DARPA Awards Moderna up to $56 Million to Enable Small-Scale, Rapid Mobile Manufacturing of Nucleic Acid Vaccines and Therapeutics

On October 8, 2020 Moderna, Inc., (Nasdaq: MRNA) a biotechnology company pioneering messenger RNA (mRNA) therapeutics and vaccines to create a new generation of transformative medicines for patients, reported an agreement for a commitment of up to $56 million from the Defense Advanced Research Projects Agency (DARPA) to fund development of a mobile manufacturing protype leveraging Moderna’s existing manufacturing technology that is capable of rapidly producing vaccines and therapeutics (Press release, Moderna Therapeutics, OCT 8, 2020, View Source [SID1234568234]). The agreement builds on a previous assistance grant with DARPA established in 2013.

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The award is part of DARPA’s Nucleic Acids On Demand World-Wide (NOW) initiative to develop a mobile, end-to-end automated manufacturing platform to provide in-field, just-in-time manufacturing of Good Manufacturing Practice (GMP) quality nucleic acid (including mRNA) vaccines and therapeutics intended to deliver near-instantaneous protections and treatments to both military personnel and local populations. The design envisions a manufacturing unit capable of producing hundreds of doses of medicines in a matter of days in a 6 foot x 6 foot x 6 foot (1.8m x 1.8m x 1.8m) container in remote locations around the world.

"We are pleased to continue our collaboration with DARPA with a new award and we look forward to building on our experience rapidly designing and manufacturing vaccines as demonstrated with mRNA-1273, our COVID-19 vaccine currently in a Phase 3 study, and mRNA-4157, our personalized cancer vaccine currently in a Phase 2 study," said Stéphane Bancel, Chief Executive Officer of Moderna. "This new award will allow us to explore the reach of our technology to potentially enable fast, in-field, automated manufacturing of vaccines and therapeutics for both military personnel and civilians around the world in a container that can be deployed rapidly to make customized vaccines or therapeutics. The ability to make medicines in a mobile unit could have an important impact on the ability to respond to future viral challenges. Moderna is committed to being part of the solution in preventing future pandemics."

DARPA’s financial support of the NOW program is part the Agency’s commitment to creating innovative biotechnological approaches to rapidly detect, characterize and mitigate threats from newly emerging or engineered pathogens.

Conference Call and Webcast Information

Moderna will host a live conference call and webcast at 8:00 a.m. ET on Thursday, October 8, 2020. To access the live conference call, please dial 866-922-5184 (domestic) or 409-937-8950 (international) and refer to conference ID 5596196. 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. The archived webcast will be available on Moderna’s website approximately two hours after the conference call.

Soligenix to Present at the BIO Investor Forum

On October 8, 2020 Soligenix, Inc. (Nasdaq: SNGX) (Soligenix or the Company), a late-stage biopharmaceutical company focused on developing and commercializing products to treat rare diseases where there is an unmet medical need, reported that its President and Chief Executive Officer, Christopher J. Schaber, Ph.D., will deliver a corporate presentation at the BIO Investor Forum, held virtually October 13-15, 2020 (Press release, Soligenix, OCT 8, 2020, View Source [SID1234568233]). The presentation will be available on-demand for conference attendees.

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Seattle Genetics, Inc. Announces Corporate Name Change to Seagen Inc.

On October 8, 2020 Seagen Inc. reported that it is the new corporate name for Seattle Genetics, Inc. (Nasdaq:SGEN), a global biotechnology company dedicated to developing innovative cancer medicines that make a meaningful difference in people’s lives around the world (Press release, Seattle Genetics, OCT 8, 2020, View Source [SID1234568232]). The evolution of the corporate name reflects the transformation of Seagen as it expands operations globally to bring its marketed medicines to more patients, pursues new indications for approved medicines and continues to advance its pipeline of novel therapies for solid tumors and blood-related cancers. The Company’s common stock will continue to trade under its current ticker symbol: "SGEN."

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"The change in our corporate name from Seattle Genetics to Seagen reflects who we are today, as we expand our presence beyond the Pacific Northwest and outside of the United States to support the commercialization of TUKYSA globally," said Clay Siegall , Ph.D., President and Chief Executive Officer of Seagen. "We have three marketed products and a robust development pipeline of novel targeted product candidates. As we increase our global presence by adding new team members and locations outside of the United States as well as through strategic partnerships, we are better positioned to bring important new therapies to cancer patients around the world. Our passion for helping patients is stronger than ever."

