Fengxun Bio Announces Upcoming IIT for In Vivo CAR-T Therapy GI-001 Developed from Shanghai Jiao Tong University Professor Cai Yujia's Pioneering Research

In the industry context where technical innovators and BD dominate, the core question for in vivo CAR-T is "What do MNCs want?".

Based on past BD observations and MNC communications, Dr. Kaikai Shi, founder and CEO of DeliNova Therapeutics, believes thatDue to the limited clinical data available recently, BD focuses on platform modification and technical pathway discussions. MNCs are looking to buy platforms—one or more—and through integration, validate a feasible technical pathway. This also means there are still many opportunities left for early-stage biotech companies.

"In 2025, nearly a hundred related Biotechs suddenly emerged in China." Dr. Shi Kaikai pointed out that the surge in numbers contradicts the quality of innovative targets — on one hand, the entire field is still in a very early stage of technological breakthroughs, and more efforts are needed in terms of drugability, efficacy, and safety. However, driven by several large BD deals from MNCs, hot money quickly flowed in. The platform construction and technical approaches of various companies are still 'Eight Immortals crossing the sea, each showing their magic powers.' Most companies are still working on being part of the 'denominator.'

On the other hand, three groups quickly joined the competition for in-vivo CAR-T — traditional CAR-T R&D Biotech companies; Biotechs following the LNP and mRNA technology pathways; and Biotechs with accumulated expertise in in-vivo delivery technologies, building in-vivo CAR-T from scratch.

DeliNova Therapeutics belongs to the third type. In May 2025, Dr. Kaikai Shi and Professor Yujia Cai from Shanghai Jiao Tong University's "In Vivo CAR-T Therapy" team officially established Nantong DeliNova Biotechnology Co., Ltd. (hereinafter referred to as "DeliNova Therapeutics").In just half a yearCompleted seed and angel rounds of financing, with investors includingHanyuan Asset (Shanghai Jiaotong University Mother Fund), Legend Capital, CAS Star, etc.

Amid the热潮, how did DeliNova Therapeutics build a Biotech team from scratch and advance its first pipeline to initiate an IIT within half a year? What are the unique aspects of its in vivo CAR-T technology approach? During the third stop of the "Path to Innovation and Leap in China's Biotechnology"硬科技media tour by CAS Star, VCBeat spoke with Dr. KaiKai Shi in Shanghai.

It is already the depth of winter in December, but places where college students and innovative forces gather are always full of vitality and clear skies.

DeliNova Therapeutics' Shanghai office is located in the Yunjing·Future 443 Park, just a 15-minute walk from Shanghai Jiao Tong University. This is an emerging industrial park transformed from old factories, situated in the core area of Minhang District's "Greater Zero Bay" development zone, next to the expanding Dongchuan Road Station on Line 5.

As a young top talent selected by the Organization Department of the CPC Central Committee, Professor Cai Yujia has been deeply engaged in virus vector modification and in vivo gene editing for nearly 20 years. He currently serves as a researcher and assistant dean at the Institute of Systems Biomedicine, Shanghai Jiao Tong University, and as the deputy director of the Shanghai Key Laboratory of Hematological Disease Gene Editing and Cellular Immunotherapy. Based on his pioneering virus-like particle (VLP) delivery technology, he founded BDgene, achieving major breakthroughs such as the world's first clinical application of in vivo gene editing against viruses. Since 2017, his lab has been laying the groundwork for in vivo CAR-T cell therapy, establishing a solid technical foundation for DeliNova Therapeutics' virus vector modifications.

Dr. Shi Kaikai has over 10 years of biopharmaceutical R&D experience in regenerative medicine and the CGT field. After returning to China in 2018, he joined a medical investment institution, leading investments in more than 10 early-stage biotech companies and participating as a founding member in their "from 0 to 1" deep incubation and establishment. Bendgene was also on his list of targets.

However, this is not the first encounter between Professor Cai Yujia and Dr. Shi Kaikai. As early as 2014, both were in Denmark, researching gene therapy and gene editing.Professor Yujia Cai during his postdoc and Kaikai Shi during his Ph.D. studies had already collaborated on research.

"Timing is crucial." In 2024, Professor Cai believed that the time for the transformation of in vivo CAR-T had arrived. He quickly connected with Shi Kaikai, who has a deep understanding of scientists' entrepreneurship, Biotech management, and investment financing. This led to the launch of DeliNova Therapeutics.

In-vivo CAR-T simplifies cancer treatment into an "off-the-shelf" solution by directly completing T-cell genetic modification and activation within the patient through a single intravenous injection of a vector (viral or non-viral), eliminating the need for ex vivo culture and lymphodepletion pretreatment.

Its core advantage lies in simplifying the treatment process into a single 30-minute intravenous infusion, eliminating the need for patients to endure long waits and avoiding the risk of disease progression that may occur during the traditional CAR-T therapy’s 2-4 week preparation period. Meanwhile, the "universal solution" will also significantly reduce the costs of production, transportation, and clinical application, bringing down the treatment price.

