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Penetrium™ Breaks Oncology Barriers: The Solution to Cold Tumors and Metastatic Cancer Unveiled at AACR 2025

  • Penetrium™ Achieves Historic Breakthrough
  • Overcoming Cold Tumor Failure and the Challenge of Metastatic Cancer in Immunotherapy and Antibody Therapy
  • Presented at AACR 2025, Chicago

CHICAGO, May 8, 2025 /PRNewswire/ — Hyundai Bioscience presented the results of its Penetrium™ combination preclinical studies at the 2025 American Association for Cancer Research (AACR) Annual Meeting, held in Chicago.

The studies established that the repeated failures of immunotherapy and antibody treatments in cold tumors are not primarily caused by genetic resistance, as traditionally believed, but by pseudo-resistance**—a physical failure of infiltration resulting from extracellular matrix (ECM) stiffening. For the first time, Penetrium™ has been shown to structurally overcome this barrier.

Correcting 80 Years of Misconception:  The Real Problem Is Not Genetic Mutations—It’s Pseudo-Resistance

For decades, the dominant theory behind cancer treatment failure centered around genetic mutations. 

However, Hyundai Bioscience’s latest findings show that the actual obstacle lies in stiffened ECM that prevents immune cells and antibodies from reaching the tumor core.

Penetrium™ remodels the ECM, restoring infiltration pathways and enabling effective drug and immune cell access—providing a fundamental solution to the cold tumor problem.

Penetrium™ + Immunotherapy: Exceptional Results in Triple-Negative Breast Cancer (TNBC) Models

① In a TNBC mouse model, Penetrium™ combined with anti-PD-1 therapy led to:

  • A 48.3% reduction in tumor burden compared to anti-PD-1 monotherapy,
  • Complete elimination of metastasis observed in the combination group, which remained present in the monotherapy group.

Significantly, necrosis was induced within 3 days of Penetrium™ administration, and necrotic areas continued to grow with repeated dosing**—a trend not observed in the control group.

② Penetrium™ + Antibody Therapy:  Complete Suppression of Lung Metastasis in a Metastatic Lung Cancer Model

In a metastatic lung cancer model:

  • Bevacizumab monotherapy showed only 33% metastasis suppression,
  • The Penetrium™ combination group recorded 0% lung metastasis at 100 mg/kg dosage.

Additionally, a marked decrease in MMP-9 and VEGF expression confirmed ECM normalization and the restoration of drug penetration routes at the molecular level.

③ Penetrium™ + Chemotherapy: Overcoming the Limitations of Paclitaxel

Paclitaxel monotherapy was found to paradoxically promote lung metastasis. 

However, when combined with Penetrium™, metastatic lesion areas were reduced by over 70–80% compared to controls.

Furthermore, suppression of MMP-9 and restoration of E-cadherin demonstrated that Penetrium™ not only enhances chemotherapy efficacy but also structurally blocks metastasis—without additional toxicity.

Validated in Naturally Occurring Canine Mammary Cancer Model:  Stronger Responses Observed in Metastatic Tumors

In a naturally occurring canine mammary cancer model:

  • The Penetrium™ + POLYTAXEL® combination reduced primary tumor volume by up to 38.7%, compared to 21.1% with monotherapy,
  • Metastatic lymph node lesions showed up to 78.99% tumor volume reduction.

Notably, metastatic lesions responded more strongly than primary tumors, challenging the long-standing notion that metastatic cancer is untreatable.

Proven Safety and Clinical Readiness

Penetrium™ was administered at less than 9% of the NOAEL dose established in a 13-week GLP-compliant toxicity study. 

Its safety has also been verified in humans during a Phase 2 COVID-19 trial using the same API, niclosamide.

These results confirm Penetrium™ is fully prepared for human clinical application.

Official Statement from Dr. Soo-Jung Kim, Head of Research

“Penetrium™ is the world’s first platform to structurally solve the infiltration failure that has caused repeated failure of immunotherapy and antibody therapy in cold tumors. 

Our combination study with immunotherapy exceeded expectations, and Hyundai Bioscience will soon initiate clinical trials of Penetrium™ combinations for both TNBC and metastatic lung cancer.” 

— Dr. Soo-Jung Kim, Head of Research, Hyundai Bioscience

Clinical Expansion Underway

Hyundai Bioscience is currently:

  • Conducting a Phase 1 trial for prostate cancer in South Korea,
  • Preparing an investigator-initiated trial for acute myeloid leukemia (AML) in France.

Penetrium™: Launching a Tumor-Agnostic Cancer Treatment Platform

Penetrium ECM Remodeling Therapy™ is evolving into a tumor-agnostic universal cancer treatment platform with applicability not only to TNBC and metastatic lung cancer, but also to pancreatic, gallbladder, ovarian cancers, and hematological malignancies such as AML.

This breakthrough research is the first to structurally resolve infiltration failure in cold tumors, while also proving that metastatic cancers can be effectively treated**—a historic achievement in oncology.

