On June 1, 2021 NOXXON Pharma N.V. (Euronext Growth Paris: ALNOX), a biotechnology company focused on improving cancer treatments by targeting the tumor microenvironment (TME), reported that it has received two batches of bulk NOX-A12 drug substance and has made additional manufacturing commitments (Press release, NOXXON, JUN 1, 2021, View Source [SID1234583346]). As such, NOXXON has drawn down additional financing tranches from its financing agreement with Atlas Special Opportunities, LLC (ASO), for a total consideration of €2.325 million, and issued 2,368 convertible bonds (including 43 convertible bonds issued in relation to the transaction fee) with a nominal value of EUR 1,000 each.

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As NOXXON advances its pipeline with upcoming start of clinical trials this additional liquidity will mostly focus on the following developments:

– Manufacturing of NOX-A12 clinical trial supply in anticipation of upcoming clinical trials;
– Manufacturing of NOX-E36 clinical trial supply in anticipation of the planned upcoming clinical trial;
– Purchase of stocks of starting materials at more cost-effective scale which will also allow more rapid production of future batches of NOX-A12 or NOX-E36.

The tranches are split as follows:

– Issuance of the remainder of the Drug Manufacturing tranche for a consideration of €900,000;
– Issuance of 3 additional tranches for a total consideration of €1,425,000.

The additional cash brings NOXXON’s runway into Q1 2022 without additional financing or use of the ASO convertible bond vehicle.

NOXXON maintains an updated summary table of issued convertible bonds in the Investors’ section of its website.

The characteristics, terms, conditions and dilutive potential of the ASO financing may be found in the Annex to the press release published on October 14, 2020 available on the company’s website.

On June 1, 2021 Tempus, a leader in artificial intelligence and precision medicine, reported eleven abstracts accepted for presentation at the 2021 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting taking place virtually from June 4 – 8 (Press release, Tempus, JUN 1, 2021, View Source [SID1234583345]).

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"These high impact ASCO (Free ASCO Whitepaper) presentations from Tempus collaborators and investigators illustrate the power of over 35 petabytes worth of clinical and molecular data collected since Tempus started five years ago," said Dr. Kimberly Blackwell, Chief Medical Officer at Tempus. "By combining extensive tumor and germline genomic profiling with just-in-time clinical trial matching in our TIME Trial Network, Tempus is bringing the right treatments to patients facing cancer in a data-driven and expedited way. I am really excited to share how our multi-modal data is helping transform precision cancer care."

One abstract selected for oral presentation and four abstracts selected for poster presentation at ASCO (Free ASCO Whitepaper) 2021 are highlighted below. The complete list of Tempus-affiliated abstracts and poster presentations can be found at www.tempus.com/publications.

