KRAS inhibitor delivers major survival gain in pancreatic cancer
Revolution Medicines has reported Phase 3 data showing its KRAS inhibitor daraxonrasib nearly doubled overall survival in metastatic pancreatic cancer, with patients living a median of 13.2 months compared with 6.7 months on standard chemotherapy. While efficacy signals are h4, the treatment was associated with notable dermatologic toxicities, which may influence dosing and combination strategies in future development. Source
GSK advances ADC with h4 responses in refractory gynecologic cancers
GSK has reported early clinical data for its antibody-drug conjugate Mo-Rez, showing tumor shrinkage or elimination in 62–67 percent of patients with chemotherapy-resistant ovarian and endometrial cancers. The results come from early-stage trials but suggest meaningful activity in patient populations with few remaining treatment options. The company plans to move rapidly into late-stage development, reflecting confidence in the program and broader momentum behind ADC platforms. Source
Gilead to acquire Tubulis in $3.15B ADC deal
Gilead has agreed to acquire German biotech Tubulis in a deal worth $3.15 billion upfront, with up to $1.85 billion in additional milestone payments, significantly expanding its antibody-drug conjugate (ADC) capabilities. The acquisition brings TUB-040, a NaPi2b-targeting ADC currently in Phase 1b/2 for ovarian cancer and non-small cell lung cancer, along with a second clinical asset, TUB-030, and a suite of next-generation conjugation technologies. Central to the deal is Tubulis’ platform, including its tubutecan linker-payload system, designed to improve tumor selectivity and payload delivery. Gilead said Tubulis will operate as a dedicated ADC research unit, with its Munich site becoming a hub for ADC innovation, reflecting continued strategic investment in oncology and platform technologies. Source
FDA’s real-time CRL releases increase CMC visibility
The FDA has begun publishing complete response letters (CRLs) in near real time through its public database. An April 10 entry includes a CRL issued for a biologics license application, outlining deficiencies that prevented approval. CRLs typically detail issues related to clinical, manufacturing, or quality aspects of submissions. The database provides access to newly issued and previously unpublished letters, including information on regulatory feedback and required actions for resubmission. Source
Interchangeable biosimilars reach the US market
Biocon announced the US commercial launch of two interchangeable denosumab biosimilars, Bosaya and Aukelso, for the treatment of osteoporosis and bone-related conditions. The products received FDA approval with interchangeability designation, allowing substitution at the pharmacy level under applicable regulations. The announcement includes details on indications, regulatory status, and market availability. Denosumab is a monoclonal antibody targeting RANKL and is used in multiple bone-related disease settings. Source
Anti-PD-1 combination shows Phase 3 benefit
A phase 3 study reports results for penpulimab in combination with chemotherapy in patients with recurrent or metastatic nasopharyngeal carcinoma. The study compares the combination therapy with chemotherapy plus placebo. The trial reports improved clinical outcomes in the treatment arm, including efficacy endpoints measured during the study period. Safety and tolerability data were also assessed as part of the trial. Source
Merck partners with Infinimmune on AI-driven antibody discovery
Merck has entered a collaboration with Infinimmune to discover and develop novel antibody therapeutics using a platform that combines large-scale human immune repertoire screening with AI-guided engineering. The partnership will focus on multiple undisclosed targets, with Infinimmune eligible for up to $838 million in milestone payments in addition to an upfront fee. The company’s approach uses single-cell screening of memory B cells alongside its GLIMPSE antibody language model to identify and optimize candidates with favorable drug-like properties. The deal highlights growing interest in “human-first” antibody discovery strategies that integrate biological data with machine learning to accelerate and de-risk early-stage biologics development. Source
The Process and the Product
Digital CHO models move closer to the plant floor
A reduced-form approach to CHO metabolic modeling maintains predictive performance while significantly lowering computational demands. Using extracellular metabolomics data, researchers simplified genome-scale metabolic models without losing the ability to reproduce key cellular behaviors across different conditions. The approach was evaluated against experimental datasets, where the reduced models were shown to capture core metabolic dynamics despite a smaller and more tractable structure.
By enabling faster simulations with fewer computational resources, the method could support more routine use of metabolic modeling in process development. The authors also point to potential applications in process optimization and integration with data-driven workflows for monitoring and control in biomanufacturing environments. Source
New insights into frozen bulk biologics stability
Processing conditions during freezing play a significant role in determining the stability of protein drug substances, with measurable effects linked to cryoprotectant use, cooling rates, and levels of supercooling. In this study, researchers evaluated a range of protein concentrations and systematically assessed outcomes including aggregation, structural integrity, and recovery following thawing. The results show that variations in freezing protocols and formulation components lead to distinct stability profiles, with some conditions promoting greater protein preservation than others. By comparing these parameters across controlled experiments, the work provides a clearer understanding of how physical and chemical factors interact during freezing and storage. Source
Faster route to intensified CHO processes
A time-resolved design-of-experiments strategy enables faster and more detailed characterization of CHO semi-perfusion processes than conventional steady-state approaches. Rather than holding parameters constant, the method varies process conditions over time to capture dynamic cellular responses, generating more information-rich datasets within shorter experimental timelines. The study reports improved visibility into how changes in operating conditions affect cell growth, productivity, and metabolite profiles, providing a more complete picture of process behavior. Source
For this weeks’ cell and gene therapy news – including tighter FDA expectations for genome editing safety, advances in CRISPR precision and delivery, and continued momentum for off-the-shelf CAR-T – click here.