Redhill Biopharma Ltd., of Tel-Aviv, Israel, said a phase II study evaluating Yeliva (ABC294640), an orally-administered, sphingosine kinase-2 (SK2) selective inhibitor, in patients with advanced hepatocellular carcinoma (HCC) has been initiated, with enrollment expected to start shortly. It will be conducted at the Medical University of South Carolina Hollings Cancer Center (MUSC) and additional clinical centers in the U.S. and is supported by a $1.8 million grant from the National Cancer Institute awarded to MUSC. Read More
Financings in the biopharma sector were decidedly better in the third quarter compared to their dismal showing during the second quarter. The total generated from public and private transactions were well over double the amount that was raised in the second quarter. In the period, investor confidence returned, fueling a broad market rally after its tumble following Brexit and that helped the biotech sector. The strong showing has helped bring the year-to-date financings to $25 billion. Read More
Merck & Co. Inc.'s Keytruda (pembrolizumab) continued to shine in non-small cell lung cancer (NSCLC) in data presented at the European Society for Medical Oncology (ESMO) 2016 Congress in Copenhagen, Denmark. The anti-programmed cell death protein 1 (PD-1) therapy showed superior overall survival (OS) at 18 months compared to docetaxel in patients with metastatic NSCLC previously treated with platinum-containing chemotherapy whose tumors expressed programmed death ligand 1 (PD-L1) – measured as tumor proportion score (TPS) of 1 percent or more – as well as those with high levels of PD-L1 expression (TPS of 50 percent or more). Read More
Oncoresponse Inc., of Houston, said it raised $7 million in a supplemental series A financing, consisting of a $3.5 million investment from Greatpoint Ventures and $3.5 million from the Helsinn Investment Fund. In October 2015, the company secured $9.5 million as part of an initial closing of its series A financing; an additional $3 million investment by Baxalta, acquired by Shire plc in May, along with the current investments bring the total series A financing to $19.5 million, which will be used to support its ongoing efforts to interrogate the humoral response of elite responders to cancer immunotherapy to identify antibodies and potential targets for therapeutic development. Read More
Endocyte Inc., of West Lafayette, Ind., presented poster updates on its two lead clinical programs and said EC1456 and EC1169 have shown anti-tumor activity during the dose escalation phase of their respective trials, even in patients not specifically identified as positive for the drug targets. The activity seen to date with EC1169 in prostate cancer patients is particularly encouraging, the firm said, with the first confirmed radiologic partial response recorded. Read More
Nordic Nanovector ASA, of Oslo, Norway, entered into a collaboration with Legochem Bioscience Inc., of Daejeon, South Korea, to develop CD37-targeting antibody-drug conjugates to treat leukemias. This collaboration supports Nordic Nanovector's strategy to expand its pipeline of targeted therapies to include CD37-targeting antibody products conjugated to anti-cancer compounds that are not radionuclides. Deal terms were not disclosed. Read More
Helsinn Group's newly established corporate venture arm, Helsinn Investment Fund SA, which plans to invest $50 million across a range of early stage opportunities in drug development, medical devices, medical technology and supportive care, has already completed its first three investments. Read More
LONDON – Crescendo Biologics Ltd has landed the first major partner for its Humabody pared back antibody constructs, agreeing to an oncology collaboration worth up to $790 million with Takeda Pharmaceuticals Ltd. Read More
Beating the U.S. Department of Justice (DoJ) to the punch on the eve of a federal holiday weekend, Mylan NV announced a $465 million settlement late Friday to resolve potential state and federal lawsuits over its classification of its Epipen auto-injector as a generic for Medicaid rebate purposes. Read More
While many in the biopharma world had their eyes on the European Society of Medical Oncology meeting in Copenhagen and scratched for more data – or for a sightline on the meaning of the avalanche of results that spilled out – Nicox S.A. took a back seat with its complete response letter (CRL) for the NDA related AC-170 for ocular itching in allergic conjunctivitis (AC). Read More
Full results of Tesaro Inc.'s phase III NOVA trial presented at the European Society for Medical Oncology meeting show that the company's once-daily PARP inhibitor, niraparib, significantly extended the time during which women with recurrent ovarian cancer were able to live with their disease before their tumors began to grow again. Read More