On April 23, 2020 Moderna, Inc., (Nasdaq: MRNA) a clinical stage biotechnology company pioneering messenger RNA (mRNA) therapeutics and vaccines to create a new generation of transformative medicines for patients, reported that it will host a live conference call and webcast at 8:00 a.m. ET on Thursday, May 7, 2020 to report its first quarter 2020 financial results and provide a corporate update (Press release, Moderna Therapeutics, APR 23, 2020, View Source [SID1234556544]).

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To access the live conference call, please dial 866-922-5184 (domestic) or 409-937-8950 (international) and refer to conference ID 6698719. A webcast of the call will also be available under "Events and Presentations" in the Investors section of the Moderna website at investors.modernatx.com. A replay of the webcast will be archived on Moderna’s website for one year following the presentation.

On April 23, 2020 Idera Pharmaceuticals, Inc. ("Idera") (Nasdaq: IDRA) reported that updates on ILLUMINATE-206 and ILLUMINATE-101, two studies investigating intratumoral tilsotolimod, Idera’s investigational Toll-like receptor 9 (TLR9) agonist, will be presented at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) Virtual Annual Meeting I, to be held April 27-28, 2020, as part of a "Clinical Trial Poster Session (Press release, Idera Pharmaceuticals, APR 23, 2020, View Source [SID1234556543])."

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ILLUMINATE-206 is an ongoing phase 2, open-label, multicohort, multicenter study to test the safety and efficacy of intratumoral tilsotolimod in combination with Yervoy* (ipilimumab) and Opdivo (nivolumab) for the treatment of solid tumors. The trial initiated in September 2019 with the microsatellite stable colorectal cancer (MSS-CRC) cohort. A description of the trial in progress will be presented.

ILLUMINATE-101 was a phase 1b trial of intratumoral tilsotolimod monotherapy in patients with refractory solid tumors, which was completed in December 2019. Final results will be presented.

Hani M. Babiker, M.D., from the University of Arizona Cancer Center will present both studies. The abstract titles are as follows:

Abstract # 10614: Tilsotolimod engages the TLR9 pathway to promote antigen presentation and Type-I IFN signaling in solid tumors

Abstract # 10591: A phase 2 multicenter study to evaluate the efficacy of tilsotolimod in combination with nivolumab and ipilimumab for treatment of microsatellite-stable colorectal cancer (ILLUMINATE-206)
"We are very pleased that Dr. Babiker from the University of Arizona Cancer Center will present information from our studies investigating tilsotolimod in solid tumors," stated Elizabeth Tarka, M.D., Idera’s Chief Medical Officer. "We continue to be excited about the broader potential of tilsotolimod beyond melanoma."

The abstracts and video presentations will be available at 12:01 AM ET on Monday, April 27. Video presentations will be available for viewing on demand through the virtual meeting platform.

About Tilsotolimod (IMO-2125)

Tilsotolimod is an investigational, synthetic Toll-like receptor 9 agonist. Intratumoral injection of tilsotolimod has been shown to promote both innate and adaptive immune activation. Tumors with an active immune response appear to respond better to CPIs than those that exclude or inhibit anti-tumor immune cells. Tilsotolimod in combination with CPIs may cause regression of locally injected and distant tumor lesions and increase the number of patients who benefit from immunotherapy.

Tilsotolimod has received both Fast Track designation and Orphan Drug designation from the FDA and is being evaluated in multiple tumor types and in combination with multiple checkpoint and costimulation therapies. For more information on tilsotolimod trials, please visit ClinicalTrials.gov.

On April 23, 2020 Tocagen Inc. (Nasdaq: TOCA), historically a clinical-stage, cancer-selective gene therapy company, reported financial results for the first quarter ended March 31, 2020 (Press release, Tocagen, APR 23, 2020, View Source [SID1234556540]).

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On February 19, 2020, Tocagen announced it had entered into a definitive agreement in which a wholly-owned subsidiary of Tocagen will merge, in an all-stock transaction, with Forte Biosciences Inc., a privately held clinical-stage biopharmaceutical company developing a live biotherapeutic for the treatment of inflammatory skin diseases. Upon stockholder approval, the combined company is expected to operate under the name Forte Biosciences Inc. and trade on the Nasdaq Capital Market under the ticker symbol FBRX. The transaction has been unanimously approved by the Board of Directors of both companies and is expected to close in the second quarter of 2020, subject to customary conditions, including approval by Tocagen and Forte stockholders.

