News Highlights – June 2021
06/07/2021
The beginning of this summer saw an important landmark with the WHO report on AI application in healthcare, which includes the six key principles for AI design and use: autonomy, beneficence, transparency, responsibility and accountability, equity and sustainability. The report release is aligned with recent proliferation of AI platforms for big data management and data generation as well as for implementing diagnostic analysis. Just this June FDA granted Ibex with the Breakthrough Device Designation for its AI-based platform applied to IHC image analysis; and PathAI presented a quality control system for HER2 IHC analysis based on a machine learning algorithm during ASCO 2021. Moreover, Philips has been selected as the national partner in the Netherlands for creating the infrastructure for image data exchange.
June marked important developments beyond Europe and the US. In Japan, Eiken Chemical has started a partnership with Illumina to provide IVD kits for the MiSeq Dx platform, and AmoyDx received the MHLW approval for their Pan Lung Cancer PCR Panel. In Brazil, Dasa has performed further acquisitions consolidating its position in the Northeast and diversifying its product portfolio. Additionally, recent study on the use of OncotypeDx may lead to broader adoption by the SUS, a major win for Brazilian patients. Saudi Al Borg labs might also file for an IPO, fueling its leadership for biomarker testing in the gulf region. In South Korea, VUNO is expanding its services towards digital pathology, empowered also by a partnership with Samsung. In China, the partnerships Berry Oncology with Alibaba and Natera with BGI will lead to disruptive changes in the market and will have consequences in the international landscape.
On the MRD run, Guardant, Inivata and Natera have presented strong data during ASCO. Natera has taken the spotlight with the CIRCULATE-Japan data, the ADLT status for Signatera and the agreements with FMI and BGI.
I/O field saw multiple approvals, with Infigratinib for the treatment of cholangiocarcinoma (US), tislelizumab for NSCLC and hepatocellular carcinoma (China), pembrolizumab combined with chemotherapy for esophageal cancer or HER2-negative gastroesophageal junction adenocarcinoma and nivo+ipi for the treatment of Mismatch Repair Deficient or MSI-H metastatic colorectal cancer (EU).
Regarding targeted therapies, AstraZeneca and HUTCHMED’s savolitinib was granted conditional approval by NMPA for NSCLC patients with MET exon 14 skipping alterations. FDA also granted Mirati’s adagrasib with a breakthrough designation, following Amgen’s sotorasib last month.
Summary of news (with links)
Regulatory decisions on Rx (12) |
- Janssen Announces U.S. FDA Breakthrough Therapy Designation Granted for Teclistamab for the Treatment of Relapsed or Refractory Multiple Myeloma
- Onco360® selected by Amgen to be a specialty pharmacy partner for LUMAKRAS™ (sotorasib)
- BeiGene Announces Acceptance of a Supplemental Biologics License Application in China for Tislelizumab in Microsatellite Instability-High (MSI-H) or Mismatch Repair-Deficient (dMMR) Solid Tumors
- BERGENBIO RECEIVED FDA FAST-TRACK DESIGNATION FOR BEMCENTINIB / ANTI-PD-(L)1 COMBINATION IN NSCLC
- China NMPA Approves Tislelizumab in Non-Small Cell Lung Cancer and Hepatocellular Carcinoma
- Mirati Therapeutics' Adagrasib Receives Breakthrough Therapy Designation from U.S. Food and Drug Administration for Patients with Advanced Non-Small Cell Lung Cancer Harboring the KRASG12C Mutation
- Bristol Myers Squibb Receives Positive CHMP Opinion for Opdivo (nivolumab) as Adjuvant Treatment for Esophageal or Gastroesophageal Junction Cancer Patients with Residual Pathologic Disease Following Chemoradiotherapy
- European Commission Approves Merck’s KEYTRUDA® (pembrolizumab) Plus Chemotherapy for Certain Patients With Esophageal Cancer or HER2-Negative Gastroesophageal Junction (GEJ) Adenocarcinoma
- Orelabrutinib Lands FDA Breakthrough Therapy Designation for R/R MCL
- SNDX-5613 Granted FDA Fast Track Designation for the Treatment of Relapsed/Refractory Acute Leukemias
- Bristol Myers Squibb Receives European Commission Approval for Opdivo (nivolumab) Plus Yervoy (ipilimumab) for the Treatment of Mismatch Repair Deficient or Microsatellite Instability–High Metastatic Colorectal Cancer After Prior Chemotherapy
