NovaRock Biotherapeutics Files for IPO: Pioneered by Key Developers of Opdivo and Keytruda, the 'Antibody Drug Engine' Targets Solid Tumors with Innovative NovaTE Platform

In recent years, the landscape of antibody-based therapeutics has undergone significant changes, presenting numerous opportunities: patents for blockbuster antibody drugs are expiring sequentially, while interest in antibody-drug conjugates (ADCs) and bispecific antibodies continues to rise. Indeed, Chinese scientists have long played a pivotal role in the field of antibody drug development, with many leaving multinational corporations (MNCs) to found biotech companies aimed at accelerating antibody drug discovery.

NovaRock Biotherapeutics is one of them,ThisFounded by Chinese Scientists, Headquartered in New JerseyNovaRock Biotherapeutics Inc., an antibody drug discovery company, is dedicated to the research and development of antibody therapies for cancer and autoimmune diseases.Team members hail from Merck & Co., Bristol Myers Squibb, Sanofi, and other leading pharmaceutical companies. Their contributions include the discovery and invention of drugs such as:Opdivo (O drug), Keytruda (K drug), Arzerra, and Ilumya.

NovaRock’s founding members have brought their extensive experience in first-in-class (FIC) and best-in-class (BIC) antibody discovery from multinational corporations (MNCs) to this highly efficient new company. Currently, NovaRock’s pipeline comprises more than 10 innovative biologics, with indications spanning oncology, autoimmune diseases, and other therapeutic areas.Known as the “antibody drug R&D engine” within the industry, its multi-specific antibody product platform, NovaTE, benchmarks against the most advanced international T-cell co-stimulation platforms., enabling sustained T-cell activation and maintaining tumor cell-killing potency, with a focus on the treatment of solid tumors. On August 16, NBL-028, one of the company’s core pipeline candidates, received Investigational New Drug (IND) approval in the United States. A Phase I clinical study to evaluate its safety, tolerability, and efficacy in patients with advanced solid tumors expressing CLDN6 will soon be initiated.

How Does This “Engine” Operate Efficiently?Recently, VCBeat interviewed Dr. Li Han, Co-founder and CEO of NovaRock Biotherapeutics.

2009 was a pivotal year in the field of oncology: Bristol Myers Squibb (BMS) acquired Medarex to secure its PD-1 program, while Merck & Co. (MSD) acquired Schering-Plough to obtain its PD-1 asset. Five years later, BMS’s Opdivo and Merck’s Keytruda entered the market as the first PD-1 inhibitors, fully igniting the PD-1 boom.

A founding team member of NovaRock Biotherapeutics, who participated in the most remarkable “battle” against tumors in human history to date.Dr. Huang Haichun, Co-founder and Executive Vice President of Antibody Discovery, brings over 25 years of experience in antibody discovery. He joined Medarex in 1998 as one of the earliest scientists involved in humanized antibody research, leading the team that identified the PD-1 and CD20 antibodies. Following Medarex’s acquisition by Bristol Myers Squibb (BMS), Dr. Li Han (Co-founder and CEO), Lei Ming (Co-founder and COO), and Dr. Huang Haichun continued to work together for many years.

Dr. Li Han joined BMS in 2013, where she is responsible for supporting the development of all early-stage large-molecule biologics in the BMS pipeline. Previously, she led new drug project R&D at Sanofi, accumulating extensive experience in guiding new drug projects from initiation through to clinical trials. Lei Ming joined BMS in 2004, focusing on developing and building functional optimization platforms for immuno-oncology and oncology clinical candidate molecules. He has supported more than 10 new drug projects into clinical stages and had in-depth collaborations with Medarex prior to its acquisition.

Following the market launch of PD-1 therapeutics, the overall limited response rates associated with this target, coupled with the substantial unmet needs in solid tumors and the limitations of existing drugs for autoimmune diseases, have become key challenges that the antibody industry must address.The three co-founders’ experience at multinational corporations (MNCs) has given them extensive expertise in project management for drug development and the construction of technical platforms. After more than a decade working within large pharmaceutical companies, they began to entertain the idea of starting their own venture: biotech companies are more agile, enabling rapid identification and resolution of problems.Combining the experience of large pharmaceutical companies with the speed and efficiency of biotech firms to develop new therapies for patients faster and better was the original intention of the three founders in starting their business.

