On June 22, 2021 Chugai Pharmaceutical Co., Ltd. (TOKYO: 4519) reported that it obtained approval from the Ministry of Health, Labour and Welfare (MHLW) on June 21, 2021, for FoundationOne CDx Cancer Genomic Profile to be used as a companion diagnostic (CDx) for both a human anti-human PD-1 monoclonal antibody, Opdivo [generic name: nivolumab (genetical recombination)] and a humanized anti-human PD-1 monoclonal antibody, Keytruda [generic name: pembrolizumab (genetical recombination)] for the treatment of patients with microsatellite instability high (MSI-High) tumors (Press release, Chugai, JUN 22, 2021, View Source [SID1234584213]).

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"High microsatellite instability has been identified in tumors in various organs, and immune-checkpoint inhibitors can be a therapeutic option. FoundationOne CDx Cancer Genomic Profile is characterized by the ability to comprehensively capture information on individual gene alterations, as well as the ability to detect microsatellite instability," said Dr. Osamu Okuda, Chugai’s President and CEO. "Through testing with FoundationOne CDx Cancer Genomic Profile, we will contribute to ensuring as many patients as possible to have access to optimal treatments."

As a companion diagnostic, FoundationOne CDx Cancer Genomic Profile will be used to identify patients with MSI-High unresectable advanced or recurrent colorectal cancer that have progressed following chemotherapy who may benefit from nivolumab. It will also be used to identify patients with microsatellite instability (MSI-H) solid tumors that have advanced or relapsed after chemotherapy (limited to use when difficult to treat with standard of care), who may benefit from pembrolizumab.

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

Approval information The underlined part has been newly added.

Intended uses or indications

The Product is used for comprehensive genomic profiling of tumor tissues in patients with solid cancers.
The Product is used for detecting gene mutations and other alterations to support the assessment of drug indications listed in the table below.
Alterations Cancer type Relevant drugs
Activated EGFR alterations Non-small cell lung cancer (NSCLC) afatinib dimaleate, erlotinib hydrochloride, gefitinib, osimertinib mesylate
EGFR exon 20 T790M alterations osimertinib mesylate
ALK fusion genes alectinib hydrochloride, crizotinib, ceritinib
ROS1 fusion genes entrectinib
MET exon 14 skipping alterations capmatinib hydrochloride hydrate
BRAF V600E and V600K alterations Malignant melanoma dabrafenib mesylate, trametinib dimethyl sulfoxide, vemurafenib
ERBB2 copy number alterations (HER2 gene amplification positive) Breast cancer trastuzumab (genetical recombination)
KRAS/NRAS wild-type Colorectal cancer cetuximab (genetical recombination), panitumumab (genetical recombination)
Microsatellite instability high nivolumab (genetical recombination)
Microsatellite instability high Solid tumors pembrolizumab (genetical recombination)
NTRK1/2/3 fusion gene entrectinib, larotrectinib sulfate
BRCA1/2 alterations Ovarian cancer olaparib
BRCA1/2 alterations Prostate cancer olaparib
FGFR2 fusion genes Biliary tract cancer pemigatinib
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 Microsatellite instability high (MSI-High)
The genome contains several short strings of DNA (deoxyribonucleic acid) called microsatellites that are repeated many times. High-frequency microsatellite instability (MSI-High) is an abnormal number of microsatellite repeats1). Abnormal microsatellites do not lead to cancer, but tissues that show MSI-High are thought to be more likely to develop cancer. MSI-High has been found in patients with cancer of various organs, including endometrial, gastric, small intestine, colorectal, ovarian, renal pelvis/ureteral, prostate, and breast cancers2, 3). MSI-High is also a hallmark of people with Lynch syndrome who are born with genomic alterations that predispose them to developing cancer3).

Trademarks used or mentioned in this release are protected by laws.

