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Tag: ImmunityBio

  • New Sign-Off Propels ImmunityBio – Los Angeles Business Journal

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    Shares of Culver City-based immunotherapy company ImmunityBio Inc. had a huge runup in January, more than tripling in value to more than $7 a share on a pair of favorable developments.

    On Jan. 14, ImmunityBio announced that the Saudi Food and Drug Authority had granted accelerated approval for the company’s Anktiva drug, in combination with the bacterium Bacillus Calmette-Guérin (BCG) to treat a rare form of bladder cancer that does not respond to treatment with BCG alone. ImmunityBio also said it plans to open a regional office in Saudi Arabia and collaborate with a local distribution partner.

    The recent announcement came after Anktiva had been approved for this specific bladder cancer treatment in the U.S. in 2024 and the United Kingdom last year. The drug has also received conditional approval in the 27-member-nation European Union, with the final nod expected later this year.

    “We are pleased to bring Anktiva to Saudi patients with NMIBC, who otherwise have no viable options but life-altering surgery,” Richard Adcock, ImmunityBio’s chief executive, said in a statement, referring to non-muscle invasive bladder cancer carcinoma.

    The company also announced that week that Saudi authority also approved Anktiva in combination with an immune checkpoint inhibitor for use to treat metastatic non-small cell lung cancer. This is the first approval of Anktiva anywhere for this purpose.

    Both announcements led to a near-doubling of ImmunityBio’s share price to $5.52 on Jan. 16 from $2.82 the trading day before both news events.

    Shares rallied again on a Jan. 20 announcement from ImmunityBio. The company said it had held what it regarded as a successful meeting with the U.S. Food and Drug Administration on resubmitting its drug application for Anktiva for another form of bladder cancer with papillary tumors, or finger-like projections stemming from cells that line the bladder. The FDA had initially rejected this use for Anktiva just about a year ago.

    In its meeting, the FDA recommended that the company provide some additional information to support resubmission of the application, the company said. It shared that it would submit the information this month.

    The FDA has been known to give guidance to a company on submitting or resubmitting a drug application, only to change course once the application is filed for review. For example, Thousand Oaks-based Atara Biotherapeutics Inc.‘s executives were stunned at a reversal from the FDA last month for its drug Ebvallo to treat a runaway immune response condition in patients who have undergone organ or tissue transplants. The decision has left the company in a financially precarious position.

    On this news, investors sent shares up to $7.34 on Jan. 22 before some profit-taking set in. As of last week, the share price was in the low $6 range, still more than three times the value three weeks earlier.

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    Howard Fine

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  • ImmunityBio Wins U.K. Approval – Los Angeles Business Journal

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    Culver City-based ImmunityBio Inc. has started to take its Anktiva immunotherapy drug global.

    Last month, the United Kingdom Medicines and Healthcare Products Regulatory Agency approved Anktiva for treatment alongside a bacterial therapy for certain bladder cancer patients. This is the first approval for Anktiva outside the United States, where it received approval in April of last year.

    Anktiva works by stimulating the production of “natural killer” and T-cells – immune cells that kill cancer cells. ImmunityBio has paired Anktiva with a bacterial agent called Bacillus Calmette-Guérin, or BCG. That benign bacterium induces an immune response in the bladder in proximity to the cancer cells, leading to clearance of the cancer in many patients.

    But in roughly one-third of patients, BCG fails to clear the cancer, and in about half the remaining cases, the cancer returns in a relatively short time. In these instances, according to ImmunityBio, adding in Anktiva to the BCG treatment significantly boosts the chances of clearing the cancer.

    ImmunityBio first submitted Anktiva for approval in the United States with the FDA in late 2023. Initially, the FDA rejected the drug, citing concerns about the quality of the third-party manufacturing process. ImmunityBio addressed those concerns and later resubmitted the drug; this time, the FDA approved it. 

    ImmunityBio announced last week that the Michael DeBakey Department of Veterans Affairs Medical Center in Houston recently became one of the first VA hospitals in the nation to provide Anktiva treatments.

    ImmunityBio has also begun applying for broader use of Anktiva, both to treat other conditions and diseases in the U.S. and to other countries. The U.K.’s Medicines Agency is the first of what the company hopes will be many approvals in the international arena.

    “With the MHRA’s authorization of ANKTIVA plus BCG, we can now offer our immunotherapy outside the U.S. to help patients with a disease that, if not effectively treated, can lead to bladder removal,” Patrick Soon-Shiong, founder, executive chairman and global chief scientific and medical officer of ImmunityBio, said in the company’s announcement.

    Next up abroad for ImmunityBio is the European Medicines Agency, which oversees drug applications for the 27 European Union member states, as well as Iceland, Norway and Liechtenstein. Immunity submitted its application to the EMA in January.

    Also last week, ImmunityBio reported favorable early-stage clinical trial results for a new cell therapy drug it is developing to treat a type of non-Hodgkins lymphoma. The news sent ImmunityBio shares up 14% on Aug. 13 to close at $2.82.

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    Howard Fine

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