On April 24, 2025 Akoya Biosciences, Inc. (Nasdaq: AKYA), The Spatial Biology Company, reported the availability of a new assay designed to advance antibody-drug conjugate (ADC) development in breast cancer (Press release, Akoya Biosciences, APR 24, 2025, View Source [SID1234652094]). The new assay will be featured alongside customer-generated real-world data from the PhenoCode Discovery IO60 panel—Akoya’s flagship ultrahigh-plex immuno-oncology solution—at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) 2025 Annual Meeting, taking place April 25–30 in Chicago, Illinois.

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New ADC Assay: Advancing Breast Cancer Precision

The emergence of HER2- and TROP2-targeting ADCs—such as those used in the DESTINY, ASCENT, and TROPiCS trials—have transformed breast cancer treatment while introducing greater complexity in therapeutic decision-making. Akoya’s newly launched multiplex immunofluorescence (mIF) panel is designed to address these challenges by enabling more precise patient selection within established breast cancer subtypes.

This ADC-focused panel includes HER2, TROP2, Ki-67, ER/PR, and a proprietary membrane-localization cocktail. It allows for simultaneous quantification of ADC target expression with precise subcellular localization, providing:

Normalized protein expression
Membrane/cytoplasmic expression ratios
Comparative analysis with standard-of-care IHC biomarkers
Now available through Akoya’s Advanced Biopharma Services (ABS), the ADC panel includes comprehensive support—from assay customization to tissue staining, high-resolution imaging, image analysis, and reporting. ABS is purpose-built to accelerate the path from translational discovery to IUO and IVD, with capabilities anchored in:

A CLIA-certified laboratory for clinical-grade assay development
Integrated imaging and analysis workflows for multiplexed biomarker quantification
A clinical trial site and global CRO network for end-to-end study support
The panel is optimized for:

Identifying HER2-low and TROP2-high patients in clinical trial cohorts
Resolving membrane versus cytoplasmic marker expression—critical for ADC efficacy
Delivering consistent, quantitative scoring of each ADC marker
"Multiplexing key targets in context with state-of-the-art membrane resolution is a catalyst for designing precise ADC combination strategies," said Pascal Bamford, Chief Clinical Officer at Akoya. "Our goal is to equip translational and clinical teams with assays that reflect the complexity of the tumor microenvironment while preserving clinical relevance."

Real-World Impact of IO60: Proven in the Field

Originally launched at SITC (Free SITC Whitepaper) 2024, the PhenoCode Discovery IO60 panel remains the fastest ultrahigh-plex spatial proteomics solution for immuno-oncology research. At AACR (Free AACR Whitepaper) 2025, one of Akoya’s customers will present real-world data generated using IO60, showcasing its power in:

Deep immune phenotyping
Tumor microenvironment (TME) profiling
Translating biomarker discovery across oncology pipelines
"Seeing our partners generate impactful insights using IO60 is the strongest validation of our platform’s potential," said Brian McKelligon, Chief Executive Officer of Akoya. "This is how spatial biology becomes translational—by helping researchers get closer to patient-relevant outcomes."

Visit Akoya at AACR (Free AACR Whitepaper) 2025 – Booth #3045

Both innovations—the ADC-focused breast cancer panel and customer-generated data using IO60—will be featured at Booth #3045, where Akoya will highlight the full potential of spatial biology in translational research. Visit us to explore the PhenoCode panel portfolio, meet with our scientific team, and experience our latest innovations firsthand.

