News Archive2021-01-26T20:12:43+00:00

News Archive

News Archive

News Archive

1207, 2019

IBT Receives Phase I SBIR grant from NIAID for development of neutralizing monoclonal antibodies against Marburg Virus

July 12th, 2019|

IBT in collaboration with the laboratory of Dr. Yuxing Li, at the University of Maryland, and Dr. Tom Geisbert laboratory and University of Texas Medical Branch (UTMB) receive a collaborative SBIR grant from NIH, entitled Monoclonal antibodies targeting novel sites of vulnerability in marburg virus glycoprotein.

Marburg virus has caused highly lethal outbreaks in the last few decades.  Currently there is only a single class of antibodies known to neutralize marburgviruses.   Under this grant IBT investigator Dr. M. Javad Aman with work with Dr. Li’s team to develop novel monoclonal antibodies from B cells of macaques immunized with IBT’s proprietary vaccine candidates. These antibodies will be tested in rodents and nonhuman primates at UTMB to select lead therapeutic candidates.

107, 2019

IBT Receives Phase II STTR grant from NIAID for development of Novel ISTAb therapeutics for B. anthracis

July 1st, 2019|

IBT in collaboration with Dr. Daniel Nelson’s lab at University of Tulane National Primate Center received a collaborative Phase II STTR grant from NIH, entitled Infection Site Targeted Antitoxin Antibody (ISTAb) against Bacillus anthracis

This Phase II Project builds upon successfully completed Phase I studies that showed proof of concept for a highly promising therapeutic strategy. This strategy is based on a novel technology that uses Infection Site Targeted neutralizing anti-toxin Antibodies (ISTAb) that are directed to the site of B. anthracis infection. In this Phase II project, Dr. Adhikari of IBT and collaborators will select a final product candidate based on the efficacy studies in mouse and NHP, as well as extended PK and stability studies.  Work under this project further includes computer-aided optimization of the lead ISTAb candidates and selection based on efficacy in rodents and nonhuman primates, as well as analytical development.

103, 2019

IBT Receives Phase I SBIR grant from NIAID for development of monoclonal antibodies against Marburg Virus using a novel discovery platform

March 1st, 2019|

IBT in collaboration with the laboratory of Dr. Brandon Dekosky, at the University of Kansas, and Dr. Tom Geisbert laboratory and University of Texas Medical Branch (UTMB) receive a collaborative SBIR grant from NIH, entitled Mining natively paired macaque antibodies for Marburg virus protective antibodies.

Marburg virus has caused highly lethal outbreaks in the last few decades.  Currently there is a paucity of immunotherapeutic options in the pipeline for treatment of this deadly diseases.  Under this grant IBT investigator Dr. Shweta Kailasan with work with Dr. Dekosky’s team to develop novel monoclonal antibodies using a new method for identification of natively paired heavy and light chains from B cells of macaques immunized with IBT’s proprietary vaccine candidates. These antibodies will be tested in rodents at UTMB to select lead therapeutic candidates.

103, 2019

IBT Receives Phase I/II Fast Track SBIR grant from NIAID for development of broadly protective monoclonal antibodies against Influenza Virus

March 1st, 2019|

IBT in collaboration with Abviro, LLC (Bethesda, MD) received a collaborative SBIR grant from NIH, entitled Development of a Universal Immunotherapeutic for Influenza Viruses.

Influenza virus (INFV) results in global seasonal and pandemic outbreaks estimated to cause severe illness in 3 to 5 million people annually causing significant morbidity and economic impact. Vaccination is currently the most effective disease control intervention, but constant annual surveillance of circulating viruses is necessary to predict effective vaccine composition. Currently available influenza drugs only result in modest clinical efficacy with limited effectiveness due to viral resistance.

In this fast track SBIR IBT and Abviro will perform advanced development activity for the lead product 3I14 as broad-spectrum antibody therapeutic against multiple influenza A strains.  In phase I, we will establish a highly productive stable CHO Research Cell Bank and generate a characterized stable lot of 3I14 to support phase II objectives. Phase II will characterize the 3I14 dose response in INFV A mouse models and therapeutic window, establish the pharmacokinetics and tolerability of 3I14 in mice, and confirm 3I14 does not lose potency as a result of viral resistance. Completion of these studies will position the product for IND-enabling manufacturing, efficacy and toxicology studies necessary to advance 3I14 to clinical studies.

103, 2019

IBT Receives Phase I SBIR grant from NIAID for development of Novel ISTAb therapeutics for Staph aureus

March 1st, 2019|

IBT in collaboration with Dr. Jean Lee lab at Brigham and Women Hospital, Harvard University, received a collaborative SBIR grant from NIH, entitled ISTAb: A novel therapy to target staphylococcal toxins at the site of infection.

Staphylococcus aureus (SA) is a Gram-positive human pathogen that causes a wide range of diseases from skin and soft tissue infections (SSTI) to life threatening sepsis and pneumonia. Numerous virulence factors, including cell surface proteins and polysaccharides, as well as secreted toxins are involved in SA pathogenesis. The cytolytic toxins kill key immune cells, allowing the pathogen to evade the immune response, induce tissue damage, and promote bacterial dissemination and metastatic growth in distant organs. There are currently no vaccine or immunotherapeutics against S. aureus.

In this Phase I SBIR, led by Dr. Rajan P. Adhikari, we will target neutralizing anti-toxin antibodies to the site of SA infection by taking advantage of the cell wall targeting (CWT) domain of lysostaphin (lyso) that specifically binds to the SA cell wall. The isolated CWT domain will be fused to specific anti-toxin monoclonal antibodies (mAbs) to generate Infection Site Targeted anti-toxin Antibodies (ISTAbs). A number of engineered candidates will be produced and tested in animal models of S. aureus invasive disease to select a preclinical candidate therapeutic.

101, 2018

IBT Receives Phase I SBIR grant from NIAID for development of rationally designed vaccines against multiple Ebolaviruses

January 1st, 2018|

IBT in collaboration with Integral Molecular (Philadelphia, PA) and US Army Medical Research Institute of Infectious diseases (USAMRIID) receive a collaborative SBIR grant from NIH, entitled Remodeled glycoprotein for broad protection against ebolaviruses.

