Compass Therapeutics: Pointing Themselves Right At Some Tough Cancers (NASDAQ:CMPX)

Topline Abstract

Compass Therapeutics (NASDAQ:CMPX) is an oncology-focused developmental biotech engaged on novel immunotherapies to deal with totally different types of stable tumor, with probably the most notable photographs on objective being within the gastrointestinal cancers area. They’ve skilled vital declines in valuation by 2023 and 2024, regardless of being deep in late-stage scientific research. So at present I need to try their initiatives, what they’ve shared to this point, and the outlook for potential drug approvals down the road.

Pipeline Overview

CTX-009

Probably the most superior candidate being developed by CMPX is CTX-009, a bispecific antibody being studied in a number of later-stage scientific trials. Not like most of the different bispecific antibodies you will encounter on this area, CTX-009 doesn’t ligate tumor cells and T cells by binding an antigen and CD3 (suppose alongside the strains of Amgen’s BiTE therapies like tarlatamab and blinatumomab).

Fairly, CTX-009 binds DLL4, a cell floor Notch ligand that’s strongly related to vascular tissue, notably in tumors. It additionally binds VEGF, making it act as a double blocker of angiogenesis, which the corporate hopes can be useful towards tumors which are identified to be extremely vascularized, comparable to colorectal most cancers.

CMPX has an ongoing section 3 trial known as COMPANION-002, investigating CTX-009 as a part of second-line remedy for sufferers with superior biliary tract most cancers. Biliary tract cancers embody tumors like cholangiocarcinoma (inside or exterior the liver), ampullary most cancers, and gallbladder most cancers, and outcomes are notably poor, even after current enhancements in the usual of care by the incorporation of immunotherapy. Focused remedy choices are serving to a choose group of sufferers on this setting, however we’re nonetheless in dire want of remedy choices that may transfer the needle.

COMPANION-002 builds on a section 2 research introduced at ASCO GI 2023, which took 24 sufferers with totally different types of biliary tract most cancers and handled them with CTX-009 and paclitaxel, yielding a response charge of 37.5%. Illness management was established in all evaluable sufferers, with no clear indicator that one tumor sort appeared to profit greater than the others. Bleeding and perforations have been adversarial occasions of particular curiosity that appeared related to CTX-009 remedy.

Prime-line outcomes from COMPANION-002 are anticipated by early 2025, per company steering. They’ve additionally beforehand introduced FDA Quick Observe designation for this routine.

CMPX can also be operating a section 2 research enrolling sufferers with third-line or past metastatic colorectal most cancers to obtain CTX-009. They’ve guided that outcomes needs to be accessible by the center of the yr.

CTX-471

An earlier undertaking additionally in scientific trials is CTX-471, an activator of CD137is designed to activate T cells and pure killer cells close to the tumor.

CMPX introduced the primary outcomes from a section 1 research at ASCO 2024 this previous month, specializing in superior stable tumors which have progressed on prior anti-PD-1/PD-L1 remedy. Remedy was nicely tolerated, they usually had some very early alerts of exercise in a affected person with small cell lung most cancers, along with 3 partial responses amongst 11 sufferers with refractory melanoma.

CMPX is now planning a section 2 research of CTX-471 in sufferers with melanoma refractory to remedy with pembrolizumab, and they’re increasing enrollment of their section 1 research to seize extra sufferers with melanoma and lung most cancers (each non-small cell and small cell).

CTX-8371

Briefly, CMPX can also be engaged on a bispecific antibody concentrating on each PD-1 and PD-L1, with the largest information for this undertaking being that they formally started section 1 research again in April. This agent has the chance to be a best-in-class checkpoint inhibitor, however we positively must see scientific information earlier than drawing even early conclusions.

Monetary Overview

As of their newest quarterly submitting, CMPX held $158.6 million in present property, together with $23.7 million in money and equivalents, in addition to $132.6 million in marketable securities. Their working losses for the quarter reached $12.8 million, up $3 million yr over yr. After recognizing different earnings, the corporate had a internet loss for the quarter of $10.8 million.

