Pharmaceutical Technology Editors

BioNTech and Kite, a Gilead company, announced on July 19, 2021 that they have entered into a purchase agreement for BioNTech to acquire Kite’s solid tumor neoantigen T-cell receptor (TCR) R&D platform and clinical manufacturing facility in Gaithersburg, Md. The transaction is expected to close by end of July 2021.

The Gaithersburg facility will provide production capacity to support clinical trials in the United States and will complement BioNTech’s existing cell therapy manufacturing facility in Idar-Oberstein, Germany. The facility will also support the development of BioNTech’s growing pipeline of novel cell therapies, including cancer product candidates based on its chimeric antigen T cell (CAR-T) amplifying messenger RNA (mRNA) vaccine (CARVac) and NEOSTIM platforms as well as the newly acquired individualized neoantigen TCR program.

Under the transaction, Kite will receive a one-time upfront payment from BioNTech. Financial terms were not disclosed. All Kite employees at the Gaithersburg facility will be offered employment with BioNTech prior to the date of closing. BioNTech also plans to further invest in the site to support its growing cell therapy pipeline, including hiring additional personnel. Kite’s new manufacturing facility in Frederick, Md., for commercial production of CAR-T cell therapy is not part of the acquisition.

“The development of individualized cancer therapies is at the core of our work at BioNTech. The acquisition of the Kite facility and its individualized TCR platform allows us to accelerate the clinical development of our cell therapies in the US and advance at the forefront of individualized cell therapies,” said Ugur Sahin, MD, CEO and co-founder of BioNTech, in a company press release. “It also strengthens our presence in the US, building on our successful integration of adoptive T-cell and neoantigen TCR therapies as part of our acquisition of Neon Therapeutics last year.”

“In order to serve more patients that need cell therapy today, Kite is rapidly growing both through global expansion and seeking new indications for our existing approved CAR-T cell therapies. This transaction will enable us to focus our energies and investment on accelerating the reach of our current CAR-T cell therapies and midterm pipeline,” said Christi Shaw, CEO of Kite, in the press release. “As a company solely focused on cell therapy for over a decade, our approach to solid tumors and allogeneic cell therapy will progress through a combination of both internal research and external partnerships.”

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BioNTech will acquire a TCR cell therapy R&D platform as well as a manufacturing facility in Gaithersburg, Md., from Kite, a Gilead company. 

BioNTech to Acquire Kite’s TCR Cell Therapy Platform and Manufacturing Facility

Nkarta, a clinical-stage biotechnology company focused on allogeneic, off-the-shelf natural killer (NK) cell therapies, announced on July 14, 2021, that it has signed a lease agreement for a facility to support research and development and future commercial manufacturing of its cell therapy pipeline at its South San Francisco, Calif., site. The new facility will also serve as the company’s headquarters.

The manufacturing facility will be custom designed to complement the company’s technology platform and optimize production of multiple off-the-shelf NK cell therapy investigational products. Nkarta plans to produce materials for potential pivotal clinical trials and commercial launch at the new 88,000-ft2 scalable facility. Further planned production expansion will build on Nkarta’s foundational manufacturing, operational, and process development expertise.

Earlier this year, Nkarta completed the construction and qualification of a 2700-ft2 current good manufacturing practice facility in South San Francisco for clinical manufacturing. The company is currently manufacturing clinical supply for its planned Phase I study for its candidate, NKX019, which is expected to start in the second half of 2021. The company also plans to transfer the production of NKX101 and other proprietary platform materials to the clinical manufacturing facility in the future.

The new facility, meanwhile, will be built-out as a multi-product facility and is expected to be operational by the end of 2023. At full capacity, this manufacturing center is expected to have the flexibility to produce commercial supply of multiple cell therapy products.

“Our goal is to ensure that cost-effective, commercial-scale production of cell therapies can be made available widely and rapidly to the cancer patients who need them, and we expect this new facility will enable us to do just that,” said Paul J. Hastings, president and CEO of Nkarta, in a company press release. “As we advance our NKX101 and NKX019 clinical programs and enhance our proprietary platform with exciting new capabilities like CRISPR [clustered regularly interspaced short palindromic repeats] Cas9 genome engineering, we believe our expanded footprint will drive continued operational excellence and accelerate the development of transformative NK cell therapies for a broad range of cancers.”

