On December 7, 2020 OncoMyx Therapeutics, a privately-held oncolytic immunotherapy company, reported that The University of Western Ontario (Western) has assigned to OncoMyx the technology and patent rights associated with pioneering research on the use of myxoma virus in the treatment of cancer (Press release, OncoMyx Therapeutics, DEC 7, 2020, View Source [SID1234572370]). This research was led by OncoMyx cofounder Grant McFadden, Ph.D., when he was a Professor at Western and the Robarts Research Institute.

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Lisa Cechetto, the Executive Director of WORLDiscoveriesTM, the technology transfer office for Western, Robarts Research Institute, and Lawson Research Institute, said, "We are pleased to assign these patents to OncoMyx, as it is important that the outputs of pioneering research, such as Dr. McFadden’s use of myxoma virus to create novel oncolytic therapies, be further developed to improve the lives of cancer patients or others who may benefit."

"The assignment of this technology and intellectual property to OncoMyx further reinforces our IP portfolio protecting our use of myxoma virus and our pipeline of myxoma virotherapies for the treatment of cancer," said Steve Potts, Ph.D., MBA, cofounder and chief executive officer of OncoMyx. "The myxoma virus has a number of important attributes that we are leveraging to develop potentially impactful oncolytic immunotherapies with the goal of increasing the number of cancer patients who could benefit from immunotherapies."

"Oncolytic viruses are emerging as a new pillar of cancer care with the potential to expand the effectiveness of immunotherapies, such as immune checkpoint inhibitors," said Dr. McFadden. "I am pleased that OncoMyx has been assigned the patent rights associated with the pioneering myxoma research that was done at Western, as the myxoma virus is unique as a technology platform to build oncolytic immunotherapies."

About Myxoma Virotherapy for the Treatment of Cancer

The myxoma virus is highly immuno-interactive and can selectively infect and kill a broad range of cancer cell types. Because myxoma virus is not pathogenic to humans, myxoma virotherapy does not have to overcome pre-existing immunity. As a large dsDNA poxvirus, myxoma is engineerable to express multiple transgenic payloads, such as immunomodulatory proteins, to target multiple points in the cancer immunity cycle. The company’s preclinical data demonstrates efficacy of multi-armed myxoma virotherapies via intravenous (IV) and intratumoral (IT) delivery in a number of tumor models across multiple cancer indications and supports a pan-tumor approach to expand the therapeutic effectiveness of immunotherapies.

On December 7, 2020 Artiva Biotherapeutics, Inc., an oncology company focused on developing and commercializing primary allogeneic natural killer (NK) cell therapies to treat cancer, reported U.S. Food and Drug Administration (FDA) allowance of the company’s investigational new drug (IND) application for AB-101, an optimized and cryopreserved off-the-shelf NK cell therapy (Press release, Artiva Biotherapeutics, DEC 7, 2020, View Source [SID1234572369]). Artiva plans to conduct a Phase 1/2 clinical trial at up to 20 U.S. cancer centers to assess the safety and clinical activity of AB-101 alone and in combination with the anti-CD20 monoclonal antibody, rituximab, in patients with relapsed or refractory B-cell non-Hodgkin lymphoma (NHL) who have progressed beyond two or more prior lines of therapy.

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"Monoclonal antibodies are mainstays of cancer therapy, but many patients have sub-optimal responses, and those who progress have limited options," said Tom Farrell, President and CEO of Artiva. "With AB-101, we intend to leverage our proprietary off-the-shelf NK cell platform to enhance and extend the clinical application of monoclonal antibodies and other cancer targeted therapies that rely on NK cells to mediate their anti-cancer activity."

AB-101 is a cryopreserved NK cell product candidate with high and consistent expression of tumor-engaging receptors including the high-affinity variant of CD16. These NK cell attributes have demonstrated improved outcomes for cancer patients in both the transplant and therapeutic monoclonal antibody settings. Furthermore, in preclinical models, AB-101 demonstrates enhanced antibody-dependent cellular cytotoxicity with a variety of therapeutic antibodies.

"Allogeneic NK cells have been tested in clinical trials for more than a decade. Based on this experience, we expect that AB-101 will be well tolerated. This contrasts with T-cell therapies that are associated with life-threatening cytokine release syndrome, neurotoxicity, and graft-versus-host-disease," said Jason Litten, MD, Chief Medical Officer of Artiva.

About the Clinical Trial

After receiving standard lymphodepleting chemotherapy, patients will receive eight weekly doses of up to four billion NK cells per AB-101 dose. The primary endpoint is objective response rate, per the 2014 Lugano Criteria. In Phase 2, indolent and aggressive NHL patients will receive AB-101 plus rituximab combination therapy in two parallel Simon two-Stage designed cohorts, each with independent interim analyses for objective clinical response.

