On October 20, 2025 BeOne Medicines Ltd. (Nasdaq: ONC; HKEX: 06160; SSE: 688235), a global oncology company, reported the presentation of data from two pivotal Phase 3 trials – RATIONALE-307 and 312 – offering new evidence of the benefits of its PD-1 inhibitor, TEVIMBRA (tislelizumab), at the European Society of Medical Oncology (ESMO) (Free ESMO Whitepaper) 2025 Congress (ESMO 2025) in Berlin, Germany, October 17-21. The results reinforce TEVIMBRA’s consistent and durable efficacy across lung cancer subtypes, including non-small cell lung cancer (NSCLC) and extensive-stage small cell lung cancer (ES-SCLC). In addition, the first clinical data from BeOne’s investigational HPK1 inhibitor, BGB-26808, as a single agent and in combination with TEVIMBRA, will be presented, highlighting promising antitumor activity and a generally manageable safety and tolerability profile in patients with advanced solid tumors.

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"The results presented at ESMO (Free ESMO Whitepaper) 2025 strengthen the evidence base for TEVIMBRA in lung cancer, with consistent survival benefit across subtypes. We’re also encouraged by clinical activity from our investigational HPK1 inhibitor, BGB-26808, which supports our TEVIMBRA-based combination strategy," said Mark Lanasa, M.D., Ph.D., Chief Medical Officer, Solid Tumors at BeOne. "With TEVIMBRA’s recent European approval in perioperative resectable NSCLC and our diversified, combination-rich pipeline, we are advancing next-generation options for people with lung cancer."

New Data Builds on Strong Evidence Base for TEVIMBRA in Lung Cancer Treatment

The European Commission’s approvals of TEVIMBRA in lung cancer are based on five randomized Phase 3 studies from the RATIONALE program. At ESMO (Free ESMO Whitepaper) 2025, BeOne will present new data from two of these trials, further substantiating TEVIMBRA’s efficacy across lung cancer settings, including NSCLC and ES-SCLC, with a consistent safety profile.

RATIONALE-307 (NCT03594747): Long-term data show TEVIMBRA plus chemotherapy significantly improved overall survival over chemotherapy alone across different subgroups of patients with locally advanced or metastatic squamous NSCLC, including patients with stage IV disease, irrespective of PD-L1 expression. These survival benefits were observed even in the presence of high in-study crossover from chemotherapy to TEVIMBRA, a factor that typically reduces the observed benefit of treatment1. TEVIMBRA plus chemotherapy demonstrated a generally well-tolerated safety profile with no new safety signals even at the longer follow-up. The most common Grade 3 or 4 treatment-related adverse events (TRAEs) were associated with chemotherapy and included decreased neutrophil counts, neutropenia and leukopenia. (poster #1858, Oct. 18, 12:00-12:45 PM CEST).

A post-progression analysis from RATIONALE-307 also suggests that continued TEVIMBRA monotherapy may help extend survival in select patients whose disease progresses in a slower, more localized way (poster #1871​, Oct. 18, 12:00-12:45 PM CEST).
RATIONALE-312 (NCT04005716): Three-year data confirmed long-term efficacy and safety of first-line TEVIMBRA plus chemotherapy in ES-SCLC, with meaningful and sustained improvements in overall survival in both the intent-to-treat population and PD-L1-expressing subgroups, and no new safety signals identified. The most common Grade 3 or 4 TRAEs for TEVIMBRA given in combination with chemotherapy were neutropenia, anemia, thrombocytopenia, and decreased white blood count (poster #2765, Oct. 18, 12:00-12:45 PM CEST).
Pipeline Momentum: Early Findings from HPK1 Inhibitor BGB-26808

Preliminary findings from the Phase 1a dose-escalation trial (NCT05981703) assessing BGB-26808, a novel, second-generation HPK1 inhibitor, as monotherapy and combined with TEVIMBRA showed encouraging antitumor activity in the combination arm. The combination arm achieved an unconfirmed objective response rate (ORR) of 15.4%, including one complete response and seven partial responses. Safety was manageable in patients with advanced, metastatic, and unresectable solid tumors. Grade 3 or 4 TRAEs with single-agent BGB-26808 were reported in 21.8% of patients and in 21.2% of patients in the combination arm (poster #1564, Oct. 19, 12:00-12:45 PM CEST).

