On July 28, 2020 Cue Biopharma, Inc. (NASDAQ: CUE), a clinical-stage biopharmaceutical company engineering a novel class of injectable biologics designed to selectively engage and modulate targeted T cells within the body, reported it has advanced CUE-101 into cohort 5 in its ongoing multicenter, open-label, dose escalation Phase 1 monotherapy trial in patients with human papilloma virus-positive recurrent/metastatic head and neck squamous cell carcinoma (HPV+ HNSCC) (NCT03978689) (Press release, Cue Biopharma, JUL 28, 2020, View Source [SID1234608300]).
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Patients in cohort 5 will receive 2 mg/kg of CUE-101, which is two times the CUE-101 dose of 1 mg/kg in cohort 4. The first patient in cohort 5 received their dose and has been monitored for the initial protocol safety period of seven days with no evidence of adverse reactions. The next two patients in cohort 5 have been identified and have been scheduled to receive their first dose of CUE-101.
As previously noted in a press release dated June 15, 2020, three additional patients were enrolled in cohort 4 at the recommendation of the Safety Review Committee to further characterize immune activity and confirm safety after one of the first three patients in cohort 4 experienced a possible treatment-related dose limiting toxicity (DLT). That patient subsequently received the next planned dose of CUE-101 at the same 1.0 mg/kg dosage without an observed adverse event. As no serious (Grade 3 or higher) treatment-related adverse events were observed during a 21-day safety evaluation period for the three additional cohort 4 patients, Cue Biopharma received approval from the Safety Review Committee to initiate enrollment and treatment of patients in cohort 5.
"We are pleased to have enrolled three more patients in cohort 4 and to rapidly initiate cohort 5. Our progress is due, in large part, to the continued enthusiasm and support of our leading investigators during this challenging and uncertain time of COVID-19," said Ken Pienta, M.D., acting chief medical officer of Cue Biopharma. "In parallel to evaluating CUE-101 at the cohort 5 dose level, we have identified additional patients to be enrolled in a further expansion of up to nine patients in cohort 4, as permitted per protocol. This allows us to further enhance our understanding of the pharmacokinetics (PK), pharmacodynamics (PD), and clinical activity of CUE-101 at what we believe could be a clinically active dose."
To date, sixteen patients have been dosed in the Phase 1 trial. Apart from a patient in cohort 4 with a possible treatment-related Grade 3 DLT as mentioned above, there have been no other DLTs. Importantly, the Grade 3 DLT and all other reported adverse events have resolved without further complications. To date, there have been no patient discontinuations from the trial due to adverse events.
About the CUE-100 Series
The CUE-100 series consists of Fc-fusion biologics that incorporate peptide-MHC (pMHC) molecules along with rationally engineered IL-2 molecules. This singular biologic is anticipated to selectively target, activate and expand a robust repertoire of tumor-specific T cells directly in the patient. The binding affinity of IL-2 for its receptor has been deliberately attenuated to achieve preferential selective activation of tumor-specific effector T cells while reducing potential for effects on regulatory T cells (Tregs) or broad systemic activation, potentially mitigating the dose-limiting toxicities associated with current IL-2-based therapies.