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 Innate Pharma SA (Euronext Paris: IPH; Nasdaq: IPHA) ("Innate" or the "Company") reported that it will present new data from the Phase 2 expansion cohort (‘cohort 3’) exploring the triplet combination of monalizumab, cetuximab and durvalumab, in first-line IO and chemo-naïve patients with recurrent or metastatic head and neck squamous cell cancer (R/M SCCHN) at the ESMO (Free ESMO Whitepaper) Immuno-oncology Congress 2021, being held virtually from December 8-11 2021 (Press release, Innate Pharma, DEC 2, 2021, View Source [SID1234596396]).

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Monalizumab, Innate’s lead partnered asset, is a potentially first-in-class immune checkpoint inhibitor targeting NKG2A receptors expressed on tumor-infiltrating cytotoxic CD8+ T cells and NK cells.

Additionally, Pr. Eric Vivier, Ph.D., DVM, Chief Scientific Officer at Innate Pharma, will present in the NK cell biology educational session. Details can be found below.

Presentation Details:

Monalizumab: The oral presentation (#123MO) entitled, "Monalizumab, cetuximab and durvalumab in first-line treatment of recurrent or metastatic squamous cell carcinoma of the head and neck (R/M SCCHN): a phase 2 trial," will be presented from 12:15-12:20 pm CET on December 9, 2021.
NK cells: Prof. Vivier will discuss Innate’s multi-specific NK cell engager platform, ANKETTM (Antibody-based NK cell Engager Therapeutics), in the educational session entitled, "NK cells biology and therapeutic opportunities, innate immunity, adaptive immunity" from 11:40 – 12 pm CET on December 9, 2021.
About Monalizumab:

Monalizumab is a potentially first-in-class immune checkpoint inhibitor targeting NKG2A receptors expressed on tumor-infiltrating cytotoxic CD8+ T cells and NK cells.

NKG2A is an inhibitory checkpoint receptor for HLA-E. By expressing HLA-E, cancer cells can protect themselves from killing by NKG2A+ immune cells. HLA-E is frequently overexpressed in the cancer cells of many solid tumors and hematological malignancies. Monalizumab may re-establish a broad anti-tumor response mediated by NK and T cells and may enhance the cytotoxic potential of other therapeutic antibodies1.

AstraZeneca obtained full oncology rights to monalizumab in October 2018 through a co-development and commercialization agreement initiated in 2015. The ongoing development for monalizumab is focused on investigating monalizumab in various combination strategies in different malignancies.

About ANKETTM:

ANKETTM (Antibody-based NK cell Engager Therapeutics) is Innate’s proprietary platform for developing next-generation, multi-specific natural killer (NK) cell engagers to treat certain types of cancer. The Company’s latest innovation, its tetra-specific ANKETTM molecule, is the first NK cell engager technology to engage two NK cell-activating receptors (NKp46 and CD16), a tumor antigen and the interleukin-2 receptor (by an IL-2 variant, IL-2v), via a single molecule. This molecule leverages the advantages of harnessing NK cell effector functions against cancer cells and also provides proliferation and activation signals targeted to NK cells.

In pre-clinical studies, Innate’s tri-2 and tetra-specific ANKETTM technologies promote potent NK cell activation, cytotoxicity and efficient control of tumor growth in pre-clinical models. This versatile fit-for-purpose technology is creating an entirely new class of molecules to induce synthetic immunity against cancer.

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 SQZ Biotechnologies Company (NYSE: SQZ), a cell therapy company developing novel treatments for multiple therapeutic areas, reported interim results from the highest-dose monotherapy cohort of its ongoing Phase 1/2 clinical trial of SQZ-PBMC-HPV, an investigational cell therapy being evaluated in certain patients with advanced or metastatic Human Papillomavirus positive (HPV16+) solid tumors (Press release, SQZ Biotech, DEC 2, 2021, View Source [SID1234596397]). In an abstract published today by the European Society for Medical Oncology Immuno-Oncology (ESMO-IO) Congress, taking place December 8-11, the company reported that a highly treatment experienced patient in the highest-dose cohort demonstrated a radiographic response in conjunction with substantial increases in CD8 T cell tumor infiltration and PD-L1 expression – both markers of tumor inflammation. The cell therapy was generally well tolerated and no dose limiting toxicities were observed in the final monotherapy stage of the trial.

