On August 20, 2026 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, reported a corporate update and announced its financial results for the six-month period ended June 30, 2026.

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In the first half of 2026, Brii Bio generated additional clinical data supporting its differentiated hepatitis B virus (HBV) functional cure strategy while continuing to expand its internal discovery capabilities and advance its RNA-based technology platforms.

In its HBV clinical program, the Company presented end-of-study data from its Phase 2 ENSURE study at the European Association for the Study of the Liver (EASL) Congress 2026. On July 3, the Company also announced topline end-of-treatment data from its Phase 2b ENRICH and ENHANCE studies. To date, findings across the ENSURE, ENRICH and ENHANCE studies have consistently supported the potential of BRII-179 to improve functional cure outcomes as part of a combination regimen. Detailed data from the ENRICH and ENHANCE studies are expected to be presented in the second half of 2026.

Beyond its HBV portfolio, the Company continued to advance its internal discovery capabilities and invest in the development of RNA-based technology platforms. Subsequent to the reporting period, the first participant was dosed in a clinical study evaluating BRII-5395, an internally discovered mRNA therapeutic vaccine for advanced hepatocellular carcinoma (HCC). This milestone represents the first clinical evaluation of an RNA-based therapeutic originating from Brii Bio’s internal discovery efforts. While BRII-5395 is an mRNA therapeutic vaccine, the Company’s broader RNA platforms encompass multiple RNA modalities. During the first half of 2026, Brii Bio progressed multiple internally discovered candidates across various stages of discovery and preclinical development, including programs that extend the application of its technology platforms into additional therapeutic areas beyond infectious diseases.

With effective cost control measures and optimized operating structure in place, Brii Bio remains well-capitalized, with a cash position of approximately US$260 million as of June 30, 2026, providing financial flexibility to support its late-stage HBV programs and early discovery initiatives.

"Our progress in the first half of the year reflects meaningful advances across both our late-stage HBV portfolio and our expanding discovery capabilities," said Dr. Zhi Hong, Chairman and Chief Executive Officer of Brii Bio. "Data generated across our HBV studies continue to inform our functional cure strategy. At the same time, the initiation of clinical evaluation for BRII-5395 demonstrates our ability to translate internal discovery into pipeline assets. We look forward to sharing additional milestones later this year. Together, these efforts are building a more diversified pipeline and strengthening the foundation for sustainable innovation and long-term value creation."

Corporate and Clinical Updates

HBV Program

Brii Bio continued to advance its HBV pipeline with a focus on achieving higher functional cure rates through novel combination regimens. The Company’s differentiated HBV portfolio, including BRII-179, a recombinant protein-based HBV immunotherapeutic, and elebsiran, an HBV-targeting siRNA, has generated a growing body of clinical data supporting Brii Bio’s functional cure strategy through the completed Phase 2b ENSURE study and ongoing ENRICH and ENHANCE Phase 2b studies.

The Phase 2b ENSURE study was designed to assess the safety and efficacy of combination approaches aimed at improving functional cure outcomes. Cohorts 1-3 evaluated elebsiran in combination with PEG-IFNα compared to PEG-IFNα monotherapy. Cohort 4 evaluated the potential role of BRII-179 in enhancing immune responsiveness and improving hepatitis B surface antigen (HBsAg) loss rates. In the first half of 2026, end-of-study data from Cohorts 1-4 of the Phase 2 ENSURE study were presented at EASL 2026, demonstrating that:

The HBsAg loss benefit observed in the elebsiran and PEG-IFNα combination cohorts resulted in a higher functional cure rate compared to the PEG-IFNα alone cohort.
BRII-179-experienced participants achieved higher functional cure rates, particularly among anti-HBs responders, suggesting that BRII-179 may play an important role in achieving durable immunological control of HBV.

To further define the role of BRII-179 in HBV treatment and identify an optimal combination regimen for potential registrational development, the Company is evaluating BRII-179 in two additional ongoing Phase 2b studies: ENRICH and ENHANCE studies.

