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New model-based analysis further supports the potential of TECVAYLI® (teclistamab-cqyv) plus DARZALEX FASPRO® (daratumumab and hyaluronidase-fihj) to redefine long-term survival expectations in early line relapsed/refractory multiple myeloma

On September 23, 2026 Johnson & Johnson (NYSE:JNJ), a worldwide leader in multiple myeloma therapies, reported new data from the Phase 3 MajesTEC-3 study showing sustained disease control and survival with TECVAYLI (teclistamab-cqyv) plus DARZALEX FASPRO (daratumumab and hyaluronidase-fihj) in patients with relapsed or refractory multiple myeloma (RRMM) who had received 1-3 prior lines of therapy. 1,2

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Using a relative survival mixture cure model (MCM) and actual progression-free survival (PFS) and overall survival (OS) data from the trial, statistical modeling estimated that ~87% of patients treated with TECVAYLI plus DARZALEX FASPRO (Tec-Dara) may experience a mortality risk and projected life expectancy similar to an age-matched general population.1 Modeling further predicted that median overall survival with Tec-Dara would be nearly four-fold longer than with the standard of care (SOC) comparator in the study, dexamethasone with pomalidomide or bortezomib (DPd/DVd). These data help to illustrate to what extent treatment with TECVAYLI plus DARZALEX FASPRO as early as second line may reshape survival expectations in multiple myeloma.1

In the MajesTEC-3 study, TECVAYLI plus DARZALEX FASPRO significantly improved overall survival versus standard of care (SOC), with an estimated 83% of patients alive at 3 years.3 A post hoc analysis showed that Tec-Dara reduced the risk of cumulative incidence of disease progression by 90% versus SOC, with no significant difference in non-relapse mortality over time between the treatment arms.2 These data (Abstract #OA-58 and Abstract #OA-49) will be presented in two oral sessions at the International Myeloma Society (IMS) Annual Meeting.

Expert and company perspectives emphasize the potential for durable, long-term disease control

"These findings underscore how consequential treatment choice at first relapse can be in shaping a patient’s long-term trajectory," said Dr. Luciano J. Costa, Professor of Multiple Myeloma and Director of the Multiple Myeloma Research and Treatment Program at the University of Alabama at Birmingham.* "The sustained disease control observed with TECVAYLI plus DARZALEX FASPRO is changing expectations for what treatment can achieve in relapsed or refractory multiple myeloma, moving beyond just delaying the next relapse toward the possibility of durable long-term disease control."

"The continued analyses of the unprecedented MajesTEC-3 trial challenge long-held expectations of what may be possible in multiple myeloma," said Yusri Elsayed, M.D., M.H.Sc., Ph.D., Global Therapeutic Area Head, Oncology, Johnson & Johnson Innovative Medicine. "Our ambition is to build on this progress by fundamentally changing the long-term trajectory of multiple myeloma and, ultimately, creating a future in which this disease is no longer defined as incurable."

Model-based analysis projects potential long-term survival outcomes

The MajesTEC-3 study evaluated TECVAYLI plus DARZALEX FASPRO versus investigator’s choice of daratumumab SC plus DPd/DVd in patients with RRMM who had received one to three prior lines of therapy.3 In this analysis, a relative survival mixture cure model was applied to patients treated with TECVAYLI plus DARZALEX FASPRO (n=291) and DPd/DVd (n=296) to assess whether long-term disease control could translate into outcomes approaching those of the general population.1 Best-fit models estimated cure fractions of 86.6% (95% confidence interval [CI], 81–91) for OS with the combination, compared with 0% (95% conCI, 0–53) with DPd/DVd, with substantially greater uncertainty in the DPd/DVd estimates.1 Model projected remaining life expectancy was 18.5 years with the combination, nearly four times the 4.9 years projected with DPd/DVd and approaching 21.1 years for the matched general population.1

Reduced disease progression drives survival benefit

A separate post hoc analysis provided further insight into the survival benefit observed in MajesTEC-3.2 At 36 months, the cumulative incidence of disease progression was 8.7% with TECVAYLI plus DARZALEX FASPRO, versus 62.1% with DPd/DVd, representing a 90% reduction in the risk of disease progression (subdistribution hazard ratio [sHR]=0.10; 95% CI, 0.07–0.16; P<0.0001).2 The 36-month OS rate was 83.3% versus 65.0%, respectively (hazard ratio [HR]=0.46; 95% CI, 0.32–0.65; P<0.0001).2 There was no significant difference in non-relapse mortality between treatment groups, with 36-month rates of 10.2% with TECVAYLI plus DARZALEX FASPRO and 9.0% with DPd/DVd (sHR=1.16; 95% CI, 0.69–1.98; P=0.5668).2

