On October 2, 2020 Chugai Pharmaceutical Co., Ltd. (TOKYO: 4519) reported that it filed an application with the Ministry of Health, Labour and Welfare (MHLW) for the expanded use of FoundationOne CDx Cancer Genomic Profile as a companion diagnostic (CDx) for the tropomyosin receptor kinase (TRK) inhibitor, larotrectinib for the treatment of tropomyosin receptor kinase fusion cancer on July 30, 2020 (Press release, Chugai, OCT 2, 2020, View Source [SID1234567898]).

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"Neurotrophic tyrosine receptor kinase (NTRK) gene fusions are rare and occur across various tumor types regardless of age. Comprehensive genomic profiling is a useful tool for detecting this rare fusion gene," said Dr. Osamu Okuda, Chugai’s President and COO. "We hope FoundationOne CDx Cancer Genomic Profile will become available as a CDx for larotrectinib with this filing and will promote advanced personalized healthcare by providing information that can support informed treatment decisions for more patients."

FoundationOne CDx evaluates substitutions, insertion and deletion alterations (indels), and copy number alteration in 324 genes and select gene rearrangements, inclusive of gene fusions. The filing aims to expand the use of FoundationOne CDx Cancer Genomic Profile as a CDx to identify patients who could benefit from larotrectinib for the treatment of TRK fusion cancer by detecting NTRK gene fusions which produces the TRK fusion protein across solid tumors. The efficacy and safety of larotrectinib was investigated in clinical trials conducted by Bayer; phase I trial of adult patients, the phase II NAVIGATE trial in adult and adolescent patients, and the phase I/II pediatric SCOUT trial. Bayer Yakuhin, Ltd. submitted an application of larotrectinib for the treatment of TRK fusion cancer to the MHLW on May 22, 2020.

As a leading company in the field of oncology, Chugai is committed to advancing personalized oncology care and contribute to patients and healthcare professionals through improving access to comprehensive genomic profiling.

About FoundationOne CDx Cancer Genomic Profile
Developed by Foundation Medicine Inc., FoundationOne CDx Cancer Genomic Profile is a next-generation sequencing based in vitro diagnostic device for the detection of substitutions, insertion and deletion alterations, and copy number alterations in 324 genes and select gene rearrangements, as well as genomic signatures including microsatellite instability (MSI) and tumor mutational burden (TMB) using DNA isolated from formalin-fixed, paraffin-embedded (FFPE) tumor tissue specimens. The program is available as a companion diagnostic for multiple molecular-targeted drugs approved in Japan.

About larotrectinib
Larotrectinib, a specific oral TRK inhibitor, was exclusively designed to treat tumors that have an NTRK gene fusion. Larotrectinib, was granted Orphan Drug Designation by the Ministry of Health, Labour and Welfare for the expected indication of "Locally advanced or metastatic solid tumor harboring an NTRK gene fusion".

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On October 2, 2020 Bioscept reported that an agreement has been signed with pre-clinical CAR T development company, Carina Biotech, that will see the advancement of a promising cancer immunotherapy (Press release, Biosceptre, OCT 2, 2020, View Source;utm_medium=rss&utm_campaign=biosceptre-signs-deal-with-carina-biotech [SID1234567897]).

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Biosceptre, a biopharmaceutical company developing targeted therapeutics and immune-oncology products, has acquired the exclusive rights to Carina Biotech’s nfP2X7-targeted CAR-T cells and associated intellectual property, which has shown encouraging cancer-killing capacity against a number of cancers in pre-clinical testing.

Biosceptre and Carina will collaborate to further develop the nfP2X7 CAR-T program with the aim of advancing towards clinical trials in the near future. Under the terms of the deal Carina received an upfront cash payment and equity in Biosceptre.

"With this deal we are building on our commitment to therapies focussed on non-functional P2X7, a cancer target that has been shown to be present on the majority of cancers", said Gavin Currie CEO of Biosceptre. "Our goal is to bring novel therapeutics to patients suffering from a wide range of malignancies and CAR-T therapy is an important part of our immune-oncology approach".

Deborah Rathjen, PhD, CEO of Carina Biotech said

"This agreement with Biosceptre represents a significant milestone for Carina as it is the first commercial agreement involving our proprietary CAR-T technology. We believe that nfP2X7-targeting CAR-T cells hold significant promise as a potential treatment for a range of solid cancers and we are pleased to be working with Biosceptre to further bolster their pipeline of therapies exploiting the novel nfP2X7 target".

On October 1, 2020 Ziopharm Oncology, Inc. (Nasdaq: ZIOP), reported that Laurence Cooper, M.D., Ph.D., Chief Executive Officer of Ziopharm, is scheduled to participate in a fireside chat at the 7th Annual Jefferies Cell Therapy Virtual Summit on October 5, 2020 at 12:30 pm ET (Press release, Ziopharm, OCT 1, 2020, View Source [SID1234569926]).

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To access the live webcast presentation, or the subsequent archived recording, please visit the "Investors" section of the Ziopharm website at www.ziopharm.com.

On October 1, 2020 Geron Corporation (Nasdaq: GERN), a late-stage clinical biopharmaceutical company, reported that it has entered into a loan facility for up to $75 million with Hercules Capital, Inc. (NYSE: HTGC) and Silicon Valley Bank (SVB) (Press release, Geron, OCT 1, 2020, View Source [SID1234569805]). The loan facility provides the Company with access to non-dilutive financial resources to support the imetelstat development program, as well as working capital and general corporate purposes.

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"This debt financing strengthens our balance sheet and provides additional financial flexibility as our imetelstat program advances with two Phase 3 registration-enabling clinical trials – the ongoing IMerge trial in lower risk myelodysplastic syndromes and the planned trial in refractory myelofibrosis," said Olivia K. Bloom, Chief Financial Officer. "We look forward to working with Hercules and SVB in the future as we include non-dilutive capital in our financing strategy."

The loan facility is available to Geron in three tranches. The Company received $25 million as part of the first tranche at closing, with the remaining $10 million available through June 15, 2021. The second tranche of an additional $15 million is available to Geron in 2021, subject to achievement of certain clinical milestones. The remaining $25 million in the third tranche is available to the Company through year-end 2022, and subject to approval from the lenders.

About Imetelstat

Imetelstat is a novel, first-in-class telomerase inhibitor exclusively owned by Geron and being developed in hematologic myeloid malignancies. Early clinical data suggest imetelstat may have disease-modifying activity through the apoptosis of malignant stem and progenitor cells, which allows potential recovery of normal hematopoiesis. Geron’s imetelstat development program includes two registration-enabling studies, IMerge, an ongoing Phase 2/3 clinical trial in lower risk myelodysplastic syndromes (MDS), and a planned Phase 3 clinical trial in refractory myelofibrosis (MF) expected to be open for patient screening and enrollment in the first quarter of 2021. Imetelstat has been granted Fast Track designation by the United States Food and Drug Administration for both the treatment of patients with non-del(5q) lower risk MDS who are refractory or resistant to an erythropoiesis-stimulating agent and for patients with Intermediate-2 or High-risk MF whose disease has relapsed after or is refractory to janus kinase (JAK) inhibitor treatment.

On October 1, 2020 Replimune Presented the Corporate Presentation (Presentation, Replimune, OCT 1, 2020, View Source [SID1234568709]).

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