On April 25, 2025 NextPoint Therapeutics, a clinical-stage biotechnology company launching a new world of precision therapeutics through its leading scientific work on the novel B7-H7 axis, reported it will present compelling data on NPX125, its lead B7-H7-targeting antibody-drug conjugate (ADC) with a proprietary novel linker technology, at the American Association for Research (AACR) (Free AACR Whitepaper) Annual Meeting 2025 in Chicago (Press release, NextPoint Therapeutics, APR 25, 2025, View Source [SID1234652181]).

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NPX125, which utilizes NextPoint’s proprietary linker technology paired with a clinically validated topoisomerase 1 inhibitor payload in a DAR8 (drug-antibody ratio) format, is initiating IND-enabling work with an anticipated IND filing in mid-2026. Leveraging B7-H7’s superb internalization profile that enables efficient payload delivery, the company expects this first-in-class ADC targeting B7-H7 to enter the clinic shortly thereafter, expanding NextPoint’s multimodal approach to targeting the B7-H7 axis.

Poster Details
Title: B7-H7 is a novel ADC target for solid tumors and shows potent activity with multiple payload-linker technologies
Abstract Number: 7336
Section: 40
Session Date/Time: Wednesday, April 30, 2025, 9:00 AM – 12:00 PM

"The data we’re presenting at AACR (Free AACR Whitepaper) validate the B7 family as an outstanding ADC target with a highly favorable profile compared to other clinically successful targets and even members of the B7 family, like B7-H3 and B7-H4," said Tatiana Novobrantseva, PhD, Chief Scientific Officer at NextPoint Therapeutics. "NPX125 emerged as the lead candidate among multiple B7-H7-targeting ADCs tested, and has demonstrated remarkable internalization kinetics, potent cytotoxicity and strong anti-tumor activity across tumor models with varying levels of B7-H7 expression, supporting our conviction in its potential to deliver meaningful benefits to patients."

Key Program Attributes include:

Superior ADC Properties
NPX125 via its interaction with B7-H7 demonstrated efficient internalization across many different tumor cell lines
Showed both direct and bystander cytotoxic activity, critical for addressing tumor heterogeneity
NPX125 demonstrated superior serum stability in rat pharmacokinetic studies
Robust developability profile due to antibody selection and unique linker properties
Strong Anti-Tumor In Vivo Efficacy
NPX125 achieved tumor regressions in multiple preclinical mouse models with variable B7-H7 expression levels
Additional Poster Presentations at AACR (Free AACR Whitepaper)
NextPoint will also present three additional posters at AACR (Free AACR Whitepaper) showcasing its comprehensive approach to targeting the B7-H7 axis:

"B7-H7-CD3 bispecific T cell engaging antibodies demonstrate potent anti-tumor activity in B7-H7+ preclinical tumor models" (Abstract #1556)
"Comprehensive analysis of B7-H7/HHLA2 expression in pan-solid tumors and its potential significance in anti-tumor immunity" (Abstract #3302)
"Safety and tolerability of NPX372, a novel B7-H7 bispecific T cell engaging antibody" (Abstract #4354)
The poster presentations are available in the "News & Publications" section of NextPoint’s website: View Source

About B7-H7
B7-H7 (also known as HHLA2) represents an ideal tumor-targeting antigen, with limited normal tissue expression and upregulation on a broad range of solid tumor histologies. Unlike other B7 family members which may be expressed on tumor cells and immune cell populations, B7-H7 expression is detectable only on tumor epithelial cells, which makes it a more specific tumor-targeting antigen. B7-H7’s expression across multiple tumor types, coupled with its role in immunomodulation in the tumor microenvironment, positions it as a promising target for precision therapeutic approaches.

On April 25, 2025 Prelude Therapeutics Incorporated (Nasdaq: PRLD), a clinical-stage precision oncology company, reported the presentation of new preclinical data at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting for its highly selective IV SMARCA2 degrader and its highly selective KAT6A degraders (Press release, Prelude Therapeutics, APR 25, 2025, View Source [SID1234652149]).

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Peggy Scherle, Ph.D., Chief Scientific Officer of Prelude, stated, "We are pleased to provide further preclinical data on the discovery of our lead selective SMARCA2 degrader PRT3789, currently advancing in early clinical development for patients with SMARCA4 mutated cancers. We are also delighted to report initial preclinical data from our selective KAT6A degrader discovery program. These data demonstrate that selectively degrading KAT6A results in robust anti-cancer activity in various pre-clinical models of breast cancer and other solid tumors. We believe that our first-in-class, highly potent KAT6A selective degraders have the potential to expand the therapeutic reach of KAT6A/B inhibitors currently advancing in the clinic, while addressing safety challenges associated with non-selective approaches to this clinically validated target."

