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- | timdarpacept (IMM01) / ImmuneOnco Biopharma
Journal: Combining CD38 antibody with CD47 blockade is a promising strategy for treating hematologic malignancies expressing CD38. (Pubmed Central) - Jul 10, 2024
Fc fusion protein)...A panel of BsAbs targeting CD38 and CD47 developed based on the "mAb-tarp" platform showed potent tumor-killing ability in vitro and in vivo. As BsAbs had lower affinity for binding to CD47, higher affinity for binding to CD38, no affinity for binding to RBCs, and did not induce RBC agglutination, we concluded that CD38/CD47 BsAbs are safe and have a satisfactory tolerability profile.
- Tevimbra (tislelizumab-jsgr) / BeiGene, timdarpacept (IMM01) / ImmuneOnco Biopharma
Timdarpacept (IMM01) in combination with tislelizumab in prior anti-PD-1 failed classical Hodgkin lymphoma: An open label, multicenter, phase II study (IMM01-04) evaluating safety as well as preliminary anti-tumor activity. (E450b) - Apr 24, 2024 - Abstract #ASCO2024ASCO_2355;
P1b/2
IMM01-04 showed a robust anti-tumor effectivity with a well-tolerated safety profile in prior anti-PD-1 failed cHL patients. The phase II study is ongoing.
- timdarpacept (IMM01) / ImmuneOnco Biopharma
Latest results of a phase 2 study of IMM01 combined with azacitidine (AZA) as the first-line treatment in adults with higher risk myelodysplastic syndromes (MDS). (E450b) - Apr 24, 2024 - Abstract #ASCO2024ASCO_1147;
P1/2
The phase II study is ongoing. IMM01 (without low-dose priming) combined with AZA were well tolerated and showed exciting efficacy results in patients with treatment-naive higher-risk MDS.
- Tevimbra (tislelizumab) / BeiGene, IMM01 / ImmuneOnco Biopharma
IMM01 Plus Tislelizumab in Prior Anti-PD-1 Failed Classic Hodgkin Lymphoma: An Open Label, Multicenter, Phase 2 Study (IMM01-04) Evaluating Safety As Well As Preliminary Anti-Tumor Activity (Grand Hall B (Manchester Grand Hyatt San Diego)) - Nov 3, 2023 - Abstract #ASH2023ASH_3290;
IMM01-04 showed a robust anti-tumor effectivity with a well-tolerated safety profile in prior anti-PD-1 failed classical Hodgkin Lymphoma patients. The phase 2 study is ongoing.
- IMM01 / ImmuneOnco Biopharma
Preliminary Results of a Phase 2 Study of IMM01 Combined with Azacitidine (AZA) As the First-Line Treatment in Adult Patients with Chronic Myelomonocytic Leukemia (CMML) (Halls G-H (San Diego Convention Center)) - Nov 3, 2023 - Abstract #ASH2023ASH_2285;
P1/2
Preliminary data showed that IMM01 (without a low-dose priming) combined with AZA were well tolerated. The combo, when compared to the historical data of AZA alone, showed exciting efficacy result for patients with treatment-naive CMML1-2.
- IMM01 / ImmuneOnco Biopharma
Preliminary Results of a Phase 2 Study of IMM01 Combined with Azacitidine (AZA) As the First-Line Treatment in Adult Patients with Higher Risk Myelodysplastic Syndromes (MDS) (Pacific Ballroom Salons 18-19 (Marriott Marquis San Diego Marina)) - Nov 3, 2023 - Abstract #ASH2023ASH_1370;
P1/2
The combo, when compared to the historical data of AZA alone, showed exciting efficacy result for patients with treatment-naive CMML1-2. Preliminary data from IMM01 (without low-dose priming) combined with AZA were well tolerated and showed exciting efficacy results in patients with treatment-naive higher-risk MDS.
- | IMM01 / ImmuneOnco Biopharma
New P1 trial: Exploratory Study of IMM01 for Injection in the Treatment of Refractory or Recurrent Hematologic Malignancy (clinicaltrials.gov) - May 16, 2023
P1, N=73, Terminated, Sponsor: ImmuneOnco Biopharmaceuticals (Shanghai) Inc.
- Baizean (tislelizumab) / BeiGene, Novartis, IMM01 / ImmuneOnco Biopharma
IMM01 plus tislelizumab in patients with advanced solid tumors and lymphoma: An open-label, multicenter, phase 1b/2 dose escalation and expansion study (IMM01-04). (On Demand | Hall A; Poster Bd # 442) - Apr 26, 2023 - Abstract #ASCO2023ASCO_2367;
The RP2D of IMM01 was determined as 2mg/kg, this was the highest IMM01 dose evaluated in human as a single agent. IMM01 plus tislelizumab showed preliminarily anti-tumor activity in patients with advanced solid tumors.
- | IMM01 / ImmuneOnco Biopharma
Enrollment open, Enrollment change, Trial primary completion date: IMM01-02: A Study of IMM01 Combined With Azacitidine in Patients With Acute Myeloid Leukemia and Myelodysplastic Syndrome (clinicaltrials.gov) - Apr 26, 2023
P1/2, N=126, Recruiting, Sponsor: ImmuneOnco Biopharmaceuticals (Shanghai) Inc.
