On June 9, 2026 Actuate Therapeutics, Inc. (NASDAQ: ACTU), a clinical-stage biopharmaceutical company focused on developing novel therapies for difficult-to-treat cancers, reported that elraglusib will be evaluated in the BEACON2 clinical trial, an international, multi-arm, multi-stage platform study designed to identify and advance promising treatment approaches for children with relapsed and refractory neuroblastoma.

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Under the BEACON2 trial design, the combination of elraglusib with dinutuximab beta plus chemotherapy will initially be assessed in a dose confirmation cohort of up to 20 patients to evaluate safety and to determine the maximum tolerated dose (MTD), recommended Phase 2 dose (RP2D), and pharmacokinetics (PK) profile of the regimen. Following successful completion of the dose confirmation stage, the regimen may advance into a randomized portion of the platform trial, where approximately 75 patients will be enrolled with a planned interim analysis.

"Selection for inclusion in BEACON2 represents a defining milestone for the elraglusib program and underscores growing recognition of its novel mechanism and potential applicability in treating pediatric cancers," said Daniel Schmitt, President & Chief Executive Officer of Actuate. "Neuroblastoma remains one of the most devastating diseases for many children whose cancer relapses or becomes resistant to treatment, and we are honored to be part of a collaborative effort dedicated to improving outcomes of these patients. BEACON2 is sponsored by the Cancer Research UK Clinical Trials Unit, University of Birmingham, enabling us to generate meaningful clinical data in a capital-efficient manner. We are particularly encouraged by the convergence of compelling preclinical evidence, early clinical evidence in pediatric cancer, including a complete response achieved in a neuroblastoma patient, and regulatory recognition through FDA Rare Pediatric Disease Designation. Together, these factors provide a strong foundation for further exploring the potential of elraglusib in this area of significant unmet medical need."

Scientific Rationale

The scientific rationale for evaluating elraglusib in neuroblastoma is firmly supported by a growing body of preclinical and clinical evidence. GSK-3β inhibition, elraglusib’s primary mechanism, has been shown to suppress neuroblastoma cell proliferation, promote apoptosis, and disrupt pathways involved in MYCN-driven disease biology, a key driver of high-risk neuroblastoma. Preclinical studies demonstrated that elraglusib enhanced the activity of both chemotherapy and anti-GD2-based immunotherapy, producing significant improvements in tumor control and survival across multiple neuroblastoma models. Notably, 60% of Th-MYCN mice treated with elraglusib plus temozolomide/irinotecan (TEMIRI)/14G2a, remained tumor-free at one year of age compared to 0% in the TEMIRI/14G2a only arm (P<0.0001). These effects were associated with increased infiltration of CD4+ and CD8+ T cells and NK cells within the tumor microenvironment, suggesting a meaningful immunomodulatory component.

Clinical findings further support the development in neuroblastoma. In the Phase 1/2 (NCT04239092) study of elraglusib in combination with cyclophosphamide plus topotecan chemotherapy, patients with advanced relapsed or refractory disease achieved clinical responses or disease control. Importantly, a heavily pretreated neuroblastoma patient with a high-risk molecular profile achieved a complete bone marrow response within 9 cycles.

About BEACON2

BEACON2 (EudraCT 2024-516115-24) is an international, open-label, multi-arm, multi-stage randomized Phase 1/2 trial evaluating multiple treatment regimens aimed at identifying treatment approaches that will lead to improved outcomes. BEACON2 is being conducted by the Cancer Research UK Clinical Trials Unit (CRCTU), University of Birmingham, one of the most respected academic clinical trials organizations in the world and one of only eight units directly funded by Cancer Research UK, the UK’s largest cancer research charity. The trial is currently active across 14 UK sites and has received European regulatory approval via CTIS, with an international network spanning up to 60 sites across 16 countries, including the European Union, UK, Switzerland, Israel, Australia, and New Zealand.

BEACON2 builds on the original BEACON trial, which established a pan-European platform for evaluating and comparing treatment regimens in relapsed and refractory neuroblastoma. Conducted between 2012 and 2021, BEACON enrolled 225 patients across Europe, making it the largest randomized clinical trial ever conducted in this patient population. The study successfully identified two combination regimens worthy of further investigation, including irinotecan and temozolomide and dinutuximab beta administered with a chemotherapy backbone, which demonstrated one-year progression-free survival rates of 65% and 49%, respectively.

