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."

On April 8, 2025 Vincerx Pharma, Inc. (Nasdaq: VINC) reported that it has terminated the previously reported non-binding Letter of Intent (LOI) with Global Digital Holdings Inc., conducting business as QumulusAI, regarding a potential merger (Press release, Vincerx Pharma, APR 8, 2025, View Source [SID1234651838]).

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Following this decision, the Company’s board of directors has authorized management to initiate wind-down activities and continue exploring monetization of assets and out-licensing opportunities.

"I want to express our deepest gratitude to the investigators, patients, employees, and partners who have supported Vincerx’s mission," said Raquel Izumi, Ph.D., Acting Chief Executive Officer of Vincerx. "Your contributions have meant everything. Although unprecedented, adverse market dynamics prevented us from continuing the development of our programs, numerous patients with cancer—who had few therapeutic options—benefited from our therapies in the Phase 1 trials. For the chance you gave us to help those patients, we thank you."

On April 8, 2025 SELLAS Life Sciences Group, Inc. (NASDAQ: SLS) ("SELLAS" or the "Company"), a late-stage clinical biopharmaceutical company focused on the development of novel therapies for a broad range of cancer indications, reported Cohort 3 data from the ongoing Phase 2 trial of SLS009 (tambiciclib), a highly selective CDK9 inhibitor, in relapsed/refractory acute myeloid leukemia (r/r AML) (Press release, Sellas Life Sciences, APR 8, 2025, View Source [SID1234651837]).

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"The remarkable results from Cohort 3 of the ongoing Phase 2 trial reinforce the potential of SLS009 to transform outcomes for these heavily pretreated AML patients," said Angelos Stergiou, MD, ScD h.c., President and Chief Executive Officer of SELLAS. "Not only have we observed unprecedented survival benefits, but the high response rate underscores the therapy’s efficacy profile. The data reveal that relapsed or refractory to venetoclax-based regimens patients receiving 30 mg BIW achieved a mOS of 8.8 months, far surpassing the historical benchmark of 2.5 months. Additionally, the therapy demonstrated a 67% ORR in patients with AML-MRC and 46% in all evaluable patients, significantly exceeding the targeted 20% ORR. With responses seen across different genetic mutations, this approach could be transformational for many underserved patients. We are continuing to explore SLS009’s potential in expansion cohorts to further validate its potential to address critical unmet medical needs."

Patients Characteristics:

14 relapsed and refractory AML patients who previously failed venetoclax-based therapies were enrolled and treated with SLS009 and venetoclax/azacitidine in Cohort 3.
10 out of 14 patients (71%) had AML MRC (acute myeloid leukemia with myelodysplasia-related cytogenetics).
4 of those patients had myelomonocytic phenotype (M4 per FAB classification). The myelomonocytic phenotype has been shown to exhibit inferior responses to venetoclax-based therapies. It is thought to depend more on the MCL1 anti-apoptotic protein than on the BCL2 anti-apoptotic protein.
In terms of specific mutations, 6 patients had ASXL1, 5 had RUNX1 and 3 had TP53.
The median age was 71 (range 35-89 years).
The median number of prior failed therapy was 1 (range 1-6).
13/14 patients were evaluable for efficacy.
All patients had adverse risk cytogenetics per ELN 2022.
Key Results from Cohort 3:

The median overall survival (mOS) for all patients in Cohort 3 was 8.8 months, while the mOS in AML MRC patients reached 8.9 months.
The overall response rate (ORR) in all evaluable patients was 46% in all Cohort 3 patients and 67% in AML-MRC patients, far exceeding the targeted ORR of 20%.
In the subgroup of patients with myelomonocytic AML, 75% of patients responded (3 out of 4).
Among patients with mutation ASXL1, 4/6 (67%) responded; among those with RUNX1 3/5 (60%) responded, and among those with TP53 1/3 (33%) responded. In addition, there were 3 patients with adverse karyotypes and 1 responded.
SLS009 was well-tolerated with no new safety signals observed to date as the regimen remains safe in additional patients enrolled to date.
Phase 2 trial continues in expansion cohorts 4 and 5, in patients with AML-myelodysplasia-related changes (AML-MRC) with ASXL1 mutation (cohort 4) and mutations and cytogenic changes other than ASXL1 (cohort 5).
The Phase 2 clinical trial of SLS009 is an open-label, single-arm, multi-center study designed to evaluate the safety, tolerability, and efficacy of SLS009 in combination with venetoclax and azacitidine at two dose levels, 45 and 60 mg. In the 60 mg dose cohort patients were treated at either a 60 mg dose once per week or a 30 mg dose two times per week. The trial was expanded to include two additional cohorts, one with ASXL1 mutated AML patients and one with patients with myelodysplasia-related molecular abnormalities other than ASXL1. The target response rate at the optimal dose level is 20% with a target median survival of at least 3 months. In addition, the study aims to identify biomarkers for the target patient population and enrichment for further trials. For more information on the study, visit clinicaltrial.gov identifier NCT04588922.