melanoma

The FDA has provided feedback regarding Iovance Biotherapeutics Inc's  (NASDAQ: IOVA) proposed matrix of potency assays for its upcoming Biologics License Application (BLA) for lifileucel in metastatic melanoma.  The company received positive feedback from the FDA...

Merck & Co Inc (NYSE: MRK) announced data from Phase 3 KEYNOTE-716 trial of Keytruda (pembrolizumab) as adjuvant treatment for patients with resected stage IIB and IIC melanoma. The trial has met its key secondary endpoint of distant metastasis-free survival (DMFS) at a...

The French National Agency for the Safety of Medicines and Health Products has signed off Phio Pharmaceuticals Corp's (NASDAQ: PHIO) clinical trial with its lead product candidate, PH-762 in melanoma. The Company expects to dose the first patient in Q1 of 2022.  PH-762 activates immune...

The FDA has approved Merck & Co Inc's (NYSE: MRK) Keytruda, an anti-PD-1 therapy, for the adjuvant treatment of adult and pediatric (12 years and older) patients with stage IIB or IIC melanoma following complete resection.  Additionally, the FDA expanded the indication...

Merck & Co Inc (NYSE: MRK) announced new data from studies evaluating Keytruda (pembrolizumab) in melanoma patients.  The Company shared the data at the Society for Melanoma Research (SMR) 2021 Congress.  210 former participants of KEYNOTE-006 (158 patients treated...

​​​​​Sonnet BioTherapeutics Holdings Inc (NASDAQ: SONN) stock is soaring during premarket in reaction to the selection of SON-1410 as a development candidate for melanoma and renal cancers. SON-1410 represents Sonnet's second bispecific compound integrating Interleukin 12 (IL-12...

The FDA has granted Fast Track designation to Alkermes plc's (NASDAQ: ALKS) nemvaleukin alfa (nemvaleukin) for mucosal melanoma. Nemvaleukin is an investigational engineered interleukin-2 (IL-2) variant immunotherapy. Earlier this year, the FDA also granted orphan drug...

OncoSec Medical Inc (NASDAQ: ONCS) will evaluate its DNA-plasmid interleukin-12 (IL-12) TAVO (tavokinogene telseplasmid) with Merck & Co Inc's (NYSE: MRK) Keytruda (pembrolizumab) in KEYNOTE-C87 Phase 3 trial.  The planned trial will evaluate the overall survival...

BioNTech SE (NASDAQ: BNTX) has dosed the first patient in its Phase 2 trial evaluating the BNT111 cancer vaccine. The study evaluates the therapeutic cancer vaccine candidate BNT111 in combination with Regeneron Pharmaceuticals Inc (NASDAQ: REGN) - Sanofi SA's...

BriaCell Therapeutics Corp (NASDAQ: BCTX) has advanced its targeted oncology therapeutics into several novel immunotherapy cell lines, including - Bria-Pros for prostate cancer, Bria-Mel for melanoma, and Bria-Lung for lung cancer. The company anticipates commencing clinical trials...

Sorrento Therapeutics Inc (NASDAQ: SRNE) entered into a research collaboration agreement with Mayo Clinic to conduct human clinical proof of concept studies using the Sofusa Lymphatic Drug Delivery System (S-LDDS) technology. Sofusa is a drug delivery platform that delivers biologic...

Iovance Biotherapeutics Inc (NASDAQ: IOVA) announced updated clinical data for lifileucel from Cohort 2 of C-144-01 clinical study in patients with advanced melanoma. Data were presented at the ASCO 2021 Annual Meeting. All patients in Cohort 2 had a high baseline disease burden and were...

Yesterday the FDA asked Iovance Biotherapeutics Inc (NASDAQ: IOVA) for more data on the assays for lifileucel US application. Now the company announced additional clinical data for lifileucel alone and in combination with pembrolizumab in advanced melanoma. Data will...

Bristol Myers Squibb Co (NYSE: BMY) announced detailed results from the Phase 2/3 RELATIVITY-047 trial evaluating a fixed-dose combination of relatlimab and Opdivo (nivolumab) in untreated metastatic or unresectable melanoma patients. The data will be presented at the 2021 ASCO in...

Idera Pharmaceuticals Inc (NASDAQ: IDRA) has decided not to continue the ILLUMINATE-301 Phase 3 trial evaluating tilsotolimod in melanoma to its overall survival (OS) primary endpoint. The trial assessed tilsotolimod in combination with ipilimumab versus ipilimumab alone in patients...