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Association details:
| Biomarker: | HER-2 expression |
|---|---|
| Cancer: | Endometrial Cancer |
| Drug: | BNT323 (Topoisomerase I inhibitor, HER2-targeted antibody-drug conjugate) |
| Direction: | Sensitive |
Evidence:
Source:
Title:
BioNTech and DualityBio Receive FDA Breakthrough Therapy Designation for Antibody-Drug Conjugate Candidate BNT323/DB-1303 in Endometrial Cancer
Published date:
12/21/2023
Excerpt:
BioNTech SE...and Duality Biologics...announced that the U.S. Food and Drug Administration (“FDA”) granted Breakthrough Therapy designation for BNT323/DB-1303 for the treatment of advanced endometrial cancer in patients who progressed on or after treatment with immune checkpoint inhibitors. BNT323/DB-1303 is a next-generation antibody-drug conjugate (“ADC”) candidate targeting the Human Epidermal Growth Factor Receptor 2 (“HER2”), a cell surface protein which is expressed in a range of tumor types. The designation is based on encouraging topline data from a Phase 1/2 study (NCT05150691) with BNT323/DB-1303 in patients with HER2-expressing advanced endometrial cancer.
Source:
Title:
430 - DB-1303, A HER2-Targeting ADC, For Patients With Advanced/Metastatic Endometrial Cancer: Preliminary Clinical Results From An Ongoing Phase 1/2a Trial (NCT05150691)
Published date:
09/18/2023
Excerpt:
This is the first report of dose escalation and expansion results of DB-1303 in patients with HER2-expressing (IHC 1/2/3+ or ISH+) advanced/metastatic endometrial cancer (EC)....DB-1303 demonstrated a manageable safety profile and promising antitumor activity, with high disease control in patients with advanced/metastatic EC.
Trial ID:
