On January 29, 2026 Aprea Therapeutics, Inc. (Nasdaq: APRE) ("Aprea" or the "Company"), a clinical-stage biopharmaceutical company developing innovative therapies that exploit cancer-specific vulnerabilities while minimizing damage to healthy cells, reported the first unconfirmed partial response (uPR) observed in a patient enrolled in its ongoing Phase 1 ACESOT-1051 dose-escalation study (A Multi-Center Evaluation of WEE1 Inhibitor APR-1051 in Patients with Advanced Solid Tumors).

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This early clinical activity was observed in a patient with PPP2R1A-mutated uterine serous carcinoma, a form of endometrial cancer, treated at the 150 mg dose level of APR-1051, with dose escalation continuing into higher dose cohorts to establish the recommended Phase 2 dose (RP2D). At the protocol-defined 8-week imaging assessment, the patient achieved a 50% reduction in target lesion size per RECIST v1.1 criteria, along with a marked reduction in cancer antigen 125 (CA-125) levels, from 732 to 70 U/mL, a well-recognized tumor marker in endometrial cancer.

In earlier cohorts of ACESOT-1051 study, multiple patients achieved stable disease with reductions in tumor burden, including a 5% reduction at the 70 mg dose in a patient with HPV-positive head and neck squamous cell carcinoma (HNSCC) and a 15% reduction in a patient with FBXW7-mutated colon cancer treated at the 100 mg dose. This patient has remained on therapy for over 210 days and is approaching their eighth treatment cycle. In addition, a second patient treated at the 150 mg dose level achieved stable disease at the first follow-up imaging assessment.

Collectively, these findings suggest that APR-1051 may have therapeutic potential across a range of solid tumors. Enrollment in the 220 mg dose level cohort of the study is currently underway, and the company intends to increase enrollment of HPV-positive patients in the ongoing trial.

"These early single-agent data demonstrate that APR-1051 has clinical activity as a single agent," said Anthony Tolcher, MD, FRCPC, Principal Investigator at Next Oncology. "The observation of a partial response on the first scan, together with a decrease in tumor marker at this dose level, supports continued clinical evaluation of APR-1051."

Oren Gilad, PhD, Chief Executive Officer of Aprea Therapeutics, added, "These preliminary results provide early proof-of-concept for single-agent activity of APR-1051 and support our strategy of targeting cancers with specific genomic alterations, including HPV-positive disease and PPP2R1A, FBXW7, CCNE1, TP53 and KRAS mutations. The potential dose-response trend and favorable safety profile observed in the ongoing dose-escalation study reinforce our confidence in the potential of APR-1051 as a differentiated WEE1 inhibitor for patients with advanced solid tumors. We look forward to providing additional updates in the first half of 2026 and completing dose escalation later in the year."

About the ACESOT-1051 Trial

ACESOT-1051 is a first-in-human, open-label Phase 1 study evaluating the safety, pharmacokinetics, pharmacodynamics, and preliminary efficacy of single-agent APR-1051 in patients with advanced solid tumors harboring cancer-associated genetic alterations. The dose-escalation portion of the study is expected to enroll up to 50 patients across nine planned dose cohorts, ranging from10 mg to 300 mg administered once daily. APR-1051 is administered orally once daily in continuous 28-day cycles. To date, enrollment has evaluated doses up to 150 mg, with the 220 mg cohort currently enrolling. For more information, refer to ClinicalTrials.gov ID NCT06260514.

