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Plus Therapeutics to Present Positive FORESEE Clinical Trial Summary Demonstrating Utility of CNSide™ Cerebrospinal Fluid Assay in Diagnosis and Clinical Management of Patients with Leptomeningeal Metastases

On November 22, 2024 CNSide Diagnostics, LLC, a wholly owned subsidiary of Plus Therapeutics, Inc. (Nasdaq: PSTV) ("Plus" or the "Company"), reported data from the FORESEE trial showcasing the CNSide CSF Assay Platform’s utility in diagnosing and guiding clinical decision making for breast cancer and non-small cell lung cancer patients with LM (Press release, Plus Therapeutics, NOV 22, 2024, View Source [SID1234648586]). The data will be presented at the 2024 Society for Neuro-Oncology (SNO) Annual Meeting November 21-24 in Houston, Texas.

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"Current gold standard CSF cytology lacks the sensitivity needed to reliably diagnose LM in most clinical situations and lacks utility for disease monitoring," said Marc H. Hedrick, M.D., Plus Therapeutics’ President and Chief Executive Officer. "The FORESEE trial shows that CNSide may be a useful tool in accurately identifying all patients with LM, ruling out patients at risk, and enhancing the disease management and monitoring of LM."

Key highlights:

The FORESEE trial achieved its primary endpoint, demonstrating that CNSide influenced treatment decisions in over 90% of cases evaluated, surpassing the predetermined 20% primary endpoint target
CNSide demonstrated enhanced sensitivity in detecting tumor cells (80%) vs. CSF cytology (29%) in patients with LM
CNSide identified actionable mutations in the CSF, such as HER2 amplification, influencing 24% of therapeutic selection decisions
CNSide exhibited high specificity, with no tumor cells detected in patients without LM
CNSide demonstrated improved Negative Predictive Value in ruling out LM (25%) vs. CSF cytology (10%)
CNSide revealed HER2 positivity in LM tumors in 60% of breast cancer patients with HER2-negative primary tumors, informing physician treatment strategies
The data will be presented on Sunday, November 24, at 10:15 a.m. CST in a session titled, "CSF Tumor Cell (CSF-TC) Detection, Quantification and Biomarker assessment Helps in Clinical Management of Breast Cancer and Non-Small Cell Lung Cancer Patients Having Leptomeningeal Disease (FORESEE Study, NCT-5414123)," by Priya Kumthekar, M.D., Associate Professor of Neurology and Hematology/Oncology, and Director of Brain Metastases Program at Northwestern, University, Chicago, Illinois.

About CNSide Test
The CNSide Cerebrospinal Fluid (CSF) Assay Platform consists of four laboratory developed tests (LDTs) used for diagnosis, treatment selection, and treatment monitoring of patients with Leptomeningeal Metastases (LM) from carcinomas or melanoma. The CNSide platform facilitates tumor cell detection / enumeration and biomarker identification using cellular assays (immunocytochemistry (ICC) and fluorescence in situ hybridization (FISH)) and molecular assays (next generation sequencing (NGS)). The CNSide CSF tumor cell enumeration LDT is currently being used in the ReSPECT-LM trial as an exploratory endpoint, and is anticipated to become commercially available in 2025.

About Leptomeningeal Metastases (LM)

LM is a rare complication of cancer in which the primary cancer spreads to the cerebrospinal fluid (CSF) and leptomeninges surrounding the brain and spinal cord. All malignancies originating from solid tumors, primary brain tumors, or hematological malignancies have this LM complication potential with breast cancer as the most common cancer linked to LM, with 3-5% of breast cancer patients developing LM. Additionally, lung cancer, GI cancers and melanoma can also spread to the CSF and result in LM. LM occurs in approximately 5% of people with cancer and is usually terminal with 1-year and 2-year survival of just 7% and 3%, respectively. The incidence of LM is on the rise, partly because cancer patients are living longer and partly because many standard chemotherapies cannot reach sufficient concentrations in the spinal fluid to kill the tumor cells; yet, there are no FDA-approved therapies specifically for LM patients, who often succumb to this complication within weeks to several months, if untreated.

