Today marks the PDUFA date for Cambridge, Mass.-based Epizyme Inc.’s tazemetostat. The FDA has granted priority review for the NDA related to the EZH2 inhibitor, and in December, members of the agency’s Oncologic Drugs Advisory Committee voted 11-0 to recommend approval of the oral, first-in-class therapy for metastatic or locally advanced epithelioid sarcoma not eligible for curative surgery. Shares of Epizyme (NASDAQ:EPZM) were trading midday at $26.15, up 64 cents.

Soon-Shiong's Nantkwest, Immunitybio still chasing cancer breakthroughs

Physician, scientist and investor Patrick Soon-Shiong might be considered a "square peg is a round hole," he admits. But the Abraxane (nab-paclitaxel) inventor's work to enlist natural killer, dendritic and T cells in what he calls a "triangle offense" against cancer is finally coalescing, he recently told BioWorld, with FDA registration filings for a combination immunotherapy approach in bladder, lung, Merkel cell and pancreatic cancer all within sight over the next five years. The final endpoint, captured well in the small print disclosures for a presentation he gave at the recent J.P. Morgan Healthcare Conference, will turn on nothing less that his team's "ability to pioneer immunotherapy, harness the power of the innate immune system, implement precision cancer medicine and change the current paradigm of cancer care."

Securities class action suits a growing fact of life for life sciences

Whether based in the U.S. or abroad, life sciences companies are an increasingly attractive target for securities fraud class action suits. In 2019, the number of such suits filed in the U.S. across all industries totaled 404 – just one more than the 403 cases filed in 2018. However, nearly 25% of the suits filed in 2019 involved life sciences companies, compared with about 20% the previous year, according to a Dechert LLP report. And it’s not just the companies with deep pockets that are being dragged into court. Of the 97 life sciences companies named in the suits filed last year, 31 had a market capitalization of less than $250 million.

Newco news: Ionctura closes series A for next-generation dual-targeting cancer therapies

LONDON – Ionctura SA has closed a €15 million (US$ 16.6 million) series A to fund phase I development of its lead cancer program, IOA-244, and prepare a second product, IOA-289, for clinical development. IOA-244 is a highly selective inhibitor of the delta isoform of PI3K (phosphatidylinositol-4,5-bisphosphate kinase), discovered by scientists funded by the medical charity Cancer Research UK. The second product, IOA-289, is an autotaxin inhibitor, initially discovered and developed by Merck Serono SA. The thread linking the two is that they are both orally available small molecules designed to have a direct antitumor effect whilst also driving an immune-mediated anticancer response. They are “next-generation dual immune and tumor targeting therapies,” said Catherine Pickering, founder and Ionctura CEO.

Australia’s TGA proposes fee increases to implement recent drug, device reforms

PERTH, Australia – Australia’s Therapeutic Goods Administration (TGA) reviews its fees every year to ensure it recovers its costs from industry. The TGA held meetings with peak industry bodies during 2019 to discuss the proposed fee changes for the 2020 to 2021 financial year, which begins July 1. The agency is seeking input from industry stakeholders on a proposal to increase its fees to cover projected deficits this year.

Precision Medicine World Conference: Cancer genomic tests often aren’t done to guideline

SANTA CLARA, Calif. – Just as it does with treatments, the National Comprehensive Cancer Network offers detailed guidelines on genomic testing by cancer type. These are key in determining what physicians can prescribe routinely and what insurers will cover. But those guidelines aren’t followed regularly outside a major research hospital setting, thereby obviating access to tumor genetic information that could help to better guide treatment.

Genomics Summit 2020: Ireland’s embrace of genomics remains tentative

DUBLIN – “Welcome to the conversation,” Abbvie Inc.’s head of genomic research, Howard Jacob, told delegates during a keynote address at Genomics Summit 2020 on Jan. 23. Ireland is a latecomer to that conversation and it has yet, as a country, to figure out what the shape of its contribution to the genomic era of medicine is going to be. The emergence of Genomics Medicine Ireland Ltd. (GMI), which has set out an ambitious agenda to sequence the genomes of 400,000 people in Ireland, has served to highlight the complete absence of any national agenda around integrating genomic data into the delivery of clinical services. The juxtaposition of GMI’s high-tech facility in Dublin, which is churning out large volumes of genomic data for pharmaceutical discovery, with the fractured, under-resourced, clinical genetics services on offer in the country’s hospitals is looking increasingly egregious. But the country is finally moving toward the development of a national genomics strategy. As a first step, the department of health is currently advertising for a national director of genetic and genomic medicine. 

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AGTC, Altimmune, Ascletis, Autolus, Basilea, Biohaven, Blackthorn, Blueprint, Cadent, Chi-Med, Duckhorn, Eisai, Eversana, Evoke, Evotec, Ferring, Genentech, Genprex, Horizon, Immunogen, Indivumed, Inovio, Janssen, Leap, Lipomedix, Moderna, Neuraxpharm, Onconova, Orion, Paion, Pfizer, Puretech, Sanofi, Seelos, Seneca, Summit, Synthorx, Tetraphase, Trillium, Vitro, Xenon, Zymeworks