Policy & Regulation
ImmunityBio Expands Manufacturing Capacity with Manufacturing Plant in New York for Global Pandemic Response and Preparedness
13 January 2022 - - California, US-based immunotherapy company ImmunityBio, Inc. (NASDAQ: IBRX) has entered into a definitive agreement to acquire a leasehold interest in 409,000 square feet of ISO Class 5 pharmaceutical manufacturing space in western New York, and certain related assets, from global pharmaceutical company Athenex, Inc. (NASDAQ: ATNX), the company said.

The agreement will provide ImmunityBio with a biotech production facility that will substantially expand and diversify ImmunityBio's existing manufacturing capacity in the US, South Africa, and Botswana through its strategic collaborators.

The full-scale manufacturing facility includes clean rooms for upstream and downstream manufacturing activities, as well as fill and finish and large-scale lyophilization capabilities.

ImmunityBio said it believes that the acquisition of the newly constructed facility, located in Dunkirk, New York (Chautauqua County), will fast track the company's timeline for building production capacity at a significant scale.

ImmunityBio plans to further invest in the plant by adding biological manufacturing equipment and transferring technology from California to this large-scale production plant, and anticipates it will begin producing COVID vaccine drug substance in 4Q22.

This is the latest expansion of ImmunityBio's GMP manufacturing capacity over the last five years, part of its overall growth plans in collaboration with its strategic partners designed to accelerate the company's ability to develop, prove, and bring to market its key products and therapies in competitive and regulated markets.

New York State has made significant investments in the 409,000 square foot biopharmaceutical manufacturing facility in Dunkirk.

The plant will enable ImmunityBio to fast track establishing operations and help to accelerate converting medical research into pharmaceutical products, creating sustainable manufacturing jobs in the region.

As part of purchasing the leasehold interest, ImmunityBio would assume the investment and employment commitments of Athenex pursuant to its agreements with the State.

In addition, ImmunityBio will provide contract manufacturing capacity at the Dunkirk Facility to Athenex (or one of its affiliates) for its 503B formulation program.

ImmunityBio looks forward to becoming part of the local community and providing high-quality jobs for workers in and around Dunkirk.

The Dunkirk Facility transaction is expected to close in the first quarter of 2022 and is subject to customary closing conditions, including obtaining consent of certain 3rd party organizations and a lender of Athenex.

ImmunityBio is a late-clinical-stage immunotherapy company developing next-generation therapies that drive immunogenic mechanisms for defeating cancers and infectious diseases.

The company's broad immunotherapy and cell therapy platforms, including Antibody cytokine fusion proteins, synthetic immunomodulators, vaccine technologies (hAd5 viral vector, mRNA, recombinant protein, and adjuvant), and genetically-modified, off-the-shelf natural killer cells (autologous and allogenic cytokine-enhanced memory NK cells), activate both the innate (natural killer cell and macrophage) and adaptive (T cell) immune systems to create long-term "immunological memory."

ImmunityBio's clinical pipeline consists of 21 clinical trials--13 of which are in Phase II or III development--across 12 indications in solid and liquid cancers (including bladder, pancreatic, and lung cancers) and infectious diseases (including SARS-CoV-2 and HIV).

Anktiva, ImmunityBio's lead cytokine infusion protein, is a novel interleukin-15 (IL-15) superagonist complex and has received Breakthrough Therapy and Fast Track Designations from the US Food and Drug Administration for BCG-unresponsive CIS non-muscle invasive bladder cancer (NMIBC).

The company has established GMP manufacturing capacity at scale with cutting-edge cell manufacturing expertise and ready-to-scale facilities, as well as extensive and seasoned R and D, clinical trial, and regulatory operations, and development teams.
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