IMMP

SYDNEY, Australia, Oct. 29, 2020 (GLOBE NEWSWIRE) -- Immutep Limited (ASX: IMM; NASDAQ: IMMP), a biotechnology company developing novel immunotherapy treatments for cancer and autoimmune disease, is pleased to announce that it has entered into a Licence and Collaboration Agreement with LabCorp that will support the development of immuno-oncology products or services. “Over the years, Immutep has generated a significant amount of know-how in immuno-oncology, specifically in terms of LAG-3,” said Marc Voigt, CEO of Immutep.Under the terms of the Agreement, Immutep is eligible to receive potential undisclosed milestone and service-related payments. The collaboration with LabCorp is unrelated to any of Immutep’s own in-house pharmaceutical development programs in cancer or autoimmune disease.About Immutep Immutep is a globally active biotechnology company that is a leader in the development of LAG-3 related 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 maximize value to shareholders. Immutep is listed on the Australian Securities Exchange (IMM) and on the NASDAQ (IMMP) in the United States.Immutep’s current lead product candidate is eftilagimod alpha (“efti” or “IMP321”), a soluble LAG-3 protein (LAG-3Ig) based on the LAG-3 immune control mechanism. This mechanism plays a vital role in the regulation of the T cell immune response. Efti is currently being evaluated in combination with chemotherapy for the treatment of metastatic breast cancer in a Phase IIb clinical trial termed AIPAC (clinicaltrials.gov identifier NCT02614833); a Phase II clinical trial being conducted in collaboration with Merck & Co., Inc., Kenilworth, NJ, USA (known as “MSD” outside the United States and Canada) referred to as TACTI-002 to evaluate a combination of efti with KEYTRUDA® (pembrolizumab) in several different solid tumours (clinicaltrials.gov identifier NCT03625323); a Phase I clinical trial being conducted in collaboration with Merck KGaA, Darmstadt, Germany and Pfizer Inc. referred to as INSIGHT-004 to evaluate a combination of efti with avelumab (clinicaltrials.gov identifier NCT03252938); and a Phase I combination therapy trial in metastatic melanoma termed TACTI-mel (clinicaltrials.gov identifier NCT02676869).Additional LAG-3 products, including antibodies, for immune response modulation in autoimmunity and cancer are being developed by Immutep’s large pharmaceutical partners. Immutep is also developing an agonist of LAG-3 (IMP761) for autoimmune disease.Further information can be found on the Company’s website www.immutep.com or by contacting:U.S. Media: Tim McCarthy, LifeSci Advisors +1 (212) 915.2564; tim@lifesciadvisors.comAustralian Investors/Media: Catherine Strong, Citadel-MAGNUS +61 (0)406 759 268; cstrong@citadelmagnus.com

Immutep's (IMMP) has announced that its cancer therapy eftilagimod alpha (efti or IMP321) will be tested in an investigator-initiated trial against COVID-19.The Phase 2 trial will evaluate efti in up

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Immutep Announces the Start of an Investigator-Initiated Phase II Study in COVID-19 Patients Investigator-initiated, placebo controlled and randomized Phase II study evaluating eftilagimod alpha ("efti") in

