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Xcellbio and Royal Perth Hospital Collaborate on Development of an Automated TIL Manufacturing Workflow

Xcell Biosciences Australia, an affiliate of Xcell Biosciences, and Royal Perth Hospital agreed to collaborate on developing an automated, clinical-scale manufacturing workflow for therapies based on tumor-infiltrating lymphocytes (TILs) using the AVATAR™ Foundry system. The goal is to empower Royal Perth Hospital physicians and clinical researchers to rapidly manufacture TIL therapies for use in clinical trials.

TIL therapies are a promising type of cellular immunotherapy used to treat a broad range of solid malignant tumors, with the first FDA approval of a TIL-based therapy taking place in 2024. These therapies have proven to achieve durable complete responses in patients but require tens of billions of therapeutic cells to achieve sufficient clinical potency.

Current manufacturing processes for TIL therapies are cumbersome and slow, requiring many weeks of manual and labor-intensive efforts to achieve an effective dose, according to Brian Feth, co-founder, and CEO at Xcellbio.

Manufacture potent cell therapies

To address these challenges, Xcellbio has developed the AVATAR platform to expedite the development and manufacture of potent cell therapies. The platform uses a proprietary incubation technology to enhance the metabolic fitness of TILs, resulting in a potent and persistent therapeutic product that can overcome the immunosuppressive tumor microenvironment, explained Feth.

The AVATAR Foundry system was designed to produce cell therapies under current Good Manufacturing Practice (cGMP) protocols in a fully automated capacity.

“At Royal Perth Hospital, we are dedicated to exploring cutting-edge approaches for cell therapies to enable the best care for our patients,” said Zlatibor Velickovic, PhD, director of the Ray and Bill Dobney Cell and Tissue Therapies WA facility at Royal Perth Hospital. “We are excited to team up with scientists at Xcellbio to develop a much-needed automated workflow for TIL manufacturing, and to implement the AVATAR Foundry system as the newest technology innovation in our center.”

Xcellbio scientists will work with the Royal Perth Hospital team to develop an automated TIL manufacturing process based on the AVATAR platform that achieves key goals for cell quality, quantity, and potency. The resulting workflow will be established in the hospital’s cell therapy facility to support clinical trials using TILs.

“The emerging therapeutic class of tumor-infiltrating lymphocytes is incredibly exciting, in particular for solid tumors. Current manufacturing processes require long expansion times and high cell doses to be effective in patients. The AVATAR platform will reduce manufacturing time and increase therapeutic potency,” noted James Lim, co-founder, and CSO at Xcellbio.

“We are pleased to join forces with this group to improve TIL manufacturing and to make these important therapies a more feasible option for patients in Australia and, ultimately, around the world,” said Feth.

News Team by — March 23, 2025 By News Team in Biotechnology Daily
Cellares and Cabaletta Bio Complete Manufacturing Technology Adoption Program

Cellares, an Integrated Development and Manufacturing Organization (IDMO), concluded the Technology Adoption Program (TAP) on its automated cell therapy manufacturing Cell Shuttle™ for resecabtagene autoleucel, (rese-cel, previously known as CABA-201).

Cellares’ TAP assessed the feasibility of using the Cell Shuttle platform to automate the manufacturing of Cabaletta’s rese-cel drug product, a CD19-targeting CAR T cell therapy designed to treat patients with a broad range of autoimmune diseases. The TAP successfully delivered automated, concurrent manufacture of multiple rese-cel batches on a single Cell Shuttle, according to Cellares.

Cabaletta Bio and Cellares are now working toward manufacturing cGMP cell therapy batches to be delivered to patients. The Cellares network of global IDMO Smart Factories planned for the United States, Europe, and Japan has the potential to provide Cabaletta Bio with the ability to automate, lower costs, and scale out manufacturing, according to Fabian Gerlinghaus, CEO of Cellares.

