On May 28, 2025 Archeus Technologies, a company developing multiple differentiated radiopharmaceutical therapies, and the Wisconsin Alumni Research Foundation (WARF), the patenting and licensing arm of the University of Wisconsin–Madison (UW), reported a strategic collaboration to advance ART-101 – a promising receptor-based targeting molecule – into clinical development (Press release, Archeus Technologies, MAY 28, 2025, View Source [SID1234653474]).

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ART-101 was discovered and developed at the Advanced Radiotheranostics Lab at UW–Madison, led by Dr. Reinier Hernandez, assistant professor of medical physics at the University of Wisconsin School of Medicine and Public Health. Aided by robust support from WARF through the WARF Accelerator, ART-101 has demonstrated enhanced pharmacology in preclinical studies, including significantly higher tumor uptake and retention relative to FDA-approved prostate cancer treatment Pluvicto (177Lu-PSMA-617). It has also shown superior pharmacokinetics, dosimetry and normal tissue toxicity profiles.

Through a collaboration agreement with WARF, Archeus Technologies will lead Phase 1 clinical development of this asset with trial initiation planned for 2025. ART-101 is a next-generation prostate-specific membrane antigen (PSMA)-targeting small molecule. It is being evaluated as a radiopharmaceutical agent with the potential to deliver alpha-emitting isotopes with greater tolerability compared with current standards of care.

"With strong preclinical data supporting the continued development of ART-101, Archeus is eager to lead the evaluation of this novel candidate through first-in-human studies," said Evan Sengbusch, Ph.D., chief executive officer of Archeus Technologies. "Leveraging our team’s proven experience ushering new radiopharmaceutical agents from concept through clinical translation, paired with our close collaboration with UW as a world-class radiopharmaceutical research organization, Archeus is uniquely positioned to progress ART-101 into the next stage of development. This asset adds to our Phase 1-ready portfolio of differentiated radiopharmaceutical therapies with the potential to provide curative responses to cancers that are particularly challenging to treat."

"WARF is committed to investing in cutting-edge technologies and therapeutic candidates, like ART-101, that have significant potential to advance the theranostics landscape as well as treatment options for patients in need," said Jeanine Burmania, senior director of intellectual property and licensing at WARF. "Encouraging preclinical data suggest that ART-101 could help increase lifespan and be more effective in treating prostate cancer than current therapies. We’re pleased to partner with Archeus Technologies to continue the development of this innovative asset and look forward to better understanding its role to potentially improve outcomes for prostate cancer patients."

ART-101 is compatible with multiple therapeutic isotopes, including actinium-225, lutetium-177 and terbium-161. When paired with these isotopes, preclinical data show that ART-101 provides significant potential benefit that could lead to improved outcomes for prostate cancer patients.

On May 28, 2025 Vir Biotechnology, Inc. (Nasdaq: VIR), reported that Marianne De Backer, M.Sc., Ph.D., MBA, Chief Executive Officer, will participate in a fireside chat at the Goldman Sachs 46th Annual Global Healthcare Conference 2025 on Tuesday, June 10 at 1:00 p.m. PT / 4:00 p.m. ET in Miami Beach, Florida (Press release, Vir Biotechnology, MAY 28, 2025, View Source [SID1234653473]).

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A live webcast of the fireside chat will be made available under Events & Presentations in the Investors section of the Vir Biotechnology website and will be archived for 30 days.

On May 28, 2025 bioAffinity Technologies, Inc. (Nasdaq: BIAF; BIAFW), a biotechnology company advancing noninvasive diagnostics and targeted therapeutics for cancer, reported the U.S. Patent and Trademark Office (USPTO) has issued a new patent covering a novel composition and method for selectively killing cancer by targeting the CD320 and LRP2 receptors on the cell membrane (Press release, BioAffinity Technologies, MAY 28, 2025, View Source [SID1234653472]).

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The patent, "Compositions and Methods for Treating Cancer," (Patent No. 12,305,171) provides for use of the novel therapeutic approach with cancers of the lung, breast, prostate, brain and skin. Research has begun toward development of a topical treatment for cutaneous malignancies and neoplasms of the skin.

The therapeutic patent is an important addition to bioAffinity Technologies’ patent portfolio, which includes 19 awarded U.S. and foreign patents and 36 pending patent applications related to its diagnostic platform and cancer treatment therapeutics.

The invention uses small interfering RNAs (siRNAs) to suppress the expression of CD320 and LRP2 proteins. In vitro studies demonstrated that the double knockdown of the proteins using siRNAs is selectively cytotoxic to human cancer cells but does not kill normal cells under the same treatment.

"The cancer cells killed by this discovery were not selected on the basis of any characteristic or biomarker, and the effect appears to be quite general," said William Bauta, PhD, Chief Science Officer at bioAffinity Technologies. "We believe our research has discovered a fundamental vulnerability of cancer that could be leveraged for new, highly selective therapies."

