Feliza Mirasol is the science editor for 

Feliza Mirasol

On Jan. 8, 2024, Pluri, an Israel-based biotech company, announced it launched a new business division named PluriCDMO that will offer cell therapy manufacturing services as a contract development and manufacturing organization (CDMO). The new division includes a 47,000-ft2 good manufacturing practice (GMP) cell therapy production facility.

Through this new division, Pluri will offer services relating to early preclinical development through late-stage clinical trials and commercialization. The company has expanded its experience over the past two decades to include process and analytical development, process scale-up, validation, logistics, automation, and regulatory approved comparability studies, according to a company press release.

The company operates a proprietary, patented bioreactor system that enables 3D cell expansion, allowing it to produce high-quality cells in mass quantities via an automated, fully controlled, and validated process. In addition, the company’s PluriMatrix technology enables industrial-scale production of cell-based products.

Pluri’s technology supports large-scale growth of cells and provides batch-to-batch consistency. It is also scalable, cost-effective, GMP-compliant, and has been used to support late-stage clinical trials in key jurisdictions, including FDA, the European Medicines Agency, Israeli’s Ministry of Health, Japan’s Pharmaceuticals and Medical Devices Agency, and the Ministry of Food and Drug Safety of the Republic of Korea, the company stated in its press release.

“Opening the CDMO division is a strategic move that we expect will boost revenues and cash flow utilizing our … technology and manufacturing facility,” said Yaky Yanay, Pluri’s CEO and president, in the press release. “PluriCDMO’s vision is to provide our clients with … access to valuable knowledge in cell therapy development that has been generated over the [past] two decades. PluriCDMO … can accelerate the development efforts of our partners and provide better control of the risks.”

“Pluri has an established track record of development and manufacturing in this arena and has solved many of the challenges that confront innovative companies in the cell therapy market,” said Andy Lewin, who was appointed as chief commercial officer at Pluri to lead the CDMO division, in the press release. “The [c]ompany has developed innovative production technologies, which allow it to offer large scale (and further scalable) production of cell-based products in GMP grade. Pluri’s technology, long-standing collaborations, and extensive experience enable the manufacturing of a wide range of products, including [m]esenchymal

[s]tem [c]ells (MSCs), [i]nduced [p]luripotent [s]tem Cells (iPSCs), [e]xtracellular [v]esicles (EVs) and gene-modified cells, including CAR-T [chimeric antigen receptor T] cells.”

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Pluri has launched PluriCDMO, a new contract development and manufacturing organization business that will offer cell therapy manufacturing services.

Pluri Launches New Cell Therapy CDMO Division

On Jan. 9, 2024, GSK and Aiolos Bio, a clinical-stage biopharmaceutical company specializing in the treatment of respiratory and inflammatory conditions, announced that they have entered into an agreement for GSK to acquire Aiolos for $1 billion upfront and up to $400 million in certain success-based regulatory milestone payments.

Through the acquisition, GSK will gain access to Aiolos’ AIO-001, a long-acting anti-thymic stromal lymphopoietin (TSLP) monoclonal antibody (mAb) that is ready to enter Phase II clinical development. The mAb is being evaluated for the treatment of adult patients with asthma. Other potential indications include chronic rhinosinusitis with nasal polyps. Aiolos has an exclusive license to AIO-001 outside of Greater China, which was granted by Jiangsu Hengrui Pharmaceuticals (Hengrui).

By targeting the TSLP pathway, one can address a key driver of the inflammatory response in major allergic and inflammatory diseases, according to GSK in a company press release. GSK also confirmed in the release that “TSLP is a clinically validated target in the treatment of asthma regardless of biomarker status.”

AIO-001 has shown initial safety, tolerability, pharmacokinetics, and biological activity in healthy volunteers and asthma patients in early studies. The mAb also has the potential to be administered every six months because of its enhanced potency and half-life extension technology.

“Adding AIO-001, a potentially best-in-class medicine targeting the TSLP pathway, could expand the reach of our current respiratory biologics portfolio, including to the 40% of severe asthma patients with low T2 [type 2] inflammation where treatment options are still needed,” said Tony Wood, chief scientific officer, GSK, in the press release.

“We believe that this transaction speaks to the high potential of our long-acting anti-TSLP monoclonal antibody, AIO-001. By uniting with GSK … we’re confident that we can rapidly advance this therapy in the hopes of significantly reducing the treatment burden for patients,” said Khurem Farooq, CEO, Aiolos Bio, in the release.

In a deal worth up to $1.4 billion, GSK aims to acquire Aiolos Bio and gain an expanded pipeline of biologic-based respiratory therapeutic candidates. 

