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DRUG:

ligufalimab (AK117)

i
Other names: AK117, AK 117, AK-117
Company:
Akesobio
Drug class:
CD47 inhibitor
10d
Enrollment open
|
Keytruda (pembrolizumab) • Yidafan (ivonescimab) • ligufalimab (AK117)
1m
New P1/2 trial • Combination therapy
|
ligufalimab (AK117)
2ms
A novel anti-CD47 antibody with therapeutic potential for NK/T-cell lymphoma. (PubMed, Hum Vaccin Immunother)
In addition, in vivo experiments showed that the anti-CD47 mAb AK117 significantly inhibited the growth of subcutaneous xenograft tumors in SCID mice compared to the control antibody IgG. Our results indicate that targeting CD47 monoclonal antibodies is a potential therapeutic strategy for NKTCL.
Journal • IO biomarker
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CD47 (CD47 Molecule)
|
CD47 expression
|
ligufalimab (AK117)
2ms
New P3 trial • Combination therapy • Metastases
|
Keytruda (pembrolizumab) • Yidafan (ivonescimab) • ligufalimab (AK117)
4ms
AK117 (Anti-CD47) + Anti-EGFR for R/M HNSCC (clinicaltrials.gov)
P2, N=10, Not yet recruiting, West China Hospital
New P2 trial • Metastases
|
ligufalimab (AK117)
7ms
New P1/2 trial • Combination therapy
|
Venclexta (venetoclax) • azacitidine • ligufalimab (AK117)
8ms
Enrollment open • Combination therapy
|
azacitidine • ligufalimab (AK117)
9ms
A Study of AK112 in Advanced Malignant Tumors (clinicaltrials.gov)
P1/2, N=250, Recruiting, Akeso | N=160 --> 250 | Trial completion date: Jan 2024 --> Jan 2025 | Trial primary completion date: Jan 2023 --> Aug 2024
Enrollment change • Trial completion date • Trial primary completion date • Combination therapy • Metastases
|
Yidafan (ivonescimab) • ligufalimab (AK117)
9ms
A Study of AK112 With or Without AK117 in Metastatic Colorectal Cancer (clinicaltrials.gov)
P2, N=104, Recruiting, Akeso | Trial completion date: Jan 2025 --> Dec 2026 | Trial primary completion date: Oct 2022 --> Dec 2024
Trial completion date • Trial primary completion date • Metastases
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5-fluorouracil • capecitabine • oxaliplatin • irinotecan • leucovorin calcium • Yidafan (ivonescimab) • ligufalimab (AK117)
11ms
New P2 trial • Combination therapy
|
azacitidine • ligufalimab (AK117)
1year
A Phase 1 Dose Escalation and Expansion Study of AK117 (clinicaltrials.gov)
P1, N=49, Completed, Akeso | Active, not recruiting --> Completed | Trial completion date: Jan 2024 --> May 2023
Trial completion • Trial completion date • Metastases
|
ligufalimab (AK117)
1year
Cadonilimab Combination With Chemotherapy With or Without AK117 in Resectable Gastric or Gastroesophageal Junction Adenocarcinoma (clinicaltrials.gov)
P2, N=90, Recruiting, Akeso | Not yet recruiting --> Recruiting | Trial completion date: Aug 2027 --> Nov 2027 | Trial primary completion date: Aug 2024 --> Nov 2024
Enrollment open • Trial completion date • Trial primary completion date
|
docetaxel • 5-fluorouracil • oxaliplatin • Kaitanni (cadonilimab) • Teysuno (gimeracil/oteracil/tegafur) • ligufalimab (AK117)
almost2years
Ligufalimab, a novel anti-CD47 antibody with no hemagglutination demonstrates both monotherapy and combo antitumor activity. (PubMed, J Immunother Cancer)
AK117 eliminated hemagglutination and also enabled to maintain full effectiveness of CD47 blockade on tumor cells, which resulted in excellent antitumor efficacy and favorable safety profile of AK117. A series of clinical trials of AK117 as a therapeutic agent in combination with various agents such as AK112 are in progress for the treatment of multiple hematologic malignancies and solid tumors.
Journal • PD(L)-1 Biomarker • IO biomarker
|
CD47 (CD47 Molecule) • SIRPA (Signal Regulatory Protein Alpha)
|
Erbitux (cetuximab) • Rituxan (rituximab) • magrolimab (ONO-7913) • Yidafan (ivonescimab) • ligufalimab (AK117)
over2years
A Phase Ib/II Study of AK112 in Combination With AK117 in Advanced Malignant Tumors (clinicaltrials.gov)
P1/2, N=114, Recruiting, Akeso | Not yet recruiting --> Recruiting | Initiation date: Feb 2022 --> May 2022
Enrollment open • Trial initiation date • Combination therapy
|
PD-L1 (Programmed death ligand 1)
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PD-L1 expression
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cisplatin • carboplatin • 5-fluorouracil • Yidafan (ivonescimab) • ligufalimab (AK117)
over2years
A Study of AK117/AK112 in Metastatic Triple-Negative Breast Cancer (clinicaltrials.gov)
P2, N=80, Recruiting, Akeso | Not yet recruiting --> Recruiting
Enrollment open • Combination therapy
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HER-2 (Human epidermal growth factor receptor 2) • ER (Estrogen receptor) • PGR (Progesterone receptor)
|
HER-2 negative • PGR expression
|
albumin-bound paclitaxel • Yidafan (ivonescimab) • ligufalimab (AK117)
almost3years
New P1/2 trial • Combination therapy
|
PD-L1 (Programmed death ligand 1)
|
PD-L1 expression
|
cisplatin • carboplatin • 5-fluorouracil • Yidafan (ivonescimab) • ligufalimab (AK117)
almost3years
New P2 trial • Combination therapy
|
HER-2 (Human epidermal growth factor receptor 2) • ER (Estrogen receptor) • PGR (Progesterone receptor)
|
HER-2 negative • PGR expression
|
albumin-bound paclitaxel • Yidafan (ivonescimab) • ligufalimab (AK117)