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Antengene Announces Receipt of USD 60 Million Upfront Payment from UCB

On July 13, 2026 Antengene Corporation Limited ("Antengene", SEHK: 6996.HK), a leading innovative, commercial-stage global biotech company dedicated to discovering, developing and commercializing first-in-class and/or best-in-class medicines for autoimmune diseases, solid tumors and hematological malignancies, reported that the company has received a USD 60 million upfront payment from UCB. This payment is made pursuant to the worldwide exclusive license agreement for ATG-201, a CD19/CD3 bispecific T-cell engager (TCE) antibody, entered into between the parties in March 2026.

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ATG-201 is a CD19 targeting bispecific TCE incorporating steric hindrance masking technology, designed to eliminate CD19-expressing B cells. This bispecific interaction with T and B cells through CD3 and CD19 has demonstrated potential in treating B cell-driven diseases by leveraging the body’s own immune system for precise and potent action.

Under the agreement, Antengene grants UCB a worldwide exclusive license to further develop, manufacture, and commercialize ATG-201, along with access to its associated manufacturing technology.

China’s National Medical Products Administration (NMPA) approved in June this year the Investigational New Drug (IND) application for the Phase I ATTRACT study of ATG-201 for the treatment of B cell related autoimmune diseases. Antengene is progressing the Phase I study of ATG-201 in China and concurrently preparing for its clinical development in Australia.

The receipt of the upfront payment from this license agreement with UCB has further strengthened Antengene’s cash position, providing robust financial support for the advancement of our innovative drug pipeline and accelerating benefits to more patients.

Under the terms of the global exclusive license agreement Antengene is eligible for additional near-term milestone payments of USD 20 million subject to certain conditions. The agreement also includes the potential for future success-based development and commercial milestone payments, as well as tiered royalties on future net sales.

(Press release, Antengene, JUL 13, 2026, View Source [SID1234669160])

Immutep Provides Clinical Update in 1st line NSCLC: Positive Mature Overall Survival Data from INSIGHT-003 and Update from TACTI-004

On July 13, 2026 Immutep Limited (ASX: IMM; NASDAQ: IMMP) ("Immutep" or "the Company"), a biotechnology company developing novel immunotherapies, reported a significant positive update of the investigator-initiated INSIGHT-003 Phase I trial evaluating eftilagimod alfa (efti) in combination with MSD’s (Merck & Co. Inc., Rahway, NJ, USA) anti-PD-1 therapy KEYTRUDA (pembrolizumab) and chemotherapy as 1 st line therapy for advanced/metastatic non-small cell lung cancer (1L NSCLC) in 51 evaluable non-squamous patients.

Key Results from INSIGHT-003 – Data Cutoff – 27 March 2026

Approximately 92% of patients enrolled in INSIGHT-003 had no or low PD-L1 expression (Tumour Proportion Score: TPS <50%), representing a population with significant unmet medical need. With a minimum of 30 months of follow-up, median Overall Survival (mOS) was 30.9 months in the overall population regardless of PD-L1 expression (N=51), with the same mOS observed in patients with TPS <50% (N=47) and 37.8 months in TPS>=50% (N=4).

These mature results continue to compare favourably to the 22.0 month mOS from a registrational trial of anti-PD-1 and doublet chemotherapy in non-squamous 1L NSCLC regardless of PD-L1 expression. 1 Notably, patients with TPS <50%, for whom PD-L1 inhibitor-based therapies typically perform suboptimally, were overrepresented in INSIGHT-003 compared with historical benchmarks (~92% versus ~68%1 ). No new safety signal was identified since the previous data cut-off.