About Neuroblastoma

Neuroblastoma is a rare pediatric cancer that develops from immature nerve cells and remains associated with persistently poor outcomes following relapse. Despite advances in frontline therapy, treatment options remain limited for patients whose disease recurs or becomes resistant to treatment, highlighting the need for new therapeutic approaches.

(Press release, Actuate Therapeutics, JUN 9, 2026, View Source [SID1234666518])

On June 9, 2026 Treos Bio, a clinical-stage company developing off-the-shelf and personalized active cancer immunotherapies, reported three abstracts on its proprietary Promiscuous EPItopes (PEPI) Technology accepted for presentation at the European Association for Cancer Research (EACR) 2026 Congress in Budapest, June 8–11.

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The lead clinical finding is from the OBERTO-101 trial in MSS mCRC, a tumor type that has historically responded poorly to currently available immunotherapy approaches. A patient treated with PolyPEPI1018 at Mayo Clinic in 2019 remains disease-free 77.2 months later, with pathological complete response confirmed across resected tissues, including liver lesions.

MSS disease represents the vast majority of colorectal cancer patients and remains one of the largest unmet needs in cancer immunotherapy. PolyPEPI1018 is TREOS Bio’s lead off-the-shelf multi-peptide immunotherapy candidate, already tested in three phase I/II clinical trials. If clinical efficacy continues to be demonstrated, its off-the-shelf design could offer important practical and commercial advantages compared with fully individualized approaches, including simpler logistics, faster treatment availability and broader scalability.

The presentations reinforce several elements of TREOS Bio’s strategy: advancing PolyPEPI1018 in MSS mCRC, demonstrating the potential of the PEPI platform to support target selection without requiring tumor biopsy, and extending the platform into additional difficult-to-treat cancers, including EGFR-mutant non-small cell lung cancer (NSCLC).

"These presentations highlight the potential of TREOS Bio’s PEPI Technology to support target prediction, broad T-cell activation and durable clinical benefit in difficult-to-treat cancers," said Sunjeet Sawhney, Chief Executive Officer of TREOS Bio. "They also reinforce the rationale for advancing PolyPEPI1018 in combination with standard therapies, while applying the PEPI Platform to additional immune-refractory cancers where current options remain limited."

OBERTO-101: Long-Term Pathological Complete Response in MSS mCRC
Co-authored by Dr. Mojun Zhu (Mayo Clinic), Dr. Joleen Hubbard (Allina Health Cancer Institute) and the Treos Bio scientific team, the case describes subject 01-0007: a patient with initially unresectable liver metastases plus lesions in the colon, lung and diffuse lymphadenopathy. After FOLFOX/cetuximab induction, the patient entered OBERTO-101 (NCT03391232) and received three doses of PolyPEPI1018 on top of standard fluoropyrimidine-based maintenance therapy. Tumor shrinkage led to partial response at week 36 and curative R0 surgery at week 56. Surgical pathology showed no viable tumor cells across the liver, colon and all 27 resected lymph nodes, and the patient remains disease-free.

Translational analyses documented broad immune activation, including:

T-cell responses against all seven PolyPEPI1018-targeted antigens;
Increases in tumor-infiltrating lymphocytes (CD3+ and CD8+ cells) after the third dose;
PolyPEPI1018-specific T-cell clonotypes detected in blood and tumor tissue, supporting intratumoral expansion of treatment-induced immune responses targeting non-mutated shared antigens in MSS mCRC.

EGFR-mutant NSCLC: Personalized Immunotherapy Followed by Tumor Regression on Sequential EGFR-TKI Therapy
A second case describes a 59-year-old with metastatic EGFR-mutant NSCLC and brain metastases, whose disease had progressed despite radiotherapy, EGFR-TKIs, chemotherapy and chemo-immunotherapy.

Under the German "individueller Heilversuch" regulatory framework, the patient received an 11-peptide personalized immunotherapy designed without tumor biopsy, using the patient’s HLA genotype and TREOS Bio’s PEPI Panel platform.

De novo T-cell responses against 7/11 peptides (no baseline responses);
Subsequent tumor RNA-sequencing confirmed expression of 8/11 predicted antigens;
After treatment, subsequent osimertinib produced sustained regression of lung and brain lesions, ongoing >9 months, with gene-expression signatures of an activated tumor microenvironment.

