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Second Quarter 2025

On July 29, 2025 Merck & Co reported financial results for second quarter 2025 (Presentation, Merck & Co, JUL 29, 2025, View Source [SID1234654714]).

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H1 and Q2 2025 results announcement

On July 29, 2025 AstraZeneca reported the first half and second quarter 2025 financial results (Press release, AstraZeneca, JUL 29, 2025, View Source [SID1234654662]).

New RADIOHEAD Study Validates Use of Guardant Reveal Tissue-Free Monitoring for Earlier Detection of Immunotherapy Response in Advanced Cancer

On July 29, 2025 Guardant Health, Inc. (Nasdaq: GH), a leading precision oncology company, reported the first clinical readout from their collaboration in the RADIOHEAD study with the Parker Institute for Cancer Immunotherapy (PICI), a network of the largest concentration of immuno-oncology (IO) expertise in the world (Press release, Guardant Health, JUL 29, 2025, View Source [SID1234654621]). The data, published today in Cancer Research Communications, a journal of the American Association for Cancer Research (AACR) (Free AACR Whitepaper), found that Guardant Reveal successfully detected responses to immunotherapy across multiple solid tumor types in advanced stage cancer patients and identified non-responders more than three months—and in some cases nearly five months—before disease progression was visible by standard methods.

Approximately 30% of patients with advanced-stage cancer receive immunotherapy treatment, with varying degree and duration of response. This study analyzed a large cohort of more than 500 patients with various advanced solid tumors, including lung, skin, head and neck, breast, GI, GU, and gynecologic cancers, receiving immunotherapy in a real-world setting to assess if blood-based monitoring could predict response accurately and faster than standard of care methods. The strong association found between long-term patient outcomes and changes in tumor fraction as measured with the tissue-free, methylation-based Guardant Reveal supports the use of blood-based monitoring to help predict treatment response and improve decision-making in cancer care.

"Precise serial monitoring at the molecular level provides real value to oncologists and to patients using immunotherapy," said Craig Eagle, M.D., Chief Medical Officer at Guardant Health. "This study shows that Guardant Reveal has the potential to revolutionize how oncologists assess patient response, identifying earlier insights that can empower them to make informed decisions faster and improve patient outcome and quality of care."

"Our RADIOHEAD study of Guardant Reveal in advanced stage cancers provides patients with a new caliber of precision monitoring in order to create better patient outcomes," said Tarak Mody, PhD, Chief Business Officer at PICI. "These findings exemplify PICI’s commitment to forging mission-driven partnerships to bring cutting-edge technology into clinical practice, accelerate discoveries, and advance the development of curative immune therapies for patients."

Key study findings include:

Improved patient outcomes associated with any reduction in tumor fraction
75% lower risk of progression in patients with ≥80% decrease in tumor fraction
Disease progression identified up to 5 months prior to standard of care methods

ViroCell Biologics and AvenCell Therapeutics Announce Retroviral Vector Manufacturing Collaboration to Accelerate Development of Novel Allogeneic CAR-T Therapies for Blood Cancers

On July 29, 2025 ViroCell Biologics ("ViroCell"), a specialist viral vector Contract Development and Manufacturing Organisation ("CDMO") for cell and gene therapy (CGT) clinical trials, reported a manufacturing collaboration with and the successful delivery of a novel retroviral vector to AvenCell Therapeutics, Inc. ("AvenCell"), a leading clinical-stage cell therapy company focused on advancing allogeneic switchable CAR-T cell therapies (Press release, AvenCell Therapeutics, JUL 29, 2025, View Source [SID1234654620]). This first retroviral vector will be used to manufacture AVC-203, an investigational CD19/CD20 dual-targeted cell therapy for the treatment of B cell malignancies and autoimmune diseases.

AvenCell’s AV203 is its second investigational cell therapy using its differentiated allogeneic engineering to provide an "off-the-shelf" product engineered to overcome graft-versus-host disease as well as graft rejection by host T and Natural Killer ("NK") cells. AVC-203 is designed to achieve superior efficacy compared to currently-approved CAR-Ts while enabling immediate treatment and greater patient access at much lower cost and complexity. The further inclusion of AvenCell’s RevCAR receptor in AVC203 allows for additional antigen targeting (with "off/on" capability in vivo) beyond CD19 and CD20.

