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 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 Neogap Therapeutics AB, a Swedish biotechnology company developing personalised immunotherapy for cancer treatment, reported that initial safety data from the first patients in its ongoing phase I/II trial corroborates that the treatment is well tolerated (Press release, Neogap Therapeutics, MAR 20, 2025, View Source [SID1234651314]). No serious treatment-related adverse events have been observed, reinforcing confidence in the therapy’s safety profile.

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"Safety data from the first two treated patients confirm that Neogap’s immunotherapy is well tolerated and further strengthen our confidence in its potential as a valuable treatment option for patients with difficult-to-treat cancer. The trial is progressing as planned, and we continue to gather data to assess the safety profile and analyse clinical outcomes and biomarkers as part of the exploratory evaluation," says Samuel Svensson, CEO of Neogap Therapeutics.

The ongoing phase I/II trial is a first-in-human study designed to assess the safety and tolerability of Neogap’s personalised immunotherapy, pTTL (personalised Tumour Trained Lymphocytes), in patients with advanced colorectal cancer. Several patients have already been enrolled, with the first having completed treatment. Recruitment and treatment of additional patients continue. In total, 12–16 patients are planned to receive treatment. The study is being conducted at several hospitals in Sweden, including Karolinska University Hospital, Västmanland Hospital, and Danderyd Hospital.

About Neogap’s immunotherapy, pTTL
pTTL (personalised Tumour Trained Lymphocytes) is a cell-based immunotherapy that enhances the patient’s own T cells to fight cancer. The therapy combines advanced DNA analysis with T-cell expansion in a precision treatment for solid tumours. It is based on Neogap’s patented technologies, PIOR and EpiTCer. The goal is to provide patients with a tailored and innovative therapy that meets their specific needs.

On March 20, 2025 Autolus Therapeutics plc (Nasdaq: AUTL), a commercial-stage biopharmaceutical company developing, manufacturing and delivering next-generation programmed T cell therapies, reported its operational and financial results for the full year ended December 31, 2024 (Press release, Autolus, MAR 20, 2025, View Source [SID1234651313]).

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"Reflecting on 2024, it was a year of strong execution leading to significant achievements for Autolus, including our strategic deal with BioNTech and corresponding financing to bolster our balance sheet, commencing GMP operations at our in-house CAR T manufacturing facility, and finishing the year with our first FDA approval and the commercial launch of AUCATZYL," said Dr. Christian Itin, Chief Executive Officer of Autolus. "As a result, we were well positioned to attain our most important goal of bringing this transformative therapy to patients in need. Physician enthusiasm for AUCATZYL is high, demonstrated by the 33 treatment centers we now have fully authorized as of March 19, 2025. We’re encouraged by our launch progress to date."

"As we begin 2025, we have two key objectives: execute on the commercial launch of AUCATZYL in adult ALL both in the U.S. and entering new markets; and establish the next wave of investments to expand the obe-cel opportunity, advance our clinical pipeline and drive future growth. We look forward to discussing our plans to continue to expand our clinical pipeline and strategy at our R&D event in April."

Key updates and anticipated milestones:

AUCATZYL US launch
AUCATZYL was approved by the U.S. Food and Drug Administration (FDA) for the treatment of adult patients with relapsed or refractory B-cell acute lymphoblastic leukemia on November 8, 2024
AUCATZYL is the first CAR T therapy approved by the FDA with no requirement for a REMS (Risk Evaluation Mitigation Strategy) program
In December 2024, the National Comprehensive Cancer Network (NCCN) added AUCATZYL (obecabtagene autoleucel) to its Clinical Practice Guidelines in Oncology (NCCN Guidelines) for the treatment of adult patients with relapsed/refractory B-cell precursor acute lymphoblastic leukemia (r/r B-ALL)
The US commercial launch progresses on track, with 33 centers authorized as of March 19, 2025 (versus the Company’s initial target of 30 by the end of Q1 2025), covering approximately 60% of the target U.S. patient population
Patient access to AUCATZYL is progressing well, with coverage secured for greater than 85% of total U.S. medical lives
Autolus continues to expect to complete authorization of 60 treatment centers by the end of 2025, covering approximately 90% of the target patient population

