An open-label, multicenter, Phase I/IIa study assessing the safety and efficacy of EGFR targeted EDVsTM carrying cytotoxic drug PNU-159682 plus concurrent immunomodulatory adjuvant non-targeted EDVs carrying a-galactosyl ceramide in subjects with advanced EGFR-expressing cancers who have failed second-line therapy or where first- and/or second-line therapy is not appropriate (EGFR EDV-D682/GC Trial)

Start Date03 Mar 2025

Sponsor / Collaborator

EnGeneIC Pty Ltd.

ACTRN12619000385145

/ SuspendedPhase 1/2

A Phase I/IIa Study of EGFR-Targeted EDVTMs Carrying the Cytotoxic Drug PNU-159682 (E-EDV-D682) with Concurrent Immunomodulatory Adjuvant Non-Targeted EDVs carrying an immunomodulator (EDV-GC) in (i) Cohort 1, Subjects with Advanced Pancreatic Cancer and (ii) Cohort 2, Subjects with other EGFR Expressing Solid Tumours, who have Failed First or Second-line Therapy or where other Standard Therapies are not Appropriate.

Start Date04 Mar 2019

Sponsor / Collaborator

EnGeneIC Pty Ltd.

100 Clinical Results associated with E-EDV-D682

100 Translational Medicine associated with E-EDV-D682

100 Patents (Medical) associated with E-EDV-D682

Literatures (Medical) associated with E-EDV-D682

10 Mar 2025·ONCOLOGIST

Recurrent pancreatic cancer treated with N-803 and PD-L1 t-haNK followed by an EGFR-targeted nanocell drug conjugate

Article

Author: Brahmbhatt, Himanshu ; Nangia, Chaitali ; Seery, Tara ; Sender, Lennie ; Spilman, Patricia ; Moini, Katayoun ; MacDiarmid, Jennifer ; Soon-Shiong, Patrick

Abstract:

Multimodal temporal therapy orchestrated to leverage immunotherapy, tumor-targeted chemotherapy, and natural killer (NK) cell therapy may provide an opportunity to induce immunogenic cell death for tumor response and increased survival in patients with recurrent cancer. The interleukin-15 (IL-15) superagonist N-803, an enhancer of NK cells, CD4 + T cells, cytotoxic CD8 + T cells, and memory T-cell activity, combined with off-the-shelf PD-L1-targeted high-affinity NK (PD-L1 t-haNK) cells represent novel immunotherapies designed to overcome an immunosuppressive tumor microenvironment (TME). The epidermal growth factor receptor-targeted antibody-nanocell conjugate E-EDV-D682 provides tumor-targeted chemotherapy in the form of its anthracycline metabolite PNU159682 (nemorubicin) cargo and is currently being studied in combination with immunomodulatory EDVs delivering the adjuvant α-galactosyl ceramide (GC). Here, we report the compassionate use treatment of this combination in a patient with recurrent, metastatic pancreatic cancer (mPC) after 3 lines of therapy. Under the initial single-patient Investigational New Drug (spIND) protocol, the patient received N-803, PD-L1 t-haNK cells, and the albumin doxorubicin conjugate aldoxorubicin for ~27 months. The patient’s disease became stable on this regimen, and a transient complete response was observed by ~14 months of therapy. Due to progression, a second spIND protocol was designed whereby the patient received E-EDV-D682 plus EDV-GC for more than 24 months, which resulted in stable disease and the patient’s continued survival at the time this report was written. The patient’s extended survival despite the dire prognosis associated with recurrent mPC points to the merits of this temporal combination regimen in overcoming immuno-chemo resistance with enhanced immune activity required for tumor response and extended survival.

