Tag: Infectious Disease Research

Southern Research breaks ground on new biotech center and campus renovations

Birmingham, Ala. – Southern Research today broke ground on a flagship biotech center that will anchor the development of 200,000 square feet of new or renovated wet lab space for life sciences. The new facility, located on the corner of Richard Arrington Jr., Blvd., and Ninth Avenue South, will double the organization’s lab space for researching infectious diseases and greatly expand its work to develop new treatments for cancer and other serious illnesses.

The new center is expected to create 150 new jobs at Southern Research and to double the institution’s annual economic impact to $300 million a year.

“This project represents a major investment in the city of Birmingham and in the great work being done by our Southern Research team,” said Josh Carpenter, Ph.D., president and CEO of Southern Research. “It builds on our strengths and puts us in a position for dynamic growth in the future.”

The Alabama Legislature included $45 million for the Southern Research building in the state budget for 2023, marking the state government’s first-ever investment in the 80-year-old campus.

“This represented an opportunity to create high-paying jobs in Birmingham and to support one of the state’s most important industries,” Gov. Kay Ivey said. “Scientific and technical innovation is a major driver of Alabama’s economic growth, and Southern Research has long been a key player in making it happen.”

Construction alone will create more than 1,100 project-related jobs and generate more than $190 million in economic activity, Carpenter said.

In addition to expanding space for research on infectious diseases like COVID-19, the new facility will allow Southern Research to ramp up its efforts to target common diseases that have a profound impact on the well-being of Alabamians and communities.

In addition to this new facility, Southern Research plans to renovate much of its campus and build new space to advance genomic diagnostics work over the next few years.

The city of Birmingham and Jefferson County have each been asked to provide funding alongside Southern Research and the State of Alabama to help accelerate this capital investment. While the contributions have not been approved at the City or the County, officials on both sides of Linn Park expressed support for the expansion.

“This is a transformational moment for Southern Research and for Birmingham,” said Birmingham Mayor Randall L. Woodfin. “As someone who benefited from a COVID-19 treatment developed with Southern Research’s experts, I am especially grateful to the scientists who work here and I’m proud to help them take their work to the next level.”

As Economic Development Committee Chair of the Jefferson County Commission, Steve Ammons called the Southern Research project yet another example of local leaders working across partisan and jurisdictional lines to benefit the entire Birmingham metro area.

“When we work together, we can do big things,” Commissioner Ammons said. “This expansion at Southern Research is an important project that will create economic ripples across this county and state.”

Ray Watts, MD, president of the University of Alabama at Birmingham and chair of the Southern Research board of directors, said the new facility will help fulfill his vision of creating a world-class biotech corridor that stretches from the UAB campus to Southern Research and Ascension St. Vincent’s Birmingham.

“Between UAB and Southern Research, we are working to ensure that Birmingham and Alabama become the biotech commercialization center of the Southeast,” Watts said. “This new facility will help us incubate new biotech entrepreneurs and attract top talent to this area. Southern Research and its vision for this center are intricately tied to the future success of Birmingham.”

Alongside the new construction, Southern Research has contracted Brasfield & Gorrie to help renovate more than 40,000 square feet of its existing campus facilities in Birmingham’s Southside. Investments include building out more vivarium space and launching a new clinical diagnostics lab.

CEO Josh Carpenter: Painful decision on Quinlan Castle clears way for investment in biotech, Birmingham’s future

Three weeks after I joined Southern Research as president and CEO, a 12-story condo building collapsed in Miami, killing 98 people and raising alarms about the structural integrity of buildings across the country.This tragedy led many organizations to take a hard look at the safety of their physical structures. Southern Research was no exception, and our review quickly turned to the Quinlan Castle, an old apartment building sitting in the heart of our campus.
With its stone exterior, the castle appears solid from the outside. But inside, the castle is in literal shambles, falling victim to the elements and vandals and time. To assess its safety, we hired a structural engineer and other building experts this summer to evaluate the castle and its potential for rehabilitation.

They found serious safety hazards. Beyond the obvious — fallen interior walls, caved-in ceilings, and buckled floors — they noted serious structural issues. They included corroded concrete with exposed, rusted rebar — one of the very issues cited in the Miami condo collapse.

Could we bring back the castle to use for our scientific endeavors? Our building experts concluded that addressing the safety issues alone would be cost-prohibitive, and the building simply could not be converted, at any price, into the modern lab space our scientists need.

Even with current building codes, the load requirements for an apartment building are less than half the load requirements for a research facility like ours. The assumption is that the building codes were even less stringent in 1927. The ceiling heights from that time can’t accommodate modern infrastructure and life safety needs, and trying to ensure disability access would be nearly impossible in a structure whose insides are defined by steep, narrow stairs.

After careful study and consideration of our options, we sought and received approval from the city of Birmingham’s Design Review Committee to bring down the castle. We will replace it with a modern structure that teems with some of our state’s best science, retains and attracts talent to make Southside more vibrant, and becomes a source of pride for our community.

As one of Birmingham’s oldest employers, we respect historical institutions. We don’t take joy in bringing down a building that has stood for so many years. We welcome suggestions from the community about ways that we may be able to preserve and use some elements of the castle for other purposes.

But this almost century-old structure simply does not work for Southern Research’s mission, nor for the dedicated employees who work here.