About Hyundai Bioscience

Hyundai Bioscience is a global biotech company dedicated to developing innovative therapeutics for cancer, viral diseases, and rare conditions.

Through Penetrium ECM Remodeling Therapy™, the company is opening a new era of universally applicable cancer treatment across all tumor types.

In the viral therapeutics space:

  • Hyundai Bioscience successfully completed a Phase 2 clinical trial for COVID-19 in Korea,
  • Is conducting a global Phase 2 dengue fever trial in Vietnam in collaboration with DNDi (Drugs for Neglected Diseases initiative),
  • And is developing influenza and avian influenza treatments in partnership with the NIH and global institutions.

Driven by its core belief that “There is no disease that cannot be treated,” Hyundai Bioscience continues to lead global innovation in cancer, antiviral, and rare disease therapeutics.

F88 officially becomes a public company, paving the way for UPCOM listing


HANOI, VIETNAM – Media OutReach Newswire – 8 May 2025 – On May 6, F88 Investment Joint Stock Company (F88) was officially recognised as a public company, marking a major milestone in its growth and bringing the firm closer to its long-term goal of being listed on the stock exchange.

An F88 pawn shop in Hà Nội. F88 is now eligible to become the first alternative financial services provider to move towards a listing on Việt Nam's stock market. Photo courtesy of F88
An F88 pawn shop in Hà Nội. F88 is now eligible to become the first alternative financial services provider to move towards a listing on Việt Nam’s stock market. Photo courtesy of F88

This transition signals a new chapter in the company’s sustainable development, underpinned by higher standards of corporate governance and transparency.

The State Securities Commission (SSC) confirmed that F88 has fulfilled the requirements to become a public company in accordance with the Securities Law. Per regulations, companies recognised as public must register for UPCOM trading within 30 days. With this approval, F88 shares are now eligible to trade as the first alternative financial services provider on the UPCOM platform, targeting unbanked customers and moving towards a listing on Hồ Chí Minh City Stock Exchange (HOSE).

Alternative finance refers to financial services offered outside the traditional banking and finance system, such as peer-to-peer lending and microfinance.

“Becoming a public company is a critical milestone in our development roadmap as we move towards UPCOM registration,” said Phùng Anh Tuấn, founder and chairman of F88.

“It affirms our ongoing efforts to improve transparency and standardise corporate governance in line with international benchmarks. This also sets a strong foundation for our future listing on the Hồ Chí Minh Stock Exchange (HOSE), as we strive to create long-term value for both our mass-market customers and shareholders.”

Tuấn said that this milestone not only reflects the company’s internal progress, but also represents the growing recognition of Việt Nam’s alternative finance sector, as F88’s business model has successfully met the stringent criteria set by the SSC and is now poised to be welcomed by public investors.

Backed by reputable foreign investors including Mekong Capital, Việt Nam Oman Investment (a joint venture between the Government of Oman’s State General Reserve Fund and Việt Nam’s State Capital Investment Corporation) and Granite Oak, F88 has expanded to nearly 900 branches nationwide since its founding in 2013.

The company’s core business is centred on inclusive financial services — offering loans, insurance and banking products to individuals who have limited access to traditional financial institutions.

In the first quarter of 2025, F88 disbursed over VNĐ3.28 trillion, a 25 per cent year-on-year increase. Revenue rose by 21.5 per cent while pre-tax profit surged by 204.1 per cent compared to the same period last year.

F88 aims to become a leading retail financial group in Việt Nam, reshaping how the population accesses financial services. The company envisions a future where every Vietnamese citizen can engage with formal, transparent financial products that support a better quality of life.

“To realise that vision, we must attract more capital from investors and financial institutions by adopting higher standards in governance, operations and finance,” Tuấn said. “Becoming a public company and listing on the stock exchange is a key step toward achieving that goal.”

In addition to its long-term partners, F88 is currently working with new domestic and international lenders to diversify its funding sources in 2025. The company has also rolled out detailed strategies for each business segment, aligned with its broader strategic vision and sustainability goals.

F88 plans to leverage technology to digitise operations, streamline service delivery and ensure safe, efficient handling of millions of transactions. This year, the company targets revenue growth of over 40 per cent and aims to increase its customer base by more than 30 per cent.

Hashtag: #F88

The issuer is solely responsible for the content of this announcement.

About F88

Founded in 2013, F88 is Việt Nam’s leading retail finance chain in the alternative finance sector, focusing on inclusive financial services such as lending, insurance distribution and banking products. The company primarily serves customers who lack access to conventional banking and credit services. As of early May 2025, F88 operates 888 branches across the country.

F88 has gained widespread recognition for its performance and workplace culture, including being named one of Asia’s Best Workplaces by Great Place to Work. It is also the first and only alternative finance company in Việt Nam to receive the Client Protection Certificate — a global standard for safeguarding financial consumers.

In April 2025, local credit rating agency FiinRatings upgraded F88’s credit outlook from “Stable” to “Positive”, citing improvements in asset quality and the company’s continued market leadership.

