Author: Brana, I ; Hyman, D M ; Oliva, M ; Schram, A M ; Lakhani, N J ; Siu, L L ; Hoff, D V ; Vieito Villar, M ; Garralda, E ; Hallett, R M ; Giblin, P ; Hua, F ; Spreafico, A ; Maetzel, D ; Seoane, J ; Hoffman, K ; Wasserman, R ; Tabernero, J ; Borazanci, E ; Anido, J ; Vickers, P J ; Kelly, A ; Hilbert, J

BACKGROUNDActivation of leukemia inhibitory factor (LIF) is linked to an immunosuppressive tumor microenvironment (TME), with a strong association between LIF expression and tumor-associated macrophages (TAMs). MSC-1 (AZD0171) is a humanized monoclonal antibody that binds with high affinity to LIF, promoting antitumor inflammation through TAM modulation and cancer stem cell inhibition, slowing tumor growth. In this phase I, first-in-human, open-label, dose-escalation study, MSC-1 monotherapy was assessed in patients with advanced, unresectable solid tumors.MATERIALS AND METHODSUsing accelerated-titration dose escalation followed by a 3 + 3 design, MSC-1 doses of 75-1500 mg were administered intravenously every 3 weeks (Q3W) until progression or unmanageable toxicity. Additional patients were enrolled in selected cohorts to further evaluate safety, pharmacokinetics (PK), and pharmacodynamics after escalation to the next dose had been approved. The primary objective was characterizing safety and determining the recommended phase II dose (RP2D). Evaluating antitumor activity and progression-free survival (PFS) by RECIST v1.1, PK and immunogenicity were secondary objectives. Exploratory objectives included pharmacodynamic effects on circulating LIF and TME immune markers.RESULTSForty-one patients received treatment. MSC-1 monotherapy was safe and well tolerated at all doses, with no dose-limiting toxicities. The maximum tolerated dose was not reached and the RP2D was determined to be 1500 mg Q3W. Almost half of the patients had treatment-related adverse events (TRAEs), with no apparent trends across doses; no patients withdrew due to TRAEs. There were no objective responses; 23.7% had stable disease for ≥2 consecutive tumor assessments. Median PFS was 5.9 weeks; 23.7% had PFS >16 weeks. On-treatment changes in circulating LIF and TME signal transducers and activators of transcription 3 signaling, M1:M2 macrophage populations, and CD8+ T-cell infiltration were consistent with the hypothesized mechanism of action.CONCLUSIONSMSC-1 was very well tolerated across doses, with prolonged PFS in some patients. Biomarker and preclinical data suggest potential synergy with checkpoint inhibitors.

18 Aug 2018·mAbsQ2 · MEDICINE

Homology modeling and structure-based design improve hydrophobic interaction chromatography behavior of integrin binding antibodies

Q2 · MEDICINE

Article

Author: Fransson, Johan ; Jmeian, Yazen ; Jeganathan, Ajitha ; Giblin, Patricia ; Jetha, Arif ; Thorsteinson, Nels

Monoclonal antibody (mAb) candidates from high-throughput screening or binding affinity optimization often contain mutations leading to liabilities for further development of the antibody, such as aggregation-prone regions and lack of solubility. In this work, we optimized a candidate integrin α11-binding mAb for developability using molecular modeling, rational design, and hydrophobic interaction chromatography (HIC). A homology model of the parental mAb Fv region was built, and this revealed hydrophobic patches on the surface of the complementarity-determining region loops. A series of 97 variants of the residues primarily responsible for the hydrophobic patches were expressed and their HIC retention times (RT) were measured. As intended, many of the computationally designed variants reduced the HIC RT compared to the parental mAb, and mutating residues that contributed most to hydrophobic patches had the greatest effect on HIC RT. A retrospective analysis was then performed where 3-dimentional protein property descriptors were evaluated for their ability to predict HIC RT using the current series of mAbs. The same descriptors were used to train a simple multi-parameter protein quantitative structure-property relationship model on this data, producing an improved correlation. We also extended this analysis to recently published HIC data for 137 clinical mAb candidates as well as 31 adnectin variants, and found that the surface area of hydrophobic patches averaged over a molecular dynamics sample consistently correlated to the experimental data across a diverse set of biotherapeutics.