Multimodal Profiling of Biliary Tract Cancers Detects Potentially Actionable Biomarkers and Differences in Immune Signatures Between Subtypes
Overview: This study examined the relationship between the mutational landscape and immune-related RNA signatures of different biliary tract cancer subtypes, including intrahepatic, extrahepatic cholangiocarcinoma and gallbladder cancers. Based on RNA signatures, gallbladder cancers had higher expression of select immune signatures compared to intrahepatic cancers.
This abstract has been accepted for oral presentation in the "Gastrointestinal Cancer—Gastroesophageal, Pancreatic, and Hepatobiliary" session on June 5 from 1:45 – 4:45 pm CDT.
Landscape of KRASG12C, Associated Genomic Alterations, and Interrelation With Immuno-Oncology (IO) Biomarkers
Overview: Using Lens, Tempus’ cloud-based data and analytics platform for drug discovery and development, the de-identified records of 79,004 patients diagnosed with various cancer types who underwent Tempus xT and xF next generation sequencing were analyzed to study the association between KRAS variants and cancer subtypes. Tumors harboring KRASG12C were associated with smoking status and had significantly higher tumor mutational burden and programmed death-ligand 1 expression, which are important markers for immunotherapy.
This abstract has been accepted for poster presentation in the "Developmental Therapeutics—Molecularly Targeted Agents and Tumor Biology" track and will be available on June 4 at 7:00 am CDT.
The TIME Trial Network to Facilitate Rapid Clinical Trial Activation, Patient Screening, and Enrollment in Molecularly Targeted Trials
Overview: Tempus’ TIME Trial Network was established to increase access and participation in clinical trials by applying a rapid just-in-time activation model. In the last quarter of 2020, six unique interventional clinical trials were activated across eight US states in the TIME Trial Network. Over a 3-month period, on average, TIME Trial sites were activated in 9.4 days (compared to the 20+ week industry-wide average), and patient consent was completed in 4.5 days.
This abstract has been accepted for poster presentation in the "Care Delivery and Regulatory Policy" track and will be available on June 4 at 7:00 am CDT.
Rate of Incidental Germline Findings Detected by Tumor-Normal Matched Sequencing in Cancer Types Lacking Hereditary Cancer Testing Guidelines
Overview: This study analyzed 21,395 de-identified records from patients across select cancer types sequenced using Tempus xT Tumor-normal matched approach. Incidental P/LP germline variants were detected in 6.4% of patients diagnosed with the 6 select cancer types that lack hereditary cancer testing guidelines, with the highest prevalence in patients with bladder (7.9%), brain (6.5%), and lung (6.5%) cancers. The identification of such germline findings may have clinical implications for the patients, as well as at-risk family members, resulting in the opportunity for genetic counseling and risk-stratified intervention.
This abstract has been accepted for poster presentation in the "Prevention, Risk Reduction, and Hereditary Cancer" track and will be available on June 4 at 7:00 am CDT.
Comprehensive Genomic Profiling in Advanced/Metastatic Colorectal Cancer: Number Needed to Test and Budget Impact of Expanded First-Line Use
Overview: A decision analytical model, based on Tempus xT, was developed to determine the impact of first-line genomic profiling in detection of actionable alterations in metastatic colorectal cancer, along with the associated diagnostic testing costs in a modeled US health plan setting of 5 million lives. Replacing 20% of standard of care testing with Tempus xT was associated with a small incremental testing cost, but led to identification of actionable alterations in a meaningful number of patients.
This abstract has been accepted for publication in the "Health Services Research and Quality Improvement" session and will be available on June 4 at 7:00 am CDT.

On June 1, 2021 BostonGene Corporation, a biomedical software company focused on defining optimal, precision medicine-based therapies for cancer patients, reported that two abstracts have been accepted for online publication for the 2021 ASCO (Free ASCO Whitepaper) Annual Meeting (Press release, BostonGene, JUN 1, 2021, View Source [SID1234583344]).

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"We are pleased to have multiple abstracts accepted for online publication," said Nathan Fowler, MD, Chief Medical Officer at BostonGene. "Our findings underscore the importance of the application of novel and cutting-edge analytical tools to understand the composition and activity of the tumor and the microenvironment, which will improve treatment outcomes for cancer patients."

The abstracts will be published online in the Journal of Clinical Oncology supplement for the ASCO (Free ASCO Whitepaper) Annual Meeting Proceedings.

Details about the abstracts selected for publication can be found below:

Abstract Number: e15050
Title: The development of a computational machine learning tool to decipher malignant cell gene expression from complex tumor tissue

Complex tumor tissue is composed of malignant cells and diverse tumor microenvironment (TME) cellular populations. The percentage of malignant cells present in tumor tissue varies by cancer type, with percentages sometimes falling below 10%. TME cellular transcripts may comprise the majority of the total transcripts in a tumor, potentially resulting in biases during biomarker development and for clinical decision-making. A computational tool was created to "subtract" TME-specific gene expression from total gene expression in an array of solid tumors, producing in silico "purified” malignant cell gene expression.

Abstract Number: e15085
Title: Analytical and clinical validation of the BostonGene Tumor Portrait assay

Analysis of the genetic and transcriptomic profile of solid tumors using next-generation sequencing (NGS) assays is fundamental to propel precision medicine into clinical practice. NGS technology applied to tumor analysis allows for the characterization of somatic alterations, clonality, altered gene expression, and other parameters using a small amount of tissue. The BostonGene Tumor Portrait TestsTM, which integrate whole-exome sequencing (WES) and mRNA sequencing (RNA-seq), were developed to uncover cancer-promoting and -suppressing activity of the tumor and the tumor microenvironment (TME).

On June 1, 2021 Personal Genome Diagnostics Inc. (PGDx), a leader in cancer genomics, reported the launch of elio (empowering local insight for oncology) plasma complete, a NGS kit solution for comprehensive blood-based genomic analysis (Press release, Personal Genome Diagnostics, JUN 1, 2021, View Source [SID1234583343]). The elio plasma complete kit is intended to support research in areas like biomarker discovery, therapy selection, and monitoring, and is ideal for investigating genetic mutations and genomic signatures in multiple cancer types.

