On June 3, 2025 Pheast Therapeutics, a clinical-stage biotechnology company developing novel therapies to unleash the power of macrophages on aggressive, difficult-to-treat cancers, reported that the U.S. Food and Drug Administration (FDA) has granted Fast Track Designation to PHST001 for the treatment of patients with advanced platinum-resistant ovarian cancer or in combination with chemotherapy in platinum-sensitive ovarian cancer (Press release, Pheast Therapeutics, JUN 3, 2025, View Source [SID1234653696]). PHST001 is an investigational anti-CD24 monoclonal antibody designed to enhance innate immune recognition and anti-tumor activity in solid tumors.

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"Receiving Fast Track designation from the FDA reinforces the promise of CD24 as a next-generation immuno-oncology target and highlights the potential of PHST001 to address a critical unmet need in the treatment of ovarian cancer," said Raphaël Rousseau, M.D., Ph.D., Chief Medical Officer, Pheast Therapeutics. "We are committed to advancing PHST001 through the clinic and accelerating its development for cancer patients in urgent need of more effective treatments."

The FDA’s Fast Track program is designed to facilitate the development and expedite the review of novel potential therapies intended to treat serious conditions and address significant unmet medical needs. Companies whose programs are granted Fast Track designation are eligible for more frequent interactions with the FDA during clinical development and potentially accelerated approval and/or priority review, if relevant criteria are met.

The multicenter, open-label Phase 1 clinical study of PHST001 is actively recruiting patients and will enroll up to 80 patients with advanced relapsed and/or refractory solid tumors (ClinicalTrials.gov Identifier: NCT06840886). The study’s primary objectives include evaluating safety and tolerability of PHST001 and establishing the recommended Phase 2 dose, with secondary endpoints assessing pharmacokinetics and early signs of anti-tumor activity.

About CD24

CD24 is a cell surface protein that plays a key role in tumor immune evasion by engaging Siglec-10, an inhibitory receptor on macrophages. This interaction suppresses macrophage-mediated clearance of cancer cells, allowing tumors to escape destruction by the innate immune system. CD24 was identified in Dr. Irving Weissman’s lab at Stanford as a novel macrophage checkpoint through groundbreaking work by Dr. Amira Barkal, principal founder of Pheast. Along with her other co-founders, Drs. Irving Weissman, Ravi Majeti and Roy Maute, Pheast’s research opened the door to therapeutic strategies targeting CD24 to drive innate immune responses against cancer.

About PHST001

PHST001 is an anti-CD24 macrophage checkpoint inhibitor designed to overcome immune suppression in the tumor microenvironment. CD24 is highly expressed by many human cancers, including ovarian and triple negative breast cancer (TNBC), and high expression of CD24 is a negative prognostic factor in multiple cancer indications. Pheast has engineered PHST001 to be a best-in-class antibody designed to induce macrophages to phagocytose cancer cells and initiate a powerful immune response.

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 Alector, Inc. (Nasdaq: ALEC), a late-stage clinical biotechnology company focused on developing therapies to counteract the devastating progression of neurodegeneration, reported that management will participate in a fireside chat at the Goldman Sachs 46th Annual Global Healthcare Conference on Tuesday, June 10, 2024, at 8:40 am ET (Press release, Alector, JUN 3, 2025, View Source [SID1234653665]).

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A live webcast of the fireside chat will be available on the "Events & Presentations" page within the Investors section of the Alector website at View Source A replay will be available on the Alector website for 90 days following the event.

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 [SID1234653681]).

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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 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%.