On November 10, 2025 Akeso, Inc. (HKEX: 9926. HK) reported that the first patient has been dosed in a Phase I clinical trial evaluating the personalized mRNA vaccine AK154. This trial is investigating AK154 both as a monotherapy and as a combination with the company’s first-in-class bispecific antibodies, cadonilimab (PD-1/CTLA-4) and ivonescimab (PD-1/VEGF), for the adjuvant treatment of pancreatic cancer following surgical resection.

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AK154 is Akeso’s first mRNA-based therapeutic candidate to enter clinical development. This achievement marks a significant breakthrough for the company in the field of mRNA technology, following its established leadership in multi-specific antibodies, and entry into the clinic for its antibody-drug conjugates (ADCs).

AK154 is a personalized neoantigen vaccine developed by Akeso using its mRNA platform. It designs sequence-specific mRNA vaccines by sequencing tumor tissue and identifying immunogenic mutations with high affinity. This approach aims to overcome the "cold tumor" phenotype seen in pancreatic cancer.

AK154 shows a synergistic therapeutic effect with Akeso’s bispecific antibodies in enhancing anti-tumor immunity. Preclinical data demonstrated strong immunogenicity, potent anti-tumor activity, and a favorable safety profile. The combination of AK154 with cadonilimab or ivonescimab offers potentially promising new therapeutic options for pancreatic cancer patients.

(Press release, Akeso Biopharma, NOV 10, 2025, View Source [SID1234659746])

On November 10, 2025 Vascarta Inc., a healthspan focused, clinical stage biopharmaceutical company advancing safe, patient friendly therapies for pain, inflammation, and, in collaboration with the City University of New York (CUNY), reported the publication of a preclinical study demonstrating that STO-1, a first-in-class drug candidate, can selectively eliminate glioblastoma (GBM) cells in mice while avoiding harmful autoimmune reactions.

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STO-1 is a proprietary hybrid molecule in which curcumin is linked to paclitaxel with a linker that gets broken when STO-1 enters a cell. In the study, mice treated with STO-1 experienced a 67% long-term survival rate, with several animals achieving complete tumor clearance. The therapy works in part by reprogramming deactivated tumor-associated immune cells to attack the tumor, while leaving healthy immune function intact. This minimizes the prospect of undesirable side effects often seen with immunotherapies.

Dr. Probal Banerjee, the senior author and Professor, Biochemistry, Biology, Neuroscience, Chemistry at the College of Staten Island, CUNY, said:
"Unlike other immune therapies, which can trigger dangerous autoimmune reactions, STO-1 targets only the tumor-associated cells. This study demonstrates a promising new approach to treating glioblastoma safely."

Dr. Richard Prince, Chairman, Chief Executive and President, Vascarta, stated:
"These results highlight the potential of STO-1 to offer a safe and effective option for patients with glioblastoma without the side effects."

(Press release, City University of New York, NOV 10, 2025, View Source [SID1234659745])

On November 10, 2025 Verismo Therapeutics, a clinical-stage CAR T company developing a novel KIR-CAR platform technology, reported the presentation of new preclinical data from its lead clinical pipeline, SynKIR-110 to target mesothelin on solid tumors, at the Society of Immunotherapy of Cancer (SITC) (Free SITC Whitepaper) 2025 Annual Meeting. The oral presentation showcased their latest preclinical data demonstrating SynKIR-110’s improved safety profile and enhanced anti-tumor activity compared to conventional CAR T therapies.

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The oral presentation, "A Novel NK-cell Based Split-Signaling Killer Immunoglobulin Receptor (KIR)-Based CAR T Targeting Mesothelin, SynKIR-110, Shows Increased Safety Profile and Increased Efficacy in vitro and in vivo" was delivered by Dr. Nora Yucel, Principal Scientist at Verismo Therapeutics.

Key Findings:

Enhanced Tumor-Specific Serial Killing: In vitro, SynKIR-110 showed sustained killing of MSLN-expressing tumor cells while minimizing off-target activation and cytokine release.
Reduced Exhaustion and Improved Functional Persistence: Unlike conventional 41BB-CD3ζ CAR T cells, SynKIR-110 exhibited reduced activation and exhaustion markers in vitro, suggesting less tonic signaling and functional exhaustion.
Improved Anti-Tumor Activity: In NSG mouse models of mesothelioma, SynKIR-110 induced deep and prolonged regression of implanted tumors and metastatic spread.
Less Off-tumor Activity: SynKIR-110 cells were selectively enriched in tumors and reduced in, normal tissues – contrasting with the off-tumor accumulation in lung and normal tissues observed with conventional 41BB-CD3ζ CAR T designs.
"Conventional CAR T therapies have faced significant safety and efficacy challenges in treating solid tumors," said Dr. Laura Johnson, CSO/COO of Verismo Therapeutics. "Our SynKIR platform presents a truly novel signaling platform approach designed to allow CAR T cells to rest and recover when not engaged with tumors, which in turn may reduce T cell exhaustion and improve safety and efficacy of tumor-specific killing."

SynKIR-110 is currently being evaluated in a Phase 1 clinical trial (NCT05568680) in patients with advanced ovarian cancer, cholangiocarcinoma, and mesothelioma, and has received both Orphan Drug and Fast Track Designations from the U.S. Food and Drug Administration (FDA) for the treatment of mesothelioma.

