Relay Therapeutics: 2nd-Line RLY-2608 Data Moves Program Towards Expansion

seekingalpha09-17

Relay Therapeutics, Inc. reported positive interim data from its phase 1 ReDiscover study, using RLY-2608 + fulvestrant for treatment of PI3Ka-mutated HR+/HER2- locally advanced or metastatic breast ...

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/2468873321?lang=en_US&edition=fundamental","thumbnail":"https://static.seekingalpha.com/cdn/s3/uploads/getty_images/2166845333/image_2166845333.jpg","is_english":true,"pubTime":"2024-09-17 04:57","share_image_url":"https://static.laohu8.com/5a36db9d73b4222bc376d24ccc48c8a4","id":"2468873321","market":"hk","top_or_hot":-1,"title":"Relay Therapeutics: 2nd-Line RLY-2608 Data Moves Program Towards Expansion","media":"seekingalpha","content":"<div>\n<p>Relay Therapeutics, Inc. reported positive interim data from its phase 1 ReDiscover study, using RLY-2608 + fulvestrant for treatment of PI3Ka-mutated HR+/HER2- locally advanced or metastatic breast ...</p>\n\n<a href=\"https://seekingalpha.com/article/4721435-relay-therapeutics-2nd-line-rly-2608-data-moves-program-towards-expansion\">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>Relay Therapeutics: 2nd-Line RLY-2608 Data Moves Program Towards Expansion</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\">\nRelay Therapeutics: 2nd-Line RLY-2608 Data Moves Program Towards Expansion\n</h2>\n\n<h4 class=\"meta\">\n\n\n2024-09-17 04:57 GMT+8&nbsp;&nbsp;&nbsp;<a href=https://seekingalpha.com/article/4721435-relay-therapeutics-2nd-line-rly-2608-data-moves-program-towards-expansion><strong>seekingalpha</strong></a>\n\n\n</h4>\n\n</header>\n<article>\n<div>\n<p>Relay Therapeutics, Inc. reported positive interim data from its phase 1 ReDiscover study, using RLY-2608 + fulvestrant for treatment of PI3Ka-mutated HR+/HER2- locally advanced or metastatic breast ...</p>\n\n<a href=\"https://seekingalpha.com/article/4721435-relay-therapeutics-2nd-line-rly-2608-data-moves-program-towards-expansion\">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":"IE00B19Z3B42.SGD","symbol_name":"Legg Mason ClearBridge - Value A Acc SGD","start_time":0,"source_url":"https://seekingalpha.com/article/4721435-relay-therapeutics-2nd-line-rly-2608-data-moves-program-towards-expansion","article_id":"2468873321","we_media_id":null,"thumbnails":["https://static.seekingalpha.com/cdn/s3/uploads/getty_images/2166845333/image_2166845333.jpg"],"rights":null,"url":"https://stock-news.laohu8.com/highlight/detail?id=2468873321","pubTimestamp":1726520273,"sourceInfo":{"source_id":"seekingalpha","name":"Seeking Alpha"},"weMediaInfo":null,"summary":"I would consider the second expansion opportunity as the one being the two triplet combination regimens to be evaluated as part of this program. This would be to initiate two triplet RLY-2608 regimens to target 1st-line PI3Ka-mutated HR+, HER2- breast cancer patients. Adding ribociclib into the triplet expansion cohort is expected to start in the 1st half of 2025 and then the addition of atirmociclib to the triplet expansion cohort targeting the same group of patients is expected by the end of 2024. Beyond this, there will be initial safety data from the cohort looking at RLY-2608 + fulvestrant + ribociclib in Q4 of 2024. This is another small milestone for traders/investors to keep an eye on as this year closes out. One additional expansion opportunity exists with the use of PIK3Ka inhibitor RLY-2608, which would be the ability to target tumors with vascular formations. A phase 1 study using monotherapy RLY-2608 to target such tumors is expected to begin in Q1 of 2025. RLY-2608 + Fulv","collect":0,"end_time":0,"defaultTopTitle":"seekingalpha.com","property":[],"viewcount":null,"language":"en","relate_stocks":{"IE00B19Z3B42.SGD":"Legg Mason ClearBridge - Value A Acc SGD","BK4568":"美国抗疫概念","SG9999011175.SGD":"Nikko AM Global Dividend Equity Dis SGD-H","IE00BBT3K403.USD":"LEGG