On December 5, 2022 -ImmuneOncia (CEO Heung Tae Kim) reported the results of its Phase 2 NK/T-cell lymphoma clinical trial of IMC-001, a PD-L1 monoclonal antibody, at the Asian Congress of the European Society for Medical Oncology (ESMO Asia 2022) held in Singapore on December 4th, 2022(Press release, ImmuneOncia Therapeutics, DEC 5, 2022, View Source [SID1234624816]).

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The clinical data demonstrated that 6 out of 10 evaluable patients (60%) achieved an objective response, all of whom showed a complete remission (CR). Additionally, the administration has been continued in 4 of these 6 patients for over a year, which also indicates its outstanding safety (in terms of the long-term toxicity) and durable response.

Thanks to these achievements, the results of IMC-001 were selected for Mini Oral Session at ESMO (Free ESMO Whitepaper) Asia this year.

Professor Won Seog Kim of Samsung Medical Center, a presenter and Principal Investigator of IMC-001, commented, "The complete remission and response rate of 60% of IMC-001 significantly outperform currently available drugs for the treatment, and very rare adverse events of grade 3 or higher also eliminate concerns over the side effects, making it the best-in-class among PD-(L)1 drugs. These results are expected to satisfy the criteria for approval and lead to globalization of an immune checkpoint inhibitor developed by a Korean biotech."

NK/T cell lymphoma is a rare cancer that occurs mostly in Asian countries such as China and Korea, and often treated with radiation and chemotherapy. NK/T cell lymphoma has a high recurrence rate of 75% within 2 years. Due to the absence of standard-of-care treatment for relapsed/refractory, it has high unmet needs. So far, no single immuno-oncology drug has obtained approval in this indication across the globe.

IMC-001 is a PD-L1 antibody, an immune checkpoint inhibitor that serves as the basis of the current immuno-oncology market. This antibody activates the anticancer functions of T cells by strongly inhibiting the binding between PD-1 expressed on T cells and PD-L1 expressed on the surface of cancer cells. Moreover, it can mediate ADCC (antibody-dependent cellular cytotoxicity) against tumor cells, as it maintains the Fc effector function using human IgG1.

Heung Tae Kim, CEO of ImmuneOncia said, "This achievement sets a new standard for the second-line treatment of NK/T-cell lymphoma, which has high unmet needs. This will be a momentum to secure more partnering opportunities in regions with a high incidence of NK/T-cell lymphoma, like China. ImmuneOncia is also preparing additional clinical trials to expand its indications in solid cancer."

ImmuneOncia is a biotechnology company specializing in immuno-oncology drug development, jointly established by Yuhan Corporation of Korea and a Nasdaq-listed Sorrento Therapeutics in the US. In addition to IMC-001, ImmuneOncia has a wide range of new products in the pipeline, such as IMC-002, a CD47 antibody, and IMC-201, a bispecific antibody.

On December 5, 2022 Agendia, Inc., a leader in gene expression profiling for early-stage breast cancer, reported that it has received acceptance for all six abstract submissions that will help guide the future of personalized cancer care and will be presented at the 2022 San Antonio Breast Cancer Symposium (SABCS) (Press release, Agendia, DEC 5, 2022, View Source [SID1234624815]). These studies focus on the impact of MammaPrint and BluePrint test results, unveiling the underlying biology of a breast cancer patient’s unique tumor to help inform more personalized treatment decisions. The data reaffirm Agendia’s commitment to driving the science behind early-stage breast cancer, so women and their providers have access to an accurate assessment of the tumor’s risk of metastasizing, and of which molecular pathway is driving that tumor’s growth. These informative insights come from Agendia’s proprietary signature derived directly from the tumor’s biology and go beyond conventional methods.

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Three of the studies Agendia will present are based on its FLEX trial, the largest real-world evidence database of patients with early-stage breast cancer. With over 10,000 patients enrolled, the FLEX trial allows researchers to conduct sub-studies in parallel to uncover new genomic trends and produce practice-changing results that can improve the lives of women. Because many breast cancer trials lack the diversity needed to adequately inform clear guidance on treatment recommendations for minority groups, FLEX’s inclusion of both genomic data and clinical data across a true representation of the population allows for a critical focus on the needs of diverse, marginalized patient groups.

"The value of unbiased genomic data lies in tailoring treatment plans for each individual tumor with unprecedented precision. The research derived from our FLEX trial is a key example of the type of advancements in breast cancer Agendia is helping to fuel. These critical discoveries will improve the future of personalized care for all women with breast cancer, including those who are often underrepresented in genomic studies," said William Audeh, MD, Chief Medical Officer at Agendia.

