On October 12, 2021 Synlogic, Inc. (Nasdaq: SYBX), a clinical stage company bringing the transformative potential of synthetic biology to medicine, reported the publication in Nature of preclinical research with live biotherapeutic products designed using the Company’s Synthetic Biotic platform (Press release, Synlogic, OCT 12, 2021, View Source [SID1234591151]). In the study, a live biotherapeutic product modulated the tumor microenvironment and increased susceptibility to immunotherapy in a murine model. The research was led by Synlogic collaborators and Professor Roger Geiger of the Institute of Oncology Research, Università della Svizzera Italiana, Bellinzona, Switzerland.

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The paper, "Metabolic modulation of tumours with engineered bacteria for immunotherapy" demonstrated that, following intratumoral injection in a murine model, a live biotherapeutic Escherichia coli Nissle 1917 strain engineered to convert ammonia to L-arginine colonized and was active within the tumor microenvironment. Administration of this strain also resulted in increased numbers of tumor-infiltrating T cells and demonstrated synergistic anti-tumor activity when administered in conjunction with anti-PD-L1 immunotherapy.

It has been reported that low intratumoral levels of L-arginine in human cancers may contribute to an ineffective response to immunotherapy. The administration of live biotherapeutics has the potential to improve therapeutic response.

"We were very pleased to collaborate with Professor Geiger on this research and gratified to see a novel Synthetic Biotic approach published in Nature. The data demonstrate another potential method by which our therapeutic platform may be used to modulate underlying biology of relevance to human disease," said David Hava, Ph.D. Chief Scientific Officer at Synlogic. "We believe that our investigational live biotherapeutic approach holds great promise for the development of transformative therapeutics for a variety of serious diseases. We intend to steadfastly focus on our ongoing clinical programs in metabolic diseases, while also supporting the exploration of novel applications for our platform with academic leaders such as Dr. Geiger."

On October 12, 2021 Cellectis S.A. (NASDAQ: CLLS – EURONEXT GROWTH: ALCLS) (the "Company"), a gene-editing platform company with clinical-stage immuno-oncology programs using allogeneic chimeric antigen receptor (CAR)-T cells and gene therapy programs for genetic diseases, reported that pre-clinical data that support anti-tumor activity of UCARTMESO will be presented at the Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper)’s 36th Annual Meeting (SITC 2021), to be held in Washington, D.C. and virtually on November 10 to 14, 2021 (Press release, Cellectis, OCT 12, 2021, View Source [SID1234591101]).

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Cellectis will present a poster on UCARTMESO, an allogeneic CAR-T cell product candidate targeting mesothelin – expressing solid tumors. Mesothelin is a tumor-associated antigen that is highly and consistently expressed in mesothelioma and pancreatic cancer and is also over-expressed in subsets of other solid tumors (ovarian cancer, non-small cell lung cancer, gastric cancer, triple-negative breast cancer). UCARTMESO also leverages its TALEN gene editing technology to resist immune suppression mediated by TGFβ.

Last May, during its Innovation Days, Cellectis announced the development of the new pre-clinical UCART product candidates targeting B-cell lymphomas and venturing for the first time into the solid tumor space.

Presentation Details:

Title: Mesothelin (MSLN) targeting allogeneic CAR-T cells engineered to overcome tumor immunosuppressive microenvironment

Poster Number: 143

Presenter: Roman Galetto, Ph.D, Director, Preclinical and Program Management

Date/Time: Friday November 12, 7:00AM – 8:30PM, Walter E. Washington Convention Center, Poster Hall (Hall E)

Full text of the abstracts will be released on the SITC (Free SITC Whitepaper) website at 7:00 a.m. ET on November 12, 2021.

On October 12, 2021 BostonGene Corporation, a biomedical software company committed to defining optimal precision medicine-based therapies for cancer patients, reported two research collaborations with Massachusetts General Hospital (MGH), the largest hospital-based research program in the U.S. that delivers care grounded in leading-edge research, advanced treatment offerings and the latest clinical trials (Press release, BostonGene, OCT 12, 2021, View Source [SID1234591117]). The collaborations are designed to explore the role of tumor genetics and the tumor microenvironment of patients with follicular lymphoma (FL) and to understand their impact on disease transformation and response to treatment.

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An indolent B-cell lymphoma, FL can transform into an aggressive lymphoma; however, the underlying causes of transformation remain unknown. To elucidate the molecular mechanisms and the role of the microenvironment in this process, Abner Louissaint MD, PhD, of the Department of Pathology at the MGH, developed a unique PDX mouse model of FL transformation. In support of this work, BostonGene performs large-scale analytics utilizing next generation sequencing (NGS data) and multiplex immunofluorescence (MxIF) imaging to provide insight into the cellular composition and spatial architecture of the reconstructed patient tumor and microenvironment in these PDX mouse models. BostonGene computational modeling of the molecular profiles of the primary patient FL tumors and the PDX tumors uncovers which patients may undergo transformation. This collaborative project drives the utilization of FL PDX mouse models in the personalization of therapy, the discovery of potential therapies for transformed FL, and the identification of biomarkers of transformation.

