Cue Biopharma Inc. hopes to achieve perfect harmony with LG Chem Life Sciences, the life sciences division of Korean giant LG Chem Ltd. (LGC), in a multitarget collaboration to develop its Immuno-STAT (Selective Targeting and Alteration of T cells) immuno-oncology (I-O) biologics. The deal provides LG Chem with rights in Asia to develop and commercialize Cue's lead candidate, CUE-101, and Immuno-STAT biologics that target T cells against two additional cancer antigens. Read More
Newark, Calif.-based Incarda Therapeutics Inc., a company developing an inhaled therapy for recent-onset paroxysmal atrial fibrillation (PAF), has closed a $42 million series B financing. Proceeds from the round will be used primarily to fund the company's recently initiated phase II study of Inrhythm, an inhaled flecainide drug-device combo. Results from the study will be available in the second half of 2019, Incarda's president and CEO, Grace Colón, told BioWorld. Read More
Cabaletta Bio Inc. CEO Steven Nichtberger noted that his firm is "not the first to develop chimeric T cells as therapeutics, [but] we are the first to develop them in a way that leverages the potential of T cells to specifically eliminate only the B cells that cause autoimmune disease, thus sparing the healthy cells," and he told BioWorld that the lead indication – mucosal pemphigus vulgaris (PV) – represents a "hallmark for potential efficacy in a whole host of B-cell-mediated autoimmune diseases." Read More
Until recent years, polycystic kidney disease (PKD) was a renal indication in search of solutions – a situation even truer for its autosomal dominant (ADPKD) and autosomal recessive (ARPKD) subgroups. That dearth of drug development in the space is beginning to change, however, thanks to greater understanding of the genetic drivers of kidney disease and of the molecular pathways that are subsequently up-regulated and cause disease.Those findings are enabling researchers to apply precision medicine approaches that are the hallmark of targeted cancer therapies to indications such as PKD. Buy-in from regulators, who have shown willingness to explore creative alternatives to historically broad trial designs, are beginning to attract both big pharma and newer entrants to the opportunities in renal disease. Read More
HONG KONG – Chinese biologics and biosimilars maker Bio-Thera Solutions Ltd. kicked off a phase III trial of its HER2 antibody-drug conjugate (ADC), BAT-8001, targeting HER2-positive metastatic cancer. Read More
The FDA Thursday began updating its expanded access webpages to streamline the content and provide a more user-friendly organization. The updates will reduce duplication and provide new pages with commonly requested information, such as forms and keywords. The changes are in response to an FDA-commissioned independent assessment of the expanded access program. Read More
Flexion Therapeutics Inc., of Burlington, Mass., reported net sales of non-opioid pain drug Zilretta (triamcinolone acetonide extended-release injectable suspension) totaling $7 million for the third quarter, up 84 percent over the second quarter. The drug gained approval late last year for treating knee osteoarthritis. The company's net loss for the quarter was $43.6 million, or $1.15 per share. As of Sept. 30, its cash, equivalents and marketable securities totaled $302.9 million. Shares of Flexion (NASDAQ:FLXN) gained $2.72, or 19 percent to close Thursday at $16.99. Read More
Sonoma Pharmaceuticals Inc., of Petaluma, Calif., filed an S-1 to offer 7.3 million shares of common stock, together with warrants to purchase 3.65 million shares, in a unit-based offering. The unit price has not yet been disclosed. The specialty pharma said it will use net proceeds for general corporate purposes, new product launches and working capital. Read More
Jazz Pharmaceuticals plc, of Dublin, said a recently published final appraisal determination from the National Institute for Health and Care Excellence recommended Vyxeos (daunorubicin and cytarabine) for infusion for routine use in the National Health Service in England and Wales for the treatment of adults with newly diagnosed, therapy-related acute myeloid leukemia (AML) or AML with myelodysplasia-related changes. Read More
