On October 19, 2025 Vivace Therapeutics, Inc., a small molecule discovery and development company developing first-in-class cancer therapies targeting the Hippo pathway, reported new data from the company’s ongoing Phase 1/2 clinical trial of its first-in-class transcriptional enhanced associate domain (TEAD) autopalmitoylation inhibitor, VT3989. Findings demonstrated notable antitumor activity for VT3989 in refractory mesothelioma patients, along with a manageable safety and tolerability profile. Based on these positive study results, Vivace plans to advance VT3989 into a registrational Phase 3 trial in mesothelioma in the first half of 2026. The findings were the focus of an oral presentation at the European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper) Congress 2025, as well as a peer-reviewed paper in Nature Medicine that was published concurrently with the ESMO (Free ESMO Whitepaper) presentation.

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The presentation highlighted a cohort of 22 refractory mesothelioma patients treated with the optimized Phase 3 dose and schedule for VT3989. Key findings for VT3989 in this population include:

Objective Response Rate (ORR) of 32% (7 of 22 patients achieved a partial response).

Disease Control Rate (DCR) of 86% (19 of 22 patients achieved a partial response or stable disease).

Median Progression-Free Survival (PFS) of 40 weeks, which is more than double the 15-week benchmark for standard-of-care salvage chemotherapy.
Study results showed VT3989 treatment to be safe and well tolerated with no dose-limiting toxicities in 172 patients across dose escalation and dose expansion cohorts. The majority of reported adverse events (AEs) were categorized as mild or moderate in severity and the discontinuation rate due to AEs was low (3.5%). The most commonly reported treatment-related AEs were low grade fatigue, proteinuria (a reversible increase of protein in the urine), and swelling in the extremities. The total number of patients experiencing Grade 3/4 treatment-related AEs was low at 15 (8.7%).

"These findings make a compelling case for the therapeutic potential of VT3989 in the treatment of mesothelioma, a cancer that presents significant treatment challenges and for which there are few therapeutic options beyond first‑line therapies" said Timothy A. Yap, M.B.B.S.., Ph.D., Head of Clinical Development in the Therapeutics Discovery Division at the University of Texas MD Anderson Cancer Center and lead clinical investigator for the study. "We are encouraged by the clinically meaningful disease control that was achieved with VT3989, especially in these heavily pretreated patients. We believe that the strength of these efficacy findings, combined with the encouraging safety profile demonstrated in the study, support the advancement of VT3989 into a registrational clinical trial for mesothelioma."

The ongoing Phase 1/2 study (View Source) is a multi-center, open label trial designed to evaluate the safety, tolerability, pharmacokinetics (PK) and biological activity of VT3989 in patients with refractory metastatic solid tumors, including refractory mesothelioma. The mesothelioma patients treated with the optimized Phase 3 dose represented a heavily pre-treated patient population, with all having received immunotherapy and 82% having received chemotherapy.

"It is gratifying to share these positive study data, particularly considering how much hard work our team has undertaken in not only developing a first-in-class therapy against a novel target, but doing so in a notoriously hard-to-treat cancer," said Neelesh Sharma, M.D., Ph.D., chief medical officer of Vivace. "Demonstrating such a clear and substantial benefit compared to salvage chemotherapy benchmarks gives us great confidence as we prepare to advance VT3989 into a Phase 3 program. We are committed to bringing this first-in-class therapy to patients who are in desperate need of new treatment options."

VT3989 was recently awarded Orphan Drug Designation and Fast Track Designation by the United States Food and Drug Administration for the treatment of mesothelioma. The Fast Track Designation specifically applies to the treatment of patients with unresectable malignant non-pleural or pleural mesothelioma whose disease has progressed on prior immune checkpoint inhibitor therapy and platinum-based chemotherapy.

The ESMO (Free ESMO Whitepaper) presentation will be available on Vivace’s website at www.vivacetherapeutics.com following the conference. The Nature Medicine paper can be accessed on the publication’s website at www.nature.com/nm/.

(Press release, Vivace Therapeutics, OCT 19, 2025, View Source [SID1234656795])

On October 19, 2025 iOncologi, Inc., a biotechnology company developing next-generation RNA-based cancer immunotherapies, reported that the United States Patent and Trademark Office (USPTO) has granted a U.S. patent for a novel method using RNA-based formulations to enhance tumor responsiveness to immune checkpoint inhibitor (ICI) therapy.

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The patent, owned by the University of Florida Research Foundation (UFRF) and exclusively licensed to iOncologi, further consolidates the intellectual-property portfolio supporting the company’s UNIFYRs (UNiversal Immune FortifYing RNAs) platform — an innovative approach that leverages RNA-driven immune reprogramming to restore and amplify checkpoint inhibitor efficacy across multiple solid-tumor types.

