Aequor Controls Pandemic Threats

Bacteria and fungi form "biofilm" to protect themselves from environmental stresses: immune responses, antibiotics, disinfectants, vaccines, UV, sonication, sterilization, etc. Pathogens in biofilm are 100-1000 harder to kill than free-floating pathogens. The NIH and CDC reported that 80% of all wound infections, 90% of all hospital-acquired infections, and 20% of COVID deaths are associated with biofilm. Every antimicrobial-resistant (AMR) pathogen, pandemic threat, and urgent threat is a biofilm-former. 

 Aequor's small molecules uniquely kill a broad spectrum of AMR pathogens at all stages of growth, including biofilm. They were validated to remove biofilm in minutes and prevent its formation for days. Lonza stated " Nothing else known can remove biofilm at non-toxic doses."

They also potentiate the current antibiotics (including Penicillin) to kill AMR pathogens at doses too low to trigger resistance, solving the problems of cost and rapid access to cures in the event of a pandemic outbreak.

There are currently no FDA-approved cures for AMR/ Superbug infection, no rapid diagnostics, and no sterilization/decontamination technologies of long duration.  In 2016, after confirming 700,000 AMR/Superbug deaths globally, the UN declared AMR the biggest threat to mankind’s survival, projecting over 10 million deaths/year by 2050.  The Gates Foundation has revised this estimate to 10 million deaths/month at any time.  The social and economic impacts of this public health catastrophe are incalculable.

NIH/NIAID Director Dr. Fauci himself reviewed our data and offered Aequor free pre-clinical trials as many new drug candidates as we can deliver. DOD/AMRIID offered the same because every biothreat (anthrax, tularemia, plague, botulism, etc.) is also a biofilm-former. In 2021, these contracts were renewed as the need for new drug candidates remains unmet. Aequor was also tasked by the Global Health Security Network to identify on the gaps in the WHO cleaning protocols for public places.  These will be reported to the CDC of Africa. 

Aequor seeks funding to hire identified chemists to scale up sufficient quantities of our new drug candidates required by the NIH and DOD to initiate the trials. The Biomedical Advanced R&D Agency (BARDA) has to expedite FDA approval of our new drug candidates.

Aequor's Founder discovered novel natural small molecules that eliminate biofilm and microbial contamination from inert, nano, and organic surfaces, animal and human tissues.  The molecules are produced by marine microbes that Aequor discovered. The primary natural molecule was semi-purified in milligram quantities via fermentation and tested against a broad spectrum of AMR microorganisms, including Superbugs.

The NIAID Biodefense and Emerging Infections (BEI) Resources grants Aequor access to its latest AMR and multidrug-resistant (MDR) clinical strains. Aequor’s molecule is active against the deadly strains of  Staphylococcus aureus (Methicillin-resistant/MRSA, vancomycin-intermediate/VISA, vancomycin-resistant/VRSA); Pseudomonas aeruginosa (type 2 mucoid mutant associated with Cystic Fibrosis, carbapenem-R, P179  gentamycin-R, streptomycin-R, sulfonamide-R, ampicillin-R, amoxicillin-R, metal ion-R); E. coli (serotype O157:H7 streptomycin-R, sulfisoxazole-R, tetracycline-R); Acinetobacter baumannii (carbapenem-R); Enterobacteriaceae (carbapenem-R, ESBL-producing); Salmonella enterica (Serovar Typhimurium fluoroquinolone-R, ampicillin-R, chloramphenicol-R, kanamycin-R, sulfa-trimethoprim-R, triple sulfa-R, streptomycin-R, tetracycline-R, ceftazidime-R); and Candida auris and Aspergillus fungi.  Aequor’s primary natural molecule also “potentiates” otherwise ineffective antibiotics (like Penicillin) to kill the Superbugs  MRSA, VRSA, etc.  This makes global treatment rapidly accessible in the event of an outbreak.

Aequor’s 70 synthesized chemical analogs mimic the features of the primary natural molecule: 30 for Pharma and 40 for end-uses that contribute to One Health goals.