IMM01 plus tislelizumab showed preliminarily anti-tumor activity in patients with advanced solid tumors. Not yet recruiting --> Recruiting | N=76 --> 126 | Trial primary completion date: Jan 2023 --> Feb 2024
- IMM01 / ImmuneOnco Biopharma, IMM40H / ImmuneOnco Biopharma, cusatuzumab (ARGX-110) / OncoVerity
Preclinical development of a monoclonal antibody targeting CD70 as cancer immunotherapy (Section 22; Poster Board #17) - Mar 14, 2023 - Abstract #AACR2023AACR_8526;
Interestingly, combination of IMM40H and IMM01 (a SIRP?-IgG1 Fc fusion protein targeting CD47) generated significant therapeutic synergy in models of A498 kidney cancer and Raji lymphoma...IND of IMM40H has been approved in China and US. This antibody is now in a phase 1 study in patients with advanced malignancies expressing CD70.
- IMM2902 / ImmuneOnco Biopharma
Preclinical development of a novel bispecific mAb-Trap fusion protein, IMM2902, targeting both HER2 and CD47 as cancer immunotherapy (Section 23; Poster Board #16) - Mar 14, 2023 - Abstract #AACR2023AACR_5101;
P1
Given the strong preclinical antitumor activity as well as the favorable safety profile, IMM2902 may serve as a potent immunotherapy for HER2-expressing cancers via dual blockade of CD47 and HER2. A Phase 1 clinical trial exploring safety, tolerability, and preliminary efficacy of IMM2902 in patients with HER2-expressing advanced solid tumors is currently ongoing in both China (CXSL2101035) and USA (NCT05076591).
- IMM2520 / ImmuneOnco Biopharma
Preclinical development of a novel bispecific mAb-Trap fusion protein, IMM2520, targeting both PD-L1 and CD47 as cancer immunotherapy (Section 25; Poster Board #17) - Mar 14, 2023 - Abstract #AACR2023AACR_4024;
In another in vivo efficacy study with MC38-hCD47/hPD-L1 colon cancer model, IMM2520 demonstrated a significant anti-tumor activity in a dose-dependent manner at doses between 2 mg/kg to 20 mg/kg. Given its potent preclinical anti-tumor activity as well as the favorable safety profile, IMM2520 may serve as a potent immunotherapy for multiple cancer types by targeting PD-L1 and CD47 on tumor cells.
- | IMM01 / ImmuneOnco Biopharma
Journal, PD(L)-1 Biomarker, IO biomarker: SIRPα-Fc fusion protein IMM01 exhibits dual anti-tumor activities by targeting CD47/SIRPα signal pathway via blocking the "don't eat me" signal and activating the "eat me" signal. (Pubmed Central) - Nov 18, 2022
Finally, IMM01 demonstrated a favorable safety profile with no human RBC binding activity or hemagglutination induction. IMM01 inhibits the growth of tumor cells by the following three possible mechanisms: (1) directly activating macrophages to phagocytize tumor cells; (2) activated macrophages degrade phagocytized tumor cells and present tumor antigens to T cells through MHC molecules to activate T cells; (3) activated macrophages can convert "cold tumors" into "hot tumors" and increase the infiltration of immune cells through chemotaxis by secreting some cytokines and chemokines.
- | IMM01 / ImmuneOnco Biopharma
Journal: Crystal Structure of Human CD47 in Complex with Engineered SIRPα.D1(N80A). (Pubmed Central) - Sep 18, 2022
According to the sequence alignment results of SIRPα, SIRPβ and SIRPγ in the literature of PDB ID 2JJT, except ASP100, the amino acids that form common salt bridge bonds are all conserved. Our data demonstrated crystal structure of the IMM01/CD47 complex and provides a structural basis for the structural binding interface and future clinical applications.
- | IMM01 / ImmuneOnco Biopharma
New P1/2 trial: IMM01-02: A Study of IMM01 Combined With Azacitidine in Patients With Acute Myeloid Leukemia and Myelodysplastic Syndrome (clinicaltrials.gov) - Nov 30, 2021
P1/2, N=76, Not yet recruiting, Sponsor: ImmuneOnco Biopharmaceuticals (Shanghai) Co., Ltd
- IMM01 / ImmuneOnco Biopharma
[VIRTUAL] Preliminary results of a first-in-human phase I dtudy of IMM01, SIRPα Fc protein in patients with relapsed or refractory lymphoma. () - Apr 28, 2021 - Abstract #ASCO2021ASCO_2608;
Our data demonstrated crystal structure of the IMM01/CD47 complex and provides a structural basis for the structural binding interface and future clinical applications. Preliminary data from the present phase 1 study of IMM01, a SIRPα IgG 1 fusion protein, demonstrate that IMM01 has an excellent preliminary safety, tolerability and promising anti-tumor activity up to doses of 1.0 mg/kg.
- | IMM01 / ImmuneOnco Biopharma, losartan/aldesleukin (IMM-01) / Modulate Therap
Journal: DAAM2 Variants Cause Nephrotic Syndrome via Actin Dysregulation. (Pubmed Central) - Jan 13, 2021
We conclude that DAAM2 variants are a likely cause of monogenic human SRNS due to actin dysregulation in podocytes. Further, we provide evidence that DAAM2-associated SRNS may be amenable to treatment using actin regulating compounds.
- IMM01 / ImmuneOnco Biopharma, IMM-01 / Modulate Therap
Mutations in the Diaphanous Related Formin DAAM2 as a Novel Cause of Nephrotic Syndrome (Exhibit Hall, Walter E. Washington Convention Center) - Oct 14, 2019 - Abstract #KIDNEYWEEK2019KIDNEY_WEEK_2925;
DAAM2 is likely a potential target for formin activating drugs. Funding NIDDK Support