Cue gets two patents
Targeting T Cells
Cambridge, Massachusetts-based Cue Biopharma, Inc., a clinical-stage biopharmaceutical company engineering a novel class of injectable biologics to selectively engage and modulate targeted T cells directly within the body, received two new United States patents (Nos. 11,117,945 and 11,104,712) from the United States Patent and Trademark Office. The company’s IP portfolio includes about 300 pending applications and issued patents that are either owned by Cue Biopharma or exclusively licensed from the Albert Einstein College of Medicine.
U.S. Patent No. 11,117,945 covers Cue Biopharma’s first clinical drug candidate, CUE-101, and its use in treating HPV16-associated cancers such as head and neck, cervical and genitoanal cancers. CUE-101 is currently in a Phase 1b clinical trial in which second line and beyond patients are receiving CUE-101 as a monotherapy for HPV16+ recurrent/metastatic head and neck squamous cell carcinoma (HNSCC).
Currently, CUE-101 has demonstrated monotherapy clinical activity by selective activation of targeted CD8+ T cells specific for HPV+ cancer cells with a 40% clinical benefit in the first 10 evaluable patients at the recommended Phase 2 dose of 4mg/kg. CUE-101 is also in a dose escalation study in combination with pembrolizumab in front-line patients with HPV16+ recurrent/metastatic HNSCC. A Phase 2 exploratory clinical trial in which CUE-101 will be administered in the neoadjuvant phase before standard of care (SOC) therapy in treatment-naïve, HLA-A*0201 positive patients with locally advanced, HPV-positive oropharyngeal squamous-cell carcinoma, is expected to begin enrolling patients this fall.
U.S. Patent No. 11,104,712 covers the use of CUE-101 in combination with KEYTRUDA® (pembrolizumab) for treating HPV16-associated cancers such as head and neck, cervical and genitoanal cancers. The combination of CUE-101 and pembrolizumab is being evaluated by Cue Biopharma in collaboration with Merck Sharp & Dohme Corp.
According to Daniel Passeri, chief executive officer of Cue Biopharma, “The issuance of these patents represents an important development as we continue to build-up our IP portfolio and bolster patent protection for the novel protein engineering platforms we have enabled, particularly as we begin demonstrating clinical activity in what we believe will be a disruptive and transformational breakthrough in immunotherapy for addressing cancer and other debilitating and life-threatening diseases.”
He added, “Furthermore, obtaining these patents early in the clinical development of CUE-101 enhances our ability to receive a Patent Term Extension from the United States Patent and Trademark Office if CUE-101 is approved by the FDA. We continue to make a substantial investment in protecting our intellectual property, and we look forward to the issuance of additional patents that cover our important platforms and pipeline products.”
Cue Biopharma is working on immunotherapy that has the potential to offer patients therapeutic advantages while minimizing or eliminating side effects. The company’s vision is to transform medicine by realizing the promise of safe and highly effective immunotherapy through the development of its Immuno-STAT and Neo-STAT biologics platforms engineered to overcome the current challenges faced by prevailing immuno-therapeutics. Cue’s biologics are designed to selectively engage and modulate disease relevant T cells by emulating nature’s own “cues”, or signals, to regulate the immune system. These biologics are administered directly in the patient’s body to enable the patient’s own immune system to achieve balance and restore health.
In September 2019, Cue began its first-in-human, dose-escalation and expansion Phase 1 clinical trial of CUE-101 in patients with HPV-positive recurrent or metastatic head and neck squamous cell carcinoma (NCT03978689). In February 2021, the company started a dose-escalation and expansion Phase 1 clinical trial of CUE-101 in combination with KEYTRUDA® (pembrolizumab) in newly diagnosed patients with HPV-positive recurrent or metastatic head and neck squamous cell carcinoma. Cue engaged a network of nationally recognized clinical investigators at 14 top-tier institutions to actively recruit patients.
Cue recently reported a business and clinical progress update for the second quarter 2021. As Passeri said, “During the second quarter 2021, we continued to make significant clinical progress advancing our IL-2 based CUE-100 series, represented by the Phase 1a/1b monotherapy trial of CUE-101 and combination-therapy trial with KEYTRUDA® (pembrolizumab). In addition, we have continued with the development and expansion of our pipeline programs and technology platforms, and also enhanced our capital resources. Importantly, we recently reported a confirmed partial response (PR) in a patient from our ongoing Phase 1 monotherapy dose escalation trial of CUE-101 and look forward to providing further details on this patient response during the quarterly update call. Our Phase 1 monotherapy dose escalation and expansion study is now in dose expansion and our combination study with pembrolizumab continues in dose escalation. During the call, we will also highlight the development implications for CUE-101 and potential of the CUE-100 series and Immuno-STAT™ platform.”
Kerri-Ann Millar, chief financial officer of Cue Biopharma, added, “We continue to be in a solid financial position and deployed our at-the-market (ATM) common stock facility during the second quarter to extend the anticipated operational runway further into the fourth quarter of 2022.”
The company reported the first patient dosed in the Part B expansion of its CUE-101 Phase 1 monotherapy clinical trial in HPV+ second line and beyond head and neck squamous cell carcinoma (HNSCC), at the recommended Phase 2 dose of 4mg/kg. Cue also presented preclinical data on CUE-401, the company’s first autoimmune drug product candidate from the CUE-400 series, at the 2021 Federation of Clinical Immunology Societies (FOCIS) Annual Meeting.
Cue reported collaboration revenue of about $2.7 million and $1.1 million for the three months ended June 30, 2021 and 2020, respectively. The increase in collaboration revenue of $1.6 million was primarily because of additional research and development and contract manufacturing activities in preparation of an investigational new drug (IND) filing for its second drug product candidate from the IL-2 based CUE-100 series, CUE-102, planned for the first half of 2022.
Research and development expenses were $8.8 million and $8.1 million for the three months ended June 30, 2021 and 2020, respectively. The increase in research and development expenses of $0.7 million was primarily because of an increase in laboratory and drug substance manufacturing costs and clinical expenses.
Cue’s general and administrative expenses were $4.3 million and $3.9 million for the three months ended June 30, 2021 and 2020, respectively. The increase in general and administrative expense of $0.4 million was primarily because of an increase in stock-based compensation expense and legal fees incurred in the second quarter of 2021 as compared to the same period in 2020.