Last Friday, January 7, David Bennett went into the operating room at the University of Maryland Medical Center for a surgical procedure never performed before on a human. The 57-year-old Maryland resident had been hospitalized and bedridden for months due to a life-threatening arrhythmia. His heart was failing him and he needed a new one.

Bennetts condition left him unresponsive to treatments and ineligible for the transplant list or an artificial heart pump. The physician-scientists at the Baltimore medical center, however, had anotheralbeit riskyoption: transplant a heart from a genetically-modified pig.

It was either die or do this transplant, Bennett had told surgeons at the University of Maryland Medical Center a day before the operation. I want to live. I know its a shot in the dark, but its my last choice.

On Monday, the team reported that they completed the eight-hour procedure, making Bennett the first human to successfully receive a pigs heart. Its working and it looks normal. We are thrilled, but we dont know what tomorrow will bring us. This has never been done before, Bartley Griffith, M.D., physician and director of the cardiac transplant program at the University of Maryland Medical Center who led the transplant team, told the New York Times.

While its only been five days since the operation, the surgeons say that Bennetts new pig heart was, so far, functioning as expected and his body wasnt rejecting the organ. They are still monitoring his condition closely.

I think its extremely exciting, says Robert Montgomery, M.D., transplant surgeon and director of the NYU Langone Transplant Institute, who was not involved in Bennetts operation. The results of the procedure were also personally meaningful for Montgomery, who received a heart transplant in 2018 due to a genetic disease that may also impact members of his family in the future. Its still in the early days, but still the heart seems to be functioning. And that in and of itself is an extraordinary thing.

[Related: Surgeons transplanted a pig kidney into a person, and it worked like normal]

Pig heart transplant operations are still not officially approved by the U.S. Food and Drug Administration, but the agency granted emergency authorization for the surgery on December 31. The experimental procedure comes at a time of growing need for organ transplants. More than 100,000 people in the United States are on the list to receive one, while around 17 die each day waiting, according to the latest data from the federal governments organdonor.gov. The desperate demand far exceeds the number of human organ donors.

There arent enough organs, period, Montgomery says, who was part of the team that successfully transplanted a genetically modified pig kidney in a human in 2021. Of an estimated 800,000 patients on dialysis whove developed end-stage kidney disease, only 90,000 are on the list for a human organ transplant, he points out. Pig organ transplants give another potential way to to fill that gap between the supply and the demand.

The field of research and the techniques behind animal to human organ transplants has come a long way to reach this momentfrom myth and pseudoscience to sophisticated medical application. Xenotransplantation, or grafting and transplanting of organs and tissues between two species, has a long history, says Montgomery, who has been involved in this field for more than 30 years.

It has really been considered since the dawn of transplantation, he says. People were thinking about the use of animal organs for over a hundred years.

Throughout the 19th century, chickens, rats, dogs, frogs, and other animals were used for skin grafts. Researchers continued to encounter incompatibility issues between humans and animal organs and tissues. This was because many animal species have a cell membrane sugar called galactose-1,3-galactose, commonly referred to as alpha-gal. That sugar is also on the surface of bacteria, explains Montgomery. Humans are exposed to these bacteria from birth in the GI tract, which triggers the immune system to make antibodies against alpha-gal to prevent those bacteria from entering the blood. People have a huge reserve of these antibodies just circulating in our blood all the time, Montgomery says, and those antibodies will attack animal organs because they recognize alpha-gal as a target.

Around the 1960s, surgeons began to look towards closer relatives to humans: primates. Primates are obviously much closer to humans on the evolutionary scale, and so you dont have that immediate incompatibility with alpha-gal in some of the primates, Montgomery says. A surgeon at Tulane University in New Orleans transplanted chimpanzee kidneys into patients, one of whom survived for nine months. Most famously in 1984, Baby Fae, a newborn infant with an underdeveloped heart, received a baboon heart, but her body rejected it after 20 days.

By the 1990s, the public perception towards primates as organ donors had soured. Theyre much more scarce on the planet, says Montgomery. I was at a xenotransplant meeting in the 1990s and Jane Goodall was the keynote speaker At the end of that, it was really clear to all of us that primates were not going to be the organ donors we were going to use. Concerns over zoonosis, or the transmission of disease from animal to human host, were also rising, likely because of the HIV/AIDS epidemic, Montgomery adds.

