Bintie Bio Secures Over RMB 100 Million in Series A Funding to Target 'King of Cancers' with Novel TCR-T Therapies

▎Edited by the WuXi AppTec content team

Recently, ImmuXell Biotech announced the completion of an over 100-million-yuan Series A round of financing, led bySDIC Venture CapitalLed by SDIC Venture Capital Co., Ltd., with participation from Guangzhou Huangpu Biomedical Industry Investment Fund Management Co., Ltd., Yuanxi Haihe (Tianjin) Biomedical Industry Fund Partnership (Limited Partnership), and others, the funds raised will be used to advance the research progress of product pipelines, including novel TCR-T cell therapy products targeting the KRAS G12V mutation. The announcement has also drawn industry attention to this innovative pharmaceutical start-up, ImmuXell Biotech.

ImmuXell Biotech was founded in January 2021.Focus on the R&D and production of breakthrough immunotherapy drugs, with main products being novel immune cell formulations targeting solid tumors.Currently, ImmuXell Biotech has independently developed multiple candidate drugs, including those targeting

TCR-T cell therapy products targeting KRAS mutations, TCR-NK products as allogeneic cell therapies, and more.

So, what are the advantages of ImmuXell Biotech's technology and product pipeline? What challenges in current cancer treatment do they have the potential to address? With these questions in mind, the WuXi AppTec content team conducted an exclusive interview with...Dr. Hongming Hu, Founder of ImmuXell BiotechDr. Hu has深耕多年 in the field of tumor immunology and has rich experience in basic and clinical research of tumor immunology, translational medicine, and other fields.

Image Source: Provided by ImmuXell Biotech, Produced by the WuXi AppTec Content Team

WuXi AppTec Content Team: In the field of oncology that ImmuXell Biotech is dedicated to, what are the key challenges currently faced by treatment methods or clinical solutions?

Dr. Hongming Hu:The main indication targeted by ImmuXell Biotech's products is pancreatic cancer. As is well known, pancreatic cancer is called the "king of cancers" due to its high mortality rate and difficulty in treatment. Despite the increasing number and variety of innovative therapies each year, treatment options for pancreatic cancer patients remain extremely limited. For innovative drug development companies, how do we find more effective treatments to change the decades-long dilemma of no significant breakthroughs in this field? I believe this is the primary challenge.

Looking at the entire field of oncology, I believe another key challenge we face is how to fully achieve early screening and diagnosis of cancer. For difficult-to-treat cancers like pancreatic cancer and liver cancer, early symptoms are hidden, not easily detected, and the disease progresses rapidly, with most patients already in the advanced stage at the time of diagnosis. If detected through early screening, patients would have many more treatment options and much better outcomes.

WuXi AppTec Content Team: What are the unique advantages of the pipeline being developed by ImmuXell Biotech? What pain points in current cancer treatment do they have the potential to address?

Dr. Hongming Hu:In recent years, although significant progress has been made in the development of small-molecule drugs targeting KRAS G12C, challenges remain for

Drug development for other high-frequency KRAS mutation types still faces significant challenges. The reason lies in the fact that KRAS is an intracellular target, and developing therapies for such targets is extremely difficult. TCR-T, as a novel therapy, can not only recognize surface antigens but also target intracellular antigens that are difficult for antibodies and small molecules to reach. As an immunotherapy, TCR-T therapy exhibits stronger proliferation, persistence, and tumor infiltration capabilities of cytotoxic cells in vivo, showing potential to improve survival time and quality of life for patients with solid tumors. Therefore, we believe that the development of targeted

TCR-T therapy targeting KRAS mutations holds promise as an effective treatment for refractory solid tumors such as pancreatic cancer.

ImmuXell Biotech's goal is to develop a series of TCR-T products that can treat recurrent/refractory malignant tumors such as pancreatic cancer. The company's product pipeline has two main characteristics.First, we focused on the KRAS target early on.

KRAS gene mutation is one of the most common oncogenic gene mutations in cancer patients, expressed in both primary and metastatic cancers. Taking pancreatic cancer as an example again, it is the most dependent.

Tumor types with KRAS gene mutations, found in approximately 95% of pancreatic cancers

KRAS gene mutation, which provides an entry point for new drug developers to tackle difficult-to-treat tumors such as pancreatic cancer.

The second major characteristic of ImmuXell Biotech's product pipeline isExpected to enhance the accessibility of cell therapy productsThe number of cells required for TCR-T cell therapy in the treatment of solid tumors will far exceed that of CAR-T therapy, making accessibility even more crucial.Our approach is to develop new cellular processes that enable greater expansion of patient-derived T cells within the patient's body. This not only shortens the ex vivo expansion time and reduces process costs, but also enhances the ability of T cells to infiltrate tumors and differentiate into effector cells within the tumor.In addition, we are also exploring new directions, such as non-viral gene targeting integration technology, which can help improve the safety and accessibility of cell therapies.

In addition, our product pipeline also includesTCR-NK Products as Allogeneic Cell Therapy Products`, as well as TCR fusion protein (TCR-ICE) products that can be mass-produced and are available in stock.`NK cells have the natural ability to kill tumor cells and can be applied in allogeneic cell therapy, thus offering more advantages than conventional autologous or allogeneic T-cell therapies. The TCR fusion protein product is independently developed by ImmuXell Biotech, targeting

The TCR sequence with KRAS mutation is combined with a single-chain antibody fragment (scFv) against CD3. It does not require the blood collection and reinfusion steps of cell therapy and can be mass-produced for off-the-shelf supply to hospitals. These strategies enable us to combine personalization with universality in future cell therapy products, greatly enhancing the accessibility of cell therapies.

