Walgreens Boots Alliance Acquires Remaining Stake in German GEHE-Alliance Healthcare Joint Venture From McKesson

On November 30, 2021 Walgreens Boots Alliance (Nasdaq: WBA) and McKesson Corporation (NYSE: MCK) reported that they have reached an agreement for WBA to acquire the remaining 30% share of their GEHE Pharma Handel (GEHE) and Alliance Healthcare Deutschland (AHD) joint venture (Press release, McKesson, NOV 30, 2021, View Source [SID1234596307]). Following this transaction, WBA will become the 100% owner of the combined GEHE and Alliance Healthcare businesses in Germany.

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GEHE and AHD successfully combined their operations in the German pharmaceutical market on November 1, 2020. In that transaction WBA became the 70% owner of the joint venture with McKesson holding the remaining 30%. Today’s announcement follows McKesson’s announcement in July 2021 of the sale of certain European businesses and its intention to exit the European region fully.

"We are very pleased to have reached agreement with McKesson to take full control of our joint German pharmaceutical wholesaling operations. This new, exciting step enables Walgreens Boots Alliance to further strengthen its position as a leading pharmaceutical wholesaler in Germany," said Ornella Barra, Chief Operating Officer, International, Walgreens Boots Alliance. "We thank McKesson for their partnership in forming and developing our joint venture and look forward to further improving our innovative services to manufacturers and pharmacists in Germany."

Brian Tyler, chief executive officer, McKesson: "The sale of our minority stake in the GEHE-Alliance Healthcare joint venture in Germany is part of our stated intention to exit the European market to reinvest in strategic growth opportunities elsewhere. We believe that WBA is an excellent parent company for the GEHE-Alliance Healthcare businesses in Germany and wish our colleagues all the best under their full ownership."

The transaction is subject to standard regulatory clearance by the relevant local authorities. Financial terms of the transaction have not been disclosed.

ABM Therapeutics Receives IND Approval in China for BRAF Inhibitor ABM-1310

On November 30, 2021 ABM Therapeutics (ABM), a clinical-stage biopharmaceutical company with a focus on treating brain cancers and cancer metastases, reported that its IND application for ABM-1310, a new-generation BRAF inhibitor, has been approved by the National Medical Products Administration (NMPA) to conduct Phase 1 clinical trials in patients of advanced solid tumors with BRAF mutation in China (Press release, ABM Therapeutics, NOV 30, 2021, View Source [SID1234596305]). This is the first clinical candidate and IND approval obtained by ABM Therapeutics in China.

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ABM-1310 is a brain-penetrant BRAF inhibitor. Due to its high selectivity and optimal physicochemical properties, as well as superior efficacies and high margin of safety in preclinical models, it is expected to solve issues, such as brain metastasis, that are associated with marketed drugs.

The Phase 1 trials will be a multi-center, open-label study to assess safety, tolerability, pharmacokinetics, and preliminary efficacy. The primary goal of the study is to determine the optimal dose for Phase 1b/2 studies. The company started an ongoing Phase 1 safety trial in the United States in June of 2020.

"This is excellent progress for ABM. I really appreciate the team, including members from our supporting CRO, for all their highly efficient and superbly executed hard work. This first IND approval in China is another milestone in the development of ABM-1310, which further validates ABM’s capabilities of independent R&D innovation and technological excellence," said Dr. Chen Chen, founder and CEO of ABM Therapeutics. "Due to the blood-brain barrier (BBB), most anti-cancer drugs have poor brain penetration, resulting in limited efficacy on the brain lesion. It is an indisputable fact that many cancer patients are affected by brain metastases, but current treatment options are rare. It is a challenge to develop brain-penetrant anti-cancer drugs, but there is certainly a highly unmet medical need. ABM-1310 is a novel small molecule with high water solubility, cell permeability, and selectivity. We will begin clinical development at full throttle in China with the hope of bringing the potential therapeutic benefits to patients in the near future."

As a leading company with an emphasis on small molecules with good cell/brain permeability to address cancer metastases, particularly brain metastases, ABM has a broad and robust proprietary pipeline based on its brain medicine R&D platform. The company looks forward to further collaboration with investigators, clinical sites, big pharma and biotech companies.

Nordic Nanovector R&D Day: Building Value from Betalutin® and a pipeline of broader therapeutic opportunities targeting CD37

On November 30, 2021 Nordic Nanovector ASA (OSE: NANOV), a clinical-stage biotech company focused on CD37-targeted therapies for haematological cancers and immune diseases, reported that it will host an R&D day starting at 14:00 CET/ 13:00 GMT/ 08:00 ET. The meeting will be held via a live webcast (Press release, Nordic Nanovector, NOV 30, 2021, View Source [SID1234596304]).

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Presentations will be delivered by Dr Leo I. Gordon, MD, FACP, a global key opinion leader in haematology and members of Nordic Nanovector’s executive team.

Erik Skullerud, Nordic Nanovector’s CEO, commented: "We are pleased to share our vision and strategy for creating value from Betalutin – a potential `pipeline in a product’ for treating different types of non-Hodgkin’s lymphoma (NHL) – as well as through the development of exciting opportunities that leverage the company’s deep expertise and experience in CD37 biology. CD37 is a well-established and validated therapeutic target for a range of haematological cancers and immune diseases. Nordic Nanovector has a fantastic opportunity to build a leadership position around this target and already has several early-stage assets that could form the foundation for future growth."

The webcast can be accessed from www.nordicnanovector.com in the section: Investors & Media and a recording will also be available on this page after the event. The full programme for the event and presentation slides are available today from 07:00 CET at www.nordicnanovector.com in the section: Investors & Media/Reports and Presentations/R&D Day 2021.

