Year-End Sale is Live! Find Exclusive Prices on the Best Selling Pharma & MedTech Reports.Check Now!

SystImmune is currently developing BL-B01D1, an ADC targeting both EGFR and HER3. This bispecific drug can bind to EGFR and/or HER3-positive cells and shows stronger tumor inhibition capacities than individual anti-EGFR and anti-HER3 ADCs. It comprises a bispecific antibody against EGFR/HER3 (SI-B001), a cathepsin B cleavable linker, and a novel topoisomerase I inhibitor agent (Ed-04), derived from the alkaloid camptothecin.
In ESMO 2023, the company presented data as per the cutoff date of 17 August 2023. The results presented on 21st October ESMO discussed the updated Phase I human study results. Most of the patients with PFS of 0-1 were included in the study with the majority of the patients being heavily pretreated (50%) with ≥3 lines of treatment.
In terms of safety, approximately 369 patients were evaluated, and approximately 98% of patients had any TEAE. Grade 3 and above TEAE was seen in 67% of the patients and grade 4 and above in 34% of the patients. Only one G2 ILD was observed and target toxicity was relatively low.
The previous preclinical studies have also unveiled the remarkable potential of BL-B01D1, indicating its promise as a novel therapeutic option across a wide spectrum of human cancers.
KOL insights
“After utilizing chemoimmunotherapy as the primary treatment for most of these patients, there are scarce alternatives, especially in the realm of targeted therapies. The prospect of this drug demonstrating meaningful effectiveness in NSCLC patients.” -Memorial Sloan Kettering Cancer Center in New York, New York.
Conclusion
BL-B01D1 is a First-in-Class bispecific ADC, for heavily pretreated NSCLC patients which has shown promising antitumor activity with an acceptable safety profile. With such promising results, the drug is expected to have the potential to be expanded in later lines for some patient groups. EGFR and HER3 are significantly expressed in NSCLC, which increases the potential of the drug in a late setting by targeting both potential targets.
For more insight into the patient's burden/epidemiology, treatment, and changing market landscape-related advancements, refer to the Non-Small Cell Lung Cancer Market Insight and Market Forecast and Non-Small Cell Lung Cancer Pipeline Insight Report
BL-B01D1, a bispecific ADC targeting EGFR and HER3, demonstrated manageable safety profiles in patients with previously treated solid tumors along with promising antitumor activity in patients with NSCLC.