Immunome: AL102 And Other Established Protein Targets Could Drive Value

seekingalpha06-28

Top-line data from Part B of phase 3 RINGSIDE study, using AL102 for the treatment of patients with desmoid tumors, expected 2nd half of 2025.The global desmoid tumor market is projected to grow to $...

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Value\n</h2>\n\n<h4 class=\"meta\">\n\n\n2024-06-28 02:14 GMT+8&nbsp;&nbsp;&nbsp;<a href=https://seekingalpha.com/article/4701368-immunome-al102-and-other-established-protein-targets-could-drive-value><strong>seekingalpha</strong></a>\n\n\n</h4>\n\n</header>\n<article>\n<div>\n<p>Top-line data from Part B of phase 3 RINGSIDE study, using AL102 for the treatment of patients with desmoid tumors, expected 2nd half of 2025.The global desmoid tumor market is projected to grow to $...</p>\n\n<a href=\"https://seekingalpha.com/article/4701368-immunome-al102-and-other-established-protein-targets-could-drive-value\">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":"LU2468319806.SGD","symbol_name":"MANULIFE GF HEALTHCARE \"AA\" (SGDHDG) 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antibody-drug conjugate being developed to target ROR1 expressing solid tumors; IND filing to begin a phase 1 study for this program, expected Q1 of 2025.IM-3050 is a radio-ligand therapy being developed to target FAP expressing solid tumors; IND filing to begin a phase 1 study for this program, expected Q1 of 2025.   nicolas_ Immunome, Inc. (NASDAQ:IMNM) is an interesting biotech to consider, and that's because it has various therapy types it deploys for its pipeline. One of the lead assets it has is AL102, which is being explored in the ongoing phase 3 RINGSIDE study for the treatment of patients with desmoid tumors. Enrollment for Part B of this study was completed back in February 2024 and data from this is expected to be released in the 2nd half of 2025. The truth is that AL102, along with AL101, were two clinical assets acquired from Ayala Pharmaceuticals (OTCQX:ADXS). Should phase 3 clinical testing go well for Immunome in advancing the use of AL102 for the treatment of patients with desmoid tumors, then it is highly likely that it might even be in a position to file a New Drug Application [NDA] for this program in 2025 as well. What may reduce the risk for this biotech is that it is not riding everything on only advancing AL102 forward. It has two other clinical candidates with different modes of action, which are highly sought out for. One of them is an antibody-drug conjugate [ADC] targeting the ROR1 protein for solid tumors known as IM-1021. The second one is a radioligand therapy [RLT] targeting FAP expressing solid tumors. The point here is that both of such technologies, ADC and RLTs, are highly sought out because of what has been shown with them thus far. Lastly, the company has its very own technology known as the \"Immunome Discovery Engine,\" which has a purpose to identify novel targets and antibodies. The promise here is not just the fact that the technology itself is ideal, but that AbbVie (ABBV) wanted to obtain rights to use it. Thus, this big pharma established a multi-year collaboration deal to identify up to 10 novel target antibody pairs using this very same Immunome Discovery Engine. With a data readout expecting from the AL102 program targeting desmoid tumors, plus the ability to use other highly sought out clinical products such as ADCs and RLTs, I believe that investors could benefit with any potential gains made. AL102 Acquisition Rights Already Bring In Phase 3 Ready Asset  One of the main programs to go over in Immunome's pipeline would be the development of AL102 for the treatment of patients with desmoid tumors, which is being explored in the ongoing phase 3 RINGSIDE study. The reason why it hands on this asset is that it acquired it from Ayala Pharmaceuticals. Before going over this particular late-stage study, plus any catalysts to come out of this program, it is first important to understand what desmoid tumors are and what the possible market opportunity could be. Desmoid tumors are characterized as noncancerous growths that form in connective tissues. They can appear anywhere on the persons' body, but they tend to frequent 3 specific areas, which are as follows:   Arms  Abdomen Legs.  A major problem is that the cells of the connective tissue in the body have a DNA change, which leads to rapidly developing cells forming the tumor type mass. Not only that, but nearby healthy tissue can be destroyed in the process. Some symptoms that these patients with desmoid tumors experience are as follows:  Pain Nausea  Swelling of a specific area on the body Loss of function on a certain part of the body.  The global desmoid tumor market is projected to grow to $5.49 billion by 2032. This is a huge market opportunity for sure, but there are two hurdles to consider here. The first of which is that the company has to achieve a successful outcome of the ongoing phase 3 RINGSIDE study. The second item that must be done would be to overcome competition in this particular space and potentially become the new standard of care [SOC] treatment option for them. What do I mean by this? Well, there is another Gamma Secretase Inhibitor [GSI] by the name of OGSIVEO [nirogacestat], which was approved by the FDA back in November of 2023 to treat this specific patient population. This was the first systemic therapy of its kind to be approved for desmoid tumors. Until 2023, the only option these patients had was local therapies. However, the problem with such therapy types was a high level of recurrence and tolerability issues. OGSIVEO is a GSI developed by SpringWorks Therapeutics (SWTX) to treat these patients. A GSI works by blocking the Notch pathway that is found in these tumor types; thus, it is a proven model that works. If this is the case, then is there any way Immunome can differentiate its drug AL102 compared