On March 20, 2025 NANOBIOTIX (Euronext: NANO –– NASDAQ: NBTX – the ‘‘Company’’), a late-clinical stage biotechnology company pioneering nanoparticle-based therapeutic approaches to expand treatment possibilities for patients with cancer and other major diseases, reported poster presentations from two Phase 1 studies evaluating JNJ-1900 (NBTXR3) for patients with lung cancer (NSCLC) to be presented at the 2025 European Lung Cancer Conference ("ELCC") (Press release, Nanobiotix, MAR 20, 2025, View Source [SID1234651315]).

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ABSTRACT #207P: Phase 1 Study of Reirradiation ("ReRT") with NBTXR3 (JNJ-1900) for Inoperable Locoregional Recurrent Non-Small Cell Lung Cancer ("NSCLC")
Saumil J. Gandhi, MD, PhD,1 Enoch Chang, MD,1 Aileen Chen, MD,1 Stephen G. Chun, MD,1 Steven H. Lin, MD, PhD,1 Rachel C. Maguire, BS,1 Matthew S. Ning, MD, MPH,1 Julianna K. Bronk, MD, PhD,1 David Qian, MD,1 Joe Y. Chang, MD, PhD,1 James W. Welsh, MD,1 Zhongxing Liao, MD,1 Rahul A. Sheth, MD, 2, Roberto F. Casal, MD3

1Department of Thoracic Radiation Oncology, UT MD Anderson Cancer Center, 2Department of Interventional Radiology, UT MD Anderson Cancer Center, 3Department of Pulmonary Medicine, UT MD Anderson Cancer Center

ABSTRACT #255P: NBTXR3 (JNJ-1900) Activated by SBRT in Combination with Nivolumab or Pembrolizumab for the Treatment of Patients with Lung Metastases from NSCLC or Other Solid Tumors in the Phase 1 Trial Study 1100
Colette Shen1, Aditya Juloori2, William A Stokes3, Jason Akulian1, Jared Weiss1, Kedar Kirtane4, Laurent Mayrargue5, David Rolando5, Romain Gineste5, Omar I. Vivar5, George Q. Yang4, Jimmy Caudell4, Ammar Sukari6, Nabil F Saba3, Septimiu Murgu2, Ari Rosenberg2

1University of North Carolina School of Medicine, Chapel Hill, North Carolina, USA, 2The University of Chicago, Chicago, Illinois, USA, 3Winship Cancer Institute of Emory University, Atlanta, Georgia, USA, 4Moffitt Cancer Center, Tampa, Florida, USA, 5Nanobiotix, Paris, France, 6Karmanos Cancer Institute, Detroit, MI, USA

About JNJ-1900 (NBTXR3)

NBTXR3 is a novel, potentially first-in-class oncology product composed of functionalized hafnium oxide nanoparticles that is administered via one-time intratumoral injection and activated by radiotherapy. Its proof-of-concept was achieved in soft tissue sarcomas for which the product received a European CE mark in 2019. The product candidate’s physical mechanism of action (MoA) is designed to induce significant tumor cell death in the injected tumor when activated by radiotherapy, subsequently triggering adaptive immune response and long-term anti-cancer memory. Given the physical MoA, Nanobiotix believes that NBTXR3 could be scalable across any solid tumor that can be treated with radiotherapy and across any therapeutic combination, particularly immune checkpoint inhibitors.

Radiotherapy-activated NBTXR3 is being evaluated across multiple solid tumor indications as a single agent or in combination with anti-PD-1 immune checkpoint inhibitors, including in NANORAY-312—a global, randomized Phase 3 study in locally advanced head and neck squamous cell cancers. In February 2020, the United States Food and Drug Administration granted regulatory Fast Track designation for the investigation of NBTXR3 activated by radiation therapy, with or without cetuximab, for the treatment of patients with locally advanced HNSCC who are not eligible for platinum-based chemotherapy—the same population being evaluated in the Phase 3 study.

