1stOncology™: Cancer Intelligence Service – Page 432 – 1stOncology is recognized as a Top 10 Global Pharma Analytic Provider

Imviva Biotech Presents Studies on CTD402 Allogeneic CAR-T Therapy at EHA2026 Congress

On June 11, 2026 Imviva Biotech, a clinical-stage biotechnology company developing next-generation allogeneic CAR-T cell therapies, reported new research findings at the European Hematology Association (EHA) (Free EHA Whitepaper) 2026 Congress (EHA2026), June 11-14, in Stockholm, Sweden. Shared in two poster presentations, the data demonstrated encouraging safety and efficacy results in both adult and pediatric patients with relapsed or refractory T-cell acute lymphoblastic leukemia/lymphoblastic lymphoma (R/R T-ALL/LBL), a disease with limited treatment options and poor prognosis.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

Schedule Your 30 min Free Demo!

Patients with R/R T-ALL/LBL face substantial treatment challenges due to paucity and limited efficacy of available therapies. Findings presented at EHA (Free EHA Whitepaper)2026 highlight the value of CTD402 as an "off-the-shelf", point-of-care-ready CAR-T cell therapy for heavily pretreated pediatric and adult patients.

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)

In a second poster presentation delivered by Dr. Lori Muffly of Stanford Medicine, preliminary data from TENACITY-01, a global Phase 1b/2 study of CTD402, was featured. As of June 8th, 2026, seven patients with R/R T-ALL/LBL received CTD402 at the recommended phase 2 dose following standard lymphodepletion chemotherapy. The therapy demonstrated an overall response rate of 85.7% (6/7 patients) and an overall complete remission (CRc = CR + CRi) rate of 71.4% (5/7 patients), with 80% (4/5) achieving MRD-negative status.

The safety profile has been manageable, with low-grade (<=G2) cytokine release syndrome observed in 86% of patients and immune effector cell-associated hemophagocytic lymphohistiocytosis-like syndrome observed in 29% of patients. Notably, no cases of immune effector cell-associated neurotoxicity syndrome or graft-versus-host disease were reported. CTD402 demonstrated robust pharmacokinetics with peak expansion at Day 10 and persistence beyond 28 days in 60% of patients. One highlighted case involved a heavily pretreated patient with 90% bone marrow blasts and extensive extramedullary disease who achieved complete remission with incomplete hematologic recovery and successfully transitioned to allogeneic hematopoietic stem cell transplant, continuing in remission thereafter.

"These results from TENACITY-01 validate our earlier CTD402 findings in a global setting," said Lori Muffly, MD, MS, of Stanford Medicine. "We’re now seeing consistent efficacy with an 85.7% overall response rate and high rates of MRD-negative remissions, reinforcing the potential of this off-the-shelf therapy for patients with very limited treatment options."

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

In a poster presentation delivered by Dr. Xian Zhang of Hebei Yanda Ludaopei Hospital, researchers analyzed pooled safety and efficacy data from multiple Phase 1/2 studies, conducted across five academic centers in China, evaluating CTD402 in 15 adolescent and pediatric patients with a median age of 15 years (range 10-17). Despite treating a challenging patient population who had received a median of two prior lines of therapy (range 1-5), with 26.7% having primary refractory disease, 60% with extramedullary disease, and 60% with high-risk molecular features, the therapy demonstrated an impressive 80% complete remission rate (12/15 patients), with 83.3% of responders (10/12) achieving MRD-negative status.

The safety profile was favorable, with 66.7% experiencing predominantly mild Grade 1-2 CRS and notably no neurotoxicity or severe infections observed. CAR-T cells persisted for at least 28 days in 66.7% of patients, with some showing persistence up to 90-180 days, and at a median follow-up of 21.94 months, median overall survival was not reached in patients who received consolidative allogeneic transplant, compared with 4.8 months in non-transplant patients (p=0.026), highlighting the potential benefit of post-CAR-T consolidation strategies.