Update on TACTI-004 Root Cause Analysis

In March 2026, following a planned interim futility analysis, Immutep announced that it would discontinue the TACTI-004 Phase III trial in 1st line NSCLC based on a recommendation from the Independent Data Monitoring Committee (IDMC). In the TACTI-004 futility analysis (N=173), the objective response rate (ORR) in the overall patient population receiving standard of care plus efti ("efti arm") was 42.9% compared with 55.1% in patients receiving standard of care plus placebo ("control arm"). The difference was observed across both squamous and non-squamous histologies, and the efti arm did not demonstrate superiority in any TPS subgroup. By comparison, the ORR in INSIGHT-003 has been 62.7%, despite the high proportion of patients with TPS <50%. Pending a final analysis of all patients, to date no new safety signals have been observed in TACTI-004

Preliminary immune monitoring data generated from TACTI-004 indicate that patients treated with efti exhibited a markedly different immune activation profile compared with that observed in previous studies. This assessment is based on analyses of absolute lymphocyte counts (ALC) and circulating monocyte counts in blood. In particular, these findings contrast with observations from almost 600 patients treated with efti in five earlier studies (AIPAC, AIPAC-003, TACTI-mel, TACTI002 and TACTI-003), which were presented at ASCO (Free ASCO Whitepaper) 20262 , and also contrast with observations from INSIGHT-003.

The TACTI-004 analysis, which includes all recruited and evaluable patients who received a minimum of 12 weeks of treatment, remains ongoing, with additional results expected in Q3 CY2026. The Company will continue to analyse this data as part of its ongoing root cause analysis of a range of potential factors, including manufacturing, and will share the outcome of that analysis as soon as it becomes available. Immutep is being assisted in this process by its partners, including Dr. Reddy’s and WuXi Biologics.

Marc Voigt, CEO of Immutep, said: "We are encouraged by the mature overall survival data from INSIGHT-003 in 1 st line non-squamous NSCLC, which continue to compare favourably with historical benchmarks, particularly given the high proportion of patients in this study with no or low PD-L1 expression. The observed median overall survival of 30.9 months especially in patients with no or low PD-L1 expression reinforces our confidence in efti’s potential to enhance anti-tumour immune responses, including in patient populations that have historically experienced less favourable outcomes.

At the same time, we are completing a comprehensive root cause analysis of TACTI-004 to better understand the factors underlying the outcome of that trial and their implications for the potential future development of efti. Importantly, the differences observed in the immune activation profile between TACTI-004 and prior studies are providing valuable insights to inform our strategy as we evaluate efti’s potential path forward."

Additional results from the root cause analysis related to TACTI-004 are expected in Q3 CY2026.

About Eftilagimod Alfa (Efti)

Efti is a novel immunotherapy that directly activates antigen-presenting cells or APCs (e.g. dendritic cells, monocytes) via the MHC Class II pathway to fight cancer. As an MHC Class II agonist, its activation of APCs engages the adaptive and innate immune system to initiate a broad anti-cancer immune response. This includes priming and activating cytotoxic T cells as well as generating important co-stimulatory signals and cytokines that further boost the immune system’s ability to combat cancer.

Efti is under evaluation for a variety of solid tumours including non-small cell lung cancer (NSCLC), head and neck squamous cell carcinoma (HNSCC), soft tissue sarcoma, and breast cancer. Its favourable safety profile has enabled various combinations including with anti-PD-[L]1 immunotherapy, radiotherapy, and/or chemotherapy. Efti has received Fast Track designation in 1st line HNSCC and in 1st line NSCLC from the United States Food and Drug Administration (FDA).

(Press release, Immutep, JUL 13, 2026, View Source;v=undefined [SID1234669159])

A New Approach to Treating Brain Cancer: HDT Bio Launches Canadian Clinical Program at McGill University

On July 12, 2026 HDT Bio Corp. reported the establishment of HDT Bio Canada Inc., its Canadian subsidiary, formed to advance its cancer immunotherapy programs through Canadian clinical development, Canadian manufacturing, and Canadian regulatory pathways. The company has partnered with McGill University and The Neuro (Montreal Neurological Institute-Hospital) for the clinical development of HDT-401, its investigational locally administered immune activator for glioblastoma.

