Maxwell Biosciences is a multi-asset longevity biotech company developing a powerful nasal spray (on track for FDA clinical trials in 2024) to clear pathogens and inflammation, with the long-term goal of restoring immunity, extending brain healthspan, and returning memory and personality.
Senior reviewers: senior review launched on November 26th
Shepherd: Paolo Binetti
Squad members: Abhijit Kale, Ryan Spangler, Winnie Qiu
Sourced by: Paolo Binetti via lifespan.io Longevity Investor Network
- J. Scotch McClure, founder & CEO
Maxwell is a multi-asset biotech company pioneering a new class of small molecule drugs based on biomimicry of the innate human immune system. Maxwell’s lead compound mimics the pathogen-agnostic core immune peptide, Human Cathelicidin Antimicrobial Peptide (LL-37), that has shown promise in the lab and in animal studies against a wide range of pathogens that can trigger chronic disease. These pathogens remain in the system, building inflammation and immune dysregulation over time. Our compounds’ structural stability and novel mechanism(s) of action have the potential to disrupt current standard of care for chronic diseases caused by viral, bacterial, and fungal infections, as well as post-infection inflammatory conditions correlated by the existing scientific literature with hallmarks of aging.
Maxwell’s novel drug platform was discovered using an artificial intelligence analysis of the proteomics of vulnerability in aging. Our technological breakthrough was facilitated by a grant from the US Defense Advanced Research Projects Agency (DARPA) given to develop a Synthetic Immune System.
What our artificial intelligence analysis revealed was a wide variety of potential factors in blood that could be correlated with youth and health, but specifically pointed out the multi-system value of LL-37. Our analysis pointed to LL-37 as the perfect super drug able to help with rejuvenating signs of aging, and healing all kinds of diseases, especially chronic disease and life-threatening infections. There was one major problem: LL-37 disappears quickly - cut apart or “cleaved” by protease enzymes produced by microbes, viruses, and your own body.
What our scientific researchers realized was their efforts with DARPA and in subsequent research to mimic LL-37 had solved the stability and delivery problems of peptide drugs, creating a First-In-Class novel drug delivery platform, “Claromer”. They had created small molecule mimics of LL-37 with a nitrogen-centric structure, designed to be highly biostable and highly predictable drug candidates.
Our lead candidate (MXB-22,510) has been shown to be safe in animals and able to tackle viruses, all tested bacteria and all tested fungi—including many drug-resistant strains and biofilm formations. Maxwell’s platform may provide the treatment necessary to eradicate the infectious agents that are responsible for many diseases of the aged, including Alzheimer’s disease, Parkinson’s Disease, rheumatoid arthritis, multiple sclerosis, Epstien-Barr virus, and many others with origins connected to pathogens.
The company plans to invest significant funds into its upcoming 2024 FDA clinical trials, as well as in R&D to expand its indications in the longevity field. The technology has remarkable potential in a wide range of therapeutic settings. Maxwell strategically sees a pathway to speed the development of age-related and longevity applications by first proving its infectious disease pipeline, which provides advantages for speedier clinical trials.
Our technology is backed by over $40M in government grants & private investments. The R&D team is being led by former pharmaceutical executives, who successfully commercialized over 80 drug products such as Adderall XR, Carbatrol, Equetro and Claritin. There is now preclinical scientific evidence that Maxwell’s antimicrobial drug technology works safely without developing resistance - a $72B+ revenue opportunity.
Chronic Rhinosinusitis is Maxwell’s strategic lead program. Chronic Rhinosinusitis (CRS) is a disease of the nasal cavity and paranasal sinuses and is characterized by patient complaints of inflammation that lasts 12 weeks or longer and does not resolve with antibiotic treatment. According to the CDC, CRS is suffered by around 11% of the population. The infection is triggered by a virus generally, and then driven into chronic status by combinations of opportunistic fungal and bacterial infections.
FDA considers chronic sinus infections an unmet medical need because there are no therapies approved that target the root cause of sinus infections: a mixture of bacteria, viruses and fungi. Maxwell’s First-in-Class CLAROMER® brand drug delivery platform is able to selectively target all kinds of pathogens without the use of antibodies by recognizing exposed phosphatidylserine.
Increasingly, researchers are investigating how chronic sinus infections caused by polymicrobial infections may cause a cascade of issues that impact healthspan. For instance, Frontiers in Aging Neuroscience published research showing that chronic sinus infections constitute an underappreciated player in the aging narrative. Studies have suggested a potential link between chronic sinusitis and reduced volume in certain brain regions. There are even studies showing a high correlation between sinus infections and Alzheimer’s / dementia. With the context of increasing focus on polymicrobial infection’s relationship to aging, it becomes clear that the siege of chronic sinusitis is not just a battle for our sinuses, but potentially also a battle for our minds.
