On February 1, 2022 Global pharma major, Lupin Limited (Lupin) reported that they have entered into a License, Supply and Technology Sharing agreement with Axantia Holding (Axantia), a leading pharmaceutical company in the region operating through its pharmaceutical subsidiaries; Pharma International Company and Med City Pharmaceutical Industries (Press release, Lupin, FEB 1, 2022, View Source [SID1234607548]). Under the terms of Agreement, Axantia will register, distribute and market biosimilar Pegfilgrastim Drug Product in certain territories including Saudi Arabia, certain GCC countries, Jordan, Lebanon, Iraq, Sudan, Libya and Algeria.

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Lupin had earlier received the U.S. FDA acceptance for review of the Biologics License Application (BLA) for its proposed biosimilar to Neulasta (pegfilgrastim) through a filing using the 351(k) pathway.

Pegfilgrastim is indicated to reduce the duration of neutropenia and the incidence of febrile neutropenia in patients receiving chemotherapy.

On February 1, 2022 Eisai Co., Ltd. (Headquarters: Tokyo, CEO: Haruo Naito, "Eisai") reported that it was selected as the winner of the Tokyo Governor Prize for Corporate Governance of the Year 2021, which is an award program organized by the Japan Association of Corporate Directors (JACD; Chairman: Yoshihiko Miyauchi) (Press release, Eisai, FEB 1, 2022, View Source [SID1234607547]). The award ceremony was held on January 31, 2022.

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The awards have been established to recognize the companies which have achieved and maintained the medium to long term profitability by implementing good corporate governance, since 2015. Among the eligible companies for selection of the Corporate Governance of the Year 2021, the Tokyo Governor Prize goes to a company which has excellent corporate governance and also practices ESG activities such as environmental activities, women empowerment, initiatives for diversity and work style reforms.

Commenting on the reason for selecting Eisai, Mr. Eiichiro Kodama, Director General for Global Financial City Strategy, Office of the Governor for Policy Planning, Tokyo Metropolitan Government stated, "Eisai is a pioneer in incorporating its corporate philosophy into the Articles of Incorporation and practicing "Purpose Management." With regard to corporate governance, Eisai makes the most of its status as a company with a nomination committee, etc., system to clearly separate management oversight and business execution, and places great importance to dialogue with its stakeholders including patients. In terms of ESG, Eisai is a signatory to the United Nations Global Compact and actively participates in climate change-related initiatives such as "RE100" and the Japan Climate Initiative. In addition, Eisai is taking on the challenge of quantifying values that do not appear on the balance sheet, such as investments in human capital, with attempting to select KPIs related ESG including the ratio of women in management positions, analyze its relationship with PBR (Price Book-value Ratio), and utilize the verification results for engagement with investors. Eisai is actively working to tell the story of the cause-and-effect relationship between the ESG initiatives and the enhancement of corporate value, thus taking on the extremely important challenge to visualize invisible value, embody the value of ESG, and disseminate them."

Eisai defines its corporate mission as "giving first thought to patients and their families and to increasing the benefits health care provides" in the Articles of Incorporation, and shares it with its stakeholders. Eisai calls this philosophy the human health care (hhc) philosophy, in one word, and believes that practicing philosophical management based on the hhc philosophy will contribute to achieving Sustainable Development Goals (SDGs) and further enhance its corporate value.

Eisai is committed to further strengthening its corporate governance in order to realize the hhc philosophy.

On February 1, 2022 Chimeric Therapeutics (ASX:CHM, "Chimeric"), a clinical-stage cell therapy company and the ASX leader in cell therapy, reported that it has signed a Sponsored Research Agreement with the University of Pennsylvania ("Penn") to support the continued research and development of CHM 2101, a novel 3rd generation CDH17 CAR T cell therapy.

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The research will be led by one of the inventors of CHM 2101, Xianxin Hua, MD, PhD. Dr Hua is a professor of Cancer Biology in Penn’s Perelman School of Medicine, and an investigator at the Abramson Family Cancer Research Institute.

The research will focus on furthering the development of CHM 2101 with preclinical studies in gastrointestinal cancers, enhancing the understanding of CHM 2101 through correlative studies and investigating CDH17 directed follow on candidates.

