{"id":459083,"date":"2021-03-16T16:08:15","date_gmt":"2021-03-16T20:08:15","guid":{"rendered":"http:\/\/www.marketnewsdesk.com\/?p=459083"},"modified":"2021-03-16T16:08:15","modified_gmt":"2021-03-16T20:08:15","slug":"infinity-pharmaceuticals-reports-full-year-2020-financial-results-and-provides-update-on-eganelisib-development","status":"publish","type":"post","link":"https:\/\/www.marketnewsdesk.com\/index.php\/infinity-pharmaceuticals-reports-full-year-2020-financial-results-and-provides-update-on-eganelisib-development\/","title":{"rendered":"Infinity Pharmaceuticals Reports Full Year 2020 Financial Results and Provides Update on Eganelisib Development"},"content":{"rendered":"

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Infinity Pharmaceuticals Reports Full Year 2020 Financial Results and Provides Update on Eganelisib Development<\/b><\/p>\n

\u2013 MARIO-275 data at ASCO GU demonstrate eganelisib benefits across ORR, DCR, and PFS in PD-L1 low, 2L advanced UC patients; planning registration enabling study \u2013<\/i><\/p>\n

\u2013 MARIO-3 initial data at SABCS demonstrate tumor reduction in 100% of patients and an ORR of 69.2%, irrespective of PD-L1 status, in 1L TNBC patients; updates in 1H \u201921 and 2H \u201821 \u2013<\/i><\/p>\n

\u2013 MARIO-1 data at SITC demonstrate eganelisib benefits across ORR and DCR in melanoma and SCCHN patients who had progressed on a CPI as their immediate prior therapy \u2013<\/i><\/p>\n

\u2013 Significantly strengthened balance sheet to execute on the next phase of eganelisib development with $92M public offering \u2013<\/i><\/p>\n

CAMBRIDGE, Mass.–(BUSINESS WIRE<\/a>)–Infinity Pharmaceuticals, Inc.<\/a> (NASDAQ: INFI) (\u201cInfinity\u201d or the \u201cCompany\u201d), a clinical-stage biotechnology company developing eganelisib (IPI-549), a potentially first-in-class, oral, immuno-oncology macrophage reprogramming therapeutic, today announced its full year 2020 financial results and provided an update on the Company, including recent progress with eganelisib.\n<\/p>\n

\n\u201cOver the past months, we have presented transformative data across multiple indications, I\/O combinations, and lines of therapy which together demonstrate the broad potential of eganelisib to improve upon standard of care therapy across a broad range of treatment settings addressing some of the most challenging unmet needs in oncology,\u201d said Adelene Perkins, Chief Executive Officer and Chair of Infinity Pharmaceuticals. \u201cOur data from MARIO-275, a randomized, double-blind, placebo controlled study, clearly demonstrate the benefit of adding eganelisib to nivolumab monotherapy, a standard of care in advanced 2L urothelial cancer, with improved ORR, DCR and PFS as compared to nivolumab monotherapy. Striking benefits were observed in the PD-L1 low patient population, who are underserved by checkpoint inhibitor monotherapy and represent the majority of this patient population. Based on these results, we are planning a registration enabling study in this population.\n<\/p>\n

\n\u201cCompelling safety and efficacy results presented at SITC, SABCS, and GU ASCO suggest that eganelisib may have broad potential to improve outcomes in both PD-L1 low and high patients across tumor types, driven by the immune modulatory mechanism of eganelisib targeting macrophages and other myeloid-derived immune cells,\u201d said Brian Schwartz, M.D., consulting Chief Physician of Infinity. \u201cOur initial results from MARIO-3 show that adding eganelisib to an approved front-line regimen in TNBC provide clear patient benefit above standard-of-care atezolizumab and nab-paclitaxel. We observed tumor reductions in 100% of evaluable patients, irrespective of PD-L1 status, and are excited by the broad potential of this novel triplet regimen in both PD-L1 low and high patients given the significant unmet need in this aggressive and difficult-to-treat disease. We look forward to presenting additional data in the first and second half of this year, which will include increased patient numbers, response rate, disease control rate and initial response durability data, with preliminary PFS data by the end of the year. In parallel, the RCC cohort of MARIO-3 continues to advance with data from this proof-of-concept study in a novel triplet regimen expected in the first half of 2022. With our recently strengthened balance sheet, we will continue to advance our development of eganelisib across multiple indications, leveraging data from MARIO-275 in UC, MARIO-3 in TNBC, as well as the ARC-2 data presented by Arcus Biosciences at SABCS in second line TNBC and are evaluating opportunities to further unlock the potential of eganelisib in melanoma and SCCHN from MARIO-1 and in ovarian cancer from the ARC-2 study as we seek to improve outcomes in multiple treatment settings and patient populations including those least likely to respond to immunotherapies.\u201d\n<\/p>\n

Recent Updates and Program Guidance:<\/b><\/p>\n

MARIO-275 and Advanced Urothelial Cancer<\/b><\/p>\n