On April 20, 2022 Monopteros Therapeutics Inc. ("Monopteros"), a clinical-stage biotechnology company developing MPT-0118, a first-in-class MALT1 inhibitor for the treatment of solid tumors, reported two presentations at the tumor immune microenvironment workshop of the Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper), to be held in person in San Diego and virtually from April 21-22, 2022 (Press release, Monopteros Therapeutics, APR 20, 2022, View Source [SID1234612591]). These presentations demonstrate that highly activated immunosuppressive regulatory T cells (Tregs) in solid tumors have the potential to become interferon-gamma-producing effector T cells and that the occurrence of this reprogrammed state increases the clinical response to immune checkpoint therapy in cancer patients. Further, translational nonclinical results for MPT-0118, currently undergoing a phase 1 clinical trial (NCT04859777), are presented.

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"We are excited to present these results, which shed light on how a cold, unresponsive, and immunosuppressive tumor microenvironment can be modulated to respond to immunotherapy," said Peter Keller, President and CEO of Monopteros. "Our clinical candidate MPT-0118 is pioneering the novel mechanism of reprogramming tumor-infiltrating regulatory T cells, which is the key for opening up many cold tumors to immunotherapy."

Presentation Title: Spontaneous proinflammatory conversion of regulatory T cells (Treg) is associated with improved immune checkpoint inhibitor (CPI) response
Poster Number: 042
Presenter: Kevin Litchfield, PhD, University College of London
Presentation Date and Time: April 21, 5:20 to 6:20 pm PT
Results show that around 4% of Tregs in cancer are spontaneously producing interferon-gamma. This Treg population is associated with a higher probability of response to anti-PD-1 checkpoint inhibitor therapy in cancer patients. We further demonstrate that these reprogrammed Tregs are genetically related to a pool of highly activated PD1 and Lag3 positive Tregs.

Presentation Title: Reprogramming Regulatory T cells (Treg) Using a MALT1 Inhibitor for Cancer Therapy
Poster Number: 037
Presenter: Peter Keller, MSc, Monopteros Therapeutics
Presentation Date and Time: April 21, 5:20 to 6:20 pm PT
This poster was requested for resubmission from SITC (Free SITC Whitepaper)’s annual conference in 2021 and presents the data generated with clinical-stage MPT-0118 to reprogram regulatory T cells in mouse and human tissue and its preclinical anti-tumor effects.

Following the conference, the two presentations will be available in the Publications section of Monopteros’ website at www.monopterostx.com.

On April 20, 2022 Seagen Inc. (Nasdaq: SGEN) reported plans to build a new facility in Everett, Washington, to expand the company’s biomanufacturing capacity and enable the company greater control and flexibility over the production of its medicines to treat cancer (Press release, Seagen, APR 20, 2022, View Source [SID1234612590]). The 270,000-square-foot facility will be built north of the company’s U.S. headquarters in Bothell, Washington. Seagen expects to have the facility operational in 2024 and ultimately employ up to 200 highly skilled workers to produce medicines for clinical trials and the commercial market.

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"In cancer research and development, Seagen must continue to be agile and flexible, especially in manufacturing, to advance our promising pipeline of medicines for people living with cancer and bring these medicines to patients as fast as possible," said Clay Siegall, Ph.D., President and Chief Executive Officer, Seagen. "This new biomanufacturing facility is another way we are growing and expanding operations while also positioning ourselves to attract top-flight talent to drive our business priorities."

The new biomanufacturing facility is a "greenfield" project, constructed from the ground up into a modern production facility to make advanced medicines. Seagen plans to make antibody-based medicines (also called biologics) in the new fully integrated plant for the commercial market and for use in clinical sites around the world. The new facility will add to Seagen’s existing manufacturing site in the Bothell area. This project will create up to 150 new jobs during the initial construction of the shell and core of the building.