In addition to the three founders, NovaRock’s team includes two other core executives: Dr. Yi Pei, Executive Vice President of Technology and Protein Engineering, who previously worked at Merck & Co. and Bristol Myers Squibb (BMS), leading new drug development projects across multiple therapeutic areas including oncology, immunology, and cardiovascular diseases; and Dr. Zhong Liu, Executive Vice President of Drug Development, who held senior leadership positions at Schering-Plough and Merck & Co. He was a key leader in securing the accelerated Biologics License Application (BLA) approval for Keytruda and oversaw the development of ilumya from drug discovery through Phase III clinical trials.

NovaRock Biotherapeutics has attracted the attention of CSPC Pharmaceutical Group.The latter sought partnerships with promising innovative drug teams overseas to expand its footprint, and CSPC Pharmaceutical Group quickly reached an agreement with the NovaRock team. In 2018, NovaRock was officially established in New Jersey, USA, with Dr. Nils Lonberg, a member of the U.S. National Academy of Engineering and the scientist who previously led the development of Opdivo and Yervoy, serving as the company’s scientific advisor.

T-cell co-stimulation represents a new hotspot and source of hope in the fight against solid tumors. Molecules such as CD137, CD28, OX40, and CD27 bind to receptors on the T-cell surface, thereby promoting T-cell proliferation, activation, and survival. Due to its unique mechanism, broad indications, and favorable cost-effectiveness, T-cell co-stimulation therapy has become a key area of exploration for major pharmaceutical companies.Biotech companies with T-cell co-stimulation platforms are also considered more competitive.

NovaRock’s polyclonal antibody product platform, NovaTE, is benchmarked against the most advanced international T-cell co-stimulation platforms.Precisely modulate for different tumors and targets, specifically activate and maintain the cytotoxic activity of T cells in tumors, while avoiding systemic toxicity and widening the therapeutic window.“Has the potential to conquer solid tumors.”

“While there has been significant progress in the treatment of hematologic malignancies in recent years, a substantial unmet medical need remains for patients with solid tumors. Therefore, our goal is focused on tackling solid tumors. Since the company’s inception, the targets we have laid out and selected were chosen to pave the way for future combination therapies and platform-based development. We have undertaken extensive work that may not be immediately visible in the direct progression of our pipeline,” stated Li Han. As an industry leader driving early-stage antibody drug discovery through functional screening, Li Han has guided the company in formulating a differentiated R&D strategy and development direction, amidst an environment characterized by homogenization in antibody drug development competition and increasing challenges in pioneering research.

NovaTE platform’s first pipeline candidate, NBL-028, received IND approval from the U.S. FDA on August 16 and is poised to initiate Phase I clinical trials.NBL-028 is a novel tetravalent bispecific antibody that, through unique antibody-binding epitopes and antibody engineering, enables T cells to specifically and continuously exert potent cytotoxic effects against tumor cells within the CLDN6-positive tumor microenvironment, while avoiding hepatotoxicity and systemic toxicity. NBL-028 specifically activates T cells in ovarian cancer and testicular cancer models, with no signs of liver injury or systemic toxicity detected in mouse and cynomolgus monkey studies.

“The clinical results of NBL-028 are highly anticipated and will drive breakthroughs in solid tumor therapy.” Li Han and the NovaRock team have high hopes for NBL-028,NBL-028 has also filed an Investigational New Drug (IND) application in China, and numerous companies worldwide have expressed interest in collaboration.

NBL-028 is a flagship product demonstrating the company’s efficiency and technological prowess, reflecting NovaRock’s corporate strategy:Leveraging our team’s expertise and technical advantages spanning target selection, antibody discovery, and process development, we rapidly advance our pipeline and further accelerate the development of antibody-based therapeutics through external collaborations and co-development initiatives.

