Chewy and eight other companies are violating federal law by selling or making unapproved antibiotics and other antimicrobial drugs for animals that could potentially give rise to drug-resistant superbugs, the U.S. health regulator said.
The U.S. Food and Drug Administration on Thursday sent letters to nine companies including e-commerce retailer Chewy warning them against selling the products that it said contained antibiotics such as penicillin and amoxicillin.
The products, which included brands like Aqua-Mox, Aqua-Zithro, Doxycycline and Fishbiotic, were being sold for so-called minor species like birds and fish.
"Inappropriate use of medically important antimicrobials contributes to the development of antimicrobial resistance, which affects both human and animal health," Tracey Forfa, director of the FDA's veterinary medicine center, said in a statement on Thursday.
Global health officials have repeatedly warned about the rise of antimicrobial-resistant microbes due to the misuse and overuse of antibiotics, which encourages microorganisms to evolve into "superbugs."
Chewy, and four other companies listed in the letter did not immediately respond to Reuters' requests for comment. Reuters could not immediately contact Silver Lease, Valley Veterinary Clinic, American Aquarium Products and Midland Veterinary Services.
The drugs being sold are not approved, neither are they listed on the FDA's index for unapproved animal drugs for minor species, the main legal pathways for animal drugs to reach the marketplace.
The FDA also said that using unapproved animal drugs in humans could delay effective treatment and allow infections to become severe and resistant to antibiotics and anti-fungal drugs.
Anyone using the products should safely dispose them, the agency said.
The head of the U.N. Palestinian refugee agency said on Thursday that crowds of hungry people were stopping its aid trucks in Gaza and helping themselves to the food, making it almost impossible to continue delivering aid.
The U.N. World Food Programme has said half of Gaza's population of 2.3 million is starving as Israel's military assault on the southern part of the enclave expands and people are cut off from supplies.
"People are stopping aid in trucks, taking the food and eating it right away. And this is how desperate and hungry they are," Philippe Lazzarini, UNRWA commissioner-general, told reporters at the Global Refugee Forum in Geneva.
Huge crowds on the street also mean that it is harder to reach hundreds of thousands of people in U.N. shelters in southern Gaza, Lazzarini said, speaking after a trip to Gaza.
"Hunger has now emerged over the last few weeks and we meet more and more people who haven't eaten for one two or three days," he added.
"...Our operating environment becomes more and more difficult. And the only way at this stage, in the absence of a ceasefire, to address it and to reverse this tension is to bring assistance at scale," Lazzarini said.
Aid deliveries crossing into Gaza via the sole entry point on the Egyptian border are only a fraction of pre-conflict levels despite the surge in needs.
Israel says it has ramped up aid inspection capacity and reopened the Kerem Shalom crossing for checks this week to ease flows.
According to U.N. estimates, up to 85% of the 2.3 million people in Gaza - one of the most densely populated areas of the world - have been displaced from their homes and are now crammed in an ever smaller area in the south near the border with Egypt.
Lazzarini said aid deliveries were focused on southern and middle areas of Gaza but that it has become "excruciatingly difficult" to get aid to people remaining in northern Gaza since a seven-day pause in the conflict ended on Dec. 1.
In February, a Canadian cybersecurity firm delivered an ominous forecast to the U.S. Department of Defense. America’s secrets – actually, everybody’s secrets – are now at risk of exposure, warned the team from Quantum Defen5e (QD5).
QD5’s executive vice president, Tilo Kunz, told officials from the Defense Information Systems Agency that possibly as soon as 2025, the world would arrive at what has been dubbed “Q-day,” the day when quantum computers make current encryption methods useless. Machines vastly more powerful than today’s fastest supercomputers would be capable of cracking the codes that protect virtually all modern communication, he told the agency, which is tasked with safeguarding the U.S. military’s communications.