Beside the Zaire strain of Ebolavirus other ebolaviruses such as Sudan virus, Bundibugyo virus as well as the more distant relative Marburg virus have caused highly lethal outbreaks.  As the nature of future ebolavirus disease outbreaks cannot be predicted, development of broadly protective vaccines for ebolaviruses is urgently needed.

Under the phase I of this SBIR, IBT and collaborators with generate a series of novel vaccine candidates based on engineering of ebolavirus glycoprotein. The vaccine candidates will be evaluated in rodents for their ability to protect against lethal challenge with various ebolaviruses.

111, 2017

Integrated Biotherapeutics Inc. Partners with CARB-X the first Toxoid based Multivalent Vaccine for MRSA

November 1st, 2017|

ROCKVILLE, Md., Nov. 1, 2017 /PRNewswire/ — Integrated Biotherapeutics Inc. announced today that is has been awarded up to $168,000, with the possibility of up to $8.3 million more based on the achievement of milestones, to develop the first entirely toxoid-based multivalent vaccine for the prevention of Methicillin Resistant Staphylococcus Aureus (MRSA).

“The CARB-X award will help us complete the preclinical studies and the Phase I clinical trial for IBT-V02, the first entirely toxoid based multivalent vaccine for the prevention of infections with Staph Aureus,” said Dr. M Javad Aman, President and Chief Scientific Officer of Integrated Biotherapeutics.  “Antibiotic-resistant Staph Aureus is a major public health threat causing numerous cases of invasive disease with high mortality rates in the hospitals and communities across the globe and billions of dollars in healthcare costs.”

Staphylococcus Aureus causes serious diseases including bloodstream infection, sepsis, endocarditis, surgical site infections, and pneumonia.  Methicillin-resistant Staph Aureus (MRSA) is currently a leading cause of these life-threatening infections with limited options for treatment.

IBT-V02 consists of five components representing toxoids for seven Staphylococcus Aureus toxins.  Due to cross-reactivity, these toxoids will elicit a protective response to 12-13 Staph Aureus toxins.CARB-X, which stands for Combating Antibiotic-Resistant Bacteria Biopharmaceutical Accelerator, was launched in July 2016.  This will be the first vaX portfolio, adding to the rich diversity of the pipeline and bringing a novel approach that could potentially prevent drug-resistant infection and save lives,” said Kevin Outterson, Executive Director of CARB-X, the world’s leading non-profit partnership dedicated to accelerating the development of antibiotics, diagnostics and other products to treat deadly infections caused by superbugs. “The projects in the new Powered by CARB-X portfolio are in the early stages of research, and there is always a high risk of failure. But if successful, these projects hold exciting potential in the fight against the deadliest drug-resistant bacteria.”

 

ABOUT INTEGRATED BIOTHERAPEUTICS: IBT is a biotechnology company focused on the discovery​ of novel vaccines and therapies for emerging infectious diseases with a pipeline that includes promising product candidates for bacterial and viral infections including vaccines for Staphylococcal infections, unique pan-filovirus immunotherapeutics and vaccines, and a variety of other product candidates for emerging pathogens.  Located in Rockville, MD, IBT has a close working relationship with United States Government agencies including the National Institute of Allergy and Infectious Diseases (NIAID/NIH). National Cancer Research Institute (NCI), Department of Defense (DOD), United States Army Medical Research Institute of Infection Diseases (USAMRIID) as well as many biotechnology and pharmaceutical companies and academic laboratories.  For more information, visit ibtdev.wpengine.com.

About CARB-X:

 CARB-X is the world’s largest public-private partnership devoted to early-stage antibacterial​ R&D. Funded by BARDA and Wellcome Trust, with in-kind support from NIAID, CARB-X will spend up to $455 million from 2016-2021 to support innovative antibiotics, vaccines and rapid diagnostics from ‘hit-to-lead’ stage through to Phase 1 clinical trials. CARB-X focuses on high priority drug-resistant bacteria, especially Gram-negatives. CARB-X is led by Boston University. Other partners include the Broad Institute of Harvard and MIT, MassBio, the California Life Sciences Institute and RTI International. For more information, please visit www.carb-x.org and follow us on Twitter @CARB_X.

 

Contacts:

CARB-X
Jennifer Robinson
+1-514-914-8974
jcrobinson119@icloud.com

Integrated Biotherapeutics
Robert Blackwell III
240-778-6513
rblackwell@integratedbiotherapeutics.com

View original content:http://www.prnewswire.com/news-releases/integrated-biotherapeutics-inc-partners-with-carb-x-the-first-toxoid-based-multivalent-vaccine-for-methicillin-resistant-staphylococcus-aureus-300547683.html

2107, 2017

ExpreS2ion enters multi-product agreement with US-based Integrated BioTherapeutics for expansion of their commercial reagents portfolio

July 21st, 2017|

Hørsholm, Denmark, July 17, 2017 – Today, ExpreS2ion Biotech Holding AB announces that the fully owned subsidiary ExpreS2ion Biotechnologies ApS (“ExpreS2ion”) has entered a Master Services Agreement and a Research & Commercial License Agreement with the US based Integrated BioTherapeutics, Inc. (“IBT”). The agreements enable standardised activation of a range of services and products from ExpreS2ion. This primarily targets the development and manufacturing of proteins based on the ExpreS2 platform, as well as granting IBT commercial rights to promote, sell and distribute such protein products made with ExpreS2. IBT expects to expand their unique research protein portfolio annually with up to five protein antigens manufactured in ExpreS2.  ExpreS2ion and IBT do not disclose the financial terms of the agreements, which constitutes a part of both companies’ general business models, however, when the collaboration is fully implemented, ExpreS2ion expects to generate annual revenues of up to 1.0 million SEK as a result of these agreements.

Master Services Agreement (MSA) and Research & Commercial License Agreement (RCLA)

The MSA enables IBT to retain ExpreS2ion services and products for IBT research programs in a predefined and simple manner, according to the terms and conditions stipulated in the agreement. The agreement is made based on a common understanding by the parties that such services and products will be required. ExpreS2ion’s overall role will be development and manufacturing of selected protein antigens based on the efficient proprietary technology, ExpreS2.

The RCLA grants IBT the research and commercial rights to develop and market proteins made with the ExpreS2 technology. The RCLA contains an annual Research License Fee as well as Royalty of Net Sales to be paid by IBT to ExpreS2ion for such license grant. The Royalty of Net Sales is a two-digit percentage.

