FG-3246 / Fortis Therap, FibroGen - LARVOL DELTA

FG-3246: Topline data from P1/2 trial (NCT05011188) in combination with enzalutamide for mCRPC in Q1 2026 (FibroGen) - Q3 2025 Results

P1/2 data • Castration-Resistant Prostate Cancer • Oncology • Prostate Cancer

A Study of FG-3246 in Participants With Metastatic Castration-Resistant Prostate Cancer (mCRPC) (clinicaltrials.gov) - P2 | N=75 | Recruiting | Sponsor: FibroGen | Not yet recruiting ➔ Recruiting

Enrollment open • Castration-Resistant Prostate Cancer • Genito-urinary Cancer • Oncology • Prostate Cancer • Solid Tumor • CD46

FibroGen Initiates Phase 2 Monotherapy Trial of FG-3246, a First-in-Class CD46 Targeting ADC, in Metastatic Castration-Resistant Prostate Cancer (GlobeNewswire) - "FG-3246 Phase 2 dose optimization trial to enroll 75 patients with metastatic castration-resistant prostate cancer (mCRPC) in the post-androgen receptor signaling inhibitor (ASRI) and pre-chemotherapy setting....Interim analysis expected in 2H 2026....In addition, topline results from the ongoing investigator-sponsored study of FG-3246 in combination with enzalutamide in patients with mCRPC are expected in the fourth quarter of 2025."

Clinical data • Trial status • Castration-Resistant Prostate Cancer

FOR46 in Combination With Enzalutamide in Patients With Metastatic Castration Resistant Prostate Cancer (clinicaltrials.gov) - P1/2 | N=44 | Active, not recruiting | Sponsor: Rahul Aggarwal | Recruiting ➔ Active, not recruiting | Trial completion date: Apr 2027 ➔ Jul 2027 | Trial primary completion date: Apr 2027 ➔ Jul 2027

Enrollment closed • Trial completion date • Trial primary completion date • Castration-Resistant Prostate Cancer • Genito-urinary Cancer • Oncology • Prostate Adenocarcinoma • Prostate Cancer • Solid Tumor

A Study of FG-3246 in Participants With Metastatic Castration-Resistant Prostate Cancer (mCRPC) (clinicaltrials.gov) - P2 | N=75 | Not yet recruiting | Sponsor: FibroGen | Trial completion date: Sep 2027 ➔ Mar 2028 | Initiation date: Apr 2025 ➔ Sep 2025 | Trial primary completion date: Sep 2027 ➔ Mar 2028

Trial completion date • Trial initiation date • Trial primary completion date • Castration-Resistant Prostate Cancer • Genito-urinary Cancer • Oncology • Prostate Cancer • Solid Tumor • CD46

ANALYSIS OF GENETIC TEST RESULTS FOR 46 HEMOPHILIA PATIENTS IN ANHUI AND SURROUNDING AREAS (EHA 2025) - "In patients with severe hemophilia A, the most common mutation type is intron 22 inversion mutation. Missense mutation is the most common coding - region mutation in hemophilia A. In hemophilia B, missense and nonsense mutations are relatively common. The newly discovered 5 suspected pathogenic variants and 4 novel mutations contribute to enriching the gene mutation database related to hemophilia and can assist in clinical decision - making."

Clinical • Hematological Disorders • Hemophilia • Hemophilia A • Hemophilia B • Rare Diseases • CD36 • F8 • FGA • SCARB1

FG-3246: “FG-3246 demonstrated meaningful monotherapy clinical activity in 5L+ m CRPC patients”; Prostate cancer (FibroGen) - Q1 2025 Results

P1 data • Castration-Resistant Prostate Cancer • Oncology • Prostate Cancer

FibroGen Reports First Quarter 2025 Financial Results and Provides Business Update (GlobeNewswire) - "Upcoming Milestones: FG-3246 (CD46 Targeting ADC) and FG-3180 (CD46 Targeting PET Imaging Agent): (i) Anticipate initiation of Phase 2 monotherapy dose optimization study of FG-3246 in mCRPC in the third quarter of 2025. Phase 2 trial will include FG-3180 to enable assessment of its diagnostic performance and the potential correlation between CD46 expression and response to FG-3246; (ii) Topline results from the Phase 2 portion of the investigator-sponsored Phase 1b/2 study conducted by UCSF of FG-3246 in combination with enzalutamide in patients with mCRPC expected in the fourth quarter of 2025."

