Chelation Partners – 15 September
Chelation Partners is developing a new type of therapeutic, DIBI, a non-toxic, iron-binding copolymer, as a potent, broad-spectrum, antimicrobial agent active against parasitic, fungal, bacterial, and viral infections, including drug-resistant organisms. DIBI is immune to the development of drug resistance. DIBI is also effective against sepsis and inflammatory disorders and even some forms of cancer. They are currently prioritizing DIBI therapeutic applications that support patients with COVID-19.
In terms of main competitors, the FDA has approved several small-molecule iron chelators (deferoxamine (DFO), deferiprone (DFP), and deferasirox (DFX)). These conventional clinical chelators were developed to treat hematological disorders associated with pathologically greatly elevated body iron stores and have shown serious limitations for treating infection. Importantly, these hematological chelators either carry black box warnings as to their toxicities or have been found to actually promote fungal or bacterial infection. DIBI is much more potent than conventional chelators against microorganisms and much less toxic.
Conventional anti-infective agents (antibiotics, antifungals) only target a limited number of types of pathogens and are susceptible to the development of resistance by pathogens. This has significantly impaired its use. DIBI is agnostic to the pathogen because it is starving the pathogens for free iron, to which the pathogens cannot become resistant. In addition, DIBI improves the potency of other agents, so instead of being a competitor, it is likely to be an enhancer when administered with other agents.
DIBI has been characterized in 17 published studies to be a potent, broad-spectrum, antimicrobial, and anti-inflammatory (anti-sepsis) agent. DIBI is proposed as a daily IV therapy for hospitalized COVID-19 patients, to be administered early to suppress the progression of the dysregulated inflammatory response (cytokine storm) and secondary infections, which are the two pathologies seen in nearly all fatal COVID-19 cases.
DIBI is the developmental code name for a non-toxic polymer that binds iron with high affinity and specificity, thus selectively sequestering the excess iron that enables both the dysregulated inflammatory response (cytokine storm) and secondary infections. DIBI helps avoid the damage to patients inflicted by the cascade of events cytokine storm unleashes, allowing concomitant therapies, and the patient’s immune system, more time to reach effectiveness.
DIBI has been shown to be active against fungal and bacterial infections, including those caused by drug-resistant organisms, and is predicted to be similarly potent against parasites and viral infections due to the unique mechanism of action. These antimicrobial and anti-inflammatory activities are expected to reduce mortality in COVID-19 patients by suppressing secondary infections and the damage caused by the sepsis-like response: cytokine storm and ARDS.
- DIBI can help manage key complications of COVID-19: inflammation, sepsis, ARDS, and secondary infections that are implicated in serious illness and death.
- DIBI suppresses cytokine overexpression and improves survival in models of sepsis.
- DIBI can be in clinical studies by the end of 2020.
- DIBI is nontoxic.
- DIBI does not interfere with Remdesivir, the only medication currently thought to be effective for COVID-19, and is much less toxic to cells than Remdesivir.
- DIBI can also be safely combined with antibiotics for better efficacy against secondary infections including hospital-acquired drug-resistant infections.
- There is no known physiologic pathway by which resistance can develop to DIBI.
Apart from the major tasks of raising capital, Chelation’s biggest hurdle to overcome in the following year is executing as quickly as possible so the therapeutic benefit of DIBI in COVID-19 can be realized. DIBI has many therapeutic applications outside of COVID, like antibiotic-resistant infections, but COVID is the driver of their current urgency.
Unlike most therapeutic drug candidates, DIBI is non-toxic and simple to manufacture. Therefore the biggest ordinary risks are unlikely to derail DIBI development. For that reason, their focus is on optimal execution, which requires preparation, capacity, and expertise. Already on the move to overcome this obstacle, Chelation has defined their clinical plan, lined up their manufacturers, and identified and had initial discussions with their regulatory and clinical partners. Now they just need the capital to put it all in motion.
Michael J. Weickert, PhD, Executive Chairman – Michael has been developing drugs, devices, and startup companies for over 28 years, many in the anti-infective space. He has co-founded and/or led startups as CEO of Pacylex Pharmaceuticals, illumiSonics, Sonescence, and SEA Medical Systems, CBO of Strategent Life Sciences, Corium, and Therashock, COO of Ohm Oncology, VP of development at SciDose and Auspex. At startups, he raised Seed through Series C capital and established partnerships worth more than $180 Million. He has extensive experience developing anti-infectives, as CEO of Sonescence, a Phase 2 stage drug delivery startup addressing skin and soft tissue infections. He was also the Senior Program Executive at Nektar where he set up an anti-infectives business unit and directed the flagship anti-infective product from inception through Phase 2. Michael has prepared over 40 business plans including that for an anti-viral company founded by a Nobel Prize winner and has also driven product development from pre-clinical through Phase III/NDA. He obtained Orphan Drug and Fast Track designations for anti-infective products in the US and EU. Prior to joining the pharmaceutical industry, he was at the National Cancer Institute at NIH. He received his Ph.D. in Genetics from the University of Wisconsin.
Bruce Holbein, PhD, President, CSO, Co-Founder. Bruce has a Ph.D. in microbiology with over 30 years of both academic and industrial experience in life sciences research and development and commercialization of biotechnologies. He has managed the development and commercialization of environmental and microbial biotechnologies. Bruce pioneered research on the roles of iron in the pathogenesis of bacterial disease with more than 100 publications and 15 patents.
Following their major growths and achievements, Chelation Partners is currently in the process of raising $9M USD. There is a potential for up to $3M to be available as government-backed COVID-19 stimulus funding for part of this investment. In continuous development, the secured funding will be allocated towards five main sectors which include 1) manufacturing drug substance and drug product, 2) toxicology studies, 3) regulatory authorization of clinical studies, 4) initial clinical safety study in volunteers or COVID patients, and 5) US subsidiary to oversee product development.
Since their initial launch, Chelation has received financing support from three sources including grants/non-dilutive: ~$2.1M CAD, equity: ~$1.6M CAD, and the Canadian Government loan program: ~$2.3M CAD.
Following their expansion initiatives, Chelation is seeking to grow their team. They plan to onboard senior executives to help oversee product development including chemistry, manufacturing and controls (CMC), non-clinical toxicology, clinical studies (Chief Medical Officer and head of Clinical Operations), and finally, overall operations and finance
Chelation Partners plans to develop IV DIBI for sepsis, serious infectious diseases, and pandemics, including COVID-19, the focus to which the company temporarily pivoted. After completing clinical proof-of-concept Phase 2 studies, the company will out-license or seek additional capital through private or IPO financing.
In parallel, Chelation will develop other polymers and formulations of DIBI for other infectious and non-infectious diseases, including cancer and inflammatory disease, creating a diverse pipeline for additional licensing or product development and marketing.
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