Immutep Ltd. New Age Immune Regulator; Initiate with a Buy Rating and $8.30 Price Target
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Immutep Completes Patient Enrolment of the AIPAC Phase Iib Clinical Trial in Metastatic Breast Cancer
ASX/Media Release Immutep Completes Patient Enrolment of the AIPAC Phase IIb Clinical Trial in Metastatic Breast Cancer • 226 patients with metastatic breast cancer have been enrolled in the AIPAC study • Combination of eftilagimod alpha, an antigen presenting cell (APC) activator, administered in combination with chemotherapy is designed to boost the T-cell immune responses against tumours • Read-out of progression-free survival (PFS) primary endpoint expected to occur in Q1 of calendar year 2020 SYDNEY, AUSTRALIA – June 25, 2019 – Immutep Limited (ASX: IMM; NASDAQ: IMMP) ("Immutep” or “the Company”), a biotechnology company developing novel immunotherapy treatments for cancer and autoimmune diseases, announces that it has completed patient enrolment of the Phase IIb Active Immunotherapy PAClitaxel (AIPAC) clinical trial in HER2-negative/ Hormone Receptor positive (HR+) metastatic breast cancer (MBC). The AIPAC study has enrolled 226 patients at more than 30 clinical trial sites across Germany, the UK, France, Hungary, Belgium, Poland and the Netherlands. The trial is evaluating Immutep’s lead product candidate, eftilagimod alpha (efti or IMP321), in combination with paclitaxel, a standard of care chemotherapy, as a chemo-immunotherapy combination in patients with HR+ MBC not eligible for human epidermal receptor 2 (HER2) therapies. This combination is designed to boost the immune response against tumour cells compared to chemotherapy plus placebo. Apoptotic tumour cells induced by chemotherapy release antigenic tumour debris which are then captured by APCs. Boosting the APC network with efti increases cytotoxic T-cell responses which complements the direct cytotoxic effect of the chemotherapy. The primary endpoint of the AIPAC study is PFS according to RECIST as evaluated by blinded independent central readers. -
Innovent Biologics (1801
22 Jul 2021 CMB International Securities | Equity Research | Company Initiation Innovent Biologics (1801 HK) BUY (Initiation) Growing into a global biopharma company Target Price HK$120.91 Up/Downside +43.00% Current Price HK$84.55 Rich innovative drug pipelines. Innovent is a leading integrated biopharma company with comprehensive innovative pipelines including monoclonal antibodies (mAbs), bispecific antibodies (bsAbs), small molecules and CAR- China Healthcare Sector T therapies, covering oncology, autoimmune and metabolic diseases. Besides five marketed products (sintilimab, three biosimilars and pemigatinib), Jill Wu, CFA Innovent has six innovative drugs in pivotal clinical stage, including IBI306 (852) 3900 0842 (PCSK9 antibody), IBI310 (CTLA-4 antibody), IBI376 (PI3Kδ inhibitor), IBI326 [email protected] (BCMA-CART), taletrectinib (ROS1/NTRK inhibitor) and HQP1351 (olverembatinib, third-generation BCR-ABL TKI). In addition, Innovent has Sam Hu, PhD established a comprehensive innovative portfolio covering next-generation (852) 3900 0882 immuno-oncology (I/O) targets, including CD47/SIRPα, TIGT, LAG3, 4-1BB, [email protected] etc. It’s worth noting that Innovent is an early mover in CD47-SIRPα pathway with three assets under development, including clinical-stage IBI188 (a CD47 Jonathan Zhao antibody) and IBI322 (a PD-L1/CD47 bispecific antibody), and preclinical (852) 6359 1614 stage IBI397 (AL008, a SIRPα antibody). [email protected] Tyvyt being an early mover in large indications. After the approval for r/r- cHL in Dec 2018, Tyvyt has been approved by the NMPA for 1L ns-NSCLC, Mkt. Cap. (HK$ mn) 123,312 1L s-NSCLC and 1L HCC in 2021. These three large indications may be Avg. -
LAG-3: from Molecular Functions to Clinical Applications
