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Iovance (IOVA) to Start Clinical Studies for TIL Therapy

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Iovance Biotherapeutics (IOVA - Free Report) announced that the FDA has approved its investigational new drug (IND) application seeking to start clinical studies for its first TALEN-edited tumor infiltrating lymphocyte (TIL) therapy, IOV-4001.

IOV-4001 is Iovance’s first TALEN-edited TIL therapy. The candidate leverages the TALEN technology licensed from Cellectis (CLLS - Free Report) to genetically knock out PD-1 in TIL cells. Per the company, IOV-4001 provides an opportunity to assess the safety and efficacy of the combination of a TIL therapy and a PD-1 checkpoint inhibitor in a single formulation.

IOVA plans to begin a clinical study evaluating IOV-4001 in patients with metastatic melanoma or stage III or IV non-small cell lung cancer (NSCLC) later this year.

Shares of Iovance were up 8.8% in after-market trading on Tuesday following the news announcement. Yet, the stock has plunged 34.5% so far this year in comparison with the industry’s 19.1% decrease.

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We note that IOVA collaborated with Cellectis in 2020. Per the agreement terms, IOVA has an exclusive worldwide license to use Cellectis’ proprietary TALEN technology to develop gene-editing TIL therapies targeting cancer. CLLS is entitled to receive milestone and royalty payments from IOVA upon potential development and successful commercialization of the products developed using the TALEN technology.

Next month, the company also plans to present background data on IOV-4001 at a medical meeting.

In addition to IOV-4001, Iovance has other TIL therapy candidates in its pipeline. The company is developing its lead pipeline candidate, lifileucel, as a monotherapy for treating metastatic melanoma and metastatic cervical cancer in separate pivotal phase II studies — C-144-01 and C-145-04 — for metastatic melanoma and recurrent, metastatic or persistent cervical cancer, respectively, in previously-treated patients. 

Following FDA concerns over potency assays for lifileucel, Iovance is currently working with the FDA to resolve the issues. The company plans to submit a biologics license application (BLA) for lifileucel for the treatment of melanoma in first-half 2022. A resolution for the potential assay for lifileucel will also help Iovance to proceed with regulatory plans for other indications. The company is also in discussion with the FDA for its BLA submission plans for lifileucel to treat cervical cancer.

Iovance is also evaluating LN-145, another TIL therapy, as a potential treatment for head and neck squamous cell carcinoma and NSCLC in two separate studies.

A multi-center phase II study — IOV-COM-202 — composed of seven cohorts is evaluating Iovance’s TIL therapies in multiple settings and indications, both as a monotherapy and in combination with Merck’s (MRK - Free Report) Keytruda or Bristol-Myers’ (BMY - Free Report) Opdivo/Yervoy.

Keytruda, which is the key revenue generator for Merck, is already approved for the treatment of many cancers globally. For the full year of 2021, Merck recorded $17.2 billion in sales from Keytruda. Merck is also evaluating Keytruda across a wide number of indications that are progressing well.

Opdivo and Yervoy are two of the many blockbuster drugs marketed by Bristol Myers and are key growth drivers of BMY’s top line. During full-year 2021, Bristol Myers generated $7.5 billion from Opdivo sales and recorded $2 billion as product revenues from Yervoy.

Zacks Rank

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