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was on scans for fri, on watch for mon with unusual volume: http://ditrli.com/ditrli-premier-watchlist-for-monday-1215/
popping up on my intra scans, will be on watch into todays power hour: http://ditrli.com/ditrli-premier-1212-lunchtime-scans-for-power-hour/
Looks like we are now Alpine Biosciences - by acquiring and merging with them.
I cashed in my ONTY a while back for a 25% profit.
I put my profit into weed stocks.
Thank you ONTY.
I just saw that the State of Wisconsin
Pic up 1.5ml shares a new holding for them at 1st of yr so without any DD on my part , they did theres and its worth the research thou there up 50% and could lock in gains anytime
I haven't hear read anything new ,the after hours bid and sell are all over the place. Ihub never has the same as Ameritrade. Right now Ameritrade has the bid at 2.10 and ask at 2.27 seems to be more in line with the pps. I've noticed this on a daily basis. Though that would be nice Lol.........
Any info on...
NCT01252628, NCT01556789, NCT01204099, NCT01259869
Thanks :)
... why's the ask $7.00?? Lol
I am hoping that this is not just another pump and dump. Seems to be a lot of info coming. Love to see an acquisition with Merck this would really take off.
In @ 2.15... alot of FDA updates coming soon (hoping)
So is ONTY gonna make me some coin this year?
What is with the sudden decline, I haven't heard of anything substantial.
Q3 earnings transcript
http://www.earningsimpact.com/Transcript/84414/ONTY/Q3-2013-Earnings-Call
8:05AM Oncothyreon presents ONT-10 data, has been well-tolerated (ONTY) 1.87 : Co announces the presentation of preliminary results from an ongoing Phase 1 trial of ONT-10, a therapeutic vaccine targeting the tumor-associated antigen MUC1, at the Annual Meeting of the Society for Immunotherapy of Cancer. The trial is a first-in-man dose escalation trial in patients with advanced, previously treated malignancies of types associated with the expression of MUC1. To date, 19 patients have entered the maintenance protocol. ONT-10 has been well-tolerated in this trial, with no treatment-related serious adverse events.
:02AM Oncothyreon Announces presentation of final results from phase 1 Trial of ONT-380; ONT-380 demonstrated an acceptable safety profile (ONTY) 2.05 : Co announced the presentation of final results from the first Phase 1 trial of ONT-380 at the American Association for Cancer Research Special Conference on Advances in Breast Cancer Research in San Diego.
The results were presented by Virginia F. Borges, M.D., Associate Professor in the Division of Medical Oncology, University of Colorado School of Medicine. ONT-380 (also known as ARRY-380) is an orally active, reversible and selective small-molecule HER2 inhibitor being developed by Oncothyreon in collaboration with Array BioPharma Inc. (Nasdaq: ARRY), Boulder, Colorado.
The first-in-human Phase 1 trial, with both dose-escalation and expansion components, enrolled a total of 50 patients, 43 of whom had HER2+ metastatic breast cancer. In this study, ONT-380 demonstrated an acceptable safety profile; treatment-related adverse events were primarily Grade 1. Because ONT-380 is selective for HER2 and does not inhibit EGFR, there was a low incidence and severity of treatment-related diarrhea, rash and fatigue, side effects which have been associated with EGFR inhibition.
A single patient experienced Grade 2 treatment-related diarrhea and no patient developed treatment-related Grade 3 diarrhea; one patient had a Grade 3 rash. Additionally, there were no treatment-related cardiac events or Grade 4 treatment-related adverse events reported. The maximum tolerated dose of ONT-380 established in this Phase 1 trial was 600 mg twice daily. The dose-limiting toxicity was reversible elevation in liver enzymes.
merck takeover rumors....
6:01AM Oncothyreon announces Merck Serono, unit of Merck KGaA (MKGAY.PK), decision to continue the development of tecemotide in stage III non-small cell lung cancer (ONTY) 1.80 : Co announced that Merck Serono, the biopharmaceutical division of Merck KGaA (MKGAY.PK), has decided to continue clinical development of the investigational MUC1 antigen-specific cancer immunotherapy tecemotide (also known as L-BLP25 and formerly known as Stimuvax). Merck Serono, which is developing tecemotide under a license agreement with Oncothyreon, will conduct a new Phase 3 trial called START2 for patients with unresectable, locally advanced Stage III non-small cell lung cancer (NSCLC). This decision is based on the outcome of the prior START trial. While the START trial did not meet the primary endpoint of improving overall survival (OS) in the overall patient population, data from an exploratory analysis of a predefined subgroup of patients, who received tecemotide after concurrent chemoradiotherapy (CRT), showed that these patients achieved a median OS of 30.8 months versus 20.6 months in patients treated with placebo (n=806; HR: 0.78; 95% CI 0.64-0.95; p=0.016). Concurrent CRT is a combination of chemotherapy and radiotherapy given at the same time.
ONTY MERK NEWS
You might own ONTY for all the wrong reasons! Incase you missed this!
You Might Own Oncothyreon For all the Wrong Reasons
Jake King
August 22, 2013
A recently announced collaboration with Array BioPharma (ARRY) on a small molecule HER2 inhibitor may be the best thing to happen to Oncothyreon (ONTY) since the company reincorporated in the U.S. six years ago.. Oncothyreon plans to begin Phase Ib clinical testing of ONT-380 (formerly ARRY-380), a selective inhibitor of the HER2 tyrosine kinase receptor, by the end of this year, although details of the program have yet to be revealed. HER2 is a well-understood oncology pathway, and HER2 inhibiting therapeutics like Roche’s monoclonal antibody Herceptin (trastuzumab) have been wildly successful. But small molecule tyrosine kinase inhibitors, like Tykerb (lapatinib), haven’t seen the same level of success due in-part to toxicity issues and less robust efficacy. Neratinib, in development at Puma Biotechnology (PBYI), has meanwhile rekindled an interest in HER2-inhibiting small molecules, although it and Tykerb are dual inhibitors of HER1 (EGFR) and HER2. Inhibition of HER1 has been linked to dose-limiting side effects, thus there’s reason to believe that selectively targeting HER2 without hitting EGFR, like ONT-380, may allow higher dosing and thus efficacy in both standalone and combination regimens.
