Palm Beach, FL – September 4, 2024 – The emergence of SARS-CoV-2, which triggered the COVID-19 pandemic with overall is widely regarded as the greatest medical emergency of the twentieth century. COVID-19’s impact on global society would be felt for a long time. Nonetheless, significant investment in life sciences in the last few decades has facilitated a rapid scientific response through advances in viral characterization, testing, and sequencing.  A report from Transparency Market Research projects that the global COVID-19 therapeutics market size is projected to reach more than US$ 16.2 Bn by the end of 2031.  The report continued: “The coronavirus treatment, and vaccination market witnessed significant increase in demand due to the desire of governments and people to safeguard themselves and their loved ones from the virus. Technology advancements have facilitated the rapid development of COVID medications therapies and vaccinations. In a relatively short amount of time, emerging technologies, such as CRISPR and mRNA, have made it possible to develop new medicines. Pharmaceutical corporations, biotech companies, academic institutions, and governmental entities have worked closely together to create COVID-19 treatments. New therapies and vaccines have been developed and distributed more rapidly because of this collaboration.”  Active companies in the biotech industry this week include Sunshine Biopharma Inc. (NASDAQ: SBFM), Moderna, Inc. (NASDAQ: MRNA), Pfizer Inc. (NYSE: PFE), Vir Biotechnology, Inc. (NASDAQ: VIR), INOVIO (NASDAQ: INO).

Transparency Market Research continued: “Demand for COVID-19 treatments may be influenced by the ongoing coronavirus mutational alterations that are currently affecting parts of the world, including China. The need for COVID-19 vaccines and therapies has boosted spending on research and development as well as the manufacturing and distribution of medications. Governments across the globe have taken steps to guarantee that people have access to COVID-19 treatments, which has further fueled the COVID-19 therapeutics industry.  Furthermore, according to the industry analysis of COVID-19 therapeutics, increase in the number of clinical trials for COVID-19 therapeutics, including phase III clinical trials for vaccines and phase II/III clinical trials for therapeutics, such as monoclonal antibodies and antiviral drugs, are likely to be responsible for COVID-19 therapeutics market growth in the near future.”

SUNSHINE BIOPHARMA (NASDAQ: SBFM) ANNOUNCES PUBLICATION OF SIGNIFICANT CORONAVIRUS RESEARCH RESULTS IN THE JOURNAL OF MEDICINAL CHEMISTRY

• Current Test Positivity Rate for Coronavirus Infection in the U.S. is 18%
• Development of a novel antiviral compound, XR8-23 (Compound 10), targeting SARS-CoV-2 papain-like protease (PLpro) with both submicromolar potency and animal model efficacy
• XR8-23 (Compound 10) showed significant drug accumulation in lung of mice and favorable pharmacokinetic properties
• Research was conducted in collaboration with the University of Arizona

– Sunshine Biopharma Inc., (the “Company”), a pharmaceutical company offering and researching life-saving medicines in a variety of therapeutic areas including oncology and antivirals today announced the publication of new research results in the Journal of Medicinal Chemistry. The published data demonstrate a novel PLpro inhibitor with submicromolar potency and in vivo efficacy in a mouse model of SARS-CoV-2 infection. This peer-reviewed study marks an important milestone for Sunshine Biopharma in its effort to develop an effective treatment for SARS-CoV-2 infection.

There are still unmet medical needs to combat SARS-CoV-2 infection. SARS-CoV-2 undergoes mutation at a rapid rate, which leads to the continuous emergence of variants of concern (VOC) posing a significant threat to public health. In addition, certain populations, such as immunocompromised patients who are susceptible to severe and prolonged infections, may not respond well to current therapies or vaccines. For high-risk patients, blocking early infection at home may prevent disease rapid progression and reduce hospitalization.

PLpro is a compelling therapeutic target for developing antiviral compounds against SARS-CoV-2. It is a virus encoded protease essential for viral replication and is responsible for suppression of the human immune system following infection by the virus. “Sunshine has the intuition that despite the formal end of the pandemic, a new antiviral specifically designed to attack SARS-CoV-2 is needed in the clinic”, commented co-lead Prof. Greg Thatcher of the University of Arizona. “Moreover, Sunshine has the perseverance to see the project through.”

The active site of an enzyme is almost always the primary target for drug design. PLpro eluded scientist for many years due to its featureless active site. To address the challenge of PLpro’s indistinct active site, we designed and synthesized a noncovalent inhibitor library targeting a vulnerability in PLpro remote from the active site incorporating the “BL2-groove”, a key feature discovered by project co-lead, Prof. Rui Xiong of the University of Arizona.

One of the 50 compounds, XR8-23 (Compound 10), had an enzyme inhibition activity (IC₅₀) of 0.39 µM and exhibited a broad spectrum of antiviral activity towards at least 4 strains of VOC including WA1/2020, Gamma (P.1), Delta (B.1.617.2), and Omicron (BA.1). It had over 10-fold of selective accumulation in the lungs than in plasma and exhibited in vivo activity in a mouse-adapted SARS-CoV-2 infection (MA10) at 10 mg/kg by repeated IV injections.

