I don't think there's anything new here that we haven't seen over the weekend, but it was (unusually) smart of SGEN's media relations team to summarize it today - a work day and market day. They get points for that. The top lines:
Seattle Genetics Highlights Multiple ADCETRIS® (Brentuximab Vedotin) Data Presentations in Frontline and Salvage Hodgkin Lymphoma at ASH Annual Meeting
-Long-Term Data from Phase 1 Trial of ADCETRIS Combined with AVD in Frontline Hodgkin Lymphoma Demonstrate 100 Percent Three-Year Overall Survival Rate and 92 Percent Three-Year Failure-Free Survival Rate; Data Provide Continued Strong Support for ECHELON-1 Trial-
-ADCETRIS in Combination with Bendamustine in Relapsed or Refractory Hodgkin Lymphoma as Second-line Therapy Shows Objective Response Rate of 96 Percent and Complete Remission Rate of 83 Percent-
-Interim Data from ADCETRIS Phase 2 Clinical Trial in Previously Untreated Hodgkin Lymphoma Patients Age 60 or Older Demonstrate 93 Percent Objective Response Rate-
-Data from Multiple Trials Support Goal to Establish ADCETRIS as Foundation of Therapy in Frontline and Salvage Hodgkin Lymphoma and Other CD30-Positive Malignancies-...
in December. SGN CD33A was always described as having preclinical data that was the best Clay has ever seen. I detect the same enthusiasm carrying forward to the initial clinical trial data. To be granted an oral presentation at ASH for Ph.! as opposed to a poster presentation also seems to imply that there is something significant to come in Dec, as well as already speaking in terms of combination studies on initial data alone. AML is a tough brutal disease and hopefully patients and investors alike will benefit from this new PBD dimer empowered ADC.
It was obvious from the CC that SGEN management has learned that it's also not just what they have to say, but how they say it, that impacts how wall street interprets their results.
It's obvious to me that the Aethera OS hullabaloo perpetuated by the short sighted is just that. It is only due to the effectiveness of Adcetris that the OS data is not ripe , and won't be ripe for a very long time.
If I correctly read tonight's filing, Felix Baker - an insider - recently bought about another 1.5 million shares of SGEN. When combined, the Bakers and their entities now own about 20 percent of the float.
Here are some highlights of CEO Clay Siegall’s presentation today during the annual J.P. Morgan Healthcare Conference in San Francisco, one of the pharmaceutical industry’s most important investor sessions of any given year:
- Siegall was clear, focused and animated during his presentation. No unforced errors this time around.
- That said, I didn’t hear very much that was new – at least not new to anyone who has followed the company closely.
- Significantly, Siegall provided the most clear explanation to date of the lack of OS benefit in recently released data from the AETHERA trial. “We did not guide that OS would be meaningful, with such a small number of events,” he told the group. “So, that data was really premature. The next pre-planned analysis will be in 2016. Also, most placebo patients received Adcetris after progression, so that really was a confounding fact for anyone looking for OS benefits.” He reiterated that an sBLA will be submitted by the end of June.
- He said SGEN was “very excited about working with Bristol Myers Squibb” through the collaboration that was announced this morning. “These are two of the most active single agents,” he said of the substances under study. Earlier, he noted that “the future is combining modalities to benefit patients.”
- There's a good chance that data will be released this year from the SGN-LIV1A trials in breast cancer. “We’re excited about that,” Siegall said. (I repeat my assertion that this could be a hidden gem - a true blockbuster - in SGEN's pipeline.)
- 4Q and 2014 year-end financial results will be released on Feb. 10. “Stay tuned for that,” Siegall said.
Unlike some other biotechs, SGEN did not broadcast the breakout session that followed this general session. That was a public relations/media relations mistake, imo.
As always, it is highly likely that I missed something important. Consequently, you are advised to listen to the replay.
until the ASH abstracts are released to the public. Should make for some interesting and time consuming reading. ASH accepted a record 18 abstracts from SGEN with 8 of them being granted oral presentations.
