On May 15, 2025 SparX Biopharmaceutical Corp ("SparX"), a clinical-stage biotechnology company pioneering next-generation antibody-drug conjugate (ADC) technologies, reported the signing of a research agreement with Mitsubishi Tanabe Pharma America, Inc. (MTPA) (Press release, Sparx Therapeutics, MAY 15, 2025, View Source [SID1234653195]). This collaboration aims to advance an innovative ADC program: a conceptually novel immune cell target-based ADC.

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The research with MTPA will focus on an ADC against a first-in-class immune cell target, with the potential to serve as a universal tumor-targeting strategy across multiple cancer types.

"This collaboration marks significant milestone for SparX, reflecting the strength of our novel target discovery capabilities" said Gui-Dong Zhu, Ph.D., Founder and CEO of SparX Biopharmaceutical Corp. "We are excited to work alongside MTPA to bring transformative ADC therapies to patients worldwide."

On May 15, 2025 Immunofoco, a company dedicated to advancing cell therapies for solid tumors, reported that its independently developed, innovative lentiviral vector-based In Vivo CAR-T Technology Platform made a remarkable appearance at the 28th Annual Meeting of the American Society of Gene and Cell Therapy (ASGCT) (Free ASGCT Whitepaper) (Press release, Immunofoco, MAY 15, 2025, View Source;immunofocos-in-vivo-car-t-technology-platform-debuts-with-groundbreaking-innovations-302456246.html [SID1234653194]). This platform has broken the patent barriers in this field, achieving significant in-vitro and in-vivo specificity and efficacy, and providing a new strategy for tumor immunotherapy.

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Novel Lentiviral Vector: Overcoming Patent Barriers with Superior Performance

Immunofoco’s team developed a novel lentiviral vector pseudotyped with the MxV glycoprotein (MxV-G), demonstrating performance in generating CAR-T cells in vivo. Compared with the traditional VSV-G pseudotyped lentiviral vector, MxV-G pseudotyped vector not only enhances viral titer and transduction efficiency but also enables generated CAR-T cells to more effectively target and kill tumor cells. This novel envelope has good clinical application potential in both traditional ex vivo CAR-T and in vivo CAR-T.

AI-Driven Optimization: Successful Construction of Precision-Engineered Tropism-Modified Mutants

To eliminate the natural tropism of MxV-G and enhance its specificity, the team used an AI-driven protein model to successfully design and construct a mutant MxV-G. The mutated MxV-G eliminates the infectivity to non-T cells while retaining its membrane-fusion-mediating activity. By introducing different T-cell targeting modules, its infectivity to T cells is restored, achieving precise targeting and improving the safety and efficacy of treatment.

Next-Generation T-Cell Targeting Molecules: Upgrading Specificity and Anti-Tumor Activity

To target T cells precisely, the team engineered multiple T-cell-targeting molecules (TCM). TCM3 demonstrated selective T-cell transduction with no off-target effects and outperformed αCD3/CD80/CD58 (MDF) and αCD3/CD80 in efficiency when paired with different membrane fusion protein variants. CAR-T cells generated by MxV-G-TCM3 showed high specificity across cell lines and reduced T-cell exhaustion markers, supporting sustained activity and improved tumor control. In mouse models, this combination exhibited significantly stronger in vivo anti-tumor efficacy compared to αCD3/CD80/CD58.

Dr. Hao Ruidong, Partner and Head of the R & D Center at Immunofoco, said, "CAR-T cell therapy has revolutionized cancer treatment, yet its complex manufacturing and high costs limit accessibility. Our novel in vivo CAR-T platform, powered by lentiviral technology, breaks foreign patent barriers in fusion proteins and T-cell targeting while showing strong in-vitro and in-vivo specificity and efficacy. With simpler manufacturing and lower costs, we aim to make this life-saving treatment accessible to more patients. Moving forward, we’ll advance its clinical potential to maximize impact."

On May 15, 2025 Dizal (SSE:688192), a biopharmaceutical company committed to developing novel medicines for the treatment of cancer and immunological diseases, reported that the latest data from eight hematologic malignancy clinical trials will be presented at the 2025 European Hematology Association (EHA) (Free EHA Whitepaper) Congress and the 18th International Conference on Malignant Lymphoma (ICML) (Press release, Dizal Pharma, MAY 15, 2025, View Source [SID1234653193]). Notably, Dizal’s two investigational drugs in lymphoma—golidocitinib and DZD8586—have collectively secured three oral presentations at the upcoming American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting, EHA (Free EHA Whitepaper) Congress and ICML.

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"Golidocitinib and DZD8586 are core assets in our hematologic malignancy pipeline. Accumulating clinical data continue to validate their clinical benefits to patients and attracted community’s attention," said Xiaolin Zhang, PhD, CEO of Dizal.

