av中文在线中文亚洲-av中文字幕-av中文字幕不卡无码-av中文字幕潮-av中文字幕潮喷在线-av中文字幕第一

GenFleet Therapeutics Receives Clinical Trial Approval from China’s NMPA for GFS202A, a Bispecific Antibody Targeting GDF15 and IL-6, in a Phase I Study Treating Cancer Cachexia Patients

Mar 12, 2025
Share

GenFleet Therapeutics, a commercial-stage biotechnology company focusing on cutting-edge therapies in oncology and immunology, announced Chinas National Medical Products Administration has approved the clinical trial application for GFS202A in an open-label, multi-center phase I study treating cancer patients with precachexia and cachexia. Cachexia is highly prevalent in cancer, and it severely affects patients survival rate and tolerance to cancer treatments. Extensive research conducted worldwide has identified the key roles of GDF15 and IL-6 in the progression of cachexia. To date, no therapies targeting both GDF15 and IL-6 have been approved in the world, and GFS202A is the first China-developed GDF15-targeted therapy entering clinical stage.

The trial will take place at multiple sites including the prestigious Sun Yat-sen University Cancer Center in Guangdong, China. The phase I study aims to evaluate the safety/tolerability of GFS202A among trial participants, and to determine the maximum tolerated dose (MTD) and the recommended phase II dose (RP2D). Additionally, the study will assess GFS202A's pharmacokinetic profile, and its impact on improving body weight and appetite.

According to preclinical research, GFS202A exhibits high affinity and specificity for binding to GDF15 and IL-6, thus enabling potent inhibition of their signaling pathways. Body weight, adipose tissue and muscle mass also increase dose-dependently in animal models; notably, GFS202A effectively reduces animal models C-reactive protein level and alleviates inflammatory responses.

We are delighted at the clinical trial approval for GFS202A developed by GenFleet. Cancer cachexia is highly prevalent in numerous tumor types and most patients rely on nutritional support or hormone therapies, thus leaving crucial unmet clinical need. In recent years, we are excited to see a variety of GDF15 antibodies entering clinical trials globally. We look forward to more novel treatments benefiting global patients and anticipate this GDF15/IL-6 bispecific antibody to demonstrate good safety and efficacy in the study.stated Professor Li Zhang, Sun Yat-sen University Cancer Center.

Cachexia is a complex disease characterized by debilitating symptoms including disrupted metabolic regulation, substantial weight loss, and progressive muscle breakdown. Cachexia occurs frequently in chronic conditions such as cancer, AIDS, heart failure, chronic obstructive pulmonary disease (COPD), and chronic nephritis. The prevalence of cachexia exceeds 50% in certain cancer types and contributes to a mortality rate of up to 30%. Overexpression of GDF15 and IL-6, commonly observed in cachexia, is relevant to significant morbidity and mortality among cancer patients.

Overseas clinical studies of GDF15 antibodies have achieved proof of concept, validating the improvement of cachexia symptoms through GDF15 inhibition. Furthermore, animal experiments and clinical reports both indicate that the systemic inhibition of IL-6/IL-6R improves weight loss and reduces inflammatory responses. GFS202A thereby holds the potential to enhance therapeutic efficacy through a dual-target approach, mitigating the inflammatory responses and the adverse effects from cancer treatments.

GFS202A is the first bispecific antibody to reach the clinical stage in GenFleets pipeline. The development of this product is firmly grounded in robust mechanistic exploration and innovative molecular design, and we have seen encouraging efficacy and tolerability of GFS202A in preclinical research. Preliminary validation has been achieved for GDF15 antibodies in overseas clinical studies; given the correlation between cachexia and inflammation, as well as the complexity of this metabolic syndrome, IL-6 is selected as another target for our bispecific antibody. We eagerly expect GFS202A to deliver superior safety and efficacy through its dual-target synergistic mechanism in the upcoming trial.stated Yu Wang, M.D.,Ph.D., Chief Medical Officer of GenFleet.