Facilitating global expansion

Additionally, Gerlinghaus said, this partnership may facilitate global expansion of rese-cel via rapid technology transfer to additional IDMO Smart Factories. This has the potential to allow Cabaletta Bio to achieve the global scale required to meet the total patient demand across multiple autoimmune diseases, including myositis (~70,000 patients in the United States), scleroderma (~90,000 patients in the United States), and lupus nephritis (~100,000 patients in the United States),  in a fraction of the time and initial investment it would typically take to develop and deliver global supply for these large patient populations, continued Gerlinghaus.

“Through our partnership with Cellares, our teams have successfully achieved proof of concept for the ability to automate the rese-cel cellular drug substance manufacturing process,” said Gwendolyn Binder, president, science and technology at Cabaletta Bio. “We look forward to continuing our work together to complete activities required to enable use of the Cell Shuttle in clinical trials to support the delivery of these potentially curative autologous therapies to more patients with autoimmune diseases.”

“The success of this Technology Adoption Program (TAP) demonstrates the effectiveness of the Cell Shuttle as a scalable, automated, and cost-effective platform for the manufacturing of cell therapies. Working with Cabaletta Bio proves that small biotech companies can successfully partner with Cellares to benefit from next-generation automation,” noted Gerlinghaus.

News Team by — March 23, 2025 By News Team in Biotechnology Daily
Sanofi to acquire Dren Bio’s immunology unit

March 20 (Reuters) – Sanofi (SASY.PA), opens new tab on Thursday announced an agreement with biopharmaceutical company Dren Bio for the acquisition of its autoimmune disease treatment DR-0201.

The French healthcare group will acquire the Dren Bio affiliate Dren-0201 for an upfront payment of $600 million and potential future payments totalling $1.3 billion, it said in a statement.

The transaction is expected to close in the second quarter of 2025, it added.

News Team by — March 23, 2025 By News Team in Bio Business News
MBK Partners poised to acquire CJ Cheiljedang’s $3.5 billion bio business

North Asia-focused private equity firm MBK Partners is on the verge of clinching a major acquisition deal by offering a higher bid than other contenders for South Korea’s CJ Cheiljedang Corp.’s bio business — a deal estimated at 5 trillion won ($3.5 billion).

The deal, if finalized, will help MBK overcome its reputational risks arising from its troubled investment in Korea’s leading hypermarket operator Homeplus Co., analysts said.

According to investment banking sources on Thursday, MBK Partners recently submitted its bid for CJ CheilJedang’s green bio division.

While the exact terms could change depending on further negotiations, MBK’s bid is said to be in line with the sale price of about 5 trillion won expected by the seller, placing it ahead of competing bidders, sources said.

The final agreement will likely be reached by the end of this month after a series of in-depth negotiations, they said.

Morgan Stanley is managing the sale of the bio business.

CHINA’S TWO LEADING BIOTECH FIRMS

Last month, MBK and two leading Chinese biotechnology firms — Guangxin Group and Meihua Group — joined the race for management control of CJ’s bio business in what would be Korea’s largest M&A deal so far this year.

China’s Guangxin and Meihua produce food additives such as MSG and nucleotides, as well as feed additives such as lysine and tryptophan, similar to CJ CheilJedang’s bio division.

The three bidders recently completed due diligence on the bio business.

CJ’s bio business is an attractive asset in view of its strong global presence and stable earnings.

The company’s production and sales network spans 11 countries, including the US, China, Indonesia and Brazil. It also boasts a large market share in China, the world’s top consumer of feed amino acids.

CJ is the world’s No. 1 player in amino acids, which account for 90% of its bio business sales. Feed amino acids were the driving force of the company’s ascent in the global food and beverage market.

In 2024, the company’s bio business posted 337.6 billion won in operating profit on sales of 4.21 trillion won, up 20% and 31%, respectively, from the previous year.

CJ Cheiljedang, the flagship unit of Korea’s food-to-entertainment conglomerate CJ Group, is selling the bio business in line with the parent group’s restructuring efforts to revive sagging sales at its two growth pillars, food and entertainment.

CJ CheilJedang put its bio business on the market last December and initially attracted interest from buyout firms including Blackstone, The Carlyle Group and MBK Partners.