IBT expects to expand their unique research proteins franchise annually with up to five products developed with ExpreS2.  ExpreS2ion and IBT do not disclose the financial terms of the Agreements, which constitutes a part of both companies’ general business models, however, when the collaboration is fully implemented, ExpreS2ion expects to generate annual revenues of up to 1.0 million SEK as a result of these agreements.

Integrated Biotherapeutics, Inc.

Integrated BioTherapeutics, Inc. (“IBT”) is a biotechnology company focused on the discovery of novel vaccines and therapeutics for emerging infectious diseases. IBT’s pipeline includes promising product candidates for bacterial and viral infections. IBT’s antiviral pipeline includes unique pan-filovirus antibody candidates, vaccines and a variety of other product candidates for emerging viruses, such as Zika, Ebola, dengue, Marburg, and others.  IBT is located in Rockville, Maryland, USA, and has a close working relationship with United States Government agencies including the National Institute of Allergy and Infectious Diseases (NIAID/NIH), National Cancer Institute (NCI), United States Army Medical Research Institute of Infectious Diseases (USAMRIID), and many biotechnology and pharmaceutical companies and academic laboratories.  IBT’s service and reagent division doing business as IBT Bioservices (ibtdev.wpengine.com) produces and markets high quality recombinant proteins and antibodies primarily for infectious disease research.

CEO Dr. Steen Klysner comments

“I am pleased that we have established our first broad commercial agreement in reagent supply with IBT, which has direct sales and distribution to the market for high quality proteins used in research. This expands our near-term revenue business model and demonstrates the value of the ExpreS2 platform in this and related commercial segments. We look forward to this mutually beneficial collaboration with IBT and continued work in the future.”

Certified Adviser

Sedermera Fondkommission is appointed as Certified Adviser for ExpreS2ion.

For further information about ExpreS2ion Biotech Holding AB, please contact:

Dr. Steen Klysner, CEO
Telephone: +45 2062 9908
E-mail: sk@expres2ionbio.com

This press release contains information that ExpreS2ion is obligated to make public pursuant to the EU Market Abuse Regulation. The information was submitted for publication through the agency of the contact person set out above on July 17, 2017.

About ExpreS2ion

ExpreS2ion Biotechnologies ApS, is a fully owned Danish subsidiary of ExpreS2ion Biotech Holding AB with company register number 559033-3729. The subsidiary has developed a unique platform technology, ExpreS2, enabling cost effective development and robust production of complex proteins for new vaccines and diagnostics for e.g. Malaria and Zika. Since founded in 2010, the company has used its patented ExpreS2 platform to produce more than 200 proteins in collaborations with research institutions and biopharmaceutical companies, with a superior efficiency and success rate.

3006, 2017

IBT Receives NIH R01 grant to study the mechanisms of ebolavirus vaccine protection

June 30th, 2017|

IBT Receives NIH R01 grant to study the mechanisms of ebolavirus vaccine protection

April 2017

IBT and University of Maryland receive a collaborative R01 research grant from NIH, Evolution of anti-filovirus B cell responses and mechanisms of protection.

Filoviruses represent A major global public health threat.  While major progress has been made towards development of vaccines against the Zaire Ebola virus (EBOV), development of broadly protective vaccines for filoviruses is lagging behind.  Furthermore, the mechanisms of protective immunity against filoviruses is not well understood.

Under this grant IBT will collaborate with Dr. Yuxing Li’s laboratory at the University of Maryland to better understand mechanisms of evolution of a protective antibody response against filoviruses.  The study will focus on the responses that are protective against multiple filovirus species.  Furthermore, in this study the teams in collaboration with USAMRIID, PHA Canada and Merck will study the detailed profile of antibody response to ebolavirus vaccines as well as responses to natural infections using samples from filovirus outbreaks in Africa as well as clinical trials of EBOV vaccines.

3006, 2017

IBT Receives Phase II STTR from NIAID for development of Bispecific Antibodies against multiple Ebolaviruses

June 30th, 2017|

IBT Receives Phase II STTR from NIAID for development of Bispecific Antibodies against multiple Ebolaviruses

July 2017

A Novel Paradigm for Fighting Filovirus Infections

IBT and Albert Einstein College of Medicine (EINSTEIN) receive a collaborative STTR grant from NIH, entitled Broadly Protective Bispecific Antibodies for Treatment of Ebola Virus Disease.

A major challenge in the fight against filovirus infections is the fact that the nature of epidemics cannot be predicted.  Beside the Zaire strain of Ebolavirus other ebolaviruses such as Sudan virus, Bundibugyo virus as well as the more distant relative Marburg virus have caused highly lethal outbreaks.  As the nature of future ebolavirus disease outbreaks cannot be predicted, development of broadly protective immunotherapeutics for ebolaviruses is urgently needed.

Under the phase I of this STTR, IBT worked with Dr. Jon Lai and Dr. Kartik Chandran at the Albert Einstein College of Medicine (AECOM) to generate a series of novel bispecific antibodies that target multiple broadly neutralizing epitopes in filovirus glycoprotein. This work led to a lead candidate that provided protection against Ebola and Sudan viruses and neutralization against all ebolaviruses (Published in Science, 2016; PMID:27608667)  Under the Phase II STTR the collaborating teams along with Dr. John Dye’s team at USAMRIID will manufacture this bispecific antibody in CHO cells and evaluate its efficacy in nonhuman primates.

3006, 2017

IBT Receives a Partnership R01 grant from NIAID to Develop a Pan-Ebolavirus Vaccine

June 30th, 2017|

IBT Receives a Partnership R01 grant from NIAID to Develop a Pan-Ebolavirus Vaccine

July 2017

A Structurally designed vaccine against all ebolaviruses

IBT and The Scripps Research Institute (TSRI) receive a collaborative Partnership R01 grant from NIH, entitled Rationally Designed Pan-Ebolavirus Vaccine.

A major challenge in the fight against filovirus infections is the fact that the nature of epidemics cannot be predicted.  Beside the Zaire strain of Ebolavirus other ebolaviruses such as Sudan virus, Bundibugyo virus as well as the more distant relative Marburg virus have caused highly lethal outbreaks.  Current experimental vaccines are strictly species-specific and do not provide broad protection against multiple ebolaviruses.