PEPI Panel: Rapid Target Selection Without Tumor Biopsy
The third abstract introduces the PEPI Panel, a library of 3,286 synthetic long peptides covering 184 shared tumor antigens across 19 indications. Built using proprietary data from more than 100,000 tumors and 15,693 HLA genotypes, the Panel is designed to identify peptide targets predicted to be immunogenic for individual patients using only a saliva or blood sample:

across 11 patients with seven tumor types, the PEPI Panel predicted approximately 70% of each patient’s top tumor-expressed antigens;
in 6 patients receiving PEPI-guided immunotherapies, 83% (60/72) of selected peptides induced T-cell responses.

PEPI Panel-based treatments can be designed in days, supporting a potentially faster and less invasive approach to personalized cancer immunotherapy.

(Press release, Treos Bio, JUN 9, 2026, View Source [SID1234666519])

On June 9, 2026 AIM ImmunoTech Inc. (NYSE American: AIM) ("AIM" or the "Company"), reported that it has entered into definitive agreements for a registered direct offering and concurrent private placement priced at-the-market under NYSE American rules for gross proceeds of approximately $2.65 million, before deducting placement agent commissions and other offering expenses.

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Ladenburg Thalmann & Co. Inc. is acting as the exclusive placement agent for the offering.

The offering is expected to close on or about June 10, 2026, subject to the satisfaction of customary closing conditions.

In the registered direct offering, the Company will issue and sell 2,554,119 shares of common stock, par value $0.001, at a purchase price of $0.5189 per share (the "Registered Shares"). In addition, in a concurrent private placement, the Company will issue and sell an aggregate of 2,554,119 unregistered shares of Common Stock (or pre-funded warrants in lieu thereof) (the "Unregistered Shares") at the per share purchase price and unregistered Class J warrants (the "Class J Warrants") to purchase up to 10,216,476 shares of Common Stock. The Class J Warrants will have an exercise price of $0.5189 per share, will be exercisable subject to stockholder approval and will expire five (5) years from the initial exercise date.

The Company intends to use the net proceeds from the offering for (i) the manufacture of clinical drug supply, (ii) the Company’s current clinical trial activities, (iii) the Company’s planned Phase 3 clinical trial activities, and (iv) working capital purposes.

The Registered Shares (or common stock equivalents in lieu thereof) are being offered and sold pursuant to a prospectus supplement to be filed with the Securities and Exchange Commission ("SEC") in connection with a takedown from the Company’s shelf registration statement on Form S-3 (File No. 333-286319), which was declared effective by the SEC on July 3, 2025. The offering is being made only by means of a prospectus supplement and accompanying prospectus which are a part of the effective registration statement. The Unregistered Shares and Class J Warrants will be issued in a concurrent private placement. A prospectus supplement and the accompanying prospectus relating to the registered direct offering will be filed with the SEC and will be available on the SEC’s website at www.sec.gov. Additionally, when available, electronic copies of the prospectus supplement and the accompanying prospectus may be obtained from Ladenburg Thalmann & Co. Inc., 640 Fifth Avenue, 4th Floor, New York, NY 10019, by phone at (212) 409-2000, or by email at [email protected]. The private placement of the Unregistered Shares, the Class J Warrants and the shares underlying the Class J Warrants offered to the institutional investors will be made in reliance on an exemption from registration under Section 4(a)(2) of the Securities Act of 1933, as amended (the "Securities Act"), and Regulation D promulgated thereunder. Accordingly, the securities issued in the concurrent private placement may not be offered or sold 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.

This press release shall not constitute an offer to sell or the solicitation of an offer to buy any of the securities described herein, nor shall there be any sale of these securities in any state or other jurisdiction in which such offer, solicitation, or sale would be unlawful prior to the registration or qualification under the securities laws of any such state or other jurisdiction.

(Press release, AIM ImmunoTech, JUN 9, 2026, View Source [SID1234666506])

On June 9, 2026 GSK plc (LSE/NYSE: GSK) reported that it has entered an agreement to acquire Nuvalent, Inc. ("Nuvalent") (NASDAQ: NUVL) a Boston-based clinical-stage biopharmaceutical company focused on creating precisely targeted oncology therapies, for $10.6 billion. The acquisition is consistent with GSK’s strategy of acquiring assets that have validated targets and meaningfully address efficacy and/or tolerability limitations of existing standard-of-care therapies. It includes three products in lung cancer in a single transaction.