Given the Company’s focus areas, and balanced against the scalable potential of NBTXR3, Nanobiotix has engaged in a collaboration strategy to expand development of the product candidate in parallel with its priority development pathways. Pursuant to this strategy, in 2019 Nanobiotix entered into a broad, comprehensive clinical research collaboration with The University of Texas MD Anderson Cancer Center to sponsor several Phase 1 and Phase 2 studies evaluating NBTXR3 across tumor types and therapeutic combinations. In 2023, Nanobiotix announced a license agreement for the global co-development and commercialization of NBTXR3 with Janssen Pharmaceutica NV, a Johnson & Johnson company.

On March 20, 2025 IceCure Medical Ltd. (Nasdaq: ICCM) ("IceCure", "IceCure Medical" or the "Company"), developer of minimally-invasive cryoablation technology that destroys tumors by freezing as an alternative to surgical tumor removal, reported it is in continued discussions with the U.S. Food and Drug Administration ("FDA") regarding its De Novo marketing authorization request for ProSense in early-stage low risk breast cancer with endocrine therapy (Press release, IceCure Medical, MAR 20, 2025, View Source [SID1234651331]). The Company now expects the FDA’s marketing authorization decision to be reached after the first quarter of 2025.

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"Given the novelty of our product and the importance of breast cancer in public health, the FDA has included many stakeholders in the discussion of the De Novo marketing clearance for ProSense for the treatment of early-stage, low-risk breast cancer with endocrine therapy" stated IceCure’s Chief Executive Officer, Eyal Shamir.

"We appreciate the attention of many at the FDA despite the evolving situation at the agency as we work productively together towards a decision on marketing authorization," Shamir added.

Due to the public health importance of breast cancer, the FDA convened a Medical Device Advisory Committee Panel ("Advisory Panel") in November 2024 to obtain independent non-binding expert advice on scientific, technical and policy matters related to the potential granting of marketing authorization of ProSense for treating patients with early-stage low risk breast cancer with endocrine therapy. The Advisory Panel, which included breast surgeons, interventional radiologists, breast oncologists, and representatives from the patient, consumer, and regulatory communities, voted in favor of ProSense’s benefit-risk profile in early-stage low risk breast cancer.

On March 20, 2025 SELLAS Life Sciences Group, Inc. (NASDAQ: SLS) ("SELLAS’’ or the "Company"), a late-stage clinical biopharmaceutical company focused on the development of novel therapies for a broad range of cancer indications, reported financial results for the full year ended December 31, 2024, and provided a corporate update (Press release, Sellas Life Sciences, MAR 20, 2025, View Source [SID1234651316]).

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"We are pleased with the progress of our pipeline as we continue to advance our two key assets through clinical development," said Angelos Stergiou, MD, ScD h.c., President and Chief Executive Officer of SELLAS. "The most anticipated milestones in 2025 will be the final analysis of our Phase 3 pivotal REGAL trial of GPS in acute myeloid leukemia (AML) and the full topline Phase 2 data of SLS009 in AML, both of which represent significant opportunities and offer hope to AML patients in need. If successful, the REGAL trial provides a pathway for regulatory approval in AML, and GPS could become a transformative treatment for patients in their second complete remission. Furthermore, the promising data from the ongoing Phase 2 trial of SLS009 has shown a 56% overall response rate (ORR) in AML patients with myelodysplasia-related changes (AML MRC) prospectively enrolled in two expansion cohorts, exceeding the prespecified target ORR of 33%. In the optimal dosing regimen of 30 mg BIW, the median overall survival (mOS) has not been reached but exceeds 7.7 months at the latest follow-up, where the expected mOS is historically approximately 2.5 months."

Dr. Stergiou continued, "We are especially encouraged by the multiple regulatory designations granted to our programs in 2024, including three FDA Rare Pediatric Disease Designations, one FDA Fast Track Designation, and two EMA Orphan Drug Designations, which reflect the significant potential impact of our therapies and provide valuable regulatory benefits that may accelerate development and potential approval. With strong regulatory recognition and two potentially pivotal inflection points ahead, we remain committed to driving innovation and delivering value to patients and shareholders."