P2 data • Trial status • Castration-Resistant Prostate Cancer

FG-3246: Expiry of patents in US/ex-US related to composition-of-matter in 2035 (FibroGen) - Annual Report 2024: Expiry of patents in US/ex-US related to pharmaceutical compositions and dosing in 2041

Patent • Oncology

FibroGen Announces Publication of Results from Phase 1 Monotherapy Study of FG-3246 in Patients with Metastatic Castration-Resistant Prostate Cancer in the Journal of Clinical Oncology (GlobeNewswire) - P1 | N=56 | NCT03575819 | Sponsor: Fortis Therapeutics, Inc. | "Efficacy observed in the RECIST-evaluable set of 25 patients: Confirmed objective response rate was 20% with median duration of response of 7.5 months; All objective responses observed at a starting dose of 2.7 mg/kg or higher; Disease control rate was 80% with duration of treatment exceeding 24 weeks in 12 patients (48%); PSA50 response rate of 36% in 39 evaluable patients; Of eight evaluable patients who received docetaxel in the castration-sensitive setting, four (50%) achieved a confirmed PSA50 response....The Company anticipates initiating the Phase 2 monotherapy dose optimization study of FG-3246 in patients with mCRPC by mid-2025. FG-3246 is also being evaluated in combination with enzalutamide in an investigator-sponsored study with topline results from the Phase 2 portion of the study anticipated in 2H 2025."

P1 data • P2 data • Trial status • Castration-Resistant Prostate Cancer

Phase I, First-in-Human Study of FOR46 (FG-3246), an Immune-Modulating Antibody-Drug Conjugate Targeting CD46, in Patients With Metastatic Castration-Resistant Prostate Cancer. (PubMed, J Clin Oncol) - P1 | "FOR46 demonstrated encouraging preliminary clinical activity with a manageable safety profile. Targeting CD46 elicited an immune priming effect that was associated with clinical outcomes."

Journal • P1 data • Castration-Resistant Prostate Cancer • Fatigue • Febrile Neutropenia • Genito-urinary Cancer • Hematological Disorders • Leukopenia • Neutropenia • Oncology • Prostate Cancer • Solid Tumor • CD46 • CD8

FG-3246: Interim analysis data from P2 trial (NCT06842498) for mCRPC mid-2026 (FibroGen) - Q4 2024 Results

P2 data • Genito-urinary Cancer • Oncology • Prostate Cancer

FibroGen Reports Fourth Quarter and Full Year 2024 Financial Results (GlobeNewswire) - "Initiation of the Phase 2 monotherapy trial of FG-3246, a potential first-in-class antibody-drug conjugate (ADC) targeting CD46 in metastatic castration-resistant prostate cancer (mCRPC), expected by mid-2025; Topline results from Phase 2 portion of the investigator-sponsored study of FG-3246 in combination with enzalutamide in patients with mCRPC expected in 2H 2025."

P2 data • Trial status • Castration-Resistant Prostate Cancer

FibroGen continues to advance the clinical development of its lead asset, FG-3246… (GlobeNewswire) - "In addition, FibroGen continues to advance the clinical development of its lead asset, FG-3246...with the initiation of the Phase 2 monotherapy trial of FG-3246 in patients with mCRPC expected in the second quarter of 2025."