Benefit Birmingham, Jefferson County and the state of Alabama

COVID-19 revealed healthcare heroes in our midst, and I am proud to work alongside many of them at Southern Research. Our scientists have been studying viruses like COVID-19 for 20 years. When this new global threat emerged, the team at Southern Research shifted into high gear, working nonstop to test possible treatments and employing every possible tool to combat the pandemic.

Scientists at Southern Research have made substantial contributions in testing, treatments and vaccines for COVID-19. In partnership with UAB, we helped refine remdisivir, the first treatment approved for the virus. In partnership with Tonix Pharmaceuticals, we helped develop a potential vaccine that is in clinical trials. These are just two examples, and they don’t begin to capture what Southern Research has contributed to our nation’s pandemic response.

Heading into 2022, we have an opportunity to invest more and expand this important part of our mission, both to magnify our work to combat COVID and to better prepare for the next threat that might endanger our family, our friends, and the Birmingham community.

Our plans for a new facility on our Southside campus – a center for pandemic resilience — will double the amount of lab space we have available for research and development on infectious diseases like COVID-19. It will also broaden our capacity to address common diseases and health conditions that have made COVID particularly lethal to Alabamians.

In addition to extending our scientific reach, the new space will allow us to hire 100 additional scientists and nurture commercial research, enlarging our economic impact as well.

I believe everyone agrees our plans will benefit Birmingham, Jefferson County and the state of Alabama. But there is understandably some discomfort that this important new facility will be located at the site of Quinlan Castle.

The castle is a charming, quirky, almost whimsical landmark in Birmingham. Built in 1927 as an apartment building, its appearance was designed to replicate castles that American soldiers had seen in Europe during World War I.

Like many others in Birmingham, I’ve smiled in passing the castle and seeing those turrets and battlements in the city skyline.

But we can no longer ignore the castle’s dangerous condition issues, the result of many decades of deterioration and neglect.

We firmly believe that trying to preserve the castle is not the best use of this site or our resources. We believe our community will be much better served by building a facility that allows us to meet the challenges of today and tomorrow — and that represents a real investment in Birmingham’s future.

We are building a castle for the 21st century. This new structure won’t feature turrets or battlements, but it will allow us to improve our fight against some our community’s most dangerous enemies – chronic illness and infectious disease.

Josh Carpenter, Ph.D., is president and CEO of Southern Research (SR), an independent, nonprofit scientific research organization. Now affiliated with UAB, SR was founded in 1941 and currently employs 400 full-time scientists, engineers, and professional personnel.

This column appeared on ComebackTown.com.

Southern Research sells Maryland site, paves way for new jobs in Birmingham

Southern Research has completed the sale of its Maryland facility to Tonix Pharmaceuticals.

The sale of the property in Frederick, Md., will allow Southern Research to invest nearly $20 million in its Birmingham campus and bring 50 new high-paying jobs to Alabama.

“Selling the Frederick facility is part of our strategic plan for the future of Southern Research,” said Josh Carpenter, the president and CEO of Southern Research.  “We plan to invest in new facilities in Birmingham and greatly expand our infectious disease capabilities to address current and emerging threats.”

Southern Research has been heavily involved in COVID response since the pandemic began in 2020, performing more than $30 million in research and development on COVID testing, treatment and vaccine development.

Among other things, Southern Research and Tonix collaborated on a COVID vaccine that is currently in clinical trials. Their collaboration will continue going forward, with Southern Research working on vaccines and antivirals at its Birmingham campus.

“By consolidating our work here in Birmingham, we are not just transferring existing jobs to Alabama,” Carpenter said. “We are also freeing up resources that will enable us to create even more jobs and economic impact in the future. The best days for Southern Research are still to come.”

Founded in Birmingham in 1941, Southern Research is an independent, non-profit scientific research organization where scientists and engineers work across three divisions:  Life Sciences, Engineering, and Energy & Environment.

For more information about Southern Research, visit www.southernresearch.org.

Southern Research and Tonix Pharmaceuticals Reports Positive COVID-19 Vaccine Efficacy Results

Vaccine Candidate TNX-1800 Protected Both Upper and Lower Airways After Challenge with SARS-CoV-2, Suggesting an Ability to Block Forward Transmission

 

TNX-1800 is Based on a Proprietary Vaccine Platform Designed to Stimulate Long Term T cell Immunity

 

CHATHAM, NJ, March 25, 2021 – Tonix Pharmaceuticals Holding Corp. (Nasdaq: TNXP) (Tonix or the Company), a clinical-stage biopharmaceutical company, today announced preliminary results following vaccination of non-human primates with TNX-1800 (modified horsepox virus, live vaccine), a live attenuated COVID-19 vaccine candidate engineered to express the SARS-CoV-2 (CoV-2) spike protein.  Immunogenicity and protective efficacy of single-dose TNX-1800 were assessed at two dose levels (n=4 per group). At Day 41 after the vaccination, animals were challenged with live SARS-CoV-2 through intra-nasal and intra-tracheal routes.  Protection was assessed at Day 47 or six days after challenge. The research is part of an ongoing collaboration between Southern Research, the University of Alberta and Tonix.

