On March 17, 2025 The European Organisation for Research and Treatment of Cancer (EORTC) reported the launch of the EORTC-2334-BTG LUMEN-1 clinical trial, a groundbreaking study aimed at finding potential new treatment options for patients with recurrent Meningioma (Press release, EORTC, MAR 17, 2025, View Source [SID1234651179]). Meningioma is a type of brain tumour that can return after surgery and radiotherapy, leaving patients with limited treatment options.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

The LUMEN-1 trial will investigate the effectiveness of a new treatment called [177Lu]Lu-DOTATATE, which targets a specific receptor found in most meningiomas. This treatment has shown promising results in smaller studies and is now being tested in a larger, randomised trial involving 136 patients across 35 sites in 10 European countries. This is a phase II study, meaning that it is a study aiming to show the activity of this therapy in treating recurrent Meningioma.

Patients participating in the trial will be randomly assigned to receive either [177Lu]Lu-DOTATATE or the current standard of care. The primary goal of the study is to determine whether [177Lu]Lu-DOTATATE can improve progression-free survival, allowing patients to live longer without their disease worsening. Secondary goals include assessing overall survival, safety, quality of life, and neurological function.

The trial also includes a comprehensive research program to explore various aspects of the treatment, such as dosimetry, imaging, and tissue analysis. The study is expected to be completed by 2029, with the hope of guiding the way forward to potential new, effective treatment options for patients with recurrent meningioma.

On March 17, 2025 Akoya Biosciences, Inc. (Nasdaq: AKYA) ("Akoya"), The Spatial Biology Company, reported its financial results for the fourth quarter and full year ending December 31, 2024 (Press release, Akoya Biosciences, MAR 17, 2025, View Source [SID1234651177]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

"Akoya navigated a challenging 2024 in the life science tools market, which was constrained by subdued capital equipment purchases, by successfully strengthening gross margins, reducing operating expenses and advancing our companion diagnostics programs throughout the year. We remain optimistic about the long-term growth outlook of Akoya’s leading spatial biology solutions," said Brian McKelligon, CEO of Akoya. "In 2024, Akoya achieved multiple milestones, including expanding our market-leading installed base to 1,330 instruments, launching our Manufacturing Center of Excellence to drive improvements in gross margins and the expansion of our content menu into new markets like neurobiology, and continued advancement of our clinical partnerships led by Acrivon and NeraCare."

Fourth Quarter 2024 Financial Highlights

Revenue was $21.3 million in the fourth quarter of 2024, compared to $26.5 million in the prior year period; a decrease of 19.4%. This topline revenue decrease was primarily due to a decline in instrument revenue.
Gross margin was 67.4% in the fourth quarter of 2024, compared to 62.7% in the prior year period. The increase in gross margin was primarily driven by operational efficiency from in-house reagent manufacturing and product mix.
Operating expenses were $20.1 million for the fourth quarter of 2024, compared to $26.1 million in the prior year period; an improvement of 22.9%. The improvement was primarily driven by further realized operating leverage and efficiencies.
Operating loss was $5.7 million for the fourth quarter of 2024, compared to an operating loss of $9.4 million in the prior year period; an improvement of 39.5%.
$35.0 million of cash, cash equivalents, and marketable securities as of December 31, 2024.
Business Highlights

Announced the pending acquisition of Akoya Biosciences by Quanterix Corporation (Nasdaq: QTRX), which, if consummated, would create the first integrated solution for ultra-sensitive detection of blood and tissue-based protein biomarkers.
Announced a strategic product roadmap, powered by the success of IO60 and upcoming launch of neurobiology panels to solidify leadership in spatial proteomics across new research verticals.
Announced an exclusive global license agreement with NeraCare for the development and commercialization of the Immunoprint test for early-stage melanoma patient treatment decisions.
Nature Methods named spatial proteomics "Method of the Year 2024" — a key milestone which reaffirms Akoya’s leadership position in the spatial proteomics field with the largest installed base and publications volume in the industry.
Financial Highlights

Full year 2024 revenue was $81.7 million, compared to $96.6 million in the prior year; a decrease of 15.5%.
Full year 2024 reported gross margin was 58.6% while non-GAAP adjusted gross margin(1) was 61.1% when excluding the write-off from discontinued legacy products in the first quarter of 2024. Both GAAP and non-GAAP gross margin were 58.3% in the prior year.
Full year 2024 operating expenses were $94.6 million while non-GAAP operating expenses(1) were $88.6 million when excluding the impairment charge for facility consolidation and restructuring associated with reductions in force completed in the first quarter of 2024 and third quarter of 2024, respectively. Both GAAP and non-GAAP operating expenses were $114.0 million in the prior year.
Full year 2024 loss from operations was $46.7 million while non-GAAP loss from operations(1) was $38.6 million excluding the items noted above. Both GAAP and non-GAAP loss from operations were $57.7 million in the prior year.
Instrument installed base of 1,330 as of December 31, 2024 (400 PhenoCyclers, 930 PhenoImagers), compared to an installed base of 1,183 in the prior year (342 PhenoCyclers, 841 PhenoImagers); an increase of 12.4%.
1,733 total publications citing Akoya’s technology as of December 31, 2024, compared to 1,160 total publications in the prior year; an increase of 49.4%.

