On May 8, 2026 Azalea Therapeutics, Inc., a biotechnology company redefining precision genomic medicines in vivo, reported that first-in-primate data from its proprietary in vivo CAR T cell platform have been accepted as a late-breaking abstract for oral presentation at the American Society of Gene and Cell Therapy (ASGCT) (Free ASGCT Whitepaper) 2026 Annual Meeting, taking place May 11 – 15, 2026 in Boston, Massachusetts.

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The late-breaking abstract, titled "A first-in-primate demonstration of in vivo TRAC-CAR T cell engineering via cell-selective delivery and genomic locus-specific integration," describes the first in vivo generation of genomic site-specific engineered TRAC-CAR T cells in non-human primates. Azalea’s platform is designed to generate CAR T cells directly inside the body through a dual-vector approach that combines CD3-targeted enveloped delivery vehicles (EDVs) delivering transient Cas9 complexes with a T cell-tropic AAV (AAV-T) carrying a promoterless CAR gene flanked by TRAC homology arms. This approach enables precise insertion of the CAR gene at the TRAC locus, placing CAR expression under control of the endogenous T cell promoter.

In the study, six rhesus macaques received a single intravenous administration of EDV and AAV-T vectors at different dose levels without prior lymphodepletion. The study assessed in vivo TRAC-CAR T cell generation, TRAC-CAR-mediated B cell depletion in peripheral blood, lymph nodes and bone marrow, and safety parameters.

"These first-in-primate data represent a major milestone for Azalea and for the broader field of in vivo cell engineering," said Jenny Hamilton, Ph.D., co-founder, president and chief executive officer of Azalea Therapeutics. "In immune-competent non-human primates, a single intravenous administration of our dual-vector platform generated TRAC-CAR T cells in vivo and achieved complete target B cell depletion across peripheral blood, lymph nodes and bone marrow without lymphodepletion. We believe that achieving precise insertion at a defined genomic locus will be foundational to the safety, durability and physiologic regulation of future in vivo cell therapies. We believe these findings provide important translational support for our approach and the potential to make powerful cell therapies more accessible by eliminating the need for individualized ex vivo manufacturing."

First-in-Primate In Vivo TRAC-CAR T Cell Engineering

In the study, animals demonstrated in vivo generation of TRAC-CAR T cells, with TRAC-CAR T cells peaking as high as 41% of all peripheral T cells on Day 11. All six animals demonstrated deep B cell aplasia of greater than 90% in peripheral blood by Day 10.

The study also demonstrated potent target B cell clearance beyond peripheral blood. In lymph nodes and bone marrow, B cells were deeply depleted by greater than 90% in five of six animals at the highest dose level within two weeks following treatment.

Treatment was generally well tolerated, with no deaths, no neurotoxicity and a favorable safety profile. Molecular analyses confirmed no off-target CAR expression or integration in non-T cells in the blood.

"To our knowledge, this is the first demonstration of site-specific gene integration in T cells in a non-human primate in vivo. This study demonstrates that Azalea’s platform can achieve cell-selective delivery, genomic locus-specific CAR insertion and robust pharmacodynamic activity in a clinically relevant non-human primate model," said Connor Tsuchida, Ph.D., scientific co-founder, vice president of research and development at Azalea Therapeutics and presenting author of the abstract. "The combination of TRAC-targeted integration, endogenous promoter-driven CAR expression and activity across multiple tissue compartments supports continued advancement of this genome editing-based in vivo CAR T platform toward clinical translation."

Azalea will present these data at the ASGCT (Free ASGCT Whitepaper) 2026 Annual Meeting.

