Tefferi's patent 14 May 2015

[jingledsassy]

patent #us20160287625A1 Andrew Tefferi.

Tefferi's patent states Imetelstat 44% and 50% CR'S and PR'S on certain mutations, 0% on mutated and 36% on unmutated spliceomome cells. Fisherman it mentions Imetelstat all the way through the patent and how well Imet is working on MF and MDS. Well worth reading. I am no good at cutting and pasting or I would. patent dated Oct 6, 2016.

hashtag twitter/imetelstat/patents/2016

[Fishermangents]

Thanks, jingled, for bringing this back. I made a separate topic of it, as you can see. It is a remarkable patent indeed, because it protects a method for using imetelstat for a predefined subgroup of patients. So it is criteria for patient selection + treatment method.

Btw: I think you are referring to this patent, which was publicized on 14 May 2015: Methods and materials for treating hematological malignancies
link: https://www.google.com/patents/WO201506 ... 0Q6AEIHDAA

Based on the Mayo Pilot NCT01731951 the patents gives the follow example of efficacy:
"The overall response rate was 44%. This included five patients (28%) who met the bone marrow and peripheral blood morphologic criteria for complete response (CR) («=4) or partial response (PR) (n=\) and three patients with clinical improvement, pending validation of response duration and resolution of drug- induced grade- 1 thrombocytopenia. The four CR patients (22%) experienced reversal of bone marrow fibrosis and recovery of normal megakaryocyte morphology. Two CR patients were transfusion-dependent at baseline and became transfusion-independent. Complete molecular responses were documented in two CR patients."

But there are also important conclusions about the MoA of imetelstat:
"Treatment was associated with suppression of telomerase activity, shortening of telomere length, and alteration of the hTERT isoform pattern."

It also says that imetelstat outclasses other available drugs:
"These results demonstrate that telomerase-based treatment strategies such those that involve using imetelstat sodium can be successfully used to treat myelofibrosis. The observed morphologic and molecular remissions confirmed selective anti-clonal activity, which eluded other drugs in myelofibrosis. These results also demonstrate the increased likelihood of successfully treating those patients with a myeloid malignancy having spliceosome mutations."

Definition of 'to elude': to escape in a skillful way through cleverness.

The patent shows that Tefferi has a pretty well understanding of how imet works in myeloid malignancies and that he knows how to successfully apply it to a specif subset of patients.

[sargasso]

This appears to be the same patent, correct? http://www.freshpatents.com/-dt20170223 ... 051287.php In any case this patent in some respects presents an overview of the entire imetelstat program. The information contained therein in my opinion is encouraging.

[Fishermangents]

Sargasso, I don't think it is the same. The patent you are referring to is from Geron. Also the title is different. But it is interesting anyway, as I wasn't aware that Geron had a patent specifically targeting ET (although the patent seems to expand to other MPN's too).

The biggest difference is that Geron's patent is more about the technology, while Tefferi's patent is about methods and materials for treatment of hematological malignancies. The technology (imetelstat) is only instrumental. However, Tefferi's patent also contains a lot of technical descriptions, which seem to go a kind of in parallel with the Geron patent. But for Tefferi these technical descriptions are used to come down to his invention, which is that imetelstat has a specific beneficial impact on a subgroup of patients (categorized on genetic profiles), if a certain treatment method is followed.

Other opinions are welcome.

[sargasso]

Fisher,

Yes, I believe you are correct. I just read Tefferi's patent more closely. The two patents appear to share certain language in common, thus my confusion. Thanks for the clarification.

I find these patents encouraging. What I find encouraging is that GERN, and certain medical experts like Tefferi, continue to push imetelstat forward. And Janssen is doing the same thing as evidenced by its AML study.

The next twelve months in the history of this company are going to be very interesting.

[Fishermangents]

It is certainly encouraging, because the patent actually is a confirmation that imetelstat works in a subset of patients. And Tefferi knows how to do it. What would the FDA say if he presents this to them? 44% overall response and 28%complete response? Plus a clear selection of patients who are likely to respond (which means no useless submission of patients to imet who will likely not benefit)? Control over the side effects (like thrombocytopenia and overall myelosuppression)? Why would the FDA say 'no' based on all this, knowing these patients have no alternative?

I certainly will be an interesting year.

Btw: JnJ will present data of the full imetelstat program to a regulatory body (FDA? EMA?) after Q2 review. That includes these data from the Mayo pilot.

[jingledsassy]

Fisherman ....Dr. Tefferi filed for this patent 11/5/2014....8 days later geron announced theJNJ...Janssen partnership on 11/13/2014. these patients by my math are over 4 years [about]....these are the same patients that Scarlett stated he had no memory of when asked about in a prior conferance call....just saying....

[Fishermangents]

Some people are playing chess and think many steps ahead. For sure, Tefferi had is act together already back in 2014. These patients are under the wings of Mayo and Tefferi. When asked about any update on these patients Dr.S. said that he hadn't been updated about them so he couldn't say anything more than what was already public. That doesn't mean that he knows nothing. The telco was about an update on IMbark and not the Mayo trial. So it wasn't the right occasion to answer questions in a formal manner outside the scope of that specific call. Then better say nothing than sorry.

[Fishermangents]

I corrected the publication date to prevent any misunderstandings.

[jingledsassy]

Fisherman....The patent # for the may 14th date is differant....google patent #20160287625 and you get the Oct 6th 2016 publication date???? just saying....

[huntingonthebluffs]

I agree with you Fishermanagents, a lot of chess is being played here and I suspect the market shorts will be checkmated in the near future and have to move to a different venue to play their board games. Just wanted to say that I marvel at the information you provide and shepherd here on ImetelChat and Info. You provide a great service to all of us, especially those of us who struggle to keep up with the terminology and science in general. And your friends in the field and close to the diseases also contributing here are the best.
I wonder regarding your recent post on SA, if you think the Geron and Dr. T patent info and discussion here changes your expectations on the Q2 review outcomes at all or already baked into your thinking. For example any new designations, acceleration to NDA, etc. To be clear, here is your SA post, if I may:

“Sometimes you have to go AGAINST the trend and stick to your own judgement. With 30mln shorts (20% of the float!) there is a lot of interest to keep confidence down and to negatively manipulate sentiment. It is daily practice, certainly in early biotech.
The outcomes of the Q2 review will probably give a new direction to sentiment, if positive. If negative: we know what will happen.

If positive, I expect the following:
- IMerge goes into P3 (is Part 2 = continuation decision = milestone payment)
- IMbark goes fast track into P3
- AML combo-trial announced to start enrollment in 2018 (see email Anna)

I think this series of events may change the paradigm and is a reasonable scenario. Again: only if Q2 review is positive. If it is so-so I don't know what will happen. Probably we will go on like we do now, which means no fun. In addition: I don't rule out ANY kind of surprise.”

Thanks again for your and your site’s & contributors great service, there isn’t a way I could say this too much.

[biopearl]

Fish, let me add my thanks to hunt's comments regarding the quality of this board, the service, research and courtesy you have extended us. I would add only a couple of things. One is that I think there is enough information to infer that IMbark will stop after the Q2 review. I believe at that point there will be enough data to prove disease modification and to move toward filing for approval without a phase III, an FDA rare occurrence indeed . (That is a strong statement or perhaps just a strong wish.) That data should allow granting of BAT and expedited approval with no need to reiterate the reasons well outlined in our previous discussions. Also while AACR presentations over lo these many years have not generated the overt excitement one might have expected, this year's will and will presage an announcement of a clinical AML trial, Fish you and others have made most of these points previously and I just repeat them here to think collectively. I think AML combination Rx will herald the trickling in of combination studies in solid tumor subtypes based on genotype (finally). Regards to all and best wishes, bp

[Fishermangents]

Bio, thanks for your nice and encouraging words.

You could be right about the ending of IMbark. When I read Tefferi's patent one can argue that he has the key to fast approval: he found out how to safely administer imetelstat, he found out that imetelstat targets the malignant clones AND he found out which patients would likely respond the best based on their genetic profile (ASXL1, spliceosome mutations etc.). So if JnJ is going to present the complete imetelstat program to a regulatory body, it likely will include Tefferi's findings (which are largely public due to the patent). What will keep the FDA or EMA from going straight after the patient population as specified by Tefferi's patent? Those patients have no alternative and from what I read Tefferi knows how to balance the risk/benefit ratio.

So to follow on your comment: yes, I think IMbark can suddenly take another direction, whether as I described above, or just as it is, but then as P3 fast track.

[Fishermangents]

jingled, I did a quick check. Patents can be filed and publicized in different geographical areas. The 14 May 2014 (Freshpatents) and the 6 Oct 2016 (Google patents) seem to be the same patent from Tefferi, but for different countries:

https://www.google.com/patents/WO201506 ... 0Q6AEIHDAA
http://www.freshpatents.com/-dt20161006 ... 287625.php

On the cover of the Google patent it says:
Also published under: CA2929809A1, EP3065828A1, US20160287625

The European Patent Office (EPO) says:
Also published as: WO2015069758 (A1) JP2016537423 (A) EP3065828 (A1) CA2929809 (A1) AU2014346840 (A1) EP3065828A1
The first letters are country codes:
JP = Japan
EP = Europe
CA = Canada
AU = Australia
US = USA
WO = international patent under the Patent Cooperation Treaty (PCT)

The international publication date is 14 May 2015. The difference in dates is probably because those countries have different procedures and Tefferi may have decided not to file the patent in all those countries at the same time. Fur sure Tefferi has protected his patent quite thoroughly. He must be pretty confident that it will bring benefits to him and Mayo, because all that protection is not for free.

[jingledsassy]

k

[Fishermangents]

Hunt, thanks for your nice words. Your posts are highly appreciated too. Please stay with us and see if we can increase our grip on this fascinating medicine!

@Jingled: what does 'k' means? Or did there something go wrong with your post?

[jingledsassy]

means ok thanks for the differant countries explaning the differant patent numbers...thats how my kids say ok....

[Fishermangents]

ah, so I learned something. Kids keep us young!