Industry News

ORYZON Enrolls First Patient in EVOLUTION, a Phase IIb Clinical Trial With Vafidemstat in Schizophrenia

11/22/2021

Primary objectives: to assess the effect of vafidemstat to address negative and cognitive symptoms in schizophrenia Phase IIb adaptive trial planning to enroll 100 patients Second Phase IIb study of vafidemstat in CNS disorders Excerpt from the Press Release: MADRID, Spain and CAMBRIDGE, Mass., Nov. 17, 2021 (GLOBE NEWSWIRE) — Oryzon Genomics, S.A. (ISIN Code:…

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Disulfiram, a treatment for alcoholism, may cut severe SARS-CoV-2 infection, reduce likelihood of dying from COVID-19

11/22/2021

Excerpt from the Press Release: Every day, hundreds of thousands of new COVID-19 cases and thousands of new deaths are still being reported worldwide, creating a need for drugs that can combat the disease caused by SARS-CoV-2. Now, new research led by investigators at Harvard Medical School and Boston Children’s Hospital points to a well-known…

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Moderna Files for Authorization of its COVID-19 Vaccine with Health Canada to Include Children Ages 6-11 Years

11/22/2021

Submission based on Phase 2/3 study of SPIKEVAX in children ages 6 to 11 Excerpt from the Press Release: CAMBRIDGE, Mass.–(BUSINESS WIRE)–Moderna Inc. (Nasdaq: MRNA), a biotechnology company pioneering messenger RNA (mRNA) therapeutics and vaccines, today announced that it has submitted for authorization with Health Canada for the evaluation of a 50 µg two-dose series…

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Clinical Activity of AGEN1181 Demonstrated Across Nine Treatment-Resistant Cancers at SITC

11/19/2021

Seventeen objective responses reported across nine cancers Evidence of monotherapy activity, with four cases of confirmed objective response Objective responses noted in treatment refractory, poorly immunogenic tumors including microsatellite stable (MSS) colorectal cancer, ovarian cancer, MSS endometrial cancer, and melanoma; as well as responses in tumors not previously reported including pancreatic cancer, cervical cancer, visceral…

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Ocugen Statement Regarding Publication of COVAXIN™ (BBV152) Phase 3 Study Results in The Lancet

11/19/2021

Excerpt from the Press Release: We are pleased that The Lancet, a trusted source of clinical, public health and global health knowledge, published Phase 3 data showing the COVID-19 vaccine candidate, COVAXIN™ (BBV152), has 93.4% efficacy against severe COVID-19 disease. COVAXIN™ (BBV152), a whole virion inactivated COVID-19 vaccine candidate, uses the same technology that is safely and effectively applied in the production of Bharat…

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UroGen Pharma Unveils New Phase 3 Development Plan for UGN-102 at Spotlight Event

11/19/2021

New, Single-arm Phase 3 Study Expected to Initiate in Early 2022 Excerpt from the Press Release: PRINCETON, N.J.–(BUSINESS WIRE)–UroGen Pharma Ltd. (Nasdaq: URGN), a biopharmaceutical company dedicated to building and commercializing novel solutions that treat urothelial and specialty cancers, is announcing at its virtual Spotlight Event being held today that, following recent discussions with the…

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Wugen Presents New Preclinical Data from Novel Memory Natural Killer (NK) Platform at The Society for Immunotherapy of Cancer’s (SITC) 36th Annual Meeting

11/18/2021

— Wugen’s proprietary platform employs a GMP-grade, feeder cell-free manufacturing process to produce commercially scalable, off-the-shelf, non-engineered memory natural killer (NK) cell therapies with enhanced anti-tumor function — — Lead product candidate WU-NK-101 demonstrated potent anti-tumor activity and long-term persistence in vivo — — Data support ongoing clinical development of WU-NK-101 as best-in-class memory NK…

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Sorrento Announces Publication of Significant Positive Pivotal Trial Results of Abivertinib for the Treatment of Non-Small Cell Lung Cancer (NSCLC) in the Peer-Reviewed Journal Clinical Cancer Research

11/18/2021

Abivertinib is a novel third-generation epidermal growth factor receptor (EGFR) inhibitor that irreversibly targets mutant forms of EGFR and Bruton’s tyrosine kinase (BTK) in advanced NSCLC patients resistant to first-line EGFR kinase inhibitor therapies. In this pivotal study conducted in China, 227 heavily pretreated NSCLC patients were enrolled and among 209 response evaluable patients, confirmed overall…

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Tempest Presents Data Supporting the Dual Mechanism of TPST-1495 as an Optimal Approach for Targeting the Prostaglandin Pathway in Cancer

11/18/2021

Excerpt from the Press Release: Data Reported at the 2021 Society for Immunotherapy of Cancer Annual Meeting SOUTH SAN FRANCISCO, Calif., Nov. 12, 2021 (GLOBE NEWSWIRE) — Tempest Therapeutics, Inc. (Nasdaq: TPST), a clinical-stage oncology company developing potentially first-in-class therapeutics that combine both targeted and immune-mediated mechanisms, today reported in vitro and in vivo preclinical…

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Nektar Therapeutics Announces Data Presentations for Its Immuno-Oncology Pipeline at the 2021 Society for Immunotherapy of Cancer (SITC) Annual Meeting

11/17/2021

Initial Safety and Efficacy Data for NKTR-255, a Novel IL-15 Agonist, in Combination with Cetuximab in Solid Tumors Presented in Late-Breaking Abstract Session SAN FRANCISCO, Nov. 12, 2021 /PRNewswire/ — Nektar Therapeutics (Nasdaq: NKTR) today announced three data presentations for its I-O pipeline at the 2021 Society for Immunotherapy of Cancer (SITC) Annual Meeting. Excerpt from the Press Release: Initial clinical…

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