On March 5, 2025 Astellas Pharma Inc. (TSE: 4503, President and CEO: Naoki Okamura, "Astellas") and YASKAWA Electric Corporation (TSE: 6506, President and CEO; Masahiro Ogawa, "YASKAWA") reported the companies signed a definitive agreement to establish a joint venture for the development of a cell therapy product manufacturing platform utilizing the dual-arm robot "Maholo" (Press release, Astellas, MAR 5, 2025, View Source [SID1234650923]). In addition, the joint venture will offer platform access to startups and academic institutions, fostering collaboration and innovation in the field of cell therapy.

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In the pharmaceutical industry, the commercialization of cell therapy faces many challenges stemming from the complex nature of the manufacturing process, in particular, related to the accuracy and reproducibility of cell manufacturing. Furthermore, the need for a skilled workforce, coupled with the time and cost investments required for technology transfer to manufacturing facilities, presents additional hurdles. Based on the memorandum of agreement signed in May, 2024, Astellas and YASKAWA have been advancing discussions toward establishing a joint venture to leverage their mutual strengths and accelerate efforts to address these challenges.

The planned joint venture will leverage Astellas’ expertise in R&D and manufacturing for cell therapy and the dual arm robot "Maholo," developed by YASKAWA’s subsidiary, Robotic Biology Institute. The closing and establishment of the joint venture company are subject to certain closing conditions, including receipt of required regulatory approvals.

Joint Venture Company: Overview

Name

To be determined

Capital

4.5 billion yen (includes capital reserve)

Capital Structure

Astellas 60%, YASKAWA 40%

Establishment

（tentative）

September 2025

Business

Develop a cell therapy product manufacturing platform and

offer access to startups and academic institutions.

1. Explore a manufacturing process with high precision and

reproducibility using ‘Maholo’ and optimize the digitized

manufacturing process with AI

2. Transfer the digitalized manufacturing process to ‘Maholo’

at other manufacturing facilities via one-click* transfer and

develop a cell manufacturing platform that meets GMP conditions

3. Develop manufacturing processes for cell therapy product

candidates of partners, such as academia and startups,

as well as manufacture investigational drugs in GMP facilities

* GMP (Good Manufacturing Practice):

A standard for ensuring the safety and quality of pharmaceuticalproduct manufacturing

* One Click Transfer:

Rapid transfer of established manufacturing process to facilities without hands-on training of workers

Through the establishment of a joint venture and the development of a cell therapy manufacturing platform, Astellas is committed to addressing the challenges of commercializing cell therapy and supporting academia and startup companies in implementing innovative cell therapies. By integrating advanced technologies into its cell therapy expertise, Astellas aims to develop potentially transformative cell therapy for patients with limited or no treatment options. Please visit this for more details.

YASKAWA has provided automation solutions for medical testing processes, including cancer genome diagnostics, iPS cell culture, and PCR testing, through delivering "Maholo." With the establishment of a joint venture, YASKAWA aims to expand the use cases of robots in the field of cell therapy beyond the existing life science field.

On March 5, 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 cancer, reported that the Indonesia National Agency of Drug and Food Control (BPOM) has approved a New Drug Application (NDA) for XPOVIO (selinexor) for three indications: (1) In combination with bortezomib and dexamethasone for the treatment of adult patients with multiple myeloma (MM) who have received at least one prior therapy;(2) in combination with dexamethasone for the treatment of adult patients with relapsed or refractory MM (R/R MM) who have received at least four prior therapies and whose disease is refractory to at least two proteasome inhibitors (PIs), at least two immunomodulatory agents (IMiDs), and an anti‐CD38 monoclonal antibody; and (3) as a monotherapy for the treatment of adult patients with relapsed or refractory diffuse large B‐cell lymphoma (R/R DLBCL), not otherwise specified, including DLBCL arising from follicular lymphoma, after at least two lines of systemic therapy who are not eligible for haematopoietic cell transplant (Press release, Antengene, MAR 5, 2025, View Source [SID1234650920]).

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With a novel mechanism of action, XPOVIO is the world’s first approved orally-available, selective XPO1 inhibitor, which has already been approved in ten countries and regions in APAC, and has been included in the national insurance schemes in five of these markets (the mainland of China, Taiwan market, Australia, Singapore and South Korea).

The ASEAN region, with its steady economic growth and a population exceeding 600 million, has become a market of significant potential for global biomedical development. The accelerating aging population in ASEAN has increased the overall disease burden on patients and local communities, leading to a growing demand for novel therapeutics. Currently, Antengene is actively expanding its presence into APAC markets in efforts to introduce more innovative medicines to the ASEAN region in the future, improving the level of healthcare in these regions and benefiting more patients in need.