LARGEST CRISIS IN ITS HISTORY

MBK Partners recently made headlines when Homeplus, a leading Korean hypermarket operator, filed for corporate rehabilitation with a Seoul court amid increasing market concerns about its squeezed financial position.

In 2015, MBK acquired 100% of Homeplus for 7.2 trillion won from British retailer Tesco Plc in what was at the time its biggest acquisition and the largest leveraged buyout (LBO) transaction in Asia.

With Homeplus set to come under court protection, however, MBK faces mounting scrutiny over its aggressive LBO-driven investment strategy.

MBK is also in a protracted dispute with Korea Zinc Inc. over management control of the world’s top lead and zinc smelter.

Analysts said MBK appears to be betting on the high-profile CJ bio business acquisition as a way to regain market confidence.

If the CJ deal is confirmed, it will bolster MBK’s standing in the M&A market, they said.

News Team by — March 23, 2025 By News Team in Bio Business News
Health care leaders say Medicaid cuts would further strain state hospitals and clinics

Leaders of Hennepin Healthcare, who oversee the state’s largest emergency room, fear federal cuts to Medicaid will increase the number of patients coming to the emergency department with serious, preventable conditions.

But if Congressional Republicans want to achieve their goal of extending tax cuts that primarily benefit the wealthy while leaving areas like defense and Social Security unscathed, they will almost certainly have to cut federal spending on Medicaid, the federal-state partnership that provides health insurance to low-income and disabled Americans.

Democratic U.S. Reps. Ilhan Omar and Kelly Morrison, a physician, joined Hennepin Healthcare leaders and patients Thursday at one of the health care provider’s downtown Minneapolis buildings — across the street from the already-overwhelmed Hennepin County Medical Center — to raise awareness of the potential impacts of the proposed cuts.

“Medicare and Medicaid funds just about everything I do,” said Joel Williams, who has been a patient at Hennepin Healthcare for 11 years.

The programs cover his group home, he said, and paid for a new kidney.

One-fifth of Minnesotans are enrolled in Medical Assistance, Minnesota’s Medicaid program, on par with national enrollment. One in 3 births in Minnesota are covered by Medicaid, and more than half of nursing home residents are enrolled in the program.

At Hennepin Healthcare, 62% of ER patients are covered by Medicaid, said chief of emergency medicine Dr. Tom Wyatt.

Medicaid pays for preventative services that can help keep people out of emergency rooms, Wyatt said. When diabetics can’t access insulin, they may come to his department with life-threatening diabetic ketoacidosis. Patients who can’t get their blood pressure medications may suffer a stroke.

“Those conditions are preventable if they have access to primary care,” Wyatt said.

The health care system also offers behavioral health services to Medicaid recipients, which can help patients keep mental health conditions and substance abuse issues in check, said Hennepin Healthcare CEO Jennifer DeCubellis.

Because the cost of Medicaid is shared between the federal and state government, cuts to federal spending would force Minnesota leaders to choose whether to spend extra money to maintain the same level of coverage, or to cut services.

State leaders may not have much of a choice; Minnesota’s budget picture is already bleak, with spending outpacing revenues, and a deficit on the horizon — and many of Trump’s proposed federal spending cuts could exacerbate the budget problems. Medical Assistance spending dwarves spending on every state program except education, and continues to increase as Minnesotans age and costs — including worker pay — go up.

The Medicaid cuts proposed by Congressional Republicans are already getting fierce pushback, including from some unlikely places: Minnesota Republicans in the Legislature wrote to President Donald Trump and congressional Republicans, asking them to preserve Medicaid.

Indeed, Medicaid cuts are politically volatile; many of the recipients are the rural and elderly Americans that comprise Trump’s base. More than 75% of Americans have a favorable view of Medicaid, according to a January 2025 poll.

But Trump’s desired tax cuts aren’t possible without significant cuts to Medicaid and other safety net programs, like SNAP, which helps low-income families pay for food.

“The whole reason we are here is because the Trump-Vance administration and their unelected, unaccountable benefactor-advisor Elon Musk are looking for ways to make the math work so that they can get tax cuts for billionaires,” Morrison said. “It’s really that simple.”

