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Abdera Therapeutics to Present Key Updates on its Radiopharmaceutical Development Pipeline at the 2025 American Association for Cancer Research (AACR) Annual Meeting

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.

Parabilis Medicines to Present First Preclinical Data on ERG Degrader Program at AACR Annual Meeting

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]).

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

Grove Biopharma Closes $30 Million Series A Financing to Advance Bionic Biologics™, a New Therapeutic Modality

On April 23, 2025 Grove Biopharma, a private biotechnology company pioneering its Bionic Biologics platform to develop therapies targeting previously intractable intracellular disease targets, reported the close of a $30 million Series A financing (Press release, Grove Biopharma, APR 23, 2025, View Source [SID1234652082]). The round was led by DCVC Bio with participation from Eli Lilly and Company, InVivium Capital, Walder Ventures, Gradiant Corporation, Mansueto Investments, and others. They join existing seed supporters, including Portal Innovations, where Grove was incubated. Proceeds will be used to further advance Grove Biopharma’s proprietary platform and drive its lead oncology programs towards the clinic.

Bionic Biologics represent a novel therapeutic modality that integrates principles of biologic and synthetic design. This innovative platform enables the targeting of well-validated yet previously intractable disease drivers, unlocking new possibilities for therapeutic intervention. Bionic Biologics combine advancements in precision polymer chemistry with the latest tools of medicinal chemistry, peptide chemistry, AI/ML driven computational chemistry and protein engineering. The result is an integrated platform capable of designing fully synthetic, cell-penetrant, protein-scale molecules that solve protein-scale problems.

"At Grove, we are focused on developing therapeutics for well-understood but historically intractable disease targets, with the goal of delivering better options for patients living with serious illnesses where few, if any, effective therapies exist," said Geoffrey Duyk, M.D., Ph.D., Co-founder and CEO at Grove. "We believe our Bionic Biologics platform represents a true paradigm shift for drug development, enabling us to rapidly develop molecules that can selectively inhibit or degrade even the most challenging intracellular drug targets. We are deeply grateful to our seed and Series A investors for their ongoing confidence and support as we advance this exciting new technology to patients."

"Proteins are the molecular machines that drive all essential cellular function, and dysregulated intracellular protein-protein interactions are the cause of many human diseases," said Nathan Gianneschi, Ph.D., Scientific Founder of Grove Biopharma and Professor at Northwestern University. "Existing drug modalities are either unable to penetrate cells or cannot effectively engage these large disease target domains. Bionic Biologics provide a new approach to this challenge, and I am excited to continue collaborating with the Grove team to advance this new modality to the clinic."

Bionic Biologics provide a new approach to targeting protein-protein interactions (PPI), distinguished by the following key characteristics:

Bionic: Hybrid synthetic biomolecules with enhanced functionality beyond what is possible in nature.
Cell permeable: Multivalent, chameleonic architecture enables membrane permeability for reaching intracellular targets.
Customizable: Plug-and-play design, modular construction and tunable properties to rapidly develop and implement molecules, either monofunctional or bifunctional, against any target.
Grove Biopharma’s Bionic Biologics have been demonstrated in proof-of-concept studies across several validated yet formidable intracellular targets. The company’s pipeline is initially focused on oncology and neurodegenerative diseases, where the advantage of cell-permeability enables therapeutic intervention in these disease pathways. Grove’s lead effort is an androgen receptor signaling program for the treatment of castrate-resistant prostate cancer. Data to date has demonstrated in vivo proof-of-concept and the company is advancing towards an IND submission.

"Grove Biopharma is addressing one of the most important challenges in drug development — targeting intracellular protein-protein interactions—with a novel, synthetic biology-based approach," said Kiersten Stead, Ph.D., Managing Partner at DCVC Bio and Grove board member. "We believe the Bionic Biologics platform has the potential to unlock a whole world of new therapeutic possibilities," Stead highlights. "The combination of approaches Grove is taking will be used to pursue first in-class-medicines with exceptional profiles and ease of manufacturing."

