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Which creates the opening for TGTX, assuming their TG-1101/Ibrutinib results are better than the Rituxan combos, and continue to look like the best CD-20/Ibrut combos out there in the marketplace.
In other words, until Gazyva is proven in this combo, Tg-1101 will have early mover advantage in combination with Ibrutinib.
Ok, but I think the data to date is very compelling regarding Tg-1101 superiority over Rituxan, and that what I'm betting on.
OK, I know I'll be watching...
Well, that's the conventional wisdom.
But I think if it becomes evident that either a TGR-1101/Ibrutinib combo, and/or, a TGR-1202/TG-1101 combo is the best tx for a range of B-cell indications, it won't be long before Genentech's dominance is a thing of the past in that space,
because, I think Docs will be prescribing on the basis of specific combo results, not so much the individual components of those combinations, and,
at that point(short of an acquisition), Genentech may not have a competitive combo to field.
Thanks for the feedback!
Best,
bw
Why do you think so?
And, btw, absolute victory as a(head-to-head)mono therapy doesn't really matter here for the reasons previously stated...
TGTX Exuberance
Maybe the reason it reminds you of posts for ARIA prior to its takedown is because a lot of those advocates are ARIA survivors. I'm certainly one(lol).
So, you might conclude that we just haven't learned our lesson yet. Or, alternatively, you could conclude that we have and that our exuberance is more justified this time around.
I did consider the minority ownership issue when you mentioned it, and although I would prefer a little bit more parity in that regard, the advantage(if you believe Michael Weiss knows what he's doing, and I do) is that it frees him to pursue his vision aggressively(which he has to date, to seemingly very favorable effect).
In that regard, if, after he's developed these assets and created a much larger market cap, he chooses to sell the company for a multiple which I consider insufficient in conjunction with some private insider consideration(which I believe is highly unlikely if only because as the largest shareholder, he doesn't really have to), I will still be enormously ahead of the game, so it didn't(nor does it at this juncture), seem like a good reason not to participate.
However, I think the reason most of us are as exuberant as we are, is because the prevailing thesis for owning the company(i.e.
the value of the combination of TGTX's proprietary compounds for B-cell therapy)appears to be more and more evident with the passage of time.
More specifically, if the TGR-1202(delta)/TG-1101(anti CD-20) combo initial data, to be released at the Pan Pacific Lymphoma Conference in 2 weeks, shows itself to be in any way competitive with the TGR-1202/Ibrutinib combination(as I expect it will), then it will be fairly clear PCYC either needs to buy TGTX(in at least the $25+/share range) , or, if not, suffer a significant loss of market share to the entity that does.
This recent IRAK4 deal is just potential icing on the cake.
So, I will admit to some exuberance(particularly in view of a market that finally seems to be starting to share it)!
Best regards,
bw
Best regards,
TGTX/IRAK-4/LIGAND DEAL
Although I don't know very much about IRAK-4, I have to say, if it has any B-cell combo value(in addition to other possible broader indications)this deal looks like a very good one for TGTX.
For a little over 1ml in stock upfront, they've managed to improve their portfolio, and enlist a high quality partner to boot.
In addition, assuming lgnd believes the drug has value, they must have confidence in tgtx's capabilities to develop it, or they probably wouldn't have partnered it with them, and certainly not at such a low upfront price.
If they don't believe it has much value, the terms of this deal might make a little more sense from lgnd's POV. However, just on the basis of tgtx's in-licensing judgment to date, I think there's ample reason to believe that's unlikely.
In addition, the market already seems to be weighing in on who got the better of the deal, with tgtx currently up 6+%, while lgnd is down about 5+%...
Finally, if there are any potential suitors out there accessing tgtx's interest in getting bought, this move, if nothing else, should clearly signal that the company is not just sitting there breathlessly waiting for the first offer that comes along(lol)!
Regards,
bw
Well, inevitability is actionable(to the degree it exists and can be identified-that's why I'm acting on it, lol); but let me rephrase that.
More seriously, what is becoming more and more apparent via the evolving data, is that there are a number of COs that would significantly benefit from such an acquisition, and seeing as this eventuality has always been part of Michael Weiss's playbook from the beginning, it's very very likely.
However, if it doesn't happen, I think it will be for one of 2 reasons:
1) the data falters(which again seems less and less likely due to a combination of reported efficacy, and very low tox for what's up to 18 months now-in the case of the delta, efficacy should only improve, and even if/when there is some eventual tox(after all, every drug has an MTD), it should be at an efficacy level which beats the competition.
2)TGTX decides to go it alone because the data and potential are much better than even they expected/hoped for-not sure this would be my preferred outcome(again, shadows of you know who), but if this does result, I'm very confident it will occur at a much higher market cap than the current one.
