Six Biotech Innovators Leading the Charge in Bispecific Antibody Therapeutics.

Bispecific antibodies are rapidly transforming the landscape of targeted therapeutics, offering a unique approach by binding to two different antigens or epitopes simultaneously. This dual-targeting ability makes them highly attractive for tackling complex diseases such as cancer and autoimmune disorders. With a surge in major acquisitions and the emergence of promising clinical programs, several companies are making significant strides in bispecific antibody development. Here are six companies making notable contributions to this space.

Adaptin Bio: Targeting Brain Tumors with BRiTE Technology:

Emerging from stealth mode in September 2024, Adaptin Bio is focused on precision oncology, particularly improving drug delivery to challenging areas like the brain. The company’s lead candidate, APTN-101, is a bispecific T cell engager developed using its proprietary BRiTE (brain bispecific T cell engager) platform. APTN-101 targets EGFRvIII, a mutation commonly found in gliomas, and CD3 on T cells to direct immune cells to attack tumors. The therapy has demonstrated strong preclinical efficacy against aggressive glioma models and recently received FDA clearance for its Investigational New Drug (IND) application, paving the way for a phase 1 trial in patients with WHO Grade 4 malignant glioma.

Akeso: Clinical Breakthroughs with Ivonescimab:

Chinese biotech Akeso is advancing a robust pipeline using its Tetrabody technology. The company’s standout candidate, ivonescimab, developed in collaboration with Summit Therapeutics, targets both PD-1 and VEGF – key mechanisms in cancer progression. Approved in China in May for EGFR-mutated non-squamous non-small cell lung cancer (NSCLC), ivonescimab demonstrated superior outcomes compared to Merck’s Keytruda, reducing disease progression or death risk by 49% in phase 3 trials. Akeso is developing over 50 assets, including 11 bispecific or multispecific antibodies, with 22 currently in clinical trials.

AP Biosciences: Dual-Targeting for Enhanced Immune Response:

AP Biosciences is developing advanced bispecific antibodies leveraging its Omni-Mab Discovery Library and T-CUBE platforms. Its lead program, AP505, targets PD-L1 and VEGF to both disinhibit immune responses and cut off tumor blood supply. A second candidate, AP203, also blocks PD-L1 while activating CD137 to promote T cell activity. AP203’s conditional activation only within the tumor microenvironment may reduce systemic toxicity risks. AP505 is in a phase 1 trial in China, while AP203 is being evaluated in a phase 1/2 study across Taiwan for NSCLC, esophageal, and head and neck cancers. The company raised $38 million in a series D round in June 2024.

Candid Therapeutics: Tackling Autoimmune Disease with T Cell Engagers:

Launched in September 2024 with a massive $370 million in funding, Candid Therapeutics aims to lead the autoimmune disease treatment space using T cell engager bispecific antibodies. Following the acquisition of Vignette Bio and TRC 2004, Candid added two lead programs: CND106 (targeting BCMA and CD3) and CND261 (targeting CD20 and CD3). Both candidates have completed phase 1 dose escalation trials in oncology, involving over 130 patients. The company is now preparing IND filings to evaluate these therapies in autoimmune indications.

Summit Therapeutics: Driving Global Development of Ivonescimab:

U.S.-based Summit Therapeutics, which holds development rights for ivonescimab outside China through a 2022 collaboration with Akeso, is focused on expanding the therapy’s reach in oncology. In September 2024, Summit raised $235 million to support ivonescimab’s clinical trials across NSCLC, colorectal cancer, and triple-negative breast cancer. To date, over 1,800 patients have been treated with ivonescimab globally, with phase 3 trials ongoing in Summit’s territories, including the U.S., Europe, and Japan.

Zenas BioPharma: Advancing Immunology with Obexelimab:

Zenas BioPharma is developing obexelimab, a bispecific antibody that targets CD19 and FcγRIIb to suppress B cell activity. Acquired from Xencor in 2021, obexelimab is currently in a phase 3 trial for IgG4-related disease and phase 2 studies for multiple sclerosis, systemic lupus erythematosus, and warm autoimmune hemolytic anemia. Zenas raised $200 million in a series C round in May and an additional $225 million from an IPO in September to propel these programs forward.

Big Pharma Bets on Bispecifics:

The rising promise of bispecific antibodies has drawn the attention of major pharmaceutical companies. In recent months, Merck paid $588 million upfront for LaNova Medicines’ PD-1xVEGF bispecific, echoing the design of ivonescimab. Similarly, BioNTech acquired Biotheus for $800 million, and GSK committed $300 million to Chimagen Bioscience’s bispecific program targeting lupus.

According to Grand View Research, the bispecific antibody market was valued at $5.73 billion in 2022 and is projected to grow at a 44% CAGR through 2030, fueled by rising demand for targeted therapies and continued innovation in antibody engineering.

As these six companies push forward in clinical development, their innovations are poised to redefine treatment paradigms across oncology and immune-mediated diseases.

Source:https://www.labiotech.eu/best-biotech/bispecific-antibody-companies/

This is non-financial/medical advice and made using AI so could be wrong.