The ENRICH study evaluates BRII-179 as a priming therapy administered prior to elebsiran and PEG-IFNα treatment. The ENHANCE study evaluates a concurrent triple combination regimen of BRII-179, elebsiran, and PEG-IFNα to enhance the functional cure rates. In July, the Company announced topline end-of-treatment data from its Phase 2b ENRICH and ENHANCE studies.

At EOT, the ENRICH study evaluating pre-treatment with BRII-179 followed by elebsiran and PEG-IFNα achieved HBsAg loss rates of 42.9% (42/98) and 40.0% (20/50) across two BRII-179 dosing schedules (five doses administered every 3 weeks and 7 doses administered every 2 weeks, respectively). These results were consistent with the 41.9% (13/31) HBsAg loss rate observed in ENSURE Cohort 4 among patients previously treated with BRII-179, supporting the potential immune-priming role of BRII-179.
Subgroup analyses from the ENRICH study suggest potential differentiation in subjects with higher baseline HBsAg levels (1000-3000 IU/mL) comparing with other HBV functional cure regimens under development by other companies, consistent with prior findings from ENSURE Cohort 4, indicating that BRII-179 may induce beneficial immune responses regardless of baseline HBsAg levels in this difficult-to-treat population.
At EOT, the ENHANCE (Part A-1) study evaluating a concurrent triple combination did not demonstrate improved HBsAg loss rates compared with ENSURE Cohorts 2 and 3, 29.7% (11/37), with an observed rate of 25.5% (25/98). Higher HBsAg loss rates, however, were observed compared with the PEG-IFNα control arm, 10.2% (5/49).
The ENHANCE study also evaluated a sequential approach designed to potentially shorten PEG-IFNα therapy in its Part A-2 by administering BRII-179 plus elebsiran during the first 24 weeks followed by 24 weeks of elebsiran and PEG-IFNα. At EOT, this combination regimen achieved an HBsAg loss rate of 22.5% (18/80), suggesting that a full course of PEG-IFNα therapy may be important for achieving optimal functional cure outcomes.
No new safety concerns have been identified across ENSURE, ENRICH and ENHANCE to date.

On August 19, 2026, the Company received an email notification from one of its central laboratory service providers of a product recall involving a commercial assay kit[1] used for HBsAg testing in the ENHANCE study. Based on the information currently available and the Company’s preliminary assessment, the potential impact on the clinical data of the Company’s sponsored trials publicly disclosed to date appears limited to the EOT HBsAg data for Part A-2 of the ENHANCE study. The Company is working with the service provider to identify potentially affected samples and arrange retesting using unaffected assay kits. Subject to completion of the retesting and further analysis, as at the date of this announcement, the Company has not identified any indication at this stage that the matter would materially affect its overall interpretation of the study results or the program development decisions announced to date. The Company will continue to evaluate the matter and provide updates as appropriate if any material developments arise.

The Company plans to present detailed data from the ENRICH and ENHANCE studies, including additional efficacy, safety and subgroup analyses, at a scientific conference in the second half of 2026.

Discovery Program Update

Brii Bio is expanding its RNA platforms beyond infectious diseases into new therapeutic areas. In the first half of 2026, the Company progressed multiple early-stage candidates spanning various stages of discovery and pre-clinical development, with a focus on generating differentiated therapeutic opportunities in diseases with significant unmet medical needs.

BRII-5395 is a novel mRNA therapeutic vaccine internally developed by Brii Bio. It is being evaluated as part of a combination immunotherapy approach for HBV-related HCC.

On August 12, 2026, subsequent to the reporting period, the first participant was dosed in a clinical study evaluating BRII-5395 in participants with advanced HCC. The study, conducted at the Cancer Hospital of the Chinese Academy of Medical Sciences, is designed to evaluate the safety, tolerability, immunogenicity and preliminary anti-tumor activity of BRII-5395 in combination with an anti-PD-1 antibody and an anti-VEGF antibody. The current standard of care of immune checkpoint inhibitors have limited efficacy against HCC.
As the first internally developed mRNA-based cancer therapeutic vaccine from Brii Bio to enter clinical evaluation, BRII-5395 represents an important milestone in the advancement of the Company’s internal discovery capabilities and RNA-based technology platform.
While BRII-5395 is an mRNA therapeutic vaccine, the Company’s broader RNA platforms encompass multiple RNA modalities. In addition, the Company has extended the application of its technology platforms into additional therapeutic areas beyond infectious diseases.