"This patent grant highlights the pioneering RNA therapeutics emerging from the University of Florida that have the potential to fundamentally reshape solid tumor treatment," said Dr. Duane Mitchell, co-inventor and co-founder of iOncologi. "By demonstrating that a single RNA backbone can restore responsiveness to immune checkpoint inhibitors across multiple tumor types, we are charting a course toward a universal strategy to overcome immune resistance in cancer and unlock responses in patients who currently do not benefit from immunotherapy."

Scientific Validation in Nature Biomedical Engineering

The newly granted patent builds on discoveries published earlier this year in Nature Biomedical Engineering (Qdaisat, S., et al. Sensitization of tumours to immunotherapy by boosting early type-I interferon responses enables epitope spreading. Nat. Biomed. Eng 9, 1437–1452 [2025]).

The study, led by researchers at the University of Florida, revealed how non–tumor-antigen-specific mRNA formulations can amplify early type-I interferon responses and trigger epitope spreading — a mechanism that reprograms the tumor microenvironment and restores sensitivity to ICIs.

"The findings reported in Nature Biomedical Engineering offer detailed mechanistic insight that underpins the claims in this newly granted patent," said Dr. Elias Sayour, Professor of Neurosurgery and Pediatrics at the University of Florida, co-inventor, and senior author of the study. "By demonstrating that non-antigen-encoding, systemically delivered mRNA-lipid formulations can re-educate both innate and adaptive immunity, we’re establishing the biological basis that underlies iOncologi’s UNIFYRs platform."

(Statements regarding University of Florida research are factual and provided for illustrative and contextual purposes only.)

Clinical Data Presented at ESMO (Free ESMO Whitepaper) 2025

Supporting this mechanistic foundation, new translational data were presented by Dr. Adam Grippin of MD Anderson Cancer Center on Sunday, October 19, 2025 (LBA54) during the European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper) Annual Congress in Berlin.

The presentation, titled "SARS-CoV-2 mRNA vaccines sensitize tumors to immune checkpoint blockade," reported that mRNA-based immune activation, achieved through SARS-CoV-2 mRNA vaccination, correlated with significantly improved overall survival among checkpoint-treated melanoma and non–small cell lung cancer (NSCLC) patients — findings that closely reflect the mechanistic principles first described in Nature Biomedical Engineering and have been independently reported in mainstream media, including NBC News, for their potential to enhance immunotherapy response in cancer patients.

(Statements referencing presentations by MD Anderson Cancer Center investigators are factual and provided for illustrative and contextual purposes only.)

"These findings represent a turning point for patients facing immunotherapy resistance," said Edgardo Rodriguez-Lebron, PhD, Chief Executive Officer of iOncologi, Inc. "The implications extend well beyond patient outcomes — RNA-based immune activation could revitalize immune checkpoint inhibitor franchises that have struggled to show benefit in solid tumors. With this foundation in place, iOncologi aims to work with strategic partners to accelerate the path to patients."

Advancing the UNIFYRs Platform

With this newly granted patent, iOncologi further strengthens its leadership in RNA-based immune reprogramming. The UNIFYRs platform is designed to fortify and broaden ICI efficacy across multiple tumor types, representing a new therapeutic modality positioned at the intersection of oncology, RNA technology, and systems immunology.

(Press release, iOncologi, OCT 19, 2025, View Source [SID1234656793])

On October 19, 2025 Akeso (9926.HK) reported the final analysis results from the COMPASSION-15/AK104-302 study at the 2025 European Society of Medical Oncology (ESMO) (Free ESMO Whitepaper) Congress (ESMO 2025) . COMPASSION-15 is a Phase III clinical trial evaluating cadonilimab, Akeso’s first-in-class PD-1/CTLA-4 bispecific antibody, in combination with oxaliplatin and capecitabine as first-line treatment for unresectable, locally advanced, recurrent, or metastatic gastric or gastroesophageal junction (G/GEJ) adenocarcinoma. Professor Shen Lin, principal investigator from Peking University Cancer Hospital, presented the findings in an oral session at ESMO (Free ESMO Whitepaper) 2025.

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In this final analysis presented at ESMO (Free ESMO Whitepaper) 2025 (median follow-up: 33.9 months), the cadonilimab regimen demonstrated enhanced long-term survival benefits in first-line advanced G/GEJ adenocarcinoma. With the extended follow-up period and more mature data, the cadonilimab treatment regimen showed a further reduction in the risk of death compared to the control group. This consistent benefit was observed across all PD-L1 expression subgroups.

