The latest Investing Matters Podcast episode featuring Jeremy Skillington, CEO of Poolbeg Pharma has just been released. Listen here.
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I got my question into MH about intravitreal injection and he confirmed RENE will now be testing this as well as proceeding with subretinal. It makes perfect sense for them to compete in both types of procedures. RENE's cryopreserved formula offers a real competitive advantage against jCyte's fresh formulation in widespread distribution to ophthalmologist offices.
Shame we didn't get to learn more about the number of patients treated so far in the phase 2a extension. I did ask but he didn't read out the question..
You are right Phil. We.will have to wait for the results of dosing at 2million cells. Hopefully, this will result in significantly more than the 15 letter gain obtained by jCyte in the 50% responders in their high dose group of what was basically a dose finding trial.
My view is that RENE will have no choice but to compete directly with jCyte in intravitteal injection because it's likely that jCyte will enter the subretinal hRPC.market using jCell. Henry Classen who founded JCyte has stated that he sees a place for gene therapy, intravitreal and subretinal hRPC injection in the treatment of RP depending on the type and stage of disease progression.
Onceaday, I think your point about the cost of the procedure and relative simplicity is entirely valid. However, the intravitreal injection provides little benefit at a 3m dose, whereas a sub retinal procedure has yielded impressive results at a 1m dose. The forthcoming data with a 2m subretinal dose will be interesting, as will the potential for any further dose escalation in the future.
There will ultimately also be a balance between the longevity of the treatment (jcyte have stated that they expect repeated doses to be required as their product provides only trophic support), whereas if rene can demonstrate that a subretinal procedure is capable of cell integration in human subjects (as was observed in animal models), then we could find that this approach has a sustained improvement to vision and that any redosing is minimised.
An interesting and informative critique Onceaday. Like everyone else I too want to make a buck out of Rene but some posts do make me smile. Yours is an exception and provides a counter balance to the hyperbole that is a regular feature of this board. Thank you.
50% efficacy in the 6M cell group seems pretty impressive to me. Clearly, they will be dosing at that level in their Ph3.
The fact that intravitreal injection procedure can be performed by a regular ophthalmologist rather that a highly skilled (and expensive) retinal surgeon in a specialist centre is significant. Rene has stated that sub-retinal injection confers other benefits, new photoreceptors may develop/integrate and longevity of effect may be significantly better, but this has to be balanced with ease of administration and cost. IMHO Rene need to be agnostic to the method of treatment and play to their strengths in lower cost of goods as a result of their Cryopreservation techniques.
At the end of the day, I suspect the decision on strategy will be down to the commercialisation partner who licenses the hRPC cells for the indication.
I wouldn't rush to overstate the results presented by jcyte. Based on the data in it's most basic form, they found a mean letter improvement of +2.8 in the sham group, +2.96 in the 3 million cell group, and +7.4 in the 6 million cell group.
They showed good data for a small group recieving the highest dose of 6 million cells when they went looking for it:
'In a post hoc analysis of this target population (~50% of the per-protocol population), an early and significant improvement in vision was seen in the higher-dose group, with average gain of 16 letters at month 12 compared with 2 letters in the control group.'
In the control group and 3 million dose group , when they applied the same 'target group' criteria, the results were +1.85 letters and -0.15 letter respectively. Now why would 6 million cell dose be effective for the 'target group', but a 3 million dose result in a loss of letters? To me it doesn't sound very scientific, and I think for phase 3 they will be changing their primary endpoint, as they will likely know that what they've gone looking for in the data is unlikely to reliably repeated in a larger population.
For comparision, Rene has presented data out to th e quivalent 12 month period (and up to 18 months for a couple of patients), with a mean change of +12 letters presented at 12 months. I'm sure if Rene were to expand the study and the cherry pick their own 'target population' in post hoc analysis, then they would be able to present some incredible data. However, I would prefer to just see data which shows the whole cohort tested, and the mean average improvement across the board, without having to massage the data in a way that will probably cause you to have to change your primary endpoint in future trials. Making data fit the results you want to see isn't particularly scientific in my opinion.
We may not get data as such but at least we should be able to extract further details around patient dosing progress and more details on the trial locations.
I also want to know what Rene are going to do about the jCyte phase2b results. They have now shown that intravitreal imjection of hRPC cells delivers good efficacy. RENE have the opportunity to compete directly with jCyte for intravitteal injection and leverage the competative advantage of a lower cost of goods that MH & OH make such a big deal about.
I will try to submit specific questions for the preaentation - would be good for others to do the same.
Also- I emailed Rene asking them to share Olav's video preaentation at the recent Gene and Cell Meeting on the Mesa. If others could also.nag them for this they might actually get around to putting it on their website.
I've booked myself on as well. Not added any more for perhaps a month or so, as I have concerns about getting dragged down by a wider slump in the markets. However, I do agree with your sentiment regarding the investor presentation, I think there will be something material (and good) announced regarding phase 2b on the morning that will then be expanded upon in the investor presentation.
I've booked myself on to the Webinar for next Thursday plus added 10k to my holding.
My reasoning being that if next weeks presentation is just another routine run through the well trodden path with nothing new its bit like MH trying to push a rock uphill. Why would he be up for that ?
I could be completely wrong but I do hope I'm not and we receive some early Ph2b data to liven the SP.
Chester.
Thanks for sharing.
Let's hope tbey release an RNS on the day. Michael Hunt rarely gives anything away that is not already in the public domain.
You would like to think that it's strategically timed. They presumably by now have some knowledge of early responses from the first treated patients from phase 2b.
Thanks Phil
I'm hopeful that MH will be able to lift the mood on RENE.
An RNS on the morning of the 29th giving an update on the Ph2b RP trial would be a very welcome read.
Chester.
https://www.sharesmagazine.co.uk/events/event/shares-investor-evening--webinar-291020