On September 15, 2026 GT Biopharma, Inc. (the "Company") (NASDAQ: GTBP), a clinical stage immuno-oncology company focused on developing innovative therapeutics based on the Company’s proprietary TriKE natural killer (NK) cell engager platform, reported IND clearance from the FDA for GTB-5550 in multiple myeloma.

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"Today’s IND to expand the potential indications for GTB-5550 highlights the diverse utility of our Trike platform," said Michael Breen, Executive Chairman and Chief Executive Officer of GT Biopharma. "The company remains focused on its two ongoing Phase 1 trials with GTB-5550 and GTB-3650, both of which are actively enrolling, and we look forward to the potential initiation of a third Phase 1 trial, pending receipt of non-dilutive grant funding."

"Targeting B7-H3 remains an active area for clinical development of new anti-cancer drugs, yet most competitive efforts are focused on solid tumors", said Dr. Aimee Merino, MD, PhD, Assistant Professor of Medicine, Division of Hematology, Oncology and Transplantation, The University of Minnesota1. "Based on our findings of high levels of B7-H3 expression within the bone marrow of newly diagnosed multiple myeloma patients, we have begun a dedicated effort for this novel approach in later-line patients, which continues to be an area of unmet need. We have been encouraged with our preclinical findings in a bone chip model that show high levels of antitumor cell activity mediated by NK cells in the presence of GTB-5550."

The Phase 1a/1b trial with GTB-5550 will be the first-in-human trial of a B7-H3-targeted TriKE in multiple myeloma and will use more patient-friendly subcutaneous administration intended to extend the half-life relative to prior intravenous TriKE formulations. The Phase 1a dose escalation portion will enroll 4th line and later patients with multiple myeloma and evaluate up to 6 dose cohorts to identify the maximum tolerated dose (MTD). Following dose escalation, the Phase 1b expansion cohort will enroll a total of 25 patients treated at the MTD and further evaluate safety, tolerability, and preliminary anti-tumor activity.

In the Phase 1 trial, GTB-5550 will be administered by subcutaneous (SQ) injection in the abdominal area on 3 non-consecutive days per week during Week 1 and Week 2, followed by 2 weeks of no treatment. One treatment cycle is 4 weeks in duration, and this dosing schedule is repeated for each subsequent cycle. A minimum of 2 cycles is planned, and disease reassessment (monoclonal protein and free light chain analysis) is performed on Day 28 of each cycle. Patients with stable disease may continue for up to 4 cycles total, and those with a partial response or better may continue for up to 1 year. Patients are followed for 12 months from the first dose of GTB-5550 to determine progression-free survival (PFS) and overall survival (OS).

(Press release, GT Biopharma, SEP 15, 2026, View Source [SID1234670871])

On September 15, 2026 Allarity Therapeutics, Inc. ("Allarity" or the "Company") (NASDAQ: ALLR), a Phase 2 clinical-stage pharmaceutical company dedicated to developing stenoparib (2X-121)—a differentiated, dual PARP and WNT pathway inhibitor, reported that the Japan Patent Office (JPO) has granted a key patent covering Allarity’s proprietary stenoparib-specific Drug Response Predictor (DRP) companion diagnostic. The newly granted patent, Japanese Patent No. 7917283, provides protection in Japan into 2039.

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Thomas Jensen, Chief Executive Officer of Allarity Therapeutics, said: "Japan is one of the world’s largest pharmaceutical markets and is also the home of Eisai, the original developer of stenoparib. This award of the patented patent is critical to securing stenoparib’s developability in one of the world’s most important pharmaceutical markets. This award reflects our ongoing strategic efforts to strengthen and extend our intellectual property, ensuring the development and potential commercialization of stenoparib- together with its DRP companion diagnostic- in the world’s most important commercial markets."

The granted patent covers the DRP methods for predicting clinical benefit from stenoparib based on gene-expression profiles derived from tumor samples, as well as methods for selecting patients most likely to benefit from stenoparib treatment using the stenoparib DRP test.

Allarity has previously secured patent protection for the stenoparib DRP in the United States, with protection extending into April 2042, as well as in certain European jurisdictions and Australia. Related patent applications remain pending in additional international markets.

(Press release, Allarity Therapeutics, SEP 15, 2026, View Source [SID1234670869])

On September 15, 2026 Tr1X, Inc. and Miltenyi Biotec reported that they will highlight their collaboration to support the development and manufacturing of Tr1X’s allogeneic Tr1 and CAR-Tr1 Treg cell therapy programs at the 11th Annual CAR-TCR Summit, taking place September 15–17, 2026, in Boston, Massachusetts.

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The collaboration demonstrates how strategic manufacturing partnerships can help emerging cell therapy companies establish a path toward clinical development while maintaining the flexibility and scalability needed as programs advance.

From clinical development to future scale

Tr1X is developing a clinical-stage pipeline of allogeneic and in vivo Tr1 and CAR-Tr1 Treg cell therapies for immune-mediated and inflammatory diseases. Through its collaboration with Miltenyi Biotec, Tr1X has established a manufacturing approach designed to support clinical development today while providing a foundation for future scale.

The presentation will describe how the integrated cell and gene therapy offering from Miltenyi Biotec, spanning vector design and manufacturing, process development, contract manufacturing, analytics, regulatory support, and automated manufacturing technologies, can help accelerate clinical readiness and support future scale-up for allogeneic cell therapy programs.

