On August 2, 2021 IMV Inc. ("IMV" or the "Corporation") (Nasdaq: IMV; TSX: IMV), a clinical-stage biopharmaceutical company pioneering a novel class of immunotherapies against difficult-to-treat cancers, reported that it will hold a conference call and webcast on Wednesday, August 11, 2021 at 8:00 a.m. ET to discuss the company’s second quarter 2021 financial and operational results (Press release, IMV, AUG 2, 2021, View Source [SID1234585511]).

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Financial analysts are invited to join the conference call by dialing (866) 211-3204 (U.S. and Canada) or (647) 689-6600 (international) and using the conference ID: 2877244

Other interested parties will be able to access the live audio webcast at this link: View Source The webcast will be recorded and will then be available on the IMV website for 30 days following the call.

On August 2, 2021 BioNTech SE (Nasdaq: BNTX, "BioNTech" or "the Company") reported that it will announce its financial results for the second quarter on Monday, August 9th, 2021 (Press release, BioNTech, AUG 2, 2021, View Source [SID1234585510]). BioNTech invites investors and the general public to join a conference call and webcast with investment analysts on the same day at 8.00 a.m. EDT (2.00 p.m. CEST) to report its financial results and provide a corporate update for the second quarter 2021.

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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 slide presentation and audio of the webcast will be available via this link.

To participate in the conference call, please dial the following numbers ten minutes prior to the start and provide the Conference ID:

Participants may also access the slides and the webcast of the conference call via the "Events & Presentations" page of the Investor Relations section of the Company’s website at View Source A replay of the webcast will be available shortly after the conclusion of the call and archived on the Company’s website for 30 days following the call.

On August 2, 2021 4D pharma plc (AIM: DDDD, NASDAQ: LBPS), a pharmaceutical company leading the development of Live Biotherapeutic products (LBPs), a novel class of drug derived from the microbiome, reported two poster presentations at the European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper) Congress, held from September 16-21, 2021 (Press release, 4d Pharma, AUG 2, 2021, View Source [SID1234585509]). The two e-posters will be available from 07:30 BST (02:30 ET) on September 16, 2021.

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Poster presentation details are as follows:

Presentation Title: Baseline biomarkers associated with clinical benefit in patients with solid tumors refractory to immune checkpoint inhibitors (ICIs) treated with live biotherapeutic MRx0518 in combination with pembrolizumab

Presenting Author: Dr. Edwin R. Parra, Assistant Professor, Department of Translational Molecular Pathology, University of Texas MD Anderson Cancer Center

Presentation Number: 1024P

Presentation Title: Neoadjuvant MRx0518 treatment is associated with significant gene and metagene signature changes in solid tumours

Presenting Author: Dr. Mark P. Lythgoe, Academic Clinical Fellow in Medical Oncology and Pharmacist, Imperial College London

Presentation Number: 543P

About MRx0518

MRx0518 is single strain Live Biotherapeutic product in development for the treatment of cancer. It is delivered as an oral capsule and stimulates the body’s immune system, directing it to produce cytokines and immune cells that are known to attack tumors. It is currently being evaluated in three clinical trials in cancer patients. MRx0518-I-001 is a neoadjuvant monotherapy study in a variety of solid tumors and is being conducted at Imperial College (London, UK). MRx0518-I-002 is in combination with KEYTRUDA (pembrolizumab) in patients who have previously progressed on anti PD-1 therapies. The Coordinating Investigator of the study is at The University of Texas MD Anderson Cancer Center, Houston, USA, with multiple additional sites in the US. The study is being conducted in collaboration with MSD, the tradename of Merck & Co., Inc., Kenilworth, NJ, USA. MRx0518-I-003 is in combination with preoperative radiotherapy in resectable pancreatic cancer. A fourth clinical trial, in collaboration with Merck KGaA and Pfizer Inc., of BAVENCIO (avelumab) in combination with MRx0518 as a first-line maintenance therapy for patients with locally advanced or metastatic urothelial carcinoma that has not progressed with first-line platinum-containing chemotherapy, is expected to commence in Q4 2021.

On August 2, 2021 Micronoma, the first cancer detection biotech company to diagnose cancer at an early stage with microbiome-driven liquid biopsy technology, reported that they are the recipient of the Bio-IT World Innovative Practices Award (Press release, Micronoma, AUG 2, 2021, View Source [SID1234585508]). This elite awards program highlights outstanding examples of how technology innovations and strategic initiatives can advance life sciences research, from basic biomedical research to drug development and beyond.

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Micronoma’s microbiome-driven liquid biopsy method uses machine learning to examine thousands of microbiome plasma features to discover, validate, and translate microbial-derived biomarkers into an early cancer detection method. The award from Bio-IT World recognizes that this process is designed to improve the chances of survival of cancer patients by discovering the disease in its earliest stages, including at stage I of the disease, when tumor size is still at its smallest.

"We are honored to receive the Bio-IT World Innovative Practices Award and to be in such great company with our fellow awardees," said Sandrine Miller-Montgomery, CEO of Micronoma. "This recognition from Bio-IT World adds to an incredible year of discovery and collaboration for Micronoma, and gives even more energy to our team to continue to work hard and fast to save lives."

Bio-IT World explained that the 2021 awards, which recognize work completed during 2020, are particularly noteworthy. "This has been a uniquely demanding season for the industry, but once again the Bio-IT World community has excelled and delivered innovation and solutions to serve both researchers and patients," said Allison Proffitt, Bio-IT World editorial director.