(Press release, Verismo Therapeutics, NOV 10, 2025, View Source [SID1234659744])

On November 10, 2025 at the Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper) 2025 annual meeting, Tiumbio Co., Ltd. (KOSDAQ: 321550), a clinical-stage biopharmaceutical company dedicated to developing novel therapies for rare and intractable diseases, reported the interim Phase II clinical data for its "first-in-class" Tosposertib (TU2218), a dual inhibitor against TGFβ type I receptor (TGFβRI /ALK5) and VEGFR2. The study evaluated Tosposertib in combination with MSD’s Keytruda (pembrolizumab) as a first-line therapy for patients with recurrent/metastatic(r/m) head and neck squamous cell carcinoma (HNSCC).

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Tosposertib (TU2218) is a highly potent, oral dual inhibitor designed to block the signaling pathways of transforming growth factor-beta (TGF-β) and vascular endothelial growth factor (VEGF), two critical mediators of tumor growth and metastasis. This novel drug candidate was discovered and developed by Tiumbio to enhance the therapeutic efficacy of immune-oncology agents such as Keytruda.

Hun-Taek Kim, Ph.D., CEO of Tiumbio, stated "The data presented at SITC (Free SITC Whitepaper) mark an important milestone, demonstrating that the strong antitumor activity continues to be sustained with accumulating clinical data and ongoing follow-up." He added, "The combination of Tosposertib (TU2218) and Keytruda has shown meaningful potential and value as an immuno-oncology therapy capable of overcoming the limitations of existing immunotherapies or immunotherapy/chemotherapy combinations in recurrent or metastatic head and neck cancer."

The company plans to actively advance patient enrollment for the Tosposertib combination therapy and expand its global clinical trial sites to accelerate the studies required for regulatory approval. Through these efforts, the company aims to provide patients with recurrent or metastatic head and neck cancer earlier access to treatment and, in collaboration with global partners, continue to pursue combination trials and broader indication expansion.

Tosposertib (TU2218: TGF-β/VEGF dual inhibitor): Solid Tumors

Poster title: Phase 2 trial of TU2218, TGFβ-RI and VEGF-R2 dual inhibitor in combination with Pembrolizumab in patients with head and neck squamous cell carcinoma (HNSCC)

Observations in the poster presentation include:

As of July 31, 2025 data cutoff date, 27 patients (pts) were enrolled
The efficacy-evaluable population consisted of 17 patients who had received prior treatments such as surgery, chemotherapy, or radiotherapy.
Response rates overall (N=17): 70.6%, including 9 confirmed partial responses (PRs) and 3 unconfirmed PRs by Response Evaluation Criteria in Solid Tumors (RECIST) v1.1. per investigator assessment, including
1L : Response rates overall (N=11) : 72.7% (8/11), including 6 confirmed partial responses (PRs) and 2 unconfirmed PRs
2L+ : Response rates overall (N=6) : 66.7% (4/6), including 3 confirmed partial response (PRs) and 1 unconfirmed PRs
Responses observed across PD-L1 levels (CPS 1-19: 66.7% [8/12]; CPS≥20: 80% [4/5])
At the time of data cutoff, 17 patients of the 27 enrolled, remained on treatment.
Median follow up of 2.6 months for the 27 patients
In 27 patients the combination was well tolerated and no significant overlapping toxicities with pembrolizumab were observed.
Treatment-emergent adverse events (TEAEs) were reported in 26 pts
Most were Grade (G) 1 or 2 in severity (no G5 were observed)
G≥3 TEAEs occurred in 11 patients (40.7%)
Most common adverse events included rash and mucositis.
No cases of major bleeding or cardiovascular toxicities-safety concerns typically associated with VEGF or TGF-β inhibition- were observed

(Press release, TiumBio, NOV 10, 2025, View Source [SID1234659743])

On November 10, 2025 Servier reported that it will present new and updated data from its neuro-oncology program at the 30th Annual Meeting of the Society for Neuro-Oncology (SNO) on November 19 – 23 in Honolulu, Hawaii. Presentations will demonstrate progress across Servier’s neuro-oncology portfolio, highlighting clinical and real-world evidence in isocitrate dehydrogenase (IDH) mutant glioma.

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Notably, Servier will present an analysis from the Phase 3 INDIGO trial comparing volumetric (3D) and traditional bidirectional (2D) assessment in patients with Grade 2 IDH-mutant glioma receiving VORANIGO or placebo in an oral presentation on November 22. The findings show that 3D assessments may provide a more clinically meaningful determination of progression in Grade 2 glioma trials, potentially impacting future trial design and endpoint selection.

In addition, Servier will also share results from the Phase 1b part of an ongoing Phase 1b/2 study evaluating VORANIGO in combination with temozolomide in patients with newly diagnosed Grade 4 IDH mutant astrocytoma on November 22. These data represent the first published data evaluating the safety of combining an IDH inhibitor with current standard of care chemotherapy in higher grade IDH mutant gliomas.

"As a pioneer in targeted therapies for brain tumors, Servier – working with the neuro-oncology community – is using our unmatched clinical trial datasets to better understand how these medicines affect tumor growth," said Islam Hassan, Global Head of Development-Neuro-Oncology & Senior Director, LS/LCM at Servier. "The critical insights presented at SNO will enable efficient clinical trial designs across all IDH-mutant glioma grades, including in combination with temozolomide in higher grade settings, to help us deliver potential new treatment options faster to patients who are eagerly awaiting them, all while upholding the highest level of evidence."

(Press release, Servier, NOV 10, 2025, View Source [SID1234659742])