GSK to Acquire Aiolos Bio, Expands Respiratory Portfolio

MediWound, an Israel-based biopharmaceutical company focused on next-generation enzymatic therapeutics for tissue repair, announced on Dec. 28, 2023 that the US Department of Defense, through the Medical Technology Enterprise Consortium, a biomedical technology consortium focused on developing medical solutions for US military personnel, has awarded MediWound an additional $6.7 million to develop NexoBrid as a non-surgical solution for field-care burn treatment for the US Army.

The additional funding brings MediWound’s R&D budget up to $14.4 million, which the company will use to advance the development and production of a new, temperature-stable formulation of NexoBrid. Doing so will position NexoBrid as the first-line non-surgical solution for treating severe burn injuries in pre-hospital settings, according to a company press release.

NexoBrid is a bromelain-based biological product containing a sterile mix of proteolytic enzymes that selectively removes eschar in patients with deep partial and full-thickness thermal burns (1,2). It is administered topically. The product is currently approved in the United States, European Union, and other international markets (1).

Under an agreement worth potentially $150 million, Vericel, a US-based company specializing in sports medicine and severe burn care, holds an exclusive license for the commercial and development rights to NexoBrid in North America. MediWound retains commercial rights in all non-North American territories (2).

"We are delighted to further solidify our partnership with the US Department of Defense. The additional funding will enhance our CMC [chemistry, manufacturing, and controls] activities, expedite preclinical development, and facilitate the establishment of a GMP [good manufacturing practice]-compliant aseptic production line for the temperature-stable formulation of NexoBrid," said Ofer Gonen, CEO, MediWound, in the press release. "This new award underscores our shared commitment to ensuring NexoBrid's availability for military use and its potential to significantly change the early treatment approach for severe burns."

1. MediWound. Next Generation Enzymatic Therapeutics Focused on Non-Surgical Tissue Repair. 

 (accessed Jan. 5, 2024).
2. MediWound. MediWound Enters into Exclusive License Agreement with Vericel for Commercial Rights to NexoBrid in North America. Press Release, May 7, 2019.

MediWound has been granted an additional $6.7 million by the DoD to advance NexoBrid as a non-surgical field care solution for the US military.

DoD Grants Additional Funds to MediWound for Advancement of Non-Surgical Treatment for Field Care Burns

On Jan. 3, 2024, Boehringer Ingelheim announced that it has entered into a multi-target collaboration with Suzhou Ribo Life Science and Ribocure Pharmaceuticals (Ribo) under which they will develop new RNA-based treatments for nonalcoholic or metabolic dysfunction-associated steatohepatitis (NASH/MASH). The partnership combines Ribo’s experience in the discovery and clinical development of small interfering RNA (siRNA) therapeutics and Boehringer Ingelheim’s expertise in the cardiovascular, renal, and metabolic diseases (CRM) market.

Under the agreement, Ribo will receive an upfront payment and is entitled to receive success-based milestones for clinical, regulatory, and commercial success as well as tiered royalties. The overall deal is estimated to exceed $2 billion.

Ribo’s RIBO-GalSTAR technology platform enables development of RNA interference therapeutics that target disease-causing genes specifically in hepatocytes. The technology does this by silencing the genes’ messenger RNAs (mRNAs). This approach has the potential to treat diseases by addressing previously inaccessible drug targets, according to a company press release.

“We look forward to working with the scientists from Ribo to develop new breakthrough medicines for patients with NASH,” said Søren Tullin, senior vice-president and global head of Cardiometabolic Diseases Research, Boehringer Ingelheim, in the press release. “This new partnership is part of our commitment to collaborate with peers worldwide to address the interconnected nature of CRM diseases. Our goal is to develop the next wave of innovative medicines that will lead to a holistic health gain for patients.”

“This collaboration represents a strong endorsement of the many years of investment and scientific discovery built into Ribo’s platform. We are very pleased about the opportunity to work with Boehringer Ingelheim to develop new solutions for people living with NASH,” said Zicai Liang, CEO, Ribo Life Sciences, in the release.

Under the collaboration, Boehringer Ingelheim and Ribo will develop RNA-based therapeutics to treat NASH/MASH.

Boehringer Ingelheim and Ribo Partner on RNA-based Liver Disease Therapeutics

Roche announced on Dec. 29, 2023 that it has signed a definitive agreement to acquire select parts of the LumiraDx group related to that company’s point-of-care technology. The transaction is expected to close by mid-2024. Roche will pay $295 million at closing (subject to customary closing adjustments) and an additional $55 million for the reimbursement of amounts to fund the point-of-care technology platform business until the close of transaction. Upon closing, the acquired entities will be fully integrated into Roche Diagnostics.

