BHV-1530 / Biohaven, Aimed Bio - LARVOL DELTA

Phase 1 study of BHV-1530, a first-in-class FGFR3 ADC in Advanced Tumors (EORTC-NCI-AACR 2026) - "Abstract will be available on the day of the presentation"

ADC • Metastases • P1 data • Oncology • FGFR3

Phase 1 study of BHV-1530, a first-in-class FGFR3 ADC in Advanced Tumors (ESMO 2026) - No abstract available

ADC • Metastases • P1 data • Oncology • FGFR3

Biohaven to Present New Clinical Data at ESMO Congress on BHV-1530, a Novel FGFR3-Directed ADC With a Proprietary Topoisomerase I (TopoIx) Payload (PRNewswire) - "The new Phase 1 data planned for ESMO will provide a clinically meaningful update to the early Phase 1 data initially disclosed at Biohaven's R&D Day on May 27, 2026....The data from May 27 2026, showed early signs of antitumor activity in patients with both FGFR3-altered and wild-type overexpressing tumors, and across multiple tumor types. This included a heavily pretreated patient with FGFR3-TACC3 fusion–positive metastatic urothelial cancer who had progressed on four prior lines of therapy, including Padcev (a nectin-4-directed ADC), pembrolizumab, and two FGFR-targeting small molecules. This patient has tolerated BHV-1530 with no FGFR-related toxicity."

P1 data • Urothelial Cancer

Biohaven has entered into a clinical supply agreement with Regeneron Pharmaceuticals, Inc. to evaluate the combination of BHV-1530 and cemiplimab (Libtayo) in patients with solid tumors based upon the emerging monotherapy clinical data and preclinical data demonstrating synergistic activity between BHV-1530 and immune therapy. (PRNewswire) - "This agreement builds upon the existing clinical supply agreement between Biohaven and Regeneron for BHV-1510, a next-generation TROP2-directed ADC, further deepening the collaborative relationship between the two companies across Biohaven's oncology pipeline."

Licensing / partnership • Urothelial Cancer

A Phase 1 Study of BHV-1530 in Advanced Solid Tumors (clinicaltrials.gov) - P1 | N=140 | Recruiting | Sponsor: Biohaven Therapeutics Ltd. | N=95 ➔ 140

Enrollment change • First-in-human • Monotherapy • Head and Neck Cancer • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • Squamous Cell Carcinoma of Head and Neck

Sustained progress across development pipeline (PRNewswire) - "Enrollment advances in advanced endometrial cancer expansion cohort with the next-generation TROP-2 directed ADC BHV-1510 in combination with Libtayo; Dose escalation advances with BHV-1530, a first-in-class FGFR3-directed antibody-drug conjugate (ADC). No dose-limiting toxicities observed to date."

Enrollment status • Bladder Cancer • Endometrial Cancer • Non Small Cell Lung Cancer • Renal Cell Carcinoma • Solid Tumor • Squamous Cell Carcinoma of Head and Neck • Urothelial Cancer

Biohaven Presents Oncology Program Updates… (PRNewswire) - "Biohaven also announced the first patient has been dosed in the Phase 1 study of BHV-1530, a potential first-in-class fibroblast growth factor receptor 3 (FGFR3)-directed ADC which utilizes the proprietary Topolx payload."

Trial status • Oncology • Solid Tumor

Biohaven Reports First Quarter 2025 Financial Results and Recent Business Developments (PRNewswire) - "Expected Upcoming Milestones:...Next Generation ADC Platform: (i) Preliminary Phase 1 data with BHV-1510 and dose optimization as monotherapy and combination therapy with Libtayo in epithelial tumors in 2025; (ii) Initiate Phase 1 trial of BHV-1530 in 1H 2025; (iii) Advance additional preclinical ADCs, including Merus and GeneQuantum collaborations (undisclosed targets) in 2025."

P1 data • Pipeline update • Trial status • Solid Tumor

A Phase 1 Study of BHV-1530 (AMB302) in Advanced Solid Tumors (clinicaltrials.gov) - P1 | N=95 | Recruiting | Sponsor: Biohaven Therapeutics Ltd. | Not yet recruiting ➔ Recruiting

Enrollment open • Oncology • Solid Tumor

AMB302/GR1017, an antibody-drug conjugate (ADC) with topoisomerase 1 inhibitor shows therapeutic potency in orthotopic glioblastoma PDX and bladder cancer models with FGFR3-TACC3 fusion (AACR 2023) - "AMB302/GR1017 showed robust anti-tumor efficacies in F3-T3 fusion and FGFR3 overexpression models derived from GBM and BC in vitro and in vivo. In addition, AMB302/GR1017 was well tolerated with no adverse effects in rodent model. Our data suggest AMB302/GR1017 has a potential therapeutic option as a first-in-class FGFR3 targeting ADC for GBM, BC, and other solid tumors with FGFR3 overexpression or alterations."