About FORESEE Clinical Trial

The FORESEE Study is a multi-center, prospective clinical trial enrolled patients with Breast or Non-Small Cell Lung Cancer (NSCLC) who have suspicious or confirmed Leptomeningeal Metastases (LM). Standard of Care methods to diagnose or assess the treatment response of LM (Clinical Evaluation, MRI and Cytology) have limited sensitivity and specificity. This creates challenges for physicians to manage LM or determine the best course of treatment. The goal of the FORESEE Study was to evaluate the performance of CNSide in monitoring the LM’s response to treatment and to assess the impact of CNSide on treatment decisions made by physicians.

OverT Bio Receives $120K G-Rex® Grant to Propel Solid Tumor Cell Therapy Advancements

On November 22, 2024 OverT Bio, an NYC-based cell therapy company, reported that it has been awarded a $120,000 G-Rex Grant from ScaleReadyTM, in collaboration with Wilson Wolf Manufacturing, Bio-Techne Corporation (NASDAQ: TECH), and CellReadyTM (Press release, OverT Bio, NOV 22, 2024, View Source [SID1234648585]). This grant will support OverT Bio’s ongoing development efforts that will lead to next generation cell therapies for solid tumors, based on innovative data-driven discovery platforms OverTargetTM and OverTCRTM.

"This grant, including its access to newly developed GMP closed system products and ScaleReady’s expertise, will help us accelerate the development of our products in a way that will ensure future scalability and cost-effectiveness of these potential medicines."

The G-Rex Grant is part of ScaleReady’s $20 million grant program aimed at advancing Cell and Gene Therapy (CGT) development and manufacturing. The G-Rex Grant Program offers recipients significant no-cost support allowing for expeditious optimization of cell manufacturing processes.

"We are pleased to receive ScaleReady’s support and their recognition of the potentially high impact our technology has to advance our shared mission of bringing new life-saving therapeutics to cancer patients," stated Mat Legut, PhD, CEO of OverT Bio. "This grant, including its access to newly developed GMP closed system products and ScaleReady’s expertise, will help us accelerate the development of our products in a way that will ensure future scalability and cost-effectiveness of these potential medicines."

"Our support of OverT Bio is yet another example of how our G-Rex Grant Program is being used to facilitate advancement of the field of cell and gene-modified cell therapy," said Josh Ludwig, Commercial Director of ScaleReady. "The G-Rex Grant Program augments ScaleReady’s primary purpose of providing every CGT company with the ability to save time and money while building a strong value proposition for continued investment on favorable terms."

The Children’s Inn at NIH Announces $1 Million Grant From Gilead Sciences, Inc.

On November 22, 2024 The Children’s Inn at the National Institutes of Health (NIH) reported that Gilead Sciences Inc. has awarded The Inn a $1 million grant to support its renovation and expansion (Press release, Gilead Sciences, NOV 22, 2024, View Source [SID1234648584]). The grant will fund a welcome center in the new wing of The Inn of Tomorrow, a $50-plus million project for which The Inn recently held a groundbreaking ceremony. As the first point of contact, The Gilead Sciences Welcome Center is designed to ensure young patients from around the world participating in groundbreaking clinical trials at NIH feel welcomed immediately upon their arrival at The Inn.

"Gilead is a valued partner whose therapeutic interests have intersected with The Inn’s since our beginning. With this grant, we look forward to transforming our space with new capabilities to support young patients, their families, and NIH researchers at every step along the journey from hopes to cures."

"We are grateful for Gilead’s continuing partnership with The Inn," said Jennie Lucca, The Inn’s CEO. "Gilead is a valued partner whose therapeutic interests have intersected with The Inn’s since our beginning. With this grant, we look forward to transforming our space with new capabilities to support young patients, their families, and NIH researchers at every step along the journey from hopes to cures."

