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Estrella Immunopharma Announces Activation of Additional Site for Phase I/II STARLIGHT-1 Trial in B-cell Non-Hodgkin’s Lymphoma

On June 5, 2025 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, reported the activation of a second clinical site for its ongoing STARLIGHT-1 Phase I/II clinical trial evaluating EB103, a CD19-Redirected ARTEMIS T-cell therapy, in patients with relapsed or refractory B-cell non-Hodgkin’s lymphoma (NHL) (Press release, Estrella Biopharma, JUN 5, 2025, View Source [SID1234653755]). The new site, Baylor Research Institute d/b/a Baylor Scott & White Research Institute in Dallas, Texas, is now open for patient enrollment.

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"Partnering with Baylor Research Institute, a nationally recognized medical institution, represents a key step forward in broadening the reach of our STARLIGHT-1 trial," said Cheng Liu, Chief Executive Officer of Estrella. "The expansion of our clinical footprint will help accelerate development and increase patient access to EB103, while we remain focused on our mission to deliver safer, more effective treatments for patients with advanced NHL."

The Phase I/II clinical trial for EB103 is an open-label, dose escalation, multi-center, Phase I/II clinical trial to assess the safety of EB103 autologous T-cell therapy and to determine the Recommended Phase II Dose (RP2D) in adult subjects (≥ 18 years of age) who have relapsed/refractory (R/R) B-cell NHL. The study includes a dose escalation phase followed by an expansion phase. Further details of the trial can be found at www.clinicaltrials.gov under NCT identifier: NCT06343311.

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.

The ArteraAI Prostate Test Enhanced with New Insights for Higher Risk Patients with Localized Prostate Cancer

On June 5, 2025 Artera, the developer of multimodal artificial intelligence (MMAI)-based prognostic and predictive cancer tests, reported it has updated its award-winning ArteraAI Prostate Test with new insights to help higher-risk patients optimize treatment decisions (Press release, Artera, JUN 5, 2025, View Source [SID1234653754]). Artera recently presented its validation data at the 2025 ASCO (Free ASCO Whitepaper) Annual Meeting, demonstrating the test’s ability to identify high-risk, non-metastatic prostate cancer patients most likely to benefit from the addition of abiraterone to standard therapy from those who don’t.

The STAMPEDE trial helped to establish abiraterone, an androgen receptor pathway inhibitor (ARPI), along with radiation and long-term androgen deprivation therapy (LT-ADT) as the standard of care treatment for high-risk patients, but clinicians and patients have been hesitant with its usage due to concerns around side effects, complex follow-up care, and added cost. Artera’s MMAI model was used to analyze the STAMPEDE trial patient cohort and identified that only 25% of high-risk non-metastatic patients derived meaningful benefit from abiraterone intensification, suggesting the opportunity to spare up to 75% of this cohort from unnecessary toxicities.

The commercially available ArteraAI Prostate Test provides personalized prognostic and predictive test results to guide treatment decisions. For lower-risk patients, the test can help determine if active surveillance is a suitable option, and for intermediate-risk patients, the test can predict if short-term androgen deprivation therapy (ST-ADT) is beneficial. With this new product enhancement, the ArteraAI Prostate Test will increase its clinical impact for higher-risk patients.

"We are very excited to improve the clinical utility of our test in order to better serve a patient population faced with difficult choices to make about their cancer care," said Timothy Showalter, Chief Medical Officer of Artera. "It’s a real testament to the team here at Artera, from clinical development to engineering and beyond, that we’re able to quickly take insights from the clinical research realm, rigorously validate it and to deploy it so quickly to help patients."

Prostate cancer is one of the most common cancers, with over 300,000 new diagnoses each year. While high-risk disease only constitutes ~15% of cases, 10-year survival rate is poor at only 65%. Because of the cancer’s aggressiveness, clinicians will often deploy multiple therapeutic agents at the same time, but this increases drug toxicities and can be costly. The appeal of precision medicine is to be able to determine which therapies will be beneficial and avoid under- or over-treatment.

"Abiraterone has already hugely improved the outlook for hundreds of thousands of men with advanced prostate cancer," said Nick James, MD, PhD, lead investigator of the STAMPEDE trial. "We know that for many men with cancer that has not yet spread, it can also have spectacular results. We’re excited to now have a test that can pick out the people who will respond best to abiraterone, and those who will do well from standard treatment alone – hormone therapy and radiotherapy."

