3 Different phase 3 trials:
-INSPIRE = for NSCLC being conducted by Merck of Germany under a license agreement
-START = for NSCLC being conducted by Merck of Germany under a license agreement
It is currently trading at $6.43, 30% higher than the closing price of when the secondary was announced ($4.94), on April 28, and 60% higher than where the secondary priced, at $4 dollars. This is unusual as most biotechs fall significantly post secondary offerings.
- Pivotal data points later this year… obviously the most important one of those data points will come with the end of the START trial of Stimuvax sometime next year.
- We expect investing in this company in advance of the START data, which we continue to expect later this year or in the middle of next year, will require open market purchases.
- There are two interim looks at the trial, the 1st when 50% of the expected patient events in the trail are complete and the second when by 75% of the events.
- At these interim looks, if the interim looks show that the drug has proven to work they cancel the study and treat all patients w/ the drug or if the drug has clearly failed they likewise end the trial.
- At the end of 2010 they announced that on the 1st look the trial was not stopped, meaning the drug did not clearly prove itself to work or not work.
- We continue to expect that the second interim look will occur sometime in the second half of the current year if the trial is not halted at that point, we currently believe the trial will end around the middle of next year.
- By end we mean that the event which triggers the primary efficacy analysis which is 706 patient deaths will have occurred. The trial won’t literally end as we fully expect many patients to continue on therapy, as we have seen in many trials.
- PX-866 Gleoblastoma “We have direct evidence in animal models that it crosses the blood brain brarier, we’ve been able to measure drug levels in brain tissue to measure drug levels directly “
[April 29, 2011]
- (May 4) – Oncothyreon Inc. today announced that it has closed an underwritten public offering of 11,500,000 shares of its common stock at a price to the public of $4.00 per share for gross proceeds of $46.0 million. The shares include 1,500,000 shares of common stock sold pursuant to the over-allotment option granted by the Company to the underwriters, which option was exercised in full. The net proceeds from the sale of the shares, after deducting the underwriters’ discounts and other estimated offering expenses payable by Oncothyreon, will be approximately $43.0 million.
- Oncothyreon today announced that it has priced an underwritten public offering of 10,000,000 shares of its common stock at a price to the public of $4.00 per share for gross proceeds of $40.0 million.
[/April 29, 2011]
[March 1, 2011]
- We look forward to sharing initial Phase 2 clinical data from our ongoing trials later this year (PX-866).
- PX-866 is a pan inhibitor of the PI-3K/PTEN/AKT pathway, a critical cell signaling pathway that is activated in many types of human cancer. Aberrant activation and regulation of PI-3K is implicated in a large proportion of human cancers, where it leads to increased proliferation and inhibition of apoptosis (programmed cell death). Results from a single-agent Phase 1 open-label, dose escalation study of PX-866 in patients with advanced metastatic cancer demonstrated that PX-866 was well tolerated using both an intermittent and continuous (daily) dosing schedule. Additional data from the Phase 1 trial presented at the EORTC/NCI/AACR meeting in Berlin on November 18, 2010 demonstrated that 8 of 19 (42%) evaluable patients treated with continuous dosing achieved stable disease as their best response.
[/March 1, 2011]
[Feb 9, 2011]
- Oncothyreon has entered into a $12.5 million secured loan facility from GE capital, Healthcare Financial Services. An initial term loan w/ an aggregate principle amount of $5.0 million was funded on Feb 8, 2011. The remaining $7.5 million may be drawn at Oncothyreon’s option at any time prior to November 1, 2011, subject to the achievement of certain clinical milestones and other customary conditions.
- This loan facility will provide us with significant financial flexibility to carry out our planned development of both PX-866 and ONT-10, while we await the results of the START trial of Stimuvax.
- We have already initiated two of four phase 1/2 and phase 2 trials of PX-866 and remain on track to file an investigational New Drug application for ONT-10 in the second half of the year.
- The initial term loan accrues interest at a rate of 10.57% per year and has a term of 42 months (3.5 years). During the first nine months of the initial term loan (ending November), Oncothyreon is required to pay interest only. Oncothyreon may prepay the initial term loan without penalty at any time during the nine-month interest only period. In connection with funding of the initial $5.0 million term loan, Oncothyreon issued warrants to purchase 48,701 shares of Oncothyreon common stock with an exercise price of $3.08 per share.
[/Feb 9, 2011]
[Dec 10th, 2009]
- Announced initiation of Phase 3 trial of Stimuvax in Asian Patients w/ non-small cell lung cancer (NSCLC), in Dec 10th, 2009.
- Merck of Germany is conducting the trials in Asian patients from China, Hong Kong, South Korea, Singapore, & Taiwan.
- Stimuvax is an investigational cancer vaccine being developed by Merck KGaA under a license agreement w/ Oncothyreon.
- The trial’s name is INSPIRE and is anticipated to enroll 420 patients.
- There is another Phase 3 trial of Stimuvax for NSCLC named START. Both trials are double-blind, placebo-controlled, randomized.
- Stimuvax was the first investigational cancer vaccine to enter phase 3 clinical testing in NSCLC with the launch of the START study in Feb 2007.
- Stimuvax is also being investigated in the Phase 3 STRIDE stud, which is currently enrolling patients who have hormone receptor-positive, locally advanced, recurrent or metastatic breast cancer.
- Both trials are for patients with unresectable, stage 3 NSCLC who have demonstrated either stable disease or an objective response following primary chemo-radiotherapy.
- The primary endpoint of both trials is overall patient survival.
- Stimuvax is designed to stimulate the body’s immune system to identify and target cancer cells that express MUC1, an antigen commonly expressed in NSCLC as well as in other common cancer types such as breast cancer, multiple myeloma, and colorectal, prostate and ovarian cancers.
[/Dec 10th, 2009]