Full Press Release Details
Acrivon Therapeutics Reports Positive Endometrial Cancer Data from Ongoing
ACR-368 Registrational Intent Phase 2 Study at ESMO, Advancement of ACR-2316 into Clinic Ahead of Timelines, and Progress on its AP3 Interactome for Proprietary Data
- Confirmed overall response rate (ORR) = 62.5% (95% CI, 30.4-86.5)
observed in prospectively-selected ACR-368 OncoSignature-positive (BM+) patients with endometrial cancer
- Achieved statistically significant segregation of responders in BM+ vs BM- subgroups based
on OncoSignature patient selection (p-value = 0.009)
- ACR-368 endometrial cohort data maturing with all responders still on therapy; mDoR not yet reached (~6 months at time of data-cut)
- Endometrial cancer now anticipated to be the first tumor type with potential for ACR-368
accelerated regulatory approval
- IND clearance and initial sites activated ahead of timelines for ACR-2316 with first-in-human dosing anticipated in Q4 2024
- AP3 Interactome generating proprietary, actionable insights, leveraging in-house data and
delivering algorithm-based machine learning-enabled pathway and biomarker analyses
- Acrivon to host a webcast joined by
endometrial cancer key opinion leader Dr. Ramez N. Eskander today, Saturday, September 14 at 9:00 a.m. ET
WATERTOWN, Massachusetts, September 14, 2024 Acrivon Therapeutics, Inc. ( Acrivon or Acrivon
Therapeutics ) (Nasdaq: ACRV), a clinical stage precision medicine company utilizing its Acrivon Predictive Precision Proteomics (AP3) platform for the discovery, design, and development of drug candidates through a mechanistic match to
patients whose disease is predicted sensitive to the specific treatment, today presented additional positive clinical data at ESMO from the ongoing registrational intent, multicenter Phase 2 trial of ACR-368
in patients with locally advanced or metastatic, recurrent endometrial cancer. The company has also disclosed that the Investigational New Drug (IND) application for its next clinical candidate, ACR-2316, has
been cleared by the FDA with initial clinical sites now activated, and first-in-human dosing for the Phase 1 study expected in the fourth quarter of 2024.
We are very excited to provide several significant, positive updates across our rapidly advancing clinical pipeline since our last R&D event in
April, said Peter Blume-Jensen, M.D., Ph.D., chief executive officer, president, and founder of Acrivon. First, at ESMO earlier today, we presented an updated interim efficacy and safety data cut of our registrational intent
ACR-368 Phase 2 study, which showed a confirmed ORR of 62.5% in endometrial cancer patients. Notably, endometrial cancer is a tumor type that we predicted to be sensitive to single agent ACR-368 with our AP3 indication finding screening approach which we have now confirmed in the clinic. The maturing data is particularly encouraging as the lower bound of the 95% confidence interval is now 30%, above
our targeted goal for this metric. Moreover, while median duration of response has not yet been reached, it is now approximately 6 months with all responding patients on therapy at time of data cut-off. Given
the strength of the data we believe endometrial cancer might provide the first potential approval opportunity for ACR-368. We are actively evaluating potential confirmatory trial designs, including front line,
for a potential future label expansion. We are also excited to disclose that the FDA has cleared the IND for our second clinical program, ACR-2316, well ahead of original timeline projections. Clinical trial
sites have been activated and are now actively screening patients for enrollment into a Phase 1 study. Today s update further strengthens the validation of our prospective OncoSignature patient selection method and of our differentiated AP3
platform delivering actionable data across discovery and development.
ACR-368 Updates and Highlights
AP3 Interactome Updates
Company Webcast and KOL Participation
host a webcast today, Saturday, September 14 at 9:00 a.m. ET to further discuss these data and pipeline updates. A link to the webcast can be found on the investors page of www.acrivon.com.
In addition to company executives, Ramez N. Eskander, M.D., assistant professor of Obstetrics, Gynecology, and Reproductive Sciences, University of
California, San Diego, CA, a key opinion leader in endometrial cancer will participate in the webcast. Dr. Eskander is the lead author on the influential paper Pembrolizumab plus Chemotherapy in Advanced Endometrial Cancer (N
Engl J Med (2023) 388(23):2159-2170).
About Acrivon Therapeutics
Acrivon is a clinical stage biopharmaceutical company developing precision oncology medicines that it matches to patients whose tumors are predicted to be
sensitive to each specific medicine by utilizing Acrivon s proprietary proteomics-based patient responder identification platform, Acrivon Predictive Precision Proteomics, or AP3. The AP3 platform is engineered to measure compound-specific
effects on the entire tumor cell protein signaling network and drug-induced resistance mechanisms in an unbiased manner. These distinctive capabilities enable AP3 s direct application for drug design optimization for monotherapy activity, the
identification of rational drug combinations, and the creation of drug-specific proprietary OncoSignature companion diagnostics that are used to identify the patients most likely to benefit from Acrivon s drug candidates. Acrivon is currently
advancing its lead candidate, ACR-368 (also known as prexasertib), a selective small molecule inhibitor targeting CHK1 and CHK2 in a potentially registrational Phase 2 trial across multiple tumor types. The
company has received Fast Track designation from the Food and Drug Administration, or FDA, for the investigation of ACR-368 as monotherapy based on OncoSignature-predicted sensitivity in patients with
platinum-resistant ovarian or endometrial cancer. Acrivon s ACR-368 OncoSignature test, which has not yet obtained regulatory approval, has been extensively evaluated in preclinical studies, including in
two separate, blinded, prospectively-designed studies on pretreatment tumor biopsies collected from past third-party Phase 2 trials in patients with ovarian cancer treated with ACR-368.
The FDA has granted Breakthrough Device designation for the ACR-368 OncoSignature assay for the identification of
ovarian cancer patients who may benefit from ACR-368 treatment. In addition to ACR-368, Acrivon is also leveraging its proprietary AP3 precision medicine platform for
developing its co-crystallography-driven, internally-discovered pipeline programs. These include ACR-2316, the company s second clinical stage asset, a potent,
selective WEE1/PKMYT1 inhibitor designed for superior single-agent activity as demonstrated in preclinical studies against benchmark inhibitors. The company is also progressing internally- developed preclinical programs, including a cell cycle
program with an undisclosed target.
Forward-Looking Statements
This press release includes certain disclosures that contain forward-looking statements within the meaning of the Private Securities
Litigation Reform Act of 1995 about us and our industry that involve substantial risks and uncertainties. All statements other than statements of historical facts contained in this press release, including statements regarding our future results of
operations or financial condition, preclinical and clinical results, business strategy and plans and objectives of management for future operations, are forward-looking statements. In some cases, you can identify forward-looking statements because
they contain words such as anticipate, believe, contemplate, continue, could, estimate, expect, intend, may, plan,
potential, predict, project, should, target, will, or would or the negative of these words or other similar terms or expressions. Forward-looking statements are
based on Acrivon s current expectations and are subject to inherent uncertainties, risks and assumptions that are difficult to predict. Factors that could cause actual results to differ include, but are not limited to, risks and uncertainties
that are described more fully in the section titled Risk Factors in our reports filed with the Securities and Exchange Commission. Forward-looking statements contained in this press release are made as of this date, and Acrivon
undertakes no duty to update such information except as required under applicable law.
Investor and Media Contacts:
Adam D. Levy, Ph.D., M.B.A.