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In September 2022, the new trends of Dr.
Liu Shigao, a well-known entrepreneur in the industry, were officially unveiled
in the industry.
A startup called HanchorBio announced the completion of a series A financing of about $20 million, led by China Biopharmaceutical Co.
, Ltd.
, followed by Yuexiu Fund, Qingke Group and other institutions, and the original shareholder Panacea
Venture and Yuansheng Venture Capital continue to increase their weight
.
The Founder, Chairman and Chief Executive Officer (CEO) of Hankon Biotech is none other than Dr.
Shigao Liu.
According to public information, the company was founded at the end of 2020 and is committed to developing innovative biologics with unique configurations, hoping to write a new chapter
in tumor immunotherapy.
Shigao Liu.
Committed to the development of innovative biologics with unique configurations, hoping to write a new chapter in tumor immunotherapy
Dr.
Liu has over 25 years of experience
in the development and manufacturing of biologics and drugs.
He co-founded Henlius as a co-founder and held the position of
CEO.
Over the years, Henlius has made outstanding R&D achievements in the field of biopharmaceuticals, including the development of China's first biosimilar approved in accordance with the new guidelines and China's first monoclonal antibody biosimilar approved in the European Union
.
After ten years of starting his second business, what new goals does Dr.
Liu Shigao hope to achieve? How will he lead Hankam Biotech to achieve its mission and vision of innovation? With these questions in mind, we recently interviewed Dr.
Liu Shigao.
Image source: Courtesy of Hankang Biotechnology, produced by WuXi AppTec content team
WuXi AppTec Content Team: Hinkang Biotech's research area is tumor immunity
.
In your opinion, what are the biggest challenges facing the field of immunooncology today? What of these challenges does your company look to solve?
Dr.
Liu Shigao: At present, there are two major bottlenecks in tumor immunotherapy represented by PD-1/PD-L1 inhibitors, namely, how to improve the overall treatment response rate and how to overcome the drug resistance generated in treatment
.
We know that there are many mechanisms that lead to the ineffectiveness or drug resistance of existing anti-PD-1/PD-L1 antibody therapy, such as immunosuppressive tumor microenvironment, insufficient tumor immunogenicity and tumor antigen presentation, increased expression of other immune checkpoints, etc.
, and a small antibody can not solve all drug resistance mechanisms, and combination therapy has become the core trend
of tumor immunotherapy in the future.
Data show that in 2021, the number of global clinical trials of combination therapies centered on PD-1/PD-L1 inhibitors has exceeded 5,000, five times that of 2017
.
Liu Shigao: Combination therapy has thus become the core trend of tumor immunotherapy in the future
From the perspective of antibodies, the development of antibodies has great contingencies and limitations
.
First, the antibody-receptor binding site usually covers only a small part of the receptor's interface
.
In nature, receptor-ligand binding has evolved to find the optimal binding site, while therapeutic antibodies bind to receptors through artificially designed unnaturally formed interfaces
.
Whether the optimal binding site can be found will directly determine the clinical efficacy
of a drug.
So we can see that the clinical efficacy of different antibodies for the same target is far from the same; In addition, some receptors have more than one ligand
.
For example, the well-known immune checkpoint TIM-3 has at least 4 ligands that bind to it and participate in signaling
.
The antibody appears "powerless" at this point, and it is almost impossible to block the interaction
of these 4 TIM3 ligands with TIMs at the same time.
This may also be one of
the reasons why it is difficult to see a good clinical efficacy of a single agent for inhibitors targeting these immune checkpoints.
the reasons why it is difficult to see a good clinical efficacy of a single agent for inhibitors targeting these immune checkpoints.
Based on these considerations, Hinkon Biotech has developed a unique "Fc Design-Based Biopharmaceutical (FBDB)" platform
.
The platform can develop a multifunctional bioproduct that achieves the effect
of "compound therapy" with one drug through innovative combinations on Fc fragments 。 For example, the use of engineered ligand bait completely covers the interface between ligand and receptor binding to achieve complete and effective signal blocking, and the high concentration of bait-based biological drugs is also effective enough to effectively block the binding of multiple ligands to receptors, greatly enhancing the therapeutic effect of antibodies; In addition, engineered immune cell regulators, such as tumor microenvironment regulators and T cell agonists, are expected to stimulate multiple immune synergies at the same time, including innate immunity and adaptive immune systems, to overcome multiple mechanisms
that lead to tolerance of anti-PD-1/L1 therapy.
Cancer cells are indeed "cunning rabbit three holes", then we will wipe out
all its retreats.
This is the current concept of Hankon Biotechnology to develop new anti-cancer drugs, which we summarize as: a multi-pronged approach
to expecting the enemy.
of "compound therapy" with one drug through innovative combinations on Fc fragments.
The use of engineered ligand baits to completely cover the interface between ligand and receptor binding through engineered immune cell regulators, such as tumor microenvironment regulators, T cell agonists, etc.
, is expected to stimulate multiple immune synergies at the same time
WuXi AppTec Content Team: Currently, there are many companies developing immuno-oncology therapies
.
What do you think are the main differentiators of Hinkon Biotech?
Dr.
Shigao Liu: Hankang Biotech used the strategy of "target decoy" to develop FBDB molecules
.
Globally, monomer molecules connected to a single-arm regulator or ligand bait have been approved for marketing, and only a handful of dimer molecules connected to both arms have entered the clinic
.
According to our research, no products of trimer molecules have entered the clinic
in the world.
In fact, the development of this technology is very difficult, and it is necessary to consider how to design regulators or cytokines, how to connect individual regulators to Fc molecules, so as to obtain the optimal biological function and synergy, and so on
.
