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12:36 PM, Feb 23, 2018  |  BC Week In Review | Clinical News  |  Clinical Status

FDA clears MabSpace's PD-L1 mAb for first-in-human trial

MabSpace Biosciences Co. Ltd. (Suzhou, China) said FDA approved an IND to begin a first-in-human trial of MSB2311 to treat advanced or metastatic solid tumors. MSB2311, a humanized IgG1 mAb targeting PD-L1, will be MabSpace's...
12:35 PM, Feb 23, 2018  |  BC Week In Review | Clinical News  |  Clinical Status

Eli Lilly stops Phase II trial of BTK inhibitor in RA

Eli Lilly and Co. (NYSE:LLY) discontinued the Phase II RAjuvenate trial of HM71224 (LY3337641) to treat rheumatoid arthritis after a planned analysis showed that the difference between the active and placebo control arms "was not...
12:35 PM, Feb 23, 2018  |  BC Week In Review | Clinical News  |  Clinical Status

Wilson Therapeutics starts Phase III of WTX101 for Wilson's disease

The single-blind, international trial will enroll about 100 patients. The primary endpoint is non-inferiority of WTX101 to standard of care on copper control as measured by the percentage change in free copper levels in blood...
1:12 PM, Feb 16, 2018  |  BC Week In Review | Clinical News  |  Clinical Status

Sorrento, Yuhan JV to start Korean trials of anti-PD-L1 mAb

Sorrento Therapeutics Inc. (NASDAQ:SRNE) said the South Korean Ministry of Food and Drug Safety (MFDS) approved an IND to begin Phase I testing of STI-A1015 (IMC-001) to treat solid tumors. STI-A1015 is a mAb against...
12:59 PM, Feb 16, 2018  |  BC Week In Review | Clinical News  |  Clinical Status

U.K. trial hold for Sarepta's SRP-4045 combo

Sarepta Therapeutics Inc. (NASDAQ:SRPT) said it halted dosing at U.K. study sites in the Phase III ESSENCE trial evaluating golodirsen (SRP-4053) and casimersen (SRP-4045) to treat Duchenne muscular dystrophy. In a statement, the company said the...
12:58 PM, Feb 16, 2018  |  BC Week In Review | Clinical News  |  Clinical Status

U.K. trial hold for Sarepta's SRP-4053 combo

Sarepta Therapeutics Inc. (NASDAQ:SRPT) said it halted dosing at U.K. study sites in the Phase III ESSENCE trial evaluating golodirsen (SRP-4053) and casimersen (SRP-4045) to treat Duchenne muscular dystrophy. In a statement, the company said the...
12:44 PM, Feb 16, 2018  |  BC Week In Review | Clinical News  |  Clinical Status

Biogen updates Phase III AD studies

EVP and CMO Alfred Sandrock from Biogen Inc. (NASDAQ:BIIB) said the company will enroll a total of an additional 510 patients in the Phase III ENGAGE and EMERGE trials of aducanumab (BIIB037) to treat early...
5:05 AM, Feb 16, 2018  |  BC Week In Review | Clinical News  |  Clinical Status

Merck halts Phase III trial of AD candidate verubecestat

Merck & Co. Inc. (NYSE:MRK) stopped the double-blind, international Phase III APECS trial of verubecestat (MK-8931) to treat prodromal Alzheimer’s disease after an external DMC said it was unlikely the trial would establish a positive...
12:19 PM, Feb 02, 2018  |  BC Week In Review | Clinical News  |  Clinical Status

Cabiralizumab in Phase II for pancreatic cancer, Five Prime receives $25M milestone

Bristol-Myers Squibb Co. (NYSE:BMY) began a Phase II trial to evaluate cabiralizumab (FPA008) plus Opdivo nivolumab with and without chemotherapy in patients with locally advanced or metastatic pancreatic cancer that progressed during or after one...
12:15 PM, Feb 02, 2018  |  BC Week In Review | Clinical News  |  Clinical Status

Bellicum announces trial holds for switch T cell candidates

Bellicum Pharmaceuticals Inc. (NASDAQ:BLCM) said FDA placed a clinical hold on U.S. trials of the company's adjunct, safety switch-containing T cell therapy BPX-501 in patients receiving partial match hematopoietic stem cell transplants (HSCTs). According to...

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