Therapeutic Class

Regeneron to supply Elicio with Libtayo for combo cancer vaccine study

Regeneron has agreed to supply Elicio Therapeutics with the drug Libtayo for clinical trials of its candidate cancer vaccine, ELI-002. The trial will examine the products as a combination in patients with KRAS (Kirsten rat sarcoma virus)-driven tumors including stage III and IV non-small cell lung cancer, stage IV colorectal cancer and unresectable, locally advanced or oligometastatic pancreatic ductal adenocarcinoma. KRAS mutations are among the most prevalent human cancers, driving 32% of lung cancers, 40% of colorectal cancers and 85%…

High cost of complex biomanufacturing ‘a problem worth solving,’ says Waters

With the cost of manufacturing accounting for as much as 70% for cell and gene therapies, industry must look to bioprocessing efficiencies and collaboration, says Waters Corporation. Waters Corporation is an analytical instruments, software, and service company. At the firm’s 2022 investor day last week, CEO Udit Batra spoke about the difference between producing small molecules, where “you get approval to produce a product with specific chemical and physical properties,” and the present biomanufacturing landscape, where the approval is for…

BPI Europe: Questions surround mRNA’s life beyond COVID-19

Messenger RNA (mRNA) might not become as dominant a modality as its COVID-19 success suggested, according to a senior consultant at Merck KGaA. David Loong, senior consultant for novel modalities at Germany’s Merck, made the comments during a panel discussion at BPI Europe in Vienna, Austria this week. Unsurprisingly, the COVID-19 pandemic has “completely skewed” how mRNA could be applied, he said. With the likes of Moderna and BioNTech/Pfizer releasing successful and respective vaccines, the application of mRNA technology was…

Cell and gene therapy processing: Iteration or innovation?

Cell and gene therapies represent the “next evolutionary step” in bioprocessing incorporating disruptive technologies on a well-proven manufacturing base, agree panelists at BPI Europe. “Is is cell and gene therapy really the shiny, bright object on the field that breaks all the rules and disrupts everything? Or is it just an iteration of the same principles that we had before, with slightly different practices?” That was the question Nadine Ritter, president and analytical advisor at Global Biotech Experts posed to…

Avantor and Cytovance team to address $1.5bn plasmid DNA market

The advanced therapy pipeline is driving demand says Avantor, which has collaborated with Cytovance to offer an expanded plasmid DNA service.  “The demand for plasmid DNA, especially at cGMP-grade, supporting advanced therapeutic modalities is growing rapidly,” said Ger Brophy, EVP of Biopharma Production at Avantor.  He told BioProcess Insider it is being driven by the growing, early-stage pipeline of cell and gene therapies, DNA and RNA vaccines, and gene editing technologies. “We estimate that the total addressable market for plasmid DNA…

Standardized handling practices would help cell therapy sector, study

Cell therapy developers need uniform handling, storage, and usage methods say the authors of a new report examining how the market for centrally manufactured products is evolving.  The study – published in the Journal of Translational Medicine in April – looked at the role medical center processing labs play in cell therapy distribution and usage and concluded that such facilities will be a potential bottleneck unless handling processes become more uniform.  “Cell processing laboratories at many academic medical centers are…

CAR-T approvals marred by autologous manufacturing limitations, says Allogene

Autologous therapies have not kept up with demand says Allogene Therapeutics, which claims only off-the-shelf cell therapies can serve larger patient populations. While the approval of Novartis’ Kymriah (tisagenlecleucel) in 2017 marked a breakthrough for chimeric antigen receptor (CAR) T-cell therapies, the sector has been slow to blossom. However, the past year or so has seen some breakthroughs in the space: Approvals for Bristol-Myers Squibb’s Breyanzi (liso-cel) and Abecma (ide-cel), and J&J’s Carvykti (ciltacel). Meanwhile, last month Gilead’s Yescarta (axicabtagene…

Cytiva opening Swiss single-use cell processing site

With work beginning weeks before the global pandemic, the plant has opened on schedule, boosting Cytiva’s capacity for single-use products aimed at supporting cell and gene therapy makers. The 7,400 m2 facility in Grens, Switzerland is set to have its official opening at the end of the month, strengthening bioprocess vendor Cytiva’s capabilities in providing single use kits for cell processing systems and their relevant consumables. The plant is ready 28 months after Cytiva – then known as GE Life…

CureDuchenne talks solutions to fill gaps in the CGT space

BioProcess Insider spoke with Michael Kelly, CureDuchenne’s chief scientific officer, to discuss gaps in the gene therapy space and the strategy the firm is adopting to try and fill them. Before joining CureDuchenne, Kelly served in various roles. This includes his position as president and US site head of Renovis, as well as holding senior positions at Amgen, Wyeth (Pfizer), and Wellcome (GlaxoSmithKline). BioProcess Insider (BI): What are the gaps in the gene therapy space? Mike Kelly (MK): Some of…

Gamida’s off-the-shelf lymphoma cell therapy set for trials after hold lifted

The US FDA has released Gamida Cell from a clinical hold imposed last year, clearing the way for trials of GDA-201, a candidate off-the-shelf treatment for large B cell lymphomas. The Boston biotech firm announced the decision last week, also revealing that the US regulatory agency cleared its investigational new drug (IND) application for the product. CEO Julian Adams said, “FDA clearance of our IND for the cryopreserved formulation of GDA-201 represents a significant milestone for the company and reflects…