On March 20, 2025 MAIA Biotechnology, Inc., (NYSE American: MAIA) ("MAIA", the "Company"), a clinical-stage biopharmaceutical company developing targeted immunotherapies for cancer, reported the publication of preclinical data for its lead proprietary telomere-targeting THIO dimer in the peer-reviewed scientific journal Naunyn-Schmiedeberg’s Archives of Pharmacology (Press release, MAIA Biotechnology, MAR 20, 2025, View Source [SID1234651332]).

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In a preclinical study, THIO and its new described dimer form were found to be potent inhibitors of Glutathione S-transferase Pi (GSTP1), a key enzyme implicated in cancer progression and chemoresistance and a highly important factor for the detoxification of cancer cells. The findings suggest that the dimerized form of THIO could enhance chemotherapeutic efficacy by effectively targeting GSTP1 and reducing drug resistance. The article, titled "Investigation of the inhibitory effects of the telomere-targeted compounds on glutathione S-transferase P1," was published on February 15, 2025.

"The esteemed Archives of Pharmacology has published our first peer-reviewed paper about the unique potential of the lead molecule in our second-generation THIO program," said Vlad Vitoc, M.D., CEO of MAIA. "Preclinical findings illuminate the superior GSTP1 binding affinity and inhibitory potency of this novel prodrug and support continued development of this new strategy for cancer therapy."

MAIA’s second generation research and discovery platform seeks to identify new telomere-targeting THIO-like compounds with potentially improved specificity towards cancer cells relative to normal cells and with potentially increased anticancer activity. More than 80 THIO-like compounds have been developed as part of the second-generation telomere targeting program.

"Our manuscript highlights the potential of THIO’s dimer as a potent GSTP1 inhibitor and a promising new strategy for enhancing cancer treatment and overcoming drug resistance," said Chief Scientific Officer Sergei Gryaznov, Ph.D. "Further exploration of the combinatorial effects of THIO with standard chemotherapeutic agents could provide valuable insights for optimizing standard cancer treatment protocols. These efforts could pave the way for novel, targeted strategies in cancer therapy, offering new hope in the fight against drug-resistant cancers."

About Naunyn–Schmiedeberg’s Archives of Pharmacology

Naunyn–Schmiedeberg’s Archives of Pharmacology, founded in 1873, is the oldest existing pharmacological journal and a dedicated platform for new and significant information on drug action and toxicity of chemical compounds. The peer-reviewed scientific journal covers all fields of experimental and clinical pharmacology as well as toxicology and includes studies in neuropharmacology and cardiovascular pharmacology and those describing drug actions at the cellular, biochemical and molecular levels.

About Ateganosine

Ateganosine (THIO, 6-thio-dG or 6-thio-2’-deoxyguanosine) is a first-in-class investigational telomere-targeting agent currently in clinical development to evaluate its activity in Non-Small Cell Lung Cancer (NSCLC). Telomeres, along with the enzyme telomerase, play a fundamental role in the survival of cancer cells and their resistance to current therapies. The modified nucleotide 6-thio-2’-deoxyguanosine induces telomerase-dependent telomeric DNA modification, DNA damage responses, and selective cancer cell death. Ateganosine-damaged telomeric fragments accumulate in cytosolic micronuclei and activates both innate (cGAS/STING) and adaptive (T-cell) immune responses. The sequential treatment with ateganosine followed by PD-(L)1 inhibitors resulted in profound and persistent tumor regression in advanced, in vivo cancer models by induction of cancer type–specific immune memory. Ateganosine is presently developed as a second or later line of treatment for NSCLC for patients that have progressed beyond the standard-of-care regimen of existing checkpoint inhibitors.

On March 20, 2025 Wugen, Inc., a clinical-stage U.S. biotechnology company developing allogeneic, off-the-shelf cell therapies for the treatment of hematological and solid tumor malignancies, reported the dosing of the first patients in its pivotal Phase 2 study evaluating WU-CART-007, a potential first-in-class, investigational, anti-CD7 CAR-T cell therapy for pediatric and adult patients with relapsed or refractory (R/R) T cell acute lymphoblastic leukemia or T cell lymphoblastic lymphoma (T-ALL/LBL) (Press release, Wugen, MAR 20, 2025, View Source [SID1234651317]).

