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Global Data for BioNTech and Bristol Myers Squibb’s PD-L1xVEGF-A Bispecific Pumitamig Shows Encouraging Efficacy in Patients with Non-Small Cell Lung Cancer in ROSETTA Lung-02 Trial

On May 30, 2026 BioNTech SE (Nasdaq: BNTX, "BioNTech") and Bristol Myers Squibb Company (NYSE: BMY, "BMS") reported interim Phase 2 data from the global Phase 2/3 ROSETTA Lung-02 clinical trial (NCT06712316) evaluating the investigational PD-L1xVEGF-A bispecific immunomodulator pumitamig (also known as BNT327 or BMS-986545) plus chemotherapy in patients with previously untreated advanced non-small cell lung cancer ("NSCLC").

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The data showed encouraging anti-tumor activity, with high response rates observed in both non-squamous and squamous NSCLC and at each PD-L1 expression level (TPS ˂ 1%, TPS 1 – 49%, and TPS ≥ 50%). The data are being presented today as a rapid oral presentation (abstract #8513) at the 2026 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) ("ASCO") Annual Meeting in Chicago.

"Despite significant immuno-oncology advances in the treatment of non-small cell lung cancer, most advanced diseases relapse on or after a PD-(L)1 checkpoint inhibitor treatment,1 indicating that targeting this immunologic pathway alone is insufficient to achieve durable responses," said Solange Peters, M.D., Ph.D., Lead Investigator and Director of Oncology at the University Hospital of Lausanne, Switzerland. "I am encouraged by the efficacy signal with this bispecific approach, showing robust responses across subtypes and PD-L1 levels, supporting the continued investigation of pumitamig and its potential to deliver improved outcomes for a broad range of patients with NSCLC."

The Phase 2 part of the ROSETTA Lung-02 trial evaluated pumitamig in two dose levels, in combination with chemotherapy. At this interim analysis at the April 13, 2026 data cut-off, among 40 response-evaluable patients with a median follow-up of 9.0 months, pumitamig plus chemotherapy showed a confirmed objective response rate ("cORR") of 57.1% in patients with non-squamous NSCLC and 68.4% with squamous NSCLC with a disease control rate ("DCR") of 100%. Encouraging anti-tumor activity was observed at both dose levels, with higher response rates at the lower dose showing a cORR of 63.6% for non-squamous and 72.7% for squamous NSCLC. Results were high at each PD-L1 expression level (cORR: 47.6% TPS ˂ 1%; 77.8% TPS 1 – 49 %; 100% TPS ≥ 50%).

Pumitamig plus chemotherapy demonstrated a manageable safety profile with a low discontinuation rate. Grade ≥ 3 treatment-related adverse events ("TRAEs") were reported in 48.8% of patients and were considered pumitamig-related in 23.3%, leading to treatment discontinuation in four (9.3%) patients. Immune-related AEs ("irAEs") occurred in 16 (37.2%) patients and grade ≥ 3 irAEs in two (4.7%) patients. Bleeding events were reported in nine (20.9%) patients, with only one event being grade 3.

"The data we are presenting today provide further evidence of the potential of pumitamig to enhance anti-tumor responses in advanced lung cancer, one of the most challenging indications, by simultaneously targeting PD-L1 and VEGF-A with a single molecule," said Prof. Özlem Türeci, M.D., Co-Founder and Chief Medical Officer at BioNTech. "Pumitamig has consistently shown efficacy in three global Phase 2 trials across PD-L1 expression levels. Together with our partner BMS, we are continuing to advance pumitamig in ongoing pivotal and novel-novel combination trials with the goal of delivering better outcomes for more patients."

"We are committed to advancing the science of lung cancer with pumitamig and improving on the standard of care for people with this challenging disease," said Anne Kerber, Senior Vice President, Head of Development, Hematology, Oncology, Cell Therapy at Bristol Myers Squibb. "With one of the broadest registrational programs in the class, we are focused on accelerating the development of pumitamig together with BioNTech, with the goal of delivering meaningful benefit to patients, including those who have been left behind by current therapies."

