Shares in Australian biotechnology company Immutep Ltd (ASX: IMM) are tanking on Wednesday morning, down 20% to 56 cents.
Immutep shares are on the move this morning after the company announced data from a Phase IIb trial on its lead drug candidate, etfi.
The trial success marks another step forward for the company whose novel cancer treatment hypothesis is beginning to gain steam.
Here are the details.
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What did Immutep announce?
Immutep announced readouts from its AIPAC Phase IIb trial. The study was investigating Immutep's etfi drug candidate as a combination therapy with paclitaxel chemotherapy.
The trial examined this combination treatment in patients with HER2-negative/HR positive metastatic breast cancer.
For reference, around 74% of all breast cancers are categorised in this group. It is not considered the most aggressive form of the condition.
From the trial results, the data for overall survival showed a positive trend in the population group. For instance, the cohort showed a "median survival benefit" of 2.9 months from the treatment combination versus placebo.
The positive results were identified in three distinct subgroups: those younger than 65 years old, those with low monocyte count, and those with Luminal B breast cancer.
Even in patients with the more aggressive Luminal B sub-type, there was a median overall survival benefit of 16.8 months.
Overall, the data reflects an increase in the length of survival ranging from 33% to 150% in these groups who received the treatment compared to placebo.
The efti compound was also shown to increase the abundance CD8 T cells. These are an important immune defence mechanism that have been "significantly correlated with improved overall survival".
Importantly, aside from demonstrating its effectiveness, etfi was also shown to be safe and well tolerated. The company says no new safety or adverse events were identified from the trial.
Overall, the results support the development of a Phase III trial for efti in combination with paclitaxel chemotherapy in metastatic breast cancer, according to Immutep.
What's next for Immutep?
The company is now preparing to establish a Phase III trial to further its investigation of this combination therapy in metastatic breast cancer.
A Phase III trial is typically the final phase that a candidate drug must undergo before being commercialised, with a few exceptions.
It is generally a much larger study population conducted across a number of countries to ensure an appropriate diversity in participants.
As such, Immutep is in ongoing talks with regulatory bodies in multiple countries where the trial is intended to take place.
Commenting on the results, Immutep CEO Mark Voigt said:
These very pleasing final results give us additional confidence that efti can ultimately deliver a meaningful clinical improvement for diverse sets of cancer patients. The results from our AIPAC trial are especially pleasing because metastatic breast cancer patients in the chemotherapy setting are a difficult to treat and large patient population where immunotherapies often fail to provide an additional benefit. These supportive results are also timely as we solidify the trial design for our planned Phase III study in metastatic breast cancer, subject to regulatory body interactions.
Curiously, the market has reacted poorly to Immutep's trial results today despite the positive data. The Immutep share price is now trading at 56 cents, well down from 70 cents at the close yesterday.
Yet, in spite of this morning's punishment, the Immutep share price has climbed over 114% in the last 12 months. This result comes on the back of a 42% gain since January 1.
