Week In Review: Alphamab Oncology Plans $350 Million Hong Kong IPO

AstraZeneca (NYSE: AZN) and Merck/MSD (NYSE: MRK) were approved to sell their jointly marketed PARP inhibitor in China as a first-line maintenance treatment for BRCA-mutated ovarian cancer (see story). In a Phase III trial among patients who responded to platinum-based chemotherapy, 60% of Lynparza patients hit the 36-month point without disease progression or death, against 27% for women receiving placebo, a 70% improvement. Results of the Phase III SOLO-1 trial showed 15% of ovarian cancer patients have a germline (inherited) BRCA 1/2 mutation and 7% have a somatic (acquired) mutation.

Innovative Cellular Therapeutics (ICT), a Shanghai-US CAR-T company, reported the US FDA approved its IND for ICTCAR014, a next gen CD19-targeting CAR-T cell therapy (see story). ICT said ICTCAR014 expresses a dominant negative PD-1 protein to block immunosuppression by cancer cells. The company expects the US trial will test ICTCAR014 in patients with relapsed or refractory non-Hodgkin lymphoma, including patients with PD-L1 positive tumors. ICT, which has already completed a China trial of ICTCAR014, plans to move its products rapidly through proof-of-concept trials in China and then expand into US and global development.

Bio-Thera (NYSE: JNJ), a Guangzhou biotech, was approved by China's National Medical Products Administration to start a Phase I trial that compares its Stelara® biosimilar to the original (see story). Johnson & Johnson's Stelara is indicated to treat immune disorders including Crohn's disease, ulcerative colitis and psoriasis conditions. The China trial, which will test the pharmacokinetics and safety of Bio-Thera's BAT2206, will enroll about 270 healthy volunteers. BAT2206 will be the fifth Bio-Thera biosimilar to begin clinical trials.

CASI Pharma (Nasdaq: CASI) announced China approval to start clinical trials of CNCT19, a CD19 CAR-T treatment, in leukemia and lymphoma patients (see story). Earlier this year, CASI acquired global rights to the candidate from Juventas Cell Therapy of Beijing in exchange for an $11.6 million investment in Juventas rather than an upfront payment. Juventas retains responsibility for trials of CNCT19. CASI, a Maryland-China biopharma, said the CD19 CAR-T therapy will be tested in patients with relapsed/refractory B-cell acute lymphoblastic leukemia and relapsed/refractory B-cell non-Hodgkin lymphoma.

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