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Leucid Bio Provides Update on Phase I/IIa AERIAL Trial Evaluating Lateral CAR-T LEU011 for the Treatment of Solid Tumours

On November 10, 2025 Leucid Bio ("Leucid" or the "Company"), a privately-held biotechnology company developing innovative Chimeric Antigen Receptor T-cell (CAR-T) therapies using its proprietary lateral CAR platform, reported an update on the Phase I/IIa AERIAL trial evaluating the safety and clinical activity of LEU011 in patients with relapsed/refractory solid tumours.

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Preliminary data from the ongoing AERIAL trial have established proof-of-concept for LEU011 by demonstrating key biological activity through evidence of encouraging pharmacokinetic (PK) and pharmacodynamic (PD) profiles. In particular, analysis of post-treatment biopsies (as evaluated by ddPCR and RNAScope) has shown tumour infiltration by LEU011 cells.

To date, treatment with LEU011 has been generally well tolerated. In addition, disease control (based on RECIST criteria) has been observed in multiple patients treated with the lowest dose of LEU011. Dose-escalation in the AERIAL trial continues as planned, with additional data from the trial anticipated during the first half of 2026.

Filippo Petti, Chief Executive Officer, Leucid Bio , said: "Although preliminary, we are highly encouraged by these initial data from the AERIAL trial which establish proof-of-concept for LEU011 in the treatment of solid tumours. Furthermore, they highlight LEU011’s dual mechanism of action targeting NKG2D stress ligands for tumour recognition and using CXCR2 signalling to enhance T-cell infiltration into the tumour microenvironment."

Dr. John Maher, Chief Scientific Officer, Leucid Bio, added: "Traditionally, CAR-Ts have struggled to deliver robust clinical responses in the treatment of solid tumours. We believe these preliminary data highlight the functional activity of LEU011 in the treatment of solid tumours given its unique mechanism of action. We anticipate that the early signals observed to date for LEU011 will continue to improve as we advance through the dose-escalation segment of the AERIAL trial."

AERIAL is a multi-centre, dose-escalation trial designed to evaluate the safety and clinical activity of LEU011 in patients with relapsed/refractory solid tumours, following a single intravenous dose of LEU011 after preconditioning chemotherapy. Additional information on the AERIAL trial can be found on ClinicalTrials.gov under the identifier NCT06193902.

Details of the ongoing AERIAL trial were presented at the Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper) Annual Meeting 2025.

Poster Title: A First-in-human Phase I/IIa dose escalation trial evaluating the safety and preliminary efficacy of LEU011, a novel CAR-T, in subjects with relapsed/refractory solid tumors (AERIAL)
Author / Presenter: R. Kristeleit
Session: Clinical Trials In Progress
Date: Saturday, November 8, 2025
Abstract Number: 578

About LEU011
LEU011 is a lateral CAR-T cell therapy targeting NKG2D stress ligands, which are overexpressed on more than 80% of human tumour cells and the cells within the surrounding tumour microenvironment. In addition to its novel architecture, LEU011 also co-expresses the chemokine receptor CXCR2 which is engineered to enhance cell trafficking and tumour infiltration, providing an extra mechanism to overcome significant limitations of CAR-T therapies currently in development for the treatment of relapsed/refractory solid tumours.

(Press release, Leucid Bio, NOV 10, 2025, View Source [SID1234659747])

Akeso Announces First Patient Dosed in Phase I Trial of Personalized mRNA Vaccine AK154 as Monotherapy or in Combination with Cadonilimab or Ivonescimab for Adjuvant Treatment of Pancreatic Cancer

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.

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])

Vascarta and CUNY Report Preclinical Breakthrough in Glioblastoma Treatment

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.

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])

Verismo Therapeutics Presents Promising Preclinical Data at SITC 2025 for SynKIR™-110 in Solid Tumors

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.

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])

Tiumbio to Present First Clinical Data for Dual TGF-β/VEGF Inhibitor Tosposertib (TU2218) at SITC 2025, "Robust Response Rate"

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).

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])