2023-09-12

US FDA Approves Aston Sci.’s Phase 2 IND for Ovarian Cancer Vaccine, AST-201

- A New Vaccine Approach for Ovarian Cancer PatientsSeoul, South Korea, Sept. 12, 2023 – 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.Study Highlights and the Primary Objective:The study is a randomized controlled trial designed to assess the clinical efficacy and safety of the plasmid-based DNA vaccine AST-201 when administered alongside standard adjuvant chemotherapy (Paclitaxel/Carboplatin), for patients with newly diagnosed Stage III advanced ovarian cancer following surgical intervention. The primary objective of this study is to evaluate the clinical efficacy of AST-201 compared to a placebo, as measured by the progression-free survival (PFS) rate.Aston Sci.’s Pipeline Expansion:With this milestone, Aston Sci.’s pipeline has expanded to include two drug candidates in multinational Phase 2 clinical trials: AST-201 for ovarian cancer and AST-301 for breast and gastric cancer. This milestone underscores Aston Sci.’s position as a frontrunner in the field, with a total of four drugs in advanced clinical stages. Aston Sci. is currently conducting or planning four CornerStone clinical programs in the United States, Taiwan, Korea and Europe.A New Vaccine Approach for Ovarian Cancer Patients:"In a global environment where approved immunotherapies for ovarian cancer remain scarce, our dedicated efforts are focused on delivering a safer and more advanced treatment option for ovarian cancer patients. We are committed to sharing our results at the earliest opportunity," said Dr. Hun Jung, Head of R&D Division at Aston Sci. Inc. "We will expand clinical research across various indications and reaffirm our expertise in the field of cancer vaccine development."About Aston Sci. Inc.Aston Sci. Inc. is a clinical-stage biopharmaceutical company led by a team of global pharmaceutical experts. Specializing in innovative immunotherapies, including therapeutic cancer vaccines, Aston Sci. focuses on enhancing T-cell immune responses against specific antigens, triggering cancer cell apoptosis. Central to our mission is the Th-Vac® platform. This platform, grounded in immune informatics, facilitates continuous epitope discovery, serving as the cornerstone of our ongoing efforts in therapeutic vaccine development.Headquartered in Seoul, South Korea, with a U.S. office in Seattle, Washington, Aston Sci. is deeply committed to delivering advanced treatments and preventing cancer recurrence, ultimately striving for safer and more effective options for cancer patients worldwide.

2023-05-15

Phase 2 IND Approval Granted to Aston Sci. for AST-301, Targeting HER2-Expressed Gastric Cancer Patients in Taiwan

Aston Sci. has secured approval from the TFDA (in Taiwan) for its investigational new drug (IND) application to commence a Phase 2 trial of AST-301.   Named "CornerStone-003," this study is an early proof-of-concept study targeting patients with HER2-expressed gastric cancer who have completed standard adjuvant treatment. It is a randomized-control clinical trial designed to evaluate safety and immunologic efficacy of AST-301. Participants in the study will receive a total of three or six doses of AST-301 treatment. Aston Sci. will subsequently determine the optimal dosing schedule and analyze the correlation between immunogenicity and clinical efficacy by evaluating disease-free survival (DFS) as a secondary endpoint.   AST-301 is a DNA-based therapeutic cancer vaccine encoding the HER2 antigen. Aston Sci. is conducting separate clinical trials for breast cancer and gastric cancer as indications for AST-301. Currently, the CornerStone-001 study targeting breast cancer is underway in the United States, Australia, and Taiwan.   Gastric cancer, particularly HER2-expressed gastric cancer, has a high incidence rate in Asia, but there is a lack of studies specifically focused on this patient population. Effective adjuvant therapies to prevent recurrence after surgery are needed for high-risk patients, but there are limited treatment options. Therefore, the introduction of new therapies is urgently needed. Based on the observation that some gastric cancers respond to immune checkpoint inhibitors, Aston Sci. expects that novel immunotherapies like therapeutic cancer vaccines can contribute to improving patient survival.   Eunkyo Joung, CMO of Aston Sci., stated, "Through this clinical trial, we hope to demonstrate the potential of AST-301 as a new treatment option for HER2-expressed gastric cancer and play an important role in expanding the scope of immunotherapy for gastric cancer."