"Having the right manufacturing strategy in place early is critical as we advance our allogeneic cell therapy programs toward the clinic," said James Adams, Chief Technical Officer, Tr1X, Inc. "Our collaboration with Miltenyi Biotec has helped us build a manufacturing approach that supports our clinical objectives while giving us a path toward future scale."

A partnership designed for long-term development

For emerging cell therapy companies, establishing manufacturing capabilities can require significant investment, specialized expertise, and infrastructure. Working with an experienced manufacturing partner can provide greater flexibility while allowing companies to focus resources on clinical development and advancing their pipeline.

"Tr1X is a strong example of how close collaboration between a therapy developer and manufacturing partner can help address the challenges of bringing allogeneic cell therapies toward the clinic," said Leonard Pulig, President and General Manager, Miltenyi Biotec, Inc. "We are pleased to support Tr1X as they advance their programs and establish a manufacturing foundation designed to evolve with their development needs."

The presentation will explore lessons from the collaboration, including the importance of aligning manufacturing strategy with clinical objectives, building scalability into the development process, and establishing the right operating model as cell therapy programs progress.

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Presentation: Partnering for Scale: Maximizing Allogeneic Cell Therapy Success Using the Right CDMO
Speaker: James Adams, Chief Technical Officer, Tr1X, Inc.
Date: Thursday, September 17, 2026
Time: 11:25 a.m. (EDT)
Location: The Westin Boston Seaport District, Boston, Massachusetts

The presentation will take place during the Early-Stage Manufacturing Track and will address three key considerations for allogeneic cell therapy developers: (i) accelerating the path to the clinic, (ii) designing manufacturing for future scalability and (iii) determining the right manufacturing operating model as programs mature.

(Press release, Tr1X, SEP 15, 2026, View Source [SID1234670868])

On September 15, 2026 TOLREMO therapeutics AG (TOLREMO), a clinical-stage biotechnology company pioneering therapies targeting non-oncogene addiction in cancer, reported the completion of its Phase I study of monotherapy TT125-802 (NCT06403436) and the presentation of final clinical data from the study at the 2026 World Conference on Lung Cancer (WCLC) in Seoul, South Korea. The data highlights TT125-802’s confirmed clinical activity as monotherapy in drug-resistant NSCLC and supports CBP/p300 inhibition as a novel therapeutic strategy to address transcriptional drug resistance in solid tumors.

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The completed study enrolled 45 patients with advanced solid tumors, including 24 patients with NSCLC. 10 of 24 patients (42%) experienced tumor shrinkage, including three confirmed partial responses observed in distinct resistance settings: primary resistance to first-line EGFR inhibition (osimertinib), acquired resistance to KRAS-G12C inhibition (elironrasib), and in SOX2-amplified squamous NSCLC following progression on chemo-immunotherapy.

"The completion of our Phase I marks an important milestone for TOLREMO and provides strong clinical evidence supporting our strategy of targeting non-oncogene addiction and transcriptional resistance mechanisms in cancer," said Stefanie Flückiger-Mangual, Ph.D., Chief Executive Officer and Co-founder of TOLREMO therapeutics. "The final data show durable monotherapy anti-tumor activity across biologically distinct forms of drug resistance in NSCLC. This validates our core scientific platform and positions TT125-802 as a foundational therapy capable of extending the reach and durability of existing targeted regimens."

TT125-802 demonstrated a favorable and differentiated safety profile without thrombocytopenia across the 45-patient study population. 98% of treatment-related adverse events were Grade 1 or Grade 2, reversible and manageable. The most frequently reported treatment-related adverse events included dysgeusia and low grade hyperglycemia.

"The recommended dose of 60 mg once a day without food restriction delivers continuous target coverage and anti-tumor activity in drug-resistant NSCLC, while the favorable safety profile and absence of thrombocytopenia support the development of TT125-802 as a combination partner for targeted therapies," said Alessandra Cesano, MD, Ph.D., CMO of TOLREMO therapeutics. "We are now positioned to evaluate whether simultaneously inhibiting oncogenic signaling and CBP/p300-dependent transcriptional escape can generate deeper and more durable therapeutic responses in our next study."

The final Phase 1 monotherapy dataset was presented at WCLC in the poster "TT125-802, a Selective Clinical Bromodomain Inhibitor of CBP/p300, Targeting Transcriptional Resistance Mechanisms in NSCLC." First author Martina Imbimbo, M.D., Medical Oncologist at the Oncology Institute of Southern Switzerland (IOSI) in Bellinzona, provides expert commentary on the findings and the emerging role of CBP/p300 inhibition in drug-resistant NSCLC in a video discussion available on the TOLREMO website.

(Press release, TOLREMO, SEP 15, 2026, View Source [SID1234670867])

On September 15, 2026 Parabilis Medicines, Inc. reported its guidance to reflect its intention to present updated clinical data from the ongoing Phase 1/2 study of zolucatetide in desmoid tumor patients in an oral presentation at the European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper) Congress 2026 in Madrid, Spain. The presentation is scheduled for Saturday, October 24 during a sarcoma-focused Proffered Paper session beginning at 2:45pm CEST (8:45am ET).

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The information included under Item 7.01 of this Current Report on Form 8-K is being furnished and shall not be deemed "filed" for purposes of Section 18 of the Exchange Act, or otherwise subject to the liabilities of that section, and shall not be incorporated by reference in any filing under the Securities Act or the Exchange Act, except as expressly set forth by specific reference in such filing.

(Press release, Parabilis Medicines, SEP 15, 2026, View Source [SID1234670866])