Can't wait to read about the initial SGN CD 33A data. I'm guessing that due to the fact they are looking to add additional cohort studies and combination studies with hypomethylating agents there is probably some indication that it holds promise. The pre-clinical data was nothing short of phenomenal in all subsets of AML including the multiple drug resistant subtypes. Blew away Gemtuzumab Ogazmicin ( Mylotarg) in that regard. Mylotarg had been FDA approved but voluntarily withdrawn off the market due to unacceptable toxicity and negligible survival although there is an effort to get it back on the market. The toxicity in large part was due to the ADC linker prematurely breaking down and releasing the drug systemically instead of within the tumor cells. I doubt SGEN's proven linker system will exhibit the same problems.
The full data set on Aethera should also clear up the OS speculation.
Many wonder why mgmt. doesn't reveal all this data sooner but in fairness to the researchers it is right for them to wait. These scientists themselves are embargoed from revealing the data they worked so hard to produce until the actual meeting. These researchers performing the studies on behalf of the company should be the ones to reveal their work to the scientific community.
Because insider transactions are timed to not run foul with SEC rules on insider trading, they can be used as timing clocks for traders.
In this case buying by BB is indicative that no M&A talks are ongoing and that no trial data is expected for at least 6 months therefore with the main risks to shorting removed the short traders are playing their game knowing that they have at least six months to short and distort before they have to cover. If you look at the short interest over the same period that the BB have been buying you will notice that it has increased by ~ 4.6 million shares (slightly ahead of the purchases) which coupled with amped FUD about the ASH disclosure of a potentially superior competing drug to emerge (BS if you know the facts) and all the hyping surrounding the fund raising activities of emerging CART technology has been successful in collapsing the share price to the low 30's. However the mopping of the newly minted short shares by BB has created a longer term problem for the shorts making their victory a Pirrhic one. Because of the very high institutional ownership, what is now a slight advantage will eventually turn SGEN as toxic for the shorts as it has in the past. In the meantime since I had a bit of cash available this time around I have used it to increase my already very large (relative to my account) position.
“From my experience in treating acute myeloid leukemia, it is notable to see a single agent treatment resulting in bone marrows with no detectable blasts, even by highly sensitive flow cytometry,” said Eytan Stein, M.D., Memorial Sloan Kettering Cancer Center.
Thanks for the summary. It will have to do for me until the week end.
So finally we hear mention of LIV1A and at least a time frame for when we can expect some data. To me that is and has been since first mentioned, the whale swimming in SGEN pond that WS seem to be willfully ignoring. BC is a giant market that is still vastly underserved and that SGEN technology is likely to be able to successfully address (at least based on the early data that was shared ~ 1 year ago). By saving mothers, grandmothers, sisters and wives it will become a blockbuster drug very quickly. Clay's expressed excitement seems to dovetail with Felix's enthusiasm over the past couple months and I suspect that their excitement and enthusiasm is likely supported by some knowledge that can't yet be divulged for whatever reasons. So now the stage is set for a potentially explosive 2nd half of '15 with the confluence of the CAR_T's cooling off and coming back to earth, FDA action on sBLA, PIII data on ECHELON1 and PI data on LIV1A. The shares being shorted now will only increase the boom.
Unfortunately that is likely to happen later this year or next. As with everything else it is almost always possible to build one prototype but scaling it is where the rubber meets the road. For the sake of humanity (of which I'm a member) hopefully it will eventually work, increasing the weaponry against the scourge and save lives but unfortunately it will take more time, money and additional technological development than expected.
In the utopian MO of WS hyping of CART has to necessarily discredit all other technologies, complementary or otherwise, thus turning the cliché around and two birds in the bush are better than one in the hand. The SGEN detractors (shorts) of old, who got their head handed to them in the last cycle, are coming back for revenge forgetting the other adage that rage went to town on horseback but came back on foot.
