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])

On November 3, 2025 CytoDyn Inc. (OTCQB: CYDY) ("CytoDyn" or the "Company"), a clinical-stage oncology company advancing leronlimab, a first-in-class humanized monoclonal antibody targeting the CCR5 receptor with therapeutic potential across multiple indications, including triple-negative breast cancer (TNBC) and metastatic colorectal cancer (mCRC), reported that it has secured a $30 million funding commitment from Yorkville Advisors Global.

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Under the terms of the agreement, CytoDyn has the right to sell, and Yorkville has the obligation to purchase up to $30 million worth of CytoDyn’s common stock over the next 36 months. CytoDyn, at its sole discretion, will control the timing of all sales of common stock to Yorkville, and there are no warrants, derivatives, or other share classes associated with the funding arrangement. CytoDyn is not obligated to utilize any of the $30 million available, there are no minimum commitments or minimum use penalties, and the arrangement does not impose any restrictions on the Company’s operating activities.

"This funding commitment from Yorkville is a solid step in the right direction for CytoDyn," said Robert E. Hoffman, CFO of CytoDyn. "We will utilize this underlying commitment to further develop our program centered around the ability of leronlimab to upregulate PD-L1. This type of discretionary arrangement allows us continued flexibility as we look to bring in additional capital, whether it be through additional financings or strategic partnerships."

For more information on the funding commitment secured from Yorkville, including key terms and conditions of the agreement, please see CytoDyn’s filings with the Securities and Exchange Commission, including its Current Report on Form 8-K filed on November 3, 2025.

(Press release, CytoDyn, NOV 3, 2025, View Source [SID1234659252])

On November 3, 2025 NANOBIOTIX (Euronext: NANO – NASDAQ: NBTX – the "Company"), a late-clinical stage biotechnology company pioneering nanotherapeutic approaches to expand treatment possibilities for patients with cancer and other major diseases, reported that Company management will participate in fireside chats at following conferences:

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UBS Global Healthcare Conference
Date: Monday, November 10, 2025
Time: 5pm ET / 11pm CET
Location: Palm Beach Gardens, FL
Presenter: Bart van Rhijn, Chief Financial & Business Officer of Nanobiotix

Guggenheim’s Annual Healthcare Innovation Conference
Date: Monday, November 10, 2025
Time: 4:30pm ET / 10:30pm CET
Location: Boston, MA
Presenter: Laurent Levy, Chief Executive Officer of Nanobiotix
Webcast link: Click here

Stifel Healthcare Conference
Date: Thursday, November 13, 2025
Time: 8am ET / 2pm CET
Location: New York, NY
Presenters: Laurent Levy, Chief Executive Officer of Nanobiotix and Bart van Rhijn, Chief Financial & Business Officer of Nanobiotix

The recorded fireside chats will be webcast live from the events page of the Investors section of the Company’s website. Replay of the webcast will be available following the event.

(Press release, Nanobiotix, NOV 3, 2025, View Source [SID1234659268])

On November 3, 2025 Disc Medicine, Inc. (NASDAQ:IRON), a clinical-stage biopharmaceutical company focused on the discovery, development, and commercialization of novel treatments for patients suffering from serious hematologic diseases, reported two poster presentations, including initial data from the RALLY-MF Phase 2 trial of DISC-0974 in anemia of MF, at the upcoming American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting, which will be held in Orlando, FL on December 6-9, 2025.

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"The highlight of our ASH (Free ASH Whitepaper) presentations this year will be an initial look at data from RALLY-MF, our Phase 2 trial of DISC-0974 in anemia of myelofibrosis," said John Quisel, J.D., Ph.D., President and Chief Executive Officer of Disc Medicine. "Following the strong Phase 1b results we presented at ASH (Free ASH Whitepaper) last year, we are eager to share an update on this program, including results from more patients from across the range of MF anemia patients, as a monotherapy and in combination with JAK inhibitor backbone therapies, including ruxolitinib and momelotinib. We will also present a poster on the design of our ongoing Phase 2 trial of DISC-3405 in polycythemia vera. We expect to share an initial readout for this trial, as well as for the Phase 1b trial of DISC-3405 in sickle cell disease, in 2026."

Management will host a call during the ASH (Free ASH Whitepaper) meeting to review highlights of the presented data and plans for next steps in development on Sunday, December 7 at 7:30am EST. Please register for the event on the Events and Presentations page of Disc’s website (View Source).

Details of Poster Presentations:

The abstracts are now available through the ASH (Free ASH Whitepaper) conference website. Pursuant to Disc Medicine practice, the clinical study abstracts published today contain previously presented data; new data and analyses are reserved for presentation at the conference.

DISC-0974 Poster Presentation:

Publication Number: 2042
Title: RALLY MF: A phase 2 Study of DISC-0974, an anti-hemojuvelin antibody, in patients with myelofibrosis and anemia
Date / Time: Saturday, December 6, 5:30 pm – 7:30pm EST
Presenting Author: Naseema Gangat, M.B.B.S.

DISC-3405 Poster Presentation:

Publication Number: 2053
Title: A phase 2, open-label study of the safety, tolerability, pharmacokinetics, pharmacodynamics, and efficacy of DISC-3405 in participants with polycythemia vera (PV)
Date / Time: Saturday, December 6, 5:30 pm – 7:30pm EST
Presenting Author: Marcus Carden, M.D., M.Sc.

(Press release, Disc Medicine, NOV 3, 2025, View Sourcenews-releases/news-release-details/disc-medicine-announces-presentation-initial-data-rally-mf-phase [SID1234659286])

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])