The goal of this phase 1 study is to assess the safety, and tolerability of FP002 to determine the dose recommended for dose expansion in subjects with advanced solid tumor.

Start Date02 Aug 2023

Sponsor / Collaborator

Guangdong Fapon Biopharma Inc

CTR20231847

/ SuspendedPhase 1

评估FP002在晚期恶性肿瘤受试者中的安全性、有效性、药代动力学、药效学特征的1期临床研究

[Translation] Phase 1 clinical study to evaluate the safety, efficacy, pharmacokinetics, and pharmacodynamics of FP002 in subjects with advanced malignancies

评估FP002治疗的安全性和耐受性，并确定用于治疗晚期实体瘤的剂量扩展推荐剂量。

[Translation]

To evaluate the safety and tolerability of FP002 treatment and determine the recommended dose for dose expansion in the treatment of advanced solid tumors.

Start Date21 Jul 2023

Sponsor / Collaborator

Guangdong Fapon Biopharma Inc

NCT05779917

/ RecruitingPhase 1IIT

Mesothelin/GPC3/GUCY2C Targeted CAR-T for Immunotherapy of Pancreatic Cancer: Phase I Clinical Trial

The second generation of mesothelin targeted CAR-T cells that secret a fusion protein of IL21 and scfv against PD1 have been constructed and their anti-cancer function has been verified by multiple in vitro and in vivo studies. Clinical studies will be performed to test anti-cancer function of the CAR-T cells for immunotherapy of human cancer patients with Mesothelin expressions. In this phase I study, the safety, tolerance, and preliminary efficacy of the Mesothelin-CAR-T cell immunotherapy on human cancers will firstly be evaluated.

Start Date10 Mar 2023

Sponsor / Collaborator

Second Affiliated Hospital of Guangzhou Medical University

[+1]

100 Clinical Results associated with Guangdong Fapon Biopharma Inc

0 Patents (Medical) associated with Guangdong Fapon Biopharma Inc

Literatures (Medical) associated with Guangdong Fapon Biopharma Inc

21 Apr 2025·Cancer Research

Abstract 3430: FP008, a novel anti-PD-1×IL-10M fusion protein for cancer therapy

Author: Zhou, Chang ; Shen, Bingquan ; Wu, Xiaodong ; Lu, Di ; Guo, Jian ; Ren, Baiguang ; Huo, Yongting ; Ou, Yingye ; Ding, Jiaojiao ; Chen, Ke ; Liang, Mengying ; Gu, Ce ; Ye, Linhui

