On May 26, 2025 Immutep Limited (ASX: IMM; NASDAQ: IMMP) ("Immutep" or "the Company"), a late-stage immunotherapy company targeting cancer and autoimmune diseases, reported the investigator-initiated EFTISARC-NEO Phase II trial evaluating eftilagimod alfa (efti) with radiotherapy plus KEYTRUDA (pembrolizumab) in the neoadjuvant setting for resectable soft tissue sarcoma (STS) has met its primary endpoint (Press release, Immutep, MAY 26, 2025, View Source [SID1234653375]). The novel combination significantly exceeded the study’s prespecified median of 35% tumour hyalinization/fibrosis versus 15% for historical data from radiotherapy alone in patients with resectable soft tissue sarcoma (STS).

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Tumour hyalinization/fibrosis is an early surrogate endpoint at the time of surgical resection that has been associated with improved overall survival and recurrence-free survival for STS patients.1,2 The trial’s investigators at the Maria Skłodowska-Curie National Research Institute of Oncology (MSCNRIO) in Warsaw, the national reference centre for STS in Poland, plan to present detailed results from the study at a future medical meeting.

Katarzyna Kozak, M.D., Ph.D., and Paweł Sobczuk, M.D., Ph.D., medical oncologists at the Department of Soft Tissue/Bone Sarcoma and Melanoma at MSCNRIO and the trial’s principal investigators, said: "It is very encouraging to see the chemotherapy-free combination with efti far exceed the ambitious target we initially set for the trial’s primary endpoint in resectable soft tissue sarcoma. These results support our belief that efti’s activation of antigen-presenting cells, and in turn a broad adaptive and innate immune response, helps transform the immunosuppressed tumour microenvironment of soft tissue sarcomas leading to strong anti-cancer efficacy. There remains a very high unmet need in this aggressive orphan cancer indication and we look forward to presenting detailed results at a medical meeting later this year."

As previously announced at the Connective Tissue Oncology Society (CTOS) Annual Meeting in November 2024, the combination therapy demonstrated significant efficacy with a median of 50% tumour hyalinization/fibrosis in a preliminary analysis of 21 patients with resectable STS available for primary endpoint assessment. The EFTISARC-NEO study, which is primarily funded with a grant from the Polish government awarded by the Polish Medical Research Agency program, subsequently completed enrolment of 40 patients in January 2025.

STS is an orphan disease with high unmet medical need and a poor prognosis for patients. The incidence of STS varies in different regions globally. In the United States, the number of new STS cases in 2025 is estimated to be ~13,520 with ~5,420 deaths, according to the American Cancer Society.3

For more information on EFTISARC-NEO, visit clinicaltrials.gov (NCT06128863).

About Eftilagimod Alfa (efti)
Efti is Immutep’s proprietary soluble LAG-3 protein and MHC Class II agonist that stimulates both innate and adaptive immunity for the treatment of cancer. As a first-in-class antigen presenting cell (APC) activator, efti binds to MHC (major histocompatibility complex) Class II molecules on APC leading to activation and proliferation of CD8+ cytotoxic T cells, CD4+ helper T cells, dendritic cells, NK cells, and monocytes. It also upregulates the expression of key biological molecules like IFN-ƴ and CXCL10 that further boost the immune system’s ability to fight cancer.

Efti is under evaluation for a variety of solid tumours including non-small cell lung cancer (NSCLC), head and neck squamous cell carcinoma (HNSCC), and metastatic breast cancer. Its favourable safety profile enables various combinations, including with anti-PD-[L]1 immunotherapy and/or chemotherapy. Efti has received Fast Track designation in first line HNSCC and in first line NSCLC from the United States Food and Drug Administration (FDA).

On May 23, 2025 BriaCell Therapeutics Corp. (Nasdaq: BCTX, BCTXW, BCTXZ), (TSX: BCT) (" BriaCell " or the " Company "), a clinical-stage biotechnology company developing novel immunotherapies to transform cancer care, reported the presentation of positive survival and clinical benefit data in three clinical poster presentations and one publish-only abstract at the upcoming 2025 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting taking place May 30 – June 3 at McCormick Place, Chicago, IL (Press release, BriaCell Therapeutics, MAY 23, 2025, View Source [SID1234653598]).