22 Oct 2024·JOURNAL OF VIROLOGY

Conjugation of anti-HIV gp41 monoclonal antibody to a drug capable of targeting resting lymphocytes produces an effective cytotoxic anti-HIV immunoconjugate

Article

Author: Zhu, Tong ; Ober, Kelli ; Cole, Frances M. ; Khasanov, Alisher ; Kovacs, Ernest W. ; Marcotte, Tamera ; Pincus, Seth H. ; Tokmina-Lukaszewska, Monika ; Peters, Tami ; Copié, Valérie

ABSTRACT:

HIV-infected cells persisting in the face of suppressive antiretroviral therapy are the barrier to curing infection. Cytotoxic immunoconjugates targeted to HIV antigens on the cell surface may clear these cells. We showed efficacy in mouse and macaque models using immunotoxins, but immunogenicity blunted the effect. As an alternative, we propose antibody drug conjugates (ADCs), as used in cancer immunotherapy. In cancer, the target is a dividing cell, whereas it may not be in HIV. We screened cytotoxic drugs on human primary cells and cell lines. An anthracycline derivative, PNU-159682 (PNU), was highly cytotoxic to both proliferating and resting cells. Human anti-gp41 mAb 7B2 was conjugated to ricin A chain or PNU. The conjugates were tested in vitro for cytotoxic efficacy and anti-viral effect, and in vivo for tolerability. The specificity of killing for both conjugates was demonstrated on Env+ and Env− cells. The toxin conjugate was more potent and killed more rapidly, but 7B2–PNU was effective at levels achievable in patients. The ricin conjugate was well tolerated in mice; 7B2–PNU was toxic when administered intraperitoneally but was tolerated intravenously. We have produced an ADC with potential to target the persistent HIV reservoir in both dividing and non-dividing cells while avoiding immunogenicity. Cytotoxic anti-HIV immunoconjugates may have greatest utility as part of an “activate and purge” regimen, involving viral activation in the reservoir. This is a unique comparison of an immunotoxin and ADC targeted by the same antibody and tested in the same systems.

IMPORTANCE:

HIV infection can be controlled with anti-retroviral therapy, but it cannot be cured. Despite years of therapy that suppresses HIV, patients again become viremic shortly after discontinuing treatment. A long-lived population of memory T cells retain the genes encoding HIV, and these cells secrete infectious HIV when no longer suppressed by therapy. This is the persistent reservoir of HIV infection. The therapies described here use anti-HIV antibodies conjugated to poisons to kill the cells in this reservoir. These poisons may be of several types, including protein toxins (immunotoxins) or anti-cancer drugs (antibody drug conjugates, ADCs). We have previously shown that an anti-HIV immunotoxin had therapeutic effects in animal models, but it elicited an anti-drug immune response. Here, we have prepared an anti-HIV ADC, which would be less likely to provoke an immune response, and show its potential for use in eliminating the persistent reservoir of HIV infection.

17 Jan 2024·Clinical cancer research : an official journal of the American Association for Cancer Research

Phase I/IIa Trial in Advanced Pancreatic Ductal Adenocarcinoma Treated with Cytotoxic Drug-Packaged, EGFR-Targeted Nanocells and Glycolipid-Packaged Nanocells

Article

Author: Pattison, Scott ; Ganju, Vinod ; MacDiarmid, Jennifer A. ; Brahmbhatt, Himanshu ; Williams, Bryan R.G. ; Zhao, Jing-Ting ; Amaro-Mugridge, Nancy B. ; Marx, Gavin

Abstract:

Purpose::

We assessed the safety and efficacy of an EGFR-targeted, super-cytotoxic drug, PNU-159682-packaged nanocells with α-galactosyl ceramide-packaged nanocells (E-EDV-D682/GC) in patients with advanced pancreatic ductal adenocarcinoma (PDAC) who had exhausted all treatment options.

Patients and Methods::

ENG9 was a first-in-man, single-arm, open-label, phase I/IIa, dose-escalation clinical trial. Eligible patients had advanced PDAC, Eastern Cooperative Oncology Group status 0 to 1, and failed all treatments. Primary endpoints were safety and overall survival (OS).