[Related: Lab-grown pig lungs are great news for the future of organ transplantation]

The scientific stage was set for swine. Pigs became prime donor candidates because of their abundance, large litters, ease of breeding, rapid growth, and generally similar organ size to humans.

Plus, most people have a much different relationship with the animal as a longtime food staple, says Montgomery, though he expects ethical concerns to continue to rise as the field progresses, such as whether or not animals should be genetically modified for transplants.

But there were two big hurdles the research field had to jump over before pigs could be a viable option: the issues with alpha-gal and the potential cross transmission of viruses, particularly the porcine endogenous retrovirus (PERV) discovered in 1997. Now, researchers have been able to genetically edit out the alpha-gal target from the pig genome. Today, people have undergone pig skin graft treatments for burns, have pig heart valves, or received pig cells, like those that help produce insulin, and have not experienced any diseases.

The genetic modification, particularly now with CRISPR, has become pretty easy, Montgomery says. Almost 200 people have received pig cells, pig stem cells, pig tissue, and skin grafts without exposure to zoonoses, he says.

The genetically modified pigs used for organ donation are bred, studied, and cared for in extremely clean facilities, and theyre surveilled for potential pathogens. Its almost like an operating room, says Montgomery. They are very humanely treated.

Up until now, most experimental transplant procedures have been done between pigs and other animals. Taking it into a living human, thats the leap, Montgomery says about the University of Maryland Medical Centers transplant. The genie is out of the bottle. Now, we really need to understand what this is going to look like in humans, and start to work on optimizing the outcomes. But time is of the essence, lets move ahead boldly.

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The first successful pig heart transplant into a human was a century in the making - Popular Science

On January 7, a 57-year-old male patient received a genetically-modified pig heart transplant at the University of Maryland Medical Center (UMMC). The surgery was a world-first and deemed the patients only chance for survival after he was declared unsuitable for a human donor transplant or an artificial heart pump. On January 10, the University of Maryland School of Medicine (UMSOM) published a news release stating that the patient was doing well, and is being carefully monitored over the next days and weeks to determine whether the transplant provides lifesaving benefits.

Dr. Bartley P. Griffith the surgeon responsible for transplanting the porcine heart into the patient and a professor in transplant surgery at UMSOM said, We are proceeding cautiously, but we are also optimistic that this first-in-the-world surgery will provide an important new option for patients in the future. Dr. Griffith leads the Cardiac Xenotransplantation Program at UMSOM alongside Dr. Muhammad M. Mohiuddin, professor of surgery at UMSOM.

The operation at the UMMC is an example of xenotransplantation. Xenotransplantation refers to any procedure involving the transplantation, infusion or implantation of cells, tissue or organs from a nonhuman, animal source into a human.

While the surgery was the first-of-its-kind, the concept of xenotransplantation is not novel. Chris Denning, professor of stem cell biology at the University of Nottingham told the UK Science Media Centre, Only in the late 1990s did the technologies become available and have steadily been improved ever since. Various academic and industrial teams have worked in this area for over 20 years, so it is not surprising that this has now been tested.

In the 20th century, non-human primates (NHP) were explored as potentially suitable donors for xenotransplantation due to the genetic similarities between primates and humans. However, concerns such as ethical issues, transmission of infection across species and breeding difficulties halted this research. Consequently, pigs are now considered to be the most appropriate candidate species for xenotransplantation.

"Pigs are considered for several reasons, Denning said. The size and anatomy of the pig heart is roughly the same as a humans, though there are considerable differences:

He added that, despite public perception, it is also relatively easy to keep pigs in a sterile condition.

Despite these advantages, transplanting a porcine heart into a human is considerably more challenging than transplanting a human heart. There are genetic differences between pigs and humans, which can lead to immunological rejection of the organ. Pigs have a gene that produces a molecule called (1,3)galactosyl transferase, which humans do not. This triggers an immediate and aggressive immune response, called hyperacute rejection, said Denning, ultimately causing the body to reject the organ.

The xenotransplantation conducted at UMMC involved a pig that had reportedly received 10 genetic modifications in total. Its unclear at this stage exactly what genes were modified, however the news release from UMSOM states three genes responsible for rapid antibody-mediated rejection of pig organs by humans were knocked out in the pig, and six human genes responsible for immune acceptance were inserted. An additional gene was also knocked out to stop excessive growth of the heart tissue.

Knockout means that an organism has been genetically altered such that it lacks either a single base, a whole gene or several genes. Often, genetic knockouts are utilized in laboratory research to understand how certain genes function, by monitoring changes in the organism when the gene is not expressed.

