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Sunshine Biopharma Reports In Vivo Tumor Suppression with K1.1 mRNA and Advances Novel mRNA-Cancer Vaccine Strategy for Lung Cancer

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Sunshine Biopharma (NASDAQ:SBFM) reported that its K1.1 mRNA lipid nanoparticle (LNP) program showed in vivo tumor-suppressing activity as a single agent in at least two orthotopic hepatocellular carcinoma (HCC) mouse models, with systemic delivery, dose-dependent restoration of the target tumor suppressor, and good tolerability.

The K1.1 gene is a tumor suppressor frequently mutated in HCC, non-small cell lung cancer (NSCLC), and pancreatic cancer, leading to “cold” tumors. The company also observed antiproliferative effects in several NSCLC cell lines in vitro. The next phase will test concurrent delivery of K1.1 mRNA and a cancer vaccine targeting associated antigens in NSCLC, aiming to convert “cold” tumors into “hot” tumors and suppress growth. Sunshine Biopharma also markets 60 generic drugs in Canada and is advancing a PLpro protease inhibitor for SARS coronavirus infections.

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Positive

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Negative

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Market reaction after K1.1 mRNA preclinical data: SBFM +7.02%

+7.02% $1.22 263.4x vol
15m delay
+7.02% Vs previous close
$1.22 Last Price
$1.14 $1.48 Day Range
$4.73M Market Cap
263.4x Rel. Volume

Following this news, SBFM has gained 7.02%, reflecting a notable positive market reaction. Our momentum scanner has triggered 29 alerts so far, indicating elevated trading interest and price volatility. The stock is currently trading at $1.22. Trading volume is exceptionally heavy at 263.4x the average, suggesting very strong buying interest.

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Market Context

The stock is up +7.0% following this news. The August 4 approval produced a 11.97% 24-hour gain, pro...
Analysis

The stock is up +7.0% following this news. The August 4 approval produced a 11.97% 24-hour gain, providing a favorable historical comparison for this K1.1 mRNA data update. Low short positioning remained a sourced risk factor.

Key Figures

Orthotopic HCC mouse models: at least 2 models Generic prescription drugs: 60 drugs Additional drug launches: approximately 12 drugs
3 metrics
Orthotopic HCC mouse models at least 2 models K1.1 mRNA proof-of-concept studies
Generic prescription drugs 60 drugs Currently marketed in Canada
Additional drug launches approximately 12 drugs Scheduled for the remainder of 2026

Historical Context

5 past events · Latest: Aug 07 (Positive)
Pattern 5 events
Date Event Sentiment 24h Move Catalyst
Aug 07 Amoxicillin launch Positive -12.1% Generic amoxicillin launched in Canada with pharmacy shipments beginning.
Aug 04 Dienogest approval Positive +12.0% Canadian approval expanded the company’s women’s health generic portfolio.
Jul 28 Ondansetron approval Positive -6.5% Health Canada approved generic ondansetron tablets for the Canadian market.
Jul 20 PLpro research Positive -3.9% Peer-reviewed research reported broad-spectrum antiviral activity for MR1-114.
Jun 25 Anastrozole approval Positive +4.9% Canadian approval added generic anastrozole to the commercial portfolio.

24h Move is the share-price change in the day after each event; other market factors may also have contributed.

Pattern Detected

Recent positive announcements produced mixed outcomes, with two aligned gains and three divergent declines.

Key Terms

lipid nanoparticle, hepatocellular carcinoma, immunosurveillance, orthotopic, +1 more
5 terms
lipid nanoparticle technical
"K1.1 mRNA lipid nanoparticle (LNP) program"
A lipid nanoparticle is a tiny, fat‑based microscopic shell that carries and protects delicate molecules (like RNA or drugs) and helps them enter cells, similar to a microscopic delivery bubble. It matters to investors because this delivery method can make new therapies and vaccines possible or more effective, but also affects manufacturing complexity, scalability, regulatory review and cost — all of which influence a biotech company’s commercial prospects.
hepatocellular carcinoma medical
"including hepatocellular carcinoma (HCC), non-small cell lung cancer"
Hepatocellular carcinoma is the most common form of primary liver cancer, arising from the main functional cells of the liver. For investors it matters because its serious health impact drives demand for diagnostic tests, treatments and long-term care; progress in trials or approvals can change a drugmaker’s revenue outlook much like a successful product launch can reshape a company’s future.
immunosurveillance medical
"evade host immunosurveillance"
The continuous monitoring performed by the immune system to detect and eliminate abnormal cells, infections, or early-stage tumors before they grow or spread. For investors, immunosurveillance matters because many diagnostics and therapies in development aim to boost or measure that natural patrol system—so how well it works and how drugs or tests affect it can shape the scientific rationale, trial design, and commercial potential of biotech products (think of it like a neighborhood watch for cell health).
orthotopic medical
"at least two orthotopic HCC mouse models"
Orthotopic describes placing tissue, cells, an organ, or a disease model in its normal anatomical location—for example, transplanting a liver into the liver bed or studying a tumor in the organ where it naturally grows. Investors watch for orthotopic approaches because they tend to produce results that better predict real-world safety and effectiveness than unnatural models, so they can improve the credibility of clinical data and influence regulatory and commercial prospects.
non-small cell lung cancer medical
"non-small cell lung cancer (NSCLC), and pancreatic cancer"
A broad category of lung tumors that grow from the cells lining the airways and make up the majority of lung cancer cases; it includes several subtypes that behave and respond to treatment differently, like different models of the same car family. It matters to investors because its large patient population and variety of treatment options — surgery, traditional chemo, targeted drugs and immunotherapies — create major markets where clinical trial results, drug approvals or changing treatment guidelines can quickly affect a company’s revenue and stock value.

