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C-Ray Therapeutics (Shanghai) Co., Ltd. Presents Breakthrough Clinical Data of Novel Targeted Alpha Therapy 225Ac-PSMA-CY313 at EANM 2025

On October 8, 2025 C-Ray Therapeutics (Shanghai) Co., Ltd. ("C-Ray Shanghai"), a company dedicated to the development of innovative targeted radiopharmaceuticals, reported promising new clinical results for its lead program 225Ac-PSMA-CY313 in the treatment of metastatic castration-resistant prostate cancer (mCRPC) during the 2025 Annual Congress of the European Association of Nuclear Medicine (EANM 2025) (Press release, C-Ray Therapeutics, OCT 8, 2025, View Source [SID1234656524]).

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These data, highlighted in two Top Rated Oral Presentations, provide early clinical evidence of the therapy’s significant potential and favorable safety profile, marking an important milestone for C-Ray in the field of targeted alpha therapies. Both presentations were delivered by the company’s Chief Medical Officer.

One presentation, entitled "Feasibility study of 225Ac-PSMA-CY313 dosimetry in mCRPC patients using SPECT", showcased the company’s progress in dosimetry research with 225Ac. The study successfully established and validated a quantitative dosimetry approach using SPECT/CT to evaluate internal radiation doses in patients treated with 225Ac-PSMA-CY313. Findings demonstrated that tumors (particularly soft tissue lesions) received high absorbed doses, while key organs such as the kidneys and liver remained within safe exposure limits—supporting a favorable therapeutic window. Importantly, no severe adverse events (SAEs) or grade ≥3 toxicities were observed during treatment.

The second presentation, "Evaluation of the safety and efficacy of 225Ac-PSMA-CY313 in metastatic castration-resistant prostate cancer: preliminary results", reported clinical outcomes from 13 patients treated with 225Ac-PSMA-CY313. The study results showed encouraging efficacy and manageable safety in heavily pretreated, standard therapy–resistant mCRPC patients. All patients (100%) achieved reductions in prostate-specific antigen (PSA) levels, with 81.8% achieving PSA50 response (≥50% decline). Among evaluable patients, the objective response rate (ORR) reached 60%. Most adverse events were grade 1–2, with the most common being xerostomia (dry mouth) reported in 11 of 13 patients (84.6%), including 10 grade 1 and 1 grade 2 events (per CTCAE v5.0 criteria).

"Presenting these results on such a globally recognized stage as EANM represents a significant milestone for C-Ray," said the Chief Medical Officer of C-Ray Shanghai. "There are only a few teams worldwide that have successfully advanced an alpha-emitting radiopharmaceutical into clinical development. Not only have we developed 225Ac-PSMA-CY313, but we have also generated robust early clinical data from more than a dozen patients. This underscores our strong capabilities and commitment in both radiopharmaceutical R&D and clinical translation."

Biond Biologics Announces Initiation of a Phase 2 Study of BND-22 in Combination with anti-PD-1 therapy

On October 8, 2025 Biond Biologics Ltd. ("Biond" or the "Company"), a private, clinical-stage biopharmaceutical company developing novel immunotherapies for cancer and autoimmunity, reported the launch of a Phase 2 study of BND-22 (SAR444881) in combination with anti-PD-1 therapy in patients with locally advanced or metastatic NSCLC previously treated with immune-oncology (IO) therapies, and anti–PD-1/PD-L1 naïve patients with MSS-CRC or ovarian cancer (ClinicalTrials.gov Identifier: NCT06651593) (Press release, Biond Biologics, OCT 8, 2025, View Source [SID1234656523]).

The new study is led by Dr. Aung Naing from The University of Texas MD Anderson Cancer Center and is expected to enroll patients whose tumors are known to express HLA-G, which is the ligand of ILT2 receptor, and that was found to be correlated with response to treatment with BND-22. The primary objective of the study is to identify biomarkers related to the mechanism of action of BND-22 alone and in combination with an anti-PD-1 therapy and predictive biomarkers related to response, survival and resistance. Secondary study objectives include efficacy of BND-22 and its combination with anti-PD-1 therapy, and safety/tolerability. Biond retains worldwide development and commercialization rights to BND-22.

