On November 2, 2025 Akeso (9926.HK) reported that its first-in-class bispecific antibody, ivonescimab (PD-1/VEGF bispecific antibody), in combination with chemotherapy for first-line treatment of triple-negative breast cancer (TNBC) has been granted Breakthrough Therapy Designation (BTD) by the Center for Drug Evaluation (CDE) from China’s National Medical Products Administration (NMPA).

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The Phase III multicenter, randomized, double-blind clinical trial (HARMONi-BC1/AK112-308) for this combination therapy is ongoing in China. The BTD designation is expected to further expedite the clinical development and regulatory approval process of ivonescimab for the treatment of TNBC. This marks the fourth BTD granted by the CDE for ivonescimab. The previous three designations include:

Ivonescimab combined with chemotherapy for locally advanced or metastatic NSCLC resistant to EGFR-TKI therapy, which has now been approved for marketing in China and added to China’s National Reimbursement Drug List.

First-line treatment of PD-L1-positive locally advanced or metastatic NSCLC, which has also been approved for marketing in China.

Ivonescimab combined with docetaxel for locally advanced or metastatic NSCLC patients who have failed previous PD-1/L1 inhibitors and platinum-based chemotherapy. The Phase III clinical trial for this indication in China is currently ongoing.
Receiving four Breakthrough Therapy Designations affirms ivonescimab’s substantial clinical benefit across multiple major cancer types and reinforces Akeso’s commitment to addressing critical unmet medical needs. The therapy is currently advancing in 14 Phase III clinical trials worldwide, including four international multicenter studies. These large pivotal studies, backed by repeated regulatory recognition, position ivonescimab to deliver transformative, life-saving outcomes for patients worldwide.

(Press release, Akeso Biopharma, NOV 2, 2025, View Source [SID1234659227])

On November 2, 2025 OncoHost, a global leader in precision oncology and proteomics-based biomarker development, reported the presentation of two new research posters at the 2025 International Society for Liquid Biopsy (ISLB) Annual Congress. The studies underscore the transformative potential of plasma proteomics in improving clinical decision-making and real-time disease monitoring for patients with non-small cell lung cancer (NSCLC).

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Poster 1: Plasma Proteomics as a Systemic Monitoring Approach in NSCLC Immunotherapy: Comparative Analysis with ctDNA

Presenter: Michal Harel, Ph.D., VP Translational Medicine, OncoHost
Presentation Time: Sunday, November 2, 10:45–11:45, Tuesday, November 3, 9:00-10:00

This study introduces a comparative analysis between plasma proteomic signatures and circulating tumor DNA (ctDNA) to evaluate immunotherapy response in advanced NSCLC.

Leveraging aptamer-based proteomic profiling of approximately 7,000 plasma proteins per sample, researchers identified three key proteomic signatures reflecting:

Soluble PD-1/PD-L1 drug bioavailability,
T-cell activation and immune engagement, and
Intracellular proteins indicating lung tissue damage.
Notably, the tissue-damage signature enabled early detection of non-responders up to 6.6 months before standard imaging. While ctDNA tumor load correlated modestly with this signature, only the proteomic analysis effectively distinguished clinical response groups.

"These results demonstrate the unique systemic insight offered by plasma proteomics – capturing the full tumor-immune interaction beyond what is achievable with ctDNA alone," said Dr. Harel. "This approach has the potential to revolutionize real-time treatment monitoring for immunotherapy patients."

Poster 2: A Plasma Proteomics Test Predicts Immunotherapy Benefit in NSCLC Independent of Genomic Alterations

Presenter: Anna Manasherov, MSN-FNP, MPH, Director, Scientific Affairs, OncoHost
Presentation Time: Sunday, November 2, 10:45–11:45, Tuesday, November 3, 9:00-10:00

The second study evaluated the performance of PROphetNSCLC, OncoHost’s commercially available liquid biopsy proteomics test, in predicting immunotherapy benefit across major genomic subgroups.

Analyzing pre-treatment plasma samples from 308 NSCLC patients treated with immune checkpoint inhibitors, the study revealed that a PROphet-POSITIVE result predicted significantly longer overall survival (HR=0.39, p<0.0001) – a benefit consistently observed across KRAS, STK11, TP53, and KEAP1 mutation subgroups.

