On August 25, 2026 Astellas Pharma Inc. (TSE: 4503, President and CEO: Naoki Okamura, "Astellas") reported that the first patient has been dosed in a Phase 3 study evaluating ASP2138 in combination with chemotherapy and pembrolizumab as first-line treatment in adults with locally advanced unresectable or metastatic gastric or gastroesophageal junction (GEJ) adenocarcinoma, whose tumors are Claudin 18.2 (CLDN18.2)-positive and HER2-negative.1

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This milestone marks an important step in Astellas’ commitment to advancing CLDN18.2 science through a portfolio of approved treatments and investigational assets.

Despite recent advances, many people with advanced gastric and GEJ cancers continue to face poor outcomes, with median progression-free survival of 6 to 7 months with non-CLDN18.2 directed current standard of care.2 Recognizing the importance of continued research into new treatments, Astellas is working to deepen understanding of CLDN18.2 and exploring multiple scientific approaches that may help address different patient needs.

ASP2138 is an investigational subcutaneously administered bispecific antibody designed to bind to CLDN18.2, a protein expressed on certain tumor cells, and CD3-positive T cells, a type of white blood cell with the ability to kill cancer cells.1,3 By binding to both targets, ASP2138 is intended to bring these T cells closer to CLDN18.2-expressing tumor cells and activate their anti-tumor response.4

Tadaaki Taniguchi, M.D., Ph.D., Chief Research and Development Officer, Astellas:
"The first patient dosed in this Phase 3 study is an important milestone for ASP2138 and for our broader work in CLDN18.2. By advancing multiple scientific approaches, we are building the evidence needed to better understand how CLDN18.2-targeted innovation may help address patient needs."

As Astellas’ lead program within its Immuno-Oncology Primary Focus, the ASP2138 Phase 3 study supports the Company’s execution of its Corporate Strategic Plan, including its ambition to initiate five or more Phase 3 or pivotal studies by fiscal year 2027. Astellas will share updates as the study progresses, in line with applicable disclosure requirements and company practice.

(Press release, Astellas, AUG 25, 2026, View Source [SID1234670297])

On August 24, 2026 VERAXA Biotech AG (NASDAQ: VRXA; "VERAXA"), an emerging leader in the design and development of next-generation cancer therapeutics, and Secarna Pharmaceuticals GmbH & Co. KG ("Secarna"), a company redefining the discovery and development of best-in-class oligonucleotide therapeutics, reported initial positive results from their strategic research collaboration to develop next-generation antibody oligonucleotide conjugates (AOCs) for the treatment of autoimmune and chronic immune diseases.

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In early in vitro studies, an AOC candidate sourced by combining both parties’ technologies and expertise demonstrated greater potency compared to the equivalent unconjugated, naked oligonucleotide, underlining the future therapeutic potential of the approach. Encouraged by these results, both parties are now discussing the next steps in this alliance. AOCs are increasingly seen as a potentially transformative approach in precision medicine, enabling targeted delivery of therapeutic oligonucleotides to disease-specific cells. Recent clinical advancements have demonstrated their potential in treating a broad range of diseases by overcoming traditional challenges like poor bioavailability and off-target effects.

"Achieving this milestone in our collaboration with Secarna in less than a year demonstrates that our conjugation technology powered by our proprietary click chemistry can be applied efficiently within partnerships beyond our company’s primary focus areas in solid tumors," commented Christoph Erkel, Ph.D., Chief Scientific Officer of VERAXA. "We look forward to continuing our collaboration with Secarna, a leading innovator in oligonucleotide-based therapeutics and unlocking the breadth of opportunities in this emerging drug class."

"While our oligonucleotide pipeline advances and other delivery strategies for our oligonucleotide medicines continue to be very relevant, antibody-guided oligonucleotides offer distinct advantages due to the selective targeting mechanism provided by the antibody carrier," said Konstantin Petropoulos, Ph.D., Chief Executive Officer of Secarna Pharmaceuticals.

(Press release, Veraxa Biotech, AUG 24, 2026, View Source [SID1234670310])

On August 24, 2026 TME Pharma N.V. (Euronext Growth Paris: ALTME), a clinical-stage biotechnology company specializing in the development of novel therapies for brain cancer and eye diseases, reported an update on its activities, including the strategic development options for its lead oncology asset, NOX-A12.