to OGSIVEO? In comparison, despite a shorter duration of Time On Treatment [ToT], superior responses were observed in those given AL102. This is displayed in the following efficacy measures:   Intent-to-Treat [ITT] patient population of 14 patients measured for objective response rate [ORR] by RECIST criteria given 1.2 mg of AL102 once-daily - 64% ORR ITT patient population of 70 patients measure for ORR by RECIST criteria given 150 mg of OGSIVEO twice-daily - 41% ORR   Not only did AL102 do better for these desmoid tumor patients in terms of ORR by RECIST criteria, but it also performed in superior fashion with two other measures such as tumor volume and T2 imaging test. The bottom-line here is that if this drug from Immunome is approved for this patient population, then there is a high likelihood that it could become standard of care [SOC] for these patients. Especially, when safety of AL102 was comparable to that of GSIs like OGSIVEO.  To see if AL102 can do well in treating patients with desmoid tumors, plus to possibly be able to file for regulatory approval of it, it is evaluating it in the ongoing phase 3 RINGSIDE study. This particular study is already in Part B testing, and it is expected that a total of 156 patients will be recruited into it. Patients in this trial will be randomized to receive either 1.2 mg AL102 or placebo over a 2-year period. One major risk to note is that even though there was good ORR observed in the prior phase 2 study, this efficacy measure will not be the primary endpoint to obtain FDA approval. Instead, the primary endpoint of Part B of this phase 3 RINGSIDE study will be progression-free survival [PFS]. There are two possible catalysts relating to this particular program. The first of which is that top-line results from Part B of this phase 3 RINGSIDE study, using AL102 for the treatment of patients with desmoid tumors, are expected in the 2nd half of 2025. From there, the other catalyst opportunity just depends upon whether the primary endpoint of PFS is met with statistical significance. If it is, then it is likely that the company would be in a position to file an NDA of AL102 for the treatment of this patient population during the same time period. ROR1 ADC And FAP RLT Are Two Highly Sought Out Clinical Targets  As I noted above, the whole premise of this company is to expand its capabilities in other areas besides the use of Gamma Secretase Inhibitor [GSI] AL102 for the treatment of patients with desmoid tumors. The first candidate of which that it is developing with huge promise would be a ROR1 targeting antibody-drug conjugate [ADC] being used for both hematological malignancies and solid tumors. That's right, what makes this candidate, known as IM-1021, so special is that it can be used to target both blood cancers and tumors. The truth is that there is a way where this clinical candidate could become the best-in-class ADC. How so? This is thanks to what was developed by Zentalis Pharmaceuticals (ZNTL), whereby it was made to have a superior camptothecin derivative / TOPO1 inhibitor payload. In essence, in a breast cancer model, it was shown that Immunome's payload performed better as an HER2 ADC targeting agent compared to Enhertu [Trastuzumab deruxtecan], which had already been approved to treat breast cancer and gastric cancer. The promise here is that a successful ADC can garner high interest from big pharma. There are many examples to point to, but there are two to note that were considerable deals. The first of which would be the acquisition of Seagen by Pfizer (PFE) for $43 billion. Then, another large deal to point to would be a large deal made by Merck (MRK) where it would be able to license the use of Daiichi Sankyo's DXd payload ADC technology to target solid tumors. Daiichi received a $4 billion upfront payment for this deal and is eligible to earn up to $22 billion in milestone payments over time. The catalyst of IM-1021 is that an IND filing to initiate a phase 1 study for the targeting of patients with solid tumors is expected in Q1 of 2025.  The other highly sought out candidate in the biotech space would be radioligand therapies [RLTs]. In this case, Immunome is advancing an RLT targeting FAP expressing solid tumors. This clinical candidate is known as IM-3050, and it is also expected that an IND submission, to begin a phase 1 study for this program, will occur in Q1 of 2025. A good thing about this program is that it acts in a way to kind of improve on what ADCs can't accomplish. While ADCs are ideal when they can go after specific targets, there are limitations. IM-3050 as a RLT, was designed to target FAP. Why is that? That's because ADCs can not really be used for the targeting of this specific protein. Consider that Immunome is taking what is already established for RLTs, but improving upon them in the following way:   FAP Ligand - modification made here to increase uptake of drug and enhance efficacy  Optimized linker - to reduce non-specific uptake  Include an albumin binder - to increase half-life, biodistribution to tissue, increase the amount of time drug remains in tumor.  Not only do the above modifications give IM-3050 the ability to be a best-in-class RLT, but there is another important item to note, which is high specificity. This is important because it means the ability to target tumor cells in a highly selective fashion, while leaving healthy cells alone. In essence, the ability to achieve an improved safety profile of this drug. To prove why RLTs are highly sought out for, I can point to two examples of large deals that were made. Novartis (NVS) gave an upfront payment of $1 billion and then the potential for Mariana Oncology to earn up to $750 million in pre-specified milestone payments. A likely reason why it made this deal was to expand its RLT pipeline to go after other solid tumor indications. The big pharma has already received approval for RLTs targeting metastatic castration-resistant prostate cancer [mCRPC] and gastroenteropancreatic neuroendocrine tumors. Another example would be Eli Lilly (LLY) acquiring POINT Biopharma Global, Incorporated for $1.4 billion. Again, the reasoning here was to add RLTs into the pipeline. While RLTs are in the early days of testing, they are highly sought out because of their ability to have significant antitumor efficacy, while at the same time limiting the impact to healthy tissue. It is my belief that the use of RLTs will start to grow over time as more research is done on them. Thus, you can see the potential if IM-3050 as an 177Lu-FAP targeting agent is successful in being able to effectively treat patients with solid tumors. Especially, since FAP expression is observed in over 75% of solid tumors.  