On June 19, 2019 Invivoscribe is reported that on June 5th the Ministry of Health, Labor and Welfare (MHLW) approved our LeukoStrat CDx FLT3 Mutation Assay as the companion diagnostic for Daiichi Sankyo’s Quizartinib for the treatment of FLT3-ITD positive relapse/ refractory acute myeloid leukemia (AML) patients in Japan (Press release, Invivoscribe Technologies, JUN 19, 2019, View Source [SID1234537170]). At the same time the Japanese MHLW added approval in use of EDTA collection tubes to the existing approval of heparin collection tubes used with this assay.

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The QuANTUM-R study demonstrated that quizartinib resulted in a statistically significant improvement in overall survival (OS) compared to salvage chemotherapy when patients were selected with the LeukoStrat CDx FLT3 Mutation Assay. Mutations in the FLT3 gene are among the most important driver mutations in AML.

This milestone further establishes the LeukoStrat CDx FLT3 Mutation Assay as the international gold standard for comprehensive FLT3 assessment for critically ill AML patients.

This PCR-based, in vitro diagnostic test detects internal tandem duplication (ITD) mutations and tyrosine kinase domain (TKD) mutations D835 and I836 in the FLT3 gene in genomic DNA extracted from mononuclear cells obtained from peripheral blood or bone marrow aspirates of patients diagnosed with AML. This test, which is available worldwide, includes software that interprets data, generates standardized mutant/wildtype signal ratios for ITD and TKD mutations, and predicts response to multiple tyrosine kinase inhibitors.

"Once again, our Streamlined CDx program has demonstrated its effectiveness in accelerating submissions and approvals for our partners worldwide. Invivoscribe welcomes opportunities to partner with global pharmaceutical companies interested in developing and commercializing companion diagnostics, whether their therapies are targeting hematologic diseases or solid tumors." said Dr. Jeffrey Miller, Invivoscribe’s CSO and CEO.

The LeukoStrat test is available as a test menu service through Invivoscribe’s wholly-owned subsidiaries, LabPMM LLC (San Diego, CA, U.S.), LabPMM GmbH (Martinsried, Germany) and LabPMM GK (Kawasaki City, Japan). Greater than 95% of patient samples tested using the FDA-approved LeukoStrat CDx FLT3 Mutation Assay and selection of other CLIA-validated PCR-based capillary assays report out results within 48 hours of sample receipt at any of the LabPMM laboratories. LeukoStrat CDx FLT3 Mutation Assay kits are currently distributed in Japan, Europe, and Australia, and are planned for distribution in the United States and China in the future.

On June 19, 2019 CARsgen Therapeutics, a clinical-stage company committed to developing Chimeric Antigen Receptor T cell therapies for cancer, reported that one of its leading drug candidates, CT053 fully human BCMA (B-Cell Maturation Antigen)-CAR-T cell for the treatment of patients suffering from relapsed/refractory multiple myeloma (rrMM), has received Investigational New Drug (IND) clearance from the United States Food and Drug Administration (FDA) (Press release, Carsgen Therapeutics, JUN 19, 2019, View Source [SID1234537186]). CT053 has also received IND clearance from the National Medical Products Administration in China four months ago and is the subject of an ongoing phase I clinical trial.

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"At the 5th Annual Immunotherapy in Myeloma Scientific Workshop in Denver, Colorado, CARsgen provided an update of the clinical data of CT053 and showed that as of Feb. 28, 2019, 87.5% of the patients showed overall response to the treatment. 70.8% of the patients had complete response and no grade 3 or higher cytokine release syndrome (CRS) was observed in 24 heavily pre-treated patients with rrMM. The IND clearance of CT053 by the U.S. FDA is of great significance to patients" said Dr. Zonghai Li, founder, CEO and CSO of CARsgen. "According to JAMA Oncology, in 2016, there were about 130,000 cases of myeloma, which means from 1990 to 2016, incident cases of myeloma increased by 126% globally [1] and despite the development of novel therapies, multiple myeloma remains incurable and new treatment options are needed. Our goal is to continue the development of novel, safe and effective immunotherapies. This is our long-standing commitment to cancer patients worldwide."

