SHANGHAI, China — Immunofoco, a company dedicated to developing cell therapy products for solid tumors, announced a significant milestone, that following the approval by the CDE in China for the clinical trial application of IMC001, an EpCAM-targeting autologous CAR-T cell product for infusion, it also received the IND approval from...
treatment News
BOTHELL, Wash. — Immunome, Inc. (Nasdaq: IMNM), a biotechnology company committed to developing first-in-class and best-in-class targeted cancer therapies, today announced positive topline results from the global pivotal Phase 3 RINGSIDE trial of varegacestat, an investigational, oral, once-daily gamma secretase inhibitor (GSI), in patients with progressing desmoid tumors. he trial...
BOTHELL, Wash. — Immunome, Inc. (Nasdaq: IMNM), a biotechnology company committed to developing first-in-class and best-in-class targeted cancer therapies, today announced the submission of a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for varegacestat, an investigational, oral, once-daily gamma secretase inhibitor (GSI), for the treatment...
HOUSTON – ImmunoMet Therapeutics, Inc., a clinical stage biotechnology company targeting metabolism to develop novel anti-fibrotic and anti-cancer therapies, today announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation for its lead compound IM156, an investigational Protein Complex 1 (PC1) inhibitor, being evaluated for idiopathic...
Barcelona, Spain – Patients with metastatic or recurrent cervical cancer not amenable to curative surgery and/or radiotherapy have a poor prognosis with limited treatment options. First-line treatment in this setting consists of combination cisplatin/paclitaxel chemotherapy plus antiangiogenic agent bevacizumab. This therapeutic strategy was approved based on the results of the...
Boston, Mass. – For the first time in fifty years, results from a phase 3 randomized, placebo-controlled trial have shown an overall survival benefit from an adjuvant therapy in patients with kidney cancer. Treatment with pembrolizumab, an immunotherapy drug, after surgery significantly prolonged overall survival in patients with clear-cell renal-cell...
NEW YORK, NY — Immunovant, Inc. (Nasdaq: IMVT), a clinical-stage immunology company dedicated to enabling normal lives for people with autoimmune diseases, today shared an abstract with six-month off-treatment data in uncontrolled Graves’ disease (GD) patients treated with batoclimab for 24 weeks, to be presented at the 2025 Annual Meeting...
SAN FRANCISCO, Calif. — Immusoft of CA, a clinical-stage biotechnology company pioneering engineered B cell therapies, today announced that the U.S. Food and Drug Administration (FDA) has granted Rare Pediatric Disease (RPD) designation to ISP-002, the company’s investigational therapy for the treatment of mucopolysaccharidosis type II (MPS II), also known as Hunter...
SAN FRANCISCO, Calif. — Immusoft of CA, a clinical-stage biotechnology company pioneering engineered B cell therapies, today announced that the U.S. Food and Drug Administration (FDA) has granted Orphan Drug Designation to ISP-002, the Company’s investigational engineered B cell therapy for the treatment of mucopolysaccharidosis type II (MPS II), also known as...
SYDNEY, Australia — Immutep Limited (ASX: IMM; NASDAQ: IMMP) (“Immutep” or “the Company”), a late-stage immunotherapy company targeting cancer and autoimmune diseases, today announces a patient enrolment update for the TACTI-004 (KEYNOTE-F91) Phase III trial evaluating eftilagimod alfa (efti) in combination with MSD’s (Merck & Co., Inc., Rahway, NJ, USA) anti-PD-1...