Aequor’s mission since 2008 has been to prevent AMR biofilm-related infection and disease and advance the UN One Health goals by developing novel therapeutics for the 3 vectors of pandemic threat transmission: animals and humans and the environment (water, food, air and surfaces)  

The fact that the word “pandemic” was not fully understood until 2020 and that the words “biofilm” and “One Health” are still not widely known indicates the scope of knowledge gaps that exist in the national/global preparedness plans.  Aequor’s Founders consult for multinationals, industry organizations, and public health authorities, and have been recently tapped by legislators to identify gaps in appropriations because, despite $ billions spent for decades, there are still no remedies developed or stockpiled against AMR pandemic threats. The longer the gaps remain, the more devastating the impacts will be on human life and our socio-economic fabric. 

Healthcare stakeholders need training to understand the unique characteristics of antimicrobial-resistant (AMR) bacteria and fungi that make them deadly threats:

1)Unlike the contagion vectors of viruses (animals-humans), bacteria and fungi additionally spread in water, food, surfaces, etc., requiring a One Health approach to control transmission.

2) Bacteria and fungi defy rapid diagnosis because they form "biofilm" within minutes to firmly attach themselves to surfaces (making themselves 100 - 1000x harder to remove) and to envelop themselves under the impenetrable biofilm shield.

3)Biofilm is the first and often only resistance response of AMR pathogens against surrounding stresses that threaten them: immune responses, antibiotics, vaccines, biocidal disinfectants and physical removal (debridement/scraping, sterilization, UV, ethylene oxide gas, sonication, etc.). 

4)All of the remedies designed to kill free-floating (planktonic) bacteria and fungi (biocides, antibiotics, vaccines, immune boosters, etc.) fail in the presence of biofilm, which they cannot remove or penetrate.  Physical removal methods are not 100% effective because not all surfaces are exposed to their disinfecting action.  For example, biofilm was identified on a titanium plate within 30 seconds after sterilization, indicating that it transmitted in the air -- often from air conditioners. An entire clean room was contaminated by biofilm traced to the screw hole under a table. A deadly Candida auris fungi outbreak was traced to the curtains in between patients' beds.  A MRSA outbreak in an entire ward was traced to the tie knot of the doctor making the rounds.

5)Biofilm captures multiple species in the same biofilm that exchange genetic material -- spawning new species of Superbugs.

6)Biofilm sloughs off in air and water, transporting entire colonies to new hosts.

Until its new drug candidates can be developed, Aequor has used chemicals approved under the EPA's Toxic Substances Control Act (EPA/TSCA) in formulated cleaners and water treatments validated by USDA, NASA and DOE that have superior efficacy against AMR pathogens in clinical, agro-industrial and household vectors of transmission. 

Aequor has the cures and policy background to protect public health. Prior to joining Aequor, CEO worked 16 years at the State Department and handled bird and swine flu and MERS outbreaks, assisting in the creation of the UN One Health approach for controlling pandemic transmission, etc.

Lacking then and still lacking today is a global communications network to support a rapid, coordinated pandemic response at the community, country and global levels before AMR spreads worldwide.  Containment is often the only remedy for days/months/years after the outbreak manifests until a cure can be identified, sourced or developed (e.g., Ebola, COVID). 

Lonza validated the efficacy of Aequor's novel chemical to remove biofilm in minutes and prevent biofilm formation for days.  USDA validated efficacy of synthesized analogs against fungi and confirmed that doses were too low to trigger a resistance response.  NASA conducted a 3-year study of Aequor's chemicals in the water reuse/recycling system used aboard the International Space Station. One dose eliminated bacteria and biofilm within a day and remained effective for 15 months without replenishment. For this, Aequor won NASA's iTech Award in the Life Support category. Every astronaut had returned to Earth with a biofilm-related infection because other non-toxic remedies (silver, etc.) had failed.  Because biofilm forms thicker and faster in Space than on Earth (because it is exposed to radiation, UV, etc.), NASA declared biofilm the "#1 impediment to long-duration manned Space travel."  Other validations of efficacy from pilot projects with private companies are available under NDA.

