From Labs to Breakthroughs: HanchorBio Aims High in the Immuno-Oncology Market with HCB101

Taiwan’s biotech industry is expanding its presence in the immuno-oncology market, with HanchorBio developing HCB101, an anti-cancer biologic based on its “Fc-Based Designer Biologics (FBDB)” platform. The drug has entered Phase I clinical trials, demonstrating anti-tumor effects and a defined safety profile. In 2024, HanchorBio received the “Merck Biotech Grant Grand Prize” and the “National Innovation Award – Enterprise Innovation Award.” GeneOnline spoke with Dr. Scott Liu, founder and chairman, about HCB101’s development, the company’s strategic direction, and its efforts to drive Taiwan’s role in the global biotech industry.

Advancing Fusion Protein Biologics in Tumor Immunotherapy

Cancer cases are rising fast worldwide, especially among younger people, driving massive growth in the oncology drug market. Immunotherapy—which helps the immune system attack cancer—has become a game-changer, pushing pharmaceutical giants to invest heavily in the next wave of treatments. From monoclonal and bispecific antibodies to immune checkpoint inhibitors and CAR-T cell therapy, companies are racing to develop cutting-edge solutions that could redefine cancer care.

Amid this global push for innovative oncology treatments, biotech companies are advancing new approaches to overcome the limitations of existing therapies. HanchorBio is developing multifunctional biologics to address challenges in tumor immunotherapy. The company focuses on fusion protein biologics, leveraging protein engineering, candidate selection, and preclinical model studies to accelerate drug development. With expertise in manufacturing, purification, and analytical method development, HanchorBio integrates these processes to streamline Investigational New Drug (IND) applications.

The company utilizes over 100 tumor animal models to evaluate the pharmacodynamics of its fusion protein biologics, optimizing their efficacy and safety. Its core platform, Fc-Based Designer Biologics (FBDB), enables precise modulation of immune responses, enhancing therapeutic impact. These advancements position HanchorBio as a key player in developing next-generation immunotherapies.

Expanding Clinical Trials and Manufacturing with $25 Million in Series B Funding

HanchorBio secured $25 million in Series B funding in 2024, bringing its total fundraising to over $80 million. The company is using these funds to advance HCB101’s clinical trials, targeting head and neck cancer, triple-negative breast cancer, HER2-positive gastric cancer, colorectal cancer, and small-cell lung cancer. The investment supports Phase 1b and Phase 2a trials, with plans to prioritize one or two indications for large-scale Phase 2 studies.

The Taipei-headquartered company is also allocating funding to establish a Good Manufacturing Practice (GMP) facility to ensure long-term production capacity. The company aims to license HCB101 to global pharmaceutical companies after Phase 1b and 2a trials, with potential upfront payments reaching hundreds of millions of dollars. Preclinical data show that HCB101 eliminates B-cell lymphoma cells, suggesting additional applications in autoimmune diseases linked to B-cell activation, including rheumatoid arthritis and IgA nephropathy.

Targeting CD47 on Tumor Cells: Engineering SIRPα Protein to Develop a New Generation of Cancer Therapies

HanchorBio’s immuno-oncology pipeline, led by HCB101, focuses on targeting the CD47 protein on tumor cell surfaces. CD47, a critical immune checkpoint protein, is often overexpressed in tumor cells. This protein binds to the signal regulatory protein alpha (SIRPα) on macrophages, delivering a “don’t eat me” signal that helps cancer cells avoid immune destruction. By developing monoclonal and bispecific antibodies against CD47, the company’s tech aims to block this interaction, thus enhancing macrophage-mediated tumor cell killing.

Dr. Liu explained that patients with high CD47 expression tend to have poorer prognosis and lower survival rates. He emphasized the significance of targeting CD47, noting that doing so could unlock a broader spectrum of immune responses capable of addressing multiple types of cancers. “By targeting CD47, we can create a versatile immunotherapy that not only has the potential to treat a variety of cancers but also offers the possibility of improving patient survival rates,” he stated. He believes that blocking CD47 could lead to the development of an immunotherapy effective across a range of cancers, offering both commercial potential and patient benefits. As with other immunotherapies, CD47-targeting treatments may result in longer-lasting immune responses, potentially reducing recurrence rates and improving survival outcomes.

Developing immune anti-cancer drugs targeting CD47 is not new and has progressed to the third generation. HanchorBio’s HCB101 is part of this third generation of biologics. The first generation of drugs (anti-CD47 monoclonal antibodies) either had too strong a potency, leading to toxicity, or were too weak with limited efficacy. The second generation of drugs (fusion proteins formed by SIRPα binding to antibody Fc fragments) had better safety but still lacked sufficient efficacy and required combination with other drugs, with indications mainly focusing on hematologic tumors.