Further program updates are expected throughout the remainder of 2026. The Company is actively exploring partnership opportunities to advance selected discovery programs to maximize the value of its emerging pipeline.

Additional Clinical Programs

Brii Bio is actively seeking strategic partnerships for long-acting anti-HIV and multidrug resistant (MDR) antibacterial therapeutic candidates to maximize the development and commercialization potential.
Other Corporate Updates

On April 16, 2026, the Company and Brii Biosciences Offshore Limited, a subsidiary of the Company, submitted a Demand for Arbitration to the United States-based Judicial Arbitration and Mediation Services, Inc. against Vir Biotechnology, Inc. (the "Arbitration").

The Company announced the commencement of the Arbitration on April 16, 2026 and provided a further update on May 22, 2026. As of June 30, 2026, the Arbitration remained in its early stages, and the parties had not reached a resolution of the claims.

In light of the ongoing arbitration, the Company is not currently advancing elebsiran into Phase 3 development and future development plans for elebsiran remain under evaluation pending resolution of the Arbitration. The Company will continue to monitor developments and update shareholders as appropriate.

Outlook

Looking ahead, the Company remains focused on advancing its differentiated HBV portfolio while continuing to progress its RNA-based discovery efforts.

The Company plans to continue investing in its internal discovery capabilities and RNA platform to support the advancement of future pipeline candidates. Through these efforts, Brii Bio aims to generate new therapeutic opportunities and build a sustainable pipeline of innovative medicines addressing diseases with significant unmet medical needs.

With a strong balance sheet and disciplined execution, Brii Bio is well positioned to pursue value-creating opportunities and deliver on its strategic priorities.

Interim 2026 Financial Results

The Company maintains a strong cash position to support its operations through 2029. Our bank deposits and cash and cash equivalents were RMB1,770.8 million as of June 30, 2026, representing a decrease of RMB170.2 million or 8.8% compared with RMB1,941.0 million as of December 31, 2025. The decrease was primarily due to payout of research and development activities and daily operations.
Through pipeline prioritization, resource optimization, internalization of certain clinical development activities, and cost-saving measures of third-party vendors, we have effectively controlled our operational expenses. Research and development expenses were RMB98.3 million for the six months ended June 30, 2026, representing a decrease of RMB18.7 million or 16.0%, compared with RMB117.0 million for the six months ended June 30, 2025. The decrease was primarily attributable to organizational optimization, compensation framework adjustments, and lower third-party contracting costs as Phase 2 study activities for the HBV programs wound down, partially offset by increased investment in early-stage discovery.
Administrative expenses were RMB52.6 million for the six months ended June 30, 2026, representing a decrease of RMB5.6 million or 9.6%, compared with RMB58.2 million for the six months ended June 30, 2025. The decrease primarily reflected lower employee costs following organizational optimization and adjustments to the senior management compensation framework, partially offset by the increase in professional fees and the depreciation and amortization cost.
Other income was RMB19.5 million for the six months ended June 30, 2026, representing a decrease of RMB8.6 million or 30.6%, compared with RMB28.1 million for the six months ended June 30, 2025. This was mainly due to the decrease in bank interest income of RMB7.9 million attributable to the declining interest rates on time deposits.
Conference Call Information

The Company will host a live conference call in Chinese on August 21 at 8:30 a.m. HKT (8:30 p.m. ET on August 20). For the registration link, please click here.

All participants shall use the link provided above to complete the online registration process prior to the conference call. A replay of the conference call will be available after the call and can be accessed by visiting the Company’s website at www.briibio.com under the Investor Relations section.

This press release contains references to third-party information. Such information is not deemed to be incorporated by reference in this press release. Brii Bio disclaims responsibility for such third-party information.

(Press release, Brii Biosciences, AUG 20, 2026, View Source [SID1234670259])

On August 20, 2026 FairJourney Bio ("FJBio"), a global antibody discovery expert, reported the publication of a peer-reviewed study in mAbs describing a novel approach with the potential to improve the therapeutic window of IL-12, a potent anti-tumor cytokine1. FJBio delivered the end-to-end antibody discovery and engineering campaign for the venture-backed oncology program across its sites in Porto, Portugal, and Cambridge, UK.

