On May 26, 2025 Alligator Bioscience (Nasdaq Stockholm: ATORX) reported that the European Commission has granted orphan drug designation (ODD) to HLX22, an anti-HER2 monoclonal antibody, for the treatment of gastric cancer (Press release, Alligator Bioscience, MAY 26, 2025, View Source [SID1234653378]). HLX22 is being developed by Shanghai Henlius Biotech, Inc. under a sublicense from AbClon, Inc., which had previously licensed the antibody from Alligator.

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This designation follows the ODD granted by the U.S. Food and Drug Administration (FDA) in March 2025, further highlighting HLX22’s potential as a treatment for HER2-positive gastric cancer.

Henlius is conducting a global Phase 3 clinical trial (NCT06532006) to evaluate HLX22 in combination with trastuzumab and chemotherapy as a first-line treatment for HER2-positive metastatic gastric and gastroesophageal junction (GEJ) cancer.

Søren Bregenholt, CEO of Alligator Bioscience, commented:
"The orphan designation to HLX22 in Europe represents another important regulatory milestone for this program. Following the earlier FDA designation, this reinforces the potential clinical and commercial value of the antibody. While Alligator is not directly involved in the development, we look forward to following its progress as it may contribute future revenue to Alligator."
Under the terms of the license agreement, Alligator is entitled to 35% of AbClon’s revenue from its sublicense agreement with Henlius.

On May 26, 2025 Abbisko Therapeutics (HKEX Code: 02256) reported that its self-developed, highly selective small molecule FGFR4 inhibitor, irpagratinib (ABSK011), has received approval of Breakthrough Therapy Designation from the Center for Drug Evaluation (CDE) of the China National Medical Products Administration (NMPA) for the treatment of Hepatocellular Carcinoma (HCC) (Press release, Abbisko Therapeutics, MAY 26, 2025, View Source [SID1234653376]). Irpagratinib is the first therapeutic agent to leverage molecularly defined biomarkers for precision-targeted treatment in patients with HCC.

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During clinical trials, innovative drugs or modified new drugs intended to prevent or treat life-threatening diseases or conditions that severely impact quality of life—where no effective prevention or treatment exists, or where substantial evidence shows significant clinical advantages over existing therapies—may be eligible to apply for the CDE’s Breakthrough Therapy Designation program[1]. The approval of irpagratinib for Breakthrough Therapy Designation is based on its promising Phase I clinical trial data.

Patients with advanced or unresectable HCC currently lack effective treatment options following treatment with ICI- and mTKI-based therapies. Those with FGF19 overexpression often face significantly worse prognosis, and thus new treatment options are urgently needed. The Breakthrough Therapy Designation granted to irpagratinib will expedite its subsequent application and approval process with the CDE, bringing renewed hope and transformative possibilities to patients.

Recently, Abbisko launched a pivotal registrational clinical study of irpagratinib for the treatment of HCC patients with FGF19 overexpression at Tongji Hospital, Tongji Medical College, Huazhong University of Science & Technology, and Nanjing Tianyinshan Hospital.

About Irpagratinib (ABSK-011)

Irpagratinib is a highly-selective FGFR4 small molecule inhibitor designed to target overexpression of the FGF19 signaling pathway. Several epidemiological studies indicate that approximately 30% of HCC patients worldwide exhibit FGF19 overexpression. Development of targeted therapies against FGFR4 represent an innovative and novel approach to the treatment of HCC.

To date, no FGFR4 inhibitor has been granted regulatory approval globally. According to Frost & Sullivan, irpagratinib is expected to become the first breakthrough treatment for the treatment of HCC patients with FGF19 overexpression.

In addition to monotherapy, Abbisko Therapeutics is exploring irpagratinib in combination with atezolizumab, an anti-PD-L1 antibody manufactured by F. Hoffmann-La Roche and Roche (China), in a Phase II study. At the previous 2024 ESMO (Free ESMO Whitepaper) GI Congress, Abbisko presented clinical data demonstrating 220mg irpagratinib BID in combination with atezolizumab achieved a 50% objective response rate (ORR) in FGF19+ HCC patients who had previously received immune checkpoint inhibition therapy.

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.