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- 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
Ft. Lauderdale, FL – September 4, 2024 – Sunshine Biopharma, Inc. (NASDAQ: SBFM) (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.”
About University of Arizona
The University of Arizona, a land-grant university with two independently accredited medical schools, is one of the nation’s top 50 public universities, according to U.S. News & World Report. Established in 1885, the university is widely recognized as a student-centric university and has been designated as a Hispanic Serving Institution by the U.S. Department of Education. The University ranked in the top 20 in 2019 in research expenditures among all public universities, according to the National Science Foundation, and is a leading Research 1 institution with $734 million in annual research expenditures. The university advances the frontiers of interdisciplinary scholarship and entrepreneurial partnerships as a member of the Association of American Universities, the 66 leading public and private research universities in the U.S. It benefits the state with an estimated economic impact of $4.1 billion annually.
About Sunshine Biopharma
Sunshine Biopharma currently has 61 generic prescription drugs on the market in Canada and 32 additional drugs scheduled to be launched in the remainder of 2024 and in 2025. Among the new drugs to be launched in 2024 is NIOPEG®, a biosimilar of NEULASTA®. Like NEULASTA®, NIOPEG® is a long-acting form of recombinant human granulocyte colony-stimulating factor (filgrastim). It is indicated to decrease the incidence of infection in patients with non-myeloid malignancies receiving anti-neoplastic therapy.
In addition, Sunshine Biopharma is conducting a proprietary drug development program which is comprised of (i) K1.1 mRNA, an mRNA-Lipid Nanoparticle targeted for liver cancer, and (ii) PLpro protease inhibitor, a small molecule for treatment of SARS Coronavirus infections. For more information, please visit: www.sunshinebiopharma.com.
All registered trademarks are the property of their respective owners.
Safe Harbor Forward-Looking Statements
This press release contains forward-looking statements which are based on current expectations, forecasts, and assumptions of Sunshine Biopharma, Inc. (the “Company”) that involve risks as well as uncertainties that could cause actual outcomes and results to differ materially from those anticipated or expected. These statements appear in this release and include all statements that are not statements of historical fact regarding the intent, belief or current expectations of the Company, including statements related to the Company’s drug development activities, financial performance, and future growth. These risks and uncertainties are further described in filings and reports by the Company with the U.S. Securities and Exchange Commission (SEC). Actual results and the timing of certain events could differ materially from those projected in or contemplated by the forward-looking statements due to a number of factors detailed from time to time in the Company’s filings with the SEC. Reference is hereby made to cautionary statements and risk factors set forth in the Company’s most recent SEC filings.
For Additional Information Contact:
Camille Sebaaly, CFO
Direct Line: 514-814-0464
camille.sebaaly@sunshinebiopharma.com
SOURCE: Sunshine Biopharma, Inc.
Montreal – February 28, 2023 – Sunshine Biopharma Inc. (NASDAQ: SBFM), a pharmaceutical company offering and researching life-saving medicines in a variety of therapeutic areas including oncology and antivirals today announced the signing of an exclusive worldwide license agreement (the “License Agreement”) with the University of Arizona. The License Agreement grants Sunshine Biopharma exclusive worldwide rights for all of the University of Arizona and University of Illinois Chicago technology pertaining to PLpro protease inhibitors of SARS-CoV-2, the coronavirus that causes COVID-19. Sunshine Biopharma has been working on this project in collaboration with the University of Arizona since February 2022. The collaboration granted Sunshine Biopharma an exclusive option to obtain a license for the related technology.
Specifically, the licensed technology covers small molecules which have been shown to be efficient inhibitors of PLpro, the second coronavirus protease responsible for suppression of the human immune system thereby making the SARS-CoV-2 virus capable of causing more severe illness. Paxlovid®, an inhibitor for the first protease of SARS-CoV-2 (Mpro) has recently received emergency use authorization from the FDA. Sunshine Biopharma believes that an inhibitor for the second protease will provide another target to combat the virus and help mitigate the occurrence of possible resistance events.
