Immutep Limited

Immutep Limited is pleased to announce we have received positive feedback from the U.S. Food and Drug Administration regarding our planned TACTI-004 Phase III trial of efti in combination with KEYTRUDA®, MSD's anti-PD-1 therapy, and histology-based platinum doublet chemotherapy for the treatment of first-line metastatic non-small cell lung cancer (1L NSCLC), regardless of PD-L1 expression.

The TACTI-004 Phase III trial, which will enrol ~750 patients, is based on the positive efficacy and safety data in 1L NSCLC generated from the TACTI-002 Phase II and INSIGHT-003 trials.

Read the announcement: https://bit.ly/3WvCBK9

Immutep Limited today announces it has received regulatory clearance from the ethics and competent authority in the Netherlands to initiate the first-in-human Phase I study of IMP761.

IMP761 is a first-in-class LAG-3 agonist antibody designed to treat autoimmune diseases.

The study is expected to enrol its first participants during Q3 CY2024.

Read the ASX announcement: https://bit.ly/4d1grFe

Immutep Limited is delighted to be invited to present at the ESMO - European Society for Medical Oncology Virtual Plenary session next week where it will announce new clinical data in patients with negative PD-L1 expression (Cohort B) in the TACTI-003 (KEYNOTE-PNC-34) Phase IIb trial.

The presentation will announce the substantially improved overall response rate and additional data in patients from Cohort B.

Immutep will also hold an investor webcast following the session to discuss these clinical results on Friday, July 12, at 9am AEST (7pm ET July 11).

Register for the webcast here: https://bit.ly/4eQKLUW

Immutep Limited today reported its positive topline results from TACTI-003.
In case you missed it, the webcast reply is now available to listen to via the link below.


https://www.finnewsnetwork.com.au/MediaCenter/MediaCenterMobile.aspx?Site=FNN2579

Immutep Limited is excited to report positive topline results from its TACTI-003 Phase IIb trial in first line head and neck cancer today.

Efti in combination with KEYTRUDA® (pembrolizumab) led to overall response rates that exceed KEYTRUDA monotherapy across all levels of PD-L1 expression. Read the ASX announcement for details: https://bit.ly/4cyq6Ti

Join us for a webinar to discuss the results today at 9am, or listen to the replay which will be available on our investor website following the event.

Immutep Limited today announces a License Agreement with Cardiff University / Prifysgol Caerdydd granting the Company exclusive rights to develop and commercialise anti-LAG-3 small molecules.

Professor Andrew Godkin of Cardiff University said: “Our collaboration with Immutep has been exciting and fruitful, resulting in a number of small molecules with the potential to fight cancer by blocking the interaction between LAG-3 on T cells and MHC Class II on antigen-presenting cells. Small molecules represent the next generation of anti-LAG-3 therapies and hold tremendous promise, as they can be given to cancer patients as a convenient oral pill.”

https://bit.ly/3RJfaKJ

Thank you, Rory Hunter from SG Hiscock & Company Medical Technology Fund for highlighting Immutep Limited as an exciting biotech with compelling data!

A biotech boom for the ASX? This fundie thinks so SG Hiscock’s Rory Hunter thinks CSL could “absolutely” hit $500, says biotechs are ripe for M&A, and reveals a hidden gem flying under the market’s radar.

Immutep Limited is delighted to be featured in The Australian by Cameron England following the announcement of our new collaboration with MSD (Merck) for a pivotal Phase III trial for lung cancer treatment.

“This collaboration agreement speaks to the strength of the clinical data generated to date from this novel immuno-oncology combination and its future potential,” CEO Marc Voigt said.

The article discusses the agreement enabling Immutep and Merck to pursue marketing approval for the combination treatment following the trial.

Please see article here: https://lnkd.in/grGz98mY

Immutep Limited is proud to have participated at the ASCO2024 Annual meeting last week and to have two Trials-in-Progress posters presented to our peers.

Thanks to Dr. Fredric Forget and Dr. Igor Tsaur & Dr. Sabine Beck who presented on AIPAC-003 and INSIGHT-005, respectively.

Click the link to stay updated: https://bit.ly/4eaDvT8

Immutep Limited is pleased to announce 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 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 in a pivotal Phase III trial.

The potential of this combination 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.

Please see Link to announcement: https://bit.ly/3R90apf

Immutep Limited is delighted to be featured in The Australian today by Eddy Sunarto. The article delves deep into our recent clinical results and ongoing trials with a focus on our next milestones.

Trials step up multi-pronged attack on cancers Immutep (ASX:IMM) is battling cancer, in a campaign (on many fronts) to save patients doing the same thing. And auto-immune diseases are in the crosshairs too.

Immutep Limited is excited to be quoted as a biotech pioneer with 'significant growth potential' by Andy Gracey, portfolio manager, Australian Ethical Investment in the The Australian Financial Review article entitled "Healthcare opportunities amid market challenges".

The article also talks about Immutep's position as the only LAG-3 pureplay biotech with multiple first-in-class Immunotherapeutics.
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Healthcare opportunities amid market challenges Amid a fixation on traditional pillars, investors risk overlooking the potential lurking in innovative industries like healthcare and technology.

Immutep Limited announces encouraging efficacy, safety, and pharmacodynamic data from the safety lead-in of the AIPAC-003 Phase II/III trial presented at the ESMO - European Society for Medical Oncology Breast Cancer 2024 Congress.
https://bit.ly/3ynNMez

Thank you to Eddy Sunarto for taking a close look at our recent trial results in soft tissue sarcoma for The Australian.

Combo looks potent anti-cancer mix There’s good news in the battle against a rare kind of cancer, soft tissue sarcoma (STS).