01 Jul 2018·Cancer Research

Abstract 1751: MSC-1 is a first-in-class humanized monoclonal antibody that modulates the tumor microenvironment by inhibiting a novel cancer immunotherapy target, LIF

Author: Hallett, Robin ; Seoane, Joan ; Magram, Jeanne ; Pandya, Naimish ; Fransson, Johan ; Hoffman, Kimberly ; Wasserman, Robert ; Anido, Judit ; Sala, Ada ; Raman, Swetha ; Sinclair, Angus ; Julien, Jean-Philippe ; Giblin, Patricia ; Pascual, Monica ; Huber-Ruano, Isabel ; Chigancas, Vanessa

AbstractLeukemia Inhibitory Factor (LIF) is a member of the IL-6 family of cytokines and is involved in many physiological and pathological processes including the promotion of an immunosuppressive environment to support embryo implantation, down-regulation of autoimmune processes and the regulation of stem cell homeostasis and differentiation. In cancer, LIF is hypothesized to have a complex role tumor development and progression, creating an immunosuppressive tumor microenvironment as well as promoting the activity of cancer initiating cells (CICs). LIF is highly expressed in a subset of tumors across multiple tumor types, e.g. glioblastoma multiforme (GBM), non-small cell lung cancer (NSCLC), colon, ovarian, prostate, and pancreatic cancer, and correlates with poor prognosis. Given the pleiotropic role LIF is hypothesized to play in cancer, inhibition of LIF represents an exciting new therapeutic concept sitting at the intersection of two key therapeutic approaches in oncology: blockade of tumor evasion of the immune system and blockade of tumor growth via inhibition of CICs. We have identified and developed MSC-1, a first-in-class humanized IgG1 monoclonal antibody that is a potent and selective inhibitor of LIF. MSC-1 cross reacts with mouse and non-human primate LIF and inhibits LIF signaling by blocking the recruitment of gp130 to the LIF-LIFR-gp130 signaling complex. The efficacy of MSC-1 was evaluated in multiple mouse tumor models and the mechanism of action investigated. LIF inhibition with MSC-1 or shRNAs reduced tumor growth in multiple syngeneic tumor models (NSCLC, ovarian and colon), and clear target engagement was shown for MSC-1. Investigations into the mechanism of action identified that inhibition of LIF with MSC-1 reprogrammed the tumor microenvironment by decreasing immunosuppressive M2 macrophages and increasing the number of intratumoral NK cells and total/activated T cells. MSC-1 also decreased immunosuppressive M2 macrophages in an orthotopic GBM xenograft model and human GBM organotypic tumor slices in an ex vivo model. Similarly, immunosuppressive macrophage genes were decreased when monocytes were co-cultured with supernatants from a GBM cell line in which LIF expression had been knocked-down. Given the effects of MSC-1 on intratumoral immune cells, we hypothesized that MSC-1 could be effectively combined with checkpoint inhibitors and we are currently evaluating MSC-1/checkpoint inhibitor combination therapy. Taken together, these findings form the basis of a robust therapeutic hypothesis, whereby MSC-1 treatment will lead to clinical activity in multiple cancer indications. A Phase I dose-escalation and expansion study of MSC-1 is planned to initiate early 2018 in patients with advanced solid tumors that will incorporate target engagement and PD biomarkers, as well as safety and efficacy endpoints.Citation Format: Angus Sinclair, Robin Hallett, Patricia Giblin, Isabel Huber-Ruano, Judit Anido, Naimish Pandya, Kimberly Hoffman, Ada Sala, Monica Pascual, Vanessa Chigancas, Swetha Raman, Johan Fransson, Jean-Philippe Julien, Robert Wasserman, Jeanne Magram, Joan Seoane. MSC-1 is a first-in-class humanized monoclonal antibody that modulates the tumor microenvironment by inhibiting a novel cancer immunotherapy target, LIF [abstract]. In: Proceedings of the American Association for Cancer Research Annual Meeting 2018; 2018 Apr 14-18; Chicago, IL. Philadelphia (PA): AACR; Cancer Res 2018;78(13 Suppl):Abstract nr 1751.