At a $97M market capitalization with $69.6M in cash, the markets aren’t allotting much value to the pipeline at ONTY, and rightly so – a history of cash burn, developmental disappointments (most recently the Phase III failure of Stimuvax) and now a subgroup analysis of the failed trial have soured investors on the name. Nevertheless, -380 could be a compelling asset, and perhaps the most realistic candidate in ONTY’s pipeline.
ONT-380
On May 30, Oncothyreon and Array BioPharma announced a development and commercialization collaboration for ARRY-380, an orally active, reversible and selective small molecule HER2 inhibitor. ONTY paid $10M upfront and will fund and conduct proof-of-concept trials in breast cancer before the two conduct jointly a Phase III program. Array and Oncothyreon will co-promote -380 in the U.S. (splitting expenses and profits), while ONTY receives royalties approximating 50% of profits ex-U.S., where Array commercializes alone. The deal was funded almost entirely by the sale of 5M shares of common stock and 5M warrants to Biotechnology Value Fund for $9.8M in net proceeds.
HER2 is one of four receptors in the ErbB family of plasma membrane-bound receptor tyrosine kinases, which includes ErbB1/HER1/EGFR, ErbB2/HER2, ErbB3/HER3, and ErbB4/HER4. Two of these signaling pathways, HER1 (or EGFR) and HER2, are commonly involved in the development of some cancers; over-expression of these genes plays a key role in the pathogenesis and progression of certain cancers. About 20% of breast cancers for instance, are HER2-positive, overexpressing HER2 due to a mutation in the ErbB2 gene. HER2-positive breast cancers are significantly more aggressive than HER2-negative and are generally associated with increased disease recurrence and a poor prognosis.
That’s why Roche’s HER2-targeting therapeutics like the monoclonal antibodies Herceptin and Perjeta (prestuzumab), and the antibody-drug conjugate Kadcyla (ado-trastuzumab emtansine), are on track to collectively generate more than $6B in revenue this year.
That’s also why shares of Puma Biotech (PBYI), which develops the small molecule TK inhibitor neratinib, have climbed from $10 to $50 in just over a year of public listing – PBYI, with neratinib as its sole asset, is valued at over $1.4 billion.
When HER2 was initially being explored, inhibition of HER2 and EGFR was desired given the mentality that two is better than one, with the belief that dual inhibition would be able to address potential resistances down the line. But inhibiting both EGFR and HER2 with TKIs increases toxicity significantly. That’s what makes ONT-380 an interesting asset. The small molecule is selective of HER2, with limited EGFR activity. Dual characteristics of being both a small molecule (oral availability) and the only HER2-selective asset in development allow for a meaningful differentiation between ONT-380 and other competing drugs like Neratinib and the approved Tykerb (lapatinib), demonstrated by a thus-far extremely mild side effect profile, which could open the door to a multitude of combination therapies. In addition, there’s the possibility of addressing brain metastases in HER2+ breast or solid tumors; pre-clinical testing demonstrated that -380 passes through the blood-brain barrier, which MABs are unable to do.
In 2008, Array BioPharma (ARRY) initiated its first study of ARRY-380 in order to explore its potential in patients with advanced HER2+ solid malignancies. Designed as a two-part study (Parts 1 & 2), Array split up its total enrollment of 50 patients into groups of 30 and 20 in order to first establish ARRY-380’s safety profile and maximum tolerated dose, which would then be used in the second leg of the study to examine the drug’s efficacy and PK profile.
Phase I data for ARRY/ONT-380 from the aforementioned dose escalation has been completed in 50 patients, 43 with HER2+ metastatic breast cancer and 7 with solid malignancies. These patients failed to benefit from prior treatment regimens, with 100% progressing on Herceptin and 80% progressing on Tykerb. Study data pointed towards an unusually mild side effect profile, with adverse events primarily being Grade 1. ONT-380’s selectivity of HER2 is believed to be the reason for the low incidence and severity of common EGFR-inhibition-related adverse events such as diarrhea, rash and fatigue. Phase 1 treatment resulted in no cardiac events or Grade 4 AEs. Despite the heavily pretreated patient population (failed to benefit from herceptin/tykerb), out of the 22 HER2+ breast cancer patients with measurable disease treated at maximum dosage (600mg BID), three patients demonstrated a partial response, with an additional three patients demonstrating stable disease for at least 6 months — elminating stable disease responders, Phase I data points to a response rate of 13.6%. Note that lapatinib as a monotherapy generated a 4.3% response rate in a prior Phase II trial, and neratinib as a monotherapy did 29% in a prior Phase II study, although patient pre-treatment varied between trials.
There’s certainly some evidence of clinical activity in HER2+ cancers, which we find compelling given the large addressable population, differentiated selectivity, and possibility for combination regimens. Oncothyreon is guiding for initiation of a Phase Ib program before the end of 2013 in HER2 malignancies, with top-line data later in 2014. It remains to be seen how these trials will be structured, but -380 is a compelling addition to a thus-far disappointing pipeline. Tykerb, the only approved small molecule HER2-inhibitor, did $360M in sales last year.
The Rest of the Pipeline
Biotech investors will be well-aware of the spectacular trouncing ONTY took in December of last year when the START trial, a Phase III study of the cancer vaccine Stimuvax in NSCLC, failed to reach its primary endpoint. But in mid-May, Oncothyreon and partner Merck KGaA revealed that a subgroup of patients (n= 806) who received concurrent chemoradiotherapy (CRT, chemotherapy and radiotherapy given at the same time, as opposed to sequentially) before administration of Stimuvax demonstrated a statistically significant improvement in overall survival compared to placebo. In the study’s primary population (n=1,239), median OS was 25.6 months for patients in the L-BLP25 group compared with 22.3 months for those in the placebo group (adjusted HR 0.88, 95% CI 0.75-1.03, p=0.123). In the subgroup of patients receiving initial concurrent CRT (n=806), patients receiving L-BLP25 had a median OS of 30.8 months compared to a median OS of 20.6 months in patients receiving placebo (HR 0.78; 95% CI 0.64-0.95; p=0.016).
