P.S. If I read the overnight filing correctly, the Bakers have arranged things so that they now own either EXACTLY 51 percent of Seattle Genetics or 68 percent of Seattle Genetics (one of the filings looks like it's duplicative but it might not be). Either way…that's reassuring and impressive
If someone can tell me something more bullish than large additional purchases by an entity that sits on the board and already has a near-controlling interest in the company…I would like to hear it.
Malibu, totally agree. Like any decent person, I hope that gene therapy and/or any other breakthrough proves to be the magic pill that can cure all or even most cancers (and even eventually puts SGEN out of business). But, as in investor, the reality is that the reported response rate, though promising, is hardly miraculous and it will be many, MANY years before gene therapy or anything else can supplant ADCs and other current treatments.
Maui, there you go again. Please point out the post you supposedly made "right after the sell" that you claim you made at the open today in which you "avoided today's pain." What I see is this post from you at 1 p.m. EST today, more than three hours after the open: "I'm think [sic] it is totally BS with no substance. The timing suggests a malicious attempt at manipulating the price lower." Based on your repeated twists and turns and easy to detect deceits, I'm beginning to think that you are the late and unlamented Rickarooski.
It would be nice if SGEN would respond in some way, but it's always slow off the mark on things like this. Meanwhile, brace yourselves. The trolls will be arriving here any minute.
Bull, agreed. Feels like another one of those transitory false alarms from know-nothings. And here's another tweet from David Miller, regarding the Piper comment: "Complete retread. Like I tweeted. They don't know the limits of AERS data or how dirty it is."
This comes from an experienced biotech investor on Twitter (where, by the way, SGEN's data presentations are earning wide praise today): David Miller @AlpineBV_Miller 14m; Poor Piper. Apparently their first rodeo with AERS & they really don't know how to interpret or understand where data come from. $SGEN
Clearstone - I haven't found the full report, but he apparently reiterated a low-ball SGEN pps target, supposedly on concerns (that no one else seems to have any longer) about Adcetris' possible "toxicity."
And another press release, this one with one of the longest sentences since words were invented:
NEW ORLEANS--(BUSINESS WIRE)--December 09, 2013--
Seattle Genetics, Inc. (Nasdaq: SGEN) today summarized ADCETRIS (brentuximab vedotin) data in Hodgkin lymphoma (HL) and non-Hodgkin lymphoma from multiple presentations at the 55(th) American Society of Hematology (ASH) Annual Meeting and Exposition taking place in New Orleans, Louisiana, December 7-10, 2013. Highlights include encouraging interim data from a phase 2 clinical trial evaluating ADCETRIS as a single-agent for previously untreated HL patients age 60 or older and updated data from a phase 1 clinical trial of ADCETRIS in combination with chemotherapy for the treatment of newly diagnosed mature T-cell lymphoma (MTCL) patients, commonly referred to as peripheral T-cell lymphoma (PTCL). In addition, data were presented from an investigator-sponsored phase 2 clinical trial evaluating ADCETRIS in relapsed cutaneous T-cell lymphoma (CTCL). ADCETRIS is an antibody-drug conjugate (ADC) directed to CD30. ADCETRIS is currently not approved for the treatment of frontline HL, frontline MTCL or relapsed CTCL.
Tough day for us with competition at ASH, a weird comment from a Piper analyst, and the usual SGEN ying-ynag sell the news activity, but maybe this will help:
Seattle Genetics and Takeda Highlight Long-term Follow-up Data from ADCETRIS(R) (Brentuximab Vedotin) Pivotal Clinical Trials in Relapsed or Refractory Hodgkin Lymphoma and Systemic Anaplastic Large Cell Lymphoma at ASH 2013
Last update: 09/12/2013 11:23:00 am
- Median Overall Survival of 40.5 Months in Relapsed/Refractory Hodgkin Lymphoma Patients -
- Estimated Three Year Survival Rate of 63 Percent with Median Overall Survival Not Yet Reached in Relapsed/Refractory Systemic Anaplastic Large Cell Lymphoma -
Full press release on the Seattle Genetics website
At the time of data analysis, the maximum tolerated dose had not yet been reached. Enrollment and dose escalation are ongoing.
Of the 16 adult patients treated across all dose levels, three (19 percent) achieved a complete remission or complete remission with incomplete platelet recovery, eight (50 percent) had resistant disease with clinical benefit or stable disease and five (31 percent) had progressive disease.
At dose levels greater than 1.0 milligram per kilogram (mg/kg), eight of 10 adult patients had clinical benefit, consisting of complete remission, complete remission with incomplete platelet recovery, resistant disease with clinical benefit or stable disease.
Of the four pediatric patients, one patient had resistant disease with clinical benefit, one had resistant disease without clinical benefit, one had progressive disease and one was unevaluable.
The most common adverse events of any grade occurring in adult patients were fever (56 percent), nausea (44 percent), chills (38 percent), fatigue (38 percent), blurred vision (38 percent) and vomiting (38 percent). Adverse events seen in at least two pediatric patients (50 percent or more) were vomiting (three patients) and abdominal pain, cough, shortness of breath, nausea and fever (two patients each).
