TFF Pharmaceuticals, Inc. and Augmenta Bioworks, Inc. Enter Into a Worldwide Joint Development Agreement for COVID-19 Monoclonal Antibody Therapies
Companies to collaborate in first-of-its-kind uses of Thin Film Freezing technology applied to monoclonal antibodies
TFF Pharmaceuticals, Inc. (NASDAQ: TFFP), a clinical-stage biopharmaceutical company, and Augmenta Bioworks, Inc., a biotechnology company enabling breakthroughs in medicine through immune profiling, today jointly announce that both companies have entered into a worldwide Joint Development and Collaboration Agreement to develop novel commercial products incorporating Augmenta’s human-derived monoclonal antibodies (mAbs) for potential COVID-19 therapeutics.
Under the terms of the Agreement, both companies will collaborate in a Joint Development Project to develop one or more commercial therapeutics based on, derived from, and/or incorporating Augmenta’s human monoclonal antibodies to potentially treat patients with COVID-19. These products will be developed utilizing TFF Pharmaceuticals’ Thin-Film Freezing technology to manufacture dry powder formulations of these specific mAbs for inhalation delivery directly to the lungs of patients. The Agreement also includes the development of formulations suitable for parenteral administration, where the Thin Film Freezing dry powder formulations can be reconstituted, potentially mitigating the impacts of cold-chain storage and handling. TFF Pharmaceuticals will also have the option to develop two additional Augmenta mAbs for indications other than COVID-19.
Augmenta Bioworks and TFF Pharmaceuticals will allocate patent license rights to their respective technologies to allow each company to jointly commercialize the products developed under the Joint Development Project. The companies have agreed to a 50-50 split of all costs and expenses to further the Joint Development Project and both companies have agreed to the same 50-50 split of all revenues, cash payments and/or future cash payments related to the sale and/or license of the products resulting from the Joint Development Project to a third party.
“This important agreement represents the culmination of many months of work by our scientific team, as we work towards the development of a never-before-achieved formulation of monoclonal antibodies into a dry powder therapeutic,” said Glenn Mattes, CEO, of TFF Pharmaceuticals, Inc. “It is a testament to the remarkable flexibility and capability of our Thin Film Freezing platform and we are eager to develop these potentially breakthrough mAb therapies internally, along with our other programs in Invasive Pulmonary Aspergillosis, solid organ transplant anti-rejection, and botanicals.”
“Confirmed discovery of novel anti-SARS-Cov-2 antibodies in 8 days was an achievement made possible by years of technology development, and a clear indication of the power and potential of our platform,” said Christopher Emig, Ph.D., CEO and Co-Founder of Augmenta Bioworks, Inc. “We are excited to enter this partnership to bring our COVID-19 treatment into clinical development, and are looking forward to the world’s first effective, affordable and scalable antibody therapeutic to mitigate the devastating effects of this disease.”
“We believe the interest in monoclonal-antibody therapeutics for the treatment of COVID-19 is extremely high, with the promise that they will harness the immune system’s natural response to viral invaders,” said Robert O. Williams III, Ph.D., Division Head of the University of Texas at Austin’s Division of Molecular Pharmaceutics and Drug Delivery and inventor of TFF Pharmaceuticals’ Thin Film Freezing technology.
Police bust New York City party on Halloween; England to enter 4-week lockdown; virus top campaign issue
Multiple countries in Europe are again entering lockdowns as cases surge in the United States, propelling COVID-19 as a central campaign issue yet again in the presidential race.
Former Vice President Joe Biden says President Donald Trump has been unable to control the pandemic: “We’re gonna beat this virus and get it under control and the first step to doing that is beating Donald Trump,” Biden said.
Meanwhile, Trump continues to minimize the virus’ impact. Trump told Pennsylvania voters that his administration has done “an incredible job” dealing with the pandemic. He repeated a months-old promise that the mass distribution of a vaccine was “just weeks away.”
Daily infections are at an all-time high in the U.S. heading into Tuesday’s election, according to Johns Hopkins University.
📈 Today’s numbers: The U.S. has reported more than 9 million cases and more than 230,000 deaths, according to Johns Hopkins University data. The global totals: 45 million cases and 1.19 million deaths.
