Xencor: Plamotamab NHL Data Leads To RA Program Advancement

seekingalpha03:00

Xencor's Phase 1 data using Plamotamab for the treatment of relapsed/refractory Non-Hodgkin's Lymphoma patients, expected at ASH 2024 Annual Meeting December 9th of 2024 at 6:00 to 8:00.Initiation of ...

Source Link

Disclaimer: Investing carries risk. This is not financial advice. The above content should not be regarded as an offer, recommendation, or solicitation on acquiring or disposing of any financial products, any associated discussions, comments, or posts by author or other users should not be considered as such either. It is solely for general information purpose only, which does not consider your own investment objectives, financial situations or needs. TTM assumes no responsibility or warranty for the accuracy and completeness of the information, investors should do their own research and may seek professional advice before investing.

Comments

We need your insight to fill this gap

Leave a comment

{"i18n":{"language":"en_US"},"isChannel":false,"data":{"share":"https://ttm.financial/m/news/2485417218?lang=en_US&edition=fundamental","thumbnail":"https://static.seekingalpha.com/cdn/s3/uploads/getty_images/2178482079/image_2178482079.jpg","is_english":true,"pubTime":"2024-11-23 03:00","share_image_url":"https://static.laohu8.com/5a36db9d73b4222bc376d24ccc48c8a4","id":"2485417218","market":"nz","top_or_hot":-1,"title":"Xencor: Plamotamab NHL Data Leads To RA Program Advancement","media":"seekingalpha","content":"<div>\n<p>Xencor's Phase 1 data using Plamotamab for the treatment of relapsed/refractory Non-Hodgkin's Lymphoma patients, expected at ASH 2024 Annual Meeting December 9th of 2024 at 6:00 to 8:00.Initiation of ...</p>\n\n<a href=\"https://seekingalpha.com/article/4739704-xencor-plamotamab-nhl-data-leads-to-ra-program-advancement\">Source Link</a>\n\n</div>\n","source":"seekingalpha","html":"<!DOCTYPE html>\n<html>\n<head>\n<meta http-equiv=\"Content-Type\" content=\"text/html; charset=utf-8\" />\n<meta name=\"viewport\" content=\"width=device-width,initial-scale=1.0,minimum-scale=1.0,maximum-scale=1.0,user-scalable=no\"/>\n<meta name=\"format-detection\" content=\"telephone=no,email=no,address=no\" />\n<title>Xencor: Plamotamab NHL Data Leads To RA Program Advancement</title>\n<style type=\"text/css\">\na,abbr,acronym,address,applet,article,aside,audio,b,big,blockquote,body,canvas,caption,center,cite,code,dd,del,details,dfn,div,dl,dt,\nem,embed,fieldset,figcaption,figure,footer,form,h1,h2,h3,h4,h5,h6,header,hgroup,html,i,iframe,img,ins,kbd,label,legend,li,mark,menu,nav,\nobject,ol,output,p,pre,q,ruby,s,samp,section,small,span,strike,strong,sub,summary,sup,table,tbody,td,tfoot,th,thead,time,tr,tt,u,ul,var,video{ font:inherit;margin:0;padding:0;vertical-align:baseline;border:0 }\nbody{ font-size:16px; line-height:1.5; color:#999; background:transparent; }\n.wrapper{ overflow:hidden;word-break:break-all;padding:10px; }\nh1,h2{ font-weight:normal; line-height:1.35; margin-bottom:.6em; }\nh3,h4,h5,h6{ line-height:1.35; margin-bottom:1em; }\nh1{ font-size:24px; }\nh2{ font-size:20px; }\nh3{ font-size:18px; }\nh4{ font-size:16px; }\nh5{ font-size:14px; }\nh6{ font-size:12px; }\np,ul,ol,blockquote,dl,table{ margin:1.2em 0; }\nul,ol{ margin-left:2em; }\nul{ list-style:disc; }\nol{ list-style:decimal; }\nli,li p{ margin:10px 0;}\nimg{ max-width:100%;display:block;margin:0 auto 1em; }\nblockquote{ color:#B5B2B1; border-left:3px solid #aaa; padding:1em; }\nstrong,b{font-weight:bold;}\nem,i{font-style:italic;}\ntable{ width:100%;border-collapse:collapse;border-spacing:1px;margin:1em 0;font-size:.9em; }\nth,td{ padding:5px;text-align:left;border:1px solid #aaa; }\nth{ font-weight:bold;background:#5d5d5d; }\n.symbol-link{font-weight:bold;}\n/* header{ border-bottom:1px solid #494756; } */\n.title{ margin:0 0 8px;line-height:1.3;color:#ddd; }\n.meta {color:#5e5c6d;font-size:13px;margin:0 0 .5em; }\na{text-decoration:none; color:#2a4b87;}\n.meta .head { display: inline-block; overflow: hidden}\n.head .h-thumb { width: 30px; height: 30px; margin: 0; padding: 0; border-radius: 50%; float: left;}\n.head .h-content { margin: 0; padding: 0 0 0 9px; float: left;}\n.head .h-name {font-size: 13px; color: #eee; margin: 0;}\n.head .h-time {font-size: 11px; color: #7E829C; margin: 0;line-height: 11px;}\n.small {font-size: 12.5px; display: inline-block; transform: scale(0.9); -webkit-transform: scale(0.9); transform-origin: left; -webkit-transform-origin: left;}\n.smaller {font-size: 12.5px; display: inline-block; transform: scale(0.8); -webkit-transform: scale(0.8); transform-origin: left; -webkit-transform-origin: left;}\n.bt-text {font-size: 12px;margin: 1.5em 0 0 0}\n.bt-text p {margin: 0}\n</style>\n</head>\n<body>\n<div class=\"wrapper\">\n<header>\n<h2 class=\"title\">\nXencor: Plamotamab NHL Data Leads To RA Program Advancement\n</h2>\n\n<h4 class=\"meta\">\n\n\n2024-11-23 03:00 GMT+8&nbsp;&nbsp;&nbsp;<a href=https://seekingalpha.com/article/4739704-xencor-plamotamab-nhl-data-leads-to-ra-program-advancement><strong>seekingalpha</strong></a>\n\n\n</h4>\n\n</header>\n<article>\n<div>\n<p>Xencor's Phase 1 data using Plamotamab for the treatment of relapsed/refractory Non-Hodgkin's Lymphoma patients, expected at ASH 2024 Annual Meeting December 9th of 2024 at 6:00 to 8:00.Initiation of ...</p>\n\n<a href=\"https://seekingalpha.com/article/4739704-xencor-plamotamab-nhl-data-leads-to-ra-program-advancement\">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":"XNCR","symbol_name":"Xencor Inc","start_time":0,"source_url":"https://seekingalpha.com/article/4739704-xencor-plamotamab-nhl-data-leads-to-ra-program-advancement","article_id":"2485417218","we_media_id":null,"thumbnails":["https://static.seekingalpha.com/cdn/s3/uploads/getty_images/2178482079/image_2178482079.jpg"],"rights":null,"url":"https://stock-news.laohu8.com/highlight/detail?id=2485417218","pubTimestamp":1732302053,"sourceInfo":{"source_id":"seekingalpha","name":"Seeking Alpha"},"weMediaInfo":null,"summary":"Xencor's Phase 1 data using Plamotamab for the treatment of relapsed/refractory Non-Hodgkin's Lymphoma patients, expected at ASH 2024 Annual Meeting December 9th of 2024 at 6:00 to 8:00.Initiation of ","collect":0,"end_time":0,"defaultTopTitle":"seekingalpha.com","property":[],"viewcount":null,"language":"en","relate_stocks":{"XNCR":"Xencor Inc","BK4139":"生物科技"},"translate_title":"Xencor：Plamotamab NHL数据推动RA项目进展","themeId":null,"isJumpTheme":false,"ttsUrl":null,"symbols_score_info":{"XNCR":0.9},"content_text":"Xencor's Phase 1 data using Plamotamab for the treatment of relapsed/refractory Non-Hodgkin's Lymphoma patients, expected at ASH 2024 Annual Meeting December 9th of 2024 at 6:00 to 8:00.Initiation of the phase 1b/2a study, using Plamotamab for the treatment of patients with multi-drug resistant Rheumatoid Arthritis, expected 1st half of 2025.XmAb657 is a long-acting CD19 X CD3 bispecific antibody being developed to target patients with autoimmune disorders; Phase 1 trial initiation for this program expected 2nd half of 2025.The global Rheumatoid Arthritis drugs market size is expected to reach $53.1 billion by 2031.   JTKPHOTOz/iStock via Getty Images  The last time I wrote an article on Xencor, Inc. (NASDAQ:XNCR) it was regarding a Seeking Alpha article entitled “Xencor: Vudalimab Development Along With Hidden Gem Candidate.” In this article, I wrote about the prospects of it developing the use of vudalimab for the treatment of patients with metastatic castration-resistant prostate cancer [mCRPC] in the ongoing phase 2 study. The company is still on track to report monotherapy and combination cohort data from this mid-stage trial in the 1st half of 2025. Not only that, but what also remains on track is its ability to use its Xtend Fc Domain technology to extend the half-life of its possible best-in-class anti-TL1A candidate. This is being developed to treat patients with inflammatory bowel diseases