There was no difference in OS through 10 months (HR=1.08; 95% CI, 0.64–1.81).2 Beyond 10 months, OS favored TECVAYLI plus DARZALEX FASPRO, with a 78% reduction in the risk of death versus DPd/DVd (HR=0.22; 95% CI, 0.13–0.38).2 A prespecified restricted mean survival time analysis also confirmed a significant OS benefit, with a difference of 2.15 months (P=0.0088).2

Together, these analyses provide complementary evidence supporting the long-term benefit observed with TECVAYLI plus DARZALEX FASPRO. While the MCM analysis suggests the potential for highly durable disease control to extend overall survival for patients with multiple myeloma relative to the general population, the competing risk analysis helps explain these outcomes by demonstrating a profound reduction in disease progression without a significant increase in non-relapse mortality. MajesTEC-3 is ongoing, and continued follow-up will assess whether observed outcomes confirm these model-based predictions.

About the MajecTEC-3 study

MajesTEC-3 (NCT05083169) is an ongoing, Phase 3 randomized study evaluating the safety and efficacy of teclistamab plus daratumumab SC versus investigator’s choice of daratumumab SC and dexamethasone with either pomalidomide or bortezomib (DPd/DVd) in patients with relapsed/refractory multiple myeloma who have received 1–3 prior lines of therapy. The primary endpoint is progression-free survival (PFS) and secondary endpoints include complete response or better (≥CR), overall response rate (ORR), minimal residual disease (MRD)-negativity (10⁻⁵ by next-generation sequencing), overall survival (OS), time to worsening of symptoms (MySIm-Q), and safety. The MajesTEC-3 study is a part of the MajesTEC clinical program, which includes exploring the potential of teclistamab as a combination regimen.

About multiple myeloma

Multiple myeloma is a complex blood cancer that affects a type of white blood cell called plasma cells, which are found in the bone marrow.4 In multiple myeloma, these plasma cells proliferate and spread rapidly and replace normal cells in the bone marrow with tumors.5 Multiple myeloma is the second most common blood cancer worldwide.6 More than 180,000 new cases of multiple myeloma are diagnosed globally each year.7 People living with multiple myeloma have a 5-year survival rate of 59.8%.8 While some people diagnosed with multiple myeloma initially have no symptoms, most patients are diagnosed due to symptoms that can include bone fracture or pain, low red blood cell counts, tiredness, high calcium levels and kidney problems or infections.9,10 In recent years, overall survival has improved from years to decades, with effective treatment options now available across every stage and line of therapy.

(Press release, Johnson & Johnson, SEP 23, 2026, View Source [SID1234671027])

ImmunoScape Appoints Peter Olagunju as Chief Executive Officer

On September 23, 2026 ImmunoScape Pte. Ltd., an A*STAR spin-out backed by Amgen Ventures and EDBI that is developing next-generation TCR-based cancer immunotherapies, reported the appointment of Peter Olagunju as Chief Executive Officer. Olagunju joins ImmunoScape as the company prepares to advance its Seed and Boost platform into the clinic. Co-founder Michael Fehlings, Ph.D., continues to lead the company’s scientific and technical strategy as Chief Technology Officer.

"Peter is the rare executive who has done this at every stage: building manufacturing platforms from academic starting points, guiding products through regulatory approval, and running a company from formation through successful outcomes. He has helped bring seven therapies to commercialization and knows how to build lean, capital-efficient organizations," said Adrian Bot, MD, Ph.D., ImmunoScape Board Member and former Chief Scientific Officer of both Kite Pharma and Capstan Therapeutics. "As ImmunoScape moves from platform to clinic, that combination of technical depth and operating judgment is precisely what the company needs."

Olagunju brings more than 20 years of experience in clinical development, manufacturing, and technical operations, and has contributed to seven approved products, including PROVENGE, ZYNTEGLO, ABECMA, ADSTILADRIN, SKYSONA, and LYFGENIA. He most recently served as Chief Executive Officer of a Catalio Capital-backed oncology company, which he led from formation through a $14 million seed financing to a successful corporate transaction.

