On May 27, 2026 Archeus Technologies, a clinical-stage company advancing a portfolio of differentiated small-molecule radiopharmaceutical therapies (RPTs) to address some of the most difficult-to-treat cancers, reported that it has dosed the first patient in a Phase 1 clinical trial of ARC-706, and companion diagnostic ARC-166, in patients with metastatic cancer receiving immune checkpoint inhibition (ICI) therapies.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

Archeus is developing ARC-706 for combination use with certain validated immunotherapies across a range of oncology indications. ARC-706 leverages the unique capabilities of Archeus’ NM600 tumor-targeting platform with the addition of the therapeutic beta-emitting isotope yttrium-90 (Y-90), as well as the PET isotope yttrium-86 (Y-86) comprising ARC-166. In this first-in-human imaging and therapy study, participants will receive intravenous ARC-166 for dosimetry and patient selection, followed by ARC-706 to evaluate its safety, biodistribution, pharmacokinetics, and potential to augment anti-tumor immune response. The study also aims to determine an optimal Phase 1b dose of ARC-706 and explore changes in relevant cancer-related biomarkers.

"This study allows us to evaluate a new therapeutic strategy designed to support patients who are continuing immunotherapy despite signs of disease progression," said Grace Blitzer, M.D., assistant professor of human oncology at the University of Wisconsin School of Medicine and Public Health, radiation oncologist at the UW Carbone Cancer Center, and a principal investigator of the study. "By combining functional imaging with targeted radiotherapy, we hope to demonstrate meaningful clinical benefit to patients without disrupting ongoing immune-based treatment—a goal that could have wide-reaching impact across multiple tumor types."

Preclinical studies have demonstrated tumor-selective uptake of ARC-706 in multiple cancers that are treated with ICI therapies, and that administering ARC-706 at specific dose ranges based on ARC-166 imaging results can significantly increase the response rate to ICI therapies and the durability of responses.

"By using imaging to guide therapy and selectively deliver radiation to tumors, this trial is designed to optimize treatment selection and potentially improve responses to immune checkpoint inhibitors in patients who currently face limited options," said Zachary Morris, M.D., Ph.D., chief medical officer of Archeus Technologies and co-chair of the study, as well as associate professor and chair of the Department of Human Oncology, University of Wisconsin School of Medicine and Public Health. "It also reflects our broader goal of advancing radiopharmaceutical strategies that can be applied across a range of difficult-to-treat cancers."

(Press release, Archeus Technologies, MAY 27, 2026, View Source [SID1234666122])

On May 27, 2026 Forlong Biotechnology, a clinical-stage biotech company focusing on developing transformative cytokine therapies for patients with severe unmet needs, reported that Phase I clinical studies of FL115, an IL-15 superagonist, as monotherapy via intravenous infusion in patients with advanced solid tumors have been completed, with durable treatment effects observed in 2 patients with confirmed partial response (cPR) and 1 patient with stable disease (SD).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

Phase I clinical studies of FL115 were conducted in US and China in parallel:

FL115-101 Study was conducted in US, with 11 patients treated. One patient with advanced cervical cancer and 4 prior therapies received the 1st dose in July 2024, and achieved SD. The patient was rolled off the study in Sept 2025, and continue to receive the FL115 treatment under a Single Patient IND Protocol/Treatment Plan. Data from this study will be presented at the upcoming 2026 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting (Poster Board: 291; Session Type/Title: Developmental Therapeutics—Molecularly Targeted Agents and Tumor Biology; Date and Time: May 30, 2026, 1:30 PM-4:30 PM CDT)

FL115-102 Study was conducted in China, with 23 patients treated. One patient with highly invasive NUT-NSCLC and 3 lines of prior therapies received the 1st dose of FL115 in Apr 2025, and achieved cPR. Another patient with lymphoepithelial carcinoma (parotid gland) and 4 lines of prior therapies received the 1st dose of FL115 in Jun 2025, and achieved cPR. Both patients have been rolled off the study respectively in March and May 2026, and continue to receive the FL115 under a Compassionate Treatment program. Data from this study was presented as a Late-breaking Abstract at 40th SITC (Free SITC Whitepaper) Annual Meeting.