So, although I agree with you that there is probably(strictly speaking) no such thing as inevitability, the factors which point to a favorable outcome(either way) are so overwhelming, that I'm will to behave as if there were.
Regards,
bw
Well, even a boilerplate answer may be sufficient to get this pot boiling(I should say, boiling over) seeing as it's already pretty hot at the moment...
and each data point makes it ever more obvious that a buyout here is inevitable.
TGTX/Questions For Tomorrow's JMP HCC Presentation
If I were there, I'd be asking these questions(hopefully, someone will):
1)Do you believe the ultimate efficacy of the TGR-1202/TG-1101 combo, due to the probable superiority of the delta component over Idelalisib,(because of it's superior tox & administration profiles), has the potential to be the best(i.e.most efficacious, lowest tox, and therefore, preferred)combo for the treatment of many B-cell malignancies-even as good as,or better than, Imbruvica combos, due to higher/much higher potential exposure levels facilitated by these lower tox profiles?
2)When is TGTX going to report a breakdown of the mutational status and significant biomarkers of it's trial patients-particularly the TGR-1202 pts for mono and combination therapies(b/c this would provide a better basis for comparing efficacy to Imbruvica and Idelalisib)?
3) Have you received any feelers from potential buyers since the release of ASCO and EHA data?
Wonder how many of these will be answered(or even addressed-I mean publically-lol)?
I'll be listening...
Best Regards,
bw
Bind And Roche Collaboration
Another big(very big)partner in a new repackaging/delivery technology that promises to pull a lot of previously failed meds out of the fire-
I like it now, and did before-unfortunately, I was a little too "ahead of this curve"(lol), and am still at a loss here.
However, now that the proof of concept is demonstrated(http://ir.bindtherapeutics.com/releasedetail.cfm?ReleaseID=838643), and numerous big partners have materialized, the tea leaves seem to be lining up for a gradual, though (probably)choppy, ascent.
I.E. Although JMP's $30 price target may be a bit premature, with an Ent Value of only 100ml, plenty of cash, and plenty of partners to finance it's proprietary programs and generate royalties, a target in the low to mid 20s seems reasonable to me.
I'm hoping the JMP presentation on the 24th(http://ir.bindtherapeutics.com/releasedetail.cfm?ReleaseID=854502) provides more info on Roche deal terms, etc.
Regards,
bw
TGTX-
Well, "excuse me" Dew(lol).
But I think it's fair to say that the meanings of most, if not all, terms, are pretty fungible, depending on their context of use,
and you could make the same laziness argument for all acronyms, which would, I believe, be impractical.
Nevertheless, I'll try to be more precise. best-in-class, regarding these two drugs refers to my contention that both will be shown to display efficacy and safety which are at least equivalent to any other drugs in their respective classes,
but which will at the same time be superior(and probably clearly so) in at least one of these aspects, rendering these in summary, "best-in-class", within their categories of usage.
However, to obviate much of the above in the future, I think BIC still works just fine:)
RE:TGTX at Wells Fargo/Impressions
Thanks-when you realize that B cell therapies are a 10-15bil dollar potential market,
and TGTX has 2 very likely BIC drugs in the sector, and still only sports a market cap of $330mil,
I think you have to conclude something has to give(in a big way) to the upside!
TGTX/Wells Fargo HCC/Impressions
In addition to the excellent(1st assessment delta(TG-1202)/Ibrutinib)combo data-90% ORR-likely 100% on next assessment,
what struck me was how well the single delta agent(TG-1202)at 800mgs or higher performed at first assessment(in CLL)-again 89%(8/9)achieved a nodal PR or CR with 100% likely at the next assessment.
Since Nodal and peripheral Rs only tend to improve with ongoing exposure in this drug class, assuming the favorable toxicity profile holds to any significant degree, there is good reason to believe that after exposure is increased(as reported) by 3-4 fold with the new fed/micronized protocol, the single agent performance of TG-1202 might actually be competitive with single agent Ibrutinib.
Although they were careful not to make such a claim, the fact is that limitations of exposure(due to liver tox) was the main reason previous deltas(including idelalisib)have not been in a position to test higher limits of the dose/response curve(which might show deltas to be more truly competitive), whereas TG-1202, with no liver tox to date, should be able to(no MTD to date).
