CASCADIAN THERAPEUTICS, INC. (NASDAQ:CASC) Files An 8-K Other Events
Item8.01
| Other Events. |
On December7, 2016, Cascadian Therapeutics, Inc. (the Company)
announced that, following a recent meeting with the U.S. Food and
Drug Administration and discussions with the Companys external
steering committee, it has amended the HER2CLIMB Phase 2 clinical
trial of tucatinib (also known as ONT-380) by increasing the
sample size so that, if successful, the trial could serve as a
single pivotal study to support registration. This decision is
supported by the most recent data from the Companys ongoing Phase
1b study evaluating the same triplet combination therapy being
investigated in the amended Phase 2 trial, which is tucatinib in
combination with capecitabine and trastuzumab for patients with
metastatic or locally advanced HER2-positive breast cancer,
including patients with and without brain metastases.
Updated Phase 1b trial results for the triplet combination show
that the combination continues to be well tolerated, with the
updated median progression-free survival increasing to 7.8
months, an overall response rate of 61 percent and a median
duration of response of 10 months.
A copy of the press release issued by the Company related to this
announcement is attached hereto as Exhibit 99.1 and is
incorporated by reference.
| Item9.01 | Financial Statements and Exhibits |
(d) Exhibits.
|
Exhibit Number |
Description |
|
| 99.1 |
Press Release issued by Cascadian Therapeutics, Inc. dated December 7, 2016. |
2
About CASCADIAN THERAPEUTICS, INC. (NASDAQ:CASC)
Cascadian Therapeutics, Inc., formerly Oncothyreon Inc., is a clinical-stage biopharmaceutical company. The Company focuses on the development of therapeutic products for the treatment of cancer. The Company’s clinical-stage product candidate includes ONT-380, an orally active and selective small-molecule human epidermal growth factor receptor (HER) 2 inhibitor. The Company’s ONT-10 is a therapeutic vaccine targeting the Mucin 1 peptide antigen (MUC1). The Company is engaged in developing preclinical product candidates in oncology using its Checkpoint kinase 1 (Chk1) kinase inhibitor and protocell technology. The Company completed the evaluation of approximately two dosing cohorts in its Phase Ib trial of ONT-10 in combination with the anti-CD27 T-cell agonist antibody varlilumab in collaboration with other company. The Company has completed Phase I trial of ONT-380, with both dose-escalation and expansion components. The Company has initiated Phase Ib trials of ONT-380. CASCADIAN THERAPEUTICS, INC. (NASDAQ:CASC) Recent Trading Information
CASCADIAN THERAPEUTICS, INC. (NASDAQ:CASC) closed its last trading session up +0.59 at 6.14 with 243,267 shares trading hands.