Industry News

Fulcrum Therapeutics Enrolls First Patient in Pivotal Global Phase 3 Clinical Trial of Losmapimod for Facioscapulohumeral Muscular Dystrophy (FSHD)

07/14/2022

– REACH is the first Phase 3 trial for this rare, progressive, and debilitating muscular disease –– Losmapimod is an oral small molecule that has the potential to be the first therapy to treat FSHD, the second most common form of muscular dystrophy –– U.S. Food and Drug Administration (FDA) granted Fast Track Designation in 2021 –…

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ROME Therapeutics Announces Publication of First Crystal Structure of a Human Endogenous Reverse Transcriptase in PNAS

07/14/2022

Study reveals first-ever structure of a non-viral endogenous reverse transcriptase (eRT) Human endogenous retrovirus-K (HERV-K) RT shows striking similarity to HIV RT Findings enable structure-based drug discovery for eRTs Excerpt from the Press Release: CAMBRIDGE, Mass.–(BUSINESS WIRE)–ROME Therapeutics, a biotechnology company harnessing the power of the dark genome for drug development, today announced a new…

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AN2 Therapeutics Initiates Pivotal Phase 2/3 Trial Evaluating Epetraborole for Treatment-Refractory MAC Lung Disease

07/08/2022

AN2 is developing epetraborole as a once-daily, orally administered treatment with a novel mechanism of action for patients with NTM lung disease, with an initial focus on treatment-refractory MAC lung disease Phase 2/3 pivotal trial expected to support regulatory approval for treatment-refractory MAC lung disease; Plan to use LPAD pathway Excerpt from the Press Release:…

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Anitoa Launches Molecular Test (PCR) for Monkeypox

07/08/2022

Excerpt from the Press Release: SUNNYVALE, Calif., June 29, 2022 /PRNewswire/ — Anitoa Systems, market leader in fast, portable molecular testing, today announced the availability of a CE-marked turn-key PCR solution for testing Monkeypox. This portable solution includes one of a family small foot-print real time PCR instruments called the Maverick qPCR, with an extraction-free multiplex…

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Oncology Pharma Conducting All The Preparations to Take Steps to Forward The Development Process of Nanoemulsion Drug Delivery System

07/07/2022

Excerpt from the Press Release: SAN FRANCISCO, CA / ACCESSWIRE / June 29, 2022 / Oncology Pharma Inc. (OTC PINK:ONPH) – Oncology Pharma, Inc. (“The Company”) is pleased to be reviewing the financing for taking the steps on moving forward with its development process of. the Nanoemulsuion Drug Delivery System. Many anticancer drugs have been…

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Ventyx Biosciences Announces Positive Topline Phase 1 Data for its Peripheral NLRP3 Inhibitor VTX2735

07/07/2022

Excellent safety, tolerability and pharmacokinetic profile Robust dose-dependent target engagement as measured by ex vivo IL-1β release assay Phase 2 trial planned in CAPS patients to efficiently establish clinical proof of concept Clinical update in Q3 from Phase 1 trial of VTX958, our oral, selective allosteric TYK2 inhibitor Excerpt from the Press Release: ENCINITAS, Calif., June…

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Innovation Pharmaceuticals Acquires Stake in Squalus Medical, Seeks to Reshape Cancer and Epilepsy Treatments through a New Image Guided Laser-Based Ablation Technology

07/07/2022

Innovation Pharmaceuticals acquires a minority ownership ·         Squalus has invented and is developing a leading-edge image guided surgical laser platform for treating previously inoperable cases of epilepsy and for enabling new treatment options for cancer cases in multiple key specialties, including early-stage lung cancer · Squalus to pursue the FDA 510(k) pathway for marketing clearance…

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Omega Therapeutics Presents New Preclinical Data Supporting the First Epigenomic Controller, OTX-2002, as a Potential Therapeutic Approach in Hepatocellular Carcinoma at the ESMO 2022 World Congress on Gastrointestinal Cancer

07/06/2022

Treatment with epigenomic controller, OTX-2002, resulted in robust in vivo efficacy in xenograft tumor models OTX-2002 successfully achieved pre-transcriptional downregulation of hepatocyte MYC gene expression in non-human primates Clinical potential of OTX-2002 as a monotherapy or in combination with existing standard-of-care therapies, including immune checkpoint inhibitors IND filed by the company to advance OTX-2002 into…

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Codiak Provides Platform-Validating Clinical Update and Data from Phase 1 Trials of exoSTING™ and exoIL-12™

07/06/2022

– Codiak’s engineered exosome candidates demonstrate potential for best-in-class profile, with tumor retention and delivery to the cells of interest allowing for increased therapeutic window – – exoSTING and exoIL-12 demonstrated favorable safety and tolerability profile at repeat doses tested and antitumor activity was observed in both injected and uninjected/distal lesions – – Codiak has…

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BeiGene Announces Late-Breaking Data at ESMO GI Showing Overall Survival Benefit for Tislelizumab Plus Chemotherapy in First-Line Advanced or Metastatic Esophageal Squamous Cell Carcinoma

07/06/2022

PD-1 inhibitor tislelizumab plus chemotherapy demonstrated a statistically significant and clinically meaningful survival benefit, extending survival by more than six months compared to chemotherapy alone Incidence of most common treatment-related adverse events similar for both arms of the study, with no new safety signal identified for tislelizumab Excerpt from the Press Release: CAMBRIDGE, Mass. &…

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