On November 3, 2025 CREATE Medicines, Inc. (formerly Myeloid Therapeutics), a clinical-stage biotech pioneering in vivo multi-immune programming, reported that clinical results from its Phase 1 MYE Symphony trial evaluating MT-302 have been accepted for a late-breaking oral presentation at the 40th Annual Meeting of the Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper) (SITC 2025) in National Harbor, Maryland (November 5 – 9, 2025).

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"The preliminary clinical results from our Phase 1 trial of MT-302 demonstrate that in vivo immune programming has the potential to overcome the fundamental limitations that have kept CAR therapies confined to blood cancers," said Matt Maurer, Chief Medical Officer of CREATE Medicines. "We believe this approach can create a new treatment paradigm for solid tumors, offering patients systemic, redosable therapies without the complexity and cost barriers of traditional cell therapy."

MT-302 is an investigational mRNA-LNP in vivo CAR therapy designed to elicit an adaptive immune response against solid tumors. Delivered systemically using CREATE’s mRNA-LNP platform, MT-302 programs the immune system to recognize and eliminate TROP2-expressing solid tumors by encoding a TROP2-specific chimeric antigen receptor to selectively reprogram myeloid cells. This approach eliminates the need for ex vivo manipulation or preconditioning, while enabling repeat dosing and tunable CAR expression for potent anti-tumor activity.

Additional details will be presented during the SITC (Free SITC Whitepaper) Annual Meeting and will be available on the SITC (Free SITC Whitepaper) website, View Source, following the embargo lift on November 7, 2025, at 9:00 a.m. ET.

Presentation Details:

Title: First-in-Human Dose Escalation Study to Investigate the Safety, Pharmacokinetics, Pharmacodynamics and Initial Efficacy of mRNA-LNP MT-302 In Vivo CAR Therapy in Solid Tumors
Presenting Author: Dr. Rasha Cosman, The Kinghorn Cancer Centre, St. Vincent’s Hospital, Darlinghurst, NSW, Australia
Category: Clinical Oral Abstract Session 1
Abstract Number: LBA 1342
Session Date & Time: Friday, November 7, 2025: 11:30 AM ET- 12:15 PM
Location: Gaylord National Resort & Convention Center, Potomac Ballroom, National Harbor, MD

(Press release, Create Medicines, NOV 3, 2025, View Source [SID1234659305])

On November 3, 2025 TuHURA Biosciences, Inc. (NASDAQ: HURA) ("TuHURA"), a Phase 3 immune-oncology company developing novel technologies to overcome resistance to cancer immunotherapy, reported that its research on the potential role of the Delta Opioid Receptor in controlling the immunosuppressive capabilities of MDSCs was accepted for an oral presentation at the 67th American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting and Exposition taking place in Orlando, FL from December 6-9, 2025. TuHURA will present these updated results along with a poster presentation of the effects of DOR inhibition on TAMs, another immunosuppressive cellular component critical to the tumorigenic microenvironment.

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"We are pleased to present evidence demonstrating the expression of the DOR on MDSCs and TAMs, both of which are important immune suppressing cellular components of the body’s immune system that provide the ability to regulate inflammation and autoimmunity," stated Dr. James Bianco, President and Chief Executive Officer of TuHURA Biosciences. "With our discovery of DOR expression, and that DOR activation is coupled to mechanisms by which both MDSCs and TAMs contribute to the immunosuppressive phenotype of the tumor microenvironment, we believe that the DOR represents a novel shared target for pharmacologic intervention to overcome resistance to cancer immunotherapies. TuHURA Biosciences is eager to leverage our discoveries around the DOR to develop highly potent and selective DOR inhibitors to create a new class of immune-modulating ADCs by linking a DOR inhibitor to our VISTA inhibiting antibody."

Oral Presentation Details:

Title: Delta Opioid Receptor (DOR) Expression on Myeloid-Derived Suppressor Cells (MDSCs) Represents a Novel Target to Overcome Resistance to Immune Checkpoint Inhibitors (ICIs)
Session: 201. Granulocytes, Monocytes, and Macrophages: New findings in neutropenia and myelopoiesis
Abstract Number: 14322
Presenter: Mike Turner, Ph.D. Vice President Immunology
Date and Time: December 7, 2025, from 5:15 – 5:30 PM ET
Location: W314 – OCC

Poster Presentation Details:

Title: Delta Opioid Receptor (DOR): A Novel Target for Reprogramming Tumor-Associated Macrophage (TAM) Immunosuppressive Phenotype to Overcome Acquired Resistance and Enhance the Effectiveness of Cancer Immunotherapies
Session: 201. Granulocytes, Monocytes, and Macrophages: Poster I
Abstract Number: 2568
Presenter: Krit Ritthipichai, D.V.M., Ph.D., Director of Immunology, TuHURA Biosciences
Date and Time: December 6, 2025, from 5:30 – 7:30 PM ET
Location: West Halls B3-B4 – OCCC

Additionally, The Moffitt Cancer Center, under its collaborative work with TuHURA, will present a poster outlining the pathogenic role of DOR expressing MDSCs in patients with myeloid dysplastic syndrome (MDS). Collectively, these three presentations at ASH (Free ASH Whitepaper) highlight the potential of DOR antagonism as a potential effective strategy warranting clinical investigation.

Title: Delta opioid receptor signaling modulates myeloid suppression in Myelodysplastic Syndromes
Session: 636. Myelodysplastic Syndromes: Basic and Translational: Poster II
Abstract Number: 15332
Presenter: Erika Eksioglu, M.D., Department of Immunology, Moffitt Cancer Center
Date and Time: December 7, 2025, from 6:00 – 8:00 PM ET
Location: West Halls B3-B4 – OCCC

(Press release, TuHURA Biosciences, NOV 3, 2025, View Source [SID1234659304])

On November 3, 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 option to surgical tumor removal, reported the publication of an independent study using IceCure’s Cryoablation System titled "Long-term outcomes of combination therapy with stereotactic body radiation therapy plus cryoablation using liquid nitrogen for stage I non-small cell lung cancer with tumors ≥2 cm" in the peer-reviewed journal PLOS One. The study was led by Dr. Hiroaki Nomori of the Department of Thoracic Surgery, Kashiwa Kousei General Hospital, Japan, along with researchers from Tokyo University Hospital, Kashiwa Kousei General Hospital, and Sonodakai Radiation Clinic, Tokyo.

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"While radiation therapy is the standard of care for inoperable stage I NSCLC patients, using SBRT alone unfortunately results in far lower overall survival and lower local control than surgery in certain patients. This study, which focused on people with relatively larger tumors, indicative of later stage disease, provides very encouraging results confirming that combining SBRT with our cryoablation system offers inoperable patients longer life expectancy and may also provide a minimally invasive option to surgery for the broader population of stage I NSCLC patients," stated IceCure’s Chief Executive Officer, Eyal Shamir. "The results of this study may be highly impactful in our major markets including the U.S. and Europe."

The objective of the independent retrospective observational study was to evaluate the effectiveness of combining SBRT with cryoablation for treating stage I NSCLC tumors ≥2 cm, given the limitations of local control and survival rates with SBRT monotherapy. 64 patients with tumors of mean diameter of 2.7 ± 0.5 cm and a range of 2.0–4.0 cm were treated with SBRT, followed by cryoablation. The median follow-up duration was 74 months, with a range of 3-111 months.

Results include the following:

5-Year Local Control Rate: 93%
5-Year OS Rate: 74% compared to published studies which reported 5-year OS rates of 41% – 52% after SBRT alone for stage I NSCLC, including tumors <2 cm; while surgery, the standard treatment for stage I (IA and IB) NSCLC, has a 5-year OS of 67% – 82% according to published studies
3-Year Disease-specific survival: 96%
5-Year Disease-specific survival: 92%
Treatment-Related Mortality: None
Most frequent complications post-cryoablation: pneumothorax, CTCAE grade 2, 40%
The results of this study align with prior findings from independent studies, including a prior study by Nomuri et al. which reported a recurrence-free rate of 67% – 100% in lung cancer patients treated with IceCure’s cryoablation system.

According to a study published in the CA: A Cancer Journal for Clinicians, the flagship journal of the American Cancer Society, lung cancer was the most frequently diagnosed cancer in 2022, responsible for almost 2.5 million new cases, or one in eight cancers worldwide (12.4% of all cancers) followed by breast cancer (11.6% of all cancers globally).

About ProSense

ProSense is a minimally invasive cryosurgical tool that provides the option to destroy tumors by freezing them. The system uniquely harnesses the power of liquid nitrogen to create large lethal zones for maximum efficacy in tumor destruction in benign and cancerous lesions, including in the breast, kidney, lung, and liver.

The ProSense Cryoablation System is the first and only medical device to receive FDA marketing authorization for the local treatment of early-stage, low-risk breast cancer with adjuvant endocrine therapy for women aged 70 and above, including patients who are not suitable for surgical alternatives for breast cancer treatment. A full list of benefits and risks can be found on our website.