AbstractImmune checkpoint inhibitors (ICI) such as anti-PD-1/PD-L1 antibodies have achieved remarkable clinical successes in cancer therapy. However, over 70 % of patients receiving ICI treatments are not responsive or experience disease progression after an initial period of response. Terminal exhaustion of CD8+ T cell was supposed to contribute to this low responsiveness. On the other hand, IL-10 could enhance the anti-tumor activity of ICI by reinvigorating and expanding terminally exhausted CD8+ T cells. Encouraging efficacies have been observed in phase 1 clinical trials of IL-10 therapy, but severe hematologic toxicity and low dosage greatly hindered its efficacy in further clinical trials. We therefore developed FP008, a novel anti-PD-1 × IL-10M (IL-10 monomer) fusion protein, and demonstrated its promising potential for cancer therapy.FP008 exhibited strong anti-PD-1 blocking performance and activity comparable to its parental anti-PD-1 antibody. More importantly, FP008 significantly decreased CD8+ T cells apoptosis and promoted IFN-γ secretion when co-cultured with exhausted CD8+ T cells induced in vitro. This function was mainly caused by the IL-10M moiety, which was modified into a monomer to reduce downstream signaling and the resulting hematologic toxicity. Compared with wild-type (wt) IL-10, IL-10M significantly decreased the phagocytosis of erythrocytes by macrophages in vitro. The result was consistent with the observation in the toxicity study in monkeys. FP008 induced less STAT3 phosphorylation without PD-1 crosslinking in activated CD8+ T cells or reporter cells than wt IL-10. Furthermore, the STAT3 signaling was greatly enhanced after PD-1 crosslinking, indicating FP008 may have strong activity on TILs where PD-1 is highly expressed.In both CT26 and MC38 tumor models in hPD-1 knock-in mice, FP008 dose dependently inhibited tumor growth, with stronger anti-tumor efficacy and longer survival than Keytruda. In a CT26 rechallenge model after FP008 treatment and complete tumor regression, mice were re-challenged with CT26 tumor cells but remained tumor-free without further treatment, indicating that FP008 treatment could induce immunological memory. TILs analysis showed that the number of tumor-infiltrating CD8+ T cells increased, while Treg cells decreased after FP008 treatment. In a GLP toxicology study in cynomolgus monkeys, FP008 was well tolerated at the dose of 10 mg/kg, and produced minimal decrease of erythrocyte and no tissue damage.In conclusion, FP008 showed novel characteristics such as the synergistic function of anti-PD-1 and IL-10M, cis-activation of IL-10M by PD-1 enrichment and improved safety profiles. It demonstrated promising potential for clinical therapy for the anti-PD-1 naïve or resistant patients.Citation Format:Ce Gu, Jiaojiao Ding, Baiguang Ren, Mengying Liang, Linhui Ye, Yingye Ou, Chang Zhou, Bingquan Shen, Jian Guo, Xiaodong Wu, Ke Chen, Yongting Huo, Di Lu. FP008, a novel anti-PD-1×IL-10M fusion protein for cancer therapy [abstract]. In: Proceedings of the American Association for Cancer Research Annual Meeting 2025; Part 1 (Regular Abstracts); 2025 Apr 25-30; Chicago, IL. Philadelphia (PA): AACR; Cancer Res 2025;85(8_Suppl_1):Abstract nr 3430.

21 Apr 2025·Cancer Research

Abstract 7301: FP011, A tri-specific immune checkpoint inhibitor targeting PD-1 × TIGIT × PVRIG for cancer immunotherapy

Author: Hu, Peipei ; Zhou, Chang ; Chen, Ke ; Wang, Yuanyuan ; Ren, Baiguang ; Lu, Di ; Wu, Fan ; Wu, Xiaodong ; Huo, Yongting ; Xiao, Liang

AbstractImmune checkpoint inhibitors, such as anti-PD-1/PD-L1 antibodies, have rapidly changed the treatment paradigm for multiple tumor types. Unfortunately, many patients still remain unresponsive or acquire resistance after initial response to treatment. The complex network of immunosuppressive molecules and their upregulation after initial treatment may contribute to such resistance, and lead to terminal exhaustion and fixed loss of effector functions of T cells. Here, we developed FP011, a tri-specific antibody which can simultaneously block the inhibitory signals of PD-1, PVRIG and TIGIT on effector T cells, so as to better activate T cells to kill tumor cells.In vitro, by interacting with T cells in cis, FP011 can act on T cells with higher avidity, exerting synergistic blockade of these three immunosuppressive signals. In a tri-target reporter assay, both FP011 and the combination group induced much stronger luminescence signal than those induced by bi-specific antibodies and monoclonal antibodies. In an antigen-specific (CMV) T cell activation assay, in which T cells were induced to exhaustion after long-term stimulation with CMV antigens, FP011 also induced a more significant degree of T cell activation than what bi-specific antibodies, pembrolizumab and the combination of anti-PD-1, anti-PVRIG and anti-TIGIT monoclonal antibodies could do. In a PBMC-engrafted NOD-dKO-A375 mice model, FP011 inhibited tumor growth (93%, P < 0.0001) in a way significantly better than anti-PD-1 antibody (39.45%, P = 0.0627), the combination of anti-PD1, anti-PVRIG and anti-TIGIT antibodies (90% P < 0.0001), and another tri-specific positive control (66.18%, P = 0.0007). The inhibition of tumor growth was associated with an increase of tumor-infiltrating T cells following the FP011 treatment.In conclusion, these data provide insight into the efficacy of FP011, both in vitro and in vivo, which indicates that targeting three immune checkpoints simultaneously can synergistically enhance T cell activation to achieve a better tumor-killing effect.Citation Format:Yuanyuan Wang, Liang Xiao, Fan Wu, Baiguang Ren, Chang Zhou, Peipei Hu, Ke Chen, Xiaodong Wu, Di Lu, Yongting Huo. FP011, A tri-specific immune checkpoint inhibitor targeting PD-1 × TIGIT × PVRIG for cancer immunotherapy [abstract]. In: Proceedings of the American Association for Cancer Research Annual Meeting 2025; Part 1 (Regular Abstracts); 2025 Apr 25-30; Chicago, IL. Philadelphia (PA): AACR; Cancer Res 2025;85(8_Suppl_1):Abstract nr 7301.