As it is, even if the improvements(in terms of total competitive single agent response vs ibrutinib)are small(which is probably the worst case), the current(old regimen, single agent)results bode very well for the TG-1202/TG-1101(anti CD-20) combo to be reported on at EHA. And any improvements in TG-1202 via the new regimen should just serve as icing(though perhaps very significant icing) on the cake, both in terms of that combo, as well as others to come.
http://ir.tgtherapeutics.com/eventdetail.cfm?EventID=146792
TGTX at Wells Fargo HCC
Today at 2:55pm
http://ir.tgtherapeutics.com/releasedetail.cfm?ReleaseID=854933
TGTX-TG-1202/Brentumab Combo
Another day, another combo for this PI3Kdelta which has no serious liver or other toxicities(unlike all the other deltas),
but which(again, unlike the others), shows competitive/superior efficacy(at this early stage),but has yet to reach a MTD.
Re:TGTX's BOD Majority Control Issue
Yes, not to open old wounds, but Aria's board comes to mind.
The board and insiders there never came close to owning a majority of shares, yet they did manage to screw the shareholders on a fairly consistent basis.
So, I guess it boils down to a matter of integrity either way, which is why the issue is very possibly moot(lol)...
Dew and jaybe,
Thanks for your feedback on at least a few of the many possible ways minority shareholders may "get screwed"(lol)...
Dew, I'll certainly take a closer look at your examples, although I don't think we're quit at the point where I have to worry about the company being(figuratively)sold for a song, just yet. But this certainly rounds out my appreciation of what to expect going forward.
jaybe,
Thanks for the feedback-I realize MW wears a lot of hats(either he's a great delegator, or has mastered the art of teleconferencing). But I've thought all along that although it would be possible for him to produce product when things get further along, he intends to either sell the co outright, or partner with some larger co that would take care of all those messy details.
From what I know of CNDO, I would guess that that's most likely the temporary gig(b/c nothing much seems to be happening there at the moment).
Thanks as well for the congrats, but since the gains are all virtual to date,in view of what both of us know all too well after our aria experience,I'm deferring any glee.
I'm just sorry Doug and I weren't able to persuade you and Dew to take a position here early on.
Best regards,
bw
Would "love" to hear, be directed to, some examples.
Aware of any?
Well, I'm glad you asked the question, because I assume you(and numerous others)know a whole heck of lot more than I do about the internecine working of biotech/heathcare COs.,
and I'd appreciate whatever feedback you or other people can supply.
But, my understanding, from the beginning, has been that if you become a shareholder of this co, you have signed on to the Michael Weiss Show(for better or worse), and that's it.
Assuming his clinical judgment continues to be good(as it appears to have been so far), and his financial interests as a lead shareholder are tied up with the COs increase in market cap, it's not obvious to me(apart and aside from his selling stock), what I should be concerned about.
So please advise me of any scenarios that would be concerning that shareholders should be on the lookout for, or, what is more likely to occur in the "minority shareholder" context you've outlined, vs the alternative.
The only thing I can think of is that he sells the company for too cheap a face value price, while structuring some side arrangement which benefits the insiders disproportionately.
Are you aware of what such an arrangement might look like? Can you think of any examples?
TIA,
bw
I'm not sure Dew-should they be?
I've been inclined to view the fact that over 50% of the stock is controlled by insiders as a plus, because I felt that, on balance, it tends to align the COs interests with those of the shareholders.
I guess I view a monolithic board, which I assume is also dominated by those same insiders, to fall into the same category.
Your thoughts?
TGTX/EHA News Leak?
Possibly...
Or maybe it's just that the ASCO results were good enough that people finally took their first serious look at the pieces, and realized how well they were likely to fit together,
such that now we're beginning to experience a critical mass of sorts, with shorts forced to cover in the face of so many new entrants.
In other words(and as is all too typical of the biotech sector), it suddenly seems obvious, that a $4 stock(of just a few weeks ago), which is now an $8 stock, should(assuming results which are probable on the basis of everything we already know), become a $12-15 stock in very short order(lol)...
Enjoying the ride!
Best,
bw
TGTX-Top Percentage Gainer/New Highs, On 6Xs Avg Volume>>>
Scary!
http://community.livevol.com/index.php/market-tools/stocks-on-the-move.html
TGTX>>>Catching/Caught Fire...!eom
OMER Run-up?
Anyone have a clue what precipitated the enormous reversal in this stock, following a hefty sell-off post the Omidria approval?
From an $11/share post approval low,(off an approval high of about 12.60 the previous day),it's climbed to a high of $15.65 in five days on high volume,
which is odd, since it's usually strongly tethered to the IBB, which has been pretty much consolidating for the last 2 days.
Feels like something's imminent, but no mention anywhere.
Apart and aside from being a preferred beneficiary of the resumption of biotech risk on, anyone have any idea what's up here?