ProSense enhances patient and provider value by accelerating recovery, reducing pain, surgical risks, and complications. With its easy, transportable design and liquid nitrogen utilization, ProSense opens the door to fast and convenient office-based procedures for breast tumors.

(Press release, IceCure Medical, NOV 3, 2025, View Source [SID1234659303])

On November 3, 2025 CARsgen Therapeutics Holdings Limited (Stock Code: 2171.HK), a company focused on developing innovative CAR T-cell therapies, reported clinical data for CT0596, an allogeneic BCMA-targeting CAR-T product candidate developed on its proprietary THANK-u Plus platform for relapsed/refractory multiple myeloma (R/R MM), and for CT1190B, an allogeneic CD19/CD20-targeting CAR-T product candidate for relapsed/refractory non-Hodgkin’s lymphoma (R/R NHL). The data showed that both allogeneic CAR-T products demonstrated initially favorable safety profiles and encouraging efficacy signals.

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Data for CT0596 in Relapsed/Refractory Multiple Myeloma

CT0596 is a BCMA-targeted allogeneic CAR-T cell therapy candidate developed based on CARsgen’s THANK-u Plus platform and is currently being evaluated in an investigator-initiated trial (IIT) for malignant plasma cell neoplasms. The study has now entered the dose expansion phase with a determined lymphodepletion regimen. Future work will involve dose escalation of the cells to further determine the Recommended Dose (RD).

As of June 24, 2025, the reported clinical trial (NCT06718270) had enrolled 8 R/R MM patients who received CT0596 infusion from the dose-escalation phase. The median number of prior lines of therapy was 4.5 (range: 3-9). Five patients had prior exposure to triple-class drugs (PI, IMiD, and anti-CD38 monoclonal antibody), and five patients had a history of autologous stem cell transplantation. CAR-T cell doses administered were 1.5e8 (n=1), 3e8 (n=5), and 4.5e8 (n=2).

All 8 infused patients were evaluable for efficacy, with a median follow-up time of 2.56 months (range: 0.9-5.9 months). For lymphodepletion, 6 patients received fludarabine (30 mg/m²) and cyclophosphamide (500 mg/m²), while 2 patients received a reduced lymphodepletion dose. Five patients achieved partial response (PR) or above: 3 achieved complete response / stringent complete response (CR/sCR) (all of whom had received the full dose of lymphodepletion), 1 achieved PR, and 1 achieved very good partial response (VGPR). Six patients achieved minimal residual disease (MRD)-negativity at Week 4. No patients got progression disease. Pat 01 has ongoing sCR and MRD negative for nearly 6 months. CAR-T cell expansion was observed in all 8 patients. No dose-limiting toxicities (DLT), treatment discontinuations, or deaths were observed. Four patients experienced Grade 1 cytokine release syndrome (CRS), all of which resolved within 2-10 days.

Previously, in October 2025, CARsgen announced preliminary clinical data for CT0596 in relapsed/refractory primary plasma cell leukemia (pPCL). Two heavily pretreated pPCL patients with high disease burden and rapid progression both achieved sCR after receiving CT0596 treatment.

Data for CT1190B in Relapsed/Refractory Non-Hodgkin’s Lymphoma

CT1190B is a CD19/CD20-targeted allogeneic CAR-T cell therapy candidate developed based on CARsgen’s THANK-u Plus platform and is currently being evaluated in multiple IITs for indications including R/R NHL.

As of October 17, 2025, this reported clinical trials (NCT07053670, NCT06734871) had enrolled 14 patients, including 3 with follicular lymphoma (FL), 3 with mantle cell lymphoma (MCL), and 8 with diffuse large B-cell lymphoma (DLBCL). The dose escalation study has been completed, preliminarily determining the recommended lymphodepletion regimen and cell dose.

At the lymphodepletion dose of Fludarabine 30mg/m²×3 days + Cyclophosphamide 500mg/m²×3 days, all three FL patients achieved CR. One of these FL patients had failed immunochemotherapy, a PI3K inhibitor, chemotherapy + autologous hematopoietic stem cell transplantation, and CD3/CD20 bispecific antibody therapy; another FL patient had failed immunochemotherapy + autologous hematopoietic stem cell transplantation and CD19 CAR-T therapy. The peak copy number of expansion in these three patients reached 10³-10⁴ copies/µg gDNA.