A second study focuses on the elucidation of the role of tumor microenvironment on FL patients’ response to treatments. Jacob Soumerai, MD, a clinical lymphoma investigator at the MGH Cancer Center, in collaboration with Dr. Louissaint are evaluating the influence of tumor genetics and tumor microenvironment composition on FL patient response and the development of resistance to the combinatorial therapy of rituximab and umbralisib, a PI3Kδ inhibitor. As part of this study, BostonGene provides integrated transcriptomic and genomic analysis of FL patients treated with this combination therapy such as the identification of somatic alterations, evaluation of gene expression, estimation of tumor heterogeneity, microenvironment classification and neoantigen prediction. This work will determine biomarkers of FL patient response to PI3Kδ inhibition, ultimately improving the clinical outcomes of this patient population.

"By using an analytical approach to further understand the cellular composition of patients with follicular lymphoma and identify biomarker response to therapy, we are hopeful that we can be better informed when making individual treatment decisions," said Dr. Louissaint, who is also an assistant professor of Pathology at Harvard Medical School.

"We’re proud to collaborate with MGH by providing next-generation multi-platform analytics to evaluate the molecular and immunologic profiles of follicular lymphoma patients," said Nathan Fowler, MD, Chief Medical Officer at BostonGene. "Our analysis will define genomic and transcriptional alterations that serve as predictive biomarkers of response and resistance to therapy, enabling doctors to personalize treatment plans."

On October 12, 2021 NanoString Technologies, Inc. (NASDAQ: NSTG), a leading provider of life science tools for discovery and translational research, reported the launch of the nCounter ADC Development Panel, a specialized gene expression tool for use in the rapidly expanding field of Antibody Drug Conjugates (ADCs) (Press release, NanoString Technologies, OCT 12, 2021, View Source [SID1234591154]). Created in collaboration with leading pharmaceutical and clinical scientists, this novel panel is designed to provide molecular insights into important biological questions and challenges of oncology therapies.

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ADCs are defined as a new class of highly potent therapeutics composed of an antibody attached via a chemical linker to a biologically active drug or cytotoxic compound. These targeted agents allow for sensitive discrimination between healthy and cancer tissues with the cell-killing ability of cytotoxic drugs. The field now has 10 approved drugs, over 80 investigational ADCs, and nearly 200 clinical trials and is gaining momentum as an effective approach for targeting cancer.

The new panel provides for customizable ADC content to address complex questions critical for the success of Antibody Drug Conjugates throughout discovery, pre-clinical and clinical development. The panel can be used to directly profile 770 genes addressing essential biological questions relevant to each step in the ADC development workflow, including tumor targeting and antigen expression; ADC internalization; payload release; drug mechanisms of action; target cell death; immunogenic cell death; and mechanisms of resistance.

"With this panel, researchers have a powerful, cutting-edge tool that addresses biological function with deep molecular characterization, expanding insights gained from traditional endpoint assays," said Joseph Beechem, Chief Scientific Officer at NanoString. "The specific and sophisticated characterization will allow us to fully understand mechanisms of action, potential resistance, as well as the role of the immune response."

To learn more about how NanoString is addressing the challenges within the field of ADC, visit NanoString at the virtual World ADC Conference Oct. 11-14. On Oct. 12, NanoString will present "Optimizing ADC Development and Patient-Treatment Selection," led by Dr. Funda Meric-Bernstam, the Chair of the Department of Investigational Cancer Therapeutics, Division of Cancer Medicine, MD Anderson Cancer Center.

On October 12, 2021 Bicycle Therapeutics plc (the "Company") reported that it entered into an underwriting agreement (the "Underwriting Agreement") with Goldman Sachs & Co. LLC, Morgan Stanley & Co. LLC and SVB Leerink LLC (the "Representatives"), as representatives of the several underwriters named therein (collectively, the "Underwriters"), pursuant to which the Company agreed to issue and sell 3,240,741 American Depositary Shares ("ADSs"), each representing one of the Company’s ordinary shares, nominal value £0.01 per share, at a public offering price of $54.00 per ADS (the "Offering") (Filing, 8-K, Bicycle Therapeutics, OCT 12, 2021, View Source [SID1234591239]). The net proceeds to the Company from the Offering are expected to be approximately $163.8 million, after deducting underwriting discounts and commissions and estimated offering expenses payable by the Company. The Company also granted the Underwriters an option to purchase 486,111 additional ADSs at the public offering price.

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The Offering is being made pursuant to the Company’s registration statement on Form S-3 (File No. 333-260179), which became effective upon filing with the Securities and Exchange Commission on October 12, 2021, a base prospectus dated October 12, 2021 and the related prospectus supplement dated October 12, 2021. The Offering is expected to close on October 15, 2021, subject to customary closing conditions.

The Underwriting Agreement contains customary representations, warranties and agreements by the Company, customary conditions to closing, indemnification obligations of the Company and the Underwriters, including for liabilities under the Securities Act of 1933, as amended, other obligations of the parties and termination provisions. The representations, warranties and covenants contained in the Underwriting Agreement were made only for purposes of such agreement and as of specific dates, were solely for the benefit of the parties to such agreement and may be subject to limitations agreed upon by the contracting parties, including being qualified by confidential disclosures exchanged between the parties in connection with the execution of the Underwriting Agreement. The Company’s directors and executive officers have agreed, subject to certain exceptions, not to sell or transfer any ordinary shares (including ADSs representing ordinary shares) for 60 days, and the Company has agreed not to sell or transfer any ordinary shares (including ADSs representing ordinary shares) for 60 days, in each case, after October 12, 2021, without first obtaining the written consent of the Representatives.