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.

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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 Partex NV and Fortress Biotech, Inc. (Nasdaq: FBIO) ("Fortress"), an innovative biopharmaceutical company, reported a strategic collaboration aimed at identifying and evaluating biopharmaceutical compounds using artificial intelligence (AI) for potential acquisition or licensing by Fortress (Press release, Fortress Biotech, MAR 17, 2025, View Source [SID1234651198]).

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Partex will deploy its proprietary AI-based drug discovery and development technology platform, which delivers diverse recommendations on alternative targets or indications and helps search and evaluate compounds across therapeutic areas.

"This strategic collaboration leverages the synergistic strengths of both organizations," said Dr. Frank Grams, Chief Commercial Officer, Partex. "Fortress’ expertise in identifying promising biopharmaceutical assets and advancing them through clinical development to their full potential, coupled with Partex’s advanced AI-driven platform, will enable a highly efficient and data-rich approach to identifying, evaluating, and potentially repositioning promising bio-pharmaceutical assets."

Partex’s platform will provide comprehensive analyses, including target identification, indication expansion, and molecular profiling, ultimately accelerating the process of bringing innovative therapeutics faster to market.

Lindsay A. Rosenwald, M.D., Fortress’ Chairman, President and Chief Executive Officer, also added, "In addition to the advancement of our robust late-stage pipeline of compelling product candidates at Fortress along with our partner companies and subsidiaries, plus the launch of two recently approved medicines and a third with a Prescription Drug User Fee Act (PDUFA) action date in the third quarter of this year, we are also focused on business development opportunities and expanding our portfolio. This collaboration with Partex will allow us to expeditiously identify and evaluate assets using their AI platform in conjunction with our already-established large network of Key Opinion Leaders in various therapeutic areas. The Fortress business model is focused on acquiring and advancing assets to enhance long-term value for shareholders through product revenue, equity holdings and dividend and royalty revenue. We believe utilizing AI technology will allow us to scale more efficiently and cost effectively going forward."

The collaboration is expected to expedite and support the process of search and evaluation to in-license differentiated assets, with both companies committed to utilize AI to its fullest potential.

On March 17, 2025 FibroGen, Inc. (NASDAQ: FGEN) reported financial results for the fourth quarter and full year 2024 and provided an update on the company’s recent developments (Press release, FibroGen, MAR 17, 2025, View Source [SID1234651180]).

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"We entered 2025 optimistic about our future, highlighted by the planned initiation of the Phase 2 monotherapy trial of FG-3246, our first-in-class ADC targeting CD46 for the treatment of mCRPC, by mid-2025," said Thane Wettig, Chief Executive Officer. "Through the successful implementation of our cost reduction plan, and upon the closing of our recently announced sale of FibroGen China, we will be a leaner and more focused organization, with a stronger financial position and a cash runway that takes us into 2027, with multiple potential value-creating milestones in sight."

Recent Developments and Key Highlights of 2024:

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Announced the sale of FibroGen China to AstraZeneca for a total consideration of approximately $160 million, representing an enterprise value of $85 million plus estimated net cash held in China at closing of approximately $75 million. The transaction is expected to close by mid-2025.
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Upon closing, FibroGen will repay its term loan to Morgan Stanley Tactical Value, further simplifying the Company’s capital structure.
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FibroGen maintains its rights to roxadustat in the U.S. and in all markets outside of China, South Korea, and those licensed to Astellas.
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Appointed David DeLucia, CFA, as Senior Vice President and Chief Financial Officer.
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Completed previously announced cost reduction program.

Upcoming Milestones:

FG-3246 (CD46 Targeting ADC) and FG-3180 (CD46 Targeting PET Imaging Agent)

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Anticipate initiation of Phase 2 monotherapy dose optimization study of FG-3246 in mCRPC by mid-2025.
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Phase 2 trial will include a sub-study of FG-3180 to enable assessment of its diagnostic performance and the potential correlation between CD46 expression and response to FG-3246.
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Topline results from the Phase 2 portion of the investigator-sponsored Phase 1b/2 study conducted by UCSF of FG-3246 in combination with enzalutamide in patients with mCRPC expected in 2H 2025.
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Phase 2 portion of the study will include data on FG-3180.
Roxadustat

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Plan to meet with FDA in 2Q 2025 to determine the potential next steps for the development of roxadustat in anemia associated with lower-risk myelodysplastic syndrome (LR-MDS), an indication with significant unmet medical need, in the U.S.Financial:

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Total revenue from continuing operations for the fourth quarter of 2024 was $3.1 million, as compared to $3.6 million for the fourth quarter of 2023.
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Total revenue from continuing operations for the full year 2024 was $29.6 million, as compared to $46.8 million for the full year 2023.
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Net loss from continuing operations for the fourth quarter of 2024 was $8.7 million, or $0.08 net loss per basic and diluted share, compared to a net loss of $62.5 million, or $0.63 net loss per basic and diluted share, one year ago.
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Net loss from continuing operations for the full year 2024 was $153.1 million, or $1.53 net loss per basic and diluted share, compared to a net loss of $323.0 million, or $3.32 net loss per basic and diluted share, for the full year 2023.
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At December 31, 2024, FibroGen reported $51.0 million in cash, cash equivalents and accounts receivable in the U.S. and $121.1 million in total consolidated cash, cash equivalents and accounts receivable.
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Upon closing of the announced sale of FibroGen China, the Company expects its cash, cash equivalents and accounts receivable to be sufficient to fund operations into 2027.