The porcine heart was provided by Revivicor, a subsidiary of United Therapeutics. You might recall Revivicor as the spin-out company of PPL Therapeutics, the UK-based biotech firm behind the first cloned mammal, Dolly the sheep. In December 2021, Revivicor also supplied New York University Langone Health with a kidney from a genetically-modified pig for an investigational procedure in a deceased human donor. The donor remained on ventilator support, and was closely monitored throughout the procedure and a subsequent observation period, during which the researchers said there were no signs of rejection.

According to the UMSOM news release, it received a $15.7 million research grant to evaluate Revivicor genetically-modified pig UHearts in baboon studies. Mohiuddin and colleagues reportedly applied for permission to conduct human clinical trials of the porcine heart from the US Food and Drug Administration (FDA), but were rejected. Under normal circumstances, IMPs must be evaluated in animal studies prior to human clinical trials this is standard protocol.

However, in the instance of the 57-year-old patient, an exception was made. The FDA granted emergency authorization for the procedure under its expanded access provision. This allows for an individual to access an investigational medicinal product (IMP) outside of clinical trials when there is no alternative therapy option available.

Will it be successful? asked Denning. The fact that the human patient is alive after a few days indicates that immediate hyperacute rejection has been avoided, which is the first hurdle. Only time will tell whether there are issues with chronic rejection, caused by e.g., incompatibility of major and minor histocompatibility complexes. Continuous monitoring will be needed to monitor transmission of potential pathogens, such as porcine endogenous retroviruses or hybrid porcine/human endogenous retroviruses.

Should the patient survive and the xenotransplant prove successful, it will likely raise a lot of questions as to how regulatory bodies move forward. Individual emergency authorization procedures do not generate sufficient data for the widespread implementation of xenotransplantation clinical trials are crucial for demonstrating efficacy.

However, there are logistical hurdles associated with even trialing the procedure. Seventeen people die every day waiting for an organ transplant, according to the Health Resources & Services Administration. There is a severe shortage of organs, and a steep decline in donation has been observed during the COVID-19 global pandemic. While a proposed advantage of xenotransplants is that they could provide on-demand organs, the procedure and its unknowns make it a very high-risk surgery. How does a clinician, or regulatory body, decide that a patient has waited long enough for a human organ that they qualify for inclusion in a trial?

Furthermore, if xenotransplant clinical trials support widespread adoption of xenotransplant procedures, how do we regulate a system whereby organs are widely available? Policies on patient selection and organ allocation currently exist in healthcare systems across the world. Navigating changes to these policies will require global conversations across different regulatory bodies.

Finally, a hurdle that Denning said could be the biggest of them all is: What do the general public think? Is it acceptable to harvest organs from animals? One thing that is for sure, is the outcomes of this [patient] will be watched closely by many, Denning concluded.

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What the World's First Pig to Human Heart Transplant Could Mean for the Future of Transplants - Technology Networks

MOUNTAIN VIEW, Calif., Jan. 13, 2022 (GLOBE NEWSWIRE) -- Veranome Biosystems LLC announced today that it has entered a collaboration and licensing agreement with Cold Spring Harbor Laboratory (CSHL) that adds in-situ sequencing technology to Veranome’s spatial omics portfolio. Veranome now has one of the most comprehensive portfolios of assay technologies that can allow targeted mapping of cellular spatial gene expressions with multiplexed in-situ hybridization (ISH) as well as de-novo profiling of cellular transcripts using in-situ sequencing. The expanded assay portfolio coupled with Veranome’s advanced imaging capabilities will enable customers to explore a broad range of applications, including characterization of cell and gene therapies methods and CRISPR screens. Veranome will further develop these high-sensitivity assay chemistries to offer researchers the ability to profile archival FFPE tissue blocks with the same spatial resolution as fresh frozen samples when analyzed on Veranome’s Spatial Analyzer.

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Veranome Biosystems and Cold Spring Harbor Laboratory Enter Collaboration and Licensing Agreement to Develop Advanced In-Situ Sequencing Technologies

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REPEAT -- Revelation Biosciences Inc. Announces Data Demonstrating REVTx-99 In Vitro Anti-Viral Activity Against SARS-CoV-2; Commencement of Trading...