Obe-cel in r/r adult B-ALL – The FELIX Study and regulatory updates
In December 2024, the New England Journal of Medicine published data from the pivotal Phase 1b/2 FELIX clinical trial of obecabtagene autoleucel (obe-cel) in relapsed/refractory (r/r) adult B-cell Acute Lymphoblastic Leukemia (ALL). The data from the trial demonstrate high rates of durable responses with low incidence of greater than Grade 3 immune-related toxicity
In February 2025, the FDA published a summary of the approval of AUCATZYL on JAMA Insights, citing the product’s complete remission rate
Obe-cel is under regulatory review in both the EU and the U.K., and the Company expects to receive notification of approval status from the Medicines and Healthcare products Regulatory Agency (MHRA) and European Medicines Agency (EMA) in H2 2025
Post period, Autolus submitted obe-cel for appraisal by the U.K. National Institute for Health and Care Excellence (NICE), and a decision is expected at the time of a potential MHRA approval
Autolus has presented updated data on obe-cel in adult ALL at the Society of Hematologic Oncology (SOHO) meeting in August 2024, the Lymphoma, Leukemia & Myeloma Congress in October 2024, the American Society of Hematology (ASH) (Free ASH Whitepaper) Meeting in December 2024, and post-period at TANDEM 2025. The data presented at these conferences builds on previously published obe-cel data, highlighting its tolerability and long-term responses. In addition, a health economic cost model has been presented, directly comparing the cost of serious adverse events across various comparable CAR-T cell therapies.
Abstracts were accepted at the European Society for Blood and Marrow Transplantation (EBMT) Annual Meeting being held in Florence, Italy, March 30 – April 2, 2025, and the British Society for Haematology Annual Meeting in Glasgow, UK, April 27-29, 2025. The abstracts include review of data on obe-cel in adult ALL and specifically, a sub analysis of patients 55 and older.

Obe-cel in B-cell mediated autoimmune diseases
The Phase 1 dose confirmation clinical trial (CARLYSLE) in refractory systemic lupus erythematosus (SLE) patients is ongoing, with all six patients dosed. Autolus will present the initial data from this trial and development plans at its R&D event being held on April 23, 2025, and is targeting H2 2025 for the presentation of full data with longer term patient follow-up.

Early-stage pipeline programs and collaborations
Clinical programs AUTO8 and AUTO6NG are progressing, and the Company is planning updates for programs at its R&D event which will be held on April 23, 2025.
BioNTech’s product option for AUTO1/22 was not exercised as a result of BioNTech’s pipeline prioritization, and has expired as of February 8, 2025.

Q4 2024 Operational Updates:

The FDA approval for AUCATZYL triggered a $30 million milestone payment to Autolus from Blackstone in accordance with the terms of the collaboration agreement between the parties. In addition, Autolus has made a £10 million regulatory milestone payment to UCL Business Ltd. in accordance with the license agreement between the parties
The Nucleus, Autolus’ proprietary CAR T manufacturing facility designed for 2,000+ batches ​
per year​, is now licensed by the FDA and MHRA to produce commercial supply.

On March 20, 2025 Alligator Bioscience (Nasdaq Stockholm: ATORX) reported that the U.S. Food and Drug Administration (FDA) has granted Orphan Drug Designation (ODD) to HLX22 (AC101), an anti-HER2 monoclonal antibody, for the treatment of gastric cancer (Press release, Alligator Bioscience, MAR 20, 2025, View Source [SID1234651312]). HLX22 is being developed by Shanghai Henlius Biotech, Inc. under a sublicense from AbClon, Inc., which had previously licensed the antibody from Alligator .
The FDA’s ODD provides incentives such as tax credits for clinical trials, waiver of certain regulatory fees, and market exclusivity upon approval, supporting the continued development of HLX22 as a potential treatment for HER2-positive metastatic gastric and gastroesophageal junction (GEJ) cancer.

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Henlius is conducting a Phase 3 clinical trial (HLX22-GC-301) to evaluate HLX22/AC101 in combination with trastuzumab and chemotherapy as a first-line treatment for HER2-positive metastatic gastric and GEJ cancer. The global study is enrolling patients across the U.S., China, Japan, and Australia.

Søren Bregenholt, CEO of Alligator, commented: "The FDA’s recognition of HLX22/AC101’s potential with Orphan Drug Designation is a notable recognition. While Alligator’s is not directly involved in the development of HLX22/AC101, we continue to follow its progress as it potentially represents future income to Alligator."
Under the terms of the license agreement, Alligator is entitled to 35% of AbClon’s revenue from its sublicense agreement with Henlius.