What to Look Forward To:

Live Atlas Demo with Enable Medicine – Translating spatial data into actionable insights: April 27 | 4:30–5:00 PM | Akoya Booth #3045
Spotlight Theatre Presentation: From Discovery to Translation: Scaling Spatial Biology for Oncology Breakthroughs: April 28 | 3:00–4:00 PM | Spotlight Theater A – South Hall A
CDx Strategy Discussion with Clinical Experts: April 28 | 4:15–5:00 PM | Akoya Booth #3045
Early access opportunities to Akoya’s newest translational panels and biopharma service offerings
For more information about Akoya’s AACR (Free AACR Whitepaper) 2025 presence, visit: View Source

On April 23, 2025 BriaCell Therapeutics Corp. (Nasdaq: BCTX, BCTXW) (TSX: BCT) ("BriaCell" or the "Company"), a clinical-stage biotechnology company that develops novel immunotherapies to transform cancer care, reported three clinical data poster presentations and one publish-only abstract at the 2025 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting taking place May 30 – June 3 at McCormick Place, Chicago, IL (Press release, BriaCell Therapeutics, APR 23, 2025, View Source [SID1234652430]).

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The details of the poster presentation sessions and publish-only abstract are listed below.

Abstract Title: Update on phase III pivotal trial of Bria-IMT + CPI vs physician’s choice in advanced metastatic breast cancer (BRIA-ABC)
Session Date and Time: 6/2/2025 9:00 AM-12:00 PM CDT
Abstract Number for Publication: TPS1138
Poster Board Number: 108a
Session Type and Title: Poster Session – Breast Cancer—Metastatic

Abstract Title: Bria-IMT + checkpoint inhibitor: Phase I/II survival results compared to benchmark trials in metastatic breast cancer
Session Date and Time: 6/2/2025 9:00 AM-12:00 PM CDT
Abstract Number for Publication: 1096
Poster Board Number: 75
Session Type and Title: Poster Session – Breast Cancer—Metastatic

Abstract Title: Trial in progress: A study of Bria-OTS cellular immunotherapy in metastatic recurrent breast cancer
Session Date and Time: 6/2/2025 9:00 AM-12:00 PM CDT
Abstract Number for Publication: TPS1136
Poster Board Number: 107a
Session Type and Title: Poster Session – Breast Cancer—Metastatic

Publish-Only Abstract Title : Impact of HLA Matching on Clinical Outcomes in a Phase 2 Trial of Bria-IMT Plus Anti PD1 in Advanced Breast Cancer

Abstracts will be released at 5:00 PM (ET) on Thursday, May 22, 2025.

Following the presentations, copies of the presentations will be posted on View Source

On April 23, 2025 Summit Therapeutics Inc. (NASDAQ: SMMT) ("Summit," "we," or the "Company") today noted that Akeso, Inc. (Akeso, HKEX Code: 9926.HK) reported that the Phase III clinical trial, HARMONi-6 or AK112-306, met its primary endpoint of progression-free survival (PFS) (Press release, Summit Therapeutics, APR 23, 2025, View Source [SID1234652085]). HARMONi-6 is evaluating ivonescimab in combination with platinum-based chemotherapy compared with tislelizumab, a PD-1 inhibitor, in combination with platinum-based chemotherapy in patients with locally advanced or metastatic squamous non-small cell lung cancer (NSCLC) irrespective of PD-L1 expression. HARMONi-6 is a single region, multi-center, Phase III study conducted in China sponsored by Akeso with all relevant data exclusively generated, managed, and analyzed by Akeso.

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At a prespecified interim analysis conducted by an Independent Data Monitoring Committee, ivonescimab plus chemotherapy demonstrated a statistically significant and clinically meaningful improvement in PFS by blinded independent central radiology review committee (BICR) compared to tislelizumab plus chemotherapy. The PFS benefit was demonstrated in patients with either PD-L1-positive or PD-L1-negative tumors. Akeso noted that no new safety signals were identified in this Phase III study. The full data set for HARMONi-6 is planned to be presented at an upcoming major medical conference later this year.

Prior to HARMONi-6, there were no known Phase III clinical trials in NSCLC which have shown a statistically significant improvement compared to PD-(L)1 inhibitor therapy in combination with chemotherapy in a head-to-head setting. Following the success of Akeso’s HARMONi-2 study in China where the PFS benefit was observed in a monotherapy setting for patients whose squamous or non-squamous tumors were positive for PD-L1 expression, this is the second time in which ivonescimab-based regimens have become the first known investigational therapy to demonstrate a statistically significant benefit compared to standard-of-care PD-(L)1 inhibitor-based regimens.