In the meantime, Kunz told the panel, a global effort to plunder data is underway so that intercepted messages can be decoded after Q-day in what he described as “harvest now, decrypt later” attacks, according to a recording of the session the agency later made public.
Militaries would see their long-term plans and intelligence gathering exposed to enemies. Businesses could have their intellectual property swiped. People’s health records would be laid bare.
“We are not the only ones who are harvesting, we are not the only ones hoping to decrypt that in the future,” Kunz said, without naming names. “Everything that gets sent over public networks is at risk.”
Tilo Kunz, executive vice president of Canadian cybersecurity firm QD5, predicts that quantum computers by 2025 might be capable of cracking the encryption that protects most digital communications, putting military secrets, health records, financial data and other sensitive information at risk. REUTERS/Peter McCabe
Kunz is among a growing chorus sounding this alarm. Many cyber experts believe all the major powers are collecting ahead of Q-day. The United States and China, the world’s leading military powers, are accusing each other of data harvesting on a grand scale.
The director of the Federal Bureau of Investigation, Christopher Wray, said in September that China had “a bigger hacking program than every other major nation combined.” In a September report, China’s chief civilian intelligence agency, the Ministry of State Security, accused the U.S. National Security Agency of “systematic” attacks to steal Chinese data.
The National Security Agency declined to comment on China's accusation.
More is at stake than cracking codes. Quantum computers, which harness the mysterious properties of subatomic particles, promise to deliver breakthroughs in science, armaments and industry, researchers say.
Opinion is divided on the expected arrival of Q-day, to be sure. It’s still relatively early days for quantum computing: So far, only small quantum computers with limited processing power and a vulnerability to error have been built. Some researchers estimate that Q-day might come closer to the middle of the century.
No one knows who might get there first. The United States and China are considered the leaders in the field; many experts believe America still holds an edge.
As the race to master quantum computing continues, a scramble is on to protect critical data. Washington and its allies are working on new encryption standards known as post-quantum cryptography – essentially codes that are much harder to crack, even for a quantum computer. Beijing is trying to pioneer quantum communications networks, a technology theoretically impossible to hack, according to researchers. The scientist spearheading Beijing’s efforts has become a minor celebrity in China.
Quantum computing is radically different. Conventional computers process information as bits – either 1 or 0, and just one number at a time. Quantum computers process in quantum bits, or “qubits,” which can be 1, 0 or any number in between, all at the same time, which physicists say is an approximate way of describing a complex mathematical concept.
These computers also exploit a mysterious property of quantum mechanics known as entanglement. Particles such as photons or electrons can become entangled so that they remain connected, even when separated by huge distances. Changes in one particle are immediately reflected in the other. The properties of qubits and entanglement are fundamental to quantum computers, say physicists and computer scientists, potentially allowing calculations to be carried out that would be impractical on today’s large supercomputers.
Business consultants forecast this processing power will deliver hundreds of billions of dollars in extra revenue by the middle of the next decade. Even before these computers arrive, some are predicting that advances in quantum technology will sharply improve the performance of some military hardware.
Quantum technology “is likely to be as transformational in the 21st century as harnessing electricity as a resource was in the 19th century,” said Michael Biercuk, founder and chief executive officer of Q-CTRL, a quantum tech company that was established in Australia and has major operations in the United States.
It was the codebreaking possibilities of quantum computing that sparked the field’s surge in progress in recent decades, said Q-CTRL’s Biercuk, an American who is a professor of quantum physics at the University of Sydney and a former consultant to the U.S. Defense Advanced Research Projects Agency, the Pentagon’s innovation incubator. The U.S. government saw it as a “big opportunity ” in the 1990s and has been funding research ever since, he said.
In his briefing for the Pentagon, QD5’s Kunz cited what he called one of the most successful harvest now/decrypt later operations ever: the Venona project.
