Recent News
Recent News
Recent News
Integrated BioTherapeutics Inc. and Integral Molecular Collaborate to Engineer Broadly Protective Ebolavirus Vaccines
Next-generation vaccine design strategies to protect against Ebola and related viruses
ROCKVILLE, Md., Nov. 1, 2021- Integrated BioTherapeutics Inc. (IBT) and Integral Molecular have collaboratively engineered proteins for developing broadly protective vaccines for Ebola and related viruses. Development of this next-generation vaccine was enabled by the combined application of IBT discovered neutralizing Ebola antibodies and Integral Molecular’s GeneCanvas protein engineering platform to identify glycoprotein mutations that make the Ebola virus vulnerable to immune detection.
Integrated BioTherapeutics Inc. Awarded $16.3M Contract from the National Institute of Allergy and Infectious Diseases to Develop a Treatment for Marburg Virus Disease
Contract to support manufacturing and a Phase 1 clinical trial
ROCKVILLE, Md., May 18, 2021 — Integrated BioTherapeutics Inc. (IBT), a Maryland biotechnology company specializing in emerging infectious diseases, announced today the receipt of a contract valued at up to $16.3 million from the National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health (NIH), to develop IBT-T03H, a monoclonal antibody for treatment of Marburg virus disease (MVD). MVD is caused by either of two marburgviruses, Marburg virus and Ravn virus, and has reemerged several times since it was initially described in 1967. IBT-T03H, discovered in collaboration with the University of Maryland, has been shown in preclinical studies to be protective against both Marburg and Ravn virus.
The contract, including all options, supports formulation development, process development, preclinical safety studies, manufacturing, and a first-in-human dose ranging study of IBT-T03H in a Phase 1 clinical trial. This award supports NIAID’s mission to develop medical countermeasures against emerging infectious diseases and high priority biological threat agents.
Marburg and Ravn viruses are closely related to Ebola virus, and similarly cause a potentially fatal viral hemorrhagic fever. An outbreak of MVD caused by Marburg virus occurred as recently as 2017, and the largest outbreak occurred in 2005 in Uganda, in which a 90% case fatality rate was observed. The related Ravn virus also caused outbreaks in 1987, 1998-2000, and 2007 with case fatality rates reaching 83%. Ravn virus has sometimes co-circulated with Marburg virus during outbreaks. There are no approved therapeutics for the treatment of MVD.
“The experience of the 2014-2017 Ebola virus disease outbreak and current COVID-19 pandemic are reminders of the importance of investing in countermeasures for potential future epidemics,” said Dr. M. Javad Aman, President and Chief Scientific Officer of IBT. “The timely award of this contract is a crucial step toward preparedness against future outbreaks of MVD with potentially disastrous consequences for Africa and the world.”
“IBT has an outstanding product candidate which has shown efficacy in animal models of MVD and is positioned well for entry into the clinical phase of testing,” said Dr. Gary S. Nabors, Executive Vice President and Chief Development Officer.
Prior studies that led to the discovery and development of IBT-T03H were supported by grants R41-AI47929 and R01-AI126587 from NIAID.
About Integrated BioTherapeutics:
IBT develops vaccines and immunotherapies for bacterial and viral infectious diseases. The Company’s lead vaccine product, IBT-V02 is a first-in-class multi-component vaccine against Staphylococcus aureus. Supported by CARB-X and by Novo Holdings’ Repair Impact Fund, IBT-V02 is currently undergoing cGMP manufacturing and IND-enabling studies, with initiation of clinical trials anticipated in late 2021. IBT’s immunotherapeutic pipeline includes monoclonal antibodies for the treatment of the array of viruses that cause hemorrhagic fever. IBT is also developing product candidates for the treatment of S. aureus, anthrax, and Clostridium difficile, based on its proprietary Infection Site Targeted Antitoxin Antibody (ISTAb) technology. Learn more about IBT’s pipeline at https://www.integratedbiotherapeutics.com.
IBT Bioservices, the contract research division of IBT, offers in vitro assays and animal models to enable lead-to-candidate selection and eventual progression to IND and clinical development. Learn more about IBT Bioservices at http://www.ibtbioservices.com or email us at services@ibtbioservices.com.
CONTACT: Integrated BioTherapeutics Inc.
Gary S. Nabors, Ph.D.
EVP and Chief Development Officer
Phone (240) 539-3060
Email: gnabors@integratedbiotherapeutics.com
Source: Integrated BioTherapeutics Inc.