Agendia’s Spotlight Poster will showcase one such sub-study on Wednesday, December 7th at 5pm CT, "ImPrint immune signatures in 10,000 early-stage breast cancer patients from the real-world FLEX database." Dr. Adam Brufsky, Professor and Associate Chief of Hematology and Oncology at UPMC Hillman Cancer Center will present research that found Agendia’s 53-gene signature ImPrint test identified women who may benefit from immune therapy, supporting the potential use of checkpoint inhibitors, especially among populations who are underrepresented in clinical trials, including pre-menopausal patients, Black and Latina women.

Additional research areas where Agendia is advancing breast cancer research will be presented through the following FLEX sub-studies:

"FLEX: 30K transcriptome, real-world evidence database for early-stage breast cancer and investigator initiative protocols," presented on Wednesday, December 7th at 5pm CT, by Dr. Alejandra Perez, a medical oncologist from the University of Miami Hospital. Dr. Perez and the FLEX Investigators will detail the methods behind building the FLEX registry and highlight its impact on fast data generation for underserved research areas and on advancing widespread understanding of tumor biology.

"Impact of neoadjuvant endocrine therapy on tumor transcriptome in patients with early-stage breast cancer from the FLEX trial," presented on Thursday, December 8th at 5pm CT, by Dr. Mehran Habibi, Associate Professor of Surgery at Johns Hopkins University. This study evaluated the genomic effect of short-term neoadjuvant endocrine therapy (NET) in early-stage breast cancer tumors and discovered MammaPrint test results can predict patient response within a shorter timeframe than the several months it typically takes to observe immediate genomic changes.

"As the amount of robust gene expression profiling data available for research grows, so does its influence on the way we treat early-stage breast cancer tumors, and on the outcomes of millions of women with breast cancer seeking evidence-based, personalized care plans," said Dr. Adam Brufsky. "By opening up a world of data that otherwise would have been nearly impossible to gather via traditional trial recruitment, we grow our collective understanding of tumor biology and can give patients the confidence they need to trust our treatment planning decisions."

In addition to research from the FLEX database, the following three presentations will help inform personalized treatment decisions:

"Utility of the 70-gene signature and 10-year follow up in patients with early-stage breast cancer in a single institution study," presented on Thursday, December 8th at 7am CT, by Dr. Nasrazadani, Assistant Professor in the Department of Breast Medical Oncology at The University of Texas MD Anderson Cancer Center, and Dr. Adam Brufsky. The presentation will detail findings of a retrospective analysis of women with early-stage breast cancer whose treatment plans may have changed if they had a MammaPrint test result.
On Thursday, December 8th at 10am CT in the Exhibit Product Theater, Dr. William Audeh will address leaders in oncology and highlight recent data in the Journal of Clinical Oncology that supports Agendia’s proven gene expression profiling tests can help inform the most effective treatment approaches for a woman’s unique cancer, regardless of age and menopausal status..
"Utility of the 70-gene MammaPrint test for prediction of extended endocrine therapy benefit in patients with early-stage breast cancer in the IDEAL Trial," presented on Friday, December 9th at 12pm CT, by Dr. Laura van’t Veer PhD, Professor Laboratory Medicine and Director Applied Genomics at the Cancer Center at UCSF and Founder of Agendia. During this oral presentation, Agendia will discuss the breakthrough findings uncovered by the IDEAL study and reiterate the impact of MammaPrint test results in identifying which post-menopausal women could benefit from extended endocrine therapy. The presentation will also share what these findings mean for the future of breast cancer care, most notably the ability to identify patients who can avoid overtreatment if there will be little predicted benefit.
To learn more about Agendia’s solutions being showcased at booth #315 at SABCS, visit View Source Follow Agendia on Twitter, Facebook and LinkedIn for updates throughout the conference.

On December 5, 2022 Endoluxe reported that it has entered into a know-how agreement with Mayo Clinic to research the use of artificial intelligence and machine learning in the fight against bladder cancer (Press release, Mayo Clinic, DEC 5, 2022, View Source [SID1234624814]). Mayo Clinic will utilize the Endoluxe Visualization System, a wireless endoscopic "smart" camera platform, and its unique edge computing attributes, which provide AI-powered clinical insights to clinicians and can lead to better patient outcomes.

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The novel Endoluxe technology platform provides clinicians real-time data and clinical insights onscreen during a surgical procedure–an important tool that no other endoscopic platform currently offers.

"Working with Mayo Clinic clinicians will further advance Endoluxe’s surgical insights capabilities. We are excited to accelerate our cutting-edge technology platform for the benefit of patients," said Dr. Phil Zhao, Chief Medical Officer at Endoluxe.

