On Thursday, Duality Biologics revealed the first data from a global Phase 1/2a trial of BNT324/DB-1311, which it co-developed with BioNTech SE (NASDAQ: BNTX ).

The data were presented in an oral session at the 2024 European Society of Medical Oncology Asia Annual Meeting in Singapore and showed encouraging antitumor activity alongside a manageable safety profile in heavily pretreated patients with locally advanced or metastatic solid tumors .

The ongoing Phase 1/2a trial analysis included 277 participants across various solid tumor types.

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The trial’s primary endpoints are safety and an objective response rate. The secondary endpoints include duration of response, disease control rate, progression-free survival, and overall survival.

The data showed the following results: Among all evaluable patients with at least one post-baseline tumor assessment (n=238), the overall unconfirmed objective response rate (uORR) was 32.4%, and the disease control rate (DCR) was 82.4%.

Among patients with small cell lung cancer (n=73), the uORR was 56.2%, and the DCR was 89.0%.

Most small cell lung cancer patients received 6 mg/kg and 9 mg/kg of BNT324/DB-1311, with no difference in uORR between the two dose groups (54.5% and 58.8%, respectively).

Notably, at the 9 mg/kg dose level, the uORR in patients with small cell lung cancer who had prior immunotherapy but no treatment with topoisomerase I inhibitors reached 70.4%.

Most patients with non-small cell lung cancer had non-squamous histology (n=41), exhibiting an uORR of 22.0%, while patients with squamous non-small cell lung cancer (n=25) had an uORR of 16.0%.

Among patients with castration-resistant prostate cancer (n=32), BNT324/DB-1311 demonstrated early antitumor activity with an uORR of 28.0% and a DCR of 92.0%.

The imaging progression-free survival (rPFS) data were not mature at the time of the analysis, with a median rPFS of 7.2 months. The 6-month rPFS rate was 94.7%.

In other tumor types, including cervical cancer (n=4), hepatocellular carcinoma (n=12), head and neck squamous carcinoma (n=3), and melanoma (n=11), BNT324/DB-1311 also exhibited antitumor activity with uORRs of 75.0%, 25.0%, 100.0%, and 36.4%, respectively.

BNT324/DB-1311 showed a manageable safety profile across all evaluated patients and tumor types.

BNT324/DB-1311 is one of three clinical-stage ADC candidates in BioNTech’s and DualityBio’s global strategic partnership.

Multiple clinical trials combining selected assets from BioNTech’s and DualityBio’s strategic partnership are planned for various solid tumor indications.