ivonescimab (AK112)

P2, N=30, Recruiting, Tianjin Medical University Cancer Institute and Hospital

P2, N=296, Recruiting, Akeso | Trial primary completion date: Mar 2024 --> Dec 2024

P1/2, N=233, Recruiting, Akeso | N=148 --> 233

P1/2, N=250, Recruiting, Akeso | N=160 --> 250 | Trial completion date: Jan 2024 --> Jan 2025 | Trial primary completion date: Jan 2023 --> Aug 2024

P2, N=104, Recruiting, Akeso | Trial completion date: Jan 2025 --> Dec 2026 | Trial primary completion date: Oct 2022 --> Dec 2024

P2, N=36, Not yet recruiting, Harbin Medical University

P2, N=50, Not yet recruiting, Harbin Medical University

P3, N=400, Recruiting, Summit Therapeutics | Not yet recruiting --> Recruiting

Ivonescimab monotherapy was well tolerated and demonstrated promising efficacy in patients with advanced or metastatic NSCLC.

P3, N=398, Active, not recruiting, Akeso | Recruiting --> Active, not recruiting

P3, N=396, Recruiting, Akeso | Not yet recruiting --> Recruiting

Patients in cohort 1 were previously untreated advanced NSCLC, had no epidermal growth factor receptor (EGFR) or anaplastic lymphoma kinase (ALK) gene modifications, and received AK112 combined with pemetrexed (500 mg/m) for non-squamous (non-sq)-NSCLC or paclitaxel (175 mg/m) for sq-NSCLC plus carboplatin (area under the curve of 5 mg/mL per min) for four cycles, followed by AK112 with pemetrexed for non-sq-NSCLC and AK112 alone for sq-NSCLC as maintenance therapy...The participants in cohort 3 had advanced NSCLC who failed systemic platinum-based chemotherapy and anti-PD-1/programmed death-ligand 1 (PD-L1) treatments and received AK112 plus docetaxel (75 mg/m)...AK112 plus platinum-doublet showed promising antitumor activity and safety not only in first-line treatment of advanced NSCLC patients without driver mutation but also in patients with EGFR-functional mutation who failed previous EGFR-TKI therapy and advanced NSCLC patients who failed prior systemic platinum-based chemotherapy and PD-1/PD-L1 inhibitor treatments, suggesting a valuable potential new treatment option for this patient population. Akeso Biopharma, Inc., Zhongshan, China, and National Natural Science Foundation of China.

P1/2, N=216, Not yet recruiting, Akeso

P1/2, N=148, Recruiting, Akeso | Not yet recruiting --> Recruiting

P2, N=296, Recruiting, Akeso | N=206 --> 296 | Trial completion date: Jan 2024 --> Mar 2025 | Trial primary completion date: Jan 2023 --> Mar 2024

P1/2, N=148, Not yet recruiting, Akeso

P3, N=400, Not yet recruiting, Summit Therapeutics

P1/2, N=72, Not yet recruiting, Akeso

P3, N=396, Not yet recruiting, Akeso

Background: Since the initial approval of bevacizumab (bev) with chemo in NSCLC, the subsequent focus of bev use in combination with PD1 therapy for first line metastatic disease has largely focused on non-squamous (non-SCC) histology...Pts were treated with 10 or 20 mg/kg ivonescimab once every 3wks combined with carboplatin and pemetrexed (non-SCC) or carboplatin and paclitaxel (SCC)... Ivonescimab, plus chemotherapy has shown promising anti-tumor activity in pts with advanced/metastatic NSCLC without AGA and can be administered safely in combination with platinum doublet chemotherapy to patients with SCC and non-SCC histology. Clinical trial information: NCT04736823.

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.

P3, N=388, Recruiting, Akeso | Not yet recruiting --> Recruiting

AK112 in combination with etoposide and carboplatin showed favorable safety profile and promising anti-tumor efficacy as first-line treatment in patients with ES-SCLC and may potentially be a very promising treatment option.

P1/2, N=108, Recruiting, Akeso | N=360 --> 108

P1/2, N=8, Terminated, Akeso | N=145 --> 8 | Trial completion date: Jun 2024 --> Jun 2022 | Recruiting --> Terminated | Trial primary completion date: Jun 2023 --> Jun 2022; Too low inclusion rate

P2, N=270, Active, not recruiting, Akeso | Recruiting --> Active, not recruiting

P3, N=388, Not yet recruiting, Akeso

P1/2, N=114, Recruiting, Akeso | Not yet recruiting --> Recruiting | Initiation date: Feb 2022 --> May 2022

P2, N=80, Recruiting, Akeso | Not yet recruiting --> Recruiting

P1/2, N=114, Not yet recruiting, Akeso

P2, N=80, Not yet recruiting, Akeso

MEDIOLA study showed that the combination of PD-L1 inhibitor (durvalumab) plus PARP inhibitor (olaparib) and bevacizumab demonstrated higher ORR and PFS than reported for PD-1 and PARP inhibitor doublet or single-agent PARP or VEGF inhibitors in non-gBRCAm platinum-sensitive relapsed ovarian cancer.1 Therefore, AK112, a bispecific antibody against PD-1 and VEGF, combined with PARP inhibitor may achieve a better anti-tumor effect in recurrent ovarian cancer. Subjects with active or prior autoimmune disease that may relapse, significant cardiovascular disease, prior exposure to PARP inhibitor, antiangiogenic therapy or immunotherapy will not be eligible. Clinical registration number CTR20210713

P1/2, N=145, Recruiting, Akeso

P1/2, N=360, Recruiting, Akeso

P2, N=270, Recruiting, Akeso

The dose-expansion phase will be performed in patients with selected advanced solid tumors who had no prior exposure to drugs targeting T-cell co-stimulation or immune checkpoint pathways. Research Funding: Akeso BioPharma, Inc