SCG Announces Late-Breaking Clinical Data of SCG101 in HBV-Related Hepatocellular Carcinoma Presented at EASL 2025

SINGAPORE, May 8, 2025 /PRNewswire/ — SCG Cell Therapy Pte Ltd (SCG), a clinical-stage biotechnology company pioneering TCR T cell therapy for infectious diseases and associated cancers, today announced late-breaking clinical data from its Phase 1 trial evaluating SCG101, autologous HBV-specific TCR-T cell therapy, in patients with advanced HBV-related hepatocellular carcinoma (HCC). These data were presented at the European Association for the Study of the Liver (EASL) Congress 2025.

The results demonstrated that SCG101 led to sustained clearance of serum hepatitis B surface antigen (HBsAg) and HBV-DNA in heavily pre-treated patients with HBV-related HCC. Notably, 94% of patients had received prior nucleoside analogue (NA) antiviral therapy, and 72% presented with liver cirrhosis at baseline. Following a single-dose SCG101 infusion, all treated patients experienced a rapid decline in serum HBsAg, with 94% (16/17) achieving a 1.0–4.6 log₁₀ reduction within 28 days and persisting < 100 lU/mL for up to 1 year. Notably, 4 patients (23.5%) achieved HBsAg loss.

In addition to its antiviral effects, SCG101 demonstrated encouraging antitumor activity. All patients had received at least 2 prior lines of systemic cancer treatment, including immune checkpoint inhibitors. Despite this heavily pre-treated population, 8 out of 17 patients (47%) showed measurable tumour regression. At the time of data cutoff, median overall survival (OS) had not yet been reached.

SCG101 was generally well tolerated, with a good safety profile. Transient alanine aminotransferase (ALT) elevation, consistent with the cytolytic mechanism of SCG101, was observed in 94% of patients and resolved within 14 days. Other common treatment-related adverse events (TRAEs) included cytokine release syndrome (CRS), neutropenia, and thrombocytopenia—all of which were manageable and reversible.

Prof. Dr. Shunda Du, Chief of Liver Surgery Department, Peking Union Medical College Hospital, said: “The dual antiviral and antitumor effects observed with SCG101 are highly promising, especially in this heavily pre-treated patient population. The sustained HBsAg clearance and tumour response suggest that SCG101 may offer a novel immunotherapeutic option for patients with HBV-related HCC, addressing an area of significant unmet clinical need”.

HBV remains a major global health burden, affecting over 250 million people worldwide. It is a leading cause of liver cancer, responsible for 50%–80% of hepatocellular carcinoma cases globally.1 Chronic HBV infection leads to the integration of HBV DNA into the host genome, resulting in persistent HBsAg expression, chromosomal instability, and activation of oncogenes, thereby contributing to the development of hepatocellular carcinoma.2

SCG101 is designed to selectively target and eliminate HBV-infected hepatocytes and HCC cells by recognizing specific epitope of HBV surface antigen (HBsAg) presented via the major histocompatibility complex (MHC). By triggering both cytolytic and non-cytolytic mechanisms, SCG101 effectively eliminates HBV-infected hepatocytes as well as premalignant and HBV-HCC cells with HBV-DNA integration.  

“These positive data mark an important step forward in the development of SCG101 and validate our approach of harnessing precision T cell therapy to target chronic HBV infection and HBV-related liver cancer,” said Christy Ma, Chief Executive Officer of SCG Cell Therapy. “SCG101 is the first TCR-T cell therapy to demonstrate both virologic clearance and tumour regression in HBV-related HCC patients. We are encouraged by the data, and we look forward to advancing SCG101 through further clinical development to bring this potentially curative therapy to patients in need.”

About SCG101

SCG101 is an investigational autologous T cell receptor (TCR) T cell therapy designed to selectively target specific epitope of the hepatitis B surface antigen (HBsAg). Powered by SCG’s proprietary GianT™ TCR screening platform, which enables the discovery of natural, high-affinity, high-avidity TCRs against intracellular antigens presented via the major histocompatibility complex (MHC). SCG101 delivers precise immune-mediated clearance of infected and malignant cells demonstrating significant tumour inhibition and the eradication of HBV covalently closed circular DNA (cccDNA) in preclinical and clinical studies.

About Hepatocellular carcinoma

Hepatocellular carcinoma (HCC) is the most common type of liver cancer. In 2020, it was estimated that over 905,000 new cases of liver cancer were diagnosed, and more than 830,100 deaths occurred globally, making it one of the leading causes of cancer-related mortality.3 Chronic hepatitis B virus (HBV) infection is responsible for at least 50% of HCC cases worldwide.1 HCC is typically diagnosed at an advanced stage, contributing to a poor prognosis with a five-year survival rate of less than 15%.4  

About SCG Cell Therapy

SCG Cell Therapy is a leading biotechnology company dedicated to developing novel immunotherapies for infectious diseases and associated cancers. The company focuses on targeting some of the most common cancer-causing infections, including Helicobacter pylori, HPV, HBV, and EBV. SCG is advancing a broad pipeline of TCR-based therapeutics aimed at preventing and curing infection-related cancers. Headquartered in Singapore, SCG operates across Singapore, China, and Germany, leveraging regional strengths to cover the entire value chain, from innovative drug research and discovery to manufacturing, clinical development, and commercialization. For more information, please visit www.scgcell.com.