HCB101 Shows Strong Efficacy in Hematologic and Solid Tumors, Including Head and Neck, Triple-Negative Breast, Gastric, Colorectal, and Liver Cancers

Using the FBDB technology platform, the team improved the structure of SIRPα, increasing the affinity of HCB101 for CD47 by 100 times, and enhancing its ability to block the tumor cell’s signal transmission to macrophages, preventing attack by around 1,000 times. Compared to previous generation drugs, HCB101 can achieve a higher receptor occupancy at lower doses (i.e., a higher percentage of CD47 blocked by the drug) and has demonstrated superior safety in monkey studies, providing a solid foundation for its clinical application.

Dr. Liu also mentioned that HanchorBio’s team has tested HCB101 in 78 tumor models, including models developed from directly extracted patient tumor tissues (PDX). The results showed that HCB101 not only demonstrated excellent efficacy in hematologic tumors but also showed good tumor growth inhibition in solid tumors such as head and neck cancer, triple-negative breast cancer, gastric cancer, colorectal cancer, and liver cancer. It was effective even when used as a single drug and was able to exert its effects in large tumors of approximately 300 mm³. He said, “If HCB101 is effective as a single agent, the combination therapy might be even more effective, which opens up a broader range of possibilities when designing treatment plans.”

Innovations in Anti-Tumor Immunotherapy: Challenging the Multi-Function Drug Market

In addition to HCB101, which has entered clinical Phase 1 and completed multiple dose-group trials, HanchorBio is developing two first-in-class multi-functional biologics—HCB301 and HCB303—based on HCB101. HCB301 received IND approval from the U.S. FDA at the end of June 2024. The company plans to submit an IND application for HCB303 in 2025, paving the way for future clinical trials.

Using the FBDB technology platform, the team improved the SIRPα version used to activate phagocytic cells and added additional anti-tumor components to both products. For HCB301, researchers added an anti-PD-L1 antibody fragment and a TGF-β trap. The anti-PD-L1 antibody activates T cells to attack tumors, while the TGF-β trap clears the inhibitory cytokine TGF-β, improving the tumor microenvironment. Dr. Liu noted that under this “triple-pronged” mechanism, HCB301 targets six major resistance mechanisms to PD-1 therapy, offering greater anti-tumor efficacy than HCB101. For HCB303, the TGF-β trap in HCB301 is replaced with an antibody targeting TIGIT, another immune checkpoint on T cell surfaces, further enhancing the immune system’s ability to combat cancer.

The two products under development have advantages as single-agent, broad-spectrum, and multifunctional therapies with significant potential in the immuno-oncology drug market. Dr. Liu added that monoclonal antibody biotech companies represent nearly three-quarters of the market, with about one-quarter developing bispecific antibodies. Companies like HanchorBio, which are developing tri-functional antibodies or protein drugs, account for only around 1.6% globally. He stated, “What HanchorBio is doing is developing fusion proteins, which are more difficult than antibodies. So, in terms of technological superiority and advancement, we definitely have the opportunity to ‘compete on the world stage.'”

Intense Competition in the Biopharmaceutical Field: Strengthening Product Power is Key to Victory

The immuno-oncology drug market continues to grow rapidly, with global opportunities everywhere. Many biotech companies are racing to develop new products and join the competition. Dr. Liu discussed HanchorBio’s future challenges and opportunities in the market. He noted that, although PD-1/PD-L1 inhibitors have 20 to 30 indications, over 100 types of cancer exist. Some cancers, such as pancreatic and colorectal cancer, still respond poorly to traditional immune therapies. This highlights substantial unmet medical needs and room for improvement in tumor immunotherapy.

“The key is to establish ‘product strength,'” Dr. Liu emphasized. According to him, HanchorBio leads with strong preclinical data to guide research directions, designs trial protocols effectively, and follows international standards for patient recruitment. Each clinical trial will progress step by step, with data used to demonstrate the technological superiority and market value of each product. While many biotech companies focus on public relations and government subsidies, Dr. Liu acknowledged the inevitable challenges in product development. However, he believes, “The most important thing is how good the data is when the Phase 2 or Phase 3 trial results are unblinded.”

HanchorBio built a team of experts and advisors in areas such as CMC, biomanufacturing, and clinical operations. This team secured IND approvals for two products from the U.S. FDA within four years, with HCB101 showing promising Phase 1 results. HanchorBio focuses on advancing immuno-oncology drug development and continues to make progress in its pipeline, including a planned IND submission for HCB303 in 2025. With ongoing research and technology development, HanchorBio is positioning itself to contribute to the next generation of cancer treatments.

Following HCB101, HanchorBio is actively developing the first-in-class tri-functional biologic HCB301, which adds an anti-PD-L1 antibody fragment and TGF-β trap to further enhance its anti-tumor capabilities with a “triple-pronged” mechanism. Image: GeneOnline

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