On April 8, 2025 Astrazeneca and Daiichi Snakyo reported that DATROWAY (datopotamab deruxtecan) has been approved in the European Union (EU) for the treatment of adult patients with unresectable or metastatic hormone receptor (HR) positive, HER2 negative (IHC 0, IHC 1+ or IHC 2+/ISH-) breast cancer who have received endocrine therapy and at least one line of chemotherapy in the advanced setting (Press release, AstraZeneca, APR 8, 2025, View Source [SID1234651843]).

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DATROWAY is a specifically engineered TROP2 directed DXd antibody drug conjugate (ADC) discovered by Daiichi Sankyo (TSE: 4568) and being jointly developed and commercialized by Daiichi Sankyo and AstraZeneca (LSE/STO/Nasdaq: AZN).

The approval by the European Commission follows the positive opinion of the Committee for Medical Products for Human Use of the European Medicines Agency and is based on results from the TROPION-Breast01 phase 3 trial.

In TROPION-Breast01, DATROWAY significantly reduced the risk of disease progression or death by 37% compared to investigator’s choice of chemotherapy (hazard ratio [HR]=0.63; 95% confidence interval [CI]: 0.52-0.76; p<0.0001) in patients with HR positive, HER2 negative metastatic breast cancer as assessed by blinded independent central review (BICR). Median progression free survival (PFS) was 6.9 months in patients treated with DATROWAY versus 4.9 months with chemotherapy. A confirmed objective response rate (ORR) of 36% was observed in the DATROWAY arm compared to an ORR of 23% observed in the chemotherapy arm. The median duration of response (DoR) was 6.7 months (95% CI: 5.6-9.8) in the DATROWAY arm compared to 5.7 months (95% CI: 4.9-6.8) in the chemotherapy arm. The final overall survival (OS) results of the trial did not achieve statistical significance (median OS of 18.6 months in the DATROWAY arm versus 18.3 months in the chemotherapy arm [HR 1.01; 95% CI: 0.83-1.22]) and may have been affected by subsequent ADC treatment.

"With the majority of breast cancer cases historically considered HR positive, HER2 negative, additional treatment options are needed to improve outcomes for patients with metastatic disease that continues to progress following endocrine-based therapy and initial chemotherapy," said Barbara Pistilli, MD, Head of the Breast Cancer Unit in the Medical Oncology Department of Gustave Roussy Cancer Center, Villejuif, France. "The approval of DATROWAY in the EU will provide these patients with a new treatment option that can help slow the progression of this disease."

"Treating metastatic HR positive, HER2 negative breast cancer presents challenges, particularly treatment resistance and disease progression that occur following endocrine-based therapy and initial chemotherapy," said Ken Keller, Global Head of Oncology Business, and President and CEO, Daiichi Sankyo, Inc. "DATROWAY represents the second antibody drug conjugate approved for breast cancer based on Daiichi Sankyo’s DXd technology and the third medicine to be approved in the EU from our oncology pipeline, underscoring our commitment to creating new medicines for patients with cancer."

"Though the HR positive breast cancer treatment landscape has evolved in the last several years, disease progression on front-line therapies remains a common and complex challenge for patients with metastatic disease," said Dave Fredrickson, Executive Vice President, Oncology Hematology Business Unit, AstraZeneca. "With today’s approval of DATROWAY, patients in the EU with HR positive, HER2 negative breast cancer now have a new and needed alternative to conventional chemotherapy."

Grade 3 or higher adverse events from a pooled safety analysis of two clinical studies, including 443 patients who received DATROWAY (6 mg/kg) for a median duration of 6.2 months (range: 0.7-28.5), were stomatitis (7.9%), fatigue (4.3%), anemia (3.2%), AST increased (2.7%), vomiting (1.6%), ALT increased (1.6%), nausea (1.4%), urinary tract infection (1.4%), COVID-19 (1.1%), decreased appetite (1.1%), neutropenia (1.1%) and pneumonia (1.1%). Grade 5 adverse events occurred in 0.7% of patients due to interstitial lung disease/pneumonitis, dyspnea and sepsis.

About TROPION-Breast01
TROPION-Breast01 is a global, randomized, multicenter, open-label phase 3 trial evaluating the efficacy and safety of intravenous DATROWAY (6 mg/kg) once per 21-day cycle versus investigator’s choice of single-agent chemotherapy (eribulin, capecitabine, vinorelbine or gemcitabine) in adult patients with unresectable or metastatic HR positive, HER2 negative (IHC 0, IHC 1+ or IHC 2+/ISH-) breast cancer who have progressed on and are not suitable for endocrine therapy per investigator assessment and have received at least one prior line of chemotherapy for unresectable or metastatic disease.

