BeiGene to Present Clinical and Preclinical Data from Broad Portfolio and Pipeline at AACR Annual Meeting 2024

BeiGene to Present Clinical and Preclinical Data from Broad Portfolio and Pipeline at AACR Annual Meeting 2024




BeiGene to Present Clinical and Preclinical Data from Broad Portfolio and Pipeline at AACR Annual Meeting 2024

Multiple trials underscore the potential of tislelizumab-containing immuno-oncology combinations in a variety of solid tumor settings

Additional highlights include preclinical characterization data for an investigational BTK degrader, BGB-16673, currently in clinical development for B-cell malignancies, including mantle cell lymphoma

BASEL, Switzerland & BEIJING & CAMBRIDGE, Mass.–(BUSINESS WIRE)–$BGNE #BeiGene–BeiGene, Ltd. (NASDAQ: BGNE; HKEX: 06160; SSE: 688235), a global oncology company, today announced the presentation of emerging oncology pipeline data at the American Association for Cancer Research (AACR) Annual Meeting April 5-10 in San Diego. BeiGene has nine abstracts scheduled for poster presentations at AACR.


“Our presentations at this year’s AACR showcase our ongoing development of tislelizumab combinations in solid tumors as we assess the clinical potential of multiple novel immuno-oncology candidates and make data-driven decisions for further development,” said Lai Wang, Ph.D., Global Head of Research & Development at BeiGene. “More broadly, they reflect our deep commitment to discovering innovative new medicines for cancer patients, including by pioneering novel mechanisms like targeted degradation.”

BeiGene will present results from the AdvanTIG-204 Phase 2 study of tislelizumab (anti-PD1) plus ociperlimab (anti-TIGIT) in first-line limited-stage small cell lung cancer (SCLC) as well as results of a biomarker study of the same doublet in the setting of first-line non-small cell lung cancer (NSCLC). An ongoing, global Phase 3 trial of ociperlimab plus tislelizumab in stage IV, PD-L1 high NSCLC, AdvanTIG-302, will complete enrollment this month (NCT04746924). An additional clinical presentation includes the first data from a Phase 1a dose escalation study of BGB-10188, a phosphatidylinositol 3 kinase delta (PI3Kδ) inhibitor, plus tislelizumab in patients with solid tumors.

BeiGene will also be presenting preclinical characterizations of several novel molecules from its internal discovery engine, including a CEA x 4-1BB bispecific antibody and a chimeric degradation activation compound (CDAC) targeting BTK, BGB-16673. Clinical data from an ongoing Phase 1 study of BGB-16673 in relapsed/refractory B-cell malignancies were presented at ASH 2023, demonstrating clinical responses and a tolerable safety profile in heavily pre-treated patients with B-cell malignancies, including those with BTK inhibitor-resistant disease (NCT05006716).​

An additional preclinical presentation highlights the therapeutic potential of the triple-combination of tislelizumab with anti-LAG-3 (LBL-007) and anti-TIM-3 (surzebiclimab); this combination is being evaluated in an ongoing Phase 2 study in head and neck squamous cell carcinoma (NCT05909904).

BeiGene Presentations During AACR 2024

Abstract Title

Abstract #

Presentation

Time (PDT)

Lead Author

Preclinical

Characterization of the correlation between BTK

degradation and tumor growth inhibition of the

BTK target protein degraders using PK/PD

modeling

2110

Monday, April 8

9 a.m. – 12:30 p.m.

Section 30

Board #1

Y. Wu

BGB-B167, a first-in-class 4-1BB/CEACAM5

bispecific antibody, exhibits potent in vitro and in

vivo anti-tumor activity and superior safety profile

in preclinical models

2371

Monday, April 8

9 a.m. – 12:30 p.m.

Section 38

Board #17

Z. Li

Translational assessment of triple combination

with tislelizumab (anti-PD-1), LBL-007 (anti-LAG-

3) and surzebiclimab (anti-TIM-3) highlights its

strong anti-tumor activity and clinical potential in

solid tumors such as HNSCC

4041

Tuesday, April 9

9 a.m. – 12:30 p.m.

Section 3

Board #17

H. Zhu

Clinical

Exploration of potential biomarkers correlated

with efficacy of ociperlimab (anti-TIGIT) plus

tislelizumab (anti-PD1) in 1L PD-L1+ non-small

cell lung cancer (NSCLC)

CT053

Monday, April 8

9 a.m. – 12:30 p.m.

Section 48

Board #3

S. Kim

A first in human, phase 1a, dose escalation study

of BGB 10188, a phosphatidylinositol 3 kinase

delta (PI3Kδ) inhibitor, + tislelizumab (anti-PD-1)

in patients with solid tumors

CT189

Tuesday, April 9

9 a.m. – 12:30 p.m.