BioNTech and BMS are advancing a broad development plan for pumitamig in non-small cell lung cancer across disease stages and subgroups. In addition to the ongoing global ROSETTA Lung-02 trial, which is currently recruiting for the Phase 3 part of the trial, there are two additional global Phase 3 clinical trials in NSCLC currently enrolling. These include ROSETTA Lung-201 (NCT07361497), evaluating pumitamig compared to durvalumab following concurrent chemoradiation therapy in patients with unresectable stage III NSCLC; and ROSETTA Lung-202 (NCT07361510), evaluating pumitamig compared to pembrolizumab as a first-line treatment for patients with advanced PD-L1 ≥ 50% NSCLC. Pumitamig is also being investigated in combination with other novel investigative treatments for NSCLC, including in combination with investigational antibody-drug conjugates ("ADCs") and other modalities.

About ROSETTA Lung-02
The global Phase 2/3 ROSETTA Lung-02 trial (NCT06712316) is evaluating pumitamig (BNT327/ BMS986545) in combination with chemotherapy in patients with first-line treatment of non-squamous and squamous non-small cell lung cancer without actionable genomic alterations and with any level of PD-L1 expression. In the Phase 2 dose-optimization part of the trial, patients were randomized 1:1 to 1400 mg or 2000 mg pumitamig plus histology-specific chemotherapy Q3W (non-squamous: carboplatin + pemetrexed; squamous: carboplatin + paclitaxel). The primary endpoints of the Phase 2 part of the trial are objective response rate (ORR) per investigator’s assessment (RECIST 1.1), best percentage change in tumor size from baseline, and safety. Key secondary endpoints include duration of response (DOR) and disease control rate (DCR). The Phase 3 part of the trial will evaluate pumitamig plus chemotherapy versus pembrolizumab plus chemotherapy. Based on the totality of the data, a pumitamig 1500 mg flat dose Q3W plus chemotherapy was selected for further evaluation in the Phase 3 part. The primary endpoint of the Phase 3 part of the trial is progression free survival (PFS) assessed by blinded independent central review (BICR). Key secondary endpoints include overall survival (OS), ORR, DOR.

About Pumitamig
Pumitamig is an investigational bispecific immunomodulator, jointly developed by BioNTech and BMS, designed to cooperatively bind to PD-L1 and VEGF-A. It is aimed at restoring the immune system’s ability to recognize and destroy tumor cells while simultaneously cutting off the blood and oxygen supply that feeds tumor cells (anti-angiogenesis effect), preventing them from growing and proliferating. By anchoring to PD-L1 receptors on tumor cells, we believe pumitamig localizes VEGF-A blockade within the tumor microenvironment, potentially enhancing antitumor activity while minimizing systemic exposure.

More than 2,000 patients have been treated with pumitamig in clinical trials to date. Seven global Phase 3 trials with registrational potential are currently ongoing, evaluating pumitamig plus chemotherapy compared to standard of care treatments, in first-line small cell lung cancer (ROSETTA LUNG-01, NCT06712355); first-line non-small cell lung cancer (ROSETTA LUNG-02, NCT06712316); unresectable stage III non-small cell lung cancer (ROSETTA Lung-201, NCT07361497); first-line advanced PD-L1 ≥ 50% non-small cell lung cancer (ROSETTA Lung-202, NCT07361510); first-line triple-negative breast cancer (ROSETTA BREAST-01, NCT07173751); first-line microsatellite stable colorectal cancer (ROSETTA CRC-203, NCT07221357); and first-line gastric cancer (ROSETTA GASTRIC-204, NCT07221149). Pumitamig is also being explored in 10+ novel-novel combination trials with ADCs and other novel modalities, with the aim of expanding its role across tumor types and identifying additional pivotal opportunities.

About NSCLC
Non-small cell lung cancer (NSCLC) covers all epithelial lung cancers other than small cell lung cancer and includes squamous cell carcinoma, large cell carcinoma, and adenocarcinoma of the lung. It is the most common type of lung cancer, accounting for approximately 85% of cases, and is the leading cause of cancer-related deaths worldwide.2 Scientific advances have transformed the treatment of NSCLC, improving outcomes for many patients. However, NSCLC remains an aggressive disease with a poor prognosis and a 5-year survival rate of 18 to 22% in advanced stages.3 Patients with low levels of PD-L1 expression typically do not respond well to checkpoint inhibitor-based regimens creating a significant unmet need for new treatment options that provide durable responses to a broad range of patients.

