The Promise
Pfizer’s ELREXFIO improves PFS in Phase 3 multiple myeloma trial
Pfizer has reported positive topline results from the Phase 3 MagnetisMM-5 trial of ELREXFIO, its BCMA-CD3 bispecific antibody, in adults with relapsed or refractory multiple myeloma who had received at least one prior line of therapy. The study met its primary endpoint, showing a statistically significant and clinically meaningful improvement in progression-free survival versus daratumumab plus pomalidomide and dexamethasone. Pfizer said the safety profile was consistent with previous ELREXFIO data, with no new safety signals identified. Source
Viridian reports positive Phase 3 elegrobart data in chronic thyroid eye disease
Viridian Therapeutics has reported positive topline results from REVEAL-2, a Phase 3 trial of elegrobart in patients with chronic thyroid eye disease. Elegrobart is a subcutaneous, half-life-extended monoclonal antibody targeting IGF-1R, and the study met its primary endpoint with highly statistically significant improvements in proptosis response versus placebo. If approved, elegrobart could become an at-home autoinjector option for both active and chronic thyroid eye disease. Source
J&J co-antibody shows Phase 2b promise in refractory IBD
Johnson & Johnson has reported Phase 2b data for JNJ-4804, an investigational fixed-dose co-antibody designed to block both IL-23 and TNF-α pathways in inflammatory bowel disease. The DUET-UC and DUET-CD studies evaluated the subcutaneous therapy in patients with moderately to severely active ulcerative colitis or Crohn’s disease who had responded inadequately to systemic therapies.
In Crohn’s disease, JNJ-4804 achieved a 50.8 percent clinical remission rate and 38.1 percent endoscopic response rate at Week 48, compared with 25.4 percent and 19.8 percent for golimumab. In ulcerative colitis, 41.0 percent of JNJ-4804-treated patients achieved clinical remission at Week 48, versus 11.5 percent with golimumab and 34.0 percent with guselkumab. Source
Avalo reports positive Phase 2 abdakibart data in hidradenitis suppurativa
Avalo Therapeutics has reported positive topline results from the Phase 2 LOTUS trial of abdakibart, its anti-IL-1β monoclonal antibody, in adults with moderate to severe hidradenitis suppurativa. The randomized, double-blind, placebo-controlled study enrolled 253 patients and met its primary endpoint, with both abdakibart dosing regimens achieving statistically significant HiSCR75 responses at Week 16. Source
Oncolytics reports durable responses for pelareorep in RAS-mutant colorectal cancer
Oncolytics Biotech has reported new durability data for pelareorep-based combination therapy in second-line RAS-mutant, microsatellite-stable metastatic colorectal cancer. In the REO 022 study, patients with KRAS-mutant MSS disease treated with pelareorep, bevacizumab, and FOLFIRI achieved a median duration of response of 19.5 months, compared with historical benchmarks of around four to six months.
Oncolytics is currently enrolling a randomized Phase 2 study of pelareorep plus FOLFIRI and bevacizumab in second-line RAS-mutant MSS metastatic colorectal cancer. The company said it is engaging with the FDA on a potential accelerated approval pathway based on response durability and time-to-event endpoints from the ongoing trial. Source
The Process and the Product
Amgen adds $300 million to US manufacturing expansion
Amgen has announced a further $300 million investment in its US manufacturing network, bringing its planned domestic manufacturing and innovation investments to nearly $2 billion over the past year. The latest funding will expand the company’s biologics manufacturing facility in Juncos, Puerto Rico, strengthening production capacity, supply chain resilience, and next-generation manufacturing technologies.
The Juncos site, established in 1992, is one of Amgen’s largest biomanufacturing facilities and produces biologic medicines distributed to more than 60 countries. The expansion is expected to support advanced manufacturing roles, workforce development in Puerto Rico, and hundreds of construction jobs.
The investment follows other recent Amgen commitments, including $650 million in Puerto Rico, $900 million in Ohio, and $600 million for a science and innovation center in California, alongside more than $1.5 billion already invested in North Carolina. Amgen said the latest move reflects its long-term commitment to US-based biomanufacturing and reliable medicine supply. Source
Mixed-mode filter helps prevent antibody reduction during harvest
Researchers at Merck & Co. have shown that a mixed-mode Polisher ST depth filter can reduce disulfide bond breaking during monoclonal antibody harvest, offering a practical way to improve product stability in CHO-based manufacturing. The study focused on antibody reduction driven by redox-active enzymes in harvested cell culture fluid, particularly thioredoxin and thioredoxin reductase.
The filter, which combines quaternary amine and guanidinium functionality, selectively depleted key reduction-associated enzymes, including thioredoxin, thioredoxin reductase, and G6PD. The team also found that guanidinium-containing compounds such as L-arginine and guanidine HCl extended antibody stability in higher filter-loading fractions, supporting a mechanistic role for guanidinium groups in preventing reduction. Pilot-scale testing up to 50 L supported the filter’s scalability, suggesting the approach could offer a robust secondary harvest-stage filtration strategy for reducing enzymatic degradation during bioprocessing. Source
CHO-derived MAR boosts antibody expression in dual-promoter vector system
Adding a CHO-derived matrix attachment region (MAR) to a dual-promoter IgG expression vector can improve monoclonal antibody production in CHO-S cells, according to researchers at the Institute of Chemical Technology in Mumbai. The study addresses a common challenge in CHO-based biomanufacturing: unstable transgene expression caused by position-effect variegation and epigenetic silencing.
