On May 5, 2025 Natera, Inc. (NASDAQ: NTRA), a global leader in cell-free DNA and precision medicine, reported the results of a study led by Stanford University School of Medicine for the evaluation of Signatera, Natera’s personalized molecular residual disease (MRD) test, in patients with soft tissue and bone sarcomas (Press release, Natera, MAY 5, 2025, View Source [SID1234652531]). Results of the study (Utilizing Circulating Tumor DNA to Monitor Sarcoma Treatment and Recurrence) were presented at the 2025 Society of Surgical Oncology (SSO) Annual Meeting in March.

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With evaluation of approximately 200 patients and more than 2,100 plasma samples across multiple distinct subtypes, this is the largest sarcoma cohort to date using personalized circulating-tumor DNA (ctDNA) monitoring. The study assessed the correlation of Signatera results with imaging, stratified by sarcoma subtype, and followed patients through treatment, disease progression, and surveillance.

Key findings included:

The results demonstrated excellent test performance, with overall sensitivity to recurrence of 89% and specificity of 100%.
In leiomyosarcoma, the most common subtype in the cohort, sensitivity was 93%, with specificity of 100%.
For leiomyosarcoma patients who experienced progression, ctDNA kinetics during subsequent therapy were highly correlated with treatment response (90%).
Sarcomas are a heterogeneous group of rare cancers, with more than 70 distinct histologic subtypes1, making treatment response and recurrence especially difficult to monitor through standard imaging and clinical evaluation. There are approximately 17,000 new cases of sarcoma diagnosed annually in the United States.2

"This data represents a major step forward in understanding how ctDNA monitoring can be applied across a diverse range of sarcoma subtypes," said Beatrice J. Sun, M.D., department of surgery at Stanford University. "With the ability to noninvasively detect disease recurrence and monitor treatment response, Signatera demonstrates the potential to meaningfully improve personalized care for patients with sarcoma."

"This is the most comprehensive dataset to date on ctDNA monitoring in sarcoma, and it shows excellent performance of Signatera in a difficult-to-monitor cancer," said Alexey Aleshin, M.D., corporate chief medical officer and general manager of oncology at Natera. "The heterogeneity of sarcoma demands a personalized approach, and these results support Signatera’s unique ability to track disease status with precision across a broad spectrum of subtypes."

This retrospective real-world study demonstrates the promise of Signatera as a tool to monitor disease recurrence and treatment response. To build on these findings, the team intends to launch a prospective study to further demonstrate Signatera’s clinical utility and explore its role in informing treatment decisions and improving future sarcoma care.

About Signatera

Signatera is a personalized, tumor-informed, molecular residual disease test for patients previously diagnosed with cancer. Custom-built for each individual, Signatera uses circulating tumor DNA to detect and quantify cancer left in the body, identify recurrence earlier than standard of care tools, and help optimize treatment decisions. The test is available for clinical and research use and has coverage by Medicare across a broad range of indications. Signatera has been clinically validated across multiple cancer types and indications, with published evidence in more than 100 peer-reviewed papers.

On May 5, 2025 Lantern Pharma Inc. (Nasdaq: LTRN), an artificial intelligence company developing targeted and transformative cancer therapies using its proprietary AI platform, RADR, reported that it has received clearance of its Investigational New Drug Application (IND) from the U.S. Food and Drug Administration (FDA) for a Phase 1b/2 clinical trial for LP-184 in Triple Negative Breast Cancer (Press release, Lantern Pharma, MAY 5, 2025, View Source [SID1234652530]). This achievement builds on the previous regulatory momentum including Orphan Drug Designation in 2023 and Fast Track Designation in 2024.