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"We are highly encouraged by the survival and clinical benefit data from our Phase 2 Bria-IMT study which meets and outperforms outcomes seen with FDA approved therapies – despite our patients being more heavily pre-treated," stated Dr. William V. Williams, BriaCell’s President & CEO. "These results reinforce our belief in Bria-IMT’s potential to address the urgent, unmet needs of patients with metastatic breast cancer and we look forward to confirming results in our ongoing pivotal Phase 3 study."

"These data provide additional validation of the mechanism of action and support the clinical efficacy of Bria-IMT," noted Giuseppe Del Priore, MD, MPH, BriaCell’s Chief Medical Officer. "Importantly, the regimen has been well-tolerated and its favorable safety and efficacy profile positions it as a promising, less toxic therapeutic option for patients battling metastatic breast cancer."

The details of the poster presentation sessions and publish-only abstract are listed below.

Abstract Title: Update on phase III pivotal trial of Bria-IMT + CPI vs physician’s choice in advanced metastatic breast cancer (BRIA-ABC)
Session Date and Time: June 2, 2025 9:00 AM-12:00 PM CDT
Abstract Number for Publication: TPS1138
Poster Board Number: 108a
Session Type and Title: Poster Session – Breast Cancer—Metastatic

Preliminary selected clinical and biomarker data from BriaCell’s ongoing pivotal Phase 3 study of Bria-IMT plus an immune checkpoint inhibitor (CPI) in metastatic breast cancer ( NCT06072612 ).

Abstract Title: Bria-IMT + checkpoint inhibitor: Phase I/II survival results compared to benchmark trials in metastatic breast cancer
Session Date and Time: June 2, 2025 9:00 AM-12:00 PM CDT
Abstract Number for Publication: 1096
Poster Board Number: 75
Session Type and Title: Poster Session – Breast Cancer—Metastatic

Phase 2 study of Bria-IMT in combination immunotherapy with an immune checkpoint inhibitor (CPI) consisted of 54 patients; 11 received pembrolizumab, 44 retifanlimab (1crossover).

Table 1: Median overall survival (OS), progression-free survival (PFS), objective response rate (ORR), and clinical benefit rate (CBR) were evaluated against two pivotal Phase 3 studies of FDA approved drugs, ASCENT (Trodelvy (SG) or Treatment of Physicians Choice (TPC) in triple-negative breast cancer (TNBC)) and TROPiCS-02 (SG or TPC in Hormone Receptor +/HER2- MBC)
Trial (Cohort) Age (median, range) Prior Therapies (median, range) OS (months) PFS (months) ORR
(%) CBR
(%)
Bria-IMT (Overall Cohort) 61 (38-81) 6 (2-13) 9.9 (1.8-30.3) 3.6 10% 55%
Bria-IMT (Phase 3 regimen) 62 (44-80) 6 (2-13) 13.43 (1.8-30.3) 3.6 (1.8-16.5) 14 % 61 %
ASCENT (SG) 54 (27-82) 4 (2-17) 11.8 4.8 31% 40%
ASCENT (TPC) 53 (27-81) 4 (2-14) 6.9 1.7 4% 8%
TROPiCS-02 (SG) 57 (49-65) 3 14.4 5.5 21% 34%
TROPiCS-02 (TPC) 55 (48-63) 3 11.2 4 14% 22%
Bria-IMT was well-tolerated with no treatment-related discontinuations. 22% of patients are still in active survival follow up.

This analysis does not stratify Bria-IMT patients by hormone receptor or HER2 status, and the dataset reflects the information available at the time of abstract submission. Updated data will be shared during the company’s presentation at ASCO (Free ASCO Whitepaper) 2025.

PFS (median) and OS (median): Patients treated with Bria-IMT’s selected Phase 3 formulation (without IFNγ; N = 37) demonstrated significantly improved progression-free survival (3.6 vs. 2.6 months; P = 0.01) and overall survival (13.4 vs. 6.9 months; P = 0.01) compared to those who received the alternate formulation not advanced to Phase 3.

The overall survival observed in the Phase 3 formulation cohort (13.4 months) was comparable to that reported in the ASCENT (11.8 months) and TROPiCS-02 (14.4 months) studies and exceeded survival outcomes in their respective treatment of physician’s choice (TPC) arms (6.9 and 11.2 months).

BriaCell’s Phase 2 study also achieved a Clinical Benefit Rate (CBR) of 61%, outperforming ASCENT (40%) and TROPiCS-02 (34%), and an Objective Response Rate (ORR) of 14%, which matched or exceeded the TPC arms in both studies (4% and 14%).