News (Medical) associated with Northern Biologics, Inc.

08 Jul 2024

·www.globenewswire.com

Avacta Announces the Appointment of Darlene Deptula-Hicks as Non-Executive Director of the Board of Directors

Avacta Group plc Avacta Announces the Appointment of Darlene Deptula-Hicks as Non-Executive Director of the Board of Directors London, England; July 8, 2024; Avacta Group plc (AIM: AVCT), a life sciences company developing innovative, targeted cancer treatments and powerful diagnostics, today announced the appointment of Darlene Deptula-Hicks, MBA as a Non-Executive Director of the Company’s Board of Directors, effective 26 June 2024. Ms. Deptula-Hicks is a highly accomplished financial executive with decades of experience working with and advising private and public life sciences companies. Shaun Chilton, Chairman of the Board of Avacta, commented: “Avacta is at a pivotal time in its evolution, intensifying its focus on advancing our pre|CISION™ technology through clinical development. As we do so, it’s critical that the Avacta Board has the right commercial, financial and operational experience to support this. We look forward to working with Darlene in developing our capital market strategy and potential partnerships.” Christina Coughlin MD, PhD, CEO of Avacta, added:“As our clinical progress continues to gain momentum, we have evolved the Avacta Board to provide more robust commercial and market focus. Darlene brings many years’ experience that will provide invaluable support as we progress our platform.” Ms. Deptula-Hicks is the interim CFO at Normunity, and prior to that served as CFO of F-star Therapeutics (NASDAQ:FSTX), which she took public in 2020 and successfully sold in 2023. Previously, she held the role of CFO at Northern Biologics and T2 Biosystems (NASDAQ:TTOO). She also served as SVP and CFO of Pieris Pharmaceuticals (NASDAQ:PIRS) which she also took public. Ms. Deptula-Hicks currently sits on the Board of Directors of Abcuro and Aerami Therapeutics, providing strategic financial and business direction. Ms. Deptula-Hicks received her M.B.A. from Rivier University and B.S. in Accounting from Southern New Hampshire University. Darlene Deptula-Hicks MBA, Non-Executive Director of Avacta, commented: “It’s an exciting time to be joining the Board of Avacta as the Company expands the clinical development of its therapeutic business and prepares to release a pipeline of innovative new medicines. I look forward to working with the Board and management, bringing my global market experience and contributing to the Company’s strategy and success.” About Avacta Group plc - www.avacta.com Avacta Group is a UK-based life sciences company focused on improving healthcare outcomes through targeted cancer treatments and diagnostics. Avacta Therapeutics: a clinical stage oncology biotech division harnessing proprietary therapeutic platforms to develop novel, highly targeted cancer drugs. Avacta Diagnostics focuses on supporting healthcare professionals and broadening access to diagnostics. Avacta has two proprietary platforms, pre|CISION™ and Affimer®. The pre|CISION™ platform is a highly specific substrate for fibroblast activation protein (FAP) which is upregulated in most solid tumours compared with healthy tissues. The pre|CISION™ platform harnesses this tumour specific protease to activate pre|CISION™ peptide drug conjugates and pre|CISION™ antibody/Affimer® drug conjugates in the tumour microenvironment, reducing systemic exposure and toxicity, allowing dosing to be optimised to deliver the best outcomes for patients. The lead pre|CISION™ programme AVA6000, a peptide drug conjugate form of doxorubicin, is in Phase 1 studies. It has shown an improvement in safety and tolerability in clinical trials to date compared with standard doxorubicin and preliminary signs of clinical activity in multiple patients. To register for news alerts by email go to www.avacta.com/investor-news-email-alerts. For further information from Avacta Group plc, please contact: Avacta Group plcChristina Coughlin, CEO Tony Gardiner, Chief Financial OfficerMichael Vinegrad, Group Communications Directorwww.avacta.com Peel Hunt (Nomad and Broker)James Steel / Chris Golden / Patrick Birkholmwww.peelhunt.comICR Consilium Mary-Jane Elliott / Jessica Hodgson / Sukaina Virjiavacta@consilium-comms.com

