- |||||||||| HX-009 / Waterstone Hanxbio, HanX Biopharma
A Phase Ib Clinical Trial Investigating the Safety, Tolerability, and Pharmacokinetics of HX009,a Novel Bsab Dual Targeting PD-1 x CD47,in Patients with EBV+ Non-Hodgkin Lymphoma (NHL) (Halls G-H (San Diego Convention Center)) - Nov 6, 2024 - Abstract #ASH2024ASH_3140;
P1, P1/2,
In summary, HX009 single agent at 10mg/kg Q2W dose level is well tolerated with manageable safety profile, and anti-tumor activity has been demonstrated in treating patients with R/R EBV+ NHL. Further clinical investigation of HX009, either in single agent or in combination settings, is warranted.
- |||||||||| HX-009 / Waterstone Hanxbio, HanX Biopharma
Cis-binding/blockade of CD47 by CD47xPD1 BsAb HX009 enhanced PD1 blockade induced T-cell activation (Exhibit Hall B) - Sep 27, 2023 - Abstract #SITC2023SITC_897;
This was also further confirmed with the observatiions that HX009 can compete with high-affinity CD47 mAb binding to PD1+CD47+ double positive T-cells, but not to the CD47+ single positive cells (no enhanced avidity). Conclusions HX009 CD47xPD1-BsAb T-cell could have potential superior T-cell activation than PD1-mAb, which could be potentially translated into stronger immunotherapy efficacy.
- |||||||||| HX-009 / Waterstone Hanxbio, HanX Biopharma
Non-clinical pharmacology of HX009, a novel FIC PD1xCD47 BsAb (Section 22; Poster Board #21) - Mar 14, 2023 - Abstract #AACR2023AACR_8530;
P1/2
In summary, the desired PK and safety profiles of HX009, along with anti-tumor activity, supporting further clinical development. Currently, HX009 is under clinical investigation (ClinicalTrials.gov Identifier: NCT05189093).
- |||||||||| HX-009 / Waterstone Hanxbio, HanX Biopharma
HX009, a first-in-class PD1xCD47 BsAb, demonstrated anti-AML activity in PDX models (Section 24; Poster Board #27) - Mar 14, 2023 - Abstract #AACR2023AACR_5139;
In contrast, in the subcutaneous transplanted AML cell line-derived model, MV4-11, there is little anti-tumor activity observed, although there is significant expression of CD47 on the tumor cells. In conclusion, our data seems to suggest that HX009 could be a candidate immunotherapy for CD47hi AML, with CD47 expression being a positive predictive biomarker, warranting further evaluation.
- |||||||||| HX-009 / Waterstone Hanxbio, HanX Biopharma
Trial completion, Trial completion date, Metastases: The Safety, Tolerability, and Initial Efficacy of HX009 in Patients With Advanced Malignancies (clinicaltrials.gov) - Dec 12, 2022
P1, N=21, Completed,
In conclusion, our data seems to suggest that HX009 could be a candidate immunotherapy for CD47hi AML, with CD47 expression being a positive predictive biomarker, warranting further evaluation. Active, not recruiting --> Completed | Trial completion date: Sep 2021 --> Sep 2022
- |||||||||| HX-009 / Waterstone Hanxbio, HanX Biopharma
Preclinical pharmacology modeling of HX009, a clinical stage first-in-class PD-1xCD47 BsAb, for anti-lymphoma applications (Hall C) - Oct 6, 2022 - Abstract #SITC2022SITC_826;
P1/2
Conclusions HX009 demonstrated strong preclinical anti-lymphoma activity of HX009, confirming the contributions from both targeting MOAs (CD47/PD1), as well the superior activity of dual targeting as designed, validating our hypothesis. A Phase I/II study for this first-in-class BsAb is ongoing in patients with relapsed/refractory lymphoma, including both B and T cell subtypes (ClinicalTrials.gov Identifier: NCT05189093 ).
- |||||||||| Puyouheng (pucotenlimab) / Taizhou Hanzhong Biopharma, Wuhan Binhui Biotech, Lepu Med, HanX Biopharma, HX-009 / Waterstone Hanxbio, HanX Biopharma
Development of RO assay for anti-PD-1 mAb and anti-PD-1×CD47 BsAb utilizing hPD-1/hCD47 dual humanized mice, at preclinical setting to facilitate clinical validation (Hall C) - Oct 6, 2022 - Abstract #SITC2022SITC_445;
Further detailed to be analyzed, including HX009 RO values for PD-1 receptor only, CD47 receptor only and total for combining both receptors. Conclusions Supposing further data from HX-009 RO modelling proven valid, RO assay using humanized mice could become a standard method of choice for RO assay development at the preclinical stage, enabling simpler/efficient clinical development.
- |||||||||| HX-009 / Waterstone Hanxbio, HanX Biopharma
Enrollment closed, Metastases: Recombinant Humanized Anti-CD47 / PD-1 Bifunctional Antibody HX009 Injection in the Treatment of Advanced Solid Tumors (clinicaltrials.gov) - Apr 28, 2022
P2, N=210, Active, not recruiting,
Conclusions Supposing further data from HX-009 RO modelling proven valid, RO assay using humanized mice could become a standard method of choice for RO assay development at the preclinical stage, enabling simpler/efficient clinical development. Recruiting --> Active, not recruiting
- |||||||||| HX-009 / Waterstone Hanxbio, HanX Biopharma
Enrollment closed, Enrollment change, Metastases: The Safety, Tolerability, and Initial Efficacy of HX009 in Patients With Advanced Malignancies (clinicaltrials.gov) - Jul 8, 2021
P1, N=21, Active, not recruiting,
Recruiting --> Active, not recruiting Recruiting --> Active, not recruiting | N=37 --> 21
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