Results::

Of 25 enrolled patients, seven were withdrawn due to rapidly progressive disease and one patient withdrew consent. All 25 patients were assessed for toxicity, 24 patients were assessed for OS, which was also assessed for 17 patients completing one treatment cycle [evaluable subset (ES)]. Nineteen patients (76.0%) experienced at least one treatment-related adverse event (graded 1 to 2) resolving within hours. There were no safety concerns, dose reductions, patient withdrawal, or treatment-related deaths.Median OS (mOS) was 4.4 months; however, mOS of the 17 ES patients was 6.9 months [208 days; range, 83–591 days; 95.0% confidence interval (CI), 5.6–10.3 months] and mOS of seven patients who did not complete one cycle was 1.8 months (54 days; range, 21–72; 95.0% CI, 1.2–2.2 months). Of the ES, 47.1% achieved stable disease and one partial response. Ten subjects in the ES survived over 6 months, the longest 19.7 months. During treatments, 82.0% of the ES maintained stable weight.

Conclusions::

E-EDV-D682/GC provided significant OS, minimal side effects, and weight stabilization in patients with advanced PDAC. Advanced PDAC can be safely treated with super-cytotoxic drugs via EnGeneIC Dream Vectors to overcome multidrug resistance.

News (Medical) associated with E-EDV-D682

13 May 2025

·www.globenewswire.com

EnGeneIC launches groundbreaking new Australian trial for innovative cancer therapy, with international trial site in Singapore to follow

First Patient dosed in Phase I/IIa Basket Trial for Solid Tumours at Mater Hospital, North SydneyRecruitment to open this month at Frankston Hospital, VictoriaFurther site to follow at Curie Oncology, Singapore SYDNEY, May 12, 2025 (GLOBE NEWSWIRE) -- EnGeneIC Pty Ltd, a Sydney-based biotechnology company and leader in innovative cancer therapies, has announced the successful dosing of the first patient in its open-label, multicentre, Phase I/IIa clinical trial at Mater Hospital, Sydney. The trial (ENG19) is an essential next step in progressing EnGeneIC’s novel platform technology through the clinic and to market. It will assess the safety and efficacy of EGFR-targeted EDVTM (EnGeneIC Dream Vector) nanocells carrying the super-cytotoxic drug PNU-159682, together with EDVs loaded with an immune-stimulating adjuvant in patients with advanced solid tumours expressing Epidermal Growth Factor Receptor (EGFR). This groundbreaking study targets patients for whom second-line therapy is no longer working or for whom first- and/or second-line treatments are not appropriate. The trial will focus on EGFR-positive cancers that are difficult to treat and have a poor prognosis, including but not limited to non-small cell lung cancer (NSCLC), mesothelioma, kidney and bladder cancer, pancreatic cancer, head and neck cancer, medullary thyroid cancer, and triple-negative breast cancer. Professor Fran Boyle and Dr. Luke Ardolino are Investigators for the trial at the Mater Hospital. Commenting on the significance of this trial, Professor Boyle said: “We are thrilled to be part of this innovative study, which has the potential to offer new hope to patients suffering from aggressive EGFR-expressing cancers. The treatment combines cutting-edge technology with a promising therapeutic approach, which has the potential to change the way we treat these challenging cancers.” As part of the expansion of the trial, EnGeneIC will open recruitment at Frankston Hospital, Victoria, this month under the guidance of Principal Investigator, Professor Vinod Ganju before adding further Australian sites. Additionally, the trial will be launched internationally at Curie Oncology in Singapore, where Dr. Su Pin Choo will lead the study and EnGeneIC collaborator, Singapore Advanced Medicine (SAM, Dr. S. K. Djeng) will serve as EnGeneIC’s local representative, as required by the Health Sciences Authority, Singapore. Dr Himanshu Brahmbhatt, co-CEO of EnGeneIC commented: “The EDV nanocell therapy is a globally unique technology that stimulates a complete orchestra of anti-tumor responses, individual to every patient. In early clinical studies, even patients who had exhausted all treatment options have responded. Most anti-cancer therapies are designed to hit only one tumor specific target, but the difficulty lies in the fact that as the cancer progresses, it becomes highly heterogeneous resulting in some cells escaping the therapy. This means that the multi-drug and/or immunotherapy-resistant tumor keeps coming back.” “In this clinical trial, we aim to identify which cancer indications show a favourable outcome. This trial will accelerate the development of this potentially life-changing treatment for patients, by EnGeneIC’s engagement with a committed group of investigators and clinical sites. It is a huge step for us as we take EDV therapy forward in larger, defining, clinical trials for these unresponsive low survival cancers,” he added. EnGeneIC's EDV nanocells form the backbone of the company's ongoing commitment to revolutionise cancer therapy by utilising advanced nanotechnology to improve both the precision and efficacy of treatments to stimulate an anti-tumor immune response and to overcome the drug resistance that plagues successful treatment of low survival tumour types. For more information about the trial or to inquire about participation, please visit www.engeneic.com or contact Stephen Parker whose details are listed below. The trial is registered on the Australia and New Zealand clinical trial site https://www.anzctr.org.au/ACTRN12625000203459.aspx About EnGeneIC EnGeneIC is a clinical stage biopharmaceutical company focused on developing novel cancer therapies based on its proprietary platform of EnGeneIC Dream Vector (EDV) nanocells. These nanocells are designed to deliver highly potent drugs directly to cancer cells, providing targeted treatment while minimizing damage to healthy tissue and at the same time stimulate a powerful anti-tumour innate and adaptive immune response. The company’s approach aims to improve the quality of life and extend survival for cancer patients by offering new and more effective therapies for hard-to-treat cancers. For media inquiries, please contact: Stephen ParkerBusiness Operations sparker@engeneic.com

