On June 3, 2025 The Experimental Drug Development Centre (EDDC), Singapore’s national platform for drug discovery and development, reported the presentation of updated clinical data for the ongoing Phase 1 trial for EBC-129 at the 2025 Annual Meeting of the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) in Chicago (Press release, Experimental Drug Development Centre, JUN 3, 2025, View Source [SID1234654011]).

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EBC-129 is a first-in-class antibody drug conjugate (ADC) targeting a novel, tumour-specific N256-glycosylated epitope on CEACAM5 and CEACAM6. The updated findings showed promising efficacy data from 21 heavily pre-treated pancreatic ductal adenocarcinoma (PDAC) patients across the dose escalation and the dose expansion portions of the Phase 1 study. Patients received EBC-129 at doses between 1.8 and 2.2 mg/kg, given once every 3 weeks. 17 out of 21 patients (81%) of the patients had received prior treatment with taxanes. 82% of patients had tumours which expressed the EBC-129 antigen at ≥1% at 3+ intensity and were therefore considered treatable. The overall response rates (ORRs) were 25% and 20%, with disease control rates (DCRs) of 87.5% and 63.6% and progression-free survival (PFS) of 19 and 12 weeks for 1.8 mg/kg and 2.2 mg/kg, respectively.

"Pancreatic adenocarcinoma remains one of the most challenging cancers to treat, particularly in the metastatic setting where resistance to standard therapies is common. The clinical signals observed with EBC-129 in refractory pancreatic adenocarcinoma, including tolerability, prolonged disease control and a confirmed response in a heavily pre-treated patient, are encouraging and clinically meaningful. Continued prioritisation of biology-guided trials targeting EBC-129 will be key to sustaining momentum in this important therapeutic effort," said Assistant Professor Robert W. Lentz, MD, Division of Medical Oncology, Department of Medicine, University of Colorado Anschutz School of Medicine.

This presentation follows the recent Fast Track Designation granted by the U.S. FDA for EBC-129 in the treatment of PDAC patients. This designation supports EDDC’s efforts to accelerate the advancement of the programme through increased regulatory engagement and the potential for expedited review pathways.

Other Results to Date

The dose escalation study of the Phase 1 trial was open to all patients, while the ongoing dose expansion study comprises of three cohorts in PDAC, gastroesophageal adenocarcinoma (GEA) and tumour-agnostic patients with other immunohistochemistry (IHC)-positive solid tumours. Recruitment for the GEA and IHC-positive cohorts is still ongoing.

EBC-129 showed a manageable safety profile in the 58 patients treated so far, with uncomplicated neutropenia and infusion-related reactions as the main treatment-related adverse events (TRAEs) observed.

The EBC-129 antigen was also found to be highly expressed, with 52% to 100% of tumour tissues assessed during the trial showing moderate to high expression levels of ≥20% at 2+ and/or 3+. This included samples from gastroesophageal, appendiceal, colorectal and lung cancer patients, making EBC-129 a potentially viable treatment option for these cancers.

"We have seen encouraging signs of efficacy of EBC-129 as a single-agent therapy, even in heavily pre-treated patients with metastatic pancreatic cancer. This, combined with the observed safety profile, underscores the promise of EBC-129 as a possible treatment option for PDAC patients. As a first-in-class ADC that targets both CEACAM5 and CEACAM6, EBC-129 has also shown potential against a range of other solid tumours, and we look forward to expanding clinical evaluations with the ongoing dose expansion cohorts and accelerating the development of EBC-129 to address critical unmet needs in cancer," said Professor Damian O’Connell, CEO of EDDC.

View the full abstract here: View Source

About EBC-129

EBC-129 is an ADC that targets a tumour-specific N256-glycosylation site conserved on CEACAM5 and CEACAM6. CEACAM5 and CEACAM6 are known to have functional importance in tumour formation, migration and metastasis. In the ongoing trial, the tumour-specific marker is found to be widely expressed in multiple solid tumour types, including gastric, oesophageal, pancreatic, lung, colorectal, and appendiceal cancers, based on an analytically validated immunohistochemistry (IHC) assay. The payload used in EBC-129 is monomethyl auristatin E (MMAE), which has been extensively tested and approved for clinical use in other marketed ADCs, and has demonstrated synergy with PD-1 inhibitors. The ongoing Phase 1 trial of EBC-129 is assessing the safety and tolerability of EBC-129 as a single agent and in combination with pembrolizumab in patients with advanced solid tumours. Enrolment for the PDAC cohort in the Phase 1 dose expansion study is now complete, while recruitment continues for the gastroesophageal adenocarcinoma (GEA) and IHC-positive cohorts.

For information about the trial, please visit Clinicaltrial.gov, trial identifier NCT05701527.

On June 3, 2025 MacroGenics, Inc. (Nasdaq: MGNX), a biopharmaceutical company focused on discovering, developing, manufacturing and commercializing innovative antibody-based therapeutics for the treatment of cancer, reported that members of the Company’s management team will present at the Goldman Sachs 46th Annual Global Healthcare Conference 2025 on Tuesday, June 10, 2025, at 8:00am ET in Miami, FL (Press release, MacroGenics, JUN 3, 2025, View Source [SID1234653711]).

