neutralizes a particularly broad range of HIV variants. The 10E8 bNAb binds to a conserved region of the glycoprotein gp41 on HIV's surface involved in its entry into human immune cells. Designing an immunogen -- a molecule used in a vaccine that elicits a specific immune system response -- to stimulate production of 10E8 bNAbs has been challenging because that key region of gp41 is hidden in a recessed crevice on HIV's surface. Prior vaccine immunogens have not generated bNAbs with the physical structure to reach and bind to gp41.
To address this challenge, the researchers engineered immunogens on nanoparticles that mimic the appearance of a specific part of gp41. They vaccinated rhesus macaque monkeys and mice with those immunogens and elicited specific responses from the 10E8 B cell precursors and induced antibodies that showed signs of maturing into bNAbs that could reach the hidden gp41 region. They observed similar responses when they used mRNA-encoded nanoparticles in mice. The researchers also found that the same immunogens produced B cells that could mature to produce an additional type of gp41-directed bNAb called LN01. Finally, their laboratory analysis of human blood samples found that 10E8-class bNAb precursors occurred naturally in people without HIV, and that their immunogens bound to and isolated naïve human B cells with 10E8-like features. Together these observations suggest that the promising immunization data from mice and macaques has the potential for translation to humans.
The research was conducted by the Scripps Consortium for HIV/AIDS Vaccine Development, one of two consortia supported by the National Institutes of Health's (NIH) National Institute of Allergy and Infectious Diseases (NIAID). The research also was supported by collaborating partners including the Bill & Melinda Gates Foundation and other NIH Institutes and Offices. According to the authors, these findings support the development of the immunogens as the first part of a multi-step vaccine regimen for humans. Their work further supports research in developing a germline-targeting strategy for priming the immune system to elicit a bNAb called VRC01. This bNAb was discovered by NIAID researchers almost 15 years ago. The goal of this line of research is to develop an HIV vaccine that generates multiple classes of bNAbs to prevent HIV.
ImmunotherapyVaccineClinical Study
01 Dec 2022
COLLEGE STATION, TX / ACCESSWIRE / December 1, 2022 / Enzolytics, Inc. (OTC PINK:ENZC) ( ).
World AIDS Day has been recognized on this day since 1988. It is an important day for the world to reflect on those who have been lost in the HIV pandemic and recommit to the challenge necessary to address this deadly disease.
But why has the world failed to conquer HIV?
Even though there are treatments for those with HIV - antiretroviral drugs (ARVs) -, the treatments do not cure and require lifelong use - which over a lifetime cause severe side effects including bone loss, heart disease, diabetes, lactic acidosis, kidney, liver, or pancreas damage, among others.
Additionally, ARV treatments are extremely expensive. New ARV drugs such as Biktarvy by Gilead can costs up to $75K per year. Cabenuva by VIIV Healthcare costs $48K a year. As a result, of the 38.4 Million people in the world who have HIV, only 69% have access to any available treatment, leaving 31% with no treatment. Of children in the world with HIV, only 50% have access to treatment, leaving 50% with no treatment.
During the pandemic, over 40 Million have died from the virus. In 2021, 860,000 died from HIV, over 2,000 each day. Each day in 2021, approximately 850 children became infected with HIV and approximately 301 children died from AIDS-related causes.
In 2021, 301 children died each day from HIV. More than the number of children who succumb to cancer.
Attempts to produce monoclonal antibodies to successfully treat HIV have not succeeded. The anti-HIV monoclonal antibodies VRC01 and VRC02, produced by the NIH in conjunction with Vaccine Research Center, failed - due to virus mutation - namely "virus escape". . Many other attempts have also not been successful in providing effective treatment at a reasonable cost.