Gary Nabors, Ph.D. Joins Integrated BioTherapeutics Inc. as Executive Vice President and Chief Development Officer
IBT is pioneering the development of the first multivalent toxoid-based vaccine against Staphylococcus aureus as well as immunotherapies for several viral diseases.
ROCKVILLE, MD. SEPTEMBER 14, 2020
Integrated BioTherapeutics Inc. (IBT), a Maryland company specializing in emerging infectious diseases, announced today Dr. Gary Nabors has joined the firm as Executive Vice President and Chief Development Officer. IBT is a biotechnology company focused on the development of vaccines and immunotherapeutics.
“We are pleased to welcome Dr. Nabors to the IBT team. His extensive experience in advanced development of infectious diseases products will bring great value to IBT’s efforts to transition its lead product candidates into the clinic,” said Dr. M. Javad Aman, President of IBT. “Dr. Nabors’ role as head of product development will enable IBT to effectively translate its discovery pipeline into practical solutions for infectious diseases.”
Prior to joining IBT, Dr. Nabors served in leading roles at several companies including Sanofi Pasteur, Antex Biologics, Emergent BioSolutions, and DynPort Vaccine Company (DVC). He provided strategic leadership as President of DVC from 2014 through 2020. Prior to that, Dr. Nabors oversaw the characterization of biological threat agents as the Deputy Director of the National Biological Threat Characterization Center from 2012-2014. Dr. Nabors also held positions of increasing responsibility in R&D at Emergent BioSolutions from 2003-2012, where he managed a portfolio of products as Senior Vice President of Vaccines and Therapeutics.
“I’ve had the privilege of getting to know the IBT team through past collaborations and I am excited to join the management team to help advance their breakthrough products into clinical development,” said Dr. Nabors. “I look forward to supporting IBT’s mission to bring novel drugs and therapeutics to market to address the public health threat from emerging and re-emerging infectious diseases.”
About Integrated BioTherapeutics:
IBT is developing vaccines and immunotherapies for several bacterial and viral infections. IBT’s lead vaccine product is a first-in-class multi-component toxoid vaccine (IBT-V02) against Staphylococcus aureus. Supported by CARB-X and Novo Holding’s Repair Impact Fund, IBT-V02 is currently undergoing cGMP manufacturing and IND-enabling studies with initiation of clinical trials anticipated in late 2021. IBT’s immunotherapeutic pipeline includes a cocktail of monoclonal antibodies for treatment of hemorrhagic fever caused by ebolaviruses (IBT-T02) and a potent, first-in-class, monoclonal antibody against marburgviruses. Furthermore, IBT is developing a number of product candidates for S. aureus, anthrax, and C. difficile based on its proprietary Infection Site Targeted Anti-toxin Antibody (ISTAb) technology. Learn more about IBT’s pipeline at https://www.integratedbiotherapeutics.com.
IBT Bioservices, the contract research division of IBT, offers in-vitro assays and animal infection models to enable lead-to-candidate selection and eventual progress to IND and clinical development.
To learn more visit http://www.IBTBioServices.com or email us at Services@IBTBioservices.com.
Novo Holdings REPAIR Impact Fund Invests USD 12 million in Mutabilis and IBT Vaccines and provides strategic update
Copenhagen, Denmark, 06 January 2020 – Today, the Novo Holdings REPAIR Impact Fund announced a EUR 7 million investment in Mutabilis, a company developing novel antibacterials against Gram-negative infections based near Paris, France. This investment will allow the company to accelerate its 2G-Dabocins program, a wide spectrum Gram-negative anti-infective agent, which is currently undergoing lead optimization.
“We look forward to working with the team at Novo Holdings REPAIR Impact Fund. REPAIR’s commitment to funding the development of novel antibiotics will provide us with the essential support we need to accelerate our lead asset to where it is most needed – the clinic as we strive to bring new antibiotics to the market to combat the growing threat of drug-resistant bacteria.” said Stéphane Huguet Mutabilis’s Chief Executive Officer.
The REPAIR Impact Fund also announces an investment of USD 3.9 million in IBT Vaccines, a company focused on the discovery of novel vaccines for emerging infectious diseases based in Maryland, USA. IBT is developing IBT-V02, a vaccine for Staphylococcus aureus currently in late preclinical stage. IBT-V02 is a novel mode of action vaccine consisting of five toxoids with broad coverage and with a potential to be the first to market.
