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.

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])

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])

On September 15, 2026 Nouveau Biosciences, a biotechnology company developing precision nanomedicines for cancer, reported that it has entered into a collaboration with DarwinHealth to identify and develop novel therapeutic approaches for cancer.

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The collaboration brings together DarwinHealth’s proprietary computational methodologies for identifying key biological drivers of cancer with Nouveau Biosciences’ nanotherapeutic drug-design platform. The companies intend to use these complementary technologies to identify therapeutically relevant targets and drug combinations and translate those findings into precision-engineered nanomedicines for specific cancer contexts.

DarwinHealthTM has developed proprietary, clinical-grade AI- and systems biology-based methodologies designed to predict the proteins that drive and maintain the cancer cell states that coexist in a tumor and the drugs that can inactivate them. These proteins, referred to as Master Regulators, represent critical control points—so-called "tumor checkpoints—within the molecular networks governing tumor survival and growth.

By analyzing RNA expression profiles using the lens of the cell’s regulatory network, DarwinHealth’s platform is designed to characterize the functional state of an individual patient’s tumor and identify drugs or drug combinations predicted to disrupt the regulatory architecture sustaining individual and co-existing cancer cell states across the cancer subtype spectrum. Based on work perform in the Califano Lab at Columbia University, the DarwinHealth team has pioneered these approaches over the past decade and published their results in some of the most prestigious journals in the field, including Nature, Nature Genetics, Cell, Cancer Cell, Cancer Discovery, and Nature Reviews Cancer.

Nouveau Biosciences deploys a proprietary technology to identify synthetically lethal drug combinations in a highly disease specific context, and the engineers polymer nanoparticles through its proprietary nanomedicine platform. These nanoparticles are designed to deliver individual drugs or optimized drug combinations with enhanced tumor targeting and pharmacologic properties, with the goal of improving therapeutic activity and tolerability.

Under the collaboration, Nouveau Biosciences plans to use insights generated through DarwinHealth’s platform to inform the development of a library of precision nanotherapeutics matched to defined cancer biology. The companies believe this integrated approach could ultimately enable treatment strategies tailored more closely to the molecular and regulatory characteristics of an individual patient’s disease.

"We have followed the groundbreaking work of our colleagues at DarwinHealth for years and have had the opportunity to work closely with Dr. Califano and his team," said Owen A. O’Connor, M.D., Ph.D., Founder and Chief Executive Officer of Nouveau Biosciences. "Cancer is extraordinarily complex and heterogeneous. DarwinHealthTM approaches that complexity by taking a holistic systems-biology perspective, looking beyond individual mutations to understand the regulatory networks that sustain a given tumor."

"The ability to use these molecular insights to identify rational drug combinations and then engineer therapies specifically around a patient’s cancer biology has long been an important goal for precision oncology," Dr. O’Connor continued. "By bringing together DarwinHealth’s capabilities with our ability to synthesize a specific nanotherapeutic drug or drug combination we will be taking a quantum step toward the ability to create personalized precision targeted strategies".

"We believe the platforms and methodologies DarwinHealthTM brings to this collaboration can help reshape how precision cancer therapies are conceived and developed," said Gideon Bosker, M.D., Chief Executive Officer of DarwinHealth. "Our objective is to move beyond generalized treatment paradigms toward an approach in which the functional biology of each cancer informs therapeutic selection. Combining that capability with Nouveau’s nanomedicine platform creates an exciting opportunity to translate biological insights directly into highly tailored therapeutic strategies today."

"I have had the pleasure of working closely with Drs. Bosker, Alvarez and Califano for years," said Charles Karan, Ph.D., Chief Scientific Officer of Nouveau Biosciences. "Their approach recognizes cancer as a complex system of interacting regulatory and signaling networks communicating through a restricted number of nodes, rather than as disease defined by any single mutation or singular target. That perspective is highly complementary to our ability to identify synthetically lethal combinations and to engineer nanoparticles capable of delivering therapeutic combinations precisely."

Dr. Karan added, "Integrating tumor-specific biological analysis with the design of personalized precision nanotherapeutics represents a compelling new development model. We believe this collaboration has the potential to create a highly differentiated platform for the next generation of cancer therapies."

(Press release, Nouveau Biosciences, SEP 15, 2026, View Source [SID1234670865])

On September 15, 2026 Imvax, Inc., a clinical-stage biotechnology company developing personalized, whole tumor-derived immunotherapies, reported that an abstract reporting results from the Company’s randomized, multicenter, double-blind, placebo-controlled Phase 2b trial of IGV-001 in 99 patients with newly diagnosed glioblastoma (ndGBM) has been accepted for poster and rapid oral presentation at the 31st Annual Meeting of the Society for Neuro-Oncology (SNO), taking place November 12-15, 2026 in Philadelphia. The Company also provided an update on its planned Phase 3 development of IGV-001 in ndGBM patients whose tumors had an unmethylated O6-methylguanine-DNA methyltransferase promoter (uMGMT). Patients with uMGMT ndGBM account for an estimated 55% to 60% of all ndGBM patients and they represent a biologically high-risk cohort with limited therapeutic options and poor expected outcomes with current standard-of-care approaches.

