Oncothyreon Might Be Worth It
Prescient Investment Analysis
Prescient Investment Analysis
Mon, May 9, 5:01 PM
Tue, Mar. 29, 10:47 AM
Fri, Mar. 18, 12:48 PM
Mon, Mar. 14, 4:24 PM
Mon, Feb. 29, 10:28 AM
- A Phase 2 clinical trial is underway assessing Oncothyreon's (ONTY -1.9%) ONT-380, in combination with Roche's (OTCQX:RHHBY -1.8%) Herceptin (trastuzumab) and Xeloda (capecitabine), in heavily pretreated patients with HER2-positive breast cancer with or without brain metastases.
- The randomized, double-blind, placebo-controlled study will enroll ~180 subjects. The primary endpoint is progression-free survival (PFS). According to clinicaltrials.gov, the estimated final data collection date for the primary endpoint is March 2018. The estimated study completion date is April 2019.
- ONT-380 is an oral selective small molecule inhibitor of HER2, a growth factor receptor overexpressed in certain cancers. Its value proposition is highly potent inhibition of HER2 without the unwanted side effects (e.g., skin rash, gastrointestinal toxicity) of dual (HER2 and EGFR) inhibitors.
Dec. 10, 2015, 9:14 AM
Dec. 9, 2015, 12:48 PM
Dec. 9, 2015, 9:16 AM
Dec. 8, 2015, 5:37 PM
Dec. 8, 2015, 5:04 PM
- Micro cap Oncothyreon (NASDAQ:ONTY) sets a new standard in obfuscation today with an impossible-to-fully-decipher press release about updated data from two early-stage trials evaluating lead product candidate ONT-380 for the treatment of HER2-positive breast cancer. The data will be presented at the San Antonio Breast Cancer Symposium, December 8-12.
- 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
- AAOI, ABCO, ABTL, ACAD, ACET, ACHN, AEGR, AGO, AHS, AIRM, AL, ALEX, ALIM, AMBR, AMRS, AMTG, ANET, ARCW, ATHX, ATSG, BBG, BBRG, BCEI, BEBE, BLDR, BPI, BRKS, BRS, CALD, CBI, CERS, CLNE, CLVS, CMLS, CORT, CPST, CSOD, CTCT, CUBE, CYBR, CYTX, DATA, DIOD, DIS, DMD, DWA, EAC, EBS, ECOM, ECPG, ED, EFC, EGN, EGOV, ELON, EOG, ERII, EVC, EXAR, FICO, FNGN, FTEK, FXCM, GDOT, GERN, GLUU, GSAT, GSM, GST, GXP, HAIN, HBM, HE, HK, HNSN, HTGC, ICUI, INAP, INFI, INWK, IRG, JJSF, KHC, KTOS, LBTYA, LNT, MAIN, MASI, MDRX, MDVN, MED, MHK, MITK, MNST, MRC, MSCC, MTD, NEWR, NFG, NKTR, NVDA, OLED, ONTY, OREX, OUT, PCTY, PETX, PKI, PLT, PODD, PRAA, PRO, PXLW, QRVO, RATE, RBA, RLYP, RMAX, RPTP, RRMS, RRTS, SEMG, SHAK, SKUL, SLH, SNAK, SREV, SSRI, STMP, SWIR, SWKS, TCRD, TCX, TEAR, TNGO, TRIP, TRMR, TRQ, TRUE, TTWO, UBNT, UEPS, VRNS, VVC, WAGE, WG, WIFI, WTW, XOMA, YUME
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.
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
Country: United States
Other News & PR