ImmunotherapyClinical Study

12 Dec 2024

·www.prnewswire.com

Elevation Oncology Licenses ADC Technology from Synaffix to Drive Pipeline Expansion

Licensing agreement gives Elevation Oncology access to Synaffix's ADC technology for one program in combination with SYNstatin E™ Elevation Oncology nominates a novel HER3 ADC candidate EO-1022 leveraging its antibody as well as Synaffix's proprietary ADC development technologies AMSTERDAM, Dec. 12, 2024 /PRNewswire/ -- Synaffix B.V., a Lonza company (SIX: LONN) focused on commercializing its clinical-stage platform technology for the development of antibody-drug conjugates (ADCs) with best-in-class therapeutic index, today announces that it has entered into a licensing agreement with Elevation Oncology, Inc., an innovative oncology company focused on the discovery and development of selective cancer therapies to treat patients across a range of solid tumors with significant unmet medical needs. Synaffix gives Elevation Oncology global access to its clinical stage, site-specific ADC technology platform, including GlycoConnect® antibody conjugation technology, HydraSpace® polar spacer technology, as well as the toxSYN® linker-payload, SYNstatin E™, which enables the transformation of Elevation Oncology's antibody into a differentiated ADC with best-in-class potential. Under the terms of the agreement, Synaffix is eligible to receive up to USD 368 million in upfront and clinical, regulatory, and commercial milestone payments, plus tiered royalties on net sales. Synaffix is responsible for manufacturing the components related to its proprietary technologies, and Elevation Oncology is responsible for the research, development, manufacturing, and commercialization of the ADC. Peter van de Sande, Head of Synaffix, said: "As a dedicated partner in the ADC space, Synaffix is excited to collaborate with Elevation Oncology to push the boundary of ADC innovation. With our state-of-the-art ADC technology platform and established supply chain, Elevation is well-positioned to accelerate the development of its differentiated HER3 ADC." David Dornan, Chief Scientific Officer at Elevation Oncology, commented: "Our partnership with Synaffix enables us to build a HER3 ADC candidate with best-in-class potential, which leverages Synaffix's state-of-the-art site-specific conjugation and differentiated linker-payload for a potentially improved safety and efficacy profile. We look forward to advancing our pipeline as we work toward transforming the care and treatment of patients living with solid tumors that express HER3." About Synaffix Synaffix B.V. is a biotechnology company that enables ADC product candidates using its clinical-stage, site-specific ADC technology platform based on GlycoConnect®, HydraSpace® and toxSYN® technologies, that together enable any company with an antibody to develop proprietary best-in-class ADC products under a single license from Synaffix. The Synaffix platform enables a rapid timeline to clinic due to the established supply chain of technology components. Synaffix holds granted patents to its technology. The business model of Synaffix is target-specific technology out-licensing, as exemplified through its existing deals with ADC Therapeutics, Mersana Therapeutics, Shanghai Miracogen (acquired by Lepu Biopharma), Innovent Biologics, Kyowa Kirin, Genmab, Macrogenics, Amgen, Hummingbird Biosciences, Chong Kun Dang Pharma, ABL Bio, SOTIO Biotech, Kivu Bioscience, BigHat Biosciences, Illuminaand Elevation Oncology. Synaffix was fully acquired by Lonza in June 2023. About The Synaffix ADC Platform Technology Synaffix's proprietary ADC technology platform consists of GlycoConnect®, GlycoConnect™ High DAR Technology, HydraSpace®, and toxSYN®. These technologies are aimed at enabling best-in-class ADCs from any antibody, with