Grand prize awards were granted last week to Micronoma and two other winners including Regeneron Pharmaceuticals and Duke Cancer Institute with University of California, San Francisco. Micronoma will join these highly talented recipients in presenting its innovative work at the 2021 Bio-IT World Conference & Expo in Boston in September. The event will be held both online and in-person.

Sandrine Miller-Montgomery, Micronoma’s CEO, will present Micronoma Behind the Scenes Science and Technology: Using the Microbiome to Detect Early-Stage Cancer during the Genome Informatics track on Tuesday, Sept. 21, 2021.

On August 2, 2021 Chugai Pharmaceutical Co., Ltd. (TOKYO: 4519) reported that it has launched FoundationOne Liquid CDx Cancer Genomic Profile as a liquid biopsy-based comprehensive genomic profiling (CGP) test for solid tumor, following the product’s listing on the national health insurance (NHI) reimbursement price list on August 1, 2021 (Press release, Chugai, AUG 2, 2021, View Source [SID1234585500]). In addition, SRL Inc., the clinical laboratory testing company has started providing testing services for the product today. FoundationOne Liquid CDx Cancer Genomic Profile was approved by the Ministry of Health, Labour and Welfare (MHLW) on March 22, 2021 for use as a companion diagnostic (CDx) for certain approved targeted therapies in Japan, making it the first MHLW-approved blood-based test with both CDx and solid tumor CGP indications.

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"We are very pleased that we can start providing FoundationOne Liquid CDx Cancer Genomic Profile, a blood-based CGP testing option for patients today. The test provides meaningful information that can help inform treatment for patients with advanced or recurrent cancer, which is especially valuable if they are not eligible for tissue-based CGP testing," said Chugai’s president and CEO Dr. Osamu Okuda. "We are committed to advance personalized healthcare through expanding access to CGP testing."

Developed by Foundation Medicine Inc. based in Cambridge, USA, FoundationOne Liquid CDx Cancer Genomic Profile is a blood-based diagnostic test that uses next-generation sequencing. It identifies genomic alterations in 324 cancer-related genes for cancer patients with solid tumors through detection of blood circulating tumor DNA (ctDNA). FoundationOne Liquid CDx Cancer Genomic Profile provides an integrated test report informing alterations matched to MHLW-approved targeted therapies.

As a leading company in the field of oncology, Chugai is committed to advance personalized healthcare in oncology and contributing to patients and healthcare professionals through improving access to CGP.

Approval information

Brand name FoundationOne Liquid CDx Cancer Genomic Profile
Japanese medical device nomenclature (JMDN)
Software for gene variants analysis (for cancer genome profiling)
Software for analysis of somatic cell gene variants (for eligibility identification of antineoplastic agents)
Intended uses or indications
The Product is used for comprehensive genomic profiling of blood samples in patients with solid tumors.
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 maleate, erlotinib hydrochloride, gefitinib, osimertinib mesilate
EGFR exon 20 T790M alterations osimertinib mesilate
ALK fusion genes alectinib hydrochloride, crizotinib, ceritinib
ROS1 fusion genes entrectinib
NTRK1/2/3 fusion gene Solid tumors entrectinib
BRCA1/2 alteration Prostate cancer olaparib
Conditions for approval
The necessary measures must be taken to ensure that the product is used by a physician with adequate knowledge and experience of cancer genomic medicine at a medical institution with a cancer genome profiling-based medical system pursuant to the "Guidelines for the Development of Core Hospitals and Other Facilities for Cancer Genomic Medicine," and in compliance with the scope and timing of testing stipulated in the most recent guidelines, etc., of relevant academic societies.
Appropriate procedures and controls to protect personal information and up-to-date security and privacy protection measures to prevent unauthorized access must be implemented for blood samples sent to the laboratory and for information obtained from these specimens.
Quality control of input data must be performed as described in the Remarks column of the attached Application Form. Any changes to the quality control of input data as described in the Remarks column of the Application Form (excluding minor changes specified by Order of the MHLW in Article 23-2-5, paragraph (15) of the Act on Securing Quality, Efficacy and Safety of Products Including Pharmaceuticals and Medical Devices ["the Act"]) must be approved by the MHLW Minister pursuant to Article 23-2-5, paragraph (15) of the Act. Note that this approval applies mutatis mutandis to the provisions of Article 23-2-5 paragraph (17), Article 23-2-6, and Article 23-2-7 of the Act.
Date of NHI reimbursement price listing: August 1, 2021
About FoundationOne Liquid CDx Cancer Genomic Profile
Developed by Foundation Medicine Inc. based in Cambridge, USA, FoundationOne Liquid CDx Cancer Genomic Profile is a next-generation sequencing based in vitro diagnostic device using blood samples for advanced cancer patients with solid tumors. It is intended to identify genomic alterations in 324 cancer-related genes through detection of blood circulating tumor DNA (ctDNA). The test is approved by the MHLW for use in cancer genome profiling to report substitutions, insertion and deletion alterations, and select gene rearrangements for short variants in 324 genes. It is also indicated for use as a companion diagnostic to identify patients who may benefit from treatment with specific targeted therapies (listed in Table above of Intended uses or indications). For the latest information about the product, including companion diagnostic indications, please refer to the prescribing information.

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