Oncothyreon Might Be Worth It
Prescient Investment Analysis
Prescient Investment Analysis
Dec. 8, 2015, 5:37 PM
Dec. 8, 2015, 5:04 PM
- The first presentation (Abstract P4-14-20) highlights data from a Phase 1b study of ONT-380 in HER2+ breast cancer patients who had failed treatment with Roche's (OTCQX:RHHBY) Herceptin (trastuzumab) and a taxane. The data show an overall response rate of 41% and a clinical benefit rate (CBR) of 59% in an advanced stage patient population [clinical benefit rate is considered vague but should include the overall response rate plus patients with stable disease (no progression); the term "disease control rate" is used more frequently]. 60% of the advanced stage population had a history of central nervous system metastases. The CNS CBR for patients with response assessable (unclear on how this is defined) CNS metastases was 64%.
- The second presentation (Abstract P4-14-19) combines data from the above trial and another Phase 1b assessing ONT-380 in combination with Herceptin and Roche's Xeloda (capecitabine). The data includes patients with previously untreated CNS metastases as well as those with progressive or new CNS metastases after prior treatment with radiation or surgery. No specific numbers are disclosed, only the statement "Responses and clinical benefit in the CNS were seen for both groups and in all combinations tested."
- The misdirection has clearly spooked investors. Shares are down 33% after hours on robust volume.
- In June, the company announced positive data from the Herceptin/Xeloda study that showed an 85% disease control rate (DCR) (partial responders + complete responders + those with stable disease) in all cohorts. The company also reported data from the Herceptin/taxane study that showed a 64% DCR (this equals the 64% CNS CBR stated above). Shares rallied that day.
- Previously: Oncothyreon up 46% premarket on ONT-380 study results (June 1)
Nov. 5, 2015, 4:03 PM
- Oncothyreon (NASDAQ:ONTY): Q3 EPS of -$0.05 beats by $0.04.
Nov. 4, 2015, 5:35 PM
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Sep. 23, 2015, 5:40 PM
Aug. 6, 2015, 4:05 PM
- Oncothyreon (NASDAQ:ONTY): Q2 EPS of -$0.11 misses by $0.03.
Jun. 1, 2015, 9:21 AM
Jun. 1, 2015, 8:09 AM
- TheStreet's Adam Feuerstein reports from ASCO in Chicago. On the plus side, he says Oncothyreon (NASDAQ:ONTY), Roche (OTCQX:RHHBY), Merck (NYSE:MRK), ImmonoGen (NASDAQ:IMGN), Celldex Therapeutics (NASDAQ:CLDX) and CTIBiopharma (NASDAQ:CTIC) all presented impressive data.
- On the negative side, Clovis Oncology (NASDAQ:CLVS) and Puma Biotech (NYSE:PBYI) fell short of wowing the crowd while Bristol-Myers Squibb (NYSE:BMY) was a bit of a mixed bag.
Jun. 1, 2015, 7:46 AM
- Small cap Oncothyreon (NASDAQ:ONTY) is up 46% premarket on robust volume in response to its announcement at ASCO of positive data from a Phase 1b clinical trial evaluating its lead product candidate, ONT-380, in combination with Roche's Xeloda (capecitabine) and Herceptin (trastuzumab), as third line treatment of patients with HER-positive metastatic breast cancer. The trial was a dose escalation study in patients previously treated with Herceptin and Kadcyla (ado-trastuzumab emtansine).
- The disease control rate in 27 evaluable patients in all three cohorts combined (ONT-380 + Xeloda; ONT-380 + Herceptin; ONT-380 + Xeloda + Herceptin) was 85% (n=23/27). Specifically, two patients had a complete response, 12 showed a partial response and nine showed stable disease. Four patients progressed.
- Results from another Phase 1b study assessing ONT-380 in patients with metastatic breast cancer with central nervous system (CNS) metastases showed a 64% disease control rate (n=14/22) (one complete response, four partial responses and nine with stable disease). No patient had progressive disease as a CNS best response.
- ONT-380 was well tolerated in both studies. Most adverse events were either grade 1 or 2.
- The company intends to advance ONT-380 to Phase 2 development later this year.
- Previously: ASCO abstract-stoked investors bid up Oncothyreon (May 14)
May 28, 2015, 5:40 PM
May 28, 2015, 9:16 AM
May 22, 2015, 12:47 PM
May 22, 2015, 9:16 AM
May 15, 2015, 5:38 PM
May 15, 2015, 12:45 PM
May 14, 2015, 12:58 PM
- 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)
Oncothyreon, Inc. is a clinical-stage biopharmaceutical company focused on the development of therapeutic products for the treatment of cancer. Its current clinical-stage product candidates include ONT-380, an orally active and selective small-molecule HER2 inhibitor, and ONT-10, a therapeutic... More
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