Here’s What We’re Looking For When The Heat Biologics Inc (NASDAQ:HTBX) Data Hits

2014

At the beginning of the month, we published this piece detailing the potential acquisition of Heat Biologics Inc (NASDAQ:HTBX). The company had just cancelled a pubic offering, and is heading into what’s going to be a busy period of catalysts during Q4. It’s share price is up more than 100% since we first highlighted the company, and as yet we’ve had no word as to who might be willing to acquire Heat or, instead partner with it on its lead assets. Whatever happens on that front, we’ve got two important data drops set for next quarter, and each has the potential to make Heat an attractive target. Here’s a look at each, and what we’re looking for from the two releases as indicative of success.

The two drugs are HS-410 and HS-110, targeting non-muscle invasive bladder cancer (NMIBC) and non-small cell lung cancer (NSCLC) respectively. We’ll kick things off with 410. NMIBC is a type of bladder cancer in which the cancer has not spread to the muscle of the bladder, and instead is confined to the bladder lining. It accounts for nearly 70% of the circa 75,000 bladder cancers diagnosed every year in the US, and is a precursor to the more serious, and later stage, invasive BC. Current SOC is a chemo regimen that has essentially gone unchanged in 25 years. Chemo aside, there’s also what’s called Bacillus Calmette-Guerin (BCG) available, an intravesical (catheter directly into the bladder) immunotherapy. 410 is an immunotherapy agent similar to BCG, but it’s an oral administration, making it a far more attractive treatment option if it can be proven effective.

Heat is trialing 401 as a single agent versus placebo and BCG, and in combination with BCG. The expectations are that the combined therapy will work better than the single agent, but there’s no data backing up this hypothesis as yet.

So what are we looking at from the trial? The study has two co primary endpoints. The first is safety, and our standard view applies here – low grade AEs, relatively infrequent (it’s an oncology drug, so it doesn’t have to be perfect) and few or none discontinuations. The second, the more interesting of the two, is one-year disease free survival. This figure for the BCG control arm will likely come in somewhere around 60%,  so that gives us a guideline focus as soon as the numbers hit. However, a technical hit will be anything in the sole agent or the combined administration that is above the BCG control.

Moving on to 110, this one is also an immunotherapy agent, and as mentioned above, it’s going after NSCLC. This is a deadly cancer – each year over 220,000 people are diagnosed with lung cancer in the United States alone and over 70% of these die from their disease. Current SOC is chemo and radiation, followed by a second line single agent – normally docetaxel. Beyond second line, however, there are essentially no more options, and Heat is trying to meet this need with 110. That it’s a third line won’t significantly limit its market, however. Because such a high proportion of NSCLC patients die from their disease, most will at some point reach the need for a third line option.

This one is in two separate trials, a phase Ib looking at safety and tolerability in combination with a PD1 inhibitor called nivolumab (currently marketed as Opdivo by Bristol-Myers Squibb Co (NYSE:BMY)), and a phase II investigating efficacy in combination with cyclophosphamide, an effective but very toxic chemo agent.

The phase Ib is the one we are interested in here – the phase II was initially slated for readout during Q4 but this now looks to have been delayed. The primary is overall survival. It’s difficult to gauge a mean target for this one, but it’s not entirely necessary. So long as the active group beats the control (physician’s choice SOC) then we’ll consider it an endpoint hit.

We’ll be looking at the data carefully on release. Subscribe below to get our interpretation before it moves the markets!

Disclosure: We have no position in HTBX and have not been compensated for this article.

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