While bringing XPOVIO to more APAC markets, Antengene is also striving to expand the indications of XPOVIO. Leveraging the drug’s novel mechanism of action, Antengene is currently developing multiple combination regimens of XPOVIO for the treatment of various indications including myelofibrosis (MF) and endometrial cancer.

About XPOVIO (selinexor)

XPOVIO is the world’s first approved orally-available, selective inhibitor of the nuclear export protein XPO1. It offers a novel mechanism of action, synergistic effects in combination regimens, fast onset of action, and durable responses.

By blocking the nuclear export protein XPO1, XPOVIO can promote the intranuclear accumulation and activation of tumor suppressor proteins and growth regulating proteins, and down-regulate the levels of multiple oncogenic proteins. XPOVIO delivers its antitumor effects through three mechanistic pathways: 1) exerting antitumor effects by inducing the intranuclear accumulation of tumor suppressor proteins; 2) reducing the level of oncogenic proteins in the cytoplasm by inducing the intranuclear accumulation of oncogenic mRNAs; 3) restoring hormone sensitivity by activating the glucocorticoid receptors (GR) pathway. To utilize its unique mechanism of actions, XPOVIO is being evaluated for use in multiple combination regimens in a range of indications. At present, Antengene is conducting multiple clinical studies of XPOVIO in the mainland of China for the treatment of relapsed/refractory hematologic malignancies and solid tumors (3 of these studies are being jointly conducted by Antengene and Karyopharm Therapeutics Inc. [Nasdaq:KPTI]).

On March 5, 2025 Immorta Bio Inc., a leader in longevity-focused biotechnologies, reported acceptance of its poster presentation at the upcoming Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper) Spring Scientific, Cellular Therapy for Solid Tumors in San Diego, CA, on March 12-13, 2025 (Press release, Immorta Bio, MAR 5, 2025, View Source [SID1234650919]).

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The company will present molecular and cellular mechanisms by which its First-In-Class Senolytic Immunotherapy specifically kills senescent cells associated with cancer initiation, progression, and protection.

"We plan to present data demonstrating regression of cancers in animal models of glioma, lung, breast, and pancreatic cancers using our SenoVax approach," said Dr. Thomas Ichim, President and Chief Scientific Officer of Immorta Bio. "SenoVax is an autologous senescent cell pulsed dendritic cell product for which we plan to start clinical trials for lung cancer shortly.

The poster is a result of Immorta Bio collaboration with esteemed institutions, including the University of California San Diego, George Washington University, Cedars-Sinai, and Calidi Biosciences.

"The Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper) is the world’s leading organization dedicated to the advancement of cancer immunotherapy. For us to be selected to present in front of such a distinguished audience is significant accomplishment and indicates acceptance of our "paradigm-shifting" approach in that we kill cancer by targeting the senescent cells surrounding it," said Dr. Boris Reznik, Chairman and CEO of Immorta Bio. "Based upon our preclinical data we anticipate to also see SenoVax to reduce systemic senescent cells load resulting in associated "antiaging" effects in treated patients."

On March 5, 2025 Laminar Pharma, a leader in the development of innovative cancer therapy based on membrane lipid therapy, reported optimistic results from its ongoing clinical trial evaluating LAM561 for the treatment of newly diagnosed glioblastoma (ndGBM), the most aggressive form of brain cancer, that has seen limited clinical improvement in the last 20 years (Press release, Laminar Pharma, MAR 5, 2025, View Source [SID1234650918]). The trial, partially funded with an EU H2020 Grant (ClinGlio), has shown an improvement trend in progression-free survival (PFS) in MGMT-methylated patients receiving LAM561 in combination with chemoradiotherapy (radiotherapy plus temozolomide) as the standard of care (SoC) compared to placebo plus SoC treatment. LAM561 is available for in-license for all territories. Laminar’s current fund raising round is still open, for a limited time, to additional investors.

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The pivotal phase 2b/3 trial, "A randomized, double-blind, placebo-controlled adjuvant trial in newly diagnosed primary glioblastoma subjects to assess the efficacy and safety of LAM561 in combination with radiotherapy and temozolomide standard of care treatment" (NCT04250922), enrolled 144 patients with newly diagnosed glioblastoma. In November 2024, After reaching 66 PFS events the independent data monitoring committee (IDMC) recommended: (1) Continue the trial without modifications until 90 OS events (overall survival), when the final analysis will be carried out, estimated for Q4 2026; (2) that the trial should not be stopped for reasons of safety or futility and (3) opening the study, that is, removing the blind. From that moment, patients, doctors and Laminar as sponsor are able to know if any patient received placebo or LAM561.