Seagen is focused on discovering safe and effective novel therapeutics to advance cancer care. As a pioneer in antibody-drug conjugates (ADCs), Seagen has been a leader in novel cancer therapeutics for more than 20 years. ADCETRIS (brentuximab vedotin) is approved in over 70 countries around the world and continues to make a difference in the lives of patients with several types of lymphomas. In the last year, Seagen successfully launched two new cancer medicines that address significant unmet medical needs. PADCEV (enfortumab vedotin) was the first antibody-drug conjugate (ADC) approved for locally advanced or metastatic urothelial (bladder) cancer following treatment with platinum-based chemotherapy and a PD-1 or PD-L1 inhibitor. TUKYSA (tucatinib) was approved in the U.S. for metastatic HER2-positive breast cancer following an expedited U.S. Food and Drug Administration (FDA) approval. TUKYSA has also received approval in Australia , Canada , Singapore and Switzerland under the Project Orbis initiative of the FDA Oncology Center of Excellence and is under review with the European Medicines Agency (EMA).

The company also recently entered into two strategic collaborations with Merck that will accelerate and broaden the global development of the investigational ADC ladiratuzumab vedotin and the commercialization of TUKYSA in Asia , the Middle East , Latin America and other regions outside of the U.S. , Canada and Europe . These strategic collaborations will further expand Seagen’s global presence in oncology and ability to deliver cancer medicines around the world.

Along with the new name, the company will adopt a new logo and will change its corporate website from www.seattlegenetics.com to www.seagen.com . Seagen will provide further updates to customers, suppliers and partners regarding these changes in the implementation of the new name.

Horizon Therapeutics plc to Release Third-Quarter 2020 Financial Results and Host Webcast on Nov. 2, 2020

On October 8, 2020 Horizon Therapeutics plc (Nasdaq: HZNP) reported that its third-quarter 2020 financial results will be released on Monday, Nov. 2, 2020 (Press release, Horizon Therapeutics, OCT 8, 2020, View Source [SID1234568229]). Following the announcement, Horizon’s management will host a live webcast at 8 a.m. Eastern Time to review the Company’s financial and operating results.

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The live webcast and a replay may be accessed at View Source Please connect to the Company’s website at least 15 minutes prior to the live webcast to ensure adequate time for any software download that may be needed to access the webcast. A replay of the webcast will be available approximately two hours after the live webcast.

Mustang Bio Announces MB-105 Data Selected for Presentation at the Virtual 27th Annual Prostate Cancer Foundation Scientific Retreat

On October 8, 2020 Mustang Bio, Inc. ("Mustang") (NASDAQ: MBIO), a clinical-stage biopharmaceutical company focused on translating today’s medical breakthroughs in cell and gene therapies into potential cures for hematologic cancers, solid tumors and rare genetic diseases, reported that initial Phase 1 data on MB-105, a PSCA-targeted CAR T administered systemically to patients with PSCA-positive metastatic castration-resistant prostate cancer (mCRPC), will be presented at the virtual 27th Annual Prostate Cancer Foundation Scientific Retreat, which is being held October 20 – 23, 2020 (Press release, Mustang Bio, OCT 8, 2020, View Source [SID1234568228]).

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Manuel Litchman, M.D., President and Chief Executive Officer of Mustang, said, "We are pleased that City of Hope will be presenting initial data from the Phase 1 trial of MB-105 at the virtual 27th Annual Prostate Cancer Foundation Scientific Retreat. MB-105 is our CAR T cell therapy that is being studied for the potential treatment of prostate cancer. We look forward to continuing to progress this PSCA-targeted CAR T program."

Details of the presentation are as follows:

Title: Clinical Development of PSCA-targeted CAR T cell therapy for mCRPC
Session Date and Time: Friday, October 23, 2020, 11:50 a.m. PT
Presenter: Tanya Dorff, M.D., Associate Professor, Department of Medical Oncology & Experimental Therapeutics,
Head, Genitourinary Cancer Program, City of Hope, Duarte, CA

For more information, please visit the 27th Annual Prostate Cancer Foundation Scientific Retreat website at View Source

About MB-105 (PSCA CAR T technology)
MB-105 was developed in the laboratory of Saul Priceman, Ph.D., assistant professor in City of Hope’s Department of Hematology & Hematopoietic Cell Transplantation and a scientist in the T Cell Therapeutics Research Laboratory led by Stephen Forman, M.D., leader of City of Hope’s Hematologic Malignancies and Stem Cell Transplantation Institute and the laboratory’s director.

The Phase 1 clinical trial of MB-105, one of the first chimeric antigen receptor T cell (CAR T) trials for prostate cancer in the nation, can enroll up to 33 patients. Its primary endpoints are to define the side effects and the best dose of the prostate stem cell antigen (PSCA) CAR T cells in treating patients with PSCA-positive metastatic castration-resistant prostate cancer (mCRPC). Secondary endpoints include assessing the expansion and persistence of PSCA CAR T cells, the clinical response based on Prostate Cancer Working Group 3 (PCWG3) criteria, the survival outcomes and serum cytokine profiles in peripheral blood pre- and post-therapy, as well as describing the PSCA expression level on tumor cells prior to CAR T cell infusion and the relationship it may have with disease response and toxicities. For more information on this Phase 1 trial, please visit www.clinicaltrials.gov using identifier NCT03873805.