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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]).

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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."

Xspray Pharma provides update on the FDA process for Dasynoc – observations at contract manufacturer delay approval

On October 8, 2025 Xspray Pharma reported to have received a CRL from the U.S. Food and Drug Administration (FDA) concerning the Company’s New Drug Application (NDA) for Dasynoc (dasatinib) for the treatment of chronic myeloid leukemia (CML) and acute lymphoblastic leukemia (ALL) (Press release, Xspray, OCT 8, 2025, https://xspraypharma.com/modular_finance_pressmeddelande/xspray-pharma-provides-update-on-the-fda-process-for-dasynoc-observations-at-contract-manufacturer-delay-approval/ [SID1234656517]).

The FDA’s decision is based on GMP (Good Manufacturing Practice) observations at the Company’s contract manufacturer. No observations were directed at the production line used for Dasynoc, but the FDA is pausing approvals of new products at the facility while corrective actions are being implemented. The manufacturer has confirmed that a remediation plan is already in place and that a meeting with the FDA is scheduled for December.

"It is unfortunate that manufacturing-related issues beyond our control are delaying our launch. We have made significant progress in the regulatory review and maintained discussions with the FDA regarding the product information for Dasynoc up to the PDUFA date," said Per Andersson, CEO of Xspray Pharma. "We will now work closely with both the manufacturer and the FDA to expedite the process and enable a resubmission as soon as the corrective actions have been completed."

The FDA has also requested information demonstrating that the discussed product information is appropriate and data confirming the outcome of previously implemented corrective actions at the production line.

Other programs
Xspray’s other development programs are progressing according to plan. The review of the NDA for XS003 (nilotinib) is expected to be initiated by the FDA shortly, with an anticipated PDUFA date in June 2026.