Daily Top News – July 31, 2020

July 31, 2020

llllllllll Libtayo (cemiplimab) / Sanofi, Regeneron; BNT111 / BioNTech
BioNTech Announces Strategic Collaboration with Regeneron to Advance FixVac and Libtayo (cemiplimab) Combination in Melanoma (GlobeNewswire) – Jul 31, 2020 – “BioNTech…today announced a strategic collaboration with Regeneron for a clinical trial combining BioNTech’s BNT111 FixVac product candidate and Libtayo® (cemiplimab), a fully human anti-PD-1 therapy, for the treatment of melanoma. The companies plan to jointly conduct a randomized Phase 2 study in patients with anti-PD1-refractory/relapsed, unresectable Stage III or IV cutaneous melanoma…The companies plan to disclose more details related to the planned Phase 2 study in the third quarter of 2020, with the goal of initiating the trial in the fourth quarter of 2020….Under the terms of the agreement, development costs for the clinical trial will be shared equally and both companies will contribute their products for the trial.”


llllllllll Alunbrig (brigatinib) / Takeda; mobocertinib (TAK-788) / Takeda; pevonedistat (MLN4924) / Takeda; Ninlaro (ixazomib) / Takeda; TAK-007 / Takeda
Takeda Announces FY2020 Q1 Results; Confirms Management Guidance & Raises Reported Operating Profit And Reported Net Profit for the Full Year (Businesswire) – Jul 31, 2020 – “In Oncology, TAK-007 for the treatment of hematologic malignancies on an outpatient basis, with encouraging Phase 1/2 data and cohort expansion ongoing for a pivotal study planned for next year and potential approval in FY2023; Mobocertinib (TAK-788) has the potential to set a new standard of care for a subset of Non-Small Cell Lung Cancer (NSCLC) patients with EGFR exon 20 insertions; Pevonedistat (TAK-924) has the potential to be the first novel HR-MDS therapy in over a decade; anticipated Phase 3 PANTHER trial in HR-MDS readout in second half of FY2020; Reported revenue and underlying revenue growth rates for notable Q1 FY2020 contributors include: ALUNBRIG JPY 2.0 billion +26%; NINLARO JPY 22.9 billion +31%”

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