A high proportion of PTCL patients who achieved tumor response with first-line standard therapy will relapse. Approximately 40% of patients with complete response (CR) and 80% with partial response (PR) experience disease progression within 2 years after initial tumor response. The prognosis of these relapsed patients is very poor. Currently, there is no standard maintenance therapy available.

The latest 2-year follow-up data from JACKPOT26, a prospective, multicenter Phase II study of golidocitinib, will be presented at both the upcoming EHA (Free EHA Whitepaper) Congress and ICML, where it has been selected for an oral presentation. This study explored golidocitinib as a maintenance therapy for peripheral T-cell lymphoma (PTCL) patients who achieved tumor response after first-line systemic therapy. The results showed that with more than 2 years follow-up, golidocitinib continued to demonstrate a promising effect on maintaining and enhancing tumor response in patients with PTCL post first-line therapies, with a manageable safety profile.

Initial positive results of Golidocitinib in combination with CHOP in 1st line PTCL patients will be reported during these meetings. In addition, Dizal will present results for golidocitinib in rare T-cell lymphoma subtypes, including relapsed/refractory T-cell large granular lymphocyte leukemia (r/r T-LGLL), monomorphic epitheliotropic intestinal T-cell lymphoma (MEITL).

Two studies of DZD8586 have been selected for presentation at ASCO (Free ASCO Whitepaper), EHA (Free EHA Whitepaper), and ICML. The safety and efficacy analysis of Phase I/II studies of DZD8586 in chronic lymphocytic leukemia/small lymphocytic lymphoma (CLL/SLL) patients with prior treatment using covalent and/or non-covalent BTK inhibitors and BTK degraders has been accepted for oral presentation at both ASCO (Free ASCO Whitepaper) and ICML. The study results showed DZD8586 exhibited significant anti-tumor activities with well-tolerated safety profile in these heavily pre-treated CLL/SLL patients.

Results of a Phase II study of DZD8586 as monotherapy in relapsed/refractory diffuse large B-cell lymphoma (r/r DLBCL) will be reported for the first time at the 2025 EHA (Free EHA Whitepaper) Congress. DZD8586 showed promising anti-tumor activity and a manageable safety profile.

Dizal presentation details during 2025 ICML、EHA：

Lead Author

Abstract Title

Presentation Details

Prof. Jie Jin

Maintenance Therapy of Golidocitinib, a
JAK1 Selective Inhibitor, in Patients with
Peripheral T Cell Lymphomas after First-
line Systemic Therapy: Updates of the
Phase 2 Study (JACKPOT26)

Abstract#167

ICML Oral Presentation

June 21, 2025, 10 :35 (CEST)

Abstract # PS1937

EHA Poster Session

June 14, 2025, 18 :30-19 :30 (CEST)

Prof. Jianyong Li

Phase 1/2 Studies of DZD8586 in
CLL/SLL Patients after Covalent or Non-
covalent BTK Inhibitors and BTK
Degraders

Abstract#146

ICML Oral Presentation

June 19, 2025, 17 :35 (CEST)

Abstract #PF570

EHA Poster Session

June 13, 2025, 18 :30-19 :30 (CEST)

Prof. Lugui Qiu

Phase 2 Study of DZD8586, a Non-
Covalent BBB Penetrant LYN/BTK Dual
Inhibitor, as Monotherapy in
Relapsed/Refractory Diffuse Large B-
Cell Lymphoma (r/r DLBCL) (TAI-SHAN9)

Abstract # PF962

EHA Poster Session

June 13, 2025, 18 :30-19 :30 (CEST)

Abstract #820

ICML Online Publication

June 15, 2025, 23 :59 (CEST)

Prof. Shuhua Yi

Golidocitinib Monotherapy in the
Treatment of Refractory/Relapsed
Indolent T/NK-Cell Lymphoma:
Preliminary Results from T-LGLL Cohort

Abstract # PF908

EHA Poster Session

June 13, 2025, 18 :00-19 :30 (CEST)

Abstract #750

ICML Online Publication

June 15, 2025, 23 :59 (CEST)

Prof. Wei Zhang

Golidocitinib Combined with CHOP in
Newly-Diagnosed Peripheral T-Cell
Lymphoma: Preliminary Results from a
Phase 1/2 Clinical Trial

Abstract # PB3228

EHA Online Publication

May 14, 2025, 15:30 (CEST)

Abstract #751

ICML Online Publication

June 15, 2025, 23 :59 (CEST)

Prof. Huiqiang Huang

Real-World Study of Golidocitinib for the
Treatment of Relapsed or Refractory
Peripheral T-Cell Lymphoma:
Retrospective Data from Medical Centers
in China

Abstract # PB3198

EHA Online Publication

May 14, 2025, 15:30 (CEST)

Abstract #756

ICML Online Publication

June 15, 2025, 23 :59 (CEST)

Prof. Wenyu Li

Golidocitinib Combination Therapy as
First-Line Treatment in PTCL:
Retrospective Data from a Single Centre

