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Edison Investment Research is terminating coverage on BCI Minerals (BCI) and Sunesis Pharmaceuticals (SNSS). Please note you should no longer rely on any previous research or estimates for these companies. All forecasts should now be considered redundant.
Sunesis Pharmaceuticals Inc Viracta Therapeutics, Inc.
Sunesis’s task in realigning the company towards its new lead asset SNS-510 is twofold. First, it is examining the precise direction it intends to take the drug, and it has found synergies both with certain genetic subtypes of cancer as well as with other cancer drugs. Secondly, the company is both raising capital and reducing costs in order to provide the drug a runway into the clinic, and it estimates that it has cash through most of 2021.
Sunesis announced on 23 June that it would not be advancing vecabrutinib to the Phase II portion of its Phase Ib/II study following the results from its highest dose (500mg) cohort. The cohort had three stable disease (SD) responses out of six patients enrolled in the cohort, and Sunesis determined that this level of activity was not sufficient to warrant advancing the program. The company will now refocus efforts on developing its PDK1 inhibitor SNS-510, for which it expects to file an IND by the end of 2020.
ValuEngine Rating and Forecast Report for SNSS
Sunesis Pharmaceuticals Inc
On 18 March, Sunesis released the first assessments of the 400mg cohort in its ongoing dosing study of vecabrutinib for B-cell malignancies. Two (of three) patients in this cohort showed stable disease (SD), with one showing a 48% response. These results are largely similar to those seen with the 300mg cohort (one near-responder SD, two stabilized SD, and one progressor). We would like to have seen more definitive activity in this cohort, but there is still the possibility that Sunesis will cross the line of generating partial responses (PRs) in the upcoming 500mg cohort.
Sunesis provided an update on its ongoing dosing study of vecabrutinib on its 2019 earning conference call: the first response assessment for the 400mg cohort will be available later in March and the 500mg readout should be available in Q220. Sunesis noted one patient on the 300mg arm is on his eighth line of treatment and his response has developed to a 47% response (from 41% at the last update), just shy of a partial response (PR).
Sunesis reported updated data from the dosing portion of its ongoing Phase Ib/II study of vecabrutinib for chronic lymphocytic leukemia (CLL) and other B-cell malignancies. The key data on the highest dosing cohort (300mg BID) showed stable disease (SD) in three of five patients, including one patient very close to a partial response (PR) at 40%. The company will need to escalate to higher doses (400mg is already enrolling), but we are encouraged by the activity seen here.
Sunesis recently presented a poster on the preclinical findings of its PDK1 inhibitor SNS-510. Surprisingly, researchers found that the drug was most active in cancer cell lines with mutations in the cyclin-dependent kinase inhibitor 2A (CDKN2A) gene, with the strongest activity in melanoma, leukemia and brain cancers. Additionally, the company announced that this finding pointed to potential synergies with CDK4/6 inhibitors (such as Ibrance), which are now under investigation.
Sunesis provided an update at the European Hematology Association (EHA) meeting on its ongoing Phase Ib/II study of vecabrutinib in patients with B-cell malignancies, providing detailed data on the first three cohorts (25mg, 50mg and 100mg). The data were consistent with previous reports: no safety red flags were observed, and there were indications of activity. The data did not show partial responses or better at the current dose, but four patients (of 20) demonstrated stable disease, including three out of five evaluable CLL patients with C481S mutations.
Sunesis is currently in the dose-escalation portion of the Phase Ib/II study of its BTK inhibitor vecabrutinib, and the first signs of clinical efficacy are expected in the upcoming doses. The drug is being tested in a range of B-cell malignancies where BTK inhibitors have historically shown some activity. The company will provide its next clinical update at the European Hematology Association (EHA) Congress in June 2019. In this note we review the clinical data to date and provide our clinical outlook.
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.
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 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 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.
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.
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 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.
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.
