Therapeutic Class

Laronde aims to turn cells into drug production facilities using eRNA

Venture capital backed biotech Laronde has created a new type of RNA it claims can be used to create programmable protein therapeutics. The Massachusetts based firm unveiled its “Endless RNA” platform this week, while also confirming it had secured a $50 million investment to support development and an initial pipeline of medicines from Flagship Pioneering. Endless RNA – or eRNA – is based on of long non-coding RNA (lncRNA), which is naturally abundant in circular form within mammalian cells. Unlike…

Podcast: On board the Cell Shuttle with Cellares

Cellares Corporation’s CEO Fabian Gerlinghaus talks about the current limitations in cell therapy production and how, with $82 million in hand, its Cell Shuttle technology could resolve these. Tech firm Cellares Corporation is looking to advance development of its cell therapy manufacturing platform, the Cell Shuttle. Having raised $82 million in its latest funding round, co-founder and CEO Fabian Gerlinghaus spoke about how the Cell Shuttles’ scalable, modular, and automated nature could be a gamechanger in the burgeoning space on…

Allogene and Regenxbio point to inhouse CGT advantage

With facilities set to come online in California and Maryland, Allogene and Regenxbio respectively are the latest advanced therapy firms to laud the advantages of inhouse production. Allogene launched in 2018 with backing from Pfizer and has progressively been developing its AlloCAR T allogeneic, or off-the-shelf, chimeric antigen receptor (CAR) T-cell therapies. Its lead candidate is ALLO-501A looking to move into Phase II studies for Non-Hodgkin Lymphoma later this year. The company hopes to support the trial and beyond through…

Charles River sets sights on cell therapy manufacturing after Cognate buy

US contract research firm Charles River says its expanded manufacturing business will focus mainly on cell therapy production. CEO Jim Foster outlined Charles River’s plan this week, telling analysts the firm’s recent acquisition Cognate BioServices would boost the contract research organization’s (CRO) biologics business. “Cognate gives us the ability, and particularly in combination with HemaCare and Cellero, to provide the cells to do the process development, to do the clinical trial scale up, and ultimately, to provide commercial quantities specifically…

ADC Therapeutics joins conjugate elite with Zynlonta FDA approval

The US FDA has approved Zynlonta (loncastuximab tesirine), the eleventh antibody-drug conjugate and the first for ADC Therapeutics. Zynlonta received the thumbs up from the US Food and Drug Administration (FDA) last week for the treatment of patients with relapsed or refractory (r/r) diffuse large B-cell lymphoma (DLBCL). The antibody-drug conjugate (ADC) is composed of a humanized monoclonal antibody that binds to human CD19, conjugated through a linker to a pyrrolobenzodiazepine (PBD)-based cytotoxic warhead. PBDs are a class of compounds…

Biosimilars: Roche and Biogen talk competition, price, opportunities

The complexity of the biosimilar market was much in evidence last week with Roche and Biogen both citing competition as challenges in Q1. Roche saw group revenues of CHF 14.9 billion ($16.3 billion) in the first three months of 2021, up 3% year-on-year. The contribution from diagnostics grew 55% to CHF 4.5 billion due to a surge in demand for COVID-19 testing. In contrast, revenue from medicines fell 9% to CHF 10.6 billion. Roche said the decline was mainly because…

Bayer confirms $200m Berkeley cell therapy facility

The Cell Therapy Launch Facility will support Bayer’s growing advanced therapy ambitions and comes in addition to a $1.2 billion investment in the Californian campus. Bayer has confirmed it is expanding its cell and gene capabilities through the addition of a Cell Therapy Launch Facility, which is set to join a Cell Culture Technology Center (CCTC) and Cell & Gene Therapy labs coming on-line later this year at its 46-acre campus in Berkeley, California. “The Cell Therapy Launch Facility is…

Autologous therapy firms should use tech to cut COGS, says expert

Autologous therapy developers should consider “turnkey” manufacturing systems and robotic arms to minimize costs and manual handling, says an expert. The medical benefits of patient-specific, autologous cell therapies are proven according to Greg Russotti, Century Therapeutics’ CTO who told BPI West attendees the challenge now is reducing the cost of making such products. “Autologous [therapies] are proven to make major differences in patients’ lives. And, you know, no one can say they’re cures yet, but in some cases they are…

Podcast: The future of cell and gene therapies

Collaboration, supply chain resilience, acknowledgement they work, and trust will drive the cell and gene therapy sector going forward, EY’s Adlai Goldberg says on the latest episode of the BioProcess Insider Expression Platform. The cell and gene therapy sector is on the cusp of flourishing in the vast pharma landscape. Money is flowing in, manufacturing challenges are being overcome, people are actually being treated and cured. Even COVID-19 may be seen as a driving force for the burgeoning sector. But…

Moderna trialing refrigerator stable COVID-19 vaccine

Moderna has another COVID-19 vaccine in its clinical pipeline, which if successful will potentially make distribution and administration easier. The firm already has an mRNA cell-free COVID-19 vaccine, 1273, approved under FDA emergency authorization. However, it is developing an additional COVID-19 vaccine candidate coded 1283, which it believes will be easier to allocate and administrate due to it potentially being refrigerator stable. According to the firm, the next generation COVID-19 vaccine candidate is made from portions of the spike protein,…