Under this 5-year partnership R01 grant IBT will work with the laboratories of Dr. Erica Saphire and Dr. William Schief at TSRI to rationally design engineered glycoprotein vaccines that provide protective efficacy against all ebolaviruses.  This innovative research is based on work performed in Dr. M. Javad Aman’s group at IBT and Dr. Erica Saphire laboratory at TSRI identifying and characterizing a novel set of broadly neutralizing ebolavirus glycoprotein antibodies, as well as pioneering novel engineering and epitope scaffolding approaches developed in Dr. Schief’s laboratory.  Under this grant a set of novel immunogens will be generated, characterized and tested for immunogenicity.  Vaccine candidates will be then tested in rodent and nonhuman primate models of Ebola, Sudan, and Bundibugyo virus infections.  Beside IBT and TSRI the work involves Dr. Kartik Chandran’s lab at Albert Einstein College of Medicine, Dr. John Dye’s lab at USAMRIID, Dr. Xiangguo Qiu lab at Public Health Agency of Canada, and Dr. Dorit Hanein at Sanford Burnham Prebys (SBP) Medical Discovery Institute in San Diego.

3006, 2017

IBT Receives NIH R01 grant to study the mechanisms of ebolavirus vaccine protection

June 30th, 2017|

IBT Receives NIH R01 grant to study the mechanisms of ebolavirus vaccine protection

April 2017

IBT and University of Maryland receive a collaborative R01 research grant from NIH, Evolution of anti-filovirus B cell responses and mechanisms of protection.

Filoviruses represent A major global public health threat.  While major progress has been made towards development of vaccines against the Zaire Ebola virus (EBOV), development of broadly protective vaccines for filoviruses is lagging behind.  Furthermore, the mechanisms of protective immunity against filoviruses is not well understood.

Under this grant IBT will collaborate with Dr. Yuxing Li’s laboratory at the University of Maryland to better understand mechanisms of evolution of a protective antibody response against filoviruses.  The study will focus on the responses that are protective against multiple filovirus species.  Furthermore, in this study the teams in collaboration with USAMRIID, PHA Canada and Merck will study the detailed profile of antibody response to ebolavirus vaccines as well as responses to natural infections using samples from filovirus outbreaks in Africa as well as clinical trials of EBOV vaccines.

3006, 2017

IBT Receives an SBIR from NIAID for development of a post-exposure vaccine for Streptococcus pneumoniae

June 30th, 2017|

IBT Receives an SBIR from NIAID for development of a post-exposure vaccine for Streptococcus pneumoniae

February 2017

A Novel approach to fight pneumonia

IBT receives an SBIR grant from NIH, entitled Serotype independent therapeutic vaccine for Streptococcus pneumoniae.

Antibiotic-resistant bacterial pathogens represent a major challenge within the community, healthcare settings, as well as the military. The growing incidence of bacterial pathogens signals the emergence of the so called “post-antibiotic era”. Vaccines exist only for Antibiotic-resistant bacterial pathogens. Innovative concepts are needed to face these serious challenges of the 21st century.

Under this NIAID SBIR grant IBT, in collaboration with Dr. Daniel Nelson Laboratory at University of Maryland, seeks to develop a novel technology, i.e. an Infection Site Targeted universal Bridging Antigen (ISTuBA) that builds an immunological bridge between a new invading pathogen and a pre-existing, heterologous immune response that is prevalent within the population. The prototype ISTuBA will be created for Streptococcus pneumoniae, a leading cause of pneumonia, sepsis and meningitis worldwide.

The SBIR grant will fund IBT and University of Maryland to develop the first ISTuBA prototype and demonstrate its efficacy against S. pneumoniae in mouse models of pneumonia. Upon completion of this proof of concept IBT expects to transition the program into advanced preclinical development under a Phase II SBIR.

203, 2017

Integral Molecular and Integrated BioTherapeutics Initiate Collaboration for Virus Vaccine Discovery

March 2nd, 2017|

View the article at: http://www.businesswire.com/news/home/20170302005790/en

Integral Molecular and Integrated BioTherapeutics have teamed up in the fight against the global health crises posed by Ebola and Zika viruses, signing a collaborative vaccine discovery agreement to help eradicate these threats.

The two companies will leverage their complementary technologies to produce vaccine candidates that are specifically engineered to generate a maximally protective immune response in humans. The availability of such vaccines will prevent the recurrence of the deadly 2014-2016 Ebola epidemic that killed over 11,000 people in West Africa, and has the potential to curtail the spread of the ongoing Zika virus epidemic associated with severe fetal brain defects.

Integral Molecular is an industry leader in the study of complex membrane proteins such as viral Envelope proteins. The company will use its proprietary Shotgun Mutagenesis protein engineering technology to generate and screen large panels of Envelope protein variants to identify an optimized protein that could serve as a highly immunogenic and protective vaccine, and will ultimately apply its high-resolution epitope mapping technologies to characterize the vaccine’s protective effects. Integrated BioTherapeutics, a leader in infectious disease research, will conduct preclinical studies to test the efficacy of vaccine candidates in disease models.

“The vulnerability of human populations during the recent Ebola and Zika outbreaks highlighted the consequences of the lack of effective vaccines against these pathogens. The goal of our collaboration is to meet these concerns by creating efficacious vaccine candidates based on viral Envelope proteins,” said M. Javad Aman, President and CEO of Integrated BioTherapeutics.

“We look forward to working with Integrated BioTherapeutics. Their experience in the development of a pipeline of antiviral products based on rationally designed and engineered viral proteins and antibodies will be a tremendous asset in our joint efforts towards producing Ebola and Zika vaccines,” continued Benjamin Doranz, President and CEO of Integral Molecular.

Thus far, the two companies have engaged in highly successful collaborative research that has culminated in the pursuit of these vaccine candidates. This includes the development and characterization of the protective and cross-neutralizing pan-Ebola antibody FVM04, recently published in Cell Reports (Howell et al., 2016). Additional research resulting from this collaboration is expected to be published later this year.

