On November 12, 2019 Cue Biopharma, Inc. (NASDAQ: CUE), a clinical-stage biopharmaceutical company engineering a novel class of injectable biologics to selectively engage and modulate targeted T cells within the body, reported a business update for the third quarter 2019 (Press release, Cue Biopharma, NOV 12, 2019, View Source [SID1234550968]).
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"The third quarter was marked by the dosing of the first patient in our Phase 1 clinical study of CUE-101, which represents a transformative milestone for the company as we continue to grow and develop as a clinical stage company," said Daniel Passeri, chief executive officer. "As part of this continued evolution, the promotion of Dr. Suri to President and CSO helps enhance our productivity and effectiveness by further integrating operational functions and fostering close coordination of preclinical translational studies with clinical development."
Dr. Suri stated, "We have made significant progress on several key programs in addition to CUE-101, including CUE-102, a program selected with our collaboration partner, LG Chem Life Sciences, as well as our early-stage program in auto-immune disease, through our collaboration with Merck. With our first immuno-oncology candidate now in the clinic and additional candidates in lead optimization, Cue Biopharma is well positioned for the potential of significant value inflection over the coming months."
Recent News & Business Updates
Recently initiated dosing a Phase 1 clinical trial to investigate the safety and efficacy of CUE-101 in the treatment of HNSCC. The trial is a multi-center, open-label, Phase 1 dose escalation and expansion study evaluating the safety, anti-tumor effect, and
immunogenicity of CUE-101 as a monotherapy in approximately 50 patients with confirmed HPV16-driven recurrent/metastatic HNSCC and HLA-A*02:01 serotype.
Extended cash runway through an at-the-market equity offering sales agreement for aggregate gross proceeds of up to $30 million with Stifel Nicolaus & Company, Inc. ("Stifel"), who acts as sales agent. As of September 30, 2019, the Company had sold 2,084,615 shares of common stock under the sales agreement for total proceeds of approximately $15.7 million, net of commissions paid, but excluding estimated transaction expenses.
Promoted Anish Suri, Ph.D., to the role of president in addition to his current role as chief scientific officer. As president, Dr. Suri will assume operational and management oversight of corporate functions, as well as research and development activities. Building upon the recent success of entering clinical development with its lead drug candidate CUE-101, the company plans to augment its senior management team with a number of key hires through 2020.
On Friday, November 8, 2019, Cue Biopharma presented a poster on its lead program, CUE-101, at the Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper) 34th Annual Meeting (SITC 2019) titled, "CUE-101, a novel HPV16 E7:pMHC:IL-2:Fc fusion protein, enhances tumor antigen specific T cell activation for the treatment of HPV16-driven malignancies."
Third-Quarter Results & Financial Highlights
The Company reported collaboration revenue of approximately $1.0 million and $0.4 million for the three months ended September 30, 2019 and 2018, respectively.
Research and development expenses were $5.3 million and $10.3 million for the three months ended September 30, 2019 and 2018, respectively. The decrease in research and development expenses of $5.0 million was primarily due to a reduction in headcount, operational efficiencies and a decrease in drug substance manufacturing cost as our full clinical supply for the CUE-101 Phase 1 monotherapy trial was manufactured during 2018.
General and administrative expenses were $2.8 million and $2.9 million for the three months ended September 30, 2019 and 2018, respectively. The decrease in general and administrative expense of $0.1 million was primarily due to a reduction in headcount.
As of September 30, 2019, the Company had approximately $31.3 million in cash and cash equivalents compared with $39.2 million as of December 31, 2018.
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.
About CUE-101
CUE-101, our lead program from the CUE-100 series, contains IL-2 and a pMHC composed of HLA-A*02:01 complexed with a dominant peptide derived from the human papilloma virus 16 E7 protein (HPV16-E7). The drug is a fusion protein designed to target and activate antigen-specific T cells present in the patient’s body to attack HPV16-driven cancers. CUE-101 is currently being tested in a Phase 1 clinical trial for the treatment of HPV16-driven recurrent or metastatic head and neck squamous cell carcinoma (HNSCC). For more information about the trial, please visit clinicaltrial.gov.
About Immuno-STAT
Immuno-STAT biologics are designed for targeted modulation of disease-associated T cells in the areas of immuno-oncology and autoimmune disease. Each of our biologic drugs is designed using our proprietary scaffold comprising: 1) a peptide-MHC complex (pMHC) to provide selectivity through interaction with the T cell receptor (TCR), and 2) a unique co-stimulatory signaling molecule to modulate the activity of the target T cells.
The simultaneous engagement of co-stimulatory molecules and pMHC binding mimics the signals delivered by antigen presenting cells (APCs) to T cells during a natural immune response. This design enables Immuno-STAT biologics to engage with the T cell population of interest, resulting in highly targeted T cell modulation. Because our drugs are delivered directly in the patient’s body (in vivo), they are fundamentally different from other T cell therapeutic approaches that require the patients’ T cells to be extracted, stimulated and expanded outside the body (ex vivo), and reinfused in an activated state.