Nkarta will establish a new combined scalable NK cell therapy manufacturing facility and corporate headquarters in South San Francisco, Calif.

Nkarta Establishes New NK Cell Therapy Manufacturing Facility and Headquarters

Cellares, a life sciences technology company specializing in developing automated cell therapy manufacturing, announced on July 14, 2021 that Poseida Therapeutics, a clinical-stage biopharmaceutical company specializing in proprietary genetic engineering platform technologies to create cell and gene therapies, has joined Cellares’ Early Access Partnership Program (EAPP).

The addition of Poseida marks the third organization to participate in the EAPP, following industry partner PACT Pharma and academic partner Fred Hutchinson Cancer Research Center. Cellares initiated the EAPP in 2020 to provide participants with visibility and early access to its next generation cell therapy manufacturing platform, Cell Shuttle, meant to enable closed, automated, and scalable production of cell therapies.

Poseida’s participation is expected to help advance the manufacturing platform’s development, range of use, and applicability through insight and experience with respect to manufacturing workflows for a variety of autologous and allogeneic cell therapies. Poseida will evaluate the Cell Shuttle prototypes and provide data and written feedback relevant to its function and performance. This evaluation will include user studies that assess the Cell Shuttle’s hardware and software, product requirements, release criteria, and process workflows to help ensure product–market fit.

Poseida currently has two autologous chimeric antigen T cell (CAR-T) product candidates in clinical development, including P-BCMA-101, for patients with relapsed/refractory multiple myeloma, and P-PSMA-101, for patients with metastatic castrate-resistant prostate cancer. The company also has off-the-shelf versions of both therapies in development and is exploring T-cell receptor T cell (TCR-T), anti-c-kit CAR-T, induced pluripotent stem cells (iPSCs), and genetically modified hematopoietic stem cells (HSCs) and natural killer (NK) cells.

“We’re thrilled to have Poseida Therapeutics on board to help broaden the possibilities for our Cell Shuttle platform,” said Cellares co-founder and CEO Fabian Gerlinghaus in a company press release. “Poseida’s tremendous expertise in the cell therapy space, especially spanning a diverse range of therapeutic modalities, is a huge boon to our developmental efforts. We anticipate our work with Poseida to demonstrate the Cell Shuttle’s adaptability for multiple cell therapy modalities, particularly CAR-T cells.”

“The flexibility of the Cell Shuttle matches the breadth of approaches we are developing at Poseida,” said Kerry Ingalls, chief operating officer at Poseida, in the press release. “To work across our cell therapy portfolio, an automated manufacturing system should be capable of reliably producing a range of therapies autologous and allogeneic CAR-T and in both solid and hematological cancers, for research and at scale for clinical trials and, ultimately, commercial applications. By joining forces with Cellares, we believe we can leverage the Cell Shuttle’s capabilities to help support our overall manufacturing strategy, further advancing cell therapy manufacturing.”

Cellares has entered into a strategic relationship with Poseida Therapeutics to advance a closed, automated, and scalable cell therapy manufacturing system.

Cellares and Poseida Therapeutics Partner to Accelerate Cell Therapy Manufacturing

Pall has entered into a contract worth more than $7 million with Exothera, a contract development and manufacturing organization, which will enable suspension-based manufacturing of viral vectors for gene therapies and vaccines. Under the agreement, Pall will establish a suspension-based manufacturing platform of up to 2000 L. The company will use a range of technologies, including Allegro STR single-use bioreactors, Pall announced in a July 1, 2021, press release.

Exothera has recently expanded its manufacturing capabilities with the addition of two new state-of-the-art good manufacturing practice (GMP) facilities that were built at the company’s Jumet site near Brussels, Belgium. The new facilities, which are roughly 92,000 ft2, include a variety of functions, from research and development to commercial production. The facilities begin GMP production this summer.

