On November 25, 2025 Agendia, Inc., a leader in precision oncology for breast cancer, reported that it will present new data demonstrating the utility of the MammaPrint 70-gene assay (MP) and BluePrint 80-gene assay (BP) genomic profiling in guiding the use of anthracycline chemotherapy in patients with hormone receptor positive, HER2-negative (HR+HER2–) early-breast cancer (EBC) at the 2025 San Antonio Breast Cancer Symposium (SABCS). The company will also present four additional posters at SABCS, which takes place December 9-12 in San Antonio, Texas. The complete list of poster presentations can be found here.

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The latest 3-year analysis from the prospective FLEX Study, in an update to data presented at ASCO (Free ASCO Whitepaper) 2024, confirms that patients with MP High 2 (H2), Luminal B, HR+HER2- EBC experience substantially improved invasive disease-free survival when treated with anthracycline-based chemotherapy (AC-T) compared to a regimen without anthracycline (TC). While outcomes for High 1 (H1) patients were similar between patients matched for clinical features, H2 patients saw a striking absolute invasive disease-free survival (IDFS) benefit of 10.7% with AC-T, achieving 100% 3-year IDFS. These results provide the strongest real-world evidence to date that MP can help identify the subset of HR+HER2- patients most likely to benefit from anthracycline-based therapy. Together, these findings underscore the clinical value of genomic profiling in guiding more precise and effective adjuvant treatment decisions.

"With the addition of propensity score matching, these results demonstrate how the genomic information provided by MammaPrint and BluePrint can meaningfully support adjuvant treatment decisions and therapy selection for patients with HR+HER2- early breast cancer," said William Audeh, MD, MS, Chief Medical Officer at Agendia. "By distinguishing High 2 patients – who derive substantial benefit from the addition of anthracycline to their chemotherapy regimen – from those with High 1 disease, who do not, we can better tailor therapy to each patient’s underlying tumor biology. These data further establish the value of real-world evidence and reinforces the power of precision genomics to guide more effective, individualized care and improve outcomes for patients with breast cancer."

Poster #PS2-07-03 | Dec. 10, 5:00 p.m. – 6:30 p.m. | Presenter: Joyce O’Shaughnessy

Improved 3-year IDFS with anthracycline-based therapy for patients with 70-gene signature High 2, Luminal B, HR+HER2– EBC

In this real-world cohort of 1,261 HR+/HER2– breast cancer patients with MP High Risk and BP Luminal B tumors from the FLEX Study, outcomes were evaluated in propensity-matched treatment groups with a median follow-up of 3.2 years. Patients with MP High Risk 2 tumors demonstrated a statistically significant improvement of 10.7% in invasive disease-free survival when treated with anthracycline-based therapy compared to TC-only regimens, while those with High 1 tumors saw no difference. These results provide real-world evidence that MP can identify the HR+/HER2- patients most likely to benefit from anthracycline-based therapy, underscoring the clinical value of genomic profiling in guiding more precise and effective adjuvant treatment decisions.

Agendia will present four additional abstracts that collectively highlight the broad clinical impact of MP and BP in optimizing treatment decisions and improving outcomes for patients with HR+/HER2– EBC, including a poster demonstrating that MP is more prognostic than histologic grade, as described below.

Poster #PS5-04-19 | Dec. 12, 12:30 p.m. – 2:00 p.m. | Presenter: Erin Cobain

70-gene signature high risk classification provides stronger prognostic value than histologic grade in HR+HER2– EBC

In this real-world analysis of 1,407 HR+HER2– EBC patients enrolled in the FLEX Study, patients with MP High 2 tumors treated with chemotherapy had significantly worse five-year distant relapse-free survival compared to High 1 tumors (86.4% vs 93.1%; p < 0.001), even after adjusting for clinicopathologic factors such as grade. Notably, grade lost independent prognostic value when corrected for MP score – highlighting the limitations of relying on histology alone and establishing MP as a superior prognostic biomarker.

"The data being presented at SABCS continue to build on the growing body of evidence supporting the expanded clinical utility of MammaPrint and BluePrint," said Mark Straley, Chief Executive Officer. "Each study adds a new dimension to how our tests inform multiple treatment decisions across the care journey for patients with early-stage breast cancer – helping more women receive the right care based on the unique biology of their tumor."

(Press release, Agendia, NOV 25, 2025, View Source [SID1234660955])

On November 25, 2025 Lunai Bioworks (NASDAQ: LNAI), an AI-powered drug discovery and biodefense company, reported it has secured its first Letter of Intent (LOI) to license its next-generation immune cell therapy, which achieved complete regression of both primary and metastatic pancreatic tumors with no recurrence in humanized preclinical models.

