On a reported currency basis, the company anticipates approximately 4c per share of adverse currency impact.
Tuesday, April 2, 2019
Allergan, Molecular Partners announce results from MAPLE study of abicipar
Allergan and Molecular Partners announced topline safety results from MAPLE, a 28 week open-label study which enrolled 123 age-related Neovascular Macular Degeneration patients and evaluated the safety of abicipar produced via a modified manufacturing process. In this single arm study, treatment naive or prior anti-VEGF treated patients received three monthly 2mg abicipar injections followed by 2mg injections every 8 weeks for up to a total of five injections through week 28. As a result of the improvements in the manufacturing process, the incidence of intraocular inflammation was 8.9% in the MAPLE study, which was lower than the rate observed in prior Phase 3 studies. Most IOI events were assessed as mild to moderate in severity. The incidence of severe IOI was 1.6% with one reported case of iritis and one reported case of uveitis. There were no reported cases of endophthalmitis or retinal vasculitis in this study. Allergan expects to file the abicipar Biologics License Application with the U.S. FDA in the first half of 2019. Additional data from the MAPLE study will be presented at a scientific conference later in 2019.
Sangamo, Pfizer announce Phase 1/2 interim data for SB-525 gene therapy
Sangamo Therapeutics (SGMO) and Pfizer (PFE) announced interim data from the Phase 1/2 Alta study evaluating investigational SB-525 gene therapy for severe hemophilia A. Data indicate that SB-525 was generally well-tolerated and demonstrated a dose-dependent increase in Factor VIII levels across the four dosage cohorts. Eight patients total were dosed. Based on these results, the Safety Monitoring Committee recommended cohort expansion at the 3e13 vg/kg dose. The Phase 1/2 interim data include eight patients treated across four ascending dosage cohorts. Patients demonstrated a dose-dependent increase in FVIII levels, achieving clinically relevant increases in FVIII activity in the higher dosage cohorts and normal FVIII levels in the 3e13 vg/kg dose cohort. At week 6 post infusion, the two fourth dose cohort patients reached 140% and 94% of normal and 93% and 65%. A dose-dependent reduction in the use of Factor VIII replacement therapy was also observed, with patients in the highest dose cohort not requiring factor replacement therapy after initial use of prophylactic factor and experiencing no bleeding events to date. SB-525 was generally well-tolerated, with one patient reporting a treatment-related serious adverse event of hypotension and fever, which occurred following vector infusion and resolved with treatment within 24 hours of completion of vector infusion. Patients in the Alta study were not treated with prophylactic steroids. No treatment-related serious adverse events and no ALT elevations requiring more than seven days of corticosteroid treatment were observed in the first three cohorts. One patient in the fourth cohort experienced an ALT elevation at week four that required a tapering course of oral steroids. The patient did not have any associated loss of Factor VIII activity or ALT elevations seven weeks following initiation of the steroid therapy. The same patient in the fourth cohort experienced the aforementioned serious adverse event. SB-525 comprises a recombinant adeno-associated virus serotype 6 vector encoding the complementary deoxyribonucleic acid for B domain deleted human FVIII. The SB-525 vector cassette was designed to optimize both the vector manufacturing yield and liver-specific FVIII protein expression. The SB-525 transcriptional cassette incorporates multi-factorial modifications to the liver-specific promoter module, FVIII transgene, synthetic polyadenylation signal and vector backbone sequence. Longer-term follow-up data will be presented at an upcoming scientific meeting. Per the SMC recommendation and study protocol, the fourth cohort will be expanded by up to five patients. Patient enrollment is underway.
Bausch + Lomb announces U.S. Launch of LOTEMAX SM
Bausch + Lomb announced it has begun distributing LOTEMAX SM 0.38% to U.S. pharmaceutical distributors. The company received final approval by the U.S. FDA on February 22. LOTEMAX SM is a new gel drop formulation of loteprednol etabonate, which was designed with novel SubMicron technology for efficient penetration to key ocular tissues at a low preservative level and a pH close to human tears. It is indicated for the treatment of postoperative inflammation and pain following ocular surgery.
Iovance doses first patient in in Cohort 4 of innovaTIL-01 study
Iovance announced that first patient has been dosed in Cohort 4, the pivotal cohort of the innovaTIL-01 study of lifileucel. Cohort 4 is designed to enroll 75 patients with advanced melanoma. InnovaTIL-01 is a pivotal phase 2 global multicenter study evaluating the safety and efficacy of Iovance’s autologous lifileucel TIL therapy for treatment of patients with metastatic melanoma.
ADMA Biologics reports FDA approves Asceniv intravenous immune globulin
ADMA Biologics announced that the U.S. Food and Drug Administration has approved Asceniv Immune Globulin Intravenous, Human – slra 10% Liquid, formerly referred to as RI-002. Asceniv is an Intravenous Immune Globulin drug product for the treatment of Primary Humoral Immunodeficiency Disease, or “PIDD,” in adults and adolescents. The company anticipates having the product available for commercial launch during the second half of 2019. “We are excited about this significant achievement in receiving FDA approval for Asceniv a novel, patented IVIG product that we feel is a necessary addition to existing available therapies for patients who suffer from PI. We hope availability of Asceniv will help ameliorate a portion of the current shortages facing U.S. IVIG supply,” stated Adam Grossman, President and CEO of ADMA Biologics. “With the receipt of Asceniv’s FDA approval, ADMA, at its sole option, can elect to access up to an additional $27.5M of available funding from Perceptive Advisors under ADMA’s existing credit facility. This option remains available to the company through June 2020, and such funds could be used to support the launch of Asceniv, procure plasma raw material inventory, and begin construction on potential new plasma centers, as well as for general corporate activities,” concluded Grossman.
https://thefly.com/landingPageNews.php?id=2887233
https://thefly.com/landingPageNews.php?id=2887233
Calithera Biosciences presents preclinical CB-708 data at AACR
Calithera Biosciences announced new data for the company’s CD73 inhibitor CB-708. The data will be presented at the American Association for Cancer Research, or AACR. CB-708 is a selective, oral inhibitor of CD73, an enzyme that synthesizes the immunosuppressive agent adenosine and is over-expressed in multiple tumor types. By blocking adenosine production in the tumor, CB-708 is designed to enhance T-cell activation leading to anti-tumor activity. Calithera plans to initiate clinical development of the compound in the second half of 2019. The preclinical data being presented demonstrates that CB-708 is a potent and selective inhibitor of CD73 that has immune-mediated, single agent activity in syngeneic mouse tumor models. In addition, in pre-clinical studies CB-708 is well-tolerated and shows enhanced anti-tumor activity when combined with either an anti-PD-L1 immunotherapy or with chemotherapeutic agents such as oxaliplatin or doxorubicin.
https://thefly.com/landingPageNews.php?id=2887239
https://thefly.com/landingPageNews.php?id=2887239
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