Maxwell’s CLAROMERS® have demonstrated membrane disruption across a broad-spectrum of pathogens —including confirmed pan-coronavirus and pan-influenza efficacy—and effectiveness against all tested bacterial and fungal pathogens, indicating “One drug for MANY bugs” efficacy. As shown above, our lead candidate demonstrates pathogen-agnostic activity against a broad spectrum of bacteria, viruses and fungi. We have preclinical safety data for our lead candidate MXB-22,510 demonstrating its safety in both in vitro and in vivo assays that are mandatory prior to testing in humans.
In addition, CLAROMERS®, including our lead candidate MXB-22,510, have also shown the ability to prevent the development of drug resistance, which has become an increasing problem with current antibiotics.
We aim to partner with governments to stockpile against future pandemics, service military personnel (e.g. wound care anti-infectives), and address other infectious disease concerns (e.g. Ebola, WHO [World Health Organization] ESKAPE Pathogens).
MXB-22,510 is moving into human trials next year, and could delay, prevent or even reverse the degradation of innate immune function, allowing the body to focus energy on rejuvenation. MXB-22,510 could eventually augment our defense mechanisms or even help reverse the damage caused, extending our healthspan.
The typical standard of care by a general physician for Chronic Rhinosinusitis (CRS) is to first prescribe corticosteroids and saline nasal irrigation systems and then refer to an otolaryngologist if symptoms do not resolve in 4 weeks. If the patient goes to see the otolaryngologist, they are typically prescribed antibiotics and more corticosteroids. In more than half of all patients treated for CRS, symptoms persist, leaving patients with the option of painful surgery or risky biologics.
The estimates on the prevalence of CRS in patients ranges from 14 - 28 million in the United States. A fraction of these patients seek treatment with an estimated 7.3 million people seeking medical care annually. The estimated cost for a single patient in a year with CRS is $5500. This results in a US market of over $40 billion annually. This is a massive population of people that need help to be treated and a significant economic burden for payers.
Unmet medical need: High
Addressable market: $40 billion annual US market for CRS patients; Global market is more than >$80 billion annually
Target revenue: $6 billion US; Global market >$12 billion
Chronically recurring due to reinfection from environmental pathogens
Polymicrobial fungal, bacterial, viral biofilm ecosystem uniquely well targeted by broad spectrum CLAROMERS®
Researchers have noted the significant impact of immunosenescence (the complex processes involved with the aging of the immune system) upon biological aging and age-related diseases. One major driving factor of immunosenescence is a phenomenon typically described in scientific literature as “inflammaging” – defined as a low-grade inflammatory state triggered by continuous antigenic stimulation. The duress of combating pathogens over a lifetime accumulates, accelerating the aging process of our immune system.
To address this need in longevity, Maxwell is developing a powerful nasal spray to clear pathogens and inflammation. Our compounds are able to cross the blood / brain barrier, so we hypothesize that our nasal spray may likely also impact existing immune dysregulation or chronic inflammation in the brain and upper respiratory system.
Maxwell’s scientific cofounder, Dr. Annelise Barron, has won multiple awards, including the NIH Pioneer Award in 2020, for her research into the molecular biophysics and mechanisms of LL-37 and its involvement in Alzheimer’s dementia (via LL-37 dysregulation and degradation by pathogen virulence factors). Alzheimer’s dementia can be caused by (or at least, accompanied by) polymicrobial cerebral infections. Barron’s lab is at work creating Maxwell’s biostable mimics of LL-37 as therapeutics that can combat antibiotic-resistant infections, especially cerebral infections, ear infections, and sinus / lung infections.
Mimicry of the Immune System - A Giant Leap Forward
Maxwell’s team applied their understanding of the human immune system and breakthrough biotechnology to create the CLAROMER® drug platform. One day soon, perhaps mimicry of the immune system will be counted as one of humanity’s greatest advancements in healthy lifespan.
Maxwell’s Patent Estate and intellectual property is fully owned, with full control of the CLAROMER® Platform, a tissue-safe extremely broad spectrum anti-infective with potential world-first efficacy against many viruses, fungistatic efficacy against a broad spectrum of deadly fungi (including mold and yeast), bacteria, and currently untreatable biofilms. Maxwell’s IP portfolio has 6 granted patents and 9 more in prosecution that include composition of matter and both linear and cyclic biomimetic oligomers.
In addition, Maxwell continues to develop IP around novel compounds/structures, new methods of use, and animal/livestock health.
The budget over the next 2 years is focused on:
FDA human trials
Broadening R&D efforts
Maxwell was incorporated in 2016 as a Delaware C corporation and has raised over $15M. Notable investors include Keiretsu Forum, DecentraNet, David Shaw (former Venrock partner), Accelerator Venture Partners and Cause First Ventures.
The company is actively seeking funding to continue to develop our compounds. We recognize the value that VitaDAO members bring, both in terms of financial support and expertise. We are offering an opportunity for VitaDAO members to provide funding under the current Convertible Note (raising up to $20M with a $94M cap, 20% discount to the next round and 10% interest coupon), ensuring a mutually beneficial partnership. Maxwell’s seed round closed in 2021 with a valuation of $61M. We have both hard and verbal commitments for a significant portion of this Convertible Note and anticipate closing it soon. This closure will also be based on the outcome/time frame resulting from current discussions with investors.