AvenCell selected ViroCell as its partner to manufacture the retroviral vector for this program based on the CDMO’s expertise and track record in delivering high yield vectors at speed. Incorporating a cell line acquired by AvenCell into the GMP manufacturing process, ViroCell successfully delivered a high yield vector while meeting AvenCell’s accelerated timeline. This program evidences ViroCell’s ability to deliver a bespoke, complex manufacturing process in the allogeneic CAR-T cell therapy space, ultimately, enabling AvenCell’s timelines for clinical entry. AvenCell’s AVC-203 is expected to enter a first-in-human phase I study in patients with relapsed/refractory B cell lymphoma in H2/2025.

John W. Hadden II, CEO of ViroCell, commented: "We are thrilled to partner with AvenCell and support their innovative allogeneic CAR-T therapy platform. I am proud of Team ViroCell’s accomplishments on the successful end-to-end delivery of this retroviral vector and accelerating a novel therapy into clinical development in an area of high unmet need. We look forward to continuing our work with AvenCell on their exciting platform."

Andrew Schiermeier, Ph.D., CEO, AvenCell, added: "We are delighted with ViroCell’s performance in process development and GMP manufacture of this complex retroviral vector. We selected ViroCell to support our platform because we knew that they could execute reliably in areas where other CDMOs can’t. The delivery of this retroviral vector for AVC-203 is proof that our trust in ViroCell was well placed."

Natera Announces Launch of ABCSG 61 (“TEODOR”), a Randomized Controlled Trial of Signatera™ in Early-Stage Breast Cancer

On July 29, 2025 Natera, Inc. (NASDAQ: NTRA), a global leader in cell-free DNA and precision medicine, reported the launch of the TEODOR trial (Neoadjuvant TrEatment Optimization driven by ctDNA and endOcrine Responsiveness) (Press release, Natera, JUL 29, 2025, View Source [SID1234654619]). TEODOR is a Phase II, multicenter, randomized controlled trial (RCT) that aims to replace chemotherapy with endocrine therapy prior to surgery for a subset of women with hormone receptor-positive (HR+), HER2-negative breast cancer, who are endocrine responsive and test negative with Signatera.

Sponsored by the Austrian Breast & Colorectal Cancer Study Group (ABCSG), TEODOR expects to enroll approximately 250 patients across 15 sites in Austria. Previous studies have demonstrated that patients who test Signatera-negative at diagnosis and then receive chemotherapy have excellent outcomes, with risk of recurrence at less than 5%. In an effort to reduce pre-operative chemotherapy, which can carry significant side effects, this study is designed to evaluate the efficacy of endocrine therapy compared to chemotherapy in patients who are Signatera-negative.

After a four-week course of endocrine therapy, patients who are Signatera-negative and show a favorable endocrine sensitivity as measured by the Ki-67 proliferation index will be randomized to receive either additional endocrine therapy or chemotherapy. The primary endpoint of the study is the rate of neoadjuvant therapy response, assessed via pathological complete response (pCR) and modified Preoperative Endocrine Prognostic Index (PEPI) score across the endocrine therapy and chemotherapy arms of the trial. Secondary endpoints include long-term outcomes such as breast cancer recurrence and overall survival.

"TEODOR is designed to examine whether we can use endocrine responsiveness and ctDNA status to optimize systemic therapy in the neoadjuvant setting," said ABCSG President, Michael Gnant, M.D., FACS, FEBS, who serves as professor of surgery, Comprehensive Cancer Center, Medical University of Vienna, and principal investigator of the TEODOR trial. "This study marks a critical step toward more personalized medicine, leveraging the latest technologies to improve patient care."

"With the TEODOR trial, our goal is to identify patients who may be able to safely forgo chemotherapy," said Angel Rodriguez, M.D., medical director of oncology at Natera. "We are proud to collaborate with ABCSG on this important trial, and we hope this study will support the role of Signatera in guiding neoadjuvant therapy in breast cancer."