Alvotech and Dr. Reddy’s Enter into Collaboration to Co-Develop Biosimilar Candidate to Keytruda® (pembrolizumab)

On June 5, 2025 Alvotech (NASDAQ: ALVO), a global biotech company specializing in the development and manufacture of biosimilar medicines for patients worldwide ("Alvotech"), and Dr. Reddy’s Laboratories Ltd., (BSE: 500124 | NSE: DRREDDY | NYSE: RDY | NSEIFSC: DRREDDY, along with its subsidiaries hereafter referred to as "Dr. Reddy’s"), reported that the companies have entered into a collaboration and license agreement to co-develop, manufacture and commercialize a biosimilar candidate to Keytruda (pembrolizumab) for global markets. Keytruda (pembrolizumab) is indicated for the treatment of numerous cancer types (Press release, Alvotech, JUN 5, 2025, View Source [SID1234653753]). In 2024, worldwide sales of Keytruda were US$29.5 billion [1]. The collaboration combines Dr. Reddy’s and Alvotech’s proven capabilities in biosimilars, thereby, speeding up the development process and extending the global reach for this biosimilar candidate.

Under the terms of the agreement, the parties will be jointly responsible for developing and manufacturing the biosimilar candidate and sharing costs and responsibilities. Subject to certain exceptions, each party will have the right to commercialize the product globally.

"We are very pleased to enter into this collaboration for pembrolizumab with Dr. Reddy’s. This agreement demonstrates Alvotech’s ability to leverage its dedicated R&D and manufacturing platform for biosimilars, accelerating the expansion of our pipeline by pursuing growing global markets. It further enables us to increase the availability of cost-effective, critical biologic medications to patients world-wide," said Róbert Wessman, chairman and CEO of Alvotech.

"We are happy to collaborate with Alvotech for the pembrolizumab biosimilar. This demonstrates our ability to develop and manufacture high quality and affordable treatment options for patients worldwide. Additionally, oncology has been a top focus therapy area for us and this collaboration will further enhance our capabilities in oncology, as pembrolizumab currently represents one of the most critical therapies in immuno-oncology," said Erez Israeli, CEO of Dr. Reddy’s.

Use of trademarks

Keytruda is a registered trademark of Merck Sharp & Dohme Corp.

Sources

[1] View Source Accessed on June 4, 2025.

Summit Therapeutics to Participate in the 46th Annual Goldman Sachs Global Healthcare Conference

On June 5, 2025 Summit Therapeutics Inc. (NASDAQ: SMMT) ("Summit," "we," or the "Company") reported that it will participate in and present at the 46th Annual Goldman Sachs Global Healthcare Conference in Miami, Florida on Monday, June 9, 2025, at 1:20 PM ET (Press release, Summit Therapeutics, JUN 5, 2025, View Source [SID1234653752]). Members of the Summit management team will participate in a fireside chat presentation providing a corporate overview and update on the progress of our organization, including the development of our innovative investigational bispecific antibody, ivonescimab.

The presentation will be available live from our website: www.smmttx.com. An archived version of the presentation will be available on our website following the presentation.

Mission Bio Unveils Industry-First Single-Cell Genotype and Targeted Gene Expression Solution Aimed at Derisking Cancer Drug Clinical Development

On June 5, 2025 Mission Bio, a leader in single-cell multi-omics solutions for precision medicine, reported the launch of its Single-Cell Genotype and Targeted Gene Expression assay, expanding the capabilities of its Tapestri Platform to become the only commercial solution that delivers simultaneous genotype and targeted gene expression profiling from over 10,000 single cells (Press release, Mission Bio, JUN 5, 2025, View Source [SID1234653751]). The assay, which can be leveraged for Phase 2 or 3 trials to home in on patients most likely to benefit from a cancer therapy, will be unveiled at the European Hematology Association (EHA) (Free EHA Whitepaper) meeting in Milan, Italy.

Single-Cell Genotype and Targeted Gene Expression is available through Mission Bio’s Pharma Assay Development (PAD) services, where the company’s experts provide end-to-end support from custom single-cell assay design and development to data interpretation and assay transfer. The multi-modal assay has three primary applications: helping understand therapeutic resistance, designing next-generation T-cell therapies, and improving patient selection in clinical development.