like Crohn's Disease [CD] and Ulcerative Colitis [UC]. Initial data from this candidate is still expected in the 1st half of 2025. If these are still ongoing catalysts, then why do I believe it is important to go over this biotech again? That's because there is another approaching catalyst, which is expected to take place in the coming month. It is expected that Xencor will present data from a previously completed phase 1 study, using Plamotamab for the treatment of patients with relapsed/refractory non-Hodgkin's Lymphoma [NHL]. Such data will be presented at the upcoming 66th Annual American Society Of Hematology [ASH] 2024 medical conference on Monday, December 9th 2024 between 6:00-8:00. With preliminary data from this drug being comparable to that of another competing drug of the same class, along with further preclinical proof of concept, it can also use it to target patients with Rheumatoid Arthritis [RA]. Having said that, this brings about another catalyst for investors to focus on, which would be the initiation of a phase 1b/2a study targeting patients with RA who had progress on prior Standard of Care [SOC] therapy. Plamotamab For The Treatment Of Patients With Rheumatoid Arthritis As I stated above, there is plenty to happy for about the development pipeline from this company, but another promising drug in its pipeline would be the use of Plamotamab for the treatment of patients with Rheumatoid Arthritis [RA]. The company is gearing up to initiate a phase 1b/2a proof-of-concept study using this drug to treat these patients. Plus, the positive data it achieved from the phase 1 study using it to target patients with relapsed/refractory non-Hodgkin's Lymphoma [NHL]. Before going over the prospects of this entire program, plus any catalysts to be released from it, it is first important to understand what these disorders are and what the possible market opportunity for them could be. The premise here is to first go over the NHL because that's what has been evaluated already, and then go over the other indications below in a separate paragraph. Non-Hodgkin's Lymphoma [NHL] is a type of disorder characterized as a cancer of the lymphatic system, whereby white blood cells [lymphocytes] grow abnormally and can even develop tumors in the patient's body. It is critical to point out that NHL consists of many types of lymphomas. That is, there are subtypes of this that are classified. The two most common types of NHL are diffuse large b-cell lymphoma [DLBCL] and follicular lymphoma [FL]. Further classification depends upon where the NHL begins. Thus, there are two types. There is NHL that occurs in B-cells, which is bad because this lymphocyte is responsible for producing antibodies to fight infections. The other place where NHL can occur would be in T-cells. This is also not good because these lymphocytes are responsible for killing off foreign invaders. The global Non-Hodgkin Lymphoma treatment market is projected to reach $20.55 billion by 2032. The thing is that the goal of this company was to target relapsed/refractory NHL patients. Having said that, it is believed that approximately Just to give you an idea, with DLBCL, being the most common NHL type, about 50% of patients become refractory or relapse after treatment. To see if Plamotamab would be able to treat these r/r NHL patients, it ran a phase 1 study. This particular trial recruited up to a total of 154 patients who were given this CD20 X CD3 bi-specific T-cell engager molecule. A total of 22 patients were recruited at the time of data cut-off, with it entailing patients enrolled in 4 escalating subcutaneous [SC] cohorts from December 29th 2022–November 22, 2023. The patients recruited were as follows:  14 DLBCL patients  5 high-grade B-cell lymphoma patients  3 of other NHL subtypes like: Mantle-cell lymphoma [MCL], Waldenstrom macroglobulinemia and T-cell rich lymphoma.  