TEST:

BostonGene Tumor Portrait™ Test

Conclusions The presented liquid biopsy-based approach demonstrates the feasibility of identifying malignant cell fraction, BCR repertoires, clinically significant mutations, and immune and tissue specific processes from cfRNA. This study also suggests that the cfRNA platform may support longitudinal monitoring of CLL progression and relapse, as well the development of MRD tests with future validation.

"Fujita Health University and BostonGene, a leading provider of AI-driven molecular and immune profiling solutions, announced today that the Fujita Health University Haneda Clinic will now offer genomic profile testing for cancer patients utilizing the BostonGene Tumor Portrait test."

Ethics Approval The use of clinical samples was conducted in accordance with the Declaration of Helsinki and has been granted exemption from ethics approval by the Biomedical Research Alliance of New York (BRANY) Institutional Review Board (BRANY study #22-12-938-853).Download figure Open in new tab Download powerpoint Abstract 183 Figure 1 Oncoplot showing top ten actionable biomarkers per sample in the whole cohort (left). Bubble-plot showing frequency of diagnostic fusions & TME subtypes (right)View this table:View inline View popup Download powerpoint Abstract 183 Table 1 Clinicopathologic data of included patients (N=356) and actionable finidings

Angiosarcoma tumor profiling also uncovered potentially targetable and clinically relevant alterations in these tumors, which may expand treatment options. Ethics Approval The use of clinical samples was conducted in accordance with the Declaration of Helsinki and has been granted exemption from ethics approval by the Biomedical Research Alliance of New York (BRANY) Institutional Review Board (BRANY study #22-12-938-853).View this table:View inline View popup Download powerpoint Abstract 161 Table 1 Genomic and transcriptomic alterations identified in the analyzed samples of angiosarcoma patients (N = 39)View this table:View inline View popup Download powerpoint Abstract 161 Table 2 Characteristics of patients with available information about prior ICI therapy

P=N/A; Not yet recruiting --> Recruiting

"BostonGene...announced that eight abstracts were selected for poster presentations at the American Association for Cancer Research (AACR) Annual Meeting 2024, which will be held from April 5 - 10, at the San Diego Convention Center in San Diego, CA. BostonGene will exhibit at booth #847....This study shows the feasibility and utility of comprehensive molecular profiling to match patients to WES-informed treatments within a clinically relevant time frame. The high rate of additional actionable findings identified by BostonGene’s analytical platform suggest comprehensive testing may offer benefit over traditional targeted panels in solid tumor patients."

"BostonGene...today announced its participation in the Molecular Analysis for Combination Therapy Choice (ComboMATCH) precision medicine initiative as a designated laboratory. ComboMATCH is a follow-up to the largest precision medicine clinical trial, the National Cancer Institute (NCI)-MATCH trial. ComboMATCH aims to overcome drug resistance to single-drug therapies by developing targeted drug combinations. NCI is a part of the National Institutes of Health....A unique initiative to test new combinations of cancer drugs guided by tumor biology, ComboMATCH aims to pair patients with locally advanced or advanced solid tumors with a therapy that has the potential to manage their cancer. The study will also assist physicians in devising more effective treatment strategies."

Clinically significant findings, such as ABC COO (n = 16), TP53 loss (n = 13), DHITsig+ (n = 6), and CARD11 mutations associated with ibrutinib resistance (n = 3), were identified in 33 samples... Our results show the clinical utility and acceptable TAT of using a comprehensive WES and RNA-seq assay on a cohort of lymphoma patients. The produced BostonGene Tumor PortraitTM test reports included findings on significant alterations, LymphGen and LME subtypes, COOs, and potential clinical trial matches. These robust findings, coupled with the rapid TAT, demonstrate the feasibility of using integrated WES and RNA-seq to guide clinical decision-making in lymphoma patients.

P=N/A, N=400, Not yet recruiting, BostonGene

"BostonGene...and the Sarcoma Oncology Center, announced a collaboration to expedite the availability of DeltaRex-G. This groundbreaking platform therapy, authorized by the FDA's Center for Biologics Evaluation and Research (CBER), holds immense promise for patients battling advanced pancreatic cancer, osteosarcoma, soft tissue sarcoma, and breast cancer. The designation of DeltaRex-G, a CCNG1 inhibitor, as a platform therapy with the potential to incorporate other FDA-approved drugs, was enabled by BostonGene's pivotal identification of elevated CCNG1 levels in these different cancer types."

