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.

On June 5, 2025 SELLAS Life Sciences Group, Inc. (NASDAQ: SLS) ("SELLAS’’ or the "Company"), a late-stage clinical biopharmaceutical company focused on the development of novel therapies for a broad range of cancer indications, reported the appointment of two distinguished oncology leaders to its Scientific Advisory Board (SAB) (Press release, Sellas Life Sciences, JUN 5, 2025, View Source [SID1234653741]). The new members – Philip C. Amrein, MD, and Alex Kentsis, MD, PhD bring decades of expertise in cancer research, clinical oncology, and translational medicine, further strengthening the company’s strategic guidance as it advances its therapeutic pipeline.

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"We are honored to welcome Drs. Amrein and Kentsis to our Scientific Advisory Board," said Angelos Stergiou, MD, ScD h.c., President and Chief Executive Officer of SELLAS. "Their extensive experience in clinical development and hematology-oncology research will be pivotal as we reach significant milestones with both of our assets –full topline Phase 2 data of SLS009 in acute myeloid leukemia (AML), and the final analysis of our Phase 3 pivotal REGAL trial of GPS in AML. With those inflection points expected this year, their guidance will help ensure we continue to advance our lead assets towards potential regulatory filings and commercialization, while also supporting our efforts in translational and precision medicine to maximize clinical impact. We are thrilled to collaborate with them, leveraging their exceptional expertise to drive groundbreaking success."

About the New SAB Members:

Philip C. Amrein, MD
Harvard Medical School – Massachusetts General Hospital (MGH)
Dr. Amrein is an Assistant Professor of Medicine at Harvard Medical School and a physician at the MGH, where he specializes in leukemia. He is part of the Cancer Center, Leukemia, Cellular Immunotherapy, and Hematology/Oncology departments. Dr. Amrein treats adult patients with acute and chronic leukemia, myelodysplasia, and myeloproliferative neoplasms, leading numerous clinical trials and exploring new treatment approaches. Dr. Amrein earned his MD from Johns Hopkins University School of Medicine and completed his residency at Yale Waterbury Hospital, followed by a fellowship at MGH. He is board-certified in Internal Medicine and Medical Oncology.

Alex Kentsis, MD, PhD
Memorial Sloan Kettering (MSK) Cancer Center
Dr. Kentsis is the founding Director of the MSK Tow Center for Developmental Oncology, a practicing pediatric oncologist at MSK Kids, a Member of the Sloan Kettering Institute, and Professor of Pediatrics, Pharmacology, and Physiology & Biophysics at Weill Cornell Medical College of Cornell University. His research focuses on improving understanding of blood and solid tumors, particularly in children and young adults. He and his team have identified new therapeutic targets in leukemias and solid tumors, as well as mechanisms of treatment resistance and evasion. The Kentsis Lab uses modern technologies to explore genomic plasticity, epigenetic signaling, and adaptive responses to targeted therapies. He holds an MD from Mount Sinai School of Medicine, a PhD from New York University, and completed his clinical training at the Boston Children’s Hospital and Dana-Farber Cancer Institute at Harvard Medical School.

On June 5, 2025 Scholar Rock (NASDAQ: SRRK), a late-stage biopharmaceutical company focused on developing and commercializing apitegromab for patients with spinal muscular atrophy (SMA) and other severe and debilitating neuromuscular diseases, reported that David L. Hallal, Chief Executive Officer, and members of management will participate in a fireside chat at the 46th Annual Goldman Sachs Global Healthcare Conference on Wednesday, June 11 at 9:20 a.m. ET in Miami, Florida (Press release, Scholar Rock, JUN 5, 2025, View Source [SID1234653756]).

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A live webcast of the events may be accessed by visiting the Investors & Media section of the Scholar Rock website at View Source Archived replays of the webcasts will be available on the Company’s website for approximately 90 days.

On June 5, 2025 Tempest Therapeutics, Inc. (Nasdaq: TPST), a clinical-stage biotechnology company with a pipeline of first-in-class1 targeted and immune-mediated therapeutics to fight cancer, reported that the European Medicines Agency (EMA) has granted Orphan Drug Designation (ODD) to amezalpat (TPST-1120), an oral, small molecule, selective PPAR⍺ antagonist for the treatment of patients with hepatocellular carcinoma (HCC) (Press release, Tempest Therapeutics, JUN 5, 2025, View Source [SID1234653742]).