“It’s good to see the work that we started at the beginning of the pandemic is moving forward towards real-world impact,” said Gregory Thatcher, PhD, professor of pharmacology and toxicology at the University of Arizona R. Ken Coit College of Pharmacy.
Dr. Thatcher led the initiative in collaboration with assistant professor Rui Xiong, PhD, and postdoctoral research associate Zhengnan Shen, PhD, at the University of Arizona and collaborators Kiira Ratia, PhD, Lijun Rong, PhD, and Laura Cooper, PhD, at the University of Illinois Chicago.
“The encouraging research results we have obtained in our collaboration with the University of Arizona prompted us to exercise our option to license,” said Dr. Steve Slilaty, CEO of Sunshine Biopharma. “We are very pleased with this milestone in terms of securing the intellectual property of the project as we continue to move forward with the development of our COVID-19 treatment pipeline,” he added.
About University of Arizona
The University of Arizona, a land-grant university with two independently accredited medical schools, is one of the nation’s top 50 public universities, according to U.S. News & World Report. Established in 1885, the university is widely recognized as a student-centric university and has been designated as a Hispanic Serving Institution by the U.S. Department of Education. The university ranked in the top 20 in 2019 in research expenditures among all public universities, according to the National Science Foundation, and is a leading Research 1 institution with $734 million in annual research expenditures. The university advances the frontiers of interdisciplinary scholarship and entrepreneurial partnerships as a member of the Association of American Universities, the 66 leading public and private research universities in the U.S. It benefits the state with an estimated economic impact of $4.1 billion annually. For the latest on the University of Arizona response to the novel coronavirus, visit the university’s COVID-19 webpage.
About Sunshine Biopharma Inc.
Sunshine Biopharma recently acquired Nora Pharma Inc. and as a result the Company now has 54 generic prescription drugs on the market in Canada and 44 employees. The Company is planning to expand its product offering to 86 generic pharmaceuticals over the next two years. In parallel, Sunshine Biopharma is continuing its drug development program which is comprised of (i) K1.1 mRNA for liver cancer, (ii) Adva-27a, a small chemotherapy molecule for pancreatic cancer, and (iii) PLpro inhibitor for COVID-19. For more information, please visit: www.sunshinebiopharma.com
Safe Harbor Forward-Looking Statements
This press release contains forward-looking statements which are based on current expectations, forecasts, and assumptions of Sunshine Biopharma, Inc. (the “Company”) that involve risks as well as uncertainties that could cause actual outcomes and results to differ materially from those anticipated or expected. These statements appear in this release and include all statements that are not statements of historical fact regarding the intent, belief or current expectations of the Company, including statements related to the Company’s drug development activities, financial performance, and future growth. These risks and uncertainties are further described in filings and reports by the Company with the U.S. Securities and Exchange Commission (SEC). Actual results and the timing of certain events could differ materially from those projected in or contemplated by the forward-looking statements due to a number of factors detailed from time to time in the Company’s filings with the SEC. Reference is hereby made to cautionary statements and risk factors set forth in the Company’s most recent SEC filings.
For Additional Information:
Sunshine Biopharma Contact:
Camille Sebaaly, CFO
Direct Line: 514-814-0464
camille.sebaaly@sunshinebiopharma.com
Sunshine Biopharma Media Contact:
Christine Petraglia
TraDigital IR
Direct Line: 917-633-8980
investors@sunshinebiopharma.com
University of Arizona Media Contact:
Paul Tumarkin
Tech Launch Arizona
Direct Line: 520-626-8770
Source: Sunshine Biopharma Inc.