“Antibiotic resistant Staphylococcus aureus is a leading cause of morbidity and mortality around the world. This partnership with Novo Holdings REPAIR Impact Fund will prove invaluable in advancing our efforts of delivering a new innovative class of preventive medicines to combat staphylococcal infections and reduce the burden of antibiotic resistance,” said M. Javad Aman, PhD, President and Chief Scientific Officer of IBT.
Since the launch of the REPAIR Impact Fund in 2018, a total of USD 48 million has been invested in eight companies developing promising novel anti-infective therapies across modalities, geographies, pathogens and indications.
In the last two years, the REPAIR Impact fund has built a portfolio of eight companies based in Europe and USA, working across a wide range of modalities including four small molecules, two vaccines, one peptide and one oligonucleotide-based therapy. Of these companies, five address diseases caused by Gram-negative strains and the remaining three target Gram-positive strains.
Aleks Engel, Director of the REPAIR Impact Fund, commented: “We are thrilled to have Mutabilis and IBT Vaccines join the growing REPAIR Impact Fund portfolio. Both companies were selected amongst a talented pool of contenders based on their novel science and opportunity to address the vast unmet need of antimicrobial resistance.”
Adjustment to strategic scope of REPAIR
Following four proposal rounds since its inception two years ago, Novo Holdings has screened more than 150 investment proposals and made eight investments. 2020 will see the REPAIR Impact Fund make adjustments to its strategic scope.
Given the difficult funding environment for anti-infectives, the REPAIR Impact Fund will keep certain capital in reserve to potentially support funding for its portfolio companies Phase 2 clinical trials. The Fund will continue to initially invest only in projects that are between lead optimization and Phase 1 clinical trials; however, this change in strategy will allow the REPAIR Impact Fund to continue to support its portfolio companies as they advance.
Aleks Engel, commented: “Based on experiences to date, we may slow down our early investments slightly in order to potentially advance projects further. Simultaneously we will now also consider proposals from anywhere on the globe and are very much looking forward to seeing those.”
The exact dates for the 2020 global call will be announced in May on https://www.repair-impact-
More than 700,000 people die each year from infections resistant to most or all antibiotics, and the number is increasing by the day. Such infections are projected to kill more people than cancer by 2050. Global economic output is expected to be reduced by between 2% and 3.5% and to severely cripple modern medical and surgical advances. For this reason, Novo Holdings created the REPAIR Impact Fund to confront this pending global medical catastrophe.
Enquiries
Optimum Strategic Communications
Hollie Vile, Mary Clark, Manel Mateus
+44 (0) 787 687 2224
About the REPAIR Impact Fund
The Fund invests in start-ups, early-stage companies and corporate spin-outs in Europe and the United States. It gives priority to first-in-class therapies, covering small molecules, biologics and new modalities, from the early stage of drug development (lead optimization) to the early stages of clinical development (Phase 1). It can invest as the sole investor or in a syndicate, with investments ranging from USD 1 million to USD 15 million.
The projects are selected through an investment process with support of a highly qualified Scientific Selection Board, comprising 10 world-class experts. For more information about members of the Scientific Selection Board, see www.repair-impact-fund.com/
The Fund focuses on priority pathogens as defined by the World Health Organization and the United States Centers for Disease Control and Prevention, a catalogue of 18 families of bacterial and fungal pathogens that pose the greatest threat to human health. For more details about the investment process, see www.repair-impact-fund.com/
REPAIR is an acronym: Replenishing and Enabling the Pipeline for Anti-Infective Resistance.
About Novo Holdings
Novo Seeds is the early stage investment arm of Novo Holdings. Novo Holdings A/S is a Danish private limited liability company wholly owned by the Novo Nordisk Foundation. It is the holding company of the Novo Group, comprising Novo Nordisk A/S, Novozymes A/S and NNIT A/S, and manages the Foundation’s assets.
In addition to being the major shareholder in the Novo Group companies, Novo Holdings provides seed and venture capital to development-stage companies, takes significant ownership positions in well-established companies within life science and manages a broad portfolio of financial assets.
It is the vision of Novo Holdings to be recognized as a world-leading life science investor with a focus on creating long-term value. Read more at www.novoholdings.dk.
