Seagen to Highlight Research From 16 Presentations Across Multiple Tumor Types at ESMO 2021

On September 8, 2021 Seagen Inc. (Nasdaq: SGEN) reported data and trials in progress from its diverse and growing portfolio of marketed and investigational therapies will be presented at the virtual European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper) 2021 Annual Meeting, to be held from September 16-21 (Press release, Seagen, SEP 8, 2021, View Source [SID1234587410]). Sixteen presentations will demonstrate the breadth of Seagen’s portfolio and development activities, across multiple cancer types – including a mini oral presentation featuring results from the Phase 1/2 innovaTV 205 clinical trial in recurrent or metastatic cervical cancer.

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The innovaTV 205 trial of tisotumab vedotin (TV) is designed to evaluate the safety and efficacy of TV as monotherapy and in combination with chemotherapy and other agents in recurrent or metastatic cervical cancer. Data to be shared will include interim analyses of TV plus carboplatin as a potential first-line therapy, as well as analyses of TV plus pembrolizumab in previously treated patients.

Seagen’s Biologics License Application for TV monotherapy in recurrent or metastatic cervical cancer is currently under Priority Review by the U.S. Food and Drug Administration (FDA) with a target action date of Oct. 10, 2021.

"The data to be shared at ESMO (Free ESMO Whitepaper) 2021 reflect our commitment to developing transformational cancer medicines for patients in areas of significant unmet medical need, including best-in-class antibody-drug conjugates," said Roger Dansey, M.D., Chief Medical Officer at Seagen. "Our research to advance antibody-drug conjugates as monotherapies or in combination with other therapies for the treatment of various cancers has the potential to shape future treatment paradigms."

Other research presentations include subset analyses of EV-301, a phase 3 trial of enfortumab vedotin (EV) versus chemotherapy for previously treated advanced urothelial carcinoma, and the first data from a weekly-dosing trial of ladiratuzumab vedotin (LV), an investigational anti-LIV-1 antibody-drug conjugate, in pre-treated metastatic triple-negative breast cancer.

Data to be presented at ESMO (Free ESMO Whitepaper) 2021 for Seagen medicines and investigational agents:

Presentation #

Abstract Title

Lead
Author

Presentation
Type

Tisotumab Vedotin

723MO

Tisotumab Vedotin (TV) + Carboplatin (Carbo) in First-line (1L) or + Pembrolizumab (Pembro) in Previously Treated (2L/3L) Recurrent or Metastatic Cervical Cancer (r/mCC): Interim Results of ENGOT-Cx8/GOG-3024/innovaTV 205 Study

I. Vergote

Mini Oral Session – Gynaelogical Cancers, Sunday, September 19, 5:30-5:35 PM CEST

930TiP

innovaTV 207: New Dosing Cohort in the Open Label Phase 2 Study of Tisotumab Vedotin in Solid Tumors

D. Hong

On Demand E-Poster

PADCEV (enfortumab vedotin)

698P

Analysis of hard-to-treat subgroups from EV-301, a phase 3 trial of enfortumab vedotin (EV) vs chemotherapy for previously treated advanced urothelial carcinoma

J. Rosenberg

On Demand E-Poster

705P

Systematic literature review (SLR) and network meta-analysis (NMA) of first-line (1L) therapies for locally advanced/metastatic urothelial carcinoma (la/mUC)

L. Bloudek

On Demand E-Poster

704P

Treatment Patterns Among Patients with Advanced Urothelial Carcinoma (aUC) in the US

A. Morgans

On Demand E-Poster

TUKYSA (tucatinib)

331TiP

HER2CLIMB-04: Phase 2 Trial of Tucatinib + Trastuzumab Deruxtecan in Patients With HER2+ Locally Advanced or Metastatic Breast Cancer With and Without Brain Metastases (Trial in Progress)

L. Carey

On Demand E-Poster

1434TiP

MOUNTAINEER-02: Phase 2/3 study of tucatinib, trastuzumab, ramucirumab, and paclitaxel in previously treated HER2+ gastric or gastroesophageal junction adenocarcinoma (GEC): Trial in Progress

D. Catenacci

On Demand E-Poster

557TiP

SGNTUC-019: Phase 2 basket study of tucatinib and trastuzumab in previously treated solid tumors with HER2 alterations (Trial in Progress)

M. Reck

On Demand E-Poster

1437TiP

Phase 1b/2, open label, dose escalation and expansion trial of tucatinib in combination with trastuzumab and oxaliplatin-based chemotherapy in patients with unresectable or metastatic HER2+ gastrointestinal cancers (Trial in Progress)

H. Park

On Demand E-Poster

439P

Characteristics and treatment patterns among patients with HER2-amplified advanced/metastatic colorectal cancer (mCRC): a clinical-genomic database study

J. Strickler

On Demand E-Poster

Ladiratuzumab Vedotin

259P

Weekly ladiratuzumab vedotin monotherapy for metastatic triple negative breast cancer

M. Tsai

On Demand E-Poster

643TiP

Open-Label, Phase 2 Study of Ladiratuzumab Vedotin (LV) for Unresectable Locally Advanced or Metastatic Solid Tumors (SGNLVA-005, Trial in Progress)

HT. Arkenau

On Demand E-Poster

ADCETRIS (brentuximab vedotin)