Given the very high institutional ownership of SGEN, I expect that the very high daily trading volumes in place since Q4 and still persisting, are due more to new shorting than institutional divestiture, in addition to at least 50% of it due to HFT. We got a glimpse of that at the Dec 15 short update and if my expectation is on target, we will get confirmation again for Dec 31 next Tuesday and then again to weeks later thru Jan 15.
Chances are that by the second half of this year, some of the CART immaturities will begin to show at the same time that SGEN results for the frontline ECHELON 1 should also be available, creating the condition for the SGEN detractors to get their head (and probably thei #$%$ too) handed to them for a second time.
SAN FRANCISCO (TheStreet) -- The use of Seattle Genetics' (SGEN) Adcetris as a maintenance therapy after a stem-cell transplant in "high risk" Hodgkin lymphoma patients led to a 20 percentage point improvement in relapse rates compared to a placebo after two years of follow-up, researchers reported Saturday.
The new Adcetris data comes from a phase III study known as AETHERA, which is being presented in full at the American Society of Hematology annual meeting underway here. Next year, Seattle Genetics intends to seek approval from regulators to expand the use of Adcetris into a larger pool of Hodgkin lymphoma patients based on the AETHERA study results.
The AETHERA study enrolled 327 Hodgkin lymphoma patients who had undergone stem-cell transplant to put their disease into remission but who still had certain characteristics which made them more likely to relapse. Between 30 and 45 days after transplant, the patients were randomized to receive treatment with Adcetris or a placebo for one year.
After two years of followup, 65% of Adcetris patients had no evidence of disease progression compared to 45% of patients treated with a placebo, according to new details from the AETHERA study disclosed Saturday at an ASH-sponsored media briefing.
Looks like you've got a right read Red. Thanks for the heads up. This added confirmation from the Bakers of their continued confidence in sgen should help quell the recent volatility in the stock price.
Except you weren't 'right,' Ricky. You said last night that it would go down three or four points at the open. It went down less than two points and then began recovering. (It's typical of Ricky and his many aliases to conveniently forget his/their previous posts and predictions.)
Looks like a potential winner to me.
Phase 1 data looks extremely promising not only for AML but also extending its use to Myelodysplastic syndrome.
Very old R?R patient population.
At 40mcg 16 of 38 pts achieved blast clearance.
Up to 60mcg now and a MTD has not yet been established. Study shows that at 40mcg and 60mcg patients are showing " marked and rapid' blast clearance.
AE appear minimal and are mainly due to preexisting myelosuppression.
AML and Myelodyspastic syndrome haven't really had a treatment approved in about 6 or 8 years and those hypomethylating agents while showing some efficacy are not curative.
The remissions thus far appear to have some durability to them.
They need to stop issuing good news or we'll all go broke:
1. First Clinical Data Presentation of SGN-CD33A Demonstrates Encouraging Antitumor Activity in Acute Myeloid Leukemia; Dose and Schedule Refinement Ongoing; Phase 1b Combination Trial Planned to Evaluate SGN-CD33A with Standard of Care in Frontline and Consolidation Settings for Acute Myeloid Leukemia
"Of the 52 evaluable patients treated across all dose levels, the best clinical response by investigator included 11 patients (21 percent) with a complete remission or complete remission with incomplete recovery (CR/CRi). An additional 12 patients (23 percent) achieved a morphologic leukemia free state."
2.-ADCETRIS Demonstrates Antitumor Activity in Both CD30-Positive and CD30-Undetectable Relapsed/Refractory DLBCL; Phase 2 Randomized Trial Planned for Relapsed/Refractory CD30-Positive DLBCL; ADCETRIS in Combination with RCHOP for Frontline DLBCL Shows High Complete Response Rate and Manageable Safety Profile
Of 42 evaluable patients in the CD30-undetectable DLBCL arm treated with single-agent ADCETRIS, 13 patients (31 percent) had an objective response, including four patients (10 percent) with a complete remission and nine patients (21 percent) with a partial remission.