Best regards,
bw
Shows what can happen when real assets are available within a competitive landscape, and the value of cash(if you have it, lol) is negligible...
Of course, I'm hoping this circumstance works to the advantage of tgtx and a few others...
TGTX/EHA Main Event
With 20+ patients(see below), the TG-1101/Ibrutinib proof of concept should be fairly evident...
Abstract Submission
6. Chronic lymphocytic leukemia and related disorders - Clinical
ABSSUB-4307
UBLITUXIMAB (TG-1101), A NOVEL GLYCOENGINEERED ANTI-CD20 MAB, IN COMBINATION WITH IBRUTINIB IN PATIENTS WITH CLL AND MCL; RESULTS OF AN ONGOING PHASE II TRIAL
Jeff P. Sharman, MD* 1, Charles M. Farber, MD, PhD2, Daruka Mahadevan, MD PhD3, Marshall T. Schreeder, MD4, Michelle Mackenzie, RN2, Marnie Brotherton, RN3, Emily K. Pauli, Pharm D4, Kathy Cutter, RN4, Peter Sportelli5, Hari P. Miskin, MS5, Owen A. O’Connor, MD, PhD6
1Willamette Valley Cancer Institute/US Oncology Research, Springfield, OR, 2Carol G. Simon Cancer Center, Morristown, NJ, 3West Clinic, Memphis, TN, 4Clearview Cancer Institute, Huntsville, AL, 5TG Therapeutics, Inc., 6Columbia University Medical Center, New York, NY, United States
Background: Ublituximab (UTX) is a novel, chimeric mAb targeting a unique epitope on the CD20 antigen, glycolengineered to enhance affinity to Fc?RIIIa receptors, thereby demonstrating significantly greater ADCC than rituximab (RTX). Glycoengineered anti-CD20 mAbs have recently demonstrated greater efficacy (ORR, PFS) than RTX in CLL (NEJM, 2014). A Phase I/Ib trial with UTX monotherapy in patients with relapsed/refractory CLL reported an ORR of 45% with rapid and sustained lymphocyte depletion. Data with ibrutinib (IB) + rituximab shows high response rates however, CR and minimal residual disease (MRD) negativity rates remain low. To potentially accelerate and improve responses, IB was combined with UTX.
Aims: Herein we report data from the Phase 2 of UTX + IB in patients with relapsed/refractory CLL and MCL.
Methods: Eligible patients have relapsed/refractory CLL or MCL, with an ECOG PS < 3. Informed consent was obtained in all patients. Study Design: 6 patient safety run-in followed by open enrollment. UTX (2 cohorts at 600 and 900 mg for CLL and 1 cohort at 900 mg for MCL patients) is administered weekly x 3 in Cycle 1 followed by Day 1 of Cycles 2 - 6. IB is started on Day 1 and continued daily at 420 mg for CLL and 560 mg for MCL patients. MRD assessed via central lab. Primary endpoint: Safety and Dose Limiting Toxicities (DLT). Secondary endpoint: Efficacy (ORR, CR rate, MRD).
Results: As of Feb 26, 2014, 4 CLL and 2 MCL patients have been enrolled: Median age 72 years old (range 52-76); all male. Median prior Tx = 3 (range 1-4); Median ECOG PS: 1 (range 0 – 2). All patients are evaluable for safety; no DLTs or safety concerns have been observed. The most frequent AE has been Cycle 1/Day 1 infusion related reactions in CLL patients. Clinical activity has been observed in the CLL patients by physical exam (efficacy evaluation too early for MCL patients). Anticipated enrollment of 20+ patients by June 2014.
Summary/Conclusion: UTX + IB has been well tolerated to date with early clinical activity observed. Known lymphocytosis caused by IB in CLL patients has been minimized with the addition of UTX. MRD and full response analysis will be presented at the meeting. Additional studies are ongoing in patients with CLL and NHL with UTX in combination with other novel targeted agents including PI3Kd inhibitors.
Keywords: Chronic lymphocytic leukemia, Kinase inhibitor, Mantle cell lymphoma, PI3 kinase
http://www.ehaweb.org/congress-and-events/19th-congress/congress-program/abstracts-online/
Isn't this the highest %premium, multibillion dollar buyout in recent memory? maybe ever?
Impressive!
I would think this opens the door, at least conceptually, to larger(perhaps much larger)potential purchase multiples for a select group of smaller biotechs...
Couldn't agree more-
Although investors can and do pay for all sorts of information to facilitate investment decisions, preferentially disclosed material information shouldn't be on the menu.
And while I'm sure there are limitless other ways to skirt the fair disclosure rules, requiring institutional policies to follow them would at least constitute a step in the right direction...
