On September 2, 2021 Avid Bioservices, Inc. (NASDAQ:CDMO), a dedicated biologics contract development and manufacturing organization (CDMO) working to improve patient lives by providing high quality services to biotechnology and pharmaceutical companies, reported that the company will participate in two upcoming investor conferences (Press release, Avid Bioservices, SEP 2, 2021, View Source [SID1234587169]).

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Details of the company’s participation are as follows:

Morgan Stanley 19th Annual Global Healthcare Conference
Details: Avid management will participate in a fireside chat and 1-on-1 meetings
Conference Dates: September 9-10 and 13-15, 2021
Fireside Chat Timing: 2:45 – 3:15 p.m. Eastern on Thursday, September 9, 2021
Format: Virtual conference; webcast available
HC Wainwright 23rd Annual Global Investment Conference
Details: Avid management will deliver a corporate presentation and participate in 1-on-1 meetings
Conference Dates: September 13-15, 2021
Presentation Timing: Available online at 7:00 a.m. Eastern on Monday, September 13, 2021
Format: Virtual conference
To listen to the live webcast of the Morgan Stanley fireside chat, or access the archived webcast, please visit: View Source

On September 2, 2021 Alkermes plc (Nasdaq: ALKS) reported that management will participate in a fireside chat at the Citi 16th Annual BioPharma Virtual Conference on Thursday, Sept. 9, 2021 at 8:50 a.m. ET (1:50 p.m. BST) (Press release, Alkermes, SEP 2, 2021, View Source [SID1234587168]). The presentation may be accessed under the Investors tab on www.alkermes.com and will be archived for 14 days.

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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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On September 2, 2021 Redx Pharma plc (AIM: REDX), the drug discovery and development company focused on cancer and fibrosis, reported that a milestone payment of $3 million from Jazz Pharmaceuticals plc (NASDAQ: JAZZ) has been triggered as a result of the initiation of IND-enabling studies of JZP815, a preclinical Pan-RAF inhibitor, for the potential treatment of RAF driven tumours (Press release, Redx Pharma, SEP 2, 2021, View Source [SID1234587167]). Mutations leading to uncontrolled signalling in the RAS-RAF-MAPK pathway are seen in around one third of all cancers.

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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 milestone payment is due under the agreement with Jazz Pharmaceuticals announced on 10 July 2019 for Redx’s Pan-RAF inhibitor. Under the deal, Redx is entitled to up to $203 million in development, regulatory and commercial milestone payments. The Company is also eligible for royalties based on any future net sales. The next milestone payment under the agreement is due on acceptance of an Investigational New Drug (IND) application by the U.S. Food and Drug Administration (FDA). As part of a separate ongoing collaboration agreement, Jazz paid Redx to perform research and preclinical development activities to progress the programme to this stage, with the goal of completing IND-enabling studies.

The Pan-RAF inhibitor programme aims to overcome resistance mechanisms associated with clinically approved B-RAF selective drugs. The RAF kinases A-RAF, B-RAF and C-RAF are an integral part of the RAS-RAF-MAPK pathway, with B-RAF mutations commonly seen in the clinic. Although most B-RAF V600E/K mutant skin cancers are initially sensitive to approved B-RAF selective drugs, treatment resistance often develops leading to disease progression. Moreover, B-RAF V600E mutant colorectal cancers are surprisingly insensitive to these B-RAF selective drugs as single agents due to the functions of other RAF family members. Importantly, B-RAF selective therapies fail to show clinical benefit against the more prevalent RAS-mutated tumours. This Pan-RAF inhibitor aims to overcome these resistance mechanisms.

Lisa Anson, Chief Executive Officer of Redx Pharma commented: "We are extremely pleased that Jazz Pharmaceuticals has initiated IND-enabling studies for the Pan-RAF inhibitor programme that Jazz acquired. The continuing success of this programme highlights, once again, Redx’s ability to generate molecules that have significant potential as novel medicines for unmet medical needs."

On September 2, 2021 Invivoscribe, Inc., a technology-driven international company focused on precision diagnostics with best-in-class products and services that optimize patient care and accelerate drug approvals worldwide, reported licensing of key software and two new MRD clinical services (Press release, Invivoscribe Technologies, SEP 2, 2021, View Source [SID1234587166]).

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"Clinical labs need to be able to analyze large amounts of clonality and MRD data quickly and easily. Current bioinformatics software generally requires that technicians click through software to analyze data one patient at a time; this is both tedious and prone to human errors. With such a large volume of patients samples we need to get from data to report as easily and accurately as possible," says Dr. Sean Glenn of Roswell Park Comprehensive Cancer Center, New York.

Invivoscribe’s new pipeline LymphoTrack Enterprise Software enables high volume customers to meet ever increasing testing demands. Laboratories require a high throughput platform that is both compliant with HIPAA requirements and provides seamless visualization to help interpret the raw data. They also want to be able to mine data from antigen receptor CDR3 regions. We’ve addressed both of these needs with the new pipeline software. The pipeline software for LymphoTrack on MiSeq is available now with raw data access, CDR3 mining and reporting capabilities.

Tony Lialin, Chief Commercial Officer at Invivoscribe shared, "Software has been a hugely undervalued asset at Invivoscribe. We have developed tools for internal use that our customers would love to have access to in order to streamline their workflow and reduce bottlenecks in testing. This is a bioinformatics package we can commercialize to help support our partners, so we are doing just that."

The new B-cell MRD Clonality and MyMRD-Myeloid Assays will be offered as LabPMM services using Illumina’s NextSeq 550Dx and/or NovaSeq. The release of these clinical services will rapidly follow the release of the LymphoTrack Enterprise Software. The new MRD services will be available for research studies in late 2021 and are slated for CAP/CLIA accreditation in early 2022.

With internationally standardized kits and services, custom assay development solutions, clinical trial management, regulatory expertise, and most recently, expanding availability and support for our bioinformatics analysis software, Invivoscribe continues to innovate to provide comprehensive support to our global partners.

On September 2, 2021 RedHill Biopharma Ltd. (Nasdaq: RDHL) ("RedHill" or the "Company"), a specialty biopharmaceutical company, reported that it will present at the following virtual conferences in September (Press release, RedHill Biopharma, SEP 2, 2021, View Source [SID1234587165]):

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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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H.C. Wainwright 23rd Annual Global Investment Conference (September 13-15, 2021)
Presentation: Available from Monday, September 13, 2021, 7:00 a.m. EDT
Speaker: Guy Goldberg, Chief Business Officer

Cantor Global Healthcare Conference (September 27-30, 2021)
Fireside chat: will be broadcast live on Thursday, September 30, 2021, 8:40 a.m. EDT and available for replay
Moderator: Brandon Folkes, CFA, Director, Equity Research – Healthcare, Biopharma
Speaker: Guy Goldberg, Chief Business Officer

The webcasts will be available for 30 days on the Company’s website under the Investors page: www.redhillbio.com.