LumiraDx’s technology integrates multiple point-of-care tests on a single, user-friendly instrument. This integration offers more affordable and accessible access to testing for patients globally, according to a company press release.

The technology platform offers a range of immunoassay and clinical chemistry tests, with potential for additional high medical value tests in the future. These tests can be stored at room temperature, enabling convenient handling in a range of decentralized healthcare settings, according to the press release.

“The addition of the LumiraDx technology to our diagnostics portfolio will enable us to transform testing at the point of care,” said Matt Sause, CEO, Roche Diagnostics in the press release. “LumiraDx has developed a highly versatile platform that delivers strong performance across multiple disease areas and technologies. We believe this will enable better patient access to timely results in decentralized healthcare settings worldwide.”

“Since our founding, we have sought to transform community-based healthcare by consolidating multiple [point-of-care] tests on a single instrument. We are thrilled that Roche will continue this important work and increase its reach around the globe. This will enable more patients to get fast and easy access to better diagnostic testing,” said Veronique Ameye, CEO, LumiraDx, in the release.

Roche will acquire select parts of the LumiraDx group related to that company’s point-of-care technology, which integrates multiple tests on a single instrument. 

Roche to Acquire Point-of-Care Technology from LumiraDx in $350 Million Deal

AstraZeneca is poised to acquire Gracell Biotechnologies, a clinical-stage biopharmaceutical company specializing in cell therapies for cancer and autoimmune diseases, in a deal valued at approximately $1.2 billion, according to AstraZeneca’s announcement in a Dec. 26, 2023 press release. The transaction is expected to close in the 2024 first quarter. Upon closing, Gracell will operate as a wholly owned subsidiary of AstraZeneca, with operations in China and the United States.

Under the agreement, AstraZeneca will acquire all of Gracell’s fully diluted share capital through a merger; the transaction will proceed at a price of $2.00 per ordinary share in cash at closing plus a non-tradable contingent value right of $0.30 per ordinary share in cash, which is payable upon achievement of a specified regulatory milestone.

The upfront cash portion represents a transaction value of approximately $1 billion, and, combined with the potential contingent value payments, if achieved, the overall transaction value would potentially total approximately $1.2 billion. As part of the transaction, AstraZeneca will also acquire the cash, cash equivalents, and short-term investments on Gracell’s balance sheet, a total of $234.1 million as of Sept. 30, 2023, according to the press release.

AstraZeneca expects the proposed acquisition to enrich its growing pipeline of cell therapies, particularly with the addition of GC012F, Gracell’s novel, clinical-stage B cell maturation antigen (BCMA) and CD19 dual-targeting autologous chimeric antigen receptor T-cell (CAR-T) therapy. Gracell is developing GC012F as a potential new treatment for multiple myeloma as well as other hematologic malignancies and autoimmune diseases, including systemic lupus erythematosus (SLE). Gracell has initiated a Phase Ib/II trial evaluating GC012F for treating relapsed or refractory multiple myeloma in the US.

In addition to the cell therapy candidate, AstraZeneca will also gain Gracell’s proprietary cell therapy manufacturing platform, FasTCAR. The technology was introduced in 2017 and allows for the next-day manufacturing of CAR-T therapies (1).

“The proposed acquisition of Gracell will complement AstraZeneca’s existing capabilities and previous investments in cell therapy, where we have established our presence in CAR-T and T-cell receptor therapies (TCR-Ts) in solid tumors. GC012F will accelerate our cell therapy strategy in hematology, with the opportunity to bring a potential best-in-class treatment to patients living with blood cancers using a differentiated manufacturing process, as well as exploring the potential for cell therapy to reset the immune response in autoimmune diseases,” said Susan Galbraith, executive vice-president, Oncology R&D, AstraZeneca, in the press release.

“We look forward to working with AstraZeneca to accelerate our shared goal of bringing transformative cell therapies to more patients living with debilitating diseases. By combining our expertise and resources, we can unlock new ways to harness the Gracell FasTCAR manufacturing platform, which we believe has the potential to optimize the therapeutic profile of engineered T cells, to pioneer the next generation of autologous cell therapies,” said William Cao, founder, chairman, and CEO, Gracell, in the release.

1. Gracell Biotechnologies, Gracell Biotechnologies Presents Longer-Term Results for FasTCAR-T GC012F in B-Cell Non-Hodgkin’s Lymphoma at EHA2023, Highlighting 100% Overall Response Rate. Press Release, June 10, 2023.

AstraZeneca’s acquisition of Gracell includes a clinical-stage autologous cell therapy targeting hematologic malignancies and autoimmune diseases and a proprietary manufacturing platform.