Importantly, these outcomes were achieved in a more heavily pretreated patient population than those in the comparator trials—highlighting Bria-IMT’s strong anti-cancer activity. The favorable efficacy profile of the Phase 3 formulation supports its continued evaluation in BriaCell’s ongoing pivotal Phase 3 trial comparing Bria-IMT to treatment of physician’s choice ( NCT06072612 ).

Abstract Title: Trial in progress: A study of Bria-OTS cellular immunotherapy in metastatic recurrent breast cancer
Session Date and Time: June 2, 2025 9:00 AM-12:00 PM CDT
Abstract Number for Publication: TPS1136
Poster Board Number: 107a
Session Type and Title: Poster Session – Breast Cancer—Metastatic

Heavily pre-treated MBC patients were treated in a dose escalation Phase 1/2 study of Bria-OTS monotherapy (single agent). The Phase 1 part of the study has enrolled and treated 3 patients. The first patient treated with single agent therapy has confirmed resolution of a breast cancer metastasis in the lung and remains on study.

Publish-Only Abstract Title : Impact of HLA Matching on Clinical Outcomes in a Phase 2 Trial of Bria-IMT Plus Anti PD1 in Advanced Breast Cancer

Following the presentations, copies of the presentations will be posted on View Source

On May 23, 2025 IMUNON, Inc. (NASDAQ: IMNN), a clinical-stage company in Phase 3 development of its DNA-mediated immunotherapy, reported that it has entered into definitive agreements for the issuance and sale of an aggregate of 7,222,223 shares of its common stock (or pre-funded warrants in lieu therof) and short-term warrants to purchase up to an aggregate of 14,444,446 shares of common stock at a purchase price of $0.45 per share (or pre-funded warrant in lieu thereof) and accompanying short-term warrants in a private placement priced at-the-market under Nasdaq rules (Press release, IMUNON, MAY 23, 2025, View Source [SID1234653374]). The warrants will be exercisable beginning on the effective date of stockholder approval of the issuance of the shares of common stock upon exercise of the warrants at an exercise price of $0.45 per share and will expire three years from the date of stockholder approval. The offering is expected to close on or about May 27, 2025, subject to the satisfaction of customary closing conditions.

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H.C. Wainwright & Co. is acting as the the exclusive placement agent for the offering. Brookline Capital Markets, a division of Arcadia Securities, LLC, is acting as financial advisor.

The aggregate gross proceeds to the Company from the private placement is expected to be approximately $3.25 million, before deducting placement agent fees and other offering expenses payable by the Company. The potential additional gross proceeds to the Company from the short-term warrants, if fully-exercised on a cash basis, will be approximately $6.5 million. No assurance can be given that any of such short-term warrants will be exercised. The Company intends to use the net proceeds from the offering for working capital and general corporate purposes.

The shares of common stock, pre-funded warrants and short-term warrants described above were offered in a private placement under Section 4(a)(2) of the Securities Act of 1933, as amended (the "Act") and Regulation D promulgated thereunder and, along with the shares of common stock underlying the pre-funded warrants and short-term warrants, have not been registered under the Act or applicable state securities laws. Accordingly, the shares of common stock, the pre-funded warrants, the short-term warrants and the shares of common stock underlying the pre-funded warrants and short-term warrants may not be offered or sold in the United States absent registration with the Securities and Exchange Commission ("SEC") or an applicable exemption from such registration requirements. The securities were offered only to accredited investors. Pursuant to a registration rights agreement, the Company has agreed to file one or more registration statements with the SEC covering the resale of the shares of common stock and the shares issuable upon exercise of the pre-funded warrants and short-term warrants.

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

On May 23, 2025 Antengene Corporation Limited ("Antengene", SEHK: 6996.HK), a leading innovative, commercial-stage global biopharmaceutical company dedicated to discovering, developing and commercializing first-in-class and/or best-in-class medicines for hematologic malignancies and solid tumors, reported that it will present the latest clinical data of its CD73 oral small molecule inhibitor ATG-037 and oral dual mTORC1/2 inhibitor ATG-008 in Poster Presentations at the 2025 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting, taking place from May 30th to June 3rd in Chicago, IL, the United States (Press release, Antengene, MAY 23, 2025, View Source [SID1234653373]).