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Strategic Trial Design to Address Critical Treatment Gap in TNBC

The innovative dual-approach in the clinical trial is designed to evaluate LP-184 in recurrent, advanced-stage TNBC patients through:

Monotherapy Arm: An open-label study involving approximately 30 patients with advanced-stage TNBC, focusing on dose optimization to evaluate, enhance and optimize safety and potential efficacy for TNBC patients.
Combination Therapy: Evaluation of LP-184 in combination with olaparib in second-line settings for patients with advanced-stage TNBC harboring BRCA1 or BRCA2 alterations, with primary endpoints including safety and efficacy parameters that could potentially support a pathway to regulatory approval.
This strategic approach focuses on addressing a significant unmet medical need, with average survival for newly diagnosed metastatic TNBC estimated at 10 to 18 months, representing an annual market opportunity exceeding $4 billion USD.

LP-184 Background in TNBC & Mechanistic Rationale

LP-184 is a synthetically lethal small molecule that induces DNA double strand breaks upon bioactivation by the enzyme prostaglandin reductase 1 (PTGR1) in cancer cells. Preclinical studies and artificial intelligence-driven in silico modeling suggest that cancers with DDR gene alterations may preferentially respond to LP-184.2

Preclinical findings also suggest that LP-184 is particularly well positioned for TNBC with striking data from in vivo models including complete regression seen in several PARP resistant as well as PARP sensitive PDXs (see Figure 1).

Nearly 70% of TNBCs are noted to harbor deficiency in homologous recombination pathways, making them likely to be particularly sensitive tumors for targeting with drug-candidate LP-184. In addition, it is estimated that up to 46% percent of women with TNBC will develop brain metastasis3, and LP-184 has shown blood brain barrier (BBB) penetration, with evidence of activity in preclinical brain metastasis models.

LP-184 Phase 1b/2 TNBC Trial Overview – Monotherapy

The monotherapy phase 1b/2 trial is designed to evaluate LP-184 in patients with advanced-stage TNBC. The study is designed to focus on dose optimization to evaluate and enhance both safety and potential efficacy ultimately aiding in the potential determination of the best clinical position for LP-184 in advanced-stage TNBC patients. The design of the dose optimization phase, provides for evaluation of the safety, efficacy and pharmacokinetics of LP-184 using 2 dose levels in an open-label monotherapy study involving around 30 patients to be dosed with LP-184.

LP-184 Phase 1b/2 TNBC Trial Overview – Combination Therapy with PARP inhibitor

LP-184 has also been shown in preclinical studies to be highly potent in combination with the PARP inhibitor, olaparib, including in tumors that are resistant to PARP inhibitors. In preclinical studies, treatment of a HBCx-28 TNBC PDX model, with BRCA-1 LOH and an HRD score of 63 that was resistant to the PARP inhibitor, showed evidence of re-sensitization in combination with LP-184 (See Figure 2). These data, which were initially presented at the San Antonio Breast Cancer Symposium, support the clinical evaluation of LP-184 in combination with PARPi in an earlier line of treatment. Treating patients in an earlier clinical setting has the potential to reach more patients and potentially generate a more durable and deeper earlier control of the disease.

The design of the combination phase 1b/2 trial provides for LP-184 to be evaluated in a second-line setting in patients with advanced-stage TNBC whose primary tumor harbors alterations in BRCA1 or BRCA2. The primary end points of the study are expected to include safety and efficacy, with the aim of supporting a potential pathway to a regulatory approval process.

Multi-Region Clinical Strategy with Focus on High-Incidence Countries

The trials are planned to be conducted at select centers in the United States as well as academic cancer centers and institutions in India and Nigeria, where TNBC incidence rates are particularly high—comprising nearly 40% of initial breast cancer diagnoses. This strategic site selection is focused on leveraging established collaborative research networks that have a track record of successful collaborative cancer studies with US and European pharma companies. Lantern’s planned objective will be to ensure proper local experience and support for this clinical trial while addressing regions with significant disease burden and high clinical demand.

