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UAB announces first clinical-grade transplant of gene-edited pig kidneys into brain-dead human

UAB announces the first clinical-grade transplant of gene-edited pig kidneys into brain-dead human

A doppler probe is used to assess blood flow inside the right porcine (pig) kidney after transplantation into the brain-dead recipient.Hands left to right: Katie Stegner, Dr. Babak Orandi, M.D., Ph.D. (holding the probe), Jayme Locke, M.D. (holding the kidney)Photo taken by Jeff Myers, UAB

NEWS HIGHLIGHTS

UAB researchers have achieved several world’s firsts with pig-to-human kidney transplant:

  • First peer-reviewed/published study of a genetically modified pig kidney transplanted into the body of a brain-dead human recipient
  • First such study on a pig-to-human kidney transplant using genetically modified kidneys with 10 key gene edits that may make the kidneys suitable for direct clinical-grade therapeutic use in humans
  • First validation of a UAB-developed test for compatibility before xenotransplant
  • First peer-reviewed/published study to establish brain death as a viable preclinical human model

Notably, the study was designed and conducted to meet standards directly comparable to those that would apply to a Phase I clinical trial and mirrored — as much as possible — every step of a conventional transplant between humans. Importantly, this study included removing the human brain-dead recipient’s native kidneys before replacing them with genetically modified pig kidneys.

UAB announces first clinical-grade transplant of gene-edited pig kidneys into brain-dead human

BIRMINGHAM, Ala., Jan. 20, 2022 (GLOBE NEWSWIRE) — The University of Alabama at Birmingham Marnix E. Heersink School of Medicine announces today the first peer-reviewed research outlining the successful transplant of genetically modified, clinical-grade pig kidneys into a brain-dead human individual, replacing the recipient’s native kidneys. These positive results demonstrate how xenotransplantation could address the worldwide organ shortage crisis.

In the study published in the American Journal of Transplantation, UAB researchers tested the first human preclinical model for transplanting genetically modified pig kidneys into humans. The study recipient had two genetically modified pig kidneys transplanted in his abdomen after his native kidneys were removed. The organs were procured from a genetically modified pig at a pathogen-free facility.

“Along with our partners, we have made significant investments in xenotransplantation for almost a decade hoping for the kinds of results published today,” said Selwyn Vickers, M.D., dean of the UAB Heersink School of Medicine and CEO of the UAB Health System and UAB/Ascension St. Vincent’s Alliance. “Today’s results are a remarkable achievement for humanity and advance xenotransplant into the clinical realm. With this study, our research teams have also demonstrated that the decedent model has significant potential to propel the xenotransplantation field forward.”

For the first time, the pig kidneys transplanted were taken from pigs that had been genetically modified with 10 key gene edits that may make the kidneys suitable for transplant into humans. This process demonstrates the long-term viability of the procedure and how such a transplant might work in the real world. The transplanted kidneys filtered blood, produced urine and, importantly, were not immediately rejected. The kidneys remained viable until the study was ended, 77 hours after transplant.

“This game-changing moment in the history of medicine represents a paradigm shift and a major milestone in the field of xenotransplantation, which is arguably the best solution to the organ shortage crisis,” said Jayme Locke, M.D., director of the Comprehensive Transplant Institute in UAB’s Department of Surgery and lead surgeon for the study. “We have bridged critical knowledge gaps and obtained the safety and feasibility data necessary to begin a clinical trial in living humans with end-stage kidney failure disease.”

Gene editing in pigs to reduce immune rejection has made organ transplants from pigs to humans possible, which could offer help to thousands of people who face organ failure, disease or injury. The natural lifespan of a pig is 30 years, they are easily bred and can have organs of similar size to humans.

Genetically modified pig kidneys have been extensively tested in non-human primates. In addition to testing in non-human primates, evaluating genetically modified pig kidneys in a human preclinical model research may provide important information about the potential safety and efficacy of kidneys in human transplant recipients, including in clinical trials.

