On June 2, 2025 TuHURA Biosciences, Inc. (NASDAQ:HURA) ("TuHURA"), a Phase 3 immune-oncology company developing novel technologies to overcome resistance to cancer immunotherapy, reported that Moffitt Cancer Center presented a Trial in Progress poster of the Company’s planned Phase 3 accelerated approval trial at the 2025 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting on June 1, 2025, in Chicago, Illinois (Press release, TuHURA Biosciences, JUN 2, 2025, View Source [SID1234653625]).

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The Company’s poster, titled "Multicenter, randomized, double-blinded, placebo-controlled trial of IFx-Hu2.0 (IFx) as adjunctive therapy with pembrolizumab (pembro) in checkpoint inhibitor (CPI)-naïve patients with advanced or metastatic Merkel cell carcinoma (MCC)" details the Company’s Phase 3 accelerated approval trial design of IFx-Hu2.0, its novel innate immune agonist. The Trial in Progress poster was presented by Andrew Brohl, M.D., Medical Oncologist at Moffitt Cancer Center, and highlighted the importance of innate immune system activation in Merkel cell carcinoma patients with primary resistance to checkpoint inhibitors (CPIs).

"Merkel cell carcinoma is a rare and aggressive tumor type. While checkpoint inhibitor therapy has markedly improved the outcome for patients with advanced or metastatic MCC, unfortunately for patients who don’t respond to first line checkpoint inhibitor therapy the survival is poor at less than 30 months.1 Based on the results from our Phase 1 clinical trials, IFx-Hu2.0 intralesional administration has demonstrated it can activate an innate immune response, resulting in the production and activation of tumor specific B cells and T cells, to overcome the primary CPI resistance in both advanced or metastatic MCC or melanoma," stated James Bianco, M.D., President and Chief Executive Officer of TuHURA Biosciences. "We believe we have provided data requested by the FDA that addresses the requirements listed in the partial clinical hold letter to allow us to initiate our Phase 3 accelerated approval trial this month. The FDA was constructive in the trial design, which can potentially satisfy both the requirements for accelerated and regular approval without the requirements for a post approval confirmatory trial. They continue to work with us under the SPA Agreement in preparing the trial’s initiation."

In the Phase 1b trial of IFx-Hu2.0, MCC among patients who progressed on pembrolizumab (anti-PD-1) or avelumab (anti-PDL-1) therapy, weekly administration of IFx-Hu2.0 for up to 3 doses followed by rechallenge with anti-PD(L)-1 therapy, demonstrated an overall response rate of 63% (2CR, 5 PR) with duration of responses ranging from 6 to 33 months with 5 ongoing responses as of last follow-up in June 2024.

The Company’s Phase 3 accelerated approval trial of adjunctive IFx-Hu2.0, to be conducted under a SPA agreement with the U.S. FDA, will evaluate IFx-Hu2.0 (0.1 mg) as an adjunctive therapy administered weekly for three weeks concurrent to pembrolizumab (200 mg) Q3W, compared to the same pembrolizumab regimen plus placebo. The pivotal trial is expected to enroll 118 CPI-naïve patients with advanced or metastatic MCC across approximately 22 to 25 U.S. sites. Trial participants will be randomized on a 1:1 basis and receive CPI therapy for up to two years, or until disease progression or CPI related toxicities. The primary endpoint for the trial is overall response rate (ORR) with a key secondary endpoint of progression free survival (PFS). Other secondary endpoints are safety, duration of response, and overall survival.

The Trial in Progress poster is available on the Scientific Publications page of TuHURA’s website.

On June 2, 2025 TG Therapeutics, Inc. (NASDAQ: TGTX) reported that Michael S. Weiss, the Company’s Chairman and Chief Executive Officer, will participate in the Jefferies Global Healthcare Conference, being held at the Marriott Marquis, in New York City on June 3-5, 2025 (Press release, TG Therapeutics, JUN 2, 2025, View Source [SID1234653624]). The fireside chat is scheduled to take place on Wednesday, June 4, 2025, at 12:50 PM ET.

