IMM | Jotup

Immutep Announces Positive Preliminary Topline Results from TACTI-003 Cohort B

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Wednesday, April 24, 2024

CPS, Cancer, DCR, HNSCC, Data collection, QOL, Neck, Pembrolizumab, Merck & Co., CQD, ASX, Fast track (FDA), PD-L1, Data, Autoimmune disease, Incidence, Patient, Head, Death, Quality of life, Merck, Neoplasm, IMM, Medical imaging

SYDNEY, AUSTRALIA, April 24, 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 announces preliminary topline results from Cohort B of the TACTI-003 (KEYNOTE-PNC-34) Phase IIb trial evaluating eftilagimod alpha (efti) in combination with MSD’s anti-PD-1 therapy KEYTRUDA® (pembrolizumab) as first-line treatment of recurrent/metastatic head and neck squamous cell carcinoma patients (1L HNSCC) with negative PD-L1 expression.

Key Points:

Head and neck squamous cell carcinomas are a heterogenous disease that represent a high unmet medical need regardless of PD-L1 expression.
A total of 33 patients with recurrent or metastatic HNSCC have been enrolled into Cohort B.
The final number of evaluable patients in Cohort B is expected to be higher and additional data, including complete response rate, will be released together with Cohort A data.
Patients in Cohort A are stratified by CPS >1, CPS 1-19, and CPS >20, and the clinical results for these three CPS groups will be evaluated.

Immutep Appoints Leading Research Institute to Conduct First-in-Human Phase I Study of IMP761

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Thursday, April 18, 2024

Immutep, Cancer, Safety, Pharmacokinetics, CHDR, Immunotherapy, ASX, Trial of the century, PD-1, Autoimmune disease, Principal, Rheumatoid arthritis, Multiple sclerosis, Immune system, PD, KLH, Autoimmunity, IMM, Vaccine

SYDNEY, AUSTRALIA, April 18, 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 announces it has entered into an agreement with the Centre for Human Drug Research (CHDR), a world-class institute in Leiden, the Netherlands specializing in cutting-edge early-stage clinical drug research, to perform a first-in-human clinical study of IMP761. This proprietary LAG-3 agonist antibody has been designed to restore balance to the immune system and address the underlying cause of many autoimmune diseases.

Key Points:

This proprietary LAG-3 agonist antibody has been designed to restore balance to the immune system and address the underlying cause of many autoimmune diseases.
Subject to the relevant ethic and regulatory approvals, the single and multiple ascending dose, placebo-controlled, double-blind, Phase I study will enrol approximately 49 healthy volunteers, with the objective of assessing safety, pharmacokinetics (PK) and pharmacodynamics (PD).
We’re very excited to be partnering with Immutep for this critical step in the development plan of their promising antibody.
IMP761 remains on target to enter the clinic mid-CY2024 and Immutep looks forward to providing more information as it approaches this important milestone.

Immutep Receives Positive Feedback from the Spanish Medicines Agency for Upcoming TACTI-004 Registrational Trial in Metastatic Non-Small Cell Lung Cancer

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Wednesday, April 17, 2024

Medication, Cancer, Competence, Statistics, Regulation, CHMP, ASX, Autoimmune disease, Competent authority, AEMPS, NSCLC, IMM, Pharmaceutical industry

SYDNEY, AUSTRALIA, April 17, 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 announces it has received positive feedback from the Spanish Agency for Medicines and Health Products (AEMPS) Competent Authority regarding the Company’s upcoming TACTI-004 Phase III trial of eftilagimod alpha (“efti”) for first line treatment of metastatic non-small cell lung cancer (1L NSCLC).

Key Points:

SYDNEY, AUSTRALIA, April 17, 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 announces it has received positive feedback from the Spanish Agency for Medicines and Health Products (AEMPS) Competent Authority regarding the Company’s upcoming TACTI-004 Phase III trial of eftilagimod alpha (“efti”) for first line treatment of metastatic non-small cell lung cancer (1L NSCLC).
Immutep SVP, Regulatory & Strategy, Christian Mueller commented: “We continue to be pleased with our discussions with regulatory bodies around the world regarding our upcoming pivotal TACTI-004 trial and are thankful for the positive feedback and constructive guidance received by AEMPS.
Among the other items discussed at the meeting were general aspects of the trial design, including selection of the control arm and statistics, and the specificities of the patient population.
Additional interactions with regulatory agencies as well as with other stakeholders and potential partners are ongoing in a productive manner.

