On April 7, 2021 Nucleix, a liquid biopsy company revolutionizing cancer treatment by detecting the disease earlier, reported that it has secured $55 million from a syndicate of leading life science investors in an oversubscribed financing round (Press release, Nucleix, APR 7, 2021, View Source [SID1234577700]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

The round was led by RA Capital Management, with participation from new investors including funds and accounts managed by BlackRock, Lilly Asia Ventures, LYFE Capital and MILFAM. Existing investors participating in the round include OrbiMed, Aurum Ventures, DSC Investment, OCI Bio Investments and Zohar Zisapel. Nucleix will utilize the proceeds of the financing to continue the rapid advancement of its unique methylation technology, known as EpiCheck, and to develop Lung EpiCheck, its lead product for the early detection of lung cancer.

"Early detection of cancer from a blood sample is like listening for a whisper in a crowded room – you need to separate a faint signal from considerable background noise. EpiCheck minimizes sample loss and background noise while detecting minute cancer epigenetic signals with greater sensitivity than other technologies," said Chris Hibberd, chief executive officer of Nucleix. "This new funding enables us to further demonstrate the power of the technology through a focused program in lung cancer, advancing tests designed to be highly sensitive, easily deployed and cost effective."

EpiCheck is an ultra-sensitive technology for the detection of methylation changes and is compatible with both next-generation sequencing (NGS) and polymerase chain reaction (PCR) platforms. Nucleix is applying the NGS application of EpiCheck for deep discovery, to reveal new biomarkers that may be used in the early detection and monitoring of cancer. In turn, these discoveries can be advanced as highly sensitive tests using the PCR application of EpiCheck, with the potential to run cost-effectively in both centralized and local laboratories.

Lung EpiCheck is a highly sensitive, methylation-based blood assay for the early detection of lung cancer. The test analyzes subtle, disease-specific changes in DNA methylation markers meeting the needs of its target population – current and past smokers – to catch cancer earlier when treatment can be most effective. In October 2020, clinical data on the first generation of Lung EpiCheck was published in the European Respiratory Journal. Nucleix is now developing an improved version of the assay and will initiate a prospective study to validate the test, with the goal of making it available in 2022.

"The U.S. Preventive Services Task Force (USPSTF) recently updated the screening guidelines for high-risk lung cancer patients to double the number of people who qualify for annual screening1, but a challenge remains as less than 10% of those eligible in the United States follow the guidelines today," said Aharona Shuali, M.D., VP Medical. "Lung EpiCheck has the potential to provide an effective screening option that increases compliance and drives more patients to follow guidelines in the United States – increasing chances of patients having a long-term benefit."

About Lung EpiCheck

Lung EpiCheck is designed to provide a simple blood test that detects lung cancer at its earliest stages. The test utilizes NGS and PCR-based technology for highly sensitive analysis of subtle, disease-specific changes in DNA methylation markers. Lung EpiCheck is being developed for potential use in individuals with a history of smoking who are at high-risk of developing lung cancer, and do not comply with the guidelines for annual screening with low-dose computed tomography (LDCT) scans. The test is not yet commercially available.

On April 7, 2021 TriSalus Life Sciences reported that The American Association for Cancer Research (AACR) (Free AACR Whitepaper) will host its annual meeting, AACR (Free AACR Whitepaper) 2021, virtually, over two weeks: April 10-15 and May 20-26 (Press release, TriSalus Life Sciences, APR 7, 2021, View Source [SID1234577888]). The meeting program covers the latest discoveries across the spectrum of cancer research and highlights the work of the best minds in research and medicine from institutions all over the world.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

On April 7, 2021 Artios Pharma Limited (Artios), a leading DNA Damage Response (DDR) company exploiting synthetic lethality to develop a broad pipeline of precision medicines for the treatment of cancer, reported a global research collaboration with Novartis to discover and validate next generation DDR targets to enhance Novartis’ Radioligand Therapies (RLT) (Press release, Artios Pharma, APR 7, 2021, View Source [SID1234577665]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

Under the three-year collaboration, Artios and Novartis will perform target discovery and validation, and Novartis will select up to three exclusive DDR targets, and receive worldwide rights on these targets to be utilized with its RLT’s.

Dr. Niall Martin, Chief Executive Officer at Artios Pharma, said: "This collaboration expands the reach of our discovery platform, leveraging our DDR expertise and target knowledge to enhance the potential of radioligand therapies. We are thrilled to work with Novartis, and this combined with our recent collaboration with Merck KGaA provides important validation of the power of the internal discovery capabilities at Artios. From a strategic perspective, this collaboration is an ideal fit which maximizes the application of our platform to areas beyond our current focus as we independently advance our pipeline of novel DDR candidates. We look forward to continued momentum as a clinical-stage precision medicine company, building upon our recently initiated Phase 1 study of ART0380, our potential best-in-class ATR inhibitor, with the expected entry of our first-in-class Pol Theta program into the clinic before year end."

Under the terms of the agreement, Novartis will make an up-front payment of US$20 million and provide near term research funding to support the collaboration. Artios will be eligible to receive discovery, development, regulatory and sales-based milestones, in addition to royalty payments on net sales of products commercialized by Novartis. The collaboration does not include Artios’ lead programs, ART0380, which is currently in clinical development, or ART4215, a first-in-class Pol Theta inhibitor.

Novartis’ RLT delivers targeted radiation to a specific subset of cancer cells, with minimal effect on surrounding healthy cells. RLT has been shown to improve overall survival and quality of life, particularly in the setting of cancers with bone metastases.