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A live webcast of the fireside chat will be available on the Events page, located within the Investors & Media section, of the Company’s website at View Source

On June 2, 2025 Taiho Pharmaceutical Co., Ltd. (hereinafter "Taiho Pharmaceutical") and Benz Sciences Inc. (hereinafter "Benz Sciences") reported that the two companies have entered into a license agreement for TAS1440, a LSD1 (lysine-specific demethylase 1) inhibitor discovered by Taiho Pharmaceutical (Press release, Taiho, JUN 2, 2025, View Source [SID1234653623]).

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Under the terms of agreement, Benz Sciences will obtain exclusive worldwide rights to develop, manufacture and commercialize TAS1440 (new development code SFG-03). Taiho Pharmaceutical will receive from Benz Sciences an upfront payment, milestone payments based on development progress and sales, and royalties.

TAS1440 is an orally administrable, small-molecule compound, reversible inhibitor of LSD1, an enzyme critical for hematopoiesis. It has been reported that the LSD1 gene is overexpressed in myeloproliferative neoplasms,1 diseases characterized by the excessive production of blood cells due to acquired genetic mutations in hematopoietic stem cells. Benz Sciences will undertake preparations in the United States for the Phase 1b/2 trial of TAS1440 for the treatment of myeloproliferative neoplasms.

About TAS1440
TAS1440 is a histone-competitive LSD1 inhibitor that binds to the histone H3 binding site of LSD1 to reversibly inhibit LSD1. LSD1, a critical enzyme that regulates the proliferation of hematopoietic stem cells and the maturation of progenitor cells,2 is expected to be a therapeutic target for diseases such as acute myeloid leukemia (AML) and myeloproliferative neoplasms. TAS1440 has completed a Phase 1 trial targeting AML in the United States, and the results of this trial are undergoing analysis at this time.

On June 2, 2025 SELLAS Life Sciences Group, Inc. (NASDAQ: SLS) ("SELLAS" or the "Company"), a late-stage clinical biopharmaceutical company focused on the development of novel therapies for a broad range of cancer indications, reported preclinical efficacy of SLS009 (tambiciclib) in ASXL1 mutated colorectal cancer lines. The data are featured in a presentation, entitled "In vitro efficacy of CDK9 inhibitor tambiciclib (SLS009) in ASXL1 mutated colorectal cancer cell lines" at the 2025 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting, taking place May 30- June 3, 2025, in Chicago, Illinois (Press release, Sellas Life Sciences, JUN 2, 2025, View Source [SID1234653622]).

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In a panel of cell lines, SLS009 demonstrated potent anti-proliferative activity:

In 50% (4/8) of ASXL1 mutant cell lines showed an IC50<100 nM, compared to 0% (0/4) of ASXL1 wild-type lines
Among cell lines harboring ASXL1 frameshift mutations (FSMs), 75% (3/4) responded with IC50 <100 nM versus only 12.5% (1/8) in cell lines without FSMs
All cell lines (3/3) with ASXL1 FSMs in the 637-638 protein region responded to treatment with SLS009
In cell lines with IC50 <100 nM, 75% (3/4) also demonstrated IC99 values below 100 nM, indicating steep dose response curve
Importantly, effective concentrations were significantly lower than those achieved in patients treated at the recommended phase 2 dose determined to be safe, suggesting a broad therapeutic window.
"These results provide strong rationale for continued advancement of SLS009 as a potential treatment for ASXL1-mutated cancers," said Dr. Dragan Cicic, Senior Vice President, Chief Development Officer at SELLAS. "The ability to selectively target ASXL1-driven tumors at concentrations well below the known safety threshold opens the door for tolerable and effective therapy. Based on the findings, we believe that ASXL1 mutation status could serve as a potential biomarker for response to SLS009 inhibition, which may allow us to further refine patient selection and improve outcomes. We look forward to presenting these results at ASCO (Free ASCO Whitepaper)."

Poster presentation details:

Title: In vitro efficacy of CDK9 inhibitor tambiciclib (SLS009) in ASXL1 mutated colorectal cancer cell lines
Session Date and Time: Monday, June 2, 2025, 1:30 PM-4:30 PM CDT
Session Title: Developmental Therapeutics—Molecularly Targeted Agents and Tumor Biology
Location: Hall A – Posters and Exhibits
Abstract #: 3121
Poster Board #: 436

SLS009 is currently being investigated in a Phase 2 open-label, single-arm, multi-center study designed to evaluate the safety, tolerability, and efficacy of SLS009 in combination with venetoclax and azacitidine including AML patients with ASXL1 mutations. Initial clinical safety and efficacy data are available. In addition, the study aims to identify biomarkers for the target patient population and enrichment for further trials. For more information on the study, visit clinicaltrial.gov identifier NCT04588922.