While the subgroup analysis was pre-defined, consisted of a large patient population, and the benefit statistically significant, subgroup analyses are a slippery slope. It’s unclear how many subgroup analyses were planned (is this 1 of 100 that happened to hit?), and licensee Merck KgaA, which has sole control of the asset, has yet to rationalize the survival benefit in lung cancer patients receiving concurrent chemo-radiation. To top it all off, the new class of anti- PD-1 and PDL-1 immunotherapies in development at Roche (RHHBY), Merck (MRK), and Bristol Myers (BMY) may make Stimuvax obsolete before it even hits the market if Merck KgaA runs another large Phase III trial in patients receiving concurrent chemoradiation.
Merck KgaA still hasn’t made clear whether development of Stimuvax will continue, or in what form, but Oncothyreon believes a decision will be made this Fall following discussions with regulators. Merck may simply return the asset to Oncothyreon, in which case we would expect ONTY to move the follow-on vaccine ONT-10 further through the clinic instead, as management expects a similar and improved profile in patients receiving initial concurrent chemoradiation. The company is guiding for preliminary results from a 78-patient trial of ONT-10 in solid tumors in early November at the annual meeting of the Society for Immunotherapy of Cancer.
Finally, Oncothyreon develops PX-866, an inhibitor of the phosphatidylinositol-3-kinase (PI-3K). This is a crowded space and -866 hasn’t impressed anyone so far. Most recently, Oncothyreon buried the news that a Phase I/II trial of PX-866 in combination with cetuximab did not meet its primary or secondary endpoints in patients with metastatic colorectal cancer. It seems Oncothyreon has largely given up on the asset as well – the company omitted entirely discussion of the five ongoing trials in six cancer indications from its latest investor presentation, although management mentioned Phase II data for the compound in squamous-cell carcinoma in head and neck cancers will be announced before year-end.
Would we rush out and buy ONTY based on ONT-380? Not yet, but it’s worth keeping an eye on as the next steps for Stimuvax play out and -380 moves into proof-of-concept trials, likely in CNS metastatic breast and 2nd or 3rd line metastatic HER2 cancers. It’s worth noting that in the second quarter, a number of funds took new positions in the small company, which could be attributed to the -380 licensing: First Manhattan initiated a 1.9 million-share position, Millenium now owns 2.1 million shares, and First Eagle upped its position from 200K to 1.2M shares. Oncothyreon has made clear that -380 is a focus (investor presentations have all centered on the asset since licensing), and given the poor track record of cancer vaccines – see Vical (VICL) and even Dendreon (DNDN) – not to mention the red flags raised by sub-group analyses, seeing a new asset at Oncothyreon should be encouraging for those still underwater following the Stimuvax failure.
figs not better than expected but maybe we get more Info about gamechangers ONT-380 and L-BLP25 at next weeks wedbush conference
http://www.4-traders.com/ONCOTHYREON-INC-USA-430914/news/Oncothyreon-Inc-USA-Oncothyreon-to-Present-at-Wedbush-Securities-Life-Sciences-Management-Access-17168208/
from yesterdays conference call:
Julie M. Eastland
Thank you, Stephanie. As reported in our press release this afternoon, loss from operations increased in the second quarter of 2013 to $18 million from $8.1 million in the second quarter of 2012 and to $26 million for the 6 months ending June 30, 2013, compared with $13.8 million for the comparable period in 2012. The increase in loss from operations for the 3 and 6 months ended June 30, 2013, compared to prior-year period was primarily due to an upfront payment of $10 million to Array BioPharma in connection with the initiation of Oncothyreon's collaboration with Array. This was announced on May 30, 2013.
In addition, the increase in loss from operations for the 6 months ended June 30, 2013, was also the result of increased development activity for Oncothyreon's product candidates and increased general and administrative expenses.
The net loss for the 3 months ended June 30, 2013, was $16.4 million, or $0.28 loss per basic and diluted share, compared with the net loss of $8.7 million, or $0.15 loss per basic and diluted share, for the comparable period in 2012. Oncothyreon reported a net loss of $24.7 million or $0.43 loss per basic and diluted share for the 6 months ended June 30, 2013, compared with a net income of $1 million or $0.02 earnings per basic share and $0.28 loss per diluted share for the comparable period in 2012. The increase in net loss for the 3 months ended June 30, 2013, compared to the prior-year period was primarily attributable to the upfront payment of $10 million to Array and partially offset by $1.6 million of noncash income as a result of the change in the fair value of the warrant liability for the 3 months ended June 30, 2013, compared to a $0.3 million in noncash expense as a result of the change in fair value of warrant liability for the 3 months ended June 30, 2012.
The increase in net loss for the 6 months ended June 30, 2013, compared to the prior-year period net income was primarily attributable to the upfront payment of $10 million to Array and a $1.3 million in noncash income as a result in the change of the fair value of the warrant liability for the 6 months ended June 30, 2013, as compared to $15.3 million of noncash income as a result of the change in fair value of the warrant liability for the 6 months ended June 30, 2012.
In addition, the increase in net loss for the 6 months ended June 30, 2013, was also the result of increased development activity for Oncothyreon's product candidates and increased general and administrative expenses.
As of June 30, 2013, Oncothyreon's cash, cash equivalents and investments were $69.6 million compared to $83.8 million at December 31, 2012, a decrease of $14.2 million or 16.9%. The decrease was primarily attributable to $23.9 million cash used in operations during the 6 months ended June 30, 2013. This decrease was offset in part by net proceeds of approximately $9.9 million from the closing of a June registered direct offering of 5 million shares of Oncothyreon common stock and warrants to purchase 5 million shares of stock.
Before I turn the call over to Bob, I'd like to provide financial guidance for 2013. Please note that we believe this guidance to be correct as of today, but that circumstances may change, and we assume no obligation to update this guidance.