HDT-401 has already been administered to glioblastoma patients under compassionate use protocols. The results were encouraging enough to inform and shape the design of a formal Phase 1 clinical trial. HDT Bio Canada has completed a pre-Clinical Trial Application meeting with Health Canada, a required regulatory step on the path to trial initiation and has received constructive feedback that advances the program toward CTA submission.

The planned Phase 1 study will be conducted in collaboration with Roberto Diaz, MD, PhD of The Neuro of McGill University at, along with clinical and scientific experts across McGill-affiliated institutions in Montreal. "When you operate on these patients, you understand the problem in a way that is difficult to convey. You resect what you can. You know what remains. And you know the current tools are not enough," said Dr. Diaz. "This program is about changing that."

HDT-401 combines Riboxxim, a precisely engineered molecule licensed from Riboxx GmbH of Dresden, Germany, with HDT Bio’s proprietary LION nucleic acid delivery platform. The LION platform has been evaluated in more than 6,000 patients across multiple clinical programs, providing an extensive foundation of clinical experience.

"Glioblastoma patients have waited decades for something new," said Steven Reed, PhD, Chief Executive Officer of HDT Bio Corp. "We have treated patients with HDT-401 under compassionate use. What we observed was encouraging. That is why we are moving as fast as we can to get this into a formal trial in Canada, with one of the world’s great brain cancer research teams. Our commitment to Canada is significant. We are developing products here, working through Canadian regulatory pathways, and supporting Canadian manufacturing capability. Canadian patients and Canadian science are at the center of this program."

HDT-401 is designed to activate innate immune sensing directly within the tumor bed, converting the glioblastoma microenvironment from immune-suppressed to immune-engaged. The approach is intended to induce inflammatory cytokines, recruit immune effector cells, and support local immune recognition of tumor tissue. Local administration into the tumor or surgical cavity concentrates immune activation at the site of disease while limiting systemic exposure.

"Riboxxim was engineered to solve a problem that earlier TLR3 agonist technologies have never fully addressed: precise, reproducible immune activation without the unpredictability that limited clinical developments and market access. HDT Bio’s approach of delivering Riboxxim is scientifically compelling because it concentrates immune activation exactly where it is needed most," said Prof. Dr. Jacques Rohayem, CEO of Riboxx and the inventor of Riboxxim. "The formulation expertise at HDT Bio has contributed an important step in enabling Riboxxim to become a product that can have a major impact on the treatment of glioblastoma and other cancers. I am pleased to see it advancing to the clinic."

"Glioblastoma remains one of the most difficult cancers to treat because recurrence is common and the tumor environment actively suppresses immune activity," said Roberto Diaz, MD, PhD of McGill University. "These are real patients with no good options. The tumor’s ability to suppress immune activity locally is one of the central reasons it has resisted every treatment we have thrown at it. An approach that targets that immunosuppressive environment directly, at the tumor bed, is where the science points. That is why I am committed to this program."

HDT Bio is also advancing a breast cancer vaccine program in Canada, reflecting the company’s broader commitment to Canadian patients and Canadian clinical infrastructure. For that program, the company has engaged Northern RNA Inc. of Calgary as its Canadian GMP manufacturing partner. Northern RNA is a world-class nucleic acid contract manufacturer.

"This is exactly the kind of program Northern RNA was built to support," said Jared Davis, President and CEO of Northern RNA Inc. "Canadian patients with glioblastoma deserve access to the most innovative treatments being developed anywhere in the world. Manufacturing in Canada, for Canadian patients, with a Canadian clinical partner, is how we help make that happen. We are proud to be part of HDT Bio’s Canadian commitment."

About Glioblastoma Glioblastoma is the most common and aggressive primary malignant brain tumor in adults. The five-year survival rate is below 5 percent. Standard treatment includes maximal safe surgical resection, radiation therapy, and temozolomide chemotherapy, but recurrence is common and survival remains limited. No approved immunotherapy has demonstrated a survival benefit in glioblastoma to date. Despite its devastating prognosis, glioblastoma receives significantly less research funding than other cancers of comparable lethality, leaving patients with few meaningful treatment advances and an urgent need for innovative clinical approaches. The glioblastoma treatment market exceeds $3 billion annually and is projected to reach $4.46 billion by 2030, underscoring both the scale of the disease burden and the commercial opportunity for effective new therapies.