MASON CLEARBRIDGE TACTICAL DIVIDEND INCOME \"A(USD) ACC","BK4550":"红杉资本持仓","BK4588":"碎股","LU0109394709.USD":"富兰克林生物科技新领域基金A (acc)","LU0234572021.USD":"高盛美国核心股票组合Acc","LU0321505439.SGD":"Schroder ISF Global Dividend Maximiser A Acc SGD","LU1023059063.AUD":"BGF WORLD HEALTHSCIENCE \"A2\" (AUDHDG) ACC","SG9999002232.USD":"Allianz Global High Payout USD","LU0985481810.HKD":"SCHRODER ISF GLOBAL EQUITY YIELD \"A\" (HKD) INC M","BK4139":"生物科技","LU0306806265.USD":"SCHRODER ISF GLOBAL DIVIDEND MAXIMISER \"A\" ACC","SG9999002224.SGD":"Allianz Global High Payout SGD","LU0225771236.USD":"SCHRODER ISF GLOBAL EQUITY YIELD \"A\" (USD) INC MF","LU1894683264.USD":"AMUNDI FUNDS US EQUITY RESEARCH VALUE \"A2\" (USD) ACC","BK4581":"高盛持仓","SG9999001176.SGD":"UOB UNITED GLOBAL HEALTHCARE \"SGD\" (ACC)","LU2236285917.USD":"ALLIANZ GLOBAL INCOME \"AMG\" (USD) INC","AZN":"阿斯利康","LU1066053197.SGD":"HSBC GIF GLOBAL EQUITY VOLATILITY FOCUSED \"AM3\" (SGDHDG) INC","IE0002270589.USD":"LEGG MASON CLEARBRIDGE VALUE \"A\" (USD) INC","LU0868494617.USD":"UBS (LUX) EQUITY SICAV - US TOTAL YIELD SUSTAINABLE \"P\" (USD) ACC","BK4563":"昨日强势股","IE000M9KFDE8.USD":"NEUBERGER BERMAN US LARGE CAP VALUE \"A\" (USD) ACC","LU0225284248.USD":"SCHRODER ISF GLOBAL EQUITY YIELD \"A\" ACC","BK4007":"制药","BK4592":"伊斯兰概念","SG9999001176.USD":"United Global Healthcare Acc USD","LU1894683348.USD":"AMUNDI FUNDS US EQUITY RESEARCH VALUE \"A2\" (USD) INC","LU1829250122.USD":"高盛欧洲核心股票组合Acc","LU0889565916.HKD":"FRANKLIN BIOTECHNOLOGY DISCOVERY \"A\" (HKD) ACC","IE00BLSP4239.USD":"Legg Mason ClearBridge - Tactical Dividend Income A Mdis USD Plus","IE00BLSP4452.SGD":"Legg Mason ClearBridge - Tactical Dividend Income A Mdis SGD-H Plus","LU0306807586.USD":"SCHRODER ISF GLOBAL DIVIDEND MAXIMISER \"A\" (USD) INC QF","SG9999013999.USD":"UOB UNITED GLOBAL HEALTHCARE FUND (USDHDG) INC","LU0320765992.SGD":"FTIF - Franklin Biotechnology Discovery A Acc SGD","LU1066051498.USD":"HSBC GIF GLOBAL EQUITY VOLATILITY FOCUSED \"AM2\" (USD) INC","SGXZ57979304.SGD":"United Global Healthcare A Acc SGD-H","BK4533":"AQR资本管理(全球第二大对冲基金)","LU0058720904.USD":"联博国际健康护理基金A","RLY":"SPDR SSgA Multi-Asset Real Return ETF","RLAY":"Relay Therapeutics","IE00B19Z3581.USD":"Legg Mason ClearBridge - Value A Acc USD","LU0456855351.SGD":"JPMorgan Funds - Global Equity A (acc) SGD","LU0321505868.SGD":"Schroder ISF Global Dividend Maximiser A Dis SGD","LU1057294990.SGD":"Blackrock World Healthscience A2 SGD-H","LU0289739699.SGD":"AB INTERNATIONAL HEALTH CARE PORTFOLIO \"A\" (SGD) ACC"},"translate_title":"Relay Therapeutics：二线RLY-2608数据推动项目走向扩张","themeId":null,"isJumpTheme":false,"ttsUrl":null,"symbols_score_info":{"AZN":1,"RLY":1,"RLAY":1},"content_text":"Relay Therapeutics, Inc. reported positive interim data from its phase 1 ReDiscover study, using RLY-2608 + fulvestrant for treatment of PI3Ka-mutated HR+/HER2- locally advanced or metastatic breast cancer patients.Key upcoming milestones for RLY-2608 program includes presenting data at the San Antonio Breast Cancer Symposium in December 2024 and initiating a phase 3 study in 2025.Expansion opportunities of the RLY-2608 program includes two triplet regimens targeting 1st-line PI3Ka-mutant HR+/HER2- breast cancer patients and phase 1 study for tumors with vascular formations starting in Q1 2025.The global breast cancer drugs market size is projected to surpass $78.61 billion by 2033.   