Open access Review J Immunother Cancer: first published as 10.1136/jitc-2020-001014 on 13 September 2020. Downloaded from LAG-3: from molecular functions to clinical applications Takumi Maruhashi , Daisuke Sugiura , Il- mi Okazaki , Taku Okazaki To cite: Maruhashi T, Sugiura D, ABSTRACT (PD-1) and cytotoxic T lymphocyte antigen Okazaki I, et al. LAG-3: from To prevent the destruction of tissues owing to excessive 4 (CTLA-4) significantly improved the molecular functions to clinical and/or inappropriate immune responses, immune outcomes of patients with diverse cancer applications. Journal for cells are under strict check by various regulatory ImmunoTherapy of Cancer types, revolutionizing cancer treatment. The mechanisms at multiple points. Inhibitory coreceptors, 2020;8:e001014. doi:10.1136/ success of these therapies verified that inhib- including programmed cell death 1 (PD-1) and cytotoxic jitc-2020-001014 itory coreceptors serve as critical checkpoints T lymphocyte antigen 4 (CTLA-4), serve as critical checkpoints in restricting immune responses against for immune cells to not attack the tumor Accepted 29 July 2020 self- tissues and tumor cells. Immune checkpoint inhibitors cells as well as self-tissues. However, response that block PD-1 and CTLA-4 pathways significantly rates are typically lower and immune-related improved the outcomes of patients with diverse cancer adverse events (irAEs) are also observed in types and have revolutionized cancer treatment. However, patients administered with immune check- response rates to such therapies are rather limited, and point inhibitors. This is indicative of the immune-rela ted adverse events are also observed in a continued need to decipher the complex substantial patient population, leading to the urgent need biology of inhibitory coreceptors to increase for novel therapeutics with higher efficacy and lower response rates and prevent such unwanted toxicity. -
Of Eftilagimod Alpha
Initial results from a Phase II study (TACTI-002) of eftilagimod alpha (soluble LAG-3 Presentation Number: 927P protein) and pembrolizumab as 2nd line treatment for PD-L1 unselected metastatic head and neck cancer (HNSCC) patients 1 2 3 4 5 6 7 Authors: Forster M ; Felip E ; Doger B ; Pousa P ; Carcereny E , Bajaj P ; Church M , Peguero 2, J8, Roxburgh P9, Triebel F10 Trial Design Part C stage 1 – PD-X naive 2nd line HNSCC PD-L1 all comer Affiliates: Part A: 1st line, PD-X naïve NSCLC; Stage IIIB not amenable to curative treatment or stage IV not amenable • 18 patients enrolled, treated and evaluated (16 with ≥ 1 1. Forster: UCL Cancer Institute / University College London Hospitals NHS Foundation, London, UK Baseline Parameters (n=18) N (%) 2. Felip: Vall d’Hebron University Hospital, Barcelona, Spain to EGFR/ALK based therapy, treatment-naïve for advanced/metastatic disease post baseline scan) 3. Doger: START Madrid- Fundación Jiménez Diaz, Madrid, Spain Part B: 2nd line, PD-X refractory NSCLC; Pts after failure of 1st line therapy for metastatic disease which incl. • Different types of HNSCC: Age [yrs] Median 66 (48-78) 4. Lopez Pousa : Hospital de la Santa Creu i Sant Pau, Barcelona, Spain at least 2 cycles of PD-X o 5. Carcereny: Catalan Institute of Oncology Badalona-Hospital Germans Trias i Pujol, B-ARGO group; Badalona, Spain Oropharynx n=6; 33.3 % Female / Male 1 (5.6) / 17 (94.4) 6. Bajaj: Griffith University, Gold Coast, Australia Part C: 2nd line PD-X naive HNSCC; Recurrent disease not amenable to curative treatment, or metastatic o Hypopharynx n=5; 27.8 % ECOG 0 / 1 10 (55.6) / 8 (44.4) 7. -
AIPAC Global Webcast Slides
Global Webcast Slides Interim overall survival results in metastatic breast cancer from the randomized, placebo controlled and double-blinded Phase IIb (AIPAC) trial (ASX: IMM, NASDAQ: IMMP) Notice: Forward Looking Statements The purpose of the presentation is to provide an update of the business of Immutep Limited ACN 009 237 889 (ASX:IMM; NASDAQ:IMMP). These slides have been prepared as a presentation aid only and the information they contain may require further explanation and/or clarification. Accordingly, these slides and the information they contain should be read in conjunction with past and future announcements made by Immutep and should not be relied upon as an independent source of information. Please refer to the Company's website and/or the Company’s filings to the ASX and SEC for further information. The views expressed in this presentation contain information derived from publicly available sources that have not been independently verified. No representation or warranty is made as to the accuracy, completeness or reliability of the information. Any forward looking statements in this presentation have been prepared on the basis of a number of assumptions which may prove incorrect and the current intentions, plans, expectations and beliefs about future events are subject to risks, uncertainties and other factors, many of which are outside Immutep’s control. Important factors that could cause actual results to differ materially from assumptions or expectations expressed or implied in this presentation include known and unknown risks. Because actual results could differ materially to assumptions made and Immutep’s current intentions, plans, expectations and beliefs about the future, you are urged to view all forward looking statements contained in this presentation with caution. -