About TEVIMBRA (tislelizumab)

TEVIMBRA is a uniquely designed humanized immunoglobulin G4 (IgG4) anti-programmed cell death protein 1 (PD-1) monoclonal antibody with high affinity and binding specificity against PD-1. It is designed to minimize binding to Fc-gamma (Fcγ) receptors on macrophages, helping to aid the body’s immune cells to detect and fight tumors.

TEVIMBRA is the foundational asset of BeOne’s solid tumor portfolio and has shown potential across multiple tumor types and disease settings. The global TEVIMBRA clinical development program includes almost 14,000 patients enrolled to date in 35 countries and regions across 70 trials, including 22 registration-enabling studies. TEVIMBRA is approved in 47 markets, and more than 1.7 million patients have been treated globally.

Important Safety Information

The current European Summary of Product Characteristics (SmPC) for TEVIMBRA is available from the European Medicines Agency.

The information in this press release is intended for a global audience. Product indications vary by region.

(Press release, BeOne Medicines, OCT 20, 2025, View Source [SID1234656827])

On October 20, 2025 Transgene (Euronext Paris: TNG), a biotech company that designs and develops virus-based immunotherapies for the treatment of cancer, and BioInvent International AB ("BioInvent") (Nasdaq Stockholm: BINV), a biotech company focused on the discovery and development of novel and first-in-class antibodies for cancer immunotherapy, reported a poster at the 2025 European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper) Annual Meeting on updated clinical results and positive antitumoral activity of BT-001 in patients with advanced refractory tumors.

The data show that intra-tumoral (IT) BT-001 injection in combination with MSD’s (Merck & Co., Inc., Rahway, NJ, USA) intravenous (IV) anti-PD-1 therapy KEYTRUDA (pembrolizumab[1]), was well tolerated and showed positive local, abscopal and sustained antitumoral activity in injected and non-injected lesions.

Translational analyses reveal increased T cell chemoattractants in the blood and infiltration of activated CD8+ T cells and macrophages in tumors after treatment with BT-001 in combination with pembrolizumab. Significant tumor shrinkage (≥30% decrease in longest diameter) was observed in five of 16 injected lesions (in three patients with melanoma and one patient with sarcoma). Four patients had tumor shrinkage of non-injected lesions.

Long-lasting partial responses (PRs) were observed in a patient with melanoma resistant to anti-PD-1/anti-CTLA-4 combination therapy and in a heavily pre-treated, PD-L1 negative leiomyosarcoma patient.

These immune-mediated tumor shrinkages are consistent with the mechanistic hypothesis that BT-001, in combination with pembrolizumab, turns "cold" tumors into immunologically active ones. The overall data support further development of BT-001 across a range of solid tumors to improve responses to cancer immunotherapies.

Prof. Celeste Lebbé, Dermatologist and Venereologist, Head of Dermatology Department at Hospital Saint-Louis, Paris, commented: "Many cancer patients fail to respond to existing treatments, emphasizing the urgent need for new approaches. BT-001 represents a promising new class of immunotherapy, capable of inducing a potent local immune response through the expression of GM-CSF and an anti-CTLA-4 antibody. These clinical data provide compelling proof of concept, highlighting the relevance of this oncolytic virus in transforming cold tumors into immunologically active ones. Whether administered alone or in combination with pembrolizumab, BT-001 offers the potential to expand treatment options with a favorable safety profile across multiple tumor types."