Jacob Wackerhausen/iStock via Getty Images Relay Therapeutics, Inc. (NASDAQ:RLAY) recently announced that it had achieved positive interim data from its ongoing phase 1 ReDiscover study, using its drug RLY-2608 + fulvestrant for the treatment of PI3Ka-mutated, Hormone Receptor positive [HR+], HER2 negative [HER2-] locally advanced or metastatic breast cancer patients. The important analysis done was that of the 52 out of 64 patients who were treated with the recommended phase 2 dose [RP2D], which I will be going over below. Despite this data being revealed, there is still a significant catalyst opportunity for investors to look forward to. That would be that the company is expected to present an abstract at the San Antonio Breast Cancer Symposium, taking place between December 10th — 13th of 2024. Beyond this expected milestone, the other one would be the ability to discuss this data with regulators and move the use of RLY-2608 + fulvestrant forward into a phase 3 study to treat these specific metastatic breast cancer patients. The title of this article notes two expansion opportunities, whereby the moving of this program towards late-stage clinical testing is the first of two. Then what is the second one? I would consider the second expansion opportunity as the one being the two triplet combination regimens to be evaluated as part of this program. This would be to initiate two triplet RLY-2608 regimens to target 1st-line PI3Ka-mutated HR+, HER2- breast cancer patients. Adding ribociclib into the triplet expansion cohort is expected to start in the 1st half of 2025 and then the addition of atirmociclib to the triplet expansion cohort targeting the same group of patients is expected by the end of 2024. Beyond this, there will be initial safety data from the cohort looking at RLY-2608 + fulvestrant + ribociclib in Q4 of 2024. This is another small milestone for traders/investors to keep an eye on as this year closes out. One additional expansion opportunity exists with the use of PIK3Ka inhibitor RLY-2608, which would be the ability to target tumors with vascular formations. A phase 1 study using monotherapy RLY-2608 to target such tumors is expected to begin in Q1 of 2025. RLY-2608 + Fulvestrant In Targeting 2nd-line PI3KA-mutant Breast Cancer Patients To Move Forward As I stated above, Relay Therapeutics was able to report positive interim data from its phase 1 study, using RLY-2608 + fulvestrant for the treatment of patients with PI3Ka-mutated, HR+/HER2- locally advanced or metastatic breast cancer patients. Before going over this positive data, plus any other catalysts to come out of this specific program, it is first important to go over what this type of cancer is and what the possible market opportunity for it could be. Breast cancer, as the name suggests, occurs when malignant cells in the breast change and grow out of control. These cancerous cells then form a tumor, which causes numerous problems for the patient. In terms of metastatic disease, it is said that between 20% to 30% of breast cancer patients will develop metastatic disease. Then you have the targeting of hormone receptor + [HR+] breast cancer. Hormone receptor positive means that the cancer uses hormones like estrogen to grow and spread. Thus, a treatment like endocrine therapy that is anti-estrogen can potentially block the growth of the cancer itself. About 70% to 80% of newly diagnosed breast cancers are HR+. In terms of HER2 status, this is broken down into HER2+ or HER2- [HER2 negative]. HER2+ breast cancer patients means they have a lot of the HER2 protein on the surface of cancer cells. Whereas, HER2- means the opposite, in which there is little to no HER2 cells responsible for driving the cancer. The global breast cancer drugs market size is projected to surpass $78.61 billion by 2033. This is a massive market opportunity for sure and one by which this biotech is well on track towards going after. The company believes that there are roughly 150,000 breast cancer patients in the United States who are PI3Ka-mutant HR+/HER-. The first goal is to go after these 2nd-line/3rd-line patients who had already failed with prior therapies, like with a CDK4 inhibitor, and then target 1st-line patients with a triplet as I noted in the beginning above. To see if the doublet of RLY-2608 + fulvestrant would be able to treat these types of breast cancer patients, it is in the process of running the phase 1 ReDiscover study. This