Launched in 1943, Venona was a 37-year U.S. effort to decipher Soviet diplomatic communications collected by the Americans during and after World War Two. U.S. codebreakers, aided by allies, were able to decrypt more than 2,900 cables from thousands of messages sent by Soviet intelligence agencies between 1940 and 1948, according to CIA documents.
Michael Biercuk, a former Pentagon consultant who founded Q-CTRL, a Sydney-based quantum technology firm, said the potential for quantum computers to shred encryption has fueled growth and investment in the field. REUTERS/Jaimi Joy
Q-CTRL founder Michael Biercuk shows off one of the company’s quantum magnetometers at the firm’s global headquarters in Sydney. REUTERS/Jaimi Joy
The cables revealed extensive Communist intelligence operations against the United States and its allies. The code-cracking coup led to the discovery of Soviet penetration of the Manhattan Project, the top-secret program to build the first atomic bombs, and the existence of the Cambridge Five, a group of top British civil servants spying for Moscow, the CIA documents show.
The West’s breakthrough was the realization that the Soviets had misused so-called one-time pads: a time-tested form of encryption in which a secret key is used to encode a message sent between parties. The method got its name because in its earliest forms, keys were printed on a pad whose pages each contained a unique code; the top page was ripped off and destroyed after a single use. The Soviets blundered by printing and using duplicate pages in one-time pads for a limited time. This allowed allied analysts to painstakingly decrypt some of the messages years later, according to the CIA documents.
To be truly unbreakable, cybersecurity experts say, a one-time-pad key must be a set of random numbers equal to or bigger than the size of the message – and used only once. The party receiving the message uses the same secret key to decrypt the message. The method was invented more than a century ago, and for decades was used for secret messages by most major powers. But technical factors made it too unwieldy for mass, secure communication in the modern era.
Instead, most communications today are secured with what is known as public key infrastructure (PKI), a system developed in the 1970s to enable encryption on a mass scale.
PKI enabled the rise of the internet economy and open telecommunications systems. The passwords to email accounts, online banking and secure messaging platforms all rely on it. PKI is also critical to most government and national security communications.
Security provided by PKI stems essentially from hiding information behind a very difficult math problem, Biercuk said. The most widely used algorithm that creates and manages that difficult math problem used for encryption is known as RSA, from the surname initials of its inventors: the computer scientists and cryptographers Ron Rivest, Adi Shamir and Leonard Adelman. What may be about to change is that these problems will be a cinch for quantum computers to solve.
“If you have a computer for which that math problem is not very hard,” Biercuk said, “all of that is at risk.”
Montreal-based QD5, the privately held company where Kunz is executive vice president, is taking a different approach to post-quantum cryptography. It has developed an advanced version of the one-time pad: a device, the Q PAD, which it claims customers can use to conduct communications on existing networks that will remain uncrackable forever. Pentagon officials peppered Kunz and colleagues with technical questions about the technology in February, but noted the informational session didn’t necessarily signal an intent to buy the Q PAD system.
The Defense Information Systems Agency did not respond to requests for comment.
In an interview, Kunz, a former Canadian soldier, said he first learned about one-time pads while serving with a reconnaissance unit.
“It is very simple and straightforward,” he said. “Every time you used one of those sheets of paper, you would have to destroy it. If you only have those two keys, and follow the rules,” a message may be intercepted, but the enemy “will never be able to break it.”
QD5 has overcome some of the limitations of the original one-time pad, said Chief Technology Officer Gary Swatton. One hurdle to mass use of the method was the need to generate enough sets of truly random numbers to supply modern communications networks with encryption. Before quantum technologies emerged, this took considerable time and effort.
Now, specially designed semiconductor chips and hardware, called quantum random number generators, can exploit the truly random nature of subatomic quantum particles to generate number sets in large volumes, according to researchers. “Technology has caught up and is solving these problems,” Swatton said.