Aequor's chemicals are the only broad spectrum, non-toxic remedies that kill bacteria and fungi at all stages of growth, including biofilm. Aequor's advocacy on the topic of biofilm has resulted in several promising developments:

--September 2016: Aequor was invited to speak about biofilm and One Health at the UN General Assembly High Level Meeting on AMR.

--Through Aequor's active participation in the One Health Commission, the Senate passed a bill naming January 2021 AMR Awareness Month.

--November 2021: the policymakers entrusted with public health and safety backed the U.S. Senate Ag/FDA Appropriations bill, which called for funding for biofilm R&D (https://www.appropriations.senate.gov/imo/media/doc/AGRept.pdf - page 111). 

Companies like the Pew Trust that track progress of new drugs through the “FDA pipeline” report that most fail in later-stage clinical trials. Microbiologists know that the new drug candidates, vaccines, diagnostics, antimicrobial coatings for medical devices, etc.  work in the lab but fail in the presence of biofilm. By not requiring biofilm testing for new drug candidates at the pre-clinical stage, the FDA has fallen 25 years behind the science and has soured investments in new anti-infectives. The fastest diagnostic for biofilm takes well over 48 hours. New diagnostic tool that can identify AMR pathogens that are free-floating result in the prescription of antibiotics that cannot work in the presence of biofilm, initiating the cycle of patient debilitation, sepsis and morbidity. Additionally, the U.S. still has no "reimbursement codes" for therapeutics making antibiofilm claims, so R&D to develop biofilm remedies remains unfundable.  

Our medical solutions currently serve 0 people and are unlikely to serve more in 1 year due to regulatory and other barriers.  With funding and support over the next 5 years, Aequor's solutions could save 700,000 lives annually, based on 2016 estimates of AMR deaths.  Ultimately, Aequor's new drugs could reduce the vulnerability of the world population of 8 billion people in 5 years and $ trillions in healthcare costs.

The Presidents at the recent G7 Summit have renewed their pledges to collaborate to find cures for pandemic threats. The levels of funding backing these pledges are historic, and Aequor may benefit from this R&D funding.

As a pre-revenue company on the medical side, the SDG indicators remain aspirational.  The increasing number of press and scholarly articles on biofilm, including by the NIH and CDC is a promising trend.

Aequor's in-house milestones for launching its new drug candidates  include the following:

-purify the novel natural chemical, synthesize to milligram and to gram quantities

-develop and synthesize novel analogs as potential new drug candidates, synthesize to milligram - gram quantities.

-screen for most active new drug candidates

-scale-up to half-kilo quantities required by the NIH and DOD

-design pre-clinical trials, engaging with BARDA

-initiate and conduct pre-clinical trials against NIH and DOD high priority pathogens

-compile data and FDA application package, etc., conducting one or more preliminary interviews with FDA

-file Investigational New Drug applications for as many new drug candidates as selected

-initiate and conduct clinical trials

-Achieve FDA approval(s)

2 Full-time: CEO and CSO

1Part-time: chemist

Outsourced microbiologists, chemists, CMOs, CROs, etc. plus professional service providers for IP, regulatory, etc.

6 Scientific Advisors

9 Business Advisors, Consultants

Cynthia Burzell, Ph.D. is a Marine and Medical Microbiologist and
Aequor's Founde, who has been undertaking biofilm research since 2001. She earned her MA and Ph.D. at St. George's University Medical School in Grenada, including working as a Microbiologist with local authorities on health issues. She was protégé of Dr. J. William Costerton, the bacteriologist who coined the term "biofilm" in the '90s. When her school waived rights to her discoveries, she filed her first patent in 2004. As Founder, President, and CSO of Aequor, Inc., she works closely with pilot project managers to solve the biofilm problems in multiple contexts, gaining insights into customer needs, resources, and training needs. For her many high-level lectures, training workshops, etc., she was selected by the U.S. government to represent American innovation at the Global Entrepreneurship Summit in June 2019 in The Hague. She liaises weekly with Aequor's Scientific Advisory Board of distinguished experts in natural chemistry, marine microbiology and AMR.