The interim analysis of COMPASSION-15, with a median follow-up of 18.7 months, was previously published in Nature Medicine in January 2025. The data presented at ESMO (Free ESMO Whitepaper) 2025 were analyzed using the same statistical methodology.

COMPASSION-15 2025 ESMO (Free ESMO Whitepaper) Data

In the intent-to-treat (ITT) population:

With long-term follow-up, the cadonilimab regimen demonstrated a significant 39% reduction in the risk of death (OS HR 0.61) versus the control group, showing further improvement over the data from the median 18.7-month follow-up (OS HR 0.66).
With extended follow-up, in the PD-L1 CPS ≥5 population, the cadonilimab regimen demonstrated a significant 51% reduction in the risk of death (OS HR 0.49; p < 0.001) compared to the control group, showing further improvement over the data from the median 18.7-month follow-up (OS HR 0.58).
With long-term follow-up, in the PD-L1 CPS <5 population, the cadonilimab regimen showed a significant 24% reduction in the risk of death (OS HR 0.76; 95% CI: 0.59-0.99; p = 0.019) versus the control group, with a strengthening trend of benefit compared to the data from the median 18.7-month follow-up (OS HR 0.75; 95% CI: 0.56-1.00).
Following extended the follow-up period, the cadonilimab combination regimen maintained a favorable safety profile, with no new safety signals emerging.
In the COMPASSION-15 study, patients with PD-L1 CPS <5 (low expression) and CPS <1 (negative expression) are 49.8% and 23%, respectively, of the ITT population. This represents a higher proportion of PD-L1 low and negative patient population in COMPASSION-15 compared to previous Phase III trials of other immune checkpoint inhibitors used in the treatment of first-line gastric cancer. Previous studies have shown limited responses to PD-1/L1 inhibitors in PD-L1 low-expression or negative patients.

Cadonilimab was approved by the NMPA in September 2024 for the first-line treatment for advanced gastric cancer, offering a new and effective immunotherapy option. Cadonilimab has been included in the 2025 CSCO Gastric Cancer Guidelines as the only Category I recommendation (Level 1A evidence) for first-line immunotherapy, regardless of PD-L1 expression, and is currently widely used in clinical practice.

(Press release, Akeso Biopharma, OCT 19, 2025, View Source [SID1234656792])

On October 19, 2025 CStone Pharmaceuticals ("CStone," HKEX: 2616), an innovation-driven biopharmaceutical company focused on the research and development of therapies for oncology, autoimmune/inflammation, and other key disease areas, reported the first disclosure of preliminary Phase I data for CS2009 (a PD-1/VEGF/CTLA-4 trispecific antibody) and the Phase Ib study design for CS5001 (a ROR1-targeted Antibody-Drug Conjugate [ADC]) at the 2025 European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper) Annual Congress.

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Key Highlights of CS2009 Poster Presentation:

This also represents the first known clinical data publication of a PD-1/VEGF/CTLA-4 trispecific antibody to date.

CS2009-101 is a multi-regional phase Ⅰ study currently ongoing in Australia and China. The study evaluates the safety, tolerability, pharmacokinetics (PK)/ pharmacodynamics (PD), and antitumor activity of CS2009 in patients with advanced solid tumors.

Patients baseline characteristics:

As of the data cutoff date, 72 patients with advanced solid tumors treated across 6 dose levels (DL1-6, 1-45 mg/kg); 72.2% remain on treatment.
Heavily pretreated population: over 51% received prior immuno-oncology (IO) therapies. Median follow-up: only 1.9 months (range 0.1-6.7 months) at data cutoff.
Favorable safety and tolerability:

Dose escalation completed with no dose-limiting toxicity (DLT) reported; maximum tolerated dose (MTD) not reached.
No Grade 4 or 5 treatment-related adverse event (TRAE) observed. Incidence of Grade ≥3 TRAEs, immune-related AEs (irAEs), and VEGF-related TRAEs was 13.9%, 4.2%, and 2.8%, respectively.
Only 1 treatment-emergent adverse event (TEAE) leading to drug permanent discontinuation observed (at DL4 [20 mg/kg]; 1.4% incidence).
Promising antitumor activity and high disease control rate (DCR):

CS2009 demonstrated encouraging anti-tumor activities across tumor types. As of the cutoff date, the overall follow-up duration remained limited, particularly in higher-dose cohorts where the majority patients had yet to reach the protocol-specified time point of post-baseline tumor assessment:

49/72 patients underwent at least one post-baseline tumor assessment by data cutoff.
Despite limited follow-up duration, anti-tumor activity was observed across all dose levels with dose-dependent uptrend:
Among all 49 evaluable patients, overall response rate (ORR) was 12.2%; DCR was 71.4%. Efficacy data remains immature; with additional follow-up beyond the poster data cutoff, ORR was further improved to 14.3%.
Higher ORR (25.0%) at tentative recommended Phase 2 dose (RP2D, 30 mg/kg) and higher dose.
Promising efficacy signals were observed across multiple tumor types within the short follow-up period:
Non-Small Cell Lung Cancer (NSCLC): ORR: 11.8%, DCR: 82.4%; Post-ESMO update: stable disease (SD)-to-partial response (PR) conversion observed, ORR further elevated to 17.6%; In AGA-negative subgroup, ORR reached 25%;
Ovarian Cancer (OC): ORR: 16.7%, DCR: 66.7%;
Triple-Negative Breast Cancer (TNBC): ORR: 25.0%, DCR: 75.0%;
Non–Clear Cell Renal Cell Carcinoma (nccRCC): ORR: 33.3%, DCR: 100.0%;
Soft Tissue Sarcoma (STS): ORR: 11.1%, DCR: 66.7%.
Favorable PK and PD profiles:

Linear PK with half-life of 6-8 days supported every-three-week (Q3W) dosing, with no significant accumulation observed at cycle 3.
PD profile demonstrated saturated receptor occupancy and robust T-cell activation/proliferation confirming PD-1/CTLA-4 blockade and deep and sustained VEGFA neutralization.
Receptor occupancy of PD-1/CTLA-4 on peripheral T cells reached saturation throughout dosing interval at doses ≥20 mg/kg.
On cycle 1 day 8, CS2009 induced notable, dose-dependent upregulation of Ki67 (proliferation due to PD-1 and CTLA-4 blockade) and ICOS (activation due to CTLA-4 blockade) expression on both CD4+ and CD8+ T cells, collectively demonstrating effective PD-1 and CTLA-4 inhibition.
Serum-free VEGFA reduced deeply and rapidly across all dose levels, and the effect sustained throughout dose intervals.
CStone has initiated Phase Ⅱ dose expansion study in first-line patients with selected tum or types for dose optimization and to generate data supporting registration trials in first-line NSCLC and other tumors as monotherapy or in combination therapies.

CS2009 Data Review Conference Call:

CStone will host an investor meeting to discuss presented data and future clinical development plan. The Company cordially invites all investors to attend this conference call.

Chinese-language session:

Date & Time: Monday, October 20, 2025, at 2:00 p.m. (Beijing Time)/2:00 a.m. (US Eastern Time)
Registration Link: Registration is required, please sign up via the link: View Source
English-language session:

Date & Time: Monday, October 20, 2025, at 9:00 p.m. (Beijing Time)/9:00 a.m. (US Eastern Time)
Registration Link: The Zoom meeting link will be sent to you by email after registration via the below link. You may join the meeting by clicking the link in email: View Source
Key Highlights of CS5001 ePoster Presentation:

CS5001 phase Ib study aims to determine the RP2D and further evaluate the safety, tolerability, PK, and efficacy of CS5001 as a monotherapy and in combination with systemic therapies in selected tumor types.
In monotherapy cohorts, Cohorts A-D enroll patients with chronic lymphocytic leukemia and other B-cell lymphomas, and Cohort I enrolls patients with ROR1-positive solid tumors. In combination therapy cohorts (E-H), CS5001 will be administered with standard systemic therapies (R-GemOx, R2 or R-CHOP) or with sugemalimab (an anti-PD-L1 monoclonal antibody).
Patient enrollment for CS5001 Phase Ib study commenced in December 2024 and is currently advancing smoothly at 30 sites across Australia, the United States, and China.

(Press release, CStone Pharmaceauticals, OCT 19, 2025, View Source [SID1234656791])

On October 19, 2025 CARsgen Therapeutics Holdings Limited (Stock Code: 2171.HK), a company focused on developing innovative CAR T-cell therapies, reported that the research results of the Phase Ib registrational clinical trial of satricabtagene autoleucel ("satri-cel", CT041) (an autologous CAR T-cell product candidate against protein Claudin18.2) for pancreatic cancer (PC) adjuvant therapy in China (CT041-ST-05, NCT05911217) has been presented in poster session at European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper) Congress 2025. The poster was titled "Adjuvant Therapy with Claudin18.2-specific CAR T Cells (Satri-cel) in High-Risk Pancreatic Cancer (CT041-ST-05)" (Poster number: 2220P). The trial represents the world’s first proof-of-concept (POC) study exploring CAR T-cell therapy for the adjuvant treatment of solid tumors. Professor Xianjun Yu from Fudan University Shanghai Cancer Center serves as the principal investigator.