What remains unchanged is that the technical difficulties and drugability of CAR-T in the body still lie in the delivery vector. DeliNova Therapeutics' technical approach is,Precisely Engineered Lentiviral Vector。

Shi Kaikai mentioned that there are several major pain points in the development of in vivo CAR-T: "First, how to enable the virus to enter the body more stably; second, how to make it achieve highly efficient targeting and membrane fusion; and third, how to maintain T-cell activation, transduction, expansion, and persistence in the body while ensuring the strong killing function of T cells."

Specifically, DeliNova Therapeutics has built"Multi-Dimensional" Engineered Viral Vector Modification and T Cell-Specific Delivery Platform：

Through serum resistance mutation modification, the stability and transduction efficiency of viral vectors in vivo are significantly improved, ensuring therapeutic efficacy while reducing peripheral toxicity.

Efficiently activate resting T cells and promote their expansion, generating a population of stem cell-like memory T cells with long-lasting killing ability;

Solving the problem of CAR transmembrane leakage during lentivirus production, avoiding binding with non-target cells in the body, and improving targeting specificity.

Reduce the risk of viral random insertion and improve safety

Ensure a significant reduction in treatment costs.

In December, DeliNova Therapeutics' first pipeline, GI-001, has completed preclinical key validation and is about to launch an IIT clinical trial in the near future.It is reported that GI-001 targets the classical target CD19 and is used for treating hematological tumors such as relapsed/refractory B-cell acute lymphoblastic leukemia (R/R B-ALL). Shi Kaikai mentioned, "The clinical role of the first pipeline is to validate the effectiveness of our self-developed integrated lentiviral delivery platform. Therefore, we hope to minimize variables and obtain a series of clinical data on efficacy, safety, and toxicity, which will then help advance the pipeline portfolio."

Preclinical study data confirmed that GI-001, with four core advantages, demonstrates strong clinical application potential:

· Targeted PrecisionShowing outstanding performance, it specifically targets CD3-positive T cells, posing almost no infection risk to non-target cells, effectively avoiding off-target toxicity from the source.

· Transduction efficiencySignificantly superior to similar competing products, even with low-dose administration, it can efficiently generate a sufficient amount of functional CAR-T cells in the body, laying a solid foundation for therapeutic efficacy.

· Core EfficacyGI-001 demonstrates potent tumor clearance capabilities, not only achieving rapid tumor control in animal models but also significantly improving long-term survival rates of the subjects.

· SafetySignificant breakthroughs have been made, with the incidence of adverse reactions such as cytokine release syndrome (CRS) being much lower than traditional CAR-T, providing more reliable assurance for clinical applications.

"Clinical Translation with an End-in-Mind Approach"It is the underlying logic of its pipeline matrix construction — the traditional CAR-T has already accumulated rich experience in tumor target points. The team communicates with frontline principal investigators (PIs) to identify mature target points with potential positive responses for development. Meanwhile, to address issues such as the tumor immune microenvironment and T-cell exhaustion, DeliNova Therapeutics has established a differentiated solid tumor delivery platform.

Currently, DeliNova Therapeutics has established a diversified R&D pipeline covering hematological tumors, solid tumors, autoimmune diseases, and more, with several products "First-in-class" or "Best-in-class" potential.For Solid Tumors(Lung Cancer)The GI-002 program is scheduled to initiate IIT trials in the first half of 2026.In addition, multiple candidate drugs targeting non-tumor-related diseases have been developed.

“Theoretically, the progressive process of CAR-T cells in the body may provide the organism with a longer adaptation time and better adaptability.——It enters the body through a carrier, first seeking T cells in the body, then proceeding with membrane fusion, CAR expression, and subsequently generating CAR-T. In terms of pharmacokinetics, the in vivo CAR-T from viral systems tends to lag slightly compared to LNP.

Shi Kaikai emphasized, "However, whether it’s LNP or viral vectors, both enter the body as foreign substances, and their toxic side effects still need to be closely monitored. From the perspective of molecular design and frontline clinical practice, how can we improve preventive medication? Creating adaptive windows is a goal that still has a long way to go."

But Biotech needs to get moving on its entrepreneurial journey — years of biopharmaceutical investment experience have made Shi Kaikai realize that after laying a solid technical foundation, money, talent, and timing are all indispensable.

Since its establishment in May 2025, DeliNova Therapeutics has demonstrated a rare advancement speed for a Biotech company: completing rounds of financing in June, July, and August; advancing the technology platform through laboratory transfer and validation; and building an "industry-level" team covering the entire process from early molecule discovery, preclinical research to CGT registration and medical clinical trials.

Shi Kaikai said, "In the process, DeliNova Therapeutics also encountered many knowledgeable and like-minded investors. For example, Dr. Lei Mi from Zhongke Chuangxing, I used cutting-edge technology to achieve a breakthrough -"The 'short-term' BD high-return exit path came to pitch. On the contrary, he advised me that there are no shortcuts in drug development. It’s important to do it well, even if it takes a bit longer. Bumps along the way are normal, and Zhongke Chuangxing is a partner that can provide continuous support."

Unlike the "me too/me better" narrative of traditional CAR-T, the script for the in vivo CAR-T trend is — Chinese innovation breaking into the global market with FIC and BIC. Globally, Biotechs focusing on in vivo CAR-T have just entered human trials or preliminary human data stages.In other words, this time we are on the same starting line.

However, going from 0 to 1 means more time and more validation are needed. We need to give in vivo CAR-T more patience.