Oncothyreon Might Be Worth It
Prescient Investment Analysis
Prescient Investment Analysis
Tue, Jul. 12, 9:24 AM
Wed, Jun. 22, 4:10 PM
- Nano cap Cascadian Therapeutics (NASDAQ:CASC) initiates a public offering of common stock. Price, volume and terms have yet to be announced. Shares are off 6% after hours on light volume.
- Update: On June 23, the company announced that the offering is 35M shares at $0.80 per share. Underwriters over-allotment is an additional 5.25M shares. In addition, the company has agreed to sell 17,250 shares of its Series D Convertible Preferred Stock at $800 per share to BVF Partners, L.P., an entity consisting of existing stockholders and affiliates of a board member. Each Series D share is convertible into 1,000 shares of common stock.
- Update: On June 28, the company announced the closing of the offering, including the full exercise of the 5.25M-share over-allotment. Gross proceeds were $32.2M. The Series D offering also closed yielding gross proceeds of $13.8M. Total haul: $46.0M.
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- 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)
Sep. 23, 2015, 5:40 PM
Jun. 1, 2015, 9:21 AM
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)
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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