Other companies hope to seize on demand for better security. SandboxAQ of Tarrytown, New York, a spin-off from Google owner Alphabet, has a division to help clients tackle the threat from quantum computing and leverage the benefits of this powerful technology. Even if Q-day is a decade or more away, “it’s imperative that organizations begin preparing for the migration to post-quantum cryptography now,” said Marc Manzano, SandboxAQ’s general manager of quantum security.
Some anticipate upheaval. Skip Sanzeri, founder and chief operating officer of quantum security company QuSecure in San Mateo, California, says “the entire internet and the devices connected to it” will be affected. The World Economic Forum has estimated that 20 billion devices will have to be upgraded or replaced to meet quantum security standards in the next two decades.
“This is going to be a $100 billion or trillion-dollar upgrade,” Sanzeri says.
While quantum computing threatens to upend existing security measures, the physics behind this technology could also be exploited to build theoretically unhackable networks.
In a quantum communications network, users exchange a secret key or code on subatomic particles called photons, allowing them to encrypt and decrypt data. This is called quantum key distribution, or QKD. It is one of the fundamental properties of quantum mechanics that can ensure secure communications. Any attempt to monitor or interfere with these quantum particles changes them, physicists explain. That means any attempt to intercept the communications is immediately detectable to users. If the communicating parties receive an uncorrupted encryption key, they can be confident that their subsequent communications will be secure.
With quantum networks, “our technical security comes from the laws of physics,” says physicist Gregoire Ribordy, chief executive officer of ID Quantique (IDQ), a privately held Swiss company that provides quantum communications technology. “Interception of the communications is just not possible without leaving a trace.”
Quantum communications is an area where China is spending big. The technology has the potential to safeguard Beijing’s data networks, even if Washington and other rivals are first to reach Q-day.
President Xi Jinping stressed the “strategic value” of quantum technology in a 2020 speech to top Chinese leaders, the official Xinhua news agency reported. Under Xi, China has set clear targets to dominate quantum science. It is spending more than any other country on quantum research by some estimates. In an April report, McKinsey & Company estimated that Beijing had announced a cumulative $15.3 billion in funding for quantum research, more than quadruple the equivalent U.S. figure of $3.7 billion.
A key driver of China’s quantum tech quest is Pan Jianwei, a physicist who has achieved celebrity status in China along with praise and support from the ruling Communist Party.
Pan Jianwei is shown in Shanghai at the University of Science and Technology of China in May 2023. The physicist has helped power China’s quantum technology ambitions. He led a team that launched the world’s first quantum satellite in 2016. Adam Ruszkowski/Handout via REUTERS
Pan, 53, is a professor at the University of Science and Technology of China, the country’s premier quantum research outfit. In 2011, he was elected to the Chinese Academy of Sciences, an honor given to scientists who have made important advances in their fields.
Pan in media interviews has said he wants to make China a leader in quantum technology while building an internet secure from cyberattacks. This would serve vital strategic purposes, security experts say. It would protect the Chinese leadership and military from hacking, especially in a conflict. A quantum-fortified internet could protect vital infrastructure and the vast surveillance network the Communist Party has built to stamp out any challenge to its monopoly on power, they say.
Pan did not respond to requests for an interview.
Pan’s career highlights how the absorption of foreign technology has been crucial to China in quantum and other tech fields.
He studied for his doctorate in Vienna with renowned physicist Anton Zeilinger. Zeilinger shared the 2022 Nobel Prize in Physics for his work on quantum mechanics. Pan later moved to the University of Heidelberg, where he still maintains close links, before returning home in 2008.
Zeilinger did not respond to a request for comment.
Back in China, Pan led a team that recorded a milestone in 2016 with the launch of Micius, the world’s first quantum satellite, which was used to establish secure communications links with ground stations in China.
