INSTINCT BIO TECHNICAL COMPANY HOLDINGS INC. (Nasdaq: BIOT) announced on September 30, 2026, that CelSiege Biosciences Inc. has appointed BIOT as its authorized introduction and business development representative in Japan and the People's Republic of China for IN01, a clinical-stage cancer immunotherapy program. The appointment, made on a non-exclusive basis under a Letter of Authorisation signed on September 18, 2026 by Johan Indot, Founder and Director of CelSiege, allows BIOT to introduce the IN01 Program to prospective strategic partners, investors, pharmaceutical and biotechnology companies, medical institutions, research organizations, and investment funds in both countries. BIOT may also facilitate preliminary discussions on potential investment, licensing, co-development, clinical development, manufacturing, and commercialization. Any definitive transaction remains subject to separate negotiations, due diligence, and definitive agreements.
IN01 is an active immunotherapy, or therapeutic cancer vaccine, targeting epidermal growth factor (EGF). It is designed to stimulate the patient's immune system to produce antibodies against circulating EGF, a growth factor involved in the proliferation of certain cancer cells. Development materials identify squamous non-small cell lung cancer (sqNSCLC) as the lead indication, with potential expansion into colorectal, head-and-neck, and other cancers. IN01 is a clinical-stage asset and has not received marketing approval. According to the International Agency for Research on Cancer, lung cancer was the world's most frequently diagnosed cancer in 2022, with approximately 2.5 million new cases, and the leading cause of cancer death, with approximately 1.8 million deaths. Non-small cell lung cancer accounts for approximately 80% to 85% of lung cancer cases, according to the American Cancer Society. Fortune Business Insights estimates the global NSCLC therapeutics market at approximately $38.49 billion in 2025, though this third-party estimate relates to a broad therapeutic category and should not be read as an estimate of the addressable market, commercial potential, or probability of success of IN01.
Tomoki Nagano, Chief Executive Officer of BIOT, stated, "We believe IN01 is a promising clinical-stage program in the field of active cancer immunotherapy, and we are fully committed to helping build a path for this science to reach the patients who need it." He added, "Japan and China have the world's largest lung cancer patient populations alongside world-class clinical research capabilities, placing them at the center of unmet medical needs in oncology. We share with CelSiege a mission to bring this technology to patients. As CelSiege's authorized representative in these two markets, BIOT will work with a strong sense of ownership to identify partners and pursue collaborations that can advance the development and commercialization of IN01. Our enduring aspiration is to bring more smiles to patients and their families."
The appointment extends BIOT's business development activities into clinical-stage oncology, leveraging its existing platform in beauty, wellness, regenerative medicine, and related healthcare sectors. CelSiege Biosciences, headquartered in Marseille, France, with operations in the United States, focuses on active immunotherapies. Its proprietary B-cell-mediated platform is designed to stimulate polyclonal antibody responses against disease-associated ligands, with applications in oncology and other therapeutic areas. For more information, visit CelSiege Biosciences.
For BIOT, this agreement could open new revenue streams and strategic opportunities in the Asia-Pacific region, while for CelSiege, it provides access to two major markets with significant unmet medical needs. The global impact could be substantial if IN01 successfully advances through clinical development, offering a new therapeutic option for lung cancer patients. However, risks remain, including the uncertainty of identifying suitable partners, completing definitive agreements, and obtaining regulatory approvals. As noted in the forward-looking statements, there can be no assurance that IN01 will successfully complete clinical development, demonstrate safety or efficacy, or receive marketing approval in Japan, China, or any other jurisdiction. For more information, visit https://instinct-biot.com/.