“This human preclinical model is a way to evaluate the safety and feasibility of the pig-to-non-human primate model, without risk to a living human,” Locke added. “Our study demonstrates that major barriers to human xenotransplantation have been surmounted, identifies where new knowledge is needed to optimize xenotransplantation outcomes in humans, and lays the foundation for the establishment of a novel preclinical human model for further study.”

This effort is supported by biotechnology pioneer United Therapeutics Corporation, which awarded a grant to UAB to launch the innovative xenotransplantation program. Revivicor, Inc., a subsidiary of United Therapeutics, provided the genetically modified pig that was the source of the investigational xenotransplant kidneys called UKidney™.

“All of us at Revivicor are in awe of the historic achievements at UAB with our investigational 10-gene xenokidney, or UKidney,” said David Ayares, Ph.D., Chief Scientific Officer of Revivicor and a trailblazing genetic engineer since his early work cloning the world’s first pigs and the first alpha-Gal knockout pigs. “We feel confident that this UKidney may turn out to be a life-saving solution for thousands of people on dialysis, subject to successful completion of our clinical trials and achievement of FDA approval in the next several years.”

About the study
The peer-reviewed research is a study of ambitious scope and great significance, given that more than 800,000 Americans are living with kidney failure. Most never make it to the waiting list, and far too few human organs are available to put a dent in that number. Although dialysis can sustain life for some time, transplantation offers a better quality of life and a longer life for the few individuals who can gain access to transplantation. Each stage of this decedent xenotransplant study approximated the steps that might be taken in a Phase I xenotransplant clinical trial:

  • The kidneys were removed from a donor pig housed at a pathogen-free, surgically clean facility. The kidneys were then stored, transported and processed for implantation, just as human kidneys are.
  • Before surgery, the brain-dead recipient and donor animal underwent a crossmatch compatibility test to determine whether the genetically modified pig kidney and its intended recipient were a good tissue match. A crossmatch is done for every human-to-human kidney transplant; however, this pig-to-human tissue-match test was developed at UAB and marked the first time a prospective crossmatch has been validated between the two species.
  • The pig kidneys were placed in the exact anatomic locations used for human donor kidneys, with the same attachments to the renal artery, renal vein and the ureter that carries urine from the kidney to the bladder.
  • The brain-dead recipient received standard immune-suppression therapy used in human-to-human kidney allotransplantation.

The study was conducted to meet the standards directly comparable to those that would apply to a Phase I human clinical trial, mirroring every step of a standard transplant between humans. It included Institutional Review Board and Institutional Animal Care and Use Committee approval, a tissue compatibility confirmation before starting the operations, using the standard procedures of human-to-human transplants to remove, preserve, transport and transplant the kidneys into a human, and giving the standard immunosuppression therapy to the recipient.

Transplant recipient Jim Parsons helps open doors to the future of organ transplantation
This scientific and medical breakthrough would not have been possible without Jim Parsons, the recipient, or his family.

Parsons, 57, was a registered organ donor through Legacy of Hope, Alabama’s organ procurement organization, and he had longed to have his organs help others upon his death; but his organs were not suitable for donation. His family permitted UAB to maintain Parsons on a ventilator to keep his body functioning during the study. His native kidneys were removed, and two genetically modified pig kidneys were transplanted.

“Mr. Parsons and his family allowed us to replicate precisely how we would perform this transplant in a living human. Their powerful contribution will save thousands of lives, and that could begin in the very near future,” Locke said. “Mr. Parsons’ gift honors his legacy and firmly establishes the viability, safety and feasibility of this preclinical model. Because of his gift, we have proposed this to be known as ‘The Parsons Model.’”

Parsons’ ex-wife, Julie O’Hara, and their children, Ally, David and Cole, made the decision (along with Jim’s sisters and mother) to take part in the study after they were approached by Alan Spriggs with Legacy of Hope and Locke.

“Jim was a never-met-a-stranger kind of guy who would talk to anyone and had no enemies — none,” O’Hara said. “Jim would have wanted to save as many people as he could with his death, and if he knew he could potentially save thousands and thousands of people by doing this, he would have had no hesitation. Our dream is that no other person dies waiting for a kidney, and we know that Jim is very proud that his death could potentially bring so much hope to others.”

