On June 1, 2026 Convergent Therapeutics Inc., a clinical-stage biotechnology company developing next-generation radiopharmaceuticals for the treatment of cancer, reported interim data from Part 3 of its Phase 2 CONVERGE-01 study of Ac-225 rosopatamab tetraxetan (CONV01-α) in patients with metastatic castration-resistant prostate cancer (mCRPC) previously treated with Lu-177-PSMA radioligand therapy (Lu-PSMA). In the study, CONV01-α demonstrated promising anti-tumor activity, emerging durability, and a highly favorable tolerability profile, with clinically-manageable hematologic toxicity at the target dose and no renal toxicity or high-grade xerostomia (dry mouth).

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These data support Convergent’s plan to advance CONV01-α toward a pivotal Phase 3 study in the taxane chemotherapy and Lu-PSMA-exposed patient population, where there is an increasing unmet patient need. The data were presented today in an oral symposium at the 2026 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting.

"Patients whose disease progresses after Lu-PSMA therapy represent a growing population in prostate cancer, with no clearly defined standard of care for what comes next," said Philip Kantoff, MD, co-founder and CEO of Convergent Therapeutics. "These CONVERGE-01 data begin to establish meaningful benchmarks in the Lu-PSMA-exposed setting, including antitumor activity, emerging durability, manageable safety, and a convenient two-dose regimen in a population where burden of prior treatments is already high. These data also support our central thesis that in the alpha era, the mechanism of delivery is tantamount to the payload. By pairing Actinium-225 with a PSMA-directed antibody designed for enhanced tumor retention and limited normal tissue exposure, we believe CONV01-α has the potential to become an important next-generation therapy for mCRPC and across the disease continuum."

This interim dataset from Part 3 of CONVERGE-01 reflects 35 patients with progressive mCRPC previously treated with Lu-177-PSMA radioligand therapy, a clinically challenging population with heavy prior treatment exposure. All patients had received prior androgen receptor pathway inhibitor therapy, 80% had received prior taxane chemotherapy, and all had received Lu-PSMA therapy, including 23% with 1-3 cycles. The study provides prospective Phase 2 data to inform the company’s planned pivotal development strategy.

CONVERGE-01 Part 3 Study Highlights Include:

Median rPFS was 8.4 months in the target dose range in a Lu-PSMA-exposed patient population
Among 25 patients evaluable for PSA response, 40% experienced a PSA decline of ≥50% with similar declines across dose groups and among the patients resistant to Lu-PSMA
No dose-limiting toxicities were observed at any dose level
No treatment-related adverse events led to treatment discontinuation
Clinically manageable hematologic toxicity was observed without renal toxicity
Despite the fact that 48% of the patients entered the study with a history of xerostomia, no high-grade xerostomia was observed with CONV01-α treatment; 77% of patients had Grade 0 or 1 xerostomia following treatment with CONV01-α
"These data are encouraging as Converge-01 demonstrates meaningful anti-tumor activity and emerging durability in patients who have already received Lu-PSMA therapy. These data are striking given that the regimen is comprised of only two treatments, and a reduced treatment burden is important in this very advanced population," said Michael J. Morris, MD, Prostate Cancer Section Head, Memorial Sloan Kettering Cancer Center, and CONVERGE-01 study Scientific Advisory Committee Co-Chair. "The safety profile observed in CONVERGE-01 shows manageable hematologic toxicity, and no renal toxicity or high-grade xerostomia. These data support the continued evaluation of this PSMA-targeted alpha radioantibody approach in the Lu-PSMA-exposed setting."

Supply of Reliable, High-Purity Actinium-225

Convergent has reliable access to Ac-225, a necessary requirement to ensure late-stage clinical development, pivotal studies, and future commercial readiness. A flexible, networked CMC process allows for integration of multiple sources of Ac-225 from redundant suppliers. The Company has also secured Phase 3 supply via a recently expanded agreement with NorthStar Medical Radioisotopes for domestically-generated Ac-225 and co-located drug product manufacturing.