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IL-12 is one of the most potent anti-tumor cytokines, but its development has been limited by severe immune-related systemic toxicity. Previous strategies to improve its therapeutic window, including intratumoral dosing, half-life extension and protease-cleavable pro-drugs, have had limited clinical success.

The paper, ‘Conditional activation of IL-12 through a Fibronectin-EDB dependent switch gate’, reports the generation of a dual-specificity antigen-binding fragment (Fab) engineered to bind competitively to IL-12 and fibronectin-EDB (FN-EDB), a tumor-associated matrix antigen. This reversible switch is designed to mask IL-12 until it encounters FN-EDB, enabling its conditional activation in the tumor microenvironment.

The study describes what the authors report as the first demonstration of a reversible trans-activation logic gate for tumor-conditional cytokine delivery. In vitro data demonstrates FN-EDB-dependent IL-12 availability and activity, while quantitative systems pharmacology (QSP) modeling predicts a substantially improved therapeutic window for the approach.

The novel format combines a dual-specificity switch arm with a separate, higher-affinity FN-EDB targeting arm. QSP modeling was used to define the binding parameters required for the switch to function before a candidate existed. Working to this predefined affinity window, FJBio introduced IL-12 binding into existing FN-EDB binders using targeted mutagenesis, before optimizing both specificities through a two-stage combinatorial engineering campaign. The resulting affinities were then tuned against one another, enabling the switch arm to bind competitively to IL-12 or FN-EDB, while the targeting arm supports avidity-driven localization to the tumor and conditional activation of IL-12.

Teresa Barata, PhD, Chief Scientific Officer and co-author, FairJourney Bio, commented: "Harnessing the potent anti-tumor activity of IL-12 while limiting systemic toxicity has challenged researchers for almost 30 years. We are proud of the role our teams played in engineering this complex antibody format, developing a switch molecule that unmasks IL-12 only where it is needed. This campaign demonstrates FJBio’s ability to partner at the most challenging end of discovery, engineering to a narrow, pre-defined specification and delivering a solution that recognizes two completely unrelated targets and holds them in balance. We are hugely excited by the potential this has in oncology and future treatments."

(Press release, FairJourney Biologics, AUG 20, 2026, View Source [SID1234670261])

On August 20, 2026 Adaptin Bio, Inc. (OTCQB: APTN) ("Adaptin" or the "Company"), a biotechnology company focused on developing precision cancer therapies with improved delivery to the brain and other tissues, reported that enrollment has opened for a Phase 1 clinical trial evaluating its proprietary BRiTE (Brain Bispecific T cell Engager) therapeutic, APTN-101, as a treatment for glioblastoma (GBM), the most common and aggressive primary brain tumor. The BRiTE platform was developed by a distinguished team of researchers at Duke University, the study site for the first-in-human clinical trial.

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The Phase 1 clinical trial has an open-label, dose-escalation design with the primary objective to evaluate the safety profile and maximum tolerated dose of APTN-101 in patients diagnosed with World Health Organization (WHO) Grade IV Malignant Glioma (GBM that expresses Epidermal Growth Factor Receptor variant III [EGFRvIII]). The study is expected to enroll up to 15 adult patients, and the primary endpoint is the proportion of patients with a dose limiting toxicity observed within each dose level. Secondary endpoints are the pharmacokinetics of APTN-101, and the objective response rate based on modified Response Assessment in Neuro-Oncology Criteria. Exploratory endpoints include an assessment of biological activity as evidenced by changes in cytokine levels, formation of anti-BRiTE antibodies, overall survival and progression free survival.

