Therapeutic Class

Firefly emerges with $94m to develop antibody conjugates

Firefly Bio has launched from stealth to advance oncological therapies using degrader antibody conjugates (DACs).  According to the San Francisco-based firm, its focus is on the development of DACs, which represent amalgamation of antibody drug conjugates (ADCs) and protein degraders to treat cancer.   “DACs are a new modality for cancer,” said Scott Hirsch, CEO of Firefly. “They give us the ability to hit biologically validated targets with minimal collateral damage. Our platform enables DACs at scale and vastly expands the number…

Charles River cites Casgevy as key 2024 driver

With flat demand and revenue, contract development manufacturing organization (CDMO) Charles River Laboratories looks to Vertex’s approved sickle cell disease therapy for buoyancy.   The CDMO’s revenue climbed 3.9% year-on-year but fell 7.9% in the fourth quarter from $1.01 billion in 2023 to $1.10 billion in 2022.  Following the epidemic, CDMOs worldwide are dealing with several headwinds, driven by dried up funds. During its conference call, James Foster, CEO of Charles River, reassured investors “that constrained client spending will persist into 2024, but…

AZ cites FasTCAR to drive speedier cell therapy production

AstraZeneca says the FasTCAR platform, added through the acquisition of Gracell last year, could reduce CAR-T manufacturing from three weeks to 22 hours. AstraZeneca substantially raised its stake in the cell therapy space in 2023, culminating in the acquisition of Chinese biopharmaceutical company Gracell Biotechnologies for $1.2 billion. The deal added Gracell’s FasTCAR manufacturing technology, which claims to significantly shorten manufacturing time for chimeric antigen receptor (CAR) T-cell therapies. The firm spoke about the acquisition and the technology on its…

Novo Catalent deal primed to shake up CGT outsourcing space

Big Pharma’s GLP-1 push has inadvertently caused the “biggest transaction of cell and gene capacity ever” and will cause ripples across the sector. M&A has long been rife among contract development and manufacturing organizations (CDMOs), but the general trend has been of consolidation in a fragmented space as companies fill holes in their outsourcing offerings. Thermo Fisher’s $7.2 billion Patheon buy in 2017 and Danaher Corporation’s $9.6 billion Aldevron takeover in 2021 demonstrate the money that service firms have been…

Kyverna: 3-day process a ‘gamechanger’ for CAR-T

Kyverna says its vein-to-vein manufacturing process brings the average CAR-T manufacturing time down from 8-10 days and offers patients an alternative to apheresis. California-based Kyverna Therapeutics published a paper in BioRxiv last week describing its proprietary manufacturing process, Ingenui-T, for chimeric antigen receptor (CAR) T-cell therapies. The process uses less than 300 ml of whole blood from a blood draw for the collection of T cells from patients instead of leukapheresis, a type of apheresis, which is the industry standard CAR-T…

Women in advanced therapies: ‘Get comfortable being uncomfortable’

Phacilitate’s pre-day in Miami, Florida tackled the important topic of how to get comfortable asking for what you deserve in the workplace. Becky Johnson-Kent, head of Women in Advanced Therapies (WIAT) at Phacilitate, kicked off the session by telling the audience business is not about companies, “it’s about people.” The conversation this year built on the discussion at Advanced Therapies Europe in Lisbon, Portugal last year where the panel spoke about why women often ask for less in a business…

CGTs in 2023: Floodgates open but patient access still sticky

Approvals, collaborations, and broader disease focus were among the positives in Susan Nichols’ annual ‘Top 10’ cell and gene therapy (CGT) highlights, but complexities around global patient access took the top spot. It would not be Phacilitate’s Advanced Therapies Week without Susan Nichols, CEO of Propel Biosciences, presenting her top 10 events from the previous year that drove conversation, investment, and innovation in regenerative medicine. Overall there was much positivity with the last year proving that “we now know what good…

Price point sitting at the forefront of the CGT conversation

As approvals of cell and gene therapies (CGTs) rise, experts at Phacilitate’s Advanced Therapies Week in Miami, US debated whether this means price points become a bigger issue.   The cost of CGTs continues to be a hot topic in the life sciences space. While seven CGTs were approved by the US Food and Drug Administration (FDA) in 2023, the huge price tags attached to these drugs fuel various firms and organizations to seek solutions that could potentially drive costs down…

Vertex ‘hitting the ground running’ with Casgevy launch

Vertex says physicians prefer prescribing gene edited therapies to other gene therapy mechanisms as it rolls out sickle cell disease treatment Casgevy (exa-cel). In December, Vertex Pharmaceuticals and partner CRISPR Therapeutics won approval from the US Food and Drug Administration (FDA) for sickle cell disease and transfusion-dependent beta thalassemia (TDT) treatment Casgevy. Weeks prior, the UK’s Medicines and Healthcare products Regulatory Agency (MHRA) made history by approving Casgevy as the world’s first CRISPR-based gene-edited therapy. As such, Casgevy’s launch was the…

Female-focused networking: BPI hosts the CGT Circle’s 10th event

BioProcess International (part of BioProcess Insider) hosted the CGT Circle’s networking event in London to celebrate and bring together like-minded females in a professional and personal environment.   The three founders  of the CGT Circle (Kate Fynes, CMC translation consultant at eXmoor Pharma, Nicola Ambler, Director of Olmec Communications, and Lindsey Clarke, VP of commercial at MicrofluidX) said the demand for local community led networking steered them to launch the platform which aims to to create “decentralized networking” for women…