21 Apr 2025·Cancer Research

Abstract 3425: A novel anti-EGFR × IL-10M (FP010) fusion protein for solid tumor therapy

Author: Huo, Yongting ; Ye, Linhui ; Chen, Ke ; Zhang, Zhe ; Wu, Xiaodong ; Guo, Jian ; Lu, Di ; Gu, Ce ; Shen, Bingquan ; Ren, Baiguang ; Zhou, Chang ; Ou, Yingye ; Zhu, Dujuan ; Ding, Jiaojiao

AbstractCD8+ T cell exhaustion has been recognized as an important factor contributing to the resistance to PD-1/PD-L1 inhibitors. Recently, IL-10 was found to reinvigorate tumor-infiltrating terminally exhausted CD8+ T cells via metabolic reprogramming, and enhance their proliferation, cytotoxicity and cytokine secretion. Notably, combining IL-10 with anti-PD-1 or CAR-T therapies markedly enhanced their antitumor efficacy. In a Phase 1b clinical trial, PEGylated IL-10 showed promising therapeutic potential in NSCLC and RCC. However, severe hematologic toxicities limited its clinical applications.To overcome this challenge, we engineered the dimeric IL-10 into a monomeric form (IL-10M) to reduce its downstream activity, thus minimizing its toxicity. We then developed FP010, an anti-EGFR × IL-10M fusion protein of which IL-10M was fused to the C-terminus of the heavy chain of an engineered anti-EGFR antibody (panitumumab Fab combined with IgG1 Fc). This design allowed FP010 to preferentially accumulate in EGFR-expressing tumors, thereby enhancing its therapeutic effect. In this study, we evaluated FP010’s antitumor activity in vitro and in vivo, as well as its safety profile in cynomolgus monkeys.FP010 showed binding and blocking activity similar to that of panitumumab on A431 cells, and could significantly inhibit their proliferation. Additionally, FP010 exhibited strong ADCC activity. FP010 exhibited much lower downstream signal activity than wild type IL-10 in a STAT3 reporter assay. However, FP010 still kept its ability in promoting IFN-γ secretion and inhibiting apoptosis in exhausted CD8+ T cells, indicating its ability to reinvigorate these cells. In vivo studies demonstrated potent antitumor activity of FP010 in both MC38-cEGFR and B16-cEGFR models, better than IL-10M or anti-EGFR antibody alone. We further assessed the hematologic toxicities of FP010 in cynomolgus monkeys. No evident hematologic toxicity was observed with FP010 at a dose of 10 mg/kg IV QW. In contrast, Panitumumab × wt IL-10 caused a remarkable decrease of erythrocytes at the same dose, consistent with the adverse effects of PEGylated IL-10 observed in clinical trials.FP010 has demonstrated significant antitumor activity in vitro and in vivo, with acceptable adverse effects observed in cynomolgus monkeys. These data indicate that FP010 has great potential for cancer immunotherapy, especially for tumors with resistance to PD-1/PD-L1 inhibitors due to T cell exhaustion.Citation Format:Jian Guo, Jiaojiao Ding, Ce Gu, Linhui Ye, Dujuan Zhu, Yingye Ou, Zhe Zhang, Baiguang Ren, Chang Zhou, Bingquan Shen, Xiaodong Wu, Ke Chen, Di Lu, Yongting Huo. A novel anti-EGFR × IL-10M (FP010) fusion protein for solid tumor therapy [abstract]. In: Proceedings of the American Association for Cancer Research Annual Meeting 2025; Part 1 (Regular Abstracts); 2025 Apr 25-30; Chicago, IL. Philadelphia (PA): AACR; Cancer Res 2025;85(8_Suppl_1):Abstract nr 3425.