"Ivonescimab has the opportunity to make a significant, positive difference, potentially providing patients with the next generation of treatment options against insidious solid tumors beginning with non-small cell lung cancer," stated Dr. Maky Zanganeh, President and Co-Chief Executive Officer of Summit.

Summit is currently enrolling patients in the HARMONi-3 study. HARMONi-3 is a multiregional Phase III clinical trial sponsored by Summit which is intended to evaluate ivonescimab combined with chemotherapy compared to pembrolizumab, an anti-PD-1 antibody, combined with chemotherapy in patients with first-line metastatic, squamous and non-squamous NSCLC. HARMONi-3 is currently enrolling patients globally and is conducted with registrational intent for the United States and other regions within Summit’s license territories.

"Our aligned mission with Akeso seeks to bring ivonescimab to as many patients around the world who can potentially benefit as quickly as possible," added Robert W. Duggan, Chairman and Co-Chief Executive Officer of Summit. "We are incredibly proud of Akeso’s accomplishment with the HARMONi-6 trial."

About Ivonescimab

Ivonescimab, known as SMT112 in Summit’s license territories, North America, South America, Europe, the Middle East, Africa, and Japan, and as AK112 in China and Australia, is a novel, potential first-in-class investigational bispecific antibody combining the effects of immunotherapy via a blockade of PD-1 with the anti-angiogenesis effects associated with blocking VEGF into a single molecule. Ivonescimab displays unique cooperative binding to each of its intended targets with multifold higher affinity to PD-1 when in the presence of VEGF.

This could differentiate ivonescimab as there is potentially higher expression (presence) of both PD-1 and VEGF in tumor tissue and the tumor microenvironment (TME) as compared to normal tissue in the body. Ivonescimab’s tetravalent structure (four binding sites) enables higher avidity (accumulated strength of multiple binding interactions) in the TME (Zhong, et al, SITC (Free SITC Whitepaper), 2023). This tetravalent structure, the intentional novel design of the molecule, and bringing these two targets into a single bispecific antibody with cooperative binding qualities have the potential to direct ivonescimab to the tumor tissue versus healthy tissue. The intent of this design, together with a half-life of 6 to 7 days after the first dose (Zhong, et al, SITC (Free SITC Whitepaper), 2023), is to improve upon previously established efficacy thresholds, in addition to side effects and safety profiles associated with these targets.

Ivonescimab was engineered by Akeso Inc. (HKEX Code: 9926.HK) and is currently engaged in multiple Phase III clinical trials. Over 2,300 patients have been treated with ivonescimab in clinical studies globally.

Summit has begun its clinical development of ivonescimab in non-small cell lung cancer (NSCLC), commencing enrollment in 2023 in two multi-regional Phase III clinical trials, HARMONi and HARMONi-3, and the Company has begun to activate clinical trial sites in the United States for HARMONi-7.

HARMONi is a Phase III clinical trial which intends to evaluate ivonescimab combined with chemotherapy compared to placebo plus chemotherapy in patients with EGFR-mutated, locally advanced or metastatic non-squamous NSCLC who have progressed after treatment with a 3rd generation EGFR TKI (e.g., osimertinib). Enrollment in HARMONi was completed in the second half of 2024, and top-line results are expected to be announced in the middle of this year.

HARMONi-3 is a Phase III clinical trial which is intended to evaluate ivonescimab combined with chemotherapy compared to pembrolizumab combined with chemotherapy in patients with first-line metastatic, squamous and non-squamous NSCLC.

HARMONi-7 is a Phase III clinical trial which is intended to evaluate ivonescimab monotherapy compared to pembrolizumab monotherapy in patients with first-line metastatic NSCLC whose tumors have high PD-L1 expression.

In addition, Akeso has recently had positive read-outs in three single-region (China), randomized Phase III clinical trials for ivonescimab in NSCLC: HARMONi-A, HARMONi-2, and HARMONi-6.