Exclusive of the one-time upfront payment to Array, Oncothyreon currently expects expenses in 2013 to be similar to 2012 and cash used in operations in 2013 to be approximately $29 million to $31 million. As a result, Oncothyreon estimates that its existing cash, cash equivalents and investments will be sufficient to fund operations for at least the next 12 months.
And this concludes the financial update. Let me now turn the presentation over to Oncothyreon's President and CEO, Bob Kirkman. Bob?
Robert L. Kirkman
Thanks, Julie, and thanks for joining our conference call today. As we seek to build value for our shareholders in Oncothyreon, we think the second quarter of 2013 has been especially important. In particular, I would today like to focus your attention on 2 events that we believe will shape our future: the collaboration we announced with Array BioPharma for an exciting new addition to our pipeline; and the data presentation at the American Society of Clinical Oncology for L-BLP25, formerly known as Stimuvax.
Let me begin with the Array collaboration. The subject of the collaboration as a small molecule inhibitor of HER2 discovered at Array, which they named ARRY-380, and which we now call ONT-380. HER2 is one of the most highly validated targets in oncology. It is a receptor tyrosine kinase that is overexpressed in breast cancer and other cancers, including gastric and ovarian cancer. Approved agents directed at HER2 include trastuzumab or tuzumab, T-DM1 and lapatinib. Despite these agents and their value in treating HER2-expressing cancers, especially breast cancer, we believe there remain significant unmet medical needs, which ONT-380 can potentially address. These unmet needs include improved tolerability, the treatment of metastatic disease in the central nervous system and the development of resistance to the existing agents. In addressing these unmet needs, ONT-380 has 2 characteristics that are particularly attractive. First, ONT-380 is very specific for HER2. To our knowledge, ONT-380 is the only clinical stage small molecule targeting HER2 which does not also target the EGFR receptor.
Targeting the EGFR receptor is not thought to contribute to efficacy in treating breast cancer, but it does lead to significant toxicity, particularly debilitating diarrhea and rash. If you could achieve the efficacy associated with targeting HER2 without the toxicity associated with hitting the EGFR receptor, that might significantly improve tolerability. It might also lead to improved efficacy by allowing for more intensive or prolonged dosing.
Secondly, preclinical data for ONT-380 suggest that it may be active in treating metastatic disease to the brain. ONT-380 crosses the blood brain barrier unlike antibodies. Moreover, in an intracranial HER2-positive breast cancer xenograft model, ONT-380 has demonstrated superior activity based on overall survival compared to both lapatinib and to the investigational drug, neratinib. Metastases[ph] to the brain eventually occurs in about 1/3 of all breast cancer patients with metastatic disease and is an unsolved problem with current agents.
Array previously completed a Phase I clinical trial of ARRY-380 in patients with heavily pretreated metastatic breast cancer, which demonstrated that the compound was well-tolerated and had anti-tumor activity. In this trial, treatment-related adverse events were primarily Grade 1 and there was a low incident in severity of treatment-related diarrhea and rash, consistent with the specificity of 380 for HER2 and not EGFR.
In this heavily pretreated patient population, there was a clinical benefit rate, defined as partial response plus stable disease for at least 6 months of 27%. Notably, 2 of the patients with partial responses during treatment with ONT-380 had confirmed progressions while on prior lapatinib and trastuzumab-containing regimens.
Under our collaboration agreement with Array, we are responsible for conducting an agreed set of trials through Phase II proof-of-concept. We intend to focus our development on both the treatment of CNS metastatic disease and more broadly on second or third line metastatic disease. We haven't yet made public the design of these trials, but we will be beginning with the set of Phase Ib trials to demonstrate that we can combine ONT-380 with other agents used in both of these settings. We expect these trials to start by the end of the year. We're working very hard to make this happen and are excited by this addition to our pipeline.
Let me now turn to L-BLP25. In doing so, I want to review certain aspects of the data from the L-BLP25 start trial that were presented at the American Society of Clinical Oncology Annual Meeting in early June. My goal in doing so is not only to consider the possible future of L-BLP25, but also to discuss the implications for our follow-on vaccine, ONT-10.
I suspect everyone listening to this call knows that the start trial was a randomized Phase III trial in patients with unresectable, locally advanced Stage III Non Small Cell Lung Cancer, conducted by Merck Serono, under a licensed agreement with Oncothyreon and that the primary endpoint of improving overall survival with L-BLP25 compared to placebo was not met. What was new with ASCO was the public presentation of the subgroup analysis from the start trial. This analysis demonstrated that in a pre-defined subgroup of patients receiving initial concurrent chemoradiotherapy, the median overall survival was 30.8 months in the L-BLP25 group versus 20.6 months in the placebo group, a clinically relevant improvement of over 10 months and with a hazard ratio of 0.78.
I recognize that when a BioPharma CEO starts talking about a subgroup analysis of a trial that didn't meet its endpoint, there is usually a lot of skepticism. I understand this. But in evaluating these data, I would ask you to consider these points. First, this was a predefined group based on one of the randomization strata for this trial. This means that the randomization of the subgroup should be valid. It's always possible that there are some relevant factor which is not equally distributed between the groups, but at present, one has not been identified.
Secondly, the group was very large. There were 806 patients on this subgroup, which represents about 2/3 of all the patients in the trial. As the investigator pointed out in presenting these data at ASCO, this makes the subgroup analysis alone larger than any other trial ever conducted in Stage III lung cancer.
And third, the result was statistically significant, with a p-value of 0.016. Of course, none of these point to guarantee that the result can be replicated in another trial, but we think there is a compelling reason to conduct such a trial focused on this group of patients. We also believe that the results strongly suggest that MUC1 is a valid vaccine target. At present, we do not yet know if our partner for L-BLP25, Merck Serono, will proceed with additional trials. We do know that they are in the process of discussing the data with regulatory authorities and key opinion leaders to make the determination. We also know that other trials of L-BLP25 are continuing. The INSPIRE trial of Phase III trial in Asia, similar in design to START, has been modified to only include patients receiving concurrent chemoradiotherapy and is ongoing.
