Feliza Mirasol is the science editor for 

Feliza Mirasol

On Oct. 11, 2023, Cellares, an integrated development and manufacturing organization (IDMO) specializing in cell therapy manufacturing, announced it has expanded its agreement with Bristol Myers Squibb (BMS) to include a second chimeric antigen receptor T-cell (CAR-T) program as part of the Cellares Technology Adoption Partnership (TAP) program.

Under the expanded agreement, Bristol Myers Squibb will begin a second proof-of-concept tech transfer process for the manufacture of its CAR-T cell therapy, and Cellares will optimize, automate, and tech-transfer the additional CAR-T cell therapy process onto its automated manufacturing platform (Cell Shuttle).

Cellares’ manufacturing technology supports both autologous and allogeneic cell therapy processes and approximately 90% of cell therapy modalities, according to a company press release. Meanwhile, the company’s TAP program is a fast and low-risk means by which cell therapy developers can adopt Cellares’ automated manufacturing technology for products in their pipeline.

With the TAP program, manual processes can be automated and tech-transferred onto Cellares’ Cell Shuttle platform in six months, and the transfer can happen at any stage of the therapy’s development—whether it is in pre-clinical development, clinical development, or after regulatory approval.

initial partnership between Bristol Myers Squibb and Cellares

 began in August 2023, which is also when Cellares 

launched its commercial-scale IDMO smart factory in Bridgewater, NJ

 factory was built to integrate advanced robotics, purpose-built technology, and interconnected software and will be capable of producing 40,000 cell therapy batches per year.

“We’re excited to expand our relationship with Bristol Myers Squibb even further beyond the Series C investment and the first TAP program for cell therapies,” said Cellares CEO Fabian Gerlinghaus, in the press release. “The optimization and automation of this additional CAR-T cell therapy process through our TAP program expands on our first partnership with BMS and helps our mission to accelerate access to life-saving cell therapies for patients.”

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Under an expanded agreement, Cellares will provide proof-of-concept manufacturing for a second CAR-T cell therapy from Bristol Myers Squibb.

Cellares Expands Agreement with Bristol Myers Squibb for Second CAR-T Program 

Sweden-based Salipro Biotech and Estonia-based Icosagen, a contract research, development, and manufacturing organization, announced on Oct. 10, 2023 that they have entered into a multi-target antibody research agreement to advance drug discovery programs. The companies intend to discover and characterize monoclonal antibodies (mAbs) against several challenging membrane proteins, including G protein-coupled receptors (GPCRs) and solute carrier (SLC) transporters.

Under the agreement, Icosagen will leverage its expertise in protein production and analytics. The company’s knowledge in antibody discovery encompasses high-throughput antibody screening and a variety of lead optimization techniques that the company expects will support the collaboration and form a solid basis for future biologic drug development, according to a company press release.

The partnership between the companies aims to build on Salipro's strength in establishing multiple collaboration and licensing agreements with leading pharma and biotech companies that enable drug discovery against complex membrane protein targets. The company’s experience includes small-molecule drug discovery programs as well as structural biology and antibody discovery.

“Our Salipro technology provides an enabling platform for the discovery of therapeutics against challenging drug targets. We are excited to unlock the potential of these targets with Icosagen and develop novel drugs that can improve patient outcomes," said Jens Frauenfeld, CEO of Salipro Biotech, in the press release.

"We are delighted to apply our QMCF technology and protein analytics capabilities in this project. Both teams in Icosagen and Salipro Biotech are always finding ways to push the boundaries in novel technologies of biologics development. It will be interesting to see what we’ll be able to achieve as we put our heads together for this project,” said Mart Ustav Jr., chief scientific officer, Icosagen, in the release.

Salipro Biotech and Icosagen have entered into a multi-target collaboration to discover and characterize monoclonal antibodies.

Salipro Biotech and Icosagen to Collaborate on Antibody Discovery

BIOVECTRA and Acuitas Therapeutics have entered into a technology transfer service agreement, through which Acuitas’ lipid nanoparticle (LNP) technology platform for manufacturing messenger RNA (mRNA)-based therapeutics will be transferred to BIOVECTRA’s new biomanufacturing center currently being built at its Charlottetown, Prince Edward Island site in Canada.