On December 5, 2022 MEI Pharma, Inc. (Nasdaq: MEIP), a pharmaceutical company focused on advancing new therapies for cancer, and Kyowa Kirin Co., Ltd. (Kyowa Kirin, TSE: 4151), a Japan-based global specialty pharmaceutical company creating innovative medical solutions utilizing the latest biotechnology, reported that after receiving the most recent guidance from a late November meeting with the U.S. Food and Drug Administration (FDA), the companies are discontinuing global development of zandelisib outside of Japan for B-cell malignancies (Press release, MEI Pharma, DEC 5, 2022, View Source [SID1234624813]). Kyowa Kirin is continuing the ongoing clinical trials including Phase 2 MIRAGE study evaluating Japanese patients with relapsed or refractory indolent B-cell non-Hodgkin lymphomas and will explore the potential for a submission to Japanese health authorities based on data from the MIRAGE and TIDAL clinical trials.

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"Based on the most recent guidance received from the FDA at a late November meeting, we have jointly decided with Kyowa Kirin to discontinue development of zandelisib outside of Japan. We are very disappointed to share this decision in light of our belief in the potential of zandelisib to benefit patients and meet the ongoing need for new options to treat relapsed or refractory indolent non-Hodgkin lymphomas," said Daniel P. Gold, Ph.D., president and chief executive officer of MEI Pharma. "However, in light of FDA’s guidance, we no longer believe clinical development can be completed within a time period that would support further investment, or with sufficient certainty of the regulatory requirements to justify continued global development efforts."

"We share MEI’s disappointment in making this decision," said Yoshifumi Torii, Ph.D., executive officer, vice president, head of R&D division of Kyowa Kirin. "However, given the Phase 2 data we previously announced on zandelisib, we still see potential to continue the program in Japan to address unmet patient needs. We are continuing the Japanese clinical trials including Phase 2 MIRAGE trial and will consult the PMDA to understand the potential it offers for a regulatory submission."

In March 2022, MEI Pharma and Kyowa Kirin reported the outcome of an end of Phase 2 meeting with the FDA wherein the agency discouraged a filing based on the single-arm Phase 2 TIDAL trial evaluating zandelisib in patients with relapsed or refractory follicular lymphoma. At this meeting, the FDA stated that a randomized trial should be used to support an initial zandelisib registration in patients with indolent non-Hodgkin lymphoma and, accordingly, data generated from single arm studies such as the Phase 2 TIDAL trial are insufficient to adequately assess the risk/benefit of PI3K inhibitors evaluating indolent non-Hodgkin lymphoma. At that time the FDA emphasized that the companies continue efforts with the ongoing randomized Phase 3 COASTAL trial evaluating patients with relapsed or refractory follicular or marginal zone lymphomas. Subsequently, at an April 2022 meeting of the FDA Oncology Drugs Advisory Committee, the committee voted that future approvals of PI3K inhibitors for hematologic malignancies should be supported by randomized data.

In late November 2022, MEI Pharma and Kyowa Kirin met with the FDA in a follow-up meeting to the March 2022 end of Phase 2 meeting. At this meeting, FDA provided further guidance regarding the design and statistical analysis for the COASTAL trial. Following the November meeting, the companies concluded that a clinical trial consistent with the recent FDA guidance, including modification of the COASTAL trial, would likely not be feasible to complete within a time period that would support further investment. As a result, global development of zandelisib for indolent forms of non-Hodgkin lymphoma, except for Japan, is being discontinued.

The discontinuation of zandelisib development outside of Japan is a business decision based on the most recent regulatory guidance from the FDA and is not related to the zandelisib clinical data generated to date. Kyowa Kirin is continuing the ongoing clinical trials including Phase 2 MIRAGE trial evaluating Japanese patients with relapsed or refractory indolent B-cell non-Hodgkin lymphomas and will explore submitting the MIRAGE and TIDAL trials for marketing authorization in Japan. MIRAGE is a Phase 2 trial, similar in design to the global Phase 2, single-arm, TIDAL trial. In November 2022 Kyowa Kirin and MEI announced positive topline data from the Phase 2 MIRAGE trial. MEI and Kyowa Kirin plan to immediately start winding-down ongoing clinical studies outside of Japan, including the Phase 3 COASTAL trial and the Phase 2 CORAL trial evaluating patients with relapsed or refractory chronic lymphocytic leukemia. Depending on the achievement of certain regulatory and commercial milestones in Japan, MEI may be eligible for additional payments from Kyowa Kirin under the current agreement. MEI may also be entitled to royalties on any sales of zandelisib in Japan.

About zandelisib

Zandelisib, a selective PI3Kδ inhibitor, is an investigational cancer treatment being developed as an oral, once-daily, treatment for patients with B-cell malignancies.

