Estrella Immunopharma Initiates Second Cohort and Doses First Patient in STARLIGHT-1 Trial of EB103 in Advanced B-Cell Non-Hodgkin's Lymphomas
EMERYVILLE, Calif.--(BUSINESS WIRE)--Estrella Immunopharma, Inc. (NASDAQ: ESLA) ('Estrella' or the 'Company'), a clinical stage biopharmaceutical company developing CD19 and CD22-targeted ARTEMIS ® T-cell therapies to treat cancer and autoimmune diseases, today announced that the first patient has been dosed in the second cohort of its dose escalation study of Phase I/II STARLIGHT-1 trial for EB103, a CD19-redirected ARTEMIS ® T-cell therapy to treat patients with Advanced B-Cell Non-Hodgkin's Lymphomas (NHL).
'EB103 has a significant potential to address key limitations of traditional CAR-T therapies by mitigating safety risks and expanding accessibility to high-risk patient groups," said Cheng Liu, Chief Executive Officer of Estrella.
The second cohort will evaluate EB103 at a higher dose level following a review of safety data from the first dose cohort. As previously announced, no dose-limiting toxicities (DLTs) or treatment-related serious adverse events (SAEs) were observed in the first cohort. The initiation of dosing in the second cohort reflects steady progress in Estrella's mission to complete Phase I of STARLIGHT-1.
'We are excited to announce another important milestone in our STARLIGHT-1 trial and are encouraged by the favorable safety profile and the complete response observed in the first cohort,' said Cheng Liu, Chief Executive Officer of Estrella. 'EB103 has a significant potential to address key limitations of traditional CAR-T therapies by mitigating safety risks and expanding accessibility to high-risk patient groups, including those with HIV-associated lymphoma and central nervous system (CNS) lymphoma - conditions that are excluded from existing CAR-T options. We look forward to evaluating EB103 at higher doses and delivering the treatments to patients soon.'
About EB103
EB103, a T-cell therapy, also referred to as Estrella's 'CD19-Redirected ARTEMIS ® T-Cell Therapy,' utilizes ARTEMIS ® technology licensed from Eureka Therapeutics, Inc. ('Eureka'), Estrella's parent company. Unlike a traditional CAR-T cell, the unique design of an ARTEMIS ® T-Cell, like EB103 T-cell, allows it to be activated and regulated upon engagement with cancer targets that use a cellular mechanism more closely resembling the one from an endogenous T-cell receptor. Once infused, EB103 T-cells seek out CD19-positive cancer cells, bind to these cells, and destroy them.
About Estrella Immunopharma
Estrella is a clinical-stage biopharmaceutical company developing CD19 and CD22-targeted ARTEMIS ® T-cell therapies to treat cancers and autoimmune diseases. Estrella's mission is to harness the evolutionary power of the human immune system to transform the lives of patients fighting cancer and other diseases. To accomplish this mission, Estrella's lead product candidate, EB103, utilizes Eureka's ARTEMIS ® technology to target CD19, a protein expressed on the surface of almost all B-cell leukemias and lymphomas. Estrella is also developing EB104, which also utilizes Eureka's ARTEMIS ® technology to target not only CD19, but also CD22, a protein that, like CD19, is expressed on the surface of most B-cell malignancies.
For more information about Estrella, please visit www.estrellabio.com.