"A reliable Ac-225 supply chain is essential to advancing alpha radiotherapies from early stage development through commercial supply," said Caitlyn Harvey, Senior Vice President of Technical Operations at Convergent Therapeutics. "In CONVERGE-01, no patients missed a dose due to Actinium supply, underscoring the strength of our Ac-225 supply and manufacturing infrastructure. We are continuing to build the foundation needed to support CONV01-α through pivotal development and potential commercial production."

About the CONVERGE-01 Trial
The CONVERGE-01 trial is a Phase 2, randomized, open-label, multicenter four-part study designed to assess the safety and efficacy of CONV01-α in patients with mCRPC. In Part 1, patients received radiolabelled rosopatamab tetraxetan to characterize the biodistribution of the radioantibody to target organs and prostate cancer lesions. Participants were then enrolled in either Part 2 (dose optimization), Part 3 (dose escalation), or Part 4 (extended dosing regimen) depending on their prior treatment history. Part 2 enrolled, and Part 4 continues to enroll participants naïve to Lu-PSMA. Part 3 enrolled participants who were previously exposed to Lu-PSMA-radioligand therapy. Participants received CONV01-α in a two-dose regimen administered on Days 1 and 15. Further details of the trial can be found at www.clinicaltrials.gov under NCT identifier: NCT06549465.

About CONV01-α
CONV01-α is a PSMA-targeted Ac-225 radioantibody that pairs antibody precision with the localized potency of alpha radiation. CONV01-α, which is being developed to improve the treatment of mCRPC, uses a humanized monoclonal antibody (rosopatamab) directed against PSMA, a well-established and highly expressed antigen in prostate cancer. CONV01-α is differentiated by its ability to precisely deliver actinium-225 (Ac-225) through this PSMA-targeting antibody, enabling precise short-range, high-energy alpha particle radiation that creates focused DNA damage within tumor cells while limiting exposure to surrounding tissues. Initial studies in more than 120 patients have established clinical proof-of-concept for CONV01-α, showing consistent antitumor activity and a differentiated safety profile. This selectivity, combined with strong tumor retention and minimal salivary and renal uptake, supports the potential of CONV01-α to be a clinically impactful therapy for PSMA-positive cancers.

(Press release, Convergent Therapeutics, JUN 1, 2026, View Source;in-Lu-PSMA-Exposed-Metastatic-Castration-Resistant-Prostate-Cancer-mCRPC [SID1234666302])

On June 1, 2026 Syndax Pharmaceuticals (Nasdaq: SNDX), a commercial-stage biopharmaceutical company advancing innovative cancer therapies, reported that it will host an R&D Day on Tuesday, July 14, 2026, at 8:30 AM ET in New York City. The R&D Day will feature presentations by Syndax’s management team and key opinion leaders.

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The Company will highlight its late-stage revumenib and axatilimab programs, including its ongoing trials in idiopathic pulmonary fibrosis, newly diagnosed chronic graft-versus-host disease, and newly diagnosed acute leukemia. Further, the Company will detail its new early-stage assets and broader plans to leverage its capabilities and resources to bring new treatment options to more patients.

A live webcast of the event will be available on the Investor section of the Company’s website at www.syndax.com, where a replay of the event will also be available for a limited time.

(Press release, Syndax, JUN 1, 2026, View Source [SID1234666318])

On June 1, 2026 Citius Oncology, Inc. ("Citius Oncology") (Nasdaq: CTOR), an oncology‑focused biopharmaceutical company and majority‑owned subsidiary of Citius Pharmaceuticals, Inc. ("Citius Pharma") (Nasdaq: CTXR), reported Phase 1 clinical data presented May 30, 2026, at the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting evaluating LYMPHIR (denileukin diftitox-cxdl) in combination with pembrolizumab in patients with recurrent or refractory gynecologic malignancies. The poster presentation (Abstract #2564) was presented by investigators from the University of Pittsburgh Medical Center (UPMC) Magee-Womens Hospital.

