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STK-012 / Synthekine; STK-009/SYNCAR-001 / SynthekineSynthekine Launches with $82 Million Series A Financing to Advance Pipeline of Engineered Cytokine Therapeutics Optimized for Cancer and Autoimmune Diseases (Businesswire) - Sep 17, 2020 - "Synthekine Inc...announced the closing of an $82 million Series A financing....Proceeds from this Series A financing will be used to advance Synthekine’s lead therapeutic programs into clinical studies, expand its discovery pipeline and hone its proprietary cytokine engineering platforms. The company currently has two lead programs in IND-enabling development: STK-012, an engineered Interleukin-2 (IL-2) partial agonist for the treatment of cancer, and the combination of STK-009 and SYNCAR-001, an orthogonal IL-2 ligand and a CD-19 CAR-T-cell therapy being studied in combination....Synthekine anticipates filing an IND in 2021 for the STK-009/SYNCAR-001 combination."meloxicam/rizatriptan (AXS-07) / Axsome TherapAxsome Therapeutics Announces AXS-07 Phase 3 Migraine Trial Results Selected by the American Academy of Neurology Science Committee as Featured Presentation (GlobeNewswire) - Sep 17, 2020 - P3, N=1,594; MOMENTUM (NCT03896009); Sponsor: Axsome Therapeutics, Inc.; "Axsome Therapeutics, Inc....today announced that Phase 3 data for AXS-07 in the acute treatment of migraine has been selected as a featured presentation at the 2020 American Academy of Neurology (AAN) Science Highlights platform, to be held virtually September 23, 2020 at 12:15 PM Central Time....The presentation will highlight new insights from the Phase 3 MOMENTUM trial of AXS-07, and will be followed with live Q&A."Yervoy (ipilimumab) / Ono Pharma, BMS; Opdivo (nivolumab) / Ono Pharma, BMS; Sutent (sunitinib) / PfizerFour-Year Data Continue to Show Superior, Long-Term Survival Benefit with Opdivo (nivolumab) Plus Yervoy (ipilimumab) in Patients with Previously Untreated Advanced or Metastatic Renal Cell Carcinoma (Bristol-Myers Squibb Press Release) - Sep 17, 2020 - P3, N=1,390; CheckMate 214 (NCT02231749); Sponsor: Bristol-Myers Squibb; “Bristol Myers Squibb…announced that more than half of advanced renal cell carcinoma (RCC) patients treated with the Opdivo® (nivolumab) plus Yervoy® (ipilimumab) combination were alive after four years across the entire study population of the Phase 3 CheckMate -214 clinical trial. With the longest follow-up for an immunotherapy-based combination in previously untreated advanced RCC, Opdivo plus Yervoy continued to show superior, long-term overall survival (OS) and durable responses compared to sunitinib. These sustained benefits were observed across both the primary patient population, those with intermediate- and poor-risk prognostic factors, and in the intention-to-treat (ITT, i.e. all randomized) patient population.”FAP-2286 / Clovis, 3B PharmaNew Data Presented at ESMO Virtual Congress 2020 Highlight Breadth and Potential of Clovis Oncology Products and Pipeline (Businesswire) - Sep 17, 2020 - "Clovis Oncology...today announced the data being presented as e-posters at the European Society for Medical Oncology (ESMO) Virtual Congress 2020. These include...the first presentation of preclinical data for FAP-2286 Clovis’ novel peptide-targeted radionuclide therapy...FAP is highly expressed in cancer-associated fibroblasts (CAFs) present in the tumor microenvironment of most epithelial cancers and, in some cancers, its expression has also been observed in the tumor cells...Clovis Oncology plans to submit two Investigational New Drug (IND) applications in late 2020 for use of this novel radionuclide therapy as an imaging and treatment agent, respectively, and the Company has planned clinical studies in a broad spectrum of FAP-positive cancers."Rubraca (rucaparib) / ClovisNew Data Presented at ESMO Virtual Congress 2020 Highlight Breadth and Potential of Clovis Oncology Products and Pipeline (Businesswire) - Sep 17, 2020 - P3, N=564; ARIEL3 (NCT01968213); Sponsor: Clovis Oncology, Inc; "After two years of additional follow up for those patients who continued on treatment in the study, the safety profile remains consistent with previous reports, with no new safety signals identified. As of the current safety data cutoff (December 31, 2019), 33 of 372 and 1 of 189 patients in the safety population were still receiving Rubraca or placebo, respectively. Median treatment duration was 8.3 months in the Rubraca arm and 5.5 months in the placebo arm....The median duration of the first event of frequently reported TEAEs was generally
