Indaptus Therapeutics and BeiGene Partner for New Cancer Treatment Trials

Indaptus Therapeutics, Inc., a clinical-stage biotechnology firm specializing in innovative cancer and viral infection treatments, has announced a new clinical supply agreement with BeiGene. This collaboration will combine BeiGene's checkpoint inhibitor, tislelizumab, with Indaptus' novel immune stimulator, Decoy20. The first clinical trial of this combination is set to begin in 2025.

Indaptus has shown in preclinical studies that Decoy20, when used alongside a PD-1 inhibitor, induces significant cancer regressions and immunological memory in animal models. This promising combination led the company to pursue human clinical trials aiming to duplicate these effects in treating liver, colon, and pancreatic cancers.

PD-1 inhibitors like tislelizumab are central to modern immunotherapy, showing high response rates in some cancer patients. Preclinical trials revealed that Decoy20, combined with a PD-1 inhibitor and an oral non-steroidal anti-inflammatory drug, eradicated tumors at rates between 80% and 100%. By advancing these trials in humans, Indaptus hopes to significantly enhance current cancer treatment outcomes.

Jeffrey Meckler, CEO of Indaptus Therapeutics, expressed optimism about improving cancer treatment results through a combination that broadly and safely stimulates the immune system. He highlighted the agreement with BeiGene as a crucial milestone in pursuing curative treatments for challenging cancers.

Under this agreement, BeiGene will supply its PD-1 inhibitor, coupled with technical expertise, to expedite the clinical trial launch. Decoy20 uses Indaptus’ "Pulse-Prime" approach, which aims to stimulate the immune system robustly yet briefly, with manageable side effects.

Dr. Michael Newman, Founder and Chief Scientific Officer at Indaptus, noted that Decoy20's ability to work with various therapeutic modalities, including checkpoint therapy, makes it an exciting candidate for novel combination therapies. He believes that this trial could redefine checkpoint therapy by testing a short-acting, comprehensive agent like Decoy20 in combination with a PD-1 inhibitor for the first time.

Indaptus plans to seek FDA approval to start the combination trial, expected to commence in 2025. The management team will outline this development and future plans in a conference call, scheduled for October 22, 2024.

PD-1 inhibitors are a type of immunotherapy drug that blocks the PD-1 receptor on T cells, preventing cancer cells from evading immune detection. By inhibiting the interaction between PD-1 and its ligands on tumor cells, these drugs restore the immune system's ability to identify and attack cancer cells.

Indaptus Therapeutics has a long history rooted in immunotherapy advancements. Their innovative technology focuses on activating both innate and adaptive immune responses to combat tumors and viral infections effectively. The company’s patented Decoy platform consists of non-pathogenic bacteria strains that activate various immune receptors, generating a robust anti-tumor response while minimizing toxicity.

Decoy20 has shown single-agent activity against several cancers in preclinical models and, when combined with other treatments, has led to complete tumor eradication. The technology has also demonstrated potential in treating chronic viral infections like hepatitis B and HIV.

The upcoming trial with BeiGene's tislelizumab represents a significant step toward realizing Indaptus' goal of developing more effective cancer therapies. The results could potentially shift how checkpoint therapies are used by introducing a new, potent combination approach that leverages the strengths of both companies' technologies.