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INmune Bio Harnessing the Innate Immune System to create Path breaking Therapeutics

12 Feb INmune Bio Harnessing the Innate Immune System to create Path breaking Therapeutics

INmune Bio (NASDAQ: INMB), a clinical-stage Company focussed on creating novel immunotherapies for the treatment of hematologic malignancies and solid tumors, announced the award of a grant of $500,000 by the ALS Association, an association not only providing care and assistance to those suffering from ALS but also one of the largest funder of ALS research worldwide. The grant will be utilised to fund the ongoing proof-of-concept studies for XPro1595, a protein biologic that has the potential to target soluble TNF (Tumor Necrosis Factor) and reduce neuroinflammation.

XPro1595 is a second-generation selective TNF inhibitor that has the ability to neutralize sTNF, while leaving the trans-membrane TNF (tmTNF) unaffected. This is an improvement over existing TNF inhibitors, as they are non-selective and affect both the bad “sTNF” and good “tmTNF”. This lack of differentiation is one of the primary causes of side-effects of currently approved TNF’s, which includes neurological problems such as Multiple Sclerosis, Cancer and Infections.

R.J. Tesi, M.D., Chief Executive Officer of INmune Bio, Commented,

“We are honored to receive this grant from The ALS Association, the pre-eminent organization supporting novel treatments for ALS. As an immunology company, we focus on the role that innate immune dysfunction and neuroinflammation play in the progression of neurodegenerative diseases such as ALS. This award supports our approach and moves the company’s ALS program closer to the clinic.”

XPro1595 has been tested in over 30 preclinical studies in nearly 30 CNS models and has demonstrated no safety side-effects that are associated with currently approved TNF inhibitors. The candidate is being evaluated for the treatment of Alzheimer’s and so far multiple three independent labs have tested XPro1595 in animal models. The results show improvement in cognition, clearance of toxic cellular debris, rescue neuronal communication, and normalize immune cell profiles as per a Company statement. In addition, the studies also show that the candidate can block the development of amyloid pathology, prevent loss of cognition and neuron communication.


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Amyotrophic Lateral Sclerosis (ALS) or Lou Gehrig’s disease is a progressive neurodegenerative disease, characterized by the atrophy of nerve cells in brain and spinal cord, leading to hardening and scarring in the affected region. As the disease progresses, patients gradually lose the functioning of muscles, including those that control speech, movement and breathing. The disease manifests in two forms, sporadic and familial, with 90 to 95 percent of all cases in the U.S being Sporadic. Familial or the inherited form of the disease constitutes the other 5 to 10 percent.

Image Source: ALS.Org

According to information made available by the ALS association, there are over 16,500 Americans afflicted by this illness and nearly 5000 new cases are diagnosed each year. The life expectancy after diagnosis is merely 2 to 5 years, with an estimated $250,000 being spent on out-of-pocket treatment costs. The Global ALS treatment market is expected to be worth over USD 3.6 billion by 2026, growing at a CAGR of 21.6 percent, from USD 0.75 billion in 2018, according to a report by Data Bridge Market Research.

INmune Bio is developing two proprietary delivery systems namely INKmune, which allows for relaying priming signals to resting Natural Killer (NK) cells through a simple IV infusion and DN-TNF Platform that targets TNF otherwise known as the “master” cytokine.

NeuLiv, the Company’s third development program using its proprietary DN-TNF Platform, is being developed for the treatment of nonalcoholic steatohepatitis (NASH) by harnessing the body’s innate immune system to mount an offense on the disease. INmune bio believes that NeuLiv, a TNF inhibitor that neutralizes soluble TNF (sTNF) without affecting trans-membrane TNF (tmTNF) or TNF receptors, has the potential to treat the underlying cause of NASH thereby stopping its progression and helping the liver heal.

Image Source: Company

The drug candidate can directly target soluble TNF, the cytokine which is primarily responsible for causing chronic inflammation. Unlike a more generic approach taken by other drugs, NeuLiv focuses on the peripheral, regional and local causes of chronic inflammation in patients with NASH, which helps slow down the progression of the disease and promotes hepatic repair mechanism.

Image Source: Company

In addition, the Company’s pipeline consists of candidates for Alzheimer’s disease (XPro1595) and Oncology. INmune is engaged in a phase I clinical trials in patients with mild-to-moderate Alzheimer’s disease, targeting the reduction of neuroinflammation using soluble TNF. The Company ‘s candidate for oncology, INB03, has completed a phase I open label dose escalation trial in patients with advanced cancer, with plans to initiate a phase II in the Q1 of 2020.

Risk Assessment

  • INmune Bio is targeting areas which are prohibited for existing TNF inhibitors due to their lack of selective inhibition. The company’s technology is leveraged to address the unmet needs in cancer and neurodegenerative diseases, areas that are out of bound for other TNF inhibitors owing to their immunosuppression. This differentiation will hold the Company in good stead and give it a great competitive advantage in a crowded market that has numerous companies vying to create a viable treatment solution.
  • The Company is building a diverse portfolio of candidates, targeting areas with large unmet needs namely cancer, NASH and neurodegenerative diseases. This helps diversify its risk and mitigate losses in case of a setback in any one of the clinical trials. However on the upside all three areas have a large revenue potential, especially if the candidate proves to have a superior efficacy and safety profile than those of the competitors. There have been more than 70 published reports that have shown consistent and positive testing results across both platforms that the Company is pursuing.
  • The Company enjoys a strong intellectual property rights portfolio, with patent protection for its DN- TNF and Immune Priming Therapy Platforms covering composition of matter, methods of treatment and use for Cancer and Nash. There are additional patents filed and in process, which not only add value to the Company but also stave off competition.
  • INmune Bio is expecting multiple catalysts in 2020 in the form of data readout from its INB03 phase I trial, Phase II LIVnate trial, Phase I INKmune in MDS and Ovarian Cancer and XPro1595 expected to enter into Phase 2 by late 2020 or early 2021.
  • The Company does not have any debt and relies on non-dilutive sources of financing to fund its operations and programs. As of September 2019, INmune bio had cash and cash equivalents of $7.4 million. This includes $0.4 million of cash as a result of Australian research and development tax credit.
  • INmune had previously received a grant of $1 million grant from the Alzheimer’s association, deriving from the “Part of the cloud” grant that aims to provide impetus to preclinical research to advance into clinical testing. This serves as a validation of its technology and approach to creating novel therapeutics.
  • 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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