News Team by — March 22, 2025 By News Team in Trending Now
NC Senate looks to crack down on AI in health insurance, ‘surprise billing’ by hospitals

The practice of “surprise billing” by hospitals should be severely restricted, state Senate health policy leaders said Wednesday, as they took a bipartisan vote to crack down on the practice and require more transparency for patients.

The idea is to give people a better idea of what a medical procedure might cost them before they agree to it, to give patients more certainty over whether their care will be in-network or out-of-network, and to stop new bills from continuing to arrive months or even years after the fact.

Supporters say if Senate Bill 316 becomes law, it would at least give people more information to make decisions on their health care. And ideally, they say, it could potentially also lead to lower costs for everyone in the future.

“There is, I think, no other industry that a consumer agrees to pay for a service in advance with no clue as to what the cost will be, and no clue as to what they will be charged in full for those services,” Sen. Amy Galey, R-Alamance, said Wednesday.

She added that the bill “is an attempt to shine a light on every part of the health care system — to begin to see where the cost drivers truly exist, and to start to tamp down on those costs.”

The Senate has passed similar bills twice in recent years. But both bills went nowhere in the state House, in face of intense lobbying in opposition by the hospital industry. The North Carolina Healthcare Association, which lobbies for hospitals, declined to comment Wednesday on the new bill.

In addition to the various requirements to give patients more information before a procedure, the bill would also require hospitals to send patients an itemized bill — with descriptions written in what Galey called “plain English” — before the hospital could send the patient into collections for not paying their bill.

About one in every eight North Carolina adults had medical debt before the state approved Medicaid expansion, according to health policy analysis group KFF. After North Carolina approved Medicaid expansion in 2023, then-Gov. Roy Cooper pushed hospitals to forgive approximately $4 billion in medical debt held by low-income North Carolinians. Cooper announced last year that every hospital in the state was participating.

No lawmakers or members of the public spoke against the bill Wednesday, although Sen. Gale Adcock, D-Wake, said that based on her experience as a nurse there are probably some parts of the bill that would be difficult if not impossible for hospital staff to comply with.

She suggested further conversations on how to amend the bill to ensure hospitals could follow it — and the state could enforce it.

“It could provide clarity moving forward, and make sure you can enforce what you’re trying to do,” Adcock said.

AI claims denial

The Senate Health Committee also debated a separate bill — but stopped short of taking a vote on whether to advance it — that would ban health insurance companies from relying too heavily on artificial intelligence to deny people’s claims.

Insurance companies could still use AI to help review and make decisions on claims, even if Senate Bill 315 becomes law. But it would ban AI from being used as “the sole basis” of any decisions to deny or modify someone’s health care services.

“It’s 2025 — AI is a fact of life,” Sen. Benton Sawrey, R-Johnson, said. “It’s something that’s being used by doctors around the state, and health insurers, and hospitals. It’s inevitable. It’s going to be here, but I know that every person in this room has heard stories about their health insurers across the nation having some issues with it.”

UnitedHealthcare, the nation’s largest private health insurer, faces a class action lawsuit accusing it of using AI to deny many people’s claims. Last year the company’s CEO was gunned down in what police have said was a targeted assassination, apparently based on the company’s policies and practices.

Sawrey said the other bill on surprise billing also would exempt health insurance staffers from having to put their contact information on certain forms given to customers. He said it “addresses the aftermath of fear for employee safety after the tragedy that occurred a few months ago involving the UnitedHealthcare CEO.”

UnitedHealthcare Chief Executive Brian Thompson was shot and killed in Manhattan in a targeted attack — a killing that fueled a public outcry over claim denials by insurers.

The anti-AI bill would also make a number of other changes to crack down on health insurance companies’ efforts to deny people’s claims, including by banning insurers from retroactively requiring prior authorization for certain types of care, and then using that to issue denials.

The bill would also require appeals of insurance denials to be heard by licensed doctors who have experience in the type of medicine in question.

