On June 1, 2022 Sichuan Kelun-Biotech Biopharmaceutical Co, Ltd. ("Kelun-Biotech") and Levena Biopharma ("Levena"), a subsidiary of Sorrento Therapeutics, Inc. (Nasdaq: SRNE, "Sorrento"), reported the planned presentation of A166 data (Abstract #1037 and Poster #415) in patients with HER2-expressing locally advanced or metastatic solid tumors at the 2022 Annual Meeting of ASCO (Free ASCO Whitepaper), the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper), to be held on June 3-7 in Chicago, IL (Press release, Sorrento Therapeutics, JUN 1, 2022, View Source [SID1234615311]). A166 is a HER2 antibody-drug conjugate (ADC) developed by Kelun-Biotech in a partnership with Levena Biopharma, which provided the patent-protected technologies for the generation and production of A166 in relation to (1) Duostatin-5, a proprietary tubulin inhibitor, (2) K-Lock, a site-specific conjugation technology, and (3) an enzymatically cleavable linker.

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As previously reported, in Phase 1 of the study, A166 demonstrated a safety profile that compared favorably to its commercial competitors and potentially superior efficacy as shown by the overall response rate (ORR) of 59.1% and 71.4% in the 4.8 mg/kg cohort and 6.0 mg/kg cohort, respectively, in heavily pretreated patients with HER2-positive breast cancer (data presented at the 2021 ASCO (Free ASCO Whitepaper) meeting [NCT05311397; J Clin Oncol 39, 2021 (suppl 15; abstr 1024)].

At the upcoming 2022 ASCO (Free ASCO Whitepaper) meeting, Kelun-Biotech will report updated data from this Phase 1 trial (Abstract #1037 and Poster #415). The Phase 1 dose expansion of the study was conducted in several sites in China and enrolled a total of 58 female patients (n=23 at 4.8 mg/kg and n=35 at 6.0 mg/kg) treated with A166 in 3-week cycles.

The best ORR was 73.9% (17/23; 95% CI, 51.59 to 89.77) in the 4.8 mg/kg cohort and 68.6% (24/35; 95% CI, 50.71 to 83.15) in the 6.0 mg/kg cohort.
Median progression free survival (PFS) was 12.3 months (95% CI, 6.00-not reached) in the 4.8 mg/kg cohort and 9.4 months (95% CI, 4.00 to 10.40) in the 6.0 mg/kg cohort.
Of 23 patients treated in the 4.8 mg/kg cohort, one had a confirmed and sustained CR lasting 7+ months.
Next generation sequencing was performed on tissue-derived DNA and blood-derived circulating tumor DNA.
The detailed safety data, RECIST 1.1 response rate, and biomarker analyses will be presented in a poster (#415) at the 2022 ASCO (Free ASCO Whitepaper) meeting