(Press release, Aprea, JAN 29, 2026, View Source [SID1234662349])

On January 29, 2026 Aprea Therapeutics, Inc. (Nasdaq: APRE) ("Aprea", or the "Company"), a clinical-stage biopharmaceutical company developing innovative treatments that exploit specific cancer cell vulnerabilities while minimizing damage to healthy cells, reported that it has entered into a securities purchase agreement with new and existing healthcare focused institutional investors and certain insiders of the Company to sell an aggregate of 6,288,857 shares of common stock (or pre-funded warrants in-lieu thereof), together with warrants to purchase up to an aggregate 6,288,857 shares of common stock, in a private placement priced at-the-market under Nasdaq rules (the "Offering"). The combined effective offering price for each share of common stock (or pre-funded warrant in-lieu thereof) and accompanying warrant to be issued is $0.89. The warrants to be issued will have an exercise price of $0.765 per share, will be exercisable immediately upon issuance, and will expire on the two-year anniversary from the effectiveness date of the registration statement covering the resale of the securities purchased in the Offering.

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The gross proceeds to the Company from the Offering are estimated to be approximately $5.6 million before deducting the placement agent’s fees and other estimated Offering expenses. The Company intends to use the upfront net proceeds from the private placement for general corporate purposes and for research and development expenses. The Offering is expected to close on or about January 30, 2026, subject to the satisfaction of customary closing conditions.

"We believe this financing will enable us to proactively backfill patients at key dose levels in our ongoing ACESOT-1 dose-escalation study evaluating APR-1051, our WEE1 kinase inhibitor, and this may increase the likelihood of successful dose optimization," said Oren Gilad, CEO of Aprea Therapeutics. "By adding more patients to our safety and early efficacy dataset, we expect to accelerate our ability to define the optimal dose and patient population, which we believe will drive the program toward clinical and value-creating inflection points."

Maxim Group LLC is acting as the sole placement agent in connection with the Offering.

The offer and sale of the foregoing securities are being made in a private placement under Section 4(a)(2) of the Securities Act of 1933, as amended (the "Securities Act"), and/or Regulation D promulgated thereunder, and the securities have not been registered under the Securities Act or applicable state securities laws. Accordingly, the securities may not be reoffered or resold in the United States except pursuant to an effective registration statement or an applicable exemption from the registration requirements of the Securities Act and such applicable state securities laws. The Company has agreed to file a registration statement with the Securities and Exchange Commission registering the resale of the securities purchased in the private placement.

This press release does not constitute an offer to sell or the solicitation of an offer to buy the securities, nor shall there be any sale of the securities in any state in which such offer, solicitation or sale would be unlawful prior to the registration or qualification under the securities laws of such state. Any offering of the securities under the resale registration statement will only be made by means of a prospectus.

(Press release, Aprea, JAN 29, 2026, View Source [SID1234662348])

On January 29, 2026 Alpha Tau Medical Ltd. (Nasdaq: DRTS, DRTSW) ("Alpha Tau"), the developer of the innovative alpha-radiation cancer therapy Alpha DaRT reported the following letter to shareholders:

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Following an incredibly productive 2025, culminating in several significant announcements in recent weeks, I wish to share with you an updated comprehensive picture of Alpha Tau’s position and projected upcoming milestones, as we continue to push forward with our clinical, operational and pre-commercial development on a number of different fronts.

Extensive Ongoing Clinical Activity

The Company is currently conducting multiple significant clinical trials around the world, with five concurrently approved trials in the U.S.:

● Our ReSTART (Recurrent SCC Treatment with Alpha DaRT Radiation Therapy) multi-center pivotal trial in patients with recurrent cutaneous squamous cell carcinoma (cSCC) , the second most common form of skin cancer: View Source

● Our multicenter study in immunocompromised patients with cSCC: View Source

● Our IMPACT (Intratumoral Pancreatic Alpha Combination Trial) multi-center pilot study in patients with newly-diagnosed pancreatic cancer in combination with chemotherapy: View Source

● Our feasibility study in patients with recurrent glioblastoma multiforme (GBM), a highly aggressive malignant brain tumor: View Source

● Our pilot study in patients with locally recurrent prostate cancer: View Source

We are proud of our incredibly comprehensive clinical program, with Alpha DaRT being evaluated simultaneously across a number of indications. Our strategy of parallel exploration of multiple cancer types provides several opportunities for potential regulatory approval while seeking to demonstrate the platform’s broad applicability.