On April 7, 2021 Tempus, a leader in artificial intelligence and precision medicine, reported abstracts accepted for poster presentation at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting 2021, which will convene virtually on April 10-15 and May 17-21 (Press release, Tempus, APR 7, 2021, View Source [SID1234577701]). The research leverages Tempus’ unparalleled library of multi-modal data to facilitate discovery, development, and delivery of optimized therapeutic options for patients.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

"We’re proud to present our recent research that demonstrates the power and depth of our database," said Dr. Kim Blackwell, Chief Medical Officer at Tempus. "As evidenced by the collection of abstracts, we are utilizing data-driven tools that empower physicians to optimize patient care."

Tempus will present eight posters; including two in collaboration with outside investigators from Baylor College of Medicine, Harris Health Ben Taub Hospital, and the Dan L Duncan Comprehensive Cancer Center. Four of the abstracts accepted for poster presentation at AACR (Free AACR Whitepaper) 2021 are highlighted below and the complete list can be found at www.tempus.com/publications.

Incidence of Molecular Alterations in KRAS and Other Known Cancer Genes in Patients With Pancreatic Cancer Assessed With a Commercial Genomic Profiling Panel Compared to TCGA Results
Overview: Tempus’ xT LDT assay detected common alterations in genes such as KRAS, TP53, and SMAD4 in a Baylor College of Medicine pancreatic cancer cohort at a similar incidence to The Cancer Genome Atlas Program. Approximately 13% of pancreatic cancer patients had an alteration in the homologous recombination repair pathway. Lens, Tempus’ next-generation data exploration and analysis platform, allowed researchers to identify the incidence of targetable molecular alterations landscape in patients with pancreatic cancer.
Genomic Characterization and Monitoring Molecular Response to Treatment in African Americans (AA) Advanced Prostate Cancer (PC) Patients (Pts) via Next-Generation Sequencing (NGS); Real-world Experience in a Safety Net Hospital Oncology Clinic
Overview: Tempus’ xF liquid biopsy LDT assay allows for longitudinal monitoring of treatment response and resistance in patients with advanced prostate cancer. This study reported the incidence of key prostate cancer driver gene alterations, including TP53, SPOP, AR and BRCA2, in both the Ben Taub Hospital cohort and Tempus database, and revealed the value of longitudinal xF monitoring in 4 case studies: (1) Response to first line hormonal therapy, (2) Nonresponse to third line darolutamide, and (3) Two cases of response to pembrolizumab in MSI-H metastatic prostate cancer.
Comprehensive Validation of RNA Sequencing for Clinical NGS Fusion Genes and RNA Expression Reporting
Overview: Tempus sequenced both DNA and the whole-transcriptome RNA to improve coverage and provide the most comprehensive patient molecular profile. This study reported results from the clinical and analytical validation of fusion calling for improved gene rearrangement detection, and the analytical validation of RNA expression for research purposes. The orthogonal testing concordance for targeted fusions was 100%, with 99.9% sensitivity and 99.9% specificity, and for untargeted fusions, the overall concordance was 97%, with 97% sensitivity. The enhanced RNA-sequencing assay offers unbiased detection of common and novel fusions, as well as validated gene expression data for comprehensive research analyses.
Leveraging Clinical RNA Sequencing for Scalable Tumor Immune Repertoire Profiling
Overview: Characterizing tumor-infiltrating lymphocytes (TILs) by repertoire sequencing (rep-seq) at scale can help maximize patient benefit from data-driven treatment options. This study presents a scalable method for TIL rep-seq from whole-transcriptome RNA data in approximately 500 tumors from 38 cancer types. Results of this study were consistent with an orthogonal DNA-seq method and confirmed expected trends in receptor profiles across the cohort, including monoclonality of lymphocyte receptors in T-cell/B-cell-driven malignancies, high repertoire richness in TIL-high cancers (e.g., NSCLC) and low in TIL-low cancers (e.g., multiforme glioblastoma). This method can be seamlessly integrated for improved TIL characterization from routine RNA-sequencing.

On April 7, 2021 Ziopharm Oncology, Inc. ("Ziopharm" or the "Company") (Nasdaq: ZIOP), reported it will be presenting a poster at the upcoming American Association for Cancer Research (AACR) (Free AACR Whitepaper) Virtual 2021 Annual Meeting (Press release, Ziopharm, APR 7, 2021, View Source [SID1234577667]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

The poster highlights work evaluating the ability of the non-viral Sleeping Beauty transposon/transposase gene transfer system to re-direct the specificity of T cells towards p53 and KRAS neoantigens and characterizing the resultant engineered TCR-T cell populations for specificity and function.

The poster is entitled "Hotspot mutations in KRAS and TP53 targeted by TCR-T cells genetically modified with the Sleeping Beauty transposon/transposase system."

The work summarized in the poster demonstrates that multiple TCRs with unique specificities targeting recurrent p53 and KRAS substitutions in frequent HLA haplotypes could be stably expressed using Sleeping Beauty transposition to re-direct peripheral blood T cells towards tumor cells.

Dr. Raffaele Baffa, MD, PhD, Chief Medical Officer of Ziopharm said, "We are pleased to share this update on our TCR-T directed work with the scientific community. The Company is working tirelessly on our Phase I/II clinical study for our TCR-T Library, and the work presented in this poster provides us with increased confidence in the scientific rationale behind the trial."

The poster will be presented as part of Session PO.IM02.01 – Adoptive Cell Therapy. The abstract for the poster can be found on the AACR (Free AACR Whitepaper) website using this link. The poster will be available for conference participants beginning at 8:30am ET on Saturday, April 10, 2021 and will also be posted on the Ziopharm Oncology website in the Investors section, using this link.