Humanigen Announces Completion of Enrollment in Phase 1 Study of Ifabotuzumab in Glioblastoma Multiforme
BURLINGAME, Calif. (BUSINESS WIRE) Humanigen, Inc.
(NASDAQ: HGEN) (“Humanigen”), a clinical stage biopharmaceutical company developing its portfolio of clinical and pre-clinical therapies for the treatment of cancers and infectious diseases,
today announced completing enrollment in its Phase 1 bioimaging study of ifabotuzumab in patients with recurrent glioblastoma multiforme (GBM). Ifabotuzumab, or ifab, is the Company’s proprietary anti-EphA3 monoclonal antibody. This trial is supported by funding from the Cure Brain Cancer Foundation. Results from the study, being conducted at the Olivia Newton-John Cancer Research Institute in Heidelberg, Victoria, Australia, are expected in the first half of 2021.
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Kite, a Gilead Company (Nasdaq: GILD), today announced that the European Commission has granted conditional marketing authorization for Tecartus™ (autologous, anti-CD19-transduced CD3+ cells; formerly KTE-X19). Tecartus is a chimeric antigen receptor (CAR) T cell therapy for adult patients with relapsed or refractory mantle cell lymphoma after two or more lines of systemic therapy including a Bruton’s tyrosine kinase (BTK) inhibitor. Conditional authorization is granted in the interest of public health where the benefit of immediate availability outweighs the risk of less comprehensive data available.
The conditional marketing authorization is supported from the multinational, single-arm, Phase 2 open-label ZUMA-2 pivotal trial in patients with relapsed or refractory mantle cell lymphoma who had previously received anthracycline- or bendamustine-containing chemotherapy, an anti-CD20 antibody therapy
Share: 93 Percent of Patients in ZUMA-2 Pivotal Trial Responded to Single Infusion of Tecartus Tecartus is First CAR T Therapy in Relapsed or Refractory MCL and Kite Becomes the First Company with Multiple Approved Cell Therapies in Europe
Kite, a Gilead Company (NASDAQ:GILD), today announced that the European Commission has granted conditional marketing authorization for Tecartus™ (autologous, anti-CD19-transduced CD3+ cells; formerly KTE-X19). Tecartus is a chimeric antigen receptor (CAR) T cell therapy for adult patients with relapsed or refractory mantle cell lymphoma after two or more lines of systemic therapy including a Bruton s tyrosine kinase (BTK) inhibitor. Conditional authorization is granted in the interest of public health where the benefit of immediate availability outweighs the risk of less comprehensive data available.
(2) 93 Percent of Patients in ZUMA-2 Pivotal Trial Responded to Single Infusion of Tecartus Tecartus is First CAR T Therapy in Relapsed or Refractory MCL and Kite Becomes the First Company with Multiple Approved Cell Therapies in Europe
Kite, a Gilead Company (Nasdaq: GILD), today announced that the European Commission has granted conditional marketing authorization for Tecartus (autologous, anti-CD19-transduced CD3+ cells; formerly KTE-X19). Tecartus is a chimeric antigen receptor (CAR) T cell therapy for adult patients with relapsed or refractory mantle cell lymphoma after two or more lines of systemic therapy including a Bruton s tyrosine kinase (BTK) inhibitor. Conditional authorization is granted in the interest of public health where the benefit of immediate availability outweighs the risk of less comprehensive data available.
Kite: European Commission Grants Conditional Marketing Authorization For Tecartus
FOSTER CITY (dpa-AFX) - Kite, a Gilead Company (GILD), announced the European Commission has granted conditional marketing authorization for Tecartus for the treatment of relapsed or refractory mantle cell lymphoma. Tecartus is a chimeric antigen receptor T cell therapy for adult patients with relapsed or refractory mantle cell lymphoma after two or more lines of systemic therapy.
The company said the conditional marketing authorization is supported from the multinational, single-arm, phase 2 open-label ZUMA-2 pivotal trial in patients with relapsed or refractory mantle cell lymphoma who had previously received anthracycline-
or bendamustine-containing chemotherapy, an anti-CD20 antibody therapy and a BTK inhibitor.