About AB-101 NK Cell Therapy

Leveraging a proprietary manufacturing platform that enables expansion and cryopreservation of cord blood-derived NK cells, Artiva is advancing AB-101 as a universal primary NK cell product candidate for use in combination with targeting therapies such as monoclonal antibodies or NK cell engagers. Starting cord blood units are selected for B-KIR haplotype and the homozygous polymorphism of CD16 that confers high affinity binding to antibodies, including monoclonal antibody therapies. Starting cells are isolated then expanded and activated utilizing a proprietary campaign-based manufacturing process in a state-of the art GMP facility. AB-101 is delivered as cryopreserved vials of one billion highly active NK cells in an infusion-ready media for thawing and administration on demand at the clinical trial site. The manufacturing process generates thousands of cryovials of AB-101 from a single cord blood unit.

On December 7, 2020 Guardant Health, Inc. (Nasdaq: GH), a leading precision oncology company, reported that it shares new data at the 2020 Virtual San Antonio Breast Cancer Symposium (SABCS) showing how its GuardantINFORM real-world clinical-genomic platform can be used to gain deeper insights into patients’ treatments and associated response to support the development of more effective therapies for biomarker-defined cancers (Press release, Guardant Health, DEC 7, 2020, businesswire.com/news/home/20201207005087/en/Guardant-Health-Presents-Data-at-San-Antonio-Breast-Cancer-Symposium-Demonstrating-Utility-of-GuardantINFORM-Real-World-Platform-in-Metastatic-Breast-Cancer [SID1234572368]). The data presented highlight treatment resistance in estrogen receptor positive (ER-positive), HER-2 negative metastatic breast cancer patients.

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"While we’ve seen improved outcomes for patients with ER-positive metastatic breast cancer, many eventually develop ESR1 resistance after undergoing endocrine therapy; and new data from patients treated with CDK4/6 inhibitors suggest that clinical outcomes are impacted by a patient’s molecular subtype," said Helmy Eltoukhy, Guardant Health CEO. "The results presented during SABCS demonstrate the power of our GuardantINFORM platform to deliver real-world clinical-genomic insights to help guide more precise oncology treatments and accelerate drug development efforts for these difficult to treat breast cancers."

The abstracts, now online, show how this robust platform helps characterize molecular tumor evolution and treatment resistance mechanisms throughout each patient’s treatment journey.

Abstract PS18-15: "Real-world clinical-genomic data identifies the ESR1 clonal and subclonal circulating tumor DNA (ctDNA) landscape and provides insight into clinical outcomes" shows how the data from our Guardant360 liquid biopsy dataset demonstrate the heterogeneity of ESR1 mutations associated with endocrine therapy treatment.
Abstract PS18-28: "Genomic heterogeneity and associated clinical outcomes of breast cancers treated with CDK4/6 inhibitors: Insights from real-world clinical genomic data" suggests new potential mechanisms of acquired resistance.
Abstract OT-07-01: "Guardant360 related clinical outcomes in patients who share medical records-breast cancer (GRECO-B)" shows how Guardant Health takes a novel patient-centric approach to enrolling Guardant360 breast cancer patients into this siteless, prospective, observational health outcomes study to create a more comprehensive view of patients’ clinical journey.
The GuardantINFORM platform is an in silico platform that combines de-identified longitudinal clinical information and genomic data collected from our Guardant360 liquid biopsy test. With data from over 135,000 patients, this real-world clinical-genomic dataset of advanced cancer patients is one of the largest in oncology. Notable applications include targeted drug development, clinical trial optimization, and post-marketing studies.

On December 7, 2020 Synthekine Inc., an engineered cytokine therapeutics company, reported in vivo data presented at the American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting showing STK-009, its orthogonal IL-2 ligand, improved the efficacy and durability of SYNCAR-001, its CD-19 targeted CAR-T cell therapy modified with an orthogonal IL-2 receptor (Press release, Synthekine, DEC 7, 2020, View Source [SID1234572367]). The data were delivered in a poster presentation by Paul-Joseph Aspuria, Ph.D., of Synthekine.

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"While CAR-T therapies have proven to be very effective in treating hematological malignancies, the lack of sustained activity and CAR-T cell persistence limits their full therapeutic potential in lymphoma," said Martin Oft, M.D., chief development officer at Synthekine. "The presented data demonstrate our orthogonal IL-2 system is well positioned to overcome these shortcomings. STK-009 demonstrates the ability to expand CAR-Ts in vivo in pre-clinical models, allowing for a lower starting dose of CARs while achieving deep and durable efficacy with the possibility to re-expand resting CARs long after initial transfer. We look forward to advancing STK-009 and SYNCAR-001 and filing an IND for the program in 2021."

