Tavotek Biotherapeutics Files IPO Prospectus Highlighting Proprietary Platforms and Pipeline Targeting 'Undruggable' and Novel Targets
“Tavotek,” a multifunctional, specificity-focused antibody therapeutics company equipped with world-leading protein engineering technologies, is headquartered in Suzhou, China, tackling undruggable targets and other innovative therapeutic avenues.
On May 21, 2021, major news broke in the global pharmaceutical community as the U.S. FDA approvedThe World’s Third Bispecific Antibody Drug: Rybrevant (amivantamab). The highlight is that,This approval represents a rare instance of FDA Priority Review, granted based on the drug’s outstanding performance in Phase I clinical trials (i.e., an overall response rate [ORR] of 40% and a median duration of response of 11.1 months).. Prior to this, in March 2020, the drug was granted Breakthrough Therapy Designation by the FDA.
What exactly is this “miracle drug”? It is Johnson & Johnson’s EGFR/c-Met bispecific antibody, which demonstrates potent efficacy in the treatment of locally advanced or metastatic non-small cell lung cancer.
Dr. Mark Chiu, the scientist who led the development of this drug, studied under two Nobel laureates (Richard Ernst and Werner Arber) during his academic career. Throughout his professional journey, he has achieved remarkable success. In addition to Rybrevant, he served on the core R&D teams at Johnson & Johnson and Abbott, helping launch multiple first-in-class drugs with annual sales exceeding $1 billion, such asRemicade, Stelara, and Darzalexetc.
Leveraging years of experience in drug R&D, Dr. Qiu joined forces to co-found Tavotek Biotherapeutics Ltd., serving as its Chief Scientific Officer (CSO) after retiring from Johnson & Johnson with a wealth of accumulated expertise. At the helm of the company is CEO Dr. Mann Fung, another scientist with extensive senior-level experience.
Unlike Dr. Qiu, whose background is focused on early-stage drug development, Dr. Feng possesses a comprehensive expertise. With an educational background from Johns Hopkins University and Harvard University, he has accumulated nearly 30 years of experience in the pharmaceutical industry. He previouslyHolds medical licenses in four U.S. states and has served in drug review at the U.S. FDA。
After transitioning to the pharmaceutical industry, Dr. Feng successively oversaw medical and clinical affairs for Eli Lilly in Greater China and Japan, served as Global Vice President of Oncology R&D at Johnson & Johnson, and later held the position of Venture Partner at Fidelity’s SD Capital. Dr. Feng also spearheaded the development of multiple first-in-class drugs with annual sales exceeding $1 billion.
Among them, the industry led by Dr. FengGlobal Clinical Development of the First BTK Small-Molecule Inhibitor, Ibrutinib, in terms of speed, it can still be regarded as the fastest clinical development ever achieved by humans. This drug was also the first new medication worldwide to receive the FDA’s Breakthrough Therapy Designation for an oncology indication. It was approved by the FDA for marketing in November 2013, with sales reaching $1.2 billion in 2014. By 2020, its sales had climbed to $9.442 billion, making it poised to surpass the $10 billion mark in the near future.
Leveraging its robust R&D core built on extensive corporate expertise, Tavotek Biotherapeutics has possessed cutting-edge protein engineering and multispecific antibody technologies since its inception. As an observer of the healthcare industry, VCBeat has taken a keen interest in the founding and development of Tavotek Biotherapeutics. Driven by this curiosity, VCBeat (hereinafter referred to as “VB”) had the privilege of interviewing Dr. Feng, CEO of Tavotek Biotherapeutics.
VB: How did you and Dr. Qiu meet and get to know each other?
Dr. Feng: Mark has been a close friend of mine for over a decade. He works in Johnson & Johnson’s Preclinical Research and Development department, while I am in the company’s Global Oncology R&D division; through our professional collaboration, we have gradually developed a deep friendship. Leveraging integrated multispecific technologies, he successfully developed nine new molecular entities (NMEs) within just three years. Furthermore, his team set a remarkable record in drug development by advancing an NME from concept to development within one year, and progressing the candidate into Phase I clinical trials within two and a half years.
He has extensive R&D experience and a strong track record of achievements in the field of protein engineering. Yet, it is our shared passion for innovation that truly makes us kindred spirits. We both believe that in the world of science, new generations continually drive progress forward, and emerging technologies are always full of fascination.
CEO Dr. Feng (far left) and CSO Dr. Qiu (far right)
VB: Entrepreneurship is an arduous endeavor. You and Mark have already achieved remarkable success in the pharmaceutical industry. Why did you choose to embark on this challenging path of entrepreneurship as you approach the age of sixty?
Dr. Feng: It is precisely because we have accumulated years of experience in innovative drug R&D that we have developed our own philosophy and perspective on drug development. We hope to have a space for free innovation, enabling us to more effectively develop novel drugs with innovative designs to meet the unmet therapeutic needs of patients.
Perhaps the road ahead is fraught with thorns and mud, but when we consider that patients who currently have no pharmacological treatment options may achieve a better quality of life, or even recover from their ailments, thanks to our efforts, we resolutely choose to embark on this uncharted journey together.
VB: When was Tavotek Biotherapeutics founded? What is the company's structure?
Dr. Feng: The company was officially incorporated in 2019. Currently, we have R&D centers in Suzhou, China, and Pennsylvania, USA, focusing on the development of biologics for oncology and autoimmune diseases.
VB: What drives Tavotek Biotherapeutics’ R&D efforts? How do you differentiate yourselves from other biotech companies?
