Those of you following NKTR may find this article interesting.
https://seekingalpha.com/article/4174587-nektar-therapeutics…
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Thanks Hydemarsh, I was just going to recommend the same article which is mostly about N-358, the T-reg stimulator which is being tested in patients with Lupus. Here’s a tiny excerpt.
N-358 is uniquely special because it represents a novel and unique approach toward managing SLE (Lupus) that is unprecedented. By targeting the interleukin-2 (“IL2”) complex, N-358 induces T-regs production (to suppress other immune cells). This selectivity confers great advantages in both efficacy and safety. In preclinical studies, N-358 demonstrated the stellar ability to inhibit antigen-driven inflammation in a skin hypersensitivity model. It also exhibited the ability to reduce SLE progression in mice.
It’s nice because we’ve heard so much about N-214 and this is something entirely different.
Saul
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It’s nice because we’ve heard so much about N-214 and this is something entirely different.
Yeah, not just different, it’s actually kind of the opposite. With 214, they are trying to knock down Treg stimulation so as to produce an aggressive immune response. With 358, they are trying to stimulate Tregs to slow down an already over-aggressive immune response (in autoimmune patients).
It’s cool that they can isolate that pathway and can push it either direction they want.
-lemur
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Interestingly, NKTR-214 and NKTR-358 are based upon the same IL-2 recombinant backbone (aldesleukin). It is essentially the same base biological, immune modulating cytokine. What NKTR has done is alter the surface structure of IL-2 in two different ways, so that the molecules then have different profiles of IL-2 receptor activation, in one case activating natural killer cells in the case of cancer chemotherapy, and in the other case, selectively activating regulatory T-cells for immune modulation.
It speaks to NKTRs singular expertise, the targeted surface modification (through PEGylation), of biologically active small molecules to alter their biological activity and their pharmacokinetics. The fact that they don’t have to discover the base small molecule is a huge advantage. Their niche is discovering how to package said molecule for maximal biological effect.
From an FDA approval perspective, the fact that the underlying molecule, IL-2, is an approved agent, and the fact that PEGylation is a known process for modifying drugs and is biologically harmless (examples of approved PEGlyated drugs include Adagen, Oncaspar, PegIntron, Pegasus, Neulasta, Somavert, Micera, Cimzia, Krystexxa, and Omontys), this bodes well for approval of these drugs as long as they improve disease status.
I would venture a bet (and essentially have taken the bet) that NKTR-181, a PEGylated opioid, will be approved quickly after the Nectar NDA submission this month. This drug is on Fast Track status and that fact alone carries a 70% approval rate. Opioids as a drug class are well studied and FDA approved, PEGylation is a well known drug modifying process, and NKTR-181 shows effective pain analgesia with diminished euphoria during the height of the opioid crisis. Lots of good things coming together here.
NKTR-358, if it shows effectiveness in down regulating the inflammatory component of the immune cycle, has a huge addressable market, entering the realms of the JAK inhibitors and anti TNF agents.
If anyone wants to get into the details of PEGylation, the attached article is elucidatory.
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4632829/
Jack
23 Likes
I would venture a bet (and essentially have taken the bet) that NKTR-181, a PEGylated opioid, will be approved quickly after the Nectar NDA submission this month. This drug is on Fast Track status and that fact alone carries a 70% approval rate.
Jack,
By this month, you mean May 2018, right?
Have you taken said bet via June 15 2018 expiration call options? (Sorry, Saul…there are probably a decent number of folks on this board that utilize options, as our portfolios haven’t grown past the point of them being simply a waste of time and over-complication with use of a decaying asset.)
Thanks,
volfan84
Thank you gentleman for the thorough and timely reaffirmation.
1 Like
When the NDA is submitted is not disclosed by the FDA. It may be disclosed by Nektar. They have reported that it will be this quarter I believe. However, as soon as the FDA schedules a panel review, that is public information, recorded, and I think you may actually listen in.
The thing about Fast Track status is that the FDA is intimately engaged during finalization of product development, to answer questions and provide feedback before the NDA. This means Nektar doesn’t have to necessarily go back and gather more data to satisfy FDA whims/critiques, but this is by no means absolute.
Thus, I hold just stock and Jan 20 LEAPS as a leveraged stock substitute at current time.
Jack
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Nektar is in the process of getting approval for 181. (as stated no guarantee until it happens)
It could happen this month but a safer bet is that we should know up or down by mid July. Not sure if the decision to retain ownership might be delaying their go to market strategy in the filing.
You know, some people on the board have said they wouldn’t invest in any “little” biotech whatsoever, but to me, Nektar is not a little biotech, it’s a powerhouse in the making.
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Looks like Tinker has joined in on Nektar over on NPI, so I put together a group of links from this board to have a quick cross-reference):
http://discussion.fool.com/nektar-therapeutics-33070226.aspx?sor…
Since I can still easily copy/paste those links before they get shortened by posting, I’ll go ahead and add them here too.
Saul’s thread discussing his new position in Nektar:
http://discussion.fool.com/nektar-new-position-discussion-330102…
GauchoChris’s 2 threads on NKTR from back in early November 2017 (before the 4x price rise).
http://discussion.fool.com/nktr-new-clinical-and-preclinical-dat…
http://discussion.fool.com/nktr-q3-transcript-and-highlights-328…
Recent thread discussing NKTR-358:
http://discussion.fool.com/nktr-358-sa-article-33069865.aspx?sor…
Saul’s recent summary of their latest conference call:
http://discussion.fool.com/my-summary-of-nektar39s-conf-call-330…
NKTR-214 deep dive from Ted Yun (works for J&J per his profile…and discussed some in the thread):
http://discussion.fool.com/nktr-nktr-214-deep-dive-33021896.aspx…
Saul thread about finally getting checkpoint inhibitors after reading through Ted’s deep dive:
http://discussion.fool.com/okay-i-finally-get-checkpoint-inhibit…
Thread that mentioned a contrary view on Nektar (if I’m reading the subject correctly):
http://discussion.fool.com/nktr-caps-does-not-like-33011336.aspx…
volfan84
long NKTR
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