significantly enhanced efficacy and tolerability. GlycoConnect® clinical-stage conjugation technology exploits the native antibody glycan for site-specific and stable payload attachment and is tunable to DAR1, DAR2 or DAR4 formats. The extension of GlycoConnect® with High DAR Technology enables ADCs with high drug loading (6, 8 and above), while retaining high drug substance homogeneity and therapeutic index. HydraSpace® clinical-stage compact and highly polar spacer technology is designed to further enhance therapeutic index, particularly with hydrophobic payloads. toxSYN® linker-payload platform spans key, validated MOAs for ADC product development. This includes potent topoisomerase 1 inhibitor (SYNtecan E™), DNA damaging agents (SYNeamicin D™ and SYNeamicin G™), ⍺-Microtubule (SYNtansine™) and β-Microtubule (SYNstatin E™ and SYNstatin F™) inhibitors as well as several unlaunched proprietary linker-payloads that were generated through the ongoing innovative efforts of the Synaffix R&D team. The newest proprietary linker-payload, "SYN-PNU™" is part of the established and expanding toxSYN® linker-payload portfolio. SYN-PNU™ represents (based on pre-clinical models) a significantly potency-attenuated and better tolerated version of PNU-159,682, to enable enhanced administered dose levels and competitive therapeutic properties versus ADCs prepared using the original molecule. The reference compound (PNU-159,682) is a metabolite of the anthracycline Nemorubicin and represents a highly potent DNA topoisomerase II inhibitor. The combination of these three technologies provides developers with a "one stop" and easy-to-use ADC technology platform, allowing any antibody developer to develop its own proprietary ADC and any ADC developer to expand its pipeline further and increase its competitive position. About Lonza Lonza is one of the world's largest healthcare manufacturing organizations. Working across five continents, our global community of around 18,000 colleagues helps pharmaceutical, biotech and nutrition companies to bring their treatments to market. United by our vision to bring any therapy to life, we support our customers with a combination of technological insight, world-class manufacturing, scientific expertise, process excellence and innovation. Our work enables our customers to develop and commercialize their therapeutic discoveries, allowing their patients to benefit from life-saving and life-enhancing treatments. Our business is structured to meet our customers' complex needs across four divisions: Biologics, Small Molecules, Cell & Gene, and Capsules & Health Ingredients. Our company generated sales of CHF 3.1 billion with a CORE EBITDA of CHF 893 million during the first 6 months 2024. Find out more at  Follow @Lonza on LinkedIn Follow @LonzaGroup on X About Elevation Oncology, Inc. Elevation Oncology is an innovative oncology company focused on the discovery and development of selective cancer therapies to treat patients across a range of solid tumors with significant unmet medical needs. We are leveraging our antibody-drug conjugate (ADC) expertise to advance a novel pipeline, initially targeting two clinically validated targets in oncology, Claudin 18.2 and HER3. Our lead candidate, EO-3021, is a potential best-in-class ADC designed to target Claudin 18.2 and is currently being evaluated in a Phase 1 trial (NCT05980416) in patients with advanced, unresectable or metastatic solid tumors likely to express Claudin 18.2 including gastric, gastroesophageal junction, pancreatic or esophageal cancers. We are also advancing EO-1022, a HER3-targeting ADC for the treatment of patients living with solid tumors that express HER3, through preclinical development. For more information, visit . SOURCE Synaffix B.V. WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

