Iovance Biotherapeutics announced data from an investigation of the persistence and diversity of circulating T cells from metastatic melanoma patients from the innovaTIL-01 study receiving lifileucel TIL therapy. Results from an analysis of the persisting T cell clones circulating 42 days following infusion, as compared to the initial TIL product, demonstrated two phenomena: first, that TIL product from 100 percent of the evaluated patients in Cohort 2 of the innovaTIL-01 trial are persisting in circulation at 42 days post-infusion, and second, that each patient has a unique TIL product with almost no overlap between patients for expanding clones in the human body observed post-infusion. Furthermore, the small number of overlapping clones between a few patients were not associated with a clinical response. The uniqueness of the clonal profiles associated with response highlights the challenge of identifying a few T cell receptors as mediators of activity and supports using a polyclonal product such as the Iovance bulk TIL to treat high mutational load solid tumors.
Monday, April 1, 2019
Cowen ups AstraZeneca to Outperform after cancer partnership pullback
As previously reported, Cowen analyst Steve Scala upgraded AstraZeneca to Outperform from Market Perform, stating that the 5% stock decline on news of the company’s partnership with Daiichi Sankyo for trastuzumab deruxtecan, which he calls a “promising” breast cancer drug, offers a compelling entry point. Key opinion leading doctors he speaks with anticipate use of trastuzumab deruxtecan in many patients with metastatic HER2+ disease, while low HER2+ “shows promise but requires more data,” said Scala. Meanwhile, Imfinzi, Tagrisso and Lynparza all have “big potential” and Roxadustat “offers upside,” the analyst tells investors. He raised his price target on AstraZeneca shares to $48 from $42.
Fate Therapeutics presents data on clonal master engineered iPSC lines
Fate Therapeutics presented late-breaking preclinical data highlighting the company’s “unmatched ability to mass produce uniformly engineered chimeric antigen receptor T cells for off-the-shelf cancer immunotherapy” at the American Association of Cancer Research Annual Meeting 2019 in Atlanta, Georgia. New preclinical data presented at AACR for FT819, the company’s universal, off-the-shelf CAR19 T-cell product candidate being developed under a collaboration with Memorial Sloan Kettering Cancer Center led by Michel Sadelain, M.D., Ph.D., demonstrate the production of clonal master engineered iPSC lines having complete elimination of T-cell receptor expression and insertion of a novel 1XX CAR signaling domain into the T-cell receptor alpha locus. These synthetic features are intended to mitigate the risk of graft-versus-host disease, a severe life-threatening condition that occurs when donor T cells attack a patient’s healthy tissue, and to regulate CAR expression to enhance the therapeutic profile of CAR T cells.
PolarityTE enrolls patients in trials evaluating SkinTE
PolarityTE announced that patient enrollment has begun for two new randomized controlled trials evaluating SkinTE for the treatment of chronic wounds, specifically diabetic foot ulcers and venous leg ulcers. SkinTE is commercially available through a regional market release and is a first-of-its-kind autologous, homologous human cellular and tissue-based product designed to regenerate full-thickness, functional skin for skin repair, reconstruction and replacement.
Advaxis: ADXS-PSA in combination with KEYTRUDA prolonged survival in mCRPC
Advaxis says ADXS-PSA in combination with KEYTRUDA prolonged survival in mCRPC Advaxis () announced updated data from the Phase 1/2 KEYNOTE-046 study in metastatic, castration-resistant prostate cancer. This trial is being conducted in conjunction with Merck (MRK) and is evaluating ADXS-PSA, one of Advaxis’ Listeria monocytogenes-based immunotherapies, alone and in combination with KEYTRUDA, Merck’s anti-PD-1 therapy. Findings will be highlighted in a poster discussion entitled “Effects of ADXS-PSA with or without Pembrolizumab on Survival and Antigen Spreading in Metastatic, Castration-Resistant Prostate Cancer Patients” at the American Association for Cancer Research Annual Meeting underway in Atlanta. KEYNOTE-046 is an open-label, multicenter, dose-determining safety and tolerability Phase 1/2 trial of 50 heavily pretreated patients conducted in two parts, with a Phase 2 expansion cohort. The objective of the study is to evaluate ADXS-PSA alone and in combination with KEYTRUDA for primary endpoints that include safety, tolerability and dosing. Secondary endpoints include anti-tumor activity and progression-free survival, and exploratory endpoints include associations between biomarkers of immunologic response with clinical outcomes. Key findings from the combination arm of KEYNOTE-046 include the following: The majority of treatment-related adverse events consisted of transient and reversible Grade 1-2 chills/rigors, fever, hypotension, nausea and fatigue. The combination of ADXS-PSA and pembrolizumab has been well-tolerated, to date, with no additive toxicity observed. Median overall survival was 21.1 months at data cutoff in this dataset of 37 patients. Correlative immune analyses showed T-cell responses against PSA in 75% of subjects and antigen spreading in 85% of subjects. Broader immune stimulation, including B-cell activation, was observed in the combination arm than in the ADXS-PSA monotherapy arm.
Teva receives EU marketing authorization for AJOVY
Teva Pharmaceutical Industries announced that the European Commission has granted the Marketing Authorization for AJOVY 225 mg solution for injection in pre-filled syringe for the prophylaxis of migraine in adults who have at least four migraine days per month. AJOVY is a humanized monoclonal antibody that binds to the calcitonin gene-related peptide ligand and blocks its binding to the receptor. AJOVY was evaluated in two pivotal Phase III clinical trials that enrolled patients with disabling migraine and studied fremanezumab as a prophylactic treatment for migraine in adults. In these trials, patients treated with fremanezumab had a significantly greater reduction in migraine days compared to placebo. Adverse drug reactions observed with fremanezumab were mostly mild to moderate, short-lasting skin reactions around the injection area: pain, hardening, redness, itching and rash at the injection site. The EC decision is applicable to all 28 EU member states plus Iceland, Norway and Liechtenstein after transposition into legally binding acts in these countries. AJOVY received U.S. FDA approval for the preventive treatment of migraine in adults on 14 September 2018. Additional regulatory filings are underway with other health authorities worldwide.
Amneal Pharmaceuticals agrees with Zentiva to divest Creo Pharma
Amneal Pharmaceuticals announced that it has entered into an agreement with Zentiva Group, under which Zentiva has acquired Creo Pharmaceuticals, a subsidiary of Amneal that operates the company’s commercial operations in the United Kingdom.
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