On September 23, 2021 VaxEquity, developing transformative RNA vaccines and therapeutics based on its next generation self-amplifying RNA (saRNA) platform originating from Imperial College London, reported a collaboration with AstraZeneca to progress the company’s platform technology through proof of concept to enable the development of multiple products (Press release, AstraZeneca, SEP 23, 2021, View Source [SID1234590235]). VaxEquity could receive development, approval and sales-based milestones totalling up to $195 million and royalties in the mid-single digits per drug target. VaxEquity also received an upfront equity investment from AstraZeneca and global life sciences investor Morningside Ventures.

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The strategic, long-term research collaboration with AstraZeneca aims to optimise and validate VaxEquity’s saRNA platform and apply it to advance novel therapeutic programmes. AstraZeneca will support VaxEquity with research and development funding and has the option to collaborate with VaxEquity on up to 26 drug targets. VaxEquity’s modified saRNA platform uses similar technology to mRNA but with the added ability to self-amplify, thereby expressing proteins for longer, resulting in higher protein levels per dose level.

Michael Watson, Executive Chairman of VaxEquity, said, "We are delighted to collaborate with AstraZeneca given its strong track record in innovation and welcome them as a new investor. We are also grateful for the ongoing support of our existing investor, Morningside Group. With our self-amplifying RNA platform, we aim to underpin the next generation of RNA-delivered medicines enabling not only vaccines but also broad range of therapeutic applications."

Professor Robin Shattock, Head of Immunology of Infection within the Department of Infectious Diseases at Imperial College London, and co-founder of VaxEquity, said, "We have all seen how technologies based around RNA have been fundamental to preventing ongoing severe disease and death in major global pandemics. The prospect of further therapeutic applications adds to this technology’s great potential."

Mene Pangalos, Executive Vice President, BioPharmaceuticals R&D at AstraZeneca, said "This collaboration with VaxEquity adds a promising new platform to our drug discovery toolbox. We believe self-amplifying RNA, once optimised, will allow us to target novel pathways not amenable to traditional drug discovery across our therapy areas of interest."

Professor Alice Gast, President of Imperial College London, said: "I am deeply proud of my colleagues’ work in pioneering self-amplifying RNA technology. This collaboration will help realise our ambition of building a lasting legacy from the great scientific advances Imperial made in this pandemic."

The proprietary, flexible platform enables the simultaneous expression of a broad range of targets and immunomodulatory proteins that can be rapidly produced and delivered at scale. Using saRNA, rather than mRNA, means that a lower (1/3 to 1/10th) dose of RNA is required to provide greatly enhanced protein expression as the RNA replicates for longer post-administration. VaxEquity modifies the RNA to include elements (called ‘Innate Inhibitory Proteins’ or IIPs) that finely tune the innate immune response (based on interferons) preventing suppression of RNA replication and thereby maximizing protein expression by saRNA.

As part of this investment and collaboration, Tyrell Rivers and Anders Holmén from AstraZeneca will join VaxEquity’s Board as Investor Directors. Will West and Jason Dinges will represent Morningside. Charles Mallo will represent Imperial. Robin Shattock will remain on the Board, while Michael Watson will assume the role of Executive Chair.

On September 23, 2021 Lion TCR Pte Ltd, a clinical-stage biotech company specialized in T Cell Receptor (TCR) T cell therapy reported that it has received clearance from U.S. Food and Drug Administration (FDA) for its Investigational New Drug (IND) Application for LioCyx-M004, autologous T-cells transfected with mRNA encoding Hepatitis B surface antigen (HBsAg) specific TCR (Press release, Lion TCR, SEP 23, 2021, View Source [SID1234590234]).

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Lion TCR intends to initiate a Phase 1b/2 multi-center study for its lead investigational product, LioCyx-M004, for patients with advanced Hepatitis B Virus (HBV)-related hepatocellular carcinoma (HCC). This will be the first Phase 1b/2 study that uses specific T cell receptor (TCR)-T cell therapy to target HBV-related HCC.