References: 

1. Impact of Serum GDF-15 and IL-6 on Immunotherapy Response in Cancer: A Prospective Study, Cancers, Dec. 2024

2. Body composition and lung cancer-associated cachexia in TRACERx, Nature Medicine, Apr. 2023

3. Perturbed BMP signaling and denervation promote muscle wasting in cancer cachexia, Science Translational Medicine, Aug. 2021

4. Definition and classification of cancer cachexia: an international consensus, Lancet Oncology, Feb. 2011

About GDF15, IL-6 and GFS202A

GDF15 (Growth Differentiation Factor-15) is a member of the TGF-β (Transforming Growth Factor-beta) superfamily of proteins, while the glial cell-derived neurotrophic factor receptor alpha (GFRAL) is the specific receptor for GDF-15. Numerous studies have indicated that the level of GDF-15 is significantly elevated in cancer patients. GDF-15 can activate downstream signaling pathways, thereby promoting growth, migration, and proliferation of cancer cells. Additionally, it inhibits DC (dendritic cell)-mediated T-cell stimulation and the activation and infiltration of cytotoxic T cells.

IL-6 (Interleukin-6) is a member of the glycoprotein 130 (gp130) family. IL-6 can enter the central nervous system and, through the hypothalamic-pituitary-adrenal (HPA) axis and the hypothalamic-pituitary-gonadal (HPG) axis, induce atrophy in peripheral tissues such as muscle. It can also act peripherally by activating the JAK/STAT and MAPK signaling pathways, inducing apoptosis in skeletal muscle cells and the breakdown of adipose tissue. Persistent high levels of IL-6 are strongly associated with shorter survival.

In preclinical research of GFS202A (a GDF15/IL-6 bispecific antibody), the body weight, adipose tissue and muscle mass increase dose-dependently in animal models; notably, GFS202A effectively reduces C-reactive protein levels and alleviates inflammatory responses. GFS202A also demonstrated favorable safety/tolerability profile in preclinical animal studies.

About Cachexia

Cachexia is a complex disease characterized by debilitating symptoms including disrupted metabolic regulation, significant weight loss, and progressive muscle breakdown. It is commonly observed in chronic conditions such as cancer, chronic obstructive pulmonary disease (COPD), and chronic nephritis. Cancer cachexia is a continuum with three stages of clinical relevance and not all patients traverse the entire spectrum. In precachexia, early clinical and metabolic signs can precede involuntary weight loss. The cachexia stage is marked by significant weight loss, an obvious decrease in skeletal muscle index, reduced food intake, and systemic inflammation. Refractory cachexia is associated with active catabolism, or the presence of factors that render active management of weight-loss no longer possible or appropriate; at this stage, the cachexia can be clinically refractory as a result of very advanced cancer or the presence of rapidly progressive cancer unresponsive to anticancer therapy. In China, no targeted therapies have been approved for cancer cachexia. In clinical practice, nutritional support and hormonal medications are commonly used to maintain the appetite and body weight of patients with advanced cancer.

主站蜘蛛池模板: 无码专区视频超清 | 国产精品久久夜夜 | 国产白丝亚洲 | 特级做A爰片久久毛片A片国 | 久久久国产精品日韩精品久久久肉伦网站蜜臀久久99精品久久 | 国产精品爽爽va在线观看无码 | 欧美制服丝袜一区 | 2025国产精品自慰 | 成人免费视频一区二区三区 | 四虎成人精品国产永久免费无码 | 国产va免费精品高清在线观看 | 国产精品白浆无码流出 | 成人无码精品一区二区三区 | 2024精品国产福利在线观看香 | av一本久道久久波多野结衣 | 国产一区二区精品 | 国产欧美日韩综合精品无毒 | 精品一区二区不卡麻豆 | 古装一级淫片a免费播放口 寡妇高潮一级毛片91免费看`日韩一区二区三区 | 99久久精品日本一区二区免 | 国产偷录视频叫床高潮 | 婷婷国产精品无码一区二区三区 | 成年a级毛片免费观看 | 欧美精品高清无码 | 国产九精品国产动漫人物 | 国产激情一区二区三区在线hd | 国产99在线 | 日韩毛片在线观看 | 国产成本人片无码免费 | 黑人巨茎大战俄罗斯白人美女 | 国产一区二区三区成人久久 | chinese熟女熟妇1乱老女人 | 美妇乱人伦交换小说/大乳欲妇三级一区二区三区/天天操 | 国产精品三p一区二区视频 国产精品三级 | 999精产国品一二三产区区 | 欧美日韩国产一线天午夜秀场 | 欧美视频一区在线观看 | 日韩精品一区二区三区在线观 | 国产三级a三级三级野外 | 大香线蕉伊人久久 | 少妇自慰白浆一区二区三区 |