On December 2, 2021 BeiGene (NASDAQ:BGNE; HKEX:06160), a global science-driven biotechnology company focused on developing innovative and affordable medicines to improve treatment outcomes and access for patients worldwide, reported that three of its medicines have been added to the most recent National Reimbursement Drug List (NRDL) in China by the National Healthcare Security Administration (NHSA) (Press release, BeiGene, DEC 2, 2021, View Source [SID1234596416]). BeiGene-discovered medicines in the updated NRDL include: anti-PD-1 antibody tislelizumab in three new indications, including in lung and liver cancers; BTK inhibitor BRUKINSA (zanubrutinib) in one new indication; and the initial listing for PARP inhibitor pamiparib. The changes to the NRDL will be effective on January 1, 2022.

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"The inclusion of our three internally-discovered innovative medicines in the latest NRDL will help expand access to these high-quality oncology treatments across China at affordable prices and reduce the financial burden for patients and their families"

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"The inclusion of our three internally-discovered innovative medicines in the latest NRDL will help expand access to these high-quality oncology treatments across China at affordable prices and reduce the financial burden for patients and their families," commented Xiaobin Wu, Ph.D., President of BeiGene, Chief Operating Officer, and General Manager of China. "Since its establishment, the NHSA has accelerated the frequency of adjustment to the NRDL, forming a dynamic mechanism for annual updates. Through the establishment of a comprehensive healthcare system, life-saving innovative oncology medicines are now more quickly included in the NRDL at affordable prices, covering different types of medical care and providing benefits for people living with cancer. As an innovative company with strong R&D capabilities and global reach, BeiGene is working to change the status quo in the field of treatment and fill the gap in clinical treatment options. We look forward to working with the NHSA to fulfill the demand for these treatments across China as soon as possible."

The following indications have been included in the updated NRDL:

Tislelizumab is now included in the NRDL in all five of its approved indications – three new indications in 2021 and two indications included last year:
For use in combination with pemetrexed and platinum chemotherapy as a first-line treatment in patients with unresectable, locally advanced or metastatic non-squamous non-small cell lung cancer (NSCLC), with EGFR genomic tumor aberrations negative and ALK genomic tumor negative (approved in June 2021 and included in the NRDL in 2021);
For the treatment of patients with hepatocellular carcinoma (HCC) who have been previously treated with at least one systemic therapy (conditionally approved in June 2021 and included in the NRDL in 2021);
For use in combination with paclitaxel and carboplatin as a first-line treatment in patients with unresectable, locally advanced or metastatic squamous NSCLC (approved in January 2021 and included in the NRDL in 2021);
For the treatment of patients with locally advanced or metastatic urothelial carcinoma (UC) with PD-L1 high expression whose disease progressed during or following platinum-containing chemotherapy or within 12 months of neoadjuvant or adjuvant treatment with platinum-containing chemotherapy (conditionally approved in April 2020 and included in NRDL in 2020); and
For the treatment of patients with classical Hodgkin’s lymphoma (cHL) who have received at least two prior therapies (conditionally approved in December 2019 and included in the NRDL in 2020).
BRUKINSA is now included in the NRDL in all three of its approved indications – one new indication in November 2021 and two indications included last year:
For the treatment of adult patients with Waldenström’s macroglobulinemia (WM) who have received at least one prior therapy (conditionally approved in June 2021 and included in the NRDL in 2021);
For the treatment of adult patients with mantle cell lymphoma (MCL) who have received at least one prior therapy (conditionally approved in June 2020 and included in the NRDL in 2020); and
For the treatment of adult patients with chronic lymphocytic leukemia (CLL) /small lymphocytic lymphoma (SLL) who have received at least one prior therapy (conditionally approved in June 2020 and included in the NRDL in 2020).
Pamiparib is initially included in the NRDL in its approved indication:
For the treatment of patients with germline BRCA (gBRCA) mutation-associated recurrent advanced ovarian, fallopian tube, or primary peritoneal cancer who have been treated with two or more lines of chemotherapy (conditionally approved in May and included in the NRDL in 2021).
About Tislelizumab

Tislelizumab is a humanized IgG4 anti-PD-1 monoclonal antibody specifically designed to minimize binding to FcγR on macrophages. In pre-clinical studies, binding to FcγR on macrophages has been shown to compromise the anti-tumor activity of PD-1 antibodies through activation of antibody-dependent macrophage-mediated killing of T effector cells. Tislelizumab is the first approved medicine from BeiGene’s immuno-oncology biologics portfolio and is being further developed globally as a monotherapy and in combination with other agents for the treatment of a broad array of both solid tumor and hematologic cancers.