A commitment to health equity and equitable access to NIH pediatric clinical trials are driving forces behind The Inn of Tomorrow. The Inn seeks to remove barriers to potentially lifesaving clinical research studies for diverse families, ensure all families find a "place like home" at The Inn by designing culturally inclusive programs, and use the health equity lens to determine how environment helps patients in their journey to optimal health.

"Gilead is proud to work with The Children’s Inn on their ongoing efforts to provide essential support services to these young patients and their families," said Carmen Villar, Vice President, ESG and Corporate Citizenship, Gilead Sciences. "Our contribution demonstrates our continued commitment to supporting communities and advancing health equity."

Construction on the project is scheduled to start in early 2025. In addition to the new welcome center in the 15,000-square-foot addition, The Inn of Tomorrow will incorporate improved accessibility features throughout, resulting in a state-of-the-art residential facility that reflects best practices in healthcare and hospitality. When completed in 2027, the project will expand The Inn’s capacity to serve more and younger patients – increasing annual capacity by 25% from 2,400 to 3,000 families.

Akeso’s Penpulimab Combination Therapy for First-line Treatment of Hepatocellular Carcinoma Accepted by NMPA

On Nov. 22, 2024 Akeso, Inc. (9926.HK) ("Akeso" or the "Company") reported that the National Medical Products Administration (NMPA) of China has accepted its supplemental new drug application (sNDA) for penpulimab, a differentiated PD-1 monoclonal antibody, in combination with anlotinib for the first-line (1L) treatment of advanced hepatocellular carcinoma (HCC) (Press release, Akeso Biopharma, NOV 22, 2024, View Source [SID1234648582]).

This marks penpulimab’s fifth indication, following its approval for first line treatment of squamous non-small cell lung cancer, first line and third-line or further treatment for metastatic nasopharyngeal carcinoma, and third-line treatment of relapsed or refractory classical Hodgkin lymphoma. The differentiated clinical value of the penpulimab combination therapy is expected to offer a more effective solution for patients with liver cancer.

The sNDA for this new indication is supported by the ALTN-AK105-III-02 study, a multicenter, randomized, open-label, parallel-controlled Phase III clinical trial. The study demonstrated positive outcomes in both progression-free survival (PFS) and overall survival (OS). These encouraging clinical results were featured as a "Late Breaking Abstract (LBA)" at the 2024 European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper) Annual Meeting.

Clinical data highlights:

Penpulimab combined with anlotinib regimen reduced the risk of disease progression or death by 47% compared to the control group (median PFS: 6.9 months vs. 2.8 months, HR=0.53, P<0.0001);
Penpulimab combined with anlotinib regimen reduced the risk of death by 31% compared to the control group (median OS: 16.5 months vs. 13.2 months, HR=0.69, P=0.0013).
The combination of penpulimab and anlotinib significantly improved both PFS and OS in HCC patients compared to sorafenib, with no new safety signals. This makes the combination a promising first-line treatment option for advanced HCC.

The ALTN-AK105-III-02 study marks the second global Phase III trial to achieve positive results for the combination of an immune checkpoint inhibitor and an oral multi-targeted tyrosine kinase inhibitor in the first-line treatment of advanced HCC. These encouraging findings pave the way for this combination therapy to become a superior treatment option for patients with advanced hepatocellular carcinoma.

About Penpulimab

Penpulimab is a differentiated PD-1 monoclonal antibody with an IgG1 subtype and modified Fc region, enhancing immunotherapy efficacy while minimizing adverse reactions. Developed by Akeso Biopharma, its commercialization is managed through a joint venture with Chia Tai-Tianqing Pharmaceutical Group, a subsidiary of Sino Biopharm.

Penpulimab has been approved for the following indications:

First-line treatment of locally advanced or metastatic squamous non-small cell lung cancer (sqNSCLC) in combination with chemotherapy.
Relapsed or refractory classical Hodgkin lymphoma (cHL) after at least two lines of systemic chemotherapy.
Recurrent/metastatic nasopharyngeal carcinoma (NPC) who have failed to respond to two or more prior lines of systemic therapy.
Penpulimab in combination therapy for the first-line treatment of metastatic NPC, has had its marketing application accepted by the NMPA and the FDA. Additionally, the marketing application for its monotherapy use in third-line or further treatment of metastatic nasopharyngeal carcinoma has also been accepted by the FDA.