China has deployed its scientists to top quantum labs around the world to scale the learning curve. Austrian physicist Anton Zeilinger (left), who shared the 2022 Nobel Prize in Physics for his work on entangled quantum states, taught Pan Jianwei, who is now a leader in China’s quantum research. TT News Agency/Christine Olsson via REUTERS
The following year, his team and researchers in Austria used Micius to hold the world’s first quantum-encrypted teleconference, connecting Beijing and Vienna. Pan also led a team that has reportedly built a similarly unhackable ground-based network in China linking the cities of Beijing, Jinan, Shanghai and Hefei.
Pan was one of the architects of a concerted campaign to deploy Chinese scientists to leading quantum labs around the world, with the goal of jump-starting domestic development when these researchers returned home, according to a 2019 report by Strider Technologies, a Salt Lake City-based strategic intelligence startup.
Some of those researchers, including Pan, benefited from substantial foreign government funding while studying abroad, the report found. “From that regard it has been wildly successful,” Strider Technologies Chief Executive Officer Greg Levesque said of the Chinese strategy in an interview with Reuters. “But I don’t know if they are going to win it,” he added. “It seems some U.S. companies are making some really big leaps.”
Despite China’s apparent lead in official funding, some researchers say America remains the overall quantum leader thanks to its private sector technology innovators, government labs, university researchers and collaborating allies. And Washington is moving to restrict U.S. investment in China’s quantum capabilities.
In August, President Joe Biden signed an executive order directing the U.S. Department of the Treasury to regulate U.S. investments in quantum computing, semiconductors and artificial intelligence. An annex to that order named China as a country of concern, along with its special administrative regions of Hong Kong and Macau. That could lead to bans on investment in Chinese production of quantum technologies and equipment.
China’s Ministry of Foreign Affairs did not respond to a request for comment.
Globally, government security agencies and the private sector are working on strategies to beat quantum computers. In August, the U.S. National Security Agency and other agencies urged the public and companies to adopt new measures to safeguard their communications with post-quantum cryptography.
After extensive evaluation, the U.S. National Institute of Standards and Technology (NIST) last year selected four so-called post-quantum cryptography (PQC) algorithms – new encryption standards that some cyber experts believe will provide long-term security. U.S. government agencies next year are expected to issue a new standard for post-quantum cryptography, Biden disclosed in a May memo. NIST said in August that it’s working on standardizing these algorithms, the final step before making these tools widely available for organizations to upgrade their encryption.
SandboxAQ’s Manzano said his company is working with some of the world’s biggest companies and government agencies to integrate the coming PQC cryptography algorithms into their systems. Sanzeri said QuSecure, too, is working with government and private clients to upgrade to PQC.
Not everyone agrees the new algorithms will offer reliable security. Kunz told Reuters that eventually the new cyphers could be compromised as quantum computers improve. “The problem is that PQC is not unbreakable,” he said. “It does not solve the harvest now, decrypt later problem.”
IDQ’s Ribordy said that today’s classical computers also might be able to crack these new codes. The complex math problems at the heart of PQC are “so new” that they have not been studied very extensively, he noted.
A spokesperson for NIST said the agency “has confidence in the security of the PQC algorithms selected for standardization, (or) else we wouldn’t be standardizing them. The algorithms have been studied by experts, and went through an intensive evaluation process." He added that it was not inevitable or even a "safe assumption" that they would be broken.
In the meantime, one challenge for the keepers of digital secrets is that whenever Q-day comes, quantum codebreakers are unlikely to announce their breakthrough. Instead, they’re likely to keep quiet, so they can exploit the advantage as long as possible.
“We won’t necessarily know” when the codes are broken, Kunz told the Pentagon panel. “We will probably find out the hard way,” he said. “But what we can expect is that they will be broken.”
The world is on the cusp of a computing revolution based on quantum mechanics – the theory in physics that describes the behavior of matter and energy at the level of atoms and subatomic particles. Quantum science has also been explained by a U.S. government scientist as the“rules that describe how really small things behave.”