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"LYMPHIR’s ability to transiently deplete immunosuppressive regulatory T-cells may help address immune resistance in the tumor microenvironment and enhance the effect of checkpoint inhibitors. The encouraging clinical signals and tolerability profile observed in this study support continued clinical evaluation of this "chemo-free" immunomodulatory approach, especially in tumors where resistance to checkpoint inhibitors remains a significant challenge," said Dr. Myron S. Czuczman, Chief Medical Officer of Citius Oncology.

The open-label Phase 1 study evaluated LYMPHIR in combination with pembrolizumab in 25 heavily pre-treated patients (21 evaluable for efficacy) with recurrent or metastatic solid tumors, primarily gynecologic malignancies. Enrolled patients had received a median of five prior therapies, and more than half had previously received anti-PD-1 or PD-L1 therapy.

Key Efficacy and Safety findings presented at ASCO (Free ASCO Whitepaper) included:

24% Overall Response Rate (ORR) among the 21 efficacy-evaluable patients (5 partial responses).
Median duration of response (mDOR) had not yet been reached because only 1 of the 5 partial responders had progressed at the time of analysis (80% of PRs were continuing to experience clinical benefit). The current duration of response times (time since PR was achieved) were 4.2-35 months with a median of 21.1 months.
33% ORR in endometrial cancer patients previously treated with checkpoint inhibitors, including one patient with an ongoing response greater than three years.
48% of efficacy-evaluable patients (10 of 21) achieved clinical benefit, defined as complete response (CR), partial response (PR), or durable stable disease lasting at least six months:
Median progression-free survival (mPFS) of 20.5 months (95% CI: 6.5 – NA) among the 10 patients who achieved clinical benefit; overall mPFS across all 21 efficacy-evaluable patients was 5.8 months (95% CI: 2.2 – NA);
5 patients had a PFS of > 20 months including 1 patient with > 30 months PFS;
Of the 24/25 pts evaluable for dose limiting toxicities (DLTs), only 1 case of reversible Gr 3 capillary leak syndrome (CLS) was observed at the highest dose level. A maximum tolerated dose was not achieved.
16 serious adverse events were observed in seven patients treated at the highest dose level. No new safety signals or grade 3 or greater immune-related adverse events were observed.
Dr. Alexander Olawaiye, a professor and one of the gynecologic cancer researchers at UPMC Magee-Womens Hospital and lead investigator of the study, added, "Patients with recurrent gynecologic malignancies who progress following immunotherapy often have limited treatment options. The clinical activity observed with denileukin diftitox-cxdl plus pembrolizumab, including durable responses and prolonged disease control in heavily pre-treated patients, is notable. Given the lack of effective salvage treatments for these patients, especially those that have failed prior immune-checkpoint inhibition, the novel combination of LYMPHIR plus pembrolizumab provides a potential viable therapeutic option. Importantly, the safety profile observed was manageable in this heavily pre-treated population, supporting continued evaluation in larger studies."

Ongoing translational studies are evaluating the impact of the combination on regulatory T-cells, immune effector cells, and the tumor microenvironment to help identify potential biomarkers in order to optimize future development strategies. A Phase 2 expansion study is being planned to further evaluate the combination in gynecologic cancers, including less heavily pre-treated and prior immunotherapy-exposed patient populations.

About the Study

This open‑label, dose‑escalation, investigator‑initiated Phase 1 study (NCT05200559), led by Dr. Alexander B Olawaiye at UPMC Magee‑Womens Hospital, enrolled 25 patients with recurrent or metastatic solid tumors who had received at least one prior line of therapy. LYMPHIR was administered intravenously on Days 1–3 of each 21‑day cycle at escalating doses (3, 6, 9, and 12 mcg/kg), along with pembrolizumab (200 mg IV) on Day 1. Patients who completed eight cycles of combination therapy were continued on pembrolizumab monotherapy until disease progression. Citius Oncology provided study drug and financial support to the investigator-initiated study; the study was designed, conducted, and analyzed by the UPMC investigators.