 

“We are pleased that all eight animals vaccinated with TNX-1800 had undetectable SARS-CoV-2 in their upper and lower airways 6 days after challenge with SARS-CoV-2,” said Seth Lederman, M.D., President and Chief Executive Officer of Tonix Pharmaceuticals.  “Today’s results are from the second phase of a study, in which TNX-1800 vaccinated and control animals were challenged with SARS-CoV-2. Last Fall, we reported that all eight of the animals manifested ‘takes’, a skin reaction to horsepox vaccination which is a validated biomarker of functional T cell immunity, and that vaccination was associated with neutralizing antibodies in each case.  The positive results of the protection from live CoV-2 challenge that we are reporting today validate the capacity for TNX-1800 to protect against COVID-19, and also validate the ‘take’ after TNX-1800 vaccination as a biomarker for functional T cell immunity.”

 

Dr. Lederman continued, “’Take‘ is considered important because it is otherwise difficult and costly to measure the T cell response to a vaccine.  Vaccines that elicit a strong T cell response, like horsepox and closely related vaccinia, have been established to provide long-term, durable immunity and to block forward transmission.  Single dose horsepox and vaccinia vaccination led to the eradication of smallpox, which, like CoV-2 is transmitted by the respiratory route. In the successful campaign to eradicate smallpox, ‘take’ was used as a biomarker for protective immunity.  We believe the absence of detectable CoV-2 in the upper or lower airways shows the potential for TNX-1800 to decrease shedding of virus and is consistent with decreased transmission.”

 

Dr. Lederman continued, “Although many successful vaccines have been put into use around the world, much remains unknown about COVID-19, its emerging variants, and the durability of current vaccines. We designed TNX-1800 as a single dose vaccine using a vector known to provide long term T cell immunity. This was originally demonstrated by the vector’s use as the backbone of Edward Jenner’s smallpox vaccine which typically provided lifetime immunity with a single dose.  Moreover, by preventing forward transmission of the smallpox virus, it became a defining force in establishing herd immunity.”  Dr. Lederman continued, Like Jenner’s smallpox vaccine, TNX-1800 can be scaled up for manufacturing and will not require a costly and cumbersome cold chain for distribution and storage. It will also be glass-sparing, with 100 doses filled per vial. These features, coupled with the results announced today, encourage us to advance TNX-1800 to human Phase 1 trials in the second half of 2021 when we expect to have Good Manufacturing Practice or cGMP quality TNX-1800 available.”

 

The Company believes the findings also demonstrate the flexibility of the horsepox vaccine platform and its capability to be tailored to other diseases of interest in military and civilian populations.

 

 

Key features and results:

 

  • STUDY DESIGN: This study of non-human primates compared TNX-1800 (modified horsepox virus encoding CoV-2 spike protein) to TNX-801 (horsepox virus, live vaccine) at two doses. Also a control group received a placebo.  Each of these five groups (TNX-1800 high and low dose; TNX-801 high and low dose and placebo) included four animals.
  • CoV-2 CHALLENGE: At day 41 after vaccination (or placebo), each animal was exposed to SARS-COV-2 by intra-tracheal (1 x 106 TCID50) and intra-nasal (1 x 106 TCID50) administration.
  • DETECTION OF SARS-COV-2 in Upper and Lower Airway: Upper airway virus was studied by oropharyngeal swabs and lower airway virus by tracheal lavage using qRT-PCR to determine the number of genome copies of SARS-CoV-2 present in the samples. Six days after challenge, no (0/8) samples taken from animals vaccinated with TNX-1800 had detectable SARS-CoV-2 in either upper or lower airway samples. In contrast, all (8/8) animals vaccinated with the control vaccine TNX-801 showed infection (more than 1,000 genome copies) as did three of four monkeys vaccinated with vehicle control.
  • NEUTRALIZING ANTI-CoV-2 ANTIBODIES: At day 14 after a single vaccination, all eight of the TNX-1800 vaccinated animals made anti-CoV-2 neutralizing antibodies (≥1:40 titer) and, as expected, none of the eight TNX-801 vaccinated control animals, or any of the four animals in the placebo group made anti-CoV-2 neutralizing antibodies (≤1:10 titer). At 6 days after CoV-2 challenge, TNX-1800 vaccinated animals showed neutralizing antibody titers of (≥1:1280 titer). The level of neutralizing anti-CoV-2 antibody production was similar between the low and high dose TNX-1800 groups (1 x 106 Plaque Forming Units [PFU] and 3 x 106 PFU, (respectively). For unvaccinated animals challenged with SARS-CoV-2, neutralizing antibodies were measurable after vaccination (≥1:40 titer) that were lower and appeared later than neutralizing antibodies in TNX-1800 vaccinated animals.
  • TOLERABILITY: TNX-1800 and TNX-801 were well tolerated at both doses.
  • SKIN TAKE BIOMARKER: Further, as an expected additional outcome, all 16 animals vaccinated with either dose of TNX-1800 or the control TNX-801 manifested a “take”, or cutaneous response, signaling that the horsepox vector elicits a strong T cell immune response.
  • DOSE: These results support the expectation that TNX-1800 at the low dose of 1 x 106 PFU is an appropriate dose for a one-shot vaccine in humans and indicate that 100 doses per vial is the target format for commercialization, which is well suited to manufacturing and distribution at large scale.
  • CONCLUSIONS: Together, these data show that TNX-1800 induces protection against SARS-COV-2 infection in non-human primates. These data confirm that “take” is a biomarker of protection of upper and lower airways from SARS-CoV-2 challenge, and a biomarker of immunological response to TNX-1800’s cargo COVID-19 antigen, which is the CoV-2 spike protein.
  • NEXT PHASE: Phase 1 human study targeted to start in the second half of 2021, following IND clearance by the FDA and the production of GMP material.