About Integral Molecular

Integral Molecular is a research-driven biotechnology company creating innovative technologies and a pipeline of therapeutic antibodies against under-exploited membrane protein targets, including GPCRs, ion channels, transporters, and viral envelopes. This platform is built on the company’s Lipoparticle and Shotgun Mutagenesis technologies and over 15 years of experience optimizing membrane proteins. Integral Molecular discovers antibodies for partners in parallel with its own independent work developing antibodies for licensing. The company currently has therapeutic programs focused on pain, immunity, and infectious diseases. For more information, visit www.integralmolecular.com.

About Integrated BioTherapeutics

IBT is a biotechnology company focused on the discovery of novel vaccines and therapeutics for emerging infectious diseases with a pipeline that includes promising product candidates for bacterial and viral infections including unique pan-filovirus monoclonal antibodies and vaccine candidates and a variety of other engineered product candidates for emerging viruses. IBT also operates a testing service business (ibtdev.wpengine.com) focused on in vitro and in vivo models for viral agents such as Zika, dengue, yellow fever, influenza and RSV as wells as bacterial agents such as S. aureusS. pneumoniaeE. Coli, and C. difficile. Located in Rockville, Maryland, IBT has a close working relationship with United States Government agencies including the National Institute of Allergy and Infectious Diseases (NIAID/NIH), National Cancer Institute (NCI), Department of Defense (DOD), United States Army Medical Research Institute of Infectious Diseases (USAMRIID) as well as many biotechnology and pharmaceutical companies and academic laboratories. For more information, visit ibtdev.wpengine.com.

Contacts

Integral Molecular, Inc.
Benjamin Doranz, 215-966-6061
info@integralmolecular.com
or
Integrated BioTherapeutics
M. Javad Aman, 240-454-8940
ibtdev.wpengine.com

1711, 2016

International Society for Antiviral Research (ISAR) News Vol. 26 No.2

November 17th, 2016|

View the Article at: http://c.ymcdn.com/sites/www.isar-icar.com/resource/resmgr/docs/isar_news_avr_26_2.pdf

ISAR News – Newsletter for of the International Society for Antiviral Research. Hodge, V. Sampath, A. (2016) ISAR News 26(2).

Tell us about your career path

I am a molecular biologist with a deep interest in virology. I did my Ph.D. work at the University of Mainz, Germany on the mechanisms of action of type 1 interferons in hematopoietic cells. During this time, I developed a strong interest in cell signaling processes initiated by cytokines. During my postdoctoral fellowship at the University of Virginia I worked on signal transduction of IL2, IL4 and IL-13 and discovered the human IL-13 receptor. My interest in signaling led me to work on membrane microdomains that are often used by various cellular response mediators and also viruses such as HIV. In 2000, I joined the US Army Medical Research Institute of Infectious Diseases (USAMRIID) where I had a chance to use my knowledge of membrane microdomain to initiate a project on filoviruses. During this time, we worked out a method to generate Ebola virus-like particles (VLPs) and went on to demonstrate its utility as a vaccine for filoviruses. This work led to several high impact publications in J Exp Med, PNAS, and JID. In 2007 I ventured out of USAMRIID to start the biotechnology company Integrated BioTherapeutics (IBT). October 2016 ISAR News Vol. 26 No. 2 Antiviral Research 14

How did you start Integrated Biotherapeutics?

I started IBT in 2007 with a focus on emerging infectious diseases and biodefense and with the initial objective of transitioning some of the discoveries we had made at USAMRIID to actual products. Unlike most biotech companies I started IBT entirely based on government grants and contracts and with no private equity. Over the past 9 years we have been able to secure over $45M in government funding, and have also supplemented this capital with antiviral and anti-bacterial services that we offer to the pharmaceutical industry. The combination of product development and discovery services is a unique feature of our business model. In the meantime, the company has grown to 34 people, and now operates a state of the art laboratory and a vivarium for small animals. A primary focus of IBT is the development of broadly protective therapeutic antibodies against several viral targets including filoviruses, arenaviruses, and alphaviruses. Over the past few years we have developed strategies to drive broadly neutralizing antibody response in macaques using engineered filovirus glycoproteins and VLPs. In collaboration with Steven Foung’s lab at Stanford and Yuxing Li’s lab at University of Maryland, we succeeded to generate the first in class broadly neutralizing antibodies that are protective against multiple filoviruses. This is a critical milestone in the fight against filoviruses. During the 2014 Ebola virus disease (EVD) outbreak, we were lucky that at least some products against the Zaire strain were nearing the finish line. But other filovirus species like Sudan, Bundibugyo, and Marburg viruses have also caused sizable outbreaks. It is impossible to predict what species will hit the next time, so we should be prepared. Our broadly neutralizing antibodies offer a potential solution for this problem.

What aspect of your research have you found most satisfying?

Although I am operating a business, the most exciting part of my day to day work is looking at data and discussing it with our scientists. Being in the position to do research and yet see a direct link to real applications and the mesmerizing thought that what you make in your lab today may, some day, save a person’s life is a satisfaction no amount of money can buy. We are so grateful to funding agencies as the grant funding allows us to do our research without the pressure from investors whose timelines often don’t take the unpredictable nature of scientific research into account.

What are your thoughts on antibody-based therapeutics?

I know that ISAR is heavily focused on small molecule antivirals, and this is understandable. But we should remember that the immune system evolved in the first place to fight invading pathogens. Yet, in the 21st century of over 40 FDA approved monoclonal antibodies only two are for infectious diseases. I think this is primarily driven by the focus of the pharmaceutical industry on the lucrative market of cancer and inflammation, rather than an inherent difficulty of making effective antibody-based therapeutics for infectious diseases. Recent advancements in antibody manufacturing is driving down the cost of goods. Structural biology and advances in protein engineering are helping us design much smarter antibodies with higher specificity and affinity, as well as broader reactivity. Novel technologies are evolving to generate bispecific and tri-specific antibodies that could fundamentally change what can be achieved with antibody as a drug. We have seen better antibodies emerging for RSV, influenza, HIV, alphaviruses such as chikungunya, Zika, and filoviruses. This increased activity within this space driven by the urgency of the recent large outbreaks (Ebola, Zika, influenza), will hopefully result in major breakthroughs and growing number of FDA-approved antibody-based therapeutics for infectious diseases.

How has ISAR contributed in your career?

