On June 13, 2022 Daiichi Sankyo (TSE: 4568) reported that the first patient was dosed in the global TROPION-Breast02 phase 3 trial evaluating the efficacy and safety of datopotamab deruxtecan (Dato-DXd) versus investigator’s choice of chemotherapy in patients with previously untreated locally recurrent inoperable or metastatic triple negative breast cancer (TNBC) not eligible to receive PD-1/PD-L1 inhibitor therapy (Press release, Daiichi Sankyo, JUN 13, 2022, View Source [SID1234615940]).

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Datopotamab deruxtecan is a specifically designed TROP2 directed DXd antibody drug conjugate (ADC) being jointly developed by Daiichi Sankyo and AstraZeneca (LSE/STO/Nasdaq: AZN).

Approximately 10 to 15% of breast cancers are considered triple negative, the most aggressive subtype of breast cancer.1,2,3 Compared to patients with other breast cancer subtypes, the prognosis for patients with metastatic TNBC is generally worse, with five-year survival rates estimated at 12% and median overall survival generally less than two years.3,4 TNBC is defined by tumors that test negative for estrogen and progesterone hormone receptors (HRs) as well as human epidermal growth factor 2 receptor (HER2), as determined by an IHC test and/or an ISH test; HER2 negative cancers are currently defined as IHC 0, IHC 1+ or IHC 2+/ISH-.3,5

"Patients with metastatic triple negative breast cancer who are not able to receive PD-1/PD-L1 inhibitor treatment often experience recurrence following chemotherapy, so additional options in the first-line treatment setting are needed," said Gilles Gallant, BPharm, PhD, FOPQ, Senior Vice President, Global Head, Oncology Development, Oncology R&D, Daiichi Sankyo. "The TROPION-Breast02 trial will build on the preliminary efficacy and safety profile seen in the relapsed or refractory triple negative breast cancer arm of the TROPION-PanTumor01 trial to evaluate whether datopotamab deruxtecan may be a more effective treatment than chemotherapy for patients in the first line setting."

"Initial results of datopotamab deruxtecan in patients with pretreated metastatic triple negative breast cancer, a group with a significant unmet need, have been encouraging," said Cristian Massacesi, MD, Chief Medical Officer and Oncology Chief Development Officer, AstraZeneca. "We are building on these early results by moving forward with the TROPION-Breast02 trial, the second pivotal trial of datopotamab deruxtecan in breast cancer, to determine if this antibody drug conjugate may potentially be used earlier in the treatment of metastatic triple negative breast cancer."

About TROPION-Breast02
TROPION-Breast02 is a global, randomized, open-label, two-arm, multicenter study assessing the efficacy and safety of datopotamab deruxtecan (6 mg/kg) compared with investigator’s choice of chemotherapy (paclitaxel, nab-paclitaxel, capecitabine, carboplatin or eribulin) in patients with previously untreated locally recurrent inoperable or metastatic TNBC. TNBC is defined as HR negative, meaning tumors test negative for estrogen and progesterone hormone receptors, and HER2 negative, determined by an IHC test and/or an ISH test.3,5 HER2 negative cancers are currently defined as IHC 0, IHC 1+ or IHC 2+/ISH-.5 Patients must not be candidates for PD-1/PD-L1 inhibitor therapy and must be eligible for one of the investigator’s choice of chemotherapy options.

The dual primary endpoints of TROPION-Breast02 are progression-free survival (PFS) assessed by blinded independent central review and overall survival. Secondary endpoints include PFS assessed by investigator, objective response rate, duration of response, disease control rate, pharmacokinetics and safety.

TROPION-Breast02 will randomize approximately 600 patients with TNBC at sites in Asia, Africa, Europe and North America. For more information visit ClinicalTrials.gov.

