Lyell Immunopharma: Testing The T-Cell Thesis With 2 Upcoming Data Catalysts

seekingalpha04-17

Lyell Immunopharma, Inc.'s stock price has risen over 20% YTD and over 45% in the past 12 months.The company focuses on T-cell therapies for solid tumors and has two clinical-stage assets.Lyell has ...

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Catalysts\n</h2>\n\n<h4 class=\"meta\">\n\n\n2024-04-17 06:25 GMT+8&nbsp;&nbsp;&nbsp;<a href=https://seekingalpha.com/article/4684118-lyell-immunopharma-testing-the-t-cell-thesis-with-2-upcoming-data-catalysts><strong>seekingalpha</strong></a>\n\n\n</h4>\n\n</header>\n<article>\n<div>\n<p>Lyell Immunopharma, Inc.'s stock price has risen over 20% YTD and over 45% in the past 12 months.The company focuses on T-cell therapies for solid tumors and has two clinical-stage assets.Lyell has ...</p>\n\n<a href=\"https://seekingalpha.com/article/4684118-lyell-immunopharma-testing-the-t-cell-thesis-with-2-upcoming-data-catalysts\">Source Link</a>\n\n</div>\n\n\n</article>\n</div>\n</body>\n</html>\n","isBrief":false,"type":0,"news_type":1,"symbol":"LU2125154935.USD","symbol_name":"ALLSPRING (LUX) WF GLOBAL EQUITY ENHANCED INCOME \"I\" (USD) 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cell therapies gives me some optimism upcoming data readouts can be positive - there is substantial risk to this thesis; however, that must be acknowledged.   CIPhotos Investment Overview Lyell Immunopharma, Inc.'s (NASDAQ:LYEL) stock price has risen by >20% year to date and >45% across the past 12 months. The stock has been moderately volatile, reaching highs of >$3 in early March, and at the end of last week, before dropping this week back to $2.4 (at the time of writing). Lyell IPO'd in June 2021, raising ~$425m via the issuance of 25m shares priced at $17 per share, so on a long-term basis, returns have been poor - but is the company positioned to embark on a longer term bull run? Lyell's focus is on T-cell therapies - as per the company's 2023 annual report / 10K submission:  We are a clinical-stage cell therapy company advancing a pipeline of product candidates for patients with solid tumors utilizing our proprietary ex vivo genetic and epigenetic T‑cell reprogramming technologies. Our investigational therapies use the patient’s own cells as the starting point to generate highly tumor-reactive, longer-lasting functional T cells with enhanced ability to defeat solid tumors. Our innovative reprogramming technologies address what we believe are the primary barriers that limit consistent and long-lasting responses to T‑cell therapy in solid tumors: T‑cell exhaustion and lack of durable stemness.  Before its big-money IPO, Lyell had entered into a collaboration and license agreement with the United Kingdom-based Pharma giant GSK (GSK), which saw GSK pay Lyell a $45m upfront payment, and make a ~$59m equity investment into the company, with up to $1bn in future development and commercial milestones payments on the table. The deal involved development of an initial two candidates, and the option to nominate up to seven additional targets. However, GSK opted to terminate the agreement in December 2022, without advancing any assets, by which time Lyell's stock price had already dropped <$3. One year on, and Lyell announced that it would shed 25% of its workforce, to extend its funding runway into 2027, and that its Chief Medical Officer (\"CMO\") Tina Albertson, M.D., Ph.D. would also be leaving the company. In summary, it may have been a difficult few years for Lyell - the entire listed cell therapy industry suffered heavy share price losses throughout the torrid biotech bear market that lasted throughout 2022 and into the first half of 2023 - but the company now has 2 clinical stage assets, and a \"next generation\" version of each asset in preclinical studies, as we can see below:   Lyell pipeline (February 2024 investor presentation) Lyell boasts a cash position - according to its 2023 earnings press release - of $563m, having made a net loss of $(235m) for the year, versus a net loss of $(183m) in 2022. $183m of the 2023 figure was allocated to research and development (\"R&D\"). CAR-T Cell Therapy Candidate LYL797 - Building On Success Of CAR-T? Lyell's lead programs are cell therapies, i.e., a patient's cells are extracted, engineered ex vivo in a lab to make them more effective at identifying and fighting cancerous cells, and then reinfused back into the patient. LYL797 is a CAR-T cell therapy, indicated for various solid tumor cancers - breast, lung, and other cancers that express tyrosine kinase-like orphan receptor 1 (\"ROR1\"). According to biopharmapeg.com:  ROR1 is highly expressed during early embryonic development and is involved in the regulation of cell division, proliferation and migration, and in the generation of organs such as nerves, bones and blood vessels. Along with the process of fetal development, the expression of ROR1 gradually decreases. In childhood and adult stages, ROR1 expression is low or absent in almost all normal tissues. In contrast to normal tissues, ROR1 is highly expressed in a variety of cancers, including hematological cancers such as chronic lymphocytic leukemia (CLL), mantle cell lymphoma (MCL), and solid tumors (ovarian, breast, prostate, lung, melanoma, and colorectal cancers, etc.). In recent years, Boehringer Ingelheim and Merck (MRK) both added ROR1-directed antibody-drug conjugates (ADCs) to their pipeline via acquisition, highlighting the importance of ROR1 in oncology and its promising potential as an ADC target.  