Median progression-free survival was 1.4 months (range, 0.4 to 9+).
Median duration of response had not yet been reached for patients with a complete remission and was 1.6 months for patients with a partial remission.
Among 35 patients with baseline and post-baseline assessments, 63 percent achieved tumor reduction.
Detailed why Adcetris is far superior to both of these but post was deleted. In short Adcetris had a 30% CR rate in retreatment trial. Keytrunda has a 21% rate. Statistically 50% more people have a CR on Adcetris. With opdivo trial not all patients were relapsed after Adcetris. Those who did had only one CR so a 6% CR rate.
SGEN is presenting some powerful data this conference. They have numerous trials underway-which are needed before any FDA approval. There are the leader and there lead is widening.
Hopefully in the future these drugs can be used in conjunction with Adcetris to even support better results for patients and SGEN.
The lead investigator for Keydentra is also the lead investigator for the Athera trials and called for Adcetric to be standard of care in that setting. That's says an awful lot about Adcetris.
Lets also not forget the recent large buy by the Bakers.
Forget the noise and the street news reporters. That being said no price reaction would surprise me yet am hopeful as SGEN is largest holding.
Sentiment: Strong Buy
I really think everyone is looking at the wrong thing here. Contrary to popular belief there is not likely going to be a golden arrow that strikes down cancer . Trials will continue to show promise and have coharts within in them that achieve astounding results Remission, PFS so on and so forth. But very often the data is flawed or companies are simply data mining.. I think Immune therapy and ADC's are easy ways to increase revenue streams on existing treatments. SGEN offers a revenue stream that would be profitable if not for the dollars spent on R&D. If your first indication has been in the market and there is no real change in the perception of the safety profile mediocre results will get you approval on the next indication you file. That makes SGENs platform more valuable than a Phase 1 or 2 that potentially could have more efficacy but is untested by time and in the market receiving feedback by Doctors and Patients. Not saying this is the next Pharma Champ . They definitely are not but I do believe they are worth a price tag of 60.00 plus in an acquisition bid. Bakers are holding those cards it is likely they are not wiling to ring the register and pay uncle SAM a huge tax bill. They would rather loan their shares at 15% interest rate. I am a buyer at this level I am a seller at close to 50.00
Extremely favorable response on Twitter and elsewhere. None of the previously seen nonsense about comparative OS rates (which can not yet be determined because Adcetris is working so well), at least so far. Some examples:
- nixon786 @nixon786 5m5 minutes ago $SGEN good PFS curve in Hodgkin's lymphoma. New standard of care in post transplant or. Will generate more $$$ for $SGEN
-BioWorld Today @BioWorld Takeda + $SGEN: For Hodgkin lymphoma patients at risk of relapse after auto stem cell transplant, Adcetris boosts PFS to 43 mos. v 24 #ASH14
- David Miller @AlpineBV_Miller I think AETHERA is practice changing. $SGEN #ASH14
- David Miller @AlpineBV_Miller AETHERA saw 85% of placebo patients receive subsequent Adcetris treatment. Will impact OS. FDA very likely to approve anyway. $SGEN #ASH14
One other significant development: The company's PR department finally has discovered Twitter. Someone over there live-tweeted elements of Siegall's presentation. (Never underestimate the benefit to investors of having a decent public relations program, something that SGEN has lacked. If you have a good story, and SGEN does, you want investors to know it.) Here are some of the company's tweets today:
Clay Siegall at #JPM15 w/ plan for potential $SGEN blockbuster franchise - 4 phase 3 trials & more data in HL, DLBCL, NHL in next 4 yrs
Promising early data with SGN-CD33A in acute myeloid #leukemia shown by Clay Siegall at #JPM15 $SGEN
#JPM15 Clay Siegall summarizes $SGEN ‘15 milestones: expand product in earlier therapy & CD30+ malignancies, advance robust product pipeline