About Triple Negative Breast Cancer
Approximately 10 to 15% of breast cancers are considered triple negative, the most aggressive subtype of breast cancer.1,2,3 Compared to patients with other breast cancer subtypes, the prognosis for patients with metastatic TNBC is generally worse, with five-year survival rates estimated at 12% and median overall survival generally less than two years.3,4 TNBC is defined by tumors that test negative for estrogen and progesterone hormone receptors (HRs) as well as human epidermal growth factor 2 receptor (HER2), as determined by an IHC test and/or an ISH test; HER2 negative cancers are currently defined as IHC 0, IHC 1+ or IHC 2+/ISH-.3,5

About TROP2
TROP2 (trophoblast cell-surface antigen 2) is a transmembrane glycoprotein overexpressed in several types of solid tumors, including breast cancer.6 TROP2 expression has been detected in a wide range of breast cancer subtypes, including approximately 80% of patients with TNBC.7,8,9 High TROP2 expression is an unfavorable prognostic factor for overall survival in all types of breast cancer.7

About Datopotamab Deruxtecan (Dato-DXd)
Datopotamab deruxtecan (Dato-DXd) is an investigational TROP2 directed ADC. Designed using Daiichi Sankyo’s proprietary DXd ADC technology, datopotamab deruxtecan is one of three leading ADCs in the oncology pipeline of Daiichi Sankyo, and one of the most advanced programs in AstraZeneca’s ADC scientific platform. Datopotamab deruxtecan is comprised of a humanized anti-TROP2 IgG13 monoclonal antibody, developed in collaboration with Sapporo Medical University, attached to a number of topoisomerase I inhibitor payloads, an exatecan derivative, via tetrapeptide-based cleavable linkers.

A comprehensive development program called TROPION is underway globally with trials evaluating the efficacy and safety of datopotamab deruxtecan across multiple solid tumors, including TNBC, HR positive/HER2 negative breast cancer, non-small cell lung cancer, small cell lung cancer, urothelial, gastric and esophageal cancer. Trials in combination with other anticancer treatments, such as immunotherapy, also are underway.

About the Daiichi Sankyo and AstraZeneca Collaboration
Daiichi Sankyo Company, Limited (referred to as Daiichi Sankyo) and AstraZeneca entered into a global collaboration to jointly develop and commercialize datopotamab deruxtecan in July 2020, except in Japan where Daiichi Sankyo maintains exclusive rights. Daiichi Sankyo is responsible for the manufacturing and supply of datopotamab deruxtecan.

On June 13, 2022 Asher Biotherapeutics, Inc. (Asher Bio), a biotechnology company developing precisely-targeted immunotherapies for cancer, autoimmune, and infectious diseases, reported the appointment of Andrea Pirzkall, M.D., as its first Chief Medical Officer (Press release, Asher Biotherapeutics, JUN 13, 2022, View Source [SID1234615941]). Dr. Pirzkall has a multi-disciplinary clinical background and a proven track record in developing cancer therapies from research to commercialization.

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"We are delighted to welcome Andrea to the Asher Bio team at this pivotal time as we transition to a clinical-stage company. Her broad background spans early and late-stage development and includes both small molecule and biologic agents. She has expertise in immunotherapies for cancer and is a successful leader of growing clinical teams. Andrea is an ideal fit to our team as we continue to advance our pipeline," said Craig Gibbs, Ph.D., Chief Executive Officer of Asher Bio. "Her expertise and hands-on style will be valuable assets as we implement clinical strategies to deliver our selective and differentiated immunotherapies for patients with cancer and other diseases."

"I am very excited to join Asher Bio’s highly experienced senior management team and to build and lead the clinical development organization to deliver on the company’s promising pipeline of cis-targeted therapeutics," said Dr. Pirzkall. "I am particularly intrigued by the potential of Asher Bio’s cis-targeting platform approach to overcome limitations and broaden the potential of existing immunotherapy by selectively targeting immune cell subsets, and thereby aiming to improve outcomes for patients. That includes Asher Bio’s lead cis-targeted IL-2 immunotherapy, AB248, which is approaching an IND filing and the start of a Phase 1 clinical trial. AB248 has been designed to selectively activate IL-2 signaling in CD8+ effector T cells, while avoiding systemic toxicities and limiting counterproductive pleotropic signaling that results from IL-2 binding to non-targeted cells. I look forward to working with the team to transition this compound into the clinic."