🗺️ Mapping coronavirus: Track the U.S. outbreak in your state.
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Police bust New York City party with nearly 400 people on Halloween
Police charged nine organizers in a bust of an “illegal bar/party” that had nearly 400 people in attendance in New York City, the NYC sheriff announced Saturday.
Police shut down the gathering held inside a Brooklyn warehouse early in the morning on Halloween.
New York Gov. Andrew Cuomo on Saturday warned against Halloween gatherings that increase the risk of transmitting COVID-19, tweeting “Halloween should be spooky, not scary.”
The guidelines tweeted by Cuomo say parties are particularly risky because they can bring together people from different areas for a long period of time.
— Joel Shannon
British PM announces new, four-week lockdown in England
British prime minister Boris Johnson announced plans Saturday for a four-week national lockdown in England starting this week that will shut pubs, restaurants, entertainment facilities and nonessential businesses.
Schools, universities and manufacturing facilities will remain open during the period from Thursday until Dec. 2.
“Unless we act, we could see deaths in this country running at several thousand a day,” Johnson said.
Johnson said that individuals will only be allowed to leave their homes for specific reasons like medical appointments, shopping for essentials, education and work that cannot be done from their residence.
“No one wants to be imposing these kinds of measures anywhere,” the prime minister said, but added that “no responsible prime minister can ignore” the rising number of COVID-19 cases.
Professor Chris Whitty, chief medical officer for England, told reporters at a news conference that England is experiencing 50,000 new cases daily and that the figure is rising.
Doctors groups rip Trump for touting baseless conspiracy over virus death count
Medical groups are slamming President Donald Trump for resurfacing a baseless conspiracy on campaign stops that doctors are inflating the number of COVID-19 deaths in the USA in order to drive
Nottingham and Warrington will become the latest areas of England to come under the tightest Covid restrictions, with pubs closed and all household mixing banned.
Tier 3 restrictions will come into force at 12.01am on Tuesday for Warrington and 12.01am on Thursday for Nottingham.
The new measures mean all pubs and bars must close, unless they are serving “substantial meals”. Alcohol can be served only alongside food.
Additional closures will include betting shops, adult gaming centres, casinos and soft play centres and areas.
Infection rates in Warrington are currently among the highest in the country and continue to rise rapidly, with case rates at 361 people per 100,000 among all age groups – double the England average of 180.6 people per 100,000.
Although infection rates were originally higher in the younger population, rates have now increased to 217 per 100,000 in over-60s, a 20% rise on the previous week, the Department of Health and Social Care (DHSC) said.
Warrington is sandwiched between Liverpool and Manchester, both of which are already in tier 3, along with nearby Lancashire.
As well as the city of Nottingham, residents of the commuter suburbs of Rushcliffe, Gedling and Broxtowe will also be subject to the tighter restrictions. The rest of Nottinghamshire will remain in tier 2.
“In order to reduce these numbers and ensure that the NHS isn’t overwhelmed and has capacity to treat other conditions, we need to act now. As of 20 October there are 117 confirmed Covid-19 cases in hospital in this area, with 17 mechanical ventilation beds occupied by confirmed Covid-19 patients,” the DHSC said.
“To support the local community during this period, the government will be providing a financial support package of £1.68m as well as £4.2m in business support funding. This will support local contract tracing, the enforcement of restrictions, and the provision of further local level data.”
The level of funding is roughly comparable to the amounts received by other areas in tier 3, adding up to approximately £28 per head.
Warrington residents must not socialise with anybody they do not live with, or have not formed a support bubble with, in any indoor setting, in any private garden, or at most outdoor hospitality venues and ticketed events. They can meet in a group of no more than six in an outdoor public space such as a park or beach, the countryside, a public garden or a sports venue.
People should try to avoid travelling outside the very high alert level area or entering another, other than for work, education, for caring responsibilities or to travel through as part of a longer journey.
The local government secretary, Robert Jenrick, said: “The restrictions we have agreed together will only be in place for as long as they are absolutely necessary. They will be reviewed jointly in 28 days’ time.”