On this World AIDS Day, Enzolytics wishes to call attention to the continued need for more effective, and affordable treatments for HIV, including successful treatments for the growing number of individuals living longer with HIV. Because almost ½ of those with HIV are now 50 or older and approximately 1 in 6 new diagnoses of HIV occur in this age group, people aging with HIV can face treatment-related challenges, such as drug interactions between HIV medicines and medicines used for other conditions. Because older individuals are more likely not to be diagnosed with HIV, a delayed diagnosis means treatment is also delayed, resulting in HIV potentially causing more damage to the immune system. Additionally, data suggest that untreated HIV is resulting in the development of SARS-CoV-2 variants. In this regard, the Company's technology remains focused on both HIV and SARS-CoV-2.
The Company's technologies focus on a definitive therapy for treating HIV compared to the current treatment using ARVs. Specifically, the Company is advancing two platforms, one being a clinically tested, patented, antiviral therapeutic, known as ITV-1, that has shown significant effectiveness in treating patients with HIV/AIDS. This therapeutic is complementary to the Company's development of fully human monoclonal antibodies that target and neutralize the virus. Experts in the field have consistently acknowledged that a cure for HIV will require the administration of "multiple, broadly neutralizing monoclonal antibodies." Just as multiple anti-CoronaVirus monoclonal antibodies are now widely recognized as effective in treating those with COVID-19, the same will be true for anti-HIV monoclonal antibodies. But to be successful, such antibodies must be "broadly neutralizing" - that is, they must target conserved, immutable sites not rendered ineffective by mutant strains of the HIV virus. This is exactly the focus of the Company's technology.
A.I. PLATFORM SUCCESS
To enhance its production of effective anti-HIV monoclonal antibodies, the Company has employed Artificial Intelligence (A.I.), using computer analysis to curate (analyze) the amino acid sequences of targeted viruses to identify the conserved, immutable, and neutralizable target sites (epitopes) on viruses. Once identified, the Company uses its proprietary technology to produce fully human monoclonal antibodies that target these identified immutable sites - thereby producing a therapeutic that does not fail due to virus mutations - known as virus escape. Additionally, these identified target sites may be used to develop more effective vaccines - a vaccine development methodology significantly different than mRNA vaccine production.
Using Artificial Intelligence, Enzolytics has identified immutable conserved epitopes for numerous viruses and is focused on producing monoclonal antibodies targeting these sites. The Company has fully analyzed over 87,000 HIV isolates using A.I. identifying 8 conserved epitopes and over 2 Million COVID-19 isolates to identify 19 conserved epitopes. The Company is in the process of producing antibodies targeting these conserved sites. These conserved epitope sites on the HIV and CoronaVirus are claimed in the Company's now pending PCT patent applications.
The far-reaching nature of the Company's A.I. analysis is seen by noting that in addition to curating isolates of HIV and COVID-19, the Company has fully analyzing each of the following viruses and identified the conserved epitopes on the viruses: HTLV-1, H10N3, Influenza A, and B, H1N1 influenza, Respiratory syncytial virus (RSV), Ebola, Small-Pox, Tetanus, Diphtheria, Rabies, Herpes zoster, Varicella zoster, Anthrax, Elephant endotheliotropic herpesviruses, Feline Leukemia Virus, Equine Infectious Anemia Virus, Feline Immunodeficiency virus, Small Ruminant Lentivirus, and Koala retrovirus. The Company's future efforts are production of monoclonal antibodies targeting these virus sites. PCT Patent Applications will be filed covering these discoveries.
The Company's A.I. is significant for the following reasons:
The A.I. platform incorporates genomic surveillance and monitoring of virus epidemiology. The Enzolytics AI team is working on a comprehensive Artificial Intelligence protocol to analyze existing viruses and any new virus immediately upon its emergence globally.
Enzolytics also utilizes A.I. to assess the effects of Genetics, Nutrition, and the Human Microbiome on infectious diseases, mental health disorders, and chronic medical diseases. The purpose of this focus is to:
Build prediction models for infectious diseases, mental health disorders, and chronic medical diseases.
Identify biomarkers for infectious diseases, mental health disorders, and chronic medical diseases.
Identify novel targets and clear intervention strategies for infectious diseases, mental health disorders, and chronic medical diseases.