"Opening enrollment in the Phase 1 trial is an important milestone in the clinical development of APTN-101, a potential best-in-class therapy for the treatment of glioblastoma," said Michael J. Roberts, Ph.D., President and CEO of Adaptin Bio. "In preclinical studies, APTN-101 demonstrated impressive efficacy targeting glioma cells with precision, eliminating some malignant glioma tumors across multiple aggressive disease models. Our proprietary BRiTE technology was developed to enhance APTN-101’s ability to cross the blood-brain barrier, to selectively target and then attack glioma tumor cells. We believe this mechanism of action is a significant innovation that provides a key differentiator compared to standard-of-care therapies. Since such standard-of-care therapies (including surgery, radiotherapy and chemotherapy) are not curative, disease recurrence is common. As a result, patients diagnosed with GBM currently have a median survival of only 12 to 18 months with just 5% of patients surviving beyond five years. Given the promising preclinical data that has been generated for APTN-101 so far, we believe that leveraging the BRiTE technology with APTN-101 has potential to become an important therapeutic option for patients diagnosed with this difficult-to-treat disease."

BRiTE’s unique delivery mechanism and mode of action harness the ability of T cells to precisely target and destroy glioma cells while effectively navigating the brain’s unique environment. Specifically, APTN-101 is engineered to cross the blood-brain barrier (BBB) to target EGFRvIII, a specific protein linked to aggressive brain tumors. In preclinical studies, APTN-101 demonstrated a greater than 7-fold increase in distribution of the EGFRvIII T-cell engager into the brain compared to the EGFRvIII T-cell engager alone. This resulted in complete eradication of EGFRvIII GMB tumors in 70%-80% of mice. The novel treatment is associated with an excellent safety profile and minimal off-target effects in preclinical models.

"Glioblastoma is a disease with a significant unmet clinical need, limited therapeutic options, and little improvement in outcomes," said Mustafa Khasraw, M.D., professor at Duke University School of Medicine, who led the preclinical development team for APTN-101 and is the principal investigator of the upcoming clinical trial. "By combining immune-based tumor targeting with enhanced delivery to the brain, APTN-101 is designed to address two major challenges in glioblastoma treatment. This first-in-human study is an important step in determining whether this approach can translate into meaningful benefit for patients."

Glioblastoma is one of the most aggressive and deadly forms of brain cancer, accounting for approximately 15,000 new cases per year in the U.S. Secondary malignant brain tumors account for about 200,000 new cases annually. The glioblastoma multiforme treatment market is valued at $3.02 billion in 2025, and researchers forecast an 8% CAGR over the next five years, reaching $4.44 billion by 2030.1 Growing demand for therapies that prolong survival is a top driver of the projected growth.

About BRiTE

Adaptin Bio’s proprietary BRiTE technology leverages the enhanced "hitchhiking" capabilities of manipulated immune cells to deliver therapeutic agents directly to brain tumors. This innovative approach has demonstrated high specificity for EGFRvIII expressing glioma cells, dose-responsive efficacy against diverse patient-derived glioma cell lines, and a favorable safety profile. Additional BRiTE targets are being evaluated. By manipulating the immune system either in vivo or ex vivo, BRiTE aims to overcome traditional treatment barriers and offer a promising new therapeutic option for patients with intracerebral malignancies.

(Press release, Adaptin Bio, AUG 20, 2026, View Source [SID1234670262])

On August 20, 2026 Zelluna (OSE: ZLNA), a clinical-stage company pioneering allogeneic "off-the-shelf" T Cell Receptor-based Natural Killer (TCR-NK) cell therapies for the treatment of solid cancers, reported its results for the second quarter 2026.

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Webcast scheduled for 20 August 2026 at 09:00 (CEST). Link to webcast here.

Operational Highlights:

First patient dosed with ZI-MA4-1: On 13 July 2026, Zelluna announced the dosing of the first patient in the Phase 1 ZIMA-101 study, marking the first clinical evaluation of the Company’s proprietary TCR-NK platform. ZI-MA4-1 is the world’s first MAGE-A4-targeting TCR-NK therapy to enter clinical testing. Patient recruitment is ongoing at two clinical sites in the UK.
Favourable initial safety observations support continued enrolment: On 17 August 2026, the Independent Data Monitoring Committee (IDMC) completed its planned safety review of the first patient. ZI-MA4-1 was well tolerated during the protocol-defined safety observation period, with no dose-limiting toxicities observed. The IDMC recommended recruitment of the remaining two patients at Dose Level 1. These observations represent the first clinical data from ZIMA-101.
The Royal Marsden activated as second clinical site: On 29 June 2026, Zelluna announced that The Royal Marsden NHS Foundation Trust had been activated as the second clinical site in the ZIMA-101 Phase 1 clinical trial. Together with The Christie NHS Foundation Trust, the two sites provide a strong clinical foundation for patient recruitment and execution of the ZIMA-101 study.
Private placement and retail offering successfully completed: In June 2026, Zelluna successfully completed a private placement and retail offering, raising gross proceeds of approximately NOK 58.2 million through the issuance of 3,143,958 new shares at a subscription price of NOK 18.50 per share. The financing strengthens Zelluna’s position as the Company approaches initial clinical data, supports the continued execution of the ZIMA-101 clinical trial, and enhances financial flexibility to pursue future strategic opportunities.
NOK 16 million grant awarded by the Research Council of Norway: In June 2026, the Research Council of Norway approved a NOK 16 million grant to Zelluna under the Innovation Project for the Industrial Sector (IPN) scheme. The funding will support the ongoing Phase 1 ZIMA-101 clinical study.
ZIMA-101 to be presented at ESMO (Free ESMO Whitepaper) 2026: In July 2026, an abstract describing the ongoing ZIMA-101 Phase 1 study of ZI-MA4-1 was accepted for poster presentation at the ESMO (Free ESMO Whitepaper) Congress 2026 in Madrid on 23–27 October 2026. The poster will be presented by Professor Fiona Thistlethwaite, Chief Investigator of the study at The Christie NHS Foundation Trust.
Notice of EGM – election of new Board member: On 17 August 2026, the Board called for an Extraordinary General Meeting regarding election of a new member of the Board. The Nomination Committee has proposed Martin Welschof for election as a new member of the Board, whilst Hans Ivar Robinson, who has served on the Board since its foundation, has decided to step down from the Board in line with Birk Venture’s approach of transitioning out of board positions within a reasonable period following a listing.
Financial Highlights Q2 2026:

Total operating expenses: MNOK 19.9 in Q2 2026 and MNOK 40.2 YTD
Total loss: MNOK 19.7 in Q2 2026 and MNOK 40.1 YTD
Cash and cash equivalents: MNOK 86.2 as of 30 June 2026
Financial runway: Into Q3 2027
"The second quarter and the period immediately following it have been defining for Zelluna. We set out to establish the clinical infrastructure for ZIMA-101, bring ZI-MA4-1 into the clinic and begin generating the first clinical data from our TCR-NK platform, and we have delivered on those objectives.

The first patient has now been treated, and we have reported favourable initial safety observations, with the independent monitoring committee recommending continued enrolment. I am incredibly proud of what our team has achieved. Our focus now is on continuing to execute ZIMA-101, generating the clinical data that will begin to define the potential of our TCR-NK platform, and continuing to build the pipeline that can extend that potential beyond ZI-MA4-1," says CEO Namir Hassan.

Outlook

Zelluna enters the second half of 2026 with strong momentum following the initiation of the ZIMA-101 first-in-human Phase 1 study and the Independent Data Monitoring Committee’s recommendation to continue enrolment after its review of the first patient’s safety data. With both clinical sites now activated, patient recruitment is ongoing and ZIMA-101 is progressing as planned. In parallel, Zelluna continues to strengthen its manufacturing capabilities to support the future development of ZI-MA4-1 and the broader TCR-NK platform. The Company remains focused on disciplined execution and the generation of high-quality clinical data to advance ZI-MA4-1 and its broader TCR-NK platform. Zelluna’s cash position is expected to fund planned operations into the third quarter of 2027, providing a solid foundation to execute its strategy and pursue future value-creating opportunities.

The quarterly report and presentation materials will be made publicly available on the Zelluna website at 07:00 CEST on 20 August 2026. The Company will host a webcast on 20 August at 09:00 CEST, and questions can be submitted during the event. The webcast recording will remain available on the Company’s website after the event.