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"We’re incredibly pleased to receive Orphan Drug Designation from the EMA, building on the momentum of regulatory support we’ve already received from the FDA," said Stephen Brady, president and chief executive officer of Tempest. "These designations reflect the significant unmet need in liver cancer and reinforce our belief in the potential of amezalpat to make a meaningful difference for patients and families affected by this devastating disease."

The company announced earlier this year that the FDA had granted both ODD and Fast Track Designation (FTD) to amezalpat to treat patients with HCC. These three designations follow positive data across multiple key study efficacy and safety endpoints from a global, randomized Phase 1b/2 clinical study evaluating amezalpat plus standard-of-care atezolizumab and bevacizumab versus atezolizumab and bevacizumab alone in the first-line treatment of patients with unresectable or metastatic HCC. Notable positive outcomes of the randomized comparison include a six-month improvement in median overall survival (OS) with a hazard ratio (HR) of 0.65 for patients receiving the amezalpat combination therapy. In addition, a survival benefit from patients receiving amezalpat was preserved in key sub-populations including PD-L1 negative disease, which is consistent with amezalpat’s proposed mechanism of action to target both the tumor cells directly and the patient’s immune system.

About Hepatocellular Carcinoma

HCC is an aggressive cancer with rising mortality and is projected to become the third leading cause of cancer death by 2030.2 Every year, more than 900,000 people worldwide are diagnosed with HCC.3 Incidence and mortality are highest in East Asia and are increasing in parts of Europe and the US.4 In the US, HCC represents the fastest-rising cause of cancer-related death.3

Nine out of ten cases of HCC are caused by chronic liver disease, which includes chronic hepatitis B and C infection, non-alcoholic fatty liver disease (NAFLD), non-alcoholic steatohepatitis (NASH), alcohol-related liver disease (ALD) and cirrhosis resulting from these conditions.5

Even if diagnosed in the early stage, an estimated 70-80% of people with early-stage HCC experience disease recurrence following surgery.6 Early recurrence is associated with poorer prognosis and shorter survival.5,7 Tumor size, number of tumors, and portal vein invasion are associated with an increased risk of recurrence.6

About Amezalpat

Amezalpat is an oral, small molecule, selective PPAR⍺ antagonist. Data suggest that amezalpat treats cancer by targeting tumor cells directly and by modulating immune suppressive cells and angiogenesis in the tumor microenvironment. In a global randomized Phase 1b/2 study of amezalpat in combination with atezolizumab and bevacizumab in first-line patients with advanced HCC, the amezalpat arm showed clinical superiority across multiple study endpoints, including overall survival in both the entire population and key subpopulations, when compared to atezolizumab and bevacizumab alone, the standard of care. These randomized data were supported by additional positive results observed in the Phase 1 clinical trial in patients with heavily pretreated advanced solid tumors, including renal cell carcinoma and cholangiocarcinoma.

About Orphan Drug Designation

Orphan Designation is granted to therapies intended for the treatment, prevention, or diagnosis of life-threatening or chronically debilitating diseases that affect no more than two in 10,000 people in the European Union (EU) and for which no satisfactory therapy is available. The treatment must also provide significant benefit to those affected by the condition. EMA orphan drug designation provides certain benefits, including the potential for 10 years of market exclusivity following regulatory approval in the EU, reduction in regulatory fees and a centralized EU approval process.

On June 5, 2025 Signify Bio, a pioneering biotechnology company harnessing the human body for the production of in situ protein therapeutics, reported an oversubscribed $15 million initial financing (Press release, Signify Bio, JUN 5, 2025, View Source [SID1234653757]). The round was led by Actium Group with participation from the Gates Foundation Strategic Investment Fund, Danaher Ventures LLC, a subsidiary of Danaher Corporation, Eli Lilly and Company, and BrightEdge, the American Cancer Society’s (ACS) venture capital arm.