Details on the presentations are as follows:

Title: Elucidating the Molecular Mechanism of Action of the First-in-Human SMARCA2 Selective Degrader PRT3789

Summary:

•
PRT3789 is a first-in-human SMARCA2 degrader that selectively induces deep and sustained SMARCA2 degradation in preclinical and clinical studies.
•
PRT3789 achieves high selectivity by inducing a more stable ternary complex between SMARCA2 and VHL than SMARCA4 and VHL.

•
K1405 loop in SMARCA2 provides a unique lysine residue to enable selective ubiquitination and also stabilizes the SMARCA2:PRT3789:VHL complex.
•
SMARCA2 resynthesis rate is 2-3 times slower than SMARCA4 thereby enhancing the selectivity profile and contributing to the broad therapeutic index and favorable safety profile observed with PRT3789 in clinical studies to date.
•
PRT3789 is currently under evaluation in Phase 1 and Phase 2 studies in patients with advanced solid tumors with loss of SMARCA4 (NCT05639751 and NCT06682806).

Link: Publications – Prelude Therapeutics (preludetx.com)

Title: Discovery of First-in-Class Potent and Selective Oral Degraders of KAT6A that Demonstrate Anti-cancer Activity in Pre-clinical Models

Summary:

•
KAT6A expression is associated with cancer growth and is recurrently amplified in breast, lung, ovarian and other cancers.1
•
KAT6 is a clinically validated target with a dual KAT6A/B inhibitor recently demonstrating promising efficacy in heavily pre-treated patients with ER+/HER2- breast cancer, albeit with potential on-target safety considerations including neutropenia.2
•
Prelude hypothesized that a targeted protein degradation approach could enable discovery of KAT6A selective candidates with potential for improved hematological safety and more robust single agent activity relative to other KAT6-targeted approaches.
•
Prelude believes that it has identified a series of first-in-class, sub-nanomolar, selective and readily orally bioavailable KAT6A degraders now advancing to candidate nomination.
•
Pre-clinical data presented demonstrate that Prelude’s selective KAT6A degraders:
o
Drive significantly deeper anti-cancer responses compared to non-selective KAT6A/B inhibitors across multiple KAT6A-amplified tumors.
o
Disrupt the histone acetyltransferase (HAT) complex resulting in a deeper biological effect on ERα expression.
o
Show sustained activity in ESR1- and Pi3Kalpha-mutated cells, as well as endocrine therapy- and CDK4/6i-resistant cells.
o
Exhibit robust combination benefit with SoC and potential synergy with next generation breast cancer therapies.
o
Deliver robust in vivo target engagement and deep tumor regressions, including complete regressions, in breast and lung cancer xenografts as a monotherapy at low oral daily doses.
o
Display reduced hematologic toxicity compared to KAT6A/B inhibitors.

On April 25, 2025 Bexion Pharmaceuticals, Inc., a clinical-stage biopharmaceutical company developing a novel class of biologic therapy to treat solid tumor cancers and chemotherapy-induced peripheral neuropathy (CIPN), reported that the Company will participate in the American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting 2025 taking place April 25-30, 2025, in Chicago, Illinois (Press release, Bexion, APR 25, 2025, View Source [SID1234652166]). Details of the posters are included below.

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First Poster Details:
Abstract Title: Development of an in-house methodology to analyze large clinical cancer biomarkers datasets
Abstract Number: 1105
Poster Board Number: 12
Session Title: Tumor Subtypes and Biomarker Discovery
Session Date: Sunday Apr 27, 2025
Session Time: 2:00 PM – 5:00 PM
Presenter: Dr. Tariq Arshad

Second Poster Details:
Abstract Title: Sphingolipid modulating compounds BXQ-350 and desipramine display synergy in reducing viability across multiple cancer cell types in vitro
Abstract Number: 5439
Poster Board Number: 17
Session Title: Therapeutic Targets and Mitochondrial Function
Session Date: Tuesday Apr 29, 2025
Session Time: 2:00 PM – 5:00 PM
Presenter: Dr. Tariq Arshad

The abstracts are scheduled to be posted to the AACR (Free AACR Whitepaper) Online Program Planner at 4:30 PM ET on Tuesday, March 25.