“The publication of these results in the Journal of Medicinal Chemistry reflects our commitment to advancing science and improving patient outcomes,” said Dr. Steve Slilaty, CEO of Sunshine Biopharma and a co-author of the publication. “These findings underscore the potential of XR8-23 (Compound 10) to transform the treatment landscape for coronavirus infections, and we look forward to further exploring its capabilities and clinical development in the future.”  CONTINUED… Read this and more news for Sunshine Biopharma at:   https://www.financialnewsmedia.com/news-sbfm/

In other biotech developments in the markets:

Moderna, Inc. (NASDAQ: MRNA) recently announced that the Medicines and Healthcare products Regulatory Agency (MHRA) has authorized its updated COVID-19 vaccine targeting the JN.1 variant of SARS-CoV-2.  Following the MHRA decision, doses will be available for eligible groups as part of the NHS autumn vaccination program, which is prioritized for use in people at greatest risk of serious illness from COVID-19.

For the first time in the UK, the updated vaccine, Spikevax® JN.1, will also be available to purchase privately for those who are not eligible for the NHS Autumn vaccination program. The updated vaccine will be available from high street pharmacies, occupational health providers, and private healthcare companies.  “As the SARS-CoV-2 virus continues to evolve, COVID-19 continues to present a serious health risk. Updated vaccines targeting circulating strains play a vital role in helping to protect those most at risk from severe illness and hospitalization, alleviating strain on the NHS,” said Darius Hughes, UK General Manager of Moderna. “With today’s approval from the MHRA, we are pleased that our updated COVID-19 vaccine will be available to the UK public, both through the NHS autumn vaccination program, as well as being available to purchase privately for the first time.”

Pfizer Inc.(NYSE: PFE) and BioNTech SE (BNTX, “BioNTech”) recently announced that the U.S. Food and Drug Administration (“FDA”) has approved the supplemental Biologics License Application for individuals 12 years of age and older (COMIRNATY^® (COVID-19 Vaccine, mRNA), and granted emergency use authorization for individuals 6 months through 11 years of age (Pfizer-BioNTech COVID-19 Vaccine) of the companies’ Omicron KP.2-adapted 2024-2025 Formula COVID-19 vaccine. This season’s vaccine is for use as a single dose for most individuals 5 years of age and older. Individuals 5 years of age and older with certain kinds of immunocompromise previously vaccinated with Pfizer and BioNTech COVID-19 vaccines or children under the age of 5 who have not already completed a three-dose series with previous formulas of a COVID-19 vaccine may be eligible to receive additional doses.

The KP.2 adaptation is based on guidance from the FDA, which stated that KP.2 is the preferred strain of the JN.1 lineage for COVID-19 vaccines for use in the U.S. during the 2024-2025 fall and winter season, if feasible. Staying up to date on vaccinations in line with the Centers for Disease Control and Prevention (“CDC”) recommendations remains important, particularly in light of COVID-19 cases on the rise again. This season’s Pfizer and BioNTech COVID-19 vaccine will begin shipping immediately and be available in pharmacies, hospitals, and clinics across the U.S. beginning in the coming days.

INOVIO (NASDAQ: INO), a biotechnology company focused on developing and commercializing DNA medicines to help treat and protect people from HPV-related diseases, cancer, and infectious diseases, recently announced its financial results for the second quarter of 2024 and provided an update on recent company developments.

“We continue to make progress with our lead candidate, INO-3107, which has the potential to significantly improve the lives of patients with RRP. We expect all non-device related elements of our BLA package to be completed by year end and our pre-BLA meeting last week with the FDA provided us with confidence that we remain on the right track for the regulatory submission. However, as part of the testing process required for BLA submission, we’ve recently identified a manufacturing issue with the single use disposable administration component of our device that we believe is resolvable, but will take additional time to rectify,” said Dr. Jacqueline Shea, INOVIO’s President and Chief Executive Officer. “We’re taking corrective steps to address the issue, and while we have not altered our ultimate expectations for INO-3107 to be a potentially transformative therapeutic option for RRP patients that could be the first DNA medicine approved for use in the United States, we now expect to be able to submit the BLA in mid-2025. We will continue to work hard to advance all other elements necessary for INO-3107’s success, including working to initiate our confirmatory trial, advancing plans for our redosing trial, making key regulatory progress in Europe and the U.K., and continuing commercial preparations to be launch-ready if we receive approval. These efforts will help maintain the momentum that’s carried us from Breakthrough Therapy Designation to BLA preparation in less than a year.”

Vir Biotechnology, Inc. (NASDAQ: VIR) recently announced that it has entered into an exclusive worldwide license agreement with Sanofi for three clinical-stage masked T-cell engagers (TCEs) and exclusive use of the protease-cleavable masking platform for oncology and infectious diseases, acquired by Sanofi from Amunix Pharmaceuticals. The clinical-stage assets include SAR446309 (AMX-818), a dual-masked HER2-targeted TCE; SAR446329 (AMX-500), a dual-masked PSMA-targeted TCE; and SAR446368 (AMX-525), a dual-masked EGFR-targeted TCE. Sanofi’s proprietary masking platform can be applied to TCEs, cytokines, and other molecules by exploiting the intrinsically high protease activity of the tumor microenvironment to specifically activate drugs in tumor tissues. The selective activation of the molecules in the tumor microenvironment potentially increases the therapeutic index (TI) and mitigates toxicities associated with the systemic immune activation seen with traditional TCEs.

“At Vir, the cornerstone of our commitment is and always will be patient-centered, with the aim to advance transformative medicines for patients facing severe diseases with unmet medical needs. Despite recent innovation in cancer therapeutics, the prognosis for many patients remains poor and treatment-associated toxicity is a major problem,” said Marianne De Backer, M.Sc., Ph.D., MBA, Vir’s Chief Executive Officer. “These potential best-in-class T-cell engagers aim to help address these problems and further us in our mission of powering the immune system to transform lives.”

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