Micro cap Oncothyreon (ONTY +31.8%) jumps on a 6x surge in volume in another example of investors falling all over themselves to establish positions in companies that have submitted abstracts for presentation at the upcoming American Society of Clinical Oncology (ASCO) meeting in Chicago, May 29 - June 2. Overeager punters are buying on news of positive study results, even from early-stage trials.
In ONTY's case, the enthusiasm is in response to Abstract #602, which summarizes a Phase 1b study of ONT-380, a small molecule inhibitor of HER2, a growth factor rector that is over-expressed in cancers such as breast, ovarian and stomach. The company licensed it from Array BioPharma (ARRY -0.1%) in December.
The study assessed the safety of the triplet regimen of ONT-380 + capecitabine + trastuzumab (Roche's Herceptin) as third-line therapy in patients with HER2+ metastatic breast cancer. Eight patients received two - eight cycles of treatment. The dosing regimen was well tolerated without causing grade 3 diarrhea. Preliminary efficacy was demonstrated by four partial responders, two with stable disease and two who progressed.
Study results will be presented on the morning of May 30.
Previously: Oncothyreon secures exclusive license to HER2 inhibitor (Dec. 12, 2014)
Let's see what is said at 12 at the Merrill conference
present at the actual event......either way, according to me the real catalysts still remain Positive Phase III results & FDA approval
Hi I'm a new poster and I've owned shares since last November.I wanted to thank the main people on this board,you know who you are.Just curious if your familiar w/ ms Bonnie Anderson's company and what your thoughts are. Thank you in advance, maybe you could put your thoughts on their board
Sentiment: Strong Buy
Thanks for the reply. I have been following ARRY for 1 year now.
I went to investors tab but didnt see any abstract information. All i see is registration for the event.
Sentiment: Strong Buy
A closely watched immune system-boosting drug cocktail from Britain's AstraZeneca shows promise in advanced lung cancer, despite adverse side effects in a number of patients.
Researchers said on Wednesday that the combination of the experimental drugs MEDI4736 and tremelimumab had "a manageable safety profile with evidence of clinical activity, including in PD-L1 negative disease".
AS Burnaka said Check into the ARRY website. Click up Investors link. They have two of them now listed on the front page of Investor section. Go there tomorrow the 14th about 20 minutes or so ahead of the webcast time ... noon PacificTime it says. The one on the 19th is 8:30AM Eastern time probably will be similar information passed out.
Webcast - Live
Array BioPharma Inc. at Bank of America Merrill Lynch Healthcare Conference
05/14/15 at 12:00 p.m. PT
Webcast Image Webcast - Live
Array BioPharma Inc. at UBS Global Healthcare Conference
05/19/15 at 8:30 a.m. ET
Sentiment: Strong Buy
THESE type CC are ALWAYS under the investors relations tab for every company. UMMM, if you are new to investing, always listen to the CC, and if new, you might have hit on a good stock, but be patient.
A Single arm, non-randomized, open-label, phase I,evaluated Binimetinib in combination with G and C in pts with untreated ABC, who had advanced measurable disease, ECOG 0-1, adequate bone marrow, renal, hepatic and cardiac function. The primary endpoint was to determine the MTD. Tumor tissue for targeted gene sequencing, blood samples for peripheral blood pERK expression and cell cycle analysis were evaluated. Patients received oral Binimetinib twice daily with G and C IV infusions day 8 and 15 of a 21 days cycle in a standard 3 + 3 dose escalation scheme. Binimetinib was held for 2 days prior to and on day of each G and C infusion. Results: Between 09/13 and 08/14, 12 pts were enrolled. Male = 5, Female = 7. Median age 64 years (range 48- 76). Intrahepatic cholangiocarcinoma (IHC) = 8, gallbladder cancer = 3, 1 patient mixed IHC/Hepatocellular carcinoma. 1 pt received prior adjuvant G. Best response: 6 PR (50%), 4 SD (33%), 2 PD (17%). Median progression-free survival (PFS) was 6.4 months (95% CI 1.7 – 10.9), Median OS was 9.1 months (95% CI 1.7 – 16.1). 5 pts remain on study. See table 1 for dose limiting toxicities. Conclusions: The MTDs of Binimetinib, G and C were 45mg PO BID, 800 mg/m2 and C 20mg/m2 respectively. Encouraging activity of the combination was noted. An expansion single arm phase II trial evaluating the safety and activity of Binimetinib at this dose with C & G is underway in patients with untreated metastatic ABC (clinicaltrials.gov NCT01828034). Clinical trial information: NCT01828034
This could be found on the ASCO website:
Results: Pt characteristics and results are in the table. 34 pts had grade 3 toxicities in the MS arm vs. 19 in the mFOLFOX arm. The most common grade 3 toxicities in the MS arm include rash, mucositis, dehydration and fatigue while for mFOLFOX arm, hematologic toxicities, fatigue, nausea and vomiting. In the MS arm vs. mFOLFOX, there were 0 vs 3 pts with a partial response and 8 vs 9 pts with stable disease, respectively. Shorter survival was observed in the MS arm (median OS 4.0 vs 7.5 mos, hazard ratio (HR) 1.46, 95% CI 0.90-2.38; median PFS 2 mos for each, HR 1.43, 95% CI 0.93-2.20). Approximately 50% of the patients on the mFOLFOX arm went on to receive additional therapy as compared to 30% on the MS arm.
Conclusions: MS did not improve OS in pts who previously failed gemcitabine chemotherapy. Collected tissue will be analyzed for potential biomarkers.