Dr. Alessandro Riva, Chairman and CEO of Transgene, said: "We are pleased to jointly present these clinical data on BT-001 at ESMO (Free ESMO Whitepaper) 2025, demonstrating encouraging antitumor activity in patients with solid, refractory solid tumors. These updated results confirm BT-001’s mechanism of action as a single agent administered via intra-tumoral injection and show early signs of clinical benefit, including lesion shrinkage and stable disease. With a favorable safety profile – both alone and in combination with pembrolizumab – BT-001 could represent an effective option to enhance responses to immune checkpoint inhibitors (ICI) in patients with limited treatment alternatives. Together with our partner BioInvent, we will continue to explore its safety and efficacy and share further data as it becomes available."

Andres McAllister, MD, PhD, Chief Medical Officer at BioInvent, added: "By combining BT-001 with pembrolizumab, we are building upon the promising data generated by BT-001 as a single agent. Targeting the PD-1/PD-L1 pathway in addition to BT-001’s mechanism of action is expected to further stimulate and restore the patient’s immune system, which should result in improved antitumoral activity and patient outcome. We are pleased to pursue clinical development opportunities with clinicians and further demonstrate the potential of this novel oncolytic virus."

Transgene and BioInvent are co-developing BT-001, an oncolytic virus developed using Transgene’s Invir.IO platform armed to express GM-CSF and BioInvent’s full-length anti-CTLA-4 monoclonal antibody, to elicit a strong and effective anti-tumoral response in solid tumors.

The poster titled: "Updated clinical results of BT-001, an oncolytic virus expressing an anti-CTLA4 mAb, administered in combination with pembrolizumab in patients with advanced solid tumors.", can be accessed at the websites for the ESMO (Free ESMO Whitepaper) conference, Transgene and BioInvent.

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(Press release, Transgene, OCT 20, 2025, https://www.bioinvent.com/en/press/transgene-and-bioinvents-armed-oncolytic-virus-bt-001-shows-positive-local-abscopal-and [SID1234656826])

On October 20, 2025 Tallac Therapeutics reported that the U.S. Food and Drug Administration has granted Fast Track designation to TAC-001 for the treatment of previously treated, locally advanced unresectable or metastatic cholangiocarcinoma.

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Cholangiocarcinoma (CCA) is an aggressive malignancy of the biliary tract with a poor overall prognosis and limited treatment options. The majority (~70%) of patients are diagnosed late at advanced stages and have a 5-year survival rate of less than 10%. Current treatment options, particularly for patients who relapsed after prior systemic treatment, are limited. The designation highlights TAC-001’s potential to address this urgent medical need.

Building on encouraging safety and efficacy Ph1 data in solid tumors, the Fast Track designations will greatly support the clinical development strategy to advance TAC-001, a next-generation antibody-drug conjugate (ADC) designed to safely and efficiently engage both the innate and adaptive anti-tumor immune response.

(Press release, Tallac Therapeutics, OCT 20, 2025, View Source [SID1234656825])

On October 20, 2025 Sona Nanotech Inc., (CSE: SONA) (OTCQB: SNANF) (the "Company", "Sona"), reported the completion of its first-in-human clinical study treating patients with histologically confirmed, immunotherapy-resistant cutaneous metastatic melanoma using Sona’s Targeted Hyperthermia Therapy ("THT"). Ten advanced-stage patients, all of whom were failing to respond to standard immunotherapy treatment, were recruited into this early feasibility study. Under the study protocol, patients had up to four tumors treated with Sona’s THT on days one and eight of the study. By day 15, 8/10 patients experienced a significant clinical response to treatment with a majority (6/8) showing no detectable residual melanoma in representative, biopsied tumors, and two patients showing no response.