Under the agreement, BIOVECTRA will formulate Acuitas’ LNP for licensed therapeutic partners for clinical and commercial products using a variety of payloads. Acuitas’ LNP technology is currently used in multiple vaccines and therapeutics in clinical development. The technology is also used in the Pfizer-BioNTech COVID-19 vaccine, COMIRNATY, according to an Oct. 5, 2023 company press release.

The tech transfer will occur in BIOVECTRA’s biomanufacturing center in Charlottetown, which is expected to be completed in late 2023. Upon completion, the facility will support the good manufacturing practice manufacturing of plasmid DNA, mRNA, and LNP formulations. The 36,000 additional ft2 will be able to produce the equivalent of 160 million doses of mRNA vaccines and will have the capability to fill/finish 70 million final vaccine doses per year for commercial distribution, according to the press release.

“We are thrilled about this partnership with Acuitas Therapeutics … ,” said Marc Sauer, chief science officer, BIOVECTRA, in the press release. “Our work together will provide their licensed partners with faster market access to CGMP [current good manufacturing practice]-quality LNPs for early and late-stage products. BIOVECTRA looks forward to continuing to make a difference in patients’ lives by supporting GMP and commercial-ready LNP formulation at our new mRNA biomanufacturing facility in Atlantic Canada.”

“LNP-based mRNA medicines provide the opportunity to address an incredibly wide range of health conditions, from infectious diseases such as COVID-19, flu, and malaria to therapeutic areas related to heart disease, or cancer, as well as many rare diseases,” said Chris Barbosa, vice-president, Technology Development, Acuitas Therapeutics, in the release. “As we move forward in the development process in all of these areas with our partners, the demand for Acuitas’ clinical-grade LNP for our partners increases exponentially. We look forward to working with the BIOVECTRA team to expand the CGMP manufacturing capacity for Acuitas’ LNP so that we can continue to meet the growing needs of our global partners.”

Under this agreement, Acuitas Therapeutics’ LNP technology platform will be transferred to BIOVECTRA for use in manufacturing mRNA-based therapies.

BIOVECTRA in Tech Transfer Agreement with Acuitas Therapeutics for LNP Delivery System

Roche has entered into an agreement with Ionis Pharmaceuticals for two undisclosed early stage programs for RNA-targeting investigational therapeutics for treating Alzheimer's disease (AD) and Huntington's disease (HD). According to a Sept. 27, 2023 company press release, Roche gains exclusive worldwide rights and will be responsible for clinical development, manufacturing, and commercialization of the candidates worldwide, the latter of which is dependent upon regulatory approval.

Under the agreement, Ionis' expertise in discovering medicines that target the root cause of central nervous system diseases will work in tandem with Roche's global experience developing and commercializing therapies for nervous system disorders. Ionis will receive a $60 million upfront payment and will be eligible for development, regulatory, and commercial milestone payments as well as tiered royalties. Ionis will be responsible for advancing the two programs through pre-clinical studies, after which Roche will take over. Roche will have sole responsibility for clinical development and, if approved, commercialization worldwide.

This agreement builds upon a 10-year-long partnership between the companies, which started in 2013. In 2018, the companies entered another collaboration to develop an Ionis therapeutic candidate for immunoglobulin A nephropathy and geographic atrophy treatment.

"We are excited to expand our partnership with Roche … ," said Brett P. Monia, CEO, Ionis, in the company press release. "With this new collaboration, we are joining forces to accelerate the discovery and development of novel therapies for people living with Alzheimer's disease and Huntington's disease globally. Collaborating on these two programs enables Ionis to advance our wholly owned programs, including those in neurology, aligned with our strategic priorities."