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Following comprehensive discussions and due diligence over recent months, TME Pharma has advanced conversations with two potential partners. The company is now approaching the decision-making stage to select the optimal partner and best path forward for the late-stage development and commercialization of NOX-A12.

Strategic Decision Framework & Value Creation
The evaluation of these final strategic options extends beyond transactional valuation and financial terms. TME Pharma is strictly focused on structuring the continuation of the landmark GLORIA trial in a manner that creates the highest long-term value. Key strategic parameters currently under final review include:

Trial Architecture & Regulatory Pathways: Maximization of the likelihood and confidence that the next step of clinical development will be funded and conducted by selecting a committed partner who is aligned with TME Pharma in the goal to perform the upcoming GLORIA study in a way that creates optimal additional value.
Commercial potential: Structuring the research framework to ensure that NOX-A12 reaches its full peak revenue potential within the most favorable timeframe to maximize patent-protected revenues.
Financial conditions: TME Pharma NV and its shareholders need to have a clear picture of a solid short-term future so that there is clarity regarding cash flow. Future potential value must be secured if the drug can be successfully brought to market.

Robust Scientific Validation and Significant Peak Sales Potential for NOX-A12
The strong clinical foundation of NOX-A12 in glioblastoma—an aggressive form of brain cancer with limited treatment options—is supported by compelling data from the GLORIA trial. The efficacy of the NOX-A12 "Triple Therapy" combination (NOX-A12, radiotherapy, and anti-VEGF / bevacizumab) was recently highlighted in a high-impact peer-reviewed publication in Nature Communications, demonstrating significantly improved overall survival (19,9 months against 9,5 months) compared to standard-of-care benchmark cohorts.

Building on these findings, TME Pharma has a randomized, controlled Phase 2 trial protocol ready-to-go in Germany and approved in the US, secured Fast Track Designation from the U.S. FDA and Orphan Drug Designation (granted by both the U.S. FDA and the European Medicines Agency, EMA) for NOX-A12 in glioblastoma. The Total Addressable Market for Glioblastoma is estimated at 2.5 billion. With estimated peak sales potential (upon successful market approval and commercialization) expected of approximately $1 billion, NOX-A12 represents a highly valuable flagship asset capable of transforming care in treatment-resistant solid tumors.

Capitalizing on Favorable Biotech Market Dynamics
TME Pharma has observed a clear improvement in market sentiment, characterized by increased demand from the sector for the acquisition and joint development of promising clinical-stage drugs. In addition, the stock markets are showing a positive trend, with renewed capital inflows into biotech companies.

TME Pharma is well-positioned to capitalize on these favorable market conditions, supported by a strong asset portfolio and positive outlook. Furthermore, as announced on March 9, 2026, the company’s financial flexibility has been extended into the second quarter of 2027, providing the flexibility to find the optimal partner for NOX-A12.

"Our discussions in the last months have yielded concrete strategic interest from two parties. As we enter the final evaluation phase, our priority is to select the partner and structuring strategy that maximizes both the commercial value of NOX-A12 and its clinical benefit for patients. We look forward to updating the market as soon as a decision has been made." Said Diede van den Ouden, CEO of TME Pharma NV

NOX-E36
The study announced in January has now been completed, and its objective to establish and validate a detection method for toxicology studies to support clinical ophthalmology development has been successfully achieved.
In addition, TME Pharma continues to explore partnering opportunities for NOX-E36 and will update the market if and when there is a concrete development to report.

GRDC and alternative activities
On November 5th 2025, TME Pharma announced that it had signed a LOI with a German Resource Development Company (‘GRDC’). TME Pharma has decided not to continue its collaboration with GRDC.

As a publicly traded holding company, TME Pharma also intends to develop alternative business activities in addition to entering into licensing agreements for its lead biotech assets. The objective is to create additional value for shareholders and to generate cash flow from the Company’s own operations.

TME Pharma will therefore continue its search for sound and future-proof companies and activities. It will inform the market when interesting opportunities arise and seek shareholder approval before making a final decision.