A Phase II trial in Japan is now completely enrolled with about 170 patients, almost all of whom receive concurrent chemoradiotherapy. That trial should read out late next year. Several investigator-sponsored trials in indications other than the lung cancer, including colon, prostate and breast cancer, are also continuing. We think it likely that Merck Serono will reach a decision about next steps sometime this fall.
In the meantime, we believe the START trial data provide strong validation of MUC1 as a vaccine target and that they support the ongoing development of ONT-10, our fully owned follow-on vaccine directed against the same target. We believe that ONT-10 has the potential to be a more potent vaccine. Based on our presented preclinical data, ONT-10 induces a MUC1-specific antibody response not seen with the L-BLP25. It also contains a novel adjuvant, our proprietary fully synthetic TLR4 antagonist, which is more potent than the adjuvant contained in L-BLP25 based on in-vitro assays.
Our Phase I dose escalation study of ONT-10 is ongoing in patients with tumor types that expressed MUC1. We've essentially completed enrollment on our originally planned dose escalation portion of this trial. Based on the absence of any safety issue so far, we are likely to expand this trial to explore some additional and higher doses. We've submitted an abstract about this trial to the Society for the Immunotherapy of Cancer meeting, which is in early November in Baltimore. Assuming acceptance of the abstract, we would expect to share data from this trial with you at that time.
As we look forward to the rest of the year, we will have a number of upcoming milestones. We expect to begin our initial trials of ONT-380, our exciting new pipeline compound directed at HER2. We expect our partner to announce its plans for L-BLP25. We expect to have the first clinical data for our follow-on vaccine, ONT-10. And although we didn't focus on it today, our 2 randomized trials of PX-866 for Squamous Cell Head and Neck are expected to read out by the end of the year.
Julie and I look forward to sharing our progress with you. Julie will be presenting at the Wedbush Securities Life Sciences Management Access Conference in New York next Tuesday. And both of us will be at the Rodman & Renshaw Global Investment Conference in New York, and the Stifel Healthcare Conference in Boston, the second week of September. We hope to see many of you at these events. As always, we're grateful for the support of our shareholders.
And this concludes my comments for today. Operator, we'd be now be happy to take questions.
Question-and-Answer Session
Operator
[Operator Instructions] Our first question comes from the line of Simos Simeonidis from Cowen.
Simos Simeonidis - Cowen and Company, LLC, Research Division
Bob, I had a question on, what happens in the scenario where Merck decides not to do additional trials? Do you get the rights to Stimuvax back? If that happens, do you have to pay anything? And when do they have to make that decision by?
Robert L. Kirkman
Well, it depends what they do with their other ongoing trials. As long as they are actively developing the drug with other trials, no, they would be under no obligation to return it to us. Should they stop all development and discontinue their existing trials, then yes, we do believe they would return the rights to us. There is a negotiation that would need to take place if we wanted to use the data that they've accumulated to-date and that negotiation would have to happen. But beyond that, we just have to wait for them to make up their mind what they're going to do.
Simos Simeonidis - Cowen and Company, LLC, Research Division
Okay. And then based on the timelines you've given us for the Array-Oncothyreon collaboration compound, when do you think we might see the first data from that program?
Robert L. Kirkman
Well, as I mentioned, we're going to be conducting a series of Phase Ib trials first to show that we can successfully combine 380 with other agents. I would anticipate having data from those trial sometime in the second part of 2014.
Simos Simeonidis - Cowen and Company, LLC, Research Division
Second half of '14. Okay. Great.
Operator
Our next question comes from the line of Joel Sendek from Stifel.
Joel D. Sendek - Stifel, Nicolaus & Co., Inc., Research Division
So I want to follow on from Simos' question, I guess. So it's Phase Ib data, I'm wondering what that will set you up for after you get that, just because and the reason why I'm asking that, I just want to know if you'll go into a -- if the next step will be to prioritize the brain met potential, or would you just kind of go down the broader path similar to how Puma is developing neratinib?
Robert L. Kirkman
Well, if I have to answer the question today, the answer is yes and yes. Now we think that the characteristics of 380 are particularly attractive, with respect to the treatment of CNS disease. And obviously, if we could successfully demonstrate that 380 could do that, that's a relatively straightforward path to market and something we could hopefully do relatively quickly. On the other hand, we don't think that takes advantage of all of the characteristics of the molecule, in particular, its tolerability profile. And so we also think we should be looking at the treatment of metastatic disease. So the answer is, in broad terms, we're planning to do both. The details will become clear a little bit later on. We've not made public the precise details of the trials we are planning yet.
Joel D. Sendek - Stifel, Nicolaus & Co., Inc., Research Division
Okay. And then if we go maybe to today as far as predicting the future, I'm wondering if -- I'm getting a lot of questions about how does the data we have so far in 380 compare to neratinib at the similar stage of development. Do you have any comments or any way we can get our hands around that question?
Robert L. Kirkman
Well, I think you have to compare the use of the 2 drugs as single agents, and there's a published data for neratinib in that setting and we've just reviewed the data for 380. I think from a clinical benefit rate perspective, the drugs are basically in the same ballpark. It's always difficult in Phase I for us because you'll never know that each trial has precisely the same kind of patients. But to the extent that both of those trials included heavily pretreated patients, the results are pretty similar. It's on the safety side where the differences become much more stark, where there is a fairly high incidence of Grade 3 diarrhea with neratinib we just don't see with 380. And we think that, that will prove to be a fairly key differentiating factor.
Operator
Our next question comes from the line of Adeyemi Ogunkoya from Cantor Fitzgerald.
Adeyemi Ogunkoya - Cantor Fitzgerald & Co., Research Division
I was wondering at this point, can you guys provide more color on why the patients with concurrent chemoradiation therapy did better? And whether or not this would apply to enrollment in the ONT-10 studies?