HARMONi-A was a Phase III clinical trial which evaluated ivonescimab combined with chemotherapy compared to placebo plus chemotherapy in patients with EGFR-mutated, locally advanced or metastatic non-squamous NSCLC who have progressed after treatment with an EGFR TKI.

HARMONi-2 is a Phase III clinical trial evaluating monotherapy ivonescimab against monotherapy pembrolizumab in patients with locally advanced or metastatic NSCLC whose tumors have positive PD-L1 expression.

HARMONi-6 is a Phase III clinical trial evaluating ivonescimab in combination with platinum-based chemotherapy compared with tislelizumab, an anti-PD-1 antibody, in combination with platinum-based chemotherapy in patients with locally advanced or metastatic squamous non-small cell lung cancer (NSCLC), irrespective of PD-L1 expression.

Ivonescimab is an investigational therapy that is not approved by any regulatory authority in Summit’s license territories, including the United States and Europe. Ivonescimab was approved for marketing authorization in China in May 2024. Ivonescimab was granted Fast Track designation by the US Food & Drug Administration (FDA) for the HARMONi clinical trial setting.

On April 23, 2025 Abdera Therapeutics Inc., a clinical-stage biopharmaceutical company leveraging its advanced antibody engineering ROVEr platform to design and develop tunable precision radiopharmaceuticals for cancer, reported two upcoming presentations at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting, being held from April 25 – 30, 2025 in Chicago, IL (Press release, Abdera Therapeutics, APR 23, 2025, View Source [SID1234652084]). These include: (1) a poster presentation of Abdera’s ongoing Phase 1 clinical trial for ABD-147, a DLL3-targeting radiopharmaceutical, and (2) preclinical data on ABD-320, a 5T4-targeting radiopharmaceutical and Abdera’s second development program.

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"We are pleased with the progress we’re making at Abdera and are excited to share our developments at AACR (Free AACR Whitepaper) this year," said Lori Lyons-Williams, president and chief executive officer. "Our first-in-human Phase 1 study for ABD-147 is enrolling and dosing patients. We are also unveiling compelling preclinical data for ABD-320, the first radiopharmaceutical therapy in development targeting 5T4. This widely prevalent target is associated with poor outcomes across multiple cancer types and we look forward to advancing ABD-320 into clinical development in the first half of 2026."

Details of the presentations are as follows:

Title: A phase 1a/b, open-label, dose-escalation study of 225Ac-ABD147 for locally advanced or metastatic small cell lung cancer and large cell neuroendocrine carcinoma of the lung following platinum-based chemotherapy
Abstract Number: CT107 / 2
Session: PO.CTP01.01 – Phase I Clinical Trials in Progress 1
Date/Time: April 28, 2025 / 2:00 PM – 5:00 PM
Location: Section 51

Title: 111In/225Ac-ABD320, a novel 5T4-targeted radiopharmaceutical with favorable tumor-to-normal tissue biodistribution and single-dose efficacy in preclinical cancer models
Abstract Number: 580 / 15
Session: PO.ET08.01 – Theranostics and Radiotheranostics
Date/Time: April 27, 2025 / 2:00 PM – 5:00 PM
Location: Section 25

About ABD-147

ABD-147 is a targeted radiopharmaceutical biologic therapy designed to deliver Actinium-225 (225Ac), a highly potent alpha-emitting radioisotope, to solid tumors expressing delta-like ligand 3 (DLL3) with high affinity. DLL3 is a protein in the Notch pathway that is critical for the development and regulation of neuroendocrine versus epithelial cell differentiation in the lungs. In certain high grade neuroendocrine carcinomas including small cell lung cancer (SCLC), DLL3 is upregulated and specifically expressed on the cell surface in more than 80% of cases. In contrast, DLL3 is absent or very rarely expressed on the surface of nonmalignant cells. Given the high specificity of DLL3 expression on cancer cells and the distinct mechanism of action, DLL3 represents a compelling target for treating SCLC and other DLL3+ solid tumors with targeted radiotherapy.

