reports
- Sean Conroy
Sunesis Pharmaceuticals - A shift of gears
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.
- Sean Conroy
Sunesis Pharmaceuticals - Vecabrutinib not to progress, SNS-510 elevat...
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 t...
Thanks to a better fundamental star rating, SUNESIS PHARMS.INCO. sees ...
The independent financial analyst theScreener just awarded an improved star rating to SUNESIS PHARMS.INCO. (US), active in the Biotechnology industry. As regards its fundamental valuation, the title receives an improved star rating and now shows 4 out of 4 possible stars. With regard to its market behaviour, it remains unchanged and can be qualified as risky. theScreener considers that these elements allow slightly upgrading its rating to Neutral. As of the analysis date June 9, 2020, the closin...
- Sean Conroy
Sunesis Pharmaceuticals - 400mg data similar to previous cohort
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 cros...
- Sean Conroy
Sunesis Pharmaceuticals - Sunesis 110320
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).
- Sean Conroy
Sunesis Pharmaceuticals - 300mg suggests activity, but higher doses ne...
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.
- Sean Conroy
Sunesis Pharmaceuticals - Insight into the future of SNS-510
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.
- Dr Nathaniel Calloway
Sunesis Pharmaceuticals - EHA data released
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...
- Dr Nathaniel Calloway
Sunesis Pharmaceuticals - First signs of efficacy coming up
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 ...
- Dr Nathaniel Calloway
Sunesis Pharmaceuticals - Vecabrutinib study advances
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.
- Dr Nathaniel Calloway
Sunesis Pharmaceuticals - Dosing update at ASH
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.
- Dr Nathaniel Calloway
Sunesis Pharmaceuticals - Interim readout coming up
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.
- Dr Nathaniel Calloway
Sunesis Pharmaceuticals - On track with vecabrutinib
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 medic...
- Maxim Jacobs
Redirection after EMA application pulled
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.
IMPORTANT SHAREHOLDER ALERT: Khang & Khang LLP Announces an Investigat...
IRVINE, Calif.--(BUSINESS WIRE)-- Khang & Khang LLP (the “Firm”) announces that it is investigating claims against Sunesis Pharmaceuticals, Inc. (“Sunesis” or the “Company”) (Nasdaq: SNSS) concerning possible violations of federal securities laws. If you purchased shares of Sunesis and want more information, please contact Joon M. Khang, Esquire, of Khang & Khang LLP, 18101 Von Karman Avenue, 3rd Floor, Irvine, CA 92612, by telephone: (949) 419-3834, or by e-mail at [email protected]. The investigation focuses on whe...
IMPORTANT SHAREHOLDER ALERT: Lundin Law PC Announces an Investigation ...
LOS ANGELES--(BUSINESS WIRE)-- Lundin Law PC, a shareholder rights firm, announces that it is investigating claims against Sunesis Pharmaceuticals, Inc. (“Sunesis” or the “Company”) (Nasdaq: SNSS) concerning possible violations of federal securities laws. To get more information about this investigation, please contact Brian Lundin, Esquire, of Lundin Law PC, at 888-713-1033, or by email at [email protected]. On May 2, 2017, Sunesis announced that it will withdraw its European Marketing Authorization Appli...
SHAREHOLDER ALERT: Levi & Korsinsky, LLP Reminds Shareholders of an In...
NEW YORK--(BUSINESS WIRE)-- Levi & Korsinsky, LLP announces it has commenced an investigation of Sunesis Pharmaceuticals Inc. (“Sunesis”) (NASDAQ: SNSS) concerning possible violations of federal securities laws. The investigation concerns whether the Company and its executives violated federal securities laws by failing to appropriately disclose the suitability of the Company's treatment vosaroxin for approval in Europe. Specifically, on May 2, 2017, Sunesis announced that the Company will withdraw its European Marketing Auth...
- Maxim Jacobs
Getting closer to EU approval
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.
Update: Progressing with EMA and pipeline
On 29 July 2016, Sunesis announced financial results for Q216 and provided updated guidance on the Qinprezo and SNS-062 development programs. The company reported a net loss of $10.4m for the quarter on the back of $6.6m in R&D spending. It also announced that it had met the EMA to clarify some of the questions submitted as part of the Qinprezo MAA process. Additionally, Sunesis announced that the first clinical trial data on BTK inhibitor SNS-062 will be released at a medical conference in Sept...
Update: Qinprezo/Dacogen combo stands up
Sunesis reported results from an Phase Ib/II study sponsored by MD Anderson during the European Hematology Association meeting in June 2016, detailing the effect of a combination of Qinprezo and Dacogen for the frontline treatment of patients with acute myeloid leukemia (AML) and those with myelodysplastic syndrome (MDS) unfit for intensive therapy. The 63-person open-label trial demonstrated a median overall survival of 16.1 months at the 70mg/m2 Qinprezo dose, over twice that of either of the ...
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