Although the main primary outcome of the interim analysis (Hazard Ratio of 0.5 for PFS) was not reached for the whole trial population, the unblinding of the trial has allowed Laminar to conduct an ongoing evaluation (non-statistically assessed and with data under monitoring review) considering the per protocol predefined stratification: methylation status of the MGMT promoter and RTOG score (3, 4 or 5), a scale describing the side effects caused by radiation therapy and the higher the RTOG score the worse the clinical position. By revising the data stratified by MGMT promoter methylation status and RTOG, and using data available on 18th February 2025, the median PFS for methylated patients RTOG3 was 56,7 weeks on the LAM561 treatment arm against 19 weeks on the placebo arm (n=9). Moreover, the median PFS for methylated patients RTOG4 was 86,4 weeks on the LAM561 treatment arm against 54,7 weeks on the placebo arm (n=39). With currently available data, methylated patients treated with LAM561 + SoC seem to experience a potentially clinically relevantimprovement in PFS (Hazard-ratio estimation of 0.53) compared to control group (placebo+SoC). PFS was not improved by LAM561 in unmethylated patients. This interim perspective should be taken with caution since the study is still ongoing and providing new information and the final interpretation will only be apparent once the study has completed after reaching 90 OS events; and, although progression of the disease is a relevant clinical event, overall survival is the primary outcome of the trial and conclusions on the final effect of the drug need to wait until the final analysis is performed and data is reviewed by the IDMC. Laminar intends to perform an in-depth independent objective assessment of the findings.

The methylation status of the MGMT promoter is highly relevant in the prognosis of glioblastoma [Leske et al., 2023]. MGMT-methylated patients represent 35-50% of the total glioblastoma patients.

"We are encouraged by the progression-free survival results from this trial in MGMT-methylated patients, which, if reflected by positive overall survival results, may represent a significant advance in the treatment of glioblastoma, a condition with poor prognosis that affects more than 100,000 people every year", said Dr. Pablo Escribà, CEO of Laminar Pharma. "Glioblastoma remains one of the most challenging cancers to treat, and these findings highlight the potential of LAM561 to improve outcomes for methylated patients, a considerable portion of the total glioblastoma population. Our team is committed to continuing the development of this promising therapy."

The combination of LAM561 and SoC was well-tolerated. The safety data in the trial is consistent with the known safety profile of LAM561 studied in previous clinical trials, with no new safety signals observed in the combination arm.

Trial Details and Key Findings:

The study enrolled 144 patients with newly diagnosed, IDH-wildtype, glioblastoma.

MGMT-methylated patients treated with LAM561 and SoC currently show a trend towards longer progression-free survival (86,4 weeks) compared to placebo control SoC group (54,7 weeks, HR 0.53). The study will continue until 90 OS events when final analysis will be conducted, estimated by late 2026.

Safety data showed that the treatment was well-tolerated, with adverse events consistent with previous trials and a well-known safety profile.
These results built on earlier preclinical and clinical data, which indicated that LAM561 could effectively target, through modification of the membrane lipid, the molecular pathways associated with glioblastoma growth. Further analysis and longer follow-up periods are underway to assess overall survival and other secondary endpoints.

About Glioblastoma: Glioblastoma (GBM) is the most common primary malignant brain tumor and accounts for nearly 50 percent of all gliomas and approximately 25 percent of all primary brain and CNS malignant tumors. The incidence of GBM in Europe is currently above 25,000 new cases each year, rising to over 100,000 cases per year worldwide. The prognosis for GBM patients is very poor, with a median survival time of about 14.5 months despite optimum chemo-radiation treatment. About 15% of patients survive two years after diagnosis and ca. 4% survive for five or more years. In this scenario, there is a desperate need for novel treatment alternatives that provide safe and more efficacious clinical outcomes.

About LAM561: LAM561 (2-hydroxyoleic acid (2-OHOA); idroxioleic acid, sodium) is a synthetic derivative of oleic acid and the most advanced Laminar’s R&D product which is taken orally. This drug alters the composition of the plasma membrane in cancer cells, reducing the activity of membrane-associated signaling proteins that are known to promote tumor growth and affecting tumors in the brain. LAM561 is in the process of completing its last clinical development phase and has shown promising preliminary clinical activity in the treatment of aggressive brain tumors, glioblastoma.