Robert L. Kirkman
Sure. I mean, the answer is we don't know for sure why the vaccine appeared to work better in this patient population. There are 2, so, explanations that makes the most sense. One is simply that concurrent chemoradiation therapy does a better job of controlling the primary disease in these patients and therefore, gives the chance -- the vaccine the chance to work on the micro metastatic disease and/or circulating tumor cells. I think that makes a lot of sense. We know from multiple prior studies that looked at concurrent versus sequential treatment that primary disease controls better when you give concurrent chemotherapy. I think the second potential explanation is a little more complex and really relates to the timing of the initiation of the vaccine to the conclusion of the chemotherapy that's much closer together in the concurrent and it may be simply that the vaccine is seeing a different set of immune cells at that time, and in particular, maybe acceptance to absence of certain regulatory cells. I have to confess, there's a certain amount of hand waving in that explanation in that we don't have the data to support it. Because frankly, those cell populations weren't collected in a way that lets us look at them. So we honestly don't know. Would these results carry over to ONT-10? We think the answer to that question is probably yes. But if you want to treat patients in this kind of maintenance setting with a vaccine, you'd be much better off doing that in a setting where you have better primary disease control.
Operator
Our next question comes from the line of Charles Duncan from Piper Jaffray.
Unknown Analyst
This is Roy, in for Charles. Bob, I believe there's differences in the MUC1 antigen between ONT-10 and the old Stimuvax, can you describe those in a little detail? Remind us.
Robert L. Kirkman
Sure. The antigen in ONT-10 is a little bit bigger. So it contains 2 of the 25 -- of the 20 amino acids, 10, I'm going to repeat [ph] that are -- that make up the extra cellular portion of the MUC1 protein, whereas Stimuvax has 1. The other difference is that the antigen is quite populated. It has some short-circuit chains added in ONT-10, which are not present in the L-BLP25 antigen, in which we think those sugars may contribute to the preclinical data, which shows that we had a strong antivirus response. That's the data we'll be looking forward to sharing with you from our clinical patients later this fall, when we present the Phase I data from ONT-10.
Operator
Thank you. This does conclude the question-and-answer session. I'd like to turn the program back to Dr. Kirkman for closing remarks.
Robert L. Kirkman
Well, thank you very much for joining us on this absolutely beautiful summer afternoon in Seattle. We appreciate your attention, and we appreciate your support of Oncothyreon, and we look forward to our meeting with many of you this fall as we share the milestones we've described today. Thank you very much.
tmrw more News additionally to Figs&Fins to be expected!
CEO Kirkman´s last Conference from 5th of June was promising:
...PX-866 to point out that we are still conducting Phase II trials with this product and that the two randomized trials in squamous cell carcinoma of head and neck are expected to readout close to the end of this year. So, there is a lot going on.
Our pipeline remains quite full. And let me turn the floor upto talking a little bit about our most recent transaction with. So I think this is just an overview on those slide and positive on breast cancer. This is probably a pretty familiar territory with most of you. We all know that this is a highly validated target in breast cancer. It's treated both with multiple antibody approaches and with small molecule approaches of which have relatively modest single agent activities but works quite well in combination.
...ARRAY 380 has demonstrated significantly improved activity compared to other HER2 targeting small molecule and getting into the brain and in treating metastatic disease in that area. So here is just some of the I am going to show you three preclinical data slides, I am going to show you the clinical data data that we have with us and then I will describe the collaboration that we put in place last week. So what you can see on this slide are the IC50 data for ARRAY380, for neratinib and for the approved agent Apatinib and you can see that we've very potent HER2 inhibitor essentially equivalent to neratinib but we don't inhibit EGFR at all. There is about 500 full difference we believe in the potential side effect profile for this compound.
...Once we get done with the proof-of-concept studies then it's a joint development program thereafter in which we're going to share costs, that cost there is a mechanism for us to recoup the money we put at risk in this program through asymmetric cost sharing in Phase 3 and later on in sharing profits. ARRAY does have overall responsibility for commercialization. Oncothyreon has a 50% co-promote right in the U.S and we have the 50-50 profit share in the U.S. Outside of the U.S we have structured this as a very significant royalty that's designed to be the economic equivalent of the 50-50 sharing that's easier from a lot of perspectives to manage particularly if we end up with the marketing partners.
...And I would love to give you a definitive answer to that question. My partner for this product Merck Serono is in the process of discussing these data with regulatory authorities both in the U.S and Europe meeting with a lot of key opinion leaders. Lot of that happens this at ASCO and making a determination about what they are going to do next, if anything.
They are continuing all of the other trials with this product. So there is another Phase III trial in Asia called the INSPIRE trial that's being modified to only include concurrent chemoradiation. There is a completely enrolled Phase II trial in Japan which has about 170 patients there almost all of them hadconcurrent chemoradiation that probably will read out some time late next year or early the following year.
...I believe that before that my partner will have made their decision about what they are going to do to go forward I do think that this data provides strong validation of the validity of more quality target for intervention with the therapeutic vaccine non-small cell lung cancer and in that regard again that Oncothyreon has wholly owned the follow on vaccine to.
It's something we call ONT-10 talk about this previously. This is also vaccine, targeted vaccine, it has a somewhat different, it's a little bit bigger, it's quite, it has proprietary adjuvant. LBLP25 uses MPL from the adjuvant and is proprietary to us and is a fully synthetic for agonist which we think as a number of advantages and mile systems that we've presented to you before we know that in comparison to LBLP25 we see -- to antibody response to ONT-10 which is not a problematic part of the immune response to LBLP25.
..We think the LBLP25 data that was presented yesterday at ASCO do validate MUC1 as a target and for intervention with the therapeutic vaccine with our highly clinically relevant and statistically significant survival advantage in a very large group of patients. We are waiting for Merck Serono to announce the next step and I can't give you a definitive timing on that today. In the meantime, we are moving ahead as rapidly as we can with the follow on vaccine, ONT-10 , which is in terms of its adjuvant and its improved mechanism.
