Immutep Limited American Depositary Shares - IMMP STOCK NEWS

Immutep Limited (NASDAQ: IMMP) has released positive final data from the TACTI-002 Phase II trial, focusing on 2nd line metastatic non-small cell lung cancer patients who are refractory to anti-PD-(L)1 therapy. The combination of eftilagimod alpha and pembrolizumab yielded a median overall survival (mOS) of 9.9 months and a 39% overall survival rate at 21 months, outperforming standard chemotherapy outcomes. The trial demonstrated a tumor shrinkage or deceleration in growth in 83% of patients. The combination therapy showed an objective response rate of 8.3% and a disease control rate of 33.3%, with favorable tolerance and no new safety signals.

Immutep (ASX: IMM; NASDAQ: IMMP) has announced the expansion of its INSIGHT-003 trial to 50 patients, following successful safety and efficacy results for its combination therapy involving eftilagimod alpha (efti), anti-PD-1 therapy, and chemotherapy in treating 1st line non-small cell lung cancer (1L NSCLC). The initial enrolment reached 20 patients, and additional data is expected throughout 2023. Early results show an overall response rate (ORR) of 72.7% and a disease control rate (DCR) of 90.9%. This trial aims to assess the potential of efti to address the entire NSCLC patient population.

Immutep Limited (ASX: IMM; NASDAQ: IMMP) has announced new data from the TACTI-002 Phase II trial focusing on 2nd line non-small cell lung cancer (NSCLC) patients who are refractory to anti-PD-(L)1 therapy. The trial included 36 patients showing promising results with an Overall Response Rate (ORR) of 8.3% and a 33% Disease Control Rate (DCR). Additionally, 83% of patients experienced tumor growth deceleration or shrinkage. Final safety and efficacy data, including Overall Survival (OS) metrics, will be presented at the European Lung Cancer Congress (ELCC) 2023 in Copenhagen from March 29 to April 1.

Immutep Limited (NASDAQ: IMMP) announced the initiation of the AIPAC-003 trial, combining eftilagimod alpha ('efti') with paclitaxel for metastatic breast cancer. The dual therapy targets HR+/HER2-neg/low and triple-negative breast cancer, covering about 78% of cases. Approvals received in the US and Spain, with patient enrollment expected in early Q2 CY2023. The trial design, reviewed by the FDA and EMA, aims to inform a Biologics License Application and Marketing Authorisation Application.

With a promising safety profile and earlier positive trial results showing a median overall survival increase, Immutep aims to enhance treatment outcomes in breast cancer.

Immutep Limited has announced the successful enrollment of 20 patients in the INSIGHT-003 trial, evaluating its lead product candidate, eftilagimod alpha (efti), in combination with standard anti-PD-1 therapy and chemotherapy for first-line non-small cell lung cancer (1L NSCLC). Initial results showed a promising 72.7% response rate and 90.9% disease control rate. The trial aims to assess the safety and efficacy of this triple therapy approach. Further data will be released throughout 2023 to guide the next steps in 1L NSCLC treatment.

Immutep Limited (ASX: IMM; NASDAQ: IMMP) announced significant advancements in its product development for efti and IMP761. The US FDA granted a second Fast Track designation for efti in non-small cell lung cancer (1L NSCLC), following positive Phase II results showcasing an Overall Response Rate (ORR) of 40.4%. A successful FDA meeting allowed for a combined Phase II/III trial design for metastatic breast cancer (MBC), including triple-negative patients. Additionally, the company reported a strong cash balance of $68.38 million, extending its cash runway until FY24, while also scaling manufacturing for efti.

Immutep Limited (NASDAQ: IMMP) announced that it has successfully enrolled over 50% of its target of 154 patients in the TACTI-003 Phase IIb trial, which evaluates its soluble LAG-3 protein, eftilagimod alpha (efti), in combination with Merck's KEYTRUDA® for treating recurrent or metastatic head and neck squamous cell carcinoma (HNSCC). The trial is ongoing across the U.S., Australia, and Europe, with full recruitment expected by mid-2023. The Independent Data Monitoring Committee has recommended trial continuation without modifications, reinforcing the potential efficacy of efti.

Immutep Limited (ASX: IMM; NASDAQ: IMMP) announced a successful Type C meeting with the FDA, paving the way for a Phase II/III trial of eftilagimod alpha (efti) for metastatic breast cancer (MBC). The trial’s design includes an expanded patient population to include triple-negative breast cancer. Efti aims to improve standard-of-care chemotherapy by stimulating the immune system. The company’s cash runway is secured until mid-2024, supporting ongoing clinical development efforts.

Immutep Limited (ASX: IMM; NASDAQ: IMMP) announced the successful completion of a 2,000L manufacturing run for its lead product candidate, eftilagimod alpha (efti), in partnership with WuXi Biologics. This achievement ensures readiness for late-stage clinical trials and potential commercial production. The manufacturing process was scaled up from 200L to 2,000L to meet demand for ongoing and future trials. Efti, a first-in-class soluble LAG-3 protein, is being developed for various cancer indications and has received Fast Track Designation from the FDA.