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Details of the Poster Presentations:
ATG-037 (CD73 Small Molecule Inhibitor)
Title: A First-In-Human Phase I/Ib study of ATG-037 Monotherapy and Combination Therapy with Pembrolizumab in Patients with Advanced Solid Tumors – STAMINA-01
Abstract: 3123
Session: Developmental Therapeutics—Molecularly Targeted Agents and Tumor Biology
Date: June 2, 2025
Time: 1:30 PM – 4:30 PM (Central Time)
2:30 AM – 5:30 AM, June 3, 2025 (Beijing Time)

Robust clinical benefit observed in CPI-resistant patients: As of April 27, 2025, the study has already completed the dose escalation part in which 43 patients were enrolled and received monotherapy. Among them, 28 CPI-resistant patients also received the combination therapy. Among patients treated with the combination therapy, 6 patients (4 melanoma and 2 NSCLC patients) achieved a confirmed PR with an ORR of 21.4%, and 16 patients achieved stable disease (SD) with a DCR of 78.6%. The combination regimen delivered particularly encouraging efficacy in melanoma, with all 11 CPI-resistant patients achieving disease control (DCR 100%) and an ORR of 36.4% (4 PRs), including 1 patient having maintained PR and remained in the study for over 2 years without any safety concerns. In CPI-resistant NSCLC, the combination regimen achieved an ORR of 22% (PRs) and a DCR of 67%. These results highlight the potential of ATG-037 to deliver meaningful clinical benefit across multiple tumor types, reinforcing its promise as a novel treatment option in CPI-resistant cancers.
Manageable safety profile: Treatment-related adverse events were reported in 56% (24/43) of patients receiving monotherapy and 61% (17/28) of patients receiving the combination therapy. The majority of these TRAEs were grade 1-2. Only one serious TRAE (grade 3 immune mediated hepatitis) was observed in the study.
Two key differentiators: ATG-037 is an oral small molecule CD73 inhibitor offering greater convenience over intravenous (IV) injectable agents and is uniquely designed to overcome the ‘hook effect’ commonly seen in anti-CD73 antibodies, enabling complete and more effective CD73 inhibition.
The STAMINA-01 trial: STAMINA-01 is a Phase I/Ib study jointly conducted by Antengene and MSD (Merck & Co., Inc., Rahway, NJ, USA). The study was designed to evaluate the safety, pharmacokinetics, and optimal dosing of ATG-037 as a monotherapy and in combination with MSD’s anti-PD-1 therapy, KEYTRUDA (pembrolizumab), in patients with refractory/relapsed solid tumors. At present, dose optimization and dose expansion parts of the study are being carried out as planned in China and Australia.
KEYTRUDA is a registered trademark of Merck Sharp & Dohme LLC, a subsidiary of Merck & Co., Inc., Rahway, NJ, USA.

ATG-008 (mTORC1/2 Small Molecule Inhibitor)
Title: A TORC1/2 inhibitor onatasertib combined with toripalimab in patients with advanced cervical cancers with prior anti-PD-(L)1 therapy
Abstract: 5540
Session: Gynecologic Cancer
Date: June 1, 2025
Time: 9:00 AM – 12:00 PM (Central Time)
10:00 PM, June 1, 2025 – 1:00 AM, June 2, 2025 (Beijing Time)

The TORCH-2 trial: ATG-008 is an oral dual mTOR1/2 inhibitor. The TORCH-2 trial is a Phase I/II dose escalation and dose expansion study of ATG-008 in combination with the anti-PD-1 monoclonal antibody toripalimab in patients with advanced solid tumors. This abstract reports data from patients with advanced cervical cancer who had previously received at least prior 1 line of anti-PD-(L)1 therapy and 1 line of platinum chemotherapy, regardless of the PD-L1 expression. As of November 25, 2024, 30 qualified patients were enrolled and received ATG-008 15 mg orally once a day (QD) in combination with toripalimab 240 mg, once every 21 days (Q3W). Among them, 14 and 16 patients had received 1 and at least 2 prior lines of systemic therapy, respectively. The median time since initial diagnosis was 37 months.
Encouraging efficacy in patients with CPI-resistant cervical cancer: Among 27 efficacy-evaluable patients, the combination regimen achieved an ORR of 22.2% and a DCR of 85.2%. The ORRs of PD-L1 positive and PD-L1 negative populations were 30% (3/10) and 33.3% (2/6), respectively. The median time to response was 1.7 months (1.4, 4.2) and the median duration of response (DOR) was 5.7 months (95% CI: 2.7, NE). The median progression-free survival (PFS) was 4.2 months (95% CI: 3.3, 5.8) and the median overall survival (OS) was 21.4 months (95% CI: 15.5, NE). These results underscore the potential of ATG-008 in combination with toripalimab in providing meaningful clinical benefit for CPI-resistant cervical cancer patients, reinforcing its promise as a novel treatment option for this difficult-to-treat patient population.
Manageable safety profile: All 30 patients experienced at least one TEAE, and 22 patients (73.3%) reported grade ≥3 TRAEs. The most common all-grade TRAEs were hyperglycaemia (56.7%), rash (43.3%) and white blood cell decreased (43.3%). Most TRAEs were grade 1-2, and no TEAE led to death.

