ImmunityBio: Anktiva Approval Opens Up A World Of Possibilities, Risks And Potential Gains

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San Diego-based biotech company ImmunityBio has received its first US drug approval for its lead drug candidate Anktiva, an immunotherapy for bladder cancer.Anktiva received Breakthrough Therapy ...

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Possibilities, Risks And Potential Gains\n</h2>\n\n<h4 class=\"meta\">\n\n\n2024-04-24 05:11 GMT+8&nbsp;&nbsp;&nbsp;<a href=https://seekingalpha.com/article/4685461-immunitybio-anktiva-approval-opens-up-a-world-of-possibilities-risks-and-potential-gains><strong>seekingalpha</strong></a>\n\n\n</h4>\n\n</header>\n<article>\n<div>\n<p>San Diego-based biotech company ImmunityBio has received its first US drug approval for its lead drug candidate Anktiva, an immunotherapy for bladder cancer.Anktiva received Breakthrough Therapy ...</p>\n\n<a href=\"https://seekingalpha.com/article/4685461-immunitybio-anktiva-approval-opens-up-a-world-of-possibilities-risks-and-potential-gains\">Source 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The entrepreneur has been remarkably successful in pharma.   Thomas Barwick/DigitalVision via Getty ImagesInvestment Overview ImmunityBio (NASDAQ:IBRX), the San Diego-based biotech led by well-known biotech entrepreneur Dr. Patrick Soon-Shiong, was celebrating today as the company scored its first US drug approval, for its lead drug candidate Anktiva. According to a press release issued by the company:  the U.S. Food and Drug Administration (FDA) has approved Anktiva (N-803, or nogapendekin alfa inbakicept-pmln) plus Bacillus Calmette-Guérin (\"BCG\") for the treatment of patients with BCG-unresponsive non-muscle invasive bladder cancer (NMIBC) with carcinoma in situ (CIS), with or without papillary tumors. Anktiva, a first-in-class IL-15 agonist immunotherapy for NMIBC, received Breakthrough Therapy Designation and approval from the FDA based on the safety and efficacy outcome of complete responses (\"CR\") and duration of complete response (\"DOR\").The 77 evaluable patients in this single-arm, multicenter trial received Anktiva with BCG maintenance therapy for up to 37 months. The tumor status was assessed with cystoscopy and urine cytology and will continue for up to five years after each patient began their participation in the trial. The CR rate for the 77 evaluable patients was 62% with the upper end of the confidence interval being 73%. The duration of complete response as of the November 2023 cut-off was more than 47 months and is ongoing to date. These prolonged duration of complete response results beyond 24 months with Anktiva and BCG exceed the benchmark for the magnitude of meaningful clinical results suggested by a panel of experts at the IBCG.  Anktiva has been approved at the second time of asking, after the FDA initially refused to approve Immunity's Biologics License Application (\"BLA\"), issuing a Complete Response Letter (the standard FDA response to a refused drug approval request), based on, according to Immunity's 2023 annual report / 10K submission: Pre-license inspection of the company’s third-party CMOs, among other items. At the time, the FDA further provided recommendations specific to additional CMC issues and assays to be resolved. The CRL did not request new preclinical studies or Phase III clinical trials to evaluate safety or efficacy. CMC refers to \"Chemistry, Manufacturing, and Controls, and is generally regarded as the \"least worst\" reason for rejection, as it suggests the FDA is satisfied with the safety and efficacy of the drug, but not with the manufacturing procedures - a much easier problem to rectify than making a drug more effective or safe. At the time of writing, Immunity stock is up only 8% for the day. However, the share price has risen by 92% across the past 12 months, and by >215% across the past six months, which suggests today's approval was widely expected. Immunity currently enjoys a market cap valuation of $3.7bn How Did We Get Here? And Where Are We Going? Approval Analysis Immunity was formed in 2021 via a merger, as discussed in the 2023 10K:  ImmunityBio, Inc. was established following a series of mergers and name changes. We were incorporated in Illinois on October 7, 2002 under the name ZelleRx Corporation. Our name was later changed to Conkwest, Inc., and we were reincorporated in the state of Delaware in March 2014. On July 10, 2015, we changed our name to NantKwest. NantCell, LLC was originally organized as a Delaware limited liability company in November 2014. In April 2015, it was converted to a Delaware corporation, NantCell, Inc., and in May 2019 changed its name to ImmunityBio, Inc. (a private company). On Dec. 21, 2020, NantKwest and NantCell entered into an Agreement and Plan of Merger (the Merger Agreement), pursuant to which NantKwest and NantCell agreed to combine their businesses. The Merger Agreement provided that a wholly-owned subsidiary of the company would merge with and into NantCell (the Merger), with NantCell surviving the Merger as a wholly-owned subsidiary of the company.  Dr. Soon-Shiong owns approximately 79.4% of Immunity's stock, according to the 2023 10K, as well as \"all of our outstanding convertible promissory notes, certain warrants and stock options to purchase shares of our common stock, and certain CVRs.