On January 7, 2021 ArsenalBio, a privately held programmable cell therapy company, reported the formation of a multi-year discovery collaboration with Bristol Myers Squibb (NYSE:BMY) to advance next-generation T cell therapies for the treatment of solid tumors (Press release, Arsenal Bio, JAN 7, 2021, View Source [SID1234573659]). ArsenalBio will be responsible for discovering and building preclinical candidates against multiple targets, and Bristol Myers Squibb will have the option to obtain an exclusive worldwide license to develop and commercialize preclinical candidates. Following exercise of the option, Bristol Myers Squibb would be solely responsible for developing and commercializing the licensed candidates.

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Through the multi-year collaboration, ArsenalBio will deploy its full stack of synthetic biology compositions to build programmable cell therapy product candidates, composed of its PrimeR logic gates, CARchitecture derived gene expression controls, and CellFoundry mediated nonviral manufacturing. Combined, these integrated circuit-modified T cells offer the promise of improved outcomes for patients.

"Despite the therapeutic benefit of cell therapies for hematologic cancers, cell therapies for solid tumors remain an area of significant opportunity and unmet medical need," said Ken Drazan, MD, ArsenalBio’s co-founder and chief executive officer. "We are thrilled to team up with Bristol Myers Squibb to advance next-generation T cell therapies designed to serve patients and their providers. Their expertise and leadership in cell therapy and oncology drug development will help accelerate the pace with which we can move product candidates into and through clinical development and broaden our opportunity to help more patients and save more lives."

Under the terms of the agreement, Bristol Myers Squibb will make an upfront cash payment to ArsenalBio of $70 million, and ArsenalBio will be eligible to receive additional payments associated with collaboration expansion, regulatory and sales milestones, as well as potential royalties on sales of approved products. Bristol Myers Squibb will also make an investment in ArsenalBio for an undisclosed amount.

On January 7, 2021 Crown Bioscience, a JSR Life Sciences company, reported the expansion of their state-of-the-art NGS capabilities, together with the launch of proprietary NGS panel services, providing increased opportunities for pharmaceutical partners to better understand drug mechanisms of action (MOA) and to develop predictive biomarkers for their investigational drug candidates (Press release, Crown Bioscience, JAN 7, 2021, View Source [SID1234573658]).

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The newly built, comprehensive suite of NGS capabilities provides clients with a streamlined multi-omics workflow of high-quality services, enabling full genomic understanding, including global gene expression, mutations, and genomic structures. This is a significant addition to CrownBio’s current preclinical and translational services, allowing clients greater insight into disease mechanisms, drug MOAs, and responder patient populations, to ultimately accelerate successful development of effective therapies.

The expanded services have been established at the Company’s Center of Translational Science in Suzhou, China, to meet increased client demand for whole genome sequencing (WGS), including Illumina’s Novaseq 6000 and BGI’s MGISEQ-2000 second generation sequencing platform. PacBio’s third generation Sequel Ⅱ sequencing platform allows for high throughput, high accuracy long-read NGS, and Bionano’s Saphyr Genome Imaging enables large structural variant analysis and genome mapping. Comprehensive data analysis pipelines have also been built, together offering highly sensitive genome assembly and discovery algorithms.

"With our range of validated services, we can help drug developers improve the accuracy, sensitivity and speed at which they progress their new agent programs via discovery of MOAs and predictive biomarkers," said Henry Li, PhD, chief scientific officer at CrownBio. "This type of multi-omics data is essential to understand the clinical populations that respond to anticancer agents and progress cancer treatments."

In addition to the validated commercial platforms, CrownBio has also developed various powerful biomedical applications using NGS platforms, including NGS panels for bio-sample authentication, contamination detection and quantification, mouse tumor microenvironment profiling and metagenomic sequencing services for microbiome analysis. Custom NGS services are also available for clients who wish to utilize CrownBio’s expertise and large model biobank.

"Quality downstream applications are key to maximizing the full potential of in vivo study results, including our wealth of historical model and treatment data," said Sheng Guo, PhD, head of bioinformatics at CrownBio. "These are leveraged by a highly experienced team and a proprietary, published algorithm to provide important biomarker discovery and drug mechanism probing services."

These NGS services are available for client use immediately including our newly launched mouse I/O profiling targeted RNA-seq panel. The panel will allow deep profiling of the immunogenomics of murine tumor-immune interactions through the measurement of 1080 transcripts from a single sample.

On January 7, 2021 Kezar Life Sciences, Inc. (Nasdaq:KZR), a clinical-stage biotechnology company discovering and developing breakthrough treatments for immune-mediated and oncologic disorders, reported its Chief Executive Officer, John Fowler, will present a corporate overview at the H.C. Wainwright Virtual BioConnect Conference, being held on January 11-14, 2021 (Press release, Kezar Life Sciences, JAN 7, 2021, View Source [SID1234573657]).

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The presentation will be available on Monday, January 11, 2021 at 6:00am EST and may be accessed at the "Events & Presentations" section of the Company’s website at View Source Kezar Life Sciences will maintain an archived replay of the webcast on its website for 90 days after the conference.

On January 7, 2021 OncoDNA, a theranostic and genomic company specializing in precision oncology, reported that it has signed a subcontract service agreement with HalioDx’s U.S.-based CLIA-certified laboratory located in Richmond, Virginia (Press release, OncoDNA, JAN 7, 2021, View Source [SID1234573656]). This agreement will enable OncoDNA to expand its unique offering of services to biopharmaceutical companies and research institutions in North America.