We will have additional data for our PI-3 kinase inhibitor late this year and have lung cancer which is our preclinical data showed the best results. We are adequately and well funded at the moment but we reported cash of just under $77 million at the end of Q1. We gave guidance for this year that we're going to spend about 30 million, $30 million to $33 million. We are on track for that in the first quarter and with the collaboration we announced with ARRAY for this for ARRAY380 requires us to change that guidance for the current year.
...Oncothyreon licensed a small molecule candidate, ARRY-380, from Array BioPharma Inc., which allows the company to redirect the resources originally intended for the PI3K inhibitor program to ARRY-380, an orally active, reversible and selective small-molecule HER2 inhibitor, for the treatment of HER2-positive breast cancer.
Oncothyreon is a less straightforward story. Its valuation is particularly inexpensive with a $105M market cap, and that's what keeps us interested.
very informative BIOTECH Interview with Cantor Fitzgerald´s Mara Goldstein:
http://seekingalpha.com/article/1600852-6-oncology-focused-biotech-growth-engines-mara-goldstein?source=marketwatch
form4 out, ~365.000shares @1.70-1.77
SEATTLE, May 30, 2013 /PRNewswire/ - Oncothyreon Inc. (NASDAQ: ONTY) today announced that it has agreed to sell 5,000,000 shares of its common stock and warrants to purchase 5,000,000 shares of common stock for gross proceeds of approximately $10 million. The common stock and warrants are being sold in units, with each unit consisting of one share of common stock and a warrant to purchase one share of common stock at an exercise price of $5.00 per share. Each unit is being sold at a price of $2.00. The warrants will be exercisable at any time on or after the six-month and one-day anniversary of the issuance date of the warrants and until the fifth anniversary of the date the warrants first became exercisable.
The shares were offered and are being sold to Biotechnology Value Fund, L.P. and other affiliates of BVF Partners L.P. in a registered direct offering conducted without an underwriter or placement agent. The net proceeds from the offering, after deducting estimated offering expenses, will be approximately $9.8 million. The offering is expected to close on or about June 4, 2013.
Oncothyreon intends to use the net proceeds of the offering to fund a portion of the $10 million upfront fee payable under its development and commercialization agreement with Array BioPharma Inc. and for general corporate purposes, including research and product development, such as funding pre-clinical studies and clinical trials and otherwise moving product candidates towards commercialization and the possible acquisition or licensing of new product candidates or technology.
great sign! no one wants to sell at 1.77! I think we continue higher today even though the market might be red overall... I hope we break past the $2 mark
Good accumulation in the last two days... Are we going to break $2????
yes, anything goes, closing the big gap on good figs and fins? btw mxwl is today!
Oncothyreon Announces Second Quarter 2013 Financial Results Conference Call
8:00 AM ET 7/30/13 | PR Newswire
Oncothyreon Inc. (Nasdaq: ONTY) today announced that it will conduct a conference call on Tuesday, August 6, 2013 at 4:30 p.m. Eastern Time (1:30 p.m. Pacific) to discuss its second quarter 2013 financial results and provide a review of its pipeline of products in development.
To participate in the call by telephone, please dial (877) 280-7291 (United States) or (707) 287-9361 (International). In addition, the call will be webcast live and can be accessed on the "Events" page of the "News & Events" section of Oncothyreon's website at www.oncothyreon.com. An archive of the webcast will be available after completion of the discussion and will be posted on the Oncothyreon website.
About Oncothyreon
Oncothyreon is a biotechnology company specializing in the development of innovative therapeutic products for the treatment of cancer. Oncothyreon's goal is to develop and commercialize novel synthetic vaccines and targeted small molecules that have the potential to improve the lives and outcomes of cancer patients. For more information, visit www.oncothyreon.com.
SOURCE Oncothyreon Inc.
http://rt.prnewswire.com/rt.gif?NewsItemId=TO278&Transmission_Id=201307300800PR_NEWS_USPR_____TO278&DateId=20130730
Details abt LBLP-25 & ONT-10 @ Jefferies Global Healthcare Conference
read here
http://www.earningsimpact.com/Transcript/82060/ONTY/Oncothyreon-Inc---Jefferies-2013-Global-Healthcare-Conference
~ $ONTY ~ Daily Par Sar Buy Signal ~ Criteria alert triggered during a recent trading session!
$ONTY has just triggered the "Parabolic SAR Buy Signals" scan criteria at Stockcharts.com
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c
Bad clinical news on PX-866 buried in the 1Q13 PR:
http://finance.yahoo.com/news/oncothyreon-reports-first-quarter-2013-200500701.html
exactely! thats what wer waiting for
went big long here. all we need is a catalyst to bring some volume and we'll have ourselves a nice technical run back up to 4+ on the daily chart
Thanks I narrowly missed a good buy before the take off yesterday. And just missed a buy today. I may enter tomorrow. Would be nice to get into a good technical runner.
make or break in the next couple days in my opinion. right at its recent high of 2.57, if it proves to remain above that, there's no reason it cannot close that massive technical gap on the daily chart
Is ONTY overbought with RSI at 70 or does it have a chance for the filling of the gap from the past?
uhh yezz, time to get busy
now they looking even better
no breakout today, but that's alright some nice consolidation throughout the day :)
too low volume for breakout tdy but still in biz
ya the charts looking good, profit taking at the end of day yesterday broke the 2.50 support, but now shes building back up, if we can get into that nice gap territory just a little over 2.55 it'll be a fun ride imo
i made a few cents on the share today :P, do you know why its been moving these past few days, maybe positive trial results on the horizon?
BTW thank you for kind words, yeah I like biotechs - on da move GL bud!
ONTY next trial to release $2.42 so far bud!
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company web-site - http://www.oncothyreon.com
recent event / CC - http://ir.oncothyreon.com/events.cfm -
Oncothyreon is a biotechnology company dedicated to the development of oncology products that can improve the lives and outcomes of cancer patients. We are currently developing multiple therapeutic candidates designed to target cancer in specific and effective ways. Our pipeline includes both synthetic vaccines and small molecules for a variety of cancer indications. Oncothyreon is headquartered in Bellevue, Washington. The Company is traded on the NASDAQ National Market under the symbol ONTY and on the Toronto Stock Exchange under the symbol ONY. We are The Cancer Vaccine People(TM).
