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Will Equillium’s Itolizumab emerge the winner in the COVID-19 sweepstakes?

04 Nov Will Equillium’s Itolizumab emerge the winner in the COVID-19 sweepstakes?

Equillium Bio (NASDAQ: EQ), a clinical–stage biopharmaceutical Company focused on bringing innovation in form of immune-modifying therapies to treat immuno-inflammatory diseases, announced the receipt of a Study May Proceed letter from the U.S Food and Drug Administration (FDA), to evaluate the company’s lead asset itolizumab, in a phase 3 clinical named EQUINOX. The study aims to evaluate the efficacy of itolizumab on acute respiratory distress syndrome (ARDS) in patients suffering from COVID-19.

The Company plans to initiate a phase 3 clinical trial in the fourth quarter of 2020 with 800 patients around multiple sites globally, besides the U.S, and will conduct interim assessments at 20% and 50% of enrollment. The primary endpoint of the study is to access the recovery benefit, while the secondary endpoint would be mortality benefit and clinical improvement.

Equillium expects initial clinical data by mid 2021 and if it demonstrates the safety, tolerability and pharmacokinetics of itolizumab, it may be sufficient to support regulatory filing of a Biologic License Application (BLA), as indicated by the FDA.

Bruce Steel, chief executive officer of Equillium, stated

“The initiation of the EQUINOX Phase 3 trial represents an important milestone for Equillium and for COVID-19 patients worldwide. We look forward to partnering with Dr. Douglas and our global sites to further evaluate itolizumab as a promising treatment for hospitalized COVID-19 patients.”

Itolizumab, a first-in-class immune-modifying monoclonal antibody is designed to target the CD6-ALCAM signaling pathway that plays a crucial role in the modulation of effector T cells (Teff cells), which cause immune-inflammatory diseases across a broad spectrum of diseases.

Equillium Bio (NASDAQ: EQ)

Market Cap: $122.77M; Current Share Price: 5.06 USDChart
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According to the World Health Organization (WHO), Coronavirus (CoV) is a family of viruses that cause illnesses ranging from common cold to lethal diseases such as the Middle East Respiratory Syndrome (MERS-CoV), Severe Acute Respiratory Syndrome (SARS-CoV) and a new strain of CoV named, novel coronavirus (nCoV). The virus is Zoonotic as it is transmitted from animals to humans, with there being many known strains that have not yet infected humans. The infection manifests in the form of respiratory symptoms, cough, fever, shortness of breath and can take the form of pneumonia, severe acute respiratory syndrome, kidney failure and even death.

WHO had identified a new type of coronavirus, namely 2019 novel coronavirus (2019-nCoV) in China in early January 2020, which has so far infected 45,942,902, including 1,192,644 deaths according to the WHO Coronavirus dashboard. The disease which originated from the Chinese city of Wuhan, has spread to 168 countries, areas and territories. According to the US Centers for Disease Control and Prevention (CDC), there are 9,105,230 known cases across 39 states and 229,932 people have died so far in the U.S alone (as of November 2, 2020).

The WHO has declared the Coronavirus outbreak as a global pandemic as more cases are reported around the world and the virus continues to spread beyond Wuhan, China. The notice allows members of the United Nations to take preemptive measures to contain the spread of the virus, including measures such as sealing borders, cancelling flights, proactively screen and quarantine suspected cases etc.

There is no definite cure for treatment or eradication of CoV, with treatment being limited to alleviation of symptoms, and providing support and care to patients. Scientists have been able to sequence the virus genetic code; spurring organizations around the world into action, with the researchers at the US National Institutes of Health are already working on a therapeutic. Organizations like CEPI are supporting initiatives to develop a vaccine by proving funding support.

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Itolizumab targets the CD6-ALCAM pathway, consists of CD6, a co-stimulatory receptor capable of regulating not only T cell activity but also Teff cells, besides Activated leukocyte cell adhesion molecule (ALCAM), a ligand of CD6, which plays a pivotal role in immune synapse formation and optimal co-stimulation. As per the company studies have shown that blockade of the CD6-ALCAM pathway leads to selective inhibition of pathogenic Teff cell activity and trafficking, while preserving the important regulatory function of Treg cells, which provide ongoing immune surveillance.

Equillium signed an exclusive collaboration and license agreement with Biocon (BIOCON.NS), for the development and commercialization of itolizumab in the U.S., Canada, Australia and New Zealand. The Company’s lead candidate, itolizumab is being developed for the treatment of disorders such as acute Graft-Versus-Host-Disease, uncontrolled asthma and SLE/Lupus Nephritis.

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In July 2020, the Company’s partner Biocon reported positive results from a Phase 2 randomized, controlled, open-label clinical trial of itolizumab (ALZUMAb™) conducted in India that demonstrated reduced mortality over one month in patients with COVID-19, when compared to a placebo. Consequently the drug was approved for emergency use by the Drugs Controller General of India for treating cytokine release syndrome (CRS) in COVID-19 patients, with moderate to severe ARDS. In addition, the candidate is being evaluated for safety and efficacy in a phase 4 trial with 300-patients.

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The Company’s pipeline consists of development of Itolizumab for the treatment of aGVHD, which has FDA Fast Track Designation and is in the process of enrolling subjects for EQUATE Phase 1b/2 trial. In addition the candidate has also received fast track designation for the treatment of SLE/ Lupus Nephritis and is enrolling candidates for a phase 1b trial. It is initiating a phase 1b EQUIP trial for uncontrolled asthma as well.

Key Takeaways

  • Presently Remdesivir and convalescent plasma for emergency use are the only two approved treatments for COVID-19 in the U.S. Though there are over 1000 potential drug candidates in development, Equillium is the only company that is focusing on modulating both the activity and trafficking of Teff cells through itolizumab. This novel approach may prove beneficial and could act as a key differentiator from other products in the race to the finishing line.
  • Strategic Partnerships are crucial for clinical-stage companies as they not only bring knowledge and technical know-how but also expertise in navigating regulatory and market hurdles. Equillium has a robust partnership with Biocon, which enables it to avail investigational drug products at no cost. This agreement is valid for 3 concurrent orphan conditions, till the company obtains its first U.S approval. In addition itolizumab is being manufactured at commercial scale in an FDA regulated facility as per the Company.
  • The Company holds exclusive rights to itolizumab in major markets such as United States, Canada, Australia, and New Zealand, besides the right to secure licensing for itolizumab in certain select major markets such as EU/Japan. The Company is also actively pursuing opportunities for expanding its pipeline.
  • Equillium has a strong intellectual property rights portfolio and a potential for 12-year biologics exclusivity, besides having an experienced management team with expertise in critical areas such as drug discovery, development and commercialization.
  • A diversified pipeline mitigates the risk associated with clinical trials, as they are fraught with uncertainty. The Company is focused on leveraging the therapeutic potential of itolizumab in treatment of a host of diseases, and any setbacks in clinical trials may have a negative impact on the Company. However the Company is seeking opportunities to expand its pipeline, which will help it diversify its risk and make optimal use of its resources.
  • Disclosure: I/we have no positions in any stocks mentioned, and no plans to initiate any positions within the next 72 hours.

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