* Investigator-initiated, placebo controlled and randomized Phase II study evaluating eftilagimod alpha (“efti”) in up to 110 COVID-19 patients * Immutep supplies efti to University Hospital Pilsen, Czech Republic * Study tests whether the early administration of efti prevents COVID-19 disease progression in adult patients * Initial interim results are expected to be reported from early 2021SYDNEY, Australia, Oct. 23, 2020 (GLOBE NEWSWIRE) -- Immutep Limited (ASX: IMM; NASDAQ: IMMP) ("Immutep” or “the Company”), is pleased to announce it has signed a Material Transfer Agreement (“Agreement”) with the University Hospital Pilsen, Czech Republic to enable an investigator-initiated randomized Phase II clinical trial evaluating its lead product candidate eftilagimod alpha (“efti” or “IMP321”) in hospitalized patients with COVID-19. The necessary approvals from the Czech Republic’s State Institute for Drug Control (SUKL- competent authority) and ethics committee have now been obtained, enabling the recruitment of patients to commence immediately. Initial interim results are expected to be reported from early 2021.The study, called “Eftilagimod Alpha Treatment by immune modulation in COVID-19 disease” or EAT COVID (EudraCT n° 2020-002009-25), aims to boost a patient’s immune response to prevent the patient from developing severe COVID-19 symptoms that require intensive care and can lead to respiratory failure and death. As an antigen presenting cell (APC) activator, efti could help to control the viral load in hospitalized patients by boosting CD8 effector T cells.Under the Agreement, Immutep will provide efti at no cost to the University Hospital Pilsen which will fund the study. The trial will be led by Principal Investigator, Professor Martin Matejovic who is the Head of Medical Department at University Hospital Pilsen, Professor of Medicine at University Hospital Pilsen and Charles University Medical School. The trial will also be conducted in collaboration with Dr. Dalibor Sedlacek, Associate Professor of Medicine and Head of the Department of Infectious Diseases, along with Dr. Marek Nalos, Associate Professor of Medicine and Head Medical ICU at Department of Intensive Care Medicine of the Nepean Hospital, Sydney.The study will be a placebo controlled, 1:1 randomized, double blinded Phase II clinical trial involving up to 110 adult patients hospitalized with COVID-19 at University Hospital Pilsen. Patients will receive subcutaneous injections of efti (10 mg) on days 1, 3 and 7, in addition to standard care. The primary endpoint is the patient’s clinical status at day 15 as per the WHO recommended evaluation scale.  Immutep CEO, Marc Voigt, said: “We were delighted to be approached for this study by Dr Marek Nalos and Professor Martin Matejovic. It is highly encouraging that efti, with its broad mechanism of action, attracts keen interest from clinicians who are willing and able to fund the research and commit their time to further exploring efti’s potential to fight diseases. While Immutep’s focus remains on cancer and autoimmune disease, this new trial gives us the opportunity to contribute to the global efforts to beat COVID-19. We believe efti is currently the only APC activator of its kind being evaluated against COVID-19 in a randomized Phase II trial and that the study will contribute to our further understanding of its potential in infectious diseases in general.”Immutep CSO and CMO, Dr Frederic Triebel said: “The most effective anti-viral therapy for COVID-19 is likely an effective CD8 T cell that has been empowered by activated dendritic cells and given a licence to kill by these antigen presenting cells (APCs). This effector CD8 killer T cell is then able to detect and eliminate epithelial cells which serve as reservoirs where the virus can replicate. Indeed, the vast majority of patients infected with COVID-19 have strong innate immunity/adaptive immunity crosstalk and are able to fight the infection without the help of modern medicine. In older patients due to immuno-senescence or in patients with compromised innate immunity, restoring APC function with efti may help drive an improved anti-COVID immune response before it becomes too late and the patient requires intensive care.”University Hospital Pilsen, Professor of Medicine and EAT COVID Principal Investigator, Professor Martin Matejovic said: “Some hospital patients are developing severe COVID-19 disease after 7-10 days which requires intensive care and can be fatal. Efti’s safety profile to date and its proven efficacy as an APC activator1 gives us the confidence to initiate a Phase II study for our patients as soon as they are hospitalized and before their condition deteriorates.”Recruitment will start with an open label safety run-in of 6 patients and then a first cohort of 26 randomized patients, with successive cohorts being recruited following a positive recommendation from the Data Monitoring Committee (DMC), which will evaluate safety and efficacy of the treatment.Immutep has two existing patent families with claims drawn to the use of efti in the treatment of infectious disease. For example, in September 2017 Immutep announced the grant of a Japanese patent and, in November 2018, announced the grant of a European patent from these families.Efti’s Mechanism of Action Efti is a first-in-class antigen presenting cell (APC) activator currently being developed by Immutep for the treatment of cancer. Efti binds to antigen presenting cells such as dendritic cells, monocytes and macrophages via MHC II molecules. This activates the APCs causing them to become professional antigen presenting cells, thereby presenting antigen to the adaptive immune system. This leads to activation and proliferation of CD4+ (helper) and CD8+ (cytotoxic) T cells. Thus, the aim of efti is to “push the gas” on the body’s innate and adaptive immune systems making it a suitable candidate to evaluate not only for the treatment of cancer, but also for the treatment of infectious diseases such as COVID-19.About University Hospital Pilsen The University Hospital Pilsen provides patients with basic, specialized and so-called highly-specialized medical care in all areas, with the exception of burn medicine, bone marrow transplantation in children, the most complex organ transplants and heart surgery in children. In some fields, University Hospital Pilsen provides health care for residents of adjacent regions, especially southern and northern Bohemia, Karlovy Vary and parts of central Bohemia. But, for example, in the field of artificial insemination, bone marrow transplantation, liver surgery, prostate surgery or kidney tumors, the importance of the University Hospital Pilsen is nationwide. University hospital ranks among the top hospitals in the Czech republic and represents key opinion leader in many fields of clinical medicine. The hospital also has close links with the Faculty of Medicine, Charles University in Pilsen.Further information can be found on the Company’s website www.immutep.com or by contacting:Australian Investors/Media: Catherine Strong, Citadel-MAGNUS +61 (0)406 759 268; cstrong@citadelmagnus.comU.S. Media: Tim McCarthy, LifeSci Advisors +1 (212) 915.2564; tim@lifesciadvisors.com1 https://en.wikipedia.org/wiki/APC_Activator