First Quarter 2020 Financial Results

Research and Development (R&D) Expenses: R&D expenses were $3.1 million for the quarter ended March 31, 2020, compared to $12.4 million for the quarter ended March 31, 2019. The decrease of $9.3 million was primarily due to decreases in clinical trial related costs due to wind down activities and a reduction in our workforce.

General and Administrative (G&A) Expenses: G&A expenses were $5.6 million for the quarter ended March 31, 2020, compared to $4.4 million for the quarter ended March 31, 2019. The increase of $1.1 million was primarily due to increased personnel costs, including non-cash stock-based compensation and severance costs in connection with wind down activities and a reduction in our workforce.

Net Loss: Net loss was $10.3 million, or $0.43 per common share (basic and diluted), for the quarter ended March 31, 2020, compared to a net loss of $17.1 million, or $0.74 per common share (basic and diluted), for the quarter ended March 31, 2019. The calculation is based on 23.9 million average common shares outstanding for the first quarter of 2020, compared to 23.0 million average common shares outstanding for the first quarter of 2019.

Cash Position

Cash, cash equivalents and marketable securities were $14.2 million at March 31, 2020 compared to $21.8 million at December 31, 2019.

On April 23, 2020 Surface Oncology (Nasdaq: SURF), a clinical-stage immuno-oncology company developing next-generation immunotherapies that target the tumor microenvironment, reported that it has initiated a Phase 1 clinical trial of its first-in-class antibody SRF388, which targets the immunosuppressive cytokine IL-27.

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"IL-27 is an immunosuppressive cytokine that is associated with poor outcomes in certain tumor types. Our first-in-class anti-IL-27 antibody SRF388 strongly inhibits the action of IL-27, a mechanism designed to stimulate the immune system to mount a robust attack against the tumor," said Robert Ross, M.D., chief medical officer of Surface Oncology. "The development of SRF388 is informed by a compelling translational hypothesis which led us to prioritize early assessment in hepatocellular and renal cell carcinoma, both of which are characterized by high levels of circulating EBI3, a subunit of IL-27."

The Phase 1 dose escalation study will enroll patients with advanced solid tumors. Once a recommended Phase 2 dose is reached, the study is designed to expand into cohorts consisting of patients with late-stage renal cell carcinoma and hepatocellular carcinoma. Surface expects to provide an initial clinical update from the dose escalation portion of the study by the end of 2020.

About SRF388
SRF388 is a fully human anti-IL-27 antibody designed to inhibit the activity of this immunosuppressive cytokine. Surface Oncology has identified particular tumor types, including hepatocellular and renal cell carcinoma, where IL-27 appears to play an important role in the immunosuppressive tumor microenvironment and may contribute to resistance to treatment with checkpoint inhibitors. Furthermore, Surface Oncology has identified a potential biomarker associated with IL-27 that may be useful in helping identify patients most likely to respond to SRF388.

On April 23, 2020 Spago Nanomedical AB (publ) reported that it has been told that the Japanese patent authority intends to approve the company’s application for product protection for Tumorad (Press release, Spago Nanomedical, APR 23, 2020, View Source [SID1234556538]).

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"The patent applies to the material and is therefore central to the Tumorad project. In addition, Japan is a potentially large market for radionuclide therapies, which is why the patent is important. This shows the height of our innovation and strengthens the project’s commercial conditions, "says CEO Mats Hansen.

The patent entitled "Nanostructures and applications thereof" (application number 2017-501494) is valid until 2035.

The approval means that Spago Nanomedical has product protection for Tumorad in the largest markets for radionuclide therapies. Tumorad already has patent protection in several strategically important regions, including the US and the EU.

Tumorad is being developed as a new type of radionuclide therapy based on Spago Nanomedical’s materials and a therapeutic radioactive isotope for tumor-selective radiation therapy of cancer.

Access to new therapies is a key to effective treatment of many cancers. Tumorad has the potential to treat aggressive and widespread tumors, alone or in synergy with other types of therapies. An extensive program is currently being implemented to document proof of concept for preclinical safety studies and clinical trials.