FL115 (IV) is currently being investigated in combination with an anti-PD1 monoclonal antibody in a Phase 1b/2 clinical trial in patients with advanced solid tumors. Preclinical data regarding FL115 (Subcutaneous Injection) was presented at the 2026 AACR (Free AACR Whitepaper) Annual Meeting, and a Phase 1 clinical study will be initiated in 2H 2026 to evaluate FL115 (Subcutaneous Injection) in patients with advanced solid tumors. In parallel, FL115 (Intravesicale Delivery) is currently being investigated in combination with Bacillus Calmette-Guérin (BCG) in a Phase 2 clinical trial in patients with nonmuscle invasive bladder cancer (NMIBC).

"We deeply appreciate the commitment and support from the patients and their families," said Dong Wei, Ph.D., Chief Executive Officer of Forlong Biotechnology, "With favorable safety, preliminary efficacy and duration of response observed in Phase 1 clinical studies, FL115 continues to show its potential as Best-in-class IL-15 superagonist. We are advancing FL115 for multiple indications via different delivery routes, aiming to develop optimal treatment options for cancer patients in need."

About FL-115

FL115 is an engineered IL-15/IL15Rα-Fbody fusion protein, aiming to enhance anti-tumor immunity via IL-15-mediated signaling on NK and CD8+ T cells while minimizing complexity from Fc. FL115 has demonstrated significant anti-tumor activities as a monotherapy or as part of combination therapy in vivo, and can be manufactured by a robust and efficient process with excellent product stability. Clinically, FL115 has demonstrated favorable safety profile and preliminary clinical responses as a monotherapy, and has the best-in-class potential to synergize with current and emerging T cell-targeting immunotherapies through combination therapy to significantly improve the treatment outcome for patients. It is currently being investigated in combination with Bacillus Calmette-Guérin (BCG) in a Phase 2 clinical trial to evaluate safety and preliminary efficacy in patients with nonmuscle invasive bladder cancer (NMIBC) and in combination with an anti-PD1 monoclonal antibody in a Phase 1b/2 clinical trial to evaluate safety and preliminary efficacy in patients with advanced solid tumors.

(Press release, Forlong Biotechnology, MAY 27, 2026, View Source [SID1234666121])

On May 27, 2026 Solu Therapeutics, a biotechnology company pioneering novel therapies to eliminate disease-driving cells in cancer, immunology, and other therapeutic areas, reported that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation to STX-0712, the company’s investigational therapy in development for the treatment of relapsed or refractory chronic myelomonocytic leukemia (CMML). CMML is an aggressive blood cancer with limited treatment options, particularly for patients whose disease has relapsed or become resistant to available therapies.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

Fast Track is a process designed to facilitate the development and expedite the review of drugs to treat serious conditions and fill an unmet medical need. The designation also enables more frequent interactions with the FDA throughout the development and review process.

"Fast Track designation for STX-0712 reinforces the significant need for new treatment options for people living with CMML," said Philip Vickers, President and CEO of Solu Therapeutics. "By directly depleting CCR2-positive malignant monocytes and bone marrow blasts that drive disease in CMML, STX-0712 has the potential to offer a highly specific and targeted approach. We look forward to continuing to work closely with the FDA as we advance through clinical development and work to bring this potential therapy to patients as quickly as possible."

In addition to CMML, Solu is also exploring the potential of STX-0712 in other hematologic malignancies, including acute myeloid leukemia (AML). STX-0712 is a CyTAC (Cytotoxicity Targeting Chimera) targeting the G-Protein Coupled Receptor CCR2, a selective marker expressed at high levels on malignant monocytes and bone marrow blasts, which are key drivers of disease in CMML, AML, and other hematologic cancers. By eliminating CCR2-positive cells, STX-0712 has the potential to offer a more targeted and effective treatment option with minimal effects on non-malignant cells.

The Phase 1, open-label, multicenter study evaluating STX-0712 as monotherapy in patients with relapsed or refractory CMML and AML is ongoing. It is planned that initial clinical data from this study will be submitted to a hematology conference later this year.