And it would appear to ban insurance companies from paying their on-staff doctors more money for suggesting claims be denied, by requiring appeals to be heard by doctors with “no financial interest, or other conflict of interest, in the outcome of the appeal.”

A top health insurance industry representative, Peter Daniel, spoke at the meeting to tell lawmakers they were willing to work with the Senate on the bill as it moves through the legislature.

News Team by — March 22, 2025 By News Team in Trending Now
Engineered yeast boosts D-lactic acid production, advancing eco-friendly biomanufacturing

Great recipes require the perfect combination of ingredients—biotechnology recipes are no exception. Researchers from Osaka Metropolitan University have discovered the ideal genetic “recipe” to turn yeast into a tiny yet powerful eco-friendly factory that converts methanol into D-lactic acid, a key compound used in biodegradable plastics and pharmaceuticals.

This approach could help reduce reliance on petroleum-based processes and contribute to more sustainable chemical production.

The study was published in Biotechnology for Biofuels and Bioproducts.

Lactic acid is widely used in food, cosmetics, pharmaceuticals and bioplastics. It exists in two forms: L-lactic acid and D-lactic acid. Compared to its counterpart, D-lactic acid is much less available and much more expensive.

“Most lactic acid bacteria can only produce L-lactic acid while chemical synthesis methods yield only a mixture of both forms,” said Ryosuke Yamada, an associate professor at Osaka Metropolitan University’s Graduate School of Engineering and lead author of this study.

Seeking a more efficient way to produce D-lactic acid, the team turned to Komagataella phaffii, a yeast capable of utilizing methanol. Their goal was to pinpoint the optimal combination of D-lactate dehydrogenase (D-LDH) genes and promoters in K. phaffii that would maximize the yeast’s ability to produce D-lactic acid from methanol.

D-LDH is a key enzyme responsible for converting precursor molecules into D-lactic acid, while promoters are DNA sequences that regulate gene expression.

After testing five different D-LDH genes and eight promoters, the researchers identified an ideal mix that boosted D-lactic acid production by 1.5 times compared to other methanol-based methods.

“To the best of our knowledge, our engineered yeast achieved the highest-ever reported yield using methanol as the sole carbon source,” Yamada said.

These findings show that engineered yeast strains can be tailored to produce a wide range of useful compounds for commercial use. With growing global concerns over fossil fuel depletion and environmental impact, the ability to synthesize chemicals from renewable carbon sources like methanol is deemed a critical advancement for sustainability.

“This study demonstrates that by carefully optimizing gene and promoter combinations, we can significantly enhance the efficiency of microbial processes, offering a viable alternative to traditional, petroleum-based chemical production,” Yamada said.

News Team by — March 22, 2025 By News Team in Biotechnology Daily
Computational drug discovery: Exploring natural products targeting SARS-CoV-2

The COVID-19 pandemic highlighted the urgent need for effective therapeutic agents against SARS-CoV-2. Although vaccines helped control the spread of the virus, the emergence of new variants continues to challenge global health efforts. Small-molecule inhibitors targeting viral proteins could serve as an effective alternative for controlling the spread of COVID-19 at both individual and community levels.

In this vein, a study led by Associate Professor Md. Altaf-Ul-Amin, along with Muhammad Alqaaf and others, explored natural products as potential inhibitors of the SARS-CoV-2 spike protein using computational methods.

As described in their paper published in Scientific Reports, the research team employed molecular docking analysis to screen a diverse library of natural compounds that could act against the spike proteins.

By simulating interactions at the atomic level, they identified several promising molecules with high binding affinities. Such compounds can interfere with viral entry mechanisms, thereby reducing viral activity.

“The variants of spike proteins can be divided into five distinct clusters based on the similarity of their amino acid sequences and functions,” said Associate Professor Md. Altaf-Ul-Amin. “This clustering was performed using an in-house-developed algorithm and software named DPClusSBO, which helped to effectively classify the spike proteins.”

Additionally, the natural products screened in this study were sourced from the KNApSAcK database, which was also developed at the research team’s laboratory. This database contains a comprehensive dataset of natural products useful for drug discovery.