License out/inADCPhase 1Acquisition

04 Nov 2024

·www.prnewswire.com

Lonza's Synaffix Collaborates with BigHat Biosciences on the Development of a Machine Learning-Designed ADC

Commercial license to Synaffix technologies follows a series of successful initial preclinical proof of concept studies Collaboration underscores Lonza's commitment to helping customers deliver innovative new therapies to patients by offering a comprehensive service offering for differentiated ADCs BigHat's artificial intelligence (AI)/machine learning (ML)-powered antibody design platform, Milliner™ was used to design a highly differentiated antibody that was paired with Synaffix's GlycoConnect™, HydraSpace® and toxSYN® ADC technologies to generate a next-gen ADC AMSTERDAM and BASEL, Switzerland, Nov. 4, 2024 /PRNewswire/ -- Synaffix B.V. ("Synaffix"), a Lonza company (SWX: LONN) focused on commercializing its clinical-stage platform technology for the development of antibody-drug conjugates (ADCs) with best-in-class therapeutic index, today announced that it has licensed its ADC technology to BigHat Biosciences, Inc. ("BigHat"). BigHat will combine Synaffix technology with its world-class ML antibody design platform for the development of a new ADC pipeline program. Under the terms of the agreement, BigHat will receive target-specific access to Synaffix's late-clinical stage, site-specific ADC technology platform, which enables the transformation of antibodies into proprietary, best-in-class ADC products. As a result of Lonza's acquisition of Synaffix in June 2023, BigHat will also gain access to Lonza's end-to-end ADC offering. This DNA-to-IND offering enables drug developers to seamlessly receive all necessary cGMP/non-cGMP ADC batches leading up to the first clinical trial under a single quality system encompassing all critical development and manufacturing activities, including the production of the antibody, bioconjugation, and drug product filling. BigHat's AI/ML-powered antibody design platform, Milliner™, integrates a synthetic biology-based high-speed wet lab with state-of-the-art ML technologies into a full-stack antibody discovery and engineering platform, to engineer antibodies with more complex functions and better biophysical properties. This approach reduces the difficulty of designing antibodies and other therapeutic proteins to tackle conditions ranging from chronic illness to life-threatening disease, while also massively speeding up candidate discovery and validation. The collaboration with Synaffix/Lonza is instrumental to advancing BigHat's next-gen ADC program, which is at IND-enabling stage and is on track to be BigHat's first clinical stage program. BigHat's next-gen ADC was optimized on BigHat's Milliner platform for maximum payload delivery to tumor cells and optimal drug-like-properties. The incorporation of Synaffix's GlycoConnect™, HydraSpace® and toxSYN® ADC technologies is intended to further improve the safety and efficacy of Big Hat's next-gen ADC. Peter van de Sande, Head of Synaffix, said: "The ADC space continues to develop and evolve, and our collaboration with BigHat exemplifies the continued strength and appeal of our best-in-class ADC technology. We are excited to be at the forefront of next-generation ADC R&D by joining forces with BigHat and its AI/ML-enabled antibody discovery and development platform, BigHat is the ideal partner for Synaffix to collaborate with. We look forward to supporting BigHat with every step in the ADC development and manufacturing process under the Lonza umbrella." Jean-Christophe Hyvert, President, Biologics, Lonza, added: "We are pleased to announce this collaboration with BigHat for its next-gen ADC molecule, which shows how drug developers can benefit from a fully integrated suite of services across our Biologics division. The Lonza network has continued to adapt to the evolving ADC landscape, including the recent addition of a highly potent vial fill capability at our Stein (CH) facility. This dedicated ADC drug product capacity expansion completes our offer for comprehensive, end-to-end development and manufacturing services for ADCs, simplifying the path from DNA-to-IND and beyond for our customers." Mark DePristo, CEO at BigHat Biosciences, commented: "BigHat is leveraging our AI-driven antibody design platform, Milliner™, to develop advanced biologics that provide safer and more effective treatments for difficult-to-treat cancers. We are excited to combine Synaffix's conjugation and linker-payload technologies with our custom-designed antibody to create a next-generation ADC for patients with high unmet medical need." About Synaffix Synaffix B.V. is a biotechnology company that enables ADC product candidates using its clinical-stage, site-specific ADC technology platform based on GlycoConnect™, HydraSpace® and