Important note on investigational use: The use of LYMPHIR in this study was investigational and outside of its FDA-approved indication of relapsed or refractory Stage I–III cutaneous T-cell lymphoma. LYMPHIR is not approved by the FDA for the treatment of gynecologic malignancies or any solid tumor, and the safety and efficacy of LYMPHIR in this setting have not been established. This Phase 1 study was not designed or powered to evaluate clinical efficacy, and no conclusions can be drawn regarding comparative effectiveness or long-term outcomes. Early-stage clinical data may not be predictive of results from larger or later-stage studies.

About Gynecologic Cancers

Recurrent or metastatic ovarian and endometrial cancers are two of the most common gynecologic malignancies in the United States. Endometrial cancer is the most frequently diagnosed gynecologic cancer, with an estimated 70,000 new endometrial cancer cases expected in the United States in 20261, while ovarian cancer remains the deadliest with approximately 12,700 deaths per year (51.6%) and approximately 20,000 new diagnoses each year in the United States2. These cancers are often detected at advanced stages, and although many patients initially respond to platinum‑based chemotherapy, most experience relapse and develop resistance. Survival rates in the recurrent setting remain poor, and responses to current immunotherapies such as PD‑1 inhibitors are limited, highlighting a significant unmet need for novel treatment approaches. LYMPHIR’s transient depletion of regulatory T‑cells in combination with anti-PD-1 checkpoint inhibition may potentially enhance host anti‑tumor immune responses and help overcome immunotherapy resistance in these difficult‑to‑treat tumors.

About LYMPHIR (denileukin diftitox‑cxdl)

LYMPHIR is a targeted immune therapy for relapsed or refractory cutaneous T-cell lymphoma (CTCL) indicated for use in Stage I-III disease after at least one prior systemic therapy. It is a recombinant fusion protein that combines the IL-2 receptor binding domain with diphtheria toxin (DT) fragments. The agent specifically binds to IL-2 receptors on the cell surface, causing diphtheria toxin fragments that have entered cells to inhibit protein synthesis. After uptake into the cell, the DT fragment is cleaved and the free DT fragments inhibit protein synthesis, resulting in cell death. Denileukin diftitox-cxdl-associated anti-tumor activity is achieved via a direct cytocidal action on IL-2R-expressing tumors and depletion of host immunosuppressive regulatory T lymphocytes (Tregs).

In 2021, reformulated denileukin diftitox received regulatory approval in Japan for the treatment of relapsed or refractory CTCL and peripheral T-cell lymphoma (PTCL). Subsequently, in 2021, Citius acquired an exclusive license with rights to develop and commercialize reformulated denileukin diftitox in all markets except for India, Japan and certain parts of Asia. LYMPHIR (denileukin diftitox-cxdl) was approved by the FDA and subsequently launched in the U.S. in December 2025.

(Press release, Citius Oncology, JUN 1, 2026, View Source [SID1234666334])

On June 1, 2026 GT Biopharma, Inc. (the "Company") (NASDAQ: GTBP), a clinical stage immuno-oncology company focused on developing innovative therapeutics based on the Company’s proprietary natural killer (NK) cell engager TriKE platform, reported an update on its newly implemented AI-based technological initiatives and improved pipeline discovery efficiencies, which are expected to lead to additional development candidates advancing into pre-IND development in 2027.

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"We have seen a marked acceleration in our discovery productivity following recent initiatives implementing AI-based technologies, which have been adapted to improve our drug engineering capabilities," said Michael Breen, Executive Chairman and Chief Executive Officer. "As we continue to demonstrate clinical execution acumen with GTB-3650 and GTB-5550 advancing through Phase 1 this year, we are now looking forward to our next-generation assets with potential for shorter development timeliness, increased probability of clinical success, and lower development costs in the coming years."

Implementation of AI-based technology for GT Biopharma’s Discovery Pipeline

AI-guided sequence and structural analyses are used to identify de novo candidate tumor-targeting engagers and multi-domain proteins with favorable binding, stability, and developability profiles, enabling early prioritization of molecules most likely to demonstrate translation success beyond discovery.
These tools further inform rational engineering by optimizing domain orientation, linker design, and spatial architecture to enhance binding, support productive immune synapse formation, and minimize structural liabilities that can impair potency, manufacturability, or consistency.
In downstream applications, AI-based structural modeling is applied to predict surface exposure, steric compatibility, and assay performance, guiding construct refinement prior to resource-intensive in vitro and in vivo studies.

