On January 12, 2021 Almac Sciences, a member of the Almac Group, reported that it has secured £2million of support from Invest Northern Ireland (INI) to accelerate a programme of enzyme research (Press release, Almac, JAN 12, 2021, View Source [SID1234575424]).

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Almac Sciences had previously established a cutting-edge biotechnology platform for enzyme chemistry and biology through two successfully completed rounds of R&D investment supported by Invest NI. This investment in R&D, awarded by INI and supported by the European Regional Development Fund, will further develop the program to establish IN Silico Informed metaGenomic Harvesting Technology (INSIGHT), a platform built from multi-disciplinary research bringing together computational, metagenomics, biology and chemistry methodologies.

Routes of synthesis for most drugs are amenable to biocatalytic intervention. The INSIGHT project aims to improve the enzyme discovery process to allow more robust enzymes to supersede multi-step chemical routes currently used to produce pharmaceutical intermediates and products.

The unique project involves the development of an enzyme identification platform based around the exploitation of Almac’s existing metagenomic data mining using enzyme modelling / engineered lead diversity screening married with the company’s strength on industrial focus. This combination approach has never been developed to accelerate enzyme discovery and their subsequent application in the past and is a significant research and development programme.

This new technology will bring significant benefit to, not only Almac, but also to the wider pharmaceutical industry as it will offer simpler, lower cost and less polluting enzymatic processes. Specifically, INSIGHT will deliver new, best-in-class metagenomics, computational and engineering platforms for the pharmaceutical, biotechnology, life sciences and fine chemicals sectors.

Dr Stefan Mix, Almac Sciences’ Head of Biocatalysis, will lead a team of experts to complete the project and deliver the foundations for future commercialisation. The INSIGHT project will span six work packages which will run over 36 months once recruitment has been secured.

Professor Tom Moody, VP Technology Development and Commercialisation, Almac Sciences and Arran Chemical Company commented: "This project, and the related INI support, will be vital to ensure we can achieve our aspiration of becoming a global leader in biotechnology. The ambitious project will bring together each of the critical elements to accelerate enzyme identification and discovery and will de-risk the enzyme development pipelines for Almac. As a result of this unique project there will be both major academic and commercial benefits, providing significant growth opportunity for the NI Bio-economy and the wider economy."

Welcoming the investment, Kevin Holland, CEO of Invest NI said: "Almac has long been one of Northern Ireland’s most successful companies within our thriving life & health sciences sector and has worked hard to build an impressive global reputation for ground-breaking work in the global pharmaceutical industry. It recognises the benefits of investing in cutting edge R&D and is making this new investment to build upon the foundations from previous R&D and capital investment over the last number of years.

"Invest NI has developed a strong collaborative partnership with Almac over the years, offering support for job creation and highly successful R&D projects. Our £2million ERDF funded offer of support for this new investment will further cement the company’s world-renowned reputation and enable it to expand its biocatalysis capability creating a new, greener and more cost-effective solution to industry. The development of this new technology enhances Northern Ireland’s global reputation in the field."

Invest NI’s R&D support is part financed by the European Regional Development Fund under the EU investment for Growth and Jobs Programme 2014-2020.

On January 12, 2021 Eisai Co., Ltd. (Headquarters: Tokyo, CEO: Haruo Naito, "Eisai") reported that presentations on a series of abstracts highlighting updates on its in-house discovered lenvatinib mesylate (product name: LENVIMA, the orally available kinase inhibitor, "lenvatinib") will be given at the Gastrointestinal Cancers Symposium Virtual Meeting, from January 15 to 17, 2021 (Press release, Eisai, JAN 12, 2021, View Source [SID1234574984]).

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At this symposium, regarding the lenvatinib monotherapy, the real-world effectiveness among unresectable hepatocellular carcinoma (HCC) patients treated in United States clinical practices (Abstract No: 273), as well as the results of a post hoc analysis of patients with unresectable HCC who progressed to the Child-Pugh B stage in the Phase 3 REFLECT study (Abstract No: 298), will be presented.