(Press release, Solu Therapeutics, MAY 27, 2026, View Source [SID1234666120])

On May 27, 2026 Atossa Therapeutics, Inc. (Nasdaq: ATOS) ("Atossa" or the "Company"), a clinical-stage biopharmaceutical company developing novel therapies in oncology and other areas of significant unmet medical need, reported that two abstracts featuring (Z)-endoxifen have been accepted for presentation at the 2026 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting, being held May 29 to June 2, 2026 in Chicago, IL.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

"Both abstracts highlight the scientific rationale and ongoing clinical development of (Z)-endoxifen in ER-positive breast cancer," said Dr. Steven C. Quay, M.D., Ph.D., President and Chief Executive Officer of Atossa Therapeutics. "Our preclinical data demonstrate that (Z)-endoxifen achieved robust estrogen receptor inhibition across clinically relevant ESR1 mutations associated with endocrine resistance, while the EVANGELINE trial is evaluating its potential in combination with ovarian function suppression in premenopausal women in the neoadjuvant setting. Together, these abstracts underscore our belief that (Z)-endoxifen has the potential to address important unmet needs across multiple treatment settings in ER-positive breast cancer."

Presentation details are as follows:

Session Type: Online Publication
Abstract Title: Effect of (Z)-endoxifen Demonstrates Robust Estrogen Receptor Signaling Inhibition Across Clinically Relevant ESR1 Mutations

Summary: The abstract highlights new preclinical data demonstrating that (Z)-endoxifen delivers robust ER inhibition across clinically relevant estrogen receptor alpha gene (ESR1) mutations. ESR1 mutations are a major mechanism of acquired endocrine resistance in ER-positive breast cancer and remain associated with limited treatment options despite the emergence of next-generation endocrine therapies. These data therefore support the ongoing clinical development of (Z)-endoxifen, as well as its potential as a promising treatment option for breast cancer patients with limited therapeutic alternatives.

Key Data Highlights

(Z)-endoxifen demonstrated robust dose-dependent and statistically significant inhibition of ER signaling across clinically relevant concentrations.
In parental MCF-7 breast cancer cells, ER activity was reduced to 16-26% of control (p < 0.001). In ESR1 wild-type models, studied therapies reduced ER signaling to <5% of control (p < 0.001).
(Z)-endoxifen maintained consistent ER inhibition across key ESR1 mutations (Y537N, Y537S, D538G) (p < 0.01).
Comparator oral Selective Estrogen Receptor Degraders (SERDs), including elacestrant and imlunestrant, showed reduced efficacy in ESR1-mutant settings, particularly in D538G, as compared to (Z)-endoxifen.
The D538G mutation demonstrated the highest resistance, while Y537N remained the most sensitive across treatments.
Session Type: Poster Presentation
Date: June 1, 2026, 1:30 PM-4:30 PM CT
Poster Board Number: 133b
Abstract Title: A Phase 2 Clinical Trial in Progress of (Z)-Endoxifen Plus Goserelin as Neoadjuvant Therapy in Premenopausal Women With ER+/HER2- Breast Cancer (EVANGELINE)
Presenters: Dr. Steven C. Quay & Hayley Erickson

Summary: The abstract describes EVANGELINE (NCT05607004), an ongoing, multicenter, open-label Phase 2 study evaluating daily 40 mg (Z)-endoxifen plus goserelin administered every 28 days as neoadjuvant therapy in premenopausal women with ER+/HER2-negative, cT2-3, cN0-1 breast cancer.

Key Highlights

EVANGELINE is evaluating (Z)-endoxifen plus ovarian function suppression (OFS) as a neoadjuvant therapy in premenopausal women with ER+/HER2-negative, cT2-3, cN0-1 breast cancer.
The primary objective is to determine the proportion of patients with baseline Ki-67 >10% who achieve Ki-67 of 10% or less after 4 weeks of therapy.
A Simon two-stage design is being used to study whether, after four weeks, at least 65% of patients treated achieved a Ki-67 of 10% or less, with 20 patients enrolled in the first stage and, if promising, another 25 patients enrolled in the second stage (cohort A).
A parallel cohort of 20 patients with baseline Ki-67 of 10% or less (cohort B) is enrolled to assess objective response rate at 24 weeks per RECIST v1.1.
Secondary objectives include safety and tolerability, residual cancer burden, and PEPI score; correlative analyses include examining the effect of treatment on select tumor and plasma biomarkers.
A pharmacokinetic run-in phase has been completed and informed selection of (Z)-endoxifen 40 mg daily plus OFS for Phase 2 evaluation. Phase 2 enrollment opened in May 2025.
About ESR1-Mutant Breast Cancer

Mutations in ESR1 commonly arise in patients with advanced ER+ breast cancer following endocrine therapy and are associated with resistance to treatment. These mutations drive ligand-independent ER activation, leading to continued tumor growth despite standard therapies. Effective treatment options for ESR1-mutant disease remain limited.