A total of 11 natural compounds were identified: cephaeline, emetine, uzarigenin, linifolin A, caffeine, colchamine, cytidine, (+)-epijasmonic acid, 11-hydroxyvittatine, staurosporin, and paxilline.

Among them, caffeine was particularly noteworthy, as it is commonly found in coffee and caffeinated beverages. Molecular docking along with other analyses revealed that caffeine binds strongly to the spike protein’s active site and exhibits high binding stability. Notably, a drug appropriateness analysis suggested that caffeine possesses excellent solubility and significant potential as an oral drug candidate.

The discovery that a widely known and consumed compound such as caffeine functions as a SARS-CoV-2 inhibitor presents an interesting therapeutic possibility.

In addition to its potential against viral invasion, caffeine plays a dual role in a wide range of medical applications owing to its neuroprotective and anticancer effects. These properties underscore its versatility and demonstrate its potential positive impact on global health.

“Our findings highlight the potential of natural products in the fight against COVID-19. The identified compounds provide a basis for further experimental validation and drug development strategies,” explains Alqaaf, first author of the study.

This research contributes to the broader field of computational drug discovery by demonstrating how bioinformatics and molecular modeling can accelerate the identification of novel viral inhibitors.

Future research will focus on the in vitro and in vivo validation of the identified compounds, as well as potential structural modifications to enhance their antiviral activity.

News Team by — March 22, 2025 By News Team in Biotechnology Daily
New £1.9m IUK-Funded Project Set to Develop Sustainable Materials for Applications in Bioprocessing

Innovate UK (IUK) reported the start of an industry-academia collaboration to advance sustainable bioprocessing through innovative materials for additive manufacturing (3D printing) as part of the sustainable medicines manufacturing innovation: collaborative R&D.

Project Nexus, a collaboration between Photocentric, Sartorius, Metamorphic, CPI, the University of Sheffield, and Imperial College London, is embarking on the development of new sustainable materials for application in single-use bioprocessing equipment such as bioreactors.

Single-use technologies (SUTs) offer numerous benefits, including faster setup and flexible process configurations, while significantly contributing to the reduction of resources like water, electricity, and caustic chemical usage. Although their waste contributes only about 0.002% to global plastic waste, this project aims to further enhance the advantages of SUTs by introducing sustainable material formulations for additive manufacturing.

Through £1.9M of funding via IUK, Project Nexus aims to bring together expertise across advanced manufacturing automation, digital design and optimization, as well as material innovation and bioprocessing, to pioneer the future of additive manufacturing (AM) of bioreactors at scale.

The project aspires to offer a greener alternative to SU bioreactors with enhanced circularity and end-of-life pathways, all while retaining the flexibility of disposable systems.

“Through harnessing the advanced capabilities of our latest 3D printing innovation, JENI, we’re really excited to be part of this important partnership and the development of a new generation of cost effective, sustainable solutions for biopharma,” said Paul Holt, founder and managing director, Photocentric.

“We’re excited to contribute the AMRC’s wealth of experience in sustainable design engineering to Project Nexus. This collaborative initiative will be a significant step in making the biopharmaceutical sector more sustainable, ultimately advancing the U.K.’s net zero ambitions,” noted Jose Casamayor Alarco, PhD, technical fellow at the University of Sheffield Advanced Manufacturing Research Center (AMRC).
3D printing technology
By utilizing advanced 3D printing technology and newly developed eco-friendly, bio-based resins to produce thermosets that can be autoclaved for reuse, Project Nexus aims to tackle current challenges and enhance sustainability through greater circularity, i.e., aligning with government targets for reducing waste and promoting sustainable manufacturing.

The bioreactors will be tested for pharmaceutical R&D and point-of-care manufacturing, with potential reuse in industrial biotechnology for green chemical production. In addition to this, the technical, economic, and environmental impact will be assessed, focusing on the benefits of advanced manufacturing (AM) technology in reducing waste and enhancing efficiency through material circularity and system flexibility.

