Quantabio Launches Ultra-Fast RNA Library Prep Kit with Integrated Ribosomal RNA and Globin Depletion for Precision Oncology Applications

On March 1, 2022 Quantabio, a leading provider of robust DNA and RNA amplification reagents for the most demanding molecular testing and life science research applications, reported the commercial availability of the sparQ RNA-Seq HMR Kit, an ultra-fast RNA next-generation sequencing (NGS) library preparation tool with integrated ribosomal RNA (rRNA) and globin mRNA depletion (Press release, Quantabio, MAR 1, 2022, View Source [SID1234609345]). The new kit enables scientists to generate high-quality stranded transcriptome libraries from challenging FFPE or low-input human, mouse and rat (HMR) samples in five hours with minimal hands-on time.

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RNA-seq technologies enable scientists to gain critical insights into the molecular and cellular basis of disease. Specifically, the ability to sequence the coding and non-coding regions of RNA provides oncology researchers with a complete view of the cancer transcriptome and a better understanding of tumor classification and progression. RNA-seq is particularly useful for identifying the oncogenic drivers, fusion genes and gene expression changes in tumors.

While promising, RNA-seq technologies can also be challenging due to complicated workflows, read coverage biases, limited transcript diversity, and high sample costs. The new Quantabio sparQ RNA-Seq HMR Kit overcomes many of these issues with a simple, nine-step workflow that only takes five hours compared to the 20-step, seven-hour process with standard technologies. Scientists are able to generate sequencer-ready libraries in a single day with 33% less hands-on time. The proprietary enzymes included in this kit generate high yields of directional transcriptome libraries from a wide variety of degraded sample types, including FFPE, tissue and blood, along with input amounts ranging from 1 ng to 1 µg. The versatility of the HMR sample input makes this kit ideal for studying applications beyond cancer including gene expression and transcriptome analysis, which may be used in translational research, drug discovery, companion drug diagnostic testing, mouse modeling, etc.

"We have been using the new Quantabio sparQ RNA-Seq HMR Kit as part of the early access program for the past four months," said Tony Brooks, Senior Applications Specialist at University College of London Genomics, a collaborative research facility that provides expertise in cutting-edge genomic technologies and data analysis. "We recently used the integrated library prep kit to sequence large cohorts of samples with varying RNA integrity numbers and input amounts for a cancer cell line project and a postmortem Parkinson’s study. The workflow is simple and fast with much fewer hands-on steps than other assays. We were able to achieve high yields regardless of sample quantity and quality using the same fragmentation time and number of PCR cycle parameters."

"The new sparQ RNA-Seq HMR Kit is the latest addition to our complete portfolio of industry-leading library preparation, amplification, purification, and quantification solutions for next-generation sequencing applications," said Heather Meehan, PhD, Vice President and Head of Quantabio. "Identifying a greater number of unique, high-quality transcripts from low input or degraded samples accelerates scientific discovery and can lead to a greater understanding of how gene expression drives progression of oncogenic diseases. With its unmatched efficiency and robust performance, this new high-quality, ultra-fast kit simplifies RNA-seq workflows while ensuring reproducible results and reducing overall costs."

The sparQ RNA-Seq HMR Kit seamlessly integrates efficient rRNA and globin mRNA depletion with stranded library preparation and is optimized for the rapid construction of high-quality RNA libraries for Illumina NGS platforms. The single-day protocol includes three reaction tubes, nine steps and nine components for sequencer-ready libraries. The kit is available in 24 and 96-reaction configurations and the initial template is prepared with 1 ng – 1 µg of total human, mouse or rat input RNA. For more information, please visit View Source

Sterling Pharma Solutions Expands Global API Manufacturing Capabilities with Acquisition of Novartis Facility in Ringaskiddy, Ireland

On March 1, 2022 Sterling Pharma Solutions, a global contract development and manufacturing organisation, reported that it had reached agreement with Novartis to acquire its Ringaskiddy campus (Novartis Ringaskiddy Limited), near Cork, Ireland. Financial details of the sale, which is expected to close in Q4, 2022, have not been disclosed (Press release, Novartis, MAR 1, 2022, View Source [SID1234609418]).

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Under the terms of the agreement, Sterling will acquire the 111-acre site, which includes three active pharmaceutical ingredient (API) manufacturing buildings, as well as facilities to support development and scale up in line with Sterling’s core business focus. The site currently manufactures a number of APIs across a range of therapeutic areas, and the deal includes an ongoing supply agreement between Sterling and Novartis from the Ringaskiddy facility. Upon closing, the workforce will transition to Sterling.

Sterling’s Chief Executive Officer, Kevin Cook, said: "The addition of this new, world-class facility and its highly skilled workforce, with its history of quality and regulatory excellence, to Sterling’s portfolio, will enable us to provide expanded capacity to our customers. The site at Ringaskiddy has a number of synergies with our current global facilities enabling us to continue our growth strategy in the small molecule market, as well as extending our capabilities in several key technological areas such as peptide manufacturing and large-scale chromatography."

This announcement follows several investments in Sterling’s manufacturing capabilities in 2021, as well as the acquisition of its Germantown site in Wisconsin from Alcami in 2020, and a dedicated antibody-drug conjugate facility in Deeside, UK in 2021.

The addition of the Ringaskiddy campus will see Sterling’s global network grow to five facilities across the UK, Europe and the US, with a workforce of over 1,000 employees.