Montreal, QC – February 10, 2023 — Sunshine Biopharma Inc. (NASDAQ: “SBFM”), a pharmaceutical company offering and researching life-saving medicines in a variety of therapeutic areas including oncology and antivirals today announced the signing of a research agreement with Sir Mortimer B. Davis Jewish General Hospital, a McGill University Health Center hospital located in Montreal, Quebec, Canada. The research effort will be focused on advancing the development of Sunshine Biopharma’s Adva-27a anticancer compound through the IND-enabling studies. At any time the research results become conclusive and Sunshine Biopharma wishes to proceed to conducting a Phase I clinical trial, the Jewish General Hospital is prepared to negotiating a new agreement to define the responsibilities and obligations of the parties for such Phase I clinical trial to be performed.
Adva-27a had previously been shown to be effective at destroying multidrug resistant cancer cells originating from pancreatic cancer, breast cancer, small-cell lung cancer and uterine sarcoma. The research will be conducted under the direction of Dr. Gerald Batist, Head of the Department of Oncology at the Jewish General Hospital and Director of the McGill Center for Translational Research in Cancer (MCTRC) based at the Lady Davis Institute for Medical Research.
“The Jewish General Hospital is one of the leading cancer centers in North America and we are delighted to work with their world renowned oncology physician and research scientist, Dr. Gerald Batist,” said Dr. Steve Slilaty CEO of Sunshine Biopharma. “We look forward to continuing the project with the Hospital past the IND-enabling studies and through the clinical trials to bring a new treatment for cancer sufferers around the world,” he added.
About the Jewish General Hospital
Since 1934, the Jewish General Hospital has been a mainstay of superior medical care for generations of patients of all backgrounds. The Jewish General Hospital is committed to providing patients the best possible care in a clean, safe and human-centered environment. The JGH is able to deliver pioneering, innovative medical services by strengthening its role as a McGill University teaching hospital, by expanding and upgrading its facilities, and by pursuing cutting-edge research at the Lady Davis Institute for Medical Research. The MCTRC based at the Lady Davis Research Institute brings together fundamental researchers and clinician scientists who conduct research in various steps of the cancer care continuum. The focus of the MCTRC is on co-development of innovation, new knowledge generation and rapid translation of discoveries into the clinical sphere. For more information please visit www.jgh.ca or www.ladydavis.ca or mcgill.ca/translational-research-cancer/
About Sunshine Biopharma
Sunshine Biopharma recently acquired Nora Pharma Inc. and as a result the Company now has 54 generic prescription drugs on the market in Canada and 44 employees. The Company is planning to expand its product offering to 86 generic pharmaceuticals over the next two years. In parallel, Sunshine Biopharma is continuing its drug development program which is comprised of (i) K1.1 mRNA for liver cancer, (ii) Adva-27a, a small chemotherapy molecule for pancreatic cancer, and (iii) PLpro inhibitor for COVID-19. For more information, please visit www.sunshinebiopharma.com
Safe Harbor Forward-Looking Statements
This press release contains forward-looking statements which are based on current expectations, forecasts, and assumptions of Sunshine Biopharma, Inc. (the “Company”) that involve risks as well as uncertainties that could cause actual outcomes and results to differ materially from those anticipated or expected. These statements appear in this release and include all statements that are not statements of historical fact regarding the intent, belief or current expectations of the Company, including statements related to the Company’s drug development activities, financial performance, and future growth. These risks and uncertainties are further described in filings and reports by the Company with the U.S. Securities and Exchange Commission (SEC). Actual results and the timing of certain events could differ materially from those projected in or contemplated by the forward-looking statements due to a number of factors detailed from time to time in the Company’s filings with the SEC. Reference is hereby made to cautionary statements and risk factors set forth in the Company’s most recent SEC filings.
For Additional Information:
Sunshine Biopharma Contact:
Camille Sebaaly, CFO
Direct Line: 514-814-0464
camille.sebaaly@sunshinebiopharma.com
Sunshine Biopharma Media Contact:
Christine Petraglia
TraDigital IR
Direct Line: 917-633-8980
investors@sunshinebiopharma.com
Source: Sunshine Biopharma Inc.
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About Sunshine Biopharma, Inc.
Sunshine Biopharma Inc. is a Colorado corporation headquartered in the greater Montreal area (Canada).
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