 

 

Anthony Macaluso, Ph.D., Executive Vice President, Strategic Development at Tonix Pharmaceuticals said, “In addition to their impact on the development of a COVID-19 vaccine, these data also demonstrate the utility of horsepox as a vaccine platform that can be used to address many other diseases of interest to the military and the general public. The horsepox platform has the following attributes favorable for vaccine development: strong induction of both B- and T-cell immunity; amenability to genetic modification; and the ability to express multiple genes, either alone or in combination. In addition, the horsepox vaccine platform allows for rapid scalability of manufacturing, which is a key advantage of HPXV over other platforms such as non-replicating viruses, DNA/RNA, or protein subunit vaccines.”

 

 

About TNX-1800

TNX-1800 is a live modified horsepox virus vaccine for percutaneous administration that is designed to express the Spike protein of the SARS-CoV-2 virus and to elicit a predominant T cell response.  Horsepox and vaccinia are closely related orthopoxviruses that are believed to share a common ancestor.  Tonix’s TNX-1800 vaccine candidate is administered percutaneously using a two-pronged, or “bifurcated” needle.  TNX-1800 is based on a horsepox vector, which is a live replicating, attenuated virus that elicits a strong immune response.  The major cutaneous reaction or “take” to vaccinia vaccine was described by Dr. Edward Jenner in 1796 and has been used since then as a biomarker for protective immunity to smallpox, including in the World Health Organization’s (WHO) accelerated smallpox eradication program that successfully eradicated smallpox in the 1960’s.  The “take” is a measure of functional T cell immunity validated by the eradication of smallpox, a respiratory-transmitted disease caused by variola.  Tonix’s proprietary horsepox vector is believed to be more closely related to Jenner’s vaccinia vaccine than modern vaccinia vaccines, which appear to have evolved by deletions and mutations to a phenotype of larger plaque size in tissue culture and greater virulence in mice. Live replicating orthopoxviruses, like vaccinia or horsepox, can be engineered to express foreign genes and have been explored as platforms for vaccine development because they possess; (1) large packaging capacity for exogenous DNA inserts, (2) precise virus-specific control of exogenous gene insert expression, (3) lack of persistence or genomic integration in the host, (4) strong immunogenicity as a vaccine, (5) ability to rapidly generate vector/insert constructs, (6) readily manufacturable at scale, and (7) ability to provide direct antigen presentation. Relative to vaccinia, horsepox has substantially decreased virulence in mice1.  Horsepox-based vaccines are designed to be single dose, vial-sparing vaccines, that can be manufactured using conventional cell culture systems, with the potential for mass scale production and packaging in multi-dose vials.

 

1Noyce RS, et al. (2018) PLoS One. 13(1):e0188453

 

About Southern Research

Founded in 1941, Southern Research (SR) is an independent, 501(c)(3) nonprofit, scientific research organization with more than 400 scientists and engineers working across three divisions: Drug Discovery, Drug Development, and Engineering. SR has supported the pharmaceutical, biotechnology, defense, aerospace, environmental, and energy industries. SR works on behalf of the National Institutes of Health, the U.S. Department of Defense, the U.S. Department of Energy, NASA and other major aerospace firms, utility companies, and other external academic, industry and government agencies. SR pursues entrepreneurial and collaborative initiatives to develop and maintain a pipeline of intellectual property and innovative technologies that positively impact real-world problems. SR has numerous ongoing drug discovery programs, which encompass drug discovery programs to combat various forms of cancer, Alzheimer’s, schizophrenia, opioid use disorder, human immunodeficiency virus, disease, Parkinson’s, tuberculosis, influenza, and others.  SR’s strong history, which includes over 75 years of successful collaborations to solve complex problems, has led to the discovery of seven FDA-approved cancer drugs—a number rivaling any other U.S. research institute. Furthermore, experts at SR are well-equipped to assist with the challenging landscapes of drug design and development technologies and market viability. SR is headquartered in Birmingham, Alabama with additional laboratories and offices in Frederick, Maryland.

 

Further information about SR can be found at http://southernresearch.org/

 

About Tonix Pharmaceuticals Holding Corp.

Tonix is a clinical-stage biopharmaceutical company focused on discovering, licensing, acquiring and developing small molecules and biologics to treat and prevent human disease and alleviate suffering. Tonix’s portfolio is primarily composed of central nervous system (CNS) and immunology product candidates. The CNS portfolio includes both small molecules and biologics to treat pain, neurologic, psychiatric and addiction conditions. Tonix’s lead CNS candidate, TNX-102 SL1, is in mid-Phase 3 development for the management of fibromyalgia, and positive data on the RELIEF Phase 3 trial were recently reported. The Company expects interim data from a second Phase 3 study, RALLY, in the third quarter of 20212 and topline data in the fourth quarter of 2021. The immunology portfolio includes vaccines to prevent infectious diseases and biologics to address immunosuppression, cancer, and autoimmune diseases. Tonix’s lead vaccine candidate, TNX-18003, is a live replicating vaccine based on the horsepox viral vector platform to protect against COVID-19, primarily by eliciting a T cell response. Tonix reported positive efficacy data from animal studies of TNX-1800 in the first quarter of 2021. TNX-8013, live horsepox virus vaccine for percutaneous administration, is in development to protect against smallpox and monkeypox.