He previously held Chief Operating Officer and Chief Technology Officer roles at TCR² Therapeutics, where he served as the operations lead on the company’s acquisition by Adaptimmune, and has held senior executive positions at FerGene and bluebird bio. Olagunju is Chairman of the Board of March Biosciences and holds an M.B.A. from the University of Washington’s Foster School of Business and a B.S. in Biology from the University of Illinois at Urbana-Champaign.

"Solid tumors have been the hardest problem in cell therapy, and the limiting factor has consistently been persistence — getting engineered T cells to survive and keep working inside the tumor," said Olagunju. "ImmunoScape’s Seed-and-Boost approach goes directly at that problem, and it does so with a platform that applies across autologous, allogeneic, and in vivo delivery. I’ve spent my career translating academic science into manufacturing and clinical execution at scale, and that is exactly what this moment calls for. My immediate priority is working with our partners to move our platform into the clinic."

(Press release, immunoSCAPE, SEP 23, 2026, View Source [SID1234671026])

Celyad Oncology Reports First Half Year 2026 Results

On September 23, 2026 Celyad Oncology (Euronext: CYAD) ("Celyad" or the "Company"), reported its financial results for the first half year 2026 ended June 30, 2026.

First Half 2026 financial review

As of June 30, 2026, the Company’s cash position amounted to €0.1 million.

Noteworthy is the event post balance sheet date (June 30), namely the capital increase with €0.5 million dated July 16, 2026 which has strengthened the cash position.

After due consideration of detailed budgets and estimated cash flow forecasts for the years 2026 and 2027, the Company projects that its existing cash and cash equivalents will be sufficient to fund its estimated operating and capital expenditures into 2027.

Key financial figures for first half 2026, compared with the first half of 2025 and full year 2025, are summarized below:

Selected key financial figures (€ millions) Half Year Half Year Full Year
30-Jun-26 30-Jun-25 31-Dec-25
Revenue – (0,01) 0,02
Employee benefit expense (0,4) (1,4) (3,6)
Other operating expenses (1,0) (2,5) (4,6)
Other income 0,3 0,2 8,3
Operating profit/(loss) (1,2) (3,7) 0,9
Profit/(loss) for the period/year (1,2) (3,7) 0,8
Net cash used in operations (1,5) (3,3) (6,9)
Cash and cash equivalents 0,1 0,8 1,7
The Company’s license and collaboration agreements generated no revenue in the first half of 2026, which is similar to the first half of 2025.

The total employee benefit expenses decreased significantly to €0,4 million for the six-month period ended June 30, 2026, compared to €1,4 million in the same period of 2025. The decrease is primarily attributable to the workforce reduction implemented during 2025.

Other operating expenses amounted to €0,9 million at June 30, 2026, and decreased €1,6 million compared with the same period in 2025. Overall, the reduction in other operating expenses during the first half of 2026 reflects lower external service costs, a decline in research and development spending, and continued cost control across several operational expenditure categories. The decrease is also attributable to the Company’s strategic divestments, notably the disposal of the R&D facility in 2025 and the catheter business in 2026, which resulted in a lower operating cost base and reduced spending requirements compared to the prior-year period.

For the six-month period ended June 30, 2026, other income is mainly related to a marginal gain on the sale of the C-Cath business.

Net loss was €1,2 million, or € (0,027) per share, for the first half of 2026 compared to a net loss of €3,7 million, or € (0,09) per share, for the same period of 2025.

Net cash used in operations was €1,5 million for the first half of 2026 compared to €3,3 million for the first half of 2025.

The interim financial report for first half 2026 of the Company can be found on our website: View Source

(Press release, Celyad, SEP 23, 2026, View Source [SID1234671024])

Allotera Therapeutics Announces Opening of Minimal Residual Disease Cohort in the Pivotal T-RRex Study of Sofi-cel

On September 23, 2026 Allotera Therapeutics, Inc., a clinical-stage biotechnology company developing allogeneic, off-the-shelf cell therapies for hematological malignancies, reported the opening of the minimal residual disease (MRD)-positive cohort of its global pivotal T-RRex study of Soficabtagene Geleucel (Sofi-cel).