Forward Looking Statements
This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. These statements, including but not limited to those regarding the potential benefits and therapeutic advantages of EB103 and ARTEMIS ® T-cell therapy, the anticipated progress and milestones of the STARLIGHT-1 Phase I/II clinical trial, and the future development plans for EB103, are based on our management's current expectations, estimates, forecasts, and projections about the industry and markets in which we operate and our management's current beliefs and assumptions. These statements may be identified by the use of forward-looking expressions, including, but not limited to, 'expect,' 'anticipate,' 'intend,' 'plan,' 'believe,' 'estimate,' 'potential,' 'predict,' 'project,' 'should,' 'would' and similar expressions and the negatives of those terms. These statements relate to future events or our financial performance and involve known and unknown risks, uncertainties, and other factors that could cause actual results, levels of activity, performance, or achievements to differ materially from those expressed or implied by these forward-looking statements. Factors that may cause actual results to differ materially from current expectations include, among other things, those listed under 'Risk Factors' and elsewhere in our filings with the Securities and Exchange Commission. The forward-looking statements in this press release represent our views as of the date of this press release. We anticipate that subsequent events and developments will cause our views to change. However, while we may elect to update these forward-looking statements at some point in the future, we have no current intention of doing so except to the extent required by applicable law. You should, therefore, not rely on these forward-looking statements as representing our views as of any date subsequent to the date of this press release.
Hashtags
Try Our AI Features
Explore what Daily8 AI can do for you:
Comments
No comments yet...
Related Articles
Associated Press
14 minutes ago
- Associated Press
INVESTOR DEADLINE APPROACHING: Faruqi & Faruqi, LLP Investigates Claims on Behalf of Investors of Zenas BioPharma
Faruqi & Faruqi, LLP Securities Litigation Partner James (Josh) Wilson Encourages Investors Who Suffered Losses Exceeding $75,000 In Zenas To Contact Him Directly To Discuss Their Options If you purchased or otherwise acquired stock of Zenas pursuant and/or traceable to Zenas' registration statement for the initial public offering held on or about September 13, 2024 and would like to discuss your legal rights, call Faruqi & Faruqi partner Josh Wilson directly at 877-247-4292 or 212-983-9330 (Ext. 1310). [You may also click here for additional information] New York, New York--(Newsfile Corp. - June 8, 2025) - Faruqi & Faruqi, LLP, a leading national securities law firm, is investigating potential claims against Zenas BioPharma, Inc. ('Zenas' or the 'Company') (NASDAQ: ZBIO) and reminds investors of the June 16, 2025 deadline to seek the role of lead plaintiff in a federal securities class action that has been filed against the Company. [ This image cannot be displayed. Please visit the source: ] Faruqi & Faruqi is a leading national securities law firm with offices in New York, Pennsylvania, California and Georgia. The firm has recovered hundreds of millions of dollars for investors since its founding in 1995. See As detailed below, the complaint alleges that the Company and its executives violated federal securities laws by making false and/or misleading statements and/or failing to disclose that: (1) Zenas BioPharma materially overstated the amount of time it would be able to fund its operations using existing cash and expected net proceeds from the IPO; and (2) as a result, defendants' public statements were materially false and misleading at all relevant times and negligently prepared. When the true details entered the market, the lawsuit claims that investors suffered damages. The court-appointed lead plaintiff is the investor with the largest financial interest in the relief sought by the class who is adequate and typical of class members who directs and oversees the litigation on behalf of the putative class. Any member of the putative class may move the Court to serve as lead plaintiff through counsel of their choice, or may choose to do nothing and remain an absent class member. Your ability to share in any