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This milestone follows Lunai’s recent peer-reviewed publication in Vaccines, a successful pre-IND meeting with the U.S. Food and Drug Administration (FDA), and growing third-party recognition from the biotechnology and scientific communities. Lunai has proposed a Phase I clinical trial evaluating its Dendritic Cell Combination Therapy (DCCT) across several high-need solid tumors, including pancreatic cancer, which currently has a five-year survival rate of just 13 percent.

"We are seeing accelerating validation from both researchers and industry partners," said David Weinstein, CEO of Lunai Bioworks. "Independent expert analysis confirms the strength of our data, while early licensing activity reflects growing confidence in this platform’s potential to unlock scalable, off-the-shelf treatments capable of reaching the patients who need them most."

In a widely circulated post on LinkedIn, Benjamin McLeod, Founder of Convey Bio and Co-Host of Bio2Bedside, highlighted the study as a potential breakthrough in cancer immunotherapy.

In humanized mouse models of pancreatic cancer—one of the most lethal and treatment-resistant tumors—Lunai’s DCCT achieved complete regression of both primary and metastatic lesions with no recurrence. These results demonstrate potent, multi-pathway immune activation.

Additionally, the late Dr. Anahid Jewett, Professor at UCLA and a leading authority in tumor immunology commented: "In our view, these results approach what could be called the ‘holy grail’ of cancer research. We observed an 80–90 percent reduction in tumor size and volume across two independent studies, with most of the remaining tissue consisting of immune cells rather than cancer cells."

Lunai is also advancing additional studies and expanding clinical reach for its DCCT platform through collaborations with leading investigators, including Dr. Steven Dubinett (UCLA) for non-small cell lung cancer and Dr. Xiaolin Zi (UC Irvine) for prostate cancer.

"Lunai’s dendritic cell approach has the potential to overcome longstanding barriers in solid tumor treatment," said Dr. Dubinett, Dean of the David Geffen School of Medicine at UCLA.

Lunai’s DCCT introduces a first-in-class, allogeneic immunotherapy designed to scale:

Lunai’s DCCT leverages the natural antigen-presenting power of dendritic cells while eliminating the cost, time, and variability associated with patient-specific manufacturing.
The DCCT is manufactured from healthy donor cells and stored ready-to-use. This off-the-shelf model reduces manufacturing timelines from weeks to days, lowering the overall treatment cost.
In humanized mouse models of pancreatic cancer, one of the most lethal and treatment-resistant tumors, DCCT achieved complete regression of both primary and metastatic lesions with no recurrence.
Lunai Bioworks is preparing for formal licensing negotiations and pre-IND activities in early 2026, advancing toward clinical development of its dendritic cell therapy platform.

(Press release, Lunai Bioworks, NOV 25, 2025, View Source [SID1234660954])

On November 25, 2025 GV20 Therapeutics (GV20), a clinical-stage AI-powered biotherapeutics company, reported that it has received a milestone payment under its collaboration agreement with Mitsubishi Tanabe Pharma Corporation (MTPC). GV20 and MTPC entered into this collaboration in early 2025 to leverage GV20’s antibodies, which are specifically directed against novel tumor antigen targets discovered through GV20’s proprietary STEAD AI platform, to generate potentially first-in-class antibody-drug conjugates (ADCs).

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"We are pleased to reach this important milestone in our partnership with MTPC," said Ying Gong, Ph.D., Chief Business Officer of GV20. "This progress reflects our shared commitment to rapidly advancing innovative ADC therapies for patients with cancer. We look forward to continuing this positive momentum."

Under the terms of the agreement, GV20 received an upfront payment and is eligible for milestone payments. MTPC received an exclusive right to negotiate a license to these antibodies during the collaboration term.

(Press release, GV20 Therapeutics, NOV 25, 2025, View Source [SID1234660953])

On November 25, 2025 Immorta Bio Inc., a scientific longevity company pioneering therapies focusing on Treating Diseases of Aging and Treating Aging as Disease, reported the publication of its international patent application PCT/WO2025184665[1], entitled "Senescence Vaccine."

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The application describes Immorta Bio’s proprietary approach to stimulating the immune system to selectively eliminate senescent cells: the dysfunctional "old cells" that drive aging, inflammation, organ failure, and support tumor growth. Removing these harmful cells results in a broad anti-aging effect throughout the body while simultaneously inhibiting cancer progression, addressing two major root causes of age-related decline:

accumulation of damage, and
loss of regenerative capacity.

At the center of the patent is SenoVax, Immorta Bio’s first-in-class senolytic immunotherapy, which has demonstrated potent reduction of lung, breast, brain, skin, and pancreatic cancers in established in vivo models[2]. SenoVax is also the subject of FDA submission of IND #30745 for advanced lung cancer[3].

"SenoVax is a true first-in-class immunotherapy," said Dr. Thomas Ichim, President and Chief Scientific Officer of Immorta Bio, and inventor on 26 of the company’s patent applications. "By killing senescent cells, we reduce aging biology itself while simultaneously disrupting the tumor-supportive microenvironment required for cancer survival."

