1stOncology™: Cancer Intelligence Service – Page 11837 – 1stOncology is recognized as a Top 10 Global Pharma Analytic Provider

CARsgen Therapeutics Receives IND Clearance from the NMPA for AB011 Humanized Claudin18.2 Monoclonal Antibody

On December 9, 2019 CARsgen Therapeutics, a clinical-stage biopharmaceutical company committed to discovering and developing a combined platform of Chimeric Antigen Receptor T (CAR-T) cell therapies and monoclonal antibodies for cancer, reported that one of its leading drug candidates, AB011 humanized claudin18.2 monoclonal antibody for the treatment of patients suffering from advanced gastric and pancreatic adenocarcinoma, has received Investigational New Drug (IND) clearance from the National Medical Products Administration (NMPA) in China (Press release, Carsgen Therapeutics, DEC 9, 2019, View Source [SID1234552168]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

Schedule Your 30 min Free Demo!

"We are excited to be moving AB011 into clinical development as a potentially best-in-class monoclonal antibody against claudin18.2, a rational target with outstanding properties for development of a monoclonal antibody product," said Dr. Zonghai Li, founder, CEO and CSO of CARsgen. "Currently, patients with advanced gastric and pancreatic cancer have a poor prognosis, and there’s a clear unmet medical need for better treatment options. We look forward to beginning the clinical investigation of AB011, which has shown promising results in preclinical models. We intend to submit an IND application for AB011 to the U.S. FDA in 2020."

AB011 is the first humanized monoclonal antibody targeting claudin18.2 entering clinical trials. Claudin18.2 is a stomach-specific isoform of claudin-18 (1-3). Histologically, it is only expressed in short-lived differentiated cells and not expressed in the stem cell zone of the stomach mucosa. Pathologically, it is highly expressed in a variety of cancer types, including gastric and pancreatic cancer. These characteristics suggest that claudin18.2 is a rational target for cancer.

References:

1. Jiang H, Shi Z, Wang P, Wang C, Yang L, Du G, et al. Claudin18.2 – specific chimeric antigen receptor engineered T cells for the treatment of gastric cancer. J Natl Cancer Inst 2019;111:409-18.

2. Osanai M, Takasawa A, Murata M, Sawada N. Claudins in cancer: bench to bedside. Pflugers Arch 2017;469:55–67.

3. Soini Y. Expression of claudins 1, 2, 3, 4, 5 and 7 in various types of tumours. Histopathology 2005; 46:551–60.

IDE196 Program Updates: Targeting Initiation of Potentially Registration-Enabling Phase 2 Single-Arm Monotherapy Trial in MUM and Introduction of Tablet Formulation in Q1 2020

On December 9, 2019 IDEAYA Biosciences, Inc. (NASDAQ: IDYA), an oncology-focused precision medicine company committed to the discovery and development of targeted therapeutics to treat cancer, reported further progress on key elements of its ongoing Phase 1/2 clinical trial entitled "A Phase 1/2 Study in Patients with Solid Tumors Harboring GNAQ/11 Mutations or PRKC Fusions" (ClinicalTrials.gov Identifier: NCT03947385) (Press release, Ideaya Biosciences, DEC 9, 2019, View Source [SID1234552167]). This clinical trial is evaluating the tolerability and preliminary clinical activity of IDE196 for the treatment of Metastatic Uveal Melanoma (MUM) and other solid tumors harboring GNAQ or GNA11 (GNAQ/11) mutations activating the PKC signaling pathway.

"The pharmacokinetic clinical sub-study for the tablet formulation is on-track to start in January 2020. This may enable the initiation of the Phase 2 expansion to coincide with potential introduction of the tablet in Q1 2020. We also continue to evaluate the Phase 1 dose escalation data, including pharmacokinetic and tolerability data, as we target to advance IDE196 into the potentially registration-enabling study for MUM," said Julie Hambleton, M.D., Chief Medical Officer and Senior Vice President at IDEAYA Biosciences.

Key updates include:

Initiated 13-week GLP-compliant toxicology studies in 2 species in November 2019, in support of registration-enabling FDA requirement to submit study results prior to enrollment of more than approximately 50 patients in the investigational arm of the clinical trial that will support a marketing application
Pharmacokinetic Phase 1 clinical sub-study with immediate release tablet formulation of IDE196 scheduled to initiate in January 2020, in support of potential introduction of the tablet in the Phase 2 clinical trial in Q1 2020
Targeting initiation of Phase 2 single-arm potentially registration-enabling clinical trial in MUM in Q1 2020, which we anticipate may coincide with introduction of tablet formulation
Targeting initiation of combination clinical trial of IDE196 plus a MEK inhibitor in H1 2020, accelerated from earlier guidance. Preclinical evaluation of potential additional combinations ongoing
Total of 40 patients enrolled in the Phase 1 portion of the Phase 1/2 GNAQ/11 basket trial as of as of December 6, 2019, including 38 MUM patients, for which dose escalation is complete, and 2 non-MUM patients, for which enrollment is ongoing
Launching the IDEAYA Genomics Profiling Initiative (IDEAYA GPI). IDEAYA GPI is a company initiative leveraging various Next Generation Sequencing (NGS) platforms, including in partnership, to identify patients having tumors with specific mutations, such as tumors with activating GNAQ/11 mutations for potential enrollment in our IDE196 basket trial
On track to present interim clinical data from the GNAQ/11 Phase 1/2 monotherapy basket trial in Q2/Q3 2020
"We are excited for the opportunity to initiate the single-arm Phase 2 monotherapy expansion, which is potentially registration-enabling for MUM. We also look forward to advancing the clinical combination of IDE196 with MEK, as well as the GNAQ/11 basket trial to evaluate the clinical activity of IDE196 in non-MUM patients, including in skin melanoma," said Yujiro S. Hata, Chief Executive Officer and President at IDEAYA Biosciences.