Following disease progression or discontinuation of DATROWAY or chemotherapy, patients had the option to receive a subsequent treatment at the discretion of their physician. Crossover between trial arms was not permitted.

The dual primary endpoints of TROPION-Breast01 are PFS as assessed by BICR and OS. Key secondary endpoints include ORR, DoR, investigator-assessed PFS, disease control rate, time to first subsequent therapy and safety. The PFS data and additional results for key secondary endpoints of TROPION-Breast01 were published in the Journal of Clinical Oncology and OS results were presented at a Virtual Plenary session hosted by the European Society for Medical Oncology in February 2025.

TROPION-Breast01 enrolled 732 patients in Africa, Asia, Europe, North America and South America. For more information visit ClinicalTrials.gov.

About Hormone Receptor Positive, HER2 Negative Breast Cancer
Breast cancer is the second most common cancer and one of the leading causes of cancer-related deaths worldwide.1 More than two million breast cancer cases were diagnosed in 2022 with more than 665,000 deaths globally.1 In Europe, approximately 557,000 cases of breast cancer are diagnosed annually.2 While survival rates are high for those diagnosed with early breast cancer, only about 30% of patients diagnosed with or who progress to metastatic disease are expected to live five years following diagnosis.3

Approximately 70% of diagnosed cases are considered what has been historically called HR positive, HER2 negative breast cancer (measured as HER2 score of IHC 0, IHC 1+ or IHC 2+/ISH-).3 Endocrine therapy is widely given consecutively in the early lines of treatment for metastatic HR positive breast cancer.4 However, after initial treatment, further efficacy from endocrine therapy is often limited.4

About DATROWAY
DATROWAY (datopotamab deruxtecan) is a TROP2 directed ADC. Designed using Daiichi Sankyo’s proprietary DXd ADC Technology, DATROWAY is one of six DXd ADCs in the oncology pipeline of Daiichi Sankyo, and one of the most advanced programs in AstraZeneca’s ADC scientific platform. DATROWAY is comprised of a humanized anti-TROP2 IgG1 monoclonal antibody, developed in collaboration with Sapporo Medical University, attached to a number of topoisomerase I inhibitor payloads (an exatecan derivative, DXd) via tetrapeptide-based cleavable linkers.

DATROWAY is approved in more than 30 countries for the treatment of adult patients with unresectable or metastatic HR positive, HER2 negative breast cancer who have received prior endocrine-based therapy and chemotherapy for unresectable or metastatic disease based on the results of the TROPION-Breast01 trial.

About the DATROWAY Clinical Development Program
A comprehensive global clinical development program is underway with more than 20 trials evaluating the efficacy and safety of DATROWAY across multiple cancers, including non-small cell lung cancer, triple negative breast cancer and HR positive, HER2 negative breast cancer. The program includes eight phase 3 trials in lung cancer and five phase 3 trials in breast cancer evaluating DATROWAY as a monotherapy and in combination with other anticancer treatments in various settings.

On April 8, 2025 Alpenglow Biosciences reported its upcoming Dinner Lecture during the American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting 2025 (Press release, Alpenglow Biosciences, APR 8, 2025, View Source [SID1234651842]). The event, titled "Decoding Endometrial Cancers: A Spatial Biology Odyssey in 2D and 3D," is scheduled for April 27, 2025, from 6:00 PM to 9:00 PM at Mercat a la Planxa, 638 South Michigan Avenue, Chicago, IL 60605.​

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The evening will feature a keynote address by Dr. Sammy Ferri-Borgogno, B.S., M.S., Ph.D., Assistant Professor in Gynecologic Oncology at MD Anderson Cancer Center where she is studying immune landscapes and signaling in the ovarian tumor microenvironment.

Dr. Ferri-Borgogno earned her MSc in Medical Biotechnology from the University of Turin, where she investigated alpha-enolase in pancreatic cancer, and later integrated -omics and immunology in her PhD research. Her postdoctoral work focused on epigenetic regulators in pancreatic cancer and stromal-immune interactions in ovarian cancer. Currently, she employs advanced spatial technologies to identify biomarkers linked to chemoresistance and novel therapeutic targets in ovarian cancer treatment.​

"I’m honored to have Dr. Ferri-Borgogno join us as our keynote speaker," said Nick Reder, MD, MPH, CEO and Founder of Alpenglow Biosciences. "Her work in spatial biology and cancer research is groundbreaking and aligns perfectly with our mission to advance cancer research through cutting-edge imaging technology. We’re thrilled to welcome her for what promises to be an inspiring evening."