On March 5, 2025 CStone Pharmaceuticals ("CStone", HKEX: 2616), a biopharmaceutical company dedicated to developing innovative cancer therapies, reported the submission of a Phase Ib clinical trial application in Australia for CS5001, its ROR1-targeting antibody-drug conjugate (ADC), in combination with first-line standard-of-care (SoC) for DLBCL (Press release, CStone Pharmaceauticals, MAR 5, 2025, View Source [SID1234650917]). CS5001 is also being evaluated as both a monotherapy and in combination with a PD-L1 inhibitor for advanced solid tumors in an ongoing global multi-center clinical trial.

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Building on promising data from CS5001 monotherapy in later-line aggressive and indolent lymphomas, this Phase Ib trial aims to expand the therapeutic potential of CS5001 across all DLBCL stages and solid tumors. The study will explore:

CS5001 + R-CHOP: First-line treatment for DLBCL patients who have not received prior systemic therapy.
CS5001 + SoC: For patients with relapsed or refractory DLBCL.
CS5001 Monotherapy: Targeting ROR1-expressing solid tumors.
CS5001 + Sugemalimab: Combination therapy for advanced solid tumors.
Dr. Jason Yang, CEO, President of R&D, and Executive Director at CStone, stated: "We are thrilled to reach another key clinical milestone for CS5001. The existing data underscore its broad potential in both lymphomas and solid tumors. Notably, a ROR1 ADC combined with R-CHP has demonstrated an impressive complete response (CR) rate in a Phase II trial for first-line DLBCL. As we advance from late-line monotherapy to frontline combination therapy, we are optimistic that CS5001 will provide significant clinical benefits to DLBCL patients and establish itself as a first-line treatment option. Meanwhile, we continue to explore CS5001’s potential in solid tumors and eagerly anticipate further positive outcomes."

The global multi-center Phase Ib trial for CS5001 is actively enrolling patients across the United States, Australia, and China. Recruitment is ongoing for monotherapy cohorts targeting aggressive and indolent advanced lymphomas, which could potentially expand into a Phase II single-arm registrational study. Additional cohorts, including the first-line DLBCL combination therapy and solid tumor monotherapy and combination therapy arms, will be initiated soon.

About CS5001 (ROR1 ADC)

CS5001 is a clinical-stage antibody-drug conjugate ("ADC") targeting ROR1 (receptor tyrosine kinase-like orphan receptor 1). CS5001 has been uniquely designed with proprietary tumor-cleavable linker and pyrrolobenzodiazepine ("PBD") prodrug. Only after reaching the tumor, the linker and prodrug are cleaved to release the PBD toxin, resulting in lethal DNA cross-links in cancer cells. The use of the linker plus PBD prodrug effectively helps address the toxicity associated with traditional PBD payloads, leading to a better safety profile. CS5001 has demonstrated complete tumor suppression in several preclinical cancer models and demonstrated favorable serum half-life and pharmacokinetic characteristics. CS5001 is a promising candidate drug with precision treatment potential in both hematologic tumors and malignant solid tumors. Additionally, CS5001 utilizes site-specific conjugation for a precise drug antibody ratio of which enables homogeneous production and large-scale manufacturing.

In October 2020, CStone signed a licensing agreement with LigaChem Biosciences, Inc. (LCB) for the development and commercialization of CS5001 which was originally generated by collaboration of LCB and ABL Bio, both South Korea-based leading biotech companies. Under the agreement, CStone obtains the exclusive global right to develop and commercialize CS5001 outside the Republic of Korea.

The first-in-human data for CS5001 in patients with advanced solid tumors and lymphomas was presented at the 2024 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting. Additionally, the latest clinical data on CS5001 as a monotherapy in patients with advanced lymphomas has recently been presented at the 66th American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting.

CS5001 has demonstrated encouraging safety and robust anti-tumor activity in the Phase 1a dose escalation trials across 10 dose levels.

At the tentative recommended Phase 2 dose (RP2D) of DL8 (125 μg/kg), CS5001 achieved objective response rates (ORRs) of 70% in advanced B-cell lymphoma and 100% in Hodgkin lymphoma.
Encouraging efficacy signals were also observed in advanced solid tumors, including non-small cell lung cancer and pancreatic cancer.
CS5001 was well tolerated in heavily pre-treated patients with advanced B-cell lymphomas and solid tumors.