Acrivon Therapeutics Announces Positive ACR-368 Phase 2b Endometrial Cancer Clinical Data with EU Expansion to Accelerate Enrollment, Initial ACR-2316 Clinical Data, and ACR-6840, its Next AP3-Enabled Development Candidate, Targeting CDK11
Rhea-AI Summary
Acrivon Therapeutics (Nasdaq: ACRV) reported interim clinical progress across its pipeline. Key Phase 2b ACR-368 EDC data show a 39% ORR overall and 44% ORR in subjects with ≤2 prior lines of therapy, with a confirmed ORR 67% in BM+ serous endometrial cancer (N=12) and 52% cORR in all serous subjects (N=23). Arm 3 (ACR-368 + ultra-low dose gemcitabine) will enroll up to 90 serous subjects without biopsy, targeting completion in Q4 2026 and EU sites to start in Q1 2026. Company submitted a Phase 3 protocol for ACR-368+anti-PD-1 and expects global readiness mid-2026. ACR-2316 Phase 1 (N=33) established dose regimens with tumor shrinkage in 9/20 evaluable patients and confirmed PR in endometrial cancer. ACR-6840 (CDK11) IND planned Q4 2026. Cash, cash equivalents and investments ~$119M as of 12/31/2025, funding into Q2 2027.
Positive
- ACR-368 overall ORR of 39% (EDC extract as of Dec 4, 2025)
- Confirmed ORR 67% in BM+ serous endometrial cancer (N=12)
- Arm 3 planned enrollment up to 90 biopsy‑independent serous subjects targeting completion in Q4 2026
- ACR-2316 showed tumor shrinkage in 9/20 evaluable patients and a confirmed PR in endometrial cancer
- Preliminary cash, cash equivalents and investments of ~$119M (12/31/2025) funding operations into Q2 2027
Negative
- Key efficacy subgroup sizes are small (e.g., BM+ serous cORR based on N=12), limiting statistical certainty
- Phase 3 confirmatory protocol submitted to FDA but no further feedback received to date
- Preliminary cash figure is unaudited and subject to closing adjustments, which may change runway expectations
News Market Reaction
On the day this news was published, ACRV declined 34.58%, reflecting a significant negative market reaction. Argus tracked a peak move of +19.9% during that session. Argus tracked a trough of -51.3% from its starting point during tracking. Our momentum scanner triggered 77 alerts that day, indicating high trading interest and price volatility. This price movement removed approximately $49M from the company's valuation, bringing the market cap to $93M at that time. Trading volume was exceptionally heavy at 51.1x the daily average, suggesting significant selling pressure.
Data tracked by StockTitan Argus on the day of publication.
Key Figures
Market Reality Check
Peers on Argus
Momentum scanner did not flag peers, but several related biotech names (e.g., PSTV +6.63%, RENB +19.33%) were up, suggesting stock-specific focus on ACRV rather than a coordinated sector move.
Historical Context
| Date | Event | Sentiment | Move | Catalyst |
|---|---|---|---|---|
| Jan 06 | Update webcast notice | Positive | +31.4% | Announced timing and scope of upcoming ACR-368 and ACR-2316 data webcast. |
| Dec 17 | Clinical update preview | Positive | -4.5% | Planned January 2026 clinical updates and new AP3-driven candidate disclosure. |
| Dec 17 | Clinical update announcement | Positive | -4.5% | Outlined upcoming ACR-368/ACR-2316 data and confirmatory Phase 3 planning. |
| Nov 13 | Q3 2025 earnings | Negative | -9.2% | Reported ongoing net loss with pipeline progress and updated cash runway. |
| Oct 22 | Preclinical platform data | Positive | -2.5% | Presented AP3 platform and ACR-2316 preclinical data with early clinical activity. |
Clinical and platform updates have often seen muted or negative price reactions, with the notable exception of the recent webcast scheduling headline that preceded a strong gain.
Over the past few months, Acrivon has repeatedly highlighted progress in its AP3-driven oncology pipeline. Clinical-trial communications on Dec 17, 2025 and the AACR-NCI-EORTC preclinical/clinical data on Oct 22, 2025 were followed by modest share declines despite constructive content. The Q3 2025-11-13 earnings report showed reduced net loss and continued ACR-368 and ACR-2316 advancement, yet the stock fell. In contrast, the Jan 6, 2026 announcement of today’s detailed clinical update drove a 31.44% move, framing this new Phase 2/Phase 1 data and candidate nomination as a key follow-through event in that story.
Market Pulse Summary
The stock dropped -34.6% in the session following this news. A negative reaction despite positive response rates and early ACR-2316 activity would fit prior patterns where constructive trial or platform news on Dec 17, 2025 and Oct 22, 2025 preceded declines. The stock already traded well below its $8 52-week high, and expectations were raised by the 31.44% move after the Jan 6 webcast notice. Execution risk around Phase 2/3 plans, timelines into 2026, and dilution concerns could all weigh even when clinical metrics improve.
Key Terms
overall response rate medical
ORR medical
cORR medical
PD-1 medical
PD-L1 medical
NSCLC medical
neutropenia medical
AI-generated analysis. Not financial advice.
Electronic data capture (EDC) extract from the ongoing ACR-368 registrational-intent Phase 2b monotherapy trial in OncoSignature-positive (BM+) subjects with endometrial cancer (EC) showed
Analysis of data from all-comer subjects with serous subtype and ≤2 prior lines of therapy, a high unmet need population, showed a confirmed ORR (cORR) of
Arm 3 is enrolling up to 90 subjects with serous subtype and ≤2 prior lines of therapy, without requirement for a tumor biopsy, for treatment with ACR-368 plus ultra-low dose gemcitabine (ULDG) as a tumor sensitizer and enrollment completion expected in fourth quarter 2026
Based on preclinical AP3 data showing strong synergy between ACR-368 and anti-PD-L1, company has submitted a Phase 3 confirmatory protocol to the FDA for ACR-368 plus anti-PD-1 therapy in frontline EC subjects; global trial readiness expected mid-2026
Initial data from Phase 1 dose escalation (N=33) for ACR-2316, a potential first-in-class WEE1/PKMYT1 inhibitor, showed favorable tolerability; two weekly oral dosing regimens (160 mg QD, 3d on/4d off and 240 mg QD, 2d on/5d off) established with a bi-weekly regimen initiated
Tumor shrinkage was observed at ≥120 mg dose level in 9/20 subjects, including a confirmed PR in EC, and unconfirmed PRs in SCLC and sqNSCLC, two tumor types predicted sensitive by AP3, not previously shown sensitive to WEE1 inhibitors in development
ACR-6840, a potential first-in-class AP3-derived oral CDK11 inhibitor, nominated as next preclinical development candidate, with IND submission planned for fourth quarter 2026
Company to hold video conference call and webcast today at 8:30 a.m. ET
WATERTOWN, Mass., Jan. 08, 2026 (GLOBE NEWSWIRE) -- Acrivon Therapeutics, Inc. (“Acrivon” or “Acrivon Therapeutics”) (Nasdaq: ACRV), a clinical stage biotechnology company discovering and developing precision medicines utilizing its proprietary Generative Phosphoproteomics AP3 (Acrivon Predictive Precision Proteomics) platform designed to interpret and quantify global compound-specific, drug-regulated effects in the intact cell which is deployed for rational drug design and predictive clinical development, today announced significant progress across its pipeline, including updates regarding the Phase 2 ACR-368 program, initial clinical data from the ACR-2316 Phase 1 study, and the nomination of Acrivon’s next AP3-enabled preclinical development candidate, ACR-6840, a potential first-in-class, oral CDK11 inhibitor.
“We are pleased with tangible progress accelerating across multiple high-value opportunities,” said Peter Blume-Jensen, M.D., Ph.D., chief executive officer, president, and co-founder of Acrivon. “We are particularly excited by the observation from our ongoing ACR-368 Phase 2 trial that subjects with serous endometrial cancer with up to two prior lines of therapy are showing over
“About a third of all second- and third-line endometrial cancer cases are of serous subtype and represent a challenging patient population,” said Mansoor Raza Mirza, M.D., chief medical officer of Acrivon. “Moreover, incorporating feedback from a Type B meeting in June 2025, we have recently submitted our Phase 3 confirmatory study protocol to the FDA for ACR-368 in combination with anti-PD-1 therapy in frontline endometrial cancer patients, building on the strong synergy observed preclinically between these two agents.”
“We are also very encouraged by the initial clinical data for ACR-2316, including the favorable tolerability profile and observed tumor shrinkage across multiple AP3-prioritized tumor types, including partial responses in heavily pretreated subjects with endometrial cancer, SCLC and squamous NSCLC,” continued Dr. Blume-Jensen. “Finally, we continue to demonstrate the value of our AP3 platform with the nomination from our cell cycle program of ACR-6840, a potential first-in-class CDK11 inhibitor development candidate, with IND submission expected in the fourth quarter of 2026. We believe these achievements represent transformative progress toward delivering meaningful new precision medicine treatment options for cancer patients with high unmet need.”
Additional Details
ACR-368: Potential First-in-Class CHK1 / CHK2 Inhibitor
- In Arm 1 of the ACR-368 Phase 2b registrational-intent trial (monotherapy BM+ subjects), an updated interim analysis (EDC data extract as of December 4, 2025) showed a ORR of
39% *. In subjects with ≤2 prior lines of therapy (LoT), the ORR was44% . Based on data that showed higher response rates in subjects with serous EC (also called uterine serous carcinoma) across Arm 1 and Arm 2 (ACR-368 with ULDG in BM- subjects), Arm 3 will now focus exclusively on subjects with serous cancer and ≤2 prior LoT.- Updated interim analysis of data showed a cORR of
67% in BM+ subjects (N=12) with serous EC - Interim analysis across both BM+ and BM- subjects showed a cORR of
52% (N=23) in serous subjects versus22% (N=37) in non-serous EC subjects; all subjects in this analysis received up to two prior LoT, including chemotherapy and anti-PD-1 - Consistent with the higher cORR observed across all subjects with serous EC, BM levels were overall higher in this tumor type
- These results are consistent with serous tumors often being G1-S-deficient, leading to DNA damage repair stress and dependency on the G2-M checkpoint controlled by CHK1/CHK2
- Updated interim analysis of data showed a cORR of
- EU Clinical Trial Application for Arm 3 of the ongoing US multicenter, registrational-intent Phase 2b trial in serous subjects with ≤2 prior LoT and without requirement for a tumor biopsy has been submitted, with the selection of more than 20 sites across four major EU countries (Germany, Italy, France, and Spain). Initial patient enrollment in the EU is expected in the first quarter of 2026, with enrollment at previously activated US clinical sites continuing.
- Arm 3 evaluates ACR-368 combined with ULDG as a sensitizer in BM-unselected subjects with serous EC who have received up to two prior LoT without requirement for a tumor biopsy
- The company expects to complete enrollment in Arm 3 in the fourth quarter of 2026 (design of up to N=90 subjects, with potential for validation of clinical significance in as few as 40 subjects, including possibility of earlier interim analysis)
- On November 12, 2025, after incorporating feedback from a Type B meeting held earlier in 2025 with the FDA and based on strong rationale and preclinical studies demonstrating synergy between ACR-368 and anti-PD-L1, the company submitted the proposed protocol design for the planned Phase 3 confirmatory study evaluating ACR-368 in combination with an anti-PD-1 agent in frontline advanced/recurrent pMMR EC subjects. No further feedback has been received from FDA on the protocol design.
ACR-2316: Potential First-in-Class WEE1 / PKMYT1 Inhibitor
- A total of 33 patients were dosed across two weekly oral dosing schedules in the ongoing Phase 1 monotherapy dose-escalation study (EDC data extract as of December 22, 2025)
- Initial clinical data from the study has successfully established two weekly oral dosing regimens of 160 mg QD on a 3d on / 4d off and 240 mg QD 2d on / 5d off weekly administration schedules, with a favorable tolerability profile with transient, mechanism-based hematological adverse events, predominantly neutropenia
- A cohort aiming to establish a bi-weekly 2d on / 12d off dosing regimen has been initiated, based on projected enhanced single agent activity and to provide for further dosing flexibility in potential future combination studies
- Clinical activity observed at dose level 120 mg and above, with tumor shrinkage in 9 out of 20 evaluable patients, including a confirmed PR in a subject with EC and unconfirmed partial responses in subjects with SCLC and sqNSCLC, two tumor types which have not shown sensitivity to other clinical WEE1 or PKMYT1 inhibitors currently in development:
- A subject with high grade Mullerian EC (BRCA1/2 wt) enrolled at the 120 mg dose level, who had previously received prior platinum-based chemo and tamoxifen and second-line pembrolizumab-lenvatinib, had confirmed PR and was on therapy for 42 weeks
- A subject with SCLC (MSS) enrolled at the established 160 mg dose level, who had previously received cisplatin/durvalumab, second-line tarlatamab and radiation therapy, achieved an unconfirmed PR (
50% tumor shrinkage) at first scan (with subsequent scan showing further shrinkage (69% ) of target lesion, but progression of liver metastases in non-target lesions after the date of EDC extract) - A subject with squamous NSCLC (BRCA1 mutated) enrolled at the 240 mg dose level, but reduced to 200 mg in the first cycle, had previously received platinum-based chemo with durvalumab followed by three other immune therapies. This subject achieved an unconfirmed PR (which was confirmed in a subsequent scan after the date of EDC extract)
- The trial continues to focus on selected, AP3-prioritized solid tumor types
ACR-6840: Potential First-in-Class CDK11 Inhibitor
- ACR-6840, a potential first-in-class CDK11 inhibitor, nominated as the next development candidate from company’s AP3-driven cell cycle program, with several promising back-up series also identified
- CDK11 is a challenging but compelling target with multiple isoforms and broad cell cycle regulatory roles, including transcription regulation, pre-mRNA splicing, and mitosis. ACR-6840 was rationally designed using the AP3 platform to achieve optimal on-target pathway effects
- IND submission anticipated in the fourth quarter of 2026
Anticipated Upcoming Milestones
- Initiate enrollment for the ongoing Arm 3 of the ACR-368 Phase 2 trial in EU in Q1 2026
- Provide additional update on Arm 1 and initial clinical data from Arm 3 of the ACR-368 Phase 2 trial in mid-2026
- Achieve readiness for Phase 3 confirmatory trial for ACR-368 in combination with PD-1 therapy in mid-2026
- Complete enrollment (planned N = 90 subjects) in the biopsy-independent Phase 2 Arm 3 trial for ACR-368 combined with ULDG as a sensitizer in Q4 2026
- Report additional ACR-2316 Phase 1 clinical data in weekly and bi-weekly dosing regimens and transition into dose expansion in select tumor types in 1H 2026
- Submit IND to FDA for ACR-6840 in Q4 2026
- Initiate additional internal programs utilizing AP3 platform in 2H 2026
As of December 31, 2025, the company had preliminary, unaudited cash, cash equivalents and investments of approximately
The cash, cash equivalents and investment amount is preliminary and are subject to completion of financial closing procedures. As a result, these amounts may differ materially from the amounts that will be reflected in the company’s consolidated financial statements for the quarter and year ended December 31, 2025.
The company will host an investor conference call and webcast today at 8:30 a.m. ET. The event can be accessed 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.
About Acrivon Therapeutics
Acrivon is a clinical stage biopharmaceutical company discovering and developing precision medicines utilizing its proprietary Generative Phosphoproteomics AP3 platform. The platform allows the company to interpret and quantify compound specific, drug-regulated pathway activity levels inside the intact cell in an unbiased manner, yielding terabytes of proprietary data and delivering rapid, actionable insights. The Generative Phosphoproteomics AP3 platform is comprised of a growing suite of powerful, internally-developed tools, including the AP3 Data Portal, converting multimodal data into structured data for generative AI analyses, the AP3 Kinase Substrate Relationship Predictor and the AP3 Interactome. These distinctive capabilities enable the company to go beyond the limitations of traditional drug discovery, as well as current AI-based target-centric drug discovery, and rapidly design highly differentiated compounds with desirable pathway effects through intracellular protein network analyses and advance these agents into the clinic for streamlined development.
Acrivon is currently advancing its lead program, ACR-368 (also known as prexasertib), a selective small molecule inhibitor targeting CHK1 and CHK2 in a potentially registrational Phase 2 trial for endometrial cancer. The company has received Fast Track designation from the Food and Drug Administration, or FDA, for the investigation of ACR-368 as a monotherapy based on OncoSignature-predicted sensitivity in patients with endometrial cancer. The FDA has granted a Breakthrough Device designation for the ACR-368 OncoSignature assay for the identification of patients with endometrial cancer who may benefit from ACR-368 treatment.
In addition to ACR-368, Acrivon is also leveraging its proprietary Generative Phosphoproteomics AP3 platform for developing its co-crystallography-driven, internally discovered pipeline programs. These include ACR-2316, the company’s second clinical stage asset, a novel, potent, selective WEE1/PKMYT1 inhibitor designed for superior single-agent activity through strong activation of not only CDK1 and CDK2, but also of PLK1 to drive pro-apoptotic cell death, as observed in preclinical studies against benchmark inhibitors. The Phase 1 trial of ACR-2316 is advancing, with weekly dosing regimens established. Initial data has shown a favorable tolerability profile limited to transient, mechanism-based hematological adverse events, predominantly neutropenia and initial clinical activity across AP3-selected solid tumor types, including PRs in endometrial cancer, as well as SCLC and sqNSCLC, two tumor types which have not shown sensitivity to other clinical WEE1 or PKMYT1 inhibitors currently in development. In addition, the company is advancing ACR-6840, an internally discovered development candidate targeting CDK11.
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 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
*All response rates by RECIST v1.1 and best of BICR/ investigator assessment
FAQ
What were the ACR-368 interim efficacy results announced on January 8, 2026 for ACRV?
When will Acrivon (ACRV) begin EU enrollment for Arm 3 of the ACR-368 Phase 2 trial?
What is the planned timeline for Acrivon’s Phase 3 readiness for ACR-368 plus PD-1 therapy?
What initial clinical activity was reported for ACR-2316 in the Jan 8, 2026 update?
When does Acrivon plan to submit an IND for ACR-6840 (CDK11) and what is its status?
How long is Acrivon’s reported cash runway based on the Jan 8, 2026 release?
