On April 9, 2025 Halozyme Therapeutics, Inc. (NASDAQ: HALO) (Halozyme) reported that Janssen-Cilag International NV, a Johnson & Johnson company, received European Commission (EC) approval for an indication extension of DARZALEX (daratumumab) subcutaneous (SC) co-formulated with ENHANZE in the frontline setting (Press release, Halozyme, APR 9, 2025, View Source [SID1234651857]). The approval is for daratumumab SC in combination with bortezomib, lenalidomide, and dexamethasone (daratumumab-VRd) for the treatment of adult patients with newly diagnosed multiple myeloma.1

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"The continued expansion of DARZALEX delivered subcutaneously with ENHANZE into additional settings highlights its status as a cornerstone of therapy for multiple myeloma," said Dr. Helen Torley, President and CEO of Halozyme. "This approval means that newly diagnosed patients can receive daratumumab subcutaneous plus VRd and avoid the need for lengthy IV infusions."

This approval follows the indication extension approval for daratumumab-VRd in October 2024, for the treatment of newly diagnosed patients with multiple myeloma who are eligible for autologous stem cell transplant, based on the results from the Phase 3 PERSEUS (NCT03652064) study. The study evaluated this daratumumab SC-based quadruplet regimen for induction and consolidation therapy, followed by daratumumab SC and lenalidomide maintenance.2,3

1 European Medicines Agency. DARZALEX (daratumumab) Summary of Product Characteristics. April 2025.

2 Rodríguez-Otero P, et al. Daratumumab (DARA) + bortezomib/lenalidomide/dexamethasone (VRd) in transplant-eligible (TE) patients (pts) with newly diagnosed multiple myeloma (NDMM): Analysis of minimal residual disease (MRD) in the PERSEUS trial. 2024 American Society for Clinical Oncology Annual Meeting. June 3, 2024.

3 Johnson & Johnson Innovative Medicine EMEA. DARZALEX (daratumumab)-SC based quadruplet regimen approved by the European Commission for patients with newly diagnosed multiple myeloma who are transplant-eligible. Available at: View Source Last accessed: April 2025.

On April 9, 2025 Harbour BioMed (HKEX: 02142), a global biopharmaceutical company committed to the discovery and development of novel antibody therapeutics focusing on immunology and oncology, reported the appointment of Youchen (YC) Chen as Chief Financial Officer (Press release, Harbour BioMed, APR 9, 2025, View Source [SID1234651858]). YC will be based in Shanghai and Hong Kong SAR, and report directly to Dr. Jingsong Wang, Founder, Chairman, and CEO of Harbour BioMed.

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Since joining Harbour BioMed in 2023, YC has taken on increasing responsibilities across Investor Relations, Corporate Development, Business Development, and Finance. His strategic vision and collaborative leadership have significantly contributed to key strategic transactions, global partnerships and alliances, as well as global financial management and operations. In his new role, YC will continue to leverage his expertise to further enhance shareholder value and guide Harbour BioMed through its next phase of strategic development.

Before joining Harbour BioMed, YC served as Chief Financial Officer at a clinical-stage radiopharmaceutical startup. He was previously Vice President at Credit Suisse China Investment Banking and Capital Market team, advising healthcare and technology companies in Greater China on strategic and financing transactions. Prior to Credit Suisse, YC held multiple roles as Head of Corporate Finance at Yidu Tech (2158.HK) and Audit Assistant Manager at KPMG.

Dr. Jingsong Wang, Founder, Chairman, and CEO of Harbour BioMed, commented: "YC has brought a strong strategic mindset and deep financial expertise to Harbour BioMed. His ability to lead cross-functional initiatives and drive value creation has made a significant impact across the organization. I’m confident that in his new role as Chief Financial Officer, he will continue to strengthen our financial foundation and support our long-term growth."