In November 2020, NBL-012, a fully human antibody drug independently developed by NovaRock Biotherapeutics, received Investigational New Drug (IND) approval from the U.S. Food and Drug Administration, less than three years after the company’s establishment. NBL-012 is China’s first high-affinity, fully human IgG4 antibody targeting IL-23p19, indicated for the treatment of chronic inflammatory diseases such as psoriasis and inflammatory bowel disease.

Subsequently, in August 2021, NovaRock Biotherapeutics completed another overseas licensing deal. Amidst a crowded target landscape, the company entered into a strategic collaboration and licensing agreement with Flame Biosciences, valued at up to $460 million, granting the latter exclusive rights to develop, manufacture, and commercialize NBL-015, a fully human anti-Claudin 18.2 monoclonal antibody, outside of Greater China. NBL-015 is a second-generation eADCC monoclonal antibody featuring both high affinity and a favorable safety profile, holding promise as a best-in-class (BIC) therapeutic for gastric cancer. The company’s other pipeline assets have also attracted interest from numerous domestic and international partners, with several having already signed letters of intent for collaboration.

“Since its establishment a few years ago, NovaRock has built extensive connections with pharmaceutical companies in Europe and the United States, with multiple potential collaborations underway. We have been recognized by our Western peers as an ‘R&D engine for innovative antibody drugs,’ ” introduced Li Han. “While pursuing innovation and speed, we are also a team that places a high priority on quality, letting our products speak for themselves. Fast yet rigorous, because the fastest way to achieve our goals is to get it right the first time.”

Behind the surge in anticancer drugs lies the driving force of numerous Chinese scientists. In recent years, an increasing number of Chinese scientists have transcended traditional professional boundaries to become biotech entrepreneurs. Leveraging the agility of small companies and R&D teams, biotech firms enjoy smoother development processes. With their deep understanding of mature pharmaceutical markets such as those in Europe and the United States, small biotechs comprising just a dozen or so employees can secure partnerships and payments from large pharmaceutical companies. Particularly in the wake of the multi-year pandemic, many multinational corporations (MNCs) have faced significant gaps in their pipelines, prompting aggressive searches for high-quality assets and creating a wave of opportunities for biotech firms.

This is also an advantage of NovaRock Biotherapeutics. The company is located in New Jersey’s “Pharma Valley,” adjacent to multinational corporations (MNCs) and R&D centers, which enables it to be highly attuned to cutting-edge information and industry development trends, ensuring smooth information flow.Li Han boasts over 25 years of management experience in multinational corporations (MNCs) and biotechnology companies, along with an extensive professional network.

“In addition to our network, we are also quick to pick up on industry signals,” summarized Li Han. “Core team members come from BMS and Merck & Co., giving us access to the most cutting-edge concepts in tumor immunology, such as mobilizing the body’s own anti-tumor capabilities to combat solid tumors.”

NovaRock Biotherapeutics is maintaining close ties with New Jersey while also planning its establishment in China.Leveraging CSPC Pharmaceutical Group’s resources and clinical strengths, along with NovaRock Biotherapeutics’ inherent capabilities, the company will establish a strong presence in both China and the United States.

Currently, NovaRock Biotherapeutics has more than ten pipeline projects. The company plans to complete four Investigational New Drug (IND) applications (dual filings in China and the United States) and advance five candidates into clinical trials (including Phase I and Phase II studies) within the next two years. NBL-020, a TNFR2 antagonist antibody, entered clinical trials this year, with Professor Wu Yilong from Guangdong Provincial People’s Hospital—a renowned expert in tumor immunology and lung cancer—serving as the principal investigator. The TNFR2 inhibitor not only effectively blocks the binding of TNF to TNFR2, thereby inhibiting the proliferation and function of regulatory T cells (Tregs), but also selectively targets and kills tumor cells with high TNFR2 expression. Furthermore, it demonstrates excellent synergistic effects when combined with PD-1/PD-L1 inhibitors.

Li Han stated, “We firmly believe that the core value of our company lies in its products. NovaRock translates the most cutting-edge international scientific research findings on disease mechanisms and immunomodulation into innovative product platforms and project pipelines, with the hope of making greater contributions to patients in China and around the world.”