recovery is not affected by the decision to serve as a lead plaintiff or not. Faruqi & Faruqi, LLP also encourages anyone with information regarding Zenas' conduct to contact the firm, including whistleblowers, former employees, shareholders and others. To learn more about the Zenas BioPharma class action, go to or call Faruqi & Faruqi partner Josh Wilson directly at 877-247-4292 or 212-983-9330 (Ext. 1310). Follow us for updates on LinkedIn, on X, or on Facebook. Attorney Advertising. The law firm responsible for this advertisement is Faruqi & Faruqi, LLP ( ). Prior results do not guarantee or predict a similar outcome with respect to any future matter. We welcome the opportunity to discuss your particular case. All communications will be treated in a confidential manner. To view the source version of this press release, please visit
The Hill
32 minutes ago
- The Hill
Beyond MAHA: Defeating obesity requires a new strategy
Obesity is a major health problem facing our country. According to the CDC, more than 40 percent of the U.S. population is obese, defined as having a body-mass index above 30. As astounding at that number is, it is perhaps even more surprising that nearly 20 percent of children in the U.S. are obese. Obesity leads to significant health challenges, including diabetes, stroke, cardiovascular disease and liver disease. It is clear that as a nation we must face this crisis on multiple fronts. Diet and exercise certainly help, and it's critical to ensure that people of all socioeconomic backgrounds have access to healthy foods (free of preservatives, unnecessary dyes, high fructose corn syrups etc.) and are educated in making healthy lifestyle choices. The MAHA or 'Make America Healthy Again' movement has highlighted this as one of its key objectives, and if it is successful, we should see an impact on obesity — especially in children, where diet and exercise have a huge impact on weight-related health outcomes. Obesity in adults, however, is often more challenging. Many adults with obesity struggle to lose weight, despite considerable efforts to modify their lifestyle through diet and exercise. This is because our metabolism changes as we age, and many adults who are overweight develop metabolic dysfunction or 'metabolic syndrome,' which then further perpetuates weight gain and exacerbates the situation. It has become clear in recent years that many people struggling with obesity require medical intervention – not just lifestyle intervention – and that prescriptions can substantially improve weight loss. The explosion in use of GLP-1 agonists, such as Wegovy and Zepbound, over the last two years has underscored the need for medical intervention in obese and overweight patients. Currently, about 6 percent of the U.S. population, or 15 million people, are on GLP-1 weight loss treatments, and the numbers are only expected to increase. However, while most patients lose 10 percent to 25 percent of their body weight while on a GLP-1, they do not maintain GLP-1 treatment in the long-term, with approximately 80 percent of patients discontinuing treatment within 1 year. Gastrointestinal side effects, injectable administration, and high cost have prevented long-term use of GLP-1's for weight maintenance. And unfortunately, most patients gain back all the weight after stopping the medication. Healthcare professionals and the pharmaceutical industry now recognize that obesity — like most other medical conditions — requires an 'arsenal' of treatments, rather than a one-size-fits-all approach. Post-GLP-1 weight maintenance is now widely recognized as an emerging unmet need. And patients who are not candidates for or cannot tolerate GLP-1s require alternatives. Diet and lifestyle modifications are important alongside prescription medications in fighting obesity. If we are going to be successful in overcoming this major health crisis, we need to ensure that both the pharmaceutical industry and groups like MAHA work hand in hand. Both treatment and prevention are critical in order to regain control of our nation's health. Dr. Shoshana Shendelman, Ph.D. is a scientist and entrepreneur who has founded numerous biotech companies. She is a pioneer in the development of drugs and therapeutics for rare and underserved diseases. Currently she is Vice Chair of the Advisory Board of Columbia University Medical Center and Columbia University Vagelos College of Physicians and Surgeons.