An Active Immunotherapy Combined with First-Line Weekly Paclitaxel In
An active immunotherapy combined with first-line weekly paclitaxel in metastatic breast cancer: first results of IMP321 (LAG-3Ig) as an antigen presenting cell activator in the AIPAC phase IIb trial Frédéric Triebel, CSO/CMO Precision: Breast Cancer March 7-8, 2017 Boston, MA. 1 ASX:PRR; NASDAQ:PBMD Notice: Forward Looking Statements The purpose of the presentation is to provide an update of the business of Prima BioMed Ltd ACN 009 237 889 (ASX:PRR; NASDAQ:PBMD). These slides have been prepared as a presentation aid only and the information they contain may require further explanation and/or clarification. Accordingly, these slides and the information they contain should be read in conjunction with past and future announcements made by Prima BioMed and should not be relied upon as an independent source of information. Please refer to the Company's website and/or the Company’s filings to the ASX and SEC for further information. The views expressed in this presentation contain information derived from publicly available sources that have not been independently verified. No representation or warranty is made as to the accuracy, completeness or reliability of the information. Any forward looking statements in this presentation have been prepared on the basis of a number of assumptions which may prove incorrect and the current intentions, plans, expectations and beliefs about future events are subject to risks, uncertainties and other factors, many of which are outside Prima BioMed’s control. Important factors that could cause actual results to differ materially from assumptions or expectations expressed or implied in this presentation include known and unknown risks. -
Immutep Limited (ASX: IMM; NASDAQ: IMMP) (“Immutep” Or “The Company”) Is Pleased to Announce the Grant of Canadian Patent No
ASX/Media Release (Code: ASX: IMM; NASDAQ: IMMP) 7 August 2018 IMMUTEP SECURES CANADIAN PATENT GRANT FOR IMP731 ANTIBODY SYDNEY, AUSTRALIA - Immutep Limited (ASX: IMM; NASDAQ: IMMP) (“Immutep” or “the Company”) is pleased to announce the grant of Canadian patent no. 2,685,584 entitled “Cytotoxic anti-LAG-3 monoclonal antibody and its use in the treatment or prevention of organ transplant rejection and autoimmune disease.” The patent is directed to Immutep’s IMP731 antibody that was originally developed by Immutep S.A.S., Immutep’s French subsidiary. The granted claims provide broad protection for the antibody and use of the antibody for treating or preventing organ transplant rejection or treating a T-cell mediated autoimmune disease. The patent has an expiry date of 30 April 2028, and joins corresponding patents from the same family previously granted in the United States, Europe and Japan, as announced to the market. Rights for the development of the IMP731 antibody were granted to GSK in December 2010. GSK has developed a proprietary humanized antibody derived from IMP731, known as GSK2831781. About IMP731 and GSK2831781 IMP731 and GSK2831781 are designed to specifically deplete potentially pathogenic, recently activated, LAG-3 expressing T cells that are enriched at the disease site in T-cell driven immuno‐inflammatory disorders. Depletion of these LAG-3 expressing T cells should spare other T-cells which may be necessary for disease control. About Immutep Immutep is a globally active biotechnology company that is a leader in the development of immunotherapeutic products for the treatment of cancer and autoimmune disease. Immutep is dedicated to leveraging its technology and expertise to bring innovative treatment options to market for patients and to maximise value to shareholders. -
Asx: Prr, Nasdaq: Pbmd