The Grove Biopharma team brings together experienced industry leadership and deep expertise in chemistry, biology, and materials science. Originating from Professor Nathan Gianneschi’s lab at Northwestern University, the Bionic Biologics platform is now being advanced by the Grove Biopharma R&D team, including Paul Bertin, Ph.D., Co-Founder, President and Chief Technology Officer, and Robert Campbell, Ph.D., Chief Scientific Officer.

Tempus Signs Expanded Strategic Agreements with AstraZeneca and Pathos to Develop the Largest Multimodal Foundation Model in Oncology

On April 23, 2025 Tempus AI, Inc. (NASDAQ: TEM), a technology company leading the adoption of AI to advance precision medicine and patient care, reported multi-year, strategic collaborations with AstraZeneca (LSE/STO/Nasdaq: AZN) and Pathos AI, Inc., in which the companies will work together to build a multimodal foundation model in oncology which can be used to gather biological and clinical insights, discover novel drug targets, and develop therapeutics for the broader oncology community (Press release, Tempus, APR 23, 2025, View Source [SID1234652081]).

Tempus’ de-identified oncology data will be used to build the foundation model. Upon completion, the model will be shared among all three parties to advance their individual efforts to improve patient care. The agreements include $200 million in data licensing and model development fees to Tempus.

The agreement with AstraZeneca expands on the strategic partnership between the two companies announced in 2021 and aims to leverage Tempus’ AI-enabled platform and vast repository of multimodal data to advance novel therapeutic programs in oncology on a global scale.

"Generative AI and the emergence of large multimodal models is the final catalyst needed to usher in precision medicine in oncology at scale," said Eric Lefkofsky, Founder and CEO of Tempus. "Tempus has spent the last decade investing billions of dollars into collecting the necessary data needed for a foundation model of this kind to take shape. We look forward to working with AstraZeneca and Pathos to apply AI-enabled solutions to advance therapies in an effort to help patients live longer and healthier lives."

"Cancer drug discovery and clinical development are being transformed by the ability to analyze vast amounts of rich data using artificial intelligence," said Jorge Reis-Filho, Chief AI and Data Scientist, Oncology R&D, AstraZeneca. "We are excited to collaborate with Tempus and Pathos to advance our data and AI-driven R&D strategy through the development of a multimodal oncology foundation model that we believe will accelerate and increase the probability of clinical success across our diverse pipeline."

"As artificial intelligence becomes more prominent in drug discovery and development, the opportunity for companies like Pathos to build foundation models that seemed almost unimaginable a few years ago is now taking shape," said Mohamad Makhzoumi, Co-CEO of NEA and Pathos Board Member. "We couldn’t be more excited to collaborate with Tempus and AstraZeneca given the potential of these models to improve patient outcomes."

Genialis Highlights Power of Its Supermodel to Predict and Explain Therapeutic Response at AACR 2025

On April 23, 2025 Genialis, the RNA biomarker company, reported two new studies demonstrating how predictive algorithms can drive better outcomes for patients, providers, and drug developers (Press release, Genialis, APR 23, 2025, View Source [SID1234652080]). In poster presentations at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting 2025, Genialis showed its AI foundation model of cancer—the Genialis Supermodel—can predict how a patient will respond to a specific therapy (Abstract 3313 / 16). The Supermodel can also help explain how drugs work in the body and how the tumor learns to resist treatment, as well as propose potential new drug combinations to improve outcomes. The AACR (Free AACR Whitepaper) presentations share these insights from Genialis’ own work with KRAS G12C NSCLC patient data and its collaboration with Debiopharm on the Debio 0123 WEE1 inhibitor in various cancer types. (Abstract 3659 / 21)

Most drug candidates fail in clinical trials, and of the ones that are successful, most cancer patients do not benefit, a problem that continues to plague drug developers, physicians, patients, and their families. Predictive biomarkers are known to improve these results considerably. The Genialis Supermodel is a large molecular model trained on over one billion RNA-seq-derived data points that enables rapid development and validation of accurate and information-rich biomarker algorithms across a wide range of cancer drug targets to act as a recommendation engine for every cancer target, drug, and patient.