About EVANGELINE

EVANGELINE (NCT05607004) is an ongoing, multicenter, open-label Phase 2 study evaluating (Z)-endoxifen plus goserelin as a neoadjuvant therapy in premenopausal women with ER+/HER2-negative, cT2-3, cN0-1 breast cancer. The study will characterize early antiproliferative activity, clinical response, safety and biologic effects of dual ER and PKCβ1/AKT pathway targeting in this setting.

(Press release, Atossa Therapeutics, MAY 27, 2026, View Source [SID1234666119])

On May 27, 2026 TransCode Therapeutics, Inc. (NASDAQ: RNAZ), a clinical stage company pioneering immuno-oncology and RNA for the treatment of high risk and advanced cancer, reported the initiation of its Phase 2a clinical trial. The study is to evaluate TransCode’s lead therapeutic candidate, TTX‑MC138, in patients with circulating tumor DNA (ctDNA) positive colorectal cancer following curative‑intent therapy. The trial is being conducted in collaboration with Quantum Leap Healthcare Collaborative (QLHC), sponsor of the PRE‑I‑SPY clinical trial platform. The trial builds on growing clinical and scientific momentum supporting ctDNA‑guided strategies targeting minimal residual disease (MRD) in colorectal cancer.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

The Phase 2a clinical trial is expected to enroll up to 45 patients with colorectal cancer who have completed standard curative-intent therapy and have no radiographic evidence of disease, but remain or become ctDNA-positive, indicating the presence of minimal residual disease.

Principal investigators are Dr. Emil Lou of the University of Minnesota and Dr. Zhaohui Jin of the Mayo Clinic Comprehensive Cancer Center. The trial is chaired by Dr. Paula Pohlmann of the MD Anderson Cancer Center.

The trial leverages clinical sites currently participating and actively recruiting in QLHC’s PRE‑I‑SPY platform trial. Several of those clinical sites are part of the National Comprehensive Cancer Network (NCCN). Those centers have considerable expertise and are at the forefront defining standard-of-care practices for the treatment of cancer.

It is anticipated that the trial will produce new data about the importance of ctDNA testing and the role of TTX-MC138 in reducing the risk of cancer recurrence in this at-risk patient population. The trial has been submitted to the U.S. Food and Drug Administration and received Institutional Review Board approval, enabling site activation and commencement of patient enrollment.

This clinical trial aims to evaluate the biological and clinical activity of TTX-MC138 in the minimal residual disease setting where therapeutic intervention may have the greatest opportunity to improve long-term outcomes. ctDNA testing is becoming increasingly important in oncology, particularly in colorectal cancer, because it provides a highly sensitive, real-time measure of residual disease and information about tumor biology that traditional methods often fail to detect. This approach has recently been successfully employed in the treatment of patients with muscle invasive bladder cancer.

"TTX-MC138’s safety profile, coupled with the durability of its anti-tumor effects, observed in TransCode’s Phase 1a clinical trial is particularly encouraging. These findings are consistent with the drug’s mechanism of action and provide a basis for a more rigorous efficacy evaluation. This positions TransCode and its collaborators to potentially intervene earlier in a patient’s disease, and may in the future offer a new therapeutic option for patients at risk of developing metastatic disease" noted Daniel Vlock, MD, TransCode’s Consulting Clinician.

About TTX-MC138

TTX-MC138 is a first-in-class therapeutic candidate designed to inhibit microRNA-10b, or miR-10b, a microRNA widely believed to be critical to the emergence and progression of many metastatic cancers. TransCode’s Phase 1a first-in-human clinical trial achieved its primary safety endpoint and established a recommended Phase 2 dose, as announced at ESMO (Free ESMO Whitepaper) 2025.

(Press release, TransCode Therapeutics, MAY 27, 2026, View Source [SID1234666118])