toxSYN® technologies, that together enable any company with an antibody to develop proprietary best-in-class ADC products under a single license from Synaffix. The Synaffix platform enables a rapid timeline to clinic due to the established supply chain of technology components. Synaffix holds granted patents to its technology. The business model of Synaffix is target-specific technology out-licensing, as exemplified through its existing deals with ADC Therapeutics, Mersana Therapeutics, Shanghai Miracogen (acquired by Lepu Biopharma), Innovent Biologics, Kyowa Kirin, Genmab, Macrogenics, Amgen, Hummingbird Biosciences, Chong Kun Dang Pharma, ABL Bio, and SOTIO Biotech. Synaffix was fully acquired by Lonza in June 2023. About The Synaffix ADC Platform Technology Synaffix's proprietary ADC technology platform consists of GlycoConnect™, GlycoConnect™ High DAR Technology, HydraSpace®, and toxSYN® technologies. These technologies are aimed at enabling best-in-class ADCs from any antibody, with significantly enhanced efficacy and tolerability. GlycoConnect™ clinical-stage conjugation technology exploits the native antibody glycan for site-specific and stable payload attachment and is tunable to DAR1, DAR2 or DAR4 formats. The extension of GlycoConnect™ with High DAR Technology enables ADCs with high drug loading (6, 8 and above), while retaining high drug substance homogeneity and therapeutic index. HydraSpace® clinical-stage compact and highly polar spacer technology is designed to further enhance therapeutic index, particularly with hydrophobic payloads. toxSYN® linker-payload platform spans key, validated MOAs for ADC product development. This includes potent topoisomerase 1 inhibitor (SYNtecan E™), DNA damaging agents (SYNeamicin D™, SYNeamicin G™ and SYN-PNU™), ⍺-Microtubule (SYNtansine™) and β-Microtubule (SYNstatin E™ and SYNstatin F™) inhibitors as well as several unlaunched proprietary linker-payloads that were generated through the ongoing innovative efforts of the Synaffix R&D team. The newest proprietary linker-payload, "SYN-PNU™" is part of the established and expanding toxSYN™ linker-payload portfolio. SYN-PNU™ represents (based on pre-clinical models) a significantly potency-attenuated and better tolerated version of PNU-159,682, to enable enhanced administered dose levels and competitive therapeutic properties versus ADCs prepared using the original molecule. The reference compound (PNU-159,682) is metabolite of the anthracycline Nemorubicin and represents a highly potent DNA topoisomerase II inhibitor. The combination of these three technologies provides developers with a "one stop" and easy-to-use ADC technology platform, allowing any antibody developer to develop its own proprietary ADC and any ADC developer to expand its pipeline further and increase its competitive position. About Lonza Lonza is one of the world's largest healthcare manufacturing organizations. Working across five continents, our global community of around 18,000 colleagues helps pharmaceutical, biotech and nutrition companies to bring their treatments to market. United by our vision to bring any therapy to life, we support our customers with a combination of technological insight, world-class manufacturing, scientific expertise, process excellence and innovation. Our work enables our customers to develop and commercialize their therapeutic discoveries, allowing their patients to benefit from life-saving and life-enhancing treatments. Our business is structured to meet our customers' complex needs across four divisions: Biologics, Small Molecules, Cell & Gene, and Capsules & Health Ingredients. Our company generated sales of CHF 3.1 billion with a CORE EBITDA of CHF 893 million in Half-Year 2024. Find out more at Follow @Lonza on LinkedIn Follow @LonzaGroup on X About BigHat Biosciences BigHat Biosciences is a biotechnology company with an AI/ML-guided antibody discovery and development platform, capable of engineering antibodies with more complex functions and better biophysical properties. By using its ML-powered antibody design program to iteratively improve antibodies through sequential design-build-test cycles. The system measures the biophysical properties and impact on disease activity using cell-based or other functional assays, which replicate in vivo disease processes. BigHat is a Series B biotech outside San Francisco with a team-oriented, inclusive, and family-friendly culture. Our pipeline of wholly-owned and partnered therapeutic programs focus on indications with high unmet need, such as cancer and inflammation. BigHat has raised over $100M from top investors, including Section 32, a16z, and 8VC. To learn more about us, visit and follow @BigHatBio on LinkedIn and Twitter. SOURCE Synaffix B.V. WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

