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Cascadian Therapeutics Reports Topline ONT-380 “Triplet” Data and Outlines Key Development Strategies

On June 14, 2016 Cascadian Therapeutics (NASDAQ:CASC), a clinical-stage biopharmaceutical company, reported that it will present clinical data from the Company’s ongoing Phase 1b studies, including updated clinical data from the study of ONT-380 in combination with trastuzumab and capecitabine ("Triplet"), and a review of the recent ASCO (Free ASCO Whitepaper) data from the ONT-380 combination with T-DM1, at today’s Corporate Update and R&D Day in New York City (Press release, Cascadian Therapeutics, JUN 14, 2016, View Source [SID:1234513293]). ONT-380 is an oral, highly selective small molecule HER2 inhibitor being studied as a combination therapy to treat HER2+ locally advanced or metastatic breast cancer, including patients with brain metastases.

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"The data suggest that ONT-380, in combination with other active agents, show systemic activity in pretreated patients, supporting its advancement into later stage studies," said Erika Hamilton, MD, Director of Breast and Gynecologic Cancer Research at Sarah Cannon Research Institute. "To date, ONT-380 has shown a favorable tolerability profile and the potential to improve outcomes in patients with brain metastases. Historically, great progress has been made with the approval of HER2 targeted therapies, however, patients with metastatic disease will eventually progress and need additional therapies. A new agent that can impact both systemic and brain metastases, while not adding significant toxicities, may be a substantial benefit for patients."

ONT-380 "Triplet" Phase 1b Data Update
The ongoing Phase 1b "Triplet" study is evaluating a combination of ONT-380 with trastuzumab and capecitabine in 27 previously treated, locally advanced or metastatic breast cancer patients with and without brain metastases. Patients had received a median of three prior HER2 directed agents: 100% with trastuzumab and T-DM1, and 74% with pertuzumab. Additionally, 41% of patients entered the trial with brain metastases.

Results from the combination trial show:

Safety Profile

Majority of adverse events were Grade 1, with most patients being able to continue on the full dose of ONT-380
Grade 3 diarrhea was infrequent, seen in 3/27 patients (11%) without a requirement for prophylactic anti-diarrheal medicine
Activity

Overall objective response rate (ORR), as defined by RECIST 1.1, of 58% (24 patients with measurable disease at baseline: 1 complete response, 13 partial responses, 6 with stable disease, 4 with progressive disease)
Interim median progression-free survival (mPFS) of 6.3 months overall (95% CI 4.1- n/a)
Patients with brain metastases

Outcomes in patients with brain metastases were similar to patients without brain metastases
"Our median PFS of 6.3 months and 58% objective response rate are promising in patients previously treated with T-DM1," commented Luke Walker, MD, Vice President of Clinical Development of Cascadian Therapeutics. "There are no true historical data with a comparable patient population given the recent changes in HER2 treatment. However, we believe a reasonable comparator is the Phase 3 TH3RESA trial of advanced HER2+ breast cancer, where patients in the control arm had a 3.3 month median PFS and 9% objective response rate. These patients received two prior HER2 agents and were treated on study with chemotherapy and/or an anti-HER2 agent, similar to current treatment options following T-DM1. Investigators continue to remain enthusiastic about advancing our Triplet combination into later stage studies."

Next steps
An ongoing Phase 2 study, known as HER2CLIMB, is exploring the Triplet combination in a randomized, double blind, placebo-controlled setting. This trial is enrolling patients with locally advanced or metastatic HER2+ breast cancer with prior treatment with a taxane, trastuzumab, pertuzumab, and T-DM1, including patients with brain metastases. This trial is expected to enroll 180 patients across approximately 100 clinical sites in the United States, Canada, and Western Europe. The HER2CLIMB trial is designed to show a 50% improvement in median PFS, with an assumption of 4.5 months in the control arm.

Commented Scott Myers, President and CEO of Cascadian Therapeutics, "We are pleased to report these encouraging clinical data and look forward to discussing the results with investigators and regulators to determine how best to advance the ONT-380 program. We anticipate providing updated data by year-end."

GlycoMimetics’ GMI-1271 Receives FDA Fast Track Designation for Treatment of Acute Myeloid Leukemia

On June 13, 2016 GlycoMimetics, Inc. (NASDAQ:GLYC) reported that it received Fast Track designation from the U.S. Food and Drug Administration (FDA) for its novel E-selectin antagonist GMI-1271 for treatment of adult patients with relapsed or refractory acute myeloid leukemia (AML) and elderly patients aged 60 years or older with AML (Press release, GlycoMimetics, JUN 13, 2016, View Source [SID1234617424]).

