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Biotheus Inc.. (11/6/23). "Press Release: Biotheus Enters Into Strategic Partnership with BioNTech to Develop and Commercialize Bispecific Antibody Candidate Targeting PD-L1 and VEGF in Multiple Solid Tumor Indications". Zhuhai.

Region Region ww excl China
Organisations Organisation Biotheus Inc. (CN)
  Organisation 2 BioNTech SE (Nasdaq: BNTX)
  Group BioNTech (Group)
Products Product bispecific antibody
  Product 2 drug development
Index term Index term BioNTech–Biotheus: antibody cancer drug, 202311– collab + license ww excl ex-Greater China for PM8002 $55m upfront + >$1b milestones + royalties
Persons Person Liu, Xiaolin (Biotheus 202307 CEO + Co-Founder)
  Person 2 Bao, Jun (Biotheus 202311 Business Development)

> Bispecific Antibody Candidate PM8002 demonstrated encouraging data at this year's ASCO Annual Meeting (abstract #2536 & #e13091) and ESMO Congress (abstract #1992P)

> BioNTech will hold exclusive licenses to develop and commercialize PM8002 globally excluding Greater China

Biotheus Inc. ("Biotheus"), a clinical-stage biotech company dedicated to the discovery and development of biologics for oncology and inflammatory diseases, today announced that the company has entered into an exclusive global license and collaboration agreement under which BioNTech will be developing, manufacturing and commercializing PM8002 globally ex-Greater China, whereas Biotheus retains the rights to exploit PM8002 in Greater China. PM8002 is currently being tested in Phase 2 studies in China to evaluate the efficacy and safety of the candidate as a monotherapy or in combination with chemotherapy in patients with advanced solid tumors.

Under the terms of the agreement, Biotheus will receive an upfront payment of $55 million, and is eligible to receive additional development, regulatory and sales milestone payments potentially totalling over $1 billion as well as tiered royalties on potential future product sales. The transaction is expected to close in Q4 2023, subject to customary closing conditions, including clearance under the Hart-Scott-Rodino ("HSR") Antitrust Improvements Act, and regulatory clearances.

PM8002 is a bispecific antibody candidate with humanized anti-PD-L1 single heavy-chain variable (VHH) domains fused to an anti-VEGF-A IgG1 antibody containing Fc-silencing mutations. PM8002 has demonstrated a positive safety profile and encouraging antitumor activity presumably through reduced systemic toxicity by enriching anti-VEGF activity into the tumor microenvironment at this year's ASCO Annual Meeting and ESMO Congress 2023.

"Biotheus' innovative platform has the capability to expedite preclinical research, bolstering our impressive innovative pipeline of products with encouraging efficacy and safety including PM8002. Collaborating with industry trailblazer BioNTech, we hope to advance PM8002 through multi-regional clinical trials with the aim to be able to provide it to patients worldwide," stated Xiaolin Liu, Co-founder, Chairman, and CEO of Biotheus.

About Biotheus

Biotheus Inc. is a clinical-stage biotech company dedicated to the discovery, development, and delivery of novel antibodies and cell therapies to address the unmet medical needs of patients with oncology and inflammatory diseases worldwide. Since its inception, Biotheus has established several innovative platforms for antibody discovery and a proprietary cell therapy that delivers T cell engagers into the tumor microenvironment to eradicate tumor cells. With an experienced development team, Biotheus has built a robust pipeline of ten programs at various stages of clinical development.

For more information about Biotheus, please visit

About BioNTech

Biopharmaceutical New Technologies (BioNTech) is a next generation immunotherapy company pioneering novel therapies for cancer and other serious diseases. The Company exploits a wide array of computational discovery and therapeutic drug platforms for the rapid development of novel biopharmaceuticals. Its broad portfolio of oncology product candidates includes individualized and off-the-shelf mRNA-based therapies, innovative chimeric antigen receptor (CAR) T cells, several protein-based therapeutics, including bispecific immune checkpoint modulators, targeted cancer antibodies and antibody-drug conjugate (ADC) therapeutics, as well as small molecules. Based on its deep expertise in mRNA vaccine development and in-house manufacturing capabilities, BioNTech and its collaborators are developing multiple mRNA vaccine candidates for a range of infectious diseases alongside its diverse oncology pipeline. BioNTech has established a broad set of relationships with multiple global pharmaceutical collaborators, including Duality Biologics, Fosun Pharma, Genentech, a member of the Roche Group, Genevant, Genmab, OncoC4, Regeneron, Sanofi, and Pfizer.

For more information, please visit

Biotheus Inc.
Jun Bao

Goby Global LLC
Bob Ai

Record changed: 2024-01-31


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