On June 19, 2019 Resolution Bioscience, Inc., reported that its Resolution HRD liquid biopsy assay is being developed as a companion diagnostic for niraparib, a PARP inhibitor that is currently being investigated for the treatment of patients with metastatic castration-resistant prostate cancer (mCRPC) as part of a research collaboration with Janssen Research & Development, LLC (Janssen) (Press release, Resolution Bioscience, JUN 19, 2019, View Source [SID1234537171]). The cell-free DNA (cfDNA) assay, which detects homologous recombination deficiency (HRD) mutations and gene deletions, is currently being used in phase II and III clinical studies of niraparib in prostate cancer.

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Recently granted Breakthrough Device Designation by the US Food and Drug Administration, the Resolution HRD assay has the potential to benefit late-stage prostate cancer patients when tissue can be difficult to collect. The Resolution liquid biopsy test detects sequence variations in key genes related to HRD for single nucleotide variants, copy number variants, and deletions. The ability to detect these alterations from a simple blood draw has the potential to allow for more men to receive targeted therapies, such as niraparib.

"Resolution Bioscience is committed to partnering with leading pharmaceutical companies to develop diagnostic assays that may assist in bringing new therapies to market," said Mark Li, CEO of Resolution Bioscience. "Built on our proprietary cfDNA next-generation sequencing technology platform, we expect the Resolution HRD assay will enable Janssen to identify patients with prostate cancer who may benefit from niraparib therapy."

Resolution Bioscience plans to seek approval for the Resolution HRD assay as a companion diagnostic for niraparib in prostate cancer. If approved, the Resolution HRD assay could be the first test to detect gene deletions from cfDNA, as well as to differentiate between single copy and biallelic (homozygous) gene deletions through a simple blood draw. The assay is also designed to detect biallelic loss of function through the combination of a deleterious mutation and a heterozygous deletion in the same gene, as well as homozygous deletions.

On June 19, 2019 Euronext Paris: FR0010331421 – IPH), reported that it will host a key opinion leader (KOL) call focused on the topic of IPH4102 "TELLOMAK" clinical trial design and rationale in T-cell lymphoma, including preclinical data in peripheral T-cell lymphoma (PTCL) , Thursday, June 20, at 2pm CEST / 8am ET (Press release, Innate Pharma, JUN 19, 2019, View Source [SID1234537187]).

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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

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The call will feature a presentation by Dr. Pierluigi Porcu, MD, key opinion leader and Principal Investigator of the TELLOMAK study. He will discuss the cutaneous T-cell lymphoma (CTCL) and PTCL treatment landscapes and rationale of the TELLOMAK trial design. Innate’s Chief Medical Officer, Pierre Dodion, MD, will also provide strategic perspectives on IPH4102’s development.

Prof. Pierluigi Porcu is Director of the Division of Medical Oncology and Hematopoietic Stem Cell Transplantation at the Jefferson University Hospital in Philadelphia, PA, USA. Prof. Porcu is a Lymphoma-focused hematologic oncologist with a long track record of advocacy and education for patients with cutaneous lymphoma.

To view the presentation and posters presented at the International Conference on Malignant Lymphoma ("ICML") visit: View Source

KOL webcast and conference call on Thursday, June 20, at 2pm CEST (8am ET)

The presentation and access to the live webcast will be available at this link: View Source

Participants can also join the conference call using the following dial-in numbers:

Location

Phone number

France

+33 (0) 176700794

United Kingdom, International

+44 (0) 2071 928000

Switzerland

+41 (0) 315800059

United States

+1 631-510-7495

The participation code is: 9493234

On June 19, 2019 IASO Biotherapeutics (IASO BIO), one of the top biotechnology innovators, reported their potential best-in-class therapy back-to-back at two of the most prestigious clinical meetings in the worlds of hematology and oncology, the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting 2019 in Chicago, Illinois, May 31-June 4 [Abstract#8013; Monday, June 3], and the 24th Congress of the European Hematological Society (EHA) (Free EHA Whitepaper), June 13-16 [Abstract#S827; Saturday, June 15] (Press release, IASO BioMed, JUN 19, 2019, View Source [SID1234537172]).