Stimuvax
ONTY's drug Stimuvax, in partnership with Merck KGaa, is now in large Phase 3 Pivotal Trial program for NSCLC:
Phase III NSCLC (Lung) "START" Trial - http://www.clinicaltrials.gov/ct2/show/NCT00409188
Phase III NSCLC "INSPIRE" Trial (Asia) - http://www.clinicaltrials.gov/ct2/show/NCT01015443
Phase II NSCLC w/Avastin Trial - http://www.clinicaltrials.gov/ct2/show/NCT00828009
Phase I/II NSCLC Trial in Japan - http://www.clinicaltrials.gov/ct2/show/NCT00960115
Phase IV Long-Term Safety Trial - http://www.clinicaltrials.gov/ct2/show/NCT01423760
Phase II HDPC Trial - http://bethesdatrials.cancer.gov/clinical-research/search_detail.aspx?ProtocolID=NCI-11-C-0247
Pipe-Line - http://www.oncothyreon.com/pipeline/overview.html
Remaining Pipe-Line -
ONT-10 - http://www.oncothyreon.com/pipeline/vaccines/ONT-10/overview.html
PX-866 - http://www.oncothyreon.com/pipeline/small/PX-866/overview.html
Start of Trial with Taxotere - http://ir.oncothyreon.com/releasedetail.cfm?ReleaseID=526661
Start of Trial with Erbitux - http://ir.oncothyreon.com/releasedetail.cfm?ReleaseID=537953
PRESS RELEASES
Oncothyreon Initiates Phase 2 Trial of its PI-3 Kinase Inhibitor PX-866 in Patients with Glioblastoma - http://ir.oncothyreon.com/releasedetail.cfm?ReleaseID=561867
Oncothyreon Presents Preclinical Data for ONT-10 and PX-866 at American Association for Cancer Research - http://ir.oncothyreon.com/releasedetail.cfm?ReleaseID=561521
Oncothyreon Announces Publication of Safety & Survival Data From Stimuvax Phase 1/2 NSCLC Trial - http://ir.oncothyreon.com/releasedetail.cfm?ReleaseID=515788
Oncothyreon Initiates Phase 1/2 Trial of its PI-3 Kinase Inhibitor PX-866 in Combination with Cetuximab - http://ir.oncothyreon.com/releasedetail.cfm?ReleaseID=537953
Oncothyreon announces that Merck Serono is resuming the Stimuvax clinical program in lung cancer - http://ir.oncothyreon.com/releasedetail.cfm?ReleaseID=480296
Oncothyreon announces temporary suspension of Stimuvax clinical trials - http://ir.oncothyreon.com/releasedetail.cfm?ReleaseID=453976
Oncothyreon announces STRIDE Phase 3 BC trial - June 22, 2009 http://investorshub.advfn.com/boards/read_msg.aspx?message_id=38926533
Oncothyreon announces clinical data at ASCO - May 30, 2009 - http://investorshub.advfn.com/boards/read_msg.aspx?message_id=38259984
Oncothyreon announces development plans - Dec. 18, 2008 - http://biom.client.shareholder.com/releasedetail.cfm?ReleaseID=355043
Merck KGaA buys manufacturing rights for Stimuvax - Dec. 18, 2008 - http://biom.client.shareholder.com/releasedetail.cfm?ReleaseID=355037
ONTY/Merck KGaA amend agreements - Aug 8, 2007http://www.marketwatch.com/news/story/biomira-merck-kgaa-sign-amended/story.aspx?guid=%7B43FD62A1%2D....
MEDICAL PRESENTATIONS
ASCO 2007 Stimuvax Abstract - http://www.asco.org/ASCOv2/Meetings/Abstracts?&vmview=abst_detail_view&confID=47&abstractID=32165
"16 pts were evaluated for this interim safety analysis ..........As of September 2006, 10 pts were still on study treatment."
ASCO 2008 Stimuvax Abstract - http://www.asco.org/ASCOv2/Meetings/Abstracts?&vmview=abst_detail_view&confID=55&abstractID=34755
"The 2-year survival rate of 64% ....compares favorably with previously reported survival for chemoradiation in stage III NSCLC."
ASCO 2009 Stimuvax Abstract - http://www.abstract.asco.org/AbstView_65_31704.html
"a remarkable # of pts received prolonged treatment...16 pts received L-BLP25 for 2.0-7.7 years, 10 pts were treated for >5 years."
COMPLETE MEDICAL PAPERS
Paper summarizing all Stimuvax trials to date - http://investorshub.advfn.com/boards/read_msg.aspx?message_id=39761211
Publication of Data From Phase 1/2 NSCLC Trial - http://ir.oncothyreon.com/releasedetail.cfm?ReleaseID=515788
A Peptide Vaccine Strategy in NSCLC - http://investorshub.advfn.com/boards/read_msg.aspx?message_id=39627241
Phase IIb Trial in NSCLC Stage IIIB and IV - http://investorshub.advfn.com/boards/read_msg.aspx?message_id=39099793
"The greatest difference in survival was observed in stage IIIB LR patients (adjusted HR = 0.524; 95% CI, 0.261 to 1.052; P = .069)"
- Fig 3. Overall survival by study arm - http://jco.ascopubs.org/cgi/content-nw/full/23/27/6674/F3
- Fig 4. Survival analysis for stage IIIB with MFE or stage IV patients - http://jco.ascopubs.org/cgi/content-nw/full/23/27/6674/F4
- Fig 5. Survival analysis for stage IIIB locoregional patients - http://jco.ascopubs.org/cgi/content-nw/full/23/27/6674/F5
Detailed Description of START Trial - http://investorshub.advfn.com/boards/read_msg.aspx?message_id=39062424
First Interim Look - http://investorshub.advfn.com/boards/read_msg.aspx?message_id=58060227
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