On May 23, 2025 Nona Biosciences, a global biotechnology company providing integrated solutions from "Idea to IND" (I to ITM), reported that its collaborator, Pfizer, will present an abstract detailing the first-in-human Phase 1 clinical study design of MesoC2 (HBM9033/PF-08052666), a first-in-class mesothelin (MSLN)-targeting antibody-drug conjugate (ADC), at the 2025 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting (Press release, Nona Biosciences, MAY 23, 2025, View Source [SID1234653372]).

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MesoC2, originally developed using Nona’s proprietary Harbour Mice and integrated ADC platforms, was licensed to Pfizer in December 2023 under a global rights agreement. Pfizer is currently evaluating the ADC in a Phase 1, open-label study in patients with advanced solid tumors, including mesothelioma, platinum-resistant ovarian cancer (PROC), pancreatic ductal adenocarcinoma (PDAC), non-small cell lung cancer (NSCLC), endometrial cancer (EC), and colorectal cancer (CRC).

Poster Presentation at the 2025 ASCO (Free ASCO Whitepaper) Annual Meeting
Title: A phase 1 study to evaluate the safety and tolerability of the antibody–drug conjugate (ADC) MesoC2 (PF-08052666) in patients with advanced solid tumors
Abstract Number: TPS3163
Poster Board Number: 475a
Session Title: Poster Session – Developmental Therapeutics – Molecularly Targeted Agents and Tumor Biology
Session Date and Time: 02 June 2025; 1:30 PM-4:30 PM (CDT)

Key Highlights from the Presentation:

MesoC2 is an ADC composed of a human IgG1 anti-MSLN monoclonal antibody conjugated to a cleavable tripeptide linker carrying a topoisomerase 1 inhibitor (TOP1i) payload (average drug-to-antibody ratio of 8).
MesoC2 has shown potent antitumor efficacy in in vitro assays and xenograft models and an acceptable safety profile in cynomolgus monkeys.
The Phase 1 trial (NCT06466187) will assess the safety, tolerability, pharmacokinetics, pharmacodynamics, and preliminary efficacy per RECIST v1.1 criteria of MesoC2 in up to 365 patients across dose escalation, optimization, and expansion cohorts.
"We are excited to see Pfizer advancing MesoC2 into clinical development rapidly, highlighting the potential of Nona’s Harbour Mice and integrated ADC platforms to deliver innovative cancer therapies," said Dr. Jingsong Wang, Chairman of Nona Biosciences. "The initiation of this Phase 1 trial marks a significant milestone in our collaboration and underscores our shared commitment to addressing unmet needs in oncology."

Pfizer’s presentation at the 2025 ASCO (Free ASCO Whitepaper) Annual Meeting will provide further insights into the trial design. Additional details on the study can be found at ClinicalTrials.gov (NCT06466187).

About MesoC2 (HBM9033/PF-08052666)

MesoC2 (HBM9033/PF-08052666) is an ADC drug that targets human MSLN, a tumor-associated antigen (TAA) upregulated in various solid tumors. The fully human monoclonal antibody (mAb) in MesoC2 is derived from the Harbour Mice platform and possesses well-tuned properties, exhibiting reduced binding to soluble MSLN while maintaining strong binding and internalization to membrane-bound MSLN. The unique design of the mAb was created to enhance potency in various preclinical tumor models with differing MSLN expression levels, positioning MesoC2 as a potential globally best-in-class therapeutic option.