CUE - Cue Biopharma: Nothing Stands Out For This Cancer Immunotherapy Developer

2023-08-10 18:02:10 ET

Summary

• Cue Biopharma published phase 1 data for lead candidate CUE-101, showing clinical activity and favorable tolerability in patients with HPV-positive head and neck squamous cell carcinoma.
• The company also presented data from a phase 1b trial combining CUE-101 with Keytruda, showing promising response rates in recurrent/metastatic HNSCC patients.
• Cue Biopharma has a second asset, CUE-102, targeting Wilms Tumor 1, which has shown evidence of activity in early trials.
• However, the data did not impress investors much, and the stock is trading sideways, broadly.

Last time I covered Cue Biopharma ( CUE ) was in March last year, when I said they had been in the market since 2014 and still didn’t have phase 1 data. They published phase 1 data from lead candidate CUE-101 in mid-2022. The trial “ demonstrated clinical activity and favorable tolerability as a monotherapy in a Phase 1 trial in patients with human papillomavirus (HPV16+) recurrent/metastatic head and neck squamous cell carcinoma (HNSCC).”

Cue Biopharma develops “a novel class of injectable biologics to selectively engage and modulate targeted T cells directly within the patient’s body.”

This is their pipeline:

Lead asset CUE-101 was in a monotherapy trial in 2nd and later line HPV-positive recurrent or metastatic head and neck squamous cell carcinoma. Earlier, they produced preclinical mice data which showed drug activity - in mice. Human beings have done a lot to cure diseases in mice, with a level of success that has not been replicated in humans, unfortunately.

Last time, I noted that the company published some data from the then-ongoing phase 1 trial, which showed that the treatment “led to partial responses in two out of four patients, though one of those responses was unconfirmed.” This was out of 85 patients, and the data was underwhelming, taking the stock down 26%.

In November, the company presented more data from the phase 1b monotherapy trial. Key highlights :

• 42% overall clinical benefit rate, including one PR of > 42 weeks duration and seven DSD.

• Median overall survival (mOS') approaching greater than 12 months in third line and beyond (3L+) patients treated with CUE-101 monotherapy, which is 50% greater than current standard of care (SOC) with anti-PD-1 therapies in second line (2L) patients. [In May, this was updated to 14 months mOS, or 6 months higher than current SOC]

The same SITC abstract also presented data from the keytruda combo trial, which showed “an overall response rate (ORR) of 40% and a clinical benefit rate (CBR') of 70% observed to date in first line (1L) recurrent/metastatic HNSCC patients.” Per the company , historical ORR with keytruda alone is only 19%. In June at ASCO, updated data from the trial showed “nine of the 14 evaluable patients treated with CUE-101+ KEYTRUDA® (pembrolizumab) demonstrated tumor regression, with five confirmed partial responses (PRS') and three durable stable disease (DSD) responses, two of which have tumor burden reductions of -18% and -24% and remain on treatment.”

On August 9, the company presented its earnings call but did not release any separate press release for the CUE-101 data. In the earnings call , they said the following:

The clinical data from the ongoing CUE-101 trial continues to demonstrate highly encouraging and robust metrics of clinical benefit for heavily pretreated recurrent metastatic HPV-positive head and neck cancer patients treated with monotherapy and for newly diagnosed patients with recurrent metastatic HPV-positive head and neck cancer treated in combination with pembrolizumab.

As shown on slide eight, data from the ongoing clinical trials with CUE-101 is monotherapy and in combination with pembrolizumab have provided clinical proof-of-concept and derisking of our Immuno-STAT platform.

The latest data generated to-date in 2023 continues to support prior observations and further enhances our confidence in CUE-101 as a potential therapeutic for patients battling HPV-positive head and neck cancer.

On a more granular level, the company presented details of 3 patients who had an objective response to the drug. Current median OS now stands at 14 months. The company noted historical mOS of 8 months. All of that is good, however, there does not seem to be any improvement in clinical benefit rate. If the company publishes a data release, these things will become more clear.]

A second asset received IND approval from the FDA this year. Called CUE-102, this is targeting Wilms Tumor 1 (WT1) and enrolling in a phase 1 monotherapy trial. Evidence of activity was observed in several patients, including reduction of target lesions (>12 weeks and ongoing), durable stable disease and reduction of tumor markers.

Financials

CUE has a market cap of $163mn and a cash balance of $58mn. Research and development expenses were $10.7mn for the latest quarter, while general and administrative expenses were $4.3 million. At that rate, the company has a cash runway of 3–4 quarters.

CUE recently entered into a collaboration deal with Ono Pharma for CUE-401, “a bispecific protein designed to induce and expand regulatory T cells (Tregs) for the treatment of autoimmune and inflammatory diseases.”

Retail investors hold nearly 67% of the company, while institutions hold around 24%. Keyholders are Slate Path Capital, Vanguard and others. Insiders purchased shares in May last year; there are no insider sales in the open market.

Risks

CUE has underwhelming data so far despite being in the market for nearly a decade. The cash situation is okay, but again, not really strong. The trading volume is low. In my previous article, I highlighted management compensation figures that appeared to me to be above average for a company this size. There are no major near term catalysts either.

Bottom Line

This year, as well, CUE fails to impress me with its data or progress. Nothing immediately stands out; the market has been left similarly unimpressed. I will continue covering and watching, but from the sidelines.

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