“There is a strong pipeline of viral vector-based gene therapies and vaccines, and the importance of rapidly realizing industrial-scale production for these vaccines and therapies has been brought into sharp focus by COVID-19. Pall has considerable process development expertise from working with many of the industry leaders to develop scalable upstream and downstream processes. We’re thrilled to bring this experience to support Exothera as they expand their manufacturing capabilities,” said Clive Glover, general manager, Gene Therapy, Pall, in the press release:

“Compared to other suspension solutions, Pall’s STR bioreactors are well-suited and could be adapted, if needed, to the perfusion mode, allowing higher growth and density of cells. We are pleased to establish this partnership with a very supportive company that is willing to transfer its expertise,” said Christian Borgniet, chief operating officer, Exothera, in the press release.

Pall has secured a manufacturing contract with Exothera for the suspension-based manufacture of gene therapies and viral vector-based vaccines.

Pall Enters Multi-Million Dollar Contract with Exothera for Viral Vector Manufacturing

According to a July 19, 2021 press release, AstraZeneca’s Imfinzi (durvalumab) has been approved by China’s National Medical Products Administration for the first-line treatment of adult patients in China with extensive-stage small cell lung cancer (ES-SCLC) in combination with standard of care platinum chemotherapy (etoposide plus a choice of either carboplatin or cisplatin).

SCLC is a type of lung cancer that is aggressive and fast-growing. Typically, it recurs and progresses rapidly despite any initial response to chemotherapy. Approximately, seven percent of all SCLC patients and three percent of those with ES-SCLC will survive five years after diagnosis.

The CASPIAN Phase III trial found that Imfinzi plus chemotherapy demonstrated a statistically significant and clinically meaningful improvement in overall survival (OS) as compared to chemotherapy alone. In June 2019, the CASPIAN Phase III trial met the primary endpoint of OS for Imfinzi plus chemotherapy. The risk of death was reduced by 27% versus chemotherapy alone, with a median OS of 13.0 months versus 10.3 months for chemotherapy alone. These results were published in 

 in October 2019. In addition, results from the China cohort of patients were consistent with the global results.

In the trial, a fixed dose of Imfinzi (1500 mg) was administered every three weeks for four cycles in combination with chemotherapy and then every four weeks as a monotherapy until disease progression. Based on the results, Imfinzi, in combination with etoposide and either carboplatin or cisplatin, has been approved in the first-line setting of ES-SCLC in more than 55 countries, including the US, Japan, and across the EU.

In combination with etoposide and either carboplatin or cisplatin, Imfinzi has been approved in the first-line setting of ES-SCLC by China’s National Medical Products Administration.

AstraZeneca’s Extensive-Stage Small Cell Lung Cancer Treatment Approved in China

In a distribution agreement announced on July 19, 2021, Lonza will supply a selection of hepatic cells to be prequalified by CN Bio and used in their PhysioMimix organ-on-a-chip (OOC) range of single- and multi-organ microphysiological systems, which aims to change how human-relevant preclinical data is generated. The companies’ shared goal is to develop and supply advanced cell models that better reflect an 

 environment to improve drug discovery accuracy and efficiency. Customers can avoid having to trial numerous cell types with prequalified cells. Having high-quality cells that are known to grow successfully in 3D culture will also help fast-track OOC adoption and customer research.

 models drives down attrition rates and boosts the efficiency and success of drug discovery programs. Standard 2D cell culture fails to accurately reflect the complex interactions in the body, and animal models are slow, expensive, and can have different reactions than humans. Models, such as OOC, offer another option in research.

“We’re delighted to be working with Lonza, a world-leading cell supplier, to ensure that the prevalidated cells we supply for use with our PhysioMimix single-and multi-organ MPS are of reliably high quality and are well-suited to culture in 3D,” said Tomasz Kostrzewski, director of biology at CN Bio. “Using prequalified cells will save our customers valuable time and resource, further helping to accelerate their drug development journey.”

The companies work to develop and supply advanced cell models that better reflect an in-vivo environment to improve drug discovery accuracy and efficiency.