TGTXs "Match made in Heaven"
I believe it was Roth's wording. But, in the context of sell-side analysis, it might as well(for all practical purposes)have been that of either or both.
Still, I believe the combination of TG-1101 and Ibrutinib may turn out to be so(i.e. extremely successful)for both companies(although almost all the market cap benefit would likely go to TGTX).
However, the combination of TGR-1202(TGTXs delta)& TG-1101(it's anti-CD20)could turn out to be even more of a boon for TGTX, if it provides the combination of efficacy and low tox that might be expected from what we know of the ingredients-i.e. if it can come close to or match other combos efficacy, the tremendous pricing advantage of having both in house should command a significant portion of a very large market.
For a company with what is still such a puny market cap(Ent Val=about 190ml), that can only spell large market cap appreciation, via either stock price or acquisition.
TGTX(ROTH Focus List Update)
Roth Capital affirms TG Therapeutics, Inc. (Nasdaq: TGTX) at Buy/Focus Pick with price target of $15 following presentation of TG-1101 and TGR-1202 data at ASCO.
Analyst Joseph Pantginis commented, “We are impressed with the data and we received the same question from investors; "Did you expect the data to be this good?". The KOLs running the studies are strongly behind these clinical data, especially the safety profiles, which make the therapies amenable to combination therapy. We believe TG has delivered solid proof of concept data for both drugs. We now look to two key upcoming catalysts. Of particular note, we look forward to seeing the data from the potential "match made in heaven" combination studies; 1) '1101 + Imbruvica in advanced B-cell tumors and 2) '1101 + '1202 in advanced B-cell tumor shortly. Second, one or both of these drugs is expected to enter pivotal studies by the end of 2014.”
Did they expect the data to be that good?...
I did(lol)...
http://www.streetinsider.com/Analyst+Comments/Roth+Keeps+TG+Therapeutics+%28TGTX%29+as+Focus+Pick+Following+ASCO+Presentations/9542482.html
Regards,
bw
TGTX(ASCO Impressions)
TGTXs anti CD-20(TG-1101) and PI3Kdelta(TG-1202)continue to demonstrate very competitive efficacy, with superior administration characteristics, and(most importantly, in the case of the delta), no significant liver or other toxicities.>>>
i.e. the perfect profile for tx combos which are becoming the standard form of therapy in the B-cell space(and another positive harbinger regarding the first combo data to be featured at EHA and Pan Pacific Lymphoma Conference, in June and July).
Highlights from TG-1101 Data Include:
•100% of CLL patients achieved a peripheral response with 67% achieving a partial response
•44% of Indolent NHL patients achieved a complete response (22%) or partial response (22%)
•Well tolerated at highest doses tested, with infusion time averaging 90 minutes in later infusions
Highlights from TGR-1202 Data Include:
•100% of evaluable CLL patients treated at = 800 mg exhibited significant nodal reductions, with approximately 80% achieving a partial response or a nodal partial response with lymphocytosis
•Additional responses seen in Hodgkin's Lymphoma and Indolent NHL
•No drug related hepatic toxicity or colitis observed to date, with patients on study for over 1 year
http://ir.tgtherapeutics.com/releases.cfm
Best regards,
bw
RE:TGTX
"When you're hot..."
Somebody apparently waking up to the growth and value potential here.
Up about 35%(in anticipation of ASCO, EHA, & Pan Pacific Lymphoma Conf. abstracts & data pending)over the last 3 days-
Nice to finally see it...
Thanks for the perspective-didn't realize rituxin had such a favorable relative AE record for this issue.
In view of that, and the elan experience, this PCYC selloff may have more to do with real PML fear, rather than just concern over an excessive market cap(related to increasing competition for Ibrutinib).
Regards,
bw
PCYC Sell-off
Apparently, and yet it doesn't seem to discourage Docs from using anti-CD20s like Rituxin- and, if it doesn't discourage that, why should it jeopardize the potential use profile of Ibrut in any significant way?
I think the answer is that it really doesn't, it's just that people were primed to sell already (as noted).
Much like the case of GILD's apparent political/reimbursement problems over Sovaldi setting off a whole scale biotech sell-off...
in the final analysis(as demonstrated by GILDs rapid and sustained recovery)it really had little to do with Sovaldi cost-people were ready to sell biotech and it just provided a convenient, ephemeral excuse.
PCYC
Wow-any reason to blow up at all. On the basis of 3000 pts worth of data and the Rituxin black box for PML, I can't see the logic of this sell off on that basis alone.
Instead, I think it's just the excuse people use to takes some money off the table in a competitive space where the competition(both in terms of efficacy and low price alternatives)only continues to increase.