"The foundation of the biomarker study is supported by the results of the first-in-human Phase 1/2 dose-escalation study of BND-22 which demonstrated a favorable safety profile and encouraging anti-tumor activity both as monotherapy and in combination with approved therapies. Dose-dependent activation of ILT2-expressing T cells, NK cells and monocytes were observed, with several confirmed clinical responses in heavily pre-treated patients," said Dr. Natalia Ashtamker, VP Clinical Development at Biond. "This study is an important step toward precision development of BND-22, our multi-cell checkpoint inhibitor, and by combining it with PD-1 blockade and deeply profiling patient samples, we aim to accelerate BND-22 into registrational trials for the tumors most likely to benefit. Additionally, we continue to treat responders from the Phase 1/2 trial that are still benefiting from BND-22. We are excited to collaborate with MD Anderson on this biomarker-rich study, which will guide the design of future registrational programs."

About BND-22

BND-22 is a humanized IgG4 antagonist antibody targeting the ILT2 receptor, developed for the treatment of solid tumors. ILT2 is an inhibitory immuno-modulating receptor expressed on both innate and adaptive immune cells. It binds to major histocompatibility complex (MHC) class I molecules, including HLA-G, an immunosuppressive protein expressed by various tumor types.

Preclinical studies have demonstrated that BND-22 exerts broad anti-tumor effects by disrupting ILT2-mediated "do not eat me" signals in macrophages and activating NK and CD8+ lymphocytes.

BND-22-001, a Phase 1/2 multicenter, open-label, dose-escalation, dose-expansion and dose optimization study enrolled patients with advanced solid tumors known to express HLA-G. The first-in-human Phase 1 study (BND-22-001, NCT04717375), designed to evaluate the safety and tolerability of BND-22, both as a monotherapy and in combination with the approved cancer therapies cetuximab and pembrolizumab. The phase 2 included evaluations of BND-22 as monotherapy in cholangiocarcinoma and in combination with cetuximab in patients with non-small cell lung cancer (NSCLC) and colorectal cancer (CRC).

View Source (Trial Identifier: NCT04717375).

Boehringer Ingelheim Obtains Novel Preclinical Oncology Program from Accent Therapeutics

On October 8, 2025 Accent Therapeutics reported an asset purchase agreement with Boehringer Ingelheim for a preclinical, potentially first-in-class small molecule program. This innovative asset offers a new strategy for treating tumors with high interferon-stimulated gene (ISG) expression, representing a meaningful addition to Boehringer’s portfolio of cancer cell–directed and immuno-oncology therapies.

"We are delighted that Boehringer Ingelheim will now advance this leading preclinical program with the potential to address tumors with high unmet need," said Shakti Narayan, Chief Executive Officer, Accent Therapeutics. "This strategic transaction sharpens our focus on advancing our lead clinical assets through their ongoing Phase 1/2 studies and delivering on our commitment to patients."

Notably, the acquired program is designed to stimulate antitumor immunity and its unique mechanism positions it as a strong candidate for combination with cancer immunotherapies – a cornerstone of Boehringer’s research strategy.

Accent Therapeutics will receive an upfront payment and is entitled to success-based preclinical milestone payments under the terms of the agreement. Boehringer Ingelheim will assume global responsibility for research, development, manufacturing, and commercialization of the program, advancing it toward clinical evaluation.

Source: Press release, Boehringer Ingelheim, OCT 8, 2025, View Source

Aptevo Presenting Scientific and Clinical Updates at SITC and ASH, also Participating in Leading Financial and Industry Conferences in the Fourth Quarter

On October 8, 2025 Aptevo Therapeutics ("Aptevo" or the "Company") (Nasdaq:APVO), a clinical-stage biotechnology company developing novel bispecific and trispecific immuno-oncology therapeutics, reported its participation in upcoming key financial, industry, scientific and medical conferences this fall, providing the opportunity to highlight continued momentum and recent developments among a broad range of stakeholder audiences (Press release, Aptevo Therapeutics, OCT 8, 2025, View Source [SID1234656521]).