More detail on what will be presented is as follows:

Mr Skullerud, CEO will outline the strategic vision for Nordic Nanovector beyond the pivotal Phase 2b PARADIGME trial for Betalutin, including its development in other NHL indications where Betalutin’s unique profile could address unmet patient needs. Mr Skullerud will also introduce the emerging CD37-targeting opportunities within the company’s portfolio.

Dr Leo I. Gordon, MD, FACP – Abby and John Friend Professor of Cancer Research at the Northwestern University Feinberg School of Medicine, whose research focus is to improve the outcome of patients with lymphoma – will discuss the remaining unmet medical needs in relapsed follicular lymphoma (FL), particularly in elderly and frail populations. He will also provide an update on the evolution of the treatment algorithm given the recent introduction of several novel therapies. He will look at the potential role of next generation radioimmunotherapies in addressing these challenges.

Pierre Dodion, MD, incoming Nordic Nanovector CMO, will discuss the planned expansion of the Betalutin clinical programme for earlier line treatment of FL and expansion to other NHL subtypes such as diffuse large B-cell lymphoma (DLBCL). He will also discuss how insights from earlier clinical studies are expected to inform development of Betalutin in these indications.

Marco Renoldi, MD, COO, will discuss how targeted radioimmunotherapy can be integrated into NHL care pathways, focusing on an independent government affairs project – the Radioligand Therapy Readiness Assessment Framework – funded in part by Nordic Nanovector and led by The Health Policy Partnership (HPP) to realise the potential of radioligand therapy (radioimmunotherapy).

Lars Nieba, PhD, CTO, will discuss progress being made in preparing the CMC (Chemistry, Manufacturing and Controls) component essential for the BLA (Biologics License Application) of Betalutin. He will also cover other key steps the company is undertaking to become launch ready, pending a successful clinical trial and regulatory process.

Maureen Deehan, PhD, Head of Corporate Development and Strategy, and Jostein Dahle, PhD, CSO, will discuss the rationale behind the company’s focus on CD37 as a target, and the emerging opportunities for product development and value creation within its pipeline. These opportunities include:

Humalutin, a radioimmunotherapy candidate based on a chimeric anti-CD37 antibody conjugated to lutetium-177 for NHL,
Alpha37, an alpha-emitting radioimmunotherapy candidate based on a chimeric anti-CD37 antibody conjugated to lead-212, currently being explored with partner Oranomed for relapsed refractory chronic lymphocytic leukaemia,
A fully humanized anti-CD37 antibody with potential in haematological cancers and autoimmune diseases, and
A CD37 DOTA CAR-T cell opportunity in haematological cancers, which was recently the subject of a research collaboration with the University of Pennsylvania

IDEAYA Biosciences to Participate in Investor Conferences in December 2021

On November 30, 2021 IDEAYA Biosciences, Inc. (NASDAQ: IDYA), a synthetic lethality focused precision medicine oncology company committed to the discovery and development of targeted therapeutics, reported its participation in investor conferences in December 2021 (Press release, Ideaya Biosciences, NOV 30, 2021, View Source [SID1234596303]).

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Evercore ISI HealthConX Conference
Thursday, December 2, 2021 at 10:30 am ET

Fireside Chat with Yujiro Hata, Chief Executive Officer, hosted by Josh Schimmer, M.D., M.B.A, Fundamental Research Analyst
A live audio webcast of the event will be available, as permitted by conference host, at the "Investors/News and Events/Investor Calendar" section of the IDEAYA website at View Source A replay of available webcasts will be accessible for 30 days following the live event.

Jemincare Announces the Exclusive License of the Kras Inhibitor to HUYABIO

On November 30, 2021 Jemincare, a leading pharmaceutical company from China, reported its wholly owned subsidiary company, Shanghai Jemincare Pharmaceutical Co., Ltd., had licensed exclusive worldwide ex-China rights to the Kras inhibitor, JMKX1899, to HUYABIO International, the leader in accelerating global development of China’s pharmaceutical innovations (Press release, HUYA Bioscience, NOV 30, 2021, View Source [SID1234596302]). Jemincare will retain the relevant rights in greater China area.

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Kras is one of the most mutated oncogenes in human cancers. The prevalent G12C mutation drives tumor growth and metastasis and has become an important validated target for therapy especially in lung and colorectal cancer. Targeting the GTP pocket of Kras in the switch-II region, which has made Kras druggable, enables the development of more potent and potentially effective inhibitors.

JMKX1899 is a KRAS inhibitor independently developed by Jemincare. Data from preclinical studies shows it has strong blood-brain-barrier crossing capability and has no risk of hERG inhibition and drug-drug-interaction. Jemincare has filed the IND to NMPA in Oct. 2021. The parties will work closely to file IND in US FDA in 2021 to move towards clinical development.

Mr. Hong Liang, President of Jemincare Pharmaceutical Group, said, "We are delighted to work with HUYABIO to explore global development of this unique KRAS inhibitor. This is our first new chemical entity program out-licensed to a global partner. HUYABIO has generated a lot of experience to bring innovative drugs from China to global market. We look forward to generating the clinical efficacy and safety data from global clinical trial since the candidate has huge potential to fill strong unmet needs."

Dr. Mireille Gillings, CEO & Executive Chair of HUYABIO, said, "We are excited to have added the clinical stage Kras inhibitor to our oncology pipeline especially to test in combination with our SHP inhibitor against a variety of solid tumors. We’re delighted to have an excellent partner Jemincare to co-develop combinations that can benefit patients worldwide."