COMPANY:

Foresight Diagnostics

"Allogene Therapeutics...and Foresight Diagnostics (Foresight)...announced a strategic partnership to develop a minimal residual disease (MRD) in-vitro diagnostic (IVD) to determine eligibility in ALPHA3, the first pivotal trial for first line (1L) consolidation treatment of large B-cell lymphoma (LBCL). The ALPHA3 trial uses Foresight’s investigational PhasED-Seq™ ctDNA-MRD platform to identify patients with MRD after 1L treatment for LBCL. The study will evaluate whether such patients benefit from consolidation with cemacabtagene ansegedleucel, or cema-cel (previously known as ALLO-501A)....The ALPHA3 pivotal Phase 2 trial in first line (1L) consolidation for the treatment of LBCL is expected to begin mid-2024."

"Foresight Diagnostics...announced multiple studies that consistently demonstrated higher clinical sensitivity and prognostic accuracy of Foresight Diagnostic's PhasED-Seq circulating tumor DNA (ctDNA) technology compared to that of standard-of-care imaging in patients with lymphoma...The new data have been presented across four podium presentations and two posters during this year's American Society of Hematology (ASH) annual meeting....'We are pleased to share our findings at ASH specific to the molecular response and mutational genotypes seen in DLBCL patients undergoing treatment with ZYNLONTA^® (loncastuximab tesirine-lpyl [Lonca]) to collectively improve our approaches to using ctDNA for drug development and clinical decision making.'"

"Foresight Diagnostics...announced today that six studies utilizing their patented PhasED-Seq technology will be presented at the 65th American Society of Hematology Annual Meeting and Exposition (ASH 2023) taking place December 9-12, 2023, in San Diego, California. Four of these studies have been accepted as oral presentations....Building upon these findings, Foresight and its partners will present new data at ASH 2023 that further supports the utility of Foresight's ultrasensitive PhasED-Seq MRD platform for accurate treatment response assessment."

"Foresight Diagnostics...announced...that Mark Roschewski, MD, of the National Cancer Institute, part of the National Institutes of Health, will present pooled data from six recent clinical studies on June 14th at the 17th International Conference on Malignant Lymphoma in Lugano, Switzerland...These results suggest that MRD measured using PhasED-Seq at the end of treatment is highly prognostic in patients with DLBCL and that ultrasensitive assays like PhasED-Seq should be considered in the revised Lugano response criteria."

"Foresight Diagnostics, Inc...announced...that it has closed an oversubscribed Series B financing round of $58.75 million. The financing was led by Foresite Capital, with participation by Civilization Ventures, Bluebird Ventures, Pear Ventures, Agent Capital, Stanford University, and The University of Colorado Healthcare Innovation Fund. The proceeds will be used to accelerate the clinical development and commercialization of Foresight Diagnostics’ cancer recurrence testing platform, PhasED-Seq."

"Foresight Diagnostics...announced the presentation of a study in collaboration with a leading cancer center at the upcoming annual meeting of the American Association for Cancer Research (AACR). The poster...describes the results of a study evaluating the performance of the Foresight Solid Tumor Recurrence Test in patients with lung cancer."

"An analysis presented at the American Society of Hematology's annual meeting supports the routine analysis of minimal residual disease in patients with diffuse large B-cell lymphomas using Foresight Diagnostics' PhasED-Seq circulating tumor DNA test as a surrogate endpoint in future studies...The clinical sensitivity of the PhasED-Seq test was 94 percent for detecting future progression events with lead times as long as 30 months. On the other hand, 69 out of 70 patients who were MRD-negative at the end of therapy remained progression-free after a median follow-up of 17 months."

P1b | N=60 | First-MIND (NCT04134936) | Sponsor: MorphoSys AG | "Studies were conducted to determine if ultrasensitive detection of ctDNA MRD levels could accurately track response and predict curative outcomes following experimental first line (1L) therapy. Serial blood specimens were evaluated from patients enrolled in a randomized Phase Ib study in de novo DLBCL treated with tafasitamab in combination with lenalidomide & R-CHOP (T/LR-CHOP). Cell-free DNA was profiled using Foresight Diagnostics' PhasED-Seq assay, prior to treatment, to genotype each patient's tumor for phased variants (PVs). PV detection was used to monitor MRD in blood specimens collected following 1 cycle, 3 cycles, 6 cycles/end-of-treatment (EOT), and 6-months post-treatment. MRD positivity at each timepoint was associated with likelihood of future progression or death. The results showed that the absence of ctDNA MRD as measured by PhasED-Seq, strongly correlated with durable responses to T/LR-CHOP in DLBCL."

"Foresight Diagnostics, Inc...announced...that the U.S. Patent and Trademark Office (USPTO) has granted the company patent No. 11,447,833 for the detection of minimal residual disease (MRD) using its personalized phased variant detection platform...This granted patent covers Foresight's PhasED-Seq technology and the workflow behind the Foresight Solid Tumor Recurrence Test, an assay used to detect minimum residual disease (MRD) from the plasma of cancer patients using DNA sequencing."

"Personalis, Inc...announced...it has filed an amended complaint against Foresight Diagnostics. The amended complaint asserts a newly-issued patent in Personalis’ growing intellectual property portfolio relating to detection of molecular residual disease (MRD)...Personalis’ patent portfolio protects its groundbreaking work in whole genome sequencing to identify mutations that indicate the continued presence or recurrence of cancer with an unprecedented part-per-million sensitivity, which its recently-launched MRD solution, NeXT Personal, is uniquely designed to achieve."

"Personalis, Inc...announced today that it filed a lawsuit against Foresight Diagnostics Inc. for infringement of Personalis’ U.S. Patent Nos. 10,450,611, 11,299,783, and 11,384,394. These patents are part of Personalis’ intellectual property portfolio in the field of whole genome-enabled, tumor-informed molecular residual disease (MRD) testing...NeXT Personal is purpose-built to accurately detect MRD in patient samples with low overall ctDNA, which is particularly important for cancers that have low shedding or low mutational burden, such as breast and prostate cancers, or soon after resection."

P2, N=132; NCT04002947; "Foresight Diagnostics...announced results from an ongoing phase 2 clinical trial of the lymphoma drug acalabrutinib that included Foresight’s proprietary circulating tumor DNA (ctDNA) detection and minimum residual disease (MRD) monitoring assay, Phased variant Enrichment and Detection Sequencing (PhasED-Seq)....The study includes early results from 39 patients, 18 of which (46%) responded to acalabrutinib while 21 (54%) did not based on CT imaging. MRD measurements assessed using PhasED-Seq were strongly predictive of CT response as the log-fold change in ctDNA at the end of the acalabrutinib window correlated with change on CT (r=0.75, p=0.0013)."