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David Regan, Sona’s CEO, commented, "These favorable results—demonstrated in the majority of treated patients—show that Sona’s THT therapy has successfully eliminated melanoma in tumors where leading treatments had previously failed. This outcome has exceeded our expectations and delivered on our commitment to investors to produce human efficacy data quickly. Based on findings from this study, we are preparing for a Canadian clinical trial that will provide deeper insights into the biological potential of our THT as we prepare to expand its clinical application into a broader range of solid tumor cancers. An application for an investigational testing authorization ("ITA") has been made to Health Canada to permit this next clinical study for which we have already received research ethics board approval."

The study’s principal investigator, Dr. Carlos Rojas, Executive Director of the Bradford Hill Clinical Cancer Research Center commented, "We were very impressed by the rapid and measurable responses observed in patients who had exhausted standard immunotherapy options. These outcomes have provided meaningful hope for the patients enrolled."

Dr. Carman Giacomantonio, Sona’s CMO, commented, "These tremendous results validate our earlier, published preclinical findings and provide compelling clinical evidence of the efficacy and tolerability of Sona’s novel Targeted Hyperthermia Therapy in human cancer. Although this study was not powered to determine response rates, eight out of ten patients experienced responses in a treated tumor with six out of those eight patients’ biopsied tumors showing a complete response – commands one’s attention. Equally impressive is the observation that these responses were confirmed after only two weeks from the initial treatment. This, to my knowledge, is unprecedented."

Safety and tolerability data also showed favourable results. One stage IV patient reported a serious adverse event during the trial that investigators determined to be unrelated to THT, which ultimately resolved. Also, two stage IV patients expired shortly following completion of the study period due to distant disease progression. Another aim of the study was to capture clinician-reported and patient-reported experience with the physical delivery of THT with a view to improving the overall clinical delivery of Sona’s THT. To this end, significant data was captured highlighting opportunities for design and application enhancement that will be applied and evaluated in future studies.

The Company also announces that its Chief Scientific Officer, Len Pagliaro, PhD. Is stepping back from an operational role. "Developing a powerful but gentle cancer therapy that uses nanotechnology to stimulate the immune system, and has the potential to transform lives, has been the focus of the past 16 years of my career." said Dr. Pagliaro. "These remarkable first-in-human results mark the fulfillment of that vision. I now look forward to continuing to support the Company as a member of Sona’s board of directors."

Investor Webinar details:

The Company is also pleased to announce that it will host a webinar on Monday, October 20th at noon EST to discuss these results in more detail and outline plans for the coming year. Interested parties can register here: http://bit.ly/3JcFls5. A recording of the webinar will be made available following the webinar in the Investor Information section of the Company’s website."

(Press release, Sona Nanotech, OCT 20, 2025, View Source [SID1234656823])

On October 20, 2025 Sairopa, a clinical-stage biotechnology company developing innovative cancer immunotherapies, reported new clinical data on ADU-1604, its differentiated CTLA-4 blocking antibody, at the European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper) Congress 2025, taking place October 17-21, 2025 in Berlin, Germany.

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The company presented a scientific poster showcasing significant clinical advances with ADU-1604 in melanoma patients who had previously failed PD-1 inhibitor therapy (n=27). The poster presentation featured the full results from the SRP-21C101 Phase 1 combined dose escalation and dose expansion clinical trial. Clinical efficacy was observed in 4/27 patients indicative of efficacy similar to other CTLA-4 inhibitors. Importantly, ADU-1604 showed a significantly milder safety profile as compared to existing CTLA-4 inhibitors, as evidenced by the reduced severity of immune-related adverse events.

"We are excited to share the clinical results from ADU-1604 in PD1 relapse/refractory melanoma with the international oncology community at ESMO (Free ESMO Whitepaper) Congress," said Laura Lassouw-Polman, Chief Operating Officer at Sairopa. "ADU-1604’s milder safety profile as compared to other CTLA-4 blocking agents will support its future use as combination agent, with PD-1 blocking agents and/or other agents. We are grateful to all patients, their families and investigators that supported our study."

(Press release, Sairopa, OCT 20, 2025, View Source [SID1234656822])