StemCell Therapy

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Shares of Iovance Biotherapeutics shot up Tuesday on rumors the company could be up for sale. The news comes a day after the company said it intends to speak with regulatory agencies later this year about its programs in melanoma and cervical cancer.

First reported by Bloomberg, Iovance is reportedly working with a financial adviser about a potential sale following conversations about a potential takeover from a larger company. The information was provided by unidentified sources who are familiar with the matter, Bloomberg said. The news sent shares of Iovance up more than 30% in Tuesdays trading. Part of that boost was due to the companys fourth-quarter progress in its clinical pipeline. In anticipation of potential approval and commercialization of its lead candidates, Iovance said it was building its internal manufacturing capability, as well as expanding its commercial team and infrastructure.

While nothing has been formally stated, Benjamin Burnett, an analyst with Stifel Financial Inc. said in a note that acquiring Iovance would make sense for some companies, including Takeda Pharmaceutical and Gilead Sciences, Bloomberg reported. This morning, Takeda announced its intention to acquire celiac disease-focused PvP Biologics for $330 million to complement its gastrointestinal pipeline. Burnett said Iovance is one of the few cell therapy companies in the coverage of Stifel Financial that has been de-risked to a large degree by a proof-of-concept study. Because of that, Burnett said they can see how this might be one of the more interesting cell therapy take-out candidates.

Despite the potential for an acquisition, Iovance could opt to remain independent, the unidentified sources told Bloomberg. A representative for Iovance declined to comment, Bloomberg added.

San Carlos, Calif.-based Iovance specializes in cell therapy focused on treating solid tumors with tumor infiltrating lymphocyte (TIL) therapies. In a previous interview with BioSpace, Iovance Chief Executive Officer Maria Fardis explained that TIL technology is a boosting of the bodys natural immunity. The TIL is removed from a cancerous tumor, amplified in number through cell culture to attack the disease, then are reinserted into the tumor to do the work. Because the amplified TILs can attack the whole tumor, including any potential mutations, Fardis described it as the most exquisite kind of personalized medicine for a patient.

Iovances investigational candidates include lifileucel, which is being investigated as a potential treatment for melanoma and LN-145, a potential treatment for patients with recurrent, metastatic or persistent cervical carcinoma. Lifileucel has received both fast-track and regenerative medicine advanced therapy from the U.S. Food and Drug Administration in melanoma, a common type of skin cancer, accounting for approximately 96,000 patients diagnosed annually and 7,200 deaths each year in the United States, Fardis said in a call with analysts Tuesday, according to transcripts.

In its most recent announcement regarding lifileucel in melanoma, the company reported an overall response rate (ORR) of 36.4% in 66 patients who were heavily pretreated.

The company is enrolling patients in a second pivotal study of LN-145 in patients with metastatic cervical cancer. During 2019, LN-145 received breakthrough therapy designation or BTD, as well as fast-track designation from the FDA. These designations were supported by compelling data demonstrating a 44% ORR from 27 patients in the ongoing study, Fardis said.

Read more:
Report: Iovance Exploring Potential Sale of the Company - BioSpace

This entry was posted on February 29, 2020 at 7:45 am and is filed under Personalized Medicine. You can follow any responses to this entry through the RSS 2.0 feed. Both comments and pings are currently closed. |