\" The 10K also reveals that: As of Dec. 31, 2023, our indebtedness payable at maturity totaled $735.0 million (excluding unamortized related-party notes discounts), held by entities affiliated with Dr. Soon-Shiong. In short, Dr Soon-Shiong owns the majority of the company, has provided most of its funding, and is the inspiration behind the company's research too. That could be interpreted either as a positive or a negative by existing shareholders and prospective investors, but there's no denying the entrepreneur's track record. He was the key figure behind American Pharmaceutical Partners (\"APP\") an injectable manufacturing firm that listed on the Nasdaq in 2001, with a valuation of ~$770m, and was purchased by Fresenius SE in 2008 for $5.6bn. Dr Soon-Shiong was also involved in developing the chemotherapy drug Abraxane, his company Abraxis being acquired by Celgene - now part of Bristol Myers Squibb (BMY) - in 2010, in a deal worth $3.6bn. Abraxane achieved \"blockbuster\" status - >$1bn revenues per annum - in 2020. The entrepreneur - who also owns the Los Angeles Times and part owns the Los Angeles Lakers basketball team - seemingly has no plans to slow down. In an Immunity investor presentation, the company pledges to deliver five new drug launches between 2021 and 2025, beginning with Anktiva in bladder cancer, and followed by approvals in four more indications - in pancreatic, lung, glioblastoma (brain), and head and neck cancers, as well as Lynch Syndrome.   Immunity Bio registrational dev strategy (Investor Presentation)Returning to Anktiva, the widely expected approval brings a new competitor into the field of bladder cancer treatment. In its 10K, Immunity discusses its competition in this market as follows:  Antibody-Cytokine Fusion Proteins. This platform primarily competes with large pharmaceutical companies marketing checkpoint inhibitors. However, the potential exists for some of these large pharmaceutical companies to seek collaboration for combination of N-803 with their marketed checkpoint inhibitor. This platform will also compete with immunotherapy fusion protein companies developing similar approaches, including Nektar Therapeutics (NKTR), Neoleukin Therapeutics, Inc., Novartis International AG (Novartis) (NVS), F. Hoffmann-La Roche AG (Roche) (OTCQX:RHHBY), Sanofi, S.A. (Sanofi) (SNY), Xencor, Inc., and in the context of NMIBC, CG Oncology Inc., Ferring Pharmaceuticals, Janssen Pharmaceuticals, Inc. (Janssen)/Johnson & Johnson (JNJ), and Merck & Co., Inc. (Merck) (MRK).  If the competition sounds fierce, and stacked with big pharma companies with relatively unlimited marketing budgets, Immunity investors can take comfort from the fact that in its particular approved indication, Anktiva's only current competition is Merck's PD-1 targeting immune checkpoint inhibitor (\"ICI\") keytruda and Ferring Pharmaceuticals' gene therapy adstiladrin. Seemingly, Anktiva's data is superior to the bar set by either one of these two therapies since Keytruda achieved a 41% in its pivotal study in the indication, and adstiladrin 51%. Anktiva's durability is also best in class, according to Karim Chamie, M.D., Associate Professor of Urology at UCLA and principal investigator for the QUILT 3.032 study, who was quoted in Immunity's approval press release as follows: The long duration of complete response ranging over 47 months is a game changer for NMIBC patients and provides further clinical evidence of Anktiva’s effectiveness for patients who historically have faced high rates of recurrence and significantly diminished quality of life due to radical surgeries. With this approval, Anktiva could represent a new standard of care for patients with NMIBC and has the potential to change the way we treat bladder cancer. From a safety perspective, only 2% of patients discontinued treatment of Anktiva, and only 1% of patients reported treatment related serious adverse events (\"SAEs\"), according to the investor presentation. In the approval press release, Dr Soon Shiong discusses Anktiva's mechanism of action as follows:  Anktiva not only proliferates and activates the patient’s own NK cells and CD8+ killer T cells, but also activates CD4+ T helper cells, thus enhancing the proliferation of memory killer T cells. This novel mechanism of action, which mimics the biology of the dendtritic cell, begins the evolution of immunotherapy beyond T cells alone. The combination of the proliferation of key cancer-killing immune cells, together with the activation of T cells with memory, results in durable complete responses. The \"triangle offense\" of tumor cell killing by the body’s immune system with long-term memory is the foundation of our efforts to develop a therapeutic cancer vaccine across multiple tumor types, regardless of the site of origin.  Market Opportunity Immunity also shares data from the American Cancer Society, which estimates that there will be ~83k new cases of bladder diagnosed in 2024, and nearly 17k deaths from the disease. The standard therapy is a BCG injection - BCG being \"a benign bacteria that induces an immune response in the bladder\" directly to the bladder, however in 30%-40% of cases, BCG is likely to fail, and in 50% cases, patients initially responding to BCG therapy will relapse. Analysts have speculated that Anktiva could earn peak revenues of nearly $900m per annum, by 2028, although in order to hit that figure, approvals in BCG-unresponsive bladder cancer papillary and BCG naive bladder cancer CIS and papillary may be necessary. As shown in the table above, Immunity is already enrolling patients in late-stage studies in these two indications, as well as 2nd line lung cancer - lung is the largest oncology