This is part of Enzolytics' strategic effort to expand to the personalized medicine market and increase its Intellectual Property portfolio. The Company's Chief Operating Officer, Dr. Gaurav Chandra, has described the role of Artificial Intelligence in understanding the microbiome, leading to biomarkers, innovative diagnostic tools, and novel treatment strategies in diseases in an article "Demystifying the Human Microbiome using Artificial Intelligence" published in the Yuan ( ).
HIV THERAPEUTICS
Addressing the HIV pandemic, the Company has two expectedly complementary therapeutics directed to the effective treatment of HIV. One therapeutic, ITV-1, a patented antiviral peptide that has been clinically tested, is a suspension of Inactivated Pepsin Fragment (IPF), a purified extract of porcine pepsin. This therapeutic has been shown to strengthen the immune system and has been tested in HIV patients in clinical trials with significant beneficial results. [ ]. Currently, the Company is advancing this anti-HIV therapeutic for approval under the European Medicines Agency (EMA) for use in European Union countries.
The Company also is focused on deploying this tested therapeutic in African countries, where the HIV pandemic is severe. Upon completion of final Toxicity Studies of ITV-1, the Company plans to be able to make ITV-1 available in the countries in Africa, including Rwanda, the Democratic Republic of Congo, Angola, Kenya, and South Africa. The Company sees this as significant for individuals in Africa recognizing that out of the 38.4 Million HIV-positive people worldwide, 69% live in sub-Saharan Africa. There are roughly 23.8 Million infected persons in all of Africa. 40% of those infected with HIV in Africa do not have any access to any treatment for the virus. In addition, 91% of the world's HIV-positive children live in Africa.
The second therapeutic for treating HIV, the Company's anti-HIV monoclonal antibodies, are also in development. The Company's primary anti-HIV antibody has been produced from the parent antibody in the recombinant form (a form necessary for patient treatment) by Samsung Biologics. Samsung Biologics will provide end-to-end CDMO services from cell line development, clinical drug substance, and drug product manufacturing services to support IND filings for Anti-HIV Monoclonal Antibody Therapy for the treatment of HIV. The Company notes that this anti-HIV mAb targets an immutable site on the HIV virus that has existed unchanged over 30 years of analysis of the virus. This means that the target will not mutate rendering the antibody ineffective.
SARS-CoV-2 THERAPEUTICS
Addressing the COVID-19 pandemic, the Company is producing monoclonal antibodies targeting conserved sites on the SARS-CoV-2 virus identified using Artificial Intelligence. The conserved targeted conserved sites are found in all variants of concern - including the COVID-19 Omicron variant. Thus, the monoclonal antibodies being produced by the Company, due to the conserved nature of the targeted epitopes, are expected to be effective against current and future variants of the COVID-19 virus.
The Company is using multiple processes to accelerate the production of these monoclonal antibodies. As acknowledged by experts in the field, numerous monoclonal antibodies are needed for effective therapy. By using accelerated technology systems in collaboration with Abveris, a division of Twist Bioscience Corporation, desired antibodies may be produced in shorter time frames. Abveris applies advanced immunization methods combined with B cell screening and hybridoma-based antibody discovery technologies to provide comprehensive gene-to-antibody discovery services. In addition, the Company has a strong working relationship with Samsung Biologics, which provides end-to-end CDMO services from cell line development, clinical drug substance, and drug product manufacturing services to support IND filings for produced antibodies.
ENZOLYTICS IPF IMMUNE™ THERAPEUTIC
The Company is now producing its "Enzolytics IPF Immune™," a liquid nutritional supplement that provides support for the body's immune system. The active components in the supplement have been registered with the FDA for use in the U.S. under NDI Reg. No. 1083. The Company's product is produced and sold pursuant to its license under U.S. Patent No. 8,309,072 (the '072 Patent). This '072 Patent, entitled "Irreversibly-Inactivated Pepsinogen Fragments for Modulating Immune Function," covers the use of Irreversibly Inactivated Pepsin Fragments (IPF). The primary IPF ingredient is a complex platform that provides support for the immune system. The U.S. vitamin and supplement industry currently totals $35.6 Billion in 2022 while the global sector is worth $151.9 Billion. The Company expects the product to be very well received by consumers.
