Allakos Inc., which has deflected questions about its technology since its 2012 founding, continued to let its fundraising prowess do the talking after completing a $100 million series B to advance AK-002, a therapeutic antibody the company called its lead program, in disease areas ranging from gastrointestinal (GI) to dermatologic and ocular diseases.
ATLANTA – Bioverativ Inc. wasted little time moving the monoclonal antibody (MAb) BIVV-009 into phase III development after picking up the complement C1s subcomponent inhibitor, previously known as TNT-009, in its potential $825 million acquisition of True North Therapeutics Inc. (See BioWorld Today, May 24, 2017.)
ATLANTA – Forty years after the establishment of ABVD – adriamycin, bleomycin, vinblastine and dacarbazine – as standard-of-care front-line therapy in patients with previously untreated advanced classical Hodgkin lymphoma (cHL), Seattle Genetics Inc. (Seagen) revealed details supporting its contention that replacing bleomycin with Adcetris (brentuximab vedotin) could improve efficacy and reduce toxicity in those patients, improving their chance of a cure with the first round of treatment.
ATLANTA – Shares of Blueprint Medicines Corp. (NASDAQ:BPMC) popped 25 percent at Monday's opening bell, closing the day at $88.32 for a gain of $16.46, after the company wowed participants at the American Society of Hematology (ASH) annual meeting with a presentation of data from the ongoing phase I trial of BLU-285 – now named avapritinib – in advanced systemic mastocytosis (SM). Findings from the dose-escalation portion of the phase I study showed an overall response rate (ORR) of 72 percent and a disease control rate (DCR) of 100 percent in patients evaluable for response as of Oct. 4, based on the International Working Group-Myeloproliferative Neoplasms Research and Treatment and European Competence Network on Mastocytosis (IWG-MRT-ECNM) consensus criteria. At data cut-off, avapritinib was well tolerated and most adverse events (AEs) reported by investigators were grade 1 or 2. No discontinuations occurred due to treatment-related AEs, and 30 of 32 patients remained on therapy with a median treatment duration of nine months.
ATLANTA – Forty years after the establishment of ABVD – adriamycin, bleomycin, vinblastine and dacarbazine – as standard-of-care front-line therapy in patients with previously untreated advanced classical Hodgkin lymphoma (cHL), Seattle Genetics Inc. (Seagen) revealed details supporting its contention that replacing bleomycin with Adcetris (brentuximab vedotin) could improve efficacy and reduce toxicity in those patients, improving their chance of a cure with the first round of treatment.
Three months after nabbing Kite Pharma Inc. for $11.9 billion, Gilead Sciences Inc. fine-tuned its cell therapy strategy with the structured acquisition of privately held Cell Design Labs Inc. Formed in 2015 and launched early last year, the Emeryville, Calif.-based company has focused on reengineering the molecular machinery of human cells – specifically, to fight cancer.
The Good Pharma Scorecard (GPS) released last week by the not-for-profit Bioethics International contained surprisingly good news. Two companies – Johnson & Johnson (J&J) and Sanofi SA – of 11 ranked on overall clinical trial transparency, based on drugs approved in 2014, achieved scores of 100 percent, tying them at the top of the list. Four others – Abbvie Inc., Celgene Corp., Merck & Co. Inc. and Astrazeneca plc – scored at or above the industry median of 91 percent.
Chemotherapeutic developer Odonate Therapeutics Inc. extended the 2017 biopharma IPO window, offering 6.25 million common shares at $24 apiece to raise $150 million. Although shares priced at the low end of the company's proposed range, Odonate bumped up the size of the offering, originally set at 5.88 million shares. Trading as ODT on Nasdaq, shares of the San Diego-based company closed Thursday at $23.
Michael Gilman keeps staring down retirement. The scientist and serial entrepreneur, late of Padlock Therapeutics Inc., which was sold last year to Bristol-Myers Squibb Co. for $600 million, has been splitting his time between Arrakis Therapeutics Inc., where he serves as CEO, and an Atlas Venture company focused on gene and cell therapy that was under wraps until this week. (See BioWorld Today, March 24, 2016, and Feb. 28, 2017.)
Indivior plc turned the page on treatment for severe opioid use disorder (OUD), gaining FDA approval of Sublocade (buprenorphine extended-release, previously RBP-6000) subcutaneous injection as the first once-monthly injectable buprenorphine formulation to treat moderate to severe OUD in patients who initiated treatment with a transmucosal buprenorphine-containing product, followed by dose adjustment for a minimum of seven days. Regulated as a schedule III controlled substance, Sublocade is intended to be administered by providers as part of a treatment program that includes counseling and psychosocial support.