At this money burn charge, CMPX at the moment has an working runway of between 14 and 15 quarters, which is probably going an optimistic estimate as the prices to conduct extra superior scientific trials proceed to mount.

Strengths and Dangers

Power – Adequate money to get to a top-line section 3 readout

Though their money pool will not be infinite by any stretch, CMPX has managed to rein in prices as they’ve superior 3 potential drug candidates to the clinic. As I discussed within the monetary overview, they definitely will face mounting prices, however I’ve little question that they’re going to have the ability to attain the guided early 2025 topline information readout for COMPANION-002 with no need to lift funds from a place of weak point.

Power – Orthogonal, novel method to most cancers remedy has homerun potential

Anti-angiogenic remedy has a agency place within the administration of GI cancers, most notably in colorectal most cancers. Double-hedging the wager by attacking two totally different modes of vascularization within the tumor may very nicely be the kick that this remedy wants to maneuver the needle. CMPX has seen encouraging early response information, which bodes nicely for the prospects of their section 3 trial.

Danger – New mechanisms of motion in GI most cancers very hardly ever pan out

That mentioned, while you swing for the fences, you get numerous strikes, as nicely. And biliary tract cancers are one of many greatest graveyards of promising therapies that we see. No initiatives are resistant to failure on this area, and CMPX’s isn’t any exception. Furthermore, if it fails, it’s totally tough to see how they may get better, with the distinct risk for a Glycomimetics-like collapse in share worth if the section 3 information will not be good.

Danger – Toxicity issues of their lead agent

Within the section 2 research of CTX-009, there have been regarding alerts of traditional toxicities related to anti-blood vessel medicine, like bleeding and GI perforation. These have the potential to be life-threatening, and it is attainable that the section 3 research might be optimistic from a response charge perspective, however nonetheless fail attributable to unacceptable toxicity. The research authors even lay out the issues they’ve for adversarial occasions within the poster presentation from ASCO:

The Section 2 research has proven promising efficacy in BTC pts handled in 2L or 3L setting. TRAEs primarily based on mode of motion have been excessive, however DLL4/VEGF concentrating on in BTC has a possible of growth. Additional investigation of security and efficacy of this routine is warranted

This type of recognition is a tip of the hat from the authors that there are critical security alerts right here, however that the efficacy would possibly trump toxicity issues. It’s a particular danger right here.

Danger – Biliary tract most cancers comparator arm for the section 3

Lastly, it’s price noting that for the COMPANION-002 trial, the management arm is paclitaxel, which isn’t a advisable second-line remedy for biliary tract cancers. FOLFOX is the “most well-liked” routine within the second line upon development, primarily based on the findings from ABC-06. This may elevate questions in regards to the applicability of information from the COMPANION-002 research, since there can be no comparability with FOLFOX to information remedy.

That mentioned, in ABC-06, FOLFOX had a 5% response charge. This might tip the scales in favor of CTX-009 if they can reproduce the 37.5% response charge noticed within the section 2 research. But when it is not “clearly” higher, then the trail ahead for the drug could also be hampered.

Backside-Line Abstract

There are numerous fascinating alerts popping out of the CMPX story, and the potential for a game-changing catalyst in early 2025 is one thing I am unable to actually ignore. Whereas the timeline for the topline information from COMPANION-002 has drifted (it was beforehand guided for finish of 2024), we’re nonetheless speaking one thing that is within the close to time period.

On condition that CMPX is at the moment buying and selling at a market capitalization of round $150 million, it’s clear that not one of the potential of this pipeline is at the moment baked into the valuation of the corporate, as they maintain practically this a lot in property. For that motive, CMPX is an fascinating speculative purchase, so long as you fastidiously take into account the dangers that they face. However there’s an excessive amount of near-term promise to disregard them utterly, in my view.