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www.biopharminternational.com Next-Generation Biotherapeutics April 2025 BioPharm International ® 11 Oncology duced manufacturing timelines, I think, is going to really open up the abilit y to take this from the 30,000 patients that have already been treated with cell therapy to the hundreds and thousands of pa- tients and even millions of patients in the f uture, as these technologies continue to grow and scale," she says. Gene therapies Cell therapies are not the only emerging modality in oncolog y. The precise nature of gene therapies makes them effective for the treatment of cancer, says Andrew Moreo, head of Process Development and Pre-clinical Manufacturing at Andelyn Biosci- ences, with the ability to target specific cancers and specific types of cells. Gene therapy can also be used in combination with other cancer treatments such as chemotherapy. To accelerate the development and manufacture of gene t herapies for cancer, Moreo points to t he development of platforms that provide standard- ization and consistency from product to product. Andelyn's own curator platform has a modular de- sign that has optimization built into the platform to create a smoother, more f lexible, and faster process. " B e c au se not e ver y pr oduc t i s c reate d e qu a l , we not on ly have to be able to provide the consis- tency and efficiency of a platform, but at the same time, the f lexibilit y [of ] understanding [that] dif- ferent genes, approaches, vectors, serot y pes, and transgenes perform differently and have different dem a nd s ba sed on t he need s of t he i nd icat ion ," Moreo explains. Vec tor desig n i s a l so i mpor t a nt, accord i ng to Moreo. "T here's some speci f ic nua nces to vector design for oncolog y treatments that tend to apply, and these can be accelerated by the advent of AI [ar- tificial intelligence]-assisted design and AI perfor- mance modeling," Moreo says. "This kind of goes back to the manufacturing, because you can design a vector that has beautiful expression, beautiful po- tency, and performs exceptionally well in vivo, but is not manufacturable, and then you run into trouble. So, you're really trying to balance between the vec- tor's ability to execute the treatment in vivo and our ability to manufacture it." Another factor in accelerating gene therapies for cancer that Moreo points out is the evolving regula- tory landscape. Regulators' understanding of gene therapies has improved as more products enter the market, says Moreo, a l lowing for a more stream- lined approval process. "Recently, FDA had a platform designation [that] was really built around vaccines, but it can apply here, where we ca n leverage our plat for m i n t he manufacturing of A AVs [adeno-associated virus], to be able to make the registration of the IND [inves- tigational new drug application] and registrational processes as efficient and streamlined as possible, instead of having to go through multiple layers of phase and in registration," Moreo says. The manufacturing of gene therapies for cancer treatment has challenges that are unique, includ- ing vector design and serotype, Moreo stresses. "The target genes for cancer therapies can var y in size. In one example, miRNAs are very small sequences that are used in cancer therapies [that] tend to have a lot of packaging issues. These pose challenges in production, undersized vectors, oversized vectors, lots of secondary structure. These are all things in vector design that can cause trouble." Sca labi l it y of gene t herapies is a lso a factor i n manufacturing, especially with cancer treatments. "In some ca ses, you have a ver y la rge i nd icat ion that may require multiple large-scale suspension bioreac tor s a nd a ver y h ig h t h roug hput dow n- s t rea m pu r i f icat ion process w it h pool i ng s t rat- eg ies," Moreo e x pl a i n s. " T here a re a l so sm a l ler i nd ic at ion s , i n t he c a s e of a n aut ologou s ge ne therapy, for instance. In these scenarios, there are reduced scale needs. However, speed is of the ut- most importance. Here we are also able to leverage the f lexibilit y of our curator platform to be able to t ur n somet h i ng a round quick ly i n ad herent cel l culture processes." Recent developments in oncology The oncology field has seen a variety of new treat- ments in the past few months in the clinical phase as well as market authorization. In March 2025, Astra- Zeneca's durvalumab (Imfinzi), a mAb monotherapy, was approved for the treatment of limited-stage small cell lung cancer (LS-SCLC) in Europe for adults whose disease has not progressed following platinum-based chemoradiation therapy (3). Also in March, Shilpa Biologicals, a fully owned subsidiary of Shilpa Medicare Limited, signed a stra- tegic partnership agreement with Switzerland-based mAbTree Biologics to co-develop and commercialize mAbTree's novel biologic asset—a checkpoint inhib- itor for immuno-oncological applications (4). FDA approved Pfizer's brentuximab vedotin (AD- CETRIS) in combination with lenalidomide and a rit- uximab product in February 2024 for the treatment of adults w it h relapsed or ref ractor y large B-cel l lymphoma (R/R LBCL). An ADC, brentuximab ve- dotin has a CD30-directed mAb attached by a pro- tease-cleavable linker to monomethyl auristatin E (MMAE), a microtubule disrupting agent. Its linker system is designed to remain stable in the blood- stream but then releases MMAE when internalized by CD30-positive tumor cells (5).