About HDT-401 HDT-401 is an investigational immune activator designed for local administration into the tumor or surgical cavity. It combines Riboxxim, a precisely engineered TLR3/RIG-I agonist licensed from Riboxx GmbH, with HDT Bio’s proprietary LION lipid delivery platform. HDT-401 is intended to stimulate innate immune pathways, promote inflammatory signaling in the tumor microenvironment, and recruit immune cells to support anti-tumor activity. HDT-401 has not been approved by Health Canada, the U.S. Food and Drug Administration, or any other regulatory authority.

(Press release, HDT Bio, JUL 12, 2026, View Source [SID1234669161])

SL Science Holding Limited Submits Orphan Drug Designation Request to the U.S. FDA for GDT Cell Therapy Targeting Glioblastoma

On July 10, 2026 SL Science Holding Limited ("SL Science" or the "Company") (Nasdaq: SLBT), a Taiwan-headquartered biomedical company specializing in developing innovative cellular and gene therapies, reported that the Company has submitted an Orphan Drug Designation (ODD) request to the U.S. Food and Drug Administration (FDA) for its Gamma Delta T (GDT) cell therapy product, Vdelta2+ Gamma Delta T Cells, for the treatment of glioblastoma multiforme (GBM). The FDA’s Office of Orphan Products Development (OOPD) has formally acknowledged receipt of the request and is proceeding with review on additional files about the product

The research team of JY BioMed ("JY BioMed"), licensor of the Company’s GDT cell therapy technology will present at the 20th World Congress of Basic and Clinical Pharmacology (WCP 2026) held at July 12-17, 2026 in Melbourne, Australia. JY BioMed will present the Company’s GBM treatment asset themed by "Intracranial γδ T Cell Therapy Eliminates Glioblastoma in Preclinical Models". Representatives from SL Science will also be present at the event. WCP is among the most influential international pharmacology congresses in the world, convening leading researchers and clinical scientists from across the globe. Presenting at the event reflects the growing international recognition of GDT cell therapy as a serious candidate in solid tumor oncology.

Designation Details

The ODD request was submitted pursuant to Section 526 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360bb).

Product: Vdelta2+ Gamma Delta T Cells
Disease / Condition: Glioblastoma Multiforme (GBM)
Designation Request Number: DRU-2026-11528
Date of Receipt: March 30, 2026

The GDT Platform: A Differentiated Mechanism

SL Science’s GDT cell therapy platform offers a distinct immunological mechanism. Unlike conventional T cell therapies, GDT cells recognize and target tumor cells independent of major histocompatibility complex (MHC) presentation, enabling direct cancer cell engagement and overcoming the key challenges of tumor heterogeneity and immune evasion in solid tumors.

The GDT technology is licensed from JY BioMed, the intellectual property holder of the GDT platform. The submission of the ODD request for GDT cell therapy product for the treatment of GBM marks an important regulatory milestone in advancing GDT cell therapy toward clinical development in brain cancer.

Addressing a Critical Unmet Medical Need

Glioblastoma multiforme is among the most aggressive and lethal forms of primary brain cancer. Under current standard of care, median survival is around 15 months, and patients may face severely limited effective treatment options, representing one of the largest unmet medical needs in oncology.

ODD is granted by the FDA to therapies targeting diseases affecting fewer than 200,000 patients in the United States annually. ODD formally recognizes the unmet medical need and may provide regulatory support, including potential access to accelerated review pathways and related policy incentives, to help bring innovative therapies to patients more efficiently.