(1) See discussion of "Non-GAAP Financial Measures" below.
In light of the pending acquisition by Quanterix Corporation, Akoya will not be hosting an earnings conference call or providing forward guidance at this time.

On March 17, 2025 EsoBiotec SA, a biotechnology company pioneering in vivo cell therapies that has demonstrated promising early clinical activity, reported it has entered into a definitive agreement to be acquired by AstraZeneca (Press release, EsoBiotec, MAR 17, 2025, View Source [SID1234651164]). The EsoBiotec Engineered NanoBody Lentiviral (ENaBL) platform empowers the immune system to attack cancers and could offer many more patients access to transformative cell therapy treatments delivered in just minutes rather than the current process which takes weeks.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

ENaBL uses highly targeted lentiviruses to deliver genetic instructions to specific immune cells, such as T cells, which programme them to recognise and destroy tumour cells for cancer treatment or autoreactive cells for potential use in immune-mediated diseases. This approach enables cell therapies to be administered through a simple IV injection and without the need for immune cell depletion.

Traditional cell therapies require cells to be removed from a patient, genetically modified outside the body, and then readministered to the patient as a medicine after immune cell depletion, typically taking weeks. By engineering immune cells directly within the patient’s body, the EsoBiotec in vivo approach has the potential to address many of the barriers associated with traditional cell therapies, reducing complexities and manufacturing timelines, thereby increasing access for patients.

Susan Galbraith, Executive Vice President, Oncology Haematology R&D, AstraZeneca, said: "We are excited about the acquisition of EsoBiotec and the opportunity to rapidly advance their promising in vivo platform. We believe it has the potential to transform cell therapy and will enable us to scale these innovative treatments so that many more patients around the world can access them. EsoBiotec will accelerate and expand the impact of our recent investments and marks a major step forward in realising our ambition to harness the full potential of cell therapy."

Jean-Pierre Latere, PhD, CEO, EsoBiotec, said: "We look forward to working with AstraZeneca, a global leader in drug development, to advance our shared goal of bringing transformative cost-effective cell therapies to more patients globally. By combining our expertise and resources, we can accelerate the development of our in vivo platform which has a novel delivery technology we believe will have broad therapeutic applicability."

EsoBiotec will become a wholly owned subsidiary of AstraZeneca, with operations in Belgium.

Financial considerations
AstraZeneca will acquire all outstanding equity of EsoBiotec for a total consideration of up to $1,000m, on a cash and debt free basis. This will include an initial payment of $425m on deal closing, and up to $575m in contingent consideration based on development and regulatory milestones.

The transaction is expected to close in the second quarter of 2025, subject to customary closing conditions and regulatory clearances.

Centerview Partners UK LLP is acting as exclusive financial advisor to EsoBiotec.

Cooley LLP is acting as legal advisor to EsoBiotec. Covington & Burling LLP is acting as legal advisor to AstraZeneca.

On March 16, 2025 Limula, a life science tools company specializing in automated Cell and Gene Therapy manufacturing solutions, reported the publication of a peer reviewed article in Cell Press journal Molecular Therapy – Methods & Clinical Development (Press release, Limula, MAR 16, 2025, View Source [SID1234651227]). Entitled Magnetic bead-sensitized optoporation coupled with antibodies-based activation for mRNA CAR-T cell manufacturing, the report describes the development of an innovative method for non-viral gene transfer. It is the result of a long-standing collaboration between the Limula team and Prof. Denis Migliorini from the University of Geneva.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

The introduction of synthetic genetic material into human primary cells is a key step in the production of CAR-T cells and other advanced therapy medicinal products (ATMPs). The vast majority of approved ATMPs rely on stable genetic modifications of patients’ cells using viruses that randomly integrate an exogenous sequence into the genome. More recently, therapies that rely on electroporation have also received marketing authorisation.