Youchen Chen, Chief Financial Officer of Harbour BioMed, added: "I’m honored to take on the role of Chief Financial Officer at Harbour BioMed. It’s been a privilege to work alongside such a dedicated and visionary team. I look forward to continuing our efforts to advance the company’s strategic objectives, deliver value to our stakeholders, and support our mission of transforming innovation into impactful therapies."

YC holds a bachelor’s degree in law from Fudan University and an MBA from the McDonough School of Business at Georgetown University. He is also currently pursuing an advanced degree at Harvard Medical School.

On April 9, 2025 Engine Biosciences (Engine), a Singapore- and Silicon Valley-based biotechnology company pioneering precision medicine for cancer, reported a new partnership with the Experimental Drug Development Centre (EDDC), Singapore’s national platform for drug discovery and development hosted by the Agency for Science, Technology and Research (A*STAR) (Press release, Experimental Drug Development Centre, APR 9, 2025, View Source [SID1234654013]).

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This first-of-its-kind collaboration unites Engine’s NetMAPPR platform and proprietary oncology intellectual property with EDDC’s drug discovery and development expertise to create first-in-class precision cancer treatments.

The first project under this partnership focuses on ENB-871, a novel pairing of a drug target and patient selection biomarkers discovered through Engine’s NetMAPPR platform. This platform combines AI, computation, biology, and chemistry to identify, validate, and prioritise drug targets with strong clinical and commercial potential, driving the development of new therapies that exploit specific vulnerabilities in tumours.

This programme shows significant promise for treating tumours with particular genetic mutations that predict sensitivity to the ENB-871 targeted therapy, including breast, liver, kidney and prostate cancers – diseases afflicting large and growing patient populations in Singapore and worldwide. In total, the potential addressable population exceeds 500,000 patients per year.

The teams will collaborate to develop small molecule degraders targeting ENB-871, including demonstration of in vivo efficacy. By bringing together Engine’s proprietary technology and deep translational insights with EDDC’s strengths in designing and developing therapies, this partnership aims to create targeted cancer treatments tailored to patients’ specific profiles, improving treatment effectiveness and outcomes. Engine and EDDC may also identify additional drug targets and research programmes for collaboration during the partnership.

"We’re excited by the synergies created by bringing together our two platforms, leveraging first-in-class Singapore research and innovation to advance transformative cancer therapies. This marks another key step in Engine’s mission to develop more effective, targeted and safer drugs for cancer patients." said Jeffrey Lu, CEO and Co-Founder of Engine Biosciences.

"The future of drug development lies in precision-driven innovation. Our partnership with Engine enables us to develop therapies tailored to specific patient populations through Engine’s biomarker-driven patient selection approaches. We are particularly excited to launch our first collaborative project around monovalent small molecule degraders, building on EDDC’s expanding capabilities in this field. Beyond this, we look forward to strengthening our partnership by advancing more precision therapies that have the potential to transform the lives of cancer patients in need," shared Damian O’Connell, CEO of EDDC.

On April 9, 2025 TC BioPharm (Holdings) PLC ("TC BioPharm" or the "Company") (OTC: TCBPY) a clinical-stage biotechnology company developing platform allogeneic gamma-delta T cell therapies for cancer and other indications, reported receipt of a patent, granted from the European Patent Office (EPO), for targeting microbial, oncological, and viral indications using modified gamma delta T cells (Press release, TC Biopharm, APR 9, 2025, View Source [SID1234651859]).

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The Company intends to proceed with the patent process in specific European countries, in alignment with the existing commercial strategy.

"The expanding patent portfolio secures our future development of high-value assets," said Bryan Kobel, CEO of TC BioPharm. "The potential for off-target recognition of healthy tissues limits the application of modified cell therapies. By refining the targeting of these modified cells, we can apply high-impact therapies to a broad spectrum of indications while mitigating the toxicity risks associated with modified cell therapies."