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Zidesamtinib (NVL-520) and neladalkib (NVL-655) are two late-stage, potential best-in-class, next-generation, highly selective ROS1 and ALK inhibitors for treatment of NSCLC. Both assets have received FDA Breakthrough Therapy and Orphan Drug Designations* and are in review with target decision dates of 18 September 2026 for zidesamtinib and 27 November 2026 for neladalkib. Subject to FDA approval, they are expected to launch in 2026 and have multi-blockbuster potential. The third asset, NVL-330, is a potential best-in-class HER2 inhibitor currently in phase I trials for HER2-altered NSCLC. The acquisition also includes Nuvalent’s preclinical portfolio of multiple programmes, built from their proven precision medicine capabilities and clinical insights from industry-leading physician-scientists.

Luke Miels, Chief Executive Officer, GSK said: "Today’s acquisition is a multi-product deal, consistent with our approach to acquire assets that have clinically proven targets and meaningfully address an efficacy and/or tolerability gap. The two lead products are potential best-in-class assets that could launch this year if approved by the FDA and offer significant new treatment options to patients with two forms of non-small cell lung cancer.

The acquisition provides GSK with immediate new sales growth opportunities, improving profit contributions from 2027, and a platform in lung cancer for rapid expansion with Ris-Rez, our B7-H3 targeted ADC in phase III clinical development."

Pivotal data presented at the IASLC 2025 World Conference on Lung Cancer and the 2026 ASCO (Free ASCO Whitepaper) Annual Meeting show potential best-in-class profiles for zidesamtinib and neladalkib.1,2 Both assets aim for longer effective treatment with better quality of life through high target-selectivity, durable treatment response, improved tolerability, enhanced blood-brain barrier penetration for tumour spread, and broader coverage of ALK and ROS1 mutations, potentially addressing efficacy and/or tolerability limitations of existing therapies. ROS1- and ALK-altered NSCLC primarily affect non-smoking adults aged 40-50, a uniquely defined and engaged patient population. There is substantive treatment experience with zidesamtinib and neladalkib already through their clinical development and patient assistance programmes.3,4

James Porter, PhD, Chief Executive Officer, Nuvalent, said: "Since our founding, we have leveraged our deep expertise in chemistry and structure-based drug design to develop a portfolio of novel, potentially best-in-class kinase inhibitors. Our close collaboration with leading physician-scientists and patient advocates has driven remarkable enrolment, accelerating development and building confidence in the clinical profile of these drugs. We’re excited that GSK has recognised the significant value these programmes can offer patients and shares our vision for practice-changing innovation. GSK’s proven track record, infrastructure, and expertise will support the successful commercialisation of zidesamtinib and neladalkib, as well as accelerate advancement of our broader discovery pipeline."

Financial considerations
Under the terms of the merger agreement, GSK will commence a tender offer to acquire all of Nuvalent’s outstanding shares of Class A and Class B common stock at a purchase price of $124 per share in cash within 10 business days. The aggregate equity value of the transaction is estimated to be $10.6 billion (£8.0 billion). Net of cash acquired, GSK’s aggregate investment is estimated to be $9.4 billion (£7.1 billion). The expected purchase price of $124 per share represents a 40% premium to the last closing price and a 26% premium to the 30 calendar day Volume-Weighted Average Price (VWAP).

There is no change to GSK’s 2026 full-year guidance range of 7-9% core operating profit and core EPS growth. The acquisition is expected to contribute to revenue growth from 2027, be incremental to the Group’s existing ambition for sales of >£40 billion by 2031 and to strengthen core operating profit through the dolutegravir loss of exclusivity period (2028-2030). We expect accretion to core operating profit in 2027 and core EPS in 2029 inclusive of synergies and reprioritisation. Assuming the transaction closes in Q3 2026, we expect low single-digit percentage dilution to core EPS for the current year, FY 2027 and FY 2028.

The transaction will be funded primarily from new and existing debt facilities plus cash, with no impact expected to GSK’s credit rating. GSK will maintain a strong investment grade credit profile and retains balance sheet capacity for further accretive business development.

GSK remains committed to its 70p expected dividend for 2026 and to its progressive dividend policy thereafter.

The transaction is subject to customary closing conditions, including the tender of a majority of Nuvalent’s outstanding shares of Class A common stock in the tender offer and the expiration or termination of the applicable waiting period under the Hart-Scott-Rodino Act in the US. Promptly following the closing of the tender offer, GSK expects to acquire any remaining shares of Nuvalent through a second-step merger under Delaware law at the same price per share.

GSK will account for the transaction as a business combination. GSK will also assume Nuvalent’s existing revenue-sharing arrangements of low-single-digit royalties payable to Royalty Pharma and Deerfield.