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"We are excited to present detailed interim clinical findings from the highest dose monotherapy cohort of our ongoing SQZ-PBMC-HPV Phase 1/2 study at ESMO (Free ESMO Whitepaper)-IO," said Armon Sharei, Ph.D., Chief Executive Officer and Founder of SQZ Biotechnologies. "These data build upon the initial readout in lower dose cohorts presented at the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) annual conference earlier this year. The latest clinical response data and biomarker findings further increase our enthusiasm for the SQZ APC program as we advance into the combination stage with checkpoint inhibitors."

Data on the highest dose cohort of SQZ-PBMC-HPV-101, including biomarker and tumor response findings, will be shared as an oral presentation at ESMO (Free ESMO Whitepaper)-IO on December 9. See presentation information below.

The combination stage of the trial is enrolling with checkpoint inhibitors targeting the PD-(L)1 and CTLA-4 pathways. Available clinical trial data and scientific literature suggest that SQZ APCs could work synergistically with checkpoint inhibitors due to their CD8 tumor infiltrating lymphocytes (TIL) driving mechanism.

Trial Highlights from ESMO (Free ESMO Whitepaper) IO Abstract 565

SQZ-PBMC-HPV-101 Phase 1/2 trial has four dose-escalating monotherapy cohorts ranging from 0.5 to 5.0 x10e6 cells per kg
A total of 18 patients were treated across four cohorts and patients had an average of 3.5 prior lines of systemic cancer therapy
Across all cohorts the investigational therapy was generally well-tolerated, and no dose-limiting toxicities were observed
No grade 2 or higher treatment-related severe adverse events, or grade 3 adverse events, were observed in the highest-dose cohort
In the highest-dose cohort with five patients evaluable, one patient who had been heavily treated with PD-1 inhibitors before entering the trial demonstrated radiographic response as well as substantial increases in CD8 T cell tumor infiltration and PD-L1 expression
The highest-dose monotherapy stage continues enrollment to further characterize the investigational therapy in single agent settings.

ESMO-IO Presentation Details

Oral Presentation: Thursday, December 9 at 12:10 pm CET
Presentation Number: 48MO
Abstract Title: SQZ-PBMC-HPV-101: Preliminary results of a first-in-human, dose-escalation study of a cell-based vaccine in HLA-A*02+ patients with recurrent, locally advanced, or metastatic HPV16+ solid tumors

Lead Author: Jong Chul Park, MD, Medical Oncologist and Investigator, Massachusetts General Hospital Cancer Center

The ESMO (Free ESMO Whitepaper)-IO presentation will be on the Events & Presentations section of the company’s website on December 9 at 12:10 pm CET.

Conference Call
The company will host a conference call and webcast at 8:00 a.m. ET on Thursday, December 9 to discuss the ESMO (Free ESMO Whitepaper)-IO presentation. Participants can join via webcast link or by dialing 1-877-805-7920 (domestic) or 1-629-228-0702 (international) five minutes prior to the start of the call. An archived webcast will be accessible for 90 days after the event.

SQZ-PBMC-HPV-101 Trial Design
SQZ-PBMC-HPV is being evaluated in a Phase 1/2 clinical trial for the treatment of HPV16+ advanced or metastatic solid tumors. Patients must be positive for the human leukocyte antigen serotype HLA-A*02. The investigational candidate, which targets E6 and E7 oncoproteins, is being studied as a monotherapy and in combination with immuno-oncology agents. The study’s primary outcome measures in the monotherapy and combination phases of the trial include safety and tolerability. Antitumor activity is a secondary outcome measure in both the monotherapy and combination stages of the trial, and manufacturing feasibility is a secondary outcome measure in the monotherapy phase of the trial. The monotherapy phase of the study includes escalating dose cohorts with a dose-limiting toxicity (DLT) window of 28 days and is designed to identify a recommended phase 2 dose. The planned combination phase of the study will include SQZ-PBMC-HPV and checkpoint inhibitors. DLT will be measured over 42 days.

About Human Papillomavirus Positive Cancers
Human papillomavirus (HPV) is one of the most common viruses worldwide and certain strains persist for many years leading to cancer. According to the Centers for Disease Control (CDC), in the United States HPV+ tumors represent 3% of all cancers in women and 2% of all cancers in men, resulting in over 39,000 new cases of HPV+ tumors every year. HPV infection is larger outside of the U.S., and according to the International Journal of Cancer HPV+ tumors account for 4.5% of all cancers worldwide, resulting in approximately 630,000 new cases every year. According to the CDC, HPV infection plays a significant role in the formation of more than 90% of anal and cervical cancers, and most cases of vaginal (75%), oropharyngeal (70%), vulval (70%) and penile (60%) cancers.

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.