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  • Benitec's AGM Announcements [View instapost]
    Hi 5806251,

    That depends on what you mean by "results".

    A clear safety profile for the first cohort in the TT-034 trial will result in approval for the second cohort to be dosed. This should happen in the first week of January 2015 (approximately).

    Other results are much harder to predict, as the company has learnt the hard way. However, there are a number of events expected in 2015 which could lead more results. These events include: the on-going TT-034 trial; the start of the NSCLC trial; the appeal of the European decision on the Graham patent; the publication of the results of Calimmune's HIV trial; etc..
    Nov 25, 2014. 08:27 PM | 1 Like Like |Link to Comment
  • Benitec's AGM Announcements [View instapost]
    4D are specialists in the design and use of AAV vectors. Benitec is contracting them provide the vector for the AMD program. This is quite different to the doggybone technology of Touchlight which is reported to be an easier/cleaner way of producing DNA cassettes.

    The significance of the 4D announcement is that it confirms that the AMD program is now gaining traction in the lab. The agreement with 4D will allow the pre-clinical work to proceed as both the design of the expression cassette and the vector have now been determined.

    If Benitec was so inclined, having designed both the therapeutic and its means of delivery, it could seek to partner the AMD program based on early pre-clinical work - assuming that there was someone interested.

    Personally, I think the sooner we can partner this program the better. Partnering will see an influx of capital with that a faster track to market and further validation of ddRNAi.
    Nov 21, 2014. 06:10 AM | 2 Likes Like |Link to Comment
  • Benitec's AGM Announcements [View instapost]
    After giving careful consideration to the points made in the Shareholder Briefing, I was left with some questions that I thought were in need of clarification. I contacted the company and I have now received their responses.

    My first question was with regard to the companion diagnostic test for Tribetarna (NSCLC). I asked if it had to pass its own clinical evaluation process before it would be allowed to be used with Tribetarna and, if so, would this cause further delays to the NSCLC trial? As I expected, the companion diagnostic test will have to undergo a 510(k) (FDA) approval process before it can be commercialised. However, it could be incorporated into the Tribetarna trial before the 510(k) evaluation process is completed. No indication was given that the need for a 510(k) evaluation would cause further delays to the Tribetarna trial.

    My second question was with regard to the licensing of the Touchlight DNA technology. I asked if this was the an indication that Benitec intended to move into manufacturing. The answer is that the company is not seeking to move into manufacturing but it would like to control the IP involved in the manufacturing processes so that it can generate further licensing revenue. The doggybone technology is being evaluated to see if it can produce DNA constructs in a simpler and more cost effective way than the current process. The efficiency of the technology is also under evaluation.

    My third question was with regard to the TT-034 trial scheduling. My question related to the timing of the dosing of the second cohort, given that the six week monitoring period associated with the second patient in the first cohort finishes at Christmas time. The reply states that the company expects that, all other things being equal, the dosing schedule should not be affected by the holiday season and the current guidance stands.

    I appreciate the quick and thorough response provided by the company.

    If anyone attends the New York session, then perhaps they would be good enough to post on this thread their thoughts and impressions?
    Nov 18, 2014. 01:37 AM | Likes Like |Link to Comment
  • Benitec's AGM Announcements [View instapost]
    The bottom-line here is a Plll would have inclusion/exclusion criteria that the FDA would be comfortable with. These are likely to be the same as the proposed Pllb trial.
    I would expect that the requirement to meet a BMI level would be removed. I personally doubt that the FDA would allow women of childbearing age to be treated unless they were sterile. I could be wrong but I would expect that the FDA would require a pre-clinical biodistribution study to be done in female animals before relaxing this criteria. I expect that the genotype 1 restriction would be removed. I expect that the limitation of non-responders/relapsers would be removed.
    The AAV nAb restriction may be relaxed also. However, I would expect that any strong immune response seen in patients with AAV nAb's would see this criterion re-introduced.
    All in all the pool of potential patients would increase substantially.
    If the pre-clinical work on women of childbearing age was carried out, a Pllb trial could be instigated so as to have this group included in the final drug approval.
    Nov 17, 2014. 07:36 PM | Likes Like |Link to Comment
  • Benitec's AGM Announcements [View instapost]
    Hi Brama66, Pllb trials were predominantly used for testing existing drugs for indications for which they are not currently approved. Now it seems that biotech's use Pllb trials as a mini Plll's because they cannot afford the full Plll costs.

    If a deal was done with a rich enough partner after the current trial, it would be possible to skip the Pllb trial and go straight to a Plll trial - assuming that the current trial did not discover some complications.
    Nov 15, 2014. 02:10 AM | Likes Like |Link to Comment
  • Benitec's AGM Announcements [View instapost]
    Tim, on 8 October, 2014 the company issued a statement via the ASX saying a second patient had been identified for dosing and would be dosed as soon as possible after the mandatory 28 day process was completed. As this was a public statement and as patients have to make arrangements for a two day stay in hospital for the treatment once screening is completed, doing the math, it is hardly earth-shattering news that dosing occurred the night before the meeting.

    Calimmune - actually Peter did say that the terms of the agreement with Calimmune are Commercial in Confidence. He also mentioned that those terms specifically forbid either party from disclosing the financial arrangements and any communications between the two companies.

    Regen - they are using Benitec's IP. Why would Benitec not protect its IP via an agreement with the company? What Regen does, provided it actions are within the terms of the agreement, are of little concern to Benitec.