[1] Y, Xie. (2017). Hepatitis B virus-associated hepatocellular carcinoma. Advances in experimental medicine and biology.

[2] Jiang, Y., Han, Q., Zhao, H., Zhang, J. (2021, May 20). The mechanisms of HBV-induced hepatocellular carcinoma. Journal of hepatocellular carcinoma.

[3] Liver cancer statistics: World cancer research fund international. WCRF International. (2022, April 14).

[4] Golabi P, Fazel S, Otgonsuren M, Sayiner M, Locklear CT, Younossi ZM. (2017). Mortality assessment of patients with hepatocellular carcinoma according to underlying disease and treatment modalities.

 

Rishabh Software and S4G Consulting Launch SR360 to Accelerate Digital Transformation in Australia

MELBOURNE, Australia, May 8, 2025 /PRNewswire/ — Rishabh Software and S4G Consulting have teamed up to introduce SR360, a business-driven end-to-end Technology service designed to help enterprises modernize their technology without the usual complexity and disruption.

Powered by proprietary Blueprint 3.0, SR360 provides business strategy with enterprise architecture to help organizations seamlessly navigate cloud adoption, legacy modernization, regulatory compliance, and operational efficiency.

Digital transformation isn’t just about new technology. It’s about making smart technology decisions that drive tangible business outcomes,” said Saumil Shah, Chief Strategy Officer at Rishabh Software. “SR360 offers a structured, cost-effective pathway to modernization.

How SR360 Helps Businesses

SR360 offers four core services:

  • Business Consulting – Aligning strategy and operations with business goals
  • Solution Consulting – Designing scalable, future-ready technology architectures
  • Solution Engineering – Implementing and integrating digital solutions to modernize IT ecosystems
  • Solution Sustenance – Ensuring long-term system performance, compliance, and optimization

At its core, SR360 runs on Blueprint 3.0, which ensures:

  • Faster implementation with industry-specific solutions.
  • Built-in compliance to meet security and regulatory standards.
  • Cost-efficient modernization without unnecessary technical debt.

Blueprint 3.0 removes complexity from digital transformation,” said Harsh Mishra, CTO at S4G Consulting. “It empowers businesses to evolve seamlessly while staying aligned with industry demands.”

Expanding Rishabh Software’s Presence in Australia

With SR360, Rishabh Software strengthens its digital transformation footprint in Australia, bringing:

  • Deep expertise in enterprise architecture and solution engineering.
  • Proven methodologies for business-led digital transformation.
  • Flexible onshore and offshore delivery models for optimized execution.

About Rishabh Software

Rishabh Software helps businesses worldwide build secure, scalable, and AI-driven solutions. Learn more at Rishabh Software.

About S4G Consulting

S4G Consulting helps enterprises align technology with business strategy using a business-led enterprise architecture approach. Learn more at S4G Consulting.

Photo: https://laotiantimes.com/wp-content/uploads/2025/05/rishabh_software_s4g_consulting-1.jpg
Logo: https://laotiantimes.com/wp-content/uploads/2025/05/rishabh_software_logo-1.jpg

 

Rishabh Software Partners with S4G Consulting
Rishabh Software Partners with S4G Consulting

Rishabh Software and S4G Consulting Launch SR360 to Accelerate Digital Transformation in Australia

MELBOURNE, Australia, May 8, 2025 /PRNewswire/ — Rishabh Software and S4G Consulting have teamed up to introduce SR360, a business-driven end-to-end Technology service designed to help enterprises modernize their technology without the usual complexity and disruption.

Rishabh Software Partners with S4G Consulting
Rishabh Software Partners with S4G Consulting

Powered by proprietary Blueprint 3.0, SR360 provides business strategy with enterprise architecture to help organizations seamlessly navigate cloud adoption, legacy modernization, regulatory compliance, and operational efficiency.

Digital transformation isn’t just about new technology. It’s about making smart technology decisions that drive tangible business outcomes,” said Saumil Shah, Chief Strategy Officer at Rishabh Software. “SR360 offers a structured, cost-effective pathway to modernization.

How SR360 Helps Businesses

SR360 offers four core services:

  • Business Consulting – Aligning strategy and operations with business goals
  • Solution Consulting – Designing scalable, future-ready technology architectures
  • Solution Engineering – Implementing and integrating digital solutions to modernize IT ecosystems
  • Solution Sustenance – Ensuring long-term system performance, compliance, and optimization

At its core, SR360 runs on Blueprint 3.0, which ensures:

  • Faster implementation with industry-specific solutions.
  • Built-in compliance to meet security and regulatory standards.
  • Cost-efficient modernization without unnecessary technical debt.