“The goals at the heart of the Nexus project go beyond simply enabling us to unlock the applications of today. They also allow us to realize the future obligations of us all, through the development of sustainable material formulations,” explained Jeremy Pullin, head of AM & manufacturing technology of Sartorius.

“We’re excited to contribute our expertise in material innovation to Project Nexus,” emphasized Tony Jackson, director of formulation at CPI. “By developing a high-performance, bio-based resin tailored for bioreactors, we are enabling a more sustainable future for biopharmaceutical manufacturing.
“Our focus on circularity and end-of-life solutions ensures that this project not only advances technological capabilities but also drives meaningful progress toward net zero goals. We look forward to collaborating with our partners to redefine the role of additive manufacturing in the sector.”

Project Nexus is fully established and set to deliver over the next 24 months, according to UK Research and Innovation (UKRI), a non-departmental public body sponsored by the department for science, innovation, and technology (DSIT). IUK, part of UKRI, will work with the department of health and social core (DHSC) to invest up to £15 million to support the development and adoption of sustainable technologies for the manufacturing of medicines.

News Team by — March 22, 2025 By News Team in Bio Business News
AstraZeneza Commits Up to $11B+ to Chinese Collaborations, Beijing R&D Hub

AstraZeneca will carry out potentially more than $11 billion worth of collaborations in China that include partnerships with three Chinese-based companies to develop drugs and vaccines, as well as an R&D center in Beijing that will be its sixth worldwide, the pharma giant and its partners said.

The largest of the collaborations is a potentially more than $4.68 billion partnership with Shanghai-based Harbour BioMed to discover and develop next-generation multi-specific antibodies for immunology, oncology, “and beyond.”

As part of the collaboration, AstraZeneca is making a $105 million equity investment in Harbour, toward a 9.15% stake in the Chinese biopharma. The strategic collaboration gives AstraZeneca an option to license for clinical development unspecified “multiple” programs using Harbour’s Harbour Mice® fully human antibody technology platform in unspecified “multiple” therapeutic areas. These include two preclinical immunology programs, though AstraZeneca will nominate further targets for which Harbour will work to discover next-generation multi-specific antibodies.

AstraZeneca also agreed to pay Harbour $175 million in upfront and near-term milestone payments as well as option exercise fees, plus up to $4.4 billion tied to achieving additional development and commercial milestones, along with tiered royalties on future net sales. AstraZeneca and Harbour have options to include additional programs into the collaboration over the next five years, as well as to extend their agreement for an additional five years.

To support the collaboration and earlier initiatives between the companies, Harbour said it will establish an innovation center in Beijing, to be co-located with AstraZeneca’s planned $2.5 billion R&D hub.

AstraZeneca’s planned Global Strategic R&D Center will be its second R&D hub in China; the first is in Shanghai. The Beijing hub is intended to advance early-stage research and clinical development and will feature a new AI and data science laboratory. The new R&D center will be located within the Beijing International Pharmaceutical Innovation Park (BioPark), near leading biotechs, research hospitals, and the National Medical Products Administration, China’s drug regulatory agency.

“This $2.5 billion investment reflects our belief in the world-class life sciences ecosystem in Beijing, the extensive opportunities that exist for collaboration and access to talent, and our continued commitment to China,” AstraZeneca CEO Pascal Soriot said in a statement.

The new hub and planned collaborations are expected to nearly triple the size of AstraZeneca’s Beijing-based workforce, from about 600 now to a projected 1,700.

Earlier partnerships

The latest Harbour collaboration follows earlier partnerships announced by the company and a subsidiary with AstraZeneca in recent years.

Last year, AstraZeneca agreed to license preclinical monoclonal antibodies from Harbour subsidiary Nona Biosciences toward creating targeted therapies in oncology. In return, AstraZeneca agreed to pay Nona $19 million upfront, up to $10 million in near-term milestone payments, and up to $575 million tied to achieving specified development, regulatory, and commercial milestones, plus tiered royalty payments on net sales. Nona would receive additional money if AstraZeneca exercises options to develop additional programs.