The China National Medical Products Administration (NMPA) has approved tislelizumab in five indications, including full approval for first-line treatment of patients with advanced squamous NSCLC in combination with chemotherapy and for first-line treatment of patients with advanced non-squamous NSCLC in combination with chemotherapy. NMPA also granted conditional approval for the treatment of patients with cHL who received at least two prior therapies, for the treatment of patients with locally advanced or metastatic UC with PD-L1 high expression whose disease progressed during or following platinum-containing chemotherapy or within 12 months of neoadjuvant or adjuvant treatment with platinum-containing chemotherapy, and for the treatment of patients with HCC who have received at least one systemic therapy. Full approval for these indications is contingent upon results from ongoing randomized, controlled confirmatory clinical trials.

In addition, four supplemental Biologics License Applications for tislelizumab are under review by the Center for Drug Evaluation (CDE) of the NMPA and are under review for second- or third-line treatment of patients with locally advanced or metastatic NSCLC who progressed on prior platinum-based chemotherapy, for patients with previously treated, locally advanced unresectable or metastatic microsatellite instability-high (MSI-H) or mismatch repair-deficient (dMMR) solid tumors, for the treatment of patients with locally advanced or metastatic esophageal squamous cell carcinoma (ESCC) who have disease progression following or are intolerant to first-line standard chemotherapy, and for the first-line treatment of patients with recurrent or metastatic nasopharyngeal cancer (NPC).

In the United States, a Biologics License Application for tislelizumab as a treatment for patients with unresectable recurrent locally advanced or metastatic ESCC after prior systemic therapy is currently under review by the U.S. Food and Drug Administration with a PDUFA target action date of July 12, 2022. BeiGene has initiated or completed 17 potentially registration-enabling clinical trials in China and globally, including 13 Phase 3 trials and four pivotal Phase 2 trials. In January 2021, BeiGene and Novartis entered into a collaboration and license agreement granting Novartis rights to develop, manufacture, and commercialize tislelizumab in North America, Europe, and Japan. Tislelizumab is not approved for use outside of China.

About BRUKINSA (zanubrutinib)

BRUKINSA (zanubrutinib) is a small molecule inhibitor of Bruton’s tyrosine kinase (BTK) discovered by BeiGene scientists that is currently being evaluated globally in a broad clinical program as a monotherapy and in combination with other therapies to treat various B-cell malignancies. Because new BTK is continuously synthesized, BRUKINSA was specifically designed to deliver complete and sustained inhibition of the BTK protein by optimizing bioavailability, half-life, and selectivity. With differentiated pharmacokinetics compared to other approved BTK inhibitors, BRUKINSA has been demonstrated to inhibit the proliferation of malignant B cells within a number of disease relevant tissues.

BRUKINSA is approved in one or more indications in a total of 40 countries and regions, including the United States, China, the European Union, Australia and Canada. To date, more than 20 marketing authorization applications have been submitted for BRUKINSA for various indications.

About Pamiparib

Pamiparib is an inhibitor of PARP1 and PARP2 which has demonstrated pharmacological properties such as brain penetration and PARP-DNA complex trapping in preclinical models. Discovered by BeiGene scientists, pamiparib was the first PARP inhibitor approved in both platinum-sensitive and platinum-resistant relapsed ovarian cancer in China. Pamiparib is currently being evaluated globally as a monotherapy or in combination with other agents for a variety of solid tumor malignancies.

In China, pamiparib received conditional approval for the treatment of patients with germline BRCA (gBRCA) mutation-associated recurrent advanced ovarian, fallopian tube, or primary peritoneal cancer who have been treated with two or more lines of chemotherapy in May 2021. Full approval for this indication is contingent upon results from ongoing corroborative trials confirming the clinical benefit of pamiparib in this population.

On December 2, 2021 Munich Reinsurance Company’s Canadian life branch (Munich Re) reported that partnership with the McGill University Health Centre (MUHC) Foundation to advance cutting-edge cardiovascular disease research (Press release, McGill University, DEC 2, 2021, View Source [SID1234596415]). As part of this partnership, Munch Re will help fund an innovative research project at the cutting-edge of science, MyHeart Counts Canada. In addition, Munich Re will collaborate with the project’s lead investigator, Abhinav Sharma MD, PhD., to incorporate an insurance cohort into the study to help fuel better outcomes for insured populations.