This field is full of surprises, even for the experts. Richard Feynman, the late theoretical physicist, Nobel laureate and pioneer of quantum computing, described the field as “peculiar and mysterious to everyone – both to the novice and the experienced physicist,” because it is so different to how people experience and perceive the behavior and properties of larger objects.
Quantum mechanics was developed gradually in the early decades of the 20th century by some of the biggest names in physics. In recent decades, a range of potential applications emerged, including computing, with research now underway in more than a dozen countries, according to a report from the Washington-based Center for Strategic & International Studies.
For quantum computing, a turning point came in 1994 when American mathematician Peter Shor developed an algorithm – a mathematical procedure for performing a computation – which showed that quantum computers could be used to solve problems beyond the reach of classical computers.
Codebreaking is likely to be an important early application. These computers are expected to be able to break encryption codes in minutes rather than the thousands of years that current computers would take, according to cybersecurity experts.
North America is the epicenter of quantum computing, according to industry experts. U.S. companies building quantum processors include IBM, Amazon, Intel, Google, Quantinuum, IonQ, Microsoft, Quantum Computing Inc and Rigetti Computing. In Canada, D-Wave Systems and Xanadu Quantum Technologies have been pioneers.
IBM researcher Dr. Maika Takita works on a quantum computer at the company’s Quantum Lab in Yorktown Heights, New York, in 2020. IBM/Handout via REUTERS
The United States, Canada and Britain were home to the biggest number of startups in the field as of 2022, according to a recent McKinsey report.
In January, China's Origin Quantum Computing Technology Company, based in Anhui Province, announced it had delivered a completely homemade quantum computer to a user, according to reports in China's state-controlled media. Some of China's tech giants including Baidu and Tencent are also working on quantum computing.
Origin Quantum did not respond to a request for comment.
To be sure, substantial engineering challenges must be overcome before these computers are truly useful. So far, only small computers with a relatively small number of qubits have been built in labs around the world, according to physics researchers. These computers are very fragile and the hardware is prone to “noise” such as fluctuations in the earth’s magnetic field or other electromagnetic signals, which leads to errors. And they are still too small to solve some challenging problems, including codebreaking.
But some of these early quantum computers are now in use for initial research in a variety of fields. Auto giant Mercedes-Benz, for example, is now using IBM quantum computers to design better batteries, according to IBM. Some technologists predict these computers could soon become even more useful. They say combining these early machines with traditional processors can lead to important improvements in solving complex problems.
The Boston Consulting Group (BCG) forecast in a May report that business will reap benefits from quantum computing as early as 2025. Quantum's data processing has the potential to generate income of up to $850 billion for users by about 2035, the year by which BCG expects the technology to be mature, the company said in the report.
European Union leaders granted Ukraine a major political win on Thursday by agreeing to start membership negotiations at a time when its counter-offensive against Russia's invasion has failed to make major gains and U.S. military aid has become more uncertain.
EU diplomats and officials said the unexpected green light for talks took place as Hungarian Prime Minister Viktor Orban - who had for weeks said he would block such a deal - agreed to leave the room, knowing the other leaders would go ahead and vote.
Orban confirmed that he had abstained from the vote at the EU summit on what he called a "bad decision". It was unclear at this stage what exactly he could be getting in return.
Such an unusual way to approve a decision - especially such a major one - is unheard of in Brussels, even for a place where diplomats have long been very creative about how to strike deals.
Ukrainian President Volodymyr Zelenskiy welcomed the decision.
"This is a victory for Ukraine. A victory for all of Europe. A victory that motivates, inspires, and strengthens," he said.
"I congratulate every Ukrainian on this day... History is made by those who don't get tired of fighting for freedom."
Ukraine badly needs support from its Western allies in its nearly two-year fight against Russian forces. Its counter-offensive has failed to make major gains and the Biden administration has so far been unable to get a $60 billion aid package for Ukraine through the U.S. Congress.
European Commission chief Ursula von der Leyen said it was "a strategic decision and a day that will remain engraved in the history of our Union."
