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.

Price Action: BNTX stock is up 3.01% at $122.42 at last check Friday.

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