However, there is one important aspect to note, which is that only 17 patients were evaluable at the time of data cut-off. Having said that, the objective response rate [ORR] achieved was 53% [9 out of 17 patients] & the complete response [CR] was 4 out of 17 patients [24%]. This is some pretty good data here that was achieved using Plamotamab. Why is that? Well, that's because 82% of all and 93% of DLBCL patients had received prior CAR-T therapy. That is, the majority of these patients were post CAR-T types. Not only that, but they were heavily pre-treated, with a median of 4 lines of prior therapies. As I stated above in the beginning, this program brings about a catalyst opportunity for investors to focus on. It is expected that Xencor will present this phase 1 data at the upcoming 66th Annual ASH medical conference, expected to take place on Monday, December 9th 2024 from 6:00 to 8:00. With the data of Plamotamab holding up well against a competing drug class, it believes that it can expand the use of this drug towards autoimmune disorders as well. This makes sense because such disorders have autoreactive B-cells and autoantibodies that cause it. Another factor for it moving towards autoimmune disorders would be because of significant B-cell depletion observed in preclinical testing of this drug. This is where another milestone comes into play for investors to track, which would be the initiation of a phase 1b/2a proof-of-concept study using Plamotamab to treat patients with multi-drug resistant Rheumatoid Arthritis. That is, the type of RA patients to be recruited in such a study are those who had already failed prior standard of care [SOC] therapy. This initial trial is expected to start in the 1st half of 2025. It is key to note, though, that this is only regarding evaluating safety and biomarkers first. Should this first portion go well, then the plan is to initiate a randomized phase 2a study, using the recommended dose regimen of Plamotamab, to be evaluated over a 24-week period. Rheumatoid Arthritis [RA] is a type of disorder characterized as a type of arthritis where the immune system attacks the tissue lining joints in a person's body. A problem with this disorder is that uncontrolled inflammation can damage the cartilage of the joints. Why is this an important part of the body? That's because it acts as a “shock” absorber, responsible for helping with movement and keeping the joints functioning properly. Eventually, it's also possible that the bones could be eroded as well, which might lead to fusion of the joints. The global Rheumatoid Arthritis drugs market size is expected to reach $53.1 billion by 2031. This is a considerable market opportunity to branch off to. The best part of all is that a step-up dose and priming dose regimen to be selected will be that of what was used in the phase 1 oncology study [targeting the patients with NHL noted above]. Xencor Financials According to the 10-Q SEC Filing, Xencor had cash, cash equivalents and marketable securities of $754.3 million as of September 30th of 2024. The reason for the cash on hand is because of an underwritten public offering that it had completed back in September 2024. It was able to generate approximately $189.2 million in net proceeds after deducting expenses. It is going to have enough cash on hand for an extended period of time. Why is that? Well, that's because it stated in its 10-Q SEC Filing that it believes it has enough cash on hand for a cash runway to fund its operations into 2028. Should it at some point need to raise funds, then it may do so with a Sales Agreement that it entered into with SVB Securities LLC. This is whereby it could issue and sell up to $200 million worth of shares of its common stock when needed. As of September 30th, it had made no sales under this ATM agreement. It burns roughly $58.86 million of cash per quarter. Risks To Business There are several risks that investors should be aware of before investing in Xencor. The first risk to consider would be in terms of the development of Plamotamab for the treatment