Share transaction by the CEO
TME Pharma today announces that it has received notification that Diede van den Ouden, Chief Executive Officer and a Person Discharging Managerial Responsibilities ("PDMR"), has sold 460,050 ordinary shares on Euronext Growth Paris on August 19, 2026 at an average price of EUR 0,1107 per share, pursuant to an irrevocable sell instruction with pre-set price limits and a volume cap, placed with his broker on May 20, 2026 and recorded by the broker’s compliance department. Following this transaction, Mr. Van den Ouden interests remain aligned with those of shareholders. Mr. van den Ouden holds 2,214,950 ordinary shares, approximately 6.8 million warrants (provided as part of two loan agreements by Mr. van den Ouden for a total amount of € 520,956 entered into in May 2025 and and August 2025) and 3.2 million options in the Company. The transaction has been notified to the AFM in accordance with Article 19 of the Market Abuse Regulation, and the overview of the CEO’s transactions in the Documentation section of the Company’s website has been updated accordingly. The orders were solely intended to diversify the risks across the entire portfolio. Currently, the broker still has 3 irrevocable sell instructions from Mr. van den Ouden outstanding: 214,950 ordinary shares with a pre-set minimum price limit of €0.11, and two irrevocable sell instructions of 1.0 million ordinary shares each with pre-set minimum price limits of €0.14 and €0.17, respectively, capped at a maximum of 15% of the daily trading volume, and valid until the end op 2026.

(Press release, TME Pharma, AUG 24, 2026, View Source [SID1234670309])

On August 24, 2026 Monte Rosa Therapeutics, Inc. (Nasdaq: GLUE), a clinical-stage biotechnology company developing novel molecular glue degrader (MGD)-based medicines, reported that the first patient has been dosed in MODeFIRe-1 (clinicaltrials.gov identifier NCT07745361), a Phase 2 study evaluating MRT-2359 in combination with apalutamide, a second-generation androgen receptor (AR) inhibitor, in patients with metastatic castration-resistant prostate cancer (mCRPC) with AR mutations. The study follows encouraging clinical data previously shared from the Company’s Phase 1/2 study of MRT-2359 in combination with enzalutamide in heavily pretreated mCRPC patients. MRT-2359 is an investigational, orally bioavailable, GSPT1-directed MGD discovered and developed by Monte Rosa.

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"Dosing the first patient in MODeFIRe-1 is an important step in advancing MRT-2359 as a potential therapy for patients with mCRPC with AR mutations, a population with limited therapeutic options," said Filip Janku, M.D., Ph.D., Chief Medical Officer of Monte Rosa Therapeutics. "This study builds on the encouraging results we observed in our Phase 1/2 study of MRT-2359 in combination with enzalutamide. As we disclosed previously, in that study of heavily pretreated, advanced CRPC patients – including those who had progressed on prior second-generation AR inhibitors, chemotherapy, and radioligand therapy – 5 of 5 patients with AR mutations demonstrated a PSA response, with a 100% disease control rate and two RECIST responses. MODeFIRe-1 pairs MRT-2359 with apalutamide using a design intended to efficiently further evaluate and potentially confirm clinical activity in this population. We believe this study can position MRT-2359 for advancement into registrational development if the data continue to support our earlier results, with the potential to also extend clinical benefit to additional AR-driven patient populations including patients without prior second-generation AR inhibitors, as well as into combinations with radioligand therapies independent of AR status."

MODeFIRe-1 will evaluate MRT-2359 at a dose of 0.5 mg administered orally on a 21 days on, 7 days off schedule over 28-day cycles, in combination with apalutamide. The study will enroll up to 25 patients with mCRPC with AR mutations, utilizing a Simon’s two-stage design. Eligible patients must have AR mutations, PSA with or without RECIST-measurable disease, and prior treatment with a second-generation AR inhibitor. Study endpoints include PSA response, RECIST response, duration of response, radiographic progression-free survival (rPFS), PSA progression-free survival, and safety.

