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Seagen Presents New Clinical and Preclinical Data Across a Broad Portfolio of Targeted Cancer Therapeutics at the 2023 AACR Annual Meeting

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Interim Results of Phase 2 innovaTV 207 Trial of Tisotumab Vedotin in Head and Neck Cancer Presented –

First Phase 1 Dose Escalation Data for SEA-TGT Monotherapy in Advanced Malignancies Disclosed –

Preclinical data and discovery research underscores Seagen’s mission to innovate through next-generation ADC technologies –

BOTHELL, Wash., March 14, 2023–(BUSINESS WIRE)–Seagen Inc. (Nasdaq: SGEN) today announced the presentation of 17 abstracts containing new clinical and preclinical data at the upcoming American Association for Cancer Research (AACR) Annual Meeting to be held April 14 in Orlando takes place. 19, 2023. The broad spectrum of data presented at this year’s meeting includes research results from Seagen’s approved drugs as well as data from early-stage clinical, pre-clinical and discovery research programs.

“Seagen’s strong presence at this year’s AACR, which highlights advancements in our diverse pipeline, underscores our commitment to improving and extending the lives of people living with cancer,” said Roger Dansey, MD, President of Research and Development and Chief Medical Officer at Seagen. “As a pioneer in antibody-drug conjugates, we are committed to optimizing and expanding the potential of our core technology while advancing innovative, targeted approaches to cancer.”

Highlights include an interim analysis from the Phase 2 innovaTV 207 study of tisotumab vedotin (TV) administered every 2 weeks in patients with recurrent or metastatic squamous cell carcinoma of the head and neck who have progressed after prior combination of platinum, immunotherapy and targeted therapy are, if justified. TV, being developed in partnership with Genmab, is a tissue factor (TF)-targeted antibody-drug conjugate (ADC). The innovaTV 207 study is currently ongoing evaluating alternative dosing regimens of TV in several advanced solid tumors.

Other notable clinical data include early results from a phase 1 dose escalation study of SEA-TGT monotherapy in patients with advanced malignancies. SEA-TGT is a novel investigational non-fucosylated human IgG1 antibody directed against TIGIT, an inhibitory immune checkpoint receptor that has emerged as a clinically relevant immuno-oncology target. SEA-TGT continues to be studied both as monotherapy and in combination with an anti-PD1 agent.

Seagen will also report new preclinical results on antitumor activity of disitamab vedotin, an ADC targeting cancers that express HER2, as monotherapy and in combination with tucatinib in breast and gastric cancer models, and on SGN-B6A, a wholly owned, first-in-class Vedotin ADC targeting integrin beta-6, which is highly expressed in a range of solid tumors.

Seagen and Sanofi will also report the first preclinical data of a novel topoisomerase I inhibitor ADC targeting CEACAM5 and showing potent antitumor activity in patient-derived colorectal cancer models. This is the first data from the companies’ 2022 collaboration to develop and commercialize several novel ADCs.

Additional preclinical data disclosure is planned highlighting Vedotin’s programs and novel ADC and tumor targeting technologies, including payloads with immunostimulatory properties.

Details of Seagen presentations at the 2023 AACR Annual Meeting

Abstract title

abstract #

presentation time

lead author

ADCETRIS® (brentuximab vedotin)

CD30 is a marker for activated effector-regulatory T cells in solid tumors that provides a clinical rationale for the combination of brentuximab vedotin and PD-1 inhibitors

3253

Poster presentation

Clinical research without studies / combination immunotherapies 1

Mon, April 17

1:30 p.m. – 5:00 p.m. ET

B. Grogan

Exposure-response and age subgroup analyzes to support body weight (BW) dosing of brentuximab vedotin (BV) in newly diagnosed high-risk classical Hodgkin lymphoma (cHL) in children and young adults (aged 2 to 21 years). [y]): A randomized phase 3 study by the Children’s Oncology Group (AHOD1331)

6737

Poster presentation

Clinical research without studies / preclinical therapies and clinical observations in pediatric oncology

Wednesday April 19th

9:00am – 12:30pm ET

Z.Zhang

PADCEV® (enfortumab vedotin)

Enfortumab Vedotin, a nectin-4-targeted antibody-drug conjugate, demonstrates convincing antitumor activity in non-muscle invasive bladder cancer models and accurately predicts minimal systemic exposure when administered to patients by intravesical instillation

LB246

Poster presentation

Latest Research: Experimental and Molecular Therapeutics 2

Tuesday April 18th

1:30 p.m. – 5:00 p.m. ET

D.Olson

TIDVAK® (tisotumab vedotin)

Tisotumab vedotin (TV) in squamous cell carcinoma of the head and neck (SCCHN): interim analysis from innovaTV 207

CT164

Poster presentation

Phase II clinical trials 1

Mon, April 17

1:30 p.m. – 5:00 p.m. ET

B. Cirauqui

TUKYSA® (tucatinib)

Phase 3 study of tucatinib or placebo in combination with trastuzumab and pertuzumab as maintenance therapy in HER2-positive metastatic breast cancer (HER2CLIMB-05, ongoing study)

CT065

Poster presentation

Phase II and III clinical trials are ongoing

Mon, April 17

9:00am – 12:30pm ET

E.Hamilton

Tucatinib does not alter oxaliplatin PK or associated renal function: an OCT2/MATE transport inhibition study

5060

Poster presentation

Experimental and Molecular Therapeutics – Theranostics and Radionuclides / Pharmacological Approaches

