Samsung Bioepis Initiates Phase 1 Clinical Trial for SBE303, Nectin-4 Targeting Antibody-Drug Conjugate (ADC) Candidate

On April 14, 2026 Samsung Bioepis Co., Ltd. reported the initiation of Phase 1 clinical trial for SBE303. SBE303 is Samsung Bioepis’s first novel antibody-drug conjugate (ADC) candidate engineered to bind to Nectin-4, an adhesion protein that is specifically expressed in tumor cells, including urothelial cancer, lung cancer, and breast cancer.1 The Phase 1 clinical trial for SBE303 is an open‑label, multi-center, first‑in‑human trial to evaluate the safety, tolerability and efficacy of SBE303 in participants with advanced refractory solid tumors. More information on this study is available at clinicaltrials.gov (NCT07524348).

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(Press release, Samsung Bioepis, APR 14, 2026, View Source [SID1234664379])

Adcendo ApS Completes $75 Million Series C Financing to Continue Advancing First- and Best-in-class Clinical ADC Pipeline

On April 14, 2026 Adcendo, a biotech company focused on the development of first-and best-in-class antibody-drug conjugates (ADCs) for the treatment of cancers with high unmet medical need, reported the successful closing of an oversubscribed $75 million Series C financing round. Proceeds from the fundraise will be used to support Adcendo through multiple upcoming key clinical milestones from the Company’s first- and best-in-class ADC pipeline, including the ADCE-T02 (Tissue Factor ADC) Phase I Tiffany-01 Cohort expansion study in multiple high unmet need tumor indications, the ADCE-D01 (uPARAP) ADCElerate1 dose escalation and expansion study in soft tissue sarcoma and other cancers of mesenchymal origin, and the ADCE-B05 (undisclosed target) dose escalation study in squamous cell carcinomas.

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The financing round was led by Jeito Capital, with participation from additional new investors Vida Ventures, BPI France, and EIFO (Export and Investment Fund of Denmark), as well as all existing investors, including TCGX, RA Capital Management, TPG, Orbimed, Venrock, Surveyor, Logos Capital, Novo Holdings, Pontifax Venture Capital, Dawn Biopharma, a platform controlled by KKR, HealthCap, Gilde Healthcare and Ysios Capital.

"This successful financing round, led by a distinguished group of life science investors, empowers us to continue advancing our pipeline of breakthrough ADCs for the treatment of underserved cancers," said Michael Pehl, Chief Executive Officer of Adcendo. "We are thrilled to see continued momentum of our first and best-in-class ADCs in clinic, and with the backing of this fundraising we will continue to progress ADCE-T02, ADCE-D01 and ADCE-B05 through upcoming data readouts."

Ksenija Pavletic, General Partner & Chief Commercial Officer at Jeito Capital, commented: "Adcendo stands out in the ADC field as having a noteworthy combination of bold innovation and strong clinical development strategy and execution. With a seasoned team of drug developers and biopharma leaders advancing their differentiated pipeline, we are excited to see the Company’s progress toward their mission of delivering next-generation cancer therapies to patients who need them most."

As part of the financing, Adcendo will add Ksenija Pavletic (Jeito Capital) and Rajul Jain (Vida Ventures) to its Board of Directors.

(Press release, ADCendo, APR 14, 2026, View Source [SID1234664347])

BostonGene and ImmunoGenesis Announce Strategic Partnership to Overcome Immunotherapy Resistance

On April 14, 2026 BostonGene, developer of the leading AI foundation model for tumor and immune biology, and ImmunoGenesis, a clinical-stage biotech company developing innovative, science-driven immunotherapies, reported a strategic partnership to accelerate the clinical development of IMGS-001, the company’s lead program. IMGS-001 is a cytotoxic immune checkpoint inhibitor targeting both PD-L1 and PD-L2, and is being studied in a phase 1a/b dose-escalation and dose-expansion safety and efficacy trial (NCT06014502) in patients with solid tumors that have failed to respond to standard of care therapies. This collaboration will investigate the effect of IMGS-001 on patients based on each patient’s comprehensive immune and genetic profile, which can help identify those patients most likely to respond.