"Opening the MRD-positive cohort allows us to reach patients earlier in their disease course, before relapse, when we believe Sofi-cel may have the potential to provide meaningful clinical benefit," said Kumar Srinivasan, Ph.D., M.B.A., President and Chief Executive Officer of Allotera. "This expansion of our T-RRex study demonstrates our commitment to exploring the potential of Sofi-cel across the treatment continuum for patients with T-ALL or T-LBL."

"MRD positivity after standard therapy is one of the strongest predictors of relapse, yet few therapies are directed specifically at eliminating residual disease," said Cherry Thomas, M.D., Chief Medical Officer of Allotera. "By evaluating Sofi-cel in patients with MRD positivity, we aim to determine whether treatment can achieve MRD-negative remission and ultimately improve long-term clinical outcomes."

T-RRex is a global, single-arm, open-label Phase 2 study with a pivotal cohort evaluating Sofi-cel in patients with R/R T-ALL/T-LBL. The study is also evaluating Sofi-cel in patients who are in remission and remain MRD-positive following standard therapy. The study is being conducted at 18 clinical sites in the U.S. and Australia.

About Soficabtagene Geleucel (Sofi-cel)

Sofi-cel is an allogeneic, off-the-shelf, CD7-targeted CAR-T cell therapy being developed for T-cell cancers. Allotera uses CRISPR/Cas9 gene editing to delete CD7 and the T-cell receptor alpha constant (TRAC) genes, an approach intended to prevent CAR-T cell fratricide and mitigate the risk of graft-versus-host disease.

Sofi-cel is manufactured in the United States using healthy donor-derived T cells, which is intended to avoid malignant cell contamination that can occur in the autologous CAR-T setting. Sofi-cel is currently being evaluated in a global pivotal clinical trial for relapsed or refractory T-cell acute lymphoblastic leukemia and T-cell lymphoblastic lymphoma and patients who are in remission but remain MRD-positive following standard therapy. More information on the pivotal trial is available at ClinicalTrials.gov, identifier NCT06514794.

Sofi-cel has received Breakthrough Therapy, Regenerative Medicine Advanced Therapy (RMAT), Fast Track, Orphan Drug, and Rare Pediatric Disease designations from the U.S. Food and Drug Administration for the treatment of relapsed or refractory T-ALL/T-LBL, as well as Priority Medicines, or PRIME, designation in the European Union. RMAT and PRIME designations provide increased agency support to expedite the development and review of promising therapies for patients with medical need. Sofi-cel was also selected to participate in the FDA’s Chemistry, Manufacturing, and Controls Development and Readiness Pilot Program.

(Press release, Allotera Therapeutics, SEP 23, 2026, View Source [SID1234671022])

Cartherics shares iPSC manufacturing insights at leading cell therapy conferences

On September 23, 2026 Cartherics reported at two leading cell therapy conferences in Boston, sharing insights into the development and manufacture of scalable, off-the-shelf CAR-NK therapies.

At the 6th Annual iPSC Summit, Cartherics’ Head of Clinical Manufacturing, Dr Damien Zanker, presented ‘Manufacturing iPSC Therapies at Scale: Advancing Off-the-Shelf CAR-NK Production’ on 10 September.

The presentation highlighted Cartherics’ approach to building a scalable, consistent and secure iPSC manufacturing platform designed to support reliable CAR-iNK production. By engineering cells at the iPSC stage and establishing fully-characterised master cell banks, we create the starting point for a well-controlled differentiation process, providing the basis for enhanced product consistency and scalability – key attributes for developing off-the-shelf cell therapies.

Dr Zanker also presented at the 11th Annual CAR-TCR Summit on 17 September, with a presentation titled ‘Building Quality into iPSCs Early to Minimize Testing, Improve Reproducibility & Accelerate Commercialization.’

The presentation discussed how genetic engineering and quality considerations can be incorporated early in iPSC development to reduce downstream testing, improve reproducibility and support more efficient manufacturing.

Together, the presentations highlighted the important role of manufacturing in advancing iPSC-based cell therapies from research and development towards clinical application.

Cartherics is applying this manufacturing-led approach to its pipeline, including CTH-401, an iPSC-derived TAG-72 CAR-iNK therapy for relapsed/refractory ovarian cancer, which is progressing through IND-enabling activities ahead of first-in-human studies.

Cartherics was pleased to contribute its experience and perspective to discussions with the global iPSC and cell therapy communities in Boston.

(Press release, Cartherics, SEP 23, 2026, View Source [SID1234671021])