market of all. Analysis - Post Approval, is Immunity Bio Stock Emitting \"Buy,\" \"Sell\" or \"Hold\" Signals? I find this a tricky question to answer. Clearly, for Immunity and its entrepreneurial founder, who has been studying how to harness the power of NK cells for decades, the approval represents an important win, albeit, also merely a stepping stone on the path to multiple new approvals. Seemingly, all of Immunity's other candidates - BCG, PD-L1 t-haNK, hAd5 and yeast TAAs, and aldoxorubicin - will be evaluated in combo with Anktiva, so there's some substantial \"single asset risk\" in play here. How physicians may respond to the approval of Anktiva, and also health insurers in terms of providing reimbursement for the drug, whose list price has not yet been shared to the best of my knowledge, is currently unknown. Given the apparently \"best-in-class\" pivotal study results, there appears to be a good chance that Anktiva could take market share away from its rivals Keytruda and Adstiladrin, although it should be noted that multiple other therapies are being developed for bladder cancer, including by recently listed CG Oncology (CGON), so the drug could be eclipsed by a newer therapy in the years to come. Immunity, which has ~630 employees, has racked up an accumulated deficit of $3bn, according to its 10K submission, which states: During the years ended December 31, 2023, 2022 and 2021, net losses attributable to ImmunityBio common stockholders were $583.2 million, $416.6 million, and $346.8 million, respectively. Much of that funding has been supplied by Dr. Soon Shiong, who remains pivotal to the company's future. The company has also received funding from Oberland Capital of ~$300m, in exchange for royalty rights related to Anktiva, ranging from 3% - 7% initially, and potentially rising to 10%. Additionally, the company has filed for a mixed shelf, which may enable it to raise a further $300m. Dr. Soon Shiong's majority ownership means that shareholders have little say in the future direction of the company, which could be problematic, although with the entrepreneur's incredible track record, perhaps shareholders will be content that the future of the company is in his hands. If, for any reason, the founder was to sell his shareholding or discontinue involvement with the company, the stock price could plummet. On the other hand, perhaps an exit to a major pharma could be secured, given the very good safety and efficacy profile the drug has been approved with, and the multiple expansion opportunities in play. In terms of the future direction of Immunity's share price, perhaps Dr. Soon Shiong is capable of dictating this also, although looked at objectively, Anktiva will be required to perform very well in its new markets to justify the current market cap valuation of $3.7bn. All things considered, if you're a risk-off investor looking for exposure to the pharmaceutical industry, an investment in Immunity may not be for you. If, on the other hand, you are prepared to carry out extensive due diligence, and follow the \"slings and arrows of outrageous fortune\" that Immunity seems destined to experience going forward, its growing share price will doubtless be encouraging, and if the company continues to follow the path mapped out by its leader, securing more approvals in large oncology markets with \"blockbuster\" revenue potential, an investment made today may well pay off handsomely down the line. Given the somewhat unique nature of Immunity's structure, ownership, and approach to drug development, the best advice I can offer is to remain on the sidelines for the time being, and monitor progress. Are there hidden flaws in the company's approach? How soon will we see Anktiva revenues achieve growth milestones of $50m revenues, $100m, $500m, and $1bn, if ever? And how will studies with other candidates, about which less is known, progress? All of these conundrums will be answered in time, and it may be likely that after these derisking events, Immunity stock will still be available to buy at today's price. Such an outcome is the scenario I would be looking for, and I'd be prepared to wait to see if it materializes. Others will doubtless feel differently, and may be rewarded, or punished, for either \"being greedy when others are fearful,\" or waiting longer to make up their minds.  As Dr. Soon Shiong himself has put it, \"Wall Street follows rather than leads, and we need to lead.\" Investing alongside a born winner is often a good strategy, so at the very least, Immunity is worth adding to your watch list.","kind":null,"is_publish_news":null,"is_publish_highlight":null,"is_publish_live":null,"is_publish_wemedia":null,"editions":null,"symbols":[],"gpt_button":1},"commentList":[],"isCommentEnd":true,"newsSizeData":{"likeSize":0,"commentSize":0,"repostSize":0,"favoriteSize":0,"likeStatus":false,"favoriteStatus":false},"APP":{"userAgent":"Mozilla/5.0 AppleWebKit/537.36 (KHTML, like Gecko; compatible; ClaudeBot/1.0; +claudebot@anthropic.com)","isDev":false,"isTTM":true,"deviceId":"web-server-community-laohu8-v3","version":"4.22.4","shortVersion":"4.22.4","platform":"web","vendor":"web","appName":"ttm","isIOS":false,"isAndroid":false,"isTiger":false,"isTHS":false,"isWeiXin":false,"isWeiXinMini":false,"isWeiBo":false,"isQQ":false,"isBaiduSwan":false,"isBaiduBox":false,"isDingTalk":false,"isToutiao":false,"isOnePlus":false,"isHuaWei":false,"isXiaomi":false,"isXiaomiWebView":false,"isOppo":false,"isVivo":false,"isSamsung":false,"isMobile":false},"href":"/m/news/2429140180"}