Blueprint 3.0 removes complexity from digital transformation,” said Harsh Mishra, CTO at S4G Consulting. “It empowers businesses to evolve seamlessly while staying aligned with industry demands.”

Expanding Rishabh Software’s Presence in Australia

With SR360, Rishabh Software strengthens its digital transformation footprint in Australia, bringing:

  • Deep expertise in enterprise architecture and solution engineering.
  • Proven methodologies for business-led digital transformation.
  • Flexible onshore and offshore delivery models for optimized execution.

About Rishabh Software

Rishabh Software helps businesses worldwide build secure, scalable, and AI-driven solutions. Learn more at Rishabh Software.

About S4G Consulting

S4G Consulting helps enterprises align technology with business strategy using a business-led enterprise architecture approach. Learn more at S4G Consulting.

 

 

‘No Child Left Behind’ as Singapore Turns 60: New Digital Early Intervention Platform PEIVE Launches for Inclusive Progress

SINGAPORE, May 8, 2025 /PRNewswire/ — As Singapore celebrates 60 years of independence (SG60), a new ground-up initiative is reminding the nation that true progress is measured by how we care for our most vulnerable. Today, local therapists and educators announced the launch of PEIVE (Paving Early Interventions with Vision and Empathy) , a digital Early Intervention (EI) programme designed to support young children with developmental delays. Developed in Singapore and free during its pilot phase, PEIVE harnesses technology to deliver critical early support to families facing long waits and high costs, ensuring no child is left behind in the nation’s journey forward.

Bridging the Gap in Early Support

Early intervention can significantly improve a child’s developmental trajectory, but many Singaporean families struggle to access timely help. In 2024, the average wait for a subsidised spot in an Early Intervention Programme for Infants and Children (EIPIC) was about 6 months, with some parents waiting up to 1½ years. Such delays come at a high price. “Every moment you wait makes a difference,” as one mother observed about her child’s progress. The stakes are especially high in the preschool years, when timely intervention can narrow developmental gaps and reduce the need for intensive support later in life. Yet hundreds of children remain stuck in limbo on waitlists during this crucial window.

PEIVE was created to address this urgent gap. It is a locally-built digital platform that empowers parents and caregivers to begin evidence-based intervention activities at home, without having to wait for a formal centre placement. Through a mix of expert-designed assessment tools, personalised goals and progress tracking, PEIVE guides families in supporting children with speech, motor, social, or learning delays. The programme was developed by a team of Singaporean speech therapists, occupational therapists and early childhood specialists who have witnessed first-hand the anxiety of parents in queue for help. “We’ve seen how families feel lost when told to wait months for services their child needs now,” said Ms Beatrice Teo, co-founder of PEIVE and Director of Amazing Speech Therapy. “No child should have to put their development on hold. With PEIVE, parents can start therapeutic activities immediately, coached by professionals through the platform. It’s a practical way to ensure that even if they’re on a waitlist, support doesn’t stop – it starts at home.”

A Homegrown Solution Reflecting National Values

The launch of PEIVE comes as Singapore reflects on six decades of nation-building, providing a timely reminder that inclusivity and social care must advance alongside economic progress. PEIVE’s mission echoes Singapore’s core values of care, pragmatism and shared responsibility. It demonstrates how local innovation can be applied to promote equity – using tech not just for commerce or convenience, but to uplift those who might otherwise be left behind. In recent years, the Government has intensified efforts to expand inclusive support. The Early Childhood Development Agency (ECDA) has set a target for 80% of children with moderate to high needs to receive timely early intervention support by 2027. New pilot schemes like EIPIC-EI Care and inclusive preschool programs are steps in the right direction. Still, achieving these targets will require collaboration beyond the public sector. “The journey towards inclusion requires a whole-of-society effort,”Minister of State Sun Xueling noted in 2021, emphasizing that everyone – from preschools and providers to parents and community – has a part to play.

PEIVE exemplifies this collective approach. The platform’s development has been supported by SG Enable and the Tote Board, through grants aimed at social innovation in disability support. This “many helping hands” model of funding and expertise – with public agencies, social organizations and private practitioners working in concert – underlines how Singapore can pioneer solutions that marry technology with empathy. “PEIVE is built by Singaporeans, for Singaporeans, grounded in our ethos of not leaving anyone behind,” said Ms Moona Islam, co-founder of PEIVE and an early intervention specialist. “We believe in the power of community and pragmatism. Using technology, we’re extending a helping hand to families who would otherwise be waiting in frustration. And we’re doing it in a way that reflects Singapore’s values – by being practical, inclusive and pulling together resources from across society.”

