nectin-4

OBI-902 is the first ADC utilizing OBI’s proprietary GlycOBI® ADC enabling technology TAIPEI, Taiwan I May 01, 2025 I OBI Pharma, Inc. (“OBI”), a clinical stage oncology company（4174.TWO), today announced that the U.S. Food and Drug Administration (FDA) has cleared an investigational new drug （IND） application for OBI-902, to conduct a Phase 1/2 study. OBI plans to enroll patients with advanced solid tumors. This IND clearance represents a significant milestone for OBI-902, bringing forward a potentially best-in-class Trop-2 -targeted cancer therapy for patients with high unmet medical needs. OBI’s Chief Executive Officer, Heidi Wang, Ph.D. noted, “The impending OBI-902-001 clinical trial intends to evaluate the safety, pharmacokinetics, and preliminary efficacy of OBI-902 in patients with advanced solid tumors. We are very excited to begin dosing patients in our Phase 1/2 clinical study of OBI-902 later this year.” OBI-902 is a novel Trop-2 ADC utilizing OBI’s proprietary GlycOBI ® ADC enabling technology. At the 2025 American Association for Cancer  Research (AACR) meeting, OBI presented data demonstrating enhanced linker-payload stability, favorable pharmacokinetics with superior and durable antitumor activities of OBI-902 in numerous in-vitro and animal studies compared to other Trop-2 ADCs 1 , 2 . The Phase 1/2 clinical study is planned to begin enrolling patients in 2H 2025. 1 OBI-902, a novel TROP-2 targeted antibody-drug conjugate via GlycOBI ® platform, has favorable pharmacokinetics and sustained antitumor activities in challenging solid tumors. AACR Annual Meeting 2025 Abstracts online https://www.abstractsonline.com/pp8/#!/20273/presentation/1103 2 Harnessing the GlycOBI® enabling technologies: next-generation site-specific glycan ADCs with versatile DAR to enhance therapeutic index. AACR Annual Meeting 2025 Abstracts online https://www.abstractsonline.com/pp8/#!/20273/presentation/3007 About OBI-902 OBI-902 is a Trop-2-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. Trop-2 is highly expressed in a variety of solid tumors such as breast, 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. IND of OBI-902 was submitted to the U.S. FDA on March 31, 2025, and the IND was cleared on April 30, 2025. OBI has licensed Trop-2 targeting antibody from Biosion, Inc. ( www.biosion.com ) since December 2021, holding exclusive rights worldwide except in China. OBI holds worldwide commercial rights to OBI-902, to the exception of the rights pertaining to the antibody in China. About GlycOBI ® OBI has developed a unique glycan-based ADC technology (GlycOBI ® ), which is in a ‘Plug and Play’ format and compatible with any antibodies, linkers, and payloads in various DAR. Utilizing OBI’s proprietary enzymatic technology（EndoSymeOBI®） and linker technology（HYPrOBI™), GlycOBI ® generates site-specific homogenous ADCs 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 ® has overcome the limitations of traditional ADCs and achieved better antitumor activity and stability in various in vivo animal studies. 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 cancer 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 TROP-2 ADC, OBI-992. Using the company’s proprietary ADC enabling technology, GlycOBI ® , powered by EndoSymeOBI ® and HYPrOBI™; OBI has created its second generation novel ADC pipeline, including monospecific: OBI-902 （Trop-2), OBI-904 (Nectin-4), Trastuzumab-ADC (HER2), bi-specifics and dual payload ADCs. To broaden the applicability of the linker technology, HYPrOBI™, OBI further developed a next-generation ThiOBI ® platform to enable irreversible cysteine-based conjugation. Additionally, OBI’s pipeline also 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 . SOURCE: OBI Pharma

Preclinical data demonstrates unique binding location of CT-95 on mesothelin and avoidance of binding to shed mesothelin Data supports ongoing Phase 1 clinical trial for CT-95 PHILADELPHIA, PA, USA I April 30, 2025 I Context Therapeutics Inc. (“Context” or “Company”) (Nasdaq: CNTX), a clinical-stage biopharmaceutical company advancing T cell engaging (“TCE”) bispecific antibodies for solid tumors, today announced preclinical and translational data regarding the Company’s clinical asset, CT-95, a mesothelin x CD3 TCE was presented at the American Association for Cancer Research (AACR) Annual Meeting 2025, taking place April 25-30, 2025 in Chicago, IL. “There is a high unmet need for effective treatments in mesothelin expressing cancers. CT-95 is affinity tuned and avidity enhanced to concentrate drug activity within the tumor microenvironment,” said Martin Lehr, Chief Executive Officer of Context. “We believe these preclinical and translational data support the clinical strategy to target mesothelin expressing cancers, including pancreatic, ovarian, and mesothelioma. We recently dosed the first patient in our Phase 1 clinical trial of CT-95 and expect to share initial clinical data in mid-2026.” Findings from preclinical studies evaluating CT-95 in cancer cell lines and tumor models illustrate the potential of CT-95 to treat mesothelin-positive tumors. Notably, CT-95 has shown to: A copy of the presentation materials can be accessed on the “Publications and Posters” section of the Company’s website at https://www.contexttherapeutics.com . About CT-95 CT-95 is a mesothelin (“MSLN”) x CD3 bispecific antibody that is intended to redirect T-cell-mediated lysis toward malignant cells expressing MSLN. MSLN is a membrane protein overexpressed in approximately 30% of cancers. One challenge in developing MSLN-targeted therapies has been the presence of MSLN fragments, also referred to as shed MSLN, found in both blood and the tumor microenvironment that can serve as a decoy or sink for MSLN-targeting antibodies. CT-95 is a fully humanized bispecific T cell engager that has a moderate affinity but high avidity for membrane-bound MSLN, that is intended to minimize the impact of the shed MSLN. The clinical trial is being conducted at clinical sites in the US. More information about the CT-95 clinical trial (NCT06756035) can be found on https://clinicaltrials.gov/ . About Context Therapeutics® Context Therapeutics Inc. (Nasdaq: CNTX) is a biopharmaceutical company advancing T cell engaging (“TCE”) bispecific antibodies for solid tumors. Context is building an innovative portfolio of TCE bispecific therapeutics, including CTIM-76, a Claudin 6 x CD3 TCE, CT-95, a Mesothelin x CD3 TCE, and CT-202, a Nectin-4 x CD3 TCE. Context is headquartered in Philadelphia. For more information, please visit www.contexttherapeutics.com or follow the Company on X (formerly Twitter) and LinkedIn . SOURCE: Context Therapeutics