Executive ChangePhase 1PDC

03 Nov 2023

·www.globenewswire.com

Mendus Phase 1 vididencel clinical trial results in AML and high-risk MDS patients published in peer-reviewed medical journal

Press Release Stockholm, Sweden, November 3, 2023 Mendus Phase 1 vididencel clinical trial results in AML and high-risk MDS patients published in peer-reviewed medical journal Publication provides additional clinical evidence that vididencel has strong potential as a new maintenance therapy in AML and high-risk MDS patientsPatients with low disease burden have the best chance to respond to vididencel treatment, supporting the maintenance therapy setting currently pursued in the ADVANCE II Phase 2 trialPatients with adverse cytogenetic risk profile may still respond to vididencel therapyResults also indicate that vididencel can be safely and effectively combined with azacitidine Mendus AB (“Mendus” publ; IMMU.ST), a biopharmaceutical company focused on immunotherapies addressing tumor recurrence, today announced the publication of additional Phase 1 clinical trial data on its lead development program vididencel in the peer-reviewed medical journal HemaSphere. The data supports the potential of vididencel as a novel acute myeloid leukemia (AML) maintenance therapy and provides valuable insights for the current and future clinical trials with vididencel in AML and high-risk MDS. The publication, titled “Durable Responses and Survival in High-Risk Myelodysplastic Syndrome and Acute Myeloid Leukemia Patients Receiving the Allogeneic Leukemia-derived Dendritic Cell Vaccine DCP-001”, and written by researchers from the Amsterdam UMC, Cancer Center Amsterdam and Erasmus University Medical Center, describes the long-term follow up data and additional patient characteristics from the Phase 1 clinical trial evaluating vididencel (DCP-001) in acute myeloid leukemia (AML) and high-risk myelodysplastic syndromes (MDS). “There remains a high medical need for new treatment options in AML and MDS. The Phase 1 study with vididencel demonstrated promising signs of efficacy and a benign safety profile, supporting the continued evaluation of this novel immunotherapy as a maintenance treatment, either as a monotherapy or in combination with other treatments,” said Prof. Dr. Arjan van de Loosdrecht, Professor of Hematology at Amsterdam UMC and Principal Investigator in the trial. “Since the completion of the Phase 1 trial, the knowledge in the medical community with respect to relapse dynamics, MRD and maintenance therapy in general has improved and we hope to see the combined impact of this more profound body of expertise in subsequent studies, including the ongoing ADVANCE II trial.” “In addition to a positive overall outcome based on safety and feasibility of vididencel in AML and high-risk MDS, the Phase 1 trial data support the positioning of vididencel as a maintenance therapy for patients with low tumor burden, but with a high risk of disease relapse. This is the basis of our ongoing ADVANCE II Phase 2 monotherapy study, which has demonstrated the potential of vididencel to reduce residual disease and prolong disease-free survival in AML patients in complete remission, but with measurable residual disease (MRD). The Phase 1 trial data also indicate that vididencel can be safely and effectively combined with azacitidine,” said Jeroen Rovers, MD, PhD, Chief Medical Officer at Mendus. In the Phase 1 clinical trial 12 patients were treated with vididencel (product ID: DCP-001), six patients with AML, three patients with AML with prior MDS and three patients with MDS with excess of blasts. Seven out of twelve patients showed a response to treatment; five patients showed progression of disease. The main discriminating variables in favor of response were patients who entered the study either in complete remission or who had stable disease status and a low percentage of blasts in the bone marrow at study entry. Importantly, there was no association found between response and disease risk classification with the majority of responding patients having an adverse cytogenetic risk profile, which is highly encouraging given the difficulty in effecting positive outcomes for these patients with a poor prognosis. In the seven responders, a median relapse free survival (RFS) of 420 days (≈ 14 months) and a median overall survival (OS) of 1090 days (≈ 36 months) was observed as compared to a median OS of 144 days in the five non-responders. The longest surviving patient experienced an RFS of 1,849 days (≈ 5 years) and OS of 2,160 days (≈ 5.9 years) after treatment with vididencel. In a subset of three patients, who initially responded to vididencel but later relapsed, post-vaccination treatment with azacitidine was evaluated and resulted in one complete remission and two partial responses. The data suggest that azacitidine and vididencel may act synergistically. The publication is available on the HemaSphere website. For a link to the article, please click here. FOR MORE INFORMATION, PLEASE CONTACT: Erik Manting, CEO E-mail: ir@mendus.com ABOUT MENDUS AB (publ) Mendus is dedicated to changing the course of cancer treatment by addressing tumor recurrence and improving survival outcomes for cancer patients, while preserving quality of life. We are leveraging our unparalleled expertise in allogeneic dendritic cell biology to develop an advanced clinical pipeline of novel, off-the-shelf, cell-based immunotherapies which combine clinical efficacy with a benign safety profile. Based in Sweden and The Netherlands, Mendus is publicly traded on the Nasdaq Stockholm under the ticker IMMU.ST. http://www.mendus.com/ ABOUT VIDIDENCEL Vididencel is an off-the-shelf immunotherapy which is being developed as a cancer maintenance treatment, aimed at improving disease-free survival following first-line treatment. Vididencel is currently studied in a Phase 2 monotherapy trial in acute myeloid leukemia (AML) and a Phase 1 safety and feasibility trial in ovarian cancer. In December 2022, positive results from the ADVANCE II monotherapy Phase 2 trial in AML were presented at the American Society of Hematology (ASH) Annual Meeting. The analysis demonstrated the potential of vididencel to induce durable relapse-free survival in the majority of patients. Vididencel has received Orphan Drug Designation in Europe and the US and Fast Track Designation in the US for the treatment of AML. Mendus has secured a manufacturing alliance with NorthX Biologics for large-scale production of vididencel. Attachment 231103 Mendus_HemaSphere_Publication_ENG_FINAL

