LONDON – The mutation introduced into the germline of the world's first CRISPR gene-edited babies is associated with a 21% increase in mortality in later life, according to a new study. Chinese scientist Jiankui He made the edits to the CCR5 chemokine receptor gene in human embryos with the aim of mimicking the effect of the naturally occurring delta32 mutation, which protects against HIV infection in Europeans. The birth of twin girls carrying the CRISPR edit was announced in November last year. But now an analysis based on genomic data and death register information of 409,693 of the volunteers in the UK Biobank has found that people who are homozygous for the delta32 mutation have a significantly higher death rate between the ages of 41 and 78, than people with one or no copies of the mutation. Read More
CHICAGO – Seattle Genetics Inc. (Seagen) and Tokyo-based partner Astellas Pharma Inc. saw their antibody-drug conjugate (ADC) enfortumab vedotin (EV) highlighted at the American Society of Clinical Oncology (ASCO) annual meeting by way of the abstract for data from a single-arm phase II trial in 125 patients with locally advanced or metastatic urothelial cancer. Read More
CHICAGO – Results from the phase III POLO trial presented at the 2019 American Society of Clinical Oncology's (ASCO's) 2019 annual meeting on Sunday showed that treatment with Lynparza (olaparib, Astrazeneca plc/Merck & Co Inc.) after platinum chemotherapy nearly doubled the progression-free interval (progression-free survival, PFS) in a group of 154 metastatic pancreatic cancer patients with germline BRCA mutations, from 3.8 to 7.4 months. Read More
CHICAGO – Merck & Co. Inc.'s Keytruda (pembrolizumab) gained still more laurels at the American Society of Clinical Oncology (ASCO) meeting, where attendees learned of two victorious experiments with the anti-PD-1 immunotherapy. Read More
An appreciative audience at the American Society of Clinical Oncology (ASCO) heard details of two important prostate cancer trials, including an interim analysis of the international randomized, phase III Enzamet study finding that 80% of men with metastatic hormone-sensitive prostate cancer (mHSPC) were alive after three years when given the non-steroidal anti-androgen (NSAA) drug Xtandi (enzalutamide) from New York-based Pfizer Inc. and Astellas Pharma Inc., of Tokyo, along with standard of care therapy. That number compared with 72% of men who received other NSAAs along with the typical treatment. Read More
CHICAGO – A crowded briefing session at the American Society of Clinical Oncology (ASCO) annual meeting heard society expert Harold Burstein declare that the "golden age" of cancer research is continuing with data from the phase III trial called Monaleesa-7 with Kisqali (ribociclib, Novartis AG). Read More
CHICAGO – With three featured abstracts that dealt with studies of socioeconomic disparities in access to medical help, as well as proof of boons conferred by the Affordable Care Act (ACA), panel members at the American Society of Clinical Oncology (ASCO) annual meeting found themselves in uncommonly delicate territory. Read More
CHICAGO – On the opening day of the American Society of Clinical Oncology (ASCO) annual meeting, the group's president Monica Bertagnolli unveiled the first standards of the Minimal Common Oncology Data Elements (MCODE) project, a cooperative venture to make uniform the methods of data sharing and thereby bring clinicians "one step closer to the real goal of learning from every patient with cancer." Read More
CHICAGO – Word from Genocea Biosciences Inc. of success with part A of its ongoing phase I/IIa trial testing the neoantigen vaccine candidate GEN-009 rolled out at the American Society of Clinical Oncology (ASCO) annual meeting and pushed shares (NASDAQ: GNCA) up 19.6%, or $1.10, to trade this afternoon at $6.71, after rising as high as $11.28. Read More
CHICAGO – Problems for researchers in enrolling lung cancer studies, as well as the woes felt by patients trying to gain entry so they can try prospective new drugs, could largely go away if investigators adopt eligibility criteria backed by work detailed at the American Society of Clinical Oncology (ASCO) meeting. Read More
Oligomerix Inc., of New York, said it completed phase I of the scope of work under its Small Business Innovation Research phase I/II fast-track grant to scale up and synthesize a tau oligomer inhibitor to initiate IND-enabling studies in Alzheimer's disease and related dementias. The company recently received $1 million from the NIH's National Institute on Aging to fund phase II activities. Read More
Delmar Pharmaceuticals Inc., of Vancouver, British Columbia, said it arranged securities purchase agreements with unnamed institutional investors for a registered direct offering of 1.17 million common shares and a concurrent private placement of warrants to purchase 760,500 additional common shares at a combined price of $3.10 for one common share and each warrant, generating gross proceeds of $3.6 million. Read More
Heritage Pharmaceuticals Inc., of Eatontown, N.J., agreed to pay more than $7 million in criminal penalties and civil damages for its part in a U.S. generics price fixing scheme. Under a deferred prosecution agreement with the U.S. Department of Justice (DoJ), Heritage admitted it conspired to fix prices, rig bids and allocate customers for generic versions of glyburide, a diabetes drug. Read More