Abstract # PB3297

EHA Online Publication

May 14, 2025, 15 :30 (CEST)

Prof. Li Wang

Golidocitinib Combined with CHOP in
Treatment-Naïve Monomorphic
Epitheliotropic Intestinal T-Cell
Lymphoma: preliminary results from a
phase 2 multicenter, single-arm GOAL
study

Abstract # PB3256

EHA Online Publication

May 14, 2025, 15 :30 (CEST)

On May 15, 2025 The START Center for Cancer Research ("START"), the world’s largest early-phase community-based oncology site network, reported the dosing of the first U.S. participant in Moderna’s Phase 1 study evaluating mRNA-4106, a novel Pan-Tumor Antigen Therapy candidate, in patients with advanced or metastatic solid tumors (Press release, Moderna Therapeutics, MAY 15, 2025, View Source [SID1234653192]).

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The first dose was administered at START San Antonio by Dr. Amita Patnaik who shared, "mRNA represents a bold new frontier in cancer immunotherapy, and we’re proud to provide our patients access to this innovative treatment as part of a first-in-human trial. At START, our mission is to ensure that scientific breakthroughs translate into real-world options for patients—this study is a powerful example of that commitment."

The Phase 1 trial (ClinicalTrials.gov identifier: NCT06880549) will evaluate the safety, pharmacodynamics, immunogenicity and preliminary efficacy of mRNA-4106 administered alone and in combination with checkpoint inhibitor therapy. mRNA-4106’s multivalent approach aims to broaden treatment options for patients with cancer, advancing the field beyond single-targeted immunotherapies.

"This milestone reflects the core of who we are at START – accelerating the next generation of cancer therapies by bringing them directly to patients in the communities where they live," said Nick Slack, MBE, Chairman and CEO of START. "We’re proud to support Moderna in advancing this innovation into the clinic, reinforcing our commitment to faster, more accessible early phase trials that expand opportunity and impact for patients and sponsors alike."

"With mRNA-4106, we sought to design an inclusive therapy that encodes for antigens commonly shared across patients and tumor types. We are thrilled to be able to bring this medicine to trial participants, and in partnership with forward-thinking site networks like START, further showcase the promise of mRNA to transform cancer care," said Dr. Rose Loughlin, Executive Vice President of Research at Moderna.

START’s participation in this trial reinforces its leadership in accelerating access in transformative therapies, delivering on its mission of "Hope Through Access" for patients worldwide.

On May 15, 2025 RyboDyn, Inc., a biotechnology company pioneering first-in-class immunotherapies targeting the dark proteome, reported the expansion of its strategic collaboration with Moffitt Cancer Center, a global leader in cancer care and research (Press release, RyboDyn, MAY 15, 2025, View Source [SID1234653191]). The partnership aims to accelerate the development of immunotherapies targeting novel, cancer-specific proteins identified through RyboDyn’s proprietary sequencing and AI-driven target discovery platform, RyboCypher.

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Earlier this year, RyboDyn reported the identification of a cryptic class of proteins derived from overlooked RNA species—called Dark Targets. These novel antigens, invisible to standard detection methods, represent a new and largely untapped frontier for oncology drug development. Through its expanded collaboration with Moffitt, RyboDyn will validate the presence and therapeutic potential of these Dark Targets across a wide array of tumor types, leveraging Moffitt’s uniquely annotated tumor repository—one of the largest and most comprehensive in the world. "Moffitt’s tumor bank is a critical resource in validating novel targets across a diverse set of cancer patients," said Dr. Alex Jaeger, PhD, assistant member of the Molecular Oncology Department at Moffitt Cancer Center. "The ability to correlate molecular signals with deep clinical metadata significantly accelerates both discovery and translational development."

Initial studies from the collaboration have confirmed that select Dark Targets are consistently presented on tumors—but not in healthy tissues—de-risking this novel class of antigens and providing a path toward scalable, tumor-specific therapies. "The fact that our lead targets are consistently presented across patient samples—yet absent in healthy tissues, gives us high confidence in their relevance," said Corey Dambacher, PhD, President, CTO, and Co-founder of RyboDyn.

These data support RyboDyn’s core hypothesis: while not all Dark Targets are cancer-specific, a distinct subset is uniquely and consistently presented on tumor cells—making them highly compelling candidates for therapeutic development. "We’re not building a personalized medicine platform—we’re designing therapies that combine precision with broad reach," said Imad Ajjawi, PhD, MBA, CEO and Co-founder of RyboDyn. "By focusing on conserved targets with tumor-specific presentation, we’re unlocking new opportunities for scalable, off-the-shelf therapies in oncology."

"This collaboration reflects our shared commitment to advancing the next generation of cancer immunotherapies," said Dr. Jaeger. "By combining Moffitt’s clinical and translational expertise with RyboDyn’s novel discovery platform, we’re accelerating progress toward more precise and effective treatments."