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"IMGS-001, through its multifunctional mechanism of both direct cell killing and PD-1 pathway blockade, has been specifically engineered to drive clinical benefit in patients with tumors resistant to current immunotherapies," said James Barlow, President and CEO of ImmunoGenesis. "BostonGene’s cutting edge technology can both elucidate the mechanism of action of the drug and identify those patients with unmet medical need most likely to benefit."

Through this collaboration, BostonGene will apply its AI-driven multiomic platform to perform deep molecular characterization of patients treated with IMGS-001. By integrating high-resolution spatial biology with systemic immune monitoring, the partnership will generate the critical data needed to visualize how IMGS-001 treatment may reshape the tumor microenvironment and identify specific biology to predict patient response. This data-driven approach moves beyond traditional biomarker analysis to deliver a system-level understanding of disease biology and therapeutic impact. It is expected to enable more precise patient selection, improve clinical decision-making, and accelerate the development of IMGS-001.

"We believe this partnership represents a significant leap beyond conventional clinical monitoring," said Charles Schweizer, PhD, Senior Vice President of Clinical Development at ImmunoGenesis. "By embedding BostonGene’s AI-powered insights into our clinical framework, we are decoding the precise cellular and molecular pathways driving clinical outcomes. This clarity will allow us to move with greater speed and precision, ultimately strengthening the potential of IMGS-001 to address unmet medical needs for patients with cold or immune excluded tumors."

The integration of BostonGene’s technology allows for a real-time assessment of how IMGS-001 can unlock anti-tumor immunity. By mapping the complex interactions between the immune system and the tumor, the two companies aim to eliminate the "trial and error" often associated with immunotherapy, ensuring the right patients receive the most effective treatment at the right time.

"Modern oncology demands a shift from broad application to data-driven precision," said Nathan Fowler, MD, Chief Medical Officer of BostonGene. "By combining our spatial and multiomic expertise with the innovative pipeline at ImmunoGenesis, we are defining the mechanism by which IMGS-001 overcomes immunotherapy resistance. This critical collaboration delivers important evidence needed to guide the next generation of precision immunotherapy."

(Press release, BostonGene, APR 14, 2026, View Source [SID1234664380])

Asgard Therapeutics appoints Professor Dr Wolfram Brugger as Chief Medical Officer as it advances transformative ‘personalized off-the-shelf’ immunotherapy toward clinical development

On April 14, 2026 Asgard Therapeutics, a privately held biotech company pioneering in vivo direct cell reprogramming for cancer immunotherapy, reported the appointment of Prof Dr Wolfram Brugger as Chief Medical Officer. Prof Dr Brugger, who has been involved in more than 130 Phase I-III clinical oncology trials with numerous modalities across a wide variety of cancer types, including solid tumors, will strengthen Asgard’s leadership as it prepares to transition to a clinical-stage biotech.

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Cristiana Pires, Co-founder and Chief Executive Officer of Asgard Therapeutics, said: "Strengthening our leadership team with Wolfram, who is such a highly experienced clinical trials expert and practicing medical oncologist, is a privilege and we are excited to welcome him on board. Wolfram’s proven capabilities and track record will ensure that Asgard is perfectly positioned as we advance AT-108 towards the clinic."

Prof Dr Wolfram Brugger, incoming Chief Medical Officer of Asgard Therapeutics, said: "I’ve always been driven by bringing new modalities to patients, and I am excited to be developing a ‘personalized off-the-shelf’ immunotherapy which has great potential to help patients with a wide variety of cancers. Asgard’s in vivo cell reprogramming technology has transformative potential, and the pre-clinical proof-of-concept data, both published and upcoming data to be presented at key scientific conferences, is highly convincing. Having treated hundreds of cancer patients in clinical trials throughout my career, I look forward to utilizing my experience to shape Asgard’s clinical strategy, driving AT-108 through clinical development."