- Orpathys approved in China for patients with lung cancer and MET gene alterations
Dx approvals, market access and reimbursement (7) |
- Ibex Granted FDA Breakthrough Device Designation
- Lucid Diagnostics Obtains CE Mark for Esophageal Cancer Molecular Test
- Kheiron’s AI Breast Screening Solution Mia® Receives Regulatory Clearance in Australia and New Zealand
- WHO issues first global report on Artificial Intelligence (AI) in health and six guiding principles for its design and use
- AmoyDx® Pan Lung Cancer PCR Panel Receives MHLW Approval as Companion Diagnostic for 9 Targeted Therapies for Use in Patients with Advanced Non-Small Cell Lung Cancer
- VUNO Acquires Ministry of Food and Drug Safety Certification for 'VunoMed Passquant', an AI solution for digital pathology analysis
- Natera Awarded Advanced Diagnostic Laboratory Test (ADLT) Status for its Signatera® MRD Test From CMS
Latest diagnostic developments, investment and CDx deals (21) |
- Intensity Therapeutics’ INT230-6 demonstrates efficacy as either monotherapy or in combination with checkpoint inhibitors in patients with relapsed, refractory, metastatic solid tumors
- As ASCO 2021 Spotlights Biomarkers, New InCrowd Data Shows 80% of US Oncologists Anticipate Broader Liquid Biomarkers Use, Despite Insurance Barriers
- Agilent announces new SureSelect Human All Exon V8
- Humanetics Corporation Receives Funding From Regenerative Medicine Minnesota to Study New Drug for Triple Negative Breast Cancer
- Invitae opens early access to liquid biopsy-based Personalized Cancer Monitoring as a central laboratory service
- GRAIL Presents Interventional PATHFINDER Study Data at 2021 ASCO Annual Meeting and Introduces Galleri, a Groundbreaking Multi-Cancer Early Detection Blood Test
- NIH Earmarks $38M for Consortium Studying Polygenic Risk Scores in Diverse Populations
- PathAI to Present Machine Learning-based Quality Control Tool for HER2 Testing in Breast Cancer at the American Society of Clinical Oncology Virtual Scientific Program 2021
- Foundation Medicine Launches FoundationOne®Tracker ctDNA Monitoring Assay for Research Use in Partnership with Natera
- InterVenn Biosciences Announces Clinical Validation of World’s First Glycoproteomic Diagnostic Test
- New AI-Based Clinical Trial Matching Solution, Deep Lens’ Viper™, Expanding Offering to Cancer Patients at Norton Healthcare
- Umoja Biopharma Raises $210M in Series B Funding Round
- Guardant Health Expands Guardant360® Portfolio With New Tests for Treatment Response Monitoring and Complete Genomic Profiling
- Genomic Testing Cooperative Completes New York State Approval and Medicare (Palmetto) Coverage for all DNA and RNA Tests Offered for Molecular Profiling of Hematologic and Solid Tumors
- Liquid Biopsy Startup Adela Launches With $60M Series A Financing Round
- XCures Raises $12.7M in Series A Funding
- McGill University Health Center Receives $250K for Colorectal Cancer Research Program
- Synaffix Licenses its Award-Winning ADC Technology in Deal Adding a New ADC to Innovent’s Pipeline
- Foundation Medicine and Flatiron Health Announce First-of-its-Kind Integration of Genomic Profiling Into OncoEMR®
- Investcorp weighs taking Saudi Arabia’s chain of Al Borg medical labs public
- Liquid Biopsy MRD Research at ASCO Showcases Uses in Variety of Tumor Types, Indications
Clinical trials and drug development (19) |
- Intensity Therapeutics’ INT230-6 demonstrates efficacy as either monotherapy or in combination with checkpoint inhibitors in patients with relapsed, refractory, metastatic solid tumors
- LYNPARZA® (olaparib) reduced the risk of cancer recurrence by 42% in the adjuvant treatment of patients with germline BRCA-mutated high-risk early breast cancer in OlympiA Phase III trial
- Merck’s KEYTRUDA® (pembrolizumab) given after surgery reduced the risk of disease recurrence or death by 32% versus placebo as adjuvant therapy in patients with renal cell carcinoma (RCC)
- Bristol Myers Squibb presents data from CheckMate -648 showing Opdivo plus chemotherapy and Opdivo plus Yervoy significantly improved overall survival compared to chemotherapy in unresectable advanced or metastatic esophageal squamous cell carcinoma