Preclinical • Bladder Cancer • Brain Cancer • CNS Tumor • Genito-urinary Cancer • Glioblastoma • Oncology • Solid Tumor • Urothelial Cancer • FGFR3 • TACC3

Preclinical characterization of AMB302/GQ1011, a first-in-class FGFR3 antibody-drug conjugate (ADC) with topoisomerase 1 inhibitor against diverse FGFR3 overexpression or alteration (AACR 2024) - "AMB302/GQ1011 demonstrated a potent antitumor efficacy in vitro and in vivo models with FGFR3 overexpression and alterations across various solid tumors. Notably, AMB302/GQ1011 suggests the potential for combination with ICI treatment. Moreover, AMB302/GQ1011 exhibited excellent tolerability at high doses in NHP, indicating its safety profile."

IO biomarker • Preclinical • Bladder Cancer • Brain Cancer • CNS Tumor • Genito-urinary Cancer • Glioblastoma • Head and Neck Cancer • Oncology • Solid Tumor • Squamous Cell Carcinoma • Squamous Cell Carcinoma of Head and Neck • FGFR3

Samsung Life Sciences Fund makes 1st investment in domestic biotech, AIMEDBIO (Korea Biomedical Review) - "Samsung Biologics said on Wednesday that Samsung Life Science Fund made an equity investment in AIMEDBIO, a domestic company specializing in therapeutic solutions for neuro-oncological and neuro-degenerative diseases....Consequently, AIMEDBIO has received support from the Korea Drug Development Foundation (KDDF) for three new drug candidates, of which AMB302 is a FGFR3-targeting ADC first-in-class candidate for glioblastoma and bladder cancer, which will enter the first clinical trial next year."

Financing • Bladder Cancer • Brain Cancer • CNS Tumor • Genito-urinary Cancer • Glioblastoma • Oncology • Solid Tumor

GeneQuantum expands deal with Aimed Bio to develop five innovative ADC drugs (The Pharma Letter) - "GeneQuantum Healthcare...has expanded its partnership with a South Korean biotech company Aimed Bio, a spin-off from Samsung Medical Center. This strategic collaboration, financial terms of which are not disclosed, aims to jointly develop up to five new ADC drugs to address unmet clinical needs. It adds to an around $1 billion collaboration signed by GeneQuantum earlier this year with Pyramid Bio....'The collaboration with Aimed Bio in the development of a series of innovative ADC drugs fully embodies GeneQuantum's core technology and integration of various high-quality innovative resources from both international and domestic upstream and downstream sectors, presents a promising outlook for the revolutionary ADC therapy innovation'."

Licensing / partnership • Bladder Cancer • Brain Cancer • CNS Tumor • Genito-urinary Cancer • Glioma • Oncology • Solid Tumor

A Phase 1 Study of BHV-1530 (AMB302) in Advanced Solid Tumors (clinicaltrials.gov) - P1 | N=95 | Not yet recruiting | Sponsor: Biohaven Therapeutics Ltd.

New P1 trial • Oncology • Solid Tumor

CEO Heo Nam-gu, “Aimed Bio’s dream ADC… apply for phase 1 in the U.S. in August” [Google translation] (HIT News) - "'Currently, we have completed a non-clinical toxicity test (GLP tox study) for 'AMB302/GQ1011 (development code name)' and plan to apply for a phase 1 clinical trial (IND) to the U.S. Food and Drug Administration (FDA) in August...AMB302 is a first-in-class ADC candidate targeting FGFR3 for malignant brain tumor called glioblastoma and bladder cancer...'AMB302/GQ1011 is showing high efficacy compared to the ADC treatment developed by Eli Lilly. Safety has also been confirmed in a mouse model.'....'We plan to apply for phase 1 clinical trials to the Ministry of Food and Drug Safety by October.'"

IND • New P1 trial • Preclinical • Bladder Cancer • Genito-urinary Cancer • Oncology • Solid Tumor

Biohaven Reports Recent Business Developments and Fourth Quarter and Full Year 2024 Financial Results (PRNewswire) - "Next Generation ADC Platform: Interim Phase 1 data with BHV-1510 and dose optimization as monotherapy and combination therapy with Libtayo in epithelial tumors in 2025. Initiate Phase 1 trial of BHV-1530 in 1H 2025. Advance Merus collaboration ADCs (undisclosed targets) and TopoIx ADCs in 2025."

Licensing / partnership • New P1 trial • P1 data • Oncology • Solid Tumor