In April 2020, MEI and Kyowa Kirin entered a global license, development, and commercialization agreement to further develop and commercialize zandelisib. MEI and Kyowa Kirin were to co-develop and co-promote zandelisib in the U.S., with MEI booking all revenue from the U.S. sales. Kyowa Kirin has exclusive commercialization rights outside of the U.S.

On December 5, 2022 MEI Pharma, Inc. (Nasdaq: MEIP), a clinical-stage pharmaceutical company focused on advancing new therapies for cancer, reported that it plans to initiate a realignment of its clinical development efforts following the discontinuation of global development outside Japan of its PI3K delta inhibitor, zandelisib (Press release, MEI Pharma, DEC 5, 2022, View Source [SID1234624812]). As part of the realignment, the company plans to streamline its organization towards the development of two earlier clinical-stage assets, voruciclib and ME-344. Following completion of the workforce reductions, MEI expects its existing cash, cash equivalents and marketable securities will be sufficient to fund operations through clinical data milestones for both voruciclib and ME-344. The company further announced that it has engaged Torreya Partners as financial advisor to help explore additional strategic opportunities.

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"In light of the determination we made with our global partner, Kyowa Kirin, to discontinue development of zandelisib outside of Japan after a recent meeting with FDA, we have had to make some tough decisions. We intend to continue development of our earlier-stage clinical assets, streamline MEI’s operations towards these efforts, and consider additional strategic opportunities," said Daniel P. Gold, Ph.D., president and chief executive officer of MEI Pharma. "As we move forward with the planned development of voruciclib and ME-344, two investigational candidates representing potential treatments for various hematological and solid tumor cancers, I want to express my deep gratitude to the MEI team. I am very proud of our work, and the simply exemplary efforts, to develop zandelisib. I also want to recognize the collaborative efforts of our partner, Kyowa Kirin, and sincerely thank all the healthcare providers and patients that contributed to zandelisib’s development."

Expected Drug Candidate Pipeline Developments

Voruciclib – Oral cyclin-dependent kinase 9 (CDK9) inhibitor for the treatment of B-cell malignancies and acute myeloid leukemia, as well as solid tumors.

After initiating dosing of the first patient in November, continue advancing the dosing of patient cohorts evaluating voruciclib in combination with Venclexta (venetoclax) in patients with acute myeloid leukemia in the ongoing Phase 1 study.
Provide a clinical data update in CY2023.
Continue preclinical evaluation of the role CDK9 in cMYC regulation in solid tumors expressing KRAS mutations to support potential clinical development as a treatment for solid tumors.
ME-344 – Tumor selective mitochondrial inhibitor for the treatment of solid tumors.

Initiate a Phase 1b study evaluating ME-344 plus Avastin (bevacizumab) in relapsed colorectal cancer patients in the first half of calendar year 2023.
Strategic Realignment Overview

MEIP plans to streamline its organization towards the continued clinical development of voruciclib and ME-344. As a result, it plans to initiate a staggered workforce reduction, initially representing approximately 30% of the current workforce in connection with the wind down of the zandelisib development program outside of Japan, which costs are shared with Kyowa Kirin, our global development partner. Following completion of the zandelisib wind down and associated workforce reductions, MEI expects that, along with any additional workforce reductions to be determined to fully align resources going forward, its existing cash, cash equivalents and marketable securities will be sufficient to fund operations through clinical data milestones for both voruciclib and ME-344.

About Voruciclib

Voruciclib is an orally administered Cyclin-dependent kinase 9 (CDK9) inhibitor being clinically investigated for hematological malignancies. Potential applications in solid tumors are also being actively explored. CDK9 has important functions in cell cycle regulation, including the modulation of two therapeutic targets in cancer: myeloid leukemia cell differentiation protein ("MCL1") and the MYC proto-oncogene protein ("MYC") which regulates cell proliferation and growth. Voruciclib is currently being evaluated in a Phase 1b trial evaluating dose and schedule in patients with acute myeloid leukemia ("AML") and B-cell malignancies. Applications in solid tumors are also being considered where MYC is dysregulated.

About ME-344

ME-344 is a tumor selective mitochondrial inhibitor drug candidate targeting the OXPHOS pathway involved in the production of adenosine triphosphate, or ATP, in the mitochondria. It is in clinical development to treat solid tumors. Although clinical investigation of ME-344 has demonstrated single agent activity in patients with solid tumors, using it in combination with other cancers therapies is thought to hold more significant potential for patients. Data reported at the 2018 ASCO (Free ASCO Whitepaper) conference from an investigator-initiated, multi-center, randomized study of ME-344 in combination with the VEGF inhibitor bevacizumab (Avastin) in women with demonstrated biologic activity in the ME-344 treatment group supporting further clinical investigation.