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mAbxience and Abiogen Pharma Announce Strategic Licensing Agreement for Biosimilar Candidate in Italy

On May 26, 2025 mAbxience, a Fresenius Kabi majority-owned group with partial ownership from Insud Pharma, and Abiogen Pharma reported a new strategic licensing agreement to develop and commercialize a biosimilar candidate in Italy (Press release, mAbxience, MAY 26, 2025, View Source [SID1234653380]).

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Under the terms of this agreement, mAbxience will hold the marketing authorization for the biosimilar candidate, while Abiogen Pharma will be responsible for all commercialization and marketing activities in Italy. This collaboration combines mAbxience’s expertise in biosimilar development with Abiogen Pharma’s strong presence and commercial capabilities in the Italian market.

"We are thrilled to partner with Abiogen Pharma to bring this biosimilar candidate to patients in Italy. Our collaboration reflects mAbxience’s commitment to delivering high-quality, accessible therapies across various geographies," said José Ramón Millán, Global Partnering & Portfolio Director at mAbxience.

"This agreement is part of a broader, long-term strategic path for us," said Prisca Di Martino, Chief Commercial Officer at Abiogen Pharma. "It reflects our dedication to therapeutic areas where we bring deep expertise. Partnering with mAbxience supports our goal to expand access to advanced biologic therapies in Italy. This is another step towards innovative, sustainable solutions for patients and healthcare systems."

This agreement marks another milestone in mAbxience’s strategy to provide affordable, life-saving therapies worldwide. Both mAbxience and Abiogen Pharma expect that this partnership will enhance patient access to advanced treatments, while also helping healthcare systems manage the rising costs of biologic therapies.

Lupin Announces Presentation of Phase 1 Data on LNP7457 (PRMT5 inhibitor) at the American Society of Clinical Oncology – Annual Meeting 2025

On May 26, 2025 Lupin Limited (Lupin) reported it will present data from its Phase 1a clinical trial evaluating LNP7457, a PRMT5 inhibitor, at the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) annual meeting in Chicago, Illinois, from May 30 to June 3, 2025 (Press release, Lupin, MAY 26, 2025, View Source [SID1234653379]). The presentation titled "A phase 1 dose escalation study of LNP7457 (PRMT5 inhibitor) in patients with advanced or metastatic solid tumors," will be featured in the Developmental Therapeutics—Molecularly Targeted Agents and Tumor Biology session. It can be viewed at Poster Board #422 on June 2, 2025, from 1.30 to 4.30 pm (CDT).

Key findings from the study include:

LNP7457 is generally safe and well tolerated in patients with advanced or metastatic solid tumors, with desirable PK/PD profile and no impact of food on the pharmacokinetics.
The maximum tolerated dose, recommended phase 2 dose was determined based on safety, efficacy, PK/PD data, aligning with preclinical findings and the known safety profile of PRMT5 inhibitors.
"We are delighted to share the initial results from Phase I study of our PRMT5 Inhibitor, a novel epigenetic onco-therapeutic targeted for monotherapy. We are committed to innovation and advancing cutting-edge science to offer meaningful therapeutic options for patients with difficult-to- treat cancers," said Vinita Gupta, CEO.

Current data from Lupin indicates that LNP7457 is unique within its field and appears to be safe and well-tolerated as a SAM-competitive PRMT5 inhibitor. Lupin will continue to study the efficacy of LNP7457 in its phase 1b trial in India and explore its potential for treatment of cancers with significant unmet medical needs.

Details of the Presentation:

Date and time: June 2, 2025, 1:30 pm – 4:30 pm (CDT)
Location: Hall A – Posters and Exhibits | McCormick Place, Chicago, IL
Session Title: Developmental Therapeutics—Molecularly Targeted Agents and Tumor Biology
Sub Track: Small Molecules
Clinical Trial Registration Number: CTRI/2023/07/054753
Doi: 10.1200/JCO.2025.43.16_suppl.3107
Abstract Number: 3107
Poster Board Number: 422
Abstract link: View Source

Alligator Bioscience announces European orphan drug designation for HLX22 in gastric cancer

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.

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.

Abbisko Therapeutics Receives CDE Approval of Breakthrough Therapy Designation for Irpagratinib (ABSK011) in the Treatment of HCC

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.

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.

Immutep’s Efti with Radiotherapy & KEYTRUDA® (pembrolizumab) Meets Primary Endpoint in Phase II for Soft Tissue Sarcoma

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).

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).