Yesterday Starpharma (ASX : SPL) announced that it had done some mouse models with a Herceptin-conjugated DEP dendrimer. It wasn’t peer reviewed data. It wasn’t an exhaustive pre-clinical package. It was just a one-off science experiment packaged up and served to retail investors as company propaganda. 20 mice. The company even states that some of the experiments are “ongoing” (page 2) so they didn’t even bother to sacrifice the animals and do histology before making this announcement. i.e. they didn’t finish the job.
AND price sensitive no less* – blatant share price manipulation, in my opinion. By way of reward for crappy science and poor corporate governance, YOU gave the company a 24% share bump. Shame on you.
There are several things that are offensive about this announcement.
The first is that the SKOV-3 / NOD-SCID model is an immune compromised model and it is pretty sensitive. A lot can disrupt tumour growth that has nothing to do with the anti-cancer effect of a drug. In fact, there isn’t actually enough information in the “science” of this announcement to explain the significance of these results, or what they mean. This is just sensationalist drivel. For all we know, the DEP acted as a vascular disrupting agent and it had nothing to do with cytotoxic release.
Secondly, the correct “control” for an experiment like this isn’t saline, it’s the non-drug loaded antibody-drug conjugate (ADC). There is absolutely no test for the DEP “vehicle” in this study. Also, if you are doing a proper pre-clinical study for an ADC, you would compare the conjugated dendrimer to the unconjugated dendrimer to see what effect the dendrimer has alone (ideally with and without drug loading). As such, this data is just meaningless rubbish and makes no valid claims whatsoever about the real benefit of a targeted DEP – it’s just half an experiment. In fact, the data is so meaningless it doesn’t actually tell you anything about whether the targeted-DEP made it to/into cells – Her2 is a rapidly internalising target and ADC development for this target is very tricky (i.e. there is no histology). If Starpharma had sent the contents of this press release to even a bottom-feeder science journal, they would have been laughed out of the room.
Thirdly, Kadcyla and Adcetris are “reasonably” successful drugs, but they have also highlighted (to the whole industry) the difficulty of ADC drug development. For example, Kadcyla failed to beat Herceptin (i.e. the unconjugated drug) and chemo in the very large (and VERY expensive MARIANNE study that Roche conducted last year) so making glowing claims about a “better” Kadcyla is intrinsically flawed. Seattle Genetic’s Adcetris product is also not without controversy and some of the early ADC payloads are proving to be trickier in the clinic than previously thought. There is no responsible disclosure of this to retail investors, just a lot of hype around “billion dollar” drugs.
Fourth – the cytotoxic drug payloads that are used by Kadcyla (and also Adcetris, the other example in the press release) are far from the most potent ADC payloads we have going these days. Therefore to imply that targeted DEP technology is somehow the “best in class” is completely misleading. The DM1/Mertansine (Kadcyla) and the MMAE (Adcetris) linker/payloads were absolutely first generation technologies and are no longer the benchmark for performance. Far from it.
Fifth – I completely reject the manufacturing “advantages” of an ADC strategy that involves a dendrimer, targeting agents, cytotoxins and PEGs to boot. The diagram on page 3 suggests anything but a simple product to manufacture and characterise. Also, it is one thing to spruik an application of the DEP technology that is essentially “outside” the body (the intra-vaginal application) – i.e. has no pharmacokinetics. If you can show that in “external” delivery, the dendrimer doesn’t enter the blood stream, then the regulators don’t get too concerned and you get away with things like device classifications. But to market very early and very preliminary data like this, without disclosing that there is a massive regulatory hurdle in toxicology for each and every DEP product that is used in in vivo, is just irresponsible.
But you want to know the really irritating thing about this announcement?
Starpharma is just taunting us because they know that – if they are honest with themselves – using the dendrimer technology in the cancer setting is far more exciting that using it for treating recurrent bacterial infections of the vagina (r-BV). The market obviously feels that way too, given that they were prepared to reward an almost 25% bump for announcing a stupid, half-baked mouse study with a sensationalist headline. Yet the company continues to plough on and spend millions of dollars of shareholder capital on a Phase III study in r-BV that is very likely to fail.
I have previously expressed a polite modicum of respect for Starphama and its technology. I do believe that this kind of direction in oncology is a smart move for the company. I was a bit lukewarm about the AstraZeneca announcement but it at least hinted some grown-up commercial behaviour. But when I see this kind of rubbish going out into the public domain – rubbish that doesn’t help the company’s image in the eyes of potential pharma partners either – It just makes me feel like that company is yet another hollow chocolate ASX bunny, serving up irrelevant and misleading garbage to retail investors.
Truly, Starpharma as proven they are no better than our buddies at Novogen. It’s very disappointing.
As such, I downgrade Starpharma from being a reasonable prospect to the “turd” category.
Awesome Photo Credit: Ryan McGuire. http://www.gratisography.com/.
* I realise that price sensitivity is determined by the ASX, not the company, but the nature and substance of a communication determines whether an announcement gets classified as “price sensitive”. When a press release like this talks of markets, competitive products, financial expectations, etc. it will – invariably – get classified as price sensitive. That’s the sham.