Eftilagimod alpha

Sydney, Australia, June 05, 2024 (GLOBE NEWSWIRE) -- Immutep Limited ACN 009 237 889 (ASX: IMM, NASDAQ: IMMP) (Immutep or the Company) is pleased to announce the successful completion of its institutional placement (Placement) and the institutional component (Institutional Entitlement Offer) of its 1 for 16 pro rata accelerated non-renounceable entitlement offer (Entitlement Offer and, together with the Placement, the Offer) of new fully paid ordinary shares in Immutep (NewShares). The Placement and Institutional Entitlement Offer (together, the InstitutionalOffer) closed on 4 June 2024. The Institutional Offer had strong support from institutional investors, with a take-up rate from eligible institutional investors of approximately 100%. The Institutional Offer raised gross proceeds of approximately A$89.6 million at an offer price of A$0.38 per New Share, consisting of approximately A$72.0 million under the Placement and approximately A$17.6 million under the Institutional Entitlement Offer. Dr Russell Howard, Chairman of Immutep, said: “Immutep has gone from strength to strength with the team working tirelessly to deliver our late-stage clinical program in three cancer areas: lung, breast, and head and neck cancer. As we traverse our path towards marketing authorisation in the US for efti, we’ve continued to report outstanding efficacy and safety data which has strengthened our belief that it has an exciting future, changing patient outcomes as part of a combination with other cancer therapeutics. “We’re delighted to have such strong and unwavering support from our shareholders who share our belief in efti and have continued to invest in Immutep through this financing. I would also like to welcome our new institutional investors to our share register. There are many milestones ahead for Immutep and we will keep you updated as we progress.” No shareholder approval is required in connection with the issue of New Shares under the Institutional Offer. New Shares subscribed for under the Institutional Offer are expected to be settled on Tuesday, 11 June 2024 and to be issued on Wednesday, 12 June 2024. New Shares issued under the Institutional Offer will rank equally with existing fully paid ordinary shares in Immutep as at their date of issue. The Offer is expected to raise approximately A$100.2 million, comprising the Institutional Offer of approximately A$89.6 million and Retail Entitlement Offer of approximately A$10.6 million. Immutep expects ASX to lift its trading halt and for Immutep’s ordinary shares to recommence trading on ASX on an ex-entitlements basis from market open today. Retail EntitlementOffer The retail component of the fully underwritten Entitlement Offer (RetailEntitlementOffer) is expected to open at 9.00am on Friday, 7 June 2024 and close at 5.00pm (Sydney, Australia time) on Thursday, 20 June 2024. The despatch of the retail entitlement offer booklet for the Retail Entitlement Offer (Booklet) with personalised entitlement and acceptance forms for eligible retail shareholders is scheduled to occur on Friday, 7 June 2024. Eligible retail shareholders will be able to subscribe for 1 New Share for every 16 existing ordinary shares held in Immutep as at 7.00pm (Sydney, Australia time) on the record date of Wednesday, 5 June 2024, at the offer price of A$0.38 per New Share, being the same as the price paid per New Share by investors in the Institutional Offer. Only retain shareholders in Australia and New Zealand are eligible to participate in the Retail Entitlement Offer. Persons in the United States may not participate in the Retail Entitlement Offer. Under the Retail Entitlement Offer, eligible retail shareholders who subscribe for their full entitlement to New Shares may also apply for additional New Shares (Additional New Shares) in excess of their entitlement up to a maximum of 100% of their entitlement or $50,000 worth of Additional New Shares, whichever is lower, under a ‘top up’ facility. Allocations for Additional New Shares will be determined by Immutep in its absolute discretion and any allotment of Additional New Shares is not guaranteed. Offer Timetable Event Date Announcement of results of Placement and Institutional Entitlement Offer Wednesday, 5 June 2024 Trading in Immutep shares resumed on an ex-entitlement basis Wednesday, 5 June 2024 Record Date for determining entitlement for the Entitlement Offer 7.00pm Wednesday, 5 June 2024 Retail Offer Booklet made available and Retail Entitlement Offer opens Friday, 7 June 2024 Settlement of Placement and Institutional Entitlement Offer Tuesday, 11 June 2024 Allotment of New Shares issued under the Placement and Institutional Entitlement Offer Wednesday, 12 June 2024 Normal trading of New Shares issued under the Placement and Institutional Entitlement Offer Thursday, 13 June 2024 Retail Entitlement Offer closing date Thursday, 20 June 2024 Settlement of Retail Entitlement Offer Tuesday, 25 June 2024 Allotment of New Shares issued under the Retail Entitlement Offer Wednesday, 26 June 2024 Normal trading of New Shares issued under the Retail Entitlement Offer Thursday, 27 June 2024 Despatch of holding statements Friday, 28 June 2024 About Immutep Immutep is a clinical-stage biotechnology company developing novel LAG-3 immunotherapy for cancer and autoimmune disease. We are pioneers in the understanding and advancement of therapeutics