We have a number of followers identified for the Series A and are working through several options for a lead investor.
J. Scotch McClure, MBA - CEO & Co-founder
Mr. McClure is an engineer and MBA 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 anti-viral applications of Maxwell’s platform, and human gene expression technology.
Annelise Barron, PhD - Scientific Co-Founder, Co-Inventor & Board of Directors
Dr. Barron is a Professor of Bioengineering at Stanford University. She is an Associate Editor for Frontiers in Aging Neuroscience and recently received a highly competitive NIH Director’s Pioneer Award. In 1999, Dr. Barron invented the first of Maxwell’s anti-infective drugs.
Kent Kirshenbaum, PhD - Chief Scientific Officer
Professor of Chemistry at New York University. As a co-inventor of the drug class, he is able to answer questions regarding the fundamental chemical science behind the discovery of the drug class and support ongoing scientific research collaborations with academic institutions around the world.
Edward Rudnic, Ph.D. - COO
Dr. Rudnic is the former head of US R&D for Shire Pharmaceuticals where he led projects that drove over $30 billion in revenue for Shire. He has also been either the lead inventor or a co-inventor of 58 issued U.S. patents and numerous related international patents.
Tony Verco, MD, MBA - Chief Medical Officer
Tony is an anesthesiologist with over 23 years experience in the pharmaceutical industry. He has worked in both the contract clinical research sector as well as small and large pharmaceutical companies, with experience spanning research in toxicology, pharmacology, drug safety, regulatory, commercial, and product development strategy.
Our tests in vitro and in vivo indicate that our compounds can clear pathogens and inflammation
Our compounds appear to reduce “inflammaging” – defined as a low-grade inflammatory state triggered by continuous antigenic stimulation.
We have a new class of breakthrough drugs to potentially address refractory diseases with novel mechanisms of action
Our team has extensive experience bringing new drugs to market. Our COO and key leadership team successfully commercialized over 80 drug products, including several multibillion blockbusters like Adderall XR, Carbatrol & Claritin.
Signed agreement with the U.S. Army Medical Research Institute for Infectious Disease to conduct studies on our behalf for a number of dangerous pathogens - helping us to continue to develop our overall platform
Maxwell owns all IP associated with this novel class of drugs
Demonstrated preclinical safety and selectivity, including studies where CLAROMERS® have been tested in animals at over 100x times the therapeutic dose without toxicity
First-in-class, novel mechanism of action compound poses potential clinical risks. While we are conducting significant safety and efficacy testing before entering humans, the inherent complexity of the human body means we can’t know for certain how our compounds will interact until we enter human clinical trials.
Standard development risk factors and regulatory authority requirements associated with drug development
As we gain additional traction with the U.S. Government, including the Department of Defense, there are additional compliance and regulatory requirements that we must meet on the business side.
The biotech startup environment is currently experiencing a tough few years for capital raising. While we have been successful so far in raising the capital necessary to continue to develop our compounds, there is no guarantee for the future.
Alonso R, et al (2018). “Infection of Fungi and Bacteria in Brain Tissue From Elderly Persons and Patients With Alzheimer’s Disease.” Front. Aging Neurosci.
Barbé-Tuana F, et al (2020). “The Interplay between Immunosenescence and Age-related Diseases.” Semin Immunopathol.
Chongsiriwatana, et al (2017). “Intracellular Biomass Flocculation as a Key Mechanism of Rapid Bacterial Killing by Cationic, Amphipathic Antimicrobial Peptides and Peptoids.” Scientific Reports.
Cunha, L. L., et al (2020). “Remodeling of the Immune Response With Aging: Immunosenescence and Its Potential Impact on COVID-19 Immune Response.” Frontiers in immunology.
Conboy, M. J., et al (2013). “Heterochronic Parabiosis: Historical Perspective and Methodological Considerations for Studies of Aging and Longevity.” Aging cell.
Feehan, J., et al (2021). “The twilight of the immune system: The impact of immunosenescence in aging.” Maturitas.
Fülöp, T., et al (2016). “The Role of Immunosenescence in the Development of Age-Related Diseases.” Revista de investigacion clinica.
Harrass S, et al (2021). “Chronic Rhinosinusitis and Alzheimer’s Disease-A Possible Role for the Nasal Microbiome in Causing Neurodegeneration in the Elderly”. Int J Mol Sci.
Lathe, R. et al (2023). “Programmed Ageing: Decline of Stem Cell Renewal, Immunosenescence, and Alzheimer’s disease.” Biol Rev.
Rodrigues, L. P., et al (2021). “Hallmarks of aging and immunosenescence: Connecting the dots.” Cytokine & growth factor reviews.
Sansoni, P., et al (2008). “The immune system in extreme longevity.” Experimental gerontology.
Tate, Patrick M, et al (2023). “Peptidomimetic Oligomers Targeting Membrane Phosphatidylserine Exhibit Broad Antiviral Activity.” ACS Infectious Diseases.
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