Author: OBI Pharma USA, Inc.

  • OBI Pharma and TegMine Therapeutics Sign Exclusive Global License Agreement for Glycan-Targeting ADC

    OBI Pharma and TegMine Therapeutics Sign Exclusive Global License Agreement for Glycan-Targeting ADC

    Successful Delivery of Commissioned ADC Candidate to Advance the Collaboration Between OBI and TegMine

    TAIPEI, TW / ACCESS Newswire / January 12, 2026 / OBI Pharma (4174.TWO) announced that it has entered into a commercial license agreement with TegMine Therapeutics, Inc. (TegMine), a San Francisco-based biopharma focused on developing antibodies targeting cancer-associated glycans and glycoproteins, for a glycan-targeting ADC.

    Under the terms of the agreement, OBI is eligible to receive an upfront payment as well as development and commercial milestones. Following product launch, OBI will also receive royalties based on a tiered percentage of annual net sales. While the detailed financial terms are not disclosed in accordance with the confidentiality provisions, the overall deal economics are broadly comparable to those of recent similar licensing transactions in the market.

    TegMine will obtain the exclusive global rights to develop and commercialize the ADC under the license agreement. This international licensing collaboration reflects the potential value of products generated using OBI’s Obrion ADC technologies.

    The licensed ADC candidate is derived from a high-affinity anti-glycan antibody provided by TegMine and was developed into an ADC by OBI using the ObrionADC technology family, including the GlycOBI® glycan-conjugation technology, the dual-function enzymatic EndoSymeOBI®, and the highly hydrophilic linker HYPrOBI®. The ADC candidate generated with this proprietary site-specific glycan conjugation is homogeneous and scalable for manufacturing.

    Heidi Wang, Ph.D. Chief Executive Officer of OBI Pharma, said, “This strategic collaboration leverages the complementary strengths of both organizations. It not only supports the advancement of OBI’s ADC product development but also expands opportunities for strategic partnerships using our innovative ADC technologies such as GlycOBI®. We look forward to working closely with TegMine to further develop this novel ADC that may benefit patients with urgent medical needs.”

    “The transition from our successful Master Services Agreement to this global license agreement is a major milestone for TegMine,” said Jeff Bernstein, Ph.D., Chief Executive Officer of TegMine Therapeutics. “By combining OBI’s site-specific GlycOBI® conjugation with our proprietary antibodies discovered via the TegMiner platform, we have generated an ADC with exceptional tumor specificity. This TegMine program demonstrates the power of targeting cancer-specific glycan signatures to deliver potent payloads while sparing healthy tissue. We are excited to advance this program rapidly into the clinic.”

    About GlycOBI®

    OBI has developed a unique glycan-based ADC technology (GlycOBI®), designed in a Plug and Play format that is compatible with any antibodies, linkers, and payloads, and supports various drug-antibody ratios (DAR). Powered by OBI’s proprietary dual-function enzymatic technology EndoSymeOBI® and its hydrophilic linker technology HYPrOBI®, GlycOBI®, a core component of OBI’s Obrion ADC technology family, enables the generation of site-specific and homogeneous ADCs with an efficient and scalable process under GMP conditions.

    During the conjugation process, GlycOBI® avoids disrupting the antibody structure and ensures that the resulting ADC retains biophysical characteristics comparable to the native antibody. In addition, OBI’s linker technology improves payload conjugation efficiency and reduces the propensity for aggregation or degradation, further supporting a stable and well-controlled ADC manufacturing process. GlycOBI® has overcome limitations commonly associated with traditional ADC approaches and has demonstrated improved antitumor activity and stability in various in vivo studies.

    About OBI Pharma

    OBI Pharma is a clinical-stage global oncology company established in 2002 and headquartered in Taiwan. Together with its subsidiary OBI Pharma USA, Inc., the company is dedicated to developing innovative cancer therapeutics to provide new treatment options for patients with urgent medical needs.

    OBI’s research efforts center on novel antibody-drug conjugates (ADC). Through its patented next-generation conjugation technology platform, Obrion™, OBI has established diverse ADC design modalities. The platform integrates proprietary conjugation and linker technologies, including GlycOBI®, GlycOBI DUO®, EndoSymeOBI®, HYPrOBI®, and the novel cysteine-conjugation technology ThiOBI®, to advance next-generation ADC solutions. OBI has developed a next-generation suite of ADC programs. These include monospecific ADCs such as OBI-902 (TROP2) and OBI-904 (Nectin-4); a bispecific single-payload ADC, OBI-201 (HER2 x TROP2); and a bispecific dual-payload ADC, OBI-221 (cMET x HER3). In addition to its ADC programs, OBI’s assets include OBI-3424, a first-in-class AKR1C3-targeted small-molecule prodrug that selectively releases a potent DNA-alkylating agent in the presence of the aldo-keto reductase 1C3 enzyme, which is highly expressed in certain tumors. Additional information can be found at www.obipharma.com.

