TAICHUNG, June 29, 2026 /PRNewswire/ -- Ever Supreme Bio Technology Co., Ltd. (TWSE: 6712) announced on June 28 that CAR001, its proprietarily developed, allogeneic, "off-the-shelf" CAR-T cell therapy for cancer, has successfully cleared review by the Safety Monitoring Committee (SMC). Following a thorough evaluation of the Phase I safety profile and preliminary efficacy data, the committee has greenlit the advancement to the Phase IIa clinical trial. This milestone marks the successful completion of the critical safety assessment during Phase I dose-escalation. CAR001 now officially enters the expanded efficacy validation phase, establishing a vital foundation for upcoming global licensing partnerships and multi-country, multi-center clinical trials.

Phase I Safety Benchmarks Achieved; Preliminary Efficacy Signals Observed in Solid Tumors

Traditional CAR-T therapies have long faced steep hurdles when treating solid tumors, primarily due to an inhibitory tumor microenvironment, the inability of CAR-T cells to effectively infiltrate solid tumors, and lingering safety concerns. Ever Supreme's CAR001 demonstrated an excellent safety profile in its Phase I clinical trial. Furthermore, it demonstrated clinically meaningful, preliminary efficacy signals in highly treatment-resistant solid tumors, including indications such as glioblastoma (GBM), a highly aggressive brain cancer, and microsatellite stable colorectal cancer (MSS CRC).

Notably, during the Phase I trial, a case of malignant brain cancer treated with CAR001 achieved a Complete Response (CR), meaning all detectable signs of the tumor disappeared. Additionally, a colorectal cancer patient showed a noticeable reduction in tumor size. These outcomes highlight the powerful development potential of CAR001 in tackling solid tumors.

Eliminating Pre-Treatment Chemotherapy to Preserve the Patient's Natural Immune Environment

The clinical design of CAR001 offers a distinct, highly differentiated competitive advantage: patients do not need to undergo lymphodepletion, a form of preparatory chemotherapy, before receiving the cell infusion. Historically, this preparatory chemo was required to clear out immune-suppressing cells, keep the introduced CAR-T cells from being accidentally destroyed by the patient's own body, and boost their survival rate. However, this chemo comes at a heavy cost, significantly increasing the patient's risk of infection and causing side effects like anemia, cytokine release syndrome (CRS), neurotoxicity, and general chemotherapy toxicity.

Ever Supreme points out that by eliminating the need for lymphodepletion, CAR001 vastly improves clinical convenience and spares patients from the physical burden and toxic risks of traditional chemo pre-treatment. Crucially, this approach preserves the patient's existing immune environment. This allows the bispecific T-cell engager (BiTE) mechanism secreted by CAR001 to actively recruit and bond with the patient's own T cells, creating a powerful, synergistic anti-tumor attack that significantly enhances the overall therapeutic effect.

An Allogeneic γδ T Cell Platform Built for Instant Supply and Commercial Mass Production

CAR001 utilizes healthy donor-derived, "allogeneic" gamma-delta T cells as its core cell source. Compared to the alpha-beta T cells used in traditional therapies, gamma-delta T cells carry a much lower risk of triggering Graft-versus-Host Disease (GvHD), making them exceptionally well-suited for development into "off-the-shelf" cell therapy products.

By leveraging this allogeneic cell platform, CAR001 bypasses the steep limitations of traditional, patient-specific (autologous) CAR-T therapies—such as inconsistent cell quality among severely ill patients, lengthy manufacturing wait times, and capped production capacity. Instead, CAR001 delivers the advantages of immediate "off-the-shelf" availability, commercial mass production, and vastly expanded clinical accessibility, fundamentally shifting the current landscape where solid tumor patients severely lack effective cell therapy options.

Initiating Phase IIa to Maximize International Licensing and Co-Development Value

According to Ever Supreme, the smooth clearance of CAR001 through the Phase I Safety Monitoring Committee signifies that the product is fully primed for expanded efficacy validation. The upcoming Phase IIa clinical trial will focus on accumulating vital data across key clinical benchmarks, including Objective Response Rate (ORR), Disease Control Rate (DCR), Duration of Response (DoR), and Overall Survival (OS).

When global pharmaceutical giants evaluate early-stage innovative therapies for licensing or co-development, they place immense weight on safety records, preliminary efficacy signals, commercial scalability, clinical convenience, and a clear regulatory pathway. Having already secured solid Phase I safety data and visible solid tumor efficacy, the continued accumulation of Phase IIa data will significantly elevate Ever Supreme's commercial leverage and valuation when negotiating licensing deals and partnerships with global pharma leaders.

Capitalizing on Taiwan's Regenerative Medicine Acts to Advance Conditional Approval Strategies

With the official implementation of Taiwan's twin Regenerative Medicine Acts, a strategic pathway has opened for life-threatening or severely disabling diseases. If a regenerative medicine product demonstrates exceptional safety and efficacy during clinical trials, developers can apply for a conditional, five-year drug approval under the new regulations.

Ever Supreme stated that following the official launch of the CAR001 Phase IIa trial, the company will aggressively push forward with clinical data collection. If subsequent trial results continue to support its safety and therapeutic potential, the company will actively evaluate the feasibility of applying for the conditional approval under Taiwan's Regenerative Medicine Products Act, aiming to accelerate the clinical rollout of the therapy and bring it to patients as quickly as possible.

Forging the Foundation for Global Multi-Country, Multi-Center Phase IIb Trials

Ever Supreme emphasized that the first-stage clinical results of CAR001 not only validate its safety and scientific innovation, but also provide a rock-solid cornerstone for future clinical enrollment expansion, international licensing, and global development strategies. The critical clinical data gathered during the Phase IIa trial will serve as the core evidence required to propel the asset into Phase IIb trials.

Looking ahead, based on the unfolding Phase IIa data results, the company plans to map out and launch global, multi-country, multi-center clinical trials. By actively pursuing licensing deals or co-development partnerships with international pharmaceutical companies, Ever Supreme aims to accelerate CAR001's clinical development across the global solid tumor market, ultimately delivering a groundbreaking new therapeutic option to cancer patients worldwide.

Media contact:
Ever Supreme Bio Technology Co., Ltd.
Sammi Hsu 許錦婷
cthsu@ever-supreme.com.tw