StemCell Therapy

The U.S. government bought 100 million doses of mRNA-1273 from Moderna Inc., of Cambridge, Mass., with a new award worth up to $1.525 billion. The deal, part of Operation Warp Speed, also brings a U.S. government option to buy up to an additional 400 million doses from Moderna. The implied price per dose is about $15.25, below SVB Leerinks $22 price per dose model from previous Moderna-Operation Warp Speed deals. On July 27, Moderna dosed the first of what could be as many as 30,000 healthy volunteers as it began its phase III COVID-19 vaccine trial. Those volunteers at increased risk of contracting COVID-19, with a large percentage being elderly or people with co-morbidities those most at risk for life-threatening COVID-19 infections are receiving placebo or mRNA-1273.

Amid all the political positioning, finger-pointing, blame games and mountains of misinformation that have been as much a part of the COVID-19 pandemic as the infections themselves, theres one point of agreement: the pandemic has been a painful experience that everyone needs to learn from. Im hoping that memory is not short, Mike Piccarreta, a partner at global consulting firm Kearney, told BioWorld. Clearly we were not prepared for this type of pandemic in terms of government response and manufacturing capacity, he added. Had the U.S. and other countries acted on lessons that should have been learned in the past, they would have been better prepared for COVID. And if they allow the current lessons to fade with time, they will not be ready for the next pandemic.

LONDON Antifungal specialist F2G Ltd. has closed a $60.8 million round, providing the means to complete phase III development of the lead product olorofim, a treatment for life-threatening invasive infections, and to scale up in preparation for commercialization. Olorofim is the first of a new class of drugs called orotomides, discovered and developed to phase IIb by F2G. If approved, it will be the first new antifungal based on a novel mechanism in nearly 20 years.

A bid by top shareholders and managers of the U.S.-China cell therapy developer Cellular Biomedicine Group Inc. to take the company private pushed shares (NASDAQ:CBMG) 35% higher Wednesday, just shy of the offering price. "As a private company, we will have access to the resources and long-term commitment needed to better pursue new capital investment in existing assets and targeted acquisition opportunities as our sector continues to evolve, including further geographic and product diversification," CBMG's CEO Tony Liu told employees.

As part of its earnings report earlier this week, Reata Pharmaceuticals Inc. provided a regulatory update that caused some chagrin among investors. The company said the FDA is not convinced that the Moxie Part 2 results will support a single study approval without additional evidence that lends persuasiveness to the results. A phase II study with omaveloxolone for Friedreichs ataxia, Moxie Part 2 had gained the agencys sign-off regarding its primary endpoint; improvement on the modified Friedreich Ataxia Rating Scale. Reata said an NDA submission is now targeted for the first quarter of next year, assuming regulators accept the trial design of the companys planned crossover study. The company provided more encouraging news about the progress of bardoxolone in Alport syndrome. Shares (NASDAQ:RETA) took a hit Monday, dropping from $156.20 to $105.40, and were trading midday at $103.09.

Newly founded Lianbio, with offices in Shanghai and San Francisco, aims to quickly establish a presence in China and Asia with late-stage assets in-licensed from Bridgebio Pharma Inc. and Myokardia Inc. in two deals amounting to $531.5 million and $187.5 million, respectively. Launched on Aug. 11, Lianbio was founded, seeded and incubated by hedge fund Perceptive Advisors with the aim of bringing in first-in-class drugs. Perceptive will help the startup pick assets that have a good chance of becoming clinically successful.

PERTH, Australia Aussie regenerative medicine company Regeneus Ltd. has out-licensed its lead mesenchymal stem cell and secretome therapy, Progenza, to Japans Kyocera Corp. for osteoarthritis of the knee for the Japan market. Under the terms of the deal, Regeneus will receive $19 million in up-front and milestone payments, consisting of $9 million up front and $10 million in regulatory and development milestones. Regeneus will also receive double-digit royalties on sales. The company retains rights to negotiate licenses with other partners for additional indications inside and outside of Japan.

HONG KONG Singapore-based Tessa Therapeutics Pte Ltd. released the results of two independent phase I/II trials led by Baylor College of Medicine and the University of North Carolina Lineberger Comprehensive Cancer Center. It was found that Tessas autologous CD30 CAR T-cell therapy (TT-11) showed a high rate of durable complete responses and a very favorable safety profile in patients with relapsed/refractory Hodgkin lymphoma.

Adverum, Akari, Arca, Ascendis, Azurrx, Beroni, Blade, Boehringer Ingelheim,Botanix, Cellular Biomedicine, Cytovia, Eli Lilly, Eloxx, Epirium, Eyegate, Genscript, Helix, Hepion, Horizon, Ikena Oncology, India Globalization Capital, Inhibrx, Innovent, Kahr Medical, Kineta, Monopar, Nektar, Nicox, Nymox, Omeros, PDL, Pliant, Redhill, Regeneron, Sapience, Seattle Genetics, Seres, Theranexus, Therapeutic Solutions, Trevena, Vaccibody, VBL

Go here to see the original:
Moderna receives $1.525B more in COVID-19 funding from Operation Warp Speed - BioWorld Online

This entry was posted on August 13, 2020 at 7:54 pm and is filed under Regenerative Medicine. You can follow any responses to this entry through the RSS 2.0 feed. Both comments and pings are currently closed. |