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Sunesis Pharmaceuticals

Vecabrutinib study advances

Update | Pharmaceuticals & healthcare | 07 Feb 2019

In January 2019 Sunesis announced that its Phase Ib/II study of vecabrutinib for B-cell cancers advanced to the 100mg cohort. The company experienced a series of unavoidable clinical delays in the 50mg arm but was eventually able expand the number of clinical sites and overenroll the cohort. The 100mg dose is the first that is expected to potentially provide indications of efficacy and Sunesis will provide a clinical update in Q219.

Sunesis Pharmaceuticals

ASH 2018: 50mg cohort on last patient

Update | Pharmaceuticals & healthcare | 10 Dec 2018

The company provided an update at the American Society of Hematology (ASH) 2018 meeting in December on its ongoing dose-escalation study of vecabrutinib for B-cell malignancies. Four new patients have been enrolled in the past month and the 50 mg cohort is now overenrolled. Safety data is only needed from a single patient, so barring any issues, the trial should progress to 100mg soon, where we may see the first signs of efficacy.

Sunesis Pharmaceuticals

Dosing update at ASH

Update | Pharmaceuticals & healthcare | 09 Nov 2018

Sunesis released its abstracts for the upcoming American Society of Hematology (ASH) meeting, which included an update on the company’s ongoing Phase Ib/II trial of vecabrutinib in hematologic cancers. The study is still in the dosing portion of the trial on the 50mg arm, but the data to date showed a safety and tolerability profile in line with expectations. The company will provide a complete update of the trial progress at ASH.

Sunesis Pharmaceuticals

Interim readout coming up

Update | Pharmaceuticals & healthcare | 17 Aug 2018

Sunesis has reported Q2 earnings and provided an update on enrolment in its ongoing dose escalation study of vecabrutinib. It continues to enrol the 50mg cohort and will announce when it is complete. The company also stated that it intended to provide an update on the program at the American Society of Hematology (ASH) meeting in December 2018.

Sunesis Pharmaceuticals

On track with vecabrutinib

Update | Pharmaceuticals & healthcare | 18 May 2018

On the Q118 conference call, Sunesis provided an update of its ongoing vecabrutinib Phase Ib/II trial. The study is continuing to enrol the 50mg cohort in the dose-ranging Phase I portion of the study. This cohort was previously expanded to six patients per the protocol due to an adverse event, but no further dose-limiting events have been reported. The company reiterated guidance that the dose ranging would be complete in autumn 2018 and that it will present preliminary efficacy data at a medical conference.

Sunesis Pharmaceuticals

A slight delay

Update | Pharmaceuticals & healthcare | 13 Mar 2018

On the YE FY17 conference call, the company provided revised guidance on the dosing portion of its ongoing Phase Ib/II study of vecabrutinib (SNS-062) in chronic lymphocytic leukemia (CLL) and other B-cell cancers. The final dose is expected to be reached in fall 2018 (revised from mid-2018) due to an on-protocol expansion of the second (50mg) dosing cohort because of a dose-limiting adverse event (AE). At this time we do not consider this delay or the AE to be material to the success of the program.

Sunesis Pharmaceuticals

A new BTK for a new day

Outlook | Pharmaceuticals & healthcare | 16 Nov 2017

Sunesis remains on track to complete the dose-escalation portion of its Phase Ib/II clinical trial for lead compound SNS-062, an oral Bruton’s tyrosine kinase (BTK) inhibitor, in patients with confirmed Imbruvica resistance in mid-2018, and present initial safety and efficacy interim data in Q218. In addition, Sunesis is moving forward with SNS-510, a PDK1 inhibitor with potential activity across multiple tumor types, and we expect a decision from Takeda on the advancement of pan-Raf inhibitor TAK-580 by mid- to late 2018. Sunesis completed a $20m offering of common and preferred stock in October 2017. We value Sunesis at $125.9m or $3.68.

Sunesis Pharmaceuticals

SNS-062 trial up and running

Update | Pharmaceuticals & healthcare | 03 Aug 2017

Sunesis announced on 18 July 2017 that the first patient had been dosed in its Phase Ib/II study of SNS-062 for the treatment of chronic lymphocytic leukemia (CLL) and other B-cell cancers. The trial is a dose-ranging and expansion study enrolling relapsed and refractory patients, and will enroll up to 124 patients. The company announced on the Q217 conference call that it expects to have identified the correct dose and to provide an update in spring 2018.

Sunesis Pharmaceuticals

Redirection after EMA application pulled

Update | Pharmaceuticals & healthcare | 10 May 2017

Sunesis reported in May 2017 that it has pulled its application to the EMA for the approval of vosaroxin for the treatment of acute myeloid leukemia, based on feedback from the agency. The program has been de-emphasized and the new lead is SNS-062, the company's Bruton's tyrosine kinase (BTK) inhibitor with potential efficacy in Imbruvica-resistant chronic lymphocytic leukemia (CLL). The SNS-062 program will be initiating a Phase Ib/II clinical trial in Q217.

Sunesis Pharmaceuticals

Getting closer to EU approval

Update | Pharmaceuticals & healthcare | 15 Mar 2017

The company's application for EU approval for vosaroxin approval in AML continues to progress. The company will go before the Oncology Division of the Scientific Advisory Group (SAG-O) in April with a Committee for Medicinal Products for Human Use (CHMP) decision likely by mid-year. We continue to expect a launch in H217. Also, the company plans to initiate a Phase Ib/II study of SNS-062, their BTK inhibitor, in patients with various advanced B-cell malignancies in H117.

Sunesis Pharmaceuticals

Sunesis shines at ASH

Update | Pharmaceuticals & healthcare | 13 Dec 2016

Sunesis reported new data on SNS-062 as and Qinprezo at the American Society of Hematology (ASH) meeting in December 2016. The Phase Ia trial of SNS-062 was completed and the company reported positive food effect data as well as an expanded safety data set without significant adverse events. New results of the Qinprezo VALOR trial were presented, demonstrating a durable response in acute myeloid leukemia (AML) patients over 60 with a median follow-up of 39.9 months.

Sunesis Pharmaceuticals

SNS-062 looks good so far

Update | Pharmaceuticals & healthcare | 16 Sep 2016

Sunesis released the first-in-human clinical data for SNS-062, its reversible non-covalent inhibitor of Bruton's tyrosine kinase (BTK), at a scientific conference in September 2016. The results from the 32-subject, placebo-controlled Phase Ia trial validated the notion that a non-covalent inhibitor could have a viable pharmacokinetic and pharmacodynamic profile and showed a favorable safety profile. The company will be advancing the drug into a Phase Ib/II B-cell malignancy trial following these results.