China-based biotech company Asieris Pharmaceuticals has announced positive interim data indicating the Phase II trial of its small molecule drug APL-1202 achieved its primary endpoint when combined with the PD-1 inhibitor tislelizumab in participants with muscular invasive bladder cancer (MIBC).
The results were presented at the 2024 American Society of Clinical Oncology Genitourinary Cancers Symposium (ASCO GU) in San Francisco, US, on 27 January, the last day of the conference. APL-1202 also demonstrated a tolerable safety profile.
A repurposed urinary antibiotic, APL-1202 acts as an inhibitor of enzyme methionine aminopeptidase II type (MetAP2), which plays a key role in angiogenesis. The primary endpoint of pathological complete response (pCR) rate was achieved by 39% of patients receiving the combination treatment, compared to 21% of patients treated with tislelizumab alone. While tislelizumab was initially being co-commercialised by Novartis and Beigene, the agreement was terminated in September 2023 with all development and commercialisation rights being transferred to Beigene, while the former manufactures the PD-1 inhibitor.
Two out of six patients in the combination treatment group at a specific tumour stage also achieved pCR while none in the tislelizumab group with the same tumour stage did.
The Phase II trial (NCT04813107) enrolled 18 MIBC patients, either newly diagnosed patients or individuals where a radical cystectomy (RC), a procedure to remove the bladder, is planned. Patients who are cisplatin-ineligible or choose not to receive cisplatin-based neoadjuvant chemotherapy were also included in the study.
Tislelizumab is approved to treat oesophagal squamous cell carcinoma in China and is also being reviewed by the US Food and Drug Administration to treat the same cancer.
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The company announced positive interim results from the study back in September 2023 without detailing the data, with the Safety Monitoring Committee (SMC) reviewing the data and determining that the results met the pre-defined criteria. Asieris also announced Phase III results of its bladder cancer diagnosis and management candidate APL-1706 at 2024 ASCO GU.
APL-1202 is also being investigated in two other clinical trials, a Phase II trial investigating the candidate plus intravesical chemotherapy in non-muscle invasive bladder cancer (NMIBC) patients who have relapsed after receiving chemotherapy, and a Phase III trial of the candidate in untreated patients with intermediate-risk NMIBC.
According to a report on GlobalData’s Pharma Intelligence Center, market sales in bladder cancer across the seven main markets (France, Spain, Germany, Italy, UK, US and Japan) will reach $5.59bn by 2028.
GlobalData is the parent company of Clinical Trials Arena.
In February 2023, ReviR teamed up with Asieris, signing a research collaboration and option-to-license agreement. Under the deal, Asieris will gain access to ReviR’s VoyageR artificial intelligence (AI) platform to identify and develop new RNA-targeting therapies for cancer treatments.
The company has several other candidates in the pipeline. In November 2022, the US Food and Drug Administration (FDA) granted investigational new drug clearance to initiate a Phase Ib clinical trial of its ulcerative colitis (UC) drug APL-1401.
In the announcement accompanying the results, Asieris chief development officer Linda Wu said: “The interim analysis of clinical data demonstrates that the combination of APL-1202 and the PD-1 inhibitor tislelizumab has promising therapeutic potential in neoadjuvant treatment for MIBC. This further strengthens our confidence in its safety and efficacy.”