"This IND clearance for LP-184 in a Phase 1b/2 study represents a pivotal advancement in our mission to bring precisely targeted, AI-developed medicines to patients with aggressive cancers and limited treatment options," said Panna Sharma, CEO and President of Lantern Pharma. "The strategic design of our clinical program reflects both the compelling mechanistic rationale and the encouraging data supporting LP-184’s potential in TNBC."

Expanding Therapeutic Potential Across Multiple Indications

Beyond TNBC, LP-184 shows promise for the potential treatment of other cancers harboring DNA damage repair mutations, including lung, bladder, pancreatic, and ovarian cancers. Additional clinical trials in these targeted indications are in planning stages, with several being considered as Investigator Initiated Trials. LP-184 has received multiple Orphan Drug, Fast Track, and Rare Pediatric Disease Designations from the FDA across various solid tumor indications.

The global TNBC market is estimated at $3-5 billion USD annually, with over 300,000 new cases diagnosed worldwide each year. While homologous recombination deficient TNBCs are often initially treated with PARP inhibitors, resistance inevitably develops, underscoring the critical need for novel therapeutic approaches.

On May 5, 2025 AGC Biologics, your friendly CDMO expert, reported a multiphase partnership with Novelty Nobility Inc., a clinical-stage biotech company based in South Korea (Press release, Novelty Nobility, MAY 5, 2025, View Source [SID1234652529]). Novelty Nobility will leverage AGC Biologics’ expertise and proprietary CHEF1 expression technology for cell line development and prepare for Phase I clinical trials via a multi-site partnership with AGC Biologics’ Copenhagen, Denmark and Chiba, Japan facilities.

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Novelty Nobility develops innovative antibody drugs, including bispecific antibodies and antibody-drug conjugates (ADCs). The company is currently developing two clinical assets in the United States in immunology and oncology, respectively.

AGC Biologics will develop the cell line and create a master cell bank (MCB) for Novelty Nobility’s first-in-class bispecific antibody drug candidate at its Copenhagen facility. After the MCB is created, the second phase of the partnership will focus on expanded process development work and GMP manufacturing preparation at the AGC Biologics Chiba site. The first stage of the project began in March.

"We are very happy with the partnership with Novelty Nobility, where we will apply our CHEF1 platform to a novel bispecific antibody, helping support the advancement of this important candidate towards clinical trials," said Kasper Møller, Chief Technical Officer and Executive Vice President, AGC Biologics. "Our cell line development expertise in Copenhagen is strategically aligned with Novelty Nobility’s objectives, and we believe we can provide a strong foundation for their therapeutic development program."

"Chiba’s partnership with our Copenhagen team gives Novelty Nobility access to world-class cell line development experts while keeping their regional connection strong," noted Susumu Zen-in, Senior Vice President and General Manager, AGC Biologics Chiba. "When clients work with us, they tap into our entire global network – we find the right expertise wherever it exists and bring teams together for a seamless experience, no matter where the work is being done. This approach is already helping us throughout the APAC region and creating wins for both Novelty Nobility and AGC Biologics."

AGC Biologics’ CHEF1 expression technology is a proven platform for cell line development, with a track record of producing stable cell lines for a variety of biologics. With five commercial products on the market and 54 distinct molecules developed, the platform delivers a reliable and efficient path to success. The cell line platform excels in handling complex molecules, providing solutions for challenging biologics that require specialized expression systems. The CHEF1 platform is also royalty-free, eliminating additional costs for clients as their products advance through clinical phases toward commercialization.

AGC Biologics offers a comprehensive suite of services for mammalian-based drug production, from cell line development to commercial manufacturing, enabling partners to accelerate their drug development timelines and bring life-changing therapies to patients. Visit www.agcbio.com/capabilities/mammalian to learn more.

