Innovent to Present Preclinical Data of Multiple Novel Molecules at the 2025 AACR Annual Meeting

On March 26, 2025 Innovent Biologics, Inc. ("Innovent") (HKEX: 01801), a world-class biopharmaceutical company that develops, manufactures and commercializes high quality medicines for the treatment of oncology, cardiovascular and metabolic, autoimmune, ophthalmology and other major diseases, reported that preclinical data on multiple novel bispecific antibodies as well as antibody-drug-conjugates (ADCs) from its oncology pipeline will be presented at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting 2025 (Press release, Innovent Biologics, MAR 26, 2025, View Source [SID1234651476]). The AACR (Free AACR Whitepaper) Annual Meeting will take place from April 25 to April 30, 2025, in Chicago, Illinois.

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Late-Breaking Research: Immunology 2

Topic: Preclinical Data of IAR037, A Novel CD40/PD-L1 Bispecific Antibody for the Treatment of Advanced Solid Tumors Resistant to Immune Checkpoint Inhibitors
Abstract Number: LB139
Presentation Time:Monday Apr 28, 2025 9:00 AM – 12:00 PM
Location: Poster Section 52

Late-Breaking Research: Clinical Research 1

Topic: Preclinical characterization of IBI3010, a FRα targeting biparatopic antibody-drug conjugate (ADC), for the treatment of FRα expressing tumors
Abstract Number: LB222
Presentation Time:Monday Apr 28, 2025 2:00 PM – 5:00 PM
Location: Poster Section 53

Poster Session: Experimental and Molecular Therapeutics – New and Emerging Cancer Drug Targets

Topic: IBI3019, a first-in-class EGFR/CDH17/CD16A tri-specific antibody, demonstrated potent efficacy against CRC and an excellent safety profile in preclinical studies
Abstract Number: 4249
Presentation Time: Tuesday Apr 29, 2025 9:00 AM – 12:00 PM
Location: Poster Section 17
Poster Board Number: 6

Poster Session: Experimental and Molecular Therapeutics – Therapeutic Approaches to Attack the Tumor Microenvironment

Topic: IBI3026, a first-in-class anti-PD-1/IL-12 fusion protein, demonstrates the potential to be a new immuno-oncology therapy by releasing the break in immune response and strongly activating T and NK cells in the tumor microenvironment
Abstract Number: 3118
Presentation Time: Monday Apr 28, 2025 2:00 PM – 5:00 PM
Location: Poster Section 24
Poster Board Number: 2

Poster Session: Experimental and Molecular Therapeutics – Biochemical Modulators of Cancer / Differentiation Therapeutic Strategies

Topic: IBI3014, a TROP2xPD-L1 bi-specific ADC integrating ADC killing with checkpoint blockade within one molecule, exhibits promising efficacy and safety in preclinical models
Abstract Number: 344
Presentation Time: Sunday Apr 27, 2025 2:00 PM – 5:00 PM
Location: Poster Section 16
Poster Board Number: 11

Poster Session: Experimental and Molecular Therapeutics – Biochemical Modulators of Cancer / Differentiation Therapeutic Strategies

Topic: Trop2 and B7H4 bi-specific ADC with improved efficacy and safety for gynecologic cancers
Abstract Number: 345
Presentation Time: Sunday Apr 27, 2025 2:00 PM – 5:00 PM
Location: Poster Section 16
Poster Board Number: 12

Poster Session: Immunology – T Cell Engagers

Topic: A 2+1 format MUC16 targeting T cell engager induces MUC16-dependent T cell activity and superior anti-tumor efficacy
Abstract Number: 3510
Presentation Time: Monday Apr 28, 2025 2:00 PM – 5:00 PM
Location: Poster Section 38
Poster Board Number: 18

Poster Session: Immunology – Modulation of Tumor Microenvironment: Modulation of Lymphocyte Influx

Topic: A PD1-IFNα fusion protein, composed of an attenuated IFNα fused to a clinically validated PD1 mAb, induced PD1-dependent IFNα signaling and demonstrated superior anti-tumor efficacy
Abstract Number: 4881
Presentation Time: Tuesday Apr 29, 2025 9:00 AM – 12:00 PM
Location: Poster Section 40
Poster Board Number: 9

Poster Session: Experimental and Molecular Therapeutics – Novel Antitumor Agents 3