The critical need for other organ donation options
Kidney disease kills more people each year than breast or prostate cancer, according to the National Institute of Diabetes and Digestive and Kidney Diseases. Although transplantation is the gold standard treatment for end-stage kidney disease, fewer than 25,000 kidney transplants are performed each year in the United States and 240 Americans on dialysis die every day. Many of these deaths could be prevented if an unlimited supply of kidneys were available for transplant.

The wait for a deceased donor kidney can be as long as five years, and in many states, it is closer to 10 years. Almost 5,000 people per year die waiting on a kidney transplant.

About UAB transplant and the xenotransplant team
UAB Medicine is a world leader in organ transplantation and has performed 9,055 kidney transplants from Jan. 1, 1988, to Dec. 31, 2021 — the second-most kidney transplants in the United States during that time. The focus of UAB’s xenotransplantation program is to address the organ shortage by safely transplanting genetically modified pig kidneys into humans with kidney failure. Learn more.

About UAB
Known for its innovative and interdisciplinary approach to education at both the graduate and undergraduate levels, the University of Alabama at Birmingham, a part of the University of Alabama System, is an internationally renowned research university and academic medical center. UAB consistently exceeds $600 million in annual research awards and totaled almost $850 million last year, including one-time COVID-related funding. UAB is Alabama’s largest single employer, with more than 26,000 employees, and was named America’s Best Large Employer by Forbes in 2021. The institution’s annual economic impact on the state exceeds $7 billion each year. The pillars of UAB’s mission include education, research, innovation and economic development, community engagement, and patient care. Learn more at www.uab.edu.

EDITOR’S NOTE: The University of Alabama at Birmingham is one of three doctoral research universities in the University of Alabama System. In your first reference to our institution, please use University of Alabama at Birmingham and UAB on subsequent references.

FACEBOOK: www.facebook.com/UAB.edu TEXT: www.uab.edu/news
TWEETS: www.twitter.com/uabnews VIDEO: www.youtube.com/uabnews

Media Contacts:
Tyler Greer, 205-934-2041
Nicolas Kressmann, 732-532-5318

A photo accompanying this announcement is available at: https://www.globenewswire.com/NewsRoom/AttachmentNg/33d4e6ff-7c94-45e9-b4b2-54b02013eabc

A video accompanying this announcement is available at: https://www.globenewswire.com/NewsRoom/AttachmentNg/90656f74-a325-479f-9177-9d9538f11799

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Sweegen Praises New Framework on Stevia Technology By International Food Safety Authority

Sets Global Example on Standards for Countries

Rancho Santa Margarita, Calif., Jan. 20, 2022 (GLOBE NEWSWIRE) — Sweegen’s health and wellness commitment through global sugar reduction solutions became stronger after Codex Alimentarius (Codex), the international food standard safety authority, recently adopted the specifications for all four stevia technologies, including Sweegen’s bioconversion.

“The new Codex framework is timely as the benefits of steviol glycosides, the sweet component in the stevia leaf, fit into the broader health and wellness narrative, which is something consumers want to see more of, and global food and beverage manufacturers want greater access to,” said Luca Giannone, senior vice president of sales.

The significance of the adoption is that there is now a more streamlined approach to regional adoption of new production technologies. This will provide greater access to less common and better-tasting steviol glycosides at scale and a more sustainable supply of the sugar-like tasting ingredients.

Sweegen’s support for adopting the “Framework for Stevia Technology” started four years ago as a member of the alliance group, the International Stevia Council (ISC). Adopting the framework was a stevia industry effort and collaboration internationally where Sweegen represented bioconversion technology.

“With this framework, most countries in the world will gradually adopt this standard, and our global stevia footprint can expand more rapidly into countries where we are seeking approval for offering our pure, clean, and great-tasting Signature Bestevia ingredients produced by bioconversion,” said Giannone.

Modern technology advancements, such as bioconversion, produce clean new generation sweetener molecules such as Rebaudiosides M, D, and E, originally found in small quantities in the stevia leaf. Unlike first-generation ingredients like Rebaudioside A, these rebaudiosides impart a clean sugar-like taste with a better sensory profile and are highly sought-after by food and beverage manufacturers in countries where they have regulatory approvals.