Most recently, Dr. Pirzkall served as Chief Medical Officer at Replimune Group, Inc., where she was responsible for building, developing, and leading clinical development of the company’s pipeline of next-generation oncolytic immunotherapies. Prior to that, Dr. Pirzkall served as Executive Director of Clinical Development at BeiGene, Ltd., where she led and supported the development, startup and execution of several pivotal studies in lung cancer and head and neck cancers, which successfully led to approvals of tislelizumab (anti-PD1) in China and ongoing filings in other jurisdictions. She also served as the global clinical development lead on the BeiGene, Inc./Celgene Corporation joint development committee. Earlier in her career, Dr. Pirzkall spent 10 years at Genentech, Inc., where she held roles of increasing responsibility, including Principal Medical Director and Clinical Development Team Leader. In this role, she worked with cross-functional teams on therapeutics including Avastin, Tarceva, Perjeta, Cotellic and Tecentriq supporting these novel biologic agents through early to late stages of development in oncology as well as through exploratory and combination studies.

Prior to moving to industry, Dr. Pirzkall trained in radiation oncology and completed her dissertation at the University of Heidelberg and the German Cancer Research Center. She completed a fellowship in Medical Physics/Radiation Oncology at the University San Francisco (UCSF) and held academic positions as Associate Adjunct Professor of Radiation Oncology, Radiology, and Neurosurgery at UCSF. Dr. Pirzkall holds a Doctor of Medicine from Friedrich-Schiller University Jena, Germany.

On June 13, 2022 BlueSphere Bio, a T-cell receptor (TCR) T-cell therapy company developing a powerful TCR discovery platform and novel therapeutic candidates for patients with hematologic malignancies and solid tumors, reported that David Apelian, M.D., Ph.D., MBA, Chief Executive Officer of BlueSphere Bio, will provide a corporate overview at the 2022 BIO International convention on June 13, 2022 at 3:45 p.m. PT in company presentation theater 2 (Press release, BlueSphere Bio, JUN 13, 2022, View Source [SID1234616066]).

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The presentation will highlight the company’s latest data supporting future clinical development of their adoptive TCR T-cell therapies and novel high-throughput TCXpress and NEOXpress platforms designed to target some of the most challenging cancers. The TCXpress platform has enabled the discovery of BlueSphere’s first clinical candidate, a TCR T-cell therapy directed against the minor histocompatibility antigen (miHA) HA-1. The company anticipates filing its first IND by the end of 2022. The TCXpress platform has also enabled the discovery of four new TCRs reactive against other relevant miHAs, in addition to HA-1. BlueSphere plans to announce details on these other targets later this year.

BlueSphere’s management will be available to participate in one-on-one meetings with industry executives and investors registered for the conference. To schedule a meeting with the Company, please reach out through the BIO partnering system.

On June 13, 2022 Novo Nordisk reported that initiated a share repurchase programme in accordance with Article 5 of Regulation No 596/2014 of the European Parliament and Council of 16 April 2014 (MAR) and the Commission Delegated Regulation (EU) 2016/1052 of 8 March 2016 (the "Safe Harbour Rules") (Filing, 6-K, Novo Nordisk, JUN 13, 2022, View Source [SID1234615924]). This programme is part of the overall share repurchase programme of up to DKK 24 billion to be executed during a 12-month period beginning 2 February 2022.

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Under the programme initiated 3 May 2022, Novo Nordisk will repurchase B shares for an amount up to DKK 4.4 billion in the period from 4 May 2022 to 2 August 2022.