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100 Deals associated with E-EDV-D682

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Indication	Highest Phase	Country/Location	Organization	Date
Bladder Cancer	Phase 2	Australia	EnGeneIC Pty Ltd.	04 Mar 2019
Colorectal Cancer	Phase 2	Australia	EnGeneIC Pty Ltd.	04 Mar 2019
Head and Neck Neoplasms	Phase 2	Australia	EnGeneIC Pty Ltd.	04 Mar 2019
Melanoma	Phase 2	Australia	EnGeneIC Pty Ltd.	04 Mar 2019
Non-Small Cell Lung Cancer	Phase 2	Australia	EnGeneIC Pty Ltd.	04 Mar 2019
Pancreatic Cancer	Phase 2	Australia	EnGeneIC Pty Ltd.	04 Mar 2019
Renal Cell Carcinoma	Phase 2	Australia	EnGeneIC Pty Ltd.	04 Mar 2019

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


ACTRN12619000385145 (Literature) Manual	Phase 1/2	Advanced Pancreatic Ductal Adenocarcinoma	25	E-EDV-D682	cwbxgtciue(zghvvrumvd) = nqkphifspp heranmfjda (bvmckubfjs ) View more	Positive	17 Nov 2023
ACTRN12619000385145 (Literature) Manual	Phase 1/2	Advanced Pancreatic Ductal Adenocarcinoma	25	E-EDV-D682 (Evaluable Subset)	cwbxgtciue(zghvvrumvd) = zaypqkaihu heranmfjda (bvmckubfjs ) View more	Positive	17 Nov 2023
ACTRN12619000385145 (ASCO2020)	Phase 1	Metastatic Pancreatic Cancer	9	EGFR-targeted EDV nanocells carrying cytotoxic drug PNU-159682	qlokaxvzto(vgufiisoel) = A minority of patients experienced G1 infusion reactions, which responded promptly to supportive treatment eampelshjj (neowedropo )	Positive	25 May 2020

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