On June 2, 2025 QIAGEN (NYSE: QGEN; Frankfurt Prime Standard: QIA) reported the expansion of its oncology diagnostics portfolio with two strategic partnerships to advance the use of minimal residual disease (MRD) testing in clinical trials to support pharma co-development projects for companion diagnostics (Press release, Qiagen, JUN 2, 2025, View Source [SID1234653621]). The new collaborations with Tracer Biotechnologies and Foresight Diagnostics expand QIAGEN’s reach in MRD testing and cover solid tumors and hematological cancers.

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Minimal residual disease (MRD) testing is becoming a cornerstone of oncology by enabling early detection of cancer recurrence and guiding timely adjustments to therapy from a blood sample. These new partnerships support the growing demand for decentralized, non-invasive tools that advance precision medicine and help deliver more personalized care.

"These new partnerships represent an important step in strengthening QIAGEN’s leadership in oncology by aiming to bring innovative MRD technologies into clinical practice," said Jonathan Arnold, Vice President, Head of Precision Partnering Diagnostics at QIAGEN. "We want to in particular strengthen our scalable, cost-effective solutions based on our QIAcuity digital PCR system and enable laboratories and healthcare providers worldwide to use MRD insights for guiding personalized treatment decisions for cancer patients."

Under the new collaborations:

Tracer Biotechnologies, a developer of blood-based molecular diagnostics for cancer, is working with QIAGEN to create companion diagnostics for MRD testing in solid tumors. These assays, designed for use on QIAGEN’s QIAcuity digital PCR platform, are designed to enable the use of minimally invasive blood samples to monitor residual disease with high sensitivity. The approach offers a cost-efficient and quick way to support decentralized implementation in clinical laboratories with results comparable to those generated using next-generation sequencing technologies.
"Partnering with QIAGEN enables Tracer to bring our solid tumor MRD expertise to a broader market using a robust digital PCR platform in QIAcuity," said Mark Kaganovich, CEO, Tracer Biotechnologies. "With QIAcuity’s sensitivity and scalability, we can deliver high-quality companion diagnostics that integrate seamlessly into clinical workflows and offer new options to oncologists and patients."

Foresight Diagnostics and QIAGEN are creating a kit-based version of the Foresight CLARITY assay, a circulating tumor DNA (ctDNA)-based NGS test for certain types of lymphoma. Transitioning the assay from a CLIA central laboratory service to an in-lab kit is designed to allow for broader clinical access and supports pharmaceutical-sponsored trials with companion diagnostic applications.
"We are excited to partner with QIAGEN to accelerate the development of a kit-based version of our CLARITY assay and expand our ability to support pharmaceutical companies in developing companion diagnostics and IVD solutions globally," said Jake Chabon, CEO of Foresight Diagnostics. "By combining our leading MRD technology with QIAGEN’s global infrastructure and expertise, we are well-positioned to deliver a diagnostic kit that has the potential to enable personalized treatment strategies for lymphoma patients worldwide."

MRD testing offers a highly sensitive way to monitor treatment response, identify patients at risk of relapse before symptoms appear and inform decisions on therapy usage. It is also emerging as a surrogate endpoint in clinical trials, accelerating drug development and regulatory review.

QIAGEN’s MRD portfolio spans sample technologies and testing platforms that support workflows from sample to insight. This includes the QIAsymphony system for automated sample preparation, with the new generation QIAsymphony Connect upgraded version being prepared for launch in late 2025, along with PAXgene blood collection tubes for stabilized blood draws. QIAGEN also offers an extensive range of kits for use on the QIAcuity family of digital PCR instruments as well as the QIAseq targeted gene panels for use on third-party NGS systems. Complementing these solutions is the portfolio of QIAGEN Digital Insights solutions that offer integrated bioinformatics for comprehensive NGS data analysis and interpretation to enable comprehensive MRD results.