Mechelen, Belgium; 13 January 2022, 22.01 CET; regulated information – Galapagos NV (Euronext & NASDAQ: GLPG) announced today that its supervisory board created 30,000 subscription rights under a new employee subscription right plan.

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Live webcast will be at 8:30 a.m. EST on January 25 Live webcast will be at 8:30 a.m. EST on January 25

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BURLINGAME, Calif., Jan. 13, 2022 (GLOBE NEWSWIRE) -- Corvus Pharmaceuticals, Inc. (Corvus or the Company) (NASDAQ: CRVS), a clinical-stage biopharmaceutical company, today announced that its partner in China, Angel Pharmaceuticals Ltd. (Angel Pharma), has treated the first patient in its Phase 1/1b clinical trial of Corvus’ small molecule ITK inhibitor CPI-818 for the treatment of relapsed/refractory T-cell lymphomas (TCL) in China.

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Corvus Pharmaceuticals Announces Partner Angel Pharmaceuticals Initiated Phase 1/1b Clinical Trial of ITK Inhibitor CPI-818 in China

Daix (France), Long Island City (New York), January 14, 2022 – Inventiva (Euronext Paris and Nasdaq: IVA), a clinical-stage biopharmaceutical company focused on the development of oral small molecule therapies for the treatment of NASH, mucopolysaccharidoses (MPS) and other diseases with significant unmet medical needs, today announced the half-year report of its liquidity contract with Kepler Cheuvreux.

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UPPSALA, SWEDEN – LIDDS AB (publ) announced today that Nina Herne will participate at Redeye Fight Cancer Seminar on January 20, 2022.

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LIDDS presents at Redeye Fight Cancer Seminar

DURHAM, N.C., Jan. 14, 2022 (GLOBE NEWSWIRE) -- Novan, Inc. (“the Company” or “Novan”) (Nasdaq: NOVN), today announced that data from the Company’s completed Phase 2 and Phase 3 clinical studies of berdazimer 10.3% gel (previously referred to as SB206) for molluscum contagiosum will be presented at the 2022 Winter Clinical Dermatology Conference, being held January 14-19, 2022, in Koloa, Hawaii.

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Novan Announces Presentation of Two Posters at the 2022 Winter Clinical Dermatology Conference

Bagsværd, Denmark, 14 January 2022 – Novo Nordisk today announced that the company has settled a securities lawsuit in Denmark filed in August 2019. The settlement contains no admission of liability, wrongdoing or responsibility by Novo Nordisk and no payment will be made by Novo Nordisk to the plaintiffs.

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Novo Nordisk announces settlement of securities lawsuit in Denmark

RADNOR, Pa., Jan. 14, 2022 (GLOBE NEWSWIRE) -- NRx Pharmaceuticals (NASDAQ: NRXP), a clinical-stage biopharmaceutical company, responded to today’s press release issued by Relief Therapeutics.

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— Meeting to Reconvene on January 18, 2022 —

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NANTES, France, Jan. 17, 2022 (GLOBE NEWSWIRE) -- OSE Immunotherapeutics SA (ISIN: FR0012127173; Mnemo: OSE) today announced the departure of Alexis Peyroles as Chief Executive Officer. Dominique Costantini, current Chairwoman of OSE Immunotherapeutics’ Board of Directors, and previously CEO from 2012 to 2018, has been appointed interim Chief Executive Officer, effective immediately. A search for a new CEO has been launched with the assistance of a leading executive search firm.

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OSE Immunotherapeutics Announces the Appointment of Dominique Costantini as Interim CEO Following the Departure of Alexis Peyroles

John Dawson to retire from Oxford Biomedica

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John Dawson to retire from Oxford Biomedica

CAMBRIDGE, Mass., Jan. 17, 2022 (GLOBE NEWSWIRE) -- Evelo Biosciences, Inc. (Nasdaq:EVLO), a clinical stage biotechnology company developing SINTAX™ medicines as a new modality of orally delivered treatments for inflammatory disease, today announced data for EDP1815, the Company’s lead product in inflammation, detailing its mechanism of action and supporting further clinical development in patients with psoriasis and atopic dermatitis. The data were presented in two posters on Saturday, January 15, 2022, at the 2022 Winter Clinical Dermatology Congress in Koloa, Hawaii.

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Evelo Biosciences Presents Data on EDP1815 Mechanism of Action and Supporting Ongoing Clinical Development for Inflammatory Diseases

Clinical trial begins in the UK to investigate 3-in-1 high blood pressure pill

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