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.

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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.

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]).

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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."

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)

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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.

On April 23, 2025 Obsidian Therapeutics, Inc., a clinical-stage biotechnology company pioneering engineered cell and gene therapies, reported two presentations, including an oral presentation on the Phase 1/2 Agni-01 multicenter study of OBX-115, a novel engineered tumor-derived autologous T cell immunotherapy (tumor-infiltrating lymphocyte [TIL] cell therapy) armored with pharmacologically regulatable membrane-bound IL15 (mbIL15), in patients with immune checkpoint inhibitor (ICI)-resistant advanced or metastatic melanoma (NCT06060613), at the 2025 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting, taking place in Chicago on May 30–June 3 (Press release, Obsidian Therapeutics, APR 23, 2025, View Source [SID1234652079]).

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Oral Presentation:

Title: OBX-115 engineered tumor-infiltrating lymphocyte (TIL) cell therapy with regulatable membrane-bound IL15 (mbIL15) in patients (pts) with immune checkpoint inhibitor (ICI)-resistant advanced melanoma: Phase 1 results of the Agni-01 multicenter study
Session Title: Rapid Oral Abstract – Melanoma/Skin Cancers
Date and Time: Monday, June 2, at 9:45 a.m. CT/10:45 a.m. ET
Abstract Number: 9517
Speaker/Lead Author: Jason A. Chesney, UofL Health – Brown Cancer Center, Louisville, KY
Clinical Trial Identifier: NCT06060613 (Multicenter study)
Poster Presentation:

Title: OBX-115 engineered tumor-infiltrating lymphocytes (TIL) with regulatable membrane-bound IL15 (mbIL15): Translational data from a single-center phase 1 trial in patients (pts) with immune checkpoint inhibitor (ICI)-resistant advanced melanoma.
Session Title: Poster Session – Melanoma/Skin Cancers
Date and Time: Sunday, June 1, at 9:00 a.m. CT/10:00 a.m. ET
Abstract Number: 9519
Speaker/Lead Author: Rodabe N. Amaria, The University of Texas MD Anderson Cancer Center
About OBX-115
Obsidian’s lead investigational cytoTIL15 program, OBX-115, is a novel engineered tumor-derived autologous T cell immunotherapy (tumor-infiltrating lymphocyte [TIL] cell therapy) armored with pharmacologically regulatable membrane-bound IL15 (mbIL15). OBX-115 has the potential to become a meaningful therapeutic option for patients with advanced or metastatic melanoma and other solid tumors by leveraging the expected benefits of mbIL15 and Obsidian’s proprietary, differentiated manufacturing process to enhance persistence, antitumor activity, and clinical safety of TIL cell therapy. Obsidian is investigating OBX-115 in the phase 1/2 Agni-01 multicenter trial in patients with advanced solid tumors (NCT06060613).

On April 23, 2025 Novocure (NASDAQ: NVCR) reported that it will present additional results from the Phase 3 PANOVA-3 trial of its Tumor Treating Fields (TTFields) therapy for pancreatic cancer at the 2025 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting, taking place May 30 to June 3 in Chicago (Press release, NovoCure, APR 23, 2025, View Source [SID1234652078]).

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The PANOVA-3 trial evaluated the use of TTFields therapy concomitantly with gemcitabine and nab-paclitaxel as a first-line treatment for unresectable, locally advanced pancreatic adenocarcinoma. The company previously announced positive topline results from PANOVA-3 that demonstrated the trial met its primary endpoint, achieving a statistically significant improvement in median overall survival in patients treated with TTFields therapy concomitantly with gemcitabine and nab-paclitaxel compared to those treated with gemcitabine and nab-paclitaxel alone.

Data Presentation Details

Oral Presentation: Late Breaking Abstract 4005: PANOVA-3: Phase 3 study of tumor treating fields (TTFields) with gemcitabine and nab-paclitaxel for locally advanced pancreatic ductal adenocarcinoma (LA-PAC)

Presenting Author: Vincent Picozzi, MD

Date/Time: May 31, 2025, 3:00 – 6:00 PM CDT

Novocure Investor Event

Novocure will host an investor event featuring the principal investigator of the PANOVA-3 trial and Novocure leadership after the oral presentation. Event details and a link to a live webcast of the event will be available on the investor relations page of www.novocure.com. For more information or to request in-person attendance, please contact Novocure investor relations at [email protected].

About Tumor Treating Fields

Tumor Treating Fields (TTFields) are electric fields that exert physical forces to kill cancer cells via a variety of mechanisms. TTFields do not significantly affect healthy cells because they have different properties (including division rate, morphology, and electrical properties) than cancer cells. These multiple, distinct mechanisms work together to target and kill cancer cells. Due to these multimechanistic actions, TTFields therapy can be added to cancer treatment modalities in approved indications and demonstrates enhanced effects across solid tumor types when used with chemotherapy, radiotherapy, immune checkpoint inhibition, or targeted therapies in preclinical models. TTFields therapy provides clinical versatility that has the potential to help address treatment challenges across a range of solid tumors.

To learn more about TTFields therapy and its multifaceted effect on cancer cells, visit tumortreatingfields.com.