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Innate (IPHA) Gains as Blood Cancer Drug Gets Fast Track Tag

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Shares of Innate Pharma SA (IPHA - Free Report) jumped 10.3% after partner Sanofi (SNY - Free Report) announced that the FDA granted Fast Track Designation to pipeline candidate SAR’579 / IPH6101 for the treatment of hematological malignancies.

This designation from the regulatory body is designed to facilitate the development and expedite the review of drugs intended to treat serious conditions and fill unmet medical needs.

ANKET (Antibody-based NK cell Engager Therapeutics) is Innate's proprietary platform for developing next-generation, multi-specific natural killer (NK) cell engagers to treat certain types of cancer. SAR’579 is a lead asset of the ANKET platform and a trifunctional anti-CD123 NKp46×CD16 NK cell engager. The candidate has evolved from a joint research collaboration between Innate Pharma and Sanofi and is now under development by Sanofi.

We note that Innate Pharma and Sanofi entered into a research collaboration and licensing agreement in 2016 to apply Innate’s proprietary technology to the development of innovative multi-specific antibody formats engaging NK cells through the activating receptors NKp46 and CD16 to kill tumor cells.

Per this agreement (signed in 2016), Sanofi is responsible for the development, manufacturing and commercialization of products resulting from the research collaboration, which includes IPH6101/SAR’579 (Trifunctional anti-CD123 NKp46×CD16 NK cell engager) and IPH6401/SAR’514 (Trifunctional anti-BCMA NKp46×CD16 NK cell engager).

In exchange, Innate Pharma will be eligible for up to €400 million in development and commercial milestone payments, as well as royalties on net sales.

Per Innate Pharma, the Fast Track Designation for SAR’579 / IPH6101 further validates the potential of the ANKET platform to treat cancer patients with NK cell engagers.

Both companies expanded their agreement in December 2022, whereby Sanofi gained an exclusive license to Innate’s B7H3 ANKET program and options for two additional targets. Upon candidate selection, Sanofi will be responsible for all development, manufacturing and commercialization. Innate received €25 million upfront and is eligible for up to €1.35 billion in total milestones plus royalties.

Innate Pharma’s shares have lost 20.3% in the year so far compared with the industry’s 7.1% decline.

 

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Innate’s portfolio includes lead proprietary program lacutamab, developed in advanced forms of cutaneous T cell lymphomas and peripheral T cell lymphomas, monalizumab developed with AstraZeneca (AZN - Free Report) in non-small cell lung cancer (NSCLC) as well as ANKET multi-specific NK cell engagers to address multiple tumor types.

Innate has an agreement with AstraZeneca for monalizumab in the early NSCLC setting. A phase III study, PACIFIC-9, is being conducted by AstraZeneca. The study is evaluating durvalumab (anti-PD-L1) in combination with monalizumab or AstraZeneca’s oleclumab (anti-CD73) in patients with unresectable, stage III NSCLC who have not progressed following definitive platinum-based concurrent chemoradiation therapy (CRT).

Innate Pharma currently carries a Zacks Rank #3 (Hold). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.


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