UpMetrics Launches Free Impact Framework Building Tool for Impact Organizations

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Tuesday, March 26, 2024

Decal, Organization, Learning, Part, SAN, Table, Overalls, Data collection, Nonprofit organization, IMM, Video game

SAN FRANCISCO, March 26, 2024 /PRNewswire-PRWeb/ -- UpMetrics, an impact measurement and management software company, today announced the release of its new and improved Impact Measurement and Management (IMM) Suite, purpose-built to help mission-driven organizations measure, maximize, and showcase the positive social or environmental impact of their work.

Key Points:

As part of this platform rollout, UpMetrics provides free access to the Impact Framework Builder functionality as part of a Starter package offering.
"Our Impact Framework Builder is a free, easy-to-use tool that empowers organizations to measure, manage and communicate their impact, paving the way to access mission aligned capital that will maximize outcomes and long-term sustainability."
In alignment with their vision towards creating a data-driven ecosystem that drives capital and resources to impact, UpMetrics will be delivering additional updates to its platform throughout 2024, including impact framework publishing tools to connect impact organizations and an advanced two-sided portfolio reporting feature to streamline data collection and information sharing between funders and impact producers.
For more information, visit https://upmetrics.com/platform , or register for the free Impact Framework Builder via https://upmetrics.com/getstarted

Thebes Trust Alternate Thought Opens a Path for Directions Toward Building Harmony Among Adversaries

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Friday, March 22, 2024

Thus, we will address subjects using Universal Law, applying the cause factors to determine where another path might have been followed. The Trust will work with other graduate metaphysical teachers in association with the International Metaphysical Ministry -- (IMM) - (https://www.internationalmetaphysicalministry.com). Each graduate of the University of Metaphysics is opportunely ordained as a Metaphysical Minister at commencement as they work in their chosen field.

Key Points:

Thebes addresses those subjects by applying universal law, religious precepts, and Sociological norms—Thebes Trust partners with other ordained Metaphysical Ministers.
Thebes Trust adheres to the wording of the Ordination and the Vows accepted by William Cadmus.
LAS VEGAS, March 22, 2024 /PRNewswire-PRWeb/ -- Thebes Media ( https://www.thebesmedia.com ) officially announces the dawning of its product development for its Ministry.
Thus, we will address subjects using Universal Law, applying the cause factors to determine where another path might have been followed.

Immutep Announces First Clinical Data from 90mg Dosing of Efti

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Tuesday, March 5, 2024

MBC, Autoimmune disease, Safety, ASX, Observation, Paclitaxel, Patient, Disease, IMM, Cancer, Pharmaceutical industry

Updated safety data from patients with HR-positive/HER2-negative/low metastatic breast cancer (MBC) treated with this innovative immuno-oncology (IO)-chemotherapy combination reveal no treatment-emergent serious adverse events.

Key Points:

Updated safety data from patients with HR-positive/HER2-negative/low metastatic breast cancer (MBC) treated with this innovative immuno-oncology (IO)-chemotherapy combination reveal no treatment-emergent serious adverse events.
Additionally, all treatment-emergent adverse events during the safety observation period to date have been of mild severity.
The biologically active 30mg efti dose, previously the highest dose of efti ever tested, has demonstrated a stronger immune response and greater efficacy than lower dosing levels (1mg, 6mg) in multiple clinical trials.
The ongoing randomized Phase II portion of the trial, which will include up to 58 evaluable patients, is focused on whether 90mg efti dosing is safe and more efficacious than 30mg dosing.

Immutep Quarterly Activities Report Q2 FY24

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Tuesday, January 30, 2024

Well, OS, CPS, Survival, PD-L1, Congress, NSCLC, IMM, Lung cancer, Patient, TPS, Safety, Immutep, Pembrolizumab, Cancer, ASX, Autoimmune disease, Pharmaceutical industry

SYDNEY, AUSTRALIA, Jan. 30, 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, provides an update on the ongoing development of its product candidates, eftilagimod alpha (efti) and IMP761 for the quarter ended 31 December 2023 (Q2 FY24).

Key Points:

Cash receipts from customers in Q2 FY24 were $38k, compared to $132k in Q1 FY24.
The net cash used in G&A activities in the quarter was $0.8 million, compared to $1.6 million in Q1 FY24.
The net cash used in R&D activities in the quarter was $6.9 million, compared to $9.7 million in Q1 FY24.
Total net cash outflows used in operating activities in the quarter were $5.5 million compared to $12.9 million in Q1 FY24.

