Cyclacel Pharmaceuticals announced Phase 1 clinical data from the company’s DNA damage response program with an oral, sequential regimen of sapacitabine and seliciclib as a treatment in patients with BRCA mutant metastatic breast cancer. Data from the study was presented at the American Association for Cancer Research, or AACR and demonstrated that the regimen was safe and led to a clinical benefit rate of 30%. All eight PARP inhibitor naive patients, half of the patients previously treated with platinum agents and one on previous PARP inhibitor responded. Progression on previous platinum or PARP inhibitors was associated with lack of benefit. Both sapacitabine and PARP inhibitors are more effective in cancer cells with BRCA mutations or other homologous recombination repair deficiencies. Based on these data, the investigators are enrolling a Phase 1b/2 study of sapacitabine in combination with a PARP inhibitor in PARP inhibitor-naive patients with BRCA mutant breast cancer. The study evaluated an oral, sequential regimen of sapacitabine, a nucleoside analog prodrug, and seliciclib, a first generation CDK2/9 inhibitor, in patients with metastatic breast cancer harboring BRCA1/2 mutations. Patients received seven days of sapacitabine followed by three days of seliciclib. Of 20 patients treated, six progressed on prior platinum therapy and seven on prior PARP inhibitor. Two patients achieved confirmed progressed response, or PR, and four SD of at least 6 months duration for an overall clinical benefit rate of 30%. Of the two patients achieving PR, one progressed previously on platinum treatment and one had received no prior platinum or PARP inhibitor. Responses occurred in 12 patients. The most frequent grade 3 adverse events were neutropenia, AST/ALT elevation and rash. The only grade 4 adverse events were neutropenia in two patients. Progression on previous platinum agents or PARP inhibitors was associated with lack of benefit, putatively associated in some cases with BRCA reversion alterations.
Monday, April 1, 2019
Biohaven Pharmaceutical enrolls first patient in Phase 2/3 Trial of BHV-3500
Biohaven Pharmaceutical announced that it enrolled the first patient in a Phase 2/3, double-blind, randomized, placebo-controlled, dose-ranging trial of intranasally administered BHV-3500 for the acute treatment of migraine. BHV-3500 is a novel, structurally distinct, third-generation calcitonin gene-related peptide receptor antagonist being developed by Biohaven. Topline efficacy and safety results are expected in the fourth quarter.
Ziopharm initiated with a Buy at Laidlaw
Laidlaw analyst Yale Jen initiated Ziopharm with a Buy and $7.50 price target.
JPMorgan ‘encouraged on several fronts’ after Guardant Health meetings
JPMorgan analyst Tycho Peterson says he walked away from investor meetings with Guardant Health management “encouraged on several fronts.” The analyst sees continued progress on reimbursement via the Palmetto draft local coverage determination and highlights management’s confidence in driving volumes via ramping adoption. Guardant offers an attractive sales growth profile driven by continued traction in G360/OMNI and “steady momentum” in biopharma partnerships, as well as a “relatively clear line-of-sight” to expanded clinical reimbursement, Peterson tells investors in a research note. He continues to view Guardant Health as a “best-in-class asset in the attractive liquid biopsy space.” Furthermore, the recent 20% share pullback from all-time highs heading into the lock-up expiration has resulted in renewed investor interest, says the analyst. He reiterates an Overweight rating on Guardant Health with an $85 price target.
Inovio completes enrollment of Phase 1/2 immuno-oncology trial ahead of schedule
Inovio () announced that its Phase 1/2 immuno-oncology trial in patients with newly diagnosed glioblastoma has completed its enrollment three months ahead of schedule. The 52-patient trial is designed to evaluate Inovio’s INO-5401 T cell activating immunotherapy encoding multiple antigens expressed by GBM and INO-9012, an immune activator encoding IL-12, in combination with cemiplimab-rwlc, a PD-1 inhibitor developed by Regeneron Pharmaceuticals (REGN) in collaboration with Sanofi (SNY). This trial information will be presented at Phase I-III Trials in Progress session at the Annual Meeting of the American Association for Cancer Research being held in Atlanta. Inovio expects to report interim results from this study before the end of this year evaluating safety, immunological impact, progression-free survival and overall survival.
Global Blood Therapeutics price target raised to $96 from $85 at Wells Fargo
Wells Fargo analyst Jim raised his price target for Global Blood Therapeutics to $96 from $85 following senior management meetings with investors in Europe last week. Overall, the analyst came away with continued confidence in voxelotor safety and efficacy, prospects for accelerated approval, positioning within the evolving SCD market, opportunity for additional growth beyond initial labeling and broader opportunity to lead a transformation of SCD treatment in a similar way as seen previously in blood disorders like myeloma. Birchenough reiterates an Outperform rating on the shares.
ShockWave Medical initiated with a Market Perform at Wells Fargo
Wells Fargo analyst Larry Biegelsen started coverage of ShockWave Medical with a Market Perform rating and a $33 price target. The analyst believes the company’s intravascular lithotripsy is an innovative technology that has several key advantages over the competition, and that it will be able to both grow the market opportunity for calcium modification devices and take share from the atherectomy players. That stated, at current valuations, Biegelsen does not see the potential for meaningful multiple expansion.
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