During its pilot phase, PEIVE will be offered free-of-charge to families and preschools. The team will collect feedback from users and early childhood educators to refine the platform for wider roll-out. The ultimate vision is to integrate PEIVE with Singapore’s existing early intervention ecosystem – complementing physical services and enabling a continuum of care. By equipping caregivers with guided strategies and connecting them to professionals through the platform, PEIVE ensures that help is not only early but also continuous. In doing so, it hopes to give every child a fair head start, aligning with national agendas like the Enabling Masterplan which call for more inclusive and resilient communities.

As Singapore enters its next chapter after SG60, initiatives like PEIVE highlight how the nation can be a global leader not just in economic innovation, but in technology for social good. This digital EI programme is a small example of how a society that values every individual can harness creativity and compassion to pave the way for inclusive growth. In the words of its founders, the message is simple: Progress must include everyone.

Brii Bio Presents Late-Breaking Data from Its Ongoing Phase 2 ENSURE Study at EASL Congress 2025, Suggesting BRII-179’s Role in Advancing Higher HBsAg Loss

  • End of treatment (EOT) data from Cohort 4 of the ENSURE study suggest that patients responding to prior BRII-179 treatment achieved faster and higher rate of surface antigen clearance with curative treatments compared to BRII-179 naïve participants , strengthening the case for a novel enrichment strategy, utilizing BRII-179 to identify and prime patients for improved functional cure outcomes
  • 24 Week follow-up results from Cohorts 1-3 of the ENSURE study demonstrated sustained off-treatment benefits of elebsiran + PEG-IFNα combination therapy vs PEG-IFNα alone

DURHAM, N.C. and BEIJING, May 8, 2025 /PRNewswire/ — Brii Biosciences Limited (“Brii Bio” or the “Company”, stock code: 2137.HK), a biotechnology company developing therapies to improve patient health and choice across diseases with high unmet medical need, today announced data from its ongoing Phase 2 ENSURE study as late-breaking posters at the European Association for the Study of the Liver (EASL) Congress 2025 in Amsterdam, the Netherlands.

ENSURE (NCT05970289) is a multicenter, open-label Phase 2 study. Cohorts 1-3 were designed to evaluate the contribution of elebsiran, an investigational small interfering ribonucleic acid (siRNA), to the combination treatment with pegylated interferon alpha (PEG-IFNα) in participants with chronic HBV infection with baseline hepatitis B surface antigen (HBsAg) of 100-3,000 IU/mL.

Cohort 4 enrolled participants who completed 9 doses of BRII-179, a recombinant protein-based therapeutic vaccine, in combination with elebsiran in a previous APAC study BRII-179-835-001 (NCT04749368) to receive elebsiran and PEG-IFNα combination treatment. These participants were grouped based on their anti-HBs response induced by prior BRII-179 treatment: those with peak anti-HBs titers ≥ 10 IU/L are defined as anti-HBs responders, and those with peak anti-HBs titers < 10 IU/L as non-responders. The design of Cohort 4 as part of this study was based on the insight that BRII-179 could differentiate between immune responders and non-responders, offering the potential to predict future response to therapy.

Interim data from Cohort 4 showed that anti-HBs responders achieved a substantially higher rate of HBsAg seroclearance than non-responders. At EOT (Week 48), 61% (11/18) of anti-HBs responders achieved HBsAg seroclearance, compared to 10% (1/10) of non-responders. Among the 11 anti-HBs responders who achieved HBsAg loss, 91% (10/11) had anti-HBs titers ≥ 100 IU/L at EOT.

Of note, BRII-179 experienced participants in Cohort 4 achieved HBsAg loss faster than BRII-179 naïve participants in Cohort 2 and 3. 83% (10/12) of HBsAg loss in BRII-179 experienced participants occurred by Week 24, compared to 55% (6/11) in BRII-179 naïve participants. These findings suggest rapid HBsAg seroclearance in subjects with higher anti-HBs titers may translate into durable HBsAg loss and the potential to evaluate shorter treatment durations of PEG-IFNα.

Additional data from Cohorts 1-3 of the ENSURE study showed the combination therapy of elebsiran either 100 mg or 200 mg and PEG-IFNα resulted in higher HBsAg loss rate at 24 weeks post EOT compared to PEG-IFNα alone, supporting the additive benefit of siRNA.

“The data from Cohort 4 of the ENSURE study are encouraging. We saw in target populations that patients who were immune-responsive through pre-treatment with BRII-179 demonstrated a significant advantage in achieving a higher HBsAg seroclearance rate,” said David Margolis, MD, Chief Medical Officer of Brii Bio. “With BRII-179, we may identify patients with less impaired intrinsic immunity and further prime their immune response. This approach may provide more durable HBsAg loss and potentially shorter treatment duration of PEG-IFNα. We are moving full speed ahead with our clinical efforts to deliver a meaningful option to the chronic hepatitis B patients long left waiting.”

