News Highlights – January 2022

10/02/2022

This year’s opening was flagged by several announcements on clinical application of advanced tools for molecular diagnostics as well as new deals for precision oncology.

The JP Morgan Healthcare Conference showcased major healthcare companies and their strategic plans foreseen for 2022. Illumina introduced Chemistry X, a new breakthrough technology advancing current sequencing status, and the DRAGEN platform for cfDNA, cfRNA and methylation analysis. Seer presented its new system for proteomic profiling of plasma and serum samples, while 10xGenomic is ready to launch a new kit for RNA profiling of FFPE samples. Furthermore, Guardant announced the release of Smart Liquid Biopsy, boosting current screening performance of 360 CDx by 100 folds.

Among the partnerships announced by Illumina in this venue stood out the one with Roche, with a 15-years long non-exclusive agreement to develop new CDx through Illumina’s TruSight Oncology 500. Likewise, an agreement with Bristol Squibb Myers provides for the use of this platform to develop new CDx, including MSI analysis. A further partnership involves Illumina’s MySeqDx to be applied by Agendia for expanding testing capabilities in breast cancer. In China, Amoy Diagnostics’ Pan Lung Cancer PCR panel was adopted by Takeda as a CDx for Alunbrig (brigatinib) for the treatment of ALK+ NSCLC patients.

Within the digital pathology field a milestone decision was taken by Brazil healthcare institutions adopting Agendia’s Digital MammaPrint, which provides physicians with an AI-aided algorithm for the prediction of likelihood of distant recurrences through the analysis of digitized breast cancer slides.

Moreover, a cloud-based storage system for data analysis allowed scientists from Stanford University to beat the previous Guinness World Record for the fastest sequencing of human genome, with a diagnostic rate 12% higher than average to spot unidentified mutations.

On liquid biopsy this month, CE mark was granted to the NeoGenomics’ RaDaR liquid biopsy test for MRD analysis and prediction of cancer recurrence. Lucence presented an expanded version of LiquidHALLMARK kit for cfDNA which includes cfRNA analysis, while Epic Sciences released DefineMBC, a multianalyte approach for metastatic BC patients with lack of tissue, comprising IF-based assay for HER2 and ER, WGS single-cell analysis on CTCs and NGS of cfDNA. Leiden University and the Biotech Support group validated a protein-based liquid biopsy test as a prognostic tool for cancer assessing the proteins expressed in the tumor microenvironment. Moreover, clinical evidence supporting Bluestar’s NGS test predictive value for pancreatic cancer’s blood samples was presented at the ASCO GI symposium.

As for drugs’ regulatory decisions, Pfizer’s Lorviqua (lornatinib) was approved by the EMA for the treatment of advanced ALK+ NSCLC patients. FDA granted a fast track designation to Celularity’s CYNK-101 in combination with chemotherapy, trastuzumab, and pembrolizumab for the treatment of advanced HER2-positive gastric or gastroesophageal junction adenocarcinoma (G/GEJ). Fast track designations for BC were granted to enobosarm (Ostarine), a new AR inhibitor for AR+/ER+/HER- mBC; gedatolisib for HR+/HER2- mBC, while a supplement biologics license application (sBLA) was assigned to Enhertu (fam-trastuzumab deruxtecan-nxki), granting its priority review for the treatment of adult patients with unresectable or HER2-positive mBC. For NSCLC, a breakthrough designation was accorded to Cullinan Oncology's TAS6417 (CLN-081) for the treatment of locally advanced NSCLC patients harboring EGFR exon 20 insertion mutation, previously treated with platinum-based systemic chemotherapy. In addition, Genprex’s gene therapy REQORSA combined with pembrolizumab received fast track designation for the Treatment of NSCLC. UK NICE, after having accepted AstraZeneca’s Lynparza (olaparib) for the treatment of prostate cancer in Scotland, denied its application in England and Wales due to insufficient cost-effectiveness.

Updates on clinical trials of targeted therapies include AstraZeneca’s Tagrisso (osimertinib), showing durable response in EGFR+ NSCLC patients with CNS Metastases. Merck’s Keytruda (pembrolizumab) adjuvant treatment showed positive results on disease-free survival in patients with stage IB-IIIA NSCLC and a prolonged overall survival (OS) in patients with hepatocellular carcinoma. AstraZeneca’s Imfinzi (durvalumab) plus chemotherapy, showed an improvement in OS and progression-free survival (PFS) versus chemotherapy alone as a 1st-line treatment for patients with advanced biliary tract cancer. Primary endpoint of OS was met by BeiGene’s tislelizumab plus chemotherapy as a first-line treatment for patients with PD-L1+ unresectable or metastatic G/GEJ.

Summary of news (with links)

 

Regulatory decisions on Rx (13)

 

 

Dx approvals, market access and reimbursement (1)

 


Latest diagnostic developments, investment and CDx deals (24)

 

Clinical trials and drug development (20)

 

 

Observational studies (3)

 

 

Merge and acquisitions (3)

 

 

Partnerships (21)

 

 

Giovanni Dothel, PhD - gdothel@ipbadvisors.com - Inflection Point Biomedical Advisors

Jaume Calafell - jcalafell@ipbadvisors.com - Inflection Point Biomedical Advisors