Adaptive Phage gets $10M from DoD for antibacterial phage therapies

MedCity News | January 08, 2020

A company developing treatments for drug-resistant bacterial infections is getting a boost from the Department of Defense. Gaithersburg, Maryland-based Adaptive Phage Therapeutics, also known as APT, said Tuesday that it the DoD had awarded it $10.2 million to fund a clinical trial to develop its personalized bacteriophage therapeutic, PhageBank. “This is a promising step toward making phage therapy available to military and potentially non-military patients alike as a rapid and cost-effective option for multi-drug resistant bacterial infections,” APT CEO Greg Merril said in a statement. “APT’s proprietary technologies enable the rapid administration of phage therapy as a precise treatment tailored to a patient’s individual infection.”

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Evaluate is the trusted provider of commercial intelligence including product sales and consensus forecasts to 2022 for commercial teams and their advisors within the global life science industry. We help our clients make high value decisions through superior quality, timely, must-have data and insights, combined with personalised, expert client support. EvaluatePharma® delivers exclusive consensus sales forecasts and trusted commercial insight into biotech and pharmaceutical performance.

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CTA approval of BioInvent's BI-1808, a first-in-class anti-TNFR2 antibody, sets stage for Phase I/IIa trial

BioInvent | October 27, 2020

BioInvent International AB ("BioInvent") (OMXS: BINV), a biotech company focused on novel and first-in-class immune-modulatory antibodies for cancer immunotherapy, today announces it has received regulatory authority approval of its clinical trial application (CTA) in Denmark for a Phase I/IIa, first-in-human study of BI-1808, as monotherapy and in combination with the anti-PD-1 therapy Keytruda® (pembrolizumab) for the treatment of solid tumors and cutaneous T-cell lymphoma (CTCL). Martin Welschof, CEO of BioInvent, says, "CTA approval for our Phase I/IIa trial of BI-1808 marks the first anti-TNFR2 antibody to enter clinical development. BI-1808 is a first-in-class anti-TNFR2 antibody, which we believe is a very promising approach for cancer therapy, and testament to the power of our proprietary n-CoDeR® and F.I.R.S.TTM platforms to generate antibodies to novel targets with potent anti-tumoral activity. We expect to enroll the first patient before the end of the year and to submit an investigational new drug (IND) application in the U.S. in the coming weeks." The study will explore the safety, tolerability, and potential signs of efficacy of BI-1808 as a single agent and in combination with Keytruda® in patients with ovarian cancer, non-small cell lung cancer and CTCL. It will also investigate the expression of potential immunological markers that might be associated with clinical responses. The trial will be conducted at several sites across Europe and the U.S. and is expected to enroll approximately 120 patients.

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Acticor Biotech Announces the Success of the First Phase of its ACTIMIS study with Glenzocimab In Patients with Acute Ischemic Stroke

Acticor Biotech | October 05, 2020

Acticor Biotech, a clinical stage biotechnology company involved in the acute phase of thrombotic diseases, including acute ischemic stroke, today announced the completion of its ACTIMIS Dose Escalation Phase of Glenzocimab Study as add-on to standard of care in Patients with acute ischemic stroke. This Dose Escalation Phase was successfully completed with 60 patients enrolled from 6 European countries (France, Belgium, Germany, Spain, Switzerland and Italy). 5 cohorts of patients presenting with an acute ischemic stroke episode of moderate to severe intensity were enrolled in this study and randomly received glenzocimab at one of 4 ascending doses or a placebo, in a blind fashion as a 6-hour single-dose infusion. Patients were evaluated continuously for 24 hours, then 7 and 90 days after the episode. Approximately 50% were also treated with the thrombolytic agent rtPA (ACTILYSE®), and the other 50% received rtPA and underwent a mechanical thrombectomy. The DSMB met on 5 occasions in between each cohort and at the end of the last administration, and they analyzed the safety data with a particular focus on the advent of intra-cerebral hemorrhages and other bleeding related events. The last analysis performed after the target dose of 1000mg had been administered to 12 patients confirmed both the absence of increased bleeding when glenzocimab is added to rtPA and to rtPA and thrombectomy, and the absence of any dose-related trend in the number and nature of adverse events recorded.

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CELL AND GENE THERAPY

Mission Bio and S2 Genomics to Provide Tumor Sample for Single-cell DNA Analysis

Mission Bio | April 20, 2022

Mission Bio, Inc., a leader in high-throughput single-cell DNA and multi-omics analysis, announced today a co-marketing agreement with S2 Genomics, Inc., a leading developer of laboratory automation solutions for processing solid tissues for single-cell applications, to provide a single streamlined workflow for solid tumor applications from sample prep to analysis. Christine A. Iacobuzio-Donahue, MD, Ph.D., Director of the Center for Pancreatic Cancer Research at Memorial Sloan Kettering Cancer Center (MSKCC), validated the automated nuclei workflow, which she presented at the American Association for Cancer Research (AACR) Annual Meeting last week. Single-cell DNA analysis has revolutionized cancer research, allowing researchers to gain high-resolution insights into tumor heterogeneity, leading to a slew of high-profile papers on disease causes. Solid tumor profiling, on the other hand, presents significant problems, as existing prep procedures sometimes fail to yield enough cells or nuclei to offer relevant data. Mission Bio introduced their Tapestri Solution for Solid Tumor Research last month to address this issue, which includes new pre-designed research panels for breast cancer and glioblastoma multiforme, as well as an upgraded single-cell copy number variation (CNV) bioinformatic analysis tool. S2 Genomics' SingulatorTM 100 technology for automated dissociation of solid tissue into single-cell or nuclei suspensions can now be used in conjunction with Tapestri to achieve scalable, high-yield, efficient, and repeatable tissue processing. We are eager to partner with leading companies to address key challenges to sample prep in solid tumor research, As Dr. Iacobuzio-Donahue's lab demonstrates, the Singulator 100 and Tapestri together are a powerful solution enabling single-cell DNA sequencing at scale, in pancreatic cancer research and across a variety of tissue types." Yan Zhang, Ph.D., CEO of Mission Bio. The Singulator 100 has been an important tool for enabling single-cell sequencing in solid tissue, but cancer researchers have been unable to directly interrogate DNA, Tapestri is the only commercial platform capable of single-cell DNA analysis, and we're excited to offer this single automated pipeline connecting cell and nuclei prep to Tapestri's microfluidics-based workflow." John Bashkin, Chief Strategy Officer of S2 Genomics.

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