Yahoo
32 minutes ago
- Yahoo
1 Stock Down 34% This Year to Buy and Hold
Investors are withdrawing their money from stocks like Viking Therapeutics due to the current uncertainty. However, the biotech has a duo of mid-stage candidates that look incredibly promising. Though it carries above-average risk, Viking has significant upside potential. 10 stocks we like better than Viking Therapeutics › Shares of Viking Therapeutics (NASDAQ: VKTX), a mid-cap biotech, are down by 34% this year. This poor performance may suggest that recent company-specific developments have rendered the stock less attractive or that it is being affected by broader market issues. The latter is true, at least to some extent, but Viking Therapeutics' thesis has not changed significantly this year. The drugmaker remains attractive compared to most of its similarly sized peers. Here is why. Viking Therapeutics is a clinical-stage biotech. That means the company has no product on the market, generates no revenue, and is consistently unprofitable. Investors aren't too keen on buying shares of companies that fit this profile when broader equities are experiencing significant volatility due to potential macroeconomic issues. In fairness, that makes sense. Clinical-stage biotechs carry above-average risk. Their products may never see the light of day outside the clinic, and even when they do, many do not generate substantial revenue. However, Viking Therapeutics is a bit different. The company is developing medicines across several areas with high unmet needs. First, there is the drugmaker's work in the weight management space. The anti-obesity drug market has experienced significant growth in recent years. Yet, analysts continue to predict that the best is yet to come. Viking Therapeutics' leading candidate in this area, VK2735, is a dual GLP-1/GIP agonist. The only approved medicine of this kind on the market is Eli Lilly's Zepbound, an undisputed leader. Being in the same class as Zepbound doesn't guarantee VK2735's success, but it's still worth pointing out that a similar mechanism of action that led to Zepbound's breakthrough and efficacy could also prove successful for Viking Therapeutics' crown jewel. And more importantly, the investigational medicine has produced better results than almost any other mid-stage candidate in weight management, outside of those being developed by Eli Lilly and Novo Nordisk. That's impressive for a mid-cap biotech, considering significantly larger drugmakers with far more resources are trying to dominate this market. Viking Therapeutics' other mid-stage program, VK2809, performed well in patients with metabolic dysfunction-associated steatohepatitis (MASH), a disease with obesity as one of the main risk factors and whose prevalence is on the rise. However, the U.S. Food and Drug Administration approved just the first MASH medicine last year, although that will likely change soon. The point, though, is that VK2809 could join a relatively young market in a few years and generate massive sales down the road. These two candidates set Viking Therapeutics apart from other clinical-stage biotech companies. It's also worth noting that Viking Therapeutics recently signed a multiyear manufacturing agreement with privately held CordenPharma for VK2735. Per the terms of the deal, CordenPharma will manufacture more than a billion oral formulations of the medicine annually, as well as over 100 million autoinjectors and another 100 million syringes per year. Viking Therapeutics will make payments to CordenPharma, totaling $150 million through 2028. This deal highlights that Viking Therapeutics is already planning some post-commercial activity for its leading candidate. That's a great sign for investors. Viking Therapeutics is developing other candidates, including another weight management product that is still in preclinical studies. Following a similar blueprint, this product is a dual agonist that mimics the action of not just one but two gut hormones: amylin, which helps regulate blood sugar, and calcitonin, which regulates calcium levels. There is slow progress on that front, but Viking Therapeutics' commitment to innovation is impressive for such a small biotech. Now, Viking Therapeutics' most advanced programs could fail in phase 3 studies. If that happens, especially with VK2735, the stock price is likely to plummet. That's a significant risk to consider. That's why the stock is probably not suitable for risk-averse investors. However, those who are comfortable with volatility should strongly consider initiating a small position in the stock. If the business goes under, which isn't that rare for smaller biotech companies, your losses will be relatively small so long as the company makes a tiny portion of your overall portfolio. But there is significant upside potential that those who invest in Viking Therapeutics today could enjoy over the long run. Before you buy stock in Viking Therapeutics, consider this: The Motley Fool Stock Advisor analyst team just identified what they believe are the for investors to buy now… and Viking Therapeutics wasn't one of them. The 10 stocks that made the cut could produce monster returns in the coming years. Consider when Netflix made this list on December 17, 2004... if you invested $1,000 at the time of our recommendation, you'd have $669,517!* Or when Nvidia made this list on April 15, 2005... if you invested $1,000 at the time of our recommendation, you'd have $868,615!* Now, it's worth noting Stock Advisor's total average return is 792% — a market-crushing outperformance compared to 171% for the S&P 500. Don't miss out on the latest top 10 list, available when you join . See the 10 stocks » *Stock Advisor returns as of June 2, 2025 Prosper Junior Bakiny has positions in Eli Lilly, Novo Nordisk, and Viking Therapeutics. The Motley Fool recommends Novo Nordisk and Viking Therapeutics. The Motley Fool has a disclosure policy. 1 Stock Down 34% This Year to Buy and Hold was originally published by The Motley Fool
