03:21 , Nov 17, 2018 |  BioCentury  |  Product Development

Betting Combos on Biomarkers

Despite lackluster monotherapy data at SITC from the latest tranche of immunotherapy candidates, drug developers are moving into combination trials with PD-1 and PD-L1 inhibitors based on biomarkers of pharmacodynamic activity. Results from the next...
22:19 , Nov 16, 2018 |  BC Extra  |  Company News

CHMP backs first all-oral sleeping sickness treatment, extensions for Blincyto, Opdivo-Yervoy combo

EMA's CHMP recommended a basket of approvals and label extensions on Friday, including the first all-oral treatment for African trypanosomiasis (sleeping sickness). The agency issued no negative opinions in its monthly roundup. The agency backed...
20:42 , Nov 16, 2018 |  BC Extra  |  Clinical News

Imfinzi fails again in MYSTIC trial for first-line NSCLC

In another strike against tremelimumab, AstraZeneca plc (LSE:AZN; NYSE:AZN) said the anti-CTLA-4 mAb in combination with PD-L1 inhibitor Imfinzi durvalumab missed the co-primary endpoint of improving overall survival (OS) in the Phase III MYSTIC trial...
16:02 , Nov 16, 2018 |  BC Week In Review  |  Clinical News

Nektar makes case for NKTR-214 optimism

On a Nov. 10 call with investors, Nektar Therapeutics (NASDAQ:NKTR) and a PI for the Phase I/II PIVOT-2 trial highlighted differences in patient demographics that could be critical for NKTR-214 plus Opdivo nivolumab to achieve...
15:56 , Nov 16, 2018 |  BC Week In Review  |  Financial News

Kleo raises $21M series B to advance to clinic in 2020

Immuno-oncology company Kleo Pharmaceuticals Inc. (New Haven, Conn.) raised $21 million in an untranched series B round on Nov. 13 to propel its next-generation Antibody Recruiting Molecules (ARMs) into the clinic by 2020. The round...
21:18 , Nov 12, 2018 |  BC Extra  |  Clinical News

Nektar makes case for NKTR-214 optimism

On a call with investors Saturday, Nektar Therapeutics (NASDAQ:NKTR) and a PI for the Phase I/II PIVOT-2 trial highlighted differences in patient demographics that could be critical for NKTR-214 plus Opdivo nivolumab to achieve a...
01:02 , Nov 10, 2018 |  BC Extra  |  Clinical News

NKTR-214 CR data at SITC suggest advantage over SOC

Updated Phase I/II data presented Friday for NKTR-214 from Nektar Therapeutics (NASDAQ:NKTR) plus Opdivo nivolumab to treat previously untreated patients with metastatic stage IV melanoma showed an objective response rate (ORR) that included more patients...
20:15 , Nov 9, 2018 |  BC Week In Review  |  Clinical News

FDA approves Empliciti plus pomalidomide and dexamethasone for MM

Bristol-Myers Squibb Co. (NYSE:BMY) said FDA approved an sBLA for Empliciti elotuzumab in combination with pomalidomide and dexamethasone to treat adults with multiple myeloma patients who have received at least two prior therapies, including lenalidomide...
18:25 , Nov 9, 2018 |  BC Week In Review  |  Company News

Pfizer's PARP, androgen inhibitors next combo partners for NKTR-214

Pfizer Inc. (NYSE:PFE) will combine NKTR-214 from Nektar Therapeutics Inc. (NASDAQ:NKTR) with the pharma's marketed drugs Xtandi enzalutamide, Talzenna talazoparib and Bavencio avelumab to treat prostate cancer, testing the biotech's hypothesis that stimulation of IL-2...
21:13 , Nov 6, 2018 |  BC Extra  |  Clinical News

Nektar shares fall on updated response data for NKTR-214 combo

Nektar Therapeutics (NASDAQ:NKTR) was off $3.92 (10%) to $36.08 on Tuesday as investors digested updated response data released in an abstract ahead of this week's SITC meeting from a Phase I/II trial of NKTR-214 plus...