"Our lasting partnership with Ionis … is a great example of two collaborators mutually benefiting from their relationship by complementing and learning from each other," said James Sabry, global head of Roche Pharma partnering, in the press release. "By expanding our alliance, we bring together the companies' combined knowledge of the science in Alzheimer's disease and Huntington's disease with Roche's proven capabilities in the development and commercialization of innovative treatments in neuroscience."

Roche will gain exclusive worldwide rights to develop, manufacture, and commercialize Ionis’ investigational RNA-based therapeutic candidates for Alzheimer's and Huntington's disease.

Roche to Develop Two Novel RNA-targeted Programs from Ionis for CNS Diseases

Eli Lilly and Company (Lilly) announced on Oct. 2, 2023 that it received a complete response letter (CRL) from FDA for the biologics license application (BLA) for lebrikizumab, a candidate for treating moderate-to-severe atopic dermatitis (eczema).

The letter cited findings that arose during the multi-sponsor inspection of a third-party, contract manufacturing organization that included a monoclonal antibody drug substance used in lebrikizumab. However, the CRL stated no concerns about the clinical data package, safety, or label for lebrikizumab. No other marketed or pipeline Lilly products are affected, according to a company press release.

Lilly has submitted data from three studies (ADvocate 1, ADvocate 2, and Adhere), which included more than 1000 adults and adolescents, from ages 12 to older, who have moderate-to-severe eczema and who were unable to control symptoms with topical medicines or other systemic treatments.

"We are confident in lebrikizumab's potential to help people living with eczema and in the clinical data that supports our submission package for the medicine," said Patrik Jonsson, Lilly executive vice-president, president of Lilly Immunology and Lilly USA, and chief customer officer, in the press release. "We will continue to work closely with the third-party manufacturer and [FDA] to address the feedback in order to make lebrikizumab available to patients."

News of the CRL occurred within the same week that Lilly announced 

a major $1.4-billion acquisition of radiopharmaceutical company, POINT Biopharma Global

. This acquisition will boost Lilly’s oncology pipeline with both clinical and preclinical-stage radioligand therapies under development for treating cancers.

Eli Lilly and Company has received a complete response letter from FDA for its anti-dermatitis biologic therapeutic, lebrikizumab.

Lilly Receives Complete Response Letter from FDA for Lebrikizimab

Science laboratory test tubes, laboratory equipment | Image Credit: © BillionPhotos.com - © BillionPhotos.com - stock.adobe.com

Ginkgo Bioworks announced a collaboration on Sept. 27, 2023 with Pfizer under which Pfizer will use Ginkgo's proprietary RNA technology to advance the discovery and development of novel RNA molecules across priority research areas.

Pfizer will pay Ginkgo an upfront payment. Ginkgo is eligible to receive research fees and development and commercial milestone payments. All told, the company may receive up to an aggregate total of $331 million across three programs. In addition, Ginkgo is entitled to potential royalties on sales further downstream.

Ginkgo's RNA technology combines high-throughput screening that evaluates the behavior of RNA constructs with a multi-parameter design framework. The technology allows the company to identify novel natural and synthetic elements that are optimal for a particular application. Ginkgo will apply its technology to achieve efficient production, circularization, improved stability, and enhanced translation of each RNA construct.

"RNA therapeutics are proving to be an important platform to advance the world of scientific innovation, and with progress in synthetic biology we have the potential to create new RNA treatments that may benefit patients worldwide," said Will Somers, head, Biomedicine Design, Pfizer, in a company press release. "Access to Ginkgo's proprietary platform will help enable Pfizer to search for novel and exciting RNA constructs with improved stability and expression that could lead to more effective treatments."

"Billions of patients around the world have already benefited from advances in RNA-based technologies. We're thrilled to be able to help enable the discovery and development of novel drugs using this powerful modality by applying our platform technologies, which are designed to program RNA for maximum therapeutic effect," said Jason Kelly, CEO and co-founder, Ginkgo Bioworks, in the release. "Ginkgo's approach enables and accelerates discovery across different disease areas and modalities for our partners, who bring deep expertise in drug development."

Pfizer has entered into a collaboration with Ginkgo Bioworks to discover novel RNA molecules across priority research areas.