Maxwell Biosciences, a preclinical drug platform company that develops Claromers, synthetic small molecules that mimic compounds of the human immune system, recently signed its fifth Cooperative Research & Development Agreement (CRADA) with the U.S. military to address biodefense pathogens and potential therapeutics for viral and bacterial pathogens. The most recent agreement aims to address Dengue Fever, a rapidly growing mosquito-borne viral infection and a national priority biodefense threat.

In the following interview, Joshua McClure, Founder, CEO & Chairman of Maxwell Biosciences, discusses how the company is working with the U.S. military to combat infectious diseases leveraging its Claromer Platform to help advance antiviral and antibacterial therapeutics.

Contract Pharma: What are the development goals under each of the agreements with the U.S. military?

Joshua McClure: For each of the programs, Maxwell is dedicated to providing a pathogen agnostic treatment or prophylactic to the US military and warfighter. Utilizing our Claromer™ product platform to develop a range of dosage forms, Maxwell hopes to provide universal tools to address multiple infectious disease obstacles.

Maxwell received a nearly $3 million award from the Medical Technology Enterprise Consortium (MTEC) for its proposal titled “Pathogen-Agnostic Claromer™ Prophylactic to Prevent Infection in Battlefield Wounds. The award will be used to fund in vitro, ex vivo and in vivo preclinical studies of Claromer™ compound candidates intended to help select the most promising candidates for preventing wound infection in the battlefield setting.  

In addition to the CRADA associated with the MTEC award, Maxwell has entered into four additional CRADAs and one Material Transfer Agreement (MTA), outlined below.

United States Army Medical Research Institute of Infectious Diseases (USAMRIID) will initially test four different Claromers™ against six different biodefense pathogens, including Orthopoxviruses, Filoviruses (including Ebola Viral Disease), Arenaviruses, Paramyxoviruses, Bunyaviruses, and Alphaviruses to determine which, if any of the compounds, will progress to animal testing models. 

United States Army Medical Research Institute of Infectious Diseases (USAMRIID) will test Maxwell Biosciences’ Claromer™ peptoids for use as an antiviral therapeutic agent in USAMRIID’s established in vivo infection models and as an antibacterial therapeutic against USAMRIID’s bacterial select agent collection. Pending successful results from initial testing and by mutual agreement, small animal dosing and tolerability tests would also be performed by USAMRIID. 

U.S. Naval Infectious Diseases Diagnostic Laboratory will test Maxwell Biosciences’ Claromer™ compounds for use as an antiviral therapeutic agent against the four known serotypes of dengue fever, a mosquito-borne viral infection. 

U.S. Army Institute of Surgical Research (USAISR)’s laboratory will initially conduct in vitro studies with potential subsequent in vivo safety studies to explore core scientific aspects of Claromers.

Lastly, under the MTA, Walter Reed Army Institute of Research (WRAIR) will study Claromer activity in their broad screening systems.

Contract Pharma: Please describe the Claromer platform and how it’s designed to work?

Joshua McClure: The Claromer platform is designed to mimic the functions of the innate immune system of the human body, killing all pathogens.

Contract Pharma: What are the advantages and challenges of developing Claromers™?

Joshua McClure: The Claromer™ drug family is completely novel. So, our scientists and pharmacists needed to develop novel synthesis techniques and animal models to test the compounds. Fortunately, we have had a lot of support from governments to help with that process.

Contract Pharma: Are there any specific regulatory considerations developing Claromers?

Joshua McClure: The Claromer™ compounds are small molecules which make them much more straightforward for regulatory purposes. On the other hand, they are a totally novel technology, and so we have spent significant time working with the FDA on how they will be regulated. The FDA has been very proactive in working with us.

Contract Pharma: Does Maxwell Biosciences work with contract development/manufacturing partners? If so, what capabilities and services do these candidates require?

Joshua McClure: We have had a great deal of good fortune working with Contract Research Organizations and Contract Manufacturers who continue to move the Claromer™ family forward in both scaling manufacturing and developing the required studies.

Joshua “Scotch” McClure, MBA, Founder, CEO & Chairman 
Mr. McClure is an engineer with over 20 years of experience as a CEO, and 10 years of experience as a corporate board director. He is a multi-patent inventor including antiviral applications of Maxwell’s platform, and human gene expression technology. His background includes leading engineering and scientific research teams, as well as military intelligence and commercial applications such as high tech hardware and software.  He designed and commercialized the world’s first dual core laptop in partnership with Advanced Micro Devices. He is a pioneer in the field of plasma proteomics Big Data computation, and biomimetic drug design.