In addition, the data to be presented regarding the combination therapy of lenvatinib plus pembrolizumab (product name: KEYTRUDA), the anti-PD-1 therapy from Merck & Co., Inc., Kenilworth, N.J., U.S.A. (known as MSD outside the United States and Canada), are results from the biliary tract cancer cohort (Abstract No: 321), the colorectal cancer cohort (Abstract No: 94), and the gastric cancer cohort (Abstract No: 230) of the basket-type Phase 2 LEAP-005 clinical study for 6 types of previously treated advanced solid tumors.

In March 2018, Eisai and Merck & Co., Inc., Kenilworth, N.J., U.S.A., through an affiliate, entered into a strategic collaboration for the worldwide co-development and co-commercialization of lenvatinib.

Eisai positions oncology as a key therapeutic area, and is aiming to discover revolutionary new medicines with the potential to cure cancer. Eisai will continue to create innovation in the development of new drugs based on cutting-edge cancer research, as it seeks to contribute further to addressing the diverse needs of, and increasing the benefits provided to, patients with cancer, their families, and healthcare providers.

This release discusses investigational compounds and investigational uses for FDA-approved products. It is not intended to convey conclusions about efficacy and safety. There is no guarantee that any investigational compounds or investigational uses of FDA-approved products will successfully complete clinical development or gain FDA approval.

The full list of Eisai presentations are below.

Product / Compound
Abstract No. Title / Scheduled Date and Time (local time: Eastern Standard Time)
Lenvatinib 273

Real-world effectiveness of lenvatinib monotherapy among unresectable hepatocellular carcinoma patients treated in United States clinical practices
January 15 (Fri)

Lenvatinib 298

Post hoc analysis in patients (pts) with unresectable hepatocellular carcinoma (uHCC) who progressed to Child-Pugh B (CPB) liver function in the phase 3 REFLECT study of lenvatinib (LEN)
January 15 (Fri)

Lenvatinib + pembrolizumab 321

Lenvatinib plus pembrolizumab for patients with previously treated biliary tract cancers in the multicohort phase 2 LEAP-005 study
January 15 (Fri)

Lenvatinib + pembrolizumab 94

LEAP-005: A phase 2, multicohort study of lenvatinib plus pembrolizumab in patients with previously treated selected solid tumors: results from the colorectal cancer cohort
January 15 (Fri)

Lenvatinib + pembrolizumab 230

LEAP-005: A phase 2 multicohort study of lenvatinib plus pembrolizumab in patients with previously treated selected solid tumors: results from the gastric cancer cohort
January 16 (Sat), 4:30 PM-5:15 PM　(Accepted in poster highlight session)

On January 12, 2021 BriaCell Therapeutics Corp. ("BriaCell" or the "Company") (TSX-V:BCT) (OTCQB:BCTXF), a clinical-stage biotechnology company specializing in targeted immunotherapies for advanced breast cancer, reported that the Company will present a poster at the 2021 Keystone Symposia, "Emerging Cell Therapies: Realizing the Vision of NextGen Cell Therapeutics," a virtual scientific conference which is being held Jan. 25-27, 2021 (Press release, BriaCell Therapeutics, JAN 12, 2021, View Source [SID1234574783]).

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BriaCell will deliver a presentation with poster highlighting the clinical and pathological findings of its lead candidate, Bria-IMT, a novel immunotherapy for advanced breast cancer, as monotherapy (i.e. the Bria-IMT regimen alone) and a Phase I/IIa clinical study of Bria-IMT in combination with immune checkpoint inhibitors including pembrolizumab (KEYTRUDA; manufactured by Merck & Co., Inc.), and more recently, Incyte’s INCMGA00012 (under corporate collaboration with Incyte Corporation).

The details of the presentation are as follows:

Poster Title: Personalized off-the-shelf whole cell immunotherapy for cancer

Date and Time: January 25, 2021 10:00 AM ET – January 27, 2021 8:00 PM ET

A copy of the poster will be posted at the following: View Source

On January 12, 2021 Anticancer Bioscience (ACB), pioneers in synthetic lethal approaches to precision oncology, reported that it is participating in Biotech Showcase Digital 2021, for the first time, providing an on-demand company presentation (Press release, Anticancer Bioscience, JAN 12, 2021, View Source [SID1234574526]).