“The adopted framework is good news for brands that want greater access to Sweegen’s pure and clean tasting stevia ingredients, Rebs D, E, M, and more,” said Giannone. “By leveraging proprietary bioconversion technology, we start with the stevia leaf, and with the support of enzymes, produce a final product that is a single purified steviol glycoside (not a mixture) that naturally occurs in the stevia leaf.”

Under the new framework, all of Sweegen’s rebaudiosides are approved by Codex. Last year, Sweegen earned regulatory approval for its Signature Bestevia Reb M in Europe, which enables greater flexibility in satisfying regional preferences for sweetness and great taste.

“We welcome the adoption of the Codex framework and the opportunity to support our customers globally with new sugar reduction innovations,” said Steven Chen, Sweegen’s chief executive officer. “Sweegen is proud to be part of this collaborative effort to bring much-needed innovation to the food and beverage industry.”

About Sweegen

Sweegen provides sweet taste solutions for food and beverage manufacturers around the world.

We are on a mission to reduce the sugar and artificial sweeteners in our global diet.  Partnering with customers, we create delicious zero-sugar products that consumers love.  With the best next-generation stevia sweeteners in our portfolio, such as Bestevia® Rebs B, D, E, I, M, and N, along with our deep knowledge of flavor modulators and texturants, Sweegen delivers market-leading solutions that customers want, and consumers prefer. Be well. Choose well.

For more information, please contact [email protected] and visit Sweegen’s website, www.sweegen.com.

Cautionary Statement Concerning Forward-Looking Statements

This press release contains forward-looking statements, including, among other statements, statements regarding the future prospects for Reb M stevia leaf sweetener. These statements are based on current expectations but are subject to certain risks and uncertainties, many of which are difficult to predict and are beyond the control of Sweegen, Inc.

Relevant risks and uncertainties include those referenced in the historic filings of Sweegen, Inc. with the Securities and Exchange Commission. These risks and uncertainties could cause actual results to differ materially from those expressed in or implied by the forward-looking statements, and therefore should be carefully considered. Sweegen, Inc. assumes no obligation to update any forward-looking statements due to new information or future events or developments.

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Ana Arakelian
Sweegen
949-709-0583
[email protected]
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CoinEx Offers Emergency Aids to Filipinos Affected by Typhoon Rai as A Gesture of Goodwill

HONG KONG, Jan. 20, 2022 /PRNewswire/ — Recently, Typhoon Rai hit the Philippines and to assist in disaster relief, CoinEx has offered emergency aid to disaster-stricken areas. As one of the strongest storms the country witnessed in 2021, Rai has brought strong winds, heavy rainfall, as well as floods. On December 31, 2021, the Philippine National Disaster Risk Reduction and Management Council (NDRRMC) briefed that Rai had affected 4.45 million people in this country and damaged more than 530,000 houses.

CoinEx dispatched support teams to the three worst-hit areas, respectively Southern Leyte, Cebu, and Negros. Sparing no effort in supporting disaster relief in the country, CoinEx also provided emergency assistance donations for local rescue organizations. Each support team consisted of 20 members. Soon after Rai hit the country, they prepared and distributed the relevant supplies to locals who need them the most.

On 6th and 8th January , the support teams visited locals in areas hit by Rai and distributed a total of 300 supply packages that included rice, noodles, sardines, water, bread, biscuits, and other daily suppliers. Apart from the provision of emergency supplies, CoinEx also gave a $10,000 emergency donation to the local government and spared no effort in supporting disaster relief in the country.

CoinEx’s assistance to disaster relief in the Philippines fully reflected its mission of “Via Blockchain, Making The World A Better Place”. CoinEx always committed to its social responsibilities, has been actively involved in various charitable causes and held charitable events around the world. With a loving heart, CoinEx has been doing its utmost to give back to society and extend a helping hand.