In 2020, there are more than 900,000 new cases with liver cancer worldwide, of which 90% been hepatocellular carcinoma (HCC). In Asia, HBV is an important inducer of HCC, for example, 80% – 90% of HCC is related to HBV infection in China. The use of LioCyx-M004 has been tested in Phase 1 study in primary HBV-related HCC. LioCyx-M004 infusions were well-tolerated with no occurrence of cytokine release syndrome (CRS) nor neurotoxicity. Disease control rate was 60% and partial response (PR) as per RECIST 1.1 was observed with a duration of response of 27.7 months. Median overall survival (OS) was 33.1 months.

The upcoming study aims to evaluate LioCyx-M004 as a monotherapy treatment and the safety and efficacy of LioCyx-M004 in combination with lenvatinib. Considering lenvatinib as a well-established first-line treatment for advanced HCC and its potential to revert the immunosuppressive tumor microenvironment towards an immune-supportive profile, the combination of lenvatinib and LioCyx-M004 treatment is expected to further improve clinical outcome.

"LioCyx-M004, with its unique mechanism of action and its excellent safety profile and radiological tumor response, has the potential to become a first-in-class TCR T cell therapy for HCC. We also have a strong scientific rationale for the use of our TCR-T therapy in combination with other therapies to extend its effectiveness. We are proud of our significant progress in recent years and look forward to initiating the Phase 1b/2 study in the upcoming weeks for the benefits of HCC patient refractory or relapsed to current systemic treatment. Patient recruitment for this study will begin at City of Hope Comprehensive Cancer Center in United States, a leading research and treatment center for cancer," said Dr Tina Tingting Wang, COO and CMO of Lion TCR.

"This Phase 1b/2 IND clearance is a very important milestone for Lion TCR! We will continue our dedication to be the world leading biotech company using cutting-edge TCR-T immunotherapy to provide innovative therapeutic options for patients in need. Lion TCR has developed various TCR-T technology platform including TCR discovery platform, autologous and allogeneic TCR platform incorporating with gene editing technologies. With the potential of our revolutionary TCR-T cell immunotherapy, we aim to be the pioneer company for benchmarking in the field of liver cancer treatment," said Dr Peng Xiaoming, Managing Director & CEO of Lion TCR.

On September 23, 2021 Novavax, Inc. (Nasdaq: NVAX), a biotechnology company developing and commercializing next-generation vaccines for serious infectious diseases, reported that it will participate in a fireside chat at the 2021 Cantor Virtual Global Healthcare Conference (Press release, Novavax, SEP 23, 2021, View Source [SID1234590233]). Novavax’ recombinant nanoparticle protein-based COVID-19 vaccine candidate, NVX-CoV2373, will be a topic of discussion.

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Fireside chat details:

Date:

Wednesday, September 29, 2021

Time:

8:40 – 9:10 a.m. Eastern Daylight Time (EDT)

Moderator:

Charles C. Duncan, Ph.D.

Novavax participants:

Gregory M. Glenn, M.D., President, Research and Development and John J. Trizzino, Executive Vice President, Chief Commercial Officer and Chief Business Officer

A replay of the recorded fireside session will be available through the events page of the Company’s website at ir.novavax.com for 90 days.

On September 23, 2021 Thermo Fisher Scientific Inc. (NYSE: TMO), the world leader in serving science, reported that its board of directors has authorized the repurchase of $3 billion of shares of its common stock in the open market or in negotiated transactions (Press release, Thermo Fisher Scientific, SEP 23, 2021, View Source [SID1234590232]). The authorization has no expiration date. This replaces the company’s existing repurchase authorization, of which $500 million was remaining.

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On September 23, 2021 Fusion Pharmaceuticals Inc. (Nasdaq: FUSN), a clinical-stage oncology company focused on developing next-generation radiopharmaceuticals as precision medicines, reported that the Company will present at the 2021 Cantor Fitzgerald Virtual Global Healthcare Conference on Wednesday, September 29, 2021 at 2:40pm ET. Presenting on behalf of Fusion will be Chief Executive Officer John Valliant, Ph.D (Press release, Fusion Pharmaceuticals, SEP 23, 2021, View Source [SID1234590231]).

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A live webcast of the event will be available on the "Events and Presentations" page in the "Investors & Media" section of the Company’s website at View Source A replay of the webcast will be archived on the Company’s website for 90 days following the presentation.