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A webcast of the above presentation may be accessed under "Events & Presentations" in the Investor Relations section of MacroGenics’ website at View Source The Company will maintain an archived replay of the webcast on its website for 30 days.

On June 3, 2025 The Experimental Drug Development Centre (EDDC), Singapore’s national platform for drug discovery and development, reported the presentation of updated clinical data for the ongoing Phase 1 trial for EBC-129 at the 2025 Annual Meeting of the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) in Chicago (Press release, Experimental Drug Development Centre, JUN 3, 2025, View Source [SID1234653702]).

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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!

EBC-129 is a first-in-class antibody drug conjugate (ADC) targeting a novel, tumour-specific N256-glycosylated epitope on CEACAM5 and CEACAM6. The updated findings showed promising efficacy data from 21 heavily pre-treated pancreatic ductal adenocarcinoma (PDAC) patients across the dose escalation and the dose expansion portions of the Phase 1 study. Patients received EBC-129 at doses between 1.8 and 2.2 mg/kg, given once every 3 weeks. 17 out of 21 patients (81%) of the patients had received prior treatment with taxanes. 82% of patients had tumours which expressed the EBC-129 antigen at ≥1% at 3+ intensity and were therefore considered treatable. The overall response rates (ORRs) were 25% and 20%, with disease control rates (DCRs) of 87.5% and 63.6% and progression-free survival (PFS) of 19 and 12 weeks for 1.8 mg/kg and 2.2 mg/kg, respectively.

"Pancreatic adenocarcinoma remains one of the most challenging cancers to treat, particularly in the metastatic setting where resistance to standard therapies is common. The clinical signals observed with EBC-129 in refractory pancreatic adenocarcinoma, including tolerability, prolonged disease control and a confirmed response in a heavily pre-treated patient, are encouraging and clinically meaningful. Continued prioritisation of biology-guided trials targeting EBC-129 will be key to sustaining momentum in this important therapeutic effort," said Assistant Professor Robert W. Lentz, MD, Division of Medical Oncology, Department of Medicine, University of Colorado Anschutz School of Medicine.

This presentation follows the recent Fast Track Designation granted by the U.S. FDA for EBC-129 in the treatment of PDAC patients. This designation supports EDDC’s efforts to accelerate the advancement of the programme through increased regulatory engagement and the potential for expedited review pathways.

Other Results to Date

The dose escalation study of the Phase 1 trial was open to all patients, while the ongoing dose expansion study comprises of three cohorts in PDAC, gastroesophageal adenocarcinoma (GEA) and tumour-agnostic patients with other immunohistochemistry (IHC)-positive solid tumours. Recruitment for the GEA and IHC-positive cohorts is still ongoing.

EBC-129 showed a manageable safety profile in the 58 patients treated so far, with uncomplicated neutropenia and infusion-related reactions as the main treatment-related adverse events (TRAEs) observed.

The EBC-129 antigen was also found to be highly expressed, with 52% to 100% of tumour tissues assessed during the trial showing moderate to high expression levels of ≥20% at 2+ and/or 3+. This included samples from gastroesophageal, appendiceal, colorectal and lung cancer patients, making EBC-129 a potentially viable treatment option for these cancers.

"We have seen encouraging signs of efficacy of EBC-129 as a single-agent therapy, even in heavily pre-treated patients with metastatic pancreatic cancer. This, combined with the observed safety profile, underscores the promise of EBC-129 as a possible treatment option for PDAC patients. As a first-in-class ADC that targets both CEACAM5 and CEACAM6, EBC-129 has also shown potential against a range of other solid tumours, and we look forward to expanding clinical evaluations with the ongoing dose expansion cohorts and accelerating the development of EBC-129 to address critical unmet needs in cancer," said Professor Damian O’Connell, CEO of EDDC.

About EBC-129

EBC-129 is an ADC that targets a tumour-specific N256-glycosylation site conserved on CEACAM5 and CEACAM6. CEACAM5 and CEACAM6 are known to have functional importance in tumour formation, migration and metastasis. In the ongoing trial, the tumour-specific marker is found to be widely expressed in multiple solid tumour types, including gastric, oesophageal, pancreatic, lung, colorectal, and appendiceal cancers, based on an analytically validated immunohistochemistry (IHC) assay. The payload used in EBC-129 is monomethyl auristatin E (MMAE), which has been extensively tested and approved for clinical use in other marketed ADCs, and has demonstrated synergy with PD-1 inhibitors. The ongoing Phase 1 trial of EBC-129 is assessing the safety and tolerability of EBC-129 as a single agent and in combination with pembrolizumab in patients with advanced solid tumours. Enrolment for the PDAC cohort in the Phase 1 dose expansion study is now complete, while recruitment continues for the gastroesophageal adenocarcinoma (GEA) and IHC-positive cohorts.

For information about the trial, please visit Clinicaltrial.gov, trial identifier NCT05701527.

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.