Acrivon Therapeutics Inc (ACRV)

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“Today we present initial clinical data from our ongoing Phase 2 clinical trial which we believe highlights the power of our next generation proteomics-based AP3 precision medicine platform,” said Peter Blume-Jensen, M.D., Ph.D., chief executive officer, president, and founder of Acrivon Therapeutics. “For the first time, we share statistically significant prospective validation of our AP3 patient selection approach via our ACR-368 OncoSignature assay, which demonstrated the ability to effectively identify cancer patients whose tumors are likely to respond to ACR-368 monotherapy treatment. We are extremely gratified to not only confirm the ability to identify and enrich for patient responders with ovarian cancer, but also for patients with endometrial cancer, a new tumor type identified and predicted to be sensitive to ACR-368 by our AP3 platform prior to clinical trial initiation.”

“Today’s R&D event provides us an opportunity to present the compelling preclinical data of our AP3-based, rationally-designed ACR-2316 dual WEE1/PKMYT1 inhibitor,” said Kristina Masson, Ph.D., M.B.A., co-founder and executive vice president of business operations at Acrivon Therapeutics, Inc. and president and CEO of the company´s research subsidiary Acrivon AB. “We are excited to announce our accelerated timelines for IND filing, now expected in the third quarter with potential clinical study initiation now anticipated in the fourth quarter of this year. We believe this potential first-in-class asset, which is specifically designed for superior single-agent activity as demonstrated in preclinical studies against benchmark inhibitors, has the potential to address significant unmet treatment needs against a broad range of tumors in patients with limited treatment options.”

Company Provides Program and Data Highlights:

An overview of the broad, actionable scientific capabilities and clinically demonstrated deliverables of the AP3 platform
Initial ACR-368 clinical data in patients with ovarian or endometrial cancers (n=26; 10 OncoSignature-positive and 16 OncoSignature-negative) in the ongoing registrational-intent Phase 2b trial are being presented (data cut as of April 1, 2024).
A confirmed ORR (per RECIST 1.1) of 50% was observed in the prospective cohort of OncoSignature-positive patients who were efficacy-evaluable. All confirmed responders continue to be on treatment, median duration of response (DoR) has not yet been reached. Notably, endometrial cancer is a new tumor type with significant unmet medical need that was identified and predicted to be sensitive to ACR-368 by AP3 indication screening.
Initial, prospective validation of the AP3-based ACR-368 OncoSignature assay demonstrating its ability to identify ovarian and endometrial patients sensitive to ACR-368 monotherapy in the ongoing clinical trial, with clear segregation of RECIST responders in the OncoSignature-positive (50% confirmed ORR in 10 patients) versus OncoSignature-negative (0% ORR in 16 patients) arms (p-value=0.0038).
In the OncoSignature-negative arm with ovarian or endometrial cancers, encouraging signs of clinical activity were observed in response to ACR-368 with ultra-low dose gemcitabine at the recommended Phase 2 combination dose, with 8 out of 16 patients achieving stable disease.
Consistent with past trials, the ACR-368 treatment-related adverse event profile was predominantly reversible and transient with only mechanism-based, hematological adverse events.
ACR-2316, a potential first-in-class, potent WEE1/PKMYT1 inhibitor continues to advance rapidly with IND filing now expected in Q3 2024 (vs. previous guidance of Q4 2024) and the initiation of a clinical trial is anticipated in Q4 2024. ACR-2316 is uniquely designed by AP3 for superior single-agent activity and to overcome limitations of current WEE1 inhibitors and PKMYT1 inhibitors.
A preview of the AP3 Interactome, which is a proprietary, machine-learning-enabled interactive platform used to uncover actionable drug-induced pathway effects across all studies.
A live and recorded webcast of the event will be available through a link on the Events & Presentations page within the investor section of the company’s website at https://ir.acrivon.com/news-events/events-presentations. The webcast will be available for at least 30 days following the event.