AST-021p / Aston Sci. - LARVOL DELTA

Long-term clinical outcomes of AST-021p, an HSP90 peptide vaccine, in advanced solid tumors: Follow-up results of the phase I CornerStone-002 trial (ESMO Asia 2025) - P1 | "AST-021p demonstrated favorable safety, tolerability, and immunogenicity in advanced solid tumors. The 3.6 mg dose was selected as the recommended phase 2 dose based on safety and immune durability. These results support further phase 2 evaluation of biomarker-enriched populations to confirm efficacy."

Clinical • Clinical data • IO biomarker • Metastases • P1 data • Oncology • Solid Tumor • CD4 • CD8 • CDC37 • HSP90AA1 • IFNG

Aston Science, “Cancer vaccine increases survival time for cancer patients with no cure” [Google translation] (Hankyung) - P1 | N=19 | NCT04864418 | Sponsor: Aston Sci. Inc. | "The latest clinical results from Aston Science, a cancer treatment vaccine development company, were revealed at the American Association for Cancer Research's annual conference (AACR 2024)....AST-021p is a cancer treatment vaccine indicated for recurrent or progressive solid cancer. Induces an immune response of type 1 helper T cells (Th1), which increases immune activity. In clinical trials conducted with a total of four doses, the drug's tolerability, safety, and optimal dose were confirmed. An Aston Science official said in particular, 'We were able to confirm long-term survival in patients with certain types of cancer, even though these patients no longer have standard treatments available.' Aston Science plans to conduct a phase 2 clinical trial targeting two cancer types whose efficacy was confirmed in the results of this study."

P1 data • Oncology • Solid Tumor

Phase 1 clinical trial evaluating the safety, tolerability, and immunogenicity of AST-021p, a novel cancer vaccine targeting HSP90-derived epitopes in advanced solid tumor patients (CornerStone-002) (AACR 2024) - "This study, as the first-in-human (FIH) administration of the AST-021p, demonstrated safety and tolerability across all four dose groups. Plus, optimal immunogenic dose (OID) and recommended phase 2 dose (RP2D) were confirmed based on AST-021p-specific immunogenicity and safety."

Clinical • Metastases • P1 data • Oncology • Solid Tumor • CDC37 • HSP90AA1 • IFNG

Aston Science attends the American Association for Cancer Research… Announcement of results from a total of 6 studies, including cancer treatment vaccine [Google translation] (MedigateNews) - "Aston Science announced on the 11th that it will present research results on a total of five cancer treatment vaccines and one cancer targeted treatment at the American Association for Cancer Research (AACR 2024) annual conference held in San Diego, USA from April 5th to 10th...The most notable announcement is the results of a phase 1 study of AST-021p, a cancer treatment vaccine being developed for advanced solid cancer. The safety and immunogenicity of AST-021p were confirmed through the first phase 1 administration to humans, and based on this, phase 2 clinical trials are currently being prepared...AST-07X, which targets the TROP2 antigen of cancer cells, induces a Th1 anti-cancer immune response and showed superior anti-tumor efficacy compared to TROP2 ADC in a mouse model with triple-negative breast cancer (TNBC) tumors....the results confirmed that a stronger synergy effect occurred when administered in combination with TROP2 ADC..."

P1 data • Preclinical • Breast Cancer • Oncology • Solid Tumor • Triple Negative Breast Cancer

AST-021p Study in Advanced Solid Tumors (clinicaltrials.gov) - P1 | N=19 | Active, not recruiting | Sponsor: Aston Sci. Inc. | Recruiting ➔ Active, not recruiting | Trial completion date: Jul 2023 ➔ Nov 2023 | Trial primary completion date: Mar 2023 ➔ Aug 2023

Enrollment closed • Trial completion date • Trial primary completion date • Oncology • Solid Tumor • IFNG

Aston Science announces preclinical results of two cancer treatment vaccines at AACR in the US [Google translation] (HIT News) - "Aston Science...announced on the 20th that it announced the results of preclinical studies of two cancer treatment vaccines at the American Association for Cancer Research (AACR 2023) held in Orlando, USA from the 14th to the 19th...On the last day, the 19th, the company announced the research results of 'AST-021p', a peptide-based cancer vaccine using a part of the HSP90 antigen as an epitope. This is the result of a non-clinical study aimed at confirming the effect of AST-021p and TLR-agonist immune enhancer combination therapy in a breast cancer mouse model. The tumor growth inhibitory effect and immunogenicity that occurred when used in combination with several immunostimulants were compared and confirmed."

Preclinical • Breast Cancer • Oncology • Solid Tumor

The anti-tumor activity of HSP-90 therapeutic cancer vaccine (AST-021p) combine with TLR2/3 agonist in a MMTV-neu transgenic model (AACR 2023) - "Combination regimen of AST-021p and TLR-2/3 agonist (as immune adjuvant) demonstrated significant immunogenicity and tumor prevention effect in in-vivo study. These data supported the clinical study of AST-021p combined with TLR-2/3 agonist as active immune adjuvant in certain tumor types, and phase 1/2 clinical program would be expected to be initiated."

Breast Cancer • Oncology • Solid Tumor • CD4 • HSP90AA1 • IFNG • TLR2 • TLR4 • TLR7

Aston Science announces preclinical trial of cancer vaccine and Keytruda combination at AACR (Hankyung) - "Aston Science announced on the 9th that it will present the results of a preclinical study on the combination of 'AST-301', a HER2-ICD cancer vaccine, and Keytruda at the American Association for Cancer Research (AACR) to be held on the 14th of next month....At this AACR, Aston Science will also present the results of a preclinical study of 'AST-021p', a cancer vaccine using a peptide-based HSP90 antigenic determinant (epitope). This vaccine is currently undergoing phase 1 (CornerStone-002) for patients with solid cancer. The final results of the second half of the year are about to be announced."

P1 data • Preclinical • Gastric Cancer • Gastrointestinal Cancer • Oncology • Solid Tumor

AST-021p Study in Advanced Solid Tumors (clinicaltrials.gov) - P1 | N=19 | Recruiting | Sponsor: Aston Sci. Inc. | Trial completion date: Feb 2023 ➔ Jul 2023 | Trial primary completion date: Oct 2022 ➔ Mar 2023

Trial completion date • Trial primary completion date • Oncology • Solid Tumor • IFNG

The anti-tumor activity of HSP-90 therapeutic cancer vaccine (AST-021p) combine with TLR2/3 agonist in a MMTV-neu transgenic model (SITC 2021) - "These data supported the clinical study of AST-021p combined with TLR-2/3 agonist as active immune adjuvant in certain tumor types, and phase 1/2 clinical program would be expected to be initiated. Trial Registration Not applicable"

Breast Cancer • Oncology • Solid Tumor • CD4 • HSP90AA1 • IFNG • TLR4 • TLR7