Why Imugene is using a virus to “mark” tumors for CAR-T attack—and what JW Therapeutics brings to the table

Clinical-stage immuno-oncology company Imugene Ltd (ASX: IMU) has entered into a co-development agreement with JW Therapeutics (HKEX: 2126) to investigate whether its oncolytic virus-based platform can unlock the next frontier in cancer cell therapy: treating solid tumors with CD19-directed CAR-T therapies. The collaboration, announced on November 27, 2025, will evaluate the combination of Imugene’s CF33-CD19 oncolytic virus, also referred to as onCARlytics, with JW Therapeutics’ commercial CD19 autologous CAR-T cell therapy, Carteyva, in patients with refractory solid tumors.

The partnership will begin with a series of preclinical studies followed by a Phase 1 investigator-initiated trial in China. This clinical trial will be conducted across top-tier CAR-T clinical centers in the country. The central concept being explored is a “mark and kill” approach, whereby the oncolytic virus forces tumor cells to express CD19, thereby making them susceptible to destruction by CD19-targeted CAR-T cells. This is considered a potentially transformative strategy that may allow existing CAR-T therapies to expand into new treatment landscapes beyond blood cancers.

Why Imugene and JW Therapeutics are testing CAR-T in solid tumors with a virus-induced CD19 target

Imugene’s CF33-CD19 is derived from the company’s onCARlytics platform, which utilizes genetically engineered oncolytic viruses to not only lyse tumor cells but also manipulate their surface markers. In this specific application, the virus is designed to make tumor cells express CD19, a surface antigen that is typically absent in solid tumors but commonly present in certain types of blood cancers.

The goal is to use the virus to make solid tumors visible to CD19 CAR-T therapies, such as JW Therapeutics’ Carteyva. Once the tumor cells begin expressing CD19, they can be recognized and eliminated by CAR-T cells that were originally engineered to target blood cancers. The ability to redirect CD19-targeted CAR-Ts toward solid tumors without altering the CAR-T product itself represents a major innovation in the field of cancer immunotherapy.

Imugene’s Managing Director and Chief Executive Officer Leslie Chong said that this collaboration offers a high-efficiency pathway to test the clinical potential of the company’s onCARlytics platform. She explained that Carteyva is already approved for hematologic malignancies, making it an ideal candidate to assess the safety and efficacy of this novel combination in solid tumors.

The trial will focus on a subset of cancers classified as “difficult-to-treat” based on their immunologic inaccessibility, aggressive growth, or resistance to other therapies. According to both companies, the decision to anchor the trial in China also reflects the country’s growing infrastructure and patient pool for CAR-T development.

How Carteyva and CF33-CD19 combine to execute a “mark and kill” approach

Carteyva is JW Therapeutics’ lead product and a CD19-directed autologous CAR-T therapy that has already received regulatory approval in China for relapsed or refractory B-cell lymphoma. The therapy uses a patient’s own immune cells, genetically engineered to recognize and destroy cells that express CD19.

On its own, Carteyva would not be able to target solid tumors, which typically lack CD19 expression. However, Imugene’s CF33-CD19 virus serves as the molecular bridge. It infects the tumor and triggers the expression of CD19 on the cancer cell surface. This turns the tumor into a target that Carteyva can then recognize and attack.

By combining a clinically approved CAR-T therapy with a tumor-modifying oncolytic virus, the two firms aim to test a new treatment paradigm that bypasses the need to engineer tumor-specific CAR-Ts for every type of cancer. This modularity could potentially open the door for off-the-shelf application of CD19 CAR-T products across multiple solid tumor indications, provided the virus delivery and antigen expression are effective and safe.

The partnership will include clearly defined milestones and go/no-go decision points based on safety, immunogenicity, and preliminary efficacy data. These checkpoints are designed to ensure capital discipline and development efficiency.

Why Asia’s clinical infrastructure is key to the first trial of this solid tumor CAR-T strategy

The trial will be conducted as an investigator-initiated study at major CAR-T centers in China, leveraging JW Therapeutics’ deep network of clinical sites and regulatory familiarity in the region. Since its founding in 2016, JW Therapeutics has established a vertically integrated platform for cell immunotherapy that spans research, development, manufacturing, and commercialization.

This infrastructure allows for rapid trial activation and patient recruitment, especially in hematologic oncology where CAR-T treatment protocols are now standardized. Solid tumors, however, remain a largely unmet need within the CAR-T landscape, with no approved CAR-T products for solid tumor indications as of late 2025.