In its 10K submission, Lyell states as follows:  Cell therapy has demonstrated profound results in some patients suffering from hematologic malignancies, but solid tumors are more complex and have evolved multiple mechanisms to evade and ultimately resist clearance by the immune system. This has limited the use of cell therapy in solid tumors, which account for 90% of cancer deaths. Based on clinical data and other scientific evidence, we believe T‑cell exhaustion and lack of durable stemness, which include the ability of T cells to persist and self-renew to drive durable tumor cytotoxicity, are two primary barriers limiting the efficacy of cell therapy in solid tumors.  This is borne out by the commercial markets, in which several cell therapies have been approved to treat hematological cancers - Bristol-Myers Squibb's (BMY) Abecma and Breyanzi, Gilead Sciences (GILD) Tecartus and Yescarta, Johnson & Johnson (JNJ) and Legend Biotech's (LEGN) Carvykti, with several expected to go on and earn \"blockbuster\" (>$1bn per annum) revenues, while only a single cell therapy has been approved to treat a solid tumor cancer - Iovance Biotherapeutics' (IOVA) Amtagvi, which was approved in February this year. The drug has a list price of ~$500k and is expected to drive \"blockbuster\" (>$1bn per annum) revenues in time. Iovance's therapy is slightly different from a CAR-T cell therapy in that T-cells are extracted from a patients tumor and expanded in a lab, without being modified, but Iovance's success in winning approval for Amtagvi - which has resulted in a 300% share price gain across the past 6 months - will certainly have boosted Lyell's confidence that its own solid tumor candidate can be successful. Lyell says that LYL797 is \"genetically reprogrammed to overexpress c-Jun and epigenetically reprogrammed using Lyell’s proprietary Epi-RTM manufacturing protocol\" (c-Jun is a transcription factor protein involved in cell proliferation, apoptosis, survival, and other functions), and it has been entered into a Phase 1 clinical study in patients with relapsed or refractory (\"r/r\") triple negative breast cancer patients who have failed two prior lines of therapy, and r/r non small cell lung cancer (\"NSCLC\") patients who have failed one prior line of therapy. With breast and lung cancer being the two largest markets in oncology, data from this study, if positive, has the potential to send Lyell's share price skywards. Planned enrollment (according to a Lyell investor presentation) is for 15 patients in each indication, and management has promised that:  Initial clinical and translational data from at least 20 patients in the Phase 1 trial of LYL797 are expected in the first half of 2024.  As such, there is a potentially momentous near-term price catalyst in play, but with only limited preclinical data to support Lyell's thesis that its Epi-R reprogramming technology, which corrects imbalances of c-Jun, to produce \"transcriptionally distinct populations of T-cells that resist exhaustion an maintain cytotoxicity,\" it is difficult to state with confidence that data will be positive. Tumor Infiltrating Lymphocyte Candidate LYL845 Building On \"Robust Clinical Data\" & Success Of Iovance Biotherapeutics LYL845 is Lyell's second candidate in a Phase 1 clinical study, which the company calls an \"intravenously‑administered autologous TIL therapy for multiple solid tumors.\" \"TIL\" stands for tumor infiltrating lymphocyte. Iovance's Amtagvi falls into this category. According to the National Cancer Institute TIL's are: A type of immune cell that has moved from the blood into a tumor. Tumor-infiltrating lymphocytes can recognize and kill cancer cells. In cancer therapy, tumor-infiltrating lymphocytes are removed from a patient’s tumor, grown in large numbers in a laboratory, and then given back to the patient to help the immune system kill the cancer cells. In its 10K, Lyell states: Published data from third-party TIL trials show that treating metastatic melanoma patients with TIL can result in complete and durable responses. Response rates to TIL therapy in patients with other advanced solid tumors such as lung, colorectal and breast have been much lower than those observed in advanced melanoma. Broad TIL efficacy has been limited by poor enrichment of tumor-reactive T cells and the poor quality and limited growth potential of expanded T cells   LYL845 versus standard TIL (investor presentation) As we can see above, Lyell believes it may have a competitive advantage over other TIL therapies in development as its TIL targets genes with stem-like properties, as opposed to targets associated with cell exhaustion, such as TIGIT, or PD-1, although it should be noted that, using a different mechanism of