Investment Summit Highlights: Advancements in Therapeutics & Pharmaceuticals

During the BIO Asia-Taiwan 2024 convention, the Investment Summit held on July 24-25, at the Taipei Nangang Exhibition Center, brought together industry leaders to discuss the latest advancements in therapeutics and pharmaceuticals. Organized by the Taiwan Bio Industry Organization (TBIO), Biotechnology & Pharmaceutical Industries Promotion Office (BPIPO), CDIB Capital Group, DCI Partners Co. Ltd., Diamond Biofund, PwC Taiwan, and Taiwania Capital, the event featured key insights from prominent companies in the sector.

OBI Pharma: Globo H Active Immunotherapy Target for TNBC

During the “Therapeutics and Pharmaceuticals” session, companies showcased their products and market strategies. Each company highlighted key investment aspects and summarized their projects and pipelines. They stressed the need for investment to drive collaborations and improve patient care globally. Consequently, they detailed the anticipated outcomes and benefits of ongoing efforts.

Here, Heidi Wang, CEO of OBI Pharma, outlined the company’s five-year plan focusing on new drug development, agile strategy licensing, and partnerships. With an 8-year history in ADC development and expertise in carbohydrate chemistry, OBI Pharma targets breast cancer and associated immunotherapies. Their latest target is the Globo H antigen for triple-negative breast cancer (TNBC), represented by OBI-833 (adagloxad simolenin). Globo H, a carbohydrate antigen expressed on cancer cells, is a key focus for developing immunotherapies. Researchers are exploring vaccines and monoclonal antibodies to target Globo H, aiming to enhance immune system efficacy against cancer cells while sparing normal tissues.

Trop-2 ADC Capitalizing on AI to Accelerate Dose Selection

Essentially, adagloxad simolenin (OBI-833), recently passed Phase 2 trials and is currently in Phase 3. With the first interim approval already achieved and the second expected in early 2026, preparations for a Biologics License Application (BLA) are suggested to begin two years in advance, and as such OBI Pharma is working toward capitalizing on the time, already starting to compile the relevant documentation. Not far behind OBI 833 in the pipeline development is OBI 992, a Trop-2 ADC in Phase 1, that is leveraging AI to accelerate dose selection. “We are currently working with PUMAS AI data to advance to the next stage of dose expansion very quickly. We are using AI to expedite our dose selection process,” Wang stated.

Wang further mentioned that the proprietary glycan site-specific ADC platform enables efficient and homogeneous drug delivery technology. This platform incorporates a stable linker, described as the “soul” of the ADC, which ensures precise and stable attachment of the drug to the antibody. Currently, the platform supports drug-to-antibody ratios of 4:1 or 8:1, allowing for optimized therapeutic effectiveness. Wang highlighted that Glycobi’s platform demonstrates notable promise in treating colorectal cancer, showing better performance compared to existing ADCs like Trodelvy. Currently, OBI Pharma is fundraising and seeking both regional and global collaborations.

Heidi Wang, CEO of OBI Pharma.

Ochre Bio: Advancing RNA Therapies for Liver Diseases, MASH Market Opportunities

Ochre Bio, represented by Ms. Lu (Tess), Head of Research Development, focuses on novel RNA therapies for liver diseases. The company utilizes three foundational platforms—computations, chemistry, and validation—to understand chronic liver diseases.

A key aspect of their research, based in Taiwan, addresses the high incidence of chronic liver diseases. They have established a network for obtaining fresh biopsy samples quickly, with tissues delivered within 60 minutes of surgery from hospitals and surgeons in Taipei.

Initially considered challenging, MASH (Metabolic Dysfunction-associated Steatosis Hepatitis) has recently shown promise with the Madigral therapeutic, despite significant unmet needs in the field. Consequently, Ms. Lu noted, “There are a lot of unmet needs and a lot of market opportunity in this area,” referring specifically to MASH. Their late-stage and early development projects include MASH, cirrhosis, and primary biliary cholangitis (PBC). 

ONWARD THERAPEUTICS: Innovative Bispecific Antibodies and Cell Therapies for Hematologic and Solid Tumors

ONWARD THERAPEUTICS, led by Dr. Armand de Gramont, Founder and CEO, has a pipeline featuring three bispecific antibodies in Phase 1 trials. These are projected to enter Phase 2 by 2025, targeting both hematologic and solid tumors. Notably, OT-A201 stands out as a second-generation bispecific immune checkpoint inhibitor (ICI), uniquely addressing both tumor types.

In addition, OT-C001, a promising cell therapy with monoclonal antibody combinations, is currently in clinical trials and expected to enter Phase 1 in about six months. Meanwhile, OT-S00X represents an early research program in onco-metabolism.

The company aims to complete Series B1 funding soon and anticipates an IPO approximately three years after reaching Phase 2 with current assets. Investment highlights emphasize the bispecific antibody’s potential in a niche area of immuno-oncology. Presently, ONWARD THERAPEUTICS employs 16 people, with Series A funding projected to last until the end of 2025, ensuring a stable financing situation.

Dr. Armand de Gramont, Founder and CEO of ONWARD THERAPEUTICS

REGiMMUNE: Focusing on Regulatory T Cells and Transplant Patients

REGiMMUNE, led by Stephen Huang, originated in Japan and expanded in Taiwan, with global ambitions. The company’s name combines “regulatory” and “immunology,” reflecting its focus on regulatory T cells (Tregs) to treat oncology and autoimmune diseases. Their reVex platform offers unique antigen-specific immune modulation.

The next target for REGiMMUNE is type 1 diabetes, while their current indication is acute graft-versus-host disease (GvHD). Here, RGI 2001, the first pipeline product, has completed Phase 2b clinical studies in the US, demonstrating significant therapeutic efficacy for GvHD prophylaxis. 

Looking ahead, REGiMMUNE aims to compete with BMS’s existing product, which is a strong immunosuppressant, by offering a potentially superior alternative. The GvHD market is substantial, with about 10,000 patients receiving transplants annually in the US. However, over 20,000 patients lack a suitable transplant match. Regimmune’s drug is applicable for both matched and unmatched patients, addressing a market size estimated at $600 million annually.

The Investment Summit highlighted significant advancements in therapeutics and pharmaceuticals, showcasing innovative approaches and strategic plans from OBI Pharma, Ochre Bio, ONWARD THERAPEUTICS, and REGiMMUNE. These companies are addressing critical unmet medical needs with promising pipelines and strategic collaborations, poised to drive future growth in the industry.

Author

Bernice Lottering