In addition, the Company has trials approved in France and Italy and is planning a large potential basket trial in the UK to evaluate our Alpha DaRT across numerous cancer types, alongside a number of ongoing feasibility studies in Israel. In particular, I would cite the ongoing trials in Israel treating patients with tumors of the prostate, lung and pancreas, as well as our TARGETS trial, which is open to patients with any type of malignant tumors of up to 7 cm in length, in lieu of ad hoc compassionate use treatments.

We also continue to maintain open and ongoing dialogue with the FDA, including in the context of regular quarterly meetings, as we continue to explore new potential applications and more comprehensive U.S. trials of the Alpha DaRT.

Continued Clinical Validation and Upcoming Milestones Across Expanded Indication Set

As you all know, the Company started its clinical evaluations by treating superficial tumors as a proof of concept, i.e., tumors of the skin or head and neck, and has acquired significant experience in the U.S., Europe, Japan and Israel. More recently, we have started receiving results from trials in internal organs, primarily pancreatic cancer, and continue to be encouraged by the potential of Alpha DaRT to deliver a potent but conformal dose of alpha radiation to a very a broad set of tumors with poor or no available alternatives.

Targeting Completion of Patient Recruitment in Pancreatic Cancer Study End of Q1 2026

In light of the encouraging data from the Company’s first-in-human studies in Canada and Israel in patients with pancreatic cancer, which was initially read out in interim form last year (View Source) and then recently reported from the Canadian study in more detail at the 2026 ASCO (Free ASCO Whitepaper) Gastrointestinal Cancers Symposium (View Source), we continue to conduct our IMPACT study with great clinician and patient interest, and are targeting the completion of patient accrual at the end of the first quarter of 2026 and initial results by the end of the year.

Expecting Initial GBM Results Around End of Q4 2026

Recently we reported the treatment of our first patient in GBM at Ohio State University (View Source). Per the protocol and in line with our conservative approach to carefully watching for any safety signals, we will limit our treatments to one patient per month for the first three patients, all at Ohio State University. To the extent that no safety concerns arise, we would anticipate the removal of enrollment restrictions as well as expansion to New York University as a second site in the trial, in which case we would target the completion of patient accrual for ten patients later in the year, with initial results targeted around year end 2026.

Potential Regulatory Approval in Japan

In addition, the Company is anticipating a response shortly from Japan’s Ministry of Health, Labour and Welfare regarding our application for approval of Alpha DaRT in the treatment of recurrent head & neck cancer. We are preparing for potential post-marketing surveillance requirements in Japan should the response be positive. A positive regulatory decision in Japan would mark Alpha DaRT’s first commercial approval outside of Israel, further validating our technology and regulatory strategy.

Alpha DaRT as a Combination Therapy with Checkpoint Inhibitors

The Company also anticipates exploring an additional clinical trial with the FDA in 2026, examining the combination of Alpha DaRT with checkpoint inhibitor therapeutics for patients with locally advanced or metastatic head & neck squamous cell carcinoma, on the back of fantastic interim data we released last year from a similar study conducted in Jerusalem, and we are hoping that this will become our sixth active trial in parallel in the U.S. We reported interim results in January 2025 from the clinical study conducted in Israel in this use case (View Source). This trial is incredibly important from a strategic perspective, as it reaches a very special population and also looks to demonstrate broader systemic relevance of Alpha DaRT treatment. While the majority of our clinical trials focus on the first two of our strategic pillars of focus (localized & unresectable tumors, and tumors of high unmet need), this is our first foray into exploring our third strategic pillar, the potential use of Alpha DaRT to provide systemic benefits to patients with metastatic tumors.

In parallel, the Company is also engaged in significant pre-clinical work in partnership with leading academic institutions, including Mayo Clinic, McGill University, Emory University and MD Anderson Cancer Center, exploring different combinations with immunotherapy, which we see as an important future direction for use of Alpha DaRT.