* Encouraging clinical results from TACTI-002 and INSIGHT-004 trials of eftilagimod alpha * completed recruitment for Stage 1 of Part B in TACTI-002 Study * Granted United States patent relating to eftilagimod alpha and LAG525SYDNEY, Australia, Oct. 22, 2020 (GLOBE NEWSWIRE) -- Immutep Limited (ASX: IMM; NASDAQ: IMMP) a biotechnology company developing novel immunotherapy treatments for cancer and autoimmune diseases, today provided a business update for the quarter ended September 30, 2020, including for the ongoing development of its product candidates, eftilagimod alpha (“efti” or “IMP321”) and IMP761, and the activity of its new and existing partners. “During the quarter, we continued to report supportive clinical data from our trials of efti in multiple cancers. These data have further bolstered our confidence in the therapeutic potential for these assets as we enter discussions with potential out licensing and collaboration partners. We already have committed partnerships in place with five of the world’s largest pharmaceutical companies: Merck, Pfizer, Merck MSD, Novartis and GSK, plus our partner in China, EOC Pharma, which give us confidence that we can build on our LAG-3 leadership position,” said Marc Voigt, CEO of Immutep.Eftilagimod Alpha Clinical UpdatesTACTI-002 - Phase II clinical trial In September, Immutep presented encouraging interim results from its TACTI-002 Phase II trial in two poster presentations at the ESMO Virtual Congress 2020. These results showed three patients had complete responses (complete disappearance of all lesions) to the combination therapy of efti with KEYTRUDA® (pembrolizumab). Two of these patients had second-line head and neck squamous cell carcinoma (HNSCC) and one had first-line non-small cell lung cancer (NSCLC). Five partial responses were reported from patients (across both indications) with negative (< 1%) or moderate PD-L1 expression. Pembrolizumab monotherapy is typically less effective in these patients.A median Progression Free Survival (PFS) of 4.3 months was achieved for patients with second-line HNSCC and 47% of these patients were progression free at the six-month landmark in this very aggressive late-stage disease. For first-line NSCLC patients, median PFS continues to improve and is 11.8 months. The combination treatment continues to be safe and well tolerated with no new safety signals reported thus far.In August, Immutep enrolled and safely dosed the last patient for Stage 1 of Part B (second-line NSCLC) of the TACTI-002 study, completing recruitment of this stage. Recruitment is also complete for both stages of Part A (first-line NSCLC) and is ongoing for Stage 2 of Part C (second-line HNSCC). Pending the Data Monitoring Committee’s recommendation, Immutep will consider opening Stage 2 of Part B for recruitment. Overall, recruitment for the trial continues to progress well, with 92 out of up to 109 patients now enrolled.The TACTI-002 study is evaluating the combination of efti with Merck & Co’s KEYTRUDA® (pembrolizumab) in up to 109 patients with second line HNSCC or NSCLC in first and second line.INSIGHT-004 - Phase I clinical trial In September, Immutep reported improving interim data from its INSIGHT-004 trial of efti at the ESMO Virtual Congress 2020. In the trial 41.7% of patients showed a Partial Response to the combination therapy of efti and avelumab, building on the previous interim data of 33%.More importantly, the trial also reported encouraging early anti-tumour activity signals across a variety of cancer indications not typically sensitive to immune checkpoint inhibitor (ICI) therapy, including PD-L1-negative cervical cancer, squamous anal cell carcinoma, and mesothelioma. The combination of efti and avelumab continues to be safe and well tolerated.INSIGHT-004 is evaluating the combination of efti with avelumab, a human anti-PD-L1 antibody, in 12 patients with different advanced solid malignancies, primarily gastrointestinal indications. The trial is being conducted under Immutep’s collaboration with Merck KGaA, Darmstadt, Germany, and Pfizer Inc., as the fourth arm of the ongoing INSIGHT