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MyHeart Counts is a revolutionary smartphone app created at Stanford University in the United States as part of a research study to understand better how to keep hearts healthy. It allows users to see how their physical activity and lifestyle affect their cardiovascular health by tracking their movement using their phone or wearable fitness tracker. The app then provides assessments that measure risk and teaches users how to improve their heart health.

Dr. Sharma, a cardiologist at the McGill University Health Centre (MUHC) in Montreal, was part of the Stanford team that created MyHeart Counts, and now he is bringing the app to Canadians. MyHeart Counts Canada will improve the heart health of Canadians from coast to coast while allowing Dr., Sharma and his team to gain a deeper understanding of the factors that lead to cardiovascular disease – one of the leading causes of death in Canada.

"Munich Re is proud to partner with the MUHC Foundation and support this innovative research project spearheaded by Dr. Sharma," said Bernard Naumann, President and CEO, Munich Re, Canada (Life). "The utilization of digital health technologies to improve cardiovascular health is an important area of interest for us. As one of the world’s leading life reinsurers, we constantly strive to improve our knowledge of cardiovascular disease in its myriad manifestations, and apply these advances in our risk assessment paradigm. We look forward to understanding how digital technologies will improve cardiovascular outcomes and ultimately both the quality of life and life expectancy"

Dr Sharma added, "I am grateful to Munich Re for supporting the development of MyHeart Counts Canada. Cardiovascular disease kills millions of people worldwide each year, and their generous support will help us better understand why heart disease develops and what we can do to prevent it."

"Munich Re’s investment in and support of MyHeart Counts Canada has the potential to change the lives of millions. While the app will benefit its users in the short term, the new insights into cardiovascular disease prevention will benefit everyone, now and in the future," commented Julie Quenneville, President, and CEO, McGill University Health Centre Foundation.

On December 2, 2021 Paige, the global leader in AI-based diagnostic software in pathology, reported that the United Kingdom’s National Institute for Health and Care Excellence (NICE) published a Medtech Innovation Briefing (MIB) on Paige Prostate, a clinical-grade artificial intelligence (AI)-based diagnostic software system that aids pathologists in detecting, grading and measuring prostate tumors in biopsies obtained from patients at risk of prostate cancer (Press release, Paige AI, DEC 2, 2021, View Source [SID1234596414]).* This marks the first-ever MIB for a digital pathology product.

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NICE conducted a systematic literature review and thoroughly evaluated five peer-reviewed clinical utility studies that included a total of 3,444 prostate needle biopsies. Based on the evidence evaluated, Paige Prostate may be an effective addition to standard care to increase sensitivity in detecting prostate cancer, and it may also help more efficient analysis to support the demands of high caseloads in the field.

"We are pleased that NICE has conducted a fastidious review of the available clinical literature on Paige Prostate, guided by neutrality and the strictest criteria," said David Klimstra, M.D., Co-Founder and Chief Medical Officer at Paige. "This MIB will help decision makers in the NHS and beyond to assess the value and potential of Paige Prostate."

MIBs are commissioned by the National Health Service (NHS) in England and are designed to support NHS and social care commissioners and staff who are considering using new medical devices. The briefing includes a description of Paige Prostate technology, how it is used, clinical and technical evidence and perspectives from expert pathologists consulted in the development of the MIB.

"Ultimately, we aim to measurably improve outcomes and experiences for patients, which is why we developed Paige Prostate to have the highest standards of performance and robustness. This first-ever digital pathology NICE advice for clinicians will further help bring these systems into real-world clinical use to fully realize their potential," said Thomas J. Fuchs, Dr.Sc., Co-Founder and Chief Scientist at Paige, and Dean of Artificial Intelligence and Human Health at Mount Sinai. "We are pleased to see that the UK is leading the way in the adoption of digital pathology tools. This NICE advice provides important information to clinicians so that they access essential information on this system was developed, and its potential to further impact routine clinical practice."

Additionally, Paige is currently working with Oxford University and regional NHS partners to study Paige Prostate prospectively in a real-world pathology laboratory setting and generate new health economics evidence as part of a successful Phase 4 NHSx Artificial Intelligence Health and Care Award.

Read the full MIB here: View Source

* In the U.S., Paige received FDA market authorization to assist pathologists in the detection of foci that are suspicious for prostate cancer. Outside of the U.S., Paige Prostate is CE-marked for the detection, grading and quantification of prostate tumors for use in laboratories and hospitals in the European Economic Area, Switzerland and the UK. FullFocus is FDA cleared and CE-marked. The products are otherwise available for research use only in other territories.

