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11:34 AM, Oct 19, 2018  |  BC Week In Review | Clinical News  |  Clinical Status

Apellis pauses Phase III trials after single lot of APL-2 causes inflammation

Apellis Pharmaceuticals Inc. (NASDAQ:APLS) voluntarily paused dosing in Phase III trials of intravitreal APL-2 to treat geographic atrophy due to eight reported cases of non-infectious inflammation in patients treated from a single manufacturing lot of...
10:49 AM, Oct 19, 2018  |  BC Week In Review | Clinical News  |  Clinical Status

FDA OKs U.S. trial for Alphamab Oncology's HER2 bispecific antibody

Alphamab Oncology (Suzhou, China) said it received clearance from FDA to begin a U.S. Phase I trial of KN026, a HER2 bispecific antibody. Alphamab Oncology Chairman and CEO Ting Xu said in a statement that this...
10:35 AM, Oct 19, 2018  |  BC Week In Review | Clinical News  |  Clinical Status

Transgene brings IV oncolytic virus into the clinic for GI tumors

Transgene S.A. (Euronext:TNG) started a European Phase I/II trial to evaluate its IV-administered oncolytic virus TG6002 in combination with oral 5-fluorouracil (5-FU) chemotherapy prodrug in patients with gastrointestinal tumors. TG6002's viral vector expresses the Saccharomyces...
11:17 AM, Oct 12, 2018  |  BC Week In Review | Clinical News  |  Clinical Status

Clinical holds for Affimed's T cell bispecific following patient death

Affimed N.V. (NASDAQ:AFMD) fell $1.13 (24%) to $3.50 Oct. 9 after it placed a clinical hold on two studies of blood cancer candidate AFM11 following three treatment-related serious adverse events, including a patient death. The...
11:16 AM, Oct 12, 2018  |  BC Week In Review | Clinical News  |  Clinical Status

Alphamab's bispecific checkpoint antibody enters clinic in Australia, Chinese trials planned

Alphamab Oncology (Suzhou, China) started an Australian Phase I trial of KN046 to treat advanced solid tumors. Data are expected this quarter. Alphamab also said China's National Medical Products Administration (NMPA) approved an IND for the...
11:14 AM, Oct 12, 2018  |  BC Week In Review | Clinical News  |  Clinical Status

FDA lifts hold on IND for CRISPR's sickle cell trial

CRISPR Therapeutics AG (NASDAQ:CRSP) and partner Vertex Pharmaceuticals Inc. (NASDAQ:VRTX) said FDA lifted a clinical hold on an IND for a Phase I/II trial of gene therapy CTX001 to treat sickle cell disease. Vertex declined...
11:36 AM, Sep 28, 2018  |  BC Week In Review | Clinical News  |  Clinical Status

TG won't seek accelerated approval of CLL combo

TG Therapeutics Inc. (NASDAQ:TGTX) shed $4.10 (44%) to $5.15 on Sept. 25 after the company said it will not seek accelerated approval of ublituximab (TG-1101) plus umbralisib (TGR-1202) to treat chronic lymphocytic leukemia. The company...
10:38 AM, Sep 28, 2018  |  BC Week In Review | Clinical News  |  Clinical Status

Cell Medica doses first neuroblastoma patient with NK cell therapy

Cell Medica Ltd. (London, U.K.) dosed the first patient in the open-label, U.S. Phase I GINAKIT2 trial of CMD-501 to treat relapsed or refractory pediatric neuroblastoma, which the company said marks the first use of...
10:27 AM, Sep 28, 2018  |  BC Week In Review | Clinical News  |  Clinical Status

FDA lifts holds on Epizyme, Sarepta programs

FDA lifted separate clinical holds on tazemetostat from Epizyme Inc. (NASDAQ:EPZM) and a gene therapy program targeting micro-dystrophin from Sarepta Therapeutics Inc. (NASDAQ:SRPT), the companies said Sept. 24. Epizyme is reopening enrollment in all of its...
10:38 AM, Sep 21, 2018  |  BC Week In Review | Clinical News  |  Clinical Status

Sosei, Allergan to delay trials of dementia candidate

Sosei Group Corp. (Tokyo:4565) and partner Allergan plc (NYSE:AGN) have suspended clinical development of neurodegenerative candidate HTL0018318 to investigate a toxicity signal -- a rare tumor -- found in a non-human primate treated with the...

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