WuXi AppTec Content Team: What are the key challenges to fully realizing the potential of ImmuXell Biotech's products under development? And what are the potential solutions?

Dr. Hongming Hu:TCR-T therapy involves cloning T-cell receptors (TCRs) that can specifically recognize particular HLA-tumor antigen peptide complexes using corresponding experimental techniques, followed by delivering them via retroviral gene transfer.

TCR gene coding sequences are delivered to more T cells, endowing these T cells with new antigen recognition specificity. From the specific treatment process, patient-derived T cells are transduced in vitro.

TCR genes, massively amplified, can effectively recognize tumor cell-specific antigens. Infusing these T cells back into the patient can specifically kill tumor cells and exert anti-tumor activity. Therefore, similar to CAR-T cell therapy, the key challenges for TCR-T therapy lie in the production of the cells and the reinfusion process at the hospital. As for potential solutions, I believe they lie in improving processes and enhancing technology, enabling us to shorten the in vitro transduction.

The time for TCR gene and amplification processes aims to return cells to the patient's body at the fastest speed, or in the future, achieve direct production and reinfusion at hospitals.

WuXi AppTec Content Team: In the next few years, what milestone advancements are expected in ImmuXell Biotech's R&D pipeline?

Dr. Hongming Hu:Currently, ImmuXell Biotech's novel TCR-T cell therapy product targeting the KRAS G12V mutation has completed TCR screening, in vitro functional validation, in vivo efficacy testing, and has been advanced in multiple clinical centers for...Advanced Pancreatic Ductal AdenocarcinomaThe investigator-initiated clinical trial (IIT) has entered the IND application preparation stage. In the next few years, we hope this product will achieve positive clinical data. Secondly, ImmuXell Biotech is also expected to advance its TCR-NK product and TCR fusion protein product to the registrational clinical research stage.

At the same time,We will also gradually expand the pipeline indications to more.

Tumor types with KRAS mutations, such as colorectal cancer and lung cancer, will leverage the current innovative platform to explore new targets, hoping to also provide innovative TCR therapies for patients with liver cancer, brain cancer, and more in the future. Additionally, we are exploring non-viral gene delivery vectors that could reduce production costs, which are also expected to yield corresponding results in the coming years.

WuXi AppTec Content Team: How do you view the current innovation trends in the biopharmaceuticals industry? Where are the opportunities for innovation? What is your prediction for the next few years?

Dr. Hongming Hu:Different molecular types and different products can address different issues. For me, I am most optimistic about cell therapy. In terms of mechanism of action, cell therapy can harness the patient's own immune capabilities and create immune memory, which is expected to significantly extend patients' survival time.

From the perspective of industrial development trends, I believe that whether they are scientists, entrepreneurs, or investors, everyone will become more cautious. Moreover, the professionalism of investment institutions is also increasing, which helps to form a positive innovation ecosystem and reduce the waste of new drug R&D resources. Everyone can truly start from unmet clinical needs and develop products that can benefit patients.

WuXi AppTec Content Team: In terms of original innovation, what challenges do you think scientific research transformation is currently facing?

Dr. Hongming Hu:Scientific research transformation cannot be achieved by a single institution or company alone. It requires the establishment of an entire system, including enhancing the innovation capability at the source, cooperation between various links such as medical institutions/research institutes, innovative drug development companies, CROs, and more. At the same time, we must also consider how to deliver truly clinically valuable innovative drugs to patients more quickly. Over the past years, through the efforts of all parties, I believe that the ecosystem for scientific research transformation in China has begun to take shape. I am confident that in the future, the system for scientific research transformation will become increasingly mature, leading to more research achievements being transformed into effective medicines that benefit patients.

WuXi AppTec Content Team: How do you view the role of collaboration in new drug development? Specifically, in the field of cancer immunotherapy, what kind of collaboration is needed to accelerate the introduction of innovative treatments?

Dr. Hongming Hu:As I just mentioned, in order to form a positive and self-reinforcing innovation ecosystem, cooperation is very important. I believe good cooperation means that all parties can shine, complement each other's strengths, and at the same time push things to the extreme, bringing innovative therapies to eagerly awaiting patients as soon as possible. Specifically, in the field of cancer immunotherapy, I think we need to work together, make rational use of limited resources such as funding, patients, medical resources, and new drug R&D talent, and drive original innovation through differentiation and diversification.Create a truly "diverse and thriving" innovation ecosystem.

WuXi AppTec Content Team: If we gather here again 10 years from now, what changes do you foresee in the landscape of cancer treatment? Could you paint a picture of what the field might look like in 10 years?

Dr. Hongming Hu:First, I look forward to seeing significant breakthroughs in the treatment of difficult-to-treat cancers like pancreatic cancer, similar to the advancements achieved in lung and breast cancer. The emergence of truly safe and effective innovative therapies could enable at least half of the patients to survive for more than five years. Second, cell therapy is expected to become a mainstream treatment for cancer, with a series of cell therapies gaining approval for marketing in the field of solid tumors. Third, thanks to technological innovations and improvements, the accessibility of cell therapy will be greatly enhanced, making it affordable for most patients. Although scientific breakthroughs still involve a degree of chance and are hard to predict, I believe the future holds great promise.

WuXi AppTec Content Team: Looking ahead to the upcoming 2024, can you describe your expectations in one sentence?

Dr. Hongming Hu:In 2024, I believe the first TIL and TCR-T cell therapies for treating solid tumors are both likely to gain approval from the U.S. FDA for market release., while the field of cell therapy will present more anticipated R&D data, bringing hope to patients.

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