On January 30, 2026 ALX Oncology Holdings Inc. ("ALX Oncology," Nasdaq: ALXO), a clinical-stage biotechnology company advancing a pipeline of novel therapies designed to treat cancer and extend patients’ lives, reported new data from a Phase 1b/2 clinical trial evaluating the company’s investigational CD47-inhibitor evorpacept in combination with Jazz Pharmaceuticals’ ZIIHERA (zanidatamab-hrii) in heavily pretreated patients with metastatic breast cancer (mBC). The topline findings, from an exploratory analysis in this trial, indicate that among patients with confirmed HER2-positive mBC, CD47 expression is predictive of evorpacept activity.

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"These new findings support a CD47-dependent, HER2-driven biology for evorpacept," said Barbara Klencke, M.D., Chief Medical Officer at ALX Oncology. "Going forward, we believe that a biomarker-driven approach incorporating CD47 expression may optimize patient selection for evorpacept combinations with HER2-targeted agents. Additionally, taken together, the data from this trial and the ASPEN-06 clinical trial reinforce our confidence in the ongoing ASPEN-09-Breast Phase 2 trial."

The Phase 1b/2 open-label, multi-center clinical trial (NCT05027139) evaluated the potential of evorpacept in combination with zanidatamab as a novel treatment for patients with previously treated, inoperable, locally advanced, or metastatic HER2-expressing breast cancer and other cancers. The primary trial results, presented at the 2024 San Antonio Breast Cancer Symposium (SABCS), demonstrated that the investigational combination generated promising anti-tumor activity and a manageable safety profile in patients with heavily pretreated HER2-positive breast cancer (median of six prior therapies), including treatment with ENHERTU. Researchers previously reported a 56% (5/9) confirmed objective response rate (cORR) and a median progression-free survival (mPFS) of 7.4 months in the nine patients with centrally confirmed HER2-positive breast cancer who received the investigational combination.

The additional exploratory analysis, conducted to identify biomarkers of response to the evorpacept/zanidatamab combination, shows that responses in this trial were largely restricted to patients with higher CD47 expression. This finding reinforces results from the ASPEN-06 clinical trial, which demonstrated that CD47 expression is a predictive biomarker for response and durable benefit from evorpacept among patients with advanced gastric cancer that has retained HER2 expression.

The full biomarker analysis from the Phase 1b/2 clinical trial has been submitted to an upcoming scientific congress for presentation.

(Press release, ALX Oncology, JAN 30, 2026, View Source [SID1234662367])

On January 29, 2026 Quetzal Therapeutics, a biopharmaceutical company focused on developing treatments for rare diseases, reported that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation to QTX-2101, the company’s investigational oral arsenic trioxide capsule, for the treatment of patients with acute promyelocytic leukemia (APL).

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QTX-2101 is an oral capsule formulation of arsenic trioxide developed with the goal of addressing limitations associated with intravenous administration, including the need for frequent clinic visits. The potential for QTX-2101 to simplify treatment administration while maintaining precise dosing and stability is under investigation. QTX-2101 is currently being evaluated in a global, multicenter, randomized, controlled Phase III clinical trial comparing the investigational oral capsule to standard-of-care therapy in patients with newly diagnosed APL. The trial builds on pharmacokinetic and safety data from prior Phase I studies conducted in the United States.

The Fast Track designation is intended to facilitate the development and expedite the review of investigational therapies for serious conditions, underscoring the severity of APL and the continued unmet medical need despite an effective standard of care therapy. This designation allows for more frequent interaction with the FDA as the clinical development of QTX-2101 progresses, and may enable a more efficient registration filing upon positive data. The therapy remains investigational, and its safety and efficacy have not yet been established. Fast Track designation does not change the standards for approval and does not guarantee that QTX-2101 will receive FDA approval.

About Acute Promyelocytic Leukemia (APL)

APL is a rare and aggressive subtype of acute myeloid leukemia, accounting for approximately 10-15% of all AML cases. It is defined by the PML-RARA gene fusion and is associated with severe bleeding complications and rapid disease progression if untreated. While advances in therapy have transformed outcomes, current treatments often require patients to undergo a large number of lengthy intravenous infusions over the course of therapy. This relentless treatment schedule can disrupt daily life and place a significant burden on both patients and their support networks. There remains a clear need for innovative and more accessible therapies.

(Press release, Quetzal Therapeutics, JAN 29, 2026, View Source [SID1234664175])

On January 29, 2026 Hoffmann-La Roche reported strong 2025 results with 7% sales growth.

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(Presentation, Hoffmann-La Roche, JAN 29, 2026, View Source [SID1234664004])

On January 29, 2026 Takeda reported Quarterly Financial Report For the Quarter Ended December 31, 2025.

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(Presentation, Takeda, JAN 29, 2026, View Source [SID1234662534])

On January 29, 2026 Sanofi reported financial results for Q4 and full year 2025.

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(Presentation, Sanofi, JAN 29, 2026, View Source [SID1234662533]).