Qinghui Lianuo and Global Peers Advance γδ T-Cell Therapies with DCR Up to 100%, IND Approvals Surge Across Oncology and Autoimmune Indications

High-grade gliomas are one of the most aggressive malignant tumors of the central nervous system, among which glioblastoma has the highest incidence.(Accounting for approximately 50% of high-grade gliomas), the median overall survival of patients is only 14-16 months after diagnosis, and the expected survival after recurrence is just 6-8 months,The five-year survival rate is less than 7%., while traditional treatment methods are difficult to meet clinical needs, and there is an urgent need to develop innovative therapies to address the challenges.

QH104A pioneeringly integrates the natural anti-tumor properties of γδ T cells with the precise targeting advantages of CAR-T technology. It can recognize abnormal tumor metabolic products through the "γδ TCR-BTN-phosphoantigen" signaling pathway and specifically identify the highly expressed tumor antigen B7H3 through CAR, formingDual TargetingFunction, significantly enhancing anti-tumor efficacy and safety.

In terms of preparation, relying onFully enclosed semi-automated production process system, a breakthrough in the large-scale preparation of cellular drugs, significantly reducing the production cost per dose of cellular drugs, and supporting long-term cryopreservation in liquid nitrogen, thereby reducing patient waiting time.

At last year's European Society for Medical Oncology（ESMO）At the annual meeting, Qinghui Lianuo announced QH104 for the treatment of recurrent glioblastoma.（rGBM）First-in-human phase 1 clinical trial data of the patient, 7 patients with high-grade rGBM received more than 1 intrathecal infusion of QH104.Objective Response Rate（ORR）Was 42.9%, disease control rate（DCR）Reach 100%。

Globally, more than 10 companies have laid out in the γδ T cell field. Among them, TC BioPharm's OmnImmune is the most advanced.Already in Phase 2b/3, the overall progress abroad is faster than that in China. From the perspective of the R&D pipeline,The vast majority are universal γδ T, some also incorporate CAR technology for cell modification; from the perspective of indications, it mainly targets solid tumors, but also involves hematological tumors and autoimmune diseases.

▲ Representative pipelines of 12 global companies布局 γδ T 赛道企业的代表性管线

(Source: Yimaike Organization)

TC BioPharm's first off-the-shelf, unmodified allogeneic γδ T cell therapy, OmnImmune, is undergoing Phase 2b/3 clinical trials, following the Phase 1b/2a clinical data for the treatment of AML, which showed a complete remission rate.（CR）For 50%In February this year, TC BioPharm announced that the first patient in Cohort B of the ACHIEVE Phase 2B clinical trial of OmnImmune in the UK had completed dosing, with new data expected to be released this year.

IN8bio has multiple γδ T-cell therapy pipelines in clinical stages, mainly including INB-400, INB-200, and INB-100. This year's transplantation and cell therapy（TCT）At the meeting, IN8bio announced updated data from the Phase 1 clinical trial of its universal γδ T cell therapy, INB-100.

As of January 17, 2025, 100% of AML patients treated with INB-100 remained relapse-free, with a median follow-up time of 20.1 months;1-Year Progression-Free Survival Rate for All Leukemia Patients（PFS）Was 90.9%, 1-year overall survival rate（OS）For 100%, all of which are better than the historical controls in the real world; the overall safety is good.

In May this year, Adicet Bio released its first-quarter financial report and reported progress on its pipeline products ADI-001 and ADI-270. ADI-001 is a universal CAR-γδ T cell therapy targeting CD20.Intended for the treatment of six autoimmune diseases, with preliminary clinical data expected to be released in the second half of this year. In February this year, ADI-001 was granted Fast Track designation by the FDA for the potential treatment of adult refractory systemic lupus erythematosus with extrarenal involvement.（SLE ）Patient.

ADI-270 is a universal CAR-γδ T cell therapy targeting CD70, aimed at metastatic/advanced clear cell renal cell carcinoma, and is currently in Phase 1 clinical trials.

In April this year, BoSunGene developed a universal CAR-T targeting CD19 based on Vδ1T cells.(Research and Development Code: UTAA09 Injection)Clinical trial application approved by CDE for adult relapsed/refractory acute B lymphoblastic leukemia.（B-ALL）。

UTAA09 Injection is filed by Boehringer Ingelheim.The FirstUniversal CAR-T cell therapy, the product under development is a UCAR-Vδ1T cell therapy prepared from healthy donor apheresis as the starting raw material. Reportedly, this is also the first of its kind globally.First Approved INDThe universal off-the-shelf CD19-UCAR-Vδ1T cell therapy.

