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.

On December 2, 2021 CTI BioPharma Corp. (NASDAQ: CTIC) reported that management will provide a corporate overview at the JMP Securities Hematology & Oncology Summit at 3:40 p.m. ET (Press release, CTI BioPharma, DEC 2, 2021, View Source [SID1234596395]). The conference will be held in a virtual meeting format.

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Presentation details:
Event: JMP Securities Hematology & Oncology Summit
Date: Monday, December 6, 2021
Time: 3:40 p.m. ET

The presentation will be webcast live and available for replay from the Investors section of CTI BioPharma’s website at www.ctibiopharma.com.

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.