As a world-leading crypto trading platform, CoinEx will continue to perfect its products and provide users with the best services. Meanwhile, it will also keep sending a positive message and engage in more charitable events. Aiming to give back to the public and its global users, the exchange will strive to take on more social responsibilities while calling on more people to contribute to charitable causes.

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Public Health Expert Kate Onyejekwe to Lead JSI’s Washington Office

WASHINGTON, Jan. 19, 2022 /PRNewswire/ — John Snow, Inc. (JSI), is proud to announce that Kate Onyejekwe has been appointed to the position of International Division Washington, DC, office director.

Kate Onyejekwe

Onyejekwe will provide leadership and programmatic oversight to the Washington, DC-based portfolio of 75 projects in 40 countries, seven technical core competency centers, and the office’s corporate services teams.

“My passion has always been to serve people and communities around the world to engender strong health systems, build resilience, and facilitate equitable health services for all. This role provides an even greater platform for the International Division, and JSI as a whole, to continue to shape and advance the global public health agenda,” said Onyejekwe.

Most recently, Onyejekwe was deputy director of the MOMENTUM Integrated Health Resilience program, where she oversaw global staff and regional and country-level partnerships to achieve country-level programming goals.

John Snow, Inc. Logo Onyejekwe has more than 25 years of technical and program management experience in family planning and reproductive health; maternal and child health; immunization; HIV gender and youth programming; community health; capacity building; pharmaceutical  management; and  financial and operational management in multicultural settings. Her work in more than 14 countries underpins her commitment to innovate with and galvanize nations, communities, families, and individuals to advance their skills and create lasting solutions to their priority health and development challenges, especially during the COVID-19 era.

John Snow, Inc, and the nonprofit JSI Research & Training Institute are public health management consulting and research organizations dedicated to improving the health of individuals and communities throughout the world. We partner with community-based organizations, the private sector, and government agencies to strengthen their capacity to streamline services, develop their workforce, collect and use data, promote healthy behaviors, and strengthen supply chains in an effort to deliver better health services to all.

Contact:
Pamela Bond, Senior Communications Advisor
[email protected]

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Seegene to Launch New COVID-19 PCR Test with a Reduced Turnaround Time Optimized for Mass Testing

Scheduled to launch in late January, Seegene’s new COVID-19 test supports swift, large-scale lab testing with the same degree of accuracy as the conventional PCR test

SEOUL, South Korea, Jan. 19, 2022 /PRNewswire/ — Seegene Inc. (KQ 096530), South Korea’s leading molecular diagnostics company, announced today the upcoming launch of the Allplex™ SARS-CoV-2 Fast PCR Assay, which can deliver PCR results in just 60 minutes. The company says that this assay is expected to reduce the total turnaround time to a third and expand testing capacity up to 3 times for hospitals and laboratories without additional instruments or compromise on accuracy.

Reduction of the turnaround time was attributable to two primary reasons: 1) the application of a novel enzyme developed by Seegene, which reduces PCR process time to half. 2) Seegene’s innovative extraction-free method, which can let Allplex™ SARS-CoV-2 Fast PCR Assay be available without the extraction of the sample preparation in PCR-based tests. This drastically reduces the total turnaround time for each result. As such, the new assay lessens the amount of hands-on processing time required, allowing facilities to triple their testing capacity in the same hour.

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“This assay will be the optimized choice for laboratories and hospitals where they conduct large-scale testing as it helps them immediately expand the testing capacity with lessening the burden of healthcare workers,” said Ho Yi, Chief Sales and Marketing Officer of Seegene. “For the time being, we plan to target large-scale testing markets in more than 60 countries all across the globe. The next step in our journey is to develop a new gold-standard molecular diagnostic assay that fully matches the speed of antigen tests with the same degree of accuracy as PCR test”

The Allplex™ SARS-CoV-2 Fast PCR Assay targets three COVID-19 genes––E, RdRP, and N–– to reliably detect COVID-19 regardless of the variants. According to clinical research conducted by 17 laboratories in seven countries, this assay showed the same or better accuracy for the COVID-19 detection as other diagnostic tests available in the market.

Visit www.seegene.com for more information.

About Seegene, Inc.