The U.S. Food and Drug Administration (FDA) has granted Fast Track designation to ABD-147 for the treatment of patients with extensive stage small cell lung cancer (ES-SCLC) who have progressed on or after platinum-based chemotherapy and Orphan Drug Designation to ABD-147 for the treatment of neuroendocrine carcinoma. ABD-147 is currently being evaluated in a first-in-human Phase 1 clinical trial in patients with SCLC or large cell neuroendocrine carcinoma of the lung who have previously received platinum-based therapy.

About Small Cell Lung Cancer and Large Cell Neuroendocrine Carcinoma

The global incidence for SCLC and LCNEC has been reported to represent approximately 325,000 patients and is expected to increase 4% annually through 2029. In the U.S., the incidence has been reported to be approximately 35,000 new cases annually. Fifteen percent of all lung cancer cases are high-grade neuroendocrine cancers. These cancers have the most aggressive clinical course of any type of pulmonary tumor and often metastasize to other parts of the body, including the brain, liver and bone. Without treatment, the median survival from diagnosis has been reported to be only two to four months. With treatment, the overall survival at five years is 5% to 10% for SCLC, and 15% to 25% for LCNEC. SCLC and LCNEC generally carry a poor prognosis and new treatment options are urgently needed.

About ABD-320

ABD-320 is a targeted radiopharmaceutical biologic therapy engineered to deliver Actinium-225 (225Ac) to solid tumors expressing 5T4. This oncofetal protein is rarely expressed in normal adult tissues but has been shown to be up-regulated in multiple cancer types, including colorectal, head and neck, non-small cell lung, pancreatic, gastric, mesothelioma, bladder, renal, cervical, ovarian, and breast cancers. By driving tumor cell migration and survival, 5T4 plays a key role in cancer progression and is associated with advanced disease, increased invasiveness, and poor clinical outcomes in solid tumors. ABD-320 was developed leveraging Abdera’s ROVEr platform and is custom-engineered to achieve an ideal balance of tumor uptake and retention while avoiding systemic radiotoxicities. Preclinical data with ABD-320 demonstrates potent anticancer activity. ABD-320 represents the first radiopharmaceutical therapy in development to address 5T4.

On April 23, 2025 Parabilis Medicines (formerly Fog Pharmaceuticals), a clinical-stage biopharmaceutical company committed to creating extraordinary medicines for people living with cancer, reported the presentation of preclinical data on its first-in-class targeted protein degrader of ERG at the upcoming American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting, being held April 25–30, 2025, in Chicago, Illinois (Press release, Parabilis Medicines, APR 23, 2025, View Source [SID1234652083]).

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The transcription factor ERG has been a long-recognized high-value target in prostate cancer, where ERG fusions have been implicated in 40-50% of all cases. Despite its relevance, ERG has remained undrugged by conventional inhibitors or first-generation degraders because the protein lacks small molecule binding pockets.

Parabilis’s ERG degrader overcomes this challenge by using the company’s proprietary Helicon peptide technology, which enables intracellular targeting of "flat" protein surfaces. The company’s prostate cancer franchise also includes a selective degrader of androgen receptor (AR) targeting a site outside the canonical androgen-binding site on the protein, thereby addressing a common resistance mechanism that arises in response to AR antagonist therapies. Together Parabilis’s degraders of ERG and AR could potentially provide meaningful and differentiated therapeutic approaches to treat patients with metastatic castrate-resistant prostate cancer (mCRPC).

Full details of the poster are as follows:

Title: "Degradation of the ETS transcription factor ERG by stabilized helical peptide (Helicon) degraders enables pharmacological validation in ERG-fusion prostate cancer models"
Abstract Number: 4246/3
Presentation Date and Time: Tuesday, April 29, 9:00 a.m. – 12:00 p.m. CDT
Session: New and Emerging Cancer Drug Targets
Location: Poster Section 17