In particular, the Single-Cell Genotype and Targeted Gene Expression assay addresses critical challenges in oncology drug development, where obtaining the complete picture of tumor heterogeneity and therapeutic resistance mechanisms has been hampered by limitations in existing and disparate methods. By capturing both genomic mutations and targeted gene expression changes in the same cell, the enhanced Tapestri Platform enables pharmaceutical researchers to gain a comprehensive, high-resolution view of cancer cell behavior and treatment response – allowing companies to derisk late-stage development.

"The majority of clinical failures in hematologic cancer drug development occur in Phases II and III, often due to inadequate patient response and lack of predictive biomarkers for patient stratification," said Brian Kim, CEO of Mission Bio. "We’re directly addressing the urgent need to understand which patients will respond to which drugs at what time, by adding this custom capability to our portfolio of tools. It builds on our continuing mission to offer the tools that drug developers need to understand drug impact at the single-cell level and de-risk late-stage clinical trial failures."

The new Single-Cell Genotype and Targeted Gene Expression assay also features sample multiplexing capabilities, reducing the cost of single-cell analysis by approximately 60% compared to using multiple technologies to generate similar insights. Tapestri users have previously developed bespoke capabilities to leverage targeted gene expression alongside single-cell genotype and multi-omics, an early demonstration of the value of Mission Bio’s newly integrated approach. Among multiple use cases has been the deconvolution of clonal architecture and tracking resistant subclones under therapeutic pressure in AML. In the future, Mission Bio’s PAD team will enable true multi-omics by adding immunophenotyping to the Single-Cell Genotype and Targeted Gene Expression assay.

Mission Bio and Partners Presenting at EHA (Free EHA Whitepaper)

EHA will feature two oral presentations from Mission Bio’s academic partners featuring use of the Tapestri Platform.

Interrogating clonal evolution of NPM1-mutant AML through genetic and genomic approaches

Dr. Linde Miles, assistant professor at Cincinnati Children’s Hospital Medical Center
Friday, 13 June, 15:45 – 16:15 CEST
Amber Hall 7+8
Session 3 Keynote lecture: Cell fate and cell plasticity in normal and malignant hematopoiesis

Dr. Lars Velten, Centre for Genomic Regulation (CRG) Barcelona, Spain
Saturday, 14 June, 14:00 – 14:20 CEST
Brown Hall 2
Both Dr. Miles and Dr. Velton will also present at Mission Bio’s EHA (Free EHA Whitepaper) evening event, The Power of One: A Night of Multi-Omics Discovery @ EHA (Free EHA Whitepaper) 2025, Friday, June 13, 2025 at 7:00 PM.

Late-Breaking Oral Session: INCA33989 is a Novel, First In Class, Mutant Calreticulin-Specific Monoclonal Antibody that Demonstrates Safety and Efficacy in Patients with Essential Thrombocythemia (ET)

Dr. John Mascarenhas, Icahn School of Medicine at Mount Sinai
Sunday, June 15, 2025, 09:15 CEST
Location TBD
Mission Bio will also be presenting six posters at EHA (Free EHA Whitepaper) in Poster Hall, beginning on Saturday, 14 June, 18:30 CEST.

CXCR4 Expression In Aml Blasts And Its Impact On CXCR4 Inhibitor Efficacy During Consolidation Therapy: Results From The Sal Blast Trial
Dr. Enise Ceran (Heidelberg, Germany)
Single Cell Multi-omic Analysis Uncovers Molecular And Clonal Events Associated With Ruxolitinib Treatment Response In Myelofibrosis
Dr. Sebastiano Rontauroli (Modena, Italy)
Characterization Of CD9 As A Novel Marker For Disease-Propagating Stem Cells In Myelofibrosis
Dr. Lara Tavernari (Modena, Italy)
Deciphering Clonal Heterogeneity In Aml Npm1 Through Single-Cell Multi-Omic
Dr. Wencke Walter (Munich, Germany)
Three Patterns Of Molecular Minimal Residual Disease Kinetics In Venetoclax + Azacitidine (V+A) Treated Acute Myeloid Leukemia (AML) Patients
Dr. Jiří Mayer (Brno, Czechia)
High-Throughput And Highly Sensitive Single Cell Genotyping With Simultaneous Chromatin Accessibility Profiling In Myeloid Precursor Conditions
Dr. Masanori Motomura (Kyoto, Japan)
For more information about Mission Bio’s Targeted Single-Cell Gene Expression assay and Pharma Assay Development services, please visit missionbio.com.

Visit Mission Bio at EHA (Free EHA Whitepaper) at booth M.10.