On September 15, 2023 Harpoon Therapeutics, Inc. (Nasdaq: HARP), a clinical-stage immuno-oncology company developing novel T cell engagers, reported dosing of the first patients with small cell lung cancer (SCLC) in an ongoing Phase 1/2 trial of HPN328, a DLL3 targeting TriTAC, in combination with atezolizumab (Tecentriq) (Press release, Harpoon Therapeutics, SEP 15, 2023, View Source [SID1234635186]). Harpoon previously entered a Master Clinical Supply Agreement with F. Hoffmann-La Roche for the supply of atezolizumab. Under this agreement, Harpoon is the sponsor of the trial and Roche will supply atezolizumab. This announcement is being made in conjunction with Harpoon’s investor event, "DLL3 Market Opportunity and KOL Discussion of HPN328," held virtually and in person today in New York beginning at 8 a.m. ET.

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"Dosing the first patients in these combination cohorts for HPN328 with atezolizumab in patients with SCLC marks a significant milestone for this clinical program," said Luke Walker, M.D., Chief Medical Officer for Harpoon Therapeutics. "Building on the strength of our Phase 1 data, we remain committed to realizing the full potential of HPN328 as an important treatment option for patients with SCLC and other neuroendocrine tumors across early and late lines of therapy."

About the HPN328 + Atezolizumab Combination Cohort
Previously treated extensive stage SCLC patients enrolled in these combination cohorts will be dosed with HPN328 administered once every 2 weeks (Q2W) by IV infusion during each 28-day cycle. Atezolizumab will be administered once every 4 weeks (Q4W) by IV infusion on day 1 of each 28-day cycle. Primary outcome measures will include frequency and severity of treatment emergent adverse events (TEAEs), number and severity of dose limiting toxicities (DLTs), and pharmacokinetic parameters. Secondary outcome measures will include objective response rate (ORR), progression-free survival (PFS), overall survival (OS), duration of response (DOR), and anti-drug antibody (ADA) formation. Enrollment in the combination cohorts has been initiated at the 12 mg Q2W HPN328 dose level, and escalation is planned per protocol dependent on data, with initial results from these combination cohorts expected in 2024. Separately, HPN328 interim Phase 1 monotherapy data will be presented at the European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper) held on October 20-24, 2023.

Webcast Information for "DLL3 Market Opportunity and KOL Discussion of HPN328"

The webcast will begin at 8 a.m. ET and can be accessed using this link:
View Source;tp_key=667a2aef59
A live webcast and archived replay of the event will be accessible on the Investor Relations page of the Harpoon website at View Source