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Signify Bio is built on three proprietary and novel platforms encompassing both nucleic acid payloads and non-viral delivery systems designed to control the production, secretion and localization of protein therapeutics directly within the human body. The first is its modular Signal peptide Engineered Nucleic acid Design (SEND) platform, which enables control over the secretion and localization of any nucleic acid encodable protein of interest. The second platform, iPhos, is a novel lipid nanoparticle delivery system based on ionizable phospholipid (iPhos) lipid nanoparticles (iPLNPs) engineered to maximize endosomal escape and tissue specificity. The third utilizes Signify’s computational methods for design and discovery of novel signal peptides sequences. Together, these platforms drive innovation in personalized protein therapeutics by combining the promise of signal peptide engineering with the speed and power of mRNA encoded design.

Originally conceived in the Siegwart Lab at University of Texas Southwestern Medical Center (UTSW), Signify Bio has access to a world class team of scientists and cutting-edge technology through a strategic partnership with the university. This collaboration provides access to scalable LNP manufacturing and nucleic acid generation, broad expertise ranging from chemical synthesis to pre-clinical models and a core competency in chemistry and engineering all situated at UT Southwestern.

"Signify Bio’s modular platforms offer an unprecedented opportunity to engineer personalized protein therapeutics directly within the body, addressing long-standing challenges in drug production, delivery, and efficacy," said Daniel J. Siegwart, Ph.D., Co-founder and Chief Scientific Advisor at Signify Bio, and Director of the Program in Genetic Drug Engineering at UT Southwestern Medical Center. "With its versatility and adaptability, the company lays the groundwork for a new generation of precision medicine across a wide range of chronic and genetic disorders."

"The quality and diversity of our investor syndicate underscores the agility, flexibility, and broad applications for our proprietary platforms," said RA Session II, Co-founder and Chief Executive Officer at Signify Bio. "The SEND platform and iPhos LNP system represent a groundbreaking step forward in nucleic acid therapeutics, transforming the human body into a biofactory for precise, targeted protein production."

Signal peptides enable secretion and localization of nucleic acid-encoded proteins, replicating natural protein trafficking pathways. The SEND platform supports modular control over the secretion of proteins into systemic circulation and their localization to cellular organelles including the cell membrane, nucleus, lysosome, mitochondria, synapse among others. The iPhos LNP system allows for dose-dependent protein secretion from diverse cell types with compatibility across multiple routes of administration including subcutaneous (SQ), intramuscular (IM) and intravenous (IV).

"We are thrilled to support Signify Bio in their mission to create personalized medicines that will revolutionize therapeutic protein delivery," said Jun Il Kwun, Managing Director of Actium Group and Chair of the Board of Directors at Signify Bio. "The exceptional team at Signify Bio, with their deep expertise in nucleic acid engineering, is uniquely positioned to bring these technologies to patients. Their groundbreaking innovations and commitment to addressing unmet medical needs will transform the field of genetic medicine."

Signify Bio is led by a management team with deep industry expertise and is founded by pioneers in chemistry and nucleic acid engineering including:

Daniel J. Siegwart, Ph.D., Co-founder and Chief Scientific Advisor, Director of the Program in Genetic Drug Engineering at UT Southwestern, Professor and W. Ray Wallace Distinguished Chair in Molecular Oncology Research, Departments of Biomedical Engineering and Biochemistry at UT Southwestern, Co-founder of ReCode Therapeutics;
RA Session II, Co-founder, President, and Chief Executive Officer, former President, CEO, and Founder of Taysha Gene Therapies and former Chief Business Officer of the gene therapy subsidiaries of BridgeBio, former Board Member of ReCode Therapeutics;
Lukas J. Farbiak, Ph.D., Co-founder and Chief Technology Advisor, Assistant Professor, Departments of Biomedical Engineering and Biochemistry at UT Southwestern;
David Morrissey, Ph.D., Chief Scientific Officer, former Vice President, Head RNA Accelerator at Pfizer and Senior Vice President, Platform & Delivery Technology at Intellia Therapeutics; and
Morag Stewart, Ph.D., Vice President of Translational Biology, former Senior Director, RNA Medicines at Pfizer Centers for Therapeutic Innovation and Head of Exploratory Biology at Flagship Pioneering.
Chardan Capital served as Strategic Advisor to Signify Bio.