Orban had very different words to describe the decision.
"Hungary's stance is clear, Ukraine is not prepared for us to start talks on EU membership," he said, calling the decision to start talks "irrational" and "inappropriate."
"But 26 member states were adamant that this decision must be made so Hungary decided that if 26 decide so, they should go on their own path and Hungary does not wish to participate in this bad decision," he said.
TALKS TO TAKE YEARS
The talks themselves are likely to take years.
Ukraine, which has a population of 44 million and is geographically bigger than any EU member, presents some unique challenges for admission to the 27-member bloc.
Several diplomats said German Chancellor Olaf Scholz came up with the suggestion that Orban leave the room so the decision could be approved.
"Prime Minister Orban made his case very strongly. He disagrees with this decision and he is not changing his opinion, but essentially decided not to use the veto power," Ireland's Prime Minister Leo Varadkar told reporters.
In intense diplomacy on the matter, Scholz and French President Emmanuel Macron met with Orban before the summit, alongside von der Leyen and European Council President Charles Michel.
The European Commission on Wednesday restored Hungary's access to up to 10.2 billion euros in refunds for economic projects after finding it had fulfilled conditions on the independence of its judiciary.
Talks will continue at the summit on the bloc's multi-annual budget framework.
Michel said the European Council had also decided on Thursday to open accession negotiations with Moldova.
He went on to say the summit granted EU candidate status to Georgia and would also advance an EU bid by another hopeful - Bosnia - once it reaches "the necessary degree of compliance" with criteria.
Earlier in the day as the 27 EU leaders gathered for their last summit of the year, Orban insisted that the EU should not start membership talks with Ukraine. He was a lone hold-out at the summit.
Other EU leaders had warned that not agreeing to start negotiations would have been seen as a victory for Russian President Vladimir Putin.
Belgium's Prime Minister Alexander De Croo said the decision to start the membership talks was as much a message to Kyiv as it was to Moscow.
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NextCure isdumpinga phase 1 monoclonal antibody so it can spend more time on its antibody-drug conjugate (ADC) aimed at the same target.
The Maryland-based biotech jumped into the increasingly crowded ADC space in November 2022 when it signed a pact with LegoChem. The idea was to combine the two companies’ resources to find a new use for NextCure’s anti-B7-H4 antibody NC762 as part of an ADC.
Now, NextCure is halting its work on NC762, which had been undergoing a phase 1b trial in solid tumors, citing “the competitive environment” and “limited activity to date.” Instead, the biotech will shift those resources over to the B7-H4-directed ADC, dubbed LNCB74, that resulted from the LegoChem collaboration.
“Based on a comprehensive preclinical data package, we plan to initiate a dose range-finding toxicology study and GMP manufacturing for LNCB74 in early 2024,” the company explained.
B7-H4 is abnormally expressed by a range of solid tumors and plays a role in key processes such as cell proliferation and metastasis that support the development and spread of cancers. Because of its limited expression in healthy tissues, multiple companies have identified the cell-surface glycoprotein as a good target for ADCs that deliver cytotoxic payloads to cells with certain markers.
A B7-H4 targeted ADC was at the center of GSK’s $85 million upfront licensing deal with Hansoh Pharma in October. The Big Pharma joined the likes of AstraZeneca, which already has a B7-H4-directed ADC called AZD8205 in a phase 2 trial for solid tumors, and Seagen, which has its own candidate in phase 1.
NextCure has a couple of other clinical-stage assets in the works. A readout from a phase 1b trial of a LAIR-2 fusion protein called NC410 in combination with Keytruda in patients with colorectal cancer is due in the first half of next year. In that same period, the biotech expects data from a phase 1 dose escalation study of its LAIR-1 monoclonal antibody NC525 in acute myeloid leukemia.
In November, the biotech said the $118 million it had on hand should last through to mid-2025.