 

1TNX-102 SL is an investigational new drug and has not been approved for any indication.

2Pending submission and agreement from FDA on statistical analysis plan.

3TNX-1800 and TNX-801 are investigational new biologics and have not been approved for any indication.

 

This press release and further information about Tonix can be found at www.tonixpharma.com.

 

Forward Looking Statements

Certain statements in this press release are forward-looking within the meaning of the Private Securities Litigation Reform Act of 1995. These statements may be identified by the use of forward-looking words such as “anticipate,” “believe,” “forecast,” “estimate,” “expect,” and “intend,” among others. These forward-looking statements are based on Tonix’s current expectations and actual results could differ materially. There are a number of factors that could cause actual events to differ materially from those indicated by such forward-looking statements. These factors include, but are not limited to, risks related to failure to obtain FDA clearances or approvals and noncompliance with FDA regulations; delays and uncertainties caused by the global COVID-19 pandemic; risks related to the timing and progress of clinical development of our product candidates; our need for additional financing; uncertainties of patent protection and litigation; uncertainties of government or third party payor reimbursement; limited research and development efforts and dependence upon third parties; and substantial competition. As with any pharmaceutical under development, there are significant risks in the development, regulatory approval and commercialization of new products. Tonix does not undertake an obligation to update or revise any forward-looking statement. Investors should read the risk factors set forth in the Annual Report on Form 10-K for the year ended December 31, 2019, as filed with the Securities and Exchange Commission (the “SEC”) on March 24, 2020, and periodic reports filed with the SEC on or after the date thereof. All of Tonix’s forward-looking statements are expressly qualified by all such risk factors and other cautionary statements. The information set forth herein speaks only as of the date thereof.

Southern Research and Tonix Pharmaceuticals COVID-19 Vaccine Research Update

On the 16th of November, 2020, Tonix Pharmaceuticals Holding Corp., a clinical-stage biopharmaceutical company, announced preliminary results for a live attenuated COVID-19 vaccine candidate engineered to express the SARS-CoV-2 (CoV-2) spike protein after vaccination. The research is part of an ongoing collaboration with Southern Research, Tonix Pharmaceuticals, and others.

Southern Research Tonix
Southern Research reports positive
immune response results with New York-based Tonix Pharmaceuticals.

In the announcement, they explain that the preliminary results produced the desired reaction.  This reaction of the skin showed that there is functional T cell immunity in the subjects and the result of the given vaccine led to the counteracting of antibodies in each of the cases .  Vaccines that bring about strong T cell responses have been established to provide prolonged and enduring immunity and the ability to block continued transmission.

Dr. Lederman, President and Chief Executive Officer of Tonix, commented that their hope “is to produce a vaccine that will provide long term immunity with a single dose using a proven technology that can be readily scaled up” to manufacture and distribute quickly.

Southern Research, Tonix expand COVID-19 vaccine collaboration

Southern Research announced an expansion of its strategic collaboration with New York-based Tonix Pharmaceuticals Holding Corp. to include a study of immune responses to SARS-CoV-2, the virus that causes COVID-19.

This research will focus specifically on T cell immune responses to SARS-CoV-2 in volunteers who have recovered from the disease or who remain asymptomatic after exposure to COVID-19.

Raj Kalkeri, Ph.D., MBA, a senior scientist in Southern Research’s Infectious Disease Research Group, said the study’s findings will shed new light on the role that T cells – a central part of the immune system – may play in the development of a vaccine against the novel coronavirus.

“As scientists, we know that the most successful vaccines mimic and potentiate how the immune system responds to an invader,” Kalkeri said. “This additional work we are doing with Tonix will add focus to that objective.”

Southern Research
Birmingham-based Southern Research is teaming with Tonix Pharmaceuticals to study immune system responses to SARS-CoV-2, the virus that causes COVID-19.

The research is part of an ongoing and broader collaboration between Tonix and Southern Research to develop and conduct testing of the pharmaceutical company’s TNX-1800, a potential vaccine designed to protect against COVID-19.

The collaboration on vaccine development was announced in February 2020. Results from this testing are expected in the fourth quarter of 2020, followed by subsequent human trials of TNX-1800.

“The data we plan to collect from recovered and asymptomatic COVID-19 volunteers is expected to inform vaccine development on how to safely provide to vaccine recipients the same immune responses that others got from recovering from actual CoV-2 infection,” said Tonix CEO and President Seth Lederman, M.D.

T CELL RESPONSES

Lederman said TNX-1800, the firm’s leading COVID-19 vaccine candidate, is designed to elicit a predominant T cell response, along with some antibody response. Three other early candidates in the company’s vaccine portfolio are designed to elicit an almost pure T cell response, he added.