As such, we expect an incredibly busy year in 2026 from a clinical perspective, including significant data readouts from our ReSTART pivotal trial and trials in cancers of internal organs.

Commercial and Operational Readiness

We see tremendous importance to generating additional data on the use of Alpha DaRT in tumors of internal organs such as the pancreas and the brain, in order to support future decisions on launch sequencing in different indications. As we have reported in the past, we expect to complete recruitment of the ReSTART study in this quarter, and have started to submit modules of our Modular PMA to the FDA (View Source), and expect to complete the submission toward year end. Therefore, launch sequencing continues to present interesting strategic questions in light of the broad applicability of Alpha DaRT.

As we have reported in the past, the Company is currently manufacturing Alpha DaRT treatments in Jerusalem and Thorium-228 generators in Lawrence, MA, at a scale that can supply our clinical trials, validations and pre-clinical work. However, we have also reported the receipt of a radioactive license for the first phase of our Hudson, NH facility, which is being built in phases (View Source), and are currently working on equipping that first phase with the equipment needed for Alpha DaRT manufacturing.

At the same time, we continue to build out and adjust our organizational structure to prepare for future commercialization, including investments in scaling up manufacturing, in devices and accessories for mass production such as injection molds, in robotics and automation, and in development of new manufacturing methods that will increase our output and efficiency.

Well Financed and Positioned for Execution

Our cash burn rate has remained fairly stable to date other than some minor peaks associated with investment into our manufacturing capacity, and we remain confident that we can continue to execute on our current plans.

We continue to vigorously seek protection of our intellectual property, which we see as an important fruit of the extensive labors of our R&D teams, and key to protecting our future commercial potential. In 2025 alone, we filed over 60 new patent applications of different types around the world and were granted or allowed nearly 50 patents around the world.

In light of increasing recognition of the relevance of Alpha DaRT to the broader radiotherapy and oncology therapeutics landscapes, we see increased strategic dialogue with potential partners, across a number of potential areas for collaboration. We continue to entertain a number of interesting conversations, while not losing sight of our core focus on executing on our strategy.

(Press release, Alpha Tau Medical, JAN 29, 2026, View Source [SID1234662346])

On January 29, 2026 AB Science SA (Euronext – FR0010557264 – AB) reported that the United States Patent and Trademark Office (USPTO) issued a Notice of Allowance (NOA) for a patent relating to methods of treating metastatic castrate resistant prostate cancer (mCRPC) with its lead compound masitinib (US 18/040884).

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Delivery of masitinib patent in mCRPC

Once granted, this new US secondary medical use patent will provide intellectual property (IP) protection for masitinib in mCRPC until May 2042. A NOA signifies that the USPTO intends to grant the patent application after completing certain formal procedural steps. The US NOA is issued after an examiner confirms that the patent application meets all patentability requirements.

This new US patent adds to the IP coverage already granted in Europe (EP4175639) [1].

Counterpart patent applications have also been filed in other major international markets.

Masitinib positioning in metastatic prostate cancer after failure to hormone therapy

In metastatic prostate cancer, patients take hormone therapies (i.e., androgen-deprivation therapy) in first line and second line. Then when metastatic cancer advances patients have to be treated by chemotherapy. There is only one chemotherapy registered, docetaxel, and no drug in combination with docetaxel or replacement of docetaxel has improved PFS or OS and has been registered for the last 20 years.

Masitinib is positioned in combination with docetaxel as a treatment of mCRPC patients who are eligible to chemotherapy. That is to say, it is administered directly following the metastatic hormone-sensitive prostate cancer (mHSPC) treatment space.

Masitinib is one of the rare drugs to have generated positive data on progression free survival (PFS) in combination with docetaxel in this population.

Masitinib positioning in mCRPC with low metastatic involvement measured by a biomarker

More specifically, this patent provides protection for masitinib and related compounds for the treatment of mCRPC in a patient subpopulation with low metastatic involvement (as measured by baseline alkaline phosphatase levels).