    GlycOBI®, EndoSymeOBI®, ThiOBI®, HYPrOBI®, and GlycOBI DUO® are registered trademarks of OBI. Obrion is a trademark under registration.

    About TegMine Therapeutics

    TegMine is redefining precision oncology by targeting highly expressed glycans and glycoproteins that drive cancer aggressiveness and immune evasion. Our mission is to eradicate cancer by identifying unique tumor antigens that are consistently prevalent across the tumor while being largely absent from healthy tissues. The company’s proprietary TegMiner platform utilizes glyco-engineered cell lines and advanced mass spectrometry to identify previously inaccessible, cancer-specific glycan epitopes. This discovery engine is designed to generate high-specificity antibodies that deliver maximum therapeutic impact across numerous treatment modalities, including antibody-drug conjugates (ADCs) and other next-generation antibody formats. For more information, please visit www.tegminetx.com.

    Forward-Looking Statements

    Statements included in this press release that are not a description of historical facts are forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Such forward-looking statements include, but are not limited to, statements about future clinical trials, results and the timing of such trials and results. Such risk factors are identified and discussed from time to time in OBI Pharma’s reports and presentations, including OBI Pharma’s filings with the Taiwan Securities and Futures Bureau.

    COMPANY CONTACT:

    Kevin Poulos, Chief Business Officer
    OBI Pharma USA, Inc.
    +1 (619) 537 7698, ext. 102
    kpoulos@obipharma.com

    Jeff Bernstein, Chief Executive Officer
    TegMine Therapeutics, Inc.
    jeff@tegminetx.com

    SOURCE: OBI Pharma USA, Inc.

    View the original press release on ACCESS Newswire

  • OBI-902 Has Been Granted by US FDA for Orphan Drug Designation for the Treatment of Cholangiocarcinoma

    OBI-902 Has Been Granted by US FDA for Orphan Drug Designation for the Treatment of Cholangiocarcinoma

    OBI-902 is the first ADC utilizing OBI’s proprietary GlycOBI® glycan-based ADC enabling technology for evaluation of safety and efficacy in patients with Cancer.

    TAIPEI, TW / ACCESS Newswire / November 17, 2025 / OBI Pharma, a clinical-stage oncology company (4174.TWO) received notification from the US FDA stating that the request for Orphan Drug Designation of OBI-902 TROP2 ADC for the treatment of Cholangiocarcinoma has been granted. OBI-902 is the first OBI-developed ADC that incorporates our proprietary site-specific glycan-conjugated ADC enabling technology.

    Cholangiocarcinoma is a rare and lethal malignancy with fewer than 50,000 patients in the United States and a 5-year survival rate ranging from 2% and 23% depending on disease stage, histological subtype, and localization 1 . At present, there are no FDA approved ADC therapies for cholangiocarcinoma.

    To encourage the industry to develop new treatment options for rare diseases, the US FDA grants Orphan Drug Designation to experimental therapies that have the potential to treat these diseases. In the United States, a rare disease is defined as any condition that affects fewer than 200,000 patients. After granting Orphan Drug Designation, the US FDA qualifies companies or drug developers incentives such as tax credits for clinical trials, exemption from user fees, and marketing exclusivity2.

    In August 2025, OBI launched a phase I/II clinical trial in the United States and Taiwan, recruiting patients with advanced solid tumors. The objectives of the trial are to study the safety, pharmacokinetics, and preliminary efficacy profile of OBI-902 in these patient populations.

    Heidi Wang, Ph.D, OBI Pharma’s Chief Executive Officer noted, “Based on our preclinical data, OBI-902 has several important advantages over other TROP2 ADCs either approved or in development; including high stability in blood circulation, excellent bystander effect that extends the killing to neighboring cancer cells lacking TROP2 expression, potential ability to overcome drug resistance, and outstanding activity in animal and organoid models of cancer. Importantly, this marks the first time an ADC that incorporates OBI’s proprietary GlycOBI® ADC technology is being evaluated in patients, including those diagnosed with cholangiocarcinoma. We look forward to investigating this potential best-in-class TROP2 ADC in the clinic.”

    About OBI-902

    OBI-902 is a TROP2-targeted antibody-drug conjugate (ADC) that carries a potent topoisomerase I inhibitor payload to kill tumor cells and with a drug-antibody ratio (DAR) of 4. TROP2 is highly expressed in a variety of solid tumors such as breast, lung, biliary, bile duct (cholangiocarcinoma), ovarian, gastric, and many other cancer types, rendering it an ideal target for cancer therapy.