Advisors
Leerink Partners LLC and Citigroup Inc. are acting as financial advisors and Davis Polk & Wardwell LLP and Slaughter and May are serving as legal counsel to GSK in connection with the transaction. Centerview Partners LLC is serving as financial advisor and Ropes & Gray LLP is serving as legal counsel to Nuvalent. Jefferies LLC also provided financial advice to Nuvalent. Sidley Austin LLP is corporate counsel to Nuvalent.

About NSCLC
NSCLC is the most common form of lung cancer and is often characterised by specific genetic alterations, such as those in ALK, ROS1, or HER2. It can often metastasise (i.e. spread) to the central nervous system. It primarily affects working-age individuals. Current treatments are associated with mutation resistance and side effects, including metabolic and neurologic events, that can adversely impact patients’ quality of life.

(Press release, GlaxoSmithKline, JUN 9, 2026, View Source [SID1234666507])

On June 9, 2026 Zetagen Therapeutics, a clinical-stage biopharmaceutical company developing novel therapies for primary and metastatic breast cancer, reported preliminary topline results from its Phase 2a clinical study evaluating ZetaMet (Zeta BC 003) in subjects with metastatic breast cancer (MBC) with lytic bone lesions.

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In this open-label study, no skeletal-related events (SREs) or fractures were observed, no treatment-emergent adverse events (AEs) or serious adverse events (SAEs) were reported, and cessation of tumor activity was noted in treated vertebral bodies. Zeta BC 003 is an investigational product that has received Breakthrough Designation from the U.S. Food and Drug Administration (FDA) and has not been approved by the FDA or any regulatory authority.

"We are encouraged by the preliminary findings from this Phase 2a study, which provide important clinical observations on the investigational use of ZetaMet in patients with metastatic breast cancer involving bone," said Joe C. Loy, President & CEO of Zetagen Therapeutics. "These results also highlight a major achievement for our team, overcoming longstanding industry challenges in intratumoral administration by developing proprietary carriers which deliver compounds that demonstrate solubility and localized bio-adhesion."

The preliminary findings were presented by Dr. Bryan Margulies, Chief Scientific Officer, and Joe C. Loy, President & CEO, at the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting on Monday, June 2, 2026. Abstract: View Source

Study Overview
The open-label Phase 2a study (ZGMBC; NCT05280067), conducted at the University of British Columbia, enrolled 10 subjects with a mean age of 52, representing multiple MBC subtypes:

HR+ (n=6)
HR+/HER2+ (n=2)
HER2+/HR– (n=1)
TNBC (n=1)
Five subjects had breakthrough lytic lesions despite prior bisphosphonate therapy. One subject died due to pleural edema, unrelated to study treatment. Across the 10 subjects, 11 target lesions received a single intratumoral injection of Zeta BC 003 under sedation. Four adjacent, non-injected lesions were also evaluated.

Study Context
Historical literature reports SRE rates of approximately 53% (Parke et al., Journal Oncologist, 2018) in metastatic breast cancer with bone involvement under conventional therapy, with SREs, particularly fractures, associated with a reduction in overall survival of approximately 4.8 months (Saad et al., Journal of the National Cancer Institute, 2004).

Observed Study Findings
No SREs or fractures reported
Cessation of tumor activity within treated vertebral bodies
Therapeutic spread observed to adjacent, untreated lesions within the same vertebral body
No treatment-emergent AEs or SAEs
Mean bone defect volume decreased 65.4% at Day 84 (±20.5%; p=0.0003)
Mean bone defect volume decreased 84.1% at Day 180 (±13.1%; p<0.0001)
Pain scores (NRS) decreased by 4.16 points (p<0.05)
Opioid use (MED) decreased 33–67% among opioid-treated subjects
Spinal stability (SINS) improved 18.5% (p<0.05)
Quality of life improved:
PCS increased 24.2%
MCS increased 12.1%
While cross-study comparisons have inherent limitations, the absence of AEs and SREs in this Phase 2a study provides supportive information for continued investigation.

These observations are also consistent with two published Expanded Access case reports (seven lesions, 2-year follow-up; Palma et al., Pain Management, 2023), which similarly demonstrated absence of SREs, cessation of tumor activity, neo-trabecular bone formation, and therapeutic spread within treated vertebral bodies.

(Press release, Zetagen Therapeutics, JUN 9, 2026, View Source [SID1234666509])