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Topline Abstract
Cue Biopharma (NASDAQ:CUE) is a biotech centered on the event of immunogenic peptides designed to set off the physique’s immune cells to struggle particular illnesses, most prominently cancers. Whereas they’ve attention-grabbing early knowledge, money issues and a very long time to incubate make this an fairness that I do not suppose fairly reaches the chance/profit ratio I would be comfy with. Nevertheless it’s positively value placing in your pipeline of immunotherapy performs to observe. Let’s discover out why.
Pipeline Overview
CUE-101
By far essentially the most superior venture within the CUE pipeline is CUE-101, an immunotherapy candidate designed to assist cells determine and assault HPV E7, a protein that could be a hallmark of HPV-driven cancers. The primary shot on deck for CUE-101 is in recurrent or metastatic head and neck most cancers, the place CUE has an ongoing part 1 trial.
An interim readout was offered finally yr’s ASCO Annual Assembly, together with early findings from 2 affected person teams. Sufferers with 1 or extra prior strains of platinum chemotherapy or checkpoint inhibitor acquired CUE-101 monotherapy. Sufferers with beforehand untreated, PD-L1-positive illness got CUE-101 plus pembrolizumab.
No maximally tolerated dose was recognized, and a beneficial part 2 dose was chosen for each the monotherapy and mixture arms. CUE highlighted favorable tolerability of CUE-101, in addition to favorable pharmacokinetics and pharmacodynamics. Of the 19 sufferers receiving monotherapy on the beneficial part 2 dose who had been evaluable, 1 had a partial response, and median total survival was 24.four months.
In the meantime, 5 of 12 evaluable sufferers within the mixture arm had a response to remedy. This tracks favorably with the findings from KEYNOTE-048, which confirmed a response fee of 23% of pembrolizumab alone in sufferers with PD-L1 CPS 20% or greater. Clearly, you’ll be able to’t make an excellent comparability right here for quite a lot of causes, however it’s a good early sign.
A more moderen replace at SITC 2023 revised the response fee to 47% within the first-line setting with this mixture, together with knowledge from 17 evaluable sufferers. The monotherapy cohort added extra sufferers, as nicely, with median OS being revised to 20.Eight months, which tracks favorably with research like KEYNOTE-040 which confirmed a median OS of 8.four months for pembrolizumab in an identical setting.
The corporate guided that these findings illustrate a number of potential paths ahead for registrational trials, they usually have submitted a request to the FDA to achieve suggestions and readability on the subsequent steps for scientific improvement. CUE additionally highlighted that these findings have allowed for barely loosened reins in creating different molecules because the complete platform they’re constructing (based mostly totally on interleukin-2 signaling) is modular and capable of have the goal of curiosity sizzling swapped.
CUE-102
The primary such “sizzling swap” of antigens is with CUE-102, which makes use of the identical platform as CUE-101 however now concentrating on Wilms’ Tumor 1 (WT1), a marker of poor prognosis in numerous cancers. CUE supplied a primary have a look at the protection and efficacy of CUE-102 at SITC 2023 in a poster presentation.
As soon as once more, no dose-limiting toxicities had been recognized throughout dose escalation. Furthermore, 2 sufferers within the research have skilled tumor discount, although it is rather early days for any type of efficacy evaluation.
Monetary Overview
Per their Q3 2023 SEC submitting, CUE held $57.5 million in whole present property, most of which ($54.7 million) had been held in money and equivalents. Their whole working bills reached $13.5 million. With collaboration revenues and earnings factored in, the web loss for the quarter was $11.zero million.
Given this web loss, and assuming it holds regular, CUE has roughly four to five extra quarters of operational runway earlier than they run out of money.
Strengths and Dangers
I uncared for to focus on that CUE has a good variety of packages based mostly on their CUE-100 platform in preclinical improvement concentrating on numerous antigens of curiosity. These might be value watching however aren’t value dwelling on in the intervening time, for my part.
Two ideas come to thoughts instantly in looking at CUE. First, their platform is a really attention-grabbing science venture, taking this modular antigen-based concentrating on strategy and fusing it to an try at a generalized ramping of the immune system to enhance recognition and (hopefully) antitumor exercise. CUE-101 has proven some indicators of life. I would not get forward of myself simply but in getting too excited, however these are favorable early indicators.
Second, we’re already dealing with money challenges, and it is a firm nonetheless in part 1. It is little marvel why the market is not actually giving them a lot consideration, because the danger of dilution or different unfavorable money elevate proposals is excessive. They do have an ongoing collaboration with ONO Prescribed drugs that gives a small, common infusion of money, however that’s positively not sufficient to offset the mounting prices they face.
That collaboration, working towards improvement of preclinical molecule I didn’t talk about above (CUE-401), may bear fruit and convey a much bigger inflow of funds, however I am not one for relying on partnerships and M&A to bail out a dangerous funding.
Backside-Line Abstract
CUE may be very a lot value taking note of. Nevertheless, with their near-term money points needing to be addressed, it is tough to think about them having the ability to elevate funds from a place of power. At a market cap of round $120 million, there’s nonetheless draw back danger, although it’s restricted. And the potential for a giant catalyst to vault the valuation is actual. Nevertheless, I do not suppose the time is correct for this one to make me critically take into account a purchase. I believe it is value a watch and wait.