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"We are thrilled to launch elio plasma complete, the third NGS kit on our elio platform, developed specifically to meet the growing needs of scientists researching genetic biomarkers of tumors directly from blood samples," said Megan Bailey, Chief Executive Officer of PGDx. "This sample-to-answer solution brings a high quality, easy to use, comprehensive genomic profiling tool and the flexibility of a liquid biopsy format to the research community in a way never seen before. By launching this product, we hope to enable researchers and our biopharma partners to identify new biomarkers and develop new insights that inform new precision oncology medicine approaches and empower the fight against cancer."

From a simple blood draw, elio plasma complete analyzes circulating cell-free tumor DNA present in plasma for genetic alterations in cancer, eliminating the need for an invasive biopsy or tumor tissue. PGDx elio plasma complete evaluates even low-abundance sample DNA and processes samples using a high coverage next-generation sequencing panel of 521 genes. Through the elio testing platform, elio plasma complete also includes automated bioinformatics that supports the identification of somatic mutations within cell-free DNA with high sensitivity and specificity.

The launch of elio plasma complete follows PGDx’s previously released elio tissue complete and elio plasma resolve products. PGDx elio plasma complete is currently available globally for Research Use Only (RUO).

On June 1, 2021 Jasper Therapeutics, Inc., a biotechnology company focused on hematopoietic cell transplant therapies, reported that the company will host a conference call and webcast to review updated 90-day efficacy, safety and pharmacokinetic data from its ongoing multicenter Phase 1 clinical trial of JSP191, the company’s anti-CD117 monoclonal antibody, as a targeted, non-toxic conditioning regimen in older patients with myelodysplastic syndromes (MDS) or acute myeloid leukemia (AML) undergoing allogeneic hematopoietic (blood) cell transplantation (Press release, Jasper Therapeutics, JUN 1, 2021, View Source [SID1234583342]).

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The webcast, which will take place on Tuesday, June 8, 2021 at 12:00 pm ET, will include presentations from Jasper management, along with guest speakers:

Lori Muffly, M.D., M.S., Assistant Professor of Medicine (Blood and Bone Marrow Transplantation) at Stanford Medicine and lead investigator of the study. Dr. Muffly will present the JSP191 data in a poster session at the 2021 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting, which is being held online June 4-8, 2021.
Gail Roboz, M.D., Professor of Medicine (Hematology and Medical Oncology) and Director of the Clinical and Translational Leukemia Program at Weill Cornell Medicine.
Conference Call and Webcast Details:
A live webcast of the event, including presentation slides, will be available on Tuesday, June 8, 2021 at 12:00 pm ET by clicking here. To access the investor event by phone and participate in the question and answer session, dial 1-877-705-6003 (domestic) or 1-201-493-6725 (international) and reference conference ID: 13720248. A replay of the webcast will be available for 90 days following the live event.

About MDS and AML
Myelodysplastic syndromes (MDS) are a group of disorders in which immature blood-forming cells in the bone marrow become abnormal and do not make new blood cells or make defective blood cells, leading to low numbers of normal blood cells, especially red blood cells.i In about one in three patients, MDS can progress to acute myeloid leukemia (AML), a rapidly progressing cancer of the bone marrow cells.i Both are diseases of the elderly with high mortality. Each year, about 29,000 patients are diagnosed with MDS and approximately 42,000 patients are diagnosed with AML in the G7 countries for which approximately 2,500 patients with MDS and approximately 8,000 people with AML receive hematopoietic stem cell transplants. While hematopoietic cell transplantation is potentially curative in these patients, its use is limited in older and frail patients because standard high dose myeloablative conditioning is associated with severe toxicities and standard low dose conditioning has limited efficacy.

About JSP191
JSP191 is a humanized monoclonal antibody in clinical development as a conditioning agent that blocks stem cell factor receptor signaling leading to clearance of hematopoietic stem cells from bone marrow, creating an empty space for donor or gene-corrected transplanted stem cells to engraft. To date, JSP191 has been evaluated in more than 90 healthy volunteers and patients. It is currently enrolling in two clinical trials for myelodysplastic syndromes (MDS)/acute myeloid leukemia (AML) and severe combined immunodeficiency (SCID) and expects to begin enrollment in three additional studies in 2021 for severe autoimmune disease, sickle cell disease and Fanconi anemia patients undergoing hematopoietic cell transplantation.