Clinical ResultPhase 2Fast TrackImmunotherapyPhase 1

02 Nov 2023

·www.globenewswire.com

Mendus announces multiple abstracts to be presented at ASH 2023 including oral presentation on ADVANCE II survival data

Press Release Stockholm, Sweden, November 2, 2023 Mendus announces multiple abstracts to be presented at ASH 2023 including oral presentation on ADVANCE II survival data Three abstracts based on the ADVANCE II trial to be presented at ASH2023Relapse-free and overall survival data update to be presented as oral presentation on December 11Additional abstracts to be presented based on ADVANCE II immunomonitoring data Mendus AB (“Mendus” publ; IMMU.ST), a biopharmaceutical company focused on immunotherapies addressing tumor recurrence, today announced the presentation of three abstracts related to the development of Mendus’ lead product candidate vididencel in acute myeloid leukemia (AML) at the American Society of Hematology’s upcoming 65th Annual Meeting, held in San Diego, California December 9-12, 2023 (ASH 2023). Relapse-free and overall survival data from the ongoing ADVANCE II monotherapy trial will be presented as an oral presentation. Two additional abstracts will be presented by Mendus and academic collaborators based on immunomonitoring data, supporting vididencel’s mechanism of action. ASH abstracts were released today, November 2, at 9am ET (14.00 CET) and can be viewed here. Of note, the oral presentation will present results from the ADVANCE II trial based on survival data which extend past the cut-off date as published in the ASH abstract submitted. “We are excited to have the opportunity to share the progress made in the development of vididencel in AML at ASH 2023, the largest and most significant hematology conference in the world,” said Jeroen Rovers, CMO of Mendus. “The fact that the ADVANCE II trial update has again been selected for an oral presentation underscores the growing interest in vididencel as a novel maintenance treatment option in AML by the specialist medical community.” ASH 2023 will take place on December 9-12, 2023 at the San Diego Convention Center in San Diego, California, and virtually. Details of the Mendus abstracts to be presented are below: 1. Title: Induction of Cellular and Humoral Immune Responses Is Associated with Durable Remissions in MRD+ AML-Patients after Maintenance Treatment with an Allogeneic Leukemia-Derived Dendritic Cell Vaccine Abstract Number: 769 Presenter: Prof Dr A.A. van de Loosdrecht (Amsterdam UMC, The Netherlands) Session Name: 704. Cellular Immunotherapies: Early Phase and Investigational Therapies: Novel Approaches to Enhance Cellular Therapies and Immune Responses in Leukemias and Lymphomas Session Date: Monday, December 11, 2023 Session Time: 10:30 AM - 12:00 PM Presentation Time: 10:30 AM Room: San Diego Convention Center, Room 6CF 2. Title: Vaccination Using an Allogeneic Leukemia-Derived Dendritic Cell Vaccine, Maintains and Improves Frequencies of Circulating Antigen Presenting Dendritic Cells Correlating with Relapse Free and