The Dinner Lecture is complimentary for attendees from pharmaceutical, biotech, and academic institutions.

RSVP is required and can be completed through the following link: View Source;

In addition to the Dinner Lecture, Alpenglow Biosciences will be available for one-on-one meetings during the AACR (Free AACR Whitepaper) Annual Meeting 2025.

To schedule a slot, please visit: View Source

On April 8, 2025 A team of researchers from the Rice Biotech Launch Pad at Rice University reported it has developed an implantable "cytokine factory" that safely triggers potent immune responses against hard-to-treat cancers, including metastatic melanoma, pancreatic and colorectal tumors (Press release, Rice University, APR 8, 2025, View Source [SID1234651841]).

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The study, published in The Journal of ImmunoTherapy of Cancer, details how an immunoprotected device near the tumor microenvironment containing cells engineered to locally release interleukin-12 (IL-12) — an "IL-12 cytokine factory" — successfully induces the recruitment of specialized immune cells called precursor exhausted T cells (Tpex cells). This Tpex cell recruitment results in a large, durable population of tumor-targeting T cells with broad molecular profiles, both in isolation and in an enhanced manner when implemented in combination with other immunotherapy approaches.

The IL-12 cytokine factories in combination with checkpoint inhibitors successfully eliminated local and distal tumors in preclinical models of metastatic melanoma and colorectal and pancreatic cancers. In addition to this robust efficacy signal, the IL-12 cytokine factory demonstrated safety in both mouse and nonhuman primate models.

This published research will serve as the foundation for an investigational new drug application (IND) with the U.S. FDA in early 2026, and RBL LLC expects to launch an emerging biotech company centered on the groundbreaking IL-12 cytokine factory technology.

"We designed the IL-12 cytokine factory to enhance immunotherapy approaches while minimizing toxicity, a critical need in the treatment of particularly aggressive cancers," said Omid Veiseh, professor of bioengineering, faculty director of the Rice Biotech Launch Pad and senior corresponding author of the publication. "IL-12 is particularly impactful compared to other cytokines, as our research demonstrates that other cytokines primarily recruit homogeneous T cell populations and show reduced efficacy over time, while IL-12 generates a more robust antitumor response by recruiting a more durable, broader repertoire of tumor-targeting T cells.

"We are incredibly grateful to ARPA-H for their support in advancing this groundbreaking project and are hopeful that this technology will significantly impact the lives of cancer patients by enhancing the efficacy of immunotherapy approaches in the clinic."

"Harnessing the cellular immune system to target solid tumors is a common but often fraught approach to fighting cancer as the associated challenge of efficacious treatment without toxicity remains elusive," said Nathan Reticker-Flynn, assistant professor of otolaryngology at Stanford University. "Our study demonstrates not only the efficacy of this technology in preclinical models but also its safety profile, which is a critical aspect as we move toward clinical trials. This research represents an important step forward in the quest to provide more effective treatments for patients battling metastatic cancers."

The research was supported through an Avenge Bio Sponsored Research Award to Rice, the Cancer Prevention Research Institute of Texas (RR160047), the National Institutes of Health (R01CA272769, DP2 AI177915) and ARPA-H (AY1AX000003). The content is solely the responsibility of the authors and does not necessarily represent the official views of the funding institutions.

Full Publication Details:

Title: IL-12-producing cytokine factories induce precursor exhausted T cells and elimination of primary and metastatic tumors

Journal: The Journal of ImmunoTherapy of Cancer

Corresponding Authors: Omid Veiseh

Full Author List: Amanda M. Nash, Jonathon DeBonis, Danna Murungi, Bertha Castillo, Boram Kim, Fangheng Hu, Courtney Chambers, Annie Nguyen, Andrea Hernandez, Zeshi Wang, Peter D. Rios, Sofia Ghani, Ira Joshi, Douglas Isa, Ningbo Zheng, Weiyi Peng, Oleg A. Igoshin, Jose Oberholzer, H. Courtney Hodges, Nathan Reticker-Flynn and Omid Veiseh

On April 8, 2025 TuHURA Biosciences, Inc. (NASDAQ:HURA) ("TuHURA"), a Phase 3 immune-oncology company developing novel technologies to overcome resistance to cancer immunotherapy, reported that an abstract highlighting Kineta Inc.’s novel KVA12123 antibody and an abstract from Moffitt Cancer Center scientists examining the mechanisms of Company’s IFx-Hu2.0 therapy in advanced melanoma have been selected for poster presentation at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting 2025, taking place April 25-30, 2025, at the McCormick Place Convention Center in Chicago, IL (Press release, TuHURA Biosciences, APR 8, 2025, View Source [SID1234651840]).

