Ever Supreme's Allogeneic Solid Tumor CAR-T CAR001 Advances to Phase IIa, Targets 2028 Taiwan Provisional Approval
核心洞察
Ever Supreme BioTechnology (搜索)'s allogeneic solid tumor CAR-T therapy CAR001 has advanced from Phase I to Phase IIa, with the first patient enrolled and a target to complete the trial in 2027.
Phase I data showed a recurrent glioblastoma (搜索) patient achieving complete response with remission maintained through one year, and a colorectal cancer (搜索) patient achieving partial response with 72.8% tumor shrinkage.
None of the 15 Phase I patients experienced Grade 2 or higher CRS, ICANS, or GvHD, underscoring a favorable safety profile for the off-the-shelf γδ T cell (搜索) platform.
Ever Supreme BioTechnology (搜索)'s allogeneic solid tumor CAR-T therapy CAR001 has officially transitioned from Phase I to Phase IIa, with management for the first time providing a concrete regulatory timeline: complete the Phase IIa trial in 2027 and apply to the Taiwan FDA for a five-year provisional drug approval in 2028. The announcement came during the company's FY2026 Q2 earnings call at the Taipei Exchange, where Chairman Liu Chu-Chi framed the milestone with a slide from eight years prior: "Eight years ago we said 'we are about to use cells to treat disease.' Now we are already using cells to treat disease."
CAR001 has successfully passed review by the Safety Monitoring Committee (SMC) after completing the US FDA- and Taiwan TFDA-approved Phase 1 dose-escalation trial, and has officially entered the efficacy-validation stage of the Phase 2a clinical trial with the first patient enrolled.
Phase I Efficacy Signals in Solid Tumors
The most compelling data presented involved individual Phase I case results. Among 15 subjects, one end-stage brain tumor (glioblastoma (搜索)) patient achieved complete tumor disappearance after treatment and has been followed for 382 days as of publication. Liu Chu-Chi described the patient's current condition: "He was originally bedridden. Now he can get up and go to work. After more than a year of follow-up, the tumor has completely disappeared."
A second patient with end-stage colorectal cancer (搜索) saw the tumor marker CEA decline significantly after the first dose, with tumor shrinkage of 72.8% after three months. The company separately reported that a patient with microsatellite-stable colorectal cancer (MSS CRC) achieved partial response (PR), while a patient with recurrent glioblastoma (搜索) (GBM) achieved complete response (CR), maintaining remission through one year of follow-up.
Favorable Safety Profile
Safety data was described as equally impressive: none of the 15 patients experienced Grade 2 or higher cytokine release syndrome (CRS), immune effector cell-associated neurotoxicity syndrome (ICANS), or graft-versus-host disease (GvHD). Liu Chu-Chi noted that the team had originally expected more severe side effects but only observed mild fever in practice. The company also reported that CAR001 demonstrated no observed dose-limiting toxicities (DLT) in the Phase 1 trial.
Allogeneic γδ T Cell Platform
CAR001's core technology relies on γδ T cells to enable allogeneic application. Liu Chu-Chi explained: "These cells do not cause rejection, but they account for a very low proportion of our T cells — roughly 1% to 10%. Ever Supreme's technology can amplify the non-rejecting portion to over 98.2%, while reducing the rejecting αβ T cells to below 0.014." Combined with HLA-G (搜索) targeting and bispecific antibody design, CAR001 simultaneously possesses three key attributes: allogeneic, solid tumor, and low cost.
Compared to traditional autologous CAR-T therapies, the off-the-shelf platform eliminates the need for individualized manufacturing time, improves product consistency, and offers scale-up production potential, substantially increasing patient access to treatment.
Competitive Landscape and Licensing Expectations
Management highlighted the global competitive landscape for allogeneic solid tumor CAR-T. Currently, only one Chinese company has an autologous solid tumor CAR-T on the market, while there are only four players in allogeneic solid tumor CAR-T: Ever Supreme, one Singapore-based company, and two U.S. companies — the latter three are all still in preclinical or Phase I stages, with Ever Supreme being the furthest along.
On licensing valuation, Liu Chu-Chi cited the $1 billion CAR-T licensing deal that Novartis granted Legend Biotech in 2023 as an anchor: "Ever Supreme can not only treat solid tumors but also manufacture using allogeneic cells. I believe our technology transfer fee should be worth more than $1 billion."
General Manager Huang Wen-Liang added specific timing judgment during Q&A: "Several major international pharmaceutical companies are currently in contact. They prefer to see safety data and efficacy results. After Phase IIa is completed next year, there is a greater chance of initiating substantive licensing negotiations within the following 1-2 years."
Orphan Drug Designation for GBM
Given that GBM is the most common and most aggressive primary malignant brain tumor in adults with an extremely poor clinical prognosis, Ever Supreme Bio has actively initiated the US FDA orphan drug designation (ODD) application for CAR001 targeting the GBM indication. If granted, the company would benefit from accelerated regulatory review, tax incentives, and market exclusivity.
Expanding Pipeline and CDMO Engine
The company's other self-developed allogeneic, off-the-shelf CAR-T cell therapy drug candidate, CA002, has also completed US- and Taiwan-approved Phase 1 dose-escalation trials, passed SMC review, and officially entered the Phase 2a efficacy-validation stage with its first patient enrolled.
Beyond CAR-T, the exosome platform represented a second major theme. The targeted exosome drug dEV-001 (搜索) (Parkinson's disease (搜索)) has completed animal studies and held a pre-IND meeting with the U.S. FDA, with plans to file an IND and initiate Phase I/IIa in 2027. Another candidate, EXO-001 (in-vivo CAR-T), remains preclinical but has demonstrated dose-dependent anti-tumor efficacy in animal studies.
Financially, the company's CDMO business continues to provide cash flow to support new drug R&D. July 2026 revenue reached approximately NT$99.25 million (about $3.1 million), up 20.72% year-over-year and 5.72% month-over-month, setting a new monthly high. First-half 2026 revenue, operating income, pre-tax profit, and net profit all grew approximately 25% year-over-year, with gross margin rising from 72% to 78%.