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."

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 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 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 7, 2025 OS Therapies (NYSE-A: OSTX) ("OS Therapies" or "the Company"), a clinical-stage immunotherapy and Antibody Drug Conjugate (ADC) biopharmaceutical company, reported that it has submitted a request for a formal meeting with the Center for Biologics Evaluation and Research (CBER) of the United States Food & Drug Administration (FDA) to gain alignment on the clinical endpoints required to support Breakthrough Therapy Designation (BTD) and Accelerated Approval via a conditional BLA of investigational off-the-shelf immunotherapy candidate OST-HER2 in the prevention or delay of recurrence of fully resected, lung metastatic osteosarcoma (Press release, OS Therapies, APR 7, 2025, View Source [SID1234651825]). The meeting is expected to occur in the second quarter of 2025, and thereafter the Company intends to initiate a rolling BLA submission with the potential to receive Accelerated Approval as early as year-end 2025. The Company has sufficient cash on hand to operate into mid-2026.

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"We are excited to meet with the FDA – and commence market access discussions – the goal of receiving Accelerated Approval for a Biologics License Application of OST-HER2 in the prevention or delay of recurrence lung metastatic osteosarcoma by year-end 2025," said Dr. Robert Petit, Chief Medical & Scientific Officer of OS Therapies. "We believe that we have identified the comparator data necessary to address the comments from FDA regarding our prior BTD request. We expect this data will also be able support our application for Accelerated Approval. Our clinical and regulatory teams are diligently preparing for the meeting and the subsequent BLA submission that is targeted to begin after the public release of additional clinical trial data at MIB Factor in June."

OST-HER2 has received Rare Pediatric Disease Designation (RPDD) for osteosarcoma from the US FDA, and if it receives a conditional BLA via Accelerated Review prior to September 30, 2026, it will become eligible to receive a Priority Review Voucher (PRV) that it intends to immediately sell. The most recent PRV sale, valued at $150 million, occurred in February 2025.

"We congratulate the new Acting Director at CBER, Dr. Scott Steele, who comes from a translational medicine background and understands the importance of Comparative Oncology in the development of new cancer immunotherapies and note that President Trump cited deadly rare pediatric cancers as a priority for continued product development for the administration," said Paul Romness, CEO of OS Therapies. "We believe OST-HER2 will make a significant difference in the treatment of osteosarcoma and welcome the opportunity to engage with FDA to get this investigational treatment to patients as quickly as possible."

The Company announced positive Phase 2b clinical trial results from its US-based, 21 site, single-arm, open-label clinical study of 39 patients in recurrent, fully resected, lung metastatic osteosarcoma that demonstrated a statistically significant improvement in the proportion of patients that achieved the primary endpoint of 12-month event free survival (EFS) when compared with historical control (33% vs. 20%, p=0.0158), as recommended by FDA prior to the initiation of the study. Due to the aggressive nature of osteosarcoma metastatic to the lung, an aggressive form of rare pediatric bone cancer that requires resections to sequentially remove tumors from the lung given the very poor clinical responses and survival rates to current treatments, placebo-controlled trials are generally disfavored.

Following feedback from FDA, the Company designed OST-400, a Retrospective Longitudinal Study of Recurrent Osteosarcoma after Resection in Children and Young Adults being conducted with clinicians from leading oncology centers in the United States, the United Kingdom and France to obtain potentially over 200 suitable de-identified patient records from which the appropriate matched, external historic control is being developed. At the invitation of FDA on April 2, 2025, the requested meeting is to get agreement with respect to the methods the Company is using to finish collecting OST-400 so that the appropriate matched, external, historic control is used to complete the statistical analysis that will be used to support BTD and Accelerated Approval.

The Company intends to present the data from the Phase 2b clinical trial of OST-HER2 compared with the matched, external, historic control comparator agreed upon with FDA derived from OST-400 at MIB Factor in June 2025. Thereafter, the Company intends to file a BLA for OST-HER2 in the prevention or delay of recurrence of fully resected, lung metastatic osteosarcoma, with the aim of receiving approval by the end of 2025.

OST-HER2, an immunotherapy for osteosarcoma using a HER2 bioengineered form of the bacteria Listeria monocytogenes to trigger a strong immune response against cancer cells expressing HER2, is being featured in the upcoming movie Shelter Me: The Cancer Pioneers. The movie offers a look into canine comparative oncology, a field that compares treatment of cancers in dogs to those in people and covers developing treatments for rare forms of cancer. A trailer for the movie is available here. The movie will be aired live nationally on PBS and will available via streaming on PBS’ website in early May 2025.