This patient population is fully consistent with the results of the masitinib study AB12003 [2] and the ongoing clinical development program of masitinib in mCRPC.

As a reminder, the key results from study AB12003 include:

Masitinib (6.0 mg/kg/day) plus docetaxel conferred a significant progression-free survival (PFS) benefit in mCRPC patients with baseline alkaline phosphatase levels (ALP) less than or equal to 250 IU/L; hazard ratio of 0.79 [0.64,0.97] (p=0.0087), corresponding to a 21% reduction in risk of progression relative to control.
Assessment of PFS rates was convergent with this primary outcome, with 12-, 18-, and 24-month PFS rates showing significant improvement in favor of masitinib plus docetaxel relative to the control: 1.6-fold (p=0.0035), 1.9-fold (p=0.0001), and 1.9-fold (p=0.0028), respectively.
A progressively greater masitinib treatment effect was observed for lower baseline ALP levels (i.e., less advanced metastatic disease), with a significant 47% reduced risk of progression in patients with ALP less than or equal to 100 IU/L (hazard ratio=0.53, p=0.002).
The safety profile of masitinib plus docetaxel was acceptable and consistent with the known masitinib profile, with no new safety signals observed.
Unmet medical need in mCRPC

Although localized disease is associated with high survival rates, metastatic prostate cancer still represents an unmet medical need with a 5-years survival rate of approximately 32% [3]. Practically all patients with metastatic disease become resistant to androgen-deprivation therapy.

With 1.5 million new cases and 397,000 deaths worldwide, prostate cancer is the world’s second most frequent cancer and the fifth leading cause of cancer death among men [4]. It is estimated that there are at least 3.5 million men living with prostate cancer in the United States [5] and 2.5 million in Europe [6]. Approximately 2% of all prostate cancer cases are mCRPC [7], and practically all patients with metastatic disease will become resistant to androgen-deprivation therapy. As such, the population with mCRPC eligible to chemotherapy is around 50,000 in the EU and 70,000 in the USA.

(Press release, AB Science, JAN 29, 2026, https://www.ab-science.com/ab-science-receives-notice-of-allowance-for-us-patent-covering-masitinib-in-the-treatment-of-metastatic-castrate-resistant-prostate-cancer/ [SID1234662345])

On January 29, 2026 Oncoinvent, a clinical stage, radiopharmaceutical company developing innovative treatments for solid cancers, reported that the first patient has been enrolled at one of the newly activated sites in its Phase 2 study of Radspherin in patients with peritoneal carcinomatosis from ovarian cancer.

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The randomized part of the study has been actively recruiting patients at six sites since March 2025. Four additional sites have now been opened, and the first patient has been enrolled at one of these newly activated sites.

"The process of opening new clinical sites involves extensive regulatory reviews, contracting, and site-readiness work. We are therefore pleased to see both the successful activation of additional sites and the enrollment of the first patient at a newly onboarded site," said Kari Myren, Chief Medical Officer at Oncoinvent.

The Phase 2 trial (Clinicaltrial.gov: NCT06504147) is a randomized controlled trial assessing the efficacy and safety of Radspherin in patients with peritoneal metastases from ovarian cancer. The primary objective is to compare progression-free survival (PFS) between patients who receive Radspherin after complete surgical resection following pre-operative chemotherapy, and patients receiving pre-operative chemotherapy and surgery alone.

The study will recruit patients at a total of 11 sites across Norway (1), Spain (5), Belgium (1), the United Kingdom (2), the United States (1), and Italy (1). Positive Phase 1/2a data from the safety interim analysis demonstrated that Radspherin was well tolerated with no dose-limiting toxicity observed at the recommended dose of 7MBq.

(Press release, Oncoinvent, JAN 29, 2026, https://www.oncoinvent.com/press-release/four-additional-sites-open-for-recruitment-in-oncoinvents-phase-2-trial/ [SID1234662334])