Conference Call and Webcast Presentation

The FibroGen management team will host a conference call and webcast presentation to discuss the financial results and provide a business update. A live Q&A session will follow the brief presentation. Interested parties may access a live audio webcast of the conference call here. To access the call by phone, please register here, and you will be provided with dial in details. A replay of the webcast will also be available for a limited time on the Events & Presentations page on FibroGen’s website.

About FG-3246

FG-3246 (FOR46) is a potential first-in-class fully human antibody-drug conjugate (ADC), exclusively in-licensed from Fortis Therapeutics, and is being developed by FibroGen for metastatic castration-resistant prostate cancer and potentially other tumor types. FG-3246 binds to an epitope of CD46, a cell receptor target, that induces internalization upon antibody binding, is present at high levels in prostate cancer and other tumor types and demonstrates very limited expression in most normal tissues. FG-3246 is comprised of an anti-CD46 antibody, YS5, linked to the anti-mitotic agent, MMAE, which is a clinically and commercially validated ADC payload. FG-3246 has demonstrated anti-tumor activity in both preclinical and clinical studies.

FG-3246 is currently in an ongoing Phase 1b/2 study being conducted at UCSF as an investigator-sponsored trial to evaluate FG-3246 in combination with enzalutamide. An additional investigator-sponsored radiopharmaceutical marker trial using a zirconium-89 positron emission tomography (PET) tracer for CD46 that utilizes the YS5 antibody is also underway at UCSF. The initiation of the Phase 2 monotherapy dose optimization trial for FG-3246 in metastatic castration-resistant prostate cancer is anticipated by mid-2025. FG-3246 is an investigational drug and not approved for marketing by any regulatory authority.

About Roxadustat

Roxadustat, an oral medication, is the first in a new class of medicines comprising HIF-PH inhibitors that promote erythropoiesis, or red blood cell production, through increased endogenous production of erythropoietin, improved iron absorption and mobilization, and downregulation of hepcidin. Roxadustat is in clinical development for chemotherapy-induced anemia (CIA) and a Supplemental New Drug Application (sNDA) has been accepted by the China Health Authority.

Roxadustat is approved in China, Europe, Japan, and numerous other countries for the treatment of anemia of CKD in adult patients on dialysis (DD) and not on dialysis (NDD). FibroGen has the sole rights to roxadustat in the United States, Canada, Mexico, and in all markets not held by AstraZeneca or licensed to Astellas. Astellas and FibroGen are collaborating on the commercialization of roxadustat for the treatment of anemia in territories including Japan, Europe, Turkey, Russia, and the Commonwealth of Independent States, the Middle East, and South Africa.

On March 17, 2025 Tract Bio, a biotechnology company discovering and developing novel therapies for cancer and inflammatory disease, reported the publication of preclinical research in Gastroenterology (Press release, Tract Bio, MAR 17, 2025, View Source [SID1234651199]). The article, "Evolution of Esophageal Adenocarcinoma from Precursor Lesion Stem Cells" describes results from a preclinical study applying the Company’s proprietary stemECHO epithelial stem cell cloning technology, where regenerative stem cells were cloned from epithelial tissues to analyze the evolution of esophageal adenocarcinoma (EAC) and identify potential therapeutic targets and drug combinations.

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In the study, each of the precursor lesions in the evolution of EAC, including Barrett’s esophagus (BE), low-grade dysplasia (LGD), and high-grade dysplasia (HGD), were shown to possess discrete populations of clonogenic cells that are potential therapeutic targets. DNA sequencing of these clones revealed intralesional heterogeneity and clonal resolution of the mutation progression in patients with BE, LGD, HGD, and EAC. High-throughput chemical screens against BE stem cells reveal drug combinations that are similarly effective against stem cells of LDG, HGD, and EAC. Synthetic lethal combinations were then developed that appear effective against BE, LGD, HGD, and EAC, both in vitro and in vivo, while simultaneously promoting normal esophageal stem cells.

"EAC, as with all metastatic cancers, is the result of an evolutionary process which is dominated by a succession of precursor lesions," said Frank McKeon, Ph.D., Interim Chief Scientific Officer of Tract Bio. "In this study, our unique and proprietary epithelial stem cell cloning platform, stemECHO, allowed us to clone epithelial stem cells while preserving their genetic integrity, enabling the discovery of the underlying mechanism. By maintaining the genetic consistency of the cloned cells, we are able to study disease mechanisms with unprecedented precision, opening the door to new diagnostic tools and therapies. We look forward to continuing this important work."

"The clonogenic cells in each of the regenerative lesions described in this paper, BE, LGD, HGD and EAC, each display functional properties of stem cells. Given the role of stem cells of normal epithelia in the regenerative growth of these tissues, the lesional stem cells could represent important therapeutic targets within tumors," said Richard Russell, Chief Executive Officer of Tract Bio. "Toward this end, our synthetic lethal strategies identified highly effective drug combinations against BE stem cells that showed similar efficacy against stem cells from each lesion in the progression to EAC and EAC itself. Based on these findings, we expect that the continued development of these drug combinations may lead to clinically effective treatments to prevent or treat EAC and perhaps other epithelial cancers by targeting the root causes of these conditions."

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]).

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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."