On May 27, 2025 TCG Labs Soleil, a venture firm integrating dedicated capital with an in-house biotech R&D hub, and EpimAb Biotherapeutics, Inc. ("EpimAb") reported that Juri Biosciences, Inc. ("Juri"), a portfolio company of TCG Labs Soleil, has entered into a worldwide licensing agreement with EpimAb, a clinical-stage biopharmaceutical company specializing in the discovery and development of multi-specific antibodies for diseases with high unmet need (Press release, EpimAb Biotherapeutics, MAY 27, 2025, View Source [SID1234654051]). The agreement grants Juri exclusive global rights to a development-ready T-cell engager targeting kallikrein-related peptidase 2 (KLK2) and CD3 for the treatment of metastatic prostate cancer.

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Under the terms of the agreement, EpimAb is eligible to receive up to $210 million, including an upfront payment and milestone payments tied to development, regulatory, and commercial events, plus tiered royalties. Further financial details were not disclosed.

Juri is one of several portfolio companies formed by TCG Labs Soleil. Dr. Charles Sawyersi, the inaugural Director of the Human Oncology and Pathogenesis Program at Memorial Sloan Kettering Cancer Center, will serve as a strategic scientific advisor, working closely with the TCG Labs Soleil team to support the program and help guide the advancement of KLK2-directed therapies. A leading expert in metastatic prostate cancer and translational oncology, Dr. Sawyers co-discovered enzalutamide, one of the most widely used therapies for advanced prostate cancer today.

"This agreement with EpimAb is a clear demonstration of our venture-biotech model at work. We’ve acquired an exciting external innovation and are deploying our dedicated capital, scientific leadership and operational infrastructure to move it rapidly into the clinic," said Jin-Long Chen, Ph.D., Managing Partner of TCG Labs and Chief Executive Officer of TCG Labs Soleil. "Prostate cancer remains a leading cause of cancer-related death in men, and KLK2 is a highly prostate-specific antigen with the potential to enable more precise, targeted therapy. We look forward to advancing this program through our portfolio company, Juri Biosciences."

Chengbin Wu, Ph.D., Founder and Chief Executive Officer of EpimAb Biotherapeutics, commented, "We are pleased to have identified a partner for our KLK2 program in Juri Biosciences, backed by the experienced team of TCG Labs Soleil. By partnering in the solid tumor space, EpimAb further validated the broad potential of our TCE platform beyond immunology and hematology."

On May 27, 2025 BriaCell Therapeutics Corp. (Nasdaq: BCTX, BCTXW, BCTXZ; TSX: BCT), a clinical-stage biotechnology company advancing personalized immunotherapies for cancer, reported that Bria-OTS has cleared its safety evaluation in the Phase 1/2 monotherapy study and has now transitioned to dosing patients in combination with a checkpoint inhibitor (CPI) (Press release, BriaCell Therapeutics, MAY 27, 2025, View Source [SID1234653599]). The first patient has been dosed in the checkpoint inhibitor combination cohort of the ongoing Phase 1/2 study of Bria-OTS (NCT06471673) in metastatic breast cancer.

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Bria-OTS, a personalized next-generation version of Bria-IMT—currently in a pivotal Phase 3 trial—is designed to enhance immune responses against tumors. The CPI combination cohort follows the successful completion of a three-patient monotherapy safety run-in. Notably, the first monotherapy patient remains on study with complete resolution of lung metastasis .

"The encouraging responses seen will give us reason to believe that combining Bria-OTS with a checkpoint inhibitor could yield even greater anti-tumor activity," said Neal S. Chawla, MD, Director at the Sarcoma Oncology Center, Santa Monica, Ca., and Principal Investigator for the Bria-OTS study. "This approach may offer a new option for patients who have not responded to existing to antibody-drug-conjugates (ADCs) or checkpoint inhibitors. We are excited to further explore the therapeutic potential of the Bria-OTS platform."

"Initiating the CPI combination cohort marks a significant milestone for BriaCell," added Dr. William V. Williams, BriaCell’s President and CEO. "We believe Bria-OTS has the potential to address major gaps in current cancer care, and this step brings us closer to offering a much-needed personalized immunotherapy for difficult-to-treat cancers."

The ongoing study will assess Bria-OTS in combination with a CPI in up to 12 patients with metastatic breast cancer, with safety and objective response rate (ORR) as primary endpoints. BriaCell also plans to evaluate Bria-OTS+, a further optimized version of the platform, across multiple cancer types including breast and prostate cancers.