of patients with RA. The goal is to first initiate a phase 1b/2a proof-of-concept study first and then move to a randomized phase 2a afterward. The risk here is that there is no assurance that the initial phase 1b/2a study will achieve the desired biomarkers and/or safety data necessary to move to the randomized trial. The second risk then relates to this other study specifically. Even if the biomarkers and safety are good in the first part of clinical testing of Plamotamab for RA patients, there is no assurance that the 24-week efficacy endpoint will be positive, nor be good enough to move to a larger clinical study. The second risk to consider would be in terms of the development of XmAb942 being explored in a phase 1 healthy volunteer study as an anti-TL1A drug. The goal of this class of drugs is to be used to treat patients with inflammatory bowel disorders [IBDs]. There is no assurance that the safety to be produced in this trial or pharmacokinetic/pharmacodynamic data, will be enough to warrant further testing. Nor, that the stock market is going to view this data favorably, either. Not only that, but the thing is that its Xtend Fc Domain technology must extend the half-life enough to the point of generating a competitive advantage over other anti-TL1A drugs in development. They are also going to be used to target IBDs like Ulcerative Colitis [UC] and Crohn's Disease [CD]. The third and final risk to consider would be in terms of the development of its other candidate in its pipeline, known as XmAb657. This is a long-acting CD19 X CD3 bispecific antibody being developed to target patients with autoimmune disorders as well. This provides another shot on goal in targeting this considerable market space. Preclinical testing has shown the extended half-life of this drug candidate to be 15 days, along with B-cell reduction of 99.98% observed. There were also no signs of cytokine release syndrome [CRS] present either from this preclinical testing. A first-in-human study for this program is expected to begin in the 2nd half of 2025. The risk here is that there is no assurance that the drug will be very safe in humans, despite that which has been observed in preclinical testing. Nor, that the data to be released afterward will be positive and/or warrant further testing in another trial. Conclusion Xencor has done well to continue development of several of its candidates from its pipeline. It is still in the process of gearing up to report monotherapy and combination dose cohort data, from its phase 2 study using its drug vudalimab for the treatment of patients with metastatic castration-resistant prostate cancer [mCRPC]. What makes this candidate ideal is that it is a PD-1 and CTLA-4 bispecific antibody with dual targeting capability. Such results from this mid-stage study are to be released in the 1st half of 2025.  Secondly, the anti-TL1A drug remains on track and as long as it proves to extend the half-life of the drug to create enough of a competitive advantage, then it will be another very promising program to keep an eye on. I believe that this company is well poised because of the versatility of its drugs in the pipeline. Specifically, Plamotamab is being developed to target both cancers and autoimmune disorders. With the presentation of phase 1 data using this drug to treat r/r NHL patients at the 66th ASH Annual Meeting on Monday, December 9th, 2024, at 6:00 to 8:00, plus the initiation of a phase 1b/2a proof-of-concept study using the very same drug in multi-drug resistant RA patients, I believe that investors could benefit with any potential gains made here.","kind":null,"is_publish_news":true,"is_publish_highlight":false,"is_publish_live":false,"is_publish_wemedia":null,"editions":null,"column":"","sentiment":"1","news_tag":"Product Release,analysis","news_rank":0,"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":"4.29.2","shortVersion":"4.29.2","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/2485417218"}