Wolfram joins Asgard from NASDAQ-listed Autolus Therapeutics where he led the global clinical development program of AUTO1 (AUCATZYL / obe-cel), an autologous CD19 CAR T therapy, in hematological and autoimmune indications. AUTO1 received FDA approval in 2024 for relapsed / refractory B-cell acute lymphoblastic leukemia (B-ALL) and conditional approval was granted by the EMA and MHRA in 2025. Prior to this he was at MorphoSys where he headed the global clinical development program for the monoclonal antibody tafasitamab across various blood cancer indications. Tafasitamab (in combination with lenalidomide) was granted accelerated approval by the FDA in relapsed/refractory DLBCL in 2020 and conditional approval by the EMA in the same indication in 2021. At AstraZeneca, he was global medical lead for Phase I / early Phase II trials for several oncology assets in numerous cancer types, including testing them in combination with checkpoint inhibitors.

Prior to moving into drug development, he was Chief & Medical Director in the Department of Hematology, Oncology, Immunology & Infectious Diseases at a Teaching Hospital of Freiburg University in Germany. He holds an MD and PhD from Albert-Ludwigs University Freiburg and Eberhard-Karls University Tübingen, Germany, with a specialist registration in Internal Medicine, Medical Oncology and Hematology.

Asgard is currently focused on advancing IND-enabling studies and CMC activities to support clinical development of AT-108. Key proof-of-concept data on AT-108 were published in 2024 in the high-impact, peer-reviewed journal Science.

(Press release, Asgard Therapeutics, APR 14, 2026, View Source [SID1234664348])

SST001, an α-syn PET tracer from Mabwell’s incubated company SynuSight Biotech, received NMPA approval to initiate a clinical trial

On April 14, 2026 Mabwell (688062.SH), an innovation-driven biopharmaceutical company with a fully integrated industry chain, reported that 18F-FD4 (R&D code: SST001), an α-synuclein (α-syn) targeted PET tracer independently developed by its incubated company SynuSight Biotech, has recently been approved by the National Medical Products Administration (NMPA) to initiate a Phase I clinical trial.

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The clinical trial to be initiated is a non-randomized, open-label study to be conducted at Huashan Hospital, Fudan University and the Affiliated Hospital of Jiangnan University. The study plans to enroll healthy volunteers, patients with multiple system atrophy (MSA), and patients with Parkinson’s disease (PD). The primary objectives are to evaluate the safety, tolerability, biodistribution, radiation dosimetry, and pharmacokinetics of SST001, thereby supporting subsequent clinical development.

Abnormal aggregation and deposition of α-syn protein are key pathological features of α-synucleinopathies such as PD and MSA. However, current clinical diagnosis still relies mainly on clinical symptom assessment and indirect functional imaging biomarkers. As an α-syn-specific PET molecular tracer validated through IIT (Investigator-Initiated Trial) studies, SST001 enables in vivo, real‑time, qualitative, and quantitative detection. It is expected to provide more objective and quantifiable imaging evidence for early diagnosis and disease subtyping of PD and MSA, as well as potential imaging support for subject screening and efficacy evaluation in clinical trials of related therapeutic drugs.

According to data from the Global Burden of Disease (GBD) Study 1990–2021, there were approximately 11.8 million PD patients worldwide in 2021, of which Chinese patients accounted for more than 40%. In China, the number of PD patients increased significantly from 651,800 in 1990 to 5.077 million in 2021, driven mainly by population aging. Although MSA is a rare disease, it progresses more rapidly and has a poorer prognosis, with a median survival of only 6 to 10 years, resulting in a significant disease burden.

Previously, SST001, partnering with XingImaging, has received high recognition from The Michael J. Fox Foundation for Parkinson’s Research (MJFF) and obtained a research grant of US$3.84 million, which will be specifically used to support its clinical research advancement in the United States. In January this year, SST001 received a Research IND clearance from the U.S. FDA, and clinical studies have been successfully initiated with the first subject dosed. Relevant data are being continuously collected. SST001 has now entered clinical stage in both China and the United States, entering a new phase of global development.

(Press release, Mabwell Biotech, APR 14, 2026, View Source;syn-pet-tracer-from-mabwells-incubated-company-synusight-biotech-received-nmpa-approval-to-initiate-a-clinical-trial-302741808.html [SID1234664366])