New P2 trial • Metastatic Castration-Resistant Prostate Cancer

A Study of FG-3246 in Participants With Metastatic Castration-Resistant Prostate Cancer (mCRPC) (clinicaltrials.gov) - P2 | N=75 | Not yet recruiting | Sponsor: FibroGen

New P2 trial • Castration-Resistant Prostate Cancer • Genito-urinary Cancer • Oncology • Prostate Cancer • Solid Tumor • CD46

FOR46 in Combination With Enzalutamide in Patients With Metastatic Castration Resistant Prostate Cancer (clinicaltrials.gov) - P1/2 | N=36 | Recruiting | Sponsor: Rahul Aggarwal | Phase classification: P1b/2 ➔ P1/2

Combination therapy • Metastases • Phase classification • Genito-urinary Cancer • Metastatic Castration-Resistant Prostate Cancer • Oncology • Prostate Cancer • Solid Tumor

FibroGen Reports Second Quarter 2024 Financial Results and Provides Business Update (GlobeNewswire) - "Upcoming Milestones:...Oncology Pipeline: (i) Topline results from the Phase 2 portion of the investigator-sponsored Phase 1b/2 study conducted by the University of California San Francisco of FG-3246 in combination with enzalutamide in patients with mCRPC expected in 1H 2025; (ii) Anticipate initiation of Phase 2 monotherapy dose optimization study of FG-3246 in mCRPC in 1Q 2025."

New P2 trial • P2 data • Metastatic Castration-Resistant Prostate Cancer

FibroGen to Host Part II of Virtual KOL Investor Event Series to Review FG-3246 Development Program in Metastatic Castration-Resistant Prostate Cancer on June 26, 2024 (GlobeNewswire) - "The event will feature Rahul Aggarwal, M.D...who will discuss the unmet need and evolving treatment landscape for prostate cancer, as well as the clinical development program for FG-3246 (also known as FOR46)...with first-in-class potential for the treatment of metastatic castration-resistant prostate cancer (mCRPC). The initiation of a Phase 2 monotherapy trial in mCRPC is expected in the second half of 2024....The event will additionally review data from the Phase 1b/2 study evaluating FG-3246 in combination with enzalutamide in mCRPC presented at the 2024 American Society of Clinical Oncology (ASCO) meeting."

Clinical • New P2 trial • P1/2 data • Castration-Resistant Prostate Cancer • Genito-urinary Cancer • Metastatic Castration-Resistant Prostate Cancer • Oncology • Solid Tumor

A phase 1b dose escalation study of FOR46, a novel antibody-drug conjugate targeting a tumor-specific epitope of CD46, in combination with enzalutamide (Enza) in patients with metastatic castration resistant prostate cancer (mCRPC). (ASCO 2024) - P1b/2 | "In combination with enza, the established MTD of FOR46 with primary G-CSF prophylaxis was safe and demonstrated preliminary evidence of efficacy. 89 Zr-DFO-YS5 PET demonstrates tumor-specific uptake and will be employed in the ongoing Phase 2 portion of the study as a potential predictive biomarker of response."

Clinical • Combination therapy • Metastases • P1 data • Alopecia • Cardiovascular • Fatigue • Genito-urinary Cancer • Heart Failure • Hematological Disorders • Immunology • Metastatic Castration-Resistant Prostate Cancer • Neutropenia • Oncology • Pain • Prostate Cancer • Solid Tumor • CD46

FibroGen Announces Presentation of Positive Interim Data from the Phase 1b Study of FG-3246 (FOR46) in Combination with Enzalutamide in Patients with Metastatic Castration Resistant Prostate Cancer (mCRPC) at the 2024 American Society of Clinical Oncology Annual Meeting (GlobeNewswire) - P1b/2 | N=36 | NCT05011188 | "The presentation includes data from 17 biomarker unselected patients in the dose escalation portion of the trial....The combination treatment demonstrated an encouraging preliminary estimate of median radiographic progression free survival (rPFS) of 10.2 months. The MTD was established at 2.1 mg/kg ABW, with primary G-CSF prophylaxis, in combination with enzalutamide 160 mg/day. The most frequent adverse events were consistent with other MMAE-based ADCs and included fatigue, weight loss, elevated transaminases, neutropenia, and peripheral neuropathy....The poster presentation...is scheduled for the poster session taking place on June 2, 2024..."