MARSEILLE, France I April 29, 2025 I Innate Pharma SA (Euronext Paris: IPH; Nasdaq: IPHA) (“ Innate ” or the “ Company ”) today shared new preclinical data for IPH4502, its novel and differentiated topoisomerase I inhibitor Antibody Drug Conjugate (ADC) targeting Nectin-4. The data were presented at the American Association for Cancer Research (AACR) Annual Meeting 2025. Nectin-4 targeting is validated by enfortumab vedotin (EV), an ADC with a monomethyl auristatin E (MMAE) payload, approved for urothelial carcinoma (UC), an indication with high Nectin-4 expression. However, EV discontinuation due to toxicity, disease relapse, or treatment ineligibility, along with its limited efficacy in tumors with lower Nectin-4 expression, underscores the need for a differentiated Nectin-4 ADC with improved therapeutic window and improved mechanisms of action. IPH4502 demonstrated anti-tumor activity in EV-resistant patient-derived xenograft (PDX) model with upregulation of multi-drug resistance protein 1 (MDR1), supporting its potential to overcome resistance mechanisms in EV-refractory disease. Beyond UC, IPH4502 also exhibited anti-tumor activity in preclinical models of triple-negative breast cancer, head and neck squamous cell carcinoma, and esophageal cancer, suggesting broader potential clinical applicability. In addition, in preclinical tumor models with low Nectin-4 expression, IPH4502 showed superior anti-tumor activity compared to a clinical-stage Nectin-4-exatecan ADC supported by higher internalization, cytotoxicity, and bystander killing effect. “ We are highly encouraged by these preclinical data, which suggest that IPH4502 has the potential to translate into improved clinical benefit in indications with unmet medical need. These findings also reinforce the rationale for our ongoing Phase 1 trial. We look forward to sharing initial clinical data in 2026 as the program advances, ” said Sonia Quaratino, Chief Medical Officer of Innate Pharma . IPH4502 is currently investigated in a Phase 1 trial in advanced solid tumors known to express Nectin-4 ( NCT06781983 ). The poster is available on Innate Pharma’s website . About IPH4502 IPH4502 is a differentiated topoisomerase I inhibitor Antibody Drug Conjugate (ADC) conjugated to exatecan targeting Nectin-4, a cell adhesion molecule that is overexpressed in several types of solid tumors, such as urothelial carcinoma, breast cancer, non-small cell lung cancer or gastro-intestinal tract cancer. IPH4502 is currently investigated in a Phase 1 trial in advanced solid tumors. The Phase 1 trial will assess the safety, tolerability, and preliminary efficacy of IPH4502 in different solid tumors known to express Nectin-4, including but not limited to urothelial carcinoma, non-small cell lung, breast, ovarian, gastric, esophageal, and colorectal cancers. The study plans to enroll approximately 105 patients. In preclinical models, IPH4502 demonstrates strong bystander killing effect, and efficient internalization, enabling a potent anti-tumor activity in models with various Nectin-4 expression levels. Additionally, IPH4502 shows efficacy in models resistant to MMAE-ADC. These results support its potential for development beyond UC and in cancer patients treated with MMAE-based ADCs. About Innate Pharma Innate Pharma S.A. is a global, clinical-stage biotechnology company developing immunotherapies for cancer patients. Its innovative approach aims to harness the innate immune system through three therapeutic approaches: multi-specific NK Cell Engagers via its ANKET ® (Antibody-based NK cell Engager Therapeutics) proprietary platform and Antibody Drug Conjugates (ADC) and monoclonal antibodies (mAbs). Innate’s portfolio includes several ANKET ® drug candidates to address multiple tumor types as well as IPH4502, a differentiated ADC in development in solid tumors. In addition, anti-KIR3DL2 mAb lacutamab is developed in advanced form of cutaneous T cell lymphomas and peripheral T cell lymphomas, and anti-NKG2A mAb monalizumab is developed with AstraZeneca in non-small cell lung cancer. Innate Pharma is a trusted partner to biopharmaceutical companies such as Sanofi and AstraZeneca, as well as leading research institutions, to accelerate innovation, research and development for the benefit of patients. Headquartered in Marseille, France with a US office in Rockville, MD, Innate Pharma is listed on Euronext Paris and Nasdaq in the US. Learn more about Innate Pharma at www.innate-pharma.com . Follow us on LinkedIn and X . SOURCE: Innate Pharma