Candel Therapeutics Announces $25 Million Non-dilutive Debt Financing Agreement with Silicon Valley Bank

On March 1, 2022 Candel Therapeutics, Inc. (Nasdaq: CADL) (the "Company" or "Candel"), a late clinical stage biopharmaceutical company developing novel oncolytic viral immunotherapies, reported that it has entered into a loan and security agreement with Silicon Valley Bank for $25 million, $20 million of which will be available immediately (Press release, Candel Therapeutics, MAR 1, 2022, View Source [SID1234609226]). An additional $5 million may be made available in the future if certain conditions and milestones are met. The loan agreement requires monthly payments of interest only for 24 months, after which the principal is repayable in 24 monthly payments. This financing extends the Company’s cash runway into the fourth quarter of 2023.

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"This access to additional capital positions us well ahead of important anticipated catalysts for the Company, including initial clinical data from the phase 2 clinical trial of CAN-2409 in non-small cell lung cancer, data from our phase 1 clinical trial of CAN-2409 in combination with Opdivo for the first-line treatment of high-grade glioma, data from our phase 1 clinical trial of CAN-3110 in recurrent high-grade glioma, and initiation of our phase 3 clinical trial of CAN-2409 in high-grade glioma," said Paul Peter Tak, MD, PhD, FMedSci, Chief Executive Officer of Candel. "We are especially pleased with the attractive terms and non-dilutive nature of this financing, which bolsters our cash position and provides additional operational flexibility."

StemPrintER Demonstrates Prognostic Utility in TransATAC Cohort

On March 1, 2022 Tiziana Life Sciences Ltd.’s (Nasdaq: TLSA) former subsidiary, AccuStem Sciences, Inc. (OTC PINK: ACMSY) (formerly AccuStem Sciences Ltd.), reported publication of new data in the European Journal of Cancer (Press release, Tiziana Life Sciences, MAR 1, 2022, View Source [SID1234609260]). Results demonstrate that StemPrintER is highly prognostic for risk of distant recurrence in women with breast cancer.

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Investigators from the European Institute of Oncology (IEO) in Milan and The Royal Marsden Hospital in London evaluated 776 tumor samples from the TransATAC cohort, a subgroup of estrogen receptor positive (ER+), post-menopausal patients from the prospective, randomized ATAC trial. The pivotal TransATAC study has been used to evaluate many of the commonly used breast cancer risk scoring assays, including OncotypeDX, Prosigna, EndoPredict and Breast Cancer Index.

In this analysis, investigators demonstrated that patients with a StemPrintER Risk Score (SPRS) Low result had significantly better outcomes than patients with a SPRS High result. Patients with a SPRS Low result had a 5.8% risk of distant recurrence at 10 years versus 23.2% risk of distant recurrence in patients with a SPRS High result.1

"Many genomic classifiers have been evaluated in the TransATAC cohort," said Salvatore Pece, Full Professor at the Milan University Medical School and Director of the Hormone-Related Cancers and Stem Cell Pathobiology Lab at IEO. "It is exciting that StemPrintER appears to perform as well as other commercially-available tests and indicates the potential for this novel test to inform clinical decision making."

Allakos Provides Business Update and Reports Fourth Quarter and Full Year 2021 Financial Results

On March 1, 2022 Allakos Inc. (the "Company") (Nasdaq: ALLK), a biotechnology company developing lirentelimab (AK002) and AK006 for the treatment of allergic and inflammatory diseases, reported financial results for the fourth quarter and full year ended December 31, 2021 (Press release, Allakos, MAR 1, 2022, View Source [SID1234609279]).

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Recent Events

Initiated a Phase 2 randomized, double-blind, placebo-controlled study of subcutaneous lirentelimab in patients with moderate-to-severe atopic dermatitis in the fourth quarter of 2021.

Reported topline data from ENIGMA 2, a Phase 3 randomized, double-blind, placebo-controlled study of lirentelimab in patients with eosinophilic gastritis/eosinophilic duodenitis ("EG"/"EoD") in the fourth quarter of 2021.

Reported topline data from KRYPTOS, a Phase 2/3 randomized, double-blind, placebo-controlled study of lirentelimab in patients with eosinophilic esophagitis ("EoE") in the fourth quarter of 2021.
Upcoming Milestones

Hold an End-of-Phase 2 meeting with the FDA during second quarter of 2022 to discuss the Phase 2/3 KRYPTOS data and the development path with subcutaneous lirentelimab in patients with EoE.

Report topline data from the Phase 3 study of lirentelimab in patients with EoD (EoDyssey) in the third quarter of 2022.

Initiate a Phase 2b randomized, double-blind, placebo-controlled study of subcutaneous lirentelimab in patients with chronic spontaneous urticaria in the middle of 2022.

Complete IND-Enabling studies of AK006 during 2022 and initiate the first-in-human study in the first half of 2023.
Fourth Quarter and Full Year 2021 Financial Results

Research and development expenses were $72.9 million in the fourth quarter of 2021 as compared to $28.5 million in the same period in 2020, an increase of $44.4 million. Research and development expenses were $196.3 million for the full year 2021 as compared to $105.5 million in the same period in 2020, an increase of $90.8 million.

General and administrative expenses were $23.2 million in the fourth quarter of 2021 as compared to $15.8 million in the same period in 2020, an increase of $7.4 million. General and administrative expenses were $75.1 million for the full year 2021 as compared to $51.5 million in the same period in 2020, an increase of $23.6 million.

Allakos reported a net loss of $94.4 million in the fourth quarter of 2021 as compared to $44.3 million in the same period in 2020, an increase of $50.1 million. Net loss per basic and diluted share was $1.73 for the fourth quarter of 2021 compared to $0.86 in the same period in 2020. Net loss was $269.9 million for the full year 2021 as compared to $153.5 million in the same period in 2020, an increase of $116.4 million. Net

loss per basic and diluted share was $5.01 for the full year 2021 compared to $3.10 in the same period in 2020.

Allakos ended the fourth quarter of 2021 with $424.2 million in cash, cash equivalents and marketable securities.