On May 27, 2025 Sanofi reported the completion of its acquisition of DR-0201, a targeted bispecific myeloid cell engager, from Dren Bio, Inc., a private clinical-stage biopharmaceutical company (Press release, Sanofi, MAY 27, 2025, View Source [SID1234653524]). The acquisition bolsters Sanofi’s ambition to become the foremost immunology company and broadens the company’s leading immunology pipeline.

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DR-0201, now named SAR448501, has shown robust B-cell depletion in pre-clinical and early clinical studies. The potential first-in-class targeted bispecific myeloid cell engager targets and engages specific tissue-resident and trafficking myeloid cells to induce deep B-cell depletion via targeted phagocytosis.

Recent pre-clinical and early clinical study data in autoimmune diseases suggest that deep B- cell depletion has the potential to reset the adaptive immune system, leading to sustained treatment-free remission in patients with refractory B-cell mediated autoimmune diseases such as lupus, where significant unmet medical needs remain.

Sanofi acquired DR-0201 through the acquisition of the Dren Bio affiliate Dren 0201, Inc. for an upfront payment of $600 million and potential future payments totaling $1.3 billion upon achievements of certain development and launch milestones. Dren Bio will continue to operate independently to advance its pipeline of antibody therapeutics that selectively deplete pathogenic cells and other disease-causing agents.

On May 27, 2025 Agendia, Inc., a leader in precision oncology for breast cancer, reported the presentation of four major abstracts in collaboration with independent investigators at the 2025 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting, taking place May 29th- June 3rd, 2025, in Chicago, Illinois (Press release, Agendia, MAY 27, 2025, View Source [SID1234653422]).

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The research provides new follow-up data from the ongoing FLEX Study (NCT03053193), the largest real-world data early-stage breast cancer (EBC) trial that has recently reached a 20,000 of 30,000 patient enrollment milestone. This real-world evidence study is providing critical insights into how genomic testing can address disparities in early-stage breast cancer care and optimize treatment selection across diverse patient populations. Since its launch in April 2017, the FLEX Study has enrolled patients across 100 sites in the U.S. and around the world, including 16 NCI-designated cancer centers, and has conducted over 40 sub-studies in several topics.

In the first poster, titled "Association of MammaPrint and clinical outcomes by race among 5000 individuals with HR+HER2- early-stage breast cancer enrolled in FLEX," Erin Cobain MD, Associate Professor in the Division of Hematology/Oncology at the University of Michigan Medical School, Ann Arbor and co-Principal Investigator of the SWOG S2206 Trial, examined genomic risk and 4-year distant recurrence-free interval (DRFI) outcomes in patients with HR+HER2- EBC stratified by self-reported race. Black patients were more than twice as likely to present the highest genomic risk EBC (MammaPrint High 2: 18.3% and BluePrint Basal-Type: 9.3%) compared to White patients (High 2: 7.4%; Basal: 9.3%; p<0.001). Despite this, Black patients with MammaPrint High Risk disease were less likely to receive neo/adjuvant chemotherapy, highlighting a potential gap in real-world practice where Black patients may be undertreated. Notably, for MammaPrint Low Risk EBC, excellent 4-year DRFI was observed among both Black (98.3%) and White (97.9%) patients, suggesting equivalent prognostic performance of MammaPrint regardless of race.

The following posters will also highlight new data on the importance of understanding how patients’ intrinsic tumor subtype and their age may impact breast care management decisions:

Association of ImPrintTN signature with survival outcomes by race in Basal-Type Triple Negative Breast Cancer (TNBC) [Sharma, P., et al] – These are the first data to examine the long-term prognostic performance of the newly developed immune classifier signature, ImPrintTN, in patients with TNBC stratified by race. Results revealed that 56.6% of tumors were ImPrintTN+, with no significant differences among Black or White patients. ImPrintTN+ tumors were significantly associated with higher pathological complete response (pCR) to neoadjuvant therapy (39.3% vs. 22.0%; p=0.039) and improved 3-year recurrence-free survival (RFS) (87.9% vs. 77.5%; p=0.01). The positive prognostic benefit of ImPrintTN+ status was equivalent across racial groups, however, a nonsignificant negative prognostic impact of ImPrintTN- appeared more pronounced among Black patients, compared to White, highlighting the need for exploring biological differences within the ImPrintTN- subgroup by race.
Molecular Insights into HR+/HER2+ Early-Stage Breast Cancer: Neoadjuvant Therapy Responses by MammaPrint and BluePrint genomic subtypes [Samijan, L., et al.] – The data show significant heterogeneity among 720 patients with HR+HER2+ tumors enrolled in FLEX. Among these patients, 61.4% had tumors genomically reclassified with non-HER2 molecular subtypes by BluePrint. A higher accuracy in predicting pCR was observed when stratified by BluePrint with a pCR rate of 61.2% for HER2 compared to only 26.5% for Luminal subtypes (p<0.001). These findings highlight the limitations of treatment planning among patients with conventionally classified HR+HER2+ disease and support use of genomic assays to help more accurately predict therapy response.
Real-World Evidence from FLEX: Utility of MammaPrint in guiding treatment planning for patients aged 70 and older with early-stage breast cancer [Mahtani, R., et al.] – The data reveal that patients aged ≥70 with MammaPrint High Risk tumors were less likely to receive chemotherapy. However, older women with MammaPrint High 2 risk tumors who received chemotherapy vs. Those who didn’t had an 11% improvement in 3-year recurrence-free interval (RFI), suggesting chemotherapy should be considered in older populations with genomically high risk tumors.
"These new data presented at ASCO (Free ASCO Whitepaper) further reinforce the power of genomic testing to guide precise and consistent treatment decisions within distinct patient populations," said William Audeh, MD, MS, Chief Medical Officer at Agendia. "Whether identifying treatment-responsive subgroups in TNBC, guiding therapy in older women, or ensuring consistent outcomes regardless of race, MammaPrint, BluePrint, and Agendia’s growing suite of genomic signatures for early-stage breast cancer continue to demonstrate comprehensive utility in real-world clinical practice."

