Immutep (ASX:IMM) share price hikes amid clinical trial momentum in FY21

Here we unpack the biotech company's annual report to see where it made most progress in FY21.

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Shares in clinical stage biotechnology company Immutep Ltd (ASX: IMM) are inching higher in afternoon trading, up 2.5% to 62 cents apiece.

Immutep's share price has been on the move amid the release of its annual report today, in which several investment highlights are observed.

Here we dive in and analyse the key data points from Immutep's annual report.

Lead drug candidate's begin to gain steam

Immutep is characterised as a "leader in the development of LAG-3 immuno-therapeutic products for cancer and autoimmune disease".

"Lymphocyte-activation gene 3", or LAG-3 for short, plays a critical role in our immune system against the formation of tumours.

It was actually discovered by Immutep's current Chief Scientific Officer, Frédéric Triebel, back in 1990, and is now gaining traction in oncology circles.

Immutep currently has 4 drug candidates based on the LAG-3 hypothesis, each with a different mechanism of action, per its annual report.

Its lead candidate, known in one form as IMP321, is in later stage clinical development for the treatment of cancer.

A second contender, IMP761, is currently in pre-clinical development for the treatment of autoimmune diseases, alongside 2 clinical programs with "major pharmaceutical partners".

It was in the LAG-3 domain where Immutep saw most tailwinds in FY21.

Particularly as the company advanced several clinical trials – either Phase I, II or IIa – for IMP321 across the year.

For instance, it embarked on clinical trials with pharmaceutical giants Merck & Co Inc and Merck KGaA to investigate IMP321 as a combination therapy in various forms of cancer.

In one of these studies, the TACTI-002 Phase II trial, researchers are investigating the safety and efficacy of IMP321 in combination with Merck's KEYTRUDA label, to treat some forms of lung and head & neck cancer.

Further takeouts from Immutep's annual report

Aside from this, in June, the company also advised of its plans to commence a new Phase III clinical trial.

It will be evaluating IMP321 in combination with chemotherapy in patients with metastatic breast cancer.

Phase III trials are generally one of the last stages of clinical testing that a drug must go through before being approved for commercialisation.

It involves a large sample population, across many jurisdictions, to obtain the most accurate data possible on dosages, adverse reactions and so on.

Judging from the readouts thus far, each trial has produced promising results, with Immutep's drug candidates each holding up well from a safety and efficacy standpoint.

From its annual report, Immutep's formulations are active in 10 clinical trials, that are dotted in various spots around the globe.

Alongside the trials, the company is also engaged with several licensing programs, with Novartis, GlaxoSmithkline, and Labratory Corporation of America Holdings for its LAG-3 products.

Investors seeking more on the company's financial performance can refer to its FY21 annual earnings report, released back in August and found here.

Immutep share price snapshot

The Immutep share price has been an outsized performer this year to date, having posted a return of almost 50% since January 1.

Over the last 12 months it has also climbed over 138%, well ahead of the benchmark S&P/ASX 200 index (ASX: XJO)'s return of around 21% in the same time.

The author Zach Bristow has no positions in any of the stocks mentioned. The Motley Fool Australia's parent company Motley Fool Holdings Inc. has no position in any of the stocks mentioned. The Motley Fool Australia has no position in any of the stocks mentioned. The Motley Fool has a disclosure policy. This article contains general investment advice only (under AFSL 400691). Authorised by Bruce Jackson.

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