"These encouraging results from our pediatric cohort underscore CTD402’s potential to transform care for patients with R/R T-ALL/LBL," said Imviva Biotech Chief Medical Officer Jan Davidson-Moncada, MD, PhD. "The combination of strong efficacy—with 80% of pediatric patients achieving complete remission—and a favorable safety profile, alongside CTD402’s immediate availability as an off-the-shelf therapy, demonstrates the potential to address a critical unmet need in this patient population."

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

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, JUN 11, 2026, View Source [SID1234666591])

Arima Genomics to Present Data at AMP Europe Showing Hi-C Sequencing Outperforms High-Coverage Whole Genome Sequencing for Lymphoma Rearrangement Detection

On June 11, 2026 Arima Genomics, Inc., a cancer diagnostics company bringing DNA sequence and structure together to advance cancer therapy selection, reported new data to be presented at the Association for Molecular Pathology (AMP) 2026 Europe Congress, taking place June 15–17, 2026, in Tallinn, Estonia.

The new findings demonstrate that Arima’s Hi-C sequencing-based approach, available clinically through the Aventa Lymphoma test, identified clinically relevant lymphoma rearrangements missed by high-coverage whole genome sequencing (WGS), including rearrangements involving key lymphoma-associated genes such as MYC, BCL2, BCL6, CCND1, and IRF4. The presentation builds on previously presented data showing Hi-C sequencing can overcome limitations of fluorescence in situ hybridization, or FISH, by enabling genome-wide detection of diagnostic, prognostic, and therapeutic biomarkers from FFPE lymphoma specimens.

In the WGS comparison study, 25 FFPE lymphoma specimens containing 37 clinically relevant structural variants previously identified by Hi-C sequencing and validated by orthogonal methods were analyzed using high-coverage WGS. Despite average raw sequencing coverage of 180×, with a range of 132× to 238×, many rearrangements remained undetected by two different WGS analysis pipelines. The DRAGEN Somatic Pipeline identified 19 of 37 rearrangements, representing just 51% recall when compared to Hi-C sequencing, while Sentieon TNscope showed improved but still incomplete detection, with performance particularly limited for immunoglobulin-associated rearrangements.

WGS detection was lower for rearrangements involving immunoglobulin partners than for non-immunoglobulin rearrangements. DRAGEN detected seven of 16 (44%) immunoglobulin-associated rearrangements and 12 of 21 (57%) non-immunoglobulin rearrangements, while Sentieon TNscope detected eight of 16 (50%) and 15 of 21 (71%), respectively. Key lymphoma-associated genes were also missed across both pipelines: BCL6 was missed in three of 11 cases (27%) by Sentieon and four of 11 cases (36%) by DRAGEN; MYC was missed in four of eight cases (50%) by both algorithms; and BCL2 was missed in two of six cases (33%) by both algorithms.

"Rearrangements are central to lymphoma diagnosis and classification, but they remain challenging to detect reliably with methods that were not designed to directly capture genome structure," said Anthony Schmitt, PhD, Senior Vice President, Science, Arima Genomics. "These data show that even deep whole genome sequencing can miss a substantial fraction of clinically relevant rearrangements in FFPE lymphoma specimens. By providing a more direct view of genome structure, Hi-C sequencing enables high-resolution detection of rearrangements that are critical for accurate lymphoma workup. Together with prior data showing advantages over FISH, these findings support Hi-C as a powerful approach for comprehensive rearrangement detection in routine lymphoma biopsies."

Arima will also present additional data demonstrating Hi-C sequencing shows superior performance to FISH. These data further support the use of Hi-C sequencing as a genome-wide approach to detect guideline-recommended and emerging cytogenomic biomarkers in lymphoma.