ASX: PRR, NASDAQ: PBMD August 2017 CORPORATE PRESENTATION Notice: Forward Looking Statements The purpose of the presentation is to provide an update of the business of Prima BioMed Ltd ACN 009 237 889 (ASX:PRR; NASDAQ:PBMD). These slides have been prepared as a presentation aid only and the information they contain may require further explanation and/or clarification. Accordingly, these slides and the information they contain should be read in conjunction with past and future announcements made by Prima BioMed and should not be relied upon as an independent source of information. Please refer to the Company's website and/or the Company’s filings to the ASX and SEC for further information. The views expressed in this presentation contain information derived from publicly available sources that have not been independently verified. No representation or warranty is made as to the accuracy, completeness or reliability of the information. Any forward looking statements in this presentation have been prepared on the basis of a number of assumptions which may prove incorrect and the current intentions, plans, expectations and beliefs about future events are subject to risks, uncertainties and other factors, many of which are outside Prima BioMed’s control. Important factors that could cause actual results to differ materially from assumptions or expectations expressed or implied in this presentation include known and unknown risks. Because actual results could differ materially to assumptions made and Prima BioMed’s current intentions, plans, expectations and beliefs about the future, you are urged to view all forward looking statements contained in this presentation with caution. -
ASX/Media Release (Code: ASX: PRR; NASDAQ: PBMD) 22 December 2016
ASX/Media Release (Code: ASX: PRR; NASDAQ: PBMD) 22 December 2016 PRIMA BIOMED ANNOUNCES DATA FROM IMP321 AIPAC CLINICAL TRIAL IN BREAST CANCER SYDNEY, AUSTRALIA - Prima BioMed Ltd (ASX: PRR; NASDAQ: PBMD) (“Prima” or the “Company”) today announced interim data from the AIPAC Phase IIb clinical trial for IMP321 in metastatic breast cancer (Active Immunotherapy PAClitaxel). The initial data confirms previous trial results showing IMP321 is safe and well tolerated. In this Phase IIb study of IMP321 plus paclitaxel chemotherapy in patients with hormone receptor-positive metastatic breast cancer, data from all 15 patients in the safety run-in phase demonstrated that IMP321 is safe and well tolerated at both the 6mg and 30mg dosage levels. Immune monitoring data has also confirmed that IMP321, as an Antigen Presenting Cell (APC) activator, is working to generate the desired immune responses. The data demonstrated activation and an increased level of blood monocytes, dendritic cells and CD8 T-cells. Prima’s Chief Medical Officer, Dr Frédéric Triebel, said: “Following the initial data released in June, we are now very pleased to confirm the safety, pharmacokinetics and pharmacodynamics of IMP321 across the initial patient cohorts at both dosage levels. This is another important step in de-risking our AIPAC trial as we look to commence the enlarged randomised and double- blind phase in the new year. We also look forward to providing further insights into efficacy of these safety run in patients by the middle of 2017.” Subject to the confirmation of the dose escalation committee on the 30th December, Prima will now commence the randomised phase of the trial in January 2017. -
Immutep Novartis Patent
ASX/Media Release IMMUTEP ANNOUNCES EUROPEAN PATENT GRANT FOR LAG525 ANTIBODY SYDNEY, AUSTRALIA – 14 November 2019 – Immutep Limited (ASX: IMM; NASDAQ: IMMP) ("Immutep” or “the Company”) is pleased to announce the grant of patent no. 3116909 entitled “Antibody molecules to LAG-3 and uses thereof” by the European Patent Office. The claims of the patent are directed to LAG525, and to the use of LAG525 in the treatment of cancer and infectious disease. LAG525 is a humanised form of Immutep’s IMP701 antibody that was originally developed by Immutep S.A. (now Immutep S.A.S.), a wholly owned subsidiary of the Company. The patent is co-owned by Novartis AG and Immutep S.A.S. and will expire on 13 March 2035. About IMP701 and LAG525 IMP701 is a therapeutic antibody originally developed by Immutep S.A. to target LAG-3. This antagonist antibody plays a role in controlling the signalling pathways in both effector T