The biggest challenge is the challenge
in terms of expression volume and CMC.
Liu Shigao: The biggest difficulty is the challenge
of expression and CMC.
The Hinkon Biotechnology team has more than 10 years of experience in the field of tumor immunity, and the company's chief scientist, Dr.
Zhuo Zongxian, is an expert in structural biology, with more than 25 years of experience
in protein engineering, antibody recombinant engineering and innovative development of therapeutic platforms.
This is where Hinkon Biotech is able to overcome difficulties and successfully develop products
.
At present, Hinkon Biotech has developed nearly 10 products under development, including 5 potential "first-in-class" three-arm FBDB molecules
.
This is where our innovation and uniqueness lies
.
Several of the five three-armed FBDB molecules have successfully overcome many challenges to achieve expression and display excellent CMC properties, and satisfactory biological activity and synergy have been observed in animal models
.
HankonBio's fastest advancing product, HCB101, is an engineered SIRPα-Fc fusion protein, which, although a single-arm molecule, has shown very good anti-tumor effects in preclinical studies while maintaining a good safety profile with "best-in-class" potential
.
We expect to declare the product for clinical
trial by the end of this year.
WuXi AppTec Content Team: Can you elaborate on the potential benefits of drugs developed on the "Biopharmaceutical by Fc Based (FBDB)" platform?
WuXi AppTec Content Team:Dr.
Shigao Liu: Multifunctional and innovative biopharmaceuticals represent a new and potentially better combination therapy
.
Its advantages are reflected in four aspects: first, flexibility, which can integrate different acting molecules into a biological macromolecular framework with multiple synergistic mechanisms; Second, effectiveness, because all acting molecules can reach the target near the tumor at the same time and begin to take effect, it is more effective than single or combined drugs, and reduces side effects; Third, diversity, which can target signaling pathway targets with multiple ligands and use interchangeable building blocks to design different FBDB molecules; Finally, the economy is that the purification process is greatly simplified by the transformation of the Fc domain, reducing production costs, and the development cost of a single biologic drug can be greatly reduced
compared to the combination therapy of multiple drugs.
Liu Shigao: First, flexibility is second, effectiveness is third, and diversity is finally economy
WuXi AppTec Content Team: Looking ahead, what do you see as the key milestones expected in the field of immuno-oncology?
WuXi AppTec Content Team:Dr.
Liu Shigao: I am very optimistic about
the future of tumor immunotherapy.
On the one hand, global pharmaceutical companies and biotechnology companies are focusing on this field, and there are also a large number of tumor immune combination therapies in the clinical trial stage, and these explorations will definitely bring more experience and knowledge accumulation; Second, new immune checkpoint inhibitors and targets are constantly being discovered
.
Although the efficacy of single-drug drugs for existing targets is not satisfactory, with the advancement of antibody technology, such as the multifunctional innovative biological drugs that Hankang Biotechnology is exploring, the efficacy of single-drug drugs will definitely make breakthroughs
.
On the other hand, emerging technologies such as mRNA and tumor therapeutic vaccines are expected to bring new therapeutic methods
.
I personally believe that with the efforts of colleagues in the industry, in the next one or two decades, we can see the 5-year survival rate of cancer increase from 70% to 80%~90%, and even turn cancer into a chronic disease
.
Liu Shigao:
WuXi AppTec Content Team: You have many entrepreneurial experiences
.
What was the biggest difficulty you faced in starting your own business? What experiences do you have for other industry colleagues who want to start a business?
Dr.
Liu Shigao: Since starting my business, I have often said that "it is difficult to pass the pass"
.
For biopharmaceutical companies, the core competencies of technology, products and other aspects are derived from excellent teams
.
The more top-notch talent, the more
opportunities and choices there are.
So, how to attract the best talent, bring them together, and put the right talent in the right place, and everyone to achieve a vision and mission together, I think this is the most challenging thing and the most important thing
.
It is a big project that takes decades to polish, even throughout the entrepreneurial process
.
Liu Shigao:
First, the founder must answer a fundamental question, what exactly is your innovation and differentiation? What dilemma can be solved in the current research and development of new drugs? Secondly, whether the company's founders have found a mission that is truly worthy of the yearning and recognition of first-class talents, whether they can truly embrace the core mission and values, and whether they can have strategic focus, that is, continue to adhere to a good strategy
.
WuXi AppTec Content Team: Looking ahead, what kind of company do you want Hankang Biotech to become?
WuXi AppTec Content Team:Dr.
Shigao Liu: The core mission of Hankon Biotech includes two aspects: on the one hand, to break through the bottleneck of current tumor immunotherapy and benefit cancer patients around the world by developing cutting-edge multifunctional biological drugs with specially designed molecular configurations; On the other hand, through a unique technology platform, it creates a breakthrough new path
for tumor immunotherapy.
On that basis, I hope that Hankang Biotech will eventually become a well-respected pioneering biotechnology company
.
Liu Shigao: Through the unique technology platform, we have created a breakthrough new path for tumor immunotherapy
WuXi AppTec Content Team: There are many young people
on the front lines of R&D among our readers.
What is the experience or takeaway from them that you would most like to share?
Dr.
Liu Shigao: First of all, we are serious and diligent
.
The so-called "heaven rewards hard work", especially in the field of new drug research and development, any breakthrough in technology and innovation, behind a lot of experiments and hard work
.
Second, young people should also have the sensitivity
to perceive changes in the external environment.
Time is limited, know yourself and know each other, in order to think about your core ability, and concentrate on research in your own areas of strength, coupled with diligence and time accumulation, you will definitely be able to make breakthroughs
.
Liu Shigao:
