On June 3, 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 that on May 30, 2025, it entered into a securities purchase agreement (the "Purchase Agreement") for a private investment in public equity ("PIPE") financing that is expected to result in approximately $3.35 million in gross proceeds (Press release, Estrella Biopharma, JUN 3, 2025, View Source [SID1234653701]).

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Pursuant to the terms of the securities purchase agreement, at the closing of the PIPE financing, Estrella will issue an aggregate of 2,333,334 shares of its common stock at a price of $1.50 per share. The last reported sale price of the common stock of the Company on May 29, 2025 was $1.00 per share.

Estrella intends to use the net proceeds from the PIPE to support the completion of Phase I of its STARLIGHT-1 clinical trial, evaluating EB103, a CD19-Redirected ARTEMIS T-cell therapy, in adult patients with relapsed/refractory B-cell non-Hodgkin’s lymphoma (NHL).

"We are encouraged by the strong support from our investors, which reflects confidence in the potential of our ARTEMIS T-cell therapy," said Cheng Liu, Chief Executive Officer of Estrella Immunopharma. "This financing strengthens our balance sheet and enables us to advance the clinical development of EB103, accelerating our mission to bring safer, more effective immunotherapies to patients in need."

The closing of the Private Placement is subject to the satisfaction of customary closing conditions.

The securities being offered and sold in the PIPE financing have not been registered under the Securities Act of 1933, as amended ("Securities Act"), or any state securities laws, and are being offered and sold in a transaction exempt from the registration requirements of the Securities Act. The securities may not be offered or sold in the United States absent registration or an applicable exemption from registration under the Securities Act and applicable state securities laws.

Pursuant to the Purchase Agreement, the Company agreed to file a registration statement with the Securities and Exchange Commission ("SEC") covering the resale of the securities to be issued in the PIPE financing.

This press release shall not constitute an offer to sell or the solicitation of an offer to buy these securities, nor shall there be any sale of these securities in any state or other jurisdiction in which such offer, solicitation or sale would be unlawful prior to the registration or qualification under the securities laws of any such jurisdiction.

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 3, 2025 Agenus Inc. (Nasdaq: AGEN), a leader in immuno-oncology innovation, reported it has signed definitive partnership agreements with Zydus Lifesciences Ltd. (NSE: ZYDUSLIFE), including its subsidiaries/affiliates, hereafter referred to as "Zydus," designed to accelerate clinical development, scale global manufacturing, and expand patient access to botensilimab and balstilimab (BOT/BAL) (Press release, Agenus, JUN 3, 2025, View Source [SID1234653700]).

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The strategic collaboration includes an exchange of Agenus’ state-of-the-art biologics CMC facilities in Emeryville, CA and Berkeley, CA for upfront consideration of $75M; Agenus to receive up to an additional $50M in contingent payments triggered by BOT/BAL production orders. Zydus, an India-based multinational pharmaceutical company with over 27,000 employees and operations in 55 countries, will launch a BioCDMO business using the facilities as their flagship U.S. sites to provide biologics contract manufacturing services to biopharmaceutical companies globally.

Agenus will become Zydus’ first BioCDMO customer through an exclusive manufacturing agreement for BOT/BAL to ensure the combination regimen’s BLA and launch readiness needs. This collaboration enables Agenus to unlock the value of its manufacturing assets and secure strategic capital to drive BOT/BAL toward global regulatory engagement and commercialization.

Agenus will also grant Zydus an exclusive license to develop and commercialize BOT and BAL in India and Sri Lanka, capitalizing on Zydus’ established local market presence and infrastructure. Zydus will pay Agenus a 5 percent royalty on net sales in those countries.

In a demonstration of mutual commitment, Zydus will also make a strategic equity investment in Agenus by purchasing approximately 2.1 million shares of common stock at $7.50 per share, totaling approximately $16 million in gross proceeds. Agenus intends to apply the net proceeds from the sale of the purchased shares for working capital and general corporate purposes, and will accelerate ongoing clinical development, registration and potential commercialization of BOT/BAL.

By uniting Agenus’ pioneering research and development capabilities with Zydus’ worldwide manufacturing, commercialization and operational strength, this partnership sets the stage for a new era in cancer immunotherapy in India and beyond.

"With a trade agreement between the United States and India seemingly imminent, there is a renewed sense of confidence by trading partners in both countries in the future of Indian-American relations," said Dr. Garo Armen, CEO of Agenus. "There is also a growing recognition by both countries of the need for the United States to ensure that biopharma supply chains are secure. We are working with Zydus to accelerate future clinical trials for BOT/BAL and eventually its global footprint in oncology therapeutics. This agreement is an expression of confidence in the future of Agenus and in the regulatory environment of the United States. The administration has created an environment that has brought these two trading partners together. The United States is the second largest trading partner with India. For these reasons and the strong collaborative spirit we feel with our new partners at Zydus, we decided to enter into this partnership now."