The innovative approach proposed by Limula and their collaborators is based on optoporation, a method that uses high-intensity laser to tigger transient permeabilization of the cell membrane. The resulting tiny holes allow molecular payloads, such as mRNA or CRISPR proteins, to enter the cells. The effect was previously shown to be ehanced by the addition of photosensitizers that efficiently absorb light and convert the energy into different phenomena that generate holes in the cell membrane.

Harnessing light for intracellular cargo delivery is not entirely new. Although optoporation using gold nanoparticles has demonstrated potential in the past, the work described in the scientific article demonstrates for the first time that the process can be efficiently catalysed by magnetic particles routinely used in cell therapy manufacturing.

The main contributor to the study, Dr. Noelia Maldonado-Pérez, says: "It is very satisfying to share the outcome of this project with the broader cell therapy community. The discovery that common cell activation reagents could be repurposed to catalyse the introduction of genetic material into human cells is very exciting."

Cell activation is one of the critical steps of CAR-T cell therapy manufacturing, often immediately followed by a gene transfer step. Some challenges remain in the application of the method to the production of clinical-grade advanced therapy products, but the possibility to sequence two different unit operations without the need for additional reagents could open avenues for streamlined production methods.

Prof. Denis Migliorini adds: "We believe magnetic bead-sensitized optoporation represents an interesting addition to the toolbox available to cell therapy developers."

On March 16, 2025 Akeso Inc. (9926.HK) reported that its innovative, self-developed anti-PD-1 monoclonal antibody, penpulimab, has been officially approved by the National Medical Products Administration (NMPA) for the first-line treatment of recurrent or metastatic nasopharyngeal cancer (NPC) in combination with chemotherapy (Press release, Akeso Biopharma, MAR 16, 2025, View Source [SID1234651161]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

Previously, penpulimab was approved for use as a third-line treatment for advanced NPC. With this new approval, penpulimab now provides comprehensive treatment coverage across all stages of NPC, offering patients a continuous immunotherapy option from first-line to third-line therapy.

This marks the fourth approved indication for penpulimab. In addition to the two NPC indications, penpulimab is also approved for first-line treatment of locally advanced or metastatic squamous non-small cell lung cancer (NSCLC) when combined with chemotherapy, as well as for monotherapy in patients with relapsed or refractory classical Hodgkin lymphoma (cHL) who have previously received at least two lines of systemic chemotherapy. Furthermore, a supplemental New Drug Application (sNDA) for penpulimab in combination with anlotinib for first-line treatment of advanced hepatocellular carcinoma (HCC) is currently under review.

Professor Hu Chaosu, one of the principal investigators of penpulimab at Fudan University Shanghai Cancer Center, said: "In China, there remains a significant unmet clinical need for NPC. As the only IgG1 subtype anti-PD-1 monoclonal antibody globally, penpulimab has demonstrated robust efficacy in clinical studies, enhancing the effectiveness of immunotherapy for NPC. The approval for first-line treatment marks a major milestone, as it provides a comprehensive treatment regimen for clinicians and patients, benefiting a large population of NPC patients in China, from first-line to third-line therapy."

Professor Chen Xiaozhong, one of the principal investigators of penpulimab at Zhejiang Cancer Hospital, said: "Nasopharyngeal cancer (NPC) is a highly prevalent malignancy in certain regions, and patients with recurrent or metastatic NPC typically face a poor prognosis. Penpulimab has demonstrated a significantly high response rate and prolonged survival benefits in both first-line treatment of NPC and in patients with metastatic NPC who have failed multiple lines of prior therapy. Additionally, it has shown a favorable safety profile, with a low incidence of immune-related adverse events. "

Dr. Xia Yu, Founder, Chairwoman, CEO, and President of Akeso, said: "We want to extend our sincere gratitude to all the researchers, clinical trial participants, and NPC patients who have contributed to this milestone. With its differentiated design, penpulimab has gained widespread recognition among clinicians and patients for its efficacy and safety in treating diseases like non-small cell lung cancer (NSCLC), Hodgkin lymphoma, and nasopharyngeal cancer. The approval for first-line treatment of advanced NPC will allow more patients in China to benefit from this new PD-1 monoclonal antibody, further improving survival outcomes."

"As key drugs like cadonilimab, ivonescimab, and penpulimab receive approval for a wide range of indications, Akeso’s commitment to innovation and excellence in drug development—from discovery to clinical application—is clearly demonstrated. These advancements are not only improving patient outcomes but also reaffirming our dedication to transforming global healthcare. Moving forward, Akeso will continue to pioneer breakthrough therapies with the potential to set new standards of care, driving positive change in treatment paradigms and improving the lives of patients worldwide."