particular early-stage trial recruited a total of 118 patients with an interim data cut-off of August 12th of 2024. This is where the patient population evaluated changes depending upon what type of mutation they had, plus the fact that there was a set number of patients who were given the RP2D. There were a total of 64 patients who receive the RP2D of 600 mg BID [twice daily]. However, this was not the number of patients who were evaluated as part of the RLY-2608 + fulvestrant treatment group. It was actually a total of only 52 patients who were evaluated for efficacy. Why is that? Well, that's because 12 of the patients excluded had PTEN or AKT co-mutation status. Thus, they would not likely benefit with RLY-2608, which is a PI3Ka inhibitor. The outcome was that the median progression-free survival [mPFS] achieved for patients given the RLY-2608 + fulvestrant doublet, was 9.2 months. Among the 30 patients of these who had measurable disease, one third of them responded, thus giving an objective response rate [ORR] of 33%. This may not seem like a lot, but it is. Why is that? That's because 45% of these patients had already received 2 or more prior lines of therapy. About 52% of them had already been treated with a selective estrogen receptor degrader [SERD], before being given doublet RLY-2608 + fulvestrant. One last item to consider in terms of efficacy is that Truqap [capivasertib] + fulvestrant from AstraZeneca (AZN) has already been approved to treat HR+/HER2- advanced breast cancer [aBC] or metastatic breast cancer [mBC] patients with a PIK3CA, AKT1 or PTEN mutation. I would say the advantage for the big pharma drug is that it also targets the AKT1 or PTEN mutations, which RLY-2608 does not. However, Truqap + fulvestrant in targeting such mutations achieved a mPFS of 7.3 months versus those who took fulvestrant alone as a monotherapy to achieve a mPFS rate of only 3.1 months. Again, it is important to emphasize the cross-trial difference in that AstraZeneca's CAPItello-291 study deployed other mutations not targeted by RLY-2608. In terms of possible milestones relating to this RLY-2608 doublet treatment program targeting these PI3Ka-mutant HR+/HER2- locally advanced or mBC patients, there are two of them. The first of which would be in terms of a presentation expected to happen on this released data. An abstract to present this phase 1 ReDiscover interim data has been submitted to a medical conference. If granted, then it is expected that a presentation of such interim results from this phase 1 study will be shown at the San Antonio Breast Cancer Symposium, expected to take place between December 10th — 13th of 2024. The other catalyst would be the initiation of a late-stage study for this specific program. Barring positive discussions with the FDA, then a phase 3 study using RLY-2608 + fulvestrant for the treatment of PI3Ka-mutated HR+/HER2- aBC/mBC patients, will be initiated in 2025. Ability To Add Other Drugs With RLY-2608 Doublet To Go Beyond 2nd-Line Breast Cancer Patients A good thing about this company is that even though it has seen success in targeting PI3Ka-mutant HR+/HER2- locally advanced or metastatic breast cancer patients, there is potential for it to go after an earlier line of patients. I'm talking about the potential for it to target 1st-line patients of the same caliber. Having said that, there are plans to explore two triplet combinations which might allow it to go after the very same patients who are in this 1st-line setting. The two triplets to target such 1st-line patients will be as follows:  RLY-2608 + fulvestrant + ribociclib  RLY-2608 + fulvestrant + atirmociclib.  