In both disseminated and subcutaneous RAJI lymphoma models in mice evaluating the efficacy of STK-009 with SYNCAR-001, STK-009 dosing drove increased levels of circulating SYNCAR-001 cells, resulting in complete responses. STK-009 expanded both CAR-T effector cells and stem cell memory cells, resulting in deep initial responses and long-term immune surveillance. Data on STK-009 from a multiple-ascending dose study in non-human primates were also presented, showing STK-009 was well tolerated, had long exposure, and had no effect on cells expressing only the wild type IL-2 receptor. A copy of the poster is available on Synthekine’s website.

"Selectivity of this orthogonal IL-2 ligand is fundamental, as more promiscuous activity on bystander cells could lead to systemic toxicity and limit the therapeutic potential of this combined treatment," said Dr. Aspuria. "Based on the data we presented, we are optimistic about the potential for STK-009 and SYNCAR-001 to overcome hurdles faced by CD-19 cell therapy today."

On December 7, 2020 NANOBIOTIX (Paris:NANO) (Euronext: NANO – ISIN : FR0011341205 – the "Company"), a clinical-stage nanomedicine company pioneering new approaches to the treatment of cancer, reported the start of its roadshow in connection with its intention to issue and sell, subject to market and other conditions, 6,500,000 ordinary shares of the Company in an initial public offering of American Depositary Shares ("ADSs"), each representing one ordinary share, in the United States (the "U.S. Offering") and a concurrent offering of ordinary shares in certain jurisdictions outside of the United States (the "European Offering" and, together with the U.S. Offering, the "Global Offering") (Press release, Nanobiotix, DEC 7, 2020, View Source [SID1234572365]). The Company intends to grant the underwriters for the Global Offering (the "Underwriters") a 30-day option to purchase additional ADSs and/or ordinary shares in an aggregate amount of up to 15% of the total number of ADSs and ordinary shares proposed to be sold in the Global Offering.

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All securities to be sold in the Global Offering will be offered by the Company. The Company has applied to list its ADSs on the Nasdaq Global Market under the ticker symbol "NBTX." The Company’s ordinary shares are listed on the regulated market of Euronext in Paris under the symbol "NANO."

Jefferies LLC is acting as global coordinator and joint book-running manager for the Global Offering, and Evercore Group, L.L.C. and UBS Securities LLC are acting as joint book-running managers for the U.S. Offering. Jefferies International Limited and Gilbert Dupont are acting as managers for the European Offering.

The offering price per ADS in U.S. dollars and the corresponding offering price per ordinary share in euros, as well as the final number of ADSs and ordinary shares sold in the Global Offering, will be determined following a bookbuilding process.

The ADSs and/or ordinary shares will be issued through a capital increase without shareholders’ preferential subscription rights by way of a public offering excluding offerings referred to in Article L. 411-2 1° of the French Monetary and Financial Code (Code monétaire et financier) and under the provisions of Article L.225-136 of the French Commercial Code (Code de commerce) and pursuant to the 2nd and 7th resolutions of the Company’s extraordinary general shareholders’ meeting held on November 30, 2020.

The European Offering will be open only to qualified investors as such term is defined in article 2(e) of the regulation (EU) 2017/1129 of the European Parliament and of the Council of June 14, 2017.

The securities referred to in this press release will be offered only by means of a prospectus. When available, copies of the preliminary prospectus relating to and describing the terms of the Global Offering may be obtained from Jefferies LLC, 520 Madison Avenue New York, NY 10022, or by telephone at 877-547-6340 or 877-821-7388, or by email at [email protected]; or from Evercore Group L.L.C., Attention: Equity Capital Markets, 55 East 52nd Street, 35th Floor, New York, New York 10055, or by telephone at 888-474-0200, or by email at [email protected]; or from UBS Securities LLC, Attention: Prospectus Department, 1285 Avenue of the Americas, New York, New York 10019, or by telephone at 888-827-7275, or by email at [email protected].

A registration statement on Form F-1 relating to the securities referred to herein has been filed with the U.S. Securities and Exchange Commission ("SEC") but has not yet become effective. These securities may not be sold, nor may offers to buy be accepted, prior to the time the registration statement becomes effective. The registration statement can be accessed by the public on the website of the SEC.

Application will be made to list the new ordinary shares to be issued pursuant to the Global Offering on the regulated market of Euronext in Paris pursuant to a listing prospectus subject to an approval from the French Autorité des marchés financiers ("AMF") and comprising the 2019 Universal Registration Document (Document d’Enregistrement Universel) of the Company approved by the AMF on May 12, 2020 under number R. 20-010, as amended by its amendment filed with the AMF on November 20, 2020 under number D.20-0339-A01 and a Securities Note (Note d’opération), including a summary of the prospectus. Copies of the 2019 Universal Registration Document and its amendment are available free of charge at the Company’s head office located at 60, rue de Wattignies, 75012 Paris, France, on the Company’s website (www.nanobiotix.com) and on the website of the AMF (www.amf-france.org).

This press release does not constitute an offer to sell or the solicitation of an offer to buy securities in any jurisdiction, and shall not constitute an offer, solicitation or sale in any jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of that jurisdiction.