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]).

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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.

Lisata Therapeutics and Catalent Announce Global Antibody-Drug Conjugate (ADC) License Agreement

On October 8, 2025 Lisata Therapeutics, Inc. (Nasdaq: LSTA) ("Lisata" or the "Company"), a clinical-stage pharmaceutical company developing innovative therapies for the treatment of advanced solid tumors and other serious diseases, and Catalent, Inc. ("Catalent"), a leader in enabling the development and supply of better treatments for patients worldwide, reported a global product license agreement that allows Catalent to incorporate Lisata’s certepetide into antibody-drug conjugates ("ADCs") developed using Catalent’s SMARTag technology platform (Press release, Catalent, OCT 8, 2025, https://www.catalent.com/media-advisories/lisata-therapeutics-and-catalent-announce-global-antibody-drug-conjugate-adc-license-agreement/ [SID1234656506]). Certepetide, a proprietary, internalizing RGD (arginyl-glycyl-aspartic acid) or "iRGD" cyclic peptide, is being tested by Lisata as a cancer therapeutic to be used in combination with other anti-cancer agents to enhance tumor targeting and penetration and improve treatment outcomes.

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Under the licensing agreement, Catalent gains worldwide, non-exclusive rights to develop and commercialize bioconjugate products containing certepetide and its analogs, including the ability to partner with third parties. As part of this collaboration, Catalent will have the right to evaluate certepetide and its analogs as SMARTag payloads in clinical studies across multiple ADCs targeting difficult-to-treat diseases, with the goal of creating a new class of targeted bioconjugate therapies. Lisata is eligible to receive over $10 million in tiered study initiation milestone payments plus revenue sharing on future sales and partnerships.

"This collaboration is based on positive preclinical results generated by Catalent’s use of an iRGD peptide as part of its SMARTag ADC platform," stated Kristen K. Buck, M.D., Executive Vice President of Research and Development and Chief Medical Officer of Lisata. "It underscores our mutual belief in certepetide’s broad potential and is another significant step forward in Lisata’s mission to bring transformative therapies to patients. Catalent’s technology and innovative approach are a perfect complement to certepetide’s biology." Preclinical work supporting incorporation of iRGD peptides into the SMARTag ADC platform will be highlighted at this November’s World ADC conference in San Diego.

"We are excited about the opportunity to explore iRGD biology as it relates to ADC delivery to the tumor microenvironment. Early data suggest that incorporating iRGD peptides into ADCs improves efficacy and pharmacokinetics, leading us to be optimistic about the potential of iRGD as a novel payload class," said Penelope Drake, Head of R&D, Bioconjugates at Catalent.

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.

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"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

Circio presents comprehensive circVec in vivo data package demonstrating 40-fold improvement over conventional AAV gene delivery at ESGCT 2025

On October 8, 2025 Circio Holding ASA (OSE: CRNA), a biotechnology company developing powerful circular RNA technology for next generation nucleic acid medicine, reported the publication of a comprehensive data package demonstrating AAV-circVec in vivo tissue-specific proof-of-concept (Press release, Circio, OCT 8, 2025, View Source [SID1234656507]). The results are being delivered in a poster presentation at the European Society of Cell and Gene Therapy (ESGCT) annual meeting 2025 in Seville, Spain.

In the ESGCT poster presentation, Circio is presenting new and expanded in vivo results demonstrating the advantage of circVec as a novel expression system to transform AAV gene therapy. In heart tissue, circVec 3.2 shows highly localized activity that outperforms conventional mRNA-based AAV expression by up to 40-fold. These results have been demonstrated and confirmed both by IVIS scanning and post-mortem ex vivo tissue analysis. To validate the technology in a therapeutically relevant setting, Circio has initiated technical development of circVec-AAV gene therapy constructs for Danon disease, a devastating cardiac genetic disease with no therapeutic options available today.

"Circio has worked systematically to optimize the circVec design for AAV gene delivery over the past two years. The latest circVec 3.2 generation incorporates a novel genetic feature that drives up AAV protein expression to levels that substantially exceed conventional mRNA-based AAVs. We are now advancing rapidly to validate these findings in relevant genetic disease models," said Dr. Thomas B. Hansen, CTO of Circio. "Importantly, the strong advantage in the heart is also observed in several other tissues and AAV variants. This consistency supports broad applicability of our circVec platform, thereby opening development and partnering opportunities in multiple therapeutic areas."

The presentation also includes data showing a strong increase in expression levels with the trend for continued signal accumulation following local delivery of previous generation circVec 2.0 AAV vector to the eye. Testing of the latest generation circVec 3.2 in eye and other tissues is currently being initiated, and a novel circVec generation 4.0, which incorporates further genetic enhancer elements, is due to enter initial in vivo screening experiments.

"ESGCT provides an excellent forum to showcase the circVec platform to a wide academic and industry audience as a potential solution to address the key issue preventing broad adoption and success of AAV gene therapy," said Dr. Erik D Wiklund, CEO of Circio. "The AAV field has recently experienced several major setbacks due to severe toxicity issues in ongoing clinical studies. Switching to circVec-based expression can enable substantial dose reduction, which we expect will lead to considerable improvements in safety for patients and lower treatment cost. The circVec platform could thereby completely transform the clinical and commercial viability of AAV therapy as we know it today and establish circVec as a novel gold-standard gene expression system."

Title of presentation and poster:
CircVec: Enhancing gene and cell therapy using circular RNA vector expression technology (poster no. 1041)

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Presenter: CTO Dr. Thomas B Hansen & CSO Dr. Victor Levitsky

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).