"We are thrilled to be partnering with Agenus to advance BOT/BAL, which has the potential to benefit thousands of patients in our core markets of India and Sri Lanka annually and millions of solid tumor patients globally. We plan to run clinical trials testing BOT/BAL in both early-stage and late-stage disease, along with expansion beyond colorectal cancer to other major disease settings like triple negative breast cancer," said Dr. Sharvil Patel, Managing Director at Zydus Lifesciences Ltd.

The transaction is subject to customary closing conditions and satisfactory due diligence. The parties aim to complete closing agreements within 60 days.

Conference Call and Webcast

Date/Time: Tuesday, June 3rd; 4:30 p.m. ET
To access dial-in numbers, please register at: View Source
Conference ID: 12788

Advisors

As part of this effort, Agenus was advised by Biotech Value Advisors (BVA), a strategic advisory firm, which provided guidance on transaction structure, partner selection and negotiations.

On June 3, 2025 Byondis B.V., an independent clinical stage biopharmaceutical company creating innovative targeted medicines for patients with cancer, reported the first patient dosed in its Phase 1 dose escalation and expansion BYON4228.002 clinical trial to evaluate the safety, pharmacokinetics, pharmacodynamics and efficacy of novel SIRPα-directed monoclonal antibody (mAb) BYON4228 alone and in combination with pembrolizumab in patients with advanced or metastatic solid tumors (Press release, Byondis, JUN 3, 2025, View Source [SID1234653699]).

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BYON4228 is a potential best-in-class novel mAb that targets and blocks the CD47-SIRPα axis, responsible for tumors’ ability to escape from recognition and destruction by the immune system. By targeting SIRPα and not CD47, BYON4228 offers selective targeting of myeloid cells and avoids disruption of other biologically meaningful CD47-dependent interactions. In preclinical studies, BYON4228 was found to potentiate the tumor killing capacity of tumor-targeting mAbs tested without the toxicity associated with CD47 agents.

"Building on strong preclinical data, we believe that there is broad potential for BYON4228 alone and in combination with tumor-targeting mAbs, checkpoint inhibitors and antibody drug conjugates and other modalities across hematological and solid tumors," said Louis Denis, MD, Chief Medical Officer, Byondis. "We look forward to evaluating the results of this trial to support the clinical development of BYON4228 alone and in combination with other agents and to bring a new therapeutic option to patients with high unmet medical need."

Part 1 of the BYON4228.002 trial will evaluate the safety of BYON4228 alone and in combination to determine the maximum tolerated dose (MTD), or optimal biological dose (OBD) if the MTD is not reached, and recommended combination dose regimen(s) for expansion (RDE(s)). The second part of the trial will evaluate the objective tumor response rate (ORR). The secondary objectives of this trial are safety, pharmacokinetics, immunogenicity and preliminary efficacy. The trial will be conducted at multiple sites across Europe, including the United Kingdom, Belgium and Spain.

About BYON4228

BYON4228 is a novel monoclonal antibody (mAb) from Byondis’ next generation immuno-oncology (IO) program that targets and blocks the CD47-SIRPα axis, responsible for tumors’ ability to escape from recognition and destruction by the immune system. BYON4228 is currently being studied in two Phase 1 Clinical Trials evaluating BYON4228 alone and in combination with Rituximab in patients with Relapsed/Refractory CD20 positive B-cell Non-Hodgkin’s Lymphoma (NHL) (NCT05737628) and BYON4228 alone and in combination with pembrolizumab in patients with advanced or metastatic solid tumors (NCT06932952).

On June 3, 2025 PharmaEssentia USA Corporation, a subsidiary of PharmaEssentia Corporation (TWSE: 6446), a global biopharmaceutical innovator based in Taiwan leveraging deep expertise and proven scientific principles to deliver new biologics in hematology and oncology, reported it will be presenting clinical study results at the 2025 European Hematology Association (EHA) (Free EHA Whitepaper) Congress, taking place June 12-15 in Milan, Italy (Press release, PharmaEssentia, JUN 3, 2025, View Source [SID1234653698]).

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The company’s results from the Phase 3 SURPASS-ET trial (NCT04285086) have been selected for an oral presentation during the plenary session—one of six top-ranked abstracts chosen by the EHA (Free EHA Whitepaper) 2025 Scientific Program Committee. The presentation, led by Dr. Harry Gill, hematologist and oncologist at the University of Hong Kong, will share data from the Phase 3 SURPASS-ET study demonstrating the efficacy and safety of ropeginterferon alfa-2b versus anagrelide in essential thrombocythemia (ET).

Earlier this year, PharmaEssentia announced positive topline SURPASS-ET Phase 3 results, with ropeginterferon alfa-2b-njft demonstrating a significantly higher durable clinical response rate compared to anagrelide (42.9% vs. 6.0%; p=0.0001), along with a favorable safety profile and a greater reduction in JAK2 V617F allelic burden over 12 months.

"I’m deeply honored that the SURPASS-ET study results were selected for a plenary presentation at the EHA (Free EHA Whitepaper) Congress. This recognition underscores the significance of the data for patients living with ET," said Dr. Harry Gill, hematologist and oncologist at the University of Hong Kong. "The SURPASS-ET data offer compelling evidence that ropeginterferon alfa-2b could provide a much-needed new treatment option for the ET community."