At the lymphodepletion dose of Fludarabine 30mg/m²×3 days + Cyclophosphamide 1000mg/m²×2 days (the recommended lymphodepletion dose), 8 patients were enrolled, including 2 MCL patients (cell dose 6e8) and 6 DLBCL patients (cell dose 3e8: 1 patient; 4.5e8: 1 patient; 6e8: 4 patients). The details are below:

Six patients were evaluable for efficacy, achieving an ORR of 83.3%, comprising 4 patients who achieved CR (2 MCL, 2 DLBCL) and 1 patient who achieved PR (DLBCL).
Focusing on the 6e8 cell dose, 6 patients were enrolled. Four of them were evaluable for efficacy, and 3 achieved a response, all of which were CR. The remaining 2 DLBCL patients had not reached the timepoint for efficacy assessment. A total of 6 patients received the full lymphodepletion and recommended cell dose, with a median Cmax reaching levels on the order of 10⁵ copies/ug gDNA.
The primary safety signals of CT1190B were CRS, cytopenia, and infections. Other adverse reactions, such as immune effector cell-associated neurologic syndrome (ICANS) and graft versus host disease (GVHD) were not observed.

About CT0596

CT0596 is an allogeneic BCMA-targeted CAR-T therapy developed using CARsgen’s proprietary THANK-u Plus platform. It is currently being evaluated in investigator-initiated trials for relapsed/refractory multiple myeloma (R/R MM) or plasma cell leukemia (PCL). CT0596 demonstrated preliminary favorable tolerability and encouraging efficacy signals. Further investigation is planned in additional plasma cell malignancies and autoimmune diseases mediated by autoreactive plasma cells. The company anticipates submitting an Investigational New Drug (IND) application in the second half of 2025.

About CT1190B

CT1190B is a CD19/CD20-targeted allogeneic CAR-T cell therapy developed based on CARsgen’s THANK-u Plus platform. Ongoing clinical trials include IITs for relapsed/refractory B-cell non-Hodgkin lymphoma (B-NHL), and for moderate-to-severe refractory systemic lupus erythematosus (SLE) or refractory/progressive systemic sclerosis (SSc).

(Press release, Carsgen Therapeutics, NOV 3, 2025, View Source [SID1234659302])

On November 3, 2025 Matica Biotechnology, Inc. ("Matica Bio"), a leading viral vector CDMO specializing in advanced therapies, reported a strategic partnership with Calidi Biotherapeutics, Inc. ("Calidi"), a clinical-stage immuno-oncology company developing next-generation oncolytic virus-based therapies. Under the agreement, Matica Bio will provide analytical development (AD), process development (PD), and GMP manufacturing to support the IND submission for CLD-401, the first lead from Calidi’s RedTail platform a groundbreaking approach to genetic medicines. CLD-401 is a tumor-tropic oncolytic virus designed to home to metastatic sites after systemic administration, replicate only in tumors cells, induce an immune priming event at the tumor site, and express high levels of IL-15 superagonist in the tumor microenvironment, a potent cytokine that induces NK and T-cell responses to the tumor.

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This collaboration reinforces Matica Bio’s growing reputation as one of the few CDMOs globally with proven, end-to-end capabilities, especially in oncolytic virus manufacturing. The company has successfully executed multiple oncolytic virus programs at its state-of-the-art, purpose-built GMP facility in College Station, Texas—designed specifically to support complex viral vector modalities.

"Matica Bio has become a sought-after partner especially in the oncolytic virus space because of our technical expertise, regulatory readiness, and track record of delivering seamless development-to-GMP manufacturing programs," said Paul Kim, CEO of Matica Bio. "We’re excited to work with Calidi on this breakthrough program and continue advancing next-gen cancer immunotherapies."

Calidi’s CLD-401 is part of its differentiated RedTail platform. RedTail utilizes an engineered form of extracellular enveloped vaccinia virus that is resistant to immune clearance, can be administered systemically with tropism for metastatic sites, and can deliver genetic medicine payloads to the tumor microenvironment. CLD-401 has potent oncolytic and immune priming effects and also specifically delivers IL-15 superagonist at high levels to the tumor microenvironment.

"Matica Bio stood out as the clear CDMO of choice for Calidi project due to their deep experience with viral vector and their ability to handle complex viral programs with precision," said Eric Poma, CEO of Calidi Biotherapeutics. "The team and facility give us full confidence as we prepare for IND filing and clinical advancement."

With an increasing number of biotechs developing virotherapies, the demand for CDMOs capable of managing these highly specialized programs is growing. Matica Bio’s flexible manufacturing model, integrated process and analytical development, and deep viral vector expertise—including AAV, LVV, and oncolytic viruses—make it a preferred partner for innovative CGT developers worldwide.

(Press release, Calidi Biotherapeutics, NOV 3, 2025, View Source [SID1234659301])