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Pancreatic ductal adenocarcinoma (PDAC) is characterized by a dismal prognosis even among patients who undergo surgical resection. Local recurrence and distant metastasis are common, often leading to treatment failure. Elevated carbohydrate antigen 19-9 (CA19-9) levels post resection indicate aggressive tumor biology and higher risk of recurrence. The median interval is approximately 3 months between CA19-9 elevation and radiological recurrence. [1][2] Current standard adjuvant therapies have limited effectiveness for high-risk patients, highlighting the urgent need for novel strategies.

This trial enrolled patients with Claudin18.2 positive PDAC who have undergone curative-intent resection, with abnormal CA19-9 after 3 months adjuvant chemotherapy and no evidence of recurrence. From Sep 15, 2023 to April 11, 2025 (data cut-off date), six patients received satri-cel infusion and completed at least 4 weeks of follow-up.

With a median follow-up of 6.05 months from infusion, only one patient experienced disease recurrence, while others are still under disease free. The median disease-free survival (DFS) and median overall survival (OS) were not reached (NR). The 9-month DFS rate from surgery was 83.3%. Notably, one patient who has completed 52-week follow-up post infusion is still under follow-up without disease recurrence. Moreover, significant decline in CA19-9 levels post infusion was observed in five (83.3%) patients, with reductions ranging from 51.3% to 96.1%.

All patients developed Grade 1 or 2 cytokine release syndrome (CRS) after the first satri-cel infusion. For the second infusion administered in one patient, grade 3 CRS accompanied by hypotension was observed, which was resolved within three days following tocilizumab treatment. All patients experienced gastrointestinal disorders, such as nausea and vomiting, which were all Grade 1 or 2. Only one case of Grade 3 gastritis occurred. No immune effector cell-associated neurotoxicity syndrome (ICANS) was reported.

Dr. Zonghai Li, Founder, Chairman of the Board, Chief Executive Officer, and Chief Scientific Officer of CARsgen Therapeutics, said, "We are pleased to see that satri-cel has shown promising preliminary efficacy with a manageable safety profile in the highly challenging setting of pancreatic cancer adjuvant therapy. For patients at high risk of recurrence after surgical resection of pancreatic cancer, there are currently very few effective treatment options. In this trial, the sustained disease-free survival and marked declines in CA19-9 levels suggest that satri-cel, an innovative cellular immunotherapy, may clear minimal residual disease and potentially alter the disease course for these patients. Furthermore, we are actively advancing clinical trials exploring satri-cel for gastric cancer adjuvant therapy and as a sequential treatment following first-line gastric cancer therapy, with the goal of providing better curative opportunities for a broader patient population."

About Satri-cel
Satri-cel is an autologous CAR T-cell product candidate against the protein Claudin18.2 that has the potential to be the first-in-class globally. Satri-cel targets the treatment of Claudin18.2-positive solid tumors with a primary focus on gastric/gastroesophageal junction adenocarcinoma (G/GEJA) and pancreatic cancer (PC). Initiated trials include investigator-initiated trials (CT041-CG4006, NCT03874897), a confirmatory Phase II clinical trial for advanced G/GEJA in China (CT041-ST-01, NCT04581473), a Phase Ib registrational trial for PC adjuvant therapy in China (CT041-ST-05, NCT05911217), an investigator-initiated trial for satri-cel be used as consolidation treatment following adjuvant therapy in patients with resected G/GEJA (CT041-CG4010, NCT06857786), an investigator-initiated trial for satri-cel as a sequential therapy following first-line treatment in patients with advanced G/GEJA (CT041-CG4011, NCT07179484), and a Phase 1b/2 clinical trial for advanced gastric or pancreatic adenocarcinoma in North America (CT041-ST-02, NCT04404595).

The Center for Drug Evaluation (CDE) of National Medical Products Administration (NMPA) of China has accepted the New Drug Application (NDA) for satri-cel for the treatment of Claudin18.2-positive advanced G/GEJA in patients who have failed at least two prior lines of therapy on June 25, 2025. It has been granted Priority Review in May 2025 and Breakthrough Therapy Designation in March 2025 by the CDE. Satri-cel was granted Regenerative Medicine Advanced Therapy designation by U.S. FDA for the treatment of advanced G/GEJA with Claudin18.2-positive tumors in January 2022. Satri-cel received Orphan Drug designation from the U.S. FDA for the treatment of G/GEJA in September 2020.

(Press release, Carsgen Therapeutics, OCT 19, 2025, View Source [SID1234656790])