    Frankly Tim, I think you are clutching at straws. Maybe someone else could manage the company better than Peter but if these are the best arguments you have for his removal, then I can see why the Board does not agree with you.
    Nov 14, 2014. 08:39 PM | 2 Likes Like |Link to Comment
  • Benitec's AGM Announcements [View instapost]
    A Plll trial would cost more money than Benitec can afford right now.
    Nov 14, 2014. 08:01 PM | Likes Like |Link to Comment
  • Benitec's AGM Announcements [View instapost]
    Hi Brama, The protocol for the current trial will remain unchanged until the completion of the trial. However, if and when a new Pllb trial starts, I am sure that the inclusion/exclusion criteria will be more reflective of the general HCV population. This should make recruitment of patients much easier.

    One additional point that I would make is that by extending the number of clinical trial sites in this current trial, Benitec has given itself a much better opportunity to pick successful trial sites for the next trial. Duke and UCSD may prove to be good trial sites but if they are not, then Benitec will have empirical evidence from the other sites to help them determine where to focus on next.
    Nov 13, 2014. 08:54 PM | Likes Like |Link to Comment
  • DdRNAi Center Of Excellence [View instapost]
    You could be right. This is why we have clinical trials. What we do know is that TT-034 targets viral RNA and does this very effectively. So the real issue is, can we get a high enough level of transfection to ensure a therapeutic dose is delivered?

    It would be great if TT-034 is successful but, fortunately, Benitec's long term future is not entirely dependent on the outcome of this trial.
    Nov 11, 2014. 11:07 PM | 1 Like Like |Link to Comment
  • DdRNAi Center Of Excellence [View instapost]
    Up 53% on the ASX in one week is a good start. Let's hope the trend continues.
    Nov 10, 2014. 08:34 PM | 2 Likes Like |Link to Comment
  • TT-034 Neutralizing Antibodies [View instapost]

    The interview accompanying this announcement goes a long way to addressing the points made in the main blog post above. While no actual financial modelling data has been provided, the reasoning behind the continued investment in TT-034 seems sound - being proof that ddRNAi can be made to work in humans and that, once safety has been established, the criteria for a new trial will be relaxed (as mentioned above). This is all positive news for Benitec and the TT-034 trial.

    The matter of the nAb has been addressed. The trial's first hurdle has to be safety. AAV anitbodies represent a predicable threat and so avoiding them in the very first, in-human trial does make complete sense. Once the general safety of TT-034 has been established through the current trial, that data will be a new baseline to monitor a broader range of patients (perhaps including those with AAV8 nAB). Having this safety data will make it much easier to identify the causes of any future adverse events in the extended patient population.

    While the delays in the trial are frustrating (for shareholders and management alike), I think that the latest announcement gives a factual account of why the delays have occurred. This should dismiss the absurd notion put about by some that management is deliberately conspiring to disrupt its own trial.
    Nov 2, 2014. 09:24 PM | 2 Likes Like |Link to Comment
  • TT-034 Neutralizing Antibodies [View instapost]
    "The nAb issue has not delayed the program."

    UCSD is one of only two sites testing TT-034 and so the fact that they say that nAb has been the reason why they have not recruited even a single patient seems to me to be reason for a delay. After all, if they had dosed a patient, we would not be waiting for the first cohort to be filled.

    TT-034 may still be economically viable, even with the new developments by Gilead, BMS and Regulus, but nowhere can we see how the numbers are expected to stack up. Deals with partners are not signed by the tech guys, they are signed by the accountants. This means that if we are to do a deal at the end of a Pllb trial, the numbers had better be convincing. At the moment, I would like to be assured that they are.
    Nov 1, 2014. 11:43 PM | 1 Like Like |Link to Comment
  • TT-034 Neutralizing Antibodies [View instapost]
    Hi Hindmost, The issue of the AAV8 vector was raised earlier this year when Dr Mark Kay questioned the efficiency of the vector that Benitec is using. This sparked a discussion on the Internet about AAV vectors (see previous BNIKF blogs posts on SA and Dirk Haussecker's blog post about Voyager).

    I think the best thing we can say right now is that the experts don't agree with each other about the efficiency of the AAV8 vector or the effect that aNb will have. However, if the nAb cause inflammation or increased liver enzyme levels, then additional medication will be required to treat those patients. Given the recent advancements in HCV treatments, one may question why TT-034 would be given to a patient with AAV nAb. If this is the case, then the potential market-share for TT-034 is now questionable, especially if the percentage of patients presenting with nAb is higher than originally anticipated. This is the piece of the puzzle that management needs to address and is a point that shareholders can reasonably be concerned about until they have been given an answer.

    There are newer adaptations of AAV's (Voyager having one approach) which could alleviate this problem but that would mean more cost and more testing. In the light of new HCV drugs one has to question whether such additional expense would be a commercially wise investment?

    Management has said several times that they feel that the best value for shareholders will be in taking TT-034 to the end of a Pllb trial and then doing a deal. However, if drug has a very limited market-share (and I am not saying that it does), who is going to bother to take a stake in the program? We may have reached the time when the economics of TT-034 is more of a consideration than the technology? I think that shareholders should be reassured about the economics rather than take the matter on trust of the Board of Directors.
    Nov 1, 2014. 02:30 AM | Likes Like |Link to Comment
  • TT-034 Neutralizing Antibodies [View instapost]
    If you go back through the company announcements and presentations you will see references to viral load and enzyme levels but no reference to AAV nAb. This information was provided by Duke.

    I think, at one time, there was even a mention of BMI being a problem but that may not have made it into an official announcement.
    Oct 31, 2014. 07:45 AM | Likes Like |Link to Comment
  • TT-034 Neutralizing Antibodies [View instapost]
    Now you will have a platform to voice your concerns, so why not take advantage of that opportunity? We will all be in a position to listen to management's response. If you don't take the opportunity, then sniping from the sidelines won't really mean much, will it?
    Oct 30, 2014. 11:36 PM | 1 Like Like |Link to Comment