Dr. Feng: We have two major innovative drug R&D technology platforms, which serve as the twin engines driving the entire company forward. Our first engine is called TavoPrecise.TM, is a LEGO-style plug-in platform for multi-specific antibody development. This platform utilizes LEGO-like plug-in modules, taking into account factors such as targets, mechanisms of action, and disease types.Leveraging Protein Engineering Technologies for the Development of Multispecific, Multifunctional AntibodiesOn this platform, we can load multiple functional modules onto antibody molecules, such as:
The “homing module” enables antibodies to exhibit enhanced selectivity for diseased tissues; the “shield module” prevents antibody molecules from binding to targets expressed on normal cells before reaching the diseased tissue, thereby providing a wider therapeutic index and reduced toxic side effects; and the “endocytosis module” facilitates efficient cellular entry of antibody molecules upon arrival at the diseased tissue.In addition to these modules, Tavotek also possesses various other module technologies (not listed in detail here) to maximize therapeutic efficacy and safety.
Furthermore, we also have aTavoMIP: Focused on Conquering Undruggable TargetsTM(Multicyclic Peptide Technology). It is well known that small-molecule drugs are characterized by their low molecular weight and relatively weak specificity. Although they can enter cells, their small molecular size prevents them from effectively inhibiting protein–protein interactions (PPIs). While antibody drugs offer high specificity and potency in targeting proteins, their large size precludes them from crossing the cell membrane to access intracellular targets.
Therefore, many intracellular targets possess “undruggable” characteristics for antibody drugs.TavoMIPTMLeveraging protein engineering technologies, the technical platform has developed macrocyclic peptides that address both the small size and low specificity of small-molecule drugs, as well as the inability of large-molecule drugs to penetrate cell membranes. The macrocyclic design enables more effective control of target protein activity and facilitates intracellular delivery, thereby achieving optimal modulation of protein–protein interactions (PPIs).。
Schematic Diagram of Intermolecular Interactions Between Protein Molecules
In addition to these two R&D platforms, Tavotek also has an independently developed platform for the efficient, high-quality, and precise screening of drug candidate molecules, used forTavoSelect for Early-Stage Drug Molecule DiscoveryTMPhage Library. The innovation of this phage library is reflected in itsProvides highly diverse fully human antibody sequences, applicable to the screening and development of various biologics, including VHHs, scFvs, IgGs, multispecific antibodies, fusion proteins, host cell surface receptors, and macrocyclic peptides.Currently, the capacity of our phage library has expanded to 1.2 x 10^14 and continues to grow.
Through a unique Biopanning screening process, NGS analysis, and deep learning modules, TavoSelectTMPhage libraries enable our team to accelerate the identification and optimization of lead candidate drug molecules,Reduce molecular screening time by 30%-50%. Furthermore, by incorporating biocomputational algorithms, we are able to simulate and predict in vitro efficacy, CMC manufacturability, and other parameters during the screening phase. Leveraging this unique, independently developed technology platform, we alsoCapable of identifying numerous difficult-to-drug targets, including GPCRs, low-homology protein cross-reactivity, and certain unique antibody epitopes.
TavoSelectTMThe phage library has attracted the attention of several biopharmaceutical giants in the industry, with follow-up R&D and collaboration currently under discussion.
VB: How is Tavotek Biotherapeutics’ R&D pipeline structured? When will your drug candidates be launched on the market?
Dr. Feng: Our R&D pipeline is quite robust.In the second half of 2021, we will submit Investigational New Drug (IND) applications for three new drugs in the field of autoimmune diseases. Additionally, three other novel oncology drugs are currently at the stage of stable cell line development and will soon initiate Chemistry, Manufacturing, and Controls (CMC) activities; IND applications for these candidates are expected to be submitted next year.In addition to these six drugs, we have multiple new drugs targeting innovative indications currently in the early proof-of-concept (POC) stage. Furthermore, the development of our innovative MIP macrocyclic peptide drugs is progressing vigorously.
To continuously enhance its R&D capabilities, Tavotek Biotherapeutics actively engages in collaborative development and licensing transactions with other biopharmaceutical companies worldwide. Meanwhile, we also conduct scientific research collaborations with internationally renowned universities and research institutions on forward-looking technological directions, aiming to pioneer more First-in-Class novel drugs for the company in the future.
VB: Could you introduce the company's recent financing?
Dr. Feng: In the first quarter of this year, Tavotek Biotherapeutics successively completed an oversubscribed Series A+ financing round amounting to tens of millions of US dollars. The Series A1 round was led by OrbiMed China Ventures, with participation from Yuanhe Holdings, Juming Venture Capital, and Lianxin Capital; the Series A2 round was jointly invested by GF Xinde, Qingsong Capital, and Lanhu Capital; and the Series A3 round was led by Qianhai FOF Capital, with participation from Qingsong Capital and Lanhu Capital.
Funds raised from multiple A+ financing rounds will be used to accelerate the CMC manufacturing and clinical trial applications for three self-developed antibody drugs (Tavo111, Tavo103, and Tavo101) based on the TavoPrecise platform, as well as to strengthen the R&D of other novel anticancer bispecific antibodies, multispecific antibodies, and macrocyclic peptides (MIP).
VB: Finally, as a distinguished veteran in the pharmaceutical industry who continues to scale new scientific heights, what advice would you like to share with young professionals in the field?
Dr. Feng: “Don't just aspire to make a living. Aspire to make a difference.” This is the most inspiring quote from Denzel Washington’s 2015 speech, and it is also my motto.
The Meaning of Work: Beyond Making a Living, to Making a Difference and Shining in Your FieldLife passes by quickly. We should not only focus on what we can gain from this world, but also consider what we can do to leave a mark and make the world a better place. I personally believe that this is the true value and meaning of life, and it is also the genuine purpose behind Mark and me founding Tavotek.