About Mutabilis
Mutabilis is a French biopharmaceutical company developing novel antibacterials against Gram-negative infections. Mutabilis has a unique expertise in diazabicyclooctane chemistry and its applications in the discovery of novel antibacterials and beta-lactamase inhibitors. With outstanding stability to hydrolysis by serine- and metallo-beta-lactamases, diazabicyclooctane derivatives are particularly promising to address the most difficult infections, namely those that are resistant to carbapenems. Mutabilis is based in Romainville, near Paris, France and has 27 employees, most of whom are dedicated to research and development. http://www.mutabilis.fr
About IBT Vaccines
IBT Vaccines is a wholly owned subsidiary of Integrated Biotherapeutics, 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 www.integratedbiotherapeutics.
CARB-X FUNDS INTEGRATED BIOTHERAPEUTICS TO EXPAND THE DEVELOPMENT OF ITS STAPHYLOCOCCUS AUREUS VACCINE TO FACILITATE USE IN THE DEVELOPING WORLD
Freeze-dried version of vaccine would boost availability to the world, save lives and help fight the spread of drug resistance
(BOSTON, MA) –– CARB-X, a global partnership led by Boston University, is awarding Integrated Biotherapeutics (IBT) of Rockville, Maryland, USA, $1.6 million to expand the development of its vaccine against Staphylococcus aureus, including Methicillin-resistant Staphylococcus aureus (MRSA) superbugs, so that the vaccine can be used to prevent infections in developing nations, as well as in the developed world. Under this initiative, IBT will expand its R&D to evaluate the efficacy of its vaccine, IBT-V02, against strains of the bacteria found in developing nations, and will also explore development of a freeze-dried version of the vaccine so that it can be used where cold storage systems are not available.
This funding is in addition to an award of up to $8.5 million announced by CARB-X in 2017 to support the development of the IBT’s innovative vaccine. The extra support announced today by CARB-X is possible because of funds from CARB-X partners – UK government’s Global Antimicrobial Resistance Innovation Fund (GAMRIF) for antibacterial products, and the Bill & Melinda Gates Foundation earmarked specifically for the development of antibacterial preventative approaches that can be used in low- and middle-income countries (LMICs).
“A vaccine to prevent infections caused by Staphylococcus aureus, including drug-resistant strains, could save the lives of thousands, including infants, and curb the spread of the bacteria and drug resistance,” said Kevin Outterson, Executive Director of CARB-X and Professor of Law at Boston University. “IBT’s plan to develop its vaccine to prevent these infections in all corners of the world reflects the kind of creative thinking we need in the global fight against drug resistance.”
“Effective vaccines can prevent life-threatening bacterial infections and help reduce overuse and misuse of antibiotics, which is a particular problem in many developing nations and a threat to global health security as it fuels the spread of antibiotic resistance,” said M. Javad Aman, IBT President and CSO. “CARB-X’s vision and new funding opens up new doors to better global approaches and solutions to battle drug resistant bacterial infections. We would not be able to develop this new vaccine without the support of CARB-X, its funders, as well as National Institute of Allergy and Infectious Diseases (NIAID).”
The science of preventing bacterial infection is challenging. Vaccines have been developed to prevent bacterial infections such as diphtheria and tetanus. But past efforts to develop a vaccine to prevent S. aureus have failed. S. aureus bacteria secrete a wide range of toxins that can destroy tissue, disable the patient’s immune system and help bacteria spread through the body. IBT-V02 is the first multivalent S. aureus vaccine entirely based on rationally designed toxoids that collectively enable the body to neutralize and provide protection against major families of toxins secreted by the S. aureus pathogen.
MRSA bacteria a growing global threat
MRSA bacteria cause a range of serious illnesses, from skin and wound infections to pneumonia and serious bloodstream infections that can cause sepsis and death. Sepsis, which occurs when the body’s response to an infection injures its own tissues and organs, is a leading cause of death, particularly in the developing world among infants and children. An estimated 3 million newborns and 1.2 million children suffer from sepsis globally every year. Recently published studies indicate that resistant pathogens, including MRSA, are increasingly common causes of newborn sepsis in particular, and likely contribute to excess mortality in this most vulnerable population.
Global data on the impact of S. aureus bacteria is lacking. In the US alone, the US Centers for Disease Control and Prevention (CDC) estimates that 80,461 MRSA infections and 11,285 related deaths occurred in 2011.
Expansion of IBT’s research
The IBT team is focusing on two main areas of research to expand its current vaccine development activities.
- Collaborate with health research organizations active in LMICs in Africa, Southeast Asia and South America to collect circulating strains of aureus for testing and also to potentially collaborate on future clinical trials in LMICs.
- Develop a freeze-dried version of the vaccine for use in regions where temperature-controlled supply chains are unreliable or do not exist. This involves developing a freeze-dried powder formulation for distribution that would not be affected by changes in room temperature. The formulation would be mixed with a saline-type liquid prior to administration to patients.
Driving innovation to address the growing global superbug crisis
According to the World Health Organization, an estimated 700,000 people die each year worldwide from drug-resistant bacterial infections. The CARB-X portfolio is the world’s largest antibacterial early development portfolio. It currently has 30 active projects in five countries, and is expected to grow significantly this year.
Since its launch in 2016, CARB-X has announced 45 awards exceeding $130.5 million, with the potential of additional funds if project milestones are met, to accelerate the development of antibacterial products. These funds are in addition to investments made by the companies themselves. The CARB-X pipeline will continuously evolve, as projects progress and graduate from CARB-X and others fail for a variety of reasons.
Partnership driving antibacterial innovation
CARB-X is investing more than $500 million in antibacterial R&D between 2016-2021. The goal is to support therapeutic projects in the early phases of development through Phase 1, and diagnostic development from feasibility through development and into the early phases of product verification and validation, so that they will attract additional private or public support for further clinical development and approval for use in patients. CARB-X funding is restricted to projects that target drug-resistant bacteria highlighted on the Centers for Disease Control and Prevention (CDC)’s 2013 Antibiotic Resistant Threats list, or the Priority Bacterial Pathogens list published by the WHO in 2017 – with a priority on those pathogens deemed Serious or Urgent on the CDC list or Critical or High on the WHO list.
CARB-X is led by Boston University and funding is provided by the Biomedical Advanced Research and Development Authority (BARDA), part of the Office of the Assistant Secretary for Preparedness and Response (ASPR) in the US Department of Health and Human Services , the Wellcome Trust, a global charity based in the UK working to improve health globally, Germany’s Federal Ministry of Education and Research (BMBF), the UK Department of Health and Social Care’s Global Antimicrobial Resistance Innovation Fund (GAMRIF), the Bill & Melinda Gates Foundation, and with in-kind support from National Institute of Allergy and Infectious Diseases (NIAID), part of the US National Institutes of Health (NIH). CARB-X is headquartered in the Boston University School of Law.
This news release is supported by the Cooperative Agreement Number IDSEP160030 from ASPR/BARDA and awards from Wellcome Trust, the German and UK governments and the Bill & Melinda Gates Foundation, as administrated by CARB-X. The content is solely the responsibility of the authors and does not necessarily represent the official views of the Department of Health and Human Services Office of the Assistant Secretary for Preparedness and Response, other funders, or CARB-X.
Media Contacts:
CARB-X
Jennifer Robinson
carbxpr@bu.edu
+1.514.914.8974
Integrated Biotherapeutics Inc.
Javad Aman
javad@integratedbiotherapeutics.com
O: +1.240.454.8940
M: +1.301.512.8921
About CARB-X
CARB-X is a global non-profit partnership led by Boston University and dedicated to accelerating early development antibacterial R&D to address the rising global threat of drug-resistant bacteria. CARB-X funding is provided by the Biomedical Advanced Research and Development Authority (BARDA), part of the Office of the Assistant Secretary for Preparedness and Response (ASPR) in the US Department of Health and Human Services , the Wellcome Trust, a global charity based in the UK working to improve health globally, Germany’s Federal Ministry of Education and Research (BMBF), the UK Department of Health and Social Care’s Global Antimicrobial Resistance Innovation Fund (GAMRIF), the Bill & Melinda Gates Foundation, and with in-kind support from National Institute of Allergy and Infectious Diseases (NIAID), part of the US National Institutes of Health (NIH). A non-profit partnership, CARB-X is investing more than $500 million from 2016-2021 to support innovative antibiotics and other therapeutics, vaccines, rapid diagnostics and devices. CARB-X supports the world’s largest and most innovative pipeline of preclinical products against drug-resistant infections. CARB-X focuses exclusively on high priority drug-resistant bacteria, especially Gram-negatives. CARB-X is headquartered at Boston University School of Law. https://carb-x.org/. Follow us on Twitter @CARB_X.