Sponsored by Geagen; Sponsored by Boston Gene

"BostonGene...announced its abstract has been accepted for poster presentation at the 2023 CTOS Annual Meeting being held November 1-4, 2023, in Dublin, Ireland."

"BostonGene...and FibroFighters...have announced a collaboration to advance clinical care for FLC patients. FLC is a rare form of liver cancer typically diagnosed in adolescents and young adults under 40. FibroFighters has partnered with BostonGene to leverage their AI and molecular profiling techniques to gain deeper insights and identify targeted treatments. The partnership focuses on strategies to drive patient-centric engagement. FibroFighters will actively promote access to the BostonGene Tumor Portrait test, a revolutionary diagnostic test that unveils critical information about each tumor, including immune microenvironment properties, actionable mutations, biomarkers for therapy response, and recommended treatment strategies."

"BostonGene...announced the BostonGene and Exigent Genomic INsight (BEGIN) Study, designed to demonstrate the clinical benefits of using BostonGene Tumor Portrait^™ test for advanced cancer patients in a community setting. The BEGIN Study will validate improved patient outcomes by tailoring treatments based on combined WES and RNA-seq coupled with AI-powered analytics....As part of the BEGIN study, BostonGene will perform comprehensive analysis using the BostonGene Tumor Portrait^TM test, including DNA whole exome (WES) and RNA transcriptome (RNAseq) sequencing, on patient tumor samples from participating Exigent sites. The study aims to determine the utility and frequency of actionable findings identified by a comprehensive sequencing approach in advanced cancer patients in a real-world setting. The trial will also assess the impact of the BostonGene Tumor Portrait^TM test findings on treatment decisions..."

"BostonGene...NEC Corporation...and Japan Industrial Partners...announced the formation of BostonGene Japan Inc., a Tokyo-based joint venture aimed at advancing personalized medicine and dramatically improving patient outcomes. The new company will utilize BostonGene’s high-complexity molecular technology and advanced biocomputational algorithms, including BostonGene Tumor Portrait™ tests, to accelerate the development and validation of novel precision medicine approaches."

All six patients with treatment data received chemotherapy, and of these patients, additional therapies included single-agent pazopanib (n = 2), combination chemotherapy plus ICI (n = 2)... BostonGene's Tumor Portrait® test identified clinically relevant findings for 9 RIS patients, who received integrated WES and RNA-seq testing. Over 50% of RIS patients had an IE TME subtype, which indicated the probability of a favorable response to ICI. Integrated WES and RNA-seq analysis can be used to select targeted molecular-based therapies and identify clinical trials for RIS patients.

"BostonGene...announced that four abstracts have been accepted for poster presentations and two abstracts have been accepted for online publication for the 2023 ASCO Annual Meeting (ASCO), which will be held June 2 – 6, 2023, at McCormick Place Convention Center in Chicago, IL. BostonGene will also exhibit at booth 28155."

"BostonGene announced...the launch of its CLIA-certified and CAP-accredited Liquid Biopsy, Immunoprofiling and Spatial Proteomics solutions that provide a holistic view of a patient’s disease by integrating multiple AI-based molecular and immune profiling techniques that analyze tumor, microenvironment, and host immunity. The new offerings, in addition to the BostonGene Tumor Portrait test, will support and improve the efficacy of clinical trials and research and development efforts. The solutions will ensure clinical trial populations are well-defined and representative, assess the safety and effectiveness of treatment while monitoring side effects and select the appropriate patient populations for myriad therapies."

In order to target HER2, systemic treatment was changed to a combination containing trastuzumab and pertuzumab, resulting in pathological complete response...Staining showed high PDL-1 (CPS50), prompting a change in therapy to an anti-PDL-1 (pembrolizumab) therapy... RNA-seq is emerging as an objective tool to evaluate key diagnostic and targetable events in multiple cancer types. The use of RNA-seq can also add value as an objective measurement to confirm critical IHC findings, potentially changing clinical care.

A deep interrogation of our integrated approach to genomic and transcriptomic profiling confirmed the advantages of a unified molecular analysis of tumor traits. We identified clinically significant biomarkers based on molecular features, demonstrated additional capabilities of TME analysis, and illustrated significant correlations between WTS and IHC data. These findings indicate that comprehensive WTS and WES analysis can assist clinicians in optimizing treatment plans as the landscape of personalized therapy continues to grow.