Cue Biopharma reports promising results for HPV+ head and neck cancer drug

BOSTON - Cue Biopharma, Inc. (NASDAQ:CUE), a clinical-stage biotech company with a current market capitalization of $51 million and strong balance sheet showing more cash than debt, announced Tuesday updated clinical data for its experimental cancer immunotherapy CUE-101, showing a 50% overall response rate in treatment-naïve patients with HPV-positive recurrent/metastatic head and neck squamous cell carcinoma (HNSCC). According to InvestingPro analysis, while the company maintains healthy liquidity with a current ratio of 1.03, it faces challenges with rapid cash burn.

The data, presented by Dr. Dimitrios Colevas from the company’s Phase 1 trial evaluating CUE-101 in combination with pembrolizumab (KEYTRUDA), revealed a 12-month overall survival rate of 88% and an estimated median overall survival of 32 months. Despite these promising clinical results, InvestingPro data shows the stock trading significantly below its 52-week high of $1.99, suggesting potential upside opportunity for investors looking at undervalued biotechs. Get access to 7 additional exclusive ProTips and comprehensive analysis with an InvestingPro subscription.

According to the company, these results compare favorably to historical data from the third-party KEYNOTE 048 trial, which showed a 19% response rate with pembrolizumab alone. The company noted that the current data represents a significant reduction in the risk of death (HR 0.23) compared to historical benchmarks.

CUE-101 is designed to selectively target and activate HPV16-specific T cells by incorporating peptide-MHC molecules along with engineered interleukin 2. The drug is part of Cue Biopharma’s CUE-100 series of biologics aimed at stimulating tumor-specific T cells while potentially reducing systemic side effects associated with current IL-2 therapies.

"We believe the clinical activity and enhanced survival observed in this trial to date is due to the repeated stimulation and expansion of tumor-specific T cells given the mechanism of action of CUE-101," said Matteo Levisetti, chief medical officer of Cue Biopharma.

The company indicated the maturing data positions it well for pursuing strategic alternatives, including potential partnering opportunities.

The Phase 1 trial is evaluating CUE-101 as both a monotherapy for previously treated patients and as a first-line treatment in combination with pembrolizumab.

This information is based on a company press release statement. While analysts maintain a bullish consensus with price targets ranging from $2 to $6, InvestingPro’s detailed financial health analysis reveals both challenges and opportunities ahead. Access the complete Pro Research Report, available for over 1,400 US stocks, to understand the full investment potential of CUE Biopharma and similar biotech opportunities.

In other recent news, Cue Biopharma has announced a significant partnership with Boehringer Ingelheim to develop and commercialize CUE-501, a novel therapeutic targeting CD19+ B cells in autoimmune diseases. This collaboration, valued at up to $357 million, includes an upfront payment of $12 million, strengthening Cue Biopharma’s financial position. Additionally, Cue Biopharma successfully completed a $20 million equity raise, further bolstering its cash reserves. Analysts from both Citizens JMP and JMP Securities have maintained a Market Outperform rating with a $2.00 price target, reflecting confidence in the company’s strategic direction. The partnership with Boehringer Ingelheim is expected to expand Cue Biopharma’s development pipeline and market opportunities in autoimmune therapies. Furthermore, Cue Biopharma has launched a public stock offering to enhance its financial flexibility, with Oppenheimer & Co. Inc. as the sole book-running manager. The company has a history of operating losses but anticipates that these recent financial moves will support its ongoing operations. The developments highlight Cue Biopharma’s commitment to advancing its innovative therapies and securing strategic collaborations in the biopharmaceutical sector.

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