First Patient Dosed in Trial Evaluating Efti and the Anti-PD-L1 Therapy BAVENCIO® in Metastatic Urothelial Cancer

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Thursday, January 4, 2024

IO, Merck Group, ASX, Autoimmune disease, Immune system, Death, Bladder cancer, Carcinoma, Hope, IMM, PD-L1, Avelumab, Research, Cancer, Transitional cell carcinoma, Patient, Safety, Transitional epithelium

SYDNEY, AUSTRALIA, Jan. 04, 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 announces that the first patient has been enrolled and safely dosed in the INSIGHT-005 Phase I trial. The investigator-initiated study jointly funded with Merck KGaA, Darmstadt, Germany, will evaluate eftilagimod alpha (“efti”) in combination with BAVENCIO® (avelumab) in up to 30 patients with metastatic urothelial carcinoma.

Key Points:

The investigator-initiated study jointly funded with Merck KGaA, Darmstadt, Germany, will evaluate eftilagimod alpha (“efti”) in combination with BAVENCIO® (avelumab) in up to 30 patients with metastatic urothelial carcinoma.
Encouragingly, responses were achieved even in cancer patients with low and negative PD-L1 expression, who typically would not be expected to respond to anti-PD-(L)1 therapy.
Daniel Pink, as part of the investigator-initiated INSIGHT platform for studies investigating efti in different combination treatments and routes of administration.
For 2023, it was estimated there would be 82,290 new cases of bladder cancer and 16,710 deaths in the US alone.1

Immutep Receives Constructive Regulatory Feedback on TACTI-004 Registrational Trial in Metastatic Non-Small Cell Lung Cancer

Retrieved on:

Thursday, December 21, 2023

Lung cancer, ASX, Autoimmune disease, Food, PEI, FDA, Paul Ehrlich Institute, IMM, Cancer, Committee, Safety, NSCLC, PD-L1, CHMP, Pharmaceutical industry

SYDNEY, AUSTRALIA, Dec. 21, 2023 (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 announces constructive feedback has been received from the Paul-Ehrlich-Institut (“PEI”), a German regulatory authority and part of the Committee for Medicinal Products for Human Use (CHMP), regarding the planned TACTI-004 Phase III trial of eftilagimod alpha (“efti”) for first line treatment of metastatic non-small cell lung cancer (NSCLC).

Key Points:

The PEI is supportive of Immutep moving into a registrational trial in first line NSCLC and evaluating efti in combination with an anti-PD-1 therapy in a chemotherapy-free regimen or as a triple combination approach that includes chemotherapy.
Also, the PEI acknowledged the good safety profile of efti in combination with anti-PD-1 therapy.
Immutep plans to announce its final trial design for TACTI-004 in Q1 of CY2024.
Immutep CEO, Marc Voigt, commented: “We appreciate the valuable feedback from the PEI and look forward to additional discussions with other regulatory agencies in the coming months.

Immutep Receives A$2.6 million R&D Tax Incentive from French Government

Retrieved on:

Thursday, December 7, 2023

Immunotherapy, Recherche, ASX, Research, European, IMM, Cancer, Calendar, CIR, Immutep, Eftilagimod alpha

SYDNEY, AUSTRALIA, Dec. 07, 2023 (GLOBE NEWSWIRE) -- Immutep Limited (ASX: IMM; NASDAQ: IMMP) ("Immutep“ or “the Company”), a biotechnology company developing novel LAG-3 related immunotherapy treatments for cancer and autoimmune diseases, is pleased to announce it has received a €1,595,475 (~ A$2,628,354 ) research and development (R&D) tax incentive payment in cash from the French Government under its Crédit d’Impôt Recherche scheme (CIR).

Key Points:

The “Crédit d’Impôt Recherche” (CIR), meaning “Research Tax Credit”, is a French government tax incentive by which French companies conducting research and development activities in Europe can be reimbursed 30% of their eligible expenditure.
Immutep qualifies for the CIR tax incentive through its subsidiary Immutep S.A.S.
Immutep also qualifies for cash rebates from the Australian Federal Government’s R&D tax incentive program in respect of expenditure incurred on eligible R&D activities conducted in Australia.
As previously announced, in October 2023, the company received an A$1.13 million cash rebate from the Australian Federal Government’s R&D tax incentive program for the eligible R&D activities conducted in financial year 2022.