Tuesday April 18th

1:30 p.m. – 5:00 p.m. ET

A. Topletz-Erickson

Disitamab Vedotin

Disitamab Vedotin, an investigational HER2-targeted antibody-drug conjugate, demonstrates potent antitumor activity as monotherapy and in combination with tucatinib in preclinical cancer models

560

Poster presentation

Experimental and Molecular Therapeutics / Oncogenes and Tumor Suppressor Genes as Targets for Therapy 1

Sun, April 16

1:30 p.m. – 5:00 p.m. ET

K Willis

Early Stage Programs

SGN-BB228, a CD228-targeted costimulatory antibody that is anticalin bispecific, provides potent and conditional 4-1BB costimulation to T cells in vivo and in an in vitro model of T cell depletion

5676

Poster presentation

Clinical research excluding studies/therapeutic antibodies, including engineered antibodies

Tuesday April 18th

1:30 p.m. – 5:00 p.m. ET

B. Updegraff

SGN-B6A induces immunogenic cell death as an additional mechanism of action

1522

Poster presentation

Experimental and Molecular Therapeutics / Antibody-Drug Conjugates

Mon, April 17

9:00am – 12:30pm ET

V. Trang

Generation of an antibody-drug conjugate optimized TLR7/8 agonist payload

1542

Poster presentation

Experimental and Molecular Therapeutics / Antibody-Drug Conjugates

Mon, April 17

9:00am – 12:30pm ET

CP Wang

Phase 1 dose escalation study of SEA-TGT monotherapy in patients with advanced malignancies

CT265

Poster presentation

Phase I clinical trials 2

Tuesday April 18th

1:30 p.m. – 5:00 p.m. ET

E. Garralda Cabanas

Using a Clinical Utility Index (CUI) to Determine the Optimal Biological Dose of a Non-Fucosylated Anti-TIGIT Antibody: A Proposed Alternative to the Maximum Tolerated Dose (MTD)

5668

Poster presentation

Clinical research excluding studies/therapeutic antibodies, including engineered antibodies

Tuesday April 18th

1:30 p.m. – 5:00 p.m. ET

G. Patilea-Vrana

A preclinical model of acquired anti-PD-1 resistance responds to SEA-TGT, an anti-TIGIT monoclonal antibody with enhanced effector function

6361

Poster presentation

Immunology / Immune Checkpoints

Wednesday April 19th

9:00am – 12:30pm ET

D Gruber

A novel topoisomerase I inhibitor-antibody-drug conjugate targeting CEACAM5 has potent antitumor activity in colorectal cancer models

4890

Poster presentation

Experimental and Molecular Therapeutics / Anticancer Approaches: Antibody-Drug Conjugates, Epigenetics and Tumor Environment

Tuesday April 18th

1:30 p.m. – 5:00 p.m. ET

Y. Baudate

discovery research

Oxidized anthracycline payloads induce immunogenic antitumor cell death and exhibit linker-dependent tolerability when administered as ADCs

2013

Poster presentation

Chemistry / Drug Dispensing

Mon, April 17

9:00am – 12:30pm ET

J.Hamilton

Reversible chemical modification of antibodies: A complementary approach to tuning FcγR binding that preserves antitumor activity while attenuating peripheral immune activation

2656

Poster presentation

Experimental and Molecular Therapeutics / Antibody Technologies

Mon, April 17

9:00am – 12:30pm ET

S Moquist

MMAE drives immunomodulatory changes in a preclinical xenograft model that differ from other clinical-stage ADC payloads

4892

Poster presentation

Experimental and Molecular Therapeutics / Anticancer Approaches: Antibody-Drug Conjugates, Epigenetics and Tumor Environment

Tuesday April 18th

1:30 p.m. – 5:00 p.m. ET

Mr Ulrich

About Seagen

Seagen Inc. is a global biotechnology company that discovers, develops and commercializes transformative cancer medicines that make a difference in people’s lives. Seagen is headquartered in the Seattle, Washington area with offices in California, Canada, Switzerland and the European Union. For more information on our marketed products and robust pipeline, visit www.seagen.com and follow us @SeagenGlobal on twitter.

Forward-Looking Statements

Certain statements in this press release are forward-looking, including but not limited to those relating to the therapeutic potential of Seagen’s products and product candidates, including their potential efficacy, safety and therapeutic uses, as well as the pipeline, technologies, collaborations and planned or ongoing clinical trials. Actual results or developments may differ materially from those projected or implied in these forward-looking statements. Factors that may cause such a difference include, without limitation, the difficulty and uncertainty of pharmaceutical product development, including the risks that the Company may experience delays in its clinical trials or otherwise experience failure or setbacks in its clinical development programs due to lack of efficacy or side effects events or other factors and that adverse governmental action may occur. Additional information regarding the risks and uncertainties facing Seagen is contained under the caption “Risk Factors” in the company’s Annual Report on Form 10-K for the year ended December 31, 2022 filed with the Securities and Exchange Commission. Seagen disclaims any intention or obligation to update or revise any forward-looking statements, whether as a result of new information, future events or otherwise, except as required by law.

View source version on businesswire.com: https://www.businesswire.com/news/home/20230314005811/en/

contacts

For media
David Caouette
(310) 430-3476
dcaouette@seagen.com

For investors
Douglas Maffei, Ph.D.
(425) 527-4160
dmaffei@seagen.com

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