Section 48

Board #17

R. Cosman

AdvanTIG-204: A phase 2, multicenter,

randomized, 3-arm, open-label study investigating

the preliminary efficacy and safety of ociperlimab

(anti-TIGIT) + tislelizumab (anti-PD-1) +

concurrent chemoradiotherapy (cCRT) in patients

with untreated limited-stage small cell lung cancer

(SCLC)

CT255

Tuesday, April 9

1:30 p.m. – 5 p.m. Section 48

Board #14

Y. Gong

BGB-A317-LBL-007-202 (NCT06010303): A

phase 2, randomized, active-controlled, open-

label study to evaluate the efficacy and safety of

LBL 007 (anti-LAG-3) in combination with

tislelizumab (TIS; anti-PD-1) plus chemotherapy

(chemo) as first-line (1L) treatment in patients

with unresectable locally advanced/metastatic

esophageal squamous cell carcinoma (ESCC)

CT274

Tuesday, April 9

1:30 p.m. – 5 p.m. Section 50

Board #4

S. Park

Liberty-201 (NCT05609370): Maintenance

fluoropyrimidine and bevacizumab with or without

anti-lymphocyte activation gene-3 (LAG-3)

antibody LBL-007 plus anti-programmed cell

death protein-1 (PD-1) antibody tislelizumab (TIS)

for patients (pts) with metastatic or unresectable

microsatellite stable (MSS)/mismatch repair

proficient (pMMR)colorectal cancer (CRC)

CT276

Tuesday, April 9 1:30 p.m. – 5 p.m.

Section 50

Board #6

H.-J. Lenz

BGB-LC-201 (NCT05635708): A phase 2, open-

label, multi-arm study of tislelizumab (TIS; anti-

PD-1) in combination with investigational agents

+/- chemotherapy as first-line treatment for

patients with locally advanced, unresectable, or

metastatic non-small cell lung cancer (NSCLC)

CT277

Tuesday, April 9

1:30 p.m. – 5 p.m. Section 50

Board #7

G. Blumenschein

About Tislelizumab

Tislelizumab is a uniquely designed humanized immunoglobulin G4 (IgG4) anti-programmed cell death protein 1 (PD‑1) monoclonal antibody with high affinity and binding specificity against PD‑1. It is designed to minimize binding to Fc-gamma (Fcγ) receptors on macrophages, helping to aid the body’s immune cells to detect and fight tumors.

About BeiGene

BeiGene is a global oncology company that is discovering and developing innovative treatments that are more affordable and accessible to cancer patients worldwide. With a broad portfolio, we are expediting development of our diverse pipeline of novel therapeutics through our internal capabilities and collaborations. We are committed to radically improving access to medicines for far more patients who need them. Our growing global team of more than 10,000 colleagues spans five continents, with administrative offices in Basel, Beijing, and Cambridge, U.S. To learn more about BeiGene, please visit www.beigene.com and follow us on LinkedIn and X (formerly known as Twitter).

Forward-Looking Statements

This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995 and other federal securities laws, including statements regarding BeiGene’s ability to discover innovative new medicines for cancer patients and pioneer novel mechanisms; the future development, regulatory filing and approval, and commercialization of tislelizumab, BGB-16673, and other novel molecules; and BeiGene’s plans, commitments, aspirations, and goals under the heading “About BeiGene.” Actual results may differ materially from those indicated in the forward-looking statements as a result of various important factors, including BeiGene’s ability to demonstrate the efficacy and safety of its drug candidates; the clinical results for its drug candidates, which may not support further development or marketing approval; actions of regulatory agencies, which may affect the initiation, timing, and progress of clinical trials and marketing approval; BeiGene’s ability to achieve commercial success for its marketed medicines and drug candidates, if approved; BeiGene’s ability to obtain and maintain protection of intellectual property for its medicines and technology; BeiGene’s reliance on third parties to conduct drug development, manufacturing, commercialization, and other services; BeiGene’s limited experience in obtaining regulatory approvals and commercializing pharmaceutical products; BeiGene’s ability to obtain additional funding for operations and to complete the development of its drug candidates and achieve and maintain profitability; and those risks more fully discussed in the section entitled “Risk Factors” in BeiGene’s most recent annual report on Form 10-K, as well as discussions of potential risks, uncertainties, and other important factors in BeiGene’s subsequent filings with the U.S. Securities and Exchange Commission. All information in this press release is as of the date of this press release, and BeiGene undertakes no duty to update such information unless required by law.

Contacts

Investor:

Liza Heapes

+1 857-302-5663

ir@beigene.com

Media:

Kyle Blankenship

+1 667-351-5176

media@beigene.com