These conferences include:

4th Annual ROTH Healthcare Opportunities Conference
October 9, 2025 – Metropolitan Club, New York City, New York

Aptevo will participate in a panel on Acute Myeloid Leukemia titled "Novel AML Therapies Showing Clear Clinical Progress," discussing progress and recent trial outcomes of its lead asset, mipletamig, and sharing emerging evidence of its differentiated clinical profile in frontline AML-where strong safety, tolerability, and early efficacy continue to demonstrate meaningful potential for improved patient outcomes

Biotechnology Innovation Organization (BIO)-Europe 2025 – 31st Annual International Partnering Conference
November 3-5, 2025 (in-person); Digital Partnering Days: November 11-12, 2025 – Messe Wien Exhibition & Congress Center, Vienna, Austria

The Business Development Team will be on-site and actively participating in meetings at the largest biotechnology meeting in Europe

Society of Immunotherapy in Cancer (SITC) (Free SITC Whitepaper) 2025 – 40th Anniversary Annual Meeting
November 5-9, 2025 – Gaylord National Resort & Convention Center, National Harbor, Maryland

Aptevo’s R&D Team will present a poster highlighting a novel trispecific targeting Nectin-4, CD3 and CD40 to overcome the immunosuppressive the tumor microenvironment

American Society of Hematology (ASH) (Free ASH Whitepaper) 2025 – 67th American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting & Exposition
December 6-9, 2025 – Orange County Convention Center, Orlando, Florida

Interim results from the ongoing Phase 1b/2 RAINIER trial evaluating mipletamig in frontline combination therapy for the treatment of AML, will be presented in a poster session by the clinical team.

Sapu Nano Unveils First-in-Human Clinical Trial of Sapu-003 at 8th Australian Translational Breast Cancer Research Symposium

On October 8, 2025 Sapu Nano reported the presentation of its poster, "Sapu-003: Novel Intravenous Deciparticle Everolimus Entering Phase 1 Study in Australia," at the 8th Australian Translational Breast Cancer Research Symposium (ATBCR 2025) (Press release, Sapu Bioscience, OCT 8, 2025, View Source [SID1234656520]). Sapu Nano is part of the Sapu family of companies, formed through GMP Biotechnology Limited, a joint venture between Oncotelic Therapeutics, Inc. (OTCQB: OTLC) and Dragon Overseas Capital Limited.

Sapu-003 is the first intravenous (IV) Deciparticle formulation of everolimus, an mTOR inhibitor widely used in oncology. While oral everolimus (Afinitor) has demonstrated efficacy in breast cancer, renal cell carcinoma, and neuroendocrine tumors, its broader use has been constrained by low bioavailability, variable systemic exposure, and gastrointestinal toxicities.

Global Development Partnership
The trial is being conducted in collaboration with SOCRU, a leading Phase 1 clinical unit in Australia; Ingenū, a clinical research organization with deep early-phase expertise; and Medicilon, Sapu Nano’s strategic partner for preclinical drug development. Together, these partnerships ensure robust clinical execution, regulatory alignment, and high-quality product supply for the study.

Call to Patients and Physicians
The trial (ACTRN12625001083482) is now open for enrollment at leading oncology centers across Australia. Eligible participants include adults with advanced HR+/HER2- breast cancer or other mTOR-sensitive tumors who have exhausted standard therapies. Physicians are encouraged to refer patients who may benefit from participation.

"Sapu-003 represents a significant advance in the delivery of mTOR-targeted therapies," said Vuong Trieu, PhD, Chief Executive Officer of Sapu Nano. "Through the combined expertise of SOCRU, Ingenū, and Medicilon, we are positioned to accelerate development and bring this next-generation treatment option to patients with advanced cancers."