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.
Monday, April 1, 2019
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.
TG Therapeutics reports data from MZL cohort of Phase 2b UNITY-NHL trial
TG Therapeutics reported interim data from the ongoing single-arm marginal zone lymphoma, or MZL, cohort of its Phase 2b clinical trial known as UNITY-NHL. The MZL cohort of UNITY-NHL is designed to investigate umbralisib as a single agent in patients with relapsed or refractory MZL. Umbralisib is an investigational, oral, once daily PI3K delta inhibitor with unique inhibition of CK1 epsilon and is currently under development for the treatment of non-Hodgkin lymphoma, or NHL, and chronic lymphocytic leukemia, or CLL. The MZL cohort of UNITY-NHL enrolled patients with relapsed or refractory MZL who had received prior treatment with one or more lines of therapy including at least one anti-CD20 regimen. In August 2018, the trial completed enrollment with 69 treated patients. The interim data reported included safety and tolerability data on all 69 treated patients and efficacy data on 42 patients who were enrolled at least 9 cycles prior to the data cut-off date. The primary endpoint is overall response rate, or ORR, as assessed by IRC using criteria adopted from the International Working Group criteria for malignant lymphoma. Overall, there was 88% clinical benefit rate by IRC. All patients achieving a complete response by IRC remain on study and 86% of patients had a reduction in tumor burden The median time to initial response was 2.7 months. Interim safety data were presented for all 69 treated patients with a median duration of exposure of 6.9 months. No unexpected toxicities were observed. The most common adverse events were diarrhea, nausea and fatigue, with the majority of events grade 1 in severity. The most frequent grade 3 or higher adverse events were neutropenia, diarrhea and ALT/AST increase, observed in 13%, 10% and 10% of patients, respectively. A subgroup analysis of patients treated for greater than six cycles was also conducted to evaluate long-term incidence of key toxicities of interest occurring after six cycles of treatment. Median duration of treatment of this subgroup was 10.1 months. In this subgroup, grade 3 or higher adverse events of interest were rare, limited to two patients with diarrhea and one patient with pneumonitis, with no events of ALT/AST elevation, pneumonia or colitis.
Pulmatrix in term sheet with Cipla Technologies to develop Pulmazole
Pulmatrix announced its entry into a Binding Term Sheet with Cipla Technologies, a subsidiary of Cipla for the co-development and commercialization of Pulmazole – an inhaled iSPERSE formulation of the anti-fungal drug itraconazole for the treatment of allergic bronchopulmonary aspergillosis in patients with asthma. The Binding Term Sheet lays the groundwork for entry into a definitive agreement with Cip Tec during the second quarter. Per the Binding Term Sheet, subject to entry into the definitive agreement, Cip Tec will make an upfront payment of $22M to Pulmatrix in exchange for an assignment of all rights to Pulmazole to Cip Tec. However, following this assigning, Pulmatrix will retain the right to receive 50% of the free cash flow from future sales of Pulmazole. In addition, Pulmatrix will remain primarily responsible for the implementation of the clinical development of Pulmazole and Cip Tec will be responsible for implementation of the commercialization of the product. Entry into a definitive agreement is contingent upon, Pulmatrix having at least $15M in unencumbered funds.
Evolus expects CHMP opinion on Nuceiva during April committee meeting
Evolus announced it expects the European Medicines Agency, or EMA, Committee for Medicinal Products for Human Use, or CHMP, to adopt a formal opinion on the Nuceiva marketing authorization application, or MAA, during the April committee meeting. Nuceiva is being evaluated by the EMA for the temporary improvement in the appearance of moderate to severe vertical lines between the eyebrows seen at maximum frown, when the severity of the above facial lines has an important psychological impact in adults below 65 years of age.
Aslan data show comparable activity to Dupixent, says Piper Jaffray
Aslan Pharmaceuticals reported preliminary Phase I single-ascending dose data on intravenous ASLAN004 demonstrating the IL13 receptor antibody to be safe and well tolerated in healthy volunteers with no discontinuations due to adverse events, Piper Jaffray analyst Edward Tenthoff tells investors in a research note. ASLAN004 caused complete inhibition of phosphorylation of STAT6 within one hour lasting for greater than 29 days, adds the analyst. He believes these results present the opportunity for once-monthly dosing of ASLAN004 with comparable activity to Regeneron’s (REGN) Dupixent. Tenthoff reiterates an Overweight rating on Aslan Pharmaceuticals with a $7 price target.
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