Full coverage:
Introduction
Preview Part 1 (SNTA, ASTX, NVS, INFI)
Preview Part 2
Preview Part 3 (ARRY, ASTX)
Preview Part 4 (ASTX, ARQL, BPAX)
Preview Part 5 (TKMR, EXEL, PCYC, IMMU, VRTX)
Preview Part 6 (CRIS INFI ISIS CLDX LGND PCYC)
Biotech Due Diligence |
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For the moment, this will be the final installment of the BiotechDueDiligence AACR Annual Meeting preview..thanks for sticking with us. As always, see below for another collection of presentations from biotech companies covered on the website.
Full coverage: Introduction Preview Part 1 (SNTA, ASTX, NVS, INFI) Preview Part 2 Preview Part 3 (ARRY, ASTX) Preview Part 4 (ASTX, ARQL, BPAX) Preview Part 5 (TKMR, EXEL, PCYC, IMMU, VRTX) Preview Part 6 (CRIS INFI ISIS CLDX LGND PCYC)
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In this post I will highlight some of the AACR Late-breaker abstracts that I am watching for, mostly related to clinical trial results. The big trials tend to be saved for ASCO in June, but there should be some interesting data nonetheless.
Full coverage: Introduction Preview Part 1 (SNTA, ASTX, NVS, INFI) Preview Part 2 Preview Part 3 (ARRY, ASTX) Preview Part 4 (ASTX, ARQL, BPAX) A new set of investor relations (IR) questions and responses from biotechs provided by Mike O'Neill has been posted, covering financials and upcoming catalysts for each biotech stock.
The responses are from January 2013 and feature Digirad $DRAD, InSite Vision $INSV, Oncolytics $ONCY, Oramed Pharma $ORMP, and Tekmira Pharma $TKMR. Check out the complete index of all IR Questions and Answers. Alnylam $ALNY will present the following updated results related to their RNAi cancer program at #ASCO12 in June. Note that there is an unresolved patent dispute with Tekmira $TKMR around the IP covering this therapeutic. Abstract #3062 Open-label extension study of the RNAi therapeutic ALN-VSP02 in cancer patients responding to therapy. Maria Alsina, MD Background: ALN-VSP02 is an RNA interference (RNAi) therapeutic comprised of lipid nanoparticle-formulated small interfering RNAs targeting vascular endothelial growth factor (VEGF)-A and kinesin spindle protein (KSP). In a phase 1 trial, ALN-VSP02 administered as an iv infusion q2 wks was well-tolerated and showed evidence of anti-VEGF pharmacology and antitumor activity. Methods: Patients treated on the phase I trial with stable disease (SD) or better after 4 months (8 doses) were eligible to continue on an extension study until disease progression. Main objectives included continued evaluation of safety/tolerability and assessment of disease response. Results: Seven of 37 patients (18.9%) evaluable for response went onto the extension study, including 1 of 7 (14.2%) at 0.4 mg/kg, 2 of 5 (40%) at 0.7 mg/kg, and 4 of 11 (36.3%) at 1.0 mg/kg. All had progressed after one or more prior therapies. Tumor types included head and neck squamous cell carcinoma, angiosarcoma, endometrial cancer, renal cell carcinoma (RCC, N=2), and pancreatic neuroendocrine tumor (PNET, N=2). At the time of enrollment, 6 had SD and one (endometrial cancer with multiple liver metastases) had an unconfirmed partial response (PR). The average length of time on treatment (including phase I and extension studies) was 9.5 months (range 5-19). As of January 2012, 3 patients remain on study, including the endometrial cancer patient with an ongoing PR who has had >80% tumor regression after 19 months of treatment at 0.7 mg/kg and two patients with RCC and PNET with continued SD after nearly 1 year of treatment at 1.0 mg/kg. The other patients with RCC and PNET at 1.0 mg/kg with SD came off after 8.5 and 5.5 months, respectively, for adverse events that included fatigue or elevated alkaline phosphatase. A decrease in spleen volume, likely an on-target effect and not associated with any adverse events, occurred to a greater degree on the extension study than on the phase I trial and was most pronounced in patients receiving ≥ 12 doses. Conclusions: ALN-VSP02 has preliminary activity against endometrial cancer, RCC and PNET and a favorable safety profile that permits chronic dosing. Phase II trials are warranted in these and other VEGF-overexpressing tumors.
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