AC Immune's Alzheimer's Drug JNJ-2056 Gets FDA Fast Track
Ticker: ACIU · Form: 6-K · Filed: Jul 25, 2024 · CIK: 1651625
| Field | Detail |
|---|---|
| Company | Ac Immune SA (ACIU) |
| Form Type | 6-K |
| Filed Date | Jul 25, 2024 |
| Risk Level | medium |
| Pages | 1 |
| Reading Time | 1 min |
| Sentiment | bullish |
Sentiment: bullish
Topics: FDA-designation, Alzheimer's, clinical-trial
TL;DR
FDA Fast Track for AC Immune's Alzheimer's drug JNJ-2056 targeting pTau in preclinical trials.
AI Summary
On July 25, 2024, AC Immune SA announced that its active-immunotherapy candidate, JNJ-2056 (formerly ACI-35.030), targeting phosphorylated Tau (pTau) for Alzheimer's disease, received Fast Track designation from the U.S. FDA. The company is currently recruiting participants for its Phase 2b clinical trial, ReTain, for individuals with preclinical Alzheimer's disease.
Why It Matters
This FDA designation could expedite the development and review of JNJ-2056, potentially bringing a new treatment option for preclinical Alzheimer's disease to patients sooner.
Risk Assessment
Risk Level: medium — While Fast Track designation is positive, the drug is still in early-stage clinical trials (Phase 2b) and faces significant development and regulatory hurdles.
Key Players & Entities
- AC Immune SA (company) — Registrant
- JNJ-2056 (drug_candidate) — Active-immunotherapy candidate
- ACI-35.030 (drug_candidate) — Previous name for JNJ-2056
- Tau protein (biomarker) — Target of JNJ-2056
- phosphorylated Tau (pTau) (biomarker) — Specific target of JNJ-2056
- U.S. Food and Drug Administration (FDA) (company) — Regulatory agency granting designation
- ReTain (clinical_trial) — Phase 2b trial name
- July 25, 2024 (date) — Date of press release
FAQ
What is the specific indication for JNJ-2056?
JNJ-2056 is targeting the pathologic form of the Tau protein, specifically phosphorylated Tau (pTau), for the treatment of preclinical Alzheimer's disease.
What is the significance of the Fast Track designation?
The Fast Track designation from the U.S. FDA is intended to expedite the development and review process for drugs that treat serious conditions and fill an unmet medical need.
What is the current stage of clinical development for JNJ-2056?
JNJ-2056 is currently in a Phase 2b clinical trial named ReTain, which is actively recruiting participants.
Who is being recruited for the ReTain trial?
The ReTain trial is recruiting participants with preclinical Alzheimer's disease, meaning individuals who have not yet shown clinical symptoms.
What was the previous name of the drug candidate JNJ-2056?
The drug candidate JNJ-2056 was previously known as ACI-35.030.
Filing Stats: 352 words · 1 min read · ~1 pages · Grade level 11.1 · Accepted 2024-07-25 08:00:06
Filing Documents
- dp215229_6k.htm (6-K) — 11KB
- dp215229_ex9901.htm (EX-99.1) — 16KB
- image_001.jpg (GRAPHIC) — 52KB
- 0000950103-24-010718.txt ( ) — 100KB
From the Filing
UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 6-K REPORT OF FOREIGN PRIVATE ISSUER PURSUANT TO RULE 13a-16 OR 15d-16 UNDER THE SECURITIES EXCHANGE ACT OF 1934 For the month of July, 2024 Commission file number: 001-37891 AC IMMUNE SA (Exact Name of Registrant as Specified in Its Charter) EPFL Innovation Park Building B 1015 Lausanne, Switzerland (Address of Principal Executive Offices) Indicate by check mark whether the registrant files or will file annual reports under cover of Form 20-F or Form 40-F. Form 20-F Form 40-F On July 25, 2024, AC Immune SA issued a press release announcing that its active-immunotherapy candidate, ACI-35.030 (now called JNJ-2056), targeting the pathologic form of the Tau protein, phosphorylated Tau (pTau), has received Fast Track designation from the U.S. Food and Drug Administration (FDA). The recently initiated Phase 2b clinical trial ReTain is currently recruiting participants with preclinical Alzheimer’s disease, where individuals have yet to show clinical symptoms. JNJ-2056 is being developed pursuant to a global license, development and commercialization agreement with Janssen Pharmaceuticals, Inc. (Janssen), a Johnson & Johnson company. The ReTain trial is fully funded and conducted by Janssen. A copy of the press release is attached as Exhibit 99.1 to this Report on Form 6-K. This Report on Form 6-K (other than Exhibit 99.1 hereto) shall be deemed to be incorporated by reference into the registration statements on Form F-3 (File Nos. 333-227016, 333-249655, 333-255576 and 333-277940) and Form S-8 (File Nos. 333-213865, 333-216539 and 333-233019) of AC Immune SA and to be a part thereof from the date on which this report is filed, to the extent not superseded by documents or reports subsequently filed or furnished. EXHIBIT INDEX Exhibit Number Description 99.1 Press Release dated July 25, 2024 SIGNATURE Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned, thereunto duly authorized. AC IMMUNE SA By: /s/ Andrea Pfeifer Name: Andrea Pfeifer Title: Chief Executive Officer By: /s/ Christopher Roberts Name: Christopher Roberts Title: Chief Financial Officer Date: July 25, 2024