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.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

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.

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]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

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 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.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

"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 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.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

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."

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.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

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.