As part of the agreement, Chimeric has the first right of negotiation to license Penn intellectual property arising from the conduct of the sponsored research. "We are pleased to announce this research agreement as it reflects our shared commitment to the further research and development of CHM 2101 with Dr. Hua and the University of Pennsylvania," said Jennifer Chow, Chief Executive Officer of Chimeric Therapeutics.

"We are also thrilled with the progress we have made on driving this important therapy to clinic and are excited as the execution of this agreement will enhance our ability to move forward with that goal."

Authorised on behalf of the Chimeric Therapeutics board of directors by Chairman Paul Hopper

On February 1, 2022 Clarity Pharmaceuticals (ASX: CU6) ("Clarity"), a clinical-stage radiopharmaceutical company developing next-generation products to address the growing needs in oncology, reported that it has completed cohort 1 and advanced to cohort 2 in the 64Cu/67Cu SARTATE Neuroblastoma trial (CL04 trial) (Press release, Clarity Pharmaceuticals, FEB 1, 2022, View Source [SID1234607517]).

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The SRC assessed the data from cohort 1 in three patients where no DLTs have occurred and recommended to progress the trial to cohort 2, without modification, increasing the dose from 75MBq/kg to 175MBq/kg body weight. Additional therapy cycles of 67Cu SARTATE have been requested by clinical sites and are being administered to patients in cohort 1 in the CL04 trial. As part of the trial, patients have also received multiple doses of 64Cu SARTATE for the imaging of tumours to assess disease localisation and eligibility for therapy. At the time of the SRC meeting, no adverse events had been reported relating to the administration of 64Cu-SARTATE.

Clarity’s Executive Chairman, Dr Alan Taylor, commented, "We are very excited to successfully advance our SARTATE product in neuroblastoma, having completed cohort 1 of this therapy trial with 67Cu SARTATE. Dosing patients at 75MBq/kg body weight in cohort 1 of the CL04 trial enabled us to generate initial data to assess the safety profile along with some initial efficacy data for this product. We look forward to progressing the trial at some of the leading cancer centres in the U.S at the increased dose level of 175MBq/kg body weight, which we hope will build upon the mounting diagnostic and therapeutic benefits of this theranostic product and improve the treatment paradigm for children with this insidious disease."

The CL04 trial is a theranostic (diagnosis and therapy) trial in paediatric patients with high-risk neuroblastoma (NCT04023331)1. It is a multi-centre, dose-escalation, open label, non-randomised, Phase 1/2a clinical trial with up to 34 patients conducted at five clinical sites in the US.

Neuroblastoma most often occurs in children younger than 5 years of age and presents when the tumour grows and causes symptoms. It is the most common type of cancer to be diagnosed in the first year of life and accounts for around 15% of paediatric cancer mortality.2 High-risk neuroblastoma accounts for approximately 45% of all neuroblastoma cases. Patients with high-risk neuroblastoma have the lowest 5-year survival rates at 40%-50%.3

In 2020, the US Food and Drug Administration (FDA) awarded Clarity two Orphan Drug Designations (ODDs), one for 64Cu SARTATE as a diagnostic agent for the clinical management of neuroblastoma and one for 67Cu SARTATE as a therapy of neuroblastoma, as well as two Rare Paediatric Disease Designations (RPDDs) for these products. Should Clarity be successful in achieving US FDA New Drug Applications for these two products, RPDDs may potentially allow the Company to access a total of two tradeable Priority Review Vouchers (PRVs) which most recently traded at USD110M per voucher.4

Dr Taylor said, "The support and persistence we have experienced throughout the neuroblastoma trial to date from our numerous supporters, such as the clinical sites, Clarity’s team, our collaborators and the US FDA, is indicative of the importance and urgency of improving the prognosis of children with high-risk neuroblastoma, where current treatment strategies are limited. Despite the challenges we faced during the pandemic, which had a significant impact on clinical site operations and management, as well as recruitment hurdles in the US, we continue to progress this trial with increased determination and fervour to ensure we achieve our ultimate goal of improving treatment outcomes for children and adults with cancer."

This announcement has been authorised for release by the Executive Chairman.