Biotech Values

[DewDiligence]

APGN—Sotigalimab/chemo shows activity in soft-tissue sarcoma single-arm phase-2 trial:

https://www.globenewswire.com/news-release/2023/06/03/2681514/0/en/Apexigen-Announces-Phase-2-Data-Evaluating-Sotigalimab-its-CD40-Agonist-Antibody-in-Combination-with-Doxorubicin-in-Patients-with-Advanced-Soft-Tissue-Sarcoma-Presented-at-the-Amer.html

Sotiga combined with dox was safe and well tolerated and indicated increases in overall survival (OS) with a median OS of 35.6 months across all STS patients evaluated, which is markedly higher than the historical OS of 12.8 to 20 months of dox alone across STS subtypes.

Moreover, subtype-specific analysis demonstrated improvement in median progression-free survival (mPFS) of 10.95 months in patients with dedifferentiated liposarcoma (DDLPS) which is markedly higher than the historical mPFS of 4 months in patients with DDLPS.

n=32 for the full dataset reported today, including patients with three types of STS; n=9 for the DDLPS subtype.

Curiously, the PR does not cite the ORR data, even though ORR was the primary endpoint!

APGN is enrolling an expansion cohort specifically for DDLPS, with the goal of running a phase-3 trial in this indication if the expansion cohort performs as well as the initial (n=9) cohort.

No drug regimen works well in STS, and DDLPS is probably the least responsive to treatment of any STS subtype.

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APGN is being acquired by PYXS for a paltry $16M (#msg-171981599). PYXS presumably saw the dataset reported today before pulling the trigger.

p.s. A friend of mine died from DDLPS in 2018. He had enrolled in a pilot NKTR-214 + Opdivo STS trial conducted by MSKCC, but never received the first treatment. (The trial ended up failing, and we all know what became of NKTR-214.)