Since the announcement 7 June 2022, the following transactions have been made:

The details for each transaction made under the share repurchase programme are published on novonordisk.com.

With the transactions stated above, Novo Nordisk owns a total of 14,281,381 B shares of DKK 0.20 as treasury shares, corresponding to 0.6% of the share capital. The total amount of A and B shares in the company is 2,280,000,000 including treasury shares.

Novo Nordisk expects to repurchase B shares for an amount up to DKK 24 billion during a 12- month period beginning 2 February 2022. As of 10 June 2022, Novo Nordisk has since 2 February 2022 repurchased a total of 12,541,818 B shares at an average share price of DKK 757.65 per B share equal to a transaction value of DKK 9,502,248,235

On June 13, 2022 BeiGene (NASDAQ: BGNE; HKEX: 06160; SSE: 688235), a global, science-driven biotechnology company focused on developing innovative and affordable medicines to improve treatment outcomes and access for patients worldwide reported that its BTK inhibitor BRUKINSA (zanubrutinib) has been approved by the Ministry of Health in Kuwait, the National Health Regulatory Authority in Bahrain and the Ministry of Public Health in Qatar for the treatment of adult patients with mantle cell lymphoma (MCL) who have received at least one prior therapy (Press release, BeiGene, JUN 13, 2022, View Source [SID1234615942]). BeiGene is working with NewBridge Pharmaceuticals, a specialty company in the Middle East and North Africa (MENA) regions established to bridge the access gap by partnering with global pharma and biotech companies, to bring BRUKINSA to patients in Kuwait, Bahrain, Qatar, Saudi Arabia, United Arab Emirates, and other markets in the MENA region following regulatory approvals.

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"Non-Hodgkin’s lymphoma is among the five most common cancers in Kuwait, Bahrain, and Qatar, with MCL in particular having a poor prognosis. Patients typically require multiple lines of therapy where the duration of response to subsequent lines of treatment is continually reduced," said Dr. Abdul Aziz Hamadah, Head of Hematology Department, Kuwait Cancer Control Center. "BRUKINSA is a next-generation BTK inhibitor designed as a highly potent, selective, bioavailable, and irreversible inhibitor with potentially advantageous pharmacokinetic and pharmacodynamic properties."

"BeiGene’s vision is to develop impactful medicines and reach far more patients around the world. Over the past year, BeiGene has achieved approval for BRUKINSA in five countries in the MENA region including Saudi Arabia, United Arab Emirates, Kuwait, Bahrain and Qatar," said Mohammed Al-Kapany, Senior Director of New Markets in MENA at BeiGene. "We are proud to be on a path to bringing an important new treatment option to patients."

Added Joe Henein, President and CEO of NewBridge Pharmaceuticals, "Continuing our productive collaboration with BeiGene in the MENA region, we look forward to introducing BRUKINSA to physicians and their patients in Kuwait, Bahrain and Qatar."

The recommended dose of BRUKINSA is either 160 mg twice daily or 320 mg once daily, taken orally with or without food. The dose may be adjusted for adverse reactions and reduced for patients with severe hepatic impairment and certain drug interactions.

About Mantle Cell Lymphoma (MCL)

Non-Hodgkin’s lymphoma (NHL) is one of the five most prevalent cancers in Kuwait.i MCL is rare form of NHL, accounting for five percent of all cases. It develops in the outer edge of a lymph node called the mantle zone. Mantle cell lymphoma occurs more often in men than in women. It is usually diagnosed in people in their early 60s.3 MCL has a poor prognosis, with a median survival of three to four years, and is often diagnosed at a later stage of disease.ii

About BRUKINSA

BRUKINSA is a small molecule inhibitor of Bruton’s tyrosine kinase (BTK) discovered by BeiGene scientists that is currently being evaluated globally in a broad clinical program as a monotherapy and in combