Acrivon Therapeutics to Release ACR-368 and ACR-2316 Clinical Data on January 8
Acrivon Therapeutics will be providing ACR-368 and ACR-2316 clinical data and other updates via a press release at 7:30 a.m. ET, and conference call and webcast at 8:30 a.m. ET, both on Thursday, January 8. Topics will include: Updated interim ACR-368 clinical data from the ongoing registrational-intent Phase 2b study as well as an update on the additional recently initiated tumor biopsy-independent Phase 2b arm, and the planned confirmatory Phase 3 trial; Initial clinical data from the ongoing Phase 1 study of ACR-2316, a potential first- and best-in-class WEE1/PKMYT1 inhibitor, including safety data, dosing regimen, and early clinical activity across AP3-prioritized solid tumor types; Nomination of new preclinical development candidate, including target disclosure, for Acrivon's AP3-driven cell cycle program.
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- Executive Appointments: Oncolytics Biotech has appointed John McAdory as Executive Vice President of Strategy and Operations and Yujun Wu as Vice President, Head of Biostatistics, both bringing extensive experience in late-stage oncology trial execution and regulatory strategy to advance the company's registration-directed programs in gastrointestinal cancers.
- Clinical Data Breakthrough: The company reported that pelareorep achieved a 33% objective response rate in second-line KRAS-mutant microsatellite stable metastatic colorectal cancer patients when combined with standard chemotherapy, tripling the historical response rate of 6-11%, demonstrating significant efficacy in this difficult-to-treat population.
- FDA Alignment Success: Oncolytics has secured FDA alignment on its Phase 3 study design for pelareorep in first-line metastatic pancreatic cancer, positioning it to launch the only immunotherapy registration trial currently planned for this challenging therapeutic area, further solidifying its market position.
- Strategic Expansion: The company has also expanded its Scientific Advisory Board with globally recognized experts from Memorial Sloan Kettering Cancer Center and MD Anderson Cancer Center, aiming to accelerate clinical development across multiple indications and enhance overall R&D capabilities.
- Leadership Enhancement: Oncolytics Biotech has appointed John McAdory as Executive Vice President of Strategy and Operations and Yujun Wu as Vice President, Head of Biostatistics, both bringing extensive experience in late-stage oncology trial execution and regulatory strategy to advance the company's registration-directed programs in gastrointestinal cancers.
- Breakthrough Efficacy Data: The company reported that pelareorep achieved a 33% objective response rate in second-line KRAS-mutant microsatellite stable metastatic colorectal cancer patients when combined with standard chemotherapy, significantly surpassing the historical 6-11% response rate, indicating its potential in difficult-to-treat patient populations.
- FDA Designation Approval: Oncolytics secured FDA alignment on its Phase 3 study design for pelareorep in first-line metastatic pancreatic cancer, marking the initiation of the only immunotherapy registration trial planned for this challenging area, further solidifying its market position.
- Advisory Board Expansion: The company has expanded its Scientific Advisory Board by adding globally recognized experts from Memorial Sloan Kettering Cancer Center and MD Anderson Cancer Center, laying the groundwork for accelerated clinical development across multiple indications.

- FDA Approval: ScinoPharm Taiwan (TWSE:1789) received FDA approval for its Glatiramer Acetate Injection for treating adult multiple sclerosis patients, marking the company's first finished drug approval and paving the way for regulatory submissions in Europe and Asia for broader commercialization.
- Market Reaction: Following this announcement, ScinoPharm's stock price rose by 3.08% to NT$23.40 on January 8, 2025, reflecting positive market sentiment regarding the product's prospects.
- Clinical Trial Progress: The approval supports the company's competitiveness in the global market, as Glatiramer Acetate remains a key product despite revenue erosion from generics, highlighting its ongoing relevance in the biotech sector.
- Strategic Positioning: This approval not only strengthens ScinoPharm's position in the biopharmaceutical landscape but also lays the groundwork for future market expansions, demonstrating the company's commitment to innovative drug development.

- Stock Volatility: Acrivon Therapeutics shares plummeted 28.71% after the release of updated clinical trial results for ACR-368, dropping from an opening price of $2.95 to $2.10, indicating investors' heightened sensitivity to clinical outcomes.
- Clinical Results Analysis: Despite a promising overall confirmed response rate of 52% in patients with the serous subtype of endometrial cancer, mixed interpretations of the data led to shaken market confidence, adversely affecting stock performance.
- Trial Expansion Plans: Acrivon announced plans to expand the trial into the European Union to accelerate patient enrollment, a strategic move aimed at enhancing the trial's effectiveness and market acceptance, although the stock remains under pressure in the short term.
- Surge in Trading Volume: The trading volume significantly exceeded average levels, reflecting investors' strong reactions to the clinical results, highlighting the high volatility and uncertainty prevalent in the biotech sector.
- Clinical Trial Progress: In the ACR-368 Phase 2b registrational trial for endometrial cancer, the overall response rate (ORR) was reported at 39%, with a notable 44% ORR in patients with more than two prior therapies, indicating the drug's potential in refractory cases.
- Targeted Strategy: Following the analysis of response rates in serous endometrial cancer patients, Arm 3 of the trial will focus exclusively on subjects with ≤2 prior treatments, aiming to enhance the trial's effectiveness and specificity.
- New Drug Development Update: Initial clinical data from ACR-2316 shows a tumor shrinkage rate of 45% in patients with small cell lung cancer and squamous non-small cell lung cancer at doses of 120 mg and above, providing a positive clinical basis for future treatment regimens.
- Financial Overview: As of December 31, 2025, Acrivon reported approximately $119 million in cash and cash equivalents, expected to fund operations and capital expenditures into the second quarter of 2027, ensuring continued investment in R&D.
- Jobless Claims Increase: U.S. initial jobless claims rose by 8,000 to 208,000 for the week ending January 3, slightly below market expectations of 210,000, indicating ongoing labor market pressures that could affect economic recovery confidence.
- Productivity Gains: Nonfarm business sector labor productivity increased by 4.9% in Q3, following a revised 4.1% gain in the previous quarter, suggesting progress in efficiency improvements that may support future economic growth.
- Unit Labor Costs Decline: Unit labor costs in the nonfarm business sector fell by 1.9% in Q3, contrary to market expectations of a 1.0% increase, indicating successful cost control by businesses that could bolster profit margins.
- Trade Deficit Shrinks: The U.S. trade deficit narrowed to $29.4 billion in October, the smallest gap since June 2009, significantly lower than the revised $48.1 billion deficit in September, reflecting improved international trade conditions that may contribute to economic stability.