(Press release, BioNTech, MAY 30, 2026, View Source [SID1234666242])

ENZAMET Trial Shows Veracyte’s Decipher Prostate Test Identifies Which Patients Benefit from Adding Chemotherapy in Metastatic Prostate Cancer

On May 30, 2026 Veracyte, Inc. (Nasdaq: VCYT), a leading cancer diagnostics company, reported results from the ENZAMET trial presented at the 2026 ASCO (Free ASCO Whitepaper) Annual Meeting. The analysis demonstrates that the Decipher Prostate test identifies which men with metastatic prostate cancer benefit from adding the chemotherapy docetaxel to standard hormonal therapy (ADT plus enzalutamide), known as triplet therapy, and who can safely avoid it, providing the first Level 1B 1 evidence for a genomic test guiding this decision. Complementary data presented at the meeting also reinforce Decipher Prostate’s clinical utility in high-risk localized disease.

Approximately 334,000 men are diagnosed with prostate cancer annually in the United States, including about 30,000 who present with metastatic disease at diagnosis.2, 3 While recent treatment advances have improved outcomes, clinicians still lack precision tools to guide chemotherapy decisions in this setting.

"For the first time, the ENZAMET trial analysis shows that a genomic test can guide the decision to add chemotherapy to standard of care hormonal therapy in metastatic prostate cancer," said Prof. Christopher Sweeney, M.B.B.S., DHS., Lead Investigator, South Australian Immunogenomics Cancer Institute, Adelaide University. "Decipher Prostate identifies which patients benefit from treatment intensification, and which can be safely spared chemotherapy, giving clinicians an actionable, evidence-based answer."

The ENZAMET findings build on prior validation in the STAMPEDE and CHAARTED trials, where Decipher Prostate identified patients most likely to benefit from adding docetaxel to ADT alone. ENZAMET advances that evidence with the first demonstration that the test predicts chemotherapy benefit when added to doublet therapy (ADT plus an ARPI).

Metastatic Disease: Identifying Which Men Benefit from Chemotherapy

The ENZAMET trial is an international, randomized Phase III study conducted by the Australian and New Zealand Urogenital and Prostate Cancer Trials Group (ANZUP). Researchers performed a pre-specified biomarker analysis using the Decipher Prostate test in 634 patients to assess whether the test could predict benefit from adding chemotherapy to standard hormonal therapy with a median follow-up of 5.6 years.

Results showed:

Improved outcomes guided by Decipher Prostate: Patients with higher Decipher scores (>0.85) and high-volume disease who received triplet therapy had clinically meaningful better survival compared to those on standard hormonal therapy alone.
Patients can be spared from chemotherapy: Patients with lower Decipher scores showed no benefit from adding chemotherapy, suggesting it may be safely avoided.
Practice-changing evidence: The treatment-by-biomarker interaction was statistically significant (p=0.043), providing Level 1B evidence for the test’s predictive value.
Overcoming aggressive disease: Patients with higher Decipher scores who received triplet therapy had more aggressive disease features, yet achieved comparable survival to lower-risk patients on doublet therapy, suggesting chemotherapy offset the poor prognostic effects of aggressive disease biology.
Localized Disease: Identifying Which High-Risk Patients Need Treatment Intensification

Complementing the ENZAMET findings, a combined analysis of four mature NRG/RTOG trials presented at ASCO (Free ASCO Whitepaper) 2026 adds to Decipher Prostate’s growing body of evidence into high-risk localized prostate cancer.

Key findings include:

Improved prognostic accuracy: Decipher Prostate significantly improved prognostic accuracy for survival outcomes compared to clinical variables alone.
Refined risk classification: Combining NCCN clinical risk classification with Decipher Prostate reclassified approximately 1 in 4 patients.
Expanded population for treatment intensification: Results also show many more clinically high-risk patients may benefit from intensification with ARPI.
"Decipher Prostate is the most validated transcriptomic test across the full prostate cancer continuum – from active surveillance through metastatic disease," said Elai Davicioni, Ph.D., Veracyte’s Medical Director, Urology. "For clinicians, that means a clearer answer at every decision point. For patients, it means greater confidence that their treatment is guided by the biology of their disease, and not guesswork."