related to Lymphocyte Activation Gene-3 (LAG-3), and our diversified product portfolio harnesses its unique ability to stimulate or suppress the immune response. Immutep is dedicated to leveraging its expertise to bring innovative treatment options to patients in need and to maximise value for shareholders. For more information, please visit . U.S. Media: Chris Basta, VP, Investor Relations and Corporate Communications +1 (631) 318 4000; chris.basta@immutep.com Not an offer of securities in the United States This announcement does not constitute an offer to sell, or a solicitation of an offer to buy, securities in the United States. The New Shares have not been registered under the US Securities Act of 1933 (the US Securities Act) or the securities laws of any state or other jurisdiction of the United States, The New Shares may not be offered or sold in the United States except in a transaction registered under the US Securities Act or pursuant to an exemption from, or in a transaction not subject to, the registration requirements of the US Securities Act and applicable US state securities laws. No person in the United States is not eligible to participate in the Retail Entitlement Offer. This announcement contains certain "forward-looking statements" including but not limited to projections, that are based on management's beliefs, assumptions and expectations and on information currently available to management. Forward-looking statements can generally be identified by the use of forward-looking words such as, “expect”, “anticipate”, “likely”, “intend”, “should”, “could”, “may”, “predict”, “plan”, “propose”, “will”, “believe”, “forecast”, “estimate”, “target” “outlook”, “guidance” and other similar expressions within the meaning of securities laws of applicable jurisdictions. You are strongly cautioned not to place undue reliance on forward-looking statements, particularly in light of the current economic climate and the significant volatility, uncertainty and disruption to equity and capital markets. Any such statements, opinions and estimates in this announcement speak only as of the date hereof and are based on assumptions and contingencies subject to change without notice, as are statements about market and industry trends, projections, guidance and estimates. Forward-looking statements are provided as a general guide only. The forward-looking statements contained in this announcement are not indications, guarantees or predictions of future performance and involve known and unknown risks and uncertainties and other factors, many of which are beyond the control of Immutep and its subsidiaries, and may involve significant elements of subjective judgement and assumptions as to future events which may or may not be correct. All dates and times are indicative and Immutep reserves the right to amend any or all of these events, dates and times subject to the Corporations Act 2001 (Cth), the ASX Listing Rules and other applicable laws, at any time, including extending the period for the Entitlement Offer or accepting late applications, either generally or in particular cases, without notice. The commencement of trading and quotation of New Shares issued under the Offer is subject to confirmation from ASX. All times and dates are in reference to Sydney, Australia time.

Phase III collaboration will evaluate efti in combination with KEYTRUDA, MSD’s anti-PD-1 therapy, and standard chemotherapy in first-line non-small cell lung cancer (1L NSCLC)TACTI-004 Phase III trial will enrol approximately 750 patients regardless of PD-L1 expression in order to address the entire 1L NSCLC market eligible for anti-PD-1 therapyUnder the collaboration, Immutep will conduct the registrational TACTI-004 Phase III trial and MSD will supply KEYTRUDAImmutep retains commercial rights to eftiEfti in combination with KEYTRUDA with or without chemotherapy has generated compelling efficacy and favourable safety in 1L NSCLC, one of the most relevant cancer indications with a high unmet medical need, across all levels of PD-L1 expression (negative, low, and high) SYDNEY, AUSTRALIA, June 03, 2024 (GLOBE NEWSWIRE) -- Immutep Limited (ASX: IMM; NASDAQ: IMMP) (“Immutep” or “the Company”), a clinical-stage biotechnology company developing novel LAG-3 immunotherapies for cancer and autoimmune disease, today announced that it has entered into a clinical trial collaboration and supply agreement with MSD (Merck & Co., Inc., Rahway, NJ, USA), through a subsidiary, to evaluate eftilagimod alfa (efti) in combination with MSD’s anti-PD-1 therapy, KEYTRUDA® (pembrolizumab) and chemotherapy for the first-line treatment of metastatic non-small cell lung cancer (NSCLC) in a pivotal Phase III trial. The potential for efti in combination with KEYTRUDA and chemotherapy is to set a new standard of care, by strengthening clinical outcomes for responders and broadening the number of patients who respond across the entire NSCLC patient population regardless of PD-L1 expression. TACTI-004 (Two ACTive Immunotherapies-004) Registrational Phase III Trial DesignTACTI-004 will be a 1:1 randomised, double-blind, multinational, controlled clinical study to evaluate Immutep’s efti in combination with KEYTRUDA and standard chemotherapy compared to the standard-of-care combination of KEYTRUDA, chemotherapy and placebo in first-line metastatic NSCLC, regardless of PD-L1 expression. In this pivotal