On June 19, 2019 Nouscom, an immuno-oncology company developing off-the-shelf and personalized cancer neoantigen vaccines, reported the publication of a paper in the online edition of the peer-reviewed journal, Nature Communications, entitled: Adenoviral vaccine targeting multiple neoantigens as strategy to eradicate large tumors combined with checkpoint blockade (D’Alise et al, reference below) (Press release, NousCom, JUN 19, 2019, View Source [SID1234537185]). The authors describe results from preclinical studies investigating the immunological potency and efficacy of a vaccine based on an adenovirus vector derived from non-human Great Apes (GAd) that encodes multiple neoantigens.

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The study demonstrated that a single administration of Nouscom’s GAd vaccine can eradicate large tumors in mouse models when combined with anti-PD1 or anti-PD-L1 treatment and triples the efficacy of such checkpoint inhibitors in established tumors. Nouscom’s GAd vaccine accommodates multiple neoantigens, up to 31 in these studies, and demonstrates strong and broad CD8+ and CD4+ neoantigen-specific T cell responses following vaccination. The results highlight the potential of these viral vector vaccines for development as personalized cancer vaccines.

Dr. Elisa Scarselli, Chief Scientific Officer and Co-Founder of Nouscom, said: "We are very encouraged by these preclinical results. These exciting data confirm our hypothesis that our GAd vaccine synergizes with checkpoint inhibitors. It also establishes that anti-tumor efficacy positively correlates with the breadth and potency of T cell responses induced by vaccination, including the expansion of the intratumoral T cell repertoire. Our findings have a potential translational impact, suggesting that the changes in intratumoral T cell repertoire induced by the vaccination might be an indicator of treatment efficacy."

Dr. Scarselli added, "These findings provide compelling preclinical evidence that a vaccine encoding multiple neoantigens in combination with anti-PD1 or anti-PD-L1 may be an efficacious approach for the personalized treatment of cancers. We look forward to evaluating our approach with NOUS-PEV, a personalized cancer vaccine, in human trials, which we expect to start in 2020."

References

A.M. D’Alise et al. Adenoviral vaccine targeting multiple neoantigens as strategy to eradicate large tumors combined with checkpoint blockade, Nature Communications 2019.

Online publication: View Source

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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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