#China #Suzhou #Duality Biologics #BioNTech #BNT324

Promising Progress in Cancer Treatment: BNT324/DB-1311 Showcases Efficacy

Overview of the Clinical Trial

At the recent European Society of Medical Oncology (ESMO) Asia Congress 2024 held in Singapore, Duality Biologics and BioNTech reported encouraging interim findings for their investigational antibody-drug conjugate (ADC) BNT324/DB-1311. This Phase 1/2a trial targeted heavily pretreated patients suffering from advanced solid tumors, notably small cell lung cancer (SCLC), non-small cell lung cancer (NSCLC), and castration-resistant prostate cancer (CRPC).

The results highlighted a significant antitumor activity, demonstrating a manageable safety profile, which is crucial for advancing therapeutic options in oncology. 277 participants were enrolled across several solid tumor types, with the aim of evaluating BNT324/DB-1311’s efficacy and safety in a real-world setting.

Key Findings

The study showcased remarkable outcomes:

• - For patients with SCLC, those who had received prior immunotherapy without prior treatment involving topoisomerase I inhibitors exhibited a 70.4% unconfirmed objective response rate (uORR) at the 9 mg/kg dosage.
• - In the CRPC category, there was a notable 28.0% uORR with the imaging progression-free survival (rPFS) data revealing a median duration of 7.2 months, alongside a 94.7% six-month rPFS rate.
• - Overall, across all evaluable participants, the uORR was recorded at 32.4% with an impressive disease control rate (DCR) of 82.4%.

The results from NSCLC patients indicated a slightly lower uORR, with 22.0% for non-squamous cases and 16.0% for squamous cases, yet still marked improvements were observed in other cancers such as cervical cancer and melanoma.

Safety Profile

BNT324/DB-1311 not only provided promising efficacy data but also showed a generally well-tolerated safety profile. Common side effects noted included nausea, decreased appetite, and changes in blood counts. Such manageable adverse events are a vital aspect for patients' quality of life and adherence to therapy.

Future Directions

Following these positive findings, the companies plan to expand their research. A Phase 1/2 trial assessing the combination of BNT324/DB-1311 with another investigational bispecific antibody, BNT327/PM8002, is slated for 2025. This strategic pairing aims to enhance treatment efficacy in both SCLC and NSCLC contexts.

Dr. John Zhu, the Founder and CEO of Duality Biologics, expressed optimism about BNT324/DB-1311, stating it embodies a significant leap forward in ADC technology, potentially reshaping the treatment landscape for patients with serious malignancies.

Conclusion

The presentation of these interim results at ESMO Asia marks a pivotal moment for both Duality Biologics and BioNTech as they work towards developing advanced treatments for cancers with substantial unmet needs. As clinical trials continue, the future of BNT324/DB-1311 and its role in expanding therapeutic options remains a focal point for the oncology community, promising hope for countless patients worldwide.