Abstract Number: LB25123/ LBP-018

Title: Chronic hepatitis B virus infected participants responding to prior BRII-179 treatment achieved faster and higher rate of hepatitis B virus surface antigen seroclearance on elebsiran plus pegylated interferon-alfa: end of treatment data from ENSURE study

Presenter: Grace Lai-Hung Wong, MBChB (CUHK), MD (CUHK), FRCP (Lond, Edin), FHKCP, FHKAM (Medicine), Professor of Gastroenterology and Hepatology at CUHK Medical Data Analytics Centre (MDAC) and Department of Medicine and Therapeutics in Hong Kong SAR, China

  • A total of 28 participants with baseline HBsAg > 100 and ≤ 3000 IU/mL were analyzed. 18 and 10 participants had peak anti-HBs titer ≥ 10 IU/L (defined as anti-HBs responders) and < 10 IU/L (defined as non-responders) induced by BRII-179 in the previous study, respectively.
  • Median [range] HBsAg at the time of initiating elebsiran + PEG-IFNα was numerically higher in anti-HBs responders (539.4 [106.7-2165.0] IU/mL) than in non-responders (219.3 [106.7-671.5] IU/mL). At EOT (Week 48), 61% (11/18) of anti-HBs responders achieved HBsAg seroclearance, compared to 10% (1/10) of non-responders.
  • Among the anti-HBs responders who lost HBsAg, 91% (10/11) had anti-HBs titers ≥ 100 IU/L at EOT.
  • BRII-179 experienced participants achieved HBsAg loss faster than BRII-179 naïve participants, with 83% (10/12) of HBsAg loss occurring by Week 24 (vs 55% [6/11] in BRII-179 naïve participants).
  • Elebsiran + PEG-IFNα was generally safe and tolerated in BRII-179 experienced participants.

Abstract Number: LB25115/ LBP-016
Title: Efficacy and safety of elebsiran and pegylated interferon alfa combination therapy versus pegylated interferon alfa in participants with chronic hepatitis B virus infection: follow-up results from the ongoing phase 2, randomized, open-label ENSURE study
Presenter: David Margolis, MD, MPH, Chief Medical Officer of Brii Biosciences

  • At Week 72 (24 weeks post EOT), higher HBsAg loss rate was observed in participants on combination therapy of either elebsiran 200mg or 100 mg and PEG-IFNα compared to PEG-IFNα alone (21.1% [4/19] or 33.3% [6/18] vs 5.6% [1/18]).  All the 11 participants with HBsAg loss had baseline HBsAg < 1500 IU/mL.
  • Incidence of treatment emergent adverse events (TEAEs) was comparable between combination therapy cohorts and PEG-IFNα alone cohort. Most TEAEs were consistent with known side effects of PEG-IFNα.

As part of Brii Bio’s unique approach to developing a functional cure for HBV, the Company and its partners are actively progressing multiple combination studies with our differentiated portfolio, including BRII-179 being evaluated in multiple combination studies with elebsiran led by Brii Bio; elebsiran being evaluated in combination with PEG-IFNα in studies led by Brii Bio; and tobevibart, an investigational broadly neutralizing monoclonal antibody targeting HBV, being evaluated in multiple Phase 2 and 3 tobevibart and elebsiran combination studies led by Vir Biotechnology. Key data readouts will be shared in the coming months at scientific conferences throughout 2025.

About Hepatitis B

Hepatitis B virus (HBV) infection is one of the world’s most significant infectious disease threats with more than 254 million people infected globally.[1] Chronic HBV infection is the leading cause of liver disease and an estimated 820,000 people die of complications from chronic HBV infection each year.[1] HBV is of exceptional concern in China, where 87 million people are chronically infected.[2]

About BRII-179

BRII-179 is a novel recombinant protein-based HBV immunotherapeutic candidate that expresses the Pre-S1, Pre-S2, and S HBV surface antigens, and is designed to induce enhanced and broad B-cell and T-cell immunity. In November 2023, the Center for Drug Evaluation (the “CDE”) of the National Medical Products Administration (the “NMPA”) granted BRII-179 Breakthrough Therapy Designation.

About Elebsiran (previously known as BRII-835, VIR-2218)

Elebsiran is an investigational subcutaneously administered HBV-targeting siRNA designed to degrade hepatitis B virus RNA transcripts and limit the production of hepatitis B surface antigen. It has the potential to have direct antiviral activity against HBV and HDV. It is the first siRNA in the clinic to include Enhanced Stabilization Chemistry Plus technology to enhance stability and minimize off-target activity, which potentially can result in an increased therapeutic index. Brii Bio licensed exclusive rights to develop and commercialize elebsiran for the Greater China territory from Vir Biotechnology, Inc. in 2020.

About Brii Bio

Brii Biosciences Limited (“Brii Bio”, stock code: 2137.HK) is a biotechnology company developing therapies to address major public health challenges where patients experience high unmet medical needs, limited choice and significant social stigmas. With a focus on infectious diseases, the Company is advancing a broad pipeline of unique therapeutic candidates with lead programs against hepatitis B virus (HBV) infection. The Company is led by a visionary and experienced leadership team and has operations in key biotech hubs, including Raleigh-Durham, the San Francisco Bay Area, Beijing and Shanghai. For more information, visit www.briibio.com.

