SAN DIEGO, CA, USA I August 8, 2016 I Pfenex Inc. (NYSE MKT: PFNX) announced today that the company will regain the full rights to PF582, a biosimilar candidate to Lucentis®, following our partner’s strategic review of the current therapeutic focus of its biosimilar pipeline.
“With Pfenex regaining the rights to PF582 we are announcing the PF582 phase 1/2 safety and efficacy data which we believe highlights the significant value of the program,” stated Bertrand C. Liang, chief executive officer of Pfenex. “We will consider strategic options for PF582 following the expeditious transition of the full development program back to Pfenex. Pfenex’s development capabilities, leveraging our Pfenex Expression Technology® platform, has allowed us to advance a diverse portfolio of product candidates, including PF582, which we believe will create significant value for our shareholders. We look forward to providing key updates on our pipeline progress throughout the year.”
Phase 1/2 PF582 Results
Pfenex enrolled a total of 25 VEGF-inhibitor naïve patients with neovascular age-related macular degeneration (AMD) in the PF582 phase 1/2 trial (13 received PF582, including 1 sentinel patient who received open label PF582, 12 received Lucentis). All patients received 3 monthly intravitreal injections. The primary endpoint of the study was safety and tolerability of PF582 compared to that of Lucentis in patients with neovascular AMD.
With respect to safety, there were no meaningful differences in intra-ocular pressure between PF582 and Lucentis at any of the timepoints (Figure 1). Additionally, there were no imbalances in local or systemic adverse events and no unexpected safety or tolerability findings in the population studied.
The efficacy and pharmacodynamic results indicated that there were no meaningful differences in best corrected visual acuity (Figure 2) and the decreases in central retinal thickness (Figure 3) between PF582 and Lucentis at any of the timepoints were also similar.
The immunogenicity results (Figure 4) showed comparable anti-drug antibody findings between PF582 and Lucentis throughout the three month study period.
This first-in-human study met its primary objective of demonstrating similar safety and tolerability between PF582 and Lucentis. Additionally, it demonstrated consistent pharmacological activity between PF582 and Lucentis.
View photos
Figure 1: No significant differences in intra-ocular pressure
View photos
Figure 2: No significant differences in best corrected visual acuity (BCVA)
View photos
Figure 3: Comparable decreases in central retinal thickness
Pfenex Inc. is a clinical-stage biotechnology company engaged in the development of biosimilar therapeutics and high-value and difficult to manufacture proteins. The company’s lead product candidate is PF582, a biosimilar candidate to Lucentis (ranibizumab), for the potential treatment of patients with retinal diseases. Pfenex has leveraged its Pfēnex Expression Technology® platform to build a pipeline of product candidates and preclinical products under development including other biosimilars, as well as vaccines, therapeutic equivalents to reference listed drug products, and next generation biologics.
SAN DIEGO, CA, USA I August 8, 2016 I Pfenex Inc. (NYSE MKT: PFNX) announced today that the company will regain the full rights to PF582, a biosimilar candidate to Lucentis®, following our partner’s strategic review of the current therapeutic focus of its biosimilar pipeline.
“With Pfenex regaining the rights to PF582 we are announcing the PF582 phase 1/2 safety and efficacy data which we believe highlights the significant value of the program,” stated Bertrand C. Liang, chief executive officer of Pfenex. “We will consider strategic options for PF582 following the expeditious transition of the full development program back to Pfenex. Pfenex’s development capabilities, leveraging our Pfenex Expression Technology® platform, has allowed us to advance a diverse portfolio of product candidates, including PF582, which we believe will create significant value for our shareholders. We look forward to providing key updates on our pipeline progress throughout the year.”
Phase 1/2 PF582 Results
Pfenex enrolled a total of 25 VEGF-inhibitor naïve patients with neovascular age-related macular degeneration (AMD) in the PF582 phase 1/2 trial (13 received PF582, including 1 sentinel patient who received open label PF582, 12 received Lucentis). All patients received 3 monthly intravitreal injections. The primary endpoint of the study was safety and tolerability of PF582 compared to that of Lucentis in patients with neovascular AMD.
With respect to safety, there were no meaningful differences in intra-ocular pressure between PF582 and Lucentis at any of the timepoints (Figure 1). Additionally, there were no imbalances in local or systemic adverse events and no unexpected safety or tolerability findings in the population studied.
The efficacy and pharmacodynamic results indicated that there were no meaningful differences in best corrected visual acuity (Figure 2) and the decreases in central retinal thickness (Figure 3) between PF582 and Lucentis at any of the timepoints were also similar.
The immunogenicity results (Figure 4) showed comparable anti-drug antibody findings between PF582 and Lucentis throughout the three month study period.
This first-in-human study met its primary objective of demonstrating similar safety and tolerability between PF582 and Lucentis. Additionally, it demonstrated consistent pharmacological activity between PF582 and Lucentis.
View photos
Figure 1: No significant differences in intra-ocular pressure
View photos
Figure 2: No significant differences in best corrected visual acuity (BCVA)
View photos
Figure 3: Comparable decreases in central retinal thickness
Pfenex Inc. is a clinical-stage biotechnology company engaged in the development of biosimilar therapeutics and high-value and difficult to manufacture proteins. The company’s lead product candidate is PF582, a biosimilar candidate to Lucentis (ranibizumab), for the potential treatment of patients with retinal diseases. Pfenex has leveraged its Pfēnex Expression Technology® platform to build a pipeline of product candidates and preclinical products under development including other biosimilars, as well as vaccines, therapeutic equivalents to reference listed drug products, and next generation biologics.
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