On February 20, 2024 BostonGene, a leading provider of AI-based molecular and immune profiling solutions, reported that it will participate in the 21st Japanese Society of Medical Oncology (JSMO) Annual Meeting (Press release, BostonGene, FEB 20, 2024, View Source [SID1234640307]). The research conference will be held at the Nagoya Congress Center from February 22 to 24, bringing together a diverse tumor-agnostic academic society focused on pharmacologic therapy with the objective of delivering research to enhance the quality of life for all cancer patients.

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BostonGene will deliver presentations demonstrating the utility of integrated genomic and transcriptomic profiling in identifying clinically relevant alterations for treatment decision-making and describe the development of AI-based analytical tools and pipelines to comprehensively understand each patient’s disease.

Details about the abstracts selected for presentation are below:

Oral presentations

1) An ML-based tool for predicting tissue of origin for cancer of unknown primary based on genomic and transcriptomic data
When: Friday, February 23 | 15:00 – 16:30 JST
Session: Oral Session 9
Speaker: Nathan Fowler, MD, Chief Medical Officer, BostonGene

2) Aggregated analysis of integrated whole exome (WES) and whole transcriptome (WTS) sequencing in 1,000 cancer patients
When: Saturday, February 24 | 8:20 – 9:20 JST
Session: Mini Oral Session 60
Speaker: Nathan Fowler, MD, Chief Medical Officer, BostonGene

3) An HRD scoring system based on long-focal copy number alterations that predicts PARP inhibitor response
When: Saturday, February 24 | 15:30 – 16:30 JST
Session: Mini Oral Session 53
Speaker: Nathan Fowler, MD, Chief Medical Officer, BostonGene

Poster presentation

4) Tertiary lymphoid structure (TLS) and stromal tumor-infiltrating lymphocyte (sTIL) AI-based detection in breast cancer
When: Friday, February 23 |11:30 – 12:15 JST
Session: Poster Session 77
Speaker: Nathan Fowler, MD, Chief Medical Officer, BostonGene

BostonGene Japan Inc. was established in 2023 as a Tokyo-based joint venture by BostonGene, NEC, and Japan Industrial Partners to advance personalized medicine and improve patient outcomes dramatically. Equipping cancer care centers in Japan with BostonGene solutions expands patient access to genomic testing and personalized treatments. Additionally, Japanese researchers and biopharmaceutical companies benefit from biomarker-driven therapy development through BostonGene industry solutions.

To learn more or schedule a meeting with BostonGene during the event, please contact Zlata Polyakova at [email protected].

On February 20, 2024 Immune-Onc Therapeutics, Inc. ("Immune-Onc"), a private, clinical-stage biopharmaceutical company dedicated to advancing novel therapies in immunology and oncology by targeting myeloid cell inhibitory receptors, reported a Phase 1b/2 clinical trial collaboration with Roche to evaluate Immune-Onc’s IO-108, a first-in-class antibody targeting LILRB2 (also known as ILT4), in combination with Roche’s atezolizumab and bevacizumab for the first-line treatment of patients with locally advanced or metastatic and/or unresectable hepatocellular carcinoma (HCC) (Press release, Immune-Onc Therapeutics, FEB 20, 2024, View Source [SID1234640306]). Atezolizumab and bevacizumab is the first cancer immunotherapy combination regimen approved by the U.S. Food and Drug Administration for this setting and is the recommended standard of care by the National Comprehensive Cancer Network.

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"We are excited to work with Roche to accelerate the development of IO-108," said Charlene Liao, Ph.D., chief executive officer and board chair of Immune-Onc. "IO-108 has demonstrated clinical activity and an acceptable safety profile across multiple solid tumors as monotherapy and in combination with T cell checkpoint inhibitors. The collaboration marks a significant milestone in establishing IO-108 as the preferred myeloid checkpoint inhibitor for combination with standard of care immunotherapy regimens in solid tumors."

