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.

“The challenge

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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.

This file will be updated throughout the day. For updates in your inbox, subscribe to The Daily Briefing newsletter.

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

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U.S. Hits Highest Single-Day Number of COVID-19 Cases for Any Country, England to Enter Lockdown

Karen Ducey/Getty

The U.S. recently reported the highest single-day number of COVID-19 cases for any country as the ongoing coronavirus pandemic continues to plague the nation.

According to CNN, the U.S. reported 99,321 new cases on Friday, surpassing India’s daily record of 97,894 coronavirus cases in a single day on Sept. 17.

As of Saturday afternoon, more than 9,163,700 Americans have tested positive for COVID-19, and at least 230,100 have died from the virus, according to a New York Times database.

Dr. Jonathan Reiner, a professor of medicine at George Washington University, told CNN that the increase in cases could directly translate to an increase in deaths. “The 100,000 cases yesterday two weeks from now will start to translate into massive numbers of deaths,” he said. “So we’re going to see not just cases continue to escalate but we’re going to see perhaps 2,000 deaths per day two or three weeks from now.”

RELATED: Disneyland Paris Closes Again As Second Lockdown in France Begins

Former Baltimore Health Commissioner Dr. Leana Wen also warned that if American’s don’t continue to “implement targeted measures” like mask-wearing, shutting down high-risk businesses, and avoiding social gatherings, a lockdown may be in the future. “If we don’t do these things now, we’re going to be overwhelming our health systems and then a lockdown may be necessary,” she told CNN.

On Friday, the same day that the U.S. hit its record single day statistic, a new paper by researchers at Stanford University found that President Donald Trump’s campaign rallies led to a major number of the country’s coronavirus cases.

Karen Ducey/Getty

According to CNBC, after looking at 18 Trump rallies held between June 20 and Sept. 22 and analyzing subsequent COVID-19 data, researchers found that the rallies led to more than 30,000 cases. “The communities in which Trump rallies took place paid a high price in terms of disease and death,” lead author B. Douglas Bernheim wrote.

Outside of the U.S., several other countries are continuing to struggle with the pandemic, including England which will be going into its second national lockdown next week.

On Saturday, UK Prime Minister Boris Johnson announced that the country would be entering a month-long lockdown from Nov. 5 until Dec. 2.

RELATED: More Than 40 States Have Spiking COVID Cases and Midwestern Hospitals Are ‘Struggling’ to Keep Up

PHILIPPE LOPEZ/AFP via Getty Pedestrians cross a street located in the mandatory face mask zone to limit COVID infections in Bordeaux on October 28, 2020, as France is set to put tough new measures in place.

“From Thursday until the start of December you must stay at home,” he said in a news

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Wales to Enter Two Week ‘Fire Break’ Lockdown to Curb Coronavirus Spread | Health News

Wales will enter a “fire break” lockdown for two weeks, requiring everyone to stay home in order to curb the spread of the coronavirus.

First Minister Mark Drakeford announced on Monday that beginning at 6 p.m. Friday, all non essential businesses, such as retail stores, restaurants and bars, will shut down until Nov. 9.

People will only be allowed to leave their homes for essential reasons, such as to obtain necessary supplies and health services, exercise alone, access childcare and education, attend court and visit banks. The only exception will be made for essential workers and people with jobs that make it impossible to work from home.

Between Oct. 10 and 16, Public Health Wales confirmed 3,870 new cases of the coronavirus. More than 800 people are hospitalized with COVID-19, a number that is 20% higher than just a week ago.

Officials report more than 35,620 cases of the virus in Wales and more than 1,700 people have died.

The rate of infection is currently 1.4, and the seven-day rolling incidence rate for Wales stands at more than 120 cases per 100,000 population, according to the government.

“The aim of a fire break is to reset the clock,” Drakeford said.

Non essential travel within Wales and into and out of Wales will not be allowed during the two-week fire break. Additionally, people are not permitted to visit other households or meet with people they do not live with. Secondary schools, which will be on a break period, will remain closed for an additional week, though primary schools and child care centers will remain open.

Libraries, gyms and places of worship will also be closed.

Cartoons on the Coronavirus

Face coverings continue to be mandatory in indoor public spaces that remain open and on public transportation and in taxis.

If people violate the new rules, they could face a fine up to $78 on the first offense and up to $156 on the second.

“A fire break period is our best chance of regaining control of the virus and avoiding a much longer and much more damaging national lockdown,” Drakeford said. “This is the moment to come together, to play our part in a common endeavour.”

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