Request to Bill W

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biopearl123
Posts: 1665
Joined: Fri Jul 20, 2018 5:13 pm

Request to Bill W

Post by biopearl123 » Fri Apr 12, 2019 6:30 pm

Cheng, for the benefit of the board would you consider a dispassionate (and I mean dispassionate) analysis of this paper and how this information might inform future combination studies? (If applicable at all.). Thanks, bp

A non-natural nucleotide uses a specific pocket to selectively inhibit telomerase activity
Wilnelly Hernandez-Sanchez, Wei Huang, Brian Plucinsky, Nelson Garcia-Vazquez, Nathaniel J. Robinson, William P. Schiemann, Anthony J. Berdis, Emmanuel Skordalakes, Derek J. Taylor
Published: April 5, 2019https://doi.org/10.1371/journal.pbio.3000204

cheng_ho
Posts: 202
Joined: Sun Apr 03, 2016 11:27 pm

Re: Request to Bill W

Post by cheng_ho » Mon Apr 15, 2019 4:07 pm

It's just another telomerase inhibitor, like 6-thio-G. I don't see any advantage over 6-thio-G (the advantage of 6-thio-G over imet, remember, is that it doesn't need infusion and it's more powerful), and the disadvantage is that this has never been tested in humans, while 6-thio-G has. Maybe if they had tested it in comparison with 6-thio-G and other soluble telomerase inhibitors, we would know whether there's a reason to study it.

The paper's comment about the MOA of AZT is interesting... if AZT's MOA is "telomerase inhibition", then it's technically illegal to use AZT against MDS, due to GERN's (illegal by precedents, but still in force) patent. That means that ARGX should be paying GERN for any use of its MDS combo treatment in three blood cancers.

Hope that doesn't make JNJ abandon the ARGX antibody. Geron doesn't have a lab, but they do have lawyers.

biopearl123
Posts: 1665
Joined: Fri Jul 20, 2018 5:13 pm

Re: Request to Bill W

Post by biopearl123 » Mon Apr 15, 2019 7:57 pm

I have asked HI on SA to comment, he is very knowledgeable re patent law. bp

cheng_ho
Posts: 202
Joined: Sun Apr 03, 2016 11:27 pm

Re: Request to Bill W

Post by cheng_ho » Mon Apr 15, 2019 9:06 pm

Thanks bp. Of course I meant "clinical advantage", there would be a clear patent advantage to a new molecule for any company besides Geron.

That's one of the problems in medicine... we use inferior, substitute molecules for many purposes because they are under patent, while the more suitable natural molecule is not.

biopearl123
Posts: 1665
Joined: Fri Jul 20, 2018 5:13 pm

Re: Request to Bill W

Post by biopearl123 » Tue Apr 16, 2019 7:17 am

This was kindly provided by Hoosier Investor on SA:


Hoosier Investor, Contributor
Comments619 | Following
BP,
Conclusion:
The International Search Report (ISR) is favorable on the patentability of the combination of Imetelstat + Venetoclax as a treatment for AML.
Explanation:
Two requirements must be met to obtain patent protection. First, the invention must be novel (i.e. no evidence of prior public disclosure). Second, the invention must be non-obvious (i.e. representative of an inventive step) to one skilled in the art.
The most important feedback was the finding of novelty. A lack of novelty is a killer as it means the specific embodiment has been taught. Rejections based on obviousness are more subjective and easier to argue.
The claim section of this patent application included the use of the combo as a treatment for a variety of blood & lymphoma cancers. However, the pre-clinical data presented in the specification of the patent application pertained solely to their AML test results. Janssen didn't include any pre-clincial data to back-up any of their other claims. It's for this reason the examiner found the combo treatment to be representative of an inventive step with regard to AML, and NOT representative of an inventive step for the other oncology indications listed in the claims.
Patent offices will typically only allow one invention per application, but you're allowed to make separate additional application filings (for other inventions) based on the original application. Thus, Janssen's strategy was to pursue protection specific to AML with this application. However, by including (allowing for) all of the other oncology indications, they allowed themselves (now Geron) the opportunity to file future Continuation applications aimed at the other oncology indications as they so desire....with the requirement of them supplying the appropriate pre-clinical test results for that indication as part of the future application. A very wise approach in my opinion.

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