(Press release, Veracyte, MAY 30, 2026, View Source [SID1234666241])

Alaw Therapeutics Announces Two Major Pipeline Milestones Advancing Brain-Penetrant CDK Oncology Programs

On May 29, 2026 Alaw Therapeutics, Inc. ("Alaw"), a clinical-stage biotechnology company developing precision oncology therapeutics designed to control oncogenic proliferation, tumor survival, and therapeutic resistance, reported two major pipeline milestones advancing its next-generation cyclin-dependent kinase (CDK) inhibitor portfolio.

The announcements include:

Dosing of first patients in its Phase 1a/b clinical trial evaluating AL-605, Alaw’s selective, brain-penetrant CDK2 inhibitor, in patients with CCNE1-amplified solid tumors
Drug candidate nomination of AL-433, Alaw’s selective, brain-penetrant CDK4 inhibitor, with first-in-human clinical entry planned for Q4 2026
"These milestones represent an important inflection point for Alaw and for CDK-directed oncology," said Idean Marvasty, President and CFO of Alaw. "The inability to achieve meaningful CNS exposure has remained a fundamental limitation, leaving patients with brain metastases and primary CNS tumors underserved by targeted cell-cycle therapies. AL-605 and AL-433 were specifically engineered to address that challenge through enhanced selectivity of CDK inhibition combined with robust brain penetration."

AL-605: Phase 1a/b Study Initiated for Selective Brain-Penetrant CDK2 Inhibitor

Alaw has initiated a Phase 1a/b clinical trial evaluating AL-605 in patients with cyclin E (CCNE1)-amplified solid tumors. The study is designed to assess safety, tolerability, pharmacokinetics, pharmacodynamics, and preliminary antitumor activity, while incorporating prospective biomarker-based patient selection strategies intended to enrich for tumors dependent on CDK2 signaling.

The trial is enrolling two biomarker-defined populations:

Patients with hormone receptor-positive breast cancer that has progressed following CDK4/6 inhibitor therapy and exhibits CCNE1 amplification or overexpression, a setting strongly associated with CDK2-mediated resistance
Patients with CCNE1-amplified solid tumors more broadly, including ovarian, endometrial, gastric, esophageal, and triple-negative breast cancers
The Phase 1a portion follows a standard dose-escalation design, while Phase 1b expansion cohorts are intended to confirm the recommended Phase 2 dose and evaluate early clinical activity. Interim data are anticipated in the second half of 2026.

Addressing a Critical CNS Limitation in CDK2 Therapy

CDK2 inhibition is increasingly recognized as a central strategy for overcoming resistance to CDK4/6 inhibitors, which have transformed the treatment landscape for hormone receptor-positive breast cancer but are ultimately limited by the emergence of CDK2-driven bypass signaling.

However, currently available and emerging CDK2 inhibitors demonstrate limited blood-brain barrier penetration, leaving the CNS as a pharmacologic sanctuary where resistant tumor cells can survive and proliferate. By achieving robust and selective CNS CDK2 inhibition, AL-605 is designed to address both systemic disease and intracranial tumor progression, including brain metastases arising from CDK2-dependent tumors.

Preclinical studies have demonstrated that AL-605 achieves CNS exposure exceeding leading comparator CDK2 inhibitors and produces meaningful antitumor activity in intracranial tumor models, including glioblastoma and triple-negative breast cancer brain metastases.

AL-433: Selective Brain-Penetrant CDK4 Inhibitor Advances Toward First-in-Human Development

Alaw also announced the nomination of AL-433, its selective, brain-penetrant CDK4 inhibitor, as a development candidate, with first-in-human clinical studies planned for Q4 2026.

AL-433 targets tumors driven by dysregulation of the CDK4-cyclin D1-Rb-E2F axis, a central regulator of G1-to-S phase cell-cycle progression frequently altered across aggressive solid tumors.