PD-L1 all comer trial, the dual primary endpoints will be progression-free and overall survival with a prespecified futility boundary and a pre-planned interim analysis. The globally conducted study will enrol approximately 750 NSCLC patients (including both squamous and non-squamous subtypes). Building on Encouraging Data from Prior Trials “We are eager to build upon the meaningful impact that immunotherapy has brought to patients with NSCLC, one of the largest cancer indications globally, and look for TACTI-004 to confirm the clinical benefits that have been achieved with efti in combination with KEYTRUDA. This collaboration agreement speaks to the strength of the clinical data generated to date from this novel immuno-oncology combination and its future potential. We are thankful for this significant commitment from MSD," stated Marc Voigt, CEO of Immutep. This collaboration follows two previous collaborations for the TACTI-002 Phase II and TACTI-003 Phase IIb trials, which collectively treated over 350 patients. Under the terms of the agreement, Immutep will conduct the registrational TACTI-004 study and MSD will supply KEYTRUDA. The agreement enables Immutep and MSD to seek marketing authorisation of the combination and to market their respective compounds with a relevant label indication. The parties retain the commercial rights to their respective compounds and are free to conduct other clinical studies, either individually or in combination, in any therapeutic area. The clinical data generated by the innovative immuno-oncology combination of Immutep’s MHC Class II agonist and MSD’s anti-PD-1 therapy in the TACTI-002 Phase II trial in first-line NSCLC regardless of PD-L1 expression has led to oral presentations at the ASCO, SITC, and ESMO conferences. Efti’s unique activation of dendritic cells (the most potent professional antigen-presenting cells) engages the adaptive and innate immune system to drive a broad anti-cancer immune response, including proliferation of cytotoxic T cells that complements anti-PD-1 therapy in first-line NSCLC across all levels of PD-L1 expression (negative, low, and high). Notably, over 75% of the patients in both the TACTI-002 and INSIGHT-003 clinical trials had a PD-L1 Tumor Proportion Score (TPS) of <50%, and both studies have shown strong efficacy in these patients with low and negative PD-L1 expression who are typically less responsive to anti-PD-1 therapy. Furthermore, the triple combination of efti, KEYTRUDA and carboplatin/pemetrexed in INSIGHT-003 has been well tolerated. "KEYTRUDA has revolutionized the treatment landscape in NSCLC and our confidence in efti's ability to build upon its positive impact on patient outcomes, and potentially expand the number of responding patients, stems from the compelling data in our TACTI-002 and INSIGHT-003 trials. We are excited to confirm the differentiated efficacy and safety that we have seen to date in NSCLC via efti’s first pivotal Phase III study and TACTI-004's robust randomized, double-blind trial design," added Christian Mueller, Immutep’s SVP, Regulatory and Strategy. Lung cancer is the second most common cancer. Non-small cell lung cancer accounts for approximately 80-85% of all lung cancers, impacting an estimated 1.87 million people annually, and is the highest cause of death among all cancers1-3. KEYTRUDA® is a registered trademark of Merck Sharp & Dohme LLC, a subsidiary of Merck & Co., Inc., Rahway, NJ, USA. About Eftilagimod Alfa (Efti)Efti is Immutep’s proprietary soluble LAG-3 protein and MHC Class II agonist that stimulates both innate and adaptive immunity for the treatment of cancer. As a first-in-class antigen presenting cell (APC) activator, efti binds to MHC (major histocompatibility complex) Class II molecules on APC leading to activation and proliferation of CD8+ cytotoxic T cells, CD4+ helper T cells, dendritic cells, NK cells, and monocytes. It also upregulates the expression of key biological molecules like IFN-ƴ and CXCL10 that further boost the immune system’s ability to fight cancer. Efti is under evaluation for a variety of solid tumours including non-small cell lung cancer (NSCLC), head and neck squamous cell carcinoma (HNSCC), and metastatic breast cancer. Its favourable safety profile enables various combinations, including with anti-PD-[L]1 immunotherapy and/or chemotherapy. Efti has received Fast Track designation in first line HNSCC and in first line NSCLC from the United States Food and Drug Administration (FDA). About ImmutepImmutep is a clinical-stage biotechnology company developing novel LAG-3 immunotherapy for cancer and autoimmune disease. We are pioneers in the understanding and advancement of therapeutics related to Lymphocyte Activation Gene-3 (LAG-3), and our diversified product portfolio harnesses its unique ability to stimulate or suppress the immune response. Immutep is dedicated to leveraging its expertise to bring innovative treatment options to patients in need and to maximise value for shareholders. For more information, please visit www.immutep.com. Australian Investors/Media:Catherine Strong, Morrow Sodali+61 (0)406 759 268; c.strong@morrowsodali.com U.S. Media:Chris Basta, VP, Investor Relations and Corporate Communications+1 (631) 318 4000; chris.basta@immutep.com 1 The Global Cancer Observatory, Lung Cancer Fact Sheet2 American Cancer Society, About Lung Cancer3 CDC, Lung Cancer Statistics