[Reference]

Nojadeh, J.N. et al.: Microsatellite instability in colorectal cancer. EXCLI J. 17: 159-168, 2018.
Japan Society of Cancer Therapy/Japanese Society of Clinical Oncology: Guidelines for Transversal Genomic Practice in Organs in Adult and Pediatric Advanced Solid Tumors, Second Edition, October 2019
Colorectal Cancer Study Group: Hereditary Colorectal Cancer Guidelines 2020 Version

On June 22, 2021 OPKO Health, Inc. (NASDAQ: OPK) reported the appointment of Katherine Stueland as President and Chief Executive Officer of GeneDx, Inc., the global genomics subsidiary of OPKO’s BioReference Laboratories (Press release, Opko Health, JUN 22, 2021, View Source [SID1234584229]). Ms. Stueland joins GeneDx from Invitae Corporation (NYSE: NVTA), where she served most recently as Chief Commercial Officer, establishing the corporate brand as Invitae evolved from a private company to a public entity with a market capitalization exceeding $6 billion.

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"We’re thrilled to have Katherine lead the team at GeneDx, which has served clinicians and patients for more than two decades with novel and differentiated technologies for diagnosing the most difficult human diseases," said Jon R. Cohen, MD, Executive Chairman of BioReference Laboratories. "With her depth of experience, focus on patient-centric business strategies and ability to lead and inspire, we look forward to a new era of genomics with GeneDx at the forefront."

Ms. Stueland’s career is rooted in bringing transformational technologies to patients and crafting strategies to enable broader access to diagnostics and therapeutics. She has overseen multiple commercial organizations and corporate brand transformations, and helped bring the first cancer immunotherapy to market, enabling a new standard of care for patients.

"The global opportunity is clear regarding the growing role of genomic information in providing better care to patients. We can readily and rapidly provide critical information to improve health outcomes, and GeneDx has been at the forefront of these efforts for more than 20 years," said Ms. Stueland, incoming President and CEO of GeneDx. "I’m honored to be joining this world-class team and couldn’t be more excited about what’s possible by bringing the GeneDx technologies to broader patient populations."

With more than two decades in the healthcare industry, Ms. Stueland previously held roles at Dendreon Corporation and TAP Pharmaceuticals (a joint venture of Takeda and Abbott), and consulted for biotech and pharmaceutical companies.

On June 22, 2021 TRexBio, a discovery stage company decoding human tissue immune biology to create revolutionary therapeutics, reported the successful close of the final tranche of a $59 million Series A financing (Press release, TRexBio, JUN 22, 2021, View Source [SID1234584249]). Proceeds from the financing will be used to expand the company’s unique discovery platform that maps human tissue regulatory T cell (Treg) behavior to dysregulation in disease, and to advance its six preclinical therapeutic programs. Investors include Eli Lilly and Company (Lilly), SV Health, Johnson & Johnson Innovation, Pfizer Ventures, and Alexandria Venture Investments.

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"The continued support from our investors further validates our approach to creating breakthrough therapeutics," said Carol Gallagher, Pharm.D., Executive Chair of TRexBio, and former President and CEO of Calistoga Pharmaceuticals. "We look forward to working with our investors and our academic and industry collaborators as we continue to create and advance a robust pipeline that addresses serious illnesses including cancer and auto-immune diseases."

TRexBio also announced the appointment of Johnston Erwin as Chief Executive Officer, and Ovid Trifan, M.D., Ph.D., as Chief Medical Officer, as part of the company’s plan to accelerate growth. Johnston, a seasoned industry veteran with experience in business development, venture investment, collaboration management, and clinical and regulatory development, joins TRexBio after a 36 year career with Lilly. He most recently served as VP of Corporate Business Development leading Lilly’s internal venture portfolio.

"TRex is at the forefront of one of the most exciting new areas in immunobiology and tissue homeostasis," said Johnston. "The company has a significant foundation in place, with a compelling vision, dedicated team and robust science. I am excited to lead the company into its next stage of development and ultimately transform the lives of patients by bringing a new generation of immune-based therapies to the world."

Dr. Trifan brings more than 20 years of medical research experience to TRexBio. Most recently he was the Chief Medical Officer and VP of Development at Apexigen, a clinical stage biotech company focused on immuno-oncology. Prior to Apexigen he held senior roles in clinical research at leading pharmaceutical companies including Bristol Myers Squibb and Johnson & Johnson, where he contributed to the development of multiple successful oncology drugs. Dr. Trifan will lead the advancement of TRexBio’s oncology programs into the clinic by the end of next year.

