This Day That Year: Innate Pharma (IPHA)

(RTTNews) - Shares of Innate Pharma S.A. (IPHA) are down nearly 50 percent from their 52-week high of $8.24, recorded in January of this year, and trade around $4.

Based in Marseille, France, the company made its debut on the Nasdaq Global Select Market on October 17, 2019, by setting a public offering at $5.50 per American Depositary Share. Innate has been listed on the Euronext in Paris since November 2006.

The company's lead compound is Monalizumab, a potentially first-in-class anti-NKG2A monoclonal antibody, which promotes anti-tumor immunity by unleashing both T & NK cells, and is partnered with AstraZeneca (AZN).

AstraZeneca obtained full oncology rights to Monalizumab from Innate Pharma in October 2018.

In May of this year, Innate presented Cohort 2 data from a phase II study which evaluated Monalizumab in combination with Eli Lilly's Erbitux in patients with recurrent or metastatic squamous cell carcinoma of the head and neck who were previously treated with both prior platinum-based chemotherapy and immuno-oncology treatments. The Cohort 2 demonstrated an ORR of 20%. (ORR or Overall response rate is the proportion of patients in a trial whose tumor is destroyed or significantly reduced by a drug).

A phase II expansion cohort, i.e., Cohort 3, exploring the combination of Monalizumab, Eli Lilly's Erbitux, and AstraZeneca's Imfinzi in immuno-oncology (IO)-naïve patients with recurrent or metastatic squamous cell carcinoma of the head and neck is ongoing. Data from Cohort 3 is expected to be published in 2021.

A phase III trial evaluating the combination of Monalizumab and Eli Lilly's Erbitux in patients with immuno-oncology (IO)-pre-treated recurrent or metastatic squamous cell carcinoma of the head and neck is expected to commence this quarter.

Innate Pharma will receive $50 million from AstraZeneca upon dosing of the first patient in the phase III trial, and an additional $50 million after the interim analysis demonstrates the combination meets a predefined threshold of clinical activity.

The other clinical programs in the pipeline are:

-- A phase II trial of Lacutamab alone or in combination with chemotherapy in patients with different subtypes of T-cell lymphoma, dubbed TELLOMAK IS ongoing. This international trial was placed on partial hold by the FDA and other regulatory agencies in February of this year due to Good Manufacturing Practice (GMP) deficiencies at the company's manufacturing subcontractor site.

The partial clinical hold on TELLOMAK was lifted in June and enrollment in the trial has resumed in Spain, Germany, France, UK, and the US.

TELLOMAK is designed to include 5 cohorts - Cohort 1: Relapsed/refractory Sezary Syndrome, Cohort 2: Stage IB-IV Mycosis Fungoides, KIR3DL2 expressing, Cohort 3: Stage IB-IV Mycosis Fungoides, KIR3DL2 non-expressing, Cohort 4: Peripheral T-cell lymphoma, KIR3DL2 expressing, and Cohort 5: Peripheral T-cell lymphoma, KIR3DL2 non-expressing.

Innate expects to share data from the TELLOMAK trial for mycosis fungoides in 2021 and Sézary syndrome in 2022.

-- A phase II trial of Avdoralimab in COVID-19 patients with severe pneumonia, dubbed FORCE, is underway.

-- Two investigator-sponsored studies with Avdoralimab one in chronic spontaneous urticaria and the other in bullous pemphigoid are due to be initiated this quarter.

-- A dose-escalation phase I trial evaluating Innate's IPH5201 as monotherapy or in combination with AstraZeneca's Imfinzi with or without Oleclumab in advanced solid tumors is ongoing. IPH5201 is also being developed under a collaboration with AstraZeneca.

In addition to the above, Innate has a marketed product Lumoxiti, in-licensed from AstraZeneca for the treatment of hairy cell leukemia, and a couple of pre-clinical programs. Lumoxiti is not approved in the European Union yet and is under review by the European Medicines Agency.

Cash & Financials:

In the first half of this year, Innate Pharma incurred a net loss of 10.3 million euros or 0.13 euros per share on revenue & other income of 36.74 million euros. This compared with a net income of 13.2 million euros or 0.20 euros per share and revenue & other income of 59 million euros in the first half of 2019.

Cash and cash equivalents totaled 184.6 million euros as of June 30, 2020.

On the NASDAQ, the stock has thus far hit a low of $3.30 and a high of $8.24. IPHA closed Friday's (Oct.16, 2020) trading at $4.17, up 4.25%.