The FDA approved Kite Pharma Inc.’s Tecartus (brexucabtagene autoleucel, KTE-X19), the first cell-based gene therapy for adults with mantle cell lymphoma (MCL) who have not responded to or who have relapsed following other kinds of treatment.
DUBLIN – Although Europe has moved first to approve Blenrep (belantamab mafodotin), Glaxosmithkline plc’s antibody-drug conjugate (ADC) as a fifth-line therapy in relapsed or refractory multiple myeloma, U.S. patients may well be first to gain access to the new drug.
HONG KONG – Looking to boost its R&D capacity, China’s Sunshine Guojian Pharmaceutical (Shanghai) Co. Ltd. launched an IPO on July 22 that raised ¥1.7 billion (US$240 million) on Shanghai’s STAR market. Shares (SSE:688336) almost doubled in value on the first day of trading, closing at ¥54.10, for a gain of 92%.
LONDON – Swiss startup T3 Pharma AG has raised CHF25 million (US$26.7 million) in a series C round, to fund a 100-patient phase I/II study of its live bacteria cancer immunotherapy.
Strata Oncology Inc. has inked an agreement with newcomer Elevation Oncology to ramp up patient identification and enrollment for the latter’s phase II CRESTONE study evaluating the use of seribantumab in patients with recurrent, locally advanced or metastatic solid tumors of any origin that have a neuregulin-1 (NRG1) gene fusion.
DUBLIN – Tubulis GmbH raised €10.7 million (US$12.3 million) in a series A round to progress a next-generation antibody-drug conjugate (ADC) platform, which, it claims, will improve both the stability of ADC constructs and the efficiency with which they are generated.
The first bispecific antibody to win regulatory approval, Removab (catumaxomab) was voluntarily withdrawn due to commercial reasons. Now Chinese biotech Lintonpharm Co. Ltd., of Guangzhou, said it plans to move catumaxomab to a global phase III trial following an IND approval from China’s NMPA, investigating the trifunctional bispecific antibody in patients with peritoneal carcinomatosis, a form of advanced gastric cancer.
HONG KONG – China and U.S.-based pharmaceutical company Antengene Corp. has closed a $97 million series C financing round, with proceeds mainly directed toward funding the continuing clinical development of its pipeline of hematology and oncology therapies.
IPOs from Alx Oncology Holdings Inc. and Pandion Therapeutics Inc. launched July 17 as investors continued to pour money into biopharma’s public sector. Through June, $8.53 billion in biopharma IPOs had been filed so far this year by 35 companies.
Robust financial markets continue to fuel the industry despite gloom over the COVID-19 pandemic, with Relay Therapeutics Inc. pricing its upsized, 20 million-share IPO at $20 per unit to reap $400 million.
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