As a scientist whose research is focused on antiviral antibodies and the ISAR focus being on small molecule I am not a typical ISAR member. However, our company works extensively with pharmaceutical industry for testing antivirals, mostly small molecules in vitro and animal models. For our team the annual ISAR meeting is a unique opportunity to get updated on the newest developments in the field and new methodologies that could directly be applied in our service business. Maybe the best part of attending ISAR meetings is the opportunity to network with the best scientists in the field and access to important resources through these contacts. However, I would like to see ISAR pay more attention to antibodies and try to attract scientists working on antiviral antibody therapeutics to attend ISAR. Having scientists from both sides of the aisle with October 2016 ISAR News Vol. 26 No. 2 Antiviral Research 15 their unique perspectives will only enrich future ISAR meetings.

1711, 2016

IBT Announces Licensing Agreement with Emergent BioSolutions for Development of Equine Immunoglobulin Therapeutics for Filovirus Infections

November 17th, 2016|

Filoviruses, including Ebola, Sudan, Bundibugyo, and Marburg viruses, cause a highly fatal disease in humans.  The 2014-2015 Western Africa Ebola virus disease (EVD) outbreak caused approximately 29,000 infections and more than 11,000 deaths.  While significant progress has been made towards vaccines and therapeutics for the Zaire strain of Ebola virus, the strain that caused the 2014 outbreak, the development of therapeutics against other filoviruses is lagging.  The goal of this multivalent equine product is to protect against multiple filovirus strains.

 

“Effective post-exposure therapeutics against filoviruses is critically important for control of future outbreaks of these deadly infections,” said Dr. M. Javad Aman, IBT’s President and Chief Scientific Officer. “It is impossible to predict which filovirus strain will cause the next outbreak and therefore, our focus should be to develop therapeutics that can provide broad protection.”

 

The development of this critically important hyperimmune product candidate is being directed under the auspices of a collaboration between IBT, Emergent, Auburn University, Public Health Agency of Canada, and US Army Medical Research Institute of Infectious Diseases (USAMRIID).  Emergent, supported by IBT and their network of collaborators, intend to develop this product candidate towards approval by the U.S. Food and Drug Administration for treatment of filovirus hemorrhagic fever.  Once approved, the product may be produced for inclusion in the Strategic National Stockpile for emergency use or in response to possible future outbreaks.

 

About Equine Immunoglobulins

Equine immunoglobulins are produced by hyperimmunization of horses with specific antigen preparations that can induce protective antibody responses.  Hyperimmune antibody preparations from horse serum or plasma have been used over the past century for the treatment of a variety of infectious diseases, intoxication, or envenomation such as snake envenomation, spider bites, botulism, rabies, diphtheria, and tetanus.  One equine immunoglobulin product, Botulism Antitoxin Heptavalent (A, B, C, D, E, F, G) (BAT®), developed by Emergent, is currently included in the U.S. Strategic National Stockpile.

1807, 2016

IBT Receives an SBIR from NIAID to engineer an Ebola Antibody to Achieve broad Filovirus Protection

July 18th, 2016|

A major challenge in the fight against filovirus infections is the fact that the nature of epidemics cannot be predicted. Beside the Zaire strain of Ebolavirus other ebolaviruses such as Sudan virus, Bundibugyo virus as well as the more distant relative Marburg virus have caused highly lethal outbreaks. One of the primary goals of IBT is to develop broadly protective antibodies against filoviruses.

Under this SBTR, IBT will work with Visterra, Inc. (Cambridge, MA) and US Army Medical Research Institute of Infectious Diseases (USAMRIID) to engineer a broadly reactive monoclonal antibody that only neutralizes ebolavirus species to achieve neutralizing activity towards Marburg virus. This collaborative research is based on a unique set of macaque-derived monoclonal antibodies developed at IBT and an innovative technology developed by Visterra scientists that allows for computational redesign of antibodies to achieve broad reactivity. Through this collaboration, IBT and Visterra hope to develop the first antibody with protective activity against the most divergent filoviruses.

1807, 2016

IBT Receives an STTR from NIAID for development of Bispecific Antibodies against multiple Ebolaviruses

July 18th, 2016|

A major challenge in the fight against filovirus infections is the fact that the nature of epidemics cannot be predicted. Beside the Zaire strain of Ebolavirus other ebolaviruses such as Sudan virus, Bundibugyo virus as well as the more distant relative Marburg virus have caused highly lethal outbreaks. One of the primary goals of IBT is to develop broadly protective antibodies against filoviruses.

Under this STTR, IBT will work with Dr. Jon Lai at the Albert Einstein College of Medicine (AECOM) to generate a series of novel bispecific antibodies that target multiple broadly neutralizing epitopes in filovirus glycoprotein. IBT and AECOM teams have already generated several prototypes that are currently under characterization. If successful, the antibodies will be transitioned into rodent and nonhuman primate studies under a Phase II STTR with the goal of development as a broadly protective immunotherapeutic for human use.

1105, 2016

Progress Towards a Pan-Ebolavirus Treatment

May 11th, 2016|

In 2014, the alarm for the Zaire Ebola virus was sounded around the world—but there are other deadly ebolaviruses that cause identical symptoms, and they have even fewer treatment options. In a study publishing May 5 in Cell Reports, researchers from Integrated BioTherapeutics (IBT) describe and test an antibody cocktail, created with components from ZMappTM and a new antibody called FVM04, that brings researchers a step closer to an effective and efficient pan-ebolavirus treatment. This was a large collaborative project between IBT and researchers at the US Army Medical Research Institute of Infectious Diseases, Stanford University, Mapp Biopharmaceutical Inc, Public Health Agency of Canada, Albert Einstein College of Medicine, Integral Molecular Inc., and The Scripps Research Institute.

 

The new cocktail targeted and protected against infection caused by both the Zaire and Sudan ebolavirus strains in mice and guinea pigs.

 

“We don’t know which type of ebolavirus might cause a future outbreak,” says M. Javad Aman, President and CSO at Integrated BioTherapeutics and senior author on the study. “My immediate reaction in 2014 was that whatever we’d been doing so far, we needed to speed it up. We want to have a treatment that is broadly useful. If you have to stockpile three different drugs to be prepared for all kinds of ebolaviruses, it would take three times the resources.”