“The phase 1 trial evaluating SGN-CD19A has demonstrated encouraging early antitumor activity and a generally well-tolerated safety profile among heavily pretreated patients with acute lymphoblastic leukemia and very aggressive types of lymphoma. In addition, multiple complete remissions have been observed in a parallel phase 1 study evaluating SGN-CD19A in aggressive non-Hodgkin lymphoma. Dose-escalation is ongoing in both phase 1 clinical trials, and we plan to report additional data during 2014,” said Jonathan Drachman, M.D., Chief Medical Officer and Executive Vice President, Research and Development at Seattle Genetics.
Full press release on SGEN's website
Also, Baillie Gifford, a major European fund manager, nearly doubled its stake during the three months ending on Sept. 30. It now owns nearly 12 percent of Seattle Genetics. Baillie Gifford manages $37 billion in assets, and SGEN ranks at No. 25 out of the firm's 116 holdings.
I've noticed that, too. When my other biotechs are up, SGEN is down. And vice versa. And with no new news. Not sure what to make of it, other than maybe the intermittent manipulation of biotechs that we sometimes experience. Don't get me wrong - I get a little frustrated myself, and I'd love for SGEN to go up every day or at least return to near $50, just like everyone else. But, having been in SGEN since the $7-9 range, I'm in a particularly thankful frame of mind this Thanksgiving Day. :)
scr2002, with all respect, SGEN is up 62 percent year-to-year - and the investment thesis not only remains consistent, it actually continues to improve. I really wouldn't sweat the minor day-to-day gyrations.
Clearstone, you've hit a relatively quiet period. You're right about this being a particularly knowledgeable Yahoo board and, generally speaking, it is a well-behaved one. Stick around. You won't be sorry.
Now, that's the maui I remember. :)
I agree completely. Frontline is a virtual lock. Additional revenue will come from other ADCs in the SGEN pipeline and from partnerships. As for the current pps fade, we've seen it before. This, too, shall pass.
Brentuximab Vedotin Administered Before, During, and After Multi-Agent Chemotherapy In Patients (pts) With Newly-Diagnosed CD30+ Mature T- and NK-Cell Lymphomas:
All 26 pts were assessed for a clinical response at the end of treatment with A+CHP. The ORR was 100%, with a CR rate of 88%. All 7 non-ALCL pts achieved a CR. After a median observation time of 16 months, the 1-year PFS rate was 71% (95% CI 49, 85).
At a dose of 1.8 mg/kg, brentuximab vedotin, administered sequentially with CHOP or in combination with CHP, exhibited manageable toxicity in the treatment of newly-diagnosed CD30+ mature T/NK-cell lymphomas. A+CHP exhibited substantial antitumor activity, with an ORR of 100% (CR rate 88%) and a 1-year PFS rate of 71%. A phase 3 study comparing A+CHP to CHOP in the frontline treatment of mature T-cell lymphomas is underway (ClinicalTrials.gov NCT01777152).
Three-Year Survival Results From An Ongoing Phase 2 Study Of Brentuximab Vedotin In Patients With Relapsed Or Refractory Systemic Anaplastic Large Cell Lymphoma:
Conclusions: After a median observation time of 33.4 mos from first dose of brentuximab vedotin, 64% of pts with relapsed or refractory sALCL were alive at the time of last follow up and the median OS has not yet been reached. Pts who achieved a CR with brentuximab vedotin experienced longer OS than pts who did not achieve a CR and early PET-negative status appeared to be important for long-term survival. These long-term follow-up results further underscore the durability of clinical benefit obtained with brentuximab vedotin. A randomized phase 3 study is being conducted to evaluate brentuximab vedotin in combination with cyclophosphamide, doxorubicin, and prednisone for frontline treatment of CD30-positive mature T-cell lymphomas, including sALCL.
A Phase 2 Study Of Single-Agent Brentuximab Vedotin For Front-Line Therapy Of Hodgkin Lymphoma In Patients Age 60 Years and Above: Interim Results
Of the 11 patients with a response assessment (see table), the ORR was 82% (n=9) and the complete remission (CR) rate was 64% (n=7). For the 10 patients who had interim PET scans after 2 cycles of therapy, the mean decrease in maximum standardized uptake value (SUVmax) between baseline and Cycle 2 was 83%. Cycle 2 PET scans were negative (Deauville Score 1-3) in 36% of patients, and the range of duration of response was 0.1+ to 20.6+ weeks thus far.
Treatment-related adverse events (AEs) occurring in ≥15% of patients included neutrophil count decreased, peripheral sensory neuropathy, pruritus, and rash (n=2 each); most events were Grade 1 or 2. Grade 3 treatment-related AEs included neutrophil count decreased, rash, and orthostatic hypotension (n=1 each). No Grade 4 or 5 events have been observed to date.
In this interim analysis of patients aged ≥60 years with newly diagnosed HL, compelling antitumor activity with single-agent brentuximab vedotin has been demonstrated. To date, a response rate of 82% has been shown in this historically challenging population of patients who either declined or were not eligible for standard chemotherapy. Preliminary safety data demonstrate tolerability in this patient population and the data are consistent with the current safety profile of brentuximab vedotin.