Topic: Olverembatinib* (HQP1351) in combination with lisaftoclax (APG-2575) overcomes venetoclax resistance in preclinical models of acute myeloid leukemia (AML)
Abstract Number: 5652
Presentation Time: Tuesday Apr 29, 2025 2:00 PM – 5:00 PM

Poster Session: Experimental and Molecular Therapeutics – Novel Antitumor Agents 3

Topic: Effects of olverembatinib* (HQP1351) in combination with BCL-2 inhibitor lisaftoclax (APG-2575) in T-cell acute lymphoblastic leukemia (T ALL)
Abstract Number: 5648
Presentation Time: Tuesday Apr 29, 2025 2:00 PM – 5:00 PM

* In July 2021, Innovent and Ascentage Pharma (6855.HK) reached the agreement regarding the joint development and commercialization of olverembatinib in China.

Dr. Kaijie He, Vice President of Innovent, stated: "With the expansion and enhancement of Innovent Academy’s technology platforms, our global R&D efforts are taking shape and accelerating global competitiveness, enabling the efficient generation of novel molecules with global potential. We are proud to showcase a batch of preclinical research findings at this year’s AACR (Free AACR Whitepaper) Annual Meeting, including multiple globally first-in-class bispecific antibodies, multi-specific antibodies, and antibody-drug conjugates (ADCs). These breakthroughs not only demonstrate our growing scientific capabilities but also reaffirm our commitment to delivering transformative therapeutic options for patients worldwide. Moving forward, we remain focused on innovation—optimizing precision targets and exploring novel mechanisms—to provide revolutionary solutions for some of the world’s most challenging diseases and enable more patients to benefit from the rapid advancements in cutting-edge science."

Sapience Therapeutics to Present Multiple Posters at the American Association for Cancer Research (AACR) Annual Meeting 2025

On March 26, 2025 Sapience Therapeutics, Inc., a clinical-stage biotechnology company focused on the discovery and development of peptide therapeutics to address oncogenic and immune dysregulation that drive cancer, reported four poster presentations at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting 2025, taking place April 25-30, 2025, in Chicago, Illinois (Press release, Sapience Therapeutics, MAR 26, 2025, View Source [SID1234651492]). Sapience will present non-clinical results from both of its clinical programs, lucicebtide (formerly known as ST101), a first-in-class antagonist of C/EBPβ, and ST316, a first-in-class antagonist of β-catenin and its co-activator, BCL9, as well as results from its preclinical Fra1 antagonist peptide (FraAP) program, a first-in-class antagonist of the activator protein 1 (AP-1) complex.

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"We are thrilled to be presenting a compendium of non-clinical data supportive of our clinical and preclinical SPEARs programs, including lucicebtide, ST316, and our FraAP program, at the upcoming AACR (Free AACR Whitepaper) Annual Meeting," said Jim Rotolo, Ph.D., Sapience’s Chief Scientific Officer. "Results from our lucicebtide and ST316 studies further elucidate their respective mechanisms of action and highlight their potential for combination strategies. Additionally, preclinical data demonstrate the potential of our FraAP program to induce anti-cancer activity by targeting the AP-1 complex, particularly in head and neck squamous cell carcinoma."

Poster Presentation Details and Abstract Highlights:

Title: "The clinical C/EBPβ antagonist peptide lucicebtide synergizes with molecularly targeted therapies in GBM"
Session Title: Targeted Therapies and Combinations 1
Location: Poster Section 34
Abstract Number: 839
Date and Time: Sunday, April 27, 2025, 2:00 pm – 5:00 pm CDT
Abstract Summary:

In non-clinical studies, the mechanism of lucicebtide, which has previously demonstrated antitumor activity via direct cell death and immune activation within the tumor microenvironment, enabled a synthetic lethal effect with molecularly targeted therapeutics, such as EGFR inhibitors, that are typically not effective when used as monotherapies for the treatment of glioblastoma (GBM). Transcriptional analysis utilizing GBM genetics and signatures of C/EBPβ activity were performed to identify potential target populations likely to benefit from lucicebtide combinations.
Title: "FraAP, a peptide antagonist against the activator protein 1 transcription factor complex, demonstrates cancer cell cytotoxicity and reduced invasion in vitro and tumor regression in vivo in HNSCC models"
Session Title: Gene Regulation and Transcription Factors 2
Location: Poster Section 10
Abstract Number: 1415
Date and Time: Monday, April 28, 2025, 9:00 am – 12:00 pm CDT
Abstract Summary:

FraAP selectively binds to and inhibits key oncogenic drivers of the AP-1 transcription factor complex, resulting in the suppression of AP-1 driven pathways required for cancer cell cycle progression, proliferation, and invasion and promotes apoptosis in preclinical studies. Further, in a head and neck squamous cell carcinoma (HNSCC) xenograft model, administration of FraAP results in significant tumor growth inhibition, further demonstrating the anti-cancer potential of targeting the AP-1 complex.
Title: "An ex vivo organoid study to identify biomarkers of sensitivity to ST316, a clinical-stage β-catenin antagonist peptide"
Session Title: Biomarkers and Molecular Targets for Prevention
Location: Poster Section 43
Abstract Number: 2361
Date and Time: Monday, April 28, 2025, 9:00 am – 12:00 pm CDT
Abstract Summary:

Analysis of 60 patient-derived tumor organoids revealed that tumors with TP53 WT and mutations in the MAPK pathway significantly correlate with sensitivity to ST316, a β-catenin antagonist peptide. Further, in non-clinical models, combining ST316 with encorafenib, a BRAF inhibitor, showed synergistic effects in BRAFV600E-mutant colorectal cancer (CRC) organoids, demonstrating a promising combination approach in this poor prognosis and underserved patient population. Across studies, findings support rational combinations of ST316 with clinically relevant MAPK inhibitors.
Title: "Reprogramming of MDSCs by ST316, a clinical peptide antagonist of β-Catenin/BCL9, enhances anti-tumor immuno- and chemotherapy"
Session Title: Modifiers of Tumor Microenvironment
Location: Poster Section 30
Abstract Number: 3275
Date and Time: Monday, April 28, 2025, 2:00 pm – 5:00 pm CDT
Abstract Summary:

Results reveal a novel role for Wnt/β-catenin signaling in myeloid-derived suppressor cell (MDSC) biology, a key mediator of immune-suppression, whereby antagonism of β-catenin with ST316 leads to suppression of MDSC expansion. In combination studies, ST316 significantly enhances the anti-tumor efficacy of anti-PD-1 immunotherapy and standard-of-care chemotherapies for advanced CRC such as FOLFIRI. While anti-PD-1 and FOLFIRI alone each resulted in expansion of immunosuppressive MDSCs, combination with ST316 prevented this expansion. These data suggest that therapeutically targeting the β-catenin/BCL9 interaction may be an effective strategy to enhance both chemotherapy and immunotherapy in Wnt-driven tumors that respond poorly to monotherapy.
More information can be found on the AACR (Free AACR Whitepaper) Annual Meeting 2025 website.

About Lucicebtide (formerly known as ST101)
Lucicebtide, a first-in-class antagonist of C/EBPβ, has completed the main portion of a Phase 2 dose expansion study in recurrent GBM (rGBM) (NCT04478279). An ongoing window-of-opportunity sub-study is evaluating lucicebtide in combination with radiation and temozolomide in patients with newly diagnosed GBM (ndGBM) and as a monotherapy in patients with rGBM, with patients receiving ST101 before and after surgical resection in both cohorts. ST101 has been granted Fast Track designation for rGBM from the U.S. Food and Drug Administration (U.S. FDA) and orphan designations for glioma from the U.S. FDA and the European Commission.

About ST316
ST316 is a first-in-class antagonist of the interaction between β-catenin and its co-activator, BCL9, a complex responsible for driving oncogene expression and immune exclusion in multiple cancers where aberrant Wnt/β-catenin pathway signaling is observed. ST316 exposure in cancer cells prevents BCL9-driven nuclear localization of β-catenin and formation of the enhanceosome protein complex. Disruption of this interaction selectively suppresses the transcription of oncogenic Wnt target genes that regulate proliferation, migration, invasion and the metastatic potential of tumor cells, as well as genes that regulate the immunosuppression of the tumor microenvironment. ST316 creates a pro-immune tumor microenvironment and in preclinical models has shown to be synergistic with checkpoint inhibition. Due to its selectivity and downstream modulation of the Wnt/β-catenin pathway, ST316 presents an opportunity to safely and effectively target Wnt/β-catenin driven pathologies without the toxicities previously seen with other Wnt pathway agents.

