Scopus BioPharma has Huge Scope for Growth. Find Out How!

26 May Scopus BioPharma has Huge Scope for Growth. Find Out How!

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Scopus BioPharma, Inc. (NASDAQ: SCPS), a biopharmaceutical company, announced the approval of an investigational drug application (IND) for CpG-STAT3siRNA, an immuno-oncology RNA therapy intended for the treatment of multiple cancers.

CpG-STAT3siRNA, or CO-sTiRNA™, the company’s lead product candidate is a first-in-class, targeted immuno-oncology gene therapy and a STAT3 inhibitor, that has demonstrated the ability to reduce growth and metastasis of tumors such as melanoma, leukemia, lymphoma, colon and bladder cancer in preclinical testing. The candidate was developed in City of Hope, a premier independent research and treatment center for cancer, diabetes and other life-threatening diseases, by Dr. Hua Ya and Marcin Kortylewski. The Company will be initiating a Phase 1 clinical trial for B-cell non-Hodgkin lymphoma at City of Hope.

The Company had submitted an IND in April, 2021 for the drug candidate, which encompasses both RNA therapy and immunotherapy by linking siRNA to an oligonucleotide TLR9 agonist, thereby enabling targeted gene silencing with simultaneous TLR stimulation and immune activation in the tumor microenvironment.

Speaking on the IND Submission, Joshua R. Lamstein, Chairman of Scopus BioPharma, stated,

“The IND submission to the FDA for a Phase 1 clinical trial for our lead drug candidate is a key milestone for Scopus. We are excited about the prospects of entering the clinic. We believe this, and other imminent developments, will be significant drivers of shareholder value.”

Scopus BioPharma, Inc. (NASDAQ: SCPS)

Market Cap: $ 150.83M; Current Share Price: 9.59 USD
Data by YCharts

Industry
Non-Hodgkin lymphoma (NHL) originates in the white blood cells, namely lymphocytes, a component of the body’s immune system which helps fight infections. The disease mostly affects adults but can sometimes occur in children too. The lymph tissue is generally found in the lymph nodes, spleen, bone marrow, thymus, adenoid and tonsils and the digestive tract.

The disease can be categorized into B-cell non-Hodgkin lymphoma and T-Cell non-Hodgkin lymphoma depending on the type of lymphocyte that are affected. B-Cell lymphomas are the most common forms of the disease. Furthermore, lymphomas can also be categorized by the speed at which they grow and spread such as indolent or aggressive lymphomas. These cancers can quickly spread to other parts of the body such as the liver and brain as well.

The most common risk factors for Lymphomas are age, gender, family history, chemical or radiation exposure, use of certain drugs and affect those who are immunocompromised or suffering from autoimmune diseases. The disease manifests in the form of enlarged lymph nodes, unexplained weight loss, swollen abdomen, fatigue, shortness of breath to name a few. The treatment options vary from chemotherapy, immunotherapy, targeted therapeutics, radiation therapy and stem cell transplant.

According to a report by Fortune Business Insights, the global Non-Hodgkin lymphoma (NHL) therapeutics market is poised to reach over USD 12.57 billion by the end of 2026, growing at a CAGR of 8.4%, from USD 6.60 billion in 2018. Increased research and development, growing awareness, improved diagnostic and healthcare facilities and medical breakthroughs will drive the growth in the market.

Company
Scopus BioPharma aims to develop transformational therapies that can address the unmet needs in chronic diseases. The Company is developing a pipeline of candidates that leverage its expertise in immune-oncology gene therapy to target multiple cancers.

The Company is planning to initiate phase 1 clinical trials of CO-sTiRNA™ for additional indications and in combination with immune checkpoint inhibitors and chimeric antigen receptor T-cells, or CAR-Ts. In the pipeline is MRI-1867, a peripherally-restricted, dual-action cannabinoid-1, or CB1, receptor inverse agonist and inhibitor of inducible nitric oxide synthase, or iNOS. The Company will initially develop the candidate for the treatment of systemic sclerosis, in association with NIH. The Company is also collaborating with Hebrew University on programs related to an opioid-sparing anesthetic, besides research and development of novel compounds and new chemical entities.

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Scopus owns an exclusive worldwide license for patents related to a series of novel dual-action CB1 receptor inverse agonists, including MRI-1867, which were acquired from the NIH.

CO-sTiRNA™, the Company’s lead candidate, is a STAT3 inhibitor and has shown the potential to eliminate established tumors in pre-clinical models of human and mouse B-cell lymphoma. The candidate is an intratumoral injection, which is intended to be combined with radiation therapy. Furthermore, the candidate has a two-pronged effect namely reducing survival signaling in lymphoma cells, as well as decreasing tolerogenic/proangiogenic effects of the tumor microenvironment post-RT.

MRI-1867, a dual-action, hybrid, small molecule that is an inverse agonist of the CB1 receptor, is under evaluation for the treatment of systemic sclerosis. Pre-clinical studies have demonstrated the ability of MRI-1867 to slow the progression of fibrosis and attenuate pre-existing fibrosis in liver and lungs. In addition, the candidate did not cross the blood brain barrier there by limiting CNS side effects.

The Company is also working on additional programs related to opioid-sparing anesthetic and synthesis of novel compounds and new chemical entities, including a CBD-mediated activation of TRPV1 and TRPA1 channels for pain-selective anesthesia. Scopus is also pursuing two programs in collaboration with Dr. Dmitry Tsvelikhovsky of Hebrew University that pertain to cannabinoid-based dual-action compounds and novel chemical derivatives, intended to result in proprietary NCE’s.

Key Takeaways

According to a report by Grand View Research the global market for systemic scleroderma treatment was worth USD 1.4 billion in 2019 and is expected to grow at a CAGR of 4 percent from 2020 to 2007. This presents a billion-dollar opportunity to Scopus to introduce its treatment option in a market with clear unmet needs. This is in addition to the global Non-Hodgkin lymphoma (NHL) therapeutics market, which is poised to reach over USD 12.57 billion by the end of 2026, growing at a CAGR of 8.4%, from USD 6.60 billion in 2018 as per a report by Fortune Business Insights.

The Company has built a robust intellectual property rights portfolio with both of its candidates enjoying patent protection. While CO-sTiRNA, which was licensed from City of Hope is covered by 5 issued and 2 pending patents, MRI-1867, which was licensed from NIH is protected by 3 issued and 14 pending patents. The Company is seeking to make additions to the patent portfolio through its research agreements with strategic partners namely NIH, City of Hope and Hebrew University. In addition, the Company is confident of obtaining an orphan drug designation for both of the candidates.

Clinical Trials are fraught with risk and uncertainty. The Company has two candidates in the pipeline and is focussed on developing a diverse pipeline of candidates which will help mitigate the risk in case of adverse results or the failure to meet endpoints in any of its ongoing trials of a particular candidate. The success of its clinical trials will help the Company advance its pipeline but it should also be prepared to face any setbacks, in case its ongoing trials fail to meet their endpoints.

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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