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FibroGen Announces Topline Results from Phase 1 Monotherapy Study of FG-3246 in Patients with Metastatic Castration-Resistant Prostate Cancer

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  • 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
  • FG-3246 demonstrated an acceptable safety profile; adverse events consistent with those observed in other antibody drug conjugate therapies with a MMAE payload
  • 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

SAN FRANCISCO, April 02, 2024 (GLOBE NEWSWIRE) — FibroGen, Inc.  (NASDAQ: NASDAQ:) today announced topline data from the Fortis (NYSE:) Therapeutics-sponsored Phase 1 study of FG-3246 (also known as FOR46), a potential first-in-class anti-CD46 antibody drug conjugate (ADC) with an MMAE-containing payload, in a dose-escalation and dose-expansion trial enrolling patients with metastatic castration-resistant prostate cancer (mCRPC) whose tumors have progressed on at least one androgen receptor-signaling inhibitor (ARSI).

We are delighted to showcase the latest encouraging clinical data from the FOR46-001 Phase 1 ADC trial, said Deyaa Adib, M.D., Chief Medical Officer of FibroGen. We observed a median radiographic progression free survival of 8.7 months in heavily pre-treated patients, who received biologically active doses of FG-3246 in the second line or later setting prior to chemotherapy. These Phase 1 data provide evidence of a favorable safety profile and promising clinical activity as further evidenced by prostate-specific antigen reduction of ‰¥ 50% and shrinking of measurable disease. We look forward to publishing the totality of the Phase 1 data as we advance the program further in the clinic.

In the Phase 1 dose-escalation portion of the study, ascending dose levels of FG-3246 were administered every 3 weeks. In the dose-expansion arm of the trial, patients were treated at the 2.7 mg/kg adjusted body weight dosing (AjBW) until disease progression. The endpoints were safety, tolerability, and anti-tumor activity as measured by the decline of prostate-specific antigen (PSA) from baseline, objective tumor response rate in patients with measurable disease, and radiographic progression free survival (rPFS).

The completed Phase 1 trial includes a total of 56 patients…

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