Marilyn Bruno, Ph.D., J.D. is multilingual, has 20 years’ experience in managing international businesses. She was featured in Bloomberg/Business Week and named Woman Entrepreneur of the Year for her pre-Internet trading network and 70 successful start-ups. She served 16 years with the U.S. Foreign Service serving on delegations at various international fora.  As Aequor CEO since 2008, she develops corporate policy, finance, business strategy, raises funds and liaises with the proactive Business Advisory Board with expertise in industry intelligence, marketing, finance, etc.  Advisors, customers, et al are located all over the world. 

Aequor is a Woman-Owned Small Business founded by 2 Hispanic women. Team Aequor includes Americans of Hispanic and Asian descent and our Advisors and  Consultants include several foreign nationals. One investor is Middle-Eastern.

Aequor hires qualified experts regardless of race, gender or creed, fulfilling Founders' global background and values.

Aequor actively creates opportunities for students (internships, training), participates in mentoring programs (Women in BIO Mentorship, Advisors, Peers and Sponsorship program), STEM programs (lectures and programs for students in the San Diego Unified School District), etc. Founder Burzell is a finalist for the San Diego Athena Award for demonstrating a commitment to "lifting others while climbing" to advance more women in STEM.

It wlll take more than statements at the G7 Summit to prepare for the next pandemic. The United Nations General Assembly High Level Meetings on Antimicrobial Resistance were held in 2016.  In the five years since then, there has been little more achieved than additional statements on AMR and One Health, and the funding of R&D and last resort "pull" incentives to bring Big Pharma back into the anti-infective arena. Stockpiling antiviral vaccines won't work against bacteria and fungi.  The threat level remains very high.

Through our experience with MIT/Building Global Innovators (a 9-month accelerator that was like the iCorp Beta test and including a week's training  in Cambridge), we know that MIT's networks, brainpower, technology resources and leadership are unmatched to take on the necessary task of creating and expanding a useful international communications network to handle a pandemic outbreak.

Aequor has been pushing for a very long time to puts its discoveries to their highest and best use. Becoming a Solver can help make this happen.

Aequor needs help across the board if it is to become a viable Pharma  company.

At this early stage, Aequor seeks a strong management team and Board to position the company and its products in the FDA pipeline. This will require strategy development, leveraging Aequor's current traction and injecting the momentum and connections to overcome the hurdles.

Marketing Aequor's message of the urgent need for AMR biofilm control and One Health goes hand-in-hand with raising awareness of the urgent need for a communications network for threat surveillance and containment.

Aequor would be honored to work with MIT faculty and Solve members.  We would particularly welcome the opportunity to lay out what we have done on a shoestring and see where better minds than ours can take these discoveries -- especially Lubna Alayan, Eric Schmidt, and Linda Henry.

 The Solve Advisors are the thought leaders that have every tool in their toolbox to influence the direction of the use of public and private funds to develop remedies that actually work:

--develop cures for AMR pathogens that are inexpensive, immediately available and rapidly accessible

--knock down future outbreaks at the 3 vectors of transmission before they can spread

Aequor's anti AMR remedies can be used to cure antimicrobial-resistant infection and diseases for all populations.  

Aequor’s Founder has utilized deep understanding of Marine and Medical Microbiology to discover Nature’s mechanism to eliminate the ability of pathogens to attach to surfaces.  Aequor's marine-derived chemicals and their analogs remove biofilm and prevent its formation, eliminating the pathogens’ ability to colonize on surfaces from Deep Sea to Deep Space.  Aequor eliminates he Superbugs' ability to shield themselves from sterilization, immune systems, vaccines, biocides and antibiotics by forming thicker biofilm. Aequor eliminates the protective biofilm at doses so low that they do not trigger further resistance.  

Aequor seeks support to develop and scale-up the broad-spectrum novel chemicals as new drug candidates to be able to meet the urgent need to save lives. 

In the meantime, Aequor is using its portfolio of EPA/TSCA-approved “green synthesized analogs to prevent the Superbug spread now, achieving contamination-free surfaces for unmatched periods of time. 

Our health and that our planet depends on what we do today. Aequor’s chemicals can be developed and deployed rapidly, widely and inexpensively to get an edge on the daunting Superbug problem and prepare for future threats.