AI-generated analysis. How Rhea-AI works. Not financial advice.

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  • K1.1 mRNA demonstrated tumor-suppressing activity as a single agent in multiple in vivo hepatocellular carcinoma models

  • Program targets a tumor suppressor frequently mutated in difficult-to-treat lung, pancreatic and liver cancers

  • Next phase will combine K1.1 mRNA with a cancer vaccine in NSCLC with the goal of converting "cold" tumors into "hot" tumors

FORT LAUDERDALE, FL / ACCESS Newswire / August 26, 2026 / Sunshine Biopharma Inc. (NASDAQ:SBFM) (the "Company"), a leading pharmaceutical company offering and researching life-saving medicines across multiple therapeutic areas including oncology and antivirals, today provided an update and outlined next plans for its oncology project, the K1.1 mRNA lipid nanoparticle (LNP) program.

The gene encoding the K1.1 mRNA is a tumor suppressor that is frequently mutated in a variety of cancers, including hepatocellular carcinoma (HCC), non-small cell lung cancer (NSCLC), and pancreatic cancer. Mutations in the gene of K1.1 mRNA create "cold" tumors that evade host immunosurveillance. In NSCLC and pancreatic cancers, a limited set of oncogenes is predominantly associated with mutations in the K1.1 gene, contributing to poor treatment prognosis.

Our results to date have demonstrated that the K1.1 mRNA LNP can be successfully delivered systemically in vivo. K1.1 mRNA has been shown to be well tolerated and capable of restoring expression of the target tumor suppressor in grafted liver tumors in a dose dependent manner. Proof of concept studies further indicated that K1.1 mRNA exhibits tumor suppressing activity in vivo as a single agent in at least two orthotopic HCC mouse models.

We have also obtained in vitro evidence that delivery of K1.1 mRNA alone exerts antiproliferative effects in several NSCLC cell lines. The next step in the program is to deliver K1.1 mRNA concurrently with a cancer vaccine targeting the associated antigens in vivo for the treatment of NSCLC. Our goal with this dual therapy approach is to transform "cold" tumors into "hot" tumors and suppress tumor growth, while simultaneously applying a cancer vaccine directed against the set of oncogenes associated with the K1.1 gene mutations.

"Our K1.1 mRNA program continues to deliver encouraging results that validate our tumor suppressor restoration strategy," said Steve Slilaty, CEO of Sunshine Biopharma. "The next phase-pairing K1.1 mRNA with a cancer vaccine-positions us to pursue a differentiated therapeutic pathway in NSCLC. Sunshine Biopharma is focused on bringing forward innovations that change the trajectory of difficult to treat cancers."

About Sunshine Biopharma Inc.

Sunshine Biopharma currently has 60 generic prescription drugs on the market in Canada and approximately 12 additional drugs scheduled to be launched in the remainder of 2026. 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.

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 more information, please contact:

Camille Sebaaly, CFO
Direct Line: 514-814-0464
camille.sebaaly@sunshinebiopharma.com

SOURCE: Sunshine Biopharma Inc.



View the original press release on ACCESS Newswire

FAQ

What did Sunshine Biopharma (NASDAQ:SBFM) report about K1.1 mRNA tumor suppression on August 26, 2026?

According to Sunshine Biopharma, K1.1 mRNA LNP showed tumor-suppressing activity as a single agent in at least two orthotopic hepatocellular carcinoma mouse models. The treatment restored tumor suppressor expression in a dose-dependent manner and was well tolerated in systemic in vivo delivery studies.

How does Sunshine Biopharma’s K1.1 mRNA program aim to treat lung cancer (NSCLC)?

According to Sunshine Biopharma, the next phase will deliver K1.1 mRNA concurrently with a cancer vaccine targeting associated antigens for NSCLC. The goal is to convert “cold” tumors into “hot” tumors, suppress tumor growth, and direct vaccination against oncogenes linked to K1.1 mutations.

What preclinical evidence did Sunshine Biopharma share for K1.1 mRNA in NSCLC models?

According to Sunshine Biopharma, in vitro delivery of K1.1 mRNA alone showed antiproliferative effects in several non-small cell lung cancer cell lines. These laboratory findings support the company’s plan to move to in vivo combination studies with a cancer vaccine in NSCLC models.

Which cancers are targeted by Sunshine Biopharma’s K1.1 mRNA tumor suppressor strategy (SBFM)?

According to Sunshine Biopharma, the K1.1 gene is a tumor suppressor frequently mutated in hepatocellular carcinoma, non-small cell lung cancer, and pancreatic cancer. These mutations are associated with “cold” tumors that evade immune surveillance, contributing to poor treatment prognosis in these indications.

What other drug programs does Sunshine Biopharma have besides K1.1 mRNA?

According to Sunshine Biopharma, its proprietary pipeline includes K1.1 mRNA LNP targeted for liver cancer and a PLpro protease inhibitor small molecule for treating SARS coronavirus infections. The company also markets 60 generic prescription drugs in Canada, with about 12 more planned in 2026.

What is the dual therapy approach in Sunshine Biopharma’s K1.1 mRNA and cancer vaccine strategy?

According to Sunshine Biopharma, the dual approach pairs K1.1 mRNA to restore tumor suppressor function with a cancer vaccine targeting oncogene-associated antigens. The aim is to transform immune-evasive “cold” tumors into “hot” tumors and enhance tumor growth suppression in NSCLC.