“The features of a protective immune response to SARS-CoV-2 remain unknown. But since SARS-CoV-2 is a virus, we believe that T cell responses, in particular T Helper Type 1, or TH1 responses, will play an important if not dominant role in protecting against serious illness from COVID-19,” Lederman said.

Read Tonix’s full announcement.

COVID-19
Raj Kalkeri, Ph.D., is a senior scientist in Southern Research’s Infectious Disease Research Group.

Southern Research Drug Development division scientists joining Kalkeri on the collaboration with Tonix are Elizabeth Wonderlich, Ph.D., senior scientist; John Farmer, Ph.D., manager of immunoassay; and Fusataka Koide, director of virology.

“We are looking forward to a timely completion of this study, utilizing readouts from a variety of assays that can provide information about TH1 or other types of immunity,” Kalkeri said.

Birmingham-based Southern Research, which has considerable experience in infectious disease research, has long been a leader in the evaluation of vaccine candidates and possible therapeutics for emerging biological threats.

The COVID-19 pandemic is a serious global health treat, with the World Health Organization reporting more than 14 million cases confirmed worldwide, causing  600,000 deaths.

As of July 21, more than 3.8 million COVID-19 cases have been confirmed in the United States, with over 140,369 deaths, according to the U.S. Department of Health and Human Services.

 

Support Southern Research’s work against COVID-19Donate today.

 

 

 

 

Southern Research’s screening center searches for clues to COVID-19 treatments

Inside a high-tech laboratory at Southern Research, a team led by Robert Bostwick, Ph.D., is screening vast numbers of compound samples to identify agents that could become a new treatment for COVID-19, the disease caused by the novel coronavirus.

Bostwick is director of Southern Research’s state-of-the-art High-Throughput Screening (HTS) Center, which features advanced robotic equipment and a collection of around 750,000 compounds for rapid, accurate testing.

Since 2006, the HTS Center has screened an average of 3.3 million compounds each year in biochemical, bacterial, cell-based, and antiviral assays. The center’s scientists have been working on coronaviruses for the past six years.

Since the pandemic began earlier this year, Bostwick’s team has screened compound samples for pharmaceutical companies, biotech firms and key government agencies. It’s also screened FDA-approved drugs to see if they show potential activity against the pathogen.

Bostwick, who joined the Birmingham-based research organization in 2013 after working for AstraZeneca and other bioscience companies, talks about the capabilities of the HTS Center and how his team is making a contribution to the fight against COVID-19.

What is the goal of Southern Research’s screening program as it relates to the novel coronavirus?

Southern Research
Southern Research’s High Throughput Screening Center features advanced robotic equipment and a collection of around 750,000 compounds for rapid, accurate testing.

The goal is to discover drugs that can be used as therapeutic treatments for COVID-19. By screening compounds in our HTS Center, we can rapidly identify those that exhibit antiviral effects against SARS-CoV-2, the virus that causes the disease.

These compounds can then be used as starting points for the development of new therapeutic agents.

If the screen identifies compounds that are already approved as drugs to treat various other diseases, they can potentially be repurposed for treating COVD-19.

What are Southern Research’s key capabilities in screening compounds as part of the drug discovery process?

Using automated robotic systems to perform testing is a key capability to enable high throughput screening. Southern Research’s HTS Center can also conduct screens that require containment of highly infectious agents and is internationally known for its infectious disease capabilities.

The HTS Center has screened over 15 million compound samples in over 50 different infectious disease assays. It currently serves as the screening core for the NIH-funded Antiviral Drug Discovery and Development Center (AD3C), based at UAB, our close collaborator on many projects.

 Describe the scope of Southern Research’s activities in screening compounds against COVID-19.

Southern Research COVID-19 screening
Dr. Robert Bostwick directs the High Throughput Screening Center at Southern Research.

For the past six years we have been conducting a drug discovery effort for coronaviruses through the AD3C and have expanded that effort to include SARS-CoV-2.

In addition, we are providing screening services to several major pharmaceutical companies, over two dozen biotech companies, the Gates Foundation and the National Center for Advancing Translational Sciences, which is part of the NIH.

Since early April, we have been generating over 30,000 data points weekly in screens to identify compounds with antiviral activity against SARS-CoV-2.

How many compounds has Southern Research screened as part of its internal COVID-19 research program?

Prior to the outbreak of COVID-19, we had already screened over 305,000 compounds against SARS in support of the AD3C coronavirus drug discovery project. After the outbreak, we tested the hits from that campaign against SARS-CoV-2 and identified several compounds with antiviral effects against both viruses. We are making and testing dozens of new compounds for that program every month.

We also screened a collection containing FDA-approved drugs and late-stage clinical candidates against SARS-CoV-2 to identify drugs with potential for repurposing.

Why is ‘drug repurposing’ a smart approach in this pandemic?

It takes years to invent and bring a new drug to market. Since the safety profile of marketed drugs is already known, a drug need only be evaluated in clinical studies to determine if it can effectively treat a disease other than the one for which it is marketed.

Therefore, in a pandemic, it is much quicker to repurpose existing drugs for use in combating the pathogen as opposed to inventing an entirely new drug.

 

Support Southern Research’s work against COVID-19Donate today.

