On June 1, 2021 POINT Biopharma Inc. (POINT), a radiopharmaceutical company dedicated to bringing the many benefits of precision radioligand therapy to cancer patients, reported that the U.S. Nuclear Regulatory Commission (NRC) has issued a Materials License for its new production facility located in Indianapolis, Indiana (Press release, Point Biopharma, JUN 1, 2021, View Source [SID1234583348]).

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POINT is currently finishing renovations to its 80,000-square-foot radiopharmaceutical manufacturing center which, when complete, will make it one of the largest, state-of-the-art, Good Manufacturing Practices (GMP) radioligand manufacturing facilities in the world. The NRC Materials License authorizes the handling of nuclear material in chemical and/or physical form, enabling POINT to begin work with a wide variety of radioisotopes on-site and complete testing and qualification of its operations.

"The completion of our Indianapolis facility and scope of this Materials License will enable POINT to quickly bring its drug manufacturing operations online," said Todd Hockemeyer, EVP, US Manufacturing Operations at POINT Biopharma. "Our mission is to make radioligand therapy applicable to more cancers, available to more people, thereby improving the lives of cancer patients and their families everywhere. This Materials License is an important milestone in our journey to deliver on our mission. "

"I am proud of the many accomplishments Todd and his team in Indiana have achieved," added Joe McCann, CEO of POINT Biopharma. "Attaining the NRC Materials License means we can get to work using radioisotopes like Lutetium-177 and Actinium-225 at our facility, which is a key milestone in the path to manufacturing our products in Indianapolis."

POINT expects the Indianapolis facility will begin to provide supply for its Phase 3 clinical trial targeting metastatic castration resistant prostate cancer later this year. More information about POINT’s Study Evaluating mCRPC Treatment Using PSMA [Lu-177]-PNT2002 Therapy After Second-line Hormonal Treatment (SPLASH) is available at View Source

POINT Biopharma has entered into a definitive merger agreement with Research Alliance Corp. I (Nasdaq: RACA). Upon closing, the combined company is expected to be listed on Nasdaq under the ticker symbol "PNT". A full description of the terms of the business combination can be found in registration statement on Form S-4 filed with the SEC by RACA.

On June 1, 2021 Moderna, Inc. (Nasdaq: MRNA), a biotechnology company pioneering messenger RNA (mRNA) therapeutics and vaccines, reported that it has entered into an agreement with Thermo Fisher Scientific (NYSE: TMO) for fill/finish sterile manufacturing services and supply packaging for Moderna’s COVID-19 vaccine (Press release, Moderna Therapeutics, JUN 1, 2021, View Source [SID1234583347]).

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Under the terms of the agreement, Thermo Fisher’s commercial manufacturing site in Greenville, North Carolina will be used for aseptic fill/finish, labeling and packaging to support the production of hundreds of millions of doses of the Moderna COVID-19 vaccine. Production will begin in the third quarter of 2021.

"Thermo Fisher has been a critical partner in supplying raw materials for our COVID-19 vaccine and we are now pleased to further expand our relationship as an important manufacturing partner as well," said Juan Andres, Moderna’s Chief Technical Operations and Quality Officer. "The addition of Thermo Fisher to our network will support our efforts to scale up our manufacturing ability."

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).