Ribociclib, marketed as Kisqali by Novartis, was approved back in 2017 with an aromatase inhibitor [AI] or fulvestrant to treat pre/perimenopausal or postmenopausal women with HR+/HER2- advanced or metastatic breast cancer patients. The hope is that the addition of ribociclib with RLY-2608 + fulvestrant will be able to help the targeting of PI3Ka-mutant HR+/HER2- advanced or metastatic breast cancer patients in the 1st-line setting. Ribociclib is a CDK4/6 inhibitor drug that is used to treat breast cancer. Regarding this first triplet, I'm noting here, there are two catalysts. One is that initial safety data from it will be reported in Q4 of 2024. Should this go well, then this bodes well for the second catalyst, which would be the initiation of a study using RLY-2608 + fulvestrant + ribociclib for the treatment of these patients in the 1st half of 2025. The second triplet to be studied is taking a slightly different approach in adding in a CDK4 inhibitor instead, by the name of atirmociclib. The thing to note about this investigational drug from Pfizer (PFE) is that it has not yet been approved. Truth be told, it is in clinical development for several types of solid tumors, however, the most important one as part of this conversation being breast cancer. It is exploring the use of atirmociclib in a phase 3 study targeting patients with 2nd-line metastatic breast cancer, along with another development pathway for this very same patient population type. The company is exploring the use of atirmociclib [PF-02220060 + selective CDK2 inhibitor PF-07104091] for the treatment of patients with breast cancer and other solid tumors in a phase 1/2 clinical study. It remains to be seen how well this drug works out for Pfizer, but it is good to see that Relay Therapeutics wants to test this clinical candidate out in its triplet study. Having said that, the goal is to initiate the use of RLY-2608 + atirmociclib + fulvestrant for the treatment of patients with 1st-line PI3Ka-mutated HR+/HER2- locally advanced or metastatic breast cancer by Q4 of 2024. This is one important milestone for investors to consider. However, there is another one to keep track of, which would be initial safety data from this very same triplet regimen study by the end of 2024. Financials According to the 10-Q SEC Filing, Relay Therapeutics had cash, cash equivalents and investments of $688.4 million as of June 30th of 2024. The reason for the cash on hand was because back in January 2024, it entered a private placement agreement or PIPE financing with Nextech to sell an aggregate of 2.5 million shares of its common stock at a price per share of $12. This resulted in net gross proceeds of $30 million. The thing is that this company was in good shape in terms of cash. Why is that? That's because it noted that it would have a cash runway, or enough cash on hand to fund its operations into the 2nd half of 2026. Despite this cash runway projection, it still decided to raise additional funds anyway. Having said that, it enacted an underwritten public offering of 28,571,429 shares of its common stock at a public offering price of $7 per share. It also decided to grant the underwriters of this offering a 30-day option to purchase up to an additional 4,285,714 shares of its common stock. Total gross proceeds from this offering are expected to be $200 million. However, this number doesn't include the underwriters' option to exercise additional shares of common stock under this agreement. It also has an At-The-Market offering agreement in place that it could use if it'd like to. I'm talking about an ATM agreement it made with Cowen and Company LLC., to which it could occasionally offer and sell up to an aggregate amount of $300 million. During the 3-months ending March 31st of 2024, it sold 1.88 million shares of common stock at a price of $9.73 per share to generate $17.9 million in proceeds. During the 3-months ending June 30th of 2024, it sold no shares under this agreement. The point being that if it needs to raise cash at a later time, then it may do so using this agreement, as there are still plenty of shares that can be sold under it. The company burns about $112.1 million of