    OBI-902 is a novel site-specific glycan-conjugated ADC using OBI’s proprietary GlycOBI platform, which provides improved stability and enhanced hydrophilicity. OBI-902 demonstrated remarkable antitumor efficacy, improved pharmacokinetic characteristics, and a favorable safety profile in various animal models. The IND of OBI-902 was cleared by the US FDA on April 30, 2025.

    Since December 2021, OBI has been granted by Biosion, Inc. (www.biosion.com) an exclusive, worldwide (except in China) license to a TROP2 targeting antibody amino acid sequence. Biosion holds exclusive rights to that antibody sequence in China. OBI holds worldwide commercial rights to OBI-902, except for the rights pertaining to the antibody in China.

    About GlycOBI®

    OBI has developed a unique clinical stage, glycan-based site-specific ADC technology (GlycOBI®), which is in a ‘Plug and Play’ format and compatible with any antibodies, linkers, and payloads in drug-antibody ratio (DAR) up to 16. Utilizing OBI’s proprietary dual-function enzyme (EndoSymeOBI®) and linker technology (HYPrOBI®), homogenous ADCs are manufactured with an efficient and scalable process under GMP conditions. The conjugation process of GlycOBI® avoids disrupting the antibody structure and ensures the ADC has similar biophysical characteristics to the native antibody. Furthermore, OBI’s linker technology has improved conjugation efficiency of the payload, reduced aggregation propensity, which provides advantages on manufacturing ADC products. GlycOBI® conjugated ADCs have overcome the limitations of traditional ADCs and achieved better antitumor activity and stability in various in vivo animal studies. GlycOBI®, EndoSymeOBI®, and HYPrOBI® are part of the armamentarium of OBI’s Obrion™ ADC Enabling Technologies that also include ThiOBI® and GlycOBI DUO™. OBI-902 is the first ADC utilizing OBI’s Obrion™ ADC enabling technology for evaluation of safety and efficacy in Cancer, currently under Phase I/II clinical trial in the US and Taiwan.

    About OBI Pharma

    OBI is a clinical stage global oncology company that is headquartered in Taiwan and established in 2002. Its mission, together with its wholly owned subsidiary OBI Pharma USA, Inc., is to develop novel therapeutic agents for patients with high unmet medical needs.

    OBI’s primary focus is the development of novel ADCs, including the first-generation cysteine-based TROP2 ADC, OBI-992. Using the company’s proprietary ADC enabling technology, GlycOBI®, powered by EndoSymeOBI® and HYPrOBI®; OBI has created its next-generation novel ADC pipeline, including monospecific: OBI-902 (TROP2), OBI-904 (Nectin-4), bispecific single payload (HER2 x TROP2), and bispecific, dual payload (cMET x HER3) ADCs. To broaden the applicability of linker technology, HYPrOBI®, OBI further developed a novel ThiOBI® platform to enable irreversible cysteine-based conjugation. Additionally, OBI’s pipeline includes the first-in-class AKR1C3-targeted small-molecule prodrug OBI-3424, which selectively releases a potent DNA-alkylating antitumor agent in the presence of the aldo-keto reductase 1C3 (AKR1C3) enzyme that is highly expressed in tumors. Additional information can be found at www.obipharma.com.

    GlycOBI®, EndoSymeOBI®, ThiOBI® and HYPrOBI®are registered trademarks of OBI Pharma. Obrion™ and GlycOBI DUO™ are trademarks under registration.

    1National Institute of Health for Rare Diseases. Sept. 2025

    https://rarediseases.info.nih.gov/diseases/9304/cholangiocarcinoma

    2US FDA website. Designating an Orphan Product: Drugs and Biological Products Sept.25 https://www.fda.gov/industry/medical-products-rare-diseases-and-conditions/designating-orphan-product-drugs-and-biological-products

    Forward-Looking Statements

    Statements included in this press release that are not a description of historical facts are forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Such forward-looking statements include, but are not limited to, statements about future clinical trials, results and the timing of such trials and results. Such risk factors are identified and discussed from time to time in OBI Pharma’s reports and presentations, including OBI Pharma’s filings with the Taiwan Securities and Futures Bureau.

    COMPANY CONTACT:
    Kevin Poulos, Chief Business Officer
    OBI Pharma USA, Inc.
    +1 (619) 537 7698, ext. 102
    kpoulos@obipharma.com

    SOURCE: OBI Pharma USA, Inc.

    View the original press release on ACCESS Newswire