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Seagen to Highlight New Research from its Diverse Pipeline of Targeted Cancer Therapy Candidates at the Society for Immunotherapy of Cancer’s (SITC) Annual Meeting

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Seagen Inc. (NASDAQ: SGEN) announced encouraging results from the Phase 1 study of SGN-B6A, an investigational antibody-drug conjugate, at the SITC Annual Meeting in Boston (Nov 8-12). The study enrolled 79 patients with metastatic solid tumors and demonstrated early efficacy in non-small cell lung cancer, head and neck cancer, and esophageal cancer while maintaining a manageable safety profile. The company also presented data on complementary therapies such as enfortumab vedotin and SGN-BB228, along with plans for further research.

Positive
  • Initial results from SGN-B6A show antitumor activity in various cancers.
  • Study demonstrated a manageable safety profile.
  • Ongoing expansion cohorts for SGN-B6A in multiple cancer types.
Negative
  • SGN-B6A is still in the investigational stage; safety and efficacy not yet established.

– Encouraging data from ongoing Phase 1 study of SGN-B6A illustrate commitment to pioneering novel first-in-class antibody-drug conjugates (ADCs) –

BOTHELL, Wash.--(BUSINESS WIRE)-- Seagen Inc. (Nasdaq: SGEN) today announced that data from the company’s diverse pipeline of targeted cancer therapy candidates will be presented at the Society for Immunotherapy of Cancer’s (SITC) Annual Meeting being held November 8-12 in Boston. The presentations highlight data from multiple ongoing clinical and preclinical research studies that employ Seagen’s proprietary antibody-drug conjugate (ADC) technology, as well as other novel cancer targeting approaches.

"Seagen has a deep heritage in pioneering first-in-class antibody-drug conjugates. We are encouraged by initial results from a clinical study of SGN-B6A, a wholly owned investigational antibody-drug conjugate that demonstrated antitumor activity with an acceptable safety profile in previously treated patients with non-small cell lung cancer, head and neck cancer, and esophageal cancer," said Megan O’Meara, M.D., Senior Vice President of Early-Stage Development at Seagen. "We are also sharing new data demonstrating enhanced preclinical activity of enfortumab vetodin in combination with immune checkpoint inhibitors, as well as preclinical data that support the initiation of a first-in-human study of a bispecific molecule called SGN-BB228."

Highlights From SGN-B6A Program Presented at SITC

Data from an ongoing Phase 1 study of SGN-B6A, an ADC directed to integrin beta-6, which is overexpressed in multiple solid tumors, showed early efficacy signals in at least three cancer types, including non-small cell lung cancer (NSCLC), head and neck squamous cell carcinoma (HNSCC), and esophageal squamous cell carcinoma (ESCC).

Dose escalation cohorts enrolled 79 participants with metastatic or unresectable solid tumors, whose disease had relapsed or was refractory to standard of care therapies and had not previously received an MMAE-containing agent or agent targeting integrin beta-6. Participants had received a median of 3 lines of therapy for metastatic disease prior to enrollment in the study. SGN-B6A demonstrated a manageable and tolerable safety profile at the explored dose levels and schedules. Intermittent dosing schedules (2Q3W, 2Q4W) are being evaluated further. The initial anti-tumor activity observed in heavily pre-treated patients is encouraging and has triggered expansion cohorts in NSCLC, HNSCC, and ESCC, which are currently ongoing. SGN-B6A is an investigational agent, and its safety and efficacy have not been established.

Additional Details of Seagen Presentations at SITC Annual Meeting 2022

All posters will be available at the beginning of the session, both in-person and virtually.

Abstract Title

Abstract #

Date

First Author

A first-in-human trial of an integrin beta-6 targeted antibody-drug conjugate (ADC), SGN-B6A, in patients with advanced solid tumors: Interim results of a Phase 1 study (SGNB6A-001)

731

Thursday, Nov. 10, 2022,
9:00 am - 9:00 pm

A. Hollebecque

SGN-BB228 is a first-in-class CD228-targeted costimulatory Antibody Anticalin® bispecific delivering potent and conditional 4-1BB costimulation to tumor-specific T cells

1201

Thursday, Nov. 10, 2022,
9:00 am - 9:00 pm

B. Updegraff

Enfortumab vedotin induces immunogenic cell death, elicits antitumor immune memory, and shows enhanced preclinical activity in combination with immune checkpoint inhibitors

1187

Thursday, Nov. 10, 2022,
9:00 am - 9:00 pm

D. Olson

Phase 2 multi-cohort clinical study evaluating Disitamab Vedotin alone and in combination with pembrolizumab in patients with HER2-expressing unresectable or metastatic urothelial carcinoma (RC48G001, trial in progress)

663

Thursday, Nov. 10, 2022,
9:00 am - 9:00 pm

M. D. Galsky

Phase 2 study of SEA-CD40 combination therapies in advanced malignancies (SGNS40-002, trial in progress)

705

Thursday, Nov. 10, 2022,
9:00 am - 9:00 pm

A. Salama

Reversible chemical modulation of antibody effector function maintains anti-tumor activity while mitigating peripheral immune activation

1357

Thursday, Nov. 10, 2022,
9:00 am - 9:00 pm

M. R. Levengood

SGN-B6A induces immunogenic cell death as a secondary mechanism of action

1186

Friday, Nov. 11, 2022,
9:00 am - 8:30 pm

R. P. Lyon

SGN-B7H4V induces immunomodulatory changes to the tumor microenvironment and pairs well with an anti-PD1 agent in a preclinical model

1190

Friday, Nov. 11 2022,
9:00 am - 8:30 pm

M. Ulrich

About Seagen

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

Forward-Looking Statements

Certain of the statements made in this press release are forward-looking, such as those, among others, relating to the potential of SGN-B6A, SGN-BB228, SGN-B7H4V, SEA-CD40, enfortumab vedotin and disitamab vedotin and Seagen’s other products and product candidates, their potential efficacy, safety and therapeutic uses, plans for presenting at the referenced medical conference, plans with respect to clinical trials, and the potential of the company’s pipeline. 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 even after encouraging results in early-stage trials or preclinical research, the risk of adverse events or safety signals, the inability to show sufficient efficacy in clinical trials and the possibility of adverse regulatory actions. More information about the risks and uncertainties faced by Seagen is contained under the caption “Risk Factors” included in the company’s Quarterly Report on Form 10‑Q for the quarter ended September 30, 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.

For Media

David Caouette

(310) 430-3476

dcaouette@seagen.com

For Investors

Douglas Maffei, Ph.D.

(425) 527-4881

dmaffei@seagen.com

Source: Seagen Inc.

FAQ

What are the results of the SGN-B6A Phase 1 study presented by Seagen?

The Phase 1 study of SGN-B6A showed early efficacy signals in non-small cell lung cancer, head and neck cancer, and esophageal cancer, with a manageable safety profile.

When was the SITC Annual Meeting where Seagen presented data?

The SITC Annual Meeting took place from November 8 to November 12, 2022.

What is SGN-B6A?

SGN-B6A is an investigational antibody-drug conjugate targeting integrin beta-6, which is overexpressed in multiple solid tumors.

How many participants were enrolled in the SGN-B6A Phase 1 study?

A total of 79 participants with metastatic or unresectable solid tumors were enrolled in the study.

What is the status of SGN-B6A's safety and efficacy?

SGN-B6A is still in clinical trials, and its safety and efficacy have not yet been fully established.

Seagen Inc.

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