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Details of the accepted abstracts are as follows:

Title: Initial results from a first in human phase 1 study of KVA12123, an anti-VISTA antibody, alone and in combination with pembrolizumab in patients with advanced solid tumors
Track: Experimental and Molecular Therapeutics
Session: PO.CT01.03 – Phase 0 and Phase I Clinical Trials
Abstract Number: CT041/ 20
Presenter: Thierry Guillaudeux, Ph.D., Chief Scientific Officer of Kineta
Date and Time: April 28, 2025, 9:00 AM – 12:00 PM ET
Location: Section 29

Title: Mechanistic insights into IFx-Hu2.0 responses in the first human trial after prior anti-PD-1 therapy failure
Track: Immunology
Session: PO.IM01.07 – Enhanced Antibodies, TCR Constructs, Cytokines and Chimeric Proteins
Abstract Number: 3428 / 23
Presenter: Joseph Markowitz, M.D., Ph.D.
Date and Time: April 28, 2025, 2:00 PM – 5:00 PM ET
Location: Section 35

For more and to view the abstract, visit the AACR (Free AACR Whitepaper) Annual Meeting website.

As previously announced, on December 11, 2024, TuHURA entered into a definitive agreement with Kineta, Inc. (OTC Pink: KANT) ("Kineta"), in which TuHURA would acquire Kineta, including the rights to Kineta’s novel KVA12123 antibody, for a combination of cash and shares of TuHURA common stock via a merger transaction. The merger is currently targeted to close in Q2 2025 pending the satisfaction of funding conditions and other closing conditions.

On April 8, 2025 SciTech Development, Inc., a clinical-stage oncology company pioneering innovative cancer therapeutics, reported that the U.S. Food and Drug Administration (FDA) has approved its Investigational New Drug (IND) application for "A Phase 1a/b Trial in Relapsed/Refractory Small Cell Lung Cancer (SCLC) to Determine the Safety Profile, Pharmacology, and Maximum Tolerated Dose of ST-001, a Fenretinide Phospholipid Suspension for Intravenous Infusion (Press release, SciTech Development, APR 8, 2025, View Source [SID1234651839])." This milestone greenlights SciTech to begin recruiting patients and initiates another Phase 1a/b clinical trial of ST-001, a novel nanoparticle drug designed to deliver fenretinide effectively to cancer cells.

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The FDA’s approval follows a thorough safety review, with the agency stating, "We have completed our safety review of your application and have concluded that you may proceed with your proposed clinical investigation of fenretinide phospholipid suspension (ST-001) for small cell lung cancer." This decision marks a significant step forward in SciTech’s mission to address unmet needs in oncology, particularly for patients with relapsed or refractory SCLC, a notoriously aggressive disease with limited treatment options.

Leading the trial, as Principal Investigator, is Greg Kalemkerian, MD, a renowned thoracic oncologist at the University of Michigan. "Small cell lung cancer remains a formidable challenge with few effective therapies for patients who relapse or don’t respond to initial treatment," said Dr. Kalemkerian. "ST-001 represents a promising approach, and I’m excited to oversee this trial to evaluate its safety and potential for SCLC patients who desperately need new options."

ST-001 nanoFenretinide leverages SciTech’s patented drug delivery platform to overcome fenretinide’s historical bioavailability challenges, delivering high doses intravenously with enhanced efficacy and reduced toxicity. The Phase 1a/b trial will assess the drug’s safety, pharmacology, and maximum tolerated dose, paving the way for further development in SCLC and potentially other cancers.

Building on prior success in a Phase 1a trial for T-cell non-Hodgkin lymphoma – where ST-001 demonstrated favorable pharmacokinetics and early signs of efficacy – SciTech is preparing to launch the SCLC trial in Q2/3 2025. The company anticipates that this trial will further validate the drug’s broad therapeutic potential.

"We are thrilled about the FDA’s approval of our IND for ST-001 in SCLC," said Earle T. Holsapple, CEO of SciTech Development. "This is a pivotal moment that brings us closer to offering a transformative treatment option for patients facing this devastating disease. "Our team’s dedication to advancing ST-001’s potential through innovative nanotechnology is showing promising results, and we’re eager to see its impact in the clinic."