Palm Beach, FL – September 4, 2024 – The SARS-CoV-2, literally affected the whole world in these past years and has increased a global search for therapies and treatments. A report from Transparency Market Research said that: “the emergence of new variants of coronavirus will boost covid-19 therapeutics market growth. Demand for drugs that can effectively treat new strains of the virus is likely to be significantly high, as these new variants may be less susceptible to existing therapeutics. This is projected to boost the COVID-19 therapeutics market size, as pharmaceutical companies race to develop new drugs and treatments to address these new variants.  Even after the pandemic is under control, there would still be a need for treatments and therapies to help those who have been affected by the virus, including those with long-term effects. This is anticipated to continue to drive COVID-19 therapeutics market demand. Additionally, emergence of new variants of the virus and the possibility of future outbreaks are anticipated to prompt governments and private organizations to be better prepared for future pandemics.”   Active companies in the biotech industry this week include Sunshine Biopharma Inc. (NASDAQ: SBFM), Novavax, Inc. (NASDAQ: NVAX), REGENXBIO Inc. (NASDAQ: RGNX), BioNTech SE (Nasdaq: BNTX), Abbvie (NYSE: ABBV).

Transparency Market Research added that the heavy investment in covid-19 treatment will fuel covid-19 therapeutics market. “Government and private organizations have been investing heavily in the development of new therapeutics for COVID-19 treatment. This is due in part to the urgency of the pandemic and the need for effective treatments and vaccines. These investments have helped accelerate the development and availability of new therapeutics and have driven the COVID-19 therapeutics market value.  Governments and private organizations have also formed public-private partnerships to accelerate the development of COVID-19 therapeutics.  Governments have also authorized Emergency Use Authorization (EUA) for some drugs and vaccines as a measure to speed up their availability to the public. Therefore, these investments have played a key role in the rapid development and distribution of new treatments and vaccines for COVID- 19. This has helped to mitigate the impact of the pandemic on global economies and healthcare systems. Moreover, this is expected to continue to drive COVID-19 therapeutics market developments in the 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:

Novavax, Inc. (NASDAQ: NVAX), a global company advancing protein-based vaccines with its Matrix-M adjuvant, recently announced the Novavax COVID-19 Vaccine, Adjuvanted (2024-2025 Formula) (NVX-CoV2705) has received Emergency Use Authorization (EUA) from the U.S. Food and Drug Administration (FDA) for active immunization to prevent COVID-19 in individuals aged 12 and older. Novavax’s vaccine is included in the recommendations issued by the U.S. Centers for Disease Control and Prevention (CDC) on June 27, 2024.

Pre-filled syringes of the vaccine will be available in thousands of locations, including retail and independent pharmacies and regional grocers, following the Center for Biologics Evaluation and Research release of vaccine batches.  “Today’s authorization enables Novavax to launch our updated COVID-19 vaccine in the U.S. in pre-filled syringes, and we have worked hard to ensure consumers have access in thousands of locations nationwide,” said John C. Jacobs, President and Chief Executive Officer, Novavax. “Our updated vaccine targets JN.1, the ‘parent strain’ of currently circulating variants, and has shown robust cross-reactivity against JN.1 lineage viruses, including KP.2.3, KP.3, KP.3.1.1 and LB.1.”

REGENXBIO Inc. (NASDAQ: RGNX) recently announced positive results from the Phase I/II/III CAMPSIITE^® trial of RGX-121 for the treatment of patients with Mucopolysaccharidosis Type II (MPS II), also known as Hunter syndrome. The results were presented at the Society for the Study of Inborn Errors of Metabolism (SSIEM) Annual Symposium 2024.

The totality of evidence from the CAMPSIITE trial continues to support RGX-121 as the potential first gene therapy and one-time treatment for MPS II. In the United States, RGX-121 is also on track to be the first treatment that addresses the neurocognitive decline associated with MPS II, with the potential to be the first-line treatment for patients with neuronopathic disease.

“As we quickly approach the BLA filing for RGX-121, we are very pleased with the data presented at SSIEM demonstrating encouraging evidence of systemic activity and long-term reductions of CSF D2S6,” said Steve Pakola, M.D., Chief Medical Officer of REGENXBIO. “The data continue to support that by restoring the gene missing in boys with Hunter syndrome, RGX-121 changes the course of disease and has the potential to significantly improve both vital brain function and the systemic manifestations of this devastating disease.”

BioNTech SE (Nasdaq: BNTX) recently reported financial results for the three and six months ended June 30, 2024, and provided an update on its corporate progress.  “The year to date has been marked by significant data updates across our oncology portfolio. these readouts reinforce the potential of our platform technologies including our individualized and off-the-shelf mrna vaccine platforms, inest and fixvac. we have also advanced our strategy by initiating clinical trials evaluating novel combinations of synergistic drug candidates. notably, we dosed the first patient in a trial evaluating the combination of the trop2 antibody-drug conjugate bnt325/db-1305 and the pd-l1-vegf-a bispecific bnt327/pm8002, aiming to harness the potent anti-tumor activity of antibody drug conjugates along with the sustained benefit of immunomodulators,” said prof. Ugur Sahin, M.D., CEO and co-founder of BioNTech. “in addition, we have started commercializing variant-adapted covid-19 vaccines for the upcoming season, while accelerating our clinical development efforts to realize the full potential of our technologies. we are making progress towards our goal of becoming a company with marketed medicines for cancer and infectious diseases.”

Revenues reported were €128.7 million for the three months ended June 30, 2024, compared to €167.7 million for the comparative prior year period. for the six months ended June 30, 2024, revenues were €316.3 million, compared to €1,444.7 million for the comparative prior year period. the year-over-year change was mainly due to lower revenues from the sales of the company’s covid-19 vaccines worldwide resulting from the continued shift in demand from a pandemic to a seasonal endemic covid-19 vaccine market.

Abbvie (NYSE: ABBV) recently announced that the European commission (EC) has granted conditional marketing authorization for tepkinly® (epcoritamab) as a monotherapy for the treatment of adult patients with relapsed or refractory (r/r) follicular lymphoma (fl) after two or more lines of prior therapy. Tepkinly is the first and only subcutaneous t-cell engaging bispecific antibody approved to treat both r/r fl and r/r diffuse large b-cell lymphoma (dlbcl) in the EUROPEAN UNION (EU), as well as the European Economic Area (EEA) countries (Iceland, Liechtenstein, Norway) And Northern Ireland.

“The European approval of TEPKINLY for the treatment of follicular lymphoma after two or more prior treatments is yet another step forward in our aspiration to develop TEPKINLY as a potential core therapy across multiple B-cell malignancies. First approved for the treatment of adult patients with relapsed or refractory diffuse large B-cell lymphoma, its expansion into follicular lymphoma underscores its utility as a hematological cancer treatment,” said Mariana Cota Stirner, M.D., Ph.D., vice president, therapeutic area head for hematology, AbbVie. “Together with our partner, Genmab, we are thrilled with today’s approval which advances our commitment to elevating care for people living with cancer.”

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