Acrivon Therapeutics to Host Virtual Investor Event to Review Positive Phase 2 Clinical Data of ACR-368 Presented at ESMO and Pipeline Progress, Including Clinical Candidate ACR-2316

Rhea-AI Summary

Acrivon Therapeutics (Nasdaq: ACRV) announced a virtual investor event on September 14, 2024, to review positive Phase 2 clinical data of ACR-368 presented at ESMO and pipeline progress. The event will highlight:

1. Updated ACR-368 clinical data in endometrial cancer from the ongoing registrational intent Phase 2b study

2. Updates on lead assets ACR-368, ACR-2316, and the AP3 platform

3. Previous data showed a 50% confirmed response rate across ovarian and endometrial cancer patients

4. Enrollment for endometrial cancer patients is progressing ahead of schedule

5. The study represents the first potential approval opportunity for ACR-368

The ESMO poster presentation details and webcast information are provided in the announcement.

Positive

• Phase 2 clinical data of ACR-368 shows positive results
• 50% confirmed response rate across ovarian and endometrial cancer patients
• Enrollment for endometrial cancer patients progressing ahead of schedule
• Potential first approval opportunity for ACR-368 in endometrial cancer
• Expansion of ACR-368 potential in other tumor types like squamous cell cancer

Negative

• None.

-Webcast investor event on September 14, 2024 at 9:00 a.m. ET

-ESMO poster presentation to provide updated ACR-368 clinical data in endometrial cancer

-Webcast to provide updates on its lead assets ACR-368, ACR-2316, and its AP3 platform

WATERTOWN, Mass., Sept. 09, 2024 (GLOBE NEWSWIRE) -- 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 announced that the company will host a virtual investor event to review ACR-368 clinical data that will be presented at a poster presentation at the European Society for Medical Oncology (ESMO) congress on September 14, 2024 in Barcelona, Spain, as well as other R&D updates. The poster presentation will contain updated data from the cohort of patients with endometrial cancer in the ongoing, registrational intent Phase 2b study of ACR-368.

“At our April 2024 R&D event we shared encouraging initial clinical data showing a confirmed response rate of 50% across ovarian and endometrial cancer patients, as well as initial validation of our response-predictive ACR-368 OncoSignature test,” said Peter Blume-Jensen, M.D., Ph.D., chief executive officer, president, and founder of Acrivon. “Enrollment is progressing ahead of schedule for patients with endometrial cancer, a new tumor type that we predicted to be particularly sensitive to ACR-368 with our AP3 platform, and hence we are accelerating this additional interim data disclosure at ESMO. We believe this ongoing registrational intent study for endometrial cancer represents the first potential approval opportunity for ACR-368. We continue enrollment in ovarian and bladder cancer cohorts, and are also enthusiastic about the potential of ACR-368 in other tumor types where it has shown activity, such as squamous cell cancer, and look forward to providing an update on those programs at a future date. In addition to ACR-368, we are also excited to share updates on our clinical candidate, ACR-2316, and the AP3 platform at the webcast on September 14.”

Poster Details

Title:	A Phase 2 study of ACR-368 in patients with endometrial carcinoma and prospective validation of OncoSignature patient selection (NCT05548296)
Session Category:	Gynecological Cancers
Session Date and Time:	Saturday, September 14, 2024; 9:00 a.m. – 5:00 p.m. CEST
Location:	Hall 6
Poster Number:	744P

A copy of the poster will be made available on the company’s website at https://acrivon.com/science/#publications-posters on Saturday, September 14, 2024 at or shortly after 3:00 a.m. ET to coincide with the start of the poster session.

Company Webcast
The company will host a live webcast on Saturday, September 14, 2024 at 9:00 a.m. ET. A link to the webcast can be found in the investor section of the company’s website at: https://ir.acrivon.com/news-events/events-presentations. A replay of the webcast will be available via the same link shortly following the event.

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 preclinical stage pipeline programs. These include ACR-2316, a potent, selective WEE1/PKMYT1 inhibitor designed for superior single-agent activity as demonstrated in preclinical studies against benchmark inhibitors, and 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.
alevy@acrivon.com

Alexandra Santos
asantos@wheelhouselsa.com

FAQ

What are the key findings from Acrivon Therapeutics' Phase 2 clinical data for ACR-368 (ACRV)?

Acrivon Therapeutics reported a 50% confirmed response rate for ACR-368 across ovarian and endometrial cancer patients in their Phase 2 clinical trial. The company also noted accelerated enrollment for endometrial cancer patients and potential expansion into other tumor types like squamous cell cancer.

When is Acrivon Therapeutics (ACRV) hosting its virtual investor event to review ACR-368 data?

Acrivon Therapeutics is hosting its virtual investor event on September 14, 2024, at 9:00 a.m. ET to review ACR-368 clinical data presented at ESMO and provide pipeline updates.

What will be presented at Acrivon Therapeutics' (ACRV) ESMO poster presentation for ACR-368?

Acrivon Therapeutics' ESMO poster presentation will contain updated data from the cohort of patients with endometrial cancer in the ongoing, registrational intent Phase 2b study of ACR-368.

What is the significance of ACR-368's potential approval for Acrivon Therapeutics (ACRV)?

The ongoing registrational intent study for endometrial cancer represents the first potential approval opportunity for ACR-368, which could be a significant milestone for Acrivon Therapeutics in advancing their precision medicine approach.