(Press release, Zelluna Immunotherapy, AUG 20, 2026, View Source [SID1234670229])

On August 20, 2026 4C Biomed, a biotechnology company developing novel immunotherapeutic monoclonal antibodies, reported preclinical data set on its lead asset, anti-4CB1, published in the prestigious journal, Molecular Cancer Therapeutics. The paper describes its action as a novel selective HVEM-blocking antibody, which enhances T-cell and macrophage immunity against solid tumors.

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The full article is entitled "Anti-4CB1: A Novel Selective HVEM-Blocking Antibody Enhancing T-Cell and Macrophage Immunity Against Solid Tumors" and it can be read HERE.

Checkpoint inhibitors, such as anti-PD1 (Keytruda, Opdivo), have transformed cancer treatment for many subsets of patients with common tumors. However, many cancers do not respond, and of those that do, the majority eventually progress. Treatment options for these patients are limited.

4C Biomed’s article introduces its Anti-4CB1, a fully human monoclonal antibody against HVEM (Herpes Virus Entry Mediator, or TNFRSF14), a novel immune checkpoint which is highly expressed in malignant cancer cells across multiple cancers, including melanoma, renal, ovarian, colorectal, endometrial and hepatocellular carcinoma.

HVEM acts as a brake on the immune system through two inhibitory partner molecules, BTLA and CD160. Anti-4CB1 blocks both of these molecules resulting in a much more powerful immune response than blocking either molecule alone. Anti-4CB1 binds HVEM with high affinity; screened against c.6,000 human membrane proteins, HVEM was the only protein it bound, which is highly significant for predicting side effects down the line.

Key features of the published anti-4CB1 data and details of the study:

Activating higher adaptive and innate immune responses: Anti-4CB1 increased killing of melanoma cells by patients’ own tumor-infiltrating lymphocytes by 48%, the same magnitude as anti-PD1, and raised the markers that indicate T-cell activation. Control experiments confirmed the antibody is not itself toxic to tumor cells; it works by mobilizing the immune system. Combined with anti-PD1, anti-4CB1 increased macrophage-mediated destruction of tumor cells by 168%.
Action in real patient tumors in different cancer types: Using 49 freshly collected patient tumor samples spanning multiple cancer types, Anti-4CB1 boosted tumor-cell killing in 28.5% of cases, compared with 14.3% for anti-PD1 alone. The headline finding was that nine of the responding samples responded to Anti-4CB1 but not to anti-PD1. Activity was strongest in melanoma, colon, ovarian and renal cancers.
Potential as a monotherapy or in combination: In colon cancer and melanoma in vivo models, Anti-4CB1 slowed tumor growth as a monotherapy. When combined with anti-PD1, it achieved 95% tumor growth inhibition. Animals in the combination group were still alive when the study ended – they outlived the anti-PD1-only group by a statistically significant margin (p=0.03); in the combination group 80% were still alive while in the PD1 only group, only 40% remained alive. All treatments were well tolerated, with no weight loss or observed adverse events.
Blood-based HVEM – a possible companion test: Melanoma patients who were treated in the clinic with anti-PD1 and responded, had significantly higher HVEM levels in their tumors before treatment began (p=0.004). Separately, in ex-vivo experiments, samples from patients with high levels of soluble HVEM circulating in their blood were less likely to respond to Anti-4CB1. This data suggest HVEM could be a viable biomarker for identifying which patients are most likely to benefit from the immuno-therapy.
Gilli Galore-Haskel, VP R&D of 4C Biomed and one of the lead authors on the paper, said:

"We are proud to publish this data today in such a prestigious journal. Very few preclinical programs are supported by such a range of data based on this many fresh human tumors samples across this many cancer types. Anti-4CB1 showed activity in patient samples where anti-PD1 was ineffective and also boosted its impact when used in combination. Data confirms that the antibody has a clean safety profile and these data show that it works by mobilizing both strands of the immune system – a powerful double action. Finally, data demonstrate that blood-based HVEM could be a valuable biomarker to assess whether patients will respond to Anti-4CB1 or not; a potential companion test is an increasing must-have feature for next generation immuno-oncology therapeutics.

"Taken together, this preclinical dataset supports advancing our anti-4CB1 programme into the clinic as soon as possible, which is our intention in the new year."

(Press release, 4C Biomed, AUG 20, 2026, View Source [SID1234670263])