Tag: Drug Development

Coming soon to a doctor’s office near you: Access to cutting-edge research and care

Posted on March 17, 2023

By Josh Carpenter, Ph.D.

Growing up in North Alabama, I remember watching movie trailers with excitement. They always ended with a deep voice that said, “opening soon in select theaters near you.” As it turns out, those openings were never “near me” since my local theater was not one of those “select theaters.” Those movies always premiered in big cities, often on the coasts. Most movies didn’t trickle to the theaters in Florence, Alabama, for another six or nine months. By then, I had forgotten about the trailer.

While kids (and adults) no longer have to wait for movies based on their zip code (thank you, Netflix), they are waiting for something far more important: the best proven medical treatment. Waiting on a movie is an inconvenience. Waiting on the best medical option could be the difference between life and death.

Most scientific experts estimate that it takes an average of 17 years for proven biomedical research to be implemented in clinical practice. That means it takes nearly two decades from when there is evidence of a discovery until it actually benefits patients.

For context, 17 years ago, Sen. Tommy Tuberville was still coaching Auburn, and Nick Saban was coaching the Miami Dolphins. And 17 years ago, Twitter was a brand-new platform for football fans to complain about coaching decisions and play Monday-morning quarterback.

Closing that 17-year research gap and compressing the related lag time from drug discovery to drug deployment are critical objectives of translational research – the kind of work we do at Southern Research.

Since its founding 81 years ago as an Alabama-based nonprofit, Southern Research has executed every step in the long and winding process between the point when a potential medicine is identified in a test tube and when it becomes a drug that enters the human body. Throughout our history, our process has led to 20 new drugs developed at Southern Research, and we’ve assisted hundreds more of our commercial clients in drug development throughout the world—including 50% of all chemotherapies on the market. In fact, we have 20 drugs in the pipeline of development now, many of which are developed in partnership with UAB researchers.

At Southern Research, we believe it is our duty to make the best research and best medical treatments available to our friends and neighbors in Alabama and throughout the Deep South—and, we don’t think they should have to wait 17 years for it.

This sense of duty is why we are embarking on an ambitious new project to build a clinical trials hub that will serve as a unique vehicle to support patients with cutting-edge care and give primary care physicians access to the newest tools in medicine.

This is precision medicine, and we know that it works. Aided by genomic information, precision medicine helps doctors identify the right treatment for the right patient at the right time.

This kind of precision medicine is already happening today, but too few Alabamians are enjoying the benefits. Our Community Health Catalyst platform would enable more providers to bring the best medical care to people across Alabama by giving them information about clinical trials that would meet their unique healthcare needs.

As a non-profit with a proven track record in protecting highly classified data and a long history of biomedical research with hundreds of government and commercial clients, Southern Research is an ideal partner to develop a unique platform that link patients and their doctors to clinical trials.

Motivated to close the 17-year gap, three critical pillars guide the development of the Catalyst platform. First, patients should be in control of their care, and they should know all of their options. Likewise, we are placing the patient’s relationship with their primary care physician at the center of this project. Patients will be able to review their data with their physician and decide what courses of treatment may be best for them. Second, we will make sure patient data is secured and anonymized, and it will never be shared with a third party. Third, we will organize patient data to enable them to benefit from new treatments that could improve their quality of care and open up access to the best drugs on the market.

Not only will this Catalyst improve health outcomes for Alabamians, it will grow jobs and attract investment to our state. Clinical trials are a $50 billion industry now, and that number is expected to grow to $80 billion by 2030. Our project would help Alabama secure clinical trial investments, positioning us as a top-10 state in one of the fastest growing industries in America. We estimate our new platform by itself could add 1,600 new jobs throughout the state, add $145 million in annual economic impact, and support rural healthcare providers who participate with new sources of revenue.

With advances in technology, Alabamians no longer have to wait six to nine months to watch the best new movies. We should not have to wait 17 years to receive the best medical care for our friends and families.

Josh Carpenter, Ph.D. is president and CEO of Southern Research.

Southern Research breaks ground on new biotech center and campus renovations

Posted on May 16, 2022

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.

Building a castle for the 21st century, investing in the future of Birmingham

Posted on January 24, 2022

By Josh Carpenter, Ph.D.

The coronavirus pandemic revealed healthcare heroes in our midst. I am proud to work with many of them at Southern Research. Since the pandemic began, our scientists – who have been studying viruses like COVID-19 for many years – have worked nonstop to combat the virus.

Scientists at Southern Research have made substantial contributions in every realm of coronavirus response, from prevention, to testing, to treatment. In partnership with UAB, we helped refine Remdesivir, the first treatment approved for the virus. Collaborating with Tonix Pharmaceuticals, we helped develop a potential vaccine that is in clinical trials. These are just two of many projects that underscore our critical role during this public health crisis.

We now have an opportunity to expand this important part of our mission, both to embolden our work to combat COVID-19 and to prepare for the next threat that might endanger our communities, families and friends.

We are building a Center for Pandemic Resilience. The new facility will double our lab space to study infectious diseases like COVID-19 and enhance our capacity to address common diseases that have made the coronavirus outbreak particularly lethal to Alabamians. When completed in 2023, the new facility will support a growing biotech corridor that is already the lifeblood of Alabama’s economy.

Southern Research currently employs 300 scientists and professional staff, and generates $150 million in annual economic impact. Our new facility will create 125 new jobs at SR, indirectly support an additional 400 new jobs and double our economic impact to $300 million a year.

We are asking the state of Alabama to support this important project with $45 million in federal American Rescue Plan Act funds. At less than 2% of the state’s ARPA allotment, there is no more appropriate or impactful way for Alabama to use this one-time federal money.