Under the collaboration, Roche will sponsor and conduct the global, randomized Phase 1b/2 trial to evaluate the safety, efficacy and pharmacodynamics of IO-108 in combination with atezolizumab and bevacizumab compared to atezolizumab and bevacizumab, the standard of care treatment regimen for advanced liver cancer.

ABOUT THE RANDOMIZED CLINICAL TRIAL

The Phase 1b/2 global, randomized HCC study is part of Roche’s Morpheus-Liver program. It will evaluate IO-108 in combination with atezolizumab and bevacizumab ("triplet") versus atezolizumab and bevacizumab ("doublet"), the standard of care in patients with locally advanced or metastatic and/or unresectable HCC with no prior systemic treatment.

Initially, 40 patients will be enrolled across 25 sites worldwide in the IO-108 triplet combination, which will be compared to an active control arm of the atezolizumab and bevacizumab doublet combination. The study’s primary endpoint is objective response rate, and key secondary endpoints include progression-free survival and overall survival.

Under the terms of the clinical collaboration agreement, Roche will manage the study operations, and Immune-Onc will supply IO-108 to support the trial while retaining global rights to IO-108.

Tecentriq (atezolizumab) and Avastin (bevacizumab) are registered trademarks of Genentech, a member of the Roche Group.

Learn more about the trial here.

ABOUT HEPATOCELLULAR CARCINOMA

According to the American Cancer Society1, more than 800,000 people are diagnosed with liver cancer each year worldwide. It is also one of the leading causes of cancer deaths worldwide, accounting for more than 700,000 deaths each year. The number of people diagnosed is predicted to rise, with the incidence of liver cancer increasing by 55.0% and the number of deaths increasing by 56.4% between 2020 and 20402. Hepatocellular carcinoma is the most common form of liver cancer in the United States, making up almost 90% of cases3. Nine out of ten cases of HCC are caused by chronic liver disease, which includes chronic hepatitis B and C infection, non-alcoholic fatty liver disease (NAFLD), non-alcoholic steatohepatitis (NASH), alcohol-related liver disease (ALD), and cirrhosis resulting from these conditions4.

ABOUT IO-108

IO-108 is a fully human IgG4 monoclonal antibody with high affinity and specificity towards the myeloid checkpoint, LILRB2 (also known as ILT4). It blocks the interaction of LILRB2 with multiple ligands involved in cancer-associated immune suppression, including HLA-G, ANGPTLs, SEMA4A, and CD1d. Clinical data from the U.S. Phase 1 dose escalation study of IO-108 (NCT05054348) was presented at the 2023 American Association for Cancer Research (AACR) (Free AACR Whitepaper) annual meeting and demonstrated a favorable safety profile and encouraging clinical benefit utilizing IO-108 as a monotherapy and in combination with anti-PD-1 across multiple tumor types. IO-108 is being studied in several expansion cohorts in adult cancer patients as a monotherapy and in combination with anti-PD-1 antibodies (pembrolizumab, cemiplimab or tislelizumab). A global, randomized Phase 1b/2 study is underway to evaluate IO-108 in combination with atezolizumab and bevacizumab as a potential first-line therapy for hepatocellular carcinoma (HCC).

On February 20, 2024 Lumicell, Inc., a privately held company focused on innovative fluorescence-guided imaging technologies for cancer surgery, reported promising initial data from its ongoing feasibility study for lead candidate LUMISIGHT to detect peritoneal malignancies during surgical debulking (Press release, Lumicell Diagnostics, FEB 20, 2024, View Source [SID1234640305]). The ongoing study is utilizing the investigational LUMISIGHT optical imaging drug and accompanying imaging device to distinguish tumor metastases to organs within the peritoneum. The initial results from adult patients were shared in a podium presentation by James C. Cusack, Jr. MD, Associate Professor of Surgery at Massachusetts General Hospital, at the Advanced Cancer Therapies meeting organized by the Society of Surgical Oncology.