CEO Charles Cotropia said, "In this past year, we have made great progress in advancing several platforms for providing multiple therapeutics for the treatment of many significant human conditions. While we are happy with our recent progress, we know we will be successful going forward given the wide range of our technologies and the multiple platforms we have developed. These platforms will make possible our production of therapeutics covering an extensive range of diseases for which therapies are desperately needed."
About Enzolytics, Inc.
Enzolytics, Inc. is a drug development company committed to commercializing its proprietary proteins and monoclonal antibodies for the treatment of debilitating infectious diseases. The Company is advancing multiple therapeutics targeting numerous infectious diseases. One patented and clinically tested compound, ITV-1 (Immune Therapeutic Vaccine-1), is a suspension of Inactivated Pepsin Fraction (IPF), covered by U.S. Patent Nos. 8,066,982 and 7,479,538. Studies have shown it to be effective in treating HIV/AIDS. IPF is the active component of ITV-1 and is a purified extract of porcine pepsin. ITV-1 has also been shown to modulate the immune system.
The Company is also implementing its proprietary technology to produce fully human monoclonal antibodies (mAbs) against infectious diseases, including HIV, SARS CoV-2, rabies, influenza A, influenza B, tetanus, and diphtheria. Its proprietary methodology, covered in multiple PCT Patent Applications for producing fully human monoclonal antibodies, is currently employed to produce monoclonal antibody therapeutics for numerous infectious diseases, including the Coronavirus (SARS-CoV-2) and HTLV-1.
Safe Harbor Statement: This news release contains forward-looking statements that involve risks and uncertainties associated with financial projections, budgets, milestone timelines, clinical development, regulatory approvals, and other risks described by Enzolytics, Inc. from time to time in its periodic reports filed with the SEC. ITV-1 is not approved by the U.S. Food and Drug Administration or by any comparable regulatory agencies elsewhere in the world.
While Enzolytics, Inc. believes that the forward-looking statements and underlying assumptions contained therein are reasonable, any of the assumptions could be inaccurate, including, but not limited to, the ability of Enzolytics to establish the efficacy of its therapeutics in the treatment of any disease or health condition, the development of studies and strategies leading to commercialization of its therapeutics in the United States, the obtaining of funding required to carry out the development plan, the completion of studies and tests on time or at all, and the successful outcome of such studies or tests. Therefore, there can be no assurance that the forward-looking statements included in this release will prove to be accurate.
Such forward-looking statements are based on current expectations. They involve inherent risks and uncertainties, including factors that could delay, divert or change any of the statements made, and cause actual outcomes and results to differ materially from current expectations. No forward-looking statement can be guaranteed. These forward-looking statements are made as of the date of this press release. The Company expressly disclaims any intention or obligation to update the forward-looking statements or update the reasons why actual results could differ from those projected in the forward-looking statements.
Company Contact:
Enzolytics, Inc.
Texas A&M University
Institute for Preclinical Studies
College Station, TX 77843-44
SOURCE: Enzolytics, Inc.