ST316-101 (NCT05848739) is a first-in-human, open-label, Phase 1-2 Dose Escalation and Expansion study designed to determine the safety, tolerability, PK, PD and early efficacy of ST316. The Phase 1 Dose Escalation portion of the study tested various dose levels of ST316 in patients with select advanced solid tumors that are known to harbor abnormalities of the Wnt/β-catenin signaling pathway, including colorectal cancer (CRC). ST316 is currently being tested in the Phase 2 portion of the study in CRC patients in combination with relevant standards of care and in multiple lines of treatment. The U.S. Food and Drug Administration (U.S. FDA) has granted Orphan Drug Designation to ST316 for the treatment of familial adenomatous polyposis (FAP).

Kura Oncology Announces Preclinical Data for KO-2806 Selected for Oral Presentation at the 2025 AACR Annual Meeting

On March 26, 2025 Kura Oncology, Inc. (Nasdaq: KURA), a clinical-stage biopharmaceutical company committed to realizing the promise of precision medicines for the treatment of cancer, reported that an abstract containing preclinical data for KO-2806, the Company’s next-generation farnesyl transferase inhibitor (FTI), in combination with cabozantinib, a tyrosine kinase inhibitor (TKI), in clear cell renal cell carcinoma (ccRCC), has been accepted for an oral presentation at the upcoming American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting in Chicago, IL on April 28, 2025 (Press release, Kura Oncology, MAR 26, 2025, View Source [SID1234651461]).

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"The latest findings for our next-generation farnesyl transferase inhibitor, KO-2806, being presented at this year’s AACR (Free AACR Whitepaper) Annual Meeting, add to the growing body of data demonstrating the potential of FTIs as companion therapeutic agents to augment the antitumor activities of various targeted therapies and to overcome resistance in combination," said Francis Burrows, Ph.D., Chief Scientific Officer of Kura Oncology. "We continue to make good progress in our FIT-001 trial evaluating KO-2806 in solid tumor indications where there is unmet medical need, and we look forward to presenting the first clinical data for KO-2806 as monotherapy and in combination with cabozantinib for the treatment of RCC later this year."

The title and session information for the oral presentation are listed below. Full abstract details including title and text are currently available to registrants via the AACR (Free AACR Whitepaper) online itinerary planner. Details of the oral presentation, entitled "Farnesyl transferase inhibitor KO-2806 enhances the antitumor activity of cabozantinib in ccRCC tumors that progress on anti-VEGFR agents" (oral 6370), are as follows:

Session Date and Time: Monday, April 28, 2025; 2:30 PM – 4:45 PM CT
Session Title: Minisymposium Novel Antitumor Agents
Presentation Time: 4:25 PM – 4:40 PM CT

A copy of the presentation will be available in the Posters and Presentations section on Kura’s website at the beginning of the presentation session.

Jazz Pharmaceuticals to Participate in the 24th Annual Needham Virtual Healthcare Conference

On March 26, 2025 Jazz Pharmaceuticals plc (Nasdaq: JAZZ) reported that the Company will participate in the 24th Annual Needham Healthcare Conference. Company management will participate in a fireside chat on Wednesday, April 9, 2025, at 9:45 a.m. PT / 12:45 p.m. ET / 5:45 p.m. IST (Press release, Jazz Pharmaceuticals, MAR 26, 2025, View Source [SID1234651477]).

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An audio webcast of the fireside chat will be available via the Investors section of the Jazz Pharmaceuticals website at View Source A replay of the webcasts will be archived on the website for 30 days.

GV20 Therapeutics Announces Collaboration Agreement with Mitsubishi Tanabe Pharma Corporation to Develop Novel Antibody-Drug Conjugates

On March 26, 2025 GV20 Therapeutics (GV20), a clinical-stage AI-powered biotherapeutics company, reported to have entered into a strategic research collaboration with Mitsubishi Tanabe Pharma Corporation (MTPC) (Press release, GV20 Therapeutics, MAR 26, 2025, View Source [SID1234651493]). Under this collaboration, MTPC will leverage GV20’s antibodies, which are specifically directed against novel tumor antigen targets discovered through GV20’s proprietary STEAD AI platform, to generate potentially first-in-class antibody-drug conjugates.

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"This agreement underlines the strength of GV20’s STEAD platform in discovering novel tumor targets and human-derived antibodies." said Ying Gong, Ph.D., Chief Business Officer of GV20. "We are excited to partner with MTPC, leveraging their deep expertise in linker-payload technology and therapeutics development, to advance innovative antibody-drug conjugate (ADC) therapies against these novel targets."

Under the terms of the agreement, GV20 will receive an upfront payment and is eligible for milestone payments. MTPC will receive an exclusive right to negotiate a license to these antibodies during the collaboration term.