The program is designed to address two fundamental limitations of the currently approved CDK4/6 inhibitor class:

Selective CDK4 Inhibition. AL-433 was engineered for high selectivity toward CDK4 over CDK6 with the goal of preserving antitumor efficacy while substantially improving tolerability. Reduced CDK6 inhibition may enable uninterrupted dosing and expand combination opportunities with immunotherapies and other targeted agents.
CNS Exposure and Brain Tumor Activity. Approved CDK4/6 inhibitors are substrates for efflux transporters at the blood-brain barrier and achieve minimal CNS exposure, limiting activity against glioblastoma, CDK4-amplified brain tumors, and brain metastases. AL-433 was specifically optimized for brain permeability and is designed to enable clinically meaningful CDK4 inhibition within the CNS.
Preclinical studies demonstrated that AL-433 achieves near-complete blood-brain barrier penetration, resulting in direct intracranial target engagement and antitumor activity in CDK4-dependent CNS tumor models.

AL-433 has been well tolerated in multi-species preclinical safety studies, and GLP toxicology studies are ongoing in support of clinical advancement. Planned clinical studies are expected to permit enrollment of patients with active CNS tumors or brain metastases, a population historically excluded from trials evaluating CDK4/6 inhibitors.

"The convergence of selectivity, brain penetrance, and rational combination strategy is what makes the pipeline fundamentally differentiated," added Marvasty. "We are not developing conventional next-generation CDK inhibitors. We are building the first CDK-directed therapies designed to follow the tumor wherever it goes, including the brain."

About AL-605

AL-605 is a selective, brain-penetrant CDK2 inhibitor designed for the treatment of CCNE1-amplified solid tumors and CDK2-mediated resistance to CDK4/6 inhibitors. The molecule achieves significant CNS exposure and has demonstrated antitumor activity in preclinical intracranial tumor models. AL-605 is currently being evaluated in a Phase 1a/b clinical study.

About AL-433

AL-433 is a selective, brain-penetrant CDK4 inhibitor designed to achieve highly selective inhibition of CDK4 over CDK6 while maintaining near-complete blood-brain barrier penetration. The program is intended to address both the hematologic toxicity and CNS limitations associated with approved CDK4/6 inhibitors and has demonstrated antitumor activity in preclinical CDK4-dependent CNS tumor models, including glioblastoma. Drug candidate nomination has been achieved, and first-in-human clinical studies are planned for Q4 2026.

(Press release, Alaw Therapeutics, MAY 29, 2026, View Source [SID1234666237])

Medidata Champions Collaborative Scientific Advancement at ASCO with New Research on Oncology Protocol Optimization and CAR T Efficacy

On May 29, 2026 Medidata, a Dassault Systèmes brand and leading provider of clinical trial solutions to the life sciences industry, will present two poster presentations of pivotal research abstracts at the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) 2026 Annual Meeting. This research delivers advanced intelligence to accelerate oncology trials by optimizing patient-centric breast cancer protocols and definitively validating tocilizumab’s efficacy for CAR T–induced Cytokine Release Syndrome (CRS).

The research (abstracts #11027 and #7027 at booth #30099), conducted by the Medidata Research Alliance, provides valuable insights for oncologists and clinical trial sponsors to refine studies with foresight and strengthen patient outcomes.

"Oncology trials represent some of the most intricate and demanding work in clinical research," said Sheila Diamond, MS, CGC, director, Scientific Engagement, Medidata. "By leveraging decades of clinical research expertise, powered by one of the largest clinical trial datasets in the world, we are delivering the actionable intelligence needed to accelerate cancer breakthroughs. We are transforming trial execution by driving patient-centric protocol design to boost enrollment and, simultaneously, providing definitive clinical validation for treatments of CAR T–induced CRS."