In vitro studies demonstrated that when only one of the receptors was down regulated, there was an increase in protein expression in the other receptor. The double knockdown of CD320 and LRP2 is required to kill cancer cells or significantly inhibit their proliferation.

"This patent marks a significant advancement in our therapeutic pipeline as well as our intellectual property portfolio," said Maria Zannes, President and CEO of bioAffinity Technologies. "This discovery is a continuation of the scientific curiosity that led to our CyPath Lung diagnostic for early-stage lung cancer and opens a potential new path to precision treatment across multiple cancer types. Our first target is developing a topical treatment for skin cancer."

About CyPath Lung

CyPath Lung uses proprietary advanced flow cytometry and artificial intelligence (AI) to identify cell populations in patient sputum that indicate malignancy. Automated data analysis helps determine if cancer is present or if the patient is cancer-free. CyPath Lung incorporates a fluorescent porphyrin that is preferentially taken up by cancer and cancer-related cells. Clinical study results demonstrated that CyPath Lung had 92% sensitivity, 87% specificity and 88% accuracy in detecting lung cancer in patients at high risk for the disease who had small lung nodules less than 20 millimeters. Diagnosing and treating early-stage lung cancer can improve outcomes and increase patient survival. For more information, visit www.cypathlung.com.

On May 28, 2025 InnoCare Pharma (HKEX: 09969; SSE: 688428), a leading biopharmaceutical company focusing on the treatment of cancer and autoimmune diseases, reported the approval of the Investigational New Drug (IND) by the Center for Drug Evaluation (CDE) of the China National Medical Products Administration (NMPA) to conduct the clinical trial of B-cell lymphoma-2 (BCL2) inhibitor mesutoclax (ICP-248) in combination with azacitidine for the treatment of myeloid malignancies, including but not limited to myelodysplastic syndromes (MDS) (Press release, InnoCare Pharma, MAY 28, 2025, View Source [SID1234653471]).

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Mesutoclax is a novel, orally bioavailable BCL2 selective inhibitor. BCL2 is an important regulatory protein in the apoptosis pathway, and its abnormal expression is associated with the development of various hematologic malignancies. Mesutoclax exerts anti-tumor activity by selectively inhibiting BCL2 and restoring the normal apoptosis process in cancer cells.

Myelodysplastic syndrome (MDS) is a group of heterogeneous clonal myeloid diseases characterized by the abnormal proliferation of hematopoietic stem cells, recurrent genetic abnormalities, myelodysplasia, ineffective hematopoiesis, peripheral-blood cytopenia, and a high risk of progression to acute myeloid leukemia (AML). The annual incidence of myelodysplastic syndromes is about 4 cases/100,000 people/year (reaching 40–50/100,000 in patients aged ≥ 70 years).

Mesutoclax has been granted Breakthrough Therapy Designation (BTD) by the CDE for the treatment of BTKi-treated relapsed or refractory mantle cell lymphoma (R/R MCL). This marks the first BCL2 inhibitor to receive BTD recognition in China. The Company is accelerating patient enrollment of a Phase III registrational trial of mesutoclax in combination with orelabrutinib as a first line therapy for the treatment of chronic lymphocytic leukemia/small lymphocytic lymphoma (CLL/SLL), as well as a clinical trial of mesutoclax for the treatment of AML.

Dr. Jasmine Cui, the Co-founder, Chairwoman, and CEO of InnoCare, said, "Mesutoclax is an important global asset of our company in the field of hematology. We are delighted to receive approval to initiate the clinical trial for the fourth indication of our BCL2 inhibitor. We will accelerate the clinical development of mesutoclax across multiple indications in China and globally to bring benefits to patients as early as possible."

On May 28, 2025 Strand Therapeutics, a leader in next-generation mRNA-based therapeutics, reported exciting preliminary Phase 1 clinical data for its lead investigational candidate, STX-001, in patients with advanced solid tumors (Press release, Strand Therapeutics, MAY 28, 2025, View Source [SID1234653470]). The study marks the first clinical evidence of Strand’s proprietary programmable mRNA technology platform and represents a major milestone in the company’s mission to bring next-generation mRNA therapies to patients with cancer.

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In the ongoing first-in-human Phase 1, open-label, dose-escalation clinical trial, STX-001 demonstrated a favorable safety profile and encouraging signs of anti-tumor activity as a monotherapy in patients with immune checkpoint inhibitor-refractory solid tumors, including melanoma and other solid tumor indications. As of the April 3rd, 2025 data cutoff, the trial had enrolled 22 patients across multiple sites in the United States and Australia. All patients were treated with STX-001 as a monotherapy (without combination with immune checkpoint inhibitors, etc.) with injections to surface accessible lesions.

The data will be presented at The 2025 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting in Chicago on June 1 by Sarina Piha-Paul, M.D., professor of Investigational Cancer Therapeutics at The University of Texas MD Anderson Cancer Center.