2023-04-10

Cancer vaccines: 10 biotech companies that have changed the game

A kind of immunotherapy, cancer vaccines have been around since the link between human papillomavirus (HPV) and cancer was discovered in the 1980s. For the prevention of cancers – cervical, vaginal, vulvar and anal cancers – caused by the virus, vaccines were developed, and later approved by the Food and Drug Administration (FDA). Besides the HPV vaccine, therapies to prevent hepatitis B, which can cause liver cancer, were created as well. These vaccines were the first-ever anti-cancer preventative treatments.While these vaccines have been widely used to prevent the spread of infection, cancer vaccines have evolved as a treatment method for the disease. In 1990, Bacillus Calmette-Guérin – a vaccine for tuberculosis (TB) – became the first immunotherapy to be approved by the FDA, for the treatment of early-stage bladder cancer. Since then, the potential for oncological vaccine immunotherapies to boost the immune system’s ability to target antigens has been studied and successfully administered in patients, despite some challenges with regard to immunogenicity – the ability of an antigen to provoke an immune response. As various biotechs across the world specialize in the production of cancer vaccines for different indications, here are 10 companies, presented in alphabetical order, making progress in the field of vaccine development for cancer.[Read the full article]Source: LABIOTECH

2022-09-02

Aston Sci. Receives IND Approval from U.S. FDA for Phase 2 Clinical Trial of the Therapeutic Cancer Vaccine AST-301 in Patients with HER2 1+/2+ Breast Cancer

- CornerStone-001(NCT05163223), the multiregional clinical trial for breast cancer treatment, received U.S. FDA approval for Phase 2 trial following the approvals in Australia and the Taiwan region. - As the same patient group and design of a pivotal study are adopted, a placebo-controlled randomized study has been conducted in an adjuvant treatment with standard treatment regimen.   Aston Sci. Inc., a clinical stage biopharmaceutical company specializing in clinical development of therapeutic cancer vaccines, announced that it has obtained IND approval from the U.S. Food and Drug Administration(FDA) for Phase 2 clinical trial of its main product, AST-301(HER2-hICD vaccine).   Accordingly, CornerStone-001(NCT05163223), a Phase 2 clinical trial of AST-301(pNGVL3-hICD) for treating HER2- 1+/2+ breast cancer, is anticipated to proceed smoothly in the U.S. following Australia and the Taiwan region.   Aston Sci. has already confirmed the safety/tolerability, immunogenicity, and survival rate of AST-301 by presenting the Phase 1 results(PI: Mary L. (Nora) Disis, M.D., University of Washington) including a follow-up study of more than 10 years on breast cancer patients with HER2 expression, at the American Society of Clinical Oncology(ASCO) last year. The therapeutic cancer vaccine is expected to play a major role in preventing cancer recurrence after surgery and treating advanced cancer as it causes few adverse reactions and maintains long-term immunological memory compared to existing anticancer treatments.   The Phase 2 clinical trial of AST-301 adopts a placebo-controlled randomized design and is a multiregional clinical trial(MRCT) in which AST-301(study drug) is administered in combination with standard treatments, such as Capecitabine or Pembrolizumab, in patients with a high risk of recurrence following a curative surgery. A total of 146 patients would be enrolled in the study and get 3 immunizations(every 3 weeks, intradermal injection), fully aligning with a standard treatment schedule, followed by a booster immunization based on the investigator’s discretion.    It is also emphasized that the Phase 2 clinical trial adopts the same patient group and design as in Phase 3 clinical trials. Depending on the early results, pivotal cohort expansion to generate corroborative clinical data in Phase 2 clinical trial is expected. Aston Sci. expects faster patient recruitment, subsequent to IND clearance in the U.S., from the first site(University of Washington, PI: Mary L. (Nora) Disis, M.D.) opened up in the U.S.   Dr. Choi, Regulatory Affairs Director of Aston Sci. said, “It is a remarkable milestone that is definitely a leap forward for us in the cancer vaccine clinical development field. Based on the significant regulatory value of the Phase 1 clinical trial, including more than 10 years of long-term survival data, we have reinforced regulatory-required data which complies to the latest guidelines of therapeutic cancer vaccine, and the U.S. FDA has fully reviewed and approved it.”   Eun Kyo Joung, M.D., Chief Medical Officer of Aston Sci., pointed out the ‘cancer survivorship’. Dr. Joung said, “The number of cancer survivors is rapidly increasing thanks to early cancer detection and advances in medical technology. According to 2018 statistical data, the number of fully recovered and surviving cancer patients in the past 5 years reached about 44 million worldwide. Nevertheless, cancer survivors still suffer from physical and psychological pain during the period of survival and even after full recovery due to the side effects of chemotherapy, fear of recurrence, and social problems that must be faced throughout their lives. We are confident that our therapeutic cancer vaccines will contribute to disease management, prevention of recurrence, and recovery of the overall quality of life for cancer survivors.”

2022-03-03

Aston Sci. Raises USD 22.7 Million Series C Funding

SEOUL, South Korea--(BUSINESS WIRE)--Aston Sci. (CEO: Hun Jung, Dr. Harry Hunwoo Shin) announced the completion of the Series C funding at a scale of USD 22.7 million in December last year. Aston Sci. is a clinical-stage biopharmaceutical company based on a pipeline portfolio of innovative medicines with a focus on therapeutic cancer vaccines.With a compelling safety profile and treatment effects to prevent cancer recurrence after a standard treatment, therapeutic cancer vaccines are drawing attention from the high-risk patients with early-stage cancer in the global market.In addition to the five existing investors including Timefolio Asset Management and Mirae Asset Venture Investment, four new investors participated in the Series C funding round. Including the Series C funding, Aston Sci. has attracted investment at a scale of USD 40 million in total. The raised fund will be used in global clinical development and drug discovery projects.“The funding has been made possible as investors highly evaluated the clinical development expertise and execution capacity of Aston Sci. despite recent uncertainty toward biotech sector in investment markets,” said Dr. Harry Shin. “Starting with the phase 2 randomized-controlled clinical trial (multinational study in the U.S., Australia, and Taiwan) for AST-301 expected to take place during the second quarter of this year, the value of each pipeline will continuously increase.”Aston Sci. has secured ten pipelines in preclinical and clinical stages including two clinical stage therapeutic cancer vaccines for which the study results were presented at the 2021 ASCO Annual Meeting and the 2021 SITC Annual Meeting. The company plans to develop a stable new drug development portfolio by expanding its pipeline to 15 drugs in four clinical fields by 2030. In particular, for AST-301, a phase 2 RCT program is soon to commence in Australia, the U.S., and Taiwan, targeting HER2 +1/+2 breast cancer patients.Aston Sci. decided to list on the KOSDAQ in order to facilitate its clinical and business development, and the company will prepare for its listing by applying for a technology evaluation in the second half of this year.About Aston Sci. Inc.Aston Sci. is a clinical-stage biopharmaceutical company. It is highly regarded in the industry for its active pipelines and portfolio composition that mainly focus on the clinical development of innovative medicines in oncology, immunology, and geriatrics. Aston Sci. is headquartered in Seoul, South Korea, and Aston Sci. USA, Inc. is located in Seattle.

2021-10-28

Aston Sci. Announces the Study Results of Two Therapeutic Cancer Vaccines at the 2021 Society for Immunotherapy of Cancer (SITC) Annual Meeting

SEOUL, South Korea--(BUSINESS WIRE)--Aston Sci., a portfolio model biopharmaceutical company, announced that the study results of its therapeutic cancer vaccine pipelines, AST-301 and AST-021p, will be presented at the Society for Immunotherapy of Cancer(SITC) in November. The respective abstract for AST-301 and AST-021p were accepted by the SITC. The data from the study of AST-301, a pDNA-based cancer vaccine, using mice models with HER2-expressing gastric cancer shows the efficacy of monotherapy and combination therapy of the vaccine. At the 2021 American Society of Clinical Oncology (ASCO) in June, Aston Sci. demonstrated the medical efficacy and long-term safety of AST-301 through the results from phase 1 clinical trials on 66 patients with HER2-positive advanced breast cancer. AST-301 is currently under IND review by the Ministry of Food and Drug Safety for subsequent clinical trials. Aston Sci. also presents the efficacy of combination therapy of AST-021p using a breast cancer mouse model. AST-021p is an investigational therapeutic cancer vaccine composed of two different peptides which are derived from HLA class II binding epitopes of human HSP90 protein. The results of comparative evaluation on tumor growth inhibition and immunogenicity when used in combination with several immune adjuvants, including “L-pampo™” (TLR-2/3 ligand-based immune adjuvant) in-licensed from the CHA Vaccine Institute, will be presented. Currently, AST-021p is in phase 1 clinical trial for recurrent or advanced solid tumors for which there is no standard treatment. “As cancer has become a disease requiring more prevention and management due to technological advances in early diagnosis, the need for adjuvant therapy for early cancer treatment and prevention of recurrence after surgery has increased. Aston Sci. shifted our focus to meet such demand.” said The CEO of Aston Sci., Hunwoo Shin, “We strive to increase the clinical value of cancer vaccines through subsequent clinical trials and research, and also focus our capabilities on future business development.” In addition, Aston Sci. has 10 pipelines in various preclinical and clinical stages including AST-301 and AST-021p. By 2030, the company plans to expand its pipeline to 15 drugs in 4 clinical fields, focusing on efficient development of new drugs with high unmet medical needs and high demand in clinical fields. Aston Sci. decided to list on the KOSDAQ in order to facilitate its clinical and business development, and as part of that, NH Investment & Securities was selected as the listing manager in May. It is in the works, with the goal to list in early 2023 upon receiving technology evaluation within the next year.   About Aston Sci. Aston Sci. Inc. is a portfolio model biopharmaceutical company. It is highly regarded in the industry for its active pipelines and portfolio composition that mainly focus on clinical development of innovative medicines in oncology, immunology, and geriatrics. Aston Sci. is headquartered in Seoul, South Korea, with a U.S. office in Washington.