"A shortcoming in precision medicine is we need a deeper understanding of individual patient biology and the molecular context in which a drug is acting, as this can provide crucial translational and clinical intelligence," said Rafael Rosengarten, PhD, CEO of Genialis. "We built the Genialis Supermodel to embrace the complexity and learn the underlying biology of cancer so we can guide therapy decisions and derisk drug development. At AACR (Free AACR Whitepaper), we’re showing that the same framework applies across very different drug targets and tumor types – and most importantly, that it works."

Genialis Supermodel for KRAS-mutated cancers

KRAS mutations drive approximately 25 percent of all human cancers, leading to an estimated 3.9 million new cases each year. Despite the recent approvals of two KRAS inhibitors (KRASi), these drugs show limited efficacy and durability. Response rates hover around 40 percent, and the median patient benefit lasted just 8 to 10 months, in part because the available biomarkers for patient selection rely on genotype alone. The Genialis Supermodel addresses this challenge by mapping over twenty biological modules relevant to KRASi-therapy in every tumor sample rather than focusing solely on the allele.

The first poster, led by Genialis, incorporates analysis of therapeutic mechanisms related to EGFR, immune checkpoint inhibitors (ICIs), and standard-of-care chemotherapy to stratify patients with KRAS-mutated cancers using the company’s first-in-class RNA biomarker algorithm, Genialis krasID. By broadening the biological space considered by the algorithm, Genialis is better able to predict results from both well-established and investigational therapies, to model various combinations, and to suggest the most effective sequencing/indication of various compounds. This new research expands on Genialis’ novel work presented at AACR (Free AACR Whitepaper) 2024. Genialis krasID serves as a sterling example of how the Genialis Supermodel scales to align treatment selection with the underlying tumor biology and therapeutic context.

"Genotype determines eligibility, but it often fails to predict actual clinical benefit. The Supermodel addresses this gap by capturing the functional biology that drives response," said Josh Wheeler, MD PhD, Director of Research and Innovation at Genialis. "The biology-first approach engendered by the Genialis Supermodel provides the mechanistic understanding and the necessary precision for informing and stratifying both emerging and standard of care therapeutic selection in patients."

Predicting response to WEE1 inhibitor Debio 0123

The second poster, presented in collaboration with Swiss-based global biopharmaceutical company Debiopharm, describes early results from the development of a predictive model for Debio 0123, a WEE1 inhibitor currently in phase 1 clinical trials. While the collaboration has since expanded to clinical studies, this poster describes the use of the Supermodel to identify biological modules in the DNA damage response space that contribute to Debio 0123 WEE1 response, training of a first-generation machine learning algorithm, and exploration of that biomarker across various translational models.

Using the DNA damage response (DDR)-related modules as input features, the ML algorithm was trained on patient-derived organoid datasets and tested on xenografts. The resulting biomarker algorithm achieved promising performance in leave-one-out cross-validation. Notably, it accurately predicted an in vivo responder that had been missed by organoid IC50 testing, showing the model’s ability to capture biologically relevant signals that may not be observed through traditional in vitro assays. These early findings set the foundation for further validation in independent clinical datasets and point to broader use of this biomarker framework for other DDR-targeting agents.

"The findings from this study show the Genialis Supermodel is able to learn components of complex biology that are translationally relevant and likely to prove important in human datasets. We see strong potential in using this kind of RNA-based, ML-driven approach to guide patient selection and boost development success," said Luke Piggott, Director, Global Business Development & Principal Scientist at Debiopharm. "The ability to predict, and soon validate, response is now being born out in clinical data and gives us an important strategic advantage."

These two AACR (Free AACR Whitepaper) posters demonstrate how Genialis supports drug development through its modular, interpretable Supermodel. Whether targeting KRAS-driven tumors or DDR mechanisms or entirely novel target biology, Genialis’ predictive biomarker algorithms reflect tumor biology, making it possible to match patients to successful treatment options and improve clinical outcomes.