Phase I clinical trial. The Institute of Clinical Cancer Research, Krankenhaus Nordwest GmbH in Frankfurt, Germany (“IKF”) is the trial sponsor for INSIGHT-004.IMP761 Preclinical UpdateImmutep is continuing cell line development for IMP761, an immunosuppressive agonist antibody to LAG-3 for the treatment of autoimmune diseases, such as inflammatory bowel diseases, rheumatoid arthritis, and multiple sclerosis.Partner UpdatesMonash University In August, Immutep and its research partner, Monash University, were awarded a A$671,427 grant under the Australian Research Council’s Linkage Project scheme to support their research collaboration into Lymphocyte Activation Gene-3 (LAG-3) for a further three years. The collaboration commenced in 2017.Novartis Novartis has five clinical trials ongoing for LAG525 (Ieramilimab) in multiple cancer indications, including a Phase II clinical trial in triple negative breast cancer. According to the Novartis second quarter 2020 earnings call a regulatory submission is planned for LAG525 in 2023.        Other partnerships Immutep’s other partnerships with GlaxoSmithKline, EOC Pharma and CYTLIMIC continue to progress well.Intellectual Property In August, the United States Patent and Trademark Office granted Immutep a new patent entitled “Combined Preparations for the Treatment of Cancer”. The new patent relates to the use of efti in combined therapeutic preparations with a chemotherapy agent and follows the grant of similar European, Australian and Japanese patents in May 2019, June 2019 and May 2020, respectively. The expiry date of this United States patent is 25 January 2035.In July, a new patent was granted by the United States Patent and Trademark Office entitled “Antibody molecules to LAG-3 and uses thereof”. The patent relates to embodiments of LAG525, a humanised form of Immutep’s IMP701 antibody, which is out-licensed to Novartis AG. The patent is co-owned by Novartis AG and Immutep S.A.S. and will expire on 26 March 2035.Financials for the First Quarter of FY2021 (Ended 30 September 2020)Cash receipts from customers for the first quarter fiscal year 2021 were $23,000, compared to $128,000 in the fourth quarter of fiscal year 2020. Cash receipts from government grants and tax incentives for the quarter were $126,000, compared to $5.1 million in fourth quarter of fiscal year 2020.The net cash used in G&A activities in the quarter was $350,000 compared to $360,000 in the fourth quarter of fiscal year 2020. G&A costs for the quarter includes $127,000 in payment of non-executive director’s fees and executive director’s salary.Total net cash outflows used in operating activities in the quarter was $3.34 million. In comparison, total net cash inflows from the operating activities in the fourth quarter of fiscal year 2020 were $120,000.The net cash used in Research and Development activities in the quarter was $2.10 million, compared to $3.77 million in fourth quarter of fiscal year 2020. R&D expenditure declined further as all patients in the AIPAC Phase IIb clinical trial have completed the treatment and moved into the follow-up phase.Interest paid of $6,000 is the interest component of the office lease under the application of AASB 16 Leases.The Company reported a cash balance as at 30 September 2020 of $22.7 million, compared to a cash balance of $26.3 million as at 30 June 2020. The Company’s cash runway is expected to extend to the end of calendar year 2021, beyond several significant data read-outs.Further information can be found on the Company’s website www.immutep.com or by contacting:Australian Investors/Media: Catherine Strong, Citadel-MAGNUS +61 (0)406 759 268; cstrong@citadelmagnus.comU.S. Media: Tim McCarthy, LifeSci Advisors +1 (212) 915.2564; tim@lifesciadvisors.com

European Patent Office has granted new patent (number 3344654) to Immutep ([[IMMP]] +9.1%) entitled “Anti-LAG-3 Antibodies” directed to Immutep’s pre-clinical product candidate, IMP761, as well as use of IMP761 in the treatment of

Immutep (NASDAQ: IMMP) shares are trading higher on Wednesday after the company was granted a European patent for its IMP761.