"We believe GMI-1271 has the potential to address important unmet needs for individuals with relapsed or refractory AML, as well as for older AML patients, for whom the standard of care often fails to provide outcomes as positive as those seen in other patient groups," said Helen Thackray, M.D., Chief Medical Officer of GlycoMimetics. "The FDA’s granting of a Fast Track designation for GMI-1271 to treat AML is an important step in advancing this drug candidate through the regulatory process, and if successful, in bringing a novel drug to patients in an expedited time frame."

The Fast Track Designation is designed to facilitate development and expedite review of experimental therapies that address the unmet medical needs of patients with serious conditions.

AML is a cancer of immature white blood cells that starts in the bone marrow but can quickly spread into the blood, lymph nodes, liver, spleen, central nervous system, and testicles. Each year in the United States, about 19,900 people (usually older than 45 years of age) are diagnosed, and about 10,400 people die from all forms of the disease, according to the American Cancer Society. Chemotherapeutic methods among patients with refractory and relapsed AML have low remission rates, between 25 and 30 percent.

GlycoMimetics announced on Friday, June 10, presentation of data from the Phase 1 portion of its on-going Phase 1/ 2 clinical trial testing GMI-1271 combined with induction chemotherapy, in patients with relapsed/refractory acute myeloid leukemia (AML). Data was reported at the European Hematology Association (EHA) (Free EHA Whitepaper)21stCongress in Copenhagen, Denmark in a poster entitled "Results of a Phase 1 study of GMI-1271, a potent E-selectin antagonist in combination with induction chemotherapy in relapsed/refractory AML: a novel, well-tolerated regimen with a high remission rate."

In addition, GlycoMimetics recently announced that the first patient with relapsed or refractory AML has been dosed in the company’s Phase 2 portion of the ongoing Phase 1/2 clinical trial of GMI-1271. This clinical trial is a multinational open-label study evaluating endpoints for safety, pharmacokinetics (PK) and efficacy of GMI-1271 in combination with induction chemotherapy in patients with high-risk AML. This trial is being conducted at a number of academic medical institutions in the United States, Ireland, and Australia. While the primary objective is to assess safety, additional endpoints include overall response rate, biomarkers of activity, durability of response and overall survival. The Phase 2 portion of the study is expected to include approximately 25 participants with relapsed or refractory AML and approximately 25 participants who are newly diagnosed.

About GMI-1271

GMI-1271 is designed to block E-selectin (an adhesion molecule on cells in the bone marrow) from binding with AML cells as a targeted approach to disrupting well-established mechanisms of leukemic cell resistance within the bone marrow microenvironment. Preclinical research points to the drug’s potential role in moving cancerous cells out of the protective environment of the bone marrow where they hide and escape the effects of chemotherapy. In preclinical studies using animal models of AML, the results of which were presented at meetings of the American Society of Hematology (ASH) (Free ASH Whitepaper), GMI-1271 was also associated with a reduction of chemotherapy-induced neutropenia and chemotherapy-induced mucositis.

Alligator presents at Småbolagsdagen in Stockholm

On June 13, 2016 Alligator presented the corporate presentation (Presentation, Alligator Bioscience, JUN 13, 2016, View Source [SID1234538699]).

10-K – Annual report [Section 13 and 15(d), not S-K Item 405]

Burzynski Research Institute has filed a 10-K – Annual report [Section 13 and 15(d), not S-K Item 405] with the U.S. Securities and Exchange Commission .

Perrigo Confirms First To File Patent Challenge For Generic Version Of Picato® Gel (0.015% And 0.05%)

On June 13, 2016 Perrigo Company plc (NYSE: PRGO; TASE) reported that it has filed Abbreviated New Drug Applications (ANDAs) with the U.S. Food and Drug Administration (FDA) for ingenol mebutate gel (0.015% and 0.05%), the generic versions of Picato gel (0.015% and 0.05%) (Press release, Perrigo Company, JUN 13, 2016, View Source [SID:1234514915]). Perrigo has notified Leo Pharma A/S and Leo Laboratories, Ltd., the owners of the New Drug Applications (NDAs) and patents listed in FDA’s Orange Book, of its filings.

On June 10, 2016, Leo Pharma A/S, Leo Laboratories Limited and Leo Pharma, Inc. filed suit in the United States District Court for the District of Delaware alleging patent infringement. This action formally initiates the litigation process under the Hatch-Waxman Act. Perrigo believes that it is a first filer for this opportunity, making it eligible for 180 days of generic exclusivity.

Picato gel (ingenol mebutate gel) is a prescription medicine indicated for the topical treatment of actinic keratosis. Branded sales for the twelve months ending April 2016 were approximately $69 million.

Perrigo’s CEO John T. Hendrickson stated, "This filing illustrates Perrigo’s commitment to providing Quality Affordable Healthcare Products. The Rx team continues to invest in the development of important products that strengthen our extended topicals portfolio and drive savings for our customers and consumers."