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"This data advances the potential for image-guided surgery to detect small tumors and metastases to organs in the peritoneal cavity which could provide better outcomes for our patients," said Dr. Cusack. "Further innovation is desperately needed to improve the benefits of cytoreductive surgery for this invasive and elusive cancer. We look forward to continuing the clinical development program with Lumicell and advancing patient care."

The presence of peritoneal metastases has a significant negative impact on survival for patients. One of the most important determinants of treatment success and long-term overall survival is the ability to achieve removal of all visible cancer during initial surgery prior to the heated chemotherapy for a complete cytoreduction.2-5

"We are highly encouraged by this initial data in a promising new indication, as we continue to expand the development of LUMISIGHT across the spectrum of solid tumors. Everything we do at Lumicell is focused on improving surgical outcomes for patients," said Howard Hechler, President of Lumicell.

About Peritoneal Surface Malignancies and Metastasis

Peritoneal surface malignancies include primary peritoneal malignant mesothelioma and tumors that have spread from different organs, referred to as peritoneal metastases. These metastases can originate from organs such as appendiceal, colorectal, gastric, pancreatic, and ovarian cancers, and affect more than 75,000 patients each year in the United States.1

The presence of disease and the extent of disease are often difficult to be fully evaluated by conventional non-invasive imaging techniques such as CT scan, PET scan, or MRI. Small peritoneal surface nodules are often detected at the time of surgical exploration by the surgeon’s eyes versus conventional imaging techniques.

One of the most important determinants of treatment success and overall survival is the ability to achieve complete cytoreduction (CCR).2-5 While patients with no residual disease (CCR0) or minimal residual peritoneal surface tumor nodules less than 2.5 mm in maximum diameter (CCR1) have significantly better survival than those with residual nodules more than 2.5 mm in maximum diameter (CCR2), patients with CCR0 have experienced the best clinical outcomes.

On February 20, 2024 WuXi Advanced Therapies (WuXi ATU), a wholly owned subsidiary of WuXi AppTec, reported that the U.S. Food and Drug Administration (FDA) has approved its Philadelphia site to begin the analytical testing and manufacturing of AMTAGVI for Iovance, which received FDA accelerated approval of its Biologics License Application (BLA) on February 16, 2024 (Press release, WuXi AppTec, FEB 20, 2024, View Source [SID1234640304]).

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AMTAGVI is a tumor-derived autologous T cell immunotherapy indicated for the treatment of adult patients with unresectable or metastatic melanoma previously treated with a PD-1 blocking antibody, and if BRAF V600 mutation positive, a BRAF inhibitor with or without a MEK inhibitor. AMTAGVI is also the first and only one-time, individualized T cell therapy to receive U.S. FDA approval for a solid tumor cancer.

With this announcement, WuXi ATU’s Philadelphia site becomes the first U.S. external manufacturing site and the first third-party contract testing, development, and manufacturing organization (CTDMO) to be approved by the FDA to support the commercial manufacturing and release of an individualized T cell therapy for a solid tumor cancer.

"We congratulate Iovance on this major milestone in their quest to address unmet patient needs in the treatment of advanced melanoma. WuXi ATU has partnered with Iovance since 2015, and we are thrilled to help them through each step of the drug development pipeline – from research to clinical manufacturing to FDA approval," said Edward Hu, Chief Executive Officer of WuXi ATU and Vice Chairman of WuXi AppTec. "We are proud of our track record of enabling healthcare innovators to advance medical discoveries and deliver groundbreaking treatments to patients globally."

Iovance, (NASDAQ: IOVA) is headquartered in San Carlos, California with an FDA-approved built-to-suit custom manufacturing facility, the Iovance Cell Therapy Center (iCTC), adjacent to WuXi ATU in the Navy Yard Philadelphia. The company is committed to innovating, developing, and delivering tumor infiltrating lymphocyte (TIL) cell therapies, including gene-edited cell therapies, for patients with cancer.