On May 27, 2025 REVEAL GENOMICS, S.L., a biotechnology company advancing precision oncology through biomarker innovation, reported the presentation of four independent studies at the 2025 ASCO (Free ASCO Whitepaper) Annual Meeting (Press release, REVEAL GENOMICS, MAY 27, 2025, View Source [SID1234653421]). The studies, involving more than 800 patients, evaluated the clinical utility of its flagship test, HER2DX, in early-stage HER2-positive (HER2+) breast cancer.

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The four studies, CompassHER2 pCR, BionHER, RESPECT and DFCI, validate HER2DX as a powerful genomic tool for predicting response to therapy and long-term prognosis, addressing critical questions. The findings, which provide valuable insights for optimizing treatment strategies in early-stage HER2+ breast cancer and metastatic breast cancer, will be shared in oral and poster sessions led by academic investigators from the U.S., Europe, and Japan.

CompassHER2 pCR or EA1181 (U.S.): HER2DX determining response to THP-based de-escalated therapy

This study is led by the ECOG-ACRIN Cancer Research Group (ECOG-ACRIN), a scientific organization that designs and conducts cancer research involving adults who have or are at risk of developing cancer, comprising nearly 1,400 member institutions in the U.S. and around the world.

HER2DX was evaluated as a secondary aim as part of a pre-specified, prospectively planned analysis embedded in the CompassHER2 pCR trial, also known as EA1181 (NCT04266249). This large, prospective multicenter phase II trial is assessing neoadjuvant taxane, trastuzumab, and pertuzumab (THP) in more than 2,000 patients with stage II–III HER2+ breast cancer, without the use of anthracyclines, cyclophosphamide, and carboplatin. The HER2DX assay was defined as a key secondary endpoint, with profiling of all available baseline samples planned.

Among 569 patients assessed to date for the HER2DX pathologic complete response (pCR) score, those with higher scores achieved significantly greater pCR rates, independent of estrogen receptor (ER) status. These findings confirm the ability of HER2DX to identify tumors more likely to respond to THP. Importantly, additional results are expected from this trial, as patients continue to be followed for the primary endpoints of 3-year survival outcomes, and the study team plans to profile many more baseline samples.

"The ability to predict response to THP is extremely valuable," said Dr. Nadine Tung, Director of Breast Medical Oncology at Beth Israel Deaconess Medical Center, Professor of Medicine at Harvard Medical School, and Principal Investigator of the CompassHER2 pCR (EA1181) trial. "HER2DX provides a biology-driven tool that contributes to the selection of patients who can safely reduce chemotherapy, something we’ve long needed in HER2-positive early breast cancer."

"It is encouraging to see the assay’s performance in both ER-positive and ER-negative subgroups," added Dr. Tung. "The plan is to profile all available samples from the trial, and these early data already provide valuable insights for guiding treatment selection."

BionHER trial (Spain): Validation of HER2DX-guided de-escalation strategy

The BionHER phase II trial (NCT05912062) evaluated HER2DX in 83 patients with stage I–III HER2+ breast cancer treated with neoadjuvant THP for up to 15 weeks at the Catalan Institute of Oncology (ICO L’Hospitalet, Barcelona, Spain). HER2DX was successfully performed in all baseline FFPE tumor samples.

The HER2DX pCR score was significantly associated with pCR with a performance AUC of 0.835. Patients classified by HER2DX pCR score into low, medium, and high groups had increasing pCR rates of 13.3%, 51.6%, and 81.8%, respectively. HER2DX outperformed traditional biomarkers, such as ER, Ki-67, and tumor-infiltrating lymphocytes, in predicting pCR.

"HER2DX is transforming the way we approach treatment selection in HER2-positive disease," said Dr. Sònia Pernas, head of the breast cancer unit at ICO L’Hospitalet, and Principal Investigator of the BionHER study. "By identifying tumors more likely to respond to dual HER2 blockade with a single taxane, we are increasingly able to personalize treatment intensity without compromising efficacy."

RESPECT trial (Japan): a response for an unrepresented population

Trans-RESPECT is a prespecified translational analysis within the Japanese RESPECT non-inferiority trial (NCT01104935), in which 266 patients aged 70–80 years with stage I-III HER2+ breast cancer were randomized to receive adjuvant trastuzumab with or without chemotherapy (Sawaki et al. J Clin Oncol 2020). HER2DX was assessed in 154 of these patients, with a median follow-up of 9.1 years. The HER2DX risk score effectively stratified patients by 10-year relapse-free survival (86.6% in the low-risk group vs. 68.4% in the high-risk group) and overall survival (94.5% vs.72.5%). Notably, chemotherapy conferred an overall survival benefit only in tumors classified as pCR-high by HER2DX, with a significant interaction p-value of 0.045.

"HER2DX provided clear long-term prognostic information in this elderly population," said Dr. Kazuki Nozawa, Lead Investigator of Trans-RESPECT, from the Department of Advanced Clinical Research and Development and the Department of Breast Surgery at Nagoya City University Graduate School of Medical Sciences. "Importantly, its ability to help identify which patients may benefit from adjuvant chemotherapy is highly relevant to clinical decision-making. Older patients with HER2DX low-risk scores, particularly those classified as pCR-low or -medium, appear to be ideal candidates for trastuzumab alone, without chemotherapy."

DFCI T-DXd study (U.S.): predicting survival outcome to T-DXd

Dana-Farber Cancer Institute (DFCI) conducted a retrospective analysis of 41 patients with metastatic breast cancer (25 HER2-positive, 16 HER2-negative) treated with trastuzumab deruxtecan (T-DXd) monotherapy between 2017 and 2023. The HER2DX HER2 signature score was significantly associated with time to next treatment (p=0.001). When stratified into tertiles, patients in the highest tertile had a median time to next treatment of 12.03 months compared to 4.7 months in the lowest tertile (p=0.02).

"Quantitative measurement of HER2 amplicon expression by HER2DX is a key determinant of T-DXd activity in metastatic breast cancer," said Dr. Sara M. Tolaney, Chief of the Division of Breast Oncology at Dana-Farber Cancer Institute. She added, "Further evaluation of this genomic test in ongoing T-DXd trials is warranted."

HER2DX makes a significant impact at ASCO (Free ASCO Whitepaper) 2025

"ASCO 2025 marks a pivotal milestone for HER2DX," said Dr. Aleix Prat, Chief Scientific Officer and co-founder of REVEAL GENOMICS. "This test is demonstrating clinical value in real-world practice across continents and care settings, assisting in the tailoring of chemotherapy intensity in the neoadjuvant setting and supporting chemotherapy-free decisions in the adjuvant setting."

Patricia Villagrasa, CEO and co-founder, added, "HER2DX was developed with HER2+ disease at its core, and these four high-quality, independent studies reinforce its clinical value. As we continue to grow globally, this is a clear example of how REVEAL GENOMICS is turning cutting-edge science into meaningful solutions that advance personalized cancer care worldwide."

About HER2DX

HER2DX is the world’s first diagnostic test formulated specifically for HER2+ breast cancer. Marketed by REVEAL GENOMICS since January 2022, the HER2DX is a standardized 27-gene expression test for patients with early-stage HER2+ breast cancer.

HER2DX is a prognostic and predictive assay based on clinical and genomic data. The test integrates clinical information (i.e., tumor size and nodal status) with biological information tracking immune response, luminal differentiation, tumor cell proliferation, and expression of the HER2 17q12-21 chromosomal amplicon, including the ERBB2 gene.

HER2DX️predicts:

Risk of relapse score (high vs. low): the risk of recurrence in patients with newly diagnosed HER2+ breast cancer.
pCR likelihood score (high vs. medium vs. low): the likelihood of a patient responding to anti-HER2-based treatment before surgery.
ERBB2 score (high vs. medium vs. low): the quantitative expression of ERBB2 mRNA across HER2-negative, HER2-low and HER2+ breast cancer.