Tam Anh General Hospital Announces Cancer Drug Trial In Collaboration With U.S. Researchers

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17:11 12/12/2024
Author: TAMRI

Tam Anh General Hospital, in collaboration with the Tam Anh Research Institute (TAMRI), announced the launch of the VISTA-1 project, investigating the potential oral immunotherapy drug RBS2418 from the U.S. The announcement, made in the presence of representatives from the Ministry of Health, the Ministry of Foreign Affairs, and the U.S. Centers for Disease Control and Prevention (CDC), offers new hope for terminal cancer patients who have exhausted all available treatments.

scientists on clinical trials for rbs2418

Tam Anh General Hospital partners with U.S. scientists on clinical trials for RBS2418, an oral immunotherapy drug aimed at treating late-stage cancer

This promising oral immunotherapy, RBS2418, has been approved by the U.S. Food and Drug Administration (FDA) for clinical trials. After demonstrating safety in Phase 1 trials conducted across more than 10 prestigious hospitals and medical centers in the U.S., the drug has moved into Phase 2 trials. The focus is now on its efficacy in patients with advanced colorectal cancer who no longer respond to existing treatments. ClinicalTrials.gov [Link]

Cancer remains one of the leading causes of death in Vietnam, placing a heavy burden on societies. According to the World Health Organization (WHO), cancer accounts for 16% of deaths globally. In Vietnam, over 120,000 people die of cancer each year. Colorectal cancer, in particular, is on the rise and is projected to increase significantly in the coming decades. The International Agency for Research on Cancer (IARC) estimates that by 2045, mortality rates for colorectal cancer in Asia could rise by nearly 80%.

Colorectal cancer presents unique challenges due to its high metastatic rate. Statistics indicate that 15–30% of newly diagnosed colorectal cancer patients are already in the metastatic stage, and 50–60% of localized cases eventually progress to metastasis. Treatment becomes exceedingly difficult in these late stages, with 5-year survival rates for metastatic colorectal cancer patients ranging from just 10–20%. However, in Vietnam, targeted therapies or immunotherapy have been shown to improve 5-year survival rates to 30–40%, according to Vu Huu Khiem, MD, PhD, Head of Oncology Department at Tam Anh General Hospital in Hanoi.

Despite advancements in global cancer treatment, including in Vietnam, options for metastatic colorectal cancer remain limited due to late-stage diagnoses and poor treatment response. Chemotherapy is one of the main treatment methods for various types of cancer, including metastatic colorectal cancer. However, over time, in most cases, cancer cells tend to grow back after chemotherapy, posing a risk of becoming more severe.

In the last decade, immunotherapy has emerged as a breakthrough in cancer treatment. However, its effectiveness is currently limited to around 5% of metastatic colorectal cancer patients. Therefore, the world, particularly Vietnam, is in urgent need of solutions for the remaining 95% of patients, especially those who do not respond to existing treatment regimens.

Against this backdrop, the VISTA-1 study by the U.S.-based biotech company Riboscience — developed by a team of renowned experts, including Prof Jeffrey S. Glenn, MD, PhD & Distinguished Prof Joseph D. Grant of Medicine at Stanford University School of Medicine; Klaus Klumpp, PhD, Co-Founder and Chairman of Riboscience; Mark Smith, MD, Head of Medicinal Chemistry at Stanford University — aims to provide a groundbreaking solution by leveraging immune mechanisms to treat late-stage cancers that no longer respond to current therapies.

prof jeffrey s glenn md phd

Prof Jeffrey S. Glenn, MD, PhD & Distinguished Prof Joseph D. Grant of Medicine at Stanford University School of Medicine at the event

In the initial phase, the research focuses on patients with advanced or metastatic colorectal cancer who have failed or are intolerant to existing treatments. This offers them access to an innovative and potentially effective solution. The medication, available in oral form, is easy to use, cost-effective, and enhances accessibility for a larger number of patients—particularly important for cancer, a disease with notoriously high treatment costs.

Delivered orally, RBS2418 (TPL1) activates the immune system to recognize and destroy cancer cells by converting the tumor’s immune environment from “cold” to “hot.”  The drug has been proven safe during preclinical trials and has not caused significant side effects in cancer patients during Phase 1 clinical trials conducted at more than 10 renowned hospitals and medical schools in the U.S. Preliminary data suggests RBS2418 has potential anti-tumor activity both as a standalone treatment and in combination with PD-1 checkpoint inhibitors (anti PD-1).