About AACR (Free AACR Whitepaper)
The American Association for Cancer Research (AACR) (Free AACR Whitepaper) is the first and largest cancer research organization dedicated to accelerating the conquest of cancer. The AACR (Free AACR Whitepaper) Annual Meeting program covers the latest discoveries across the spectrum of cancer research—from population science and prevention; to cancer biology, translational, and clinical studies; to survivorship and advocacy—and highlights the work of the best minds in research and medicine from institutions all over the world.

About BXQ-350
Bexion’s lead drug candidate is BXQ-350, a first-in-class biologic containing the multifunctional sphingolipid activator protein, Saposin C, and a phospholipid. Multiple Phase 1 clinical trials in adult and pediatric patients have demonstrated a robust safety profile for BXQ-350 with evidence of single agent activity across multiple solid tumor types. Additionally, other clinical and non-clinical data suggest BXQ-350 has activity in chemotherapy-induced peripheral neuropathy, an area of high unmet medical need in patients treated with oxaliplatin and other chemotoxic agents.

On April 25, 2025 Iksuda Therapeutics (Iksuda), the developer of class leading, clinically validated antibody drug conjugates (ADCs) reported that it will present three posters at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting in Chicago, Illinois (25-30 April) (Press release, Iksuda Therapeutics, APR 25, 2025, View Source [SID1234652182]). The posters cover the Company’s new payload class, the ProAlk series, its CA242-directed ADC, IKS04, being developed for the treatment of gastrointestinal (GI) cancers, and its proprietary PermaLink conjugation chemistry.

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Iksuda will introduce its new ProAlk payload class which has a novel protein alkylating mechanism and is incorporated in ADCs in a prodrug format for enhanced targeting precision. ProAlk is active across a broad range of tumours and has been designed for optimal ADC relevance. It is associated with potent bystander activity and is MDR-resistant. Its novel mechanism will help to address the growing and significant challenge of ADC sequencing, where differentiation from tubulin and topoisomerase I inhibitor payloads will become imperative. Iksuda is building a pipeline of ProAlk driven ADCs which incorporate its proprietary PermaLink conjugation chemistry for ADC stability and tumour-selective payload activation and release for enhanced precision and safety.

The Company will also present a poster on IKS04, its CA242-directed ADC for the treatment of GI cancers and which is in IND-enabling studies. IKS04 uses a pro-drug approach for the tumour-specific delivery of a highly potent pyrrolobenzodiazepine (PBD) payload, avoiding the typical toxicity profile seen in traditional PBD ADCs. In preclinical trials, IKS04 is associated with in vivo efficacy which is substantially improved over benchmark ADCs in all tumour models, and a superior therapeutic index over all other PBD-based solid tumour ADC programs. IKS04 will be administered via pre-administration of naked antibody – a novel dosing regimen in the ADC field – to overcome high expression abundance and enable higher tumour penetration and consistent levels of efficacy across tumours. IKS04 is expected to enter clinical development in GI cancers by the end of 2025.

In addition, Iksuda will highlight its proprietary PermaLink conjugation chemistry, which is used across its early-stage ADC platform alongside the Company’s glucuronide linker formats and novel ProAlk payload. PermaLink offers a simple, scalable and highly stable bioconjugation method as an alternative to maleimide-based conjugation, enabling highly stable ADCs with favourable anti-tumour activity and safety.

Dr Dave Simpson, Chief Executive Officer, Iksuda Therapeutics, said:

"These three poster presentations at AACR (Free AACR Whitepaper) demonstrate Iksuda’s leadership in ADC innovation as we unveil our novel ProAlk payload class, overcoming the challenges in ADC sequencing and which will drive Iksuda’s deepening pipeline. With two clinical-stage programs, a growing pipeline of class leading ADCs and our expanding, innovative platforms, we are strongly positioned to progress new and promising ADCs to deliver improved outcomes for patients living with cancer. We look forward to progressing IKS04 into clinical development for GI cancers later this year, an area of high unmet need with limited effective treatment options and poor five-year survival rates for the significant number of patients with advanced disease."