ARPA outlines several key objectives, all of which align with our plans: Investing in pandemic testing and treatments. Preparing for future threats. Spurring economic growth.

Southern Research is uniquely qualified to meet ARPA objectives, as we:

are the only scientific agency in Alabama whose employees directly contributed to treatment, testing and vaccine development for COVID-19
receive more National Institutes of Health funding than any other non-academic research center in Alabama
operate the state’s only High-Throughput Screening Center, which allows us to rapidly test new compounds to treat diseases and variants
are the only non-profit research center that is entirely self-sustaining through industry contracts, grants and intellectual property revenue

Throughout our 80-year history as one of Alabama’s largest non-profits, we have never asked the state to invest in our campus. This time is different. ARPA funds support projects that help communities respond to the pandemic and rebuild for the future. Our plan does both: it delivers a national center of excellence in fighting disease, while growing Alabama jobs.

As we emerge from one of our nation’s most challenging periods, we have received a once-in-a-lifetime opportunity to build a better future. By investing in Southern Research, our leaders can drive innovation and economic development in our state — and benefit Alabamians for generations to come.

Josh Carpenter, Ph.D., is president and CEO of Southern Research

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

Posted on March 25, 2021

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 https://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.

Histotechnology Professionals Day at Southern Research

Posted on March 10, 2021

In honor of Women’s History Month and Histotechnology Professionals Day, Southern Research wants to take a moment to recognize our team of histotechnologists and their team leader, LaVinia Ray. She was deemed by the National Society of Histotechnology to be the 2020 Histotechnologist of the Year and the 2016 Advanced Laboratory Technician of the Year.

LaVinia was able to receive a proclamation from the Governor of Alabama to name this week Histotechnology Professionals Week and from the Mayor of Birmingham to mark March 10^th Histotechnology Professionals Day in Birmingham. She constantly lifts up her team members and enjoys bringing her team deeper into the field by helping them get ready to sit for their HT American Society of Clinical Pathologists certification exam. We’re proud to have her and her team with us at Southern Research.

Histotechnology is a science that centers around the microscopic detection of abnormal tissue that helps in the diagnosis and treatment of diseases. This knowledge and understanding of composition is what allows pathologists to give a clinical diagnosis and treatment plan based off of differences in appearances from healthy tissue and the abnormality.

Our highly skilled technicians are HT American Society of Clinical Pathologists (ASCP) certified or certification eligible experts in their field. Our full-service laboratory team has established a long track record of proven success and high quality work. Southern Research provides necropsy and histology services tailored to the unique needs of research and veterinary clients. If you want to know more about the customized services that our qualified team can offer, check out our page on Anatomic and Clinical Pathology.

Southern Research and Tonix Pharmaceuticals COVID-19 Vaccine Research Update

Posted on November 25, 2020

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

Posted on July 22, 2020

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.”

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-19. Donate today.

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

Posted on May 26, 2020

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.

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.

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

Southern Research, Tonix team to develop potential vaccine against new coronavirus

Posted on February 26, 2020

Southern Research announced today that it has entered into a strategic collaboration with New York-based Tonix Pharmaceuticals Holding Corp., a clinical-stage biopharmaceutical company, to support the development of a vaccine, TNX-1800, against the new coronavirus disease, COVID-19, based on Tonix’s proprietary horsepox vaccine platform.

Tonix is developing TNX-801 – a live horsepox virus vaccine for percutaneous administration — as a potential smallpox preventing vaccine for the U.S. strategic national stockpile and as a vaccine against monkeypox.

Tonix’s proprietary horsepox virus has the potential to serve as a vector for vaccines to protect against other infectious agents.

Southern Research and Tonix said the new research collaboration will develop and test a potential horsepox vaccine that expresses protein from the virus that causes COVID, a SARS-CoV-2, to protect against the disease.

There are currently no vaccines to protect against COVID-19, which may cause serious complications. The SARS-CoV-2 is reportedly highly infectious and is associated with a significant rate of mortality.

“We look forward to this collaboration to advance a potential COVID-19 vaccine,” said Scott Goebel, a senior scientist in Southern Research’s Drug Development division and principal investigator of the project.

Goebel has previously worked on vaccinia and orthopoxvirus vaccines for other conditions and has studied coronaviruses.

TESTING VACCINE CONSTRUCTS

Under the terms of the research collaboration, Southern Research will test one or more vaccine constructs in the Tonix horsepox vector that express one or more proteins or protein fragments from COVID-19.

The collaboration seeks to leverage Tonix’s horsepox vaccine technology that was originally developed to protect against smallpox but has capabilities as a vector for other infectious diseases.

Tonix has previously reported that horsepox has efficacy as a vaccine and good tolerability in mice and cynomolgus macaques. Horsepox is closely related to vaccinia vaccines, which are a group of orthopoxviruses that have been used as smallpox vaccines. Some vaccinia vaccines have been engineered to express coronavirus proteins and to elicit vaccine responses successfully in the past.

“Although vaccinia vectors are available, different orthopoxvirus strains may behave differently as vectors in part because of their different repertoire of genes that modulate immune responses and host range,” said Dr. Seth Lederman, CEO of Tonix Pharmaceuticals. “Potential advantages of horsepox are the strong immunogenicity we observed in macaques and mice with good tolerability.

“The protein synthesis connected with a replicating live virus vaccine provides direct antigen presentation, which can stimulate cellular immunity in addition to humoral immunity,” added Dr. Lederman, formerly an associate professor at Columbia University who made significant original contributions to immunology.

Tonix is a clinical-stage biopharmaceutical company focused on discovering and developing small molecules and biologics to treat pain, addiction and psychiatric conditions.

To see the company’s detailed announcement on the collaboration, click here.

Researcher: Indicator points to active flu season, urges vaccination

Posted on December 10, 2019

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.