Presentation Details

Title: Hi-C FFPE Sequencing Outperforms High-Coverage WGS for Detection of Diagnostic Fusions and Rearrangements in Lymphoma

Oral Presentation:
Abstract Presentation Session 3 – Hematopathology: Wednesday, 17 June 2026, 13:00–14:00 EEST
Poster Session 2:
Poster Number H-04: Wednesday, 17 June 2026, 9:00–9:45 EEST
Title: Hi-C FFPE Sequencing for Detection of Fusions and Rearrangements that are Diagnostic, Prognostic, and Therapeutic Biomarkers in Lymphoma

Poster Session 2:
Poster Number H-10: Wednesday, 17 June 2026, 9:00–9:45 EEST

(Press release, Arima Genomics, JUN 11, 2026, View Source [SID1234666590])

Anocca has Dosed First Patients with Precision TCR-T Cell Therapy Targeting Mutant KRAS in Pancreatic Cancer

On June 11, 2026 Anocca AB (‘Anocca’ or the ‘Company’), a clinical-stage biotechnology company developing advanced T-cell immunotherapies, reported the successful dosing of the first patients across multiple clinical sites with ANOC-001, a novel T cell receptor-modified T cell therapy (TCR-T)[1] targeting KRAS G12V mutations in an aggressive form of pancreatic cancer.

ANOC-001 is the first product to enter Anocca’s VIDAR-1 clinical programme, which focuses on pancreatic ductal adenocarcinoma (PDAC). The therapy is designed for patients whose tumours carry a specific mutation in the KRAS gene. The product candidate has been discovered, developed and manufactured by Anocca at its in-house facilities in Sweden. ANOC-001 is the first non-viral gene-edited T cell therapy to be evaluated in Europe, with the deployment of this technology enabling scalable product development and future commercialisation.

Pancreatic cancer remains one of the deadliest cancer types, with a five-year survival rate below 10% (1). Despite recent advances there are currently no definitive treatments for patients with progressed disease (2). KRAS mutations are one of the most common cancer mutations and are implicated in pancreatic, lung and colorectal cancers. G12V and G12D mutations in KRAS affect around 90% of pancreatic cancer patients. VIDAR-1 addresses this unmet need by engineering the immune system’s T-cells to recognise and attack cancer cells carrying the KRAS mutation.

Reagan Jarvis, co-founder and Chief Executive Officer of Anocca, said: "The dosing of patients marks an important milestone for Anocca, and demonstrates our ability to develop, manufacture and clinically deploy precision TCR-T cell therapy products. The novel ANOC-001 clinical candidate was developed with Anocca’s proprietary analytical platform that maps targets and identifies, characterises and engineers T-cell receptors. We are grateful to our team, investors and partners whose efforts and participation made this milestone possible."

Hugh Salter, Chief Scientific Officer, added: "The VIDAR-1 clinical programme is designed to evaluate multiple TCR-T product candidates targeting distinct KRAS mutations and HLA combinations [2]. ANOC-001 is the first product in this series and additional products targeting different forms of mutant KRAS will be introduced into the uniquely designed clinical programme. By using non-viral gene editing technology, we are able to scale delivery of highly precise therapies to broader patient populations. We would like to thank our clinical collaborators for their support as well as the study participants and their families."

Recruitment and manufacture are ongoing for Phase I of the multi-centre VIDAR-1 trial, which is being conducted at eight leading university hospitals across Sweden, Denmark, Germany, and The Netherlands.

(Press release, Anocca, JUN 11, 2026, View Source [SID1234666589])

Immunome Announces First Patient Dosed in Phase 1 Trial Evaluating IM-1617, a Potential First-in-Class ADC, in Patients with Advanced Solid Tumors

On June 11, 2026 Immunome, Inc. (Nasdaq: IMNM), a biotechnology company committed to developing first-in-class and best-in-class targeted cancer therapies, reported that the first patient has been dosed in the Phase 1, first-in-human trial of IM-1617, a potential first-in-class ADC directed at an undisclosed solid tumor target and incorporating HC74, Immunome’s proprietary TOP1 inhibitor payload.

"The first patient dosed with IM-1617 is a significant milestone for Immunome’s ADC platform and a meaningful step toward our mission of delivering targeted therapies for patients with cancer," said Clay Siegall, Ph.D., President and Chief Executive Officer of Immunome. "We are encouraged by the pace of progress across our portfolio and look forward to advancing IM-1617 while continuing to expand the clinical potential of our proprietary HC74 payload through additional ADC programs."