On May 5, 2025 Immorta Bio Inc, a scientific longevity company dedicated to "Treating Diseases of Aging and Treating Aging as Disease", reported a talk called "Immunologically Mediated Senolysis" at the "Clinical Immunology Symposium" of the American Association of Immunologists Annual Meeting (Press release, Immorta Bio, MAY 5, 2025, View Source [SID1234652528]). Immorta Bio’s talk will be accompanied by presentations from Pfizer1 and University of Pittsburgh2. The talk will occur Monday, May 5 | 8:15 AM – 10:15 AM | Room 316C at the Hawai’i Convention Center.

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Immorta Bio is the first company to develop a "senolytic immunotherapy" for treatment of cancer and aging. This treatment comprises of training the immune system of patients to selectively kill "senescent cells" that promote aging and act as a shield to protect cancer against immune responses. By removing this defense mechanism, cancer becomes susceptible to immune attack.

The Company has shown that its lead senolytic immunotherapy product, SenoVax, is capable of destroying lung, breast, pancreatic and brain cancers, as well as melanoma3 in animal models.

"Having been chosen to present our work on using the immune system to fight cancer and aging in such an esteemed panel is truly an honor," said Dr. Thomas Ichim, President and Chief Scientific Officer of Immorta Bio.

T cell mediated mechanisms of how SenoVax enables its anticancer effects have previously been published in the peer-reviewed literature with collaborators at University of California San Diego, Georgetown University, Ceders Sainai, and Calidi Bio4. Additionally, the Company recently demonstrated that natural killer cell activation as a result of SenoVax therapy also plays a role in stimulation of cancer destruction5.

"We have founded Immorta Bio on the principle of ‘Scientific’ Longevity," said Dr. Boris Reznik, President and CEO of Immorta Bio. "There is no better validation of our science than to be chosen to give an oral presentation at such a prestigious and exclusive scientific gathering as AAI2025."

On May 5, 2025 Genezen, a leading viral vector Contract Development and Manufacturing Organization (CDMO), and Optieum Biotechnologies, Inc. (Optieum), a preclinical stage company dedicated to the discovery and development of innovative CAR-T cell therapies, reported a partnership for cGMP manufacturing of the lentiviral vector (LVV) construct used in the production of OPTF01, a novel CAR-T therapy for glioblastoma treatment (Press release, Genezen, MAY 5, 2025, View Source [SID1234652527]).

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Derived from Optieum’s proprietary Eumbody System, OPTF01 specifically targets Fibroblast activation protein-alpha (FAPα), a protein expressed on both tumor cells and the surrounding pericytes and Cancer-associated Fibroblasts (CAFs). Hence, OPTF01 can potentially disrupt the immunosuppressive microenvironment around the tumor while simultaneously attacking the malignant cells within the tumor. Successful development of this therapeutic approach would address a critical unmet medical need for patients with refractory glioblastoma who currently face limited treatment options with poor prognoses, as well as various other solid tumor indications.

Under this collaboration, Genezen will provide the technology transfer, process development, and cGMP manufacturing of the LVV construct used in the onward production of the OPTF01 CAR-T product. "Genezen is honored to support Optieum’s best-in-class CAR-T programs with our best-in-class LVV expertise to bring these critical therapies to life," said Steve Favaloro, Chairman and CEO of Genezen. "This collaboration with Optieum underscores our rich experience and the capabilities of both our people and state-of-the-art facilities to support customers on a global scale – now including a leading Japanese biotech."

Shun Nishioka, CEO of Optieum added, "At Optieum, we are committed to redefining the future of CAR-T therapy through relentless innovation and scientific rigor. Partnering with Genezen’s team of experts ensures that critical materials for our groundbreaking therapies are manufactured to the highest standards, accelerating our progress toward delivering next-generation therapies for glioblastoma and other solid tumors."

OPTF01 is derived from the Eumbody System, a proprietary platform representing a significant advancement in CAR-T cell therapy development. This platform leverages rapid and expansive functional screening to identify and optimize CAR constructs in unprecedented fashion. By dynamically harmonizing single-chain variable fragment (scFv) sequences to enhance the functional capabilities of T cells, the Eumbody System sets a new standard in CAR-T innovation.