Fly News Breaks for February 11, 2020
Feb 11, 2020 | 11:48 EDT
Roth Capital analyst Zegbeh Jallah says that with the Phase 3 study not meeting its primary endpoint, Pfizer's (PFE) termination notice comes as no surprise to GlycoMimetics (GLYC) investors. Further, Jallah notes that rivipansel was not included into her model. However, with the returning of all rights to Glycomimetics, this does create some possibilities, the analyst writes in a research note. She continues to believe in rivipansel's efficacy, and suspects that "multiple confounding factors" may have contributed to the lack of efficacy in the endpoint of choice. It remains anyone's guess whether GlycoMimetics would independently move forward with Rivipansel in sickle cell disease, however, writes Jallah. She sees a minimal impact from Pfizer's termination and keeps a Buy rating on GlycoMimetics with a $4.30 price target.
News For GLYC;PFE From the Last 2 Days
Apr 16, 2021 | 06:10 EDT
Ideaya Biosciences (IDYA) announced clinical data from the ongoing Phase 1/2 trial evaluating darovasertib monotherapy and binimetinib combination therapy in patients with solid tumors, including Metastatic Uveal Melanoma, or MUM, and Skin Melanoma. There have been 81 darovasertib monotherapy BID MUM and seven Skin Melanoma patients enrolled across the Ideaya and Novartis (NVS) Phase 1/2 clinical trials at the time of data and analyses cutoff on April 13, with an aggregate of 88 patients evaluable for safety and 81 evaluable for efficacy based on RECIST 1.1. Reported data is preliminary and based on an unlocked database. Evaluation and follow-up of the monotherapy arm of the clinical trial continues. Overall, a 57% one-year overall survival, or OS, rate was observed in predominantly second line, third line and heavily pre-treated MUM patients with 95% CI. Historical one-year OS rate in similar MUM populations has been reported at 37%. Median OS of 13.2 months was observed in predominanantly second line, third line and heavily pre-treated MUM patients with 95% CI. Historical median OS in similar MUM populations has been reported at approximately seven months. In total, 61% of MUM patients out of 75 evaluable had tumor reduction per RECIST 1.1. evaluation, including 15 patients with greater than 30% target lesion reduction and one confirmed complete response. In the Skin Melanoma cohort, 80% of evaluable patients had tumor reduction per RECIST 1.1. evaluation, including one confirmed partial response. Overall safety profile of darovasertib monotherapy is consistent with prior reports and includes primarily common low grade but manageable GI toxicities and hypotension. The combination of darovasertib plus binimetinib is being evaluated pursuant to a clinical trial collaboration and drug supply agreement with Pfizer (PFE), which the companies have amended to support a target enrollment of approximately 40 patients in the darovasertib and binimetinib clinical combination arm in MUM. At the time of the data and analyses cutoff on April 13, twenty four MUM patients have enrolled in the darovasertib and binimetinib combination study, including eight patients dosed in the Phase 1/2 dose expansion cohort of the combination study. Reported data is preliminary and based on an unlocked database. Enrollment in the darovasertib and binimetinib combination arm of the clinical trial is ongoing. Two partial responses observed out of nine MUM patients with at least two post-baseline scans by RECIST 1.1 guidelines, including one confirmed partial response and one unconfirmed partial response awaiting a confirmatory scan 79% of evaluable MUM patients with at least one post-baseline scan show tumor reduction; follow-up for overall response is still immature. Combination doses for Phase 1/2 dose expansion have been selected based on anticipation of activity and overall tolerability in a larger treatment cohort Treatment-related adverse events observed in the darovasertib and binimetinib combination arm in MUM primarily include: nausea, vomiting, diarrhea, rash, edema, AST/ALT increase and CK increase and hypotension. Ideaya's clinical development strategy in MUM is focused on darovasertib combinations, including with binimetinib, a MEK inhibitor, and in a separate clinical study with crizotinib, a cMET inhibitor, each pursuant to the clinical trial collaboration and drug supply agreement with Pfizer.