ubamatamab (REGN4018)

Integrating preclinical and clinical data determined a target trough concentration range of 5-30 mg/L, which supports evaluation of ubamatamab 250 mg with or without cemiplimab and 800 mg monotherapy once every 3 weeks in expansion cohorts. Preclinical data (cytokine release, tumor regression, monkey PK) had translational value in supporting regimen selection in dose escalation and subsequently in dose expansion after integration with patient data from dose escalation.

P2, N=40, Recruiting, M.D. Anderson Cancer Center | Not yet recruiting --> Recruiting

P2, N=40, Not yet recruiting, M.D. Anderson Cancer Center | Trial primary completion date: Jul 2026 --> Jul 2028

P2, N=40, Not yet recruiting, M.D. Anderson Cancer Center

P1/2, N=612, Recruiting, Regeneron Pharmaceuticals | N=326 --> 612 | Trial primary completion date: Jan 2027 --> Apr 2027

P1/2, N=690, Recruiting, Regeneron Pharmaceuticals | Trial completion date: Jul 2024 --> Jun 2026 | Trial primary completion date: Jul 2024 --> Jun 2026

Conclusion/Implications Ubamatamab +/- cemiplimab demonstrated acceptable safety and evidence of clinical activity in heavily pretreated OC. An ongoing randomised Phase 2 study is evaluating ubamatamab alone and with cemiplimab.

The impact of ubamatamab on QOL and physical functioning will be assessed. Current Trial Status: The study is currently recruiting patients to combination dose escalation, monotherapy dose expansion, and the randomized Phase 2 cohort.

No abstract available

MUC16 expression is a frequent feature in epithelioid sarcoma and may be identified in other INI-1-deficient malignancies. MUC16 is a possible therapeutic target and warrants further clinical trial development outside the ovarian cancer field.

Exclusion criteria include recent biologic therapy (7 days); approved conventional therapy (except biologics or immunotherapy) <3 weeks (wks) or investigational agents <4 wks prior to first study dose; and anti–PD-L1 therapy <5 T 1/2 prior to first study dose. Key exploratory endpoints are correlation between clinical efficacy endpoints and baseline protein expression levels of MUC16 and PD-L1. Results and Discussions NA Conclusion NA

Exclusion criteria include recent biologic therapy ( 7 days); approved conventional therapy (except biologics or immunotherapy) < 3 weeks (wks) or investigational agents < 4 wks prior to first study dose; and anti–PD-L1 therapy < 5 half-lives prior to first study dose . In expansion, primary endpoint is ORR by RECIST 1.1 for each combination; key secondary endpoints are TEAEs, serious AEs, deaths . Key exploratory endpoints are correlation between clinical efficacy endpoints and baseline protein expression levels of MUC16 and PD-L1.

No abstract available

This presentation will describe Regeneron’s bispecific platform and present preclinical data on REGN4018, a clinical-stage, T cell-engaging, bispecific-targeting Muc16 for solid tumor indications. In addition, status updates on Regeneron’s other clinical-stage bispecific antibodies (REGN1979, REGN5458, REGN5678) will be presented, as well as a discussion of new combinatorial approaches being taken to enhance bispecific anti-tumor efficacy.