"The accelerated approval of AMTAGVI is the first step in realizing Iovance’s ambition to usher in the next generation of cell therapy by bringing this breakthrough to patients with advanced solid tumors," said Frederick Vogt, Ph.D., J.D., Interim Chief Executive Officer and President of Iovance. "Given the significant unmet needs in the advanced melanoma community, we are proud to offer a personalized, one-time therapeutic option for these patients. WuXi ATU has partnered with us to manufacture this cell therapy for close to a decade. It is a great benefit to both Iovance and the healthcare community to have a contract testing, development, and manufacturing partner adjacent to our facilities. Working together, our teams can make a meaningful difference for patients."

On February 20, 2024 Servier, a global leader in oncology focused on delivering meaningful therapeutic progress for the patients it serves, reported the FDA filing acceptance and priority review for a New Drug Application (NDA) for vorasidenib, as well as the EMA granting accelerated assessment for the vorasidenib Marketing Authorization Application (MAA) (Press release, Servier, FEB 20, 2024, View Source [SID1234640303]). This innovative targeted therapy is an oral, selective, highly brain-penetrant dual inhibitor of mutant isocitrate dehydrogenase 1 and 2 (IDH1/2) enzymes for the treatment of IDH-mutant diffuse glioma. If approved, vorasidenib would become a first-in-class targeted therapy for patients with IDH-mutant gliomas and would mark Servier’s sixth approval across IDH-mutant cancers. The FDA has assigned a Prescription Drug User Fee Act (PDUFA) action date of August 20, 2024, and the European Commission approval is anticipated in the second half of 2024.

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"In the realm of glioma treatment, innovation has been stagnant for nearly a quarter-century, posing challenges for patients who, post-surgery, may opt to defer treatment due to concerns around potential toxic side effects. As a drug specifically designed to be highly blood-brain barrier penetrant, vorasidenib has demonstrated clinically meaningful efficacy in patients with IDH1/2 mutant gliomas alongside a consistently manageable safety profile," said Susan Pandya, M.D., Head of Cancer Metabolism Global Development Oncology & Immuno-Oncology, Servier. "This promising outcome brings hope to patients grappling with IDH-mutant diffuse gliomas, offering a potential breakthrough for those eagerly awaiting a new therapeutic option."

Adult-type diffuse gliomas represent approximately 81% of primary malignant brain tumors. Of those, approximately 20% harbor an IDH mutation, including 100% of grade 2 and grade 3 adult-type diffuse gliomas, as well as a much smaller portion of the grade 4 tumors.1,2 Testing for IDH mutations is essential for the accurate diagnosis of adult-type diffuse gliomas and can offer more information on the pathogenesis and prognosis of the disease.3 The 2021 WHO Classification includes disease defining histologic and molecular features, including IDH mutation status, to diagnose adult-type diffuse gliomas.4 Additionally, the National Clinical Practice Guidelines in Oncology (NCCN Guidelines) recommend IDH mutation testing in all patients with glioma, noting IDH mutation status impacts diagnosis, prognosis and treatment recommendations.5

"As the pioneer in the field of mutant IDH inhibition, Servier has consistently spearheaded the development of cutting-edge treatment options for various cancer types characterized by IDH mutations. The compelling efficacy results observed with vorasidenib in the INDIGO study underscore its full potential to emerge as the benchmark treatment for patients grappling with IDH-mutant diffuse glioma harboring IDH1/2 mutations," stated Claude Bertrand, Executive Vice-President of Research & Development and Chief Scientific Officer at Servier. "The submission of global regulatory filings for vorasidenib serve as validation of Servier’s global oncology commitment while marking a possibly significant milestone for patients who have endured more than two decades without access to new therapeutic solutions."