And in 2022, Harbour outlicensed to AstraZeneca HBM7022, a cancer-fighting CLDN18.2xCD3 bispecific antibody in return for AstraZeneca paying Harbour $25 million upfront, up to $325 million tied to achieving development, regulatory, and commercial milestones, plus tiered royalties on net sales. HBM7022 was generated through Harbour’s HCAb Based Immune Cell Engagers (HBICE®) Platform. HBM7022 appears on Harbour’s published pipeline as a Phase I candidate in development for solid tumors.

The Harbour collaboration is one of several announced as part of a strategic partnership AstraZeneca has launched with Beijing’s municipal government and the administrative office of the Beijing Economic-Technological Development Area, a state-level economic and technological development zone in the Chinese capital.

In addition to the Harbour collaboration and AstraZeneca’s planned R&D center in Beijing, AstraZeneca also announced:

• A potentially more than $3.475 billion collaboration with Beijing-based oral macrocyclic peptide drug developer Syneron Bio.

• A $400 million joint venture with vaccine developer/manufacturer BioKangtai.

• A strategic partnership of unknown value with Beijing Cancer Hospital.

AstraZeneca announced the initiatives five months after disclosing last October that Leon Wang, the president of its Chinese division as well as executive vice president of its international business, had been detained as part of an investigation by authorities. Bloomberg News has since reported that authorities were investigating Wang among some of the company’s current and former employees concerning alleged violations of law involving drug imports, data privacy, and insurance reimbursement.

Wang’s international duties are now handled by Iskra Reic, who also continues as AstraZeneca’s senior vice president for vaccines and immune therapies.

Macrocyclic peptides

Syneron will partner with AstraZeneca to develop potentially first-in-class macrocyclic peptides for the treatment of chronic diseases. Syneron has granted AstraZeneca access to its Synova™ platform, a high-throughput macrocyclic peptide drug R&D platform designed to advance research “exploring possible future treatments of chronic diseases, including rare, autoimmune, and metabolic disease,” according to Syneron.

AstraZeneca agreed to pay Syneron $75 million in upfront and potential near-term milestone payments, as well as up to $3.4 billion in additional development and commercial milestones. In addition, tiered royalties will be paid based on global sales. Syneron Bio also said it plans to expand its Beijing R&D center.

BioKangtai will partner with AstraZeneca to develop, manufacture, and commercialize new vaccines for respiratory and other infectious diseases for patients in and outside China, at what will be AstraZeneca’s first and only vaccine manufacturing facility in the country.

“The company and AstraZeneca plan to jointly establish a joint venture in the Economic Development Zone with an estimated registered capital of RMB 345 million [about $50 million] to develop global innovative vaccines (expected to include AstraZeneca’s respiratory An investigational combination vaccine against RSV and hMPV, also known as IVX-A12) and development, registration, localized production, and commercialization of other innovative products in China,” according to a Google Translate translation of the BioKangtai-AstraZeneca agreement, posted in Chinese on BioKangtai’s website.

“The total investment in this project is estimated to be approximately US$400 million (approximately RMB 2.76 billion). The actual investment amount will be determined by the joint venture company based on the project progress,” the agreement added. “The project is scheduled to be put into use before December 31, 2030, and the final time of commissioning will be subject to the actual progress of the project.”

The BioKangtai joint venture follows from a relationship between the companies highlighted when BioKangtai began distributing AsraZeneca’s COVID-19 vaccine after securing rights to manufacture and sell it in mainland China, Pakistan, and Indonesia, where it began by shipping an initial more than four million doses in November 2021.

AstraZeneca said the partnership with Beijing Cancer Hospital will focus on translational research, data science, and clinical development.

Beijing Cancer Hospital is a 790-bed facility that, according to an English text posted on its website, “has been engaged in the diagnosis and treatment of various tumors, such as breast cancer, lung cancer, colorectal cancer, liver cancer, gastric cancer, esophageal carcinoma, malignant lymphoma, gynecological cancer, tumor of head and neck, tumor of urological system, bone tumor, and melanoma.”

News Team by — March 22, 2025 By News Team in Bio Business News
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