(Press release, GT Biopharma, JUN 1, 2026, View Source [SID1234666350])

On June 1, 2026 Fate Therapeutics, Inc. (NASDAQ: FATE), a clinical-stage biopharmaceutical company dedicated to bringing a transformative pipeline of induced pluripotent stem cell (iPSC)-derived cellular immunotherapies broadly to patients with cancer and autoimmune diseases, reported clinical data this weekend featuring its off-the-shelf CAR T-cell program FT836 at the American Society of Cancer Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting being held in Chicago, IL, May 29 – June 2, 2026.

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"Early Phase 1 data for FT836 represents a truly exciting moment for patients with certain advanced solid tumors who have exhausted their treatment options" said Bob Valamehr, Ph.D., MBA, President and Chief Executive Officer of Fate Therapeutics. "In this preliminary stage of the study, we are seeing notable tumor reduction in KRASwt metastatic colorectal cancer patients after treatment with FT836, an observation that did not require conditioning chemotherapy with the inclusion of our Sword and Shield technology. This novel 9-point edited CAR T-cell product candidate is uniformly manufactured from a single clonal master cell bank, meaning we can produce FT836 at massive scale with consistency and have it available off-the-shelf and on-demand for broad access for cancer patients with unmet need. We believe FT836 has the potential to fundamentally change how solid tumor treatment is approached, especially in combination with standard-of-care therapies. We look forward to continuing to build on these early results as enrollment expands in the FT836 study."

Presentation Summary Includes:

Title: Preliminary Phase 1 Results of a MICA/B-targeted CAR T cell Designed to Overcome Solid Tumor Escape Mechanisms and Avoid the Requirement for Conditioning Chemotherapy

As of the April 20, 2026 data cutoff, nine patients have been enrolled across two regimens (Regimen C: FT836 + cetuximab, n=6 and Regimen E: FT836 + trastuzumab, n=3) with all patients evaluated for safety, and five available for initial efficacy assessment: (Regimen C, n=4 and Regimen E , n=1). Both regimens are administered without conditioning chemotherapy. Key findings include:

Favorable safety profile with no dose-limiting toxicities (DLTs), cytokine release syndrome (CRS), immune effector cell-associated neurotoxicity syndrome (ICANS), or graft versus host disease (GvHD) observed across any patient or dose level for all nine patients.
First-in-human evidence of FT836 trafficking to and persisting within tumor tissue without the use of conditioning chemotherapy, along with evidence of remodeling of the tumor immune microenvironment.
Preliminary anti-tumor activity in the two efficacy-evaluable heavily pre-treated KRAS wild-type (KRASwt) metastatic colorectal cancer (mCRC) patients, each with seven prior lines of therapy, including meaningful reductions in target lesion size and significant decreases in tumor biomarker expression, including carcinoembryonic antigen (CEA) expression. Based on these promising results, the Company plans to focus on this CRC patient population.

Sword and Shield Technology Facilitates CAR T-cell Activity without the Need for Conditioning Chemotherapy

FT836 incorporates Sword and Shield technology—a coordinated dual-engineering strategy designed to eliminate the need for lymphodepleting conditioning chemotherapy. The Sword component, an alloimmune-defense receptor (ADR), enables FT836 to selectively recognize and eliminate alloreactive host immune cells, including T cells, that would otherwise reject the allogeneic product. The Shield component, deletion of CD58, renders FT836 resistant to host immune cell surveillance, further supporting functional persistence of FT836. In previously presented preclinical data, these elements together enabled ~20–30x improvement in in vivo persistence in various allogeneic mouse models and ~5x selective containment of product-specific host immune responses, supporting the planning of clinical strategies without conditioning chemotherapy—a critical differentiator for patient tolerability and access.