The submissions are based on results from the pivotal Phase 3 INDIGO clinical trial, which met its primary endpoint of progression-free survival (PFS) per blinded independent review committee (BIRC) and key secondary endpoint of time to next intervention (TTNI) at the prespecified second interim analysis. The primary endpoint, PFS per BIRC, was statistically significant and clinically meaningful in favor of the vorasidenib arm (Hazard Ratio [HR], 0.39; 95% Confidence Interval [CI], 0.27 to 0.56; 1-sided P=0.000000067), median PFS for vorasidenib and placebo was 27.7 and 11.1 months, respectively. TTNI was also statistically significant (HR, 0.26; 95% CI, 0.15 to 0.43; 1-sided P=0.000000019). Median TTNI was not reached for vorasidenib and was 17.8 months for placebo. Vorasidenib was also shown to reduce the tumor volume by a mean of 2.5% (TGR of –2.5%; 95% CI: -4.7% to -0.2%) every 6 months, while tumor volume increased by a mean of 13.9% (TGR of 13.9%; 95% CI: 11.1% to 16.8%) every 6 months for patients randomized to the placebo arm, as measured by a blinded independent radiology committee.

The INDIGO study showed that vorasidenib was well-tolerated, and its safety profile was consistent with results from the Phase 1 studies.

The results of INDIGO were presented at the 2023 Annual Meeting of the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) and simultaneously published in The New England Journal of Medicine. The results of additional secondary endpoints, including vorasidenib’s impact on tumor growth rate (TGR) of IDH-mutant gliomas, were presented at the 2023 Annual Meeting of the Society for Neuro-Oncology (SNO) among other presentations including results on health-related quality of life, seizure control, neurocognition, and preliminary molecular translational analyses.

Priority Review is granted to FDA applications for medicines that, if approved, would provide significant improvements in the effectiveness or safety of the treatment, diagnosis or prevention of serious conditions.6 Vorasidenib was granted Fast Track Designation by the FDA in February 2023 and Breakthrough Therapy Designation by the FDA in August 2023.

The EMA’s accelerated assessment is granted if the Committee for Medicinal Products for Human Use (CHMP) decides the new medicine is expected to be of major public health interest, particularly from the viewpoint of therapeutic innovation.7

Servier has also submitted an application for project Orbis member countries, including Brazil, Canada, Australia, Israel and Switzerland. In addition, Servier plans to submit a Marketing Application in the United Kingdom if a positive CHMP opinion is received. More information about Project Orbis can be found on the FDA website.

In its ongoing commitment to addressing patient’s needs, Servier recognizes that patients and their physicians may believe that a patient with a serious or immediately life-threatening disease could benefit from Servier’s investigational drugs. An Expanded Access Program, also known as "compassionate use," is a potential pathway for a patient with an immediately life-threatening condition or serious disease or condition to gain access to an investigational medical product for treatment outside of clinical trials. More information about Servier’s expanded access program can be found at clinicaltrials.gov.

About the INDIGO Phase 3 Trial (NCT04164901)

INDIGO was a registration-enabling Phase 3 global, randomized, double-blind placebo-controlled study of vorasidenib in patients with residual or recurrent grade 2 glioma with an isocitrate dehydrogenase 1/2 (IDH1/2) mutation who have undergone surgery as their only treatment. Results were published in The New England Journal of Medicine.

About Glioma8

Adult-type diffuse gliomas represent approximately 81% of primary malignant brain tumors. Of those, approximately 20% harbor an IDH mutation, including 100% of grade 2 and grade 3 adult-type diffuse gliomas, as well as a much smaller portion of the grade 4 tumors.1,2 Establishing the IDH mutation status of these tumors is essential to both diagnosis and prognosis, per the 2021 WHO classification of CNS tumors and the NCCN treatment guidelines, respectively. As of 2021, adult-type diffuse gliomas are sub-divided into only three categories:

Astrocytoma, IDH-mutant (CNS WHO grades 2-4)
Oligodendroglioma, IDH-mutant and 1p19q-codeleted (CNS WHO grades 2-3)
Glioblastoma, IDH-wildtype (CNS WHO grade 4)