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These notable meetings feature the efforts of the brightest minds driving innovation in hematology and cancer research from around the globe. With a combined international attendance of more than 50,000, this year’s meetings focused heavily on the field of immunotherapy, presenting the latest trends and approaches in immuno-oncology, including adaptive cell therapies, immune checkpoint inhibitors, CAR-T therapies and more.

CT103A is an anti-BCMA CAR-T for the treatment of relapsed/refractory multiple myeloma (R/RMM) co-developed by IASO BIO and Innovent Biologics, Inc. (Innovent) (HKEX:01801). The data of CT103A presented at both conferences show impressive efficacy results, persistence and safety profile and an objective response rate (ORR) of 100%.

In an IIT study conducted by Tongji Hospital of Tongji Medical College, Huazhong University of Science and Technology, IASO BIO presented compelling results for efficacy and persistence of a therapy that may also provide patients, having relapsed from a prior CAR-T, an option for CAR-T retreatment.

Multiple myeloma is a malignant hematologic cancer with abnormal proliferation of clonal plasma cells, which has no medical cure so far. In many countries, myeloma is the second most common blood cancer. The American Cancer Society estimates that in the United States (U.S.), about 32,110 new cases will be diagnosed this year. In Europe, more than 48,200 people were diagnosed with multiple myeloma in 2018. Among them, 40 percent of patients are diagnosed with moderate or high-risk multiple myeloma, and their median survival is less than five years.

As of the data cutoff date of May 22nd, 2019, the objective response rate (ORR) was 100% (CR-64%, VGPR-36%) with strong persistence and high expansion of the CAR-T in vivo. All patients (100%) experienced CRS. The onset of CRS occurred within 2 to 5 days (median – 2.6) and resolved within 14 days. Mostly grade 1 and 2, at the low and medium dosage levels, CRS was routinely managed with Tocilizumab and steroids. Interestingly, the 12-patient study included 4 patients having previously relapsed from a prior CAR-T therapy, a murine anti-BCMA CAR-T.

"Relapsed/refractory multiple myeloma (R/RMM) is associated with a poor prognosis," said Dr. Chunrui Li of Tongji Hospital of Tongji Medical College, Huazhong University of Science and Technology. "Many who receive CAR-T treatments have had their disease come back, and with a non-human scFv, retreatment may not be an option due to immunogenicity. With a fully human BCMA scFv, CT103A provides an effective option for these patients. This data suggests they should not be excluded from the benefit of future trials."

About Relapsed/Refractory Multiple Myeloma:

For newly treated patients with multiple myeloma, the common first-line treatment drugs include proteasome inhibitors, immunoregulatory drugs and alkane agents. For most patients, the commonly used first-line treatment can stabilize the patient’s condition for 3-5 years, but a small number of patients show primary drug resistance at the time of initial treatment, and the disease cannot be effectively controlled. Relapse patients are patients who have a reoccurrence after complete remission of the disease. Refractory patients are patients with primary drug resistance or the patients who have finished with first-line treatment and do not achieve remission, or the patients whose disease progress within 60 days after achieving minimal response. For the majority of patients with effective treatment, they will inevitably enter the stage of relapse and refractory after 3-5 years of disease stabilization. For these patients, the overall effective rate of existing second-line treatment is about 40% to 70%, with short remission time.

About CT103A:

CT103A is an innovative therapy co-developed by IASO BIO and Innovent. Previous studies indicate patients with relapsed/refractory multiple myeloma (R/RMM) who received high-dose, BCMA-targeting CAR-T cells may achieve better remission but have worse adverse events. Moreover, once the disease progresses again, the re-infusion of CAR-T cells is not effective. To solve this dilemma, CT103A has been developed, A lentiviral vector containing a CAR structure with a fully human scFv, CD8a hinger and transmembrane, 4-1BB co-stimulatory and CD3z activation domains. Based on strict selection and screening, utilizing a proprietary in-house optimization platform, the construct of the CT103A CAR-T is potent and persistent.