 

Aman’s team had previously identified a series of antibodies in monkeys that could fight different ebolaviruses, and have now plucked out the most effective: FVM04. The antibody targets a region, shared among all ebolaviruses, on top of the virus’s outer shell. When FVM04 binds to this region, it prevents the virus from entering cells.

 

In experiments with mice infected with the Zaire or Sudan ebolaviruses, FVM04 protected against the virus when injected up to two days post-infection. In guinea pigs, FVM04 protected fully against Sudan ebolavirus, but only a third of the Zaire-infected animals survived. To create a more potent treatment, the researchers had to combine FVM04 with other antibodies.

 

Working with Mapp Biopharmaceutical, the team pulled apart the ZMappTM cocktail, which is made up of three antibodies—one targeting the cap of the viral package and two others that target the base. The researchers removed one of the base-targeting antibodies and replaced it with FVM04.

 

“We sort of developed ZMappTM 2.0,” says Katie Howell, a postdoc at Integrated BioTherapeutics and first author on the study. “It was really exciting.” The new cocktail retained FVM04’s efficiency in protecting against the Sudan ebolavirus, while also protecting guinea pigs infected with the Zaire strain at levels comparable to ZMappTM in similar studies.

 

This study is the team’s first step to demonstrating that ZMappTM can be modified and moved towards a broad reactivity. Going forward, Integrated BioTherapeutics and its collaborators are reviewing a range of antibodies to nail down the most effective cocktail, with an eye towards further development and clinical testing.

 

“In 2014, experimental drugs like ZMappTM were made available for clinical evaluation,” says Aman. “But what if it had been a Sudan outbreak? Then we would have had absolutely nothing. It’s motivated us to focus on other types of ebolaviruses and on a broad treatment that would be effective against all of them. We want to make sure we’ve turned over every rock.”

2207, 2015

New Publication from the Researchers at IBT

July 22nd, 2015|

Efforts to develop effective vaccines against Staphylococcus aureus (S. aureus) have been largely unsuccessful, in part due to the variety of virulence factors produced by this organism. Recently, researchers lead by Dr. Rajan Adhikari at IBT have published a paper entitled ‘Novel Structurally Designed Vaccine for S. aureus ?-Hemolysin: Protection against Bacteremia and Pneumonia’ in PLoS ONE , an international, peer-reviewed, open-access, online publication. S. aureus alpha-hemolysin (Hla) is a pore-forming toxin expressed by most S. aureus strains and reported to play a key role in the pathogenesis of skin and soft tissue infections and pneumonia.

This article describes a novel recombinant subunit vaccine candidate for Hla, rationally designed based on the heptameric crystal structure. The vaccine candidate, called AT-62aa, has shown significant protection against pneumonia and is the first to be reported to reduce bacterial dissemination and to provide protection in a sepsis model of S. aureus infection. Antibodies to AT-62aa and sera from vaccinated mice effectively neutralized the toxin in vitro and inhibited the formation of Hla heptamers, suggesting antibody-mediated neutralization as the primary mechanism of action. This remarkable efficacy makes the Hla-based vaccine a prime candidate for inclusion in future multivalent S. aureus vaccines. Furthermore, identification of protective epitopes within AT-62aa could lead to novel immunotherapies for S. aureus infection.

2207, 2015

IBT Presents Pan-Ebola and Pan-Filovirus Monoclonal Antibodies

July 22nd, 2015|

Integrated BioTherapeutics, Inc. (IBT), a leader in infectious disease and filovirus research, today announced the discovery of novel Pan-Ebola and Pan-Filovirus monoclonal antibodies (mAbs). IBT scientists presented the new mAbs at the 7th International Symposium on Filoviruses held in Washington, DC.

 

IBT’s broad-spectrum filovirus mAbs and cocktails are planned for development as therapeutics against filoviruses Ebola (EBOV), Sudan (SUDV), Bundibugyo (BUDV), Reston (RESTV), and Marburg (MARV). Filoviruses are highly pathogenic, high-priority public health threats with no approved vaccines or therapeutics. Current monoclonal antibody and vaccine candidates are mostly strain-specific and primarily target EBOV Zaire. Filoviruses are endemic in Africa and have caused periodic outbreaks, including the ongoing international EBOV epidemic, and are also potential bioweapon and bioterrorist threats. Patients develop severe hemorrhagic disease with up to 90% mortality. There is thus a strong unmet public health and biodefense need for broad-spectrum treatments for these highly pathogenic viruses.

The broad-spectrum filovirus mAb candidates were discovered by immunizing mice and Rhesus macaques with IBT’s proprietary filovirus antigens, isolating and cloning B cells from the animals, screening mAbs for binding to filoviruses, and conducting affinity maturation. Development then proceeded to expressing test mAb lots as humanized chimeric monoclonal IgGs, followed by characterization and efficacy testing in mouse models.

Our novel mAb candidates and cocktails have shown intriguing protection in mice against a broad spectrum of filoviruses. Cocktails of these mAbs have shown complete protection against multiple filoviruses. Our broad-spectrum filovirus mAbs bind to novel pan-Ebola and pan-filovirus epitopes. The epitopes are conserved across multiple filoviruses, enabling broad-spectrum activity and suggesting emergence of viral resistance may be limited.

The antibodies could be deployed against filoviruses in the same way that monoclonal antibody treatment or collected serum from survivors have been used in the ongoing Ebola outbreak originating in West Africa. Our mAbs or cocktails could also be considered as a prophylactic in endemic areas, before travelling, or for caregivers in close contact with filovirus patients.

Our mAbs are at the lead selection stage. The next steps in development are to select one or more broad-spectrum mAbs or cocktails as preferred lead candidates, complete proof of concept studies in rodents and NHPs, and commence a program directed towards IND and Phase 1 clinical trials.

IBT’s broad-spectrum filovirus mAbs have the following key advantages:

  • Potential for mAb or mAb cocktail to treat multiple filovirus diseases
  • Novel target epitopes conserved across multiple filoviruses enable broad-spectrum activity and suggest emergence of viral resistance may be limited
  • Ready for lead selection
2207, 2015

Chembio Update on DPP(R) Ebola and DPP(R) Febrile Illness Assays

July 22nd, 2015|

MEDFORD, N.Y., Jan. 12, 2015 (GLOBE NEWSWIRE) — Chembio Diagnostics, Inc. (Nasdaq:CEMI), a leader in point-of-care (POC) diagnostic tests for infectious diseases, today announced its progress in the development of DPP® Ebola and DPP® Febrile Illness Assays.