[1] World Health Organization. (April 2024). Global hepatitis report 2024: action for access in low- and middle-income countries. World Health Organization. Retrieved from https://www.who.int/publications/i/item/9789240091672

[2] World Health Organization. Hepatitis. World Health Organization. Retrieved from https://www.who.int/china/health-topics/hepatitis#:~:text=There%20are%2087%20million%20people,living%20with%20chronic%20hepatitis%20C.

 

Sephora Elevates Asia’s Largest Prestige Beauty Offering with Exclusive Launch of Haus Labs by Lady Gaga

Consumers across Asia Pacific can enjoy Haus Labs’ full assortment of 125 products, enhancing Sephora’s prestige beauty offering of close to 250 brands 

SINGAPORE, May 8, 2025 /PRNewswire/ — Sephora, the world’s leading omnichannel prestige beauty retailer, announces the expansion of its exclusive partnership with Haus Labs by Lady Gaga (or “Haus Labs”), the clean artistry, vegan and cruelty-free cosmetics brand renowned for its HausTech Powered™ innovations, to Southeast Asia, Oceania and Hong Kong SAR

Officially launched in May across Sephora’s extensive brick-and-click network, consumers in Australia, Hong Kong SAR, Malaysia, New Zealand, Philippines, Singapore and Thailand will be the first in Asia Pacific to access Haus Labs’ full assortment of 125 products.

Jenny Cheah, Managing Director, Southeast Asia, Oceania & India at Sephora noted, “Sephora’s expansion of its Asia Pacific prestige beauty offerings, now featuring almost 250 brands, is further enhanced by the introduction of Haus Labs by Lady Gaga. As a Sephora-exclusive global collaboration, Haus Labs has demonstrated exceptional success, a testament to its innovative, clean formulations and science-driven approach. We are proud to answer the increasing demand for such high-quality products by bringing Haus Labs to these new markets.”

“Our dedication to curating the world’s most sought-after brands is exemplified by Haus Labs, a beloved brand within Sephora’s global beauty community since its 2019 launch,” she added.

Haus Labs’ products feature innovative, skincare-optimising ingredients and key ones in the assortment include:

  • Triclone Skin Tech Foundation: Available in 51 shades, this best-selling, award-winning foundation contains over 20 skincare ingredients, including Fermented Arnica, which is 860% more effective than traditional arnica in reducing redness, inflammation, and environmental stress on the skin.
  • PhD Hybrid Nourishing Lip Oil and newly launched PhD Hybrid Plumping Lip Glaze: This 4-in-1 product that serves as a hydrating skincare-infused glaze is a lip oil, balm, plumper and gloss. It features Polyplumper Peptide Complex and Vegan Collagen.
  • Color Fuse Blush Powder: Infused with 11%+ skincare actives, this newly launched blush ensures vibrant pigmentation along with skincare benefits, featuring Fermented Arnica and Hydraberry to enhance and nourish the skin.

Ben Jones, CEO of Haus Labs by Lady Gaga concluded, “Launching in Australia, New Zealand & Southeast Asia is another critical milestone for HAUS LABS BY LADY GAGA. We are honoured to be exclusive with the global retail powerhouse, SEPHORA. We continue the march towards taking our brand to the world on May 1st in Australia and New Zealand and May 8th across Singapore, Malaysia, Thailand, Hong Kong SAR & Philippines. We will enable new consumers to see, touch and feel our products only at SEPHORA, showing them that HAUS LABS BY LADY GAGA is a leader at the forefront of Art, Science, Beauty and Technology.”

Sephora Celebrates Pride

In line with Sephora’s purpose to welcome all and foster an inclusive beauty environment, the company will celebrate Pride Month and support the LGBTQ+ community globally this June. This initiative includes Brave Spaces in participating markets*, providing safe spaces in Sephora stores where customers can receive complimentary Pride make-up looks and have them removed.

*Participating markets in Asia are Australia, Hong Kong SAR, New Zealand, Singapore and Thailand.

About Sephora

Sephora is the world’s leading global prestige beauty retail brand. With 52,000 passionate employees operating in 35 markets, Sephora connects customers and beauty brands within the world’s most trusted and dynamic beauty community. We serve a highly engaged community of hundreds of millions of beauty followers across our global omnichannel network of more than 3 000 stores and iconic flagships, and our e-commerce and digital platforms, offering personalised and immersive seamless experiences across every touchpoint. With our curation of close to 500 brands and our own label, Sephora Collection, we offer the most unique and diverse range of prestige beauty products, tailored to our customers’ needs from fragrance to make-up, haircare, skincare and beyond, as we constantly reimagine the world of prestige beauty.

Since our inception in 1969 in Limoges, France, and as part of the LVMH Group since 1997, we have been disrupting the prestige beauty retail industry. Today, we continue to break with convention to drive our mission: champion a world of inspiration and inclusion where everyone can celebrate their beauty.