Seagen has four marketed therapies used in the treatment of Hodgkin lymphoma and urothelial (bladder), breast and cervical cancers. In research and development, Seagen is advancing more than 17 programs, including approved products and a deep and diverse early- and late-stage pipeline across a range of solid tumors and hematologic malignancies.

As a global biotech company, Seagen employs more than 2,800 people worldwide including more than 1,600 people in the Pacific Northwest.

On April 20, 2022 Viracta Therapeutics, Inc. (Nasdaq: VIRX), a precision oncology company targeting virus-associated malignancies, reported that it will host a key opinion leader (KOL) webinar on Nana-val (nanatinostat and valganciclovir) for the treatment of advanced Epstein-Barr virus-positive (EBV+) solid tumors on Wednesday, April 27, 2022, at 11:00 AM EDT (Press release, Viracta Therapeutics, APR 20, 2022, View Source [SID1234612588]).

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The webinar will feature a presentation from KOL Ezra Cohen, MD, FRCPSC, FASCO (Chief of Hematology/Oncology, Department of Medicine and Co-director of the Gleiberman Head and Neck Cancer Center, University of California, San Diego), who will discuss the current treatment landscape in nasopharyngeal carcinoma (NPC) and the unmet medical need for the treatment of patients with NPC.

Additionally, members of Viracta’s management team will provide an overview of the ongoing Phase 1b/2 clinical trial evaluating Nana-val in patients with recurrent or metastatic NPC and other advanced EBV+ solid tumors. Preclinical data supporting the use of Nana-val in solid tumors and the program’s future outlook will also be discussed.

A live question and answer session will follow the formal presentation.

To register for the webinar, please click here. Following the event, materials from the presentation and a replay of the webcast will be available in the "Events and Webcasts" section of the Viracta website at View Source

KOL Biography
Ezra Cohen, MD, FRCPSC, FASCO, is the Chief of the Division of Hematology-Oncology, and Co- Director of the San Diego Center for Precision Immunotherapy. A physician-scientist, Dr. Cohen led an independently funded laboratory interested in investigating the mechanisms of action of novel therapeutics and made major contributions to the development of targeted- and immuno- therapies. His research in areas such as epidermal growth factor receptor inhibitors, cell therapy, and immunotherapy in head and neck cancer has received peer-reviewed funding. He has made major contributions to the understanding of critical signaling pathways, the integration of novel agents into standard of care, and to the defining of mechanisms to overcome resistance to drug therapy. He also recently co-developed a personalized neoantigen vaccine using unique cancer mutations to boost an anti-tumor immune response.

Dr. Cohen also serves as Associate Director for Clinical Science, Co-Leader of the Solid Tumor Therapeutics Research Program and Co-Director of the Hanna and Mark Gleiberman Head and Neck Cancer Center at Moores Cancer Center. Additionally, he is a member of the Protocol Review and Monitoring Committee (PRMC), the Cancer Council, and the Cancer Center’s Executive Committee.

About Nana-val (Nanatinostat and Valganciclovir)

Nanatinostat is an orally available histone deacetylase (HDAC) inhibitor being developed by Viracta. Nanatinostat is selective for specific isoforms of Class I HDACs, which is key to inducing viral genes that are epigenetically silenced in EBV-associated malignancies. Nanatinostat is currently being investigated in combination with the antiviral agent valganciclovir as an all-oral combination therapy, Nana-Val, in various subtypes of EBV-associated malignancies. Ongoing trials include a pivotal, global, multicenter, open-label Phase 2 basket trial in multiple subtypes of relapsed/refractory EBV+ lymphoma (NAVAL-1) as well as a multinational Phase1b/2 trial in patients with EBV+ recurrent or metastatic nasopharyngeal carcinoma and other EBV+ solid tumors.

