EP-201 / EpiThany, University of Washington, Aston Sci. - LARVOL DELTA

Aston Science-SaudiVax, Ovarian Cancer Treatment Vaccine Technology Export and Joint Clinical Term Sheet Signed [Google translation] (BioTimes) - "Aston Science Co., Ltd...announced on the 3rd that it has signed a term sheet with Saudi Arabian biopharmaceutical company SaudiVax (hereinafter 'Svax') for technology export and joint clinical development of AST-201, an ovarian cancer treatment vaccine. As part of this joint clinical development, Aston Science will provide the Phase 2 clinical trial IND package (clinical trial plan) approved by the U.S. Food and Drug Administration (FDA) and the AST-201 drug product, while Svax will bear the costs required to conduct the Phase 2 clinical study....They plan to include the Saudi region in the global phase 2 clinical program (CornerStone-004 study) of AST-201, and pursue product approval and commercialization, etc. based on the clinical results."

Commercial • Ovarian Cancer

AST-201 (pUMVC3-hIGFBP2 N-terminus) demonstrates anti-tumor effect in an ovarian cancer mouse model (AACR 2024) - P1, P2 | "A study demonstrated that AST-201 (IGFBP2 cancer vaccine) showed an anti-tumor effect as mono treatment and would be potentially leading to a synergistic effect with a combination regimen of pembrolizumab. Phase 2 randomized-controlled study of AST-201 in ovarian cancer will be initiated under the MRCT strategy (CornerStone-004 study, NCT05794659)."

Preclinical • Oncology • Ovarian Cancer • Solid Tumor • CD4 • CD8 • IGFBP2

Aptamer Sciences Inc. Files IND Application for Innovative Liver Cancer Treatment AST-201: A Promising Approach to Address Under Medical Needs (PRNewswire) - "Aptamer Sciences...announced the filing of an Investigational New Drug (IND) application for the phase 1 clinical trial of AST-201 with the Korean Ministry of Food and Drug Safety on March 12th, 2024....The planned phase 1 trial seeks to evaluate the safety, pharmacokinetic profile, and preliminary efficacy of AST-201 in patients with GPC3-positive advanced solid tumors....The trial will be conducted across four hospitals, including CHA Bundang Medical Center, Samsung Medical Center, Severance Hospital, and the National Cancer Center in South Korea."

New P1 trial • Hepatocellular Cancer

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) - "Additionally, Aston Science presented at this academic conference: immunogenicity preclinical results of AST-11X, a vaccine using KRAS non-mutated class II epitope; AST-301 (HER2 vaccine, clinical trial in gastric cancer) Preclinical results of antitumor effect for combination therapy with HER2 ADC (Phase 2 drug); Preclinical results for antitumor effect for combination therapy with AST-201 (IGFBP2 vaccine, phase 2 clinical drug) and Keytruda in ovarian cancer; Advanced solid cancer A total of six preclinical results, including the preclinical results of AST-05X, a targeted treatment targeting ISR (integrated stress response) inhibition, are scheduled to be disclosed through poster presentations."

Preclinical • Gastric Cancer • Gastrointestinal Cancer • Gynecologic Cancers • Oncology • Ovarian Cancer • Solid Tumor

AST-201 (pUMVC3-hIGFBP2 N-terminus) demonstrates anti-tumor effect in an ovarian cancer mouse model (SITC 2023) - P1, P2 | "Conclusions A study demonstrated that AST-201 (IGFBP2 cancer vaccine) showed an anti-tumor effect as mono treatment and would be potentially leading to a synergistic effect with a combination regimen of pembrolizumab. Phase 2 randomized-controlled study of AST-201 in ovarian cancer will be initiated under the MRCT strategy (CornerStone-004 study, NCT05794659)."

Preclinical • Oncology • Ovarian Cancer • Solid Tumor • CD4 • CD8 • IGFBP2

US FDA Approves Aston Sci.'s Phase 2 IND for Ovarian Cancer Vaccine, AST-201 (PRNewswire) - "Aston Sci. is proud to announce that it has received Phase 2 Clinical Investigational New Drug (IND) approval from the U.S. Food and Drug Administration (FDA) for its innovative cancer vaccine, AST-201, designed specifically for ovarian cancer. This milestone achievement, known as the CornerStone-004 program, marks a significant step forward in Aston Sci.'s fight against women's cancers."