News (Medical) associated with Guangdong Fapon Biopharma Inc

04 Jun 2024

·www.prnewswire.com

Fapon Biopharma Announces a Safer Immunotherapy for Cancers

SAN DIEGO, June 3, 2024 /PRNewswire/ -- At Bio International Convention 2024, which is taking place here in San Diego during June 3-6, Fapon Biopharma, an innovator in developing therapeutic antibodies and fusion proteins, has announced an immunocytokine with modified IL-10M fused to anti-PD-1 antibody, codenamed FP008. This fusion protein provides a promising therapeutic strategy for solid tumors refractory to anti-PD-1 therapy. The groundbreaking announcement is a testimony to Fapon Biopharma's strength in developing anticancer drugs. FP008 is a patent-pending drug candidate developed by Fapon Biopharma using cutting-edge antibody technology. It stands out as a first-in-class biologic candidate combining IL-10M (an attenuated IL-10 monomer variant) and an anti-PD-1 antibody, providing a targeted therapy with enhanced efficacy while significantly reducing the challenging toxicity associated with wtIL-10. This is a critical advancement in the field. FP008 not only reduces the apoptosis of the exhausted CD8+ T cells and restores their activity in vitro, but also significantly increases the level of CD8+ T cells within the tumor microenvironment, exhibiting a potent anti-tumor effect in vivo. It exhibited good druggability and was well tolerated in a toxicity study of up to 10 mpk in cynomolgus monkeys. As a result, FP008 is a viable drug candidate. FP008 is poised to have a substantial impact on immunotherapy for cancer in patients who do not respond to existing treatments. The company aims to present it to a global audience and seek partners to drive its development for the benefit of cancer patients around the world eventually. Fapon Biopharma plans to submit an IND application for FP008 to the FDA in early 2025. The company remains committed to developing more effective and more accessible therapeutics with consistent innovation and collaboration. About Fapon Biopharma Fapon Biopharma specializes in discovering and developing biologics for treating cancers, autoimmune diseases and other diseases where there are unmet medical needs. Leveraging cutting-edge technologies, we have built advanced drug discovery platforms, including an antibody discovery platform based on the globally leading mammalian cell display technology, a platform for generating IL-10M fusion proteins, and a platform for developing multispecific antibodies using Fibody and nanobodies. With a differentiated pipeline of leading drug candidates, we have established capabilities that cover the entire drug development process from drug discovery, preclinical research, Chemistry, Manufacturing and Controls (CMC) to early clinical development. Committed to innovation, we strive to deliver safer, more efficacious, affordable, and accessible biologics for everyone. Media contact: Tina Chen Fapon Group Email: [email protected] SOURCE Fapon

Immunotherapy

100 Deals associated with Guangdong Fapon Biopharma Inc

100 Translational Medicine associated with Guangdong Fapon Biopharma Inc

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Pipeline

Pipeline Snapshot as of 10 May 2025

The statistics for drugs in the Pipeline is the current organization and its subsidiaries are counted as organizations,Early Phase 1 is incorporated into Phase 1, Phase 1/2 is incorporated into phase 2, and phase 2/3 is incorporated into phase 3

Discovery

Preclinical

IND Approval

Phase 1 Clinical

Current Projects

Drug(Targets)	Indications	Global Highest Phase

FP-002 (Fapon Biotech) ( CD47 )	Advanced Malignant Solid Neoplasm More	Phase 1
Mesothelin targeted CAR-T cells(Fapon Biotherapy) ( MSLN x PD-1 )	Pancreatic Cancer More	Phase 1
FP-008 (Fapon Biopharma) ( IL-10R x PD-1 )	Solid tumor More	IND Approval
FPE015 ( CD112R x PDL1 x TIGIT )	Neoplasms More	Preclinical
FPE025 ( CD3 )	Neoplasms More	Preclinical

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