 

Scientist Mark Suto: Southern Research intensifying therapeutic efforts to combat COVID-19

Responding to the COVID-19 pandemic, Southern Research has accelerated its drug discovery and development activities to identify and test vaccines and therapeutics against coronavirus that could save lives and help restore the nation’s hard-hit economy.

A key figure in this effort is Mark J. Suto, Ph.D., vice president of the Drug Discovery division and interim vice president of the Drug Development division at Southern Research.

Suto, who has made wide-ranging contributions to pharmaceutical research and drug discovery efforts during a 35-plus year career, has worked in large pharmaceutical companies, as well as smaller biotech and venture-backed firms.

Since joining Southern Research in 2011, Suto has engaged in multiple research collaborations spanning a diverse range of diseases and therapeutic areas, including rare and neglected diseases.

In a question-and-answer format, Suto discusses Southern Research’s multi-pronged effort to fight COVID-19, the virus causing the serious, sometimes fatal respiratory illness.

COVID-19
Mark Suto, Ph.D., is vice president of Drug Discovery and interim vice president of Drug Development at Southern Research.

What is Southern Research doing to develop new therapies and vaccines against COVID-19?

 As part of our long history with the identification of new medicines to treat life-threatening diseases such as cancer and HIV, we have channeled our resources to address the COVID-19 pandemic. For example, we are collaborating with several pharmaceutical companies to identify new research tools and vaccines. We recently announced a collaboration with Tonix, a biopharmaceutical firm, to test its vaccine candidate.

As part of a large consortium funded by the National Institute of Allergy and Infectious Diseases (NIAID) involving our partnering institution, the University of Alabama at Birmingham (UAB), we are building upon our ongoing research on highly pathogenic coronaviruses to develop new therapies. We are also working in partnership with UAB to test compounds for antiviral activity against COVID-19.​

How did Southern Research begin its work?

 From the onset of the COVID-19 threat, Southern Research quickly worked with the Centers for Disease Control and Prevention (CDC) and other government agencies to obtain the virus for experimental testing. Due to the nature of the virus (i.e., ability to rapidly spread and cause infection), handling requires highly specialized facilities available at Southern Research. After having obtained the virus, intense research has been initiated and is ongoing which aims to identify effective therapies.

Has Southern Research activated an internal COVID-19 program?

 In addition to these activities, we established an internal research program to identify known drugs that will be effective against this new threat. In the case of combating COVID-19, speed is of the essence given wide-reaching consequences. It is well known that the development of new drugs is a costly endeavor and requires years of research. Southern Research has taken a non-traditional approach of drug discovery which could result in the identification of new therapies in a period of months rather than years.

What is Southern Research’s strategy in searching for new therapies?

 Our approach, referred to as ‘drug repurposing’, consists of developing a rapid method or screen to determine whether there are already FDA-approved drugs that would be effective against COVID-19. We’ve tested more than 3,500 drugs and have identified 12 which are highly active against the virus. An interesting fact is that those that have been identified were all originally developed not as antivirals but rather for a wide range of medical conditions.

What are the next steps in this process?

 Next, we need to further evaluate these drugs under several various conditions to identify those with clinical promise. Also, since all of these compounds are approved for use in people, clinical trials could be initiated very quickly.

 

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Researcher: Indicator points to active flu season, urges vaccination

Are we headed for a rough flu season? Southern Research scientist Landon Westfall, who specializes in influenza and vaccines, says one indicator is flashing a warning sign that the months ahead could bring flu-related misery to many Americans.

The reason: Australia experienced a fairly severe flu season. That suggests the same fate could be in store for the North Hemisphere. It’s precisely what happened in 2017, when the H3N2 flu strain clobbered Australia. In the U.S., almost 80,000 people died during that flu season.

“It’s too early to precisely gauge how severe this flu season will be for us,” said Westfall, Ph.D., associate director, influenza, in Southern Research’s Drug Development division. “But you can get an idea from how it unfolded in Australia and New Zealand. They had a relatively hard flu season this year. This often predicts we’re likely to have a severe one as well.”

Westfall said a change in how flu vaccines are being produced this year has the potential to offer increased protection. The vaccine viruses were grown in cell cultures, rather than in chicken eggs, which should reduce the risk of mutations that can lower the vaccine’s effectiveness.

“This approach should make the vaccine a better match for the circulating, ‘wild type’ flu strains,” he said. “It makes for a more stable vaccine.”

INCREASING ACTIVITY

Southern Research flu vaccine
Landon Westfall is an infectious disease scientist at Southern Research.

Levels of influenza-like illnesses have been increasing across the U.S., particularly in the South. According to the Centers for Disease Control and Prevention (CDC), high rates of influenza-like illness were being reported in the five states stretching from Georgia to Texas, including Alabama, as of late November.

The Alabama Department of Public Health reported in early December that significant influenza activity has been detected throughout the state.

Westfall — who advises everyone to get a flu shot now, if they haven’t done so already — says influenza activity typically begins to spike around this time of year.

“Right now, the level is low, but it will increase pretty dramatically over the next four to six weeks,” he said. “Once we start getting into holiday season, and people start gathering together, it will pick up.”

While Australia’s 2019 flu season didn’t match 2017 in severity, it was an unusually tough one, with the dominant strain again being H3N2, which is blamed for more hospitalizations and deaths than other strains.