cells and regulatory T cells (Treg). The antibody works to both activate effector T cells (by blocking inhibitory signals that would otherwise switch them off) and at the same time inhibit Treg function that normally prevent T cells from responding to antigen stimulation. The antibody therefore removes two brakes that prevent the immune system from responding to and killing cancer cells. In contrast, some other checkpoint antibodies in development target only the effector T cell pathway and don’t address the Treg pathway. Rights to the development and commercialisation of IMP701 were licensed to CoStim Pharmaceuticals in 2012, which was subsequently acquired by Novartis in 2014. -
IMM Granted European Patent for IMP761
ASX/Media Release IMMUTEP GRANTED EUROPEAN PATENT FOR IMP761 SYDNEY, AUSTRALIA – 21 October 2020 – Immutep Limited (ASX: IMM; NASDAQ: IMMP) ("Immutep” or “the Company”), a biotechnology company developing novel immunotherapy treatments for cancer and autoimmune disease, is pleased to announce the grant of a new patent (number 3344654) entitled “Anti- LAG-3 Antibodies” by the European Patent Office. The claims of the patent are directed to Immutep’s pre-clinical product candidate, IMP761, and also to the use of IMP761 in the treatment of T-cell mediated inflammatory and autoimmune diseases. The expiry date of the patent is 1 September 2036. Immutep CEO, Marc Voigt stated: “IMP761 is the first agonist antibody that targets the immune checkpoint LAG-3 and aims to treat the root cause of autoimmune diseases such as, for example, inflammatory bowel disease, rheumatoid arthritis and multiple sclerosis. It is very pleasing to see the grant of this patent in the important European market which will underpin ongoing investment in this promising product candidate.” Immutep CSO and CMO, Dr. Frederic Triebel also stated: “There continues to be a significant unmet medical need for patients with various autoimmune diseases and so it is highly encouraging to see the recent progress being made with IMP761 towards clinical development, both in terms of cell line development announced in April 2020 and now with securing intellectual property protection.” About IMP761 IMP761 is a first-in-class immunosuppressive agonist antibody to LAG-3. As a targeted immunosuppressive antibody, IMP761 has the potential to address the root cause of autoimmune diseases by specifically silencing the autoimmune memory T cells accumulating at the disease site which express LAG-3 as an exhaustion marker after being repeatedly stimulated with dominant self-peptides. -
Abstracts for the 25Th Annual Scientific Meeting of the International Society for Biological Therapy of Cancer
ABSTRACTS VACCINE COMBINATIONS Abstracts for the 25th Annual Scientific Meeting of the International Society for Biological Therapy of Cancer (Primary Authors are Italicized) surface marker that was used as a reporter gene. All ten constructs were used to generate RD114-pseudotyped RVV that were tested, by flow cytometry, for their ability to induce tCD34 expression in ADOPTIVE T-CELL TRANSFER: transduced human PBL. This parameter was used to select the most THE NEXT WAVE efficient combinations of miRNA backbone and cloning site, in terms of transgene expression. Thus, mir-142-, mir-155- and mir- 150-derived amiRNAs yielded the highest percentage of CD34 Development of a g-Retroviral Vector for the Expression of positive cells. Of note, vectors expressing mir-223-based amiRNAs Artificial miRNAs in Human T Lymphocytes induced almost negligible expression of transgene, as opposed to previous reports using lentiviral vectors, stressing the relevance of Daniel Abate-Daga, Tristen S. Park, Douglas C. Palmer, Nicholas P. Restifo, Steven A. Rosenberg, Richard A. Morgan. vector-specific step-wise optimization. This platform may allow for Surgery Branch, National Cancer Institute. NIH, Bethesda, MD. the validation of gene silencing as an enhancer of T cell activity, as Since its discovery, RNA interference has not only emerged as a well as a delivery vehicle for tumor-specific T cell receptors (TCR) new field of study but also provided a series of versatile tools for or Chimeric Antigen Receptors (CAR) genes concomitantly with the study of a wide range of biological processes. While chemically silencing molecules in the context of adoptive cell therapy.