IND • New P2 trial • Gynecologic Cancers • Oncology • Ovarian Cancer • Solid Tumor

Cornerstone4: Adjuvant Therapeutic Cancer Vaccine (AST-201, pUMVC3-hIGFBP-2) in Patients With Advanced Ovarian Cancer (clinicaltrials.gov) - P2 | N=98 | Not yet recruiting | Sponsor: Aston Sci. Inc. | Trial completion date: Aug 2027 ➔ Nov 2027 | Initiation date: Aug 2023 ➔ Nov 2023

Trial completion date • Trial initiation date • Oncology • Ovarian Cancer • Solid Tumor • IFNG

Cornerstone4: Adjuvant Therapeutic Cancer Vaccine (AST-201, pUMVC3-hIGFBP-2) in Patients With Advanced Ovarian Cancer (clinicaltrials.gov) - P2 | N=98 | Not yet recruiting | Sponsor: Aston Sci. Inc.

Metastases • New P2 trial • Oncology • Ovarian Cancer • Solid Tumor • IFNG

Primary Hepatic Amyloidosis as a Mimic of the Rapid Development of Decompensated Cirrhosis (ACG 2022) - "Bright blue collagen deposition is minimal. D. Congo red stain 10X (2022): Apple-green birefringence under polarized light within sinusoids and portal tracts."

Acute Kidney Injury • Amyloidosis • Cardiomyopathy • Cardiovascular • Fibrosis • Gastroenterology • Hepatitis C • Hepatology • Hypertension • Immunology • Infectious Disease • Inflammation • Liver Failure • Nephrology • Portal Hypertension • Renal Disease

A case of PL-7 positive amyopathic dermatomyositis associated with autoimmune liver disease (BSR 2022) - "A diagnosis of PL-7 positive ADM with associated AILD was made. The patient’s ADM and AILD were successfully treated with a reducing course of budesonide (6mg three times daily for 4 months reduced to 3mg twice daily for four months then 3mg daily for 3 months) and mycophenolate mofetil 720mg twice daily... Anti-PL-7 is one of a number of anti-aminoacyl tRNA synthetase (ARS) antibodies that are associated with DM, polymyositis (PM) and ADM. Other anti-ARS antibodies include Jo-1, PL-12, EJ, OJ, KS, ZO and YRS/HA. Antibodies to PL-7 have been reported to be associated with milder muscle involvement than antibodies to Jo-1."

Clinical • Dermatomyositis • Hepatitis B • Hepatology • Immunology • Infectious Disease • Interstitial Lung Disease • Myositis • Oncology • Pulmonary Disease • Respiratory Diseases • Rheumatology • AFP • MUC16

[VIRTUAL] EPO201 Ageing and dementia 2 (EAN 2021) - No abstract available

Alzheimer's Disease • CNS Disorders • Dementia

[VIRTUAL] EPR201 Ageing and dementia 4 (EAN 2021) - No abstract available

Alzheimer's Disease • CNS Disorders • Dementia

[VIRTUAL] EPO201: Ageing and dementia 2 (EAN 2020) - No abstract available

Alzheimer's Disease • CNS Disorders • Dementia

Newly added product (EpiThany Inc Press Release) - P2, Ovarian Cancer

Pipeline update • Gynecologic Cancers • Oncology • Ovarian Cancer • Solid Tumor

[VIRTUAL] EPR201: Ageing and dementia 2 (EAN 2020) - No abstract available

[VIRTUAL] EPO201 - Ageing and dementia 2 (EAN 2020) - No abstract available

HEP201-PANASH is an interventional study of increasing doses of HepaStem for the treatment of patients with cirrhotic and pre-cirrhotic NASH. The population will be divided in 4 cohorts and a total of 2 doses are planned to be administered as single or repeated infusions in an ascending manner. The safety and tolerability of HepaStem in the treatment of NASHwill be first evaluated as well as... (clinicaltrialsregister.eu) - P2; N=24; Ongoing; Sponsor: Promethera Biosciences

Clinical • New P2 trial