On October 27, 2014 the Company announced an exclusive POC partnership with Integrated BioTherapeutics, Inc. (IBT), to combine Chembio’s patented DPP® technology with IBT’s proprietary Ebola reagents to develop POC diagnostic tests for Ebola and febrile illness.

Since announcing the partnership with IBT, the Company has made the following progress to develop DPP® Ebola and DPP® Febrile Illness Assays:

  • Developed DPP® Ebola Assays in Chembio’s Research & Development facilities.
  • Successfully tested DPP® Ebola Assays in high containment (BSL4) laboratory, using wild type (real) Ebola virus, via IBT’s partner in Canada.
  • Signed a Research Collaboration Agreement with the Centers for Disease Control and Prevention (CDC) to develop and validate DPP® Ebola and DPP® Febrile Illness Assays.
  • Successfully tested DPP® Ebola Assays at CDC laboratory in Atlanta, GA.
  • Submitted DPP® Ebola pre-qualification application to World Health Organization (WHO).
  • Contacted numerous organizations for Ebola funding, to accelerate our potential development, and potential manufacturing and supply of DPP® Ebola and DPP® Febrile Illness Assays, to include both Ebola and Malaria.
2207, 2015

Integrated BioTherapeutics Partners With Chembio

July 22nd, 2015|

Integrated BioTherapeutics Partners With Chembio to Develop Point-of-Care Diagnostic Tests for Ebola and Febrile Illness

Chembio Diagnostics, Inc. (Nasdaq:CEMI), a leader in point-of-care (POC) diagnostic tests for infectious diseases, today announced that it has entered into an exclusive agreement with Integrated BioTherapeutics, Inc. (IBT), a biotechnology company focused on the discovery of novel vaccines and therapeutics for emerging infectious diseases. Under the terms of the agreement, Chembio will combine its patented DPP® technology with IBT’s proprietary Ebola reagents to develop POC diagnostic tests for Ebola and febrile illness. Chembio will have exclusive rights to any POC product developed through this agreement. Financial terms of the agreement were not disclosed.

While Ebola has caused multiple outbreaks since 1976, the frequency of epidemics in the past 15 years has drastically increased and the current outbreak in West Africa has reached unprecedented dimensions. Over 10,000 people have been infected with Ebola and recent cases outside the African continent are drawing concern from public health officials. Currently, the diagnosis of Ebola hemorrhagic fever can only be performed in specialized laboratories. This limitation significantly delays the identification and isolation of the patients who have Ebola and in turn likely makes it more difficult to control an outbreak or prevent new epidemics.

Javan Esfandiari, Chembio’s Chief Science & Technology Officer and the inventor of Chembio’s DPP® technology, commented, “We are pleased to partner with IBT, a biotechnology company with extensive experience and a substantial number of reagents for Ebola and other filoviruses, to develop a DPP® Ebola assay. In 2013, we partnered with the U.S. Government to develop a multiplex POC febrile illness assay which, in 20 minutes, can detect antigens from five different viruses, bacteria, and parasites with a single, finger-stick drop of blood. The resulting product, DPP® Febrile Illness Assay, is currently in clinical trials in several countries, including the region of West Africa. Our intent is to develop a stand-alone POC DPP® Ebola test and also include an Ebola test as part of our existing multiplex DPP® Febrile Illness Assay.”

John Sperzel, Chembio’s Chief Executive Officer, commented, “The partnership with IBT is a significant step in our continued efforts to expand Chembio’s POC infectious disease portfolio. Our prior success developing the multiplex DPP® Febrile Illness Assay demonstrates Chembio’s ability to create such tests in a short amount of time, and we believe this partnership illustrates the value that our DPP® technology brings to the broader diagnostic market. Through this agreement, Chembio’s goal is to further develop innovative, sensitive and specific POC diagnostic tests for detection of febrile illnesses, including Ebola.”

M. Javad Aman, President and Chief Scientific Officer of IBT, commented, “We are facing a humanitarian crisis and global public health challenge. Development of a rapid POC test for Ebola will be a critical step towards enabling early detection and quarantine that could help save countless lives. Through this partnership, the capabilities of the two companies will be combined to produce a POC product we believe will meet this serious challenge in a timely manner.”

Chembio is represented by Squire Patton Boggs (US) LLP and IBT is represented by Crowell & Moring LLP in this transaction.

About Chembio Diagnostics

Chembio Diagnostics, Inc. develops, manufactures, licenses and markets proprietary rapid diagnostic tests in the growing $8.0 billion point-of-care testing market. Chembio markets its DPP® HIV 1/2 Assay and HIV 1/2 STAT-PAK® Assay in the U.S. and internationally. The Company’s SURE CHECK® HIV 1/2 Assay is marketed exclusively in the U.S. as Clearview®Complete. Outside the U.S., Chembio markets its SURE CHECK® HIV 1/2 Assays through distributors.

Chembio has developed a patented point-of-care test platform technology, the Dual Path Platform (DPP®) technology, which has significant advantages over lateral-flow technologies. This technology is providing Chembio with a significant pipeline of business opportunities for the development and manufacture of new products.

Forward-Looking Statements

Statements contained herein that are not historical facts may be forward-looking statements within the meaning of the Securities Act of 1933, as amended. Forward-looking statements include statements regarding the intent, belief or current expectations of the Company and its management. Such statements, which are estimates only, reflect management’s current views, are based on certain assumptions, and involve risks and uncertainties. Actual results, events, or performance may differ materially from the above forward-looking statements due to a number of important factors, and will be dependent upon a variety of factors, including, but not limited to Chembio’s ability to obtain additional financing and to obtain regulatory approvals in a timely manner, as well as the demand for Chembio’s products. Chembio undertakes no obligation to publicly update these forward-looking statements to reflect events or circumstances that occur after the date hereof or to reflect any change in Chembio’s expectations with regard to these forward-looking statements or the occurrence of unanticipated events. Factors that may impact Chembio’s success are more fully disclosed in Chembio’s most recent public filings with the U.S. Securities and Exchange Commission.

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