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OncoDNA has a proven track record in supporting the development of personalized cancer therapies. Its portfolio includes a series of comprehensive molecular diagnostic tests on both solid and liquid biopsies. Combined with an advanced bioinformatic technology, OncoDNA’s diagnostic tests offer a unique solution to the US biopharmaceutical industry.

Today, OncoDNA products and services are already used in pan-European clinical trials and research projects, such as Kura Oncology’s HRAS tipifarnib clinical study and the AURORA metastatic breast cancer research program. OncoDNA currently offers its solutions in 50 countries worldwide and has experienced an outstanding sales growth of 180% over the last 4 years. Obtaining access to HalioDx’s laboratory capabilities will further propel the global adoption of OncoDNA’s solutions in North America.

"We have found in HalioDx a trusted partner to run our diagnostic tests for research use in the U.S. We are confident that HalioDx, and most particularly its CLIA-certified laboratory in Richmond, Virginia, has the capability to perform our complex molecular profiling assays, enabling us to assist with the identification and development of future personalized cancer treatments for patients", said Jean-Pol Detiffe, Founder of OncoDNA.

Vincent Fert, HalioDx CEO commented: "We are thrilled for the opportunity to partner with OncoDNA and help them to introduce their unique precision oncology solutions to US customers. Our respective capabilities are highly complementary to foster success in this marketplace."

HalioDx is an immuno-oncology diagnostic company that operates in compliance with the Clinical Laboratory Improvement Amendments of 1988 (CLIA). Headquartered in France, the company also has CLIA-certified laboratories and compliant facilities in Richmond, US, which will help OncoDNA penetrate the North American market.

On January 7, 2021 Repertoire Immune Medicines, a clinical-stage biotech company creating a new category of immune therapies for cancer, autoimmunity and infectious disease, reported that John Cox, Chief Executive Officer, will participate in the 39th Annual J.P. Morgan Healthcare Conference on Wednesday, January 13, 2021 at 8:05 a.m. EST (Press release, Repertoire, JAN 7, 2021, View Source [SID1234573655]). Mr. Cox will provide an update on progress and plans for its lead clinical programs and advancement of its immune medicines platform.

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Repertoire has initiated enrollment of the next cohort of patients in a Phase 1/2 study of PRIME IL-15 in patients with advanced metastatic solid tumors. PRIME IL-15 (RPTR-147) is a novel, autologous, non-genetically modified multiclonal T cell product designed to release IL-15 in a local and sustained manner, limiting systemic exposure and thus improving tolerability. In the initial stage of this study, following administration of PRIME IL-15, 10 of 17 patients with advanced metastatic disease had stable disease, of which four were stable for more than six months.

In analyses performed in this initial set of patients, persistence of T cell clones derived from PRIME IL-15 was observed in blood and within tumors by tracking T Cell Receptor (TCR) beta sequences. Additional evidence generated through the company’s DECODE platform demonstrates the expansion of rare lymphocytes derived from peripheral blood. Moreover, study data confirm that these T cells specific for tumor-associated antigens infiltrate into solid tumors when administered to patients.

In the continuing Phase 1/2 study, patients will receive PRIME IL-15 produced using a second-generation manufacturing process that generates T cells enriched for a stem-like memory phenotype. Cells with this phenotype have been previously associated with more effective anti-tumor responses. Additional clinical data from the PRIME IL-15 study are anticipated in the second half of 2021.

Repertoire also expects to initiate a clinical study with PRIME IL-12, an additional cytokine-tethered autologous T cell product. IL-12 has previously been studied as a potential treatment for cancer but severe toxicity has limited its potential. PRIME IL-12 is designed to limit systemic exposure and to allow tumor-infiltrating antigen-specific T cells to deliver IL-12 to the tumor microenvironment. PRIME IL-12 will be studied in patients with human papillomavirus (HPV) 16+ solid tumors, including patients with head and neck cancer. PRIME IL-12 study initiation is expected in the first half of 2021.

"We are highly encouraged by the ability of our PRIME IL-15 tumor antigen-specific peripheral T cells to infiltrate solid tumors, which has been a major hurdle in the development of cell therapies for solid tumors," said Anthony Coyle, Ph.D., President, Research and Development, Repertoire. "Now that we have expanded our platform with our tethered IL-12 approach, we are sharply focused on evaluating the ability of our therapeutic candidates to modify the tumor microenvironment and affect clinical outcomes."

Repertoire will also present new data from its discovery programs, which demonstrate the broad applicability of the company’s DECODE platform to identify targets not only in cancer but also new therapeutic opportunities in multiple autoimmune disorders including type 1 diabetes as well as infectious diseases. Repertoire’s DECODE platform allows the in-depth characterization of TCRs and their cognate antigens in the context of specific major histocompatibility complex (MHC) molecules. By understanding relevant immune synapses and identifying pathogenic T cells and their antigens, Repertoire plans to continue to design and develop new therapeutic modalities for important immune diseases of high unmet medical need.

"In less than a year since Repertoire was formed, we have made remarkable progress in the clinical programs we have underway and in our foundational DECODE and DEPLOY platforms," said Mr. Cox. "We look forward to an eventful year that includes biological validation of our approach of activating peripheral blood-derived T cells, arming them with our novel cytokine technologies, and directing them to solid tumors. We will continue to leverage our ability to decode the immune synapse as we build an integrated discovery and drug development engine to create differentiated immune medicines."