Seegene, Inc. was founded in Seoul, South Korea in 2000 and has subsidiaries in the U.S.A., Canada, Germany, Italy, Mexico, Brazil, Colombia, and the Middle East. Seegene, Inc. is an in-vitro diagnostics (IVD) company that has been turning innovative technologies into products through its pioneering R&D activities. Seegene owns its original patent technology including DPO™ (Dual Priming Oligonucleotide) for multiple target amplification; TOCE™ for multiple target detection in a single channel; MuDT™, the world’s first real-time PCR technology that provides individual Ct values for multiple targets in a single channel for quantitative assays.; and mTOCE™ multiplex mutation detection technology. With these cutting-edge molecular diagnostic (MDx) technologies applied to diagnostic kits and other tools, Seegene has enhanced the sensitivity, specificity, and disease-coverage per a test of PCR (polymerase chain reaction) to unprecedented levels by providing accurate high-multiplex PCR products that target and detect genes of multiple pathogens simultaneously per each fluorescence channel. This feature dramatically saves testing time and cost. Seegene continues to set new standards in MDx through cutting-edge innovations.

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Taconic Biosciences Adds New Humanized Immune System (HIS) Model to Its Portfolio For Immuno-Oncology Research

New huNOG-EXL EA Model Extends Study Windows Significantly

RENSSELAER, N.Y., Jan. 18, 2022 (GLOBE NEWSWIRE) — Taconic Biosciences, a global leader in providing drug discovery animal model solutions, announces the launch of the huNOG-EXL EA (Early Access) humanized immune system (HIS) mouse. This product expands Taconic’s widely used HIS portfolio. huNOG-EXL EA significantly lengthens the study window during which a myeloid-lineage HIS mouse model can be used successfully.

Taconic’s huNOG-EXL models support human myeloid and lymphoid cells, making these mice especially useful for immuno-oncology research and other immune-related applications. With the longest lifespan of any myeloid-supportive HIS model, the original huNOG-EXL model (now called huNOG-EXL SA, or Standard Access) has been successfully applied in preclinical drug discovery research since 2016. The huNOG-EXL SA model is provided after a quality control step at 10 weeks post-engraftment. Feedback from users suggests research applications requiring particularly long study timelines or importation into regions with long quarantine periods present experimental and logistical hurdles that can limit the utility of the Standard Access (SA) model.

The new huNOG-EXL EA model removes those challenges by providing access to huNOG-EXL mice soon after engraftment, extending the useful study window. This makes the huNOG-EXL EA ideal for engraftment of slow-growing tumors, longer treatment paradigms, or various study customizations. Early access to an extended myeloid lineage model is also advantageous to researchers who face model importation quarantines, which would otherwise consume a significant portion of the useful study window for these mice. Because the huNOG-EXL EA model is shipped before an engraftment QC step is possible, it is made using cells from donors previously validated to engraft well so as to reduce the risk of engraftment failures.

“The huNOG-EXL EA model meets critical scientific needs for investigators performing immuno-oncology research or studying other immune-related diseases,” said Dr. Michael Seiler, vice president of commercial products at Taconic. “After conducting extensive research and development, along with rigorous beta testing with several industry partners, Taconic is excited to now offer the new model and expand the usefulness of this unique humanized mouse.”

To learn more about Taconic’s huNOG-EXL EA model, please contact us at 1-888-TACONIC (888-822-6642) in the US, +45 70 23 04 05 in Europe, or email [email protected].

About Taconic Biosciences, Inc.

Taconic Biosciences is a fully licensed, global leader in genetically engineered rodent models and services. Founded in 1952, Taconic provides the best animal solutions so that customers can acquire, custom-generate, breed, precondition, test, and distribute valuable research models worldwide. Specialists in genetically engineered mouse and rat models, microbiome, immuno-oncology mouse models, and integrated model design and breeding services, Taconic operates three service laboratories and six breeding facilities in the U.S. and Europe, maintains distributor relationships in Asia and has global shipping capabilities to provide animal models almost anywhere in the world.

Media Contact:

Nancy J Sandy

CEO

608-332-6320

[email protected]