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 www.integratedbiotherapeutics.com.
About BARDA and NIAID
The US Department of Health and Human Services works to enhance and protect the health and well-being of all Americans, providing for effective health and human services and fostering advances in medicine, public health, and social services. Within HHS, ASPR’s mission is to save lives and protect Americans from 21st century health security threats. ASPR leads the nation’s medical and public health preparedness for, response to, and recovery from disasters and public health emergencies. BARDA provides a comprehensive, integrated, portfolio approach to the advanced research and development, innovation, acquisition, and manufacturing of medical countermeasures – vaccines, drugs, therapeutics, diagnostic tools, and non-pharmaceutical products for public health emergency threats. These threats include chemical, biological, radiological, and nuclear agents, pandemic influenza, and emerging infectious diseases. NIH is the primary US federal agency conducting and supporting basic, clinical, and translational medical research, and is investigating the causes, treatments, and cures for both common and rare diseases. NIAID conducts and supports research — at NIH, throughout the United States, and worldwide — to study the causes of infectious and immune-mediated diseases, and to develop better means of preventing, diagnosing and treating these illnesses.
About Wellcome Trust
Wellcome exists to improve health for everyone by helping great ideas to thrive. We’re a global charitable foundation, both politically and financially independent. We support scientists and researchers, take on big problems, fuel imaginations and spark debate. The Wellcome Trust is a charity registered in England and Wales, no. 210183. Its sole trustee is The Wellcome Trust Limited, a company registered in England and Wales, no. 2711000 (whose registered office is at 215 Euston Road, London NW1 2BE, UK)
About BMBF
Education and research are the foundations for our future. The promotion of education, science and research by the Federal Ministry of Education and Research (BMBF) represents an important contribution to securing Germany’s prosperity. Education and research are a Federal Government policy priority, which is reflected in the development of the funding it is making available to these fields.
About the Global AMR Innovation Fund (GAMRIF)
The Department for Health and Social Care (DHSC) is the UK Government department which is responsible for helping people to live more independent, healthier lives for longer.
The partnership with CARB-X is part of DHSC’s Global Antimicrobial Resistance Innovation Fund (GAMRIF). GAMRIF was established to provide seed funding for innovative research and development, specifically in neglected and underinvested areas, in the field of AMR. GAMRIF is a £50m UK Aid investment, which means all projects funded must support research primarily and directly for the benefit of people in low- and middle-income countries (LMICs). The Fund takes a ‘One Health’ approach, seeking to invest in potential solutions to reduce the threat of AMR in humans, animals, fish and the environment. The Fund seeks to leverage additional global funding through interaction with international government bodies, public-private partnerships, product development partnerships, global funding mechanisms and global fora.
About the Bill & Melinda Gates Foundation
Guided by the belief that every life has equal value, the Bill & Melinda Gates Foundation works to help all people lead healthy, productive lives. In developing countries, it focuses on improving people’s health and giving them the chance to lift themselves out of hunger and extreme poverty. In the United States, it seeks to ensure that all people—especially those with the fewest resources—have access to the opportunities they need to succeed in school and life. Based in Seattle, Washington, the foundation is led by CEO Sue Desmond-Hellmann and Co-chair William H. Gates Sr., under the direction of Bill and Melinda Gates and Warren Buffett.
About Boston University
Founded in 1839, Boston University is an internationally recognized institution of higher education and research. With more than 33,000 students, it is the fourth-largest independent university in the United States. BU consists of 17 schools and colleges, along with a number of multi-disciplinary centers and institutes integral to the University’s research and teaching mission. In 2012, BU joined the Association of American Universities (AAU), a consortium of 62 leading research universities in the United States and Canada. For further information, please contact Jeremy Thompson at jeremy22@bu.edu. www.bu.edu.
IBT Receives Phase II STTR grant from NIAID for development of Novel ISTAb therapeutics for B. anthracis
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.
IBT Receives Phase I SBIR grant from NIAID for development of monoclonal antibodies against Marburg Virus using a novel discovery platform
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.
IBT Receives Phase I SBIR grant from NIAID for development of monoclonal antibodies against Marburg Virus using a novel discovery platform
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.
IBT Receives Phase I/II Fast Track SBIR grant from NIAID for development of broadly protective monoclonal antibodies against Influenza Virus
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.
IBT Receives Phase I SBIR grant from NIAID for development of Novel ISTAb therapeutics for Staph aureus
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.
