COMPANY:

Foresight Diagnostics

"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)."

"Foresight Diagnostics today announced publication of studies demonstrating unprecedented analytical and clinical sensitivity of the Company’s proprietary circulating tumor DNA (ctDNA) detection platform for minimal residual disease (MRD) detection in B-cell lymphomas. The data showed that Phased variant Enrichment and Detection Sequencing (PhasED-Seq) nearly doubled the identification of aggressive lymphoma patients not cured with standard therapy and thus in need of new treatment strategies."

“Foresight Diagnostics…will be presented at the 16th International Conference on Malignant Lymphoma (ICML) on June 18-22, 2021. The oral presentation demonstrates the utility of Foresight Diagnostics’ proprietary PhasED-Seq technology to improve MRD detection rates in DLBCL patients in low-disease burden settings…The presentation, titled ‘Phased variants improve DLBCL minimal residual disease detection at the end of therapy’ will be presented during Session 3: Aggressive Lymphomas (Channel 3) on Sunday, June 20 at 17:45-19:15 (CEST).”

“Foresight Diagnostics…announced today that two abstracts that report the clinical performance of its minimal residual disease (MRD) detection platform in diffuse large B-cell lymphoma (DLBCL) and non-small cell lung cancer (NSCLC) were chosen for presentation at the virtual 2021 American Society of Clinical Oncology (ASCO) Annual Meeting on June 4-8, 2021…Phased variants improve DLBCL minimal residual disease detection at the end of therapy…Leveraging phased variants for personalized minimal residual disease detection in localized non-small cell lung cancer.”

"Foresight Diagnostics today announced the close of its $12.5M Series A financing led by Civilization Ventures and Bluebird Ventures, with participation by Pear Ventures, to commercialize the industry’s most sensitive minimal residual disease (MRD) detection assay. Foresight’s approach is based on a proprietary technology developed at and licensed from Stanford University called PhasED-Seq (Phased Variant Enrichment & Detection Sequencing). Based on a simple blood draw and next-generation sequencing, PhasED-Seq screens for evidence of residual cancer by testing patient plasma samples for the presence of circulating tumor DNA (ctDNA)."