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Tempest Secures Exclusive Option to License Clinical-Stage CD7-Targeted Lentiviral In Vivo CAR-T Platform

On September 15, 2026 Tempest Therapeutics, Inc. (Nasdaq: TPST) ("Tempest"), a clinical-stage biotechnology company developing in vivo CAR-T therapies designed to reset dysfunctional immunity in cancer and autoimmune disease, reported that it has entered into an exclusive option agreement with Hebei Senlang Biotechnology Co., Ltd. ("Senlang").

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The agreement provides Tempest with an exclusive option to license Senlang’s CD7-targeted lentiviral vector platform and a portfolio of in vivo CAR-T product candidates. The portfolio includes a BCMA/GPRC5D dual-targeting in vivo CAR-T candidate currently in Phase 1 dose escalation for relapsed/refractory multiple myeloma, as well as additional candidates for hematologic malignancies and autoimmune diseases.

"This agreement represents an important step in building Tempest as a multi-platform in vivo CAR-T company focused on immune reset for oncology and autoimmune indications," said Matt Angel, Ph.D., President and Chief Executive Officer of Tempest. "Upon exercise of the option, the CD7-targeted lentiviral platform would complement our targeted LNP platform, providing two distinct approaches to generating CAR-T cells directly within patients. The lead program is currently in clinical development and has demonstrated in vivo CAR-T generation and expansion, providing encouraging early clinical support."

Senlang’s proprietary platform uses targeted lentiviral vectors to deliver CAR transgenes to endogenous CD7-positive T cells and natural killer cells, generating CAR-T and CAR-NK cells directly within the patient. The approach is designed to avoid the individualized cell collection and external manufacturing required for conventional autologous CAR-T therapy. The lead program encodes a dual-targeting CAR directed against BCMA and GPRC5D, two clinically validated targets in multiple myeloma. Targeting both antigens may broaden malignant plasma-cell coverage and reduce the potential for tumor escape associated with the loss or downregulation of a single antigen.

The candidate is currently being evaluated in an ongoing Phase 1 dose-escalation study in patients with relapsed/refractory multiple myeloma. Early clinical observations at the current highest evaluable dose demonstrate successful generation and expansion of CAR-T cells in vivo. As of August 25, 2026, no Grade 3 or higher cytokine release syndrome and no immune effector cell-associated neurotoxicity syndrome were observed. The initial safety profile supports continued dose escalation, and patient enrollment and follow-up remain ongoing.

"Together, our targeted LNP and targeted lentiviral vector platforms are intended to support a broad portfolio of immune reset therapies," said Dr. Angel. "The LNP platform offers a potentially repeatable approach to transient CAR expression, while the lentiviral platform is designed to support durable CAR-cell generation. These complementary capabilities provide Tempest with the flexibility to match the delivery approach to the biology and treatment requirements of different cancers and autoimmune diseases."

Tempest and Senlang will continue to evaluate the Phase 1 results and the broader product portfolio during the option period. Tempest expects to provide additional information regarding the program as the clinical data mature.

About Senlang’s CD-7-Directed Lentiviral Platform

Senlang has a pipeline of in vivo CAR-T cell programs utilizing its CD7-directed lentiviral platform, which is designed to selectively deliver CAR payloads to endogenous CD7-positive T cells and NK cells, enabling in vivo generation of antigen-directed CAR immune cells. Proprietary nanobody-based retargeting promotes selective cell engagement and efficient transduction, while an engineered detargeted cocal envelope is intended to improve serum resistance, particle stability, and functional delivery in the bloodstream. Producer-cell engineering adds an immune-shielding feature to the lentiviral delivery particles, helping them remain functional longer in the bloodstream and improving delivery to CD7-positive immune cells. In preclinical studies, the platform demonstrated enhanced transduction in whole blood and resting PBMCs, and a single low-dose administration produced efficient in vivo transduction, rapid CAR-cell expansion, tumor-site enrichment, and durable tumor regression in mouse models.

(Press release, Tempest Therapeutics, SEP 15, 2026, View Source [SID1234670873])

Xspray Pharma invites to Investor Update in Gothenburg

On September 15, 2026 Xspray Pharma reported to have invite investors, shareholders and analysts to an Investor Update in Gothenburg on Friday, October 2, 2026. The event will be hosted by Xspray as a separate investor event at Gothia Towers, at the same time and venue as the ESH-iCMLf John Goldman Conference on Chronic Myeloid Leukemia.

The event will combine a strategy and company progress update by CEO Blake Leitch, new scientific posters explained by CSO and co-founder Per Andersson, and a moderated discussion with two internationally recognized CML experts: Michael J. Mauro, MD, and Jorge Cortes, MD. Both guest speakers are scientific advisors to Xspray and co-authors of Xspray poster abstracts being presented at the Goldman Conference.

The Investor Update will provide a broader view of Xspray’s transition toward commercial oncology execution, including Dasynoc, Nilopki, launch readiness, the current regulatory situation and the market and future role of the HyNap platform. With new scientific data being presented during the Goldman Conference, the event will also give investors the opportunity to hear how leading US clinical CML-experts view the significance of improved targeted therapies in CML.

Date: Friday, October 2, 2026
Venue: Gothia Towers, Gothenburg or participate live online
Presentation: 12:30–14:00 CEST
Light lunch and registration for participants on site from 11:45 CEST

Please register here

When you register, you can choose if you would like to participate on-site or online.
A link will be sent out in advance to registered online participants.

"The Goldman Conference provides a highly relevant scientific setting for a broader Xspray investor update. We look forward to discussing our progress, our commercial priorities and the continued development of Dasynoc, while also providing scientific context from new data being presented during the conference," says Blake Leitch, CEO of Xspray Pharma.

(Press release, Xspray, SEP 15, 2026, View Source [SID1234670872])

GT Biopharma Announces Potential New Indication for GTB-5550, a B7-H3-Targeted Natural Killer (NK) Cell Engager, for Multiple Myeloma

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.

"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])

Allarity Therapeutics Granted Japanese Patent for Stenoparib DRP® Companion Diagnostic, Further Strengthening Stenoparib Development

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.

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])

Tr1X, Inc. to highlight Miltenyi Biotec CDMO capabilities for scalable allogeneic cell therapy manufacturing at the 11th Annual CAR-TCR Summit

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.

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.

Join Tr1X at the 11th Annual CAR-TCR Summit

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])