- IMFINZI demonstrated unprecedented survival in unresectable stage III lung cancer with 43% of patients surviving five years
- Trodelvy® demonstrates superior outcomes to standard of care in second-line treatment of metastatic triple-negative breast cancer in Phase 3 ASCENT study
- Tarveda Therapeutics presents promising Phase 2 data of PEN-221 in gastrointestinal mid-gut neuroendocrine tumors
- Exelixis announces consistent efficacy benefits across subgroups of Phase 3 CheckMate -9ER Trial of CABOMETYX® (cabozantinib) in combination with OPDIVO® (nivolumab) as a first-line treatment for patients with advanced renal cell carcinoma
- Analysis of MINDACT study confirms MammaPrint accurately identifies extremely indolent ultra low risk breast cancers
- Greenwich LifeSciences publishes additional positive safety data from GP2 Phase IIb trial at ASCO 2021, confirming that GP2 treatment to prevent metastatic breast cancer recurrence is well tolerated
- Osel announces positive results from Phase 1b trial of Live Biotherapeutic Product CBM588 in combination with checkpoint inhibitor (CPI) therapy in metastatic renal cell carcinoma
- Lucence presents new data on liquid biopsy for late-stage cancer monitoring, treatment guidance
- Liquid biopsy-guided EGFR rechallenge therapy shows benefit for colorectal cancer patients
- Exelixis announces clinical trial collaboration and supply agreement with Bristol Myers Squibb to evaluate XL092 in combination with immuno-oncology therapies in advanced solid tumors
- DESTINY-Breast09 Head-to-Head First-Line Phase 3 trial of ENHERTU® initiated in patients with HER2 positive metastatic breast cancer
- FDA authorizes ImmunityBio study of Anktiva and PD-L1 t-haNK to increase effectiveness of trodelvy in triple-negative breast cancer
- A brain metastases research platform to tackle the challenge of CNS metastases in solid tumours (BrainStorm)
- KIYATEC clinical study data shows test accurately predicts brain cancer patient response to standard drug therapy prior to treatment
- Exelixis and Ipsen announce cabozantinib in combination with an immune checkpoint inhibitor significantly improved progression-free survival in Phase 3 COSMIC-312 pivotal trial in patients with previously untreated advanced liver cancer
Observational studies (5) |
- First phase results of MYLUNG Consortium provide historical view of biomarker testing patterns and identify data gaps for ongoing prospective research
- Agendia’s MammaPrint® Test is the first to demonstrate the ability to predict benefit from extended endocrine treatment in NSABP B-42 Trial
- New data published in JAMA Oncology demonstrate prognostic utility of Veracyte’s Decipher Prostate Genomic Classifier in locally advanced prostate cancer
- Foundation Medicine collaborates on research published in The New England Journal of Medicine that identifies resistance to KRAS inhibitors and underscores need for novel therapeutic strategies
- Resolution Bioscience (a part of Agilent) investigated acquired resistance to KRAS G12C inhibition
Merge and acquisitions (7) |
- Veracyte to acquire HalioDx, positioning for global cancer diagnostics growth
- Bayer acquires Noria and PSMA Therapeutics to expand pipeline in prostate cancer
- Danaher to acquire Aldevron for $9.6B
- Dante Labs acquires Cambridge Cancer Genomics
- Eurofins to acquire DNA Diagnostics Center to grow genetic testing capabilities and significantly expand further into the consumer testing market
- Novo Integrated Sciences and Novo Healthnet Limited complete acquisition of Acenzia
- Dasa announces acquisitions of more than R$1 billion
Partnerships (32) |
- Sesen Bio announces global supply partnership with Qilu Pharmaceutical
- Genmab and Bolt Biotherapeutics announce oncology research and development collaboration
- Onco360® selected by Takeda to be a specialty pharmacy partner for ALUNBRIG® (brigatinib)
- Nucleix Establishes Collaborative Research and License Agreement with MD Anderson to Develop Methylation Assays to Assess Lung Cancer Patients
- The Center for Cancer and Blood Disorders adopts novel AI-Matching Solution VIPER™ to expand Clinical Trial Program
- GoMeyra named technology partner for KSL Biomedical, Inc.