Protocol Optimization in Breast Cancer Clinical Trials

Quantifying the impact of protocol design on enrollment and dropout rates in breast cancer clinical trials. Abstract #11027 (June 1, 2026, 09:00-12:00 CDT timezone)

The analysis by Medidata and Janna Andrews, MD, Chair of Radiation Oncology, Phelps Hospital, Northwell Health, validates a predictive algorithm that quantifies the impact of patient-centric protocol design on enrollment and retention rates in breast cancer trials. The research identified specific procedures that acted as barriers to entry and others that drove retention. Key findings were:

10-23% reduction in enrollment rates associated with the inclusion of Positron Emission Tomography (PET) Imaging in select protocols where PET imaging was considered a key driver of operational outcomes
Up to 6% enrollment increases associated with bone density imaging, abdominal and pelvic imaging, and tumor and biopsy procedures
Up to 10% reductions in dropout rates were seen with the use of blood cell analyses, biomarker testing, and assessment questionnaires overall
The analysis leverages Medidata Protocol Optimization, part of the Medidata Study Experience, which transforms trial design and execution by leveraging AI trained on proprietary, cross-industry data to evaluate planned protocols against how similar clinical studies have performed, helping sponsors identify and mitigate risks proactively.

"Patient recruitment and retention is one of the greatest obstacles in clinical trials, directly impeding the speed at which patients receive potentially life-changing therapies," said Janna Andrews, MD, Chair of Radiation Oncology, Phelps Hospital, Northwell Health. "Our joint research with Medidata moves past simply identifying this challenge; it delivers quantifiable evidence that pinpoints the exact burdens and benefits of specific protocol steps. This data is critical for oncologists and sponsors to proactively design patient-centric trials, ensuring better enrollment, retention, and trial continuity."

Evaluating the Efficacy of Tocilizumab for CAR T–induced Cytokine Release Syndrome

Efficacy of tocilizumab in resolving CAR T–induced Cytokine Release Syndrome: A pooled clinical trial analysis of patients with B-cell lymphoma. Abstract #7027 (June 1, 2026, 09:00-12:00 CDT timezone)

The collaborative study by Medidata, Mayur Narkhede, MD of Mercy Cancer Institute and Sean Patrick Bliven, MD of the University of Alabama, Birmingham, examined data from multinational clinical trials spanning 2,300 patients with B-cell lymphoma on the Medidata Platform. This investigation verifies the effectiveness of tocilizumab for addressing CAR T–induced CRS (Chimeric Antigen Receptor T-cell induced Cytokine Release Syndrome) across a large patient population. This patient population was integrated from multiple multinational trials using AI-powered standardization pipelines. Key observations from the research were:

66% of the 680 patients achieved complete response with a median treatment time of four days
34% of patients did not meet the complete response criteria, highlighting a critical need for alternative rescue therapies to tocilizumab in more persistent cases
"This research is incredibly valuable in confirming that tocilizumab is a highly effective treatment for the majority of patients experiencing CAR T–induced CRS, although it also reinforces the need for further research into other treatment strategies for those who do not see clinical benefit," said Mayur Narkhede, MD, oncologist at Mercy Cancer Institute.

"It also demonstrates the power of industry collaborations such as the Medidata Research Alliance to combine knowledge of the treatment landscape and vast, robust historical clinical data sets to generate insights that may not have otherwise been researched," said Sean Patrick Bliven, MD, oncologist at University of Alabama, Birmingham.

(Press release, Medidata, MAY 29, 2026, https://www.globenewswire.com/news-release/2026/05/29/3303551/0/en/medidata-champions-collaborative-scientific-advancement-at-asco-with-new-research-on-oncology-protocol-optimization-and-car-t-efficacy.html [SID1234666236])

Imviva Biotech to Present Data from Clinical Studies of CTA313 and CTD402 Validating its ANSWER™ Allogeneic CAR-T Platform in Pediatric and Adult Patient Populations at EULAR and EHA 2026 Congresses

On May 29, 2026 Imviva Biotech, a clinical-stage biotechnology company developing next-generation allogeneic CAR-T cell therapies, reported that it will present data on CTA313, its investigational dual-targeted CD19/BCMA allogeneic CAR-T cell therapy for Systemic Lupus Erythematosus (SLE), at the European Alliance of Associations for Rheumatology 2026 Congress (EULAR) in London from June 3-6, 2026. Additionally, the company will showcase data on CTD402, its allogeneic CAR-T cell therapy candidate being developed for the treatment of relapsed or refractory (R/R) T-cell acute lymphoblastic leukemia/lymphoblastic lymphoma (T-ALL/LBL), at the European Hematology Association (EHA) (Free EHA Whitepaper) 2026 Congress (EHA) (Free EHA Whitepaper) in Stockholm from June 11-14, 2026.