About EBV-Associated Cancers

Approximately 90% of the world’s adult population is infected with Epstein-Barr virus (EBV). Infections are commonly asymptomatic or associated with mononucleosis. Following infection, the virus remains latent in a small subset of lymphatic cells for the duration of the patient’s life. Cells containing latent virus are increasingly susceptible to malignant transformation. Patients who are immunocompromised are at an increased risk of developing EBV+ lymphomas. EBV is estimated to be associated with approximately 2% of the global cancer burden and is also associated with a variety of solid tumors, including nasopharyngeal carcinoma and gastric cancer.

On April 20, 2022 QIAGEN N.V. (NYSE: QGEN) (Frankfurt Stock Exchange: QIA) reported that it plans to release results for the first quarter of 2022 on Wednesday, April 27, at approximately 22:05 Frankfurt time / 21:05 London time / 16:05 New York time (Press release, Qiagen, APR 20, 2022, View Source [SID1234612586])

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Call date/time: Thursday, April 28, at 16:00 Frankfurt time / 15:00 London time / 10:00 New York time.

Hosts: Thierry Bernard, Chief Executive Officer, and Roland Sackers, Chief Financial Officer.

Three options for joining the call

A conference call replay will be available by using the following link:
View Source;tp_key=754eca7ed7

On April 20, 2022, Monopar Therapeutics Inc. ("Monopar" or the "Company") reported that entered into a Capital on DemandTM Sales Agreement (the "Agreement") with JonesTrading Institutional Services LLC ("JonesTrading" or the "Agent"), pursuant to which Monopar may offer and sell, from time to time, through or to JonesTrading, as sales agent or principal, shares of Common Stock, par value $0.001 per share (the "Shares") (Filing, 8-K, Monopar Therapeutics, APR 20, 2022, View Source [SID1234612585]). On April 20, 2022, the Company filed a prospectus supplement relating to the offer and sale of Shares from time to time pursuant to the Agreement up to an aggregate amount of $4,870,000.

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The offer and sale of the Shares will be made pursuant to a shelf registration statement on Form S-3 and the related prospectus (File No. 333-235791) (the "Registration Statement") filed by the Company with the Securities and Exchange Commission (the "SEC") on January 3, 2020 and declared effective by the SEC on January 13, 2020, as supplemented by a prospectus supplement dated April 20, 2022 and filed with the SEC pursuant to Rule 424(b) under the Securities Act of 1933, as amended (the "Securities Act"). This Current Report on Form 8-K shall not constitute an offer to sell or the solicitation of an offer to buy the Company’s Common Stock discussed herein, nor shall there be any offer, solicitation, or sale of the Company’s Common Stock in any state in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such state.

Monopar is not obligated to sell any Shares under the Agreement. Upon delivery of a placement notice by Monopar and subject to the terms and conditions of the Agreement and such placement notice, JonesTrading may sell the Shares by methods deemed to be an "at the market offering" as defined in Rule 415(a)(4) promulgated under the Securities Act and will use commercially reasonable efforts consistent with its normal trading and sales practices and applicable state and federal law, rules and regulations and the rules of Nasdaq Capital Market, to sell the Shares from time to time.

The offering of Shares pursuant to the Agreement will terminate upon the earlier of (a) the sale of all of the Shares subject to the Sales Agreement or (b) the termination of the Sales Agreement by JonesTrading or the Company, as permitted therein.

The Company has agreed to pay JonesTrading commissions for its services in acting as agent in the sale of the Shares in the amount of up to 3% of gross proceeds from the sale of the Shares pursuant to the Agreement. The Company has also agreed to provide JonesTrading with customary indemnification and contribution rights, in connection with entering into the Agreement.

The foregoing description of the Agreement is not complete and is qualified in its entirety by reference to the full text of such agreement, a copy of which is filed herewith as Exhibit 1.1 to this Current Report on Form 8-K and is incorporated herein by reference.

The opinion of the Company’s counsel regarding the validity of the Shares that may be issued pursuant to the Agreement is also filed herewith as Exhibit 5.1.