On March 16, 2021 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 directly within the patient’s body, reported a business update for the fourth quarter and full year 2020 (Press release, Cue Biopharma, MAR 16, 2021, View Source [SID1234608282]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

"We have executed on our stated corporate goals and objectives for 2020, enabling us to begin 2021 on track, despite the ongoing challenges of the global pandemic. Accordingly, we marked the beginning of 2021 by the dosing of the first patient in our CUE-101 Phase 1 combination trial with KEYTRUDA, which has the potential for significant mechanistic synergies to provide broader patient reach and enhancement of patient benefit," said Dan Passeri, chief executive officer of Cue Biopharma. Mr. Passeri added, "Importantly, we are now well-positioned to execute throughout 2021 with the aim of demonstrating the potential significance of our approach for treating debilitating diseases by restoring immune balance. In oncology, we have the ongoing Phase 1 studies of CUE-101 which aim to establish a potential registration path, as well as proof-of-principle and a mitigated risk profile for the entire CUE-100 series. For autoimmune disease, we remain on-track to demonstrate the potential of deploying our CUE-300 series (partnered with Merck for defined indications) where the autoantigens are known and well characterized, e.g., type 1 diabetes. For autoimmune diseases where the autoantigens are unknown, or not well characterized, we look forward to further progressing our novel CUE-400 series, a recent development that is based on our IL-2 variant and modified TGF-beta."

Ken Pienta, M.D., acting chief medical officer of Cue Biopharma, commented, "We are pleased with the progress and observations made to date in our monotherapy trial and with the initiation of our combination trial of our lead drug candidate CUE-101. We continue to generate supportive clinical datasets from the ongoing dose escalation and expansion portion of the monotherapy trial in preparation for the Phase 1b monotherapy expansion segment of the trial scheduled to begin in the second half of 2021. Furthermore, with the initiation of the combination trial in front-line therapy with KEYTRUDA, combined with the expectation of launching our neo-adjuvant study in newly diagnosed patients later this year, we have implemented a clinical development approach that we believe will enable us to broaden patient reach and maximize the potential for enhancing therapeutic benefit."

Fourth Quarter 2020 Financial Results

The Company reported collaboration revenue of approximately $0.5 million and $1.0 million for the three months ended December 31, 2020 and 2019, respectively. The decrease was primarily due to adjustments in the LG Chem, Ltd. and Merck collaboration budgets and full-time employee allocations.

Research and development expenses were $8.0 million and $7.0 million for the three months ended December 31, 2020 and 2019, respectively. The increase was due to clinical trial activity for the CUE-101 monotherapy and combination clinical trials, hiring of research and development personnel in the fourth quarter of 2020, manufacturing costs for CUE-102 clinical material as well as development of the Neo-STAT cell line.

General and administrative expenses were $3.4 million and $3.1 million for the three months ended December 31, 2020 and 2019, respectively. The increase was due primarily to stock-based compensation and legal fees incurred during the fourth quarter of 2020.

Full Year 2020 Financial Results

The Company reported collaboration revenue of approximately $3.2 million and $3.5 million for the years ended December 31, 2020 and 2019, respectively. The decrease was primarily due to adjustments in the LG Chem Ltd., and Merck collaboration budgets and changes in the allocation of full-time employees to these programs during the year.

Research and development expenses were $33.5 million and $27.5 million for the years ended December 31, 2020 and 2019, respectively. The increase was due to clinical trial activity for the CUE-101 monotherapy and combination clinical trials, hiring of research and development personnel throughout 2020 and manufacturing costs related to CUE-101 and CUE-102 clinical material.

General and administrative expenses were $14.7 million and $12.7 million for the years ended December 31, 2020 and 2019, respectively. The increase in general and administrative expense was due primarily to stock-based compensation and legal fees offset by a decrease in travel expenses as the COVID-19 pandemic continued to hamper business travel throughout 2020.

As of December 31, 2020, the Company had approximately $84.9 million in cash and cash equivalents compared with $59.4 million as of December 31, 2019.

Recent News & Business Updates

Evaluated initial observations in CUE-101 Phase 1 monotherapy dose escalation clinical trial for treatment of HPV+ R/M HNSCC, which demonstrated tolerability and generated encouraging emerging metrics pertaining to pharmacokinetic and pharmacodynamic profile, as well as early signs of anti-tumor activity. Compilation of data to date supports our belief that the Immuno-STAT platform stimulates targeted immune modulation through the selective engagement of disease-relevant T cells.
Dosed the first patient in a Phase 1 dose escalation clinical trial of CUE-101 in combination with Merck’s anti-PD-1 therapy, KEYTRUDA (pembrolizumab), as first-line treatment for HPV+ R/M HNSCC, which is being conducted in parallel at the same clinics that are leading the ongoing Phase 1 monotherapy study of CUE-101.
Extended the term of the research program with Merck under the existing 2017 research collaboration and license agreement toward developing a clinical candidate for the treatment of type 1 diabetes and an additional undisclosed autoimmune disease indication. Under the terms of the extension, Cue Biopharma will receive additional financial research support to further study and develop promising preclinical biologics with the objective of identifying drug product candidates that can be advanced into the clinic.
Presented three posters highlighting the Company’s clinical development and pipeline progress at the Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper)’s 35th Anniversary Annual Meeting (SITC 2020). The posters included a clinical update on CUE-101, the lead drug candidate from the IL-2 based CUE-100 series and data supporting the potential of the Immuno-STAT platform to selectively engage and modulate targeted T cells within the body in a manner that can address a broad range of indications.