In March, the strategic cooperation project promotion meeting between Ji De Kang Min and Shanghai Tenth People's Hospital was successfully held. Ji De Kang Min plans to rely on its independently developed γδ T immune cell therapy technology, combined with the top clinical resources and scientific research capabilities of Shanghai Tenth People's Hospital in the field of urological tumors.Focus on advancing solid tumors such as bladder cancerCell therapy clinical research and indication applications. Its self-developed "γδ T Cell Injection" obtained clinical trial tacit approval from the CDE in April 2024.

Linglu Pharma once attended the 27th Annual Meeting of the American Society of Gene and Cell Therapy in 2024.（ASGCT）Displayed at the annual meetingAllogeneic γδ T Platform, capable of generating effective Vδ2-T cells and a unique subset of Vδ1-T cells with high expression of CD107, granzyme B, IFN-γ, and IL-2.

At the same time, researchers have demonstrated that CAR γδ-T cells can effectively control tumor growth in NSG mouse models. According to Zhang Xiaolei, co-founder and CEO of Overland Pharmaceuticals, the technology platform will focus more on the field of autoimmune diseases.

Notably, the development of γδ T cell therapy is also becoming increasingly diversified. In April this year, researchers from the Li Ka Shing Faculty of Medicine at the University of Hong Kong successfully developed a new therapy namedPhotosensitive Hybrid γδ-T Cell Exosomes(Hybrid γδ-T-Exos)A novel therapy, which is γδ T cell exosome therapy combined with photodynamic treatment.（PDT）ofFirst Innovative Combination。

γδ T cell exosomes can inhibit tumor progression by inducing apoptosis and enhancing anti-tumor T cell immune responses, possessing dual characteristics of a tumor vaccine and drug carrier. PDT involves the activation of photosensitizers to produce reactive oxygen species through light.（ROS）A minimally invasive treatment approach that targets cancer cells has demonstrated definitive efficacy against melanoma. In preclinical studies, the candidate therapy not only showed significant effectiveness but also exhibited good safety.

Overall, the field of γδ T cell therapy has shown a vigorous development trend since the beginning of this year.MoreItemResearch results and clinical progress continue to emerge.At the same time, the rapid iteration and innovation of technology, such as the application of gene editing technology in γδ T cell therapy, continue to deepen, enabling γδ T cells to better exert their anti-tumor and immune-regulating functions.

However, γδ T cell therapy also faces some challenges during its development. For example, γδ T cells in the bodyPersistence IssuesIt still remains to be further addressed. How to ensure that it can maintain activity and function for a long time after being reinfused into the patient is one of the key focuses of current research. Moreover, although γδ T cell therapy generally has good safety,There are still some potential adverse reactions., such as cytokine release syndrome, require further optimization of treatment plans to reduce risks.

Looking ahead, with the advancement of various clinical trials and continuous technological innovation, γδ T cell therapy is expected to achieve breakthroughs in more disease treatment areas. In cancer treatment and autoimmune diseases,Expand the Types of IndicationsAt the same time, with the continuous maturation of the industry and the reduction of costs, γδ T cell therapy is expected to be more widely applied in clinical settings, providing more patients with personalized and precise treatment services, and becoming one of the important directions for the future development of medicine.

Editorial Responsibility | Xun, Yong

Proofread by Xun

References:

1.Official Websites of Various Enterprises

Exciting Live Broadcast Preview

Press and hold to scan the QR code and participate immediately ↓

Swipe up to view

Recommendation 1

June 4th, 14:00-15:00

Controlled Ice Cryopreservation Technology Provides Efficient and Safe Precision Cryopreservation Solutions for Cell Therapy

Recommendation 2

June 5th, 19:00-20:30

Focus on the Biosafety and Quality Control Innovation of AAV Gene Therapy Products

Statement and Copyright Notice

Disclaimer: This article aims to convey industry development information and explore the cutting-edge progress in biomedicine. The content of the article represents the author's viewpoint and does not represent the position of EMedClub, nor does it constitute any value judgment, investment advice, or medical guidance. If necessary, please consult a professional for investment or visit a正规 hospital for medical advice.

Copyright Notice:Welcome to share the article on your personal Moments, but unauthorized reproduction by media or organizations in any form to other platforms is prohibited. If you need to reproduce it, please leave a message under the article to obtain authorization.

Dian Dian "Share”、“Like"And"In View"，Give me a little charge~