Australian health authorities reported laboratory-confirmed flu cases reached the nation’s highest recorded level during the 2019 season. The number of deaths attributed to the flu — 662 — was higher than normal but trailed the total of 745 from two years earlier.

Across the U.S., the 2017-18 influenza season was brutal, with nearly 49 million Americans sickened by the flu and almost 1 million of them ending up in the hospital. The death toll was estimated at 79,400, according to the CDC.

The nation’s most severe flu outbreak since the 2009 global pandemic was worsened by the fact that the seasonal flu vaccine was less effective against the H3N2 strain than usual.

While it’s too early to assess how much protection this year’s vaccine will offer, Westfall said it’s a good idea to roll up your sleeve and get the shot immediately. The vaccine is designed to protect against four different virus strains.

“I always tell people that regardless of how effective the vaccine is, you should still get it. Even though it may not be 100 percent protective, it will still lessen the effects of the flu. And if you’re elderly or very young, it might be the difference between life and death,” he said.

INFLUENZA PROGRAMS

Birmingham-based Southern Research has been heavily involved in U.S. government influenza programs since 2004, when H5N1, or bird flu, emerged as a pandemic threat. Since 2009, the organization has supported the government as a primary provider of flu vaccine testing and support.

Southern Research has worked extensively on influenza projects in support of clinical trials for the National Institutes of Health (NIH), the National Institute of Allergy and Infectious Disease (NIAID) and the Biomedical Advanced Research and Development Authority (BARDA).

Read a story about Southern Research vaccine research.

Southern Research team targets new, safer drugs for malaria

Scientists at Southern Research’s Drug Discovery division have joined the fight against malaria through efforts aimed at discovering new drugs and improving the safety and efficacy of current antimalarial medicines.

A research team lead by Babu Tekwani, Ph.D., distinguished fellow and chair of the Department of Infectious Diseases at Southern Research, is working on the development of nano-formulations of drugs that prevent relapse of the illness.

This project, funded by the NIH’s National Institute of Allergy and Infectious Diseases (NIAID), targets malaria caused by Plasmodium vivax, one of the five plasmodium parasites responsible for the serious and sometimes fatal disease in humans.

Vivax malaria is notorious for causing relapses, even after treatment with commonly used antimalarial drugs.

Southern Research Tekwani
A Southern Research team led by Dr. Babu Tekwani, center, is seeking to discover new therapeutics for malaria and to make existing medicines for the disease safer.

Today, Primaquine is the only FDA-approved drug available to prevent relapses in malaria patients, eliminating all malaria parasites from the body in what is referred to as radical cure.

The medicine, however, causes severe destruction of red blood cells, a condition known as hemolysis, in individuals with the genetic deficiency of glucose 6-phosphate dehydrogenase (G6PD).

This side effect prevents the use of Primaquine in a substantial proportion of malaria-infected individuals.

Tekwani’s team at Birmingham-based Southern Research has established specific experimental models and bioassays to evaluate the safety and efficacy of drugs in G6PD deficiency. These models are being employed to test new antimalarial drugs and formulations.

Tekwani’s team is also working on a research project to better understand the molecular basis of antimalarial drugs’ action. The goal of the project is to develop new antimalarial drugs with better safety profiles and activity against drug-resistant cases of malaria.

This project is funded by the U.S. Department of Defense in collaboration with the University of Mississippi and the Walter Reed Army Institute of Research.

“The continuous emergence of drug-resistant cases of malaria underscores the need for the identification of new drugs,” Tekwani said. “Indeed, the building and continuous augmentation of an armamentarium of multiple drugs is necessary to cope with the growing problem of drug-resistance”.

“The experimental models we’ve developed for evaluation of the safety and efficacy of antimalarial drugs have provided better tools for new antimalarial drug discovery,” he added.

BATTLING MALARIA

Malaria continues to be a global health challenge despite extensive efforts initiated by global and public health agencies for malaria control. The mosquito-borne disease claimed the lives of 435,000 people in 2017, of which included mostly children in Africa. There were 219 million cases reported worldwide that year. In addition, an estimated 1,700 cases of malaria are reported in the U.S. each year.

More than 3.3 billion people in 106 countries continue to be at risk for contracting malaria, according to a 2018 world malaria report published by the World Health Organization (WHO).

Extensive efforts initiated in 2000 by malaria-affected countries and global health agencies have led to remarkable progress in reducing malaria-related deaths from more than one million to less than 500,000 per year. However, progress has been stagnant since 2015, and malaria is even re-emerging in some countries.

“Southern Research is looking forward to making important new contributions to malaria drug discovery with the extensive experience of Dr. Tekwani in this area and funding from the NIH-NIAID and the U.S. Department of Defense,” said Mark Suto, Ph.D., vice president of Drug Discovery at Southern Research.

The Department of Infectious Diseases in Southern Research’s Drug Discovery division focuses on a diverse array of infectious disease pathogens, with the objective of identifying novel mechanisms, targets and strategies for the prevention and treatment of protozoal, bacterial and viral infectious diseases throughout the world.

Tekwani has spent more than 30 years researching tropical parasitic diseases such as malaria, leishmaniasis and human African trypanosomiasis, vector-borne infectious diseases and major global health threats. His work on new drug discovery for infectious diseases has identified potential new targets and sources for therapies.