Ongoing late-stage clinical trials of penpulimab are progressing for liver cancer, gastric cancer, and other indications.

Global Coalition for Adaptive Research Announces Evaluation of AZD1390 in GBM AGILE Trial

On Nov. 22, 2024 The Global Coalition for Adaptive Research (GCAR) reported that they have executed an agreement with AstraZeneca for the evaluation of AstraZeneca’s compound, AZD1390, in GBM AGILE (Glioblastoma Adaptive Global Innovative Learning Environment – NCT03970447), the world’s first global adaptive platform trial for glioblastoma (Press release, Global Coalition for Adaptive Research, NOV 22, 2024, View Source [SID1234648581]). The AZD1390 arm will be evaluated for the treatment of newly diagnosed glioblastoma, with recruitment of patients expected to begin by Q2 2025.

Glioblastoma is the most aggressive and common form of primary brain cancer. Treatment options and patient outcomes have seen little progress over the past several decades. Since launching in July 2019, the GBM AGILE trial has evaluated multiple therapies and has screened over 2000 patients at trial locations in six countries.

GBM AGILE is designed to more rapidly identify and confirm effective therapies for patients with glioblastoma through response adaptive randomization and a seamless phase 2/3 design. Conceived by over 130 key opinion leaders, GBM AGILE is conducted under a master protocol, allowing multiple therapies or combinations of therapies from different pharmaceutical companies to be evaluated simultaneously against a common control arm. With its innovative design and efficient operational infrastructure, data from GBM AGILE can potentially be used as the foundation for a new drug application (NDA) and biologics license application (BLA) submissions and registrations to the US FDA and other health authorities.

Professor Anthony Chalmers, Chair of Clinical Oncology at the University of Glasgow and Dr. Patrick Wen, Director, Center for Neuro-Oncology at Dana-Farber Cancer Institute, and Professor of Neurology at Harvard Medical School, will serve as arm Principal Investigators for AZD1390’s evaluation in GBM AGILE. Dr. Timothy Cloughesy, Director, Neuro-Oncology Program and Distinguished Professor of Neurology at the University of California, Los Angeles, is the Global Principal Investigator for the overall study.

"There is an urgent need for new, tolerable and effective therapies to treat glioblastoma. GBM AGILE is a revolutionary, patient-centered, potentially registration-enabling, adaptive platform trial for glioblastoma," said Dr. Patrick Wen. "We are excited to include AZD1390 in GBM AGILE, based on encouraging data from previous studies, showing encouraging preliminary efficacy in heavily treated recurrent glioblastoma patients and potential for AZD1390 to act as a radiosensitizer. This investigational drug has the potential to support improved outcomes for glioblastoma patients."

AZD1390 is brain penetrant ataxia telangiectasia mutant (ATM) kinase inhibitor that blocks ATM-dependent signaling and repair of DNA double strand breaks (DSBs) in the genome. Preclinically, AZD1390 exhibits activity in combination with agents such as irradiation that induce DSBs. AZD1390 has also been shown to achieve clinically relevant concentrations in resected glioblastoma tissue and suppress the natural repair of the DNA damage that is mediated by radiation. Furthermore, in an oral presentation at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting 2024, AZD1390 with radiotherapy showed a manageable safety profile and preliminary efficacy for patients with glioblastoma in a Phase I trial.

"GCAR is committed to accelerating the development of life-changing treatments for patients with rare and deadly diseases such as glioblastoma. We believe that adaptive platform trials have the potential to achieve that mission and make a profound difference for patients," said Dr. Meredith Buxton, Chief Executive Officer and President of GCAR. "We are delighted to collaborate with AstraZeneca and look forward to expediting the evaluation of AZD1390 in GBM AGILE for the treatment of glioblastoma, a devastating disease with a critical need for more effective treatments."