Importantly, the predictive power of PROphetNSCLC was maintained independent of mutational status and PD-L1 expression, establishing it as a universal biomarker for immunotherapy benefit prediction.

"The data reinforce the value of PROphetNSCLC as an independent, mutation-agnostic tool supporting oncologists in selecting optimal first-line treatments," said Ofer Sharon, MD, CEO at OncoHost. "Our findings highlight the power of proteomics to transcend genomic boundaries and provide actionable clinical insights."

(Press release, OncoHost, NOV 2, 2025, View Source [SID1234659228])

On November 2, 2025 Samsung Epis Holdings Co., Ltd. reported its establishment as a new investment holding company, following the spin-off of Samsung Bioepis Co., Ltd. from Samsung Biologics (KRX: 207940.KS). Samsung Epis Holdings will be listed on Korea Exchange (KRX) on November 24, 2025, after establishment of a new subsidiary company on November 14, 2025. Samsung Bioepis will continue to operate its biosimilar business as a 100% owned subsidiary of Samsung Epis Holdings.

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Kyung-Ah Kim will serve as the President and Chief Executive Officer (CEO) of Samsung Epis Holdings, in addition to her current role as the President and CEO of Samsung Bioepis. "The new investment holding company will focus on discovering and securing investment opportunities in biotechnology for the company and its subsidiaries’ long-term growth, with scientific innovation remaining the source of our value creation. In the meantime, Samsung Bioepis will remain committed to ensuring the continued development, manufacturing, and distribution of quality-assured biosimilar medicines to patients around the world," said Kyung-Ah Kim, President and CEO of Samsung Epis Holdings. "By establishing an independent decision-making structure, we see the potential for further growth and investment. Progress is being made to secure next-generation therapeutic technology on the back of the capabilities accumulated through our biosimilar business. With the spin-off, we expect to have more opportunities to explore next-generation growth drivers."

(Press release, Samsung Epis Holdings, NOV 2, 2025, View Source [SID1234659229])

On October 31, 2025 NANOBIOTIX (Euronext: NANO –– NASDAQ: NBTX – the ‘‘Company’’), a late-stage clinical biotechnology company pioneering physics-based approaches to expand treatment possibilities for patients with cancer and other major diseases, reported that it has entered into a royalty-based financing agreement with HealthCare Royalty ("HCRx"), providing up to $71 million in non-dilutive capital and establishing the financial foundation for self-sustainability and the advancement of next wave nanotherapeutic platforms for long-term growth.

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"This non-dilutive financing reflects our commitment to preserving long-term shareholder value, while strategically aligning capital to unlock the full potential of our nanotherapeutics platforms. Importantly, this funding provides the resources to advance the company through critical potential milestones that will lead to self-sustainability and durable value creation," said Bart van Rhijn, Chief Financial and Business Officer at Nanobiotix.

Key Terms of the Royalty Financing Agreement

At the closing of the agreement, Nanobiotix will receive an upfront payment of $50 million and expects to receive an additional $21 million one year post closing subject to reaching certain conditions
Assuming $71 million is funded, success-based1 remuneration to HCRx includes:
Repayment from a defined portion of royalties on the first $1 billion of net sales and a portion of certain regulatory and commercial milestone payments, subject to a cap of approximately $124 million (1.75x Multiple on Invested Capital ("MOIC")) if repayment is completed by end of 2030, increasing to approximately $178 million (2.50x MOIC) if repayment occurs thereafter (the Return Cap figures assume $71 million is funded)
Following achievement of the Return Cap, a royalty-only tail period will commence, which entitles HCRx to a predefined, reduced share of royalties not to exceed $14.9 million per year; the tail period will expire 10 years following the first commercial sale of JNJ-1900 (NBTXR3) in the US
Payment and repayment obligations under both this royalty financing agreement with HCRx and the existing royalty agreement with the European Investment Bank (EIB) will be furnished through the transfer of receivables from the JNJ-1900 (NBTXR3) license agreement to a French law trust
"We are excited to partner with Nanobiotix at this pivotal stage of its growth" said Clarke Futch, Chairman and Chief Executive Officer at HCRx. "The differentiated nature of their physics-based approach and the compelling clinical profile of JNJ-1900 (NBTXR3) align with our mission of supporting innovative therapies that address areas of significant unmet need. This investment underscores our confidence in this first-of-its-kind approach to cancer treatment, which has the potential to redefine standards of care and establish an entirely new class of therapy."