"This investigational therapy has the potential to address an important unmet need in patients with checkpoint inhibitor-refractory advanced cancers," said Dr. Piha-Paul. "We’re observing systemic immune activation and antitumor responses, including in non-injected lesions, across multiple tumor types, which is encouraging and supports continued evaluation."

Key highlights from the Phase 1 trial include:

Preliminary Clinical Activity: Multiple RECIST responses were observed, including a confirmed complete response and multiple partial responses. Furthermore, there were multiple cases of prolonged disease stabilization.
Safety and Tolerability: STX-001 was well-tolerated up to 300 µg. Treatment-related adverse events were consistent with STX-001’s intended mechanism of action of immune activation.
Pharmacodynamic Activity: Biomarker analysis confirmed dose-dependent increase in plasma IL-12 and IFN-γ, as well as infiltration of immune cells within the tumor microenvironment.
"This is a transformative moment for Strand and for the field of synthetic mRNA therapeutics," said Jake Becraft, PhD, CEO and Co-founder of Strand Therapeutics. "The Phase 1 data for STX-001 provide early clinical validation of our platform’s ability to deliver programmable, tumor-localized immunotherapy safely and effectively. Our mRNA medicines as a therapeutic modality offer the potential capability to broaden pathways to treatment for patients while seamlessly integrating into the existing healthcare ecosystem."

STX-001 encodes IL-12, an immunomodulatory protein, which the company has designed such that it can reprogram the tumor microenvironment and stimulate a systemic anti-tumor immune response. Unlike traditional mRNA therapies, Strand’s approach uses self-replicating mRNA, ensuring localized and durable therapeutic activity.

The company is currently conducting dose expansion in the Phase 1 trial. Upon completion, the company plans to transition into a Phase 2 trial of STX-001 as a monotherapy. The company also plans to initiate dose escalation of STX-001 in combination with checkpoint inhibitors and expand into additional solid tumor indications. In addition, Strand is advancing a broader pipeline powered by the company’s first-in-class cell-type specific mRNA engineering platform, including advancing STX-003, an intravenously administered version of STX-001, to patients in 2026.

ASCO Poster Presentation Information:
Abstract Title: Phase I dose escalation trial of STX-001, an LNP-encapsulated self-replicating mRNA expressing IL-12, in patients (pts) with advanced solid tumors.
Session Type: Poster
Date and Time: June 1, 9:00 AM-12:00 PM CDT
Abstract Number: 9556
Location: Hall A
Full abstract is available on the ASCO (Free ASCO Whitepaper) Annual Meeting Website.

The study, an open-label, dose escalation trial, evaluated the safety, tolerability, pharmacokinetics (PK), pharmacodynamics (PD), and preliminary antitumor activity of STX-001 in patients with advanced solid tumors. STX-001 was well-tolerated up to 300 µg, with dose-dependent and manageable treatment-related adverse events. Promising early clinical activity was observed, including multiple RECIST responses and durable disease stabilization. Findings support the further development of STX-001 as a monotherapy and in combination with checkpoint inhibitors for the treatment of solid tumors.

Additional Commentary

Professor Georgina Long AO, BSc, PhD, MBBS, FRACP, FAHMS, AAHMS, FAA, Medical Director of Melanoma Institute Australia (MIA), and Chair of Melanoma Medical Oncology and Translational Research at MIA and Royal North Shore Hospital, The University of Sydney: "I am encouraged by this early data. While intratumoral therapies offer a promising approach by initiating immune activation at the injected tumor site, they have historically struggled to generate robust systemic responses. STX-001 may represent a meaningful step forward, with early clinical evidence showing cases of regression of non-injected lesions, a sign of systemic immune engagement."

Tasuku Kitada, PhD, Co-Founder, President, and Head of R&D at Strand Therapeutics: "Patients who are refractory to immune checkpoint inhibitors urgently need new treatment options. While IL-12 has long been recognized as a powerful immune stimulator, its clinical potential has been limited by toxicity, and to date, no IL-12–based therapies have been approved by the FDA. STX-001 is designed to overcome these challenges, delivering localized IL-12 expression to activate the tumor microenvironment and drive systemic immune responses, all while seeking to minimize toxicities. These early data suggest we may finally be able to realize the promise of IL-12 in cancer therapy."

About STX-001

STX-001 is an investigational multi-mechanistic, synthetic self-replicating mRNA technology that expresses an IL-12 cytokine for an extended period of time, directly injected into the tumor microenvironment in order to promote immune modulation and antitumor activity. The company received IND clearance from the U.S. Food and Drug Administration (FDA) in December 2023 to initiate a Phase 1/2 clinical trial for STX-001, and announced its first patient dosed just before the 2024 ASCO (Free ASCO Whitepaper) Annual Meeting. Additional study details can be found at clinicaltrials.gov, using identifier: NCT06249048.