Abstract Title: A first-in-primate demonstration of in vivo TRAC-CAR T cell engineering via cell-selective delivery and genomic locus-specific integration
Presenting Author: Connor A. Tsuchida, Ph.D., Azalea Therapeutics
Session: Oral Abstract Sessions – Late-breaking abstracts
Date/Time: Friday, May 15, 2026, 8:00 am – 9:45 am ET
Location: Westin Seaport Commonwealth Ballroom ABC (Concourse Level)

(Press release, Azalea Therapeutics, MAY 8, 2026, View Source [SID1234665405])

On May 8, 2026 Soligenix, Inc. (Nasdaq: SNGX) (Soligenix or the Company), a late-stage biopharmaceutical company focused on developing and commercializing products to treat rare diseases where there is an unmet medical need, reported its recent updates and financial results for the quarter ended March 31, 2026.

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"We remain disappointed with the unanticipated outcome of the FLASH2 (Fluorescent Light Activated Synthetic Hypericin 2) study," stated Christopher J. Schaber, PhD, President and Chief Executive Officer of Soligenix. "Despite the fact that HyBryte (synthetic hypericin) demonstrated statistically significant reductions in cutaneous T-cell lymphoma (CTCL) lesions after 6 weeks treatment in the first FLASH study, a similar signal was not observed with 18 weeks of treatment in this study. Over the coming weeks, we will analyze the data to better determine why the study did not meet expectations. If there is any clarity gained from further analysis of the dataset, especially with respect to specific subsets of patients that may benefit from HyBryte therapy, then we intend to communicate our findings and explore follow-up discussions with the European Medicines Agency (EMA) and the Food and Drug Administration (FDA)."

With approximately $6.0 million in cash at March 31, 2026, and cash runway into the 2nd quarter of 2027, we will evaluate all strategic options moving forward, including but not limited to merger and acquisition opportunities, and the potential of advancing SGX945 (dusquetide) for the treatment of Behçet’s Disease, which demonstrated promising biological efficacy in a Phase 2 study last year while most recently receiving orphan drug designation from EMA and Promising Innovative Medicine (PIM) designation from the United Kingdom Medicines and Healthcare Products Regulatory Agency (MHRA). In December, we announced the extended results of the Phase 2a trial of SGX302 (synthetic hypericin) for the treatment of mild-to-moderate psoriasis where SGX302 gel therapy was well tolerated by all patients with no drug related adverse events identified. With the completion of the pilot study, we have laid the groundwork for a more detailed evaluation in this large underserved market.

Soligenix Recent Updates

On April 28, 2026, the Company announced that the Data Monitoring Committee completed the interim efficacy analysis of its pivotal Phase 3 FLASH2 trial evaluating HyBryte in the treatment of CTCL and recommended the study halt for futility. To view this press release, please click here.
On April 2, 2026, the Company announced that the positive results of its comparability study evaluating HyBryte versus Valchlor (mechlorethamine) for the treatment of CTCL have been published in Oncology and Therapy. To view this press release, please click here.
Financial Results – Quarter Ended March 30, 2026

Soligenix had no revenue or related costs for the quarter ended March 31, 2026 and 2025, respectively.

Soligenix’s net loss was $2.8 million, or ($0.28) per share, for the quarter ended March 31, 2026, compared to $3.0 million, or ($0.97) per share, for the same prior year period. This decrease in net loss was primarily due to a decrease in operating expenses.

Research and development expenses were $1.8 million as compared to $1.9 million for the quarter ended March 31, 2026 and 2025, respectively. The decrease was primarily due to decreases in costs associated with third-party manufacturing, the completed Phase 2 study in BD and site initiation fees for the second confirmatory Phase 3 CTCL trial, partially offset by an increase in patient fees for the second confirmatory Phase 3 CTCL trial.

General and administrative expenses were $1.1 million for the quarter ended March 31, 2026 as compared to $1.1 million for the same period in 2025, relatively flat with a de minimis increase.

As of March 31, 2026, the Company’s cash position was approximately $6.0 million.

(Press release, Soligenix, MAY 8, 2026, View Source [SID1234665388])

On May 8, 2026 Plus Therapeutics, Inc. (Nasdaq: PSTV) ("Plus" or the "Company"), a healthcare company developing and commercializing precision diagnostics and radiopharmaceuticals for central nervous system (CNS) cancers, reported a plenary session reviewing key clinical and translational data, including the Phase 1 ReSPECT-LM trial of REYOBIQ (rhenium Re186 obisbemeda) was presented at the 2026 American Association of Neurological Surgeons (AANS) Annual Scientific Meeting taking place May 1-4, 2026 in San Antonio, Texas.

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"This oral plenary session, which reviewed data collected to date, and included an overview of the ReSPECT-LM single dose escalation study, is an important validation of the clinical and translational evidence supporting REYOBIQ as a differentiated therapeutic approach for patients with leptomeningeal metastases, a devastating condition with no FDA-approved therapies. AANS is an important congress, and we are encouraged by these data being featured in such a prominent part of the conference," said Eric J. Daniels, M.D., M.B.A., Plus Therapeutics Chief Development Officer. "We continue to believe strongly in the potential of REYOBIQ in the clinical setting as we continue the ongoing multiple dose trial."

The oral presentation, titled, "¹⁸⁶Rhenium-Nanoliposomes (¹⁸⁶RNL) for the Treatment of Leptomeningeal Metastases: Translational Insights from Clinical and Preclinical Models," was delivered by Henriette U. Balinda, PhD, of UT Health San Antonio in a Plenary Session on Saturday, May 2, 2026.

Key Data Highlights

The Presentation highlighted the completed Phase 1 ReSPECT-LM study demonstrating:

Encouraging survival outcomes, with median overall survival of approximately 9 months in patients treated at the recommended Phase 2 dose, compared to historical survival of approximately 2–6 months
Robust anti-tumor activity, including high rates of circulating tumor cell (CTC) reduction and clinical benefit across evaluable patients
Favorable safety and tolerability profile, supporting advancement into later-stage clinical development
Highly targeted radiation delivery, with a target-to-off-target absorbed dose ratio exceeding 100:1, minimizing exposure to healthy tissue
In addition, translational analyses presented in the session demonstrate that REYOBIQ may induce immune remodeling within the tumor microenvironment, including activation of CD8+ T cells and enhancement of anti-tumor immune response, supporting potential future combination strategies with immunotherapies.

Currently, the ReSPECT-LM Phase 1 Multiple Dose trial is underway and enrolling patients at the University of Texas Health San Antonio. The primary objectives include characterizing safety and tolerability of multiple doses at defined intervals of REYOBIQ for patients of any primary solid tumor cancer with LM.

About REYOBIQ (rhenium Re186 obisbemeda)

REYOBIQ (rhenium Re186 obisbemeda) is a novel injectable radiotherapy specifically formulated to deliver direct targeted high dose radiation in CNS tumors in a safe, effective, and convenient manner to optimize patient outcomes. REYOBIQ has the potential to reduce off-target risks and improve outcomes for CNS cancer patients, versus currently approved therapies, with a more targeted and potent radiation dose. Rhenium-186 is an ideal radioisotope for CNS therapeutic applications due to its short half-life, beta energy for destroying cancerous tissue, and gamma energy for real-time imaging. REYOBIQ is being evaluated for the treatment of recurrent glioblastoma, leptomeningeal metastases, and pediatric brain cancer in the ReSPECT-GBM, ReSPECT-LM, and ReSPECT-PBC clinical trials. ReSPECT-GBM is supported by an award from the National Cancer Institute (NCI), part of the U.S. National Institutes of Health (NIH), and ReSPECT-LM is funded by a three-year $17.6M grant by the Cancer Prevention & Research Institute of Texas (CPRIT). The Company’s ReSPECT-PBC clinical trial for pediatric brain cancer is supported by a $3 million grant from the U.S. Department of Defense’s Peer Reviewed Cancer Research Program.

(Press release, Plus Therapeutics, MAY 8, 2026, View Source [SID1234665390])

On May 8, 2026 Oncolys BioPharma reported Non-consolidated Financial Results for the Three Months Ended March 31, 2026.

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(Press release, Oncolys BioPharma, MAY 8, 2026, View Source [SID1234669195])

On May 8, 2026 Allarity Therapeutics, Inc. ("Allarity" or the "Company") (NASDAQ: ALLR), a Phase 2 clinical-stage pharmaceutical company dedicated to developing stenoparib (2X-121)—a differentiated, dual PARP and WNT pathway inhibitor—reported that CEO Thomas Jensen has been invited to participate as a speaker at Precision Medicine Forum Europe 2026, taking place May 11–12, 2026, in Stockholm, Sweden.

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Presentation Details:

Event: Precision Medicine Forum Europe 2026
Presentation Title: Dual Inhibition of PARP and WNT: A Novel Drug-Biomarker Combination in Clinical Trials
Track: Oncology
Date: Monday, May 11, 2026
Time: 10:20–10:40 CEST

Mr. Jensen will discuss stenoparib’s dual mechanism of action and Allarity’s predictive biomarker, the Stenoparib DRP, based on a 414-mRNA gene expression signature, which is designed to identify patients who may be more likely to benefit from stenoparib, as well as the Company’s ongoing Phase 2 trials.

Mr. Jensen will be available for individual meetings during the conference to discuss Allarity’s clinical development strategy and potential business development opportunities.

About Stenoparib/2X-121
Stenoparib is an orally available, small-molecule dual-targeted inhibitor of PARP1/2 and tankyrase 1/2. At present, tankyrases are attracting significant attention as emerging therapeutic targets for cancer, principally due to their role in regulating the WNT signaling pathway. Aberrant WNT/β-catenin signaling has been implicated in the development and progression of numerous cancers. By inhibiting PARP and blocking WNT pathway activation, stenoparib’s unique therapeutic action shows potential as a promising therapeutic for many cancer types, including ovarian cancer, Small Cell Lung Cancer and colorectal cancer. Allarity has secured exclusive global rights for the development and commercialization of stenoparib, which was originally developed by Eisai Co. Ltd. and was formerly known under the names E7449 and 2X-121. Allarity has two ongoing Phase 2 trial protocols for stenoparib in Ovarian Cancer patients. In the first, patients who had had 2+ lines of therapy were enrolled on stenoparib and given drug twice daily. This protocol has been closed to further enrollment but continues for the enrolled patients who are still receiving benefit from stenoparib administration. The updated data from this study were presented at the AACR (Free AACR Whitepaper) special conference on advances in Ovarian Cancer in September 2025. Note that, as these data are from an ongoing trial, analyses may change as the study fully matures. An amended protocol designed expressly to capitalize on the emerging clinical experience with stenoparib in platinum resistant patients began enrolling patients in the summer of 2025. This amended protocol enrolls only platinum resistant or platinum-ineligible patients and is intended to support future pivotal development and eventual regulatory review. In parallel, a separate Phase 2 trial evaluating stenoparib in combination with temozolomide for relapsed small cell lung cancer (SCLC) began enrolling patients in early 2026 and is currently enrolling patients across multiple U.S. Veterans Administration (VA) sites.

About the Drug Response Predictor – DRP Companion Diagnostic
Allarity uses its drug-specific DRP to select those patients who, by the gene expression signature of their cancer, may have a high likelihood of benefiting from a specific drug. By screening patients before treatment, and only treating those patients with a sufficiently high, drug-specific DRP score, the therapeutic benefit rate may be enhanced. The DRP method builds on the comparison of sensitive vs. resistant human cancer cell lines, including transcriptomic information from cell lines, combined with clinical tumor biology filters and prior clinical trial outcomes. DRP is based on messenger RNA expression profiles from patient biopsies. The DRP platform has shown an ability to provide a statistically significant prediction of the clinical outcome from drug treatment in cancer patients across dozens of clinical studies (both retrospective and prospective). The DRP platform, which may be useful in all cancer types and is patented for dozens of anti-cancer drugs, has been extensively published in the peer-reviewed literature.

(Press release, Allarity Therapeutics, MAY 8, 2026, View Source [SID1234665391])