In addition to the plenary presentation, Dr. Gill will also present results from the University of Hong Kong’s Phase 2 trial (NCT05731245) evaluating ropeginterferon alfa-2b in pre-fibrotic primary myelofibrosis (PMF) and DIPSS low/intermediate-risk myelofibrosis during an oral session focused on innovative treatment approaches in myeloproliferative neoplasms (MPNs).

"Ropeginterferon alfa-2b has already reshaped the treatment landscape for polycythemia vera, and the growing body of evidence in ET and pre-fibrotic PMF points to its broader potential across the spectrum of MPNs," said Ko-Chung Lin, Ph.D., Founder and CEO of PharmaEssentia USA. "We’re proud to advance innovative science that may offer patients with an alternative treatment option."

Presentation Details

Plenary Session

Abstract Code: S102
Title: Better safety and efficacy with ropeginterferon alfa-2b over anagrelide as second-line treatment of essential thrombocythemia in the topline results of the randomized Phase 3 SURPASS-ET trial
Session: Plenary Abstracts
Date/Time: June 14, 11:45-13:15 CEST
Oral Presentation

Abstract Code: S222
Title: Ropeginterferon alfa-2b for pre-fibrotic primary myelofibrosis and DIPSS low/intermediate-risk myelofibrosis
Session: Innovative treatment approaches in MPN
Date/Time: June 12, 17:00–18:15 CEST
About Essential Thrombocythemia

Essential thrombocythemia is a chronic, rare blood disorder that is the most common type of myeloproliferative neoplasm. Essential thrombocythemia is most often caused by genetic mutations that cause the bone marrow to produce too many platelets, which can obstruct blood flow and cause a stroke, heart attack or pulmonary embolism.

About BESREMi (ropeginterferon alfa-2b-njft) in Polycythemia Vera (PV)

Ropeginterferon alfa-2b-njft is currently FDA-approved and marketed as BESREMi for the treatment of adults with polycythemia vera (PV). BESREMi has been recognized by the National Comprehensive Cancer Network (NCCN) as a preferred first-line cytoreductive therapy for adults with symptomatic, low-risk PV and the only preferred therapeutic option for both high-risk and low-risk (symptomatic) patients, regardless of treatment history. The Company plans to seek a ropeginterferon alfa-2b-njft label expansion to include ET and anticipates submitting a BLA with the U.S. FDA.

BESREMi holds orphan drug designation in the United States for the treatment of polycythemia vera (PV) in adults. It has received regulatory approval in over 40 countries, including from the European Medicines Agency (2019), the U.S. Food and Drug Administration (2021), and the Pharmaceuticals and Medical Devices Agency in Japan (2023). The product was developed by PharmaEssentia and is manufactured at the company’s facility in Taichung. PharmaEssentia retains full global intellectual property rights across all indications.

BESREMi was approved with a boxed warning for risk of serious disorders including aggravation of neuropsychiatric, autoimmune, ischemic and infectious disorders.

Please see full Prescribing Information, including Boxed Warning.

On June 3, 2025 Guardant Health, Inc. (Nasdaq: GH), a leading precision oncology company, reported that its Shield multi-cancer detection (MCD) test has been granted Breakthrough Device designation from the U.S. Food and Drug Administration (FDA) (Press release, Guardant Health, JUN 3, 2025, View Source [SID1234653697]). The Shield MCD test is a methylation-based blood test for the multi-cancer screening of multiple cancer types including bladder, colorectal, esophageal, gastric, liver, lung, ovarian and pancreas cancer in individuals aged 45 or older who are at typical average risk for cancer.

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The FDA grants Breakthrough Device designation to a limited set of qualifying devices that have the potential to provide for more effective treatment or diagnosis of life-threatening diseases, such as cancer, than current options. The goal of the FDA’s Breakthrough Devices Program is to provide patients and healthcare providers with timely access to medical devices by speeding up their development, assessment and review.

"Every late-stage cancer we avert is a win for patients and for the entire healthcare system," said AmirAli Talasaz, Guardant Health co-founder and co-CEO. "This recognition by the FDA shows the promise of the Shield MCD test to detect multiple cancers at an early stage with just a single, routine blood draw. We look forward to partnering with the agency and other stakeholders to bring this breakthrough to patients quickly."

The Breakthrough Device designation by the FDA of the Shield MCD test builds on its recent selection by the National Cancer Institute (NCI) for the Vanguard Study evaluating emerging MCD technology. The Shield MCD test was chosen for the Vanguard study based on its strong performance in predicting the presence of cancers and cancer tissue of origin.

At the 2025 American Society for Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting in Chicago, Guardant presented data on the clinical validation of the Shield MCD test showing that the blood-based test exhibits high specificity, clinically meaningful sensitivity and strong cancer signal of origin accuracy across multiple tumor types. The data presented from a case-control cohort showed that the Shield MCD test has 98.6% specificity and 75% cancer sensitivity across bladder, colorectal, esophageal, gastric, liver, lung, ovarian and pancreas cancers (per-cancer sensitivity range: 62-96%). Primary or secondary CSO (cancer signal origin) accuracy was 92%.