Immutep Limited is pleased to share positive initial clinical data reported from our efti combined with radiotherapy and checkpoint inhibitor, from our phase II trial in soft tissue sarcoma.

Read the full announcement here: https://bit.ly/44nk70Y

Immutep Limited is pleased to share its Quarterly Activities Report for Q3 FY24, providing an update on the ongoing development of efti and IMP761. Highlights include:

· First clinical data from the safety lead-in of AIPAC-003 in metastatic breast cancer shows 90mg dosing of efti safe and well tolerated: 50% overall response rate, including one patient reporting a complete response (complete disappearance of all lesions), and a 100% disease control rate
· Subsequent to quarter end announced a positive preliminary response rate of 26.9% in first line metastatic head and neck squamous cell carcinoma patients with negative PD-L1 expression
· Preclinical studies of IMP761 progressing to clinical trials mid-CY2024
· Anne Anderson joins as independent non-executive director on Immutep’s Board
· Well funded with a strong cash and cash equivalent balance of approximately $95.4m, giving it an expected cash reach into early CY2026.

https://bit.ly/3y0rWO8

Immutep Limited is pleased to announce positive preliminary topline results from our TACTI-003 Phase IIb trial evaluating efti in combination with MSD's KEYTRUDA® in first line metastatic head and neck squamous cell carcinoma patients with negative PD-L1 expression.

Trial data shows a preliminary 26.9% response rate, and data collection, cleaning, and analysis continues with additional data, including complete response rate, expected to be released in H1 CY2024.

Read the full announcement here: https://bit.ly/49PCAnN

Immutep Limited has entered into an agreement with a leading research institute, the Centre for Human Drug Research (CHDR), to perform a first-in-human clinical study of IMP761.

IMP761 is a proprietary LAG-3 agonist antibody has been designed to restore balance to the immune system and address the underlying cause of many autoimmune diseases.

CHDR is a world-class institute in Leiden, the Netherlands specialising in cutting-edge early-stage clinical drug research.

The trial is expected to begin mid-CY2024.

https://bit.ly/3Q60lRE

Immutep Limited is pleased to announce it has received positive feedback from the Spanish Agency for Medicines and Health Products (AEMPS) Competent Authority on our upcoming TACTI-004 Phase III trial of efti for treatment of metastatic non-small cell lung cancer.

https://bit.ly/3W0Cvue

You can read a great summary of our recent breast cancer results from OncLive in their article below.

Eftilagimod Alpha Plus Chemotherapy Lead-In Proves Safe in HR+/HER2-Low Breast Cancer Eftilagimod alpha in combination with chemotherapy displayed a manageable safety profile in HR+/HER2-low breast cancer.

Immutep Limited is pleased to share its 2024 Half Year Report with shareholders including an update on its products, trials and partners.



Read full report here: https://bit.ly/3IAkUBL

An exciting year lies ahead for Immutep Limited’s two first-in-class agonists designed to fight cancer and autoimmune disease: Efti, with its upcoming pivotal Phase III in non-small cell lung cancer and IMP761, which is on track to launch a first-in-human clinical trial by mid-2024.

Read our latest Investor Update for more insights: https://bit.ly/42NeCru

Immutep Limited is pleased to announce the appointment of Anne Anderson as independent non-executive director.

Ms Anderson has extensive board and leadership experience serving Australian and international companies. She brings considerable capability across capital markets, risk management and governance to Immutep’s Board.


Read full ASX announcement here: https://bit.ly/3ODM3XS

Immutep Limited is pleased to share its Quarterly Report for Q2 FY24, including clinical data reported from the TACTI-002 Phase II trial, promising efficacy and tolerability data reported from the INSIGHT-003 Phase I trial and progress on its late stage and registrational trials.

Read full ASX announcement here: https://bit.ly/47ZWFXI

From everyone at Immutep Limited, we'd like to thank you for your support throughout the year. Wishing you and your families a very joyous holiday period and we look forward to continuing our momentum in 2024.

Immutep Limited has received constructive regulatory feedback from the Paul-Ehrlich Institut on its planned TACTI-004 registrational trial in metastatic non-small cell lung cancer.

Read more: https://bit.ly/473aDI1

Immutep Limited is delighted to be selected as a top Healthcare pick by Thomas Wakim at Bell Potter Securities in their end of year note.

Bell Potter's top stock picks for 2024 Bell Potter's top analysts share their best ASX ideas for 2024 and beyond.

How does our lead product candidate, efti, work?
Our 2-minute animation shows how efti unlocks a broad immune response to fight cancer.

Efti: A Soluble LAG-3 Protein & MHC Class II Agonist that Unlocks a Broad Anticancer Immune Response Eftilagimod alpha or efti is Immutep’s proprietary soluble LAG-3 protein and MHC Class II agonist that stimulates both innate and adaptive immunity to fight ...

The Immutep Limited team was excited to present our recent biomarker data at over the weekend.

The poster was delivered by UCL's Dr Martin Forster, Principal Investigator and Dr Florian Vogl, Immutep's CMO, pictured below. The biomarker data related to blood samples from TACTI-002 trial patients and substantiates efti’s unique immune system stimulation.

https://www.immutep.com/files/content/investor/presentation/2023/2023-11-3_SITC_TACTI-002_poster.pdf

Immutep is pleased to announce new biomarker data from our TACTI-002 phase II trial in first line non-small cell lung cancer. The data shows statistically significant increases of biomarkers, circulating immune cells (lymphocytes) and RNA levels of immune activating genes and are linked to improved clinical outcomes.
Read more here: https://bit.ly/49nieDq