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Thaddeus Allen PhD, VP, translational medicine, USA Business Development presents on behalf of ACB this year delivered digitally. He is attending alongside Jing Zhang PhD, VP, high throughput and high content screening.

ACB’s presentation showcases its pioneering approach to precision oncology, and how it is applying its synthetic lethality expertise for better cancer therapies.

An international private company, ACB is commercialising discoveries emerging from China’s world-leading cancer research at the J. Michael Bishop Institute of Cancer Research. The Company is using its unique small molecule and natural product libraries and its discovery platforms in cancer biology to discover novel mechanisms to induce cancer cell death, without harming healthy cells. The Company has five distinct synthetic lethality programs in drug development.

"Our goal at Biotech Showcase is to meet potential academic, biotech, CRO, pharma and financing partners to explore opportunities to support our ambition and accelerate our programs. We are impressed with the PartneringOne networking platform and are pleased to have secured some interesting meetings" said Dr Allen.

This year registered attendees to Biotech Showcase can access recorded company presentations via 24×7 on-demand access allowing attendees to view presentations at their convenience, avoiding conflicts with busy meeting schedules during the main event week, 11-15 January 2021 https://informaconnect.com/biotech-showcase/

On January 12, 2021 Sanofi reported EUROAPI as the name for the future leading European company dedicated to the development, production and marketing of active pharmaceutical ingredients (API) (Press release, Sanofi, JAN 12, 2021, View Source [SID1234574487]).

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EUROAPI will represent the "made in Europe" API state-of-the-art industrial capabilities and technologies, with approximately €1 billion in expected sales by 2022. It will rank number 1 in small molecules API, and number 2 on the global API market2. Addressing recent increasing medicine shortages that critically impact patient care, EUROAPI will ensure additional API supply capacities for Europe and beyond, and help balancing the industry’s heavy reliance on API sourced from other regions.

Sanofi also announces the appointment of Karl Rotthier as the EUROAPI future Chief Executive Officer, effective January 18th. Karl Rotthier, 53 years old, is a seasoned leader with a strong API business experience. He was most recently the Chief Executive Officer of Centrient Pharmaceuticals, and had the opportunity throughout his 29-years international career in the Netherands, Germany, Austria, Belgium and Singapore, to also drive operational carve-outs and spin-offs.

Karl will lead the creation of EUROAPI together with the new company Management Team towards its growth ambitions. EUROAPI will employ 3,200 skilled employees and be headquartered in France. A planned IPO on Euronext Paris would be evaluated with a decision expected by 2022, subject to market conditions.

Philippe Luscan, Executive Vice President, Global Industrial Affairs at Sanofi, said: "We are very pleased today to unveil EUROAPI and welcome Karl to lead this future industry champion, as it gives further substance to our ambitious project. Sanofi is fully committed to the new company’s success, including by establishing a long-term customer relationship with EUROAPI and holding a minority stake of approximately 30% in it. To provide the optimal conditions for success, Sanofi intends the new company to be debt free in order to maximize its future investment capacities."

Karl Rotthier, future CEO of EUROAPI emphasizes: "I am particularly delighted to join EUROAPI and look forward to working with my colleagues in creating an agile, stand-alone company, able to unlock its growth potential in a market sustainably growing at a pace of 6% per year3. Building on a strong industrial legacy built over decades and broad expertise and experience, EUROAPI would help secure a greater stability in supplying quality drugs to millions of patients worldwide."

The project announced by Sanofi in February 2020, consists of creating a standalone company which will combine Sanofi’s API commercial and development activities with six of its European production sites: Brindisi (Italy), Frankfurt Chemistry (Germany), Haverhill (UK), St Aubin les Elbeuf (France), Újpest (Hungary) and Vertolaye (France). EUROAPI will have significant competitive strengths, including a broad portfolio of 200 APIs with both volume and niche products, high standards of quality and industrial means, competitive pricing and technologies across Europe, and will leverage an extensive commercial network covering more than 80 countries.

*About Active Pharmaceutical Ingredients (API)

Active pharmaceutical ingredients or APIs are the chemicals or biologicals which have a beneficial therapeutic effect in a medicine. These are the essential molecules used in the composition and the production of any drug.