- Biodesix partners with Datavant to enhance value of Lung Cancer Databank
- Deepcell collaborates with UCLA to advance the study of cancer through AI-powered cell biology
- Personal Genome Diagnostics enters collaborative partnership with Clinical Molecular Diagnostics Laboratory of Major University Health System
- NanoString and Parker Institute for Cancer Immunotherapy collaborate to optimize cell therapies to treat cancer
- Chinese oncology specialist Zai Lab brokers a deal with MacroGenics for up to 4 bispecifics with a modest down payment
- PierianDx and Intermountain Healthcare combine expertise to advance Myriad Genetics’ tumor test offering
- Eisai and Bristol Myers Squibb enter into global strategic collaboration for Eisai’s MORAb-202 antibody drug conjugate
- Eiken Chemical and Illumina announce agreement to develop and commercialize a molecular diagnostic system in Japan
- Berry Oncology and Alibaba Health partner to offer early cancer screening, health services
- Biocept to collaborate with Quest Diagnostics to provide advanced NGS-based liquid biopsy testing for patients with lung cancer
- Eurofins Discovery and ImmunoPrecise announce collaboration to expand their antibody discovery platform
- Personal Genome Diagnostics and Massachusetts General Hospital enter strategic collaboration to advance development of precision diagnostics
- National Cancer Care Alliance partners with Deep Lens to position AI-Based Clinical Trial Matching Solution Viper™ as preferred technology for network
- Natera and BGI Genomics announce commercial launch of the BGI/Natera Signatera assay in China
- Nucleai, Merck KGaA Darmstadt Ink Biomarker Discovery Partnership
- Ixaka and SomaLogic enter research collaboration to develop bispecific agents for oncology
- xCures partners with Massive Bio to help advanced cancer patients find the right treatment options
- Dayton Physicians Network adopts Deep Lens’ Novel Clinical Trial Matching Solution, VIPER™, broadening research program and offering to patients
- Eli Lilly grants Acrivon Therapeutics worldwide license to develop DNA damage inhibitor prexasertib
- QIAGEN partners with Verogen to offer broadest portfolio for human identification, including next generation sequencing solutions
- Genomic Testing Cooperative Announces Collaboration with Elevation Oncology to expand comprehensive genomic testing for NRG1 fusions across solid tumors in support of the Phase 2 CRESTONE study
- Alpine Immune Sciences to Collaborate with Merck on Immuno-Oncology Study to Evaluate ALPN-202 in Combination with KEYTRUDA® (pembrolizumab)
- Al Jalila Children’s Specialty Hospital to examine intensive care genome sequencing workflow
- The Access to Comprehensive Genomic Profiling Coalition welcomes two new members - PGDx and Sema4
- VUNO inks deal with samsung electronics to embed AI-powered algorithms in Samsung's Premium Mobile X-ray System
- New milestone for the national and digital exchange of images between different pathology departments and labs
Giovanni Dothel, PhD - gdothel@ipbadvisors.com - Inflection Point Biomedical Advisors
Jaume Calafell - jcalafell@ipbadvisors.com - Inflection Point Biomedical Advisors