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.

On January 12, 2021 BerGenBio ASA (OSE:BGBIO), a clinical-stage biopharmaceutical company developing novel, selective AXL kinase inhibitors for severe unmet medical need, reported that a member of the senior management team is presenting at the following virtual conferences (Press release, BerGenBio, JAN 12, 2021, View Source [SID1234574333]):

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Solebury Trout Management Access Event. 6-15 January 2021

H.C. Wainwright Bioconnect 2021, 11-14 January 2021

SEB Virtual Nordic Healthcare Conference, 18-19 January 2021

Live presentation at 9.40am CET on 18 January

The presentations will be made available at www.bergenbio.com after the events.