On December 2, 2021 Epizyme, Inc. (Nasdaq: EPZM), a fully integrated, commercial-stage biopharmaceutical company developing and delivering transformative therapies against novel epigenetic targets, reported that new data from across its oncology portfolio will be presented at the upcoming 63rd American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting, taking place from December 11 to 14, 2021 in Atlanta, Georgia (Press release, Epizyme, DEC 2, 2021, View Source [SID1234596413]). These presentations include trial design and data from combination studies evaluating tazemetostat in follicular lymphoma, as well as new preclinical data on EZM0414, the Company’s novel, first-in-class, oral SETD2 inhibitor, an investigational agent being evaluated for the treatment of adult patients with relapsed or refractory multiple myeloma or with diffuse large B-cell lymphoma (DLBCL).

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"We look forward to sharing the latest data from our growing oncology portfolio with the hematology community at this year’s meeting, including updated data from the Phase 1b portion of our Phase 1b/3 confirmatory study, SYMPHONY-1, which is evaluating the safety and optimal dose of tazemetostat plus Revlimid and Rituximab (R2). We will also be presenting preclinical data for EZM0414, our novel, first-in-class, oral SETD2 inhibitor development candidate; these data provided the rationale for our Phase 1/1b study with EZM0414, and we will be sharing the trial design in a "Trial-In-Progress" poster as well," said Dr. Shefali Agarwal, Executive Vice President and Chief Medical and Development Officer. "These data will add to our knowledge of the important role epigenetics plays in B-cell malignancies, and we are excited about the potential that targeting epigenetic regulators may hold for patients living with blood cancers."

Details of the poster presentations are listed below:

TAZEMETOSTAT

Tazemetostat is a first-in-class, oral, selective inhibitor of EZH2, which is an epigenetic regulator of B-cell identity and plays a role in both normal B-cell biology and the pathogenesis of follicular lymphoma. The interim data analysis being presented highlights the potential of tazemetostat as a backbone of combination therapies for patients living with follicular lymphoma, and includes updated safety run-in data from the Phase 1b portion of the confirmatory SYMPHONY-1 study, in addition to study follow-up on 40 patients treated with tazemetostat in combination with R2. Additional presentations include trial design details of ongoing SYMPHONY-2, a Phase 2 study evaluating tazemetostat in combination with rituximab, as well as an analysis of the molecular and genetic characterization of patients treated with tazemetostat to better understand the drivers of response to treatment.

Title: Interim Analysis of the Randomized Phase 1b/3 Study Evaluating the Safety and Efficacy of Tazemetostat Plus Lenalidomide and Rituximab in Patients with Relapsed/Refractory Follicular Lymphoma
Presenter: Connie Lee Batlevi MD, PhD, Medical Oncologist, Memorial Sloan Kettering Cancer Center
Abstract No: 2207
Date: Sunday, December 12, 2021, 6:00 PM-8:00 PM
Location: Hall B5 (Georgia World Congress Center)
Title: Trial in Progress: A Phase 2, Single-Arm, Open-Label, Multicenter Study of Tazemetostat in Combination with Rituximab for the Treatment of Relapsed or Refractory Follicular Lymphoma
Presenter: Krish Patel, MD, Director of Lymphoma, Swedish Cancer Institute
Abstract No: 3541
Date: Monday, December 13, 2021: 6:00 PM-8:00 PM
Location: Hall B5 (Georgia World Congress Center)
Title: Molecular and Genetic Characterization of Tumor Samples from Patients with Relapsed or Refractory Follicular Lymphoma Identifies Factors Influencing Response to Tazemetostat
Presenter: Sandeep Dave, MD, MS, Associate Professor, Division of Hematologic Malignancies & Cellular Therapy, Department of Medicine at Duke Cancer Institute
Abstract No: 1183
Date: Saturday, December 11, 2021: 5:30 PM-7:30 PM
Location: Hall B5 (Georgia World Congress Center)
EZM0414

SETD2 is a histone methyltransferase, similar to EZH2, which plays multiple important roles in oncogenesis. The preclinical data to be presented focus on the pharmacologic inhibition of SETD2 by investigational agent EZM0414, as a potential therapeutic strategy in multiple myeloma and DLBCL. These data provided the rationale for the SET-101 study, the first-in-human Phase 1/1b clinical trial designed to evaluate safety and determine the optimal dose of EZM0414. Following this dose-ranging phase, the study will be expanded to evaluate EZM0414 in three patient cohorts: t(4;14) multiple myeloma, non t(4;14) multiple myeloma, and DLBCL.

