An analysis of BNT-116's R&D progress and its clinical results presented at the 2023 SITC

BNT116 is an intravenously administered RNA-lipoplex therapeutic cancer vaccine comprising six RNAs each encoding a tumor-associated antigen (TAA) frequently expressed in non-small cell lung cancer (NSCLC). The preliminary results from patients with advanced unresectable or metastatic NSCLC (ECOG 0–2) receiving BNT116 monotherapy with optional addition of cemiplimab was reported in 2023 SITC Congress.

BNT-116's R&D Progress

BNT-116 is an RNA vaccine and therapeutic vaccine that is being developed by BioNTech SE. As an RNA vaccine, BNT-116 utilizes the genetic material of the virus or disease it is targeting to stimulate an immune response in the body. The drug is primarily focused on treating neoplasms and respiratory diseases. Its active indications include advanced lung non-small cell carcinoma and non-small cell lung cancer.

According to the Patsnap Synapse, the highest phase of development for BNT-116 is Phase 1/2, indicating that the drug has progressed to early-stage clinical trials. And the clinical trial areas for BNT-116 are primarily in the United States, Germany and Hungary. The key indication is Advanced Lung Non-Small Cell Carcinoma.

Detailed Clinical Result of BNT-116

The non-randomized, sequential assignment, open-label clinical trial (NCT05142189) was aimed to confirm the dose of BNT116 alone or as combination therapy with cemiplimab, docetaxel, and/or carboplatin/paclitaxel (21-day cycles). 

In this study, the first six BNT116 doses are administered once weekly during Cycles 1 and 2 and three-weekly from Cycle 3 onwards. The cohort reported here will confirm the dose of BNT116 as monotherapy. Cemiplimab may be added from cycle 3 if tumor samples exhibit PD-L1 expression (tumor proportion score ≥1%). Patients’ prior therapies must have included a PD-1/PD-L1 inhibitor, a platinum-based chemotherapy regimen as well as one other systemic therapy. The objectives are to determine safety (dose limiting toxicities [DLTs] in Cycle 1; treatment-emergent adverse events [TEAEs]), and clinical activity (RECIST v1.1). Tumor and blood samples will be used for biomarker analysis.

The result showed that as of 01 March 2023, 18 patients (median age 65 years) have received BNT116 in the reported cohort (n=13 monotherapy only; n=5 cemiplimab added after Cycle 3). Most (16/18 [89%]) had received ≥3 prior therapy lines. All patients experienced ≥1 TEAE, and most TEAEs were grade 1–2 (table 1). TEAEs (incidence rate ≥5%) include pyrexia (n=12 [67%], grade 1–3), chills (n=9 [50%], grade 1–2), and vomiting (n=5 [28%], grade 1–2). Pyrexia and chills were considered treatment-related TEAEs for BNT116. Serious TEAEs were observed in 5/18 (28%) patients (grade 2 pneumothorax [n=1] or pyrexia [n=1], grade 3 fatigue [n=1] or pneumonia [n=1], and grade 4 acute kidney injury [n=1]). The latter grade 4 TEAE occurred during safety follow-up after trial treatment termination and was considered as unrelated to treatment with IMP. No DLTs or deaths under treatment were observed. Ten of 18 patients were evaluable for clinical activity (n=5 monotherapy only; n=5 cemiplimab added after Cycle 3). Of these, 6/10 had stable disease and 4/10 had progressive disease. The median duration of disease control was 1.53 months.

It can be concluded that in this trial, BNT116 was generally well tolerated with an expected safety profile as monotherapy and in combination with cemiplimab. Updated safety and clinical activity data will be presented along with additional biomarker data (TAA expression, PD-L1 expression, cytokines, tumor markers).

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