Unveiled by Oxfordshire, U.K.-based Immunocore Ltd. at the November meeting of the Society for Immunotherapy of Cancer (SITC) in National Harbor, Md., were encouraging new findings from the phase I/II study with tebentafusp (also known as IMC-gp100), a bispecific protein in the pivotal works for metastatic uveal melanoma (MUM). The results showed a correlation between treatment-induced immune response and improvement in overall survival (OS) and tumor shrinkage in advanced uveal as well as cutaneous melanoma.
Though they made known their reservations about the patient sample size and queried front-line vs. second-line use of tazemetostat, members of the FDA’s Oncologic Drugs Advisory Committee (ODAC) voted 11-0 to recommend approval of the oral, first-in-class EZH2 inhibitor from Cambridge, Mass.-based Epizyme Inc.
Proteostasis Therapeutics Inc. CEO Meenu Chhabra pointed to a “new reality in cystic fibrosis [CF] research” faced by her firm and others: the challenge of enrolling the best patients.
Fueled by new positive data, Axsome Therapeutics Inc. plans to seek approval during the second half of 2020 for its dextromethorphan/bupropion modulated delivery tablet, AXS-05, an oral NMDA receptor antagonist to treat major depressive disorder.
Hitches for Horizon Pharma plc seem unlikely in the upcoming FDA advisory panel to mull the BLA for teprotumumab in thyroid eye disease (TED), though regulators did take issue with the clinical activity score (CAS) as calculated by the company.
Shares of Iterum Therapeutics plc (NASDAQ:ITRM) slid 36%, or $1.73, to close at $3.12 after the Dublin-based firm disclosed the much-anticipated but less-than-stellar results from the phase III trial called Sulopenem for Resistant Enterobacteriaceae, or SURE 3, testing oral and I.V. versions of the drug in complicated intra-abdominal infections (cIAI).
Shares of Equillium Inc. (NASDAQ:EQ) closed at $4.75, up 69 cents, or 17%, after trading as high as $5.25 as Wall Street hailed the FDA’s granting of fast track status to itolizumab – the first clinical-stage anti-CD6 therapy – for the treatment of lupus nephritis (LN).
Arqule Inc. CEO Paolo Pucci said the firm was “limited in what we can comment [on] for the time being” in connection with Merck & Co. Inc.’s deal to pay about $2.7 billion in cash for the company. “There is no better model for bringing a drug faster into the hands of patients and caregivers than the example of Keytruda. I will leave it at that.” Merck’s Keytruda (pembrolizumab), a human PD-1-blocking antibody was first approved in September 2014 for advanced melanoma. The label has been widely expanded since.
The “remarkably appealing” route of administration and every-three-month dosing put Ferring Pharmaceuticals SA’s nadofaragene firadenovec (rAd-IFN/Syn3, also known as Instiladrin) in strong position for approval in high-grade Bacillus Calmette-Guérin (BCG) unresponsive non-muscle invasive bladder cancer (NMIBC).
In the summer of 2016, when Victoria, British Columbia-based Aurinia Pharmaceuticals Inc. offered phase IIb results with its calcineurin inhibitor voclosporin in lupus nephritis (LN), Wall Street ignored the otherwise-positive results and zeroed in on the trial’s death rate: 13 casualties across three arms of the 265-subject Aura-LV study.