Stable CHO-S pools carrying the MAR-containing vector produced higher and more consistent antibody levels across ten passages. Product quality appeared to be preserved, with reducing SDS-PAGE and size-exclusion chromatography confirming properly assembled, mainly monomeric adalimumab-like antibody in both MAR and non-MAR groups. The team also identified SATB1 binding motifs within the MAR sequence and confirmed SATB1 recruitment by ChIP-qPCR, suggesting that the CHO-native MAR may enhance expression by promoting a more transcriptionally active chromatin environment. Source
The Patient
FDA clears expanded access pathway for daraxonrasib in metastatic pancreatic cancer
The FDA has issued a “safe to proceed” letter allowing Revolution Medicines to open an expanded access treatment protocol for daraxonrasib, its investigational RAS(ON) inhibitor, in patients with previously treated metastatic pancreatic ductal adenocarcinoma. The program is intended to provide monitored access outside a clinical trial for eligible patients with life-threatening disease and no comparable or satisfactory treatment options.
Revolution Medicines said the authorization is an important step toward making daraxonrasib available through a controlled and equitable US access pathway. Under FDA expanded access rules, requests cannot be made directly by patients or caregivers and must be initiated by a licensed treating physician. Source
NIKTIMVO approved in Australia for chronic graft-versus-host disease
Specialised Therapeutics has secured Australian approval for NIKTIMVO, a first-in-class CSF-1R-blocking antibody, for chronic graft-versus-host disease after failure of at least two prior systemic therapies. The TGA approval covers adults and pediatric patients aged six years and older weighing at least 40 kg, and was granted through the Priority Review pathway. Australia is the first country to grant marketing authorization for NIKTIMVO since its US FDA approval in August 2024. Specialised Therapeutics said it is exploring reimbursement through Australia’s Pharmaceutical Benefits Scheme, where NIKTIMVO is not yet listed. Source
The Bulletin Board
BioNTech to close manufacturing sites in Germany and Singapore
BioNTech plans to consolidate its manufacturing network, exiting operations at sites in Idar-Oberstein, Marburg, and Singapore, as well as CureVac sites, as part of a wider efficiency program. The restructuring could affect up to around 1,860 positions in total, with the company citing excess capacity linked to changing supply needs, recent acquisitions, partner manufacturing capacity, and completed contracts. Source
BMS licenses Lonza ADC technology for undisclosed target
Bristol Myers Squibb has signed an exclusive single-target licensing agreement with Lonza to access its antibody-drug conjugate technology platform. The deal gives BMS rights to use Lonza’s SYNtecan linker-payload platform, together with GlycoConnect and HydraSpace technologies, to develop an ADC against an undisclosed target. BMS will be responsible for research, development, manufacturing, and commercialization of the resulting ADC. Lonza, through an affiliated company, is eligible to receive upfront payments, potential milestones, and royalties on net sales, though financial terms were not disclosed. Source
UCB to acquire Candid Therapeutics in $2.2 billion immunology deal
UCB has agreed to acquire Candid Therapeutics for up to $2.2 billion, adding a clinical-stage T-cell engager platform to its immunology pipeline. The deal includes $2 billion upfront and up to $200 million in potential milestone payments, and is expected to close by the end of the second quarter or early third quarter of 2026, subject to antitrust clearance and other customary conditions. Source
CellCentric raises $220 million to advance inobrodib in multiple myeloma
CellCentric has completed an oversubscribed $220 million Series D financing to support pivotal development of inobrodib, its first-in-class oral p300/CBP inhibitor for multiple myeloma. The round was led by Venrock Healthcare Capital Partners, with participation from Fidelity Management & Research Company, Sofinnova Partners, HBM Healthcare, and existing investors including RA Capital Management, Forbion, Pfizer, Avego BioScience Capital, and American Cancer Society BrightEdge. Source
Angelini Pharma to acquire Catalyst in $4.1 billion rare disease deal
Angelini Pharma has agreed to acquire Catalyst Pharmaceuticals for $31.50 per share in cash, valuing the US rare disease company at approximately $4.1 billion. The deal, unanimously approved by both companies’ boards, marks Angelini’s entry into the US market and is expected to close in the third quarter of 2026. Source
Novelty Nobility expands AGC Biologics pact for NN4101 manufacturing
Novelty Nobility has expanded its manufacturing agreement with AGC Biologics to advance NN4101, its first-in-class bispecific antibody candidate for neovascular retinal diseases. The program will move into process development and GMP manufacturing at AGC Biologics’ Chiba facility in Japan, following earlier cell line development work completed through AGC’s Copenhagen site. Source
For this week’s cell and gene therapy news – including CAR-T’s first step into Alzheimer’s disease, stem cell memory CAR-T responses in B-cell malignancies, dual-targeting CAR-T data in myeloma and POEMS syndrome, and advances in retinal cell and gene therapies – click here.