Imugene, headquartered in Australia, brings its own clinical development expertise and virotherapy platforms to the collaboration. The CF33 platform has already been tested in multiple trials, with various payloads such as immune-modulating transgenes and tumor-selective promoters. This new collaboration allows Imugene to expand its clinical footprint into Asia while generating first-in-human data on its virus-induced CD19 strategy.

What this means for the future of off-the-shelf CAR-T and immunotherapy combinations

The broader implication of this trial lies in validating a new logic for CAR-T combinations. Instead of building increasingly complex CAR constructs to match the antigenic diversity of solid tumors, this approach flips the script: engineer the tumor to fit existing CAR-Ts.

Analysts tracking the immuno-oncology sector view this modularity as an important potential unlock in reducing the cost, complexity, and regulatory burden of CAR-T development for solid tumors. If Imugene’s virus can reliably and safely induce CD19 expression in tumors, it may become a gateway for multiple CD19 CAR-T products to be repurposed or expanded across indications.

This is particularly significant in regions where existing CAR-T platforms like Carteyva are already scaled for manufacturing and logistics. Companies would not need to reinvent the wheel for every tumor type, but could instead use a viral platform to “standardize” the tumors to match pre-existing therapies.

That said, there are biological and clinical hurdles. Inducing CD19 expression must not trigger autoimmune responses, and the expression must be sustained long enough for the CAR-T cells to recognize and kill the tumor. There are also questions about tumor heterogeneity and whether all tumor cells within a mass can be uniformly infected and marked.

How investors and analysts are viewing the Imugene–JW Therapeutics announcement

Following the announcement, Imugene shares on the Australian Securities Exchange (ASX: IMU) remained largely stable, with investors awaiting further updates on trial timelines and regulatory approvals for the investigator-initiated study. The announcement did not include specific timelines for dosing or expected readouts, though preclinical work is expected to begin in the near term.

JW Therapeutics, which trades on the Hong Kong Stock Exchange under the ticker HKEX: 2126, has seen modest trading volume increases since the collaboration was disclosed. Market sentiment toward JW Therapeutics has been mixed in 2025, amid a broader pullback in Chinese biotech stocks, but the collaboration is being seen by some institutional investors as a signal of renewed strategic focus.

Analysts who follow the sector noted that the structure of the collaboration with milestone-based progression and preclinical safety gating demonstrates capital discipline and realistic expectations. Several viewed the use of an already approved CAR-T product in combination with a virus as an efficient de-risking mechanism, compared to building new CARs from scratch.

However, sentiment remains cautious until in vivo data confirms the feasibility of inducing CD19 in human tumor models. The potential for clinical expansion into global markets will depend heavily on the outcomes of this initial trial in China.

What are the key takeaways from the Imugene–JW Therapeutics solid tumor CAR-T collaboration?

• Imugene Ltd (ASX: IMU) and JW Therapeutics (HKEX: 2126) have entered into a strategic collaboration to explore a novel immunotherapy approach targeting solid tumors.

• The partnership combines Imugene’s CF33-CD19 oncolytic virus (onCARlytics) with JW Therapeutics’ CD19-directed CAR-T therapy, Carteyva®, which is already approved in China for blood cancers.

• The goal is to make solid tumors express CD19 using the oncolytic virus, enabling Carteyva to recognize and kill those tumor cells using a “mark and kill” mechanism.

• Preclinical in vitro and in vivo studies will be followed by a Phase 1 investigator-initiated trial conducted at premier CAR-T centers in China.

• This strategy aims to repurpose existing CD19 CAR-T products for new indications, avoiding the need to develop custom CAR-Ts for every tumor type.

• The trial design includes clear go/no-go decision points and milestones for capital discipline and strategic flexibility.

• Imugene aims to validate its onCARlytics platform, while JW Therapeutics leverages its clinical infrastructure to expand into solid tumor applications.

• Investor sentiment is cautiously optimistic, with market analysts highlighting the potential to unlock broader commercial value from first-generation CAR-T assets.

• The outcome of this trial could significantly influence future strategies in modular CAR-T development and oncolytic virotherapy combinations.

• Success could position the partnership as a pioneer in converting traditionally CAR-T-resistant tumors into targetable forms using synthetic viral engineering.