Immorta Bio’s broader longevity strategy combines SenoVax with StemCellRevivify, the company’s platform for introducing young, organ-specific progenitor and mesenchymal stem cells to restore regenerative capacity. Together, the two platforms target the two fundamental drivers of aging — impaired clearance of damaged cells and loss of tissue regeneration.

"Cancer is the most prevalent disease of aging, and SenoVax allows us to attack both aging biology and tumor biology at the same time," said Dr. Boris Reznik, Chairman and CEO of Immorta Bio. "Our clinical goal is to first establish safety and efficacy in advanced cancer patients and then expand into age-related conditions and ultimately into treating aging itself."

Immorta Bio’s preclinical work shows compelling evidence across:

multiple cancer models
aging and frailty models
organ-failure models
>100% extension of lifespan and improvement in healthspan
These results, along with the publication of this PCT application, strengthen Immorta Bio’s position as the only company developing a dual-platform solution to aging that also treats its most lethal diseases.

(Press release, Immorta Bio, NOV 25, 2025, View Source [SID1234660952])

On November 25, 2025 Innova Therapeutics, a biopharmaceutical company, reported that it has completed the acquisition of Enci Therapeutics. The acquisition includes Enci Therapeutics’ main cancer therapeutic program, IVT-8086. The specific terms of the agreement and financial details regarding the acquisition between Innova Therapeutics and Enci Therapeutics have not been disclosed.

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IVT-8086 is a first-in-class, humanized monoclonal antibody (mAb) developed as a cancer therapeutic that targets and antagonizes the Secreted Frizzled-Related Protein 2 (SFRP2) pathway. SFRP2, secreted by tumor and endothelial cells, activates the non-canonical Wnt/Calcium (Ca2+) signaling cascade, a pathway involved in angiogenesis, cell survival, cell growth and proliferation, cell migration and invasion, oncogenesis, and metastasis in cancer. By blocking SFRP2 in preclinical models, IVT-8086 induces multiple antitumor effects, including potent reduction in tumor burden in primary and metastatic tumors, reduced expression of CD38 and PD-1 in tumor-infiltrating lymphocytes (TILs), inhibition of angiogenesis, and increased interferon gamma (IFNγ) in tumor-associated macrophages (TAMs) resulting in macrophage repolarization and subsequent increase in the M1/M2 ratio.

The SFRP2 pathway is highly expressed across numerous solid and hematologic malignancies, positioning IVT-8086 as a potential therapy both as monotherapy and combination with immune checkpoint inhibitors (ICIs) for multiple cancer types. Extensive internal and external validation confirms SFRP2 as a critical molecular target, with expression levels strongly correlating with patient outcomes. In parallel, a diagnostic assay is in development to serve as a potential marker for early cancer detection, a prognostic tool for assessing therapeutic benefit, and an indicator for cancer recurrence risk.

"The acquisition of Enci Therapeutics and IVT-8086 marks a pivotal step for Innova Therapeutics in our commitment to pioneering novel cancer therapies," said Robert Ryan, Ph.D., Chief Executive Officer of Innova Therapeutics. "IVT-8086’s unique mechanism of action, antagonizing SFRP2 and selectively blocking the non-canonical Wnt/Ca2+ pathway, holds substantial promise for addressing a spectrum of solid tumors, including pediatric osteosarcoma, sarcomas, breast cancer and pancreatic cancer."

"This cancer treatment platform has the highest potential in my view to change the paradigm of treatment of patients with many types of solid and hematological cancers, resulting in long term survival," said Dr. Ryan who has worked for more than 30 years in the pharmaceutical industry developing cancer therapies. "Given the extensive global patent protection (including composition of matter) through 2042 and beyond, the commercial value of this platform is high, both as monotherapy and in combination."

"This strategic acquisition of Enci Therapeutics by Innova Therapeutics, centered around IVT-8086, a monoclonal antibody targeting SFRP2, underscores our dedication to advancing treatment paradigms for refractory cancers," said Nancy Klauber-DeMore M.D., Co-founder of Enci Therapeutics. "The potential of IVT-8086 to disrupt angiogenesis, tumor cell growth and survival, immune system function, and metastasis represents a significant opportunity to improve outcomes for patients facing these challenging diseases."

About IVT-8086

IVT-8086 is a first-in-class cancer therapeutic, developed as a humanized monoclonal antibody (mAb) designed to antagonize Secreted Frizzled Related Protein 2 (SFRP2). SFRP2 is a protein expressed at high levels in many solid and hematological malignancies, and its expression is correlated with patient outcomes including overall survival making it an important therapeutic target. IVT-8086 as an SFRP2 antagonist, selectively blocks the non-canonical Wnt/Ca2+ signaling pathway.

(Press release, Innova Therapeutics, NOV 25, 2025, View Source [SID1234660951])