AC Immune Receives Second Milestone Payment Following Progress in Phase 2b ReTain Trial of ACI-35.030 in Preclinical Alzheimer's Disease
Prescreening rate of Phase 2b ReTain trial triggers clinical development milestone payment in September
Potentially registrational trial is targeting enrollment of approximately 500 participants with pre-symptomatic AD
FDA Fast Track designation granted in July for ACI-35.030 (now "JNJ-2056") for AD
Lausanne, Switzerland, September 17, 2024 – AC Immune SA (NASDAQ:ACIU), a clinical-stage biopharmaceutical company pioneering precision therapeutics for neurodegenerative diseases, today announced that it will receive the second ReTain-related milestone payment (CHF 24.6 million) under its agreement with Janssen Pharmaceuticals, Inc. (Janssen), a Johnson & Johnson company.
The milestone payment has been triggered by the rapid rate of prescreening in the potentially registrational Phase 2b ReTain trial investigating active-immunotherapy candidate ACI-35.030 (now called "JNJ-2056") to treat preclinical (pre-symptomatic) Alzheimer's disease (AD). With last December's milestone payment, this brings the total milestone payments received for ACI-35.030 related to this trial to CHF 40 million.
Dr. Andrea Pfeifer, CEO of AC Immune SA, commented: "This early milestone demonstrates that the medical community and members of the public believe, as we do, that second generation therapeutics for Alzheimer's disease, like our active immunotherapy targeting pathological phosphorylated-Tau protein (pTau), may provide an important benefit to those diagnosed early, prior to the development of disease symptoms. Early diagnosis and treatment are needed to combat neurodegeneration.
"This payment also re-affirms the quality and productivity of AC Immune's technology platforms and drug development capabilities. We have now received a total of approximately CHF 425 million in milestone and upfront payments from all of our collaboration deals to date, and there are outstanding potential milestone payments exceeding CHF 4.3 billion, plus royalties on potential sales. Importantly, in these challenging financial markets, this milestone payment adds to our already solid financial position, providing us with three years of cash for operations, in which time we expect to achieve several potentially transformational milestones."
JNJ-2056 received Fast Track designation from the U.S. Food and Drug Administration (FDA) in July, an important recognition of its differentiation and its potential value for patients. It is the second active immunotherapy from AC Immune to achieve this regulatory milestone, after ACI-24.060, which targets Abeta. AC Immune's PI-2620 Tau-PET diagnostic, which is in Phase 3 development, also received Fast Track designation this August.
ACI-35.030 has been shown in Phase 1b/2a clinical testing to induce an antibody response ...
