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Looking to expand its oncology portfolio, Gilead Sciences has tapped Vir Biotechnology’s masked T-cell engager (TCE) tech in a potential $1.9 billion biobucks deal. Under the agreement, Gilead is licensing three T-cell engagers built on Vir’s dual-masked PRO-XTEN platform, the same technology behind Vir’s potential $1.7 billion partnership with Astellas formed in February. Vir will handle the discovery, design and optimization of three TCE candidates targeting solid tumor-associated antigens. Gilead holds exclusive rights to nominate candidates and will assume responsibility for subsequent development, manufacturing and commercialization. The two companies have already selected the targets for the three programs, Vir CEO Marianne De Backer, Ph.D., told Fierce, although she declined to characterize the proposed indications further. “These are three targets that we were not interested in exploring ourselves,” De Backer said. “So it really allows us the possibility to focus on our own programs in addition to bringing in non-dilutive funding through partnerships like this.” In return, Vir will receive $90 million upfront, consisting of $65 million cash and a $25 million equity investment priced at a 30% premium. Down the line, the biopharma could also receive $45 million in near-term preclinical milestones, followed by up to $1.74 billion in additional development, regulatory and commercial milestones, as well as tiered high single-digit to low double-digit royalties on sales. De Backer touted PRO-XTEN as a “plug and play” technology, meaning it can use the same mask on the optimized TCE rather than having to develop a new mask for each molecule. “We are extremely efficient in coming up with powerful T-cell engagers, then using our AI engine dAIsy to optimize them,” she said. In a statement, Flavius Martin, M.D., Gilead’s executive vice president of research, said: “We look forward to combining Gilead’s established and growing oncology capabilities, including our extensive development expertise and focus on next-generation immunotherapies, with Vir Biotechnology’s innovative discovery capabilities.” The two California biopharmas formed the TCE alliance just as Vir is on the verge of reporting registrational data for its hepatitis delta combo, elebsiran and tobevibart, a potential competitor to Gilead’s Hepcludex. The Vir partnership adds to a busy year of oncology dealmaking for Gilead. Earlier this year, the biopharma acquired CAR-T specialist Arcellx for $7.8 billion to gain near-market multiple myeloma candidate anito-cel, before shelling out $3.15 billion upfront to buy antibody-drug conjugate (ADC) developer Tubulis. However, Gilead’s flagship solid tumor product, TROP2-directed ADC Trodelvy, has hit multiple clinical snags, most recently in first-line non-small cell lung cancer . This year also saw Gilead orchestrate a three-way acquisition of Ouro Medicines, which featured a BCMAxCD3 TCE candidate designed for autoimmune diseases. In a recent interview with Fierce, Gilead’s CEO Dan O’Day said the company’s efforts to diversify into oncology and immunology have reached “ critical mass ,” and that future M&A activities would focus on complementing this foundation. TCEs have emerged as powerful anti-tumor agents by directing immune cells to destroy cancer cells, though their application in solid tumors has often been limited by toxicity. To reduce these side effects, Vir’s PRO-XTEN tech engineers TCEs with masks that cover both the tumor-associated binding domain and the T-cell binding domain. The molecule therefore remains inactive until it reaches the tumor, where tumor-specific proteases cleave the masks to unleash its cancer-killing effect. The tech already attracted Astellas , which paid $315 million upfront in February in a mix of cash and equity to license Vir’s PSMAxCD3 candidate VIR-5500. The drug has produced promising phase 1 data and recently earned an FDA “fast track” designation in prostate cancer. Astellas and Vir have six expansion cohorts in the works for VIR-5500 across various prostate cancer settings, including in combination with Astellas and Pfizer’s Xtandi or docetaxel in first-line metastatic castration-resistant prostate cancer, as well as with Bayer’s Nubeqa in metastatic hormone-sensitive prostate cancer. The two firms plan to advance the PSMA TCE into phase 3 next year, De Backer said. Vir’s internal pipeline also includes a HER2 TCE, dubbed VIR-5818, with phase 1 dose escalation data expected later this year. Previously, Vir showed some encouraging initial data in metastatic, microsatellite-stable colorectal cancer patients from an early-stage basket trial. De Backer said the company is still exploring which indication to focus the molecule on. The dual-masking platform could enable more deals for Vir in the future, the CEO suggested. “There’s this great synergy between our protein-engineering capability and our masking technology, and we have really optimized that process quite a bit,” De Backer said. “We have many more opportunities to explore and exploit that technology platform than we can ever handle, so we have selected a number of programs that we want to progress on our own,” she added. “But there’s certainly an opportunity to do more deals in the masked T-cell engager space.” Where Big Pharma is placing its bets is one of the hot topics being discussed at Fierce Biotech's high-impact event in London next month. Find out more information and register by clicking on the banner below:

iStock, Dilok Klaisataporn Ten patients out of 20 who received Johnson & Johnson and Legend Biotech’s Carvykti remained alive at five years of follow up. Johnson & Johnson and Legend Biotech’s CAR T therapy Carvykti kept half of multiple myeloma patients alive and without disease progression after a median follow-up of at least five years. This finding comes from Cohort A in the Phase 2 CARTITUDE-2 study, presented Friday at the International Myeloma Society annual congress in Glasgow. The group featured 20 patients who received a single dose of Carvykti after at least one prior line of treatment. At a median of 60.7 months of follow-up, 10 participants remained alive and showed no signs of disease progression. Overall survival at this timepoint was 69.2%. Since the last data cut off, two deaths have occurred. One patient’s disease progressed, according to the Friday announcement. Another patient died due to the development of a new malignancy, which was breast cancer, a spokesperson for Legend told BioSpace in an email. None of the deaths observed in the cohort were deemed to be related to Carvykti, the spokesperson confirmed. CARTITUDE-2 is a multicohort, open-label trial with more than 200 patients enrolled. Cohort A focused on patients who had received between one and three prior lines of therapy. Previous data from CARTITUDE-2 presented in November 2023 showed that at a median follow-up of around 29 months, all 17 evaluable patients in Cohort A showed no detectable signs of residual cancer cells in bone marrow samples after treatment—the trial’s primary endpoint. At the time, Cohort A had accumulated five deaths. The deaths reported on Friday were new since the 29-month analysis. Of the seven total deaths in the study, one was considered related to cilta-cel, the spokesperson said. CARTITUDE-2 also includes cohorts B to F, each with specific criteria based on prior treatment exposure. Carvykti is a CAR T therapy that targets a protein called BCMA commonly expressed on malignant immune cells. In December 2017, J&J paid $350 million to license the asset. The FDA approved Carvykti in February 2022 for relapsed or refractory multiple myeloma and included a boxed warning for cytokine release syndrome, neurologic toxicities and secondary hematologic malignancies, among other side effects. The CAR-T therapy “is more suitable for a younger and higher risk population due to the proven high efficacy balanced by known toxicities that might not be suitable for older and more fragile patients,” analysts at RBC Capital Markets wrote in a Sept. 9 note. Carvykti made nearly $1.9 billion worldwide last year. Gilead is looking to challenge Carvykti in multiple myeloma with anito-cel, originally developed in collaboration with Arcellx, which the pharma acquired in February for $7.8 billion. Anito-cel is under FDA review, with a decision expected on Dec. 23. Earnings Gilead looks to upcoming inflammation, cancer catalysts as pressure to diversify mounts HIV remained Gilead’s strongest franchise in the second quarter, but the pharma is building out its pipeline beyond virology, particularly focusing on inflammation and oncology. August 5, 2026 · 3 min read · Tristan Manalac Read more