action (\"MoA\"), Merck's (MRK) Keytruda - the world's best-selling drug (>$20bn of revenues in 2023), indicated for multiple solid indications - targets PD-1. Preclinical models show that LYL845 \"preserves ~94% of predicted tumor reactive clones to enable targeting of heterogenous solid tumors,\" and that using its Epi-R process, LYL845 eliminated tumor growth more effectively than a TIL using a standard process. The Phase 1 study of LYL845 will enroll ~15 patients with melanoma, ~15 with NSCLC, and ~15 with colorectal cancer, and Phase 1 data has been promised for the second half of this year, meaning there is another catalyst in play this year that could substantially impact Lyell's share price and valuation. Looking Ahead - With 2 Crucial Data Catalysts In Play, Share Price Volatility Is Almost Certain - But In Which Direction? Truthfully, it is difficult to tell - even Lyell management cannot be sure if the mechanisms of action it has designed will work seamlessly in a clinical setting, especially in a space as nuanced and complex as cell therapy. With huge market opportunities in play, and thanks to the success of Iovance, and other T-cell targeting companies such as Janux Therapeutics (JANX), whose early prostate cancer data generated by its t-cell engager candidate sent its stock price soaring >100%, and attracted M&A rumors, perhaps it is not surprising that Lyell's stock has been rising in recent weeks. Lyell's market cap valuation is only a little higher than its cash position, at $625m at the time of writing - for context, Iovance's current market cap is $3.4bn, and Janux' ~$2.65bn. Competition in these markets is intense, however, as Lyell reveals in its 10K: T‑cell therapies for the treatment of solid tumors are being developed by a number of companies, including but not limited to Arcellx, Inc (ACLX), AstraZeneca (AZN) Autolus Therapeutics (AUTL), Bristol-Myers Squibb Co., Gilead Sciences Inc., Immunocore Holdings (IMCR), Iovance Biotherapeutics Inc., the Janssen Pharmaceutical Companies of Johnson & Johnson, Nanjing Legend Biotech and Novartis AG (NVS) Nevertheless, there are a few reasons why Lyell may stand out from the crowd at present as an intriguing, albeit risky investment opportunity. Firstly, the data catalysts in play - two sets of Phase 1 data will become available this year, and as we have seen with Janux, success is likely to be richly rewarded. Lyell, and the market will be looking for evidence of tumor shrinkage, partial, or better still, complete responses by patients, signs of durability of response, and a good safety profile, avoiding instances of cytokine release syndrome (\"CRS\"), for example, or graft vs host disease (\"GvHD\"), both potentially fatal complications that suggest the therapy is unsuitable for use in any patients. If the evidence for efficacy or safety is absent when Phase 1 results are shared, there is no question that Lyell stock will suffer a downward correction, but on a more positive note, the company does have its next-generation candidates to fall back on, so management may be able to take the learnings from disappointing data sets and apply them to development of its newer candidates, honing their MoAs. Lyell has taken several steps backward, arguably, since its IPO, and the departure from GSK from the scene is clearly a blow, taking milestone payments out of the equation, and weakening the market's faith in Lyell's underlying science and technology, although GSK may have had its own reasons for terminating its agreements - and the share price losses triggered by its exit could play into an opportunistic investor's hands. In summary, having reviewed Lyell's investor materials, and looked into its science, I think a speculative buy of Lyell's stock, so long as you are betting money you can afford to lose, could be an interesting opportunity to realize a substantial ROI in a short space of time. With two data sets in play, if either is successful, my suspicion is that Lyell's market cap valuation could easily surge beyond $1bn, and perhaps higher, and bring M&A activity into play, which could add another $1bn to the company valuation. That would be in keeping with the performance of companies who have shared promising early data that sets up an opportunity for a push for commercial approval. Given the markets in play - NSCLC, melanoma, breast cancer, CRC - the surge on positive data could be even greater. It is important that investors understand the risks in play, which are substantial - the lack of clinical data to date, the exit of GSK, unproven (in the clinic) theses around TIL and CAR-T drug development, intense competition, and high rates of failure for early-stage cell therapy projects, owing to the extreme difficulty of making safe effective therapies - but in my view, at least, there are credible reasons to be optimistic that Lyell's upcoming data readouts may justify the mega-money IPO at $17 per share, and reignite faith in the company's drug development programs.  Editor's Note: This article discusses one or more securities that do not trade on a major U.S. exchange. 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