1029TiP

Phase 2 Trial of Pembrolizumab (Pembro) and Brentuximab Vedotin (BV) in Patients With Metastatic Solid Malignancies After Progression on Prior Programmed Cell Death Protein (PD)-1 Inhibitors (SGN35-033, Trial in Progress)

C. Lance Cowey

On Demand E-Poster

Early Pipeline

555TiP

A First-in-Human Trial of the Integrin Beta-6-Targeted Antibody–Drug Conjugate, SGN-B6A, in Patients With Advanced Solid Tumors (SGNB6A-001, Trial in Progress)

E. Calvo

On Demand E-Poster

556TiP

A Phase 1 Study of SGN-STNV, a Novel Antibody–Drug Conjugate Targeting Sialyl-Thomsen-nouveau Antigen (STn), in Adults With Advanced Solid Tumors (SGNSTNV-001)

N. Lakhani

On Demand E-Poster

Xenetic Biosciences, Inc. to Present at the H.C. Wainwright 23rd Annual Global Investment Conference

On September 8, 2021 Xenetic Biosciences, Inc. (NASDAQ:XBIO) ("Xenetic" or the "Company"), a biopharmaceutical company focused on advancing XCART, a personalized CAR T platform technology engineered to target patient- and tumor-specific neoantigens, reported that Jeffrey F. Eisenberg, Chief Executive Officer of Xenetic will present at the virtual H.C. Wainwright 23rd Annual Global Investment Conference taking place September 13-15, 2021 (Press release, Xenetic Biosciences, SEP 8, 2021, https://ir.xeneticbio.com/news/detail/115/xenetic-biosciences-inc-to-present-at-the-h-c-wainwright-23rd-annual-global-investment-conference [SID1234587409]).

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In addition to the presentation, management will be available to participate in virtual one-on-one meetings with qualified members of the investor community who are registered to attend the conference. For more information about the conference, please visit the conference website.

A video webcast of the presentation will be available for viewing on-demand beginning Monday, September 13, 2021, at 7:00 AM ET for those registered for the event and will be accessible on the Events page in the Investors section of the Company’s website (xeneticbio.com). The webcast replay will be archived for 90 days following the event.

Leidos To Participate In The Morgan Stanley Virtual 9th Annual Laguna Conference

On September 8, 2021 Leidos (NYSE: LDOS), a FORTUNE 500 science and technology company, reported that it will participate in the Morgan Stanley Virtual 9th Annual Laguna Conference webcast (Press release, Leidos, SEP 8, 2021, View Source [SID1234587408]).

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Chris Cage, Chief Financial Officer, will engage in a question and answer "fireside chat" on Wednesday, Sept. 15, 2021 at 2:15 p.m. ET.

A live audio webcast of the event will be available on the Leidos Investor Relations website at View Source A replay of the webcast will be available following the presentation at the same link listed above for 90 days afterward.

Moleculin to Present at the H.C. Wainwright 23rd Annual Global Investment Conference

On September 8, 2021 Moleculin Biotech, Inc., (Nasdaq: MBRX) (Moleculin or the Company), a clinical stage pharmaceutical company with a broad portfolio of drug candidates targeting highly resistant tumors and viruses, reported that Walter Klemp, President and Chief Executive Officer of Moleculin, will present at the virtual H.C. Wainwright 23rd Annual Global Investment Conference taking place September 13-15, 2021 (Press release, Moleculin, SEP 8, 2021, https://ir.moleculin.com/news/detail/225/moleculin-to-present-at-the-h-c-wainwright-23rd-annual-global-investment-conference [SID1234587407]).

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Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

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Moleculin Biotech, Inc. is a clinical stage pharmaceutical company focused on the development of a broad portfolio of oncology drug candidates for the treatment of highly resistant tumors. (PRNewsfoto/Moleculin Biotech, Inc.)

In addition to the presentation, management will be available to participate in virtual one-on-one meetings with qualified members of the investor community who are registered to attend the conference. For more information about the conference, please visit the conference website.

A video webcast of the presentation will be available for viewing on-demand beginning Monday, September 13, 2021, at 7:00 AM ET for those registered for the event and will be accessible on the Events page in the Investors section of the Company’s website (www.moleculin.com). The webcast replay will be archived for 90 days following the event.

bluebird bio Secures $75 Million in Private Placement Equity Financing

On September 8, 2021 bluebird bio, Inc. (NASDAQ: BLUE) reported that it has entered into an agreement for a $75 million private placement of common stock and common stock equivalents with a healthcare investment fund selected as part of a competitive process (Press release, bluebird bio, SEP 8, 2021, View Source [SID1234587406]). Proceeds from the financing will support ongoing R&D and commercialization investments for bluebird bio and for 2seventy bio, which plan to launch as independent companies in October 2021. The closing of the private placement is expected to occur in September 2021, subject to the satisfaction of customary closing conditions.

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"When combined with the approximately $900 million of cash expected at the time of separation, this $75 million equity investment further strengthens the starting financial position of both businesses," said Nick Leschly, chief bluebird. "We look forward to sharing more detail on the innovative and transformative therapies being developed as well as the pipeline, milestones, and strategic outlook for both companies as we head into separation and beyond."

bluebird plans to complete the spin-off of 2seventy in October 2021, subject to customary conditions, including effectiveness of the Form 10, a favorable opinion from the IRS with respect to the tax-free nature of the transaction, and final approval from bluebird’s Board of Directors.