Enrollment in the initial Phase 1/2 study expansion arm in patients with advanced CRPC has been completed. A total of 6 patients with AR mutations were enrolled and treated with MRT-2359 in combination with enzalutamide. Monte Rosa plans to provide an update on this patient subset by the end of the year. Interim data were presented at the ASCO (Free ASCO Whitepaper) Genitourinary Cancers Symposium (ASCO GU) in February.

About MRT-2359
MRT-2359 is a potent, highly selective, and orally bioavailable investigational molecular glue degrader (MGD) of GSPT1. MYC-driven cancers, including prostate cancer, depend on enhanced translation of oncoproteins to support rapid growth. MRT-2359 exploits this therapeutic vulnerability by disrupting translation through selective degradation of the translation termination factor GSPT1. MRT-2359 treatment reduced cellular abundance of many prostate cancer-relevant oncoproteins, including AR, MYC, and Cyclin D1-E2F, and demonstrated robust anti-tumor activity across multiple preclinical models of metastatic castration-resistant prostate cancer (mCRPC). MRT-2359 is being evaluated in combination with apalutamide in MODeFIRe-1, a Phase 2 study in mCRPC patients with AR mutations. In a Phase 1/2 study, the combination of MRT-2359 with the AR inhibitor enzalutamide demonstrated encouraging early signals of clinical response in mCRPC patients with AR mutations.

(Press release, Monte Rosa Therapeutics, AUG 24, 2026, View Source [SID1234670308])

On August 24, 2026 Liminatus Pharma, Inc. (Nasdaq: LIMN) ("Liminatus" or the "Company"), a biotechnology company developing innovative cancer therapies, reported that it has engaged Synex Consulting Ltd. ("Synex"), a Korea-based full-service contract research organization ("CRO"), to support the clinical development of IBC101, the Company’s CD19xCD22 bivalent CAR-T cell therapy candidate.

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The engagement represents an important step in advancing IBC101 toward clinical execution in South Korea. IBC101 has received authorization from the Ministry of Food and Drug Safety of the Republic of Korea (MFDS) for a Phase 1/2a clinical study in patients with relapsed or refractory diffuse large B-cell lymphoma ("DLBCL"), with Seoul St. Mary’s Hospital identified as the lead clinical site.

Under the engagement, Synex will provide clinical research services pursuant to a milestone-based program, with payments linked to key clinical development milestones, including patient enrollment, database lock and completion of the clinical study report.

"Engaging Synex is another important step in moving IBC101 from regulatory authorization toward clinical execution," said Chris Kim, Chief Executive Officer of Liminatus. "Synex brings extensive experience supporting pharmaceutical clinical development in Korea, and we believe its local regulatory and clinical capabilities will be valuable as we advance the IBC101 Phase 1/2a program."

IBC101 is an autologous CD19xCD22 bivalent CAR-T cell therapy designed for relapsed or refractory B-cell malignancies. The candidate utilizes an OR-gate approach intended to recognize malignant B cells expressing either CD19 or CD22. By targeting two established B-cell antigens, IBC101 is designed to broaden antigen coverage and potentially address antigen escape and tumor heterogeneity, two mechanisms associated with relapse following single-antigen CAR-T therapy.

The IBC101 program further expands Liminatus’ oncology development portfolio beyond its IBA101 CD47 checkpoint inhibitor program and establishes an additional clinical-stage development pathway focused on hematologic malignancies.

"Following the expansion of our oncology portfolio, our focus is increasingly shifting toward execution across our development programs," added Mr. Kim. "The Synex engagement provides clinical infrastructure in Korea to support the next stage of IBC101’s development, and we look forward to progressing the program toward patient enrollment."

About IBC101

IBC101 is an investigational autologous CD19xCD22 bivalent CAR-T cell therapy candidate designed for the treatment of relapsed or refractory B-cell malignancies. The therapy is designed as an OR-gate CAR-T system capable of recognizing tumor cells expressing either CD19 or CD22, with the goal of expanding antigen coverage and reducing the potential for antigen escape associated with single-target CAR-T therapies. IBC101 has received authorization from the MFDS for a Phase 1/2a clinical study in relapsed or refractory DLBCL.

(Press release, Liminatus Pharma, AUG 24, 2026, View Source [SID1234670307])