P1 data • Metastatic Castration-Resistant Prostate Cancer

FibroGen Reports First Quarter 2024 Financial Results (GlobeNewswire) - "Upcoming Milestones:...Oncology Pipeline: (i) Anticipate initiation of Phase 2 monotherapy dose optimization study of FG-3246 in mCRPC in 2H 2024; (ii) Anticipate filing of an IND for FG-3175 (anti-CCR8 mAb) in 2025."

New P2 trial • Metastatic Castration-Resistant Prostate Cancer

FibroGen Announces Topline Results from Phase 1 Monotherapy Study of FG-3246 in Patients with Metastatic Castration-Resistant Prostate Cancer (GlobeNewswire) - P1 | N=56 | NCT03575819 | Sponsor: Fortis Therapeutics, Inc. | "The completed Phase 1 trial includes a total of 56 patients from the dose-escalation and dose-expansion cohorts....FG-3246 demonstrated efficacy in adenocarcinoma selected cohorts receiving biologically active doses of FG-3246 at ≥ 1.2 mg/kg in heavily pre-treated, biomarker unselected patients: Median radiographic progression free survival of 8.7 months; PSA50 response in 36% of patients; Confirmed radiographic objective response rate of 20%, with a median duration of response of 7.5 months....Company plans to meet with the U.S. Food and Drug Administration (FDA) to discuss development pathway; Phase 2 initiation is anticipated in 2H 2024....We are also excited about potential combinations with FG-3246 and will be presenting investigator sponsored trial data of FG-3246 in combination with enzalutamide at the upcoming ASCO 2024 annual meeting."

New P2 trial • P1 data • P1/2 data • Metastatic Castration-Resistant Prostate Cancer

FibroGen Announces Clinical Data from Dose Escalation Phase 1b Study of FG-3246 (FOR46) in Combination with Enzalutamide in Patients with Metastatic Castration Resistant Prostate Cancer will be Presented at the 2024 American Society of Clinical Oncology Annual Meeting (GlobeNewswire) - "FibroGen...announced that clinical data from the dose escalation portion of the Phase 1b/2 study of FG-3246 in combination with enzalutamide in patients with metastatic castration resistant prostate cancer have been selected for a poster presentation at the 2024 American Society of Clinical Oncology (ASCO) Annual Meeting..."

P1 data • Metastatic Castration-Resistant Prostate Cancer

FibroGen To Host Part I of Virtual KOL Investor Event Series to Review Pamrevlumab Clinical Program in Pancreatic Cancer on February 13, 2024 (GlobeNewswire) - "FibroGen, Inc...announced it will host Part I of a virtual KOL investor event series on Tuesday, February 13, 2024 at 10:30 AM ET....The event will include information on the mechanism of action of pamrevlumab as well as a review of the pre-clinical and Phase 1/2 data for pamrevlumab and the two ongoing trials: the innovative Precision Promise Phase 2/3 trial being conducted by the Pancreatic Cancer Action Network (PanCAN) for metastatic pancreatic cancer, and the LAPIS Phase 3 trial in locally advanced pancreatic cancer. The second event in the series, to be scheduled at a later date, will include a review of the development program for FG-3246; a Phase 2 ready CD46 targeting antibody-drug conjugate (ADC) for the treatment of metastatic castration-resistant prostate cancer (mCRPC)."

Clinical • P1/2 data • Preclinical • Castration-Resistant Prostate Cancer • Gastrointestinal Cancer • Genito-urinary Cancer • Metastatic Castration-Resistant Prostate Cancer • Oncology • Pancreatic Cancer • Prostate Cancer • Solid Tumor

A Phase 1 Study of FOR46 in Patients With Metastatic Castration-Resistant Prostate Cancer (mCRPC) (clinicaltrials.gov) - P1 | N=56 | Completed | Sponsor: Fortis Therapeutics, Inc. | Active, not recruiting ➔ Completed

Trial completion • Genito-urinary Cancer • Metastatic Castration-Resistant Prostate Cancer • Oncology • Prostate Cancer • Solid Tumor • CD46