The Phase 1 trial is an open-label, multicenter dose escalation and expansion study designed to determine the safety, tolerability, pharmacokinetics, and preliminary anti-tumor activity of IM-1617. The study is expected to include participants with advanced solid tumors, including colorectal cancer, non-small cell lung cancer, and breast cancer.

About IM-1617

IM-1617 is a clinical-stage solid tumor ADC. It targets an undisclosed receptor tyrosine kinase that promotes tumor cell survival and mediates immune cell exclusion, and it incorporates HC74, Immunome’s proprietary TOP1 inhibitor. Preclinical in vivo efficacy studies showed impressive tumor regression after a single, clinically relevant dose of IM-1617 in a variety of solid tumor models.

(Press release, Immunome, JUN 11, 2026, View Source [SID1234666588])

Guardant Health Announces FDA Approval of Guardant360 CDx as Companion Diagnostic for Boehringer Ingelheim’s HERNEXEOS®

On June 11, 2026 Guardant Health, Inc. (Nasdaq: GH), a leading precision oncology company, reported that the U.S. Food and Drug Administration (FDA) has approved Guardant360 CDx as a companion diagnostic (CDx) for Boehringer Ingelheim’s HERNEXEOS (zongertinib tablets), the first targeted therapy for adults with HER2 (ERBB2)-mutant advanced non-small cell lung cancer (NSCLC) as an initial treatment option.

The approval enables Guardant360 CDx, a liquid biopsy test that analyzes circulating tumor DNA (ctDNA) from a simple blood draw, to identify patients with HER2 (ERBB2) tyrosine kinase domain activating mutations who may be eligible for treatment with HERNEXEOS.

HERNEXEOS is indicated for the treatment of adult patients with unresectable or metastatic non-squamous NSCLC whose tumors have HER2 (ERBB2) tyrosine kinase domain activating mutations, as detected by an FDA-authorized test. This indication was approved under accelerated approval based on objective response rate and duration of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial. More information and full prescribing information can be found at HERNEXEOS.com.

"This approval highlights the growing impact of liquid biopsy across advanced cancer care and underscores the utility of Guardant360 CDx to ensuring more patients can be matched to the right therapy at the right time," said Helmy Eltoukhy, Guardant Health chairman and co-CEO. "Guardant360 CDx has been at the forefront of enabling comprehensive genomic profiling through a simple blood draw, helping clinicians identify actionable mutations in genes such as HER2 with speed and accuracy."

Guardant360 CDx was the first FDA-approved liquid biopsy that provides comprehensive genomic profiling across multiple tumor types and biomarkers. By detecting tumor-derived alterations in circulating cell-free DNA, the test helps clinicians match patients to appropriate targeted therapies and clinical trials.

"Companion diagnostics are essential to personalized lung cancer care, guiding biomarker-driven treatment decisions," added Vicky Brown, U.S. Therapeutic Area Head for Oncology and Emerging Areas, Boehringer Ingelheim. "Guardant360 CDx will help identify patients with HER2-mutant advanced non-small cell lung cancer and connect eligible patients to the appropriate targeted therapy when timely treatment decisions matter most."

NSCLC is the most common type of lung cancer, and a subset of patients harbor HER2 mutations that may be targetable with precision therapies. HER2-mutant NSCLC is an aggressive type of lung cancer that has been associated with a poor prognosis. Blood-based testing offers a faster, less invasive alternative to tissue biopsy, which can be challenging in advanced disease.

This latest FDA approval for Guardant360 CDx marks the 27th CDx indication across multiple tumor types globally, building on the platform’s increasing clinical utility and broad coverage by Medicare and commercial payers, representing more than 300 million covered lives.

For more information about Guardant360 CDx, visit www.guardanthealth.com.

About Guardant360 CDx

Guardant360 CDx is the first FDA-approved liquid biopsy for comprehensive genomic profiling. It detects multiple genomic alterations across all solid tumors and is approved as a companion diagnostic for therapies in non-small cell lung cancer, breast cancer, and colorectal cancer.

(Press release, Guardant Health, JUN 11, 2026, View Source [SID1234666587])