Medicenna Announces Presentation of the MDNA55 Clinical Trial at the Inaugural Glioblastoma Drug Development Annual Summit

On December 9, 2019 Medicenna Therapeutics Corp. ("Medicenna" or "the Company") (TSX: MDNA,OTCQB: MDNAF), a clinical stage immuno-oncology company, reported that it will present results from the Phase 2b clinical trial of MDNA55 for the treatment of recurrent glioblastoma (rGBM) at the Inaugural Glioblastoma Drug Development Annual Summit to be held on December 10 and 11 at the Westin Boston Waterfront Hotel in Boston, Massachusetts (Press release, Medicenna Therapeutics, DEC 9, 2019, View Source [SID1234552166]).

The oral presentation will provide details on survival seen in patients with rGBM from the MDNA55 Phase 2b clinical trial, including trends observed in different population subgroups.

The details of the presentation are as follows:

Title:

Clinical Case Study: Using a Multi-pronged Approach to Treating Recurrent GBM

– Overcoming the Tumor and its Microenvironment

Presenter:

Dr. Fahar Merchant, PhD, President and CEO of Medicenna Therapeutics

Date/Time:

Wednesday, December 11, 2019 at 10:30 AM ET

Location:

Westin Boston Waterfront Hotel, 425 Summer Street, Boston

In addition, Medicenna will be presenting at the 12th Annual LD Micro Main Event Investor Conference taking place at the Luxe Sunset Boulevard Hotel in Los Angeles, CA. Ms. Elizabeth Williams, Medicenna’s CFO is scheduled to present on Tuesday, December 10, 2019 at 3:20 p.m. Pacific Time and will be available for one-on-one meetings on December 10th and 11th.

61st ASH Congress 2019: Menarini Ricerche Presents the Latest Updates About the First In Human Clinical Trial of SEL24/MEN1703

On December 9, 2019 Menarini Ricerche reported is progressing with the clinical development of SEL24/MEN1703, and will be presenting the design of the ongoing First In Human clinical trial DIAMOND-01 (NCT03008187) at the 61st ASH (Free ASH Whitepaper) Congress, with a poster entitled: "First in Human Study of SEL24/MEN1703, First in Class, Orally Available Dual PIM/FLT3 Kinase Inhibitor, in Patients with Acute Myeloid Leukemia (Press release, Menarini, DEC 9, 2019, View Source [SID1234552165])." The poster, which will be disclosed today during the "Acute Myeloid Leukemia: Novel Therapy, excluding Transplantation" session, describes the ongoing adjustment to the dose escalation design, with the objective to obtain more robust data on the recommended phase 2 dose.

CLI24-001 (DIAMOND-01) trial is testing SEL24/MEN1703, a first in class, oral dual PIM/FLT3 inhibitor in-licensed from Ryvu Therapeutics. The primary objective of the study, currently carried out in newly diagnosed, relapsed or refractory AML (excluding acute promyelocytic leukemia) patients who are unsuitable for intensive chemotherapy, is to identify the recommended phase 2 dose of SEL24/MEN1703 given as single agent.

Furthermore, a second abstract reporting the identification of a pharmacodynamic biomarker for SEL24/MEN1703 and its implementation in the DIAMOND-01 trial, has been disclosed by ASH (Free ASH Whitepaper) as e-publication and is available in a special online-only issue of ASH (Free ASH Whitepaper)’s official Journal -Blood (2019) 134 (Supplement 1): 5087-.

Menarini strongly believes in innovation and is investing in the research and development of new treatment options for oncology patients, focusing on targeted therapies and precision medicine approaches. The contribution of Menarini Ricerche to ASH (Free ASH Whitepaper) with these data confirms such commitment to the development of innovative drugs that meet the needs of patients with difficult to treat cancers and poor prognosis.

CNS Pharmaceuticals to Participate in the 8th Annual ROTH Deer Valley Corporate Access Event

On December 9, 2019 CNS Pharmaceuticals, Inc. (NASDAQ: CNSP) ("CNS" or the "Company"), a biotechnology company specializing in the development of novel treatments for brain tumors, reported that John Climaco, Chief Executive Officer of CNS Pharmaceuticals, and Chris Downs, Chief Financial Officer, will be attending the 8th Annual ROTH Deer Valley Corporate Access Event at the Montage Deer Valley Hotel in Park City, Utah (Press release, CNS Pharmaceuticals, DEC 9, 2019, View Source [SID1234552164]).

Event:

8th Annual ROTH Deer Valley Corporate Access Event

Format:

Small Group & 1×1 Meetings

Date:

December 11-12, 2019

Location:

Montage Deer Valley Hotel, Park City, Utah

About Berubicin
Berubicin is an anthracycline, a class of drugs among the most powerful chemotherapy drugs and effective against more types of cancer than any other class of chemotherapeutic agents. Anthracyclines are designed to damage the DNA of targeted cancer cells by interfering with the action of the topoisomerase II, a critical enzyme enabling cell proliferation. Berubicin was developed at the MD Anderson Cancer Center (MDACC), the world’s largest cancer research facility. Berubicin appeared to demonstrate one Durable Complete Response in a Phase I human clinical trial conducted by a prior developer.