The FDA approved the VISTA-1 trial in September 2024, with Vietnam’s Ministry of Health granting approval in early December 2024. Phase 2A of the trial plans to enroll 150 patients across the U.S. and Vietnam, starting with Tam Anh General Hospitals in Hanoi and Ho Chi Minh City. Future expansion to three additional hospitals is anticipated.

About RBS2418

Prof Jeffrey S. Glenn said: “RBS2418 is a promising drug with the potential to revolutionize the treatment of colorectal cancer. The VISTA-1 study will provide critical data to evaluate the drug’s efficacy. Collaboration with Vietnamese researchers is invaluable in this journey, and we are excited to work alongside our colleagues in Vietnam.”

Understanding the clinical trial phases provides context for VISTA-1’s significance:

  • Phase 1: Assesses the safety of RBS2418 in a small group of patients with various solid tumors, completed successfully in the U.S. Phase 2 is typically divided into two sub-phases, 2A and 2B, each with distinct objectives and scales.
  • Phase 2A: Evaluates the drug’s efficacy in a targeted patient group and determines optimal dosing to maximize therapeutic benefits while minimizing side effects. This phase typically involves a smaller cohort (dozens to about 100 patients).
  • Phase 2B: Confirms the drug’s effectiveness at the selected dosage and evaluates safety on a larger scale (hundreds of patients), paving the way for Phase 3. The scope of the study is further expanded by assessing the efficacy of the drug in more diverse patient groups, considering factors such as age, health status and other variables. The result from Phase 2B will serve as a critical foundation for designing Phase 3 trials, which will involve a larger patient cohort and have greater applicability for practical use once the drug is approved.
  • Phase 3: Compares the new drug’s efficacy to standard treatments in a large patient population.
  • Phase 4: Monitors the drug’s long-term safety and effectiveness post-approval.

According to representatives from the Ministry of Health, this is the first Phase 2A clinical trial for colorectal cancer treatment in Vietnam. It also marks the first time a new biomarker assay technique has been transferred and implemented locally at central laboratories across all research sites in Vietnam, eliminating the need to send samples abroad. The VISTA-1 trial provides Vietnamese cancer patients with equal access to cutting-edge treatments available in the U.S., marking a significant milestone for Vietnam’s healthcare and scientific innovation. By participating in early-stage clinical trials like Phase 2A, Vietnam demonstrates readiness to conduct advanced medical research, a step forward from traditionally being involved only in late-stage trials such as Phase 3.

nguyen ngo quang phd

Nguyen Ngo Quang, PhD, Director of the Department of Science, Technology, and Training under the Ministry of Health, delivers a speech

This project highlights the growing research and development capacity of Vietnam’s medical field, elevating the country’s position in the global medical community. It also creates early access opportunities for Vietnamese patients to benefit from advanced cancer treatments. Participation in international clinical trials like VISTA-1 helps Vietnam build a robust treatment database for its population, facilitating the development and eventual approval of new drugs in the country.

The VISTA-1 study at Tam Anh General Hospital is a milestone in the effort to strengthen scientific and medical cooperation between Vietnam and the United States. This collaboration was initially formalized in November 2023 through a partnership agreement between Tam Anh General Hospital, the Tam Anh Research Institute, and Stanford University’s BiosEcuRity & PandEmic PrepAreDness Initiative (ViRx@Stanford).

To become an official research site for VISTA-1, Tam Anh General Hospital and the Tam Anh Research Institute made significant investments in personnel, state-of-the-art equipment, and streamlined processes. Notably, both proactively engaged in the early stages of the initial research conducted in the U.S. Vietnamese doctors worked closely with U.S. specialists to develop the Phase 2 study protocol and adopt standardized research procedures. Additionally, a new, fully equipped laboratory was established to serve as a central testing hub, operating in parallel with U.S.-based research labs.

Phuong Le Tri, MD, Chief Operating Officer of TAMRI, said: “VISTA-1 represents a major step in the fight against cancer, particularly colorectal cancer. Bringing this promising drug to Vietnam provides invaluable opportunities for patients, giving them a better chance at leading healthier lives. It also provides Vietnamese doctors and scientists the opportunity to learn and engage with highly professional and rigorous drug development processes at an advanced level. We are committed to contributing to this groundbreaking research and hope TAMRI becomes a hub for global and Vietnamese scientists dedicated to advancing medicine and public health.”

phuong le tri md

Phuong Le Tri, MD, Chief Operating Officer of TAMRI, at the event

Tam Anh Research Institute

10:55 13/12/2024

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