Financials According to the 10-Q SEC Filing, Immunome had cash, cash equivalents and marketable securities of $309.7 million as of March 31, 2024. The reason for the cash on hand was because it closed an underwritten public offering of 10,000,000 shares of its common stock at a public offering price of $20 per share. In addition, the underwriters exercised their right in full to acquire an additional 1,500,000 shares of common stock at this very same price. The total gross proceeds from this offering, before deducting expenses, were $230 million.  As for a cash runway, the company believes that it has enough cash on hand to fund its operations into 2026. However, just in case it needs to raise additional funds, it already has an at-the-market [ATM] offering agreement with TD Securities [USA] LLC or TD Cowen. Under this agreement, Immunome occasionally can offer and sell up to an aggregate of $200 million worth of shares of its stock. As of the deal being generated, no shares of this ATM have yet been utilized. The cash burn per quarter is $21.4 million. However, Q1 of 2024 saw an increase of in-process research and development expenses because of the acquisition of AL101 and AL102 and the exclusive license of IM-1021 and other ADC related assets. This was a one-time event because of such acquisitions of rights for these candidates. However, one risk to consider going forward is that Immunome has to pay milestones payments to Zentalis, Ayala Pharmaceuticals and Atreca upon them being met.  Risks To Business  There are several risks that investors should be aware of before investing in Immunome. The first risk to consider would be regarding the development of AL-102 as a Gamma Secretase Inhibitor [GSI] for the treatment of patients with desmoid tumors. There is no assurance that the primary endpoint of PFS will be met with statistical significance. Even if this trial meets upon the primary endpoint, plus is ultimately approved by the FDA to treat these patients, there is no guarantee that it will perform well on the market or become the new SOC. A second risk would be in terms of advancing the ROR1 ADC for the treatment of patients with solid tumors. There is no assurance that upon completion of the phase 1 study using IM-1021 that positive results will be achieved in targeting such solid tumor patients. Also, the goal is to have a payload in place that could potentially be superior over other approved ADCs like Enhertu, Trodelvy and Kadcyla.  A third risk to consider would be regarding the development of a radio-ligand therapy [RLT] targeting FAP expressing solid tumors. That's because this is also expected to be explored in a first-in-human phase 1 study targeting such solid tumor patients. Upon completion of this early-stage trial, there is no assurance that the data will turn out to be positive. Nor that the drug optimizations it made, which I listed above, will result in a superior safety/efficacy profile over other RLTs currently in clinical development.  The fourth and final risk to consider would be regarding the partnership that Immunome made with AbbVie to advance up to 10 novel target-antibody pairs using Immunome's Discovery engine. The goal of this engine is to develop novel targets and antibodies using memory B-cells. Such memory B-cells are separated from patient samples and then modified with a proprietary hybridoma technology to immortalize them. The risk here is that there is no assurance that such an approach of modifying memory B-cells will lead to significant advancements in either ADCs or RLTs. In addition, another risk here is that the ability to continue such a strategic partnership can only happen if positive preclinical and clinical data is achieved. If AbbVie feels that the data generated doesn't warrant further progression or that it doesn't like what it sees, then it could terminate such a partnership at any moment.  Conclusion  Immunome has done well to advance several of its product candidates in its pipeline. The most advanced drug in its pipeline would be the phase 3 ready asset known as AL-102, which it acquired from Ayala Pharmaceuticals. This candidate is being advanced for the treatment of patients with desmoid tumors in the ongoing phase 3 RINGSIDE study. It is expected that top-line results from this late-stage study will be released in the 2nd half of 2025.  The global desmoid tumor market is projected to grow to $5.49 billion by 2032. I believe that it is quite possible, barring a successful outcome of the phase 3 data, for Immunome, Inc.'s AL-102 to become the new SOC for this patient population. I think that if this company can successfully advance both its ROR1 ADC IM-1021 and its FAP targeting RLT IM-3050 against solid tumors, then it could either generate a partnership deal with these or just outright end up being acquired. Both case scenarios are presented above, where big pharma acquired ADC biotechs for a large sum of cash and also were on the hunt for RLTs as well.   Editor's Note: This article discusses one or more securities that do not trade on a major U.S. exchange. 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