"Submitting the ODD is a critical step forward in our strategy to accelerate the clinical development of our GDT cell platform," said Mr. William Wang, Chairman and Chief Executive Officer of SL Science. "Glioblastoma is a devastating disease with a median survival rate of around15 months, representing a significant unmet medical need and commercial opportunity. By leveraging our platform’s unique ability to bypass the defenses solid tumors use to evade standard therapies, we believe this product candidate has the potential to redefine the immuno-oncology landscape and deliver meaningful value to both patients and our shareholders."

(Press release, SL Science, JUL 10, 2026, View Source [SID1234669147])

Sanofi’s subcutaneous Sarclisa Escena approved in the US as first anticancer treatment administered via on-body injector

On July 10, 2026 The US Food and Drug Administration (FDA) reported it has approved subcutaneous (SC) Sarclisa (isatuximab-irfc) Escena in combination with standard-of-care regimens for the treatment of patients with multiple myeloma (MM) across all existing indications of Sarclisa intravenous (IV) formulation. With the approval, Sarclisa Escena is the first anticancer treatment to be administered through both an on-body injector (OBI) and manual SC administration.

The FDA approval was supported by multiple studies, including the pivotal IRAKLIA phase 3 non-inferiority study, which demonstrated Sarclisa Escena administered subcutaneously via an OBI provided similar efficacy, pharmacokinetics and safety compared to IV infusion, along with a significantly shorter treatment time and fewer infusion-related reactions.

"Multiple myeloma is a malignancy that often requires frequent IV infusions or manual subcutaneous injections. Treatment administration can be a cumbersome experience for patients, while also placing a strain on providers by requiring physical effort to push high-resistance syringes for several minutes," said Sikander Ailawadhi, MD, Professor of Medicine, Division of Hematology/Oncology at Mayo Clinic Florida, US, and the principal investigator of the IRAKLIA study. "The comparable efficacy observed across multiple studies and the patient-centric design of the OBI offers an opportunity to impact the patient experience while upholding Sarclisa’s consistent efficacy."

The studies were conducted using Enable Injections’ hands-free OBI, an automated injector designed to deliver subcutaneously high-volume medicines with the push of a button, to administer Sarclisa Escena. The OBI uses a retractable 30g needle that is shorter and thinner compared to the needles commonly used for large-volume injections. The approval of Sarclisa Escena with Enable Injections’ CirCLIQ OBI – developed using the enFuse platform – offers the potential to change the overall patient experience in MM treatment.

"Sarclisa is the cornerstone of our oncology franchise, and we have always been confident in it being widely adopted as a potential best-in-class therapy," said Manuela Buxo, Executive Vice President, Head of Specialty Care at Sanofi. "The approval of Sarclisa Escena subcutaneous formulation administered with the CirCLIQ is a definitive step in this direction. More than 70,000 patients worldwide have benefitted from Sarclisa, delivering predictable and important efficacy and safety across multiple combinations and lines of therapy. Today, we are proud to bring innovation that will empower physicians to enhance the treatment experience for patients, offering greater simplicity, flexibility and convenience."

In addition, the CirCLIQ may streamline the administration process for providers, offering the potential to reduce the physical burden on nurses with a hands-free device and providing more freedom for patient monitoring and interaction.

"The introduction of Sarclisa Escena with the innovative CirCLIQ on-body injector represents a significant advancement in multiple myeloma care," said Donna D. Catamero, ANP-BC, OCN, CCRC, Associate Director, Myeloma Research; Adjunct Faculty, Mount Sinai Phillips School of Nursing and International Myeloma Foundation Nurse Leadership Board member. "For nurses and physicians treating patients with multiple myeloma, this automated system has the potential to meaningfully reduce administrative burden, simplifying how therapy is delivered and giving healthcare teams more capacity to focus on their patients."

In the IRAKLIA phase 3 study, the first to incorporate the use of an OBI in the treatment of MM, Sarclisa SC administered via an OBI in combination with pomalidomide and dexamethasone (Pd) resulted in a 71.1% (187/263) objective response rate (ORR), compared to 70.5% (189/268) with Sarclisa IV-Pd, establishing non-inferiority (relative risk 1.008; 95% confidence interval: 0.903-1.126), in adult patients with relapsed or refractory MM (R/R MM) who have received at least one prior line of treatment.