cash per quarter. This is broken down by Research & Development expenses of $92 million and then General & Administrative expenses of $20.1 million. Risks To Business There are several risks that investors should be aware of before investing in Relay Therapeutics. The first risk to consider would be in terms of the recently positive interim data from the phase 1 ReDiscover study, using RLY-2608 + fulvestrant for the treatment of PI3Ka-mutated, HR+/HER2- locally advanced or metastatic breast cancer patients. Even though the company achieved positive interim data to warrant further investigation of this doublet in a phase 3 study, there is no assurance that the FDA will give it the green light to initiate it. Not only that, but there is no guarantee that positive data will be achieved from a late-stage study, nor that the mPFS number will turn out to be equal or superior compared to the phase 1 study data released. The second risk to consider would be in terms of the two potential expansion opportunities I noted above. The goal is to take the efficacy that has been established in targeting PI3Ka-mutated HR+/HER2- locally advanced or metastatic breast cancer with RLY-2608 + fulvestrant doublet and then add in drugs to create two new triplets to move forward with. This would be the addition of ribociclib and/or atirmociclib to the currently tested doublet of RLY-2608 to treat these specific breast cancer patients. There is no assurance that either of these triplet combinations will be superior to that of which had already been established for RLY-2608 doublet. The third and final risk to consider would be in terms of using RLY-2608 and applying it towards another possible expansion opportunity, which is the targeting of tumors with vascular formations. PI3Ka mutation is highly indicated in these types of tumors. Thus, it is believed that this drug candidate might be able to help treat these patients. A phase 1 study for this program is expected to be initiated in Q1 of 2025. Upon completion of this early-stage trial, there is no assurance that the data from it is going to end up to be positive. Nor, that the initial data released from it allows Relay to move to the next stage of clinical testing for it. Conclusion Relay Therapeutics is in a good position as it advances the use of its drug RLY-2608 as a PI3Ka inhibitor for the treatment of solid tumors. Especially, when you consider that it was able to report highly effective data in being able to use this drug in combination with fulvestrant to treat patients with PI3Ka-mutant HR+/HER2- locally advanced or metastatic breast cancer. With this data in hand, it can strike up a conversation with the FDA to see if it can initiate a late-stage phase 3 study for this very same doublet program. Beyond this, there might even be the ability to shift from the targeting of these 2nd-line patients towards 1st-line. However, in order to accomplish this, it is going to have to test out the two RLY-2608 triplet combinations above. It remains to be seen if these triplet combinations will allow it to effectively go after an earlier line of patients, but they are other shots on goal for the pipeline nonetheless. Lastly, there might even be a way for it to expand the use of its PI3Ka inhibitor RLY-2608 beyond that of breast cancer. This would be in terms of what I described above, which is the potential to target solid tumors with vascular malformations. With a phase 1 study starting next for this program, this becomes another shot on goal for PI3Ka inhibitor RLY-2608.  Editor's Note: This article discusses one or more securities that do not trade on a major U.S. exchange. Please be aware of the risks associated with these stocks.","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":0},"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":"4.28.1","shortVersion":"4.28.1","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/2468873321"}