Exclusive license for Asia (ex-Japan), Australia and New Zealand; Parties plan to conduct combination studies with BeiGene's anti-PD-1 antibody tislelizumab

BOSTON & CAMBRIDGE, Mass. & BEIJING--(BUSINESS WIRE)-- Boston Immune Technologies and Therapeutics, Inc. (BITT), a privately held developer of novel antagonist antibodies for cancer and other diseases, and BeiGene, Ltd. (NASDAQ: BGNE; HKEX: 06160) today announced that they have entered into an option and license agreement aimed at developing and commercializing BITT’s innovative tumor necrosis factor (TNF) receptor 2 (TNFR2) antagonist antibodies. BeiGene has secured an option to an exclusive license to develop, manufacture, and commercialize BITT’s proprietary TNFR2 antagonist antibodies in Asia (excluding Japan), Australia, and New Zealand. The companies plan to conduct Phase 1 clinical trials of BITR2101, BITT’s lead TNFR2 antagonist antibody, including planned combination studies with tislelizumab, BeiGene’s anti-PD-1 antibody.

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“BeiGene is a global company with an especially strong track record supporting biotechnology innovation and the ideal partner to help develop BITR2101, our investigational TNFR2 lead antibody,” said Russell LaMontagne, Co-founder and Chief Executive Officer of BITT. “The collaboration with BeiGene is strong validation of BITT’s antibody platform and an opportunity to prove the potential of BITR2101 as a single agent and in combination with checkpoint inhibitors such as tislelizumab.”

TNFR2 is a member of the TNF receptor superfamily that is selectively expressed on many tumor types as a surface oncogene and has been shown to proliferate tumor cell growth. TNFR2 is also expressed on suppressive immune cells in the tumor microenvironment, including regulatory T cells (Tregs) and myeloid-derived suppressor cells, and has been identified as a potential driver of immune escape and tumor development as well as resistance to checkpoint blockade.

“TNFR2 is an interesting target because of the high expression on the suppressive cells in the tumor microenvironment and a growing consensus that targeting TNFR2 may be a novel and effective approach to treating cancer. BITT has created antibodies that are highly specific to the tumor based on their unique and novel binding modality. We look forward to collaborating with BITT and generating clinical data for BITR2101 as single agent and in combination with tislelizumab,” said Lusong Luo, Ph.D., Senior Vice President of External Innovation at BeiGene.

Under the terms of the agreement, BITT will receive an upfront payment and potential near-term milestone payments totaling $16.6 million, inclusive of BeiGene's exercise of the option to license following initial proof-of-concept studies. Additionally, following BeiGene’s exercise of the option, BITT is eligible to receive development, regulatory, and sales milestones up to $105 million, together with tiered royalties on any product sales in the licensed territory. In connection with the exclusive option and license agreement, BeiGene also invested $4 million in BITT’s Series A preferred stock financing.

About Boston Immune Technologies and Therapeutics

Boston Immune Technologies and Therapeutics (BITT) is a Boston, MA based company developing a novel class of antagonist antibodies targeting the TNF superfamily receptors for applications in oncology, inflammation, autoimmunity, and infectious disease. BITT is initiating clinical trials for BITR2101, its lead candidate, a monoclonal antibody that targets tumor necrosis factor receptor 2 (TNFR2). BITT is also developing additional TNF superfamily antibodies including CD40 antagonists for inflammation and CD30 antagonists for oncology. For more information, visit our website at www.bostonimmunetech.com.

About BeiGene

BeiGene is a global, commercial-stage biotechnology company focused on discovering, developing, manufacturing, and commercializing innovative medicines to improve treatment outcomes and access for patients worldwide. Our 5,200+ employees in China, the United States, Australia, Europe, and elsewhere are committed to expediting the development of a diverse pipeline of novel therapeutics. We currently market two internally discovered oncology products: BTK inhibitor BRUKINSA^® (zanubrutinib) in the United States and China, and anti-PD-1 antibody tislelizumab in China. We also market or plan to market in China additional oncology products licensed from Amgen Inc., Celgene Logistics Sàrl, a Bristol Myers Squibb (BMS) company, and EUSA Pharma. To learn more about BeiGene, please visit www.beigene.com and follow us on Twitter at @BeiGeneUSA.

BeiGene 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 the further advancement of BITR2101, BITT’s lead TNFR2 antagonist antibody and BITT’s other proprietary TNFR2 antagonist antibodies under the exclusive option and license agreement with BITT, the parties’ plans to conduct combination studies with tislelizumab, the potential for TNFR2 antagonists to be a novel and effective approach to treating cancer, BeiGene’s option to obtain an exclusive license and the condition that the program demonstrates proof of concept, the parties’ commitments and the potential benefits of the collaboration, potential payments payable to BITT, and other information that is not historical information. 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 products and drug candidates, if approved; BeiGene's ability to obtain and maintain protection of intellectual property for its technology and drugs; BeiGene's reliance on third parties to conduct drug development, manufacturing and other services; BeiGene’s limited operating history and BeiGene's ability to obtain additional funding for operations and to complete the development and commercialization of its drug candidates; and the impact of the COVID-19 pandemic on the Company’s clinical development, commercial and other operations, as well as those risks more fully discussed in the section entitled “Risk Factors” in BeiGene’s most recent quarterly report on Form 10-Q, 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.

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BeiGene Contacts:
Investor Contact
Craig West
+1 857-302-5189
ir@beigene.com

Media Contact
Liza Heapes or Vivian Ni
+1 857-302-5663 or +1 857-302-7596
media@beigene.com

BITT Contact:
Karl Schmieder
+1 646-515-3392
karl@messaginglab.com

Source: BeiGene, Ltd.