ASX Health Stocks: Immutep gets positive FDA feedback for lung cancer therapy

Immutep receives FDA feedback for its TACTI-004 Phase III trial design for tackling non small-cell lung cancer
Althea forms JV to enter the US cannabis beverage market
Chimeric enrols first participant in a Phase 1/2 trial for its CHM CDH17 cell therapy

Immutep receives feedback from FDA

Immutep (ASX:IMM) has received positive feedback from the US Food and Drug Administration (FDA) regarding the design of its TACTI-004 Phase III clinical trial.

This trial will evaluate the effectiveness of efti, Immutep’s novel cancer treatment, when used in combination with KEYTRUDA (pembrolizumab), an anti-PD-1 therapy developed by Merck, along with standard chemotherapy.

The TACTI-004 trial is a major step forward for Immutep, as it marks the culmination of regulatory discussions with the FDA, as well as feedback from other regulatory bodies such as the Paul-Ehrlich-Institut and the Spanish Agency for Medicines and Health Products.

This FDA feedback has now finalised the design of the Phase III trial, which aims to address the treatment needs of first-line metastatic NSCLC (non small-cell lung cancer) patients, regardless of their PD-L1 expression levels.

PD-L1 expression levels play a crucial role in cancer, particularly in the context of lung cancer, as they influence the effectiveness of certain immunotherapy treatments.

The trial will involve approximately 750 patients and will compare the combination of efti, KEYTRUDA, and chemotherapy against the standard treatment of KEYTRUDA and chemotherapy with a placebo.

The study will be randomised, double-blind, and conducted on a global scale. It will focus on evaluating progression-free survival and overall survival as primary endpoints.

This development is based on encouraging results from earlier trials, TACTI-002 and INSIGHT-003, which demonstrated positive efficacy and safety data for efti in NSCLC patients.

NSCLC is the most common type of lung cancer, characterised by its slower growth compared to small cell lung cancer.

Althea enters into US joint venture

Althea Group (ASX:AGH) has announced the successful establishment of a joint venture between its US subsidiary, Peak USA Inc., and Flora Growth Corporation to enter the burgeoning US cannabis beverages market.

The agreements, finalised after a $2 million capital raise, mark a significant step for AGH as it expands its operations.

The US cannabis beverage market, currently valued at nearly $967 million, is expected to soar to $19 billion by 2028.

To capitalise on this growth, Peak USA and Flora have developed six cannabis-infused drinks, including three seltzers and three sodas with varying THC levels. These products are set to launch in early 2025, both online and through retail channels like wine and liquor stores.

Peak USA will handle production in the US and plans to leverage its Canadian operations to cater to US market needs.

Chimeric enrols first patient to Phase 1/2 trial

Cell-therapy biotech Chimeric Therapeutics (ASX:CHM) has announced that the first participant has been enrolled in the Phase 1/2 multi-centre clinical trial for CHM CDH17 cell therapy targeting advanced gastrointestinal cancers.

The Phase 1/2 trial is a two-stage study designed to determine a recommended Phase 2 dose of CHM CDH17, and evaluate its safety and objective response rate in patients with advanced colorectal cancer, gastric cancer, and intestinal neuroendocrine tumours.

“This is great progress for this first-in-human study for bowel cancer patients with significant unmet need; congratulations to the CHM team and our investigational sites on this milestone.” said Dr Rebecca McQualter, Chief Operating Officer of Chimeric.