The overall safety profile of Sarclisa SC-Pd observed in this study was consistent with the established safety profile of Sarclisa IV-Pd. While 25% of patients treated with Sarclisa IV-Pd experienced systemic administration reactions, 1.5% of patients treated with Sarclisa SC-Pd experienced those reactions. No new safety concerns were observed, except for injection site reactions (ISRs) that occurred in 0.4% of OBI injections (n=19/5,145 injections). Nearly all ISRs were grade 1, except for one episode of grade 2.

The most common adverse reactions (≥20%) were upper respiratory tract infection, fatigue,
pneumonia, musculoskeletal pain, and diarrhea. The most common hematology laboratory
abnormalities (≥40%) were decreased leukocytes, decreased neutrophils, decreased lymphocytes, decreased platelets, and decreased hemoglobin.

Sarclisa is currently approved across three indications in the US, including in combination with bortezomib, lenalidomide and dexamethasone in newly diagnosed multiple myeloma (NDMM) patients not eligible for autologous stem cell transplant. In R/R MM, Sarclisa is approved in combination with Pd in patients who have received ≥two prior therapies, including lenalidomide and a proteasome inhibitor and have relapsed on the last therapy, as well as in combination with carfilzomib and dexamethasone in patients who have received one to three prior lines of therapy.

About the IRAKLIA study
IRAKLIA (clinical study identifier: NCT05405166) was a randomized, open-label, pivotal phase 3 study evaluating the non-inferiority of Sarclisa Escena administered at a fixed dose of 1,400 mg SC in combination with Pd via OBI versus weight-based dosed Sarclisa IV in combination with Pd in adult patients with R/R MM who have received at least one prior line of therapy. The major efficacy measures were ORR, defined as the proportion of patients with stringent complete response (CR), CR, very good partial response, and partial response according to the 2016 International Myeloma Working Group criteria assessed by Independent Review Committee, and observed Sarclisa Escena mean concentration before dosing (Ctrough) at steady state (pre-dose at cycle 6, dose 1 [C6D1]), defined as observed Sarclisa Escena plasma concentrations.

About Enable Injections
Cincinnati-based Enable Injections is a global healthcare innovation company committed to improving the patient treatment experience through the development and manufacturing of the enFuse On-Body Delivery System. An innovative wearable technology, the enFuse system is designed to deliver large volumes of pharmaceutical and biologic therapeutics via subcutaneous administration, with the aim of improving convenience, supporting superior outcomes, and advancing healthcare system economics.

For more information, visit www.enableinjections.com.

About Sarclisa
Sarclisa (isatuximab-irfc) has been approved in almost 60 countries across four indications for certain patients with NDMM and R/R MM.

Sarclisa-based regimens have been prescribed to treat more than 70,000 patients worldwide.

Sarclisa SC (Sarclisa Escena in the US), the subcutaneous formulation of Sarclisa, is approved in the US, in the EU, and in the UK, in combination with approved standard-of-care regimens for the treatment of patients with MM across all currently approved indications for Sarclisa IV in these countries. It is the first anticancer treatment to be administered through an OBI, and the only anti-CD38 monoclonal antibody available in MM to offer the flexibility of both SC OBI and manual injection administration. Sarclisa SC is approved in Japan for manual injection and a regulatory submission for the CirCLIQ on-body injector (OBI), based on the enFuse platform and submitted by Enable Injections, is under review.

At Sanofi, we are building on a long-standing commitment to oncology as we continue to chase the miracles of science to improve the lives of those living with cancer. We are committed to transforming cancer care by developing innovative, first and best-in-class immunological and targeted therapies for rare and difficult-to-treat cancers with high unmet need.

(Press release, Sanofi, JUL 10, 2026, View Source [SID1234669146])