In a report first published on the preprint server bioRxiv on June 22, Fred Hutchinson Cancer Research Center evolutionary biologist Dr. Jesse Bloom reported uncovering SARS-CoV-2 sequences from early in the Wuhan outbreak that had been deleted from a National Institutes of Health database. In a complementary Twitter thread, he explained how he had recovered raw sequencing data from 34 samples from early Wuhan SARS-CoV-2 cases, used the data in the…
Seagen Inc. (Nasdaq:SGEN) and Astellas Pharma Inc. (TSE: 4503, President and CEO: Kenji Yasukawa, Ph.D., “Astellas”) today announced the U.S. Food and Drug Administration (FDA) granted PADCEV® (enfortumab vedotin-ejfv) regular approval in the U.S., in addition to approving a new indication for adult patients with locally advanced or metastatic urothelial cancer who are ineligible for cisplatin-containing chemotherapy and have previously received…
An innovative clinical trial led by Dr. Nicholas Vitanza, a neuro-oncologist at Seattle Children’s, shows promise that delivering cancer-fighting chimeric antigen receptor (CAR) T cells directly to the brain for children and young adults with recurrent or refractory brain and central nervous system (CNS) tumors may be feasible and tolerable. The results, published today in Nature Medicine, are the initial findings…
Silverback Therapeutics, Inc. (Nasdaq: SBTX) (“Silverback”), a clinical-stage biopharmaceutical company leveraging its proprietary ImmunoTAC technology platform to develop systemically delivered, tissue targeted therapeutics for the treatment of cancer, chronic viral infections, and other serious diseases, today announced a clinical supply agreement with Regeneron for Libtayo® (cemiplimab). The supply agreement supports the evaluation of Libtayo®, a PD-1 inhibitor, in combination with SBT6050, the…
Three mutations in the Epsilon coronavirus spike protein dampen the neutralizing potency of antibodies induced by current vaccines or past COVID infections. The mutations give this coronavirus variant of concern a means to totally evade specific monoclonal antibodies used in clinics and reduces the effectiveness of antibodies from the plasma of vaccinated people. To better understand the exact immune escape…
Seattle-based Icosavax has filed to go public via an IPO, just four years after it launched out of the University of Washington. The company, a spin-out from the UW’s Institute for Protein Design, is developing vaccines to resemble naturally occurring viruses. Icosavax initiated a phase 1 and 2 clinical trial of a COVID-19 vaccine candidate this June, with support from a $10 million grant from…
An experimental COVID-19 vaccine in development by Seattle-based HDT Bio will enter early-stage clinical trials in the U.S., the company announced yesterday after the U.S. Food and Drug Administration cleared the trial to go forward. The phase 1 trial will enroll 60 volunteers and will assess safety and the strength of the immune response against the vaccine. HDT Bio’s vaccine is based on RNA,…
HDT Bio Corp., a developer of immunotherapies for oncology and infectious diseases today announced the U.S. Food and Drug Administration (FDA) has reviewed the company’s Investigational New Drug Application (IND) and provided a notice to proceed for a US-based Phase 1 clinical trial of its HDT-301 COVID-19 RNA vaccine. HDT-301 is also designed to provide protection against variants of SARS-CoV-2,…
Neoadjuvant immune checkpoint blockade (ICB) is a promising treatment for melanoma and other cancer types, and has recently been shown to provide a modest survival benefit for patients with recurrent glioblastoma. To improve the treatment efficacy, researchers are looking for vulnerabilities in surgically removed glioblastoma tissues, but this has been difficult due to the vast differences within the tumor and…
Achieve Life Sciences, Inc. (Nasdaq: ACHV), a clinical-stage pharmaceutical company committed to the global development and commercialization of cytisinicline for smoking cessation and nicotine addiction, today announced that the Phase 3 ORCA-2 trial of cytisinicline has reached its enrollment target of 750 adult smokers. The ORCA-2 trial sites are no longer enrolling new subjects, however those currently in screening will…