FT836 Persistence in the Periphery and Tumor Tissue

A critical translational finding from this study is the first-in-human detection of FT836 in both peripheral blood and tumor tissue without conditioning chemotherapy. Using multi-parameter flow cytometry, FT836 cells were detected in the peripheral blood of patients with an intact host immune system following first dose, peaking at Day 4 and persisting for approximately another week. Strikingly, FT836 was subsequently detected in patient tumor biopsy at Day 22 by transgene-targeted RNAscope, which is well beyond their detection in the periphery, suggestive of efficient trafficking to tumor-bearing tissue and markedly prolonged tissue persistence relative to blood. This extended tissue residence, supported by CXCR2 trafficking receptor and TGFβ signal redirect receptor engineered into FT836, was accompanied by meaningful remodeling of the tumor immune microenvironment. Immunohistochemistry imaging from liver biopsy revealed that CD8+ T cells, which were spatially excluded from the tumor at baseline, were found adjacent to and in direct contact with tumor cells on-study; evidence of treatment-associated activation and recruitment of endogenous anti-tumor immunity.

Clinical Case Studies: Broad expression of MICA/B antigen and Anti-Tumor Activity in KRASwt Metastatic Colorectal Cancer

Screening biopsies from both patients confirmed broad expression of MICA/B and EGFR target antigens on tumor cells, validating the multi-antigen targeting rationale of FT836 plus cetuximab in mCRC.

Case 1: Regimen C DL1 — 19% Tumor Reduction; All target lesions reduced; 62% CEA Decline

A 45-year-old male with KRASwt metastatic CRC and lung, bone, and nodal disease received FT836 at 300 million cells/dose on Days 1 and 15 with cetuximab (no conditioning chemotherapy), following seven prior lines of therapy including prior cetuximab.

CEA tumor marker decreased from 487 ng/mL at screening to 185 ng/mL by Day 56 (62% reduction).
All RECIST target lesions decreased in size; overall 19% reduction in sum of diameters (70 mm → 55 mm) across lung and nodal lesions.
No FT836-related adverse events observed.

Case 2: Regimen C DL2 — 52% Liver Lesion Reduction; Stable Disease; Pain associated with tumor Resolved

A 53-year-old male with KRASwt metastatic CRC involving lung, liver, adrenal, and nodal disease received FT836 at 900 million cells/dose on Days 1, 8, and 15 with cetuximab (no conditioning chemotherapy), following seven prior lines of therapy including multiple cetuximab-containing regimens.

A liver target lesion demonstrated a 52% reduction in diameter; RECIST-assessed stable disease confirmed post data cutoff.
Cancer antigen (CA)19-9 decreased from 258 to 144 by Day 56 (44% reduction).
Tumor-related pain resolved during treatment.
No FT836-related adverse events observed.
About FT836

FT836 is the Company’s multipoint-edited CAR T-cell product candidate uniquely targeting major histocompatibility complex (MHC) proteins A (MICA) and B (MICB). The expression of MICA/B cell-surface proteins is induced by cellular stress or malignant transformation and is detectable across many types of cancer cells with limited expression on healthy tissue. At the Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper) 40th Annual meeting held in November 2025, the Company presented preclinical data showing FT836 exhibited potent and durable CAR-dependent antigen-driven proliferation with robust activity across diverse solid tumors and that FT836 can be combined with standard of care chemotherapy to induce MICA/B surface expression for enhanced target recognition and additive antitumor activity. In addition, the Company presented immunohistochemistry analysis showing that MICA/B is expressed throughout tumor tissue in biopsy samples obtained from patients with various cancers, including colorectal cancer. FT836 is also the Company’s first product candidate to incorporate the novel Sword & ShieldTM technology, which utilizes the Company’s novel alloimmune defense receptor (ADR) alongside CD58 knockout (KO), to both target and evade host alloreactive immune cells for a comprehensive strategy to avoid the need for conditioning chemotherapy. In January 2025, the Company secured a $4 million award from the California Institute of Regenerative Medicine (CIRM) to support IND-enabling activities for FT836.

(Press release, Fate Therapeutics, JUN 1, 2026, View Source [SID1234666303])