On April 9, 2025 Diakonos Oncology, a clinical-stage biotechnology company developing innovative immunotherapies for difficult-to-treat cancers, reported the successful presentation of an abstract at the 2025 American Academy of Neurology (AAN) Annual Meeting, which took place April 5-9, 2025, in San Diego, California (Press release, Diakonos Oncology, APR 9, 2025, View Source [SID1234651860]). The abstract presentation, titled "Phase I Analysis of DOC1021, a Cell-Based Vaccination Platform for Adjuvant Therapy of Glioblastoma", featured promising data from an open-label Phase I trial evaluating the safety, immunogenicity, and early efficacy signals of DOC1021.

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"We were honored to present our latest research at the American Academy of Neurology Annual Meeting," said Jay Hartenbach, President and Chief Operating Officer of Diakonos Oncology. "Glioblastoma remains one of the most aggressive and challenging cancers to treat, and we are committed to advancing novel immunotherapy approaches that have the potential to make a meaningful impact for patients. The results of this Phase I analysis are highly encouraging and reinforce the potential of DOC1021 as a novel immunotherapy for glioblastoma."

Abstract Presentation Details:

Title: Phase I Analysis of DOC1021, a Cell-Based Vaccination Platform for Adjuvant Therapy of Glioblastoma
Authors: Zhu J-J, Esquenazi-Levy Y, Hsu S, Zvavanjanja RC, Vu M, Schumann EH, Trivedi A, Liu W, Namekar M, Hofferek CJ, Ernste K, Mossop C, Clay CM, Amin S, Ravi V, Kemnade JO, Aguilar LK, Turtz A, Tandon N, Konduri V, Georges JF, Decker WK
Session: S29 – Neuro-oncology
Date and Time: Tuesday, April 8, from 4:06-4:18 p.m. PT
Location: San Diego Convention Center, 25C
Key Highlights:

DOC1021 vaccines were administered to 16 newly diagnosed glioblastoma patients, with 94% (15/16) being MGMT unmethylated.
No adverse events greater than Grade 2 attributable to the investigational regimen and no dose-limiting toxicities (DLTs) were observed.
CD4+ (13/13) and CD8+ (11/13) central memory T-cell compartments expanded post-vaccination (p<0.002 and p<0.05, respectively), indicating robust immune activation.
CD8+CD127+ memory precursor effector cells (MPECs) expanded in 12/13 patients (p<0.001), suggesting enhanced immune memory potential.
Spatial transcriptomics analysis of three patients showed intense CD25+ foci overlapping effector memory T-cell and migratory microglial markers post-vaccination.
One-year overall survival (OS) rate in the 15/16 unmethylated cohort was 88%, compared to 53% in an age-matched control cohort (p<0.002), highlighting a potential survival benefit.
"In the Phase I trial, the dendritic vaccine injections at the lymph nodes were well tolerated, with no significant side effects observed in any participants," said Dr. Jay-Jiguang Zhu, Principal Investigator of the study and Professor and Director of Neuro-oncology at UTHealth Houston. "We are looking forward to assessing this dendritic cell-based vaccine therapy in the upcoming Phase II trial."

About DOC1021

DOC1021 is an autologous dendritic cell vaccine (DCV) that initiates a complete cytotoxic TH1 immune response against a patient’s cancer through the company’s proprietary double loading technology. The vaccines are made with a patient’s dendritic cells combined with mRNA and proteins prepared from freshly obtained patients’ tumor specimens.

This unique approach unlocks a synergistic tumor killing TH1 response driven by dual protein and RNA antigen sourcing, and it allows targeting of the complete cancer antigen pool. Moreover, the approach does not require any molecular modification of the patient’s immune cells for manufacturing, and does not require preconditioning of bone marrow or high dose IL-2 for administration.

In addition to the lead GBM study, a clinical trial of another Diakonos dendritic cell vaccine is ongoing for the treatment of pancreatic cancer. Diakonos has received Fast Track designations from the FDA for both the GBM and pancreatic cancer programs. The company has also received Orphan Drug Designation for the GBM program.