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"The data we have previously reported from our Phase 1/2 study on the WU-CART-007 program has paved the way for the initiation of this pivotal study, and suggests it has the potential to set a new standard of care for relapsed or refractory T-ALL/LBL," said Kumar Srinivasan, Ph.D., M.B.A., president and chief executive officer of Wugen. "The program has earned multiple U.S. Food and Drug Administration accelerated approval pathway designations, including RMAT, Fast Track, Orphan Drug, and Rare Pediatric Disease, as well as Priority Medicines designation in the EU. With this pivotal study now underway, we are advancing toward a much-needed off-the-shelf CAR-T option for patients who face historically poor outcomes and limited treatment alternatives."

Wugen previously announced positive results from a Phase 1/2 cohort expansion study showing clinically manageable safety and evidence of anti-leukemic activity (overall response rate of 91%; composite complete remission rate of 73%) in heavily pretreated patients with R/R T-ALL/LBL. Results were presented at both the American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting (ASH) (Free ASH Whitepaper) in December of 2024 and the European Hematology Association (EHA) (Free EHA Whitepaper) 2024 Hybrid Congress in June of 2024.

"It’s been 20 years since a new medicine was approved for patients with relapsed or refractory T-ALL/LBL, which remain challenging hematologic malignancies with limited treatment options in the relapsed or refractory setting," said Cherry Thomas, M.D., chief medical officer of Wugen. "WU-CART-007 has shown clinical response and manageable safety, making it a promising off-the-shelf cell therapy candidate to fill a longstanding treatment gap. The enthusiasm around the program and the need for new treatments have been reflected in the study recruitment thus far, as it is enrolling faster than anticipated."

Pivotal Study Design

The pivotal study entitled, "A Phase 2 Study of WU-CART-007, an Anti-CD7 Allogeneic CAR-T Cell Therapy in Patients with Relapsed or Refractory T-Cell Acute Lymphoblastic Leukemia and Lymphoblastic Lymphoma", (T-RRex) is a single arm trial evaluating the efficacy and safety of WU-CART-007 in patients with R/R T-ALL/LBL and T-ALL/LBL. The study will involve two groups: a R/R cohort and subsequently an exploratory minimal residual disease (MRD)-positive cohort.

About WU-CART-007

WU-CART-007 is an allogeneic, off-the-shelf, fratricide-resistant CD7-targeted CAR-T cell therapy engineered to overcome the technological challenges of harnessing CAR-T cells to treat CD7+ hematological malignancies. Wugen is deploying CRISPR/Cas9 gene editing technology to delete CD7 and the T cell receptor alpha constant (TRAC), preventing CAR-T cell fratricide and mitigating the risk of graft-versus-host-disease (GvHD). WU-CART-007 is manufactured using healthy donor-derived T cells to eliminate the risk of malignant cell contamination historically observed in the autologous CAR-T setting. WU-CART-007 is currently being evaluated in a global Phase 1/2 clinical trial for the treatment of relapsed or refractory (R/R) T cell acute lymphoblastic leukemia (T-ALL)/lymphoblastic lymphoma (LBL). More information on the Phase 1/2 trial is available on clinicaltrials.gov, identifier NCT# 04984356 and on the Phase 2 pivotal trial on clinicaltrials.gov, identifier NCT06514794.

WU-CART-007 has received Regenerative Medicine Advanced Therapy (RMAT), Fast Track, Orphan Drug, and Rare Pediatric Disease designations from the U.S. Food and Drug Administration and Priority Medicines (PRIME) Scheme designation in the European Union for the treatment of relapsed/refractory (R/R) T cell acute lymphoblastic leukemia (T-ALL) and T cell lymphoblastic lymphoma (T-LBL). RMAT and PRIME designations provide increased agency support to expedite the development and review of promising therapies for patients in need.