Overall Survival in AML Patients Abstract Number: 2957 Presenter: Dr J.P. Rovers (Chief Medical Officer, Mendus) Session Name: 617. Acute Myeloid Leukemias: Biomarkers, Molecular Markers and Minimal Residual Disease in Diagnosis and Prognosis: Poster II Session Date: Sunday, December 10, 2023 Presentation Time: 6:00 PM - 8:00 PM Location: San Diego Convention Center, Halls G-H 3. Title: Intradermal Vaccination with Vididencel in MRD+ AML-Patients Leads to Increase in Antigen Presenting Cells and T-Cells to the Injection Site, Visualized Using Imaging Mass Cytometry, Showing Local Immune Cell Interactions Leading to Systemic Immune Responses Abstract Number: 2942 Presenter: Dr Ø. Sefland (Haukeland University Hospital, Bergen University, Norway) Session Name: 617. Acute Myeloid Leukemias: Biomarkers, Molecular Markers and Minimal Residual Disease in Diagnosis and Prognosis: Poster II Session Date: Sunday, December 10, 2023 Presentation Time: 6:00 PM - 8:00 PM Location: San Diego Convention Center, Halls G-H For more information, please contact: Erik Manting Chief Executive Officer E-mail: ir@mendus.com ABOUT MENDUS AB (publ) Mendus is dedicated to changing the course of cancer treatment by addressing tumor recurrence and improving survival outcomes for cancer patients, while preserving quality of life. We are leveraging our unparalleled expertise in allogeneic dendritic cell biology to develop an advanced clinical pipeline of novel, off-the-shelf, cell-based immunotherapies which combine clinical efficacy with a benign safety profile. Based in Sweden and The Netherlands, Mendus is publicly traded on the Nasdaq Stockholm under the ticker IMMU.ST. http://www.mendus.com/ ABOUT VIDIDENCEL Vididencel is an off-the-shelf immunotherapy which is being developed as a cancer maintenance treatment, aimed at improving disease-free survival following first-line treatment. Vididencel is currently studied in a Phase 2 monotherapy trial in acute myeloid leukemia (AML) and a Phase 1 safety and feasibility trial in ovarian cancer. In December 2022, positive results from the ADVANCE II monotherapy Phase 2 trial in AML were presented at the American Society of Hematology (ASH) Annual Meeting. The analysis demonstrated the potential of vididencel to induce durable relapse-free survival in the majority of patients. Vididencel has received Orphan Drug Designation in Europe and the US and Fast Track Designation in the US for the treatment of AML. Mendus has secured a manufacturing alliance with NorthX Biologics for large-scale production of vididencel. Attachment 231102 ASH abstract announcement_ENG

Clinical ResultPhase 2ImmunotherapyOrphan DrugFast Track

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Drug(Targets)	Indications	Global Highest Phase

MSC-1(Northern) ( LIF )	Neoplasms More	Preclinical
NTX-1088 ( PVR )	Solid tumor More	Discontinued
NB-6377	Acute Myeloid Leukemia More	Pending
NB-0893 ( TIM3 )	Neoplasms More	Pending
NB-6253 ( TIGIT )	Neoplasms More	Pending

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