February 14, 2021

Impact: High

During its Q4 2021 earnings call, Prothena gave an update on its prasinezumab clinical program for Parkinson’s disease. During the clinical overview, Prothena highlighted that prasinezumab specifically targets the C-terminus of alpha-synuclein and is the “first antibody to show significant slowing of motor progression and improvements in imaging biomarkers.” The company stated that preclinical studies had shown that targeting the N-terminus was suboptimal and proposed it as a potential hypothesis on why Biogen’s cinpanemab failed, a point later reiterated during the Q&A.

Prothena remains very encouraged by efficacy signals observed in its Phase 2 PASEDENA Part 1 study. Data from pre-specified exploratory subgroup analysis from the PASEDENA Part 1 study will be presented at the ADPD conference in March. Prothena expects Roche to present results from PASEDENA Part 2 at a future medical conference.

Roche is expected to initiate the Phase 2b study of prasinezumab in Parkinson’s disease in Q2 2021 with details to come in Q2 as well. Prothena will earn $60M clinical milestone payment upon dosing of first patient. Read more

February 3, 2021

Impact: High

Both Pfizer and Amgen provided updates on its BCMA bispecific programs in Q4/FY 2020 earnings calls on February 2.

  • Pfizer’s BCMAxCD3 bispecific, elranatamab (PF-06863135), received FDA Fast Track designation in late January for the treatment of multiple myeloma patients who are refractory to at least one proteasome inhibitor, one immunomodulatory drug and one CD38 antibody.
    • The potential registration-enabling phase 2 trial has been initiated and the first patient is expected to be dosed this month.
    • In the Q&A, when asked about differentiation of elranatamab in the competitive landscape, Pfizer emphasized the 83% response rate in a heavily pretreated population with a significant number of complete responses and a nice tolerability profile with the opportunity for best-in class.
      • “So although it’s filled with several entrants, I think we have an opportunity to aim for being absolutely in the first wave here and with a really nice best-in-class profile. We’re moving with first opportunity we see for accelerated approval in triple refractory patients that either have seen no prior BCMA-based treatment or have seen prior BCMA treatments such as ADC or CAR-T. So we are planning such cohorts to start soon with a potential for registration. And we’re moving into second and third line, and other combinations that are used in order to come to first and second-line opportunity.”
  • The phase 1 trial of Amgen’s BCMAxCD3, pavurutamab (AMG 701), has been paused while Amgen discusses protocol modification to optimize safety monitoring and mitigation with FDA.
    • This is the first time Amgen has communicated on this hold, despite a ClinicalTrials.gov update on December 18 stating that the trial was not recruiting.
    • Currently enrolled patients demonstrating benefit may continue to receive treatment and enrollment is expected to resume in H1 2021.
    • When asked about safety issues in the Q&A, Amgen remains “bullish” on its BiTE program and stated that “cytokine release syndrome is clearly the single challenge that sits before the entire field.”

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