Immutep Limited: Leading Not Lagging in Immuno-Oncology Development
Immutep Limited
Leading not lagging in immuno-oncology development
Immutep Limited (ASX:IMM) is a biotechnology company that is a leader in the development of LAG-3 related immunotherapeutic products for the treatment of cancer and autoimmune disease. IMM’s current lead product candidate is eftilagimod alpha (efti), a soluble LAG-3 fusion protein, which is a first-in-class antigen presenting cell activator being explored in cancer and infectious disease. IMM is also developing an agonist of LAG-3 (IMP761) for the treatment of autoimmune disease which is in pre-clinical development. The group is exploring all avenues to leverage the technology and as a result has candidates under their own development and under partnership with majors. The company’s two key clinical trials evaluating efti are a Phase 2b AIPAC trial in metastatic breast cancer and a Phase 2 TACTI-002 trial in non- small cell lung cancer and head & neck cancer. Efficacy data from these trials has been encouraging and expected to see progression into Phase 3 during FY22. The funding pathway has recently been strengthened (out to ~Q4CY23) by the issue of 129.23m shares at $0.52c to raise $67.2m, bringing proforma net cash to $113m. Funds will be used for manufacturing, working capital, R&D and progressing these programs in clinical trials.
Business model
IMM’s business model is to cement its position as a global leader in the development of LAG- 3 by exploring product candidates across immuno-oncology and autoimmune diseases. IMM has drugs under their own development and in partnership with a number of global players that have drugs already FDA approved. The group ultimately is looking to license drugs under development to big pharma to progress to commercialisation.
A summary of trials underway
IMM currently has 5 clinical trials underway evaluating lead product candidate, eftilagimod alpha (efti) in various settings. The most advanced of these trials are a phase 2b combination trial (AIPAC) with chemotherapy in metastatic breast cancer and a phase 2 combination trial (TACTI-002) with KEYTRUDATM (MSD) in 1st and 2nd line non-small cell lung carcinoma (NSCLC) and 2nd line head and neck squamous cell carcinoma (HNSCC). IMM has recently initiated a phase 2b combination trial (TACTI-003) with KEYTRUDA in 1st line HNSCC. The group also has an investigator-initiated platform trial evaluating efti in several novel settings which is being undertaken through the Institute of Clinical Cancer Research (IKF), Germany and a phase 2 investigator-initiated trial in COVID-19 being undertaken by the University Hospital Pilsen, Czech Republic. Positive data readout from the AIPAC trial is expected to result in clinical development to a phase 3 trial in FY22.
Well-funded clinical stage drug developers are key peers
Comparing biotech stocks with different technologies across different indications is complex. Addressable markets, stage of development, strength and terms of patents, licensing terms, ability to manufacture at commercial scale and potential partners are just some of the considerations. Companies that have adopted similar models to IMM with difficult indications and at an early to mid-stage of development and relatively well-funded include Kazia Therapeutics (ASX:KZA), Paradigm Biopharmaceuticals (ASX:PAR), Antisense Therapeutics (ASX:ANP) and Actinogen (ASX:ACW). Relative to this group IMM has the highest cash to market cap ratio at ~25% (PAR and KZA ~16%) and is equal largest in market cap terms along with PAR.
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- Immutep Limited: Leading Not Lagging in Immuno-Oncology Development10 Sep 2021