TD Cowen acted as sole financial advisor to Nanobiotix.

Assuming the drawdown of the second tranche one year post closing, this financing extends Nanobiotix cash runway into early 2028 subject to closing of the agreement. This extension of cash runway does not include potential milestone payments from the JNJ-1900 (NBTXR3) licensing agreement. The Company continues to expect to receive the first potential milestone payments related to clinical development in head and neck cancer (NANORAY-312) and lung cancer (CONVERGE) within this timeframe, and has thereby established the financial foundation for self-sustaining long-term growth.

About JNJ-1900 (NBTXR3)

JNJ-1900 (NBTXR3) is a novel, potentially first-in-class oncology product composed of functionalized hafnium oxide nanoparticles that is administered via one-time intratumoral injection and activated by radiotherapy. Its proof-of-concept was achieved in soft tissue sarcomas through a successful randomized Phase 2/3 study in 2018. The product candidate’s mechanism of action (MoA) is designed to induce significant tumor cell death in the injected tumor when activated by radiotherapy, subsequently triggering adaptive immune response and long-term anti-cancer memory. Given the physical MoA, Nanobiotix believes that JNJ-1900 (NBTXR3) could be scalable across any solid tumor that can be treated with radiotherapy and across any therapeutic combination, particularly immune checkpoint inhibitors.

Radiotherapy-activated JNJ-1900 (NBTXR3) is being evaluated across multiple solid tumor indications as a single agent or combination therapy. The program is led by NANORAY-312—a global, randomized Phase 3 study in locally advanced head and neck squamous cell cancers. In February 2020, the United States Food and Drug Administration granted regulatory Fast Track designation for the investigation of JNJ-1900 (NBTXR3) activated by radiation therapy, with or without cetuximab, for the treatment of patients with locally advanced HNSCC who are not eligible for platinum-based chemotherapy—the same population being evaluated in the Phase 3 study.

Given the Company’s focus areas, and balanced against the scalable potential of NBTXR3, Nanobiotix has engaged in a collaboration strategy to expand development of the product candidate in parallel with its priority development pathways. Pursuant to this strategy, in 2019 Nanobiotix entered into a broad, comprehensive clinical research collaboration with The University of Texas MD Anderson Cancer Center to sponsor several Phase 1 and Phase 2 studies evaluating JNJ-1900 (NBTXR3) across tumor types and therapeutic combinations. In 2023, Nanobiotix announced a license agreement for the global co-development and commercialization of JNJ-1900 (NBTXR3) with Janssen Pharmaceutica NV, a Johnson & Johnson company.

(Press release, Nanobiotix, OCT 31, 2025, View Source [SID1234659207])

On October 31, 2025 Alpha Fusion Inc. (Headquarters: Chiyoda-ku, Tokyo; CEO: Sunao Fujioka; hereinafter "Alpha Fusion") reported the initiation of a company-sponsored Phase I clinical trial (jRCT2031250472) of the alpha-emitting radiopharmaceutical af-001, which contains [211At]NaAt as its active pharmaceutical ingredient, in patients with differentiated thyroid cancer (papillary and follicular carcinoma).

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This clinical trial is designed based on the results of an investigator-initiated Phase I study conducted at The University of Osaka, and consists of Part Ia and Part Ib.

In Part Ia, the maximum tolerated dose (MTD) of a single intravenous administration of af-001 will be determined in patients with differentiated thyroid cancer who are refractory to or intolerant of standard therapies. Part Ib will evaluate the efficacy and safety of multiple intravenous administrations of af-001 to determine the recommended dose for Phase II trials in patients with differentiated thyroid cancer who have not received prior radioactive iodine (RAI) therapy (RAI-naïve).

Part Ia of the study will be conducted at the National Cancer Center Hospital East (Principal Investigator: Dr. Makoto Tahara, Chief, Department of Head and Neck Medical Oncology), and Part Ib will be conducted at multiple sites in Japan.

The clinical development of af-001 will proceed with the goal of obtaining regulatory approval for use in patients with RAI-naïve differentiated thyroid cancer (papillary and follicular carcinoma). If clinical efficacy and safety are indicated in this patient population, af-001 is expected to contribute as a next-generation radiopharmaceutical and as a novel therapeutic option for differentiated thyroid cancer.

af-001 is manufactured under GMP for investigational products in collaboration with the Kobe City Medical Center General Hospital (Director: Dr. Yasuki Kihara; Chuo-ku, Kobe City, Hyogo), and promptly delivered to the National Cancer Center Hospital East after production.

Regarding the initiation of this study, Sunao Fujioka, CEO of Alpha Fusion Inc., commented as follows:

"Based on the achievements of the investigator-initiated Phase I study in patients refractory or intolerant to standard therapies, we expect to maximize the potential of af-001 by confirming its safety and efficacy in RAI-naïve patients. Alpha Fusion is fully committed to advancing the clinical development of af-001, with the ultimate goal of providing outpatient alpha-emitting radiopharmaceutical therapy to more patients with thyroid cancer. In addition, we are pursuing multiple research and development pipelines utilizing At-211, aiming to create innovative radiopharmaceuticals for various types of cancer."

Background

RAI therapy is the standard treatment for differentiated thyroid cancer. However, in cases involving multiple metastases or insufficient therapeutic response despite clear iodine uptake, repeated RAI treatments may be required.

Moreover, due to radiation protection requirements in Japan, RAI therapy must be administered in shielded rooms, leading to hospitalization that imposes psychological stress on patients and financial burdens on hospitals. A survey in Japan reported an average waiting time of approximately 3.7 months, and 23% of facilities having a wait time exceeding six months (Survey Report on the Utilization of RI Therapy Rooms for Thyroid Cancer, 2022).

Given these challenges, there is a growing demand for patient-centric radiopharmaceuticals that can achieve potent tumor-reducing effects in an outpatient setting.

About At-211 (af-001)

af-001 is a radiopharmaceutical containing astatine-211 (At-211) as its active pharmaceutical ingredient. It is selectively taken up by differentiated thyroid cancer cells through the sodium/iodide symporter (NIS) and exerts a cytotoxic effect by emitting alpha particles.

At-211 emits alpha particles with higher energy than beta particles, inducing double-strand DNA breaks in cancer cell nuclei and leading to tumor regression.
Because alpha particles have a very limited range (approximately several tens of micrometers), af-001 can deliver strong therapeutic effects while minimizing damage to surrounding normal tissues. Consequently, substituting RAI with the limited-range alpha emitter af-001 may enable outpatient-based treatment.

With these unique characteristics, af-001 is being developed as a next-generation radiopharmaceutical and a novel treatment for differentiated thyroid cancer, offering both efficacy and safety.

Results of the Investigator-Initiated Clinical Trial and Positioning of the Company-Sponsored Trial

Prior to this company-sponsored trial, an investigator-initiated Phase I clinical trial (Alpha-T1 Trial) of [211At]NaAt, identical in composition to af-001, was conducted at The University of Osaka under the supervision of Dr. Tadashi Watabe, Principal Investigator (NCT05275946).

The study indicated the safety and tolerability of [211At]NaAt in patients with differentiated thyroid cancer refractory or intolerant to standard therapies. Additionally, the study reported a ≥50% reduction in thyroglobulin concentration (a tumor marker) and cases of disappearance of 131I uptake on imaging.

The present company-sponsored trial aims to evaluate the efficacy and safety of af-001 (identical in pharmaceutical ingredient to TAH-1005, [211At]NaAt) in RAI-naïve patients, with the objective of determining the recommended dose for subsequent Phase II studies.

(Press release, Alpha Fusion, OCT 31, 2025, View Source [SID1234659210])