EULAR 2026 publication details:

CTA313, CD19/BCMA Dual Targeted Allo-CAR-TANS Cell, Durable Remission in Systemic Lupus Erythematosus following Deep B-Cell Depletion, Suggestive of Immune-Reset

Abstract: AB1118

Abstracts are currently available to the public at: View Source

EHA2026 presentation details:

CTD402 Allogeneic Anti-CD7 CAR T-Cell Therapy is Safe and Effective in Adolescent/Pediatric Patients (pts) with Relapsed/Refractory (R/R) T ALL/LBL

Abstract: EHA (Free EHA Whitepaper)-3404 Short: PS2331
Session Title: Gene therapy, cellular immunotherapy and vaccination – Clinical
Session Type: Poster Session
Date & Time: Saturday, June 13, 18:45 CEST
Speaker: Dr. Xian Zhang, Hebei Yanda Ludaopei Hospital

TENACITY-01 A Global Study of CTD402, Allogeneic Anti-CD7 CAR T-Cell, In Relapsed or Refractory (R/R) T-Cell Acute Lymphoblastic Leukemia/Lymphoblastic Lymphoma (T-ALL/LBL)

Abstract: EHA (Free EHA Whitepaper)-2777 Short: PS2350
Session Title: Gene therapy, cellular immunotherapy and vaccination – Clinical
Session Type: Poster Presentation
Date & Time: Saturday, June 13, 18:45 CEST
Speaker: Dr. Lori Muffly, Professor in the Division of Blood and Marrow Transplantation-Cellular Therapies at Stanford Medicine, Palo Alto

Abstracts are currently available to the public at: View Source!*menu=6*browseby=3*sortby=2*ce_id=2934.

"These presentations at EULAR and EHA (Free EHA Whitepaper) underscore the transformative potential of our ANSWER platform to deliver readily available, off-the-shelf CAR-T therapies for patients with serious autoimmune diseases and hematologic malignancies," said Imviva Biotech Chief Medical Officer Jan Davidson-Moncada, MD, PhD. "We’re encouraged by the progress we’re making toward our goal of bringing innovative treatments to patients in need and look forward to continuing to advance our pipeline and mission."

For more information, visit www.imvivabio.com.

About CTA313

CTA313 is an investigational dual-targeting CD19/BCMA allogeneic CAR-T cell therapy derived from healthy donors and designed for B-cell-mediated autoimmune diseases. The product incorporates Imviva’s proprietary ANSWER inhibitory ligands and genetic edits to enhance resistance to host immune rejection and enable therapeutic durability. CTA313 can be manufactured in advance and stored for multiple patients, providing an off-the-shelf solution for patients in need of CAR-T cell therapy. The therapy has been evaluated in an open-label Phase 1/2 study across multiple autoimmune indications in China, including systemic lupus erythematosus, lupus nephritis, systemic sclerosis, anti-neutrophil cytoplasmic antibody (ANCA)-associated vasculitis, and idiopathic inflammatory myopathy.

About CTD402

CTD402 is an investigational ‘ready-at-point of care’ allogeneic anti-CD7 CAR-T cell therapy designed for T-cell mediated disease. The product candidate incorporates T-cell receptor (TCR) and HLA class II knockout, along with Imviva’s proprietary ANSWER inhibitory ligands to enhance resistance to host immune rejection. The robustness of CTD402’s manufacturing process, showing product consistency across multiple donors and production lots, promises to deliver an ‘off-the-shelf’ allogeneic platform with the critical advantage of immediate availability, eliminating manufacturing delays that can be life-threatening for patients with rapidly progressive disease.

A global Phase 1b/2 clinical trial (TENACITY-01) evaluating CTD402 for the treatment of relapsed/refractory T-ALL/LBL patients is enrolling patients (NCT07070219). The U.S. Food and Drug Administration has granted Rare Pediatric Disease Designation (RPDD), and Regenerative Medicine Advanced Therapy (RMAT) designation to CTD402 for the treatment of relapsed or refractory T-cell acute lymphoblastic leukemia (T-ALL).

(Press release, Imviva Biotech, MAY 29, 2026, View Source [SID1234666235])