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In a prespecified subgroup analysis of patients in the Phase 2b trial with uMGMT tumors (n=48), patients in the IGV-001 arm had a median overall survival (mOS) of 14.8 months, a difference of 4.2 months, or 40%, compared to a mOS of 10.6 months in the placebo arm (HR 0.60, P=0.0808). Additionally, patients in the IGV-001 arm experienced delayed deterioration of Karnofsky Performance Status (KPS) score, favorable quality-of-life measures, lower rates of severe toxicities, and reduced burden of serious adverse events as compared to the placebo arm.

"Patients with uMGMT ndGBM have an urgent need for more effective treatment options. The magnitude and consistency of the treatment effect observed across survival, functional, and patient-reported outcome measures support continued investigation of IGV-001 in the uMGMT patient population," said J. Bradley Elder, M.D., Director, Neurosurgical Oncology, Professor, Department of Neurological Surgery at The Ohio State University Wexner Medical Center and the highest enrolling investigator in the Phase 2b trial.

Future Clinical Development of IGV-001

The Company met with the U.S. Food and Drug Administration (FDA) earlier this year to discuss the Phase 2b data and the regulatory pathway for IGV-001. Following this, the Company met with FDA in July to align on the key elements of a proposed randomized, open-label Phase 3 study of IGV-001 in approximately 375 uMGMT ndGBM patients in the United States. The planned primary endpoint of this study is overall survival (OS), and the study would include an interim analysis after a specified number of patient deaths. Imvax has incorporated the feedback from FDA into the proposed final protocol for the study, which it plans to submit to FDA in the coming months.

"With the FDA’s recent feedback, we will be finalizing the protocol for a Phase 3 study focused on patients with uMGMT ndGBM, a population that has lacked meaningful treatment innovation in decades and where we saw a clinically meaningful benefit in the Phase 2b study," said John P. Furey, Executive Chair of the Imvax Board of Directors. "We are also actively pursuing financing to support the initiation of this planned Phase 3 trial in 2027."

SNO 2026 presentation details

• Abstract title: "Initial efficacy and safety results of a randomized, double-blind, Phase 2b study to evaluate IGV-001, an autologous cell immunotherapy, plus standard of care (SOC) versus placebo (PBO) plus SOC in adult patients with newly diagnosed glioblastoma (ndGBM)"
• Presenting author: J. Bradley Elder, M.D., Director, Neurosurgical Oncology, Professor, Department of Neurological Surgery at The Ohio State University Wexner Medical Center
• Presentation type: Rapid oral and poster
• Abstract number: CTIM-05
• Location: Pennsylvania Convention Center, Philadelphia

About IGV-001 and Glioblastoma

IGV-001 is an investigational, autologous biologic-device combination product candidate derived from Imvax’s proprietary Goldspire immuno-oncology platform. The platform is designed to induce a patient-specific immune response against a broad range of tumor antigens. FDA has granted IGV-001 Fast Track designation and Orphan Drug Designation for the treatment of ndGBM. IGV-001 has not been approved by FDA or any other regulatory authority.

Glioblastoma is the most common aggressive malignant primary brain cancer in adults and has resisted meaningful treatment advances for decades. Approximately 14,000 people are diagnosed with glioblastoma each year in the United States. Current treatment generally consists of maximal safe resection followed by radiotherapy and temozolomide, with subsequent maintenance temozolomide. MGMT promoter methylation is a biomarker associated with benefit from temozolomide. Patients whose tumors have an unmethylated MGMT promoter generally derive limited benefit from temozolomide, experience shorter overall survival than patients with methylated tumors, and currently have no approved treatment specifically for uMGMT disease.

About the Phase 2b Trial

The Phase 2b trial (NCT04485949) was a randomized, multicenter, double-blind, placebo-controlled study evaluating the safety and efficacy of IGV-001 in 99 patients with ndGBM at 19 U.S. sites. Participants were randomized 2:1 to IGV-001 or placebo. The trial assessed progression-free survival, overall survival and safety. In the trial, patients in the IGV-001 arm had a median overall survival (mOS) of 20.3 months, a difference of 6.3 months, or 45%, compared to a mOS of 14.0 months in the placebo arm. The median follow-up time for all patients in the study was 22 months. In a prespecified subgroup analysis of patients in the Phase 2b trial with uMGMT tumors (n=48), patients in the IGV-001 arm had a median overall survival (mOS) of 14.8 months, a difference of 4.2 months, or 40%, compared to a mOS of 10.6 months in the placebo arm. There were no drug-related serious adverse events in the treatment arm, and the safety profile seen in the Phase 2b trial is favorable, consistent with that observed in a previous Phase 1b study (n=33).

(Press release, Imvax, SEP 15, 2026, View Source [SID1234670863])