Mr. Erwin and Dr. Trifan are joined on the management team by Chief Scientific Officer Melanie Kleinschek, DVM, Ph.D., who has led the development of TRexBio’s unique ‘deep biology’ discovery platform. The platform uses high-resolution profiling of human tissue, modern computational biology tools, a proprietary system to generate tissue-like Tregs and disease-relevant phenotypic assays to generate novel insights into human tissue biology.

TRexBio’s accomplishments to date include:

Foundational collaborations with Lilly and the University of California San Francisco.
Advancement of six preclinical therapeutic programs across immuno-oncology and inflammation, two of which are on track to name development candidates in the next 12 months.
Identification of more than 20 novel tissue-focused targets from its proprietary ‘deep biology’ platform
The company works with an internationally recognized team of founding scientific advisors, including

Michael D. Rosenblum, M.D., Ph.D., Professor of Dermatology, Vice Chair of Research UCSF, and Co-Founder of Delinia Therapeutics;
Houman Ashrafian, BM Bch, DPhil, Managing Partner at SV Health Investors and former VP, Head of Clinical Science at UCB;
Adil Daud, M.D., Professor, Department of Medicine, Hematology/Oncology Director Melanoma Clinical Research, UCSF;
Diane Mathis, Ph.D., Professor in the Department of Immunology at Harvard Medical School, and holder of the Morton Grove-Rasmussen Chair in Immunohematology; and
Allison Simmons, M.D., Ph.D., Professor of Gastroenterology and Director of the MRC Human Immunology Unit at the University of Oxford.

On June 22, 2021 Immutep Limited (ASX: IMM; NASDAQ: IMMP) (Immutep or Company), reported that it has received commitments for a A$60 million two-tranche private placement of new ordinary shares (New Shares) to professional, institutional and sophisticated investors (Placement) (Press release, Immutep, JUN 22, 2021, View Source [SID1234584214]).

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The first tranche of the Placement will be completed without shareholder approval. The second tranche of the Placement is subject to shareholders approval.

Use of Funds

The Company will use the proceeds received from the Placement to fund the expansion of its clinical programs and to commence the process characterisation and process validation for efti commercial manufacturing (2,000 litre scale). The proceeds received from the Placement will also be used for the offering costs and working capital purposes.

Placement

The Placement will involve the issue of New Shares at an issue price of A$0.52 per New Share (representing a 12.9% discount to the volume weighted average price (VWAP) of the Company’s ordinary shares as traded on ASX over the 30 days up to and including June 16, 2021). The New Shares issued under the Placement will rank equally with existing Immutep ordinary shares on issue with effect from their date of issue.

Settlement of the first tranche of the Placement is expected to occur on June 25, 2021, with the issuance of New Shares expected to occur on June 28, 2021.

Assuming Shareholder Approval is obtained for the completion of the second tranche of the Placement, settlement is expected to occur on July 29, 2021, with the issuance of New Shares expected to occur on July 30, 2021.

Share Purchase Plan

Following completion of the issue of the first tranche of the Placement, Immutep will conduct an offer of New Shares under a non-underwritten share purchase plan (SPP) to existing shareholders in the Company with a registered address in Australia and New Zealand as at 7.00pm (Sydney, Australia time) on June 18, 2021.

The SPP will provide each Eligible Shareholder with the opportunity to apply for up to A$30,000 of New Shares at the price payable per New Share in the Placement. The SPP is targeting to raise approximately A$5 million. The SPP is expected to close at 5.00pm (Sydney, Australia time) on July 22, 2021.

On June 22, 2021 Phio Pharmaceuticals Corp. (Nasdaq: PHIO), a biotechnology company developing the next generation of immuno-oncology therapeutics based on its proprietary self-delivering RNAi (INTASYL) therapeutic platform, reported that it has rescheduled the Company’s fireside chat being hosted by H.C. Wainwright, which was previously scheduled for today, to July 12, 2021 at 11 a.m. Eastern Time (Press release, Phio Pharmaceuticals, JUN 22, 2021, View Source [SID1234584230]). Details regarding the rescheduled fireside chat will be forthcoming.

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