- IPHA is a French company with major partnerships with big pharma.
- The company is a leader in harnessing the innate immune system for therapeutic use.
- They have a number of upcoming catalysts.
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Innate Pharma (NASDAQ:IPHA) is a Marseilles, France-based developer of cancer medicines. The company focuses on harnessing the innate immune system and has expertise in natural killer cell biology. Lead (AstraZeneca) partnered program with monalizumab is in phase 3 trials in post anti PD-1/L-1 Head and Neck cancer. Proprietary programs lacutamab and avdoralimab are in multiple phase 2 trials. The entire pipeline looks like this:
Lacutamab is a first-in-class anti-KIR3DL2 humanized cytotoxicity-inducing antibody. KIR3DL2 plays a key role in innate immune response. The molecule is being developed targeting T-cell lymphomas. The company recently published phase 1 data from its Sézary syndrome program targeting patients who have received at least two prior systemic therapies, in Lancet. This program is under EMA's PRIME and FDA's Fast Track therapy designations. The asset also has orphan drug designations in the EU and US for cutaneous TCL (CTCL).
SS is an ultra-orphan market with just 80-200 patients in the US, EU, and Japan. Mycosis fungoides have 2400-4000 patients, and PTCL has around 18000 patients in these geographies. In all these diseases, the target protein is highly expressed. Mogamulizumab, brand name Poteligeo, is approved since 2018 for treatment of relapsed or refractory mycosis fungoides and Sézary disease.
The company plans to take a top down approach, targeting the smaller syndrome first, which will create a proof-of-concept situation for lacutamab.
The findings from the phase 1 study were:
Between Nov 4, 2015, and Nov 20, 2017, 44 patients were enrolled. 35 (80%) patients had Sézary syndrome, eight (18%) had mycosis fungoides, and one (2%) had primary cutaneous T-cell lymphoma, not otherwise specified. In the dose-escalation part, no dose limiting toxicity was reported and the trial's safety committee recommended a flat dose of 750 mg for the cohort-expansion, corresponding to the maximum administered dose. The most common adverse events were peripheral oedema (12 [27%] of 44 patients) and fatigue (nine [20%]), all of which were grade 1-2. Lymphopenia was the most common grade 3 or worse adverse event (three [7%]). One patient developed possibly treatment-related fulminant hepatitis 6 weeks after IPH4102 discontinuation and subsequently died. However, the patient had evidence of human herpes virus-6B infection. Median follow-up was 14·1 months (IQR 11·3-20·5). A confirmed global overall response was achieved in 16 (36·4% [95% CI 23·8-51·1]) of 44 patients, and of those, 15 responses were observed in 35 patients with Sézary syndrome (43% [28·0-59·1]).
The following graphics from the company illustrates the significance of these results.
Source: Innate Pharma
The first one shows the numbers for CR, PR, SD and PD, or complete response, partial response, stable disease and progressive disease. LCT or large cell transformation is a risk factor in Sezary Syndrome. If we take out these patients, we get the following data for DOR and PFS:
Source: Innate Pharma
The company also compares their data with currently approved therapies:
Source: Innate Pharma
Given that lacutamab is targeting a later line disease, these early results are certainly impressive.
A phase 2 study is ongoing. Last year, it was placed on partial hold due to the manufacturer of the molecule having financial problems. This trial has yielded encouraging early results of "overall response rate of ~35%* in advanced patient population with no current standard of care." Sezary syndrome data is expected in 2022, and the trial could turn into a pivotal trial for this ultra-rare disease.
The second self-owned candidate, Avdoralimab (IPH5401), was acquired from Novo Nordisk. It binds and blocks C5a receptors (C5aR1), which may have therapeutic effect on certain complement-driven inflammatory diseases.
Monalizumab (IPH2201) works by blocking HLA-E expressing tumor cells from inhibiting CD8+ T cells and NK cells. This is done through blocking NKG2A receptors, immune checkpoints present on these tumor killing immune cells. Rights to the asset are owned by AstraZeneca, with a deal valued at $1.275bn, of which $400mn has been received till date. Monalizumab is in a phase 3 trial with monalizumab and cetuximab vs. placebo and cetuximab in patients with recurrent or metastatic head and neck squamous cell carcinoma of the head and neck (R/M SCCHN) who have been previously treated with platinum-based chemotherapy and PD-(L)1 inhibitors.
Innate Pharma has a market cap of $466mn with a cash reserve of €159.4mn as of June 30, or roughly $185mn. Operating expenses were roughly $50mn in the quarter, providing them with a runway of nearly 4 quarters. The company earned around $18mn in revenue, which mainly includes money from the collaborations and some government funding.
There is very little institutional and fund interest in IPHA in the US, with nearly 64% of the company being held in the retail space. There is no insider sales data in the US, this being a French-origin company. AstraZeneca owns a 10% stake in the company, and its former cancer head is Innate's CEO.
IPHA looks like a very interesting company from Europe with a valuable set of assets, major partnerships with big pharma, and a late stage pipeline. Their cash runway could be better, but that is somewhat bolstered by their consistent income generation from partnerships. Overall, although the low volume of trading in the US makes this fairly unattractive for short to mid term investors, I think I will keep watching this name for future developments and a possible position.
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This article was written by
Avisol Capital Partners is made up of a team of medical experts, finance professionals and techies, all of whom invest their own money in the picks they share. They aim to help readers find the middle ground between value and growth investing, as they demystify the biopharma industry.They lead the investing group Total Pharma Tracker where they offer a monthly updated catalyst database, an investability scoring system for quick reference ideas, and direct access in chat for dialogue and questions. Learn more.
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