Title: A Phase 1/1b Open-Label, Multicenter, Two-Part Study of SETD2 Inhibitor EZM0414 in Patients with Relapsed/Refractory Multiple Myeloma or Diffuse Large B-Cell Lymphoma
Presenter: Paul G. Richardson, MD, Medical Oncologist at Dana-Farber Cancer Institute
Abstract No: 1679
Date: Saturday, December 11, 2021: 5:30 PM to 7:30 PM ET
Location: Hall B5 (Georgia World Congress Center)
Title: Pharmacologic Inhibition of the Histone Methyltransferase SETD2 with EZM0414 As a Novel Therapeutic Strategy in Relapsed or Refractory Multiple Myeloma and Diffuse Large B-Cell Lymphoma
Presenter: Jennifer Totman, Principal Scientist at Epizyme
Abstract No: 1142
Date: Saturday, December 11, 2021: 5:30 PM to 7:30 PM ET
Location: Hall B5 (Georgia World Congress Center)
Revlimid + Rituximab (R2) is a registered trademark of Celgene Corporation, a Bristol Myers Squibb company.

On December 2, 2021 InteRNA Technologies, a clinical-stage biotech company developing microRNA (miRNA)-based therapeutics with a focus on cancer, reported it received Investigational New Drug (IND) clearance from the U.S. Food and Drug Administration (FDA) for the company’s Phase I clinical trial evaluating lead miRNA candidate, INT-1B3, in patients with advanced solid tumors (Press release, InteRNA Technologies, DEC 2, 2021, View Source [SID1234596412]). INT-1B3 is a lipid nanoparticle (LNP) formulated, chemically modified mimic of the endogenous tumor suppressor, miR-193a-3p, and represents a promising novel therapeutic approach that is designed to simultaneously address multiple hallmarks of cancer.

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The IND approval enables InteRNA to expand the number of clinical sites and to facilitate the enrollment of patients for the dose expansion (Phase Ib) part of the trial in the United States. The first part of the Phase I trial was initiated in Europe at the beginning of 2021, with the dosing of the first patient in the dose escalation (Phase Ia) part in February. The treatment of the first patient in the Phase Ib cohort is planned for the second half of 2022.

"Receiving such a positive outcome from the FDA shortly after submitting a full IND application is a major achievement for us," commented Laurens van Pinxteren, Chief Operating Officer of InteRNA. "It underlines the high potential of our novel miRNA-based approach that enables us to address the multi-facetted disease cancer from different angles with one drug providing a novel therapeutic entity to patients with hard-to-treat solid tumors, such as advanced breast cancer or hepatocellular carcinoma."

Roel Schaapveld, CEO of InteRNA, added: "The IND approval enables us to enroll an international, diversified patient population, marking significant progress in the clinical evaluation of our novel therapeutic modality. The rapid, positive feedback by the FDA is highly encouraging and we look forward to start patient recruitment in the United States next year."

The multicentric, open-label, multiple ascending dose Phase I/Ib trial (NCT04675996) will investigate the safety, pharmacokinetics, pharmacodynamics and preliminary efficacy of INT-1B3 in patients with advanced solid tumors. The study is expected to enroll a total of up to 80 patients at up to 15 clinical centers in the United States and Europe. The Phase Ia part of the trial is currently ongoing in the Netherlands and Belgium and will enroll approximately 30 patients with advanced solid tumors. In the second part (Phase Ib) of the trial, approximately 50 patients with hepatocellular carcinoma or triple negative breast cancer will be enrolled in the United States and Europe. Topline results from the Phase Ia part of the study are expected in the first half of 2022.

About INT-1B3

INT-1B3’s unique mechanism of action addresses multiple hallmarks of cancer simultaneously. It directly targets tumor cells and the tumor microenvironment by specific modulation of multiple signaling pathway components across the PTEN tumor suppressor pathway and the oncogenic PI3K/Akt and Ras/MAPK pathways resulting in inhibition of proliferation and migration and induction of cell cycle arrest and apoptosis. The triggering of the immunogenic tumor cell death (ICD) process as well as downregulation of the adenosine-A2A receptor pathway through inhibition of CD39/CD73 leads to a decrease in immunosuppressive FoxP3/Lag3 regulatory T cells and monocytic myeloid-derived suppressor cells (mMDSCs), and maturation of dendritic cells. As a result, the immune system is activated, and long-term immunity is triggered by recruitment of CD8+ effector T cells leading to decreased metastasis development and improved animal survival compared to anti-PD1 treatment.