View source version on accesswire.com:
Clinical StudyVaccineImmunotherapy
100 Deals associated with VRC-01
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R&D Status
10 top R&D records. to view more data
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| Indication | Highest Phase | Country/Location | Organization | Date |
|---|---|---|---|---|
| HIV Infections | Phase 2 | US | 06 Apr 2016 | |
| HIV Infections | Phase 2 | BR | 06 Apr 2016 | |
| HIV Infections | Phase 2 | PE | 06 Apr 2016 | |
| HIV Infections | Phase 2 | CH | 06 Apr 2016 |
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Clinical Result
Clinical Result
Indication
Phase
Evaluation
View All Results
| Study | Phase | Population | Analyzed Enrollment | Group | Results | Evaluation | Publication Date |
|---|
Phase 1/2 | 61 | Combination Antiretroviral Therapy (cART)+VRC01 (VRC01 (Arm 1)) | fwaxwgawam(qdkwrzbiir) = ochrjlqawf xvlylczsrd (wxpoohblit, ldsrebzsio - ekuijnpwbb) View more | - | 24 May 2023 | ||
Combination Antiretroviral Therapy (cART) (No-VRC01 (Arm 2)) | fwaxwgawam(qdkwrzbiir) = ckvvphnfsi xvlylczsrd (wxpoohblit, geoatayvip - wgipbqwalm) View more | ||||||
Phase 2 | 1,924 | Placebo (Placebo) | zqnqmtlvrc(ltazrsannq) = keqhgsymtv ppwdjirzib (wdrzmaruae, cpamifunbl - vylqcbtwvy) View more | - | 08 Feb 2022 | ||
(Low-Dose VRC01) | zqnqmtlvrc(ltazrsannq) = xtvfuouokz ppwdjirzib (wdrzmaruae, puyxrynxdk - ndlhnqmfxf) View more | ||||||
Phase 2 | 2,699 | Placebo (Placebo) | gempmpuiho(wdfbixyeqd) = lzyvrhwopz kldrvpedjo (ypetcwzhva, uoavdjumbb - moazgaqfqu) View more | - | 08 Feb 2022 | ||
(Low-Dose VRC01) | gempmpuiho(wdfbixyeqd) = gsmjosgtld kldrvpedjo (ypetcwzhva, nfqakdwjsz - hnktdgavsm) View more | ||||||
Not Applicable | - | 9 | (Early ART initiation) | axryguscnk(cugrvdfgzm) = qssycxkycl zlndywlzch (awqeclikgm ) | - | 01 Jan 2022 | |
Phase 1 | 83 | (Dose Group 1) | gxnpftmcow(hgaohefsuz) = pliyoxnlls vqkamnqfxr (ccpotkkyqb, mqooilnnty - iabcgxccbz) View more | - | 23 Aug 2021 | ||
(Dose Group 2) | gxnpftmcow(hgaohefsuz) = winqufgfbp vqkamnqfxr (ccpotkkyqb, mxfxkvqhlh - bsvxiaatgr) View more | ||||||
Not Applicable | - | - | qfslvvouet(wpdajrdkaf) = uwnjxcpjdu tfqnjydzgu (hgecjiqdzd, 27.6% - 89.9%) | - | 01 Jan 2021 | ||
Phase 1 | 40 | hceorjvnoq(hmqbnoucxn) = Subcutaneous VRC01 was safe and well tolerated with only mild-to-moderate local reactions, primarily erythema, which rapidly resolved. For multiple-dose infants, local reactions decreased with subsequent injections. evelphkdmx (froqtghgzh ) | Positive | 23 Jul 2020 | |||
Phase 2 | 19 | vgszsmewkq(ldncqhomfy) = No serious adverse events were reported in either group ldeahfljoc (eijmwpwjtp ) | Negative | 01 May 2019 | |||
Placebo | |||||||
Phase 1 | 40 | pifborrsah(cyrwgwixkn) = mlzyeywmmp uctrluofvu (tkwdjeqbqu ) | Positive | 20 Oct 2018 | |||
Placebo | pifborrsah(cyrwgwixkn) = rwjkibhyek uctrluofvu (tkwdjeqbqu ) | ||||||
Phase 2 | 23 | (VRC01) | xmmgqisduc(ulkillsyap) = bwydstrrbf seyqslpuwt (odewgyqgzc, navkqgafsl - gmmjjguiab) View more | - | 17 Oct 2018 | ||
Placebo for VRC01 (Placebo for VRC01) | xmmgqisduc(ulkillsyap) = hgkvzadjrx seyqslpuwt (odewgyqgzc, zyczlepwyd - iqfhlufvwc) View more |
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