Poster Presentation details:

ProAlk

Abstract Title:

PA289, a prodrug linker-payload with a novel mechanism of action for the development of antibody drug conjugates

Session Title:

Antibody-Based Cancer Therapeutics 1

Date/Time:

April 28, 2025 9:00 AM – 12:00 PM

Location:

Poster Section 15

Poster Number:

1579/28

IKS04

Abstract Title:

IKS04, an antibody drug conjugate with a highly potent DNA crosslinker payload for the treatment of gastrointestinal cancers

Session Title:

Antibody-Based Cancer Therapeutics 2

Date/Time:

April 28, 2025 2:00 PM – 5:00 PM

Location:

Poster Section 15

Poster Number:

2885/24

PermaLink

Abstract Title:

PermaLink, a stable and scalable bioconjugation platform as an alternative to maleimide-based conjugation

Session Title:

Antibody-Based Cancer Therapeutics 1

Date/Time:

April 28, 2025 9:00 AM – 12:00 PM

Location:

Poster Section 15

Poster Number:

1570/19

On April 25, 2025 AbbVie (NYSE:ABBV) reported financial results for the first quarter ended March 31, 2025 (Press release, AbbVie, APR 25, 2025, View Source [SID1234652133]).

"AbbVie’s first-quarter results were well ahead of our expectations and reflect an excellent start to the year," said Robert A. Michael, chief executive officer, AbbVie. "The fundamentals of our business are strong and we continue to bolster our outlook with pipeline advancements and strategic investments. Based on the progress we are making, AbbVie is well positioned for the long term."

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First-Quarter Results

•Worldwide net revenues were $13.343 billion, an increase of 8.4 percent on a reported basis, or 9.8 percent on an operational basis.

•Global net revenues from the immunology portfolio were $6.264 billion, an increase of 16.6 percent on a reported basis, or 18.1 percent on an operational basis.
◦Global Skyrizi net revenues were $3.425 billion, an increase of 70.5 percent on a reported basis, or 72.0 percent on an operational basis.
◦Global Rinvoq net revenues were $1.718 billion, an increase of 57.2 percent on a reported basis, or 59.7 percent on an operational basis.
◦Global Humira net revenues were $1.121 billion, a decrease of 50.6 percent on a reported basis, or 49.5 percent on an operational basis.

•Global net revenues from the neuroscience portfolio were $2.282 billion, an increase of 16.1 percent on a reported basis, or 17.0 percent on an operational basis.
◦Global Vraylar net revenues were $765 million, an increase of 10.3 percent.
◦Global Botox Therapeutic net revenues were $866 million, an increase of 15.8 percent on a reported basis, or 17.0 percent on an operational basis.
◦Global Ubrelvy net revenues were $240 million, an increase of 17.8 percent on a reported basis, or 18.0 percent on an operational basis.
◦Global Qulipta net revenues were $193 million, an increase of 47.6 percent on a reported basis, or 48.3 percent on an operational basis.

•Global net revenues from the oncology portfolio were $1.633 billion, an increase of 5.8 percent on a reported basis, or 7.5 percent on an operational basis.
◦Global Imbruvica net revenues were $738 million, a decrease of 11.9 percent.
◦Global Venclexta net revenues were $665 million, an increase of 8.3 percent on a reported basis, or 12.3 percent on an operational basis.
◦Global Elahere net revenues were $179 million.

•Global net revenues from the aesthetics portfolio were $1.102 billion, a decrease of 11.7 percent on a reported basis, or 10.2 percent on an operational basis.
◦Global Botox Cosmetic net revenues were $556 million, a decrease of 12.3 percent on a reported basis, or 10.7 percent on an operational basis.
◦Global Juvederm net revenues were $231 million, a decrease of 22.2 percent on a reported basis, or 20.0 percent on an operational basis.

•On a GAAP basis, gross margin in the first quarter was 70.0 percent. The adjusted gross margin was 84.1 percent.

•On a GAAP basis, selling, general and administrative (SG&A) expense was 24.7 percent of net revenues. The adjusted SG&A expense was 24.6 percent of net revenues.

•On a GAAP basis, research and development (R&D) expense was 15.5 percent of net revenues. The adjusted R&D expense was 15.4 percent of net revenues.

•Acquired IPR&D and milestones expense was 1.9 percent of net revenues.

•On a GAAP basis, operating margin in the first quarter was 28.0 percent. The adjusted operating margin was 42.3 percent.

•Net interest expense was $627 million.

•On a GAAP basis, the tax rate in the quarter was 22.4 percent. The adjusted tax rate was 14.2 percent.

•Diluted EPS in the first quarter was $0.72 on a GAAP basis. Adjusted diluted EPS, excluding specified items, was $2.46. These results include an unfavorable impact of $0.13 per share related to acquired IPR&D and milestones expense.

Recent Events

•AbbVie announced that its board of directors unanimously elected chief executive officer (CEO) Robert A. Michael to assume the additional position of chairman of the board of directors, effective July 1, 2025. He will succeed Richard A. Gonzalez, who formerly served as AbbVie’s CEO and has been chairman since the Company’s formation in 2013.

•AbbVie announced that the European Commission (EC) granted marketing authorization to Rinvoq (upadacitinib) for the treatment of giant cell arteritis (GCA) in adult patients. The approval was supported by data from the pivotal Phase 3 SELECT-GCA trial which demonstrated that Rinvoq achieved the primary endpoint of sustained remission and key secondary endpoints, including reduction in disease flares, lower cumulative steroid exposure and complete remission. This authorization marks the eighth approved indication for Rinvoq in the European Union (EU).

•At the Society of Gynecologic Oncology (SGO) Annual Meeting, AbbVie announced final data analysis from the Phase 3 MIRASOL trial evaluating the efficacy and safety of Elahere (mirvetuximab soravtansine-gynx) in women with folate receptor alpha (FRα)-positive platinum-resistant ovarian cancer (PROC) compared to chemotherapy. At 30.5 months median follow-up, treatment with Elahere continued to show significant improvements in progression-free survival (PFS) and overall survival (OS) compared to investigator’s choice (IC) chemotherapy.

•AbbVie and Xilio Therapeutics, a clinical-stage biotechnology company, announced a collaboration and option-to-license agreement that will combine AbbVie’s oncology expertise with Xilio’s proprietary tumor-activation technology to develop novel immunotherapies, including masked T-cell engagers, for people living with cancer.

•AbbVie announced that it submitted a Biologics License Application (BLA) to the U.S. Food and Drug Administration (FDA) for approval of trenibotulinumtoxinE (BoNT/E) for the treatment of moderate to severe glabellar lines. TrenibotulinumtoxinE is a first-in-class botulinum neurotoxin serotype E characterized by a rapid onset of action as early as 8 hours after administration and short duration of effect of 2-3 weeks. If approved, trenibotulinumtoxinE will be the first neurotoxin of its kind available to patients.

•Allergan Aesthetics announced that the Allergan Medical Institute (AMI) will open three new state-of-the-art training centers in the U.S., expanding access to high-quality, tailored training for licensed aesthetics providers. The first training center is scheduled to open in Irvine, CA, with additional locations to follow in Atlanta, GA and Austin, TX.

•AbbVie and Gubra announced a license agreement to develop GUB014295 (ABBV-295), a potential best-in-class, long-acting amylin analog for the treatment of obesity. This partnership marks AbbVie’s entrance into the obesity field and under the terms of the agreement, AbbVie will lead development and commercialization of GUB014295 globally. Prior to the close of the agreement, Gubra announced positive interim results from Part A of a Phase 1 multiple ascending dose (MAD) study, which showed that GUB014295 was well tolerated with body weight loss that was sustained in a manner consistent with data from a previously announced single ascending dose (SAD) study.

•AbbVie announced that the FDA approved Emblaveo (aztreonam and avibactam), as the first monobactam/β-lactamase inhibitor combination antibiotic therapy to treat complicated intra-abdominal infections, including those caused by Gram-negative bacteria. The approval of Emblaveo was supported by prior findings regarding the efficacy and safety of aztreonam for the treatment of complicated intra-abdominal infections as well as clinical trial results from the Phase 3 REVISIT study, which evaluated the efficacy, safety, and tolerability of Emblaveo for the treatment of serious infections due to Gram-negative bacteria.

Full-Year 2025 Outlook

AbbVie is raising its adjusted diluted EPS guidance for the full year 2025 from $11.99 – $12.19 to $12.09 – $12.29, which includes an unfavorable impact of $0.13 per share related to acquired IPR&D and milestones expense incurred year-to-date through the first quarter 2025. The company’s 2025 adjusted diluted EPS guidance excludes any impact from acquired IPR&D and milestones that may be incurred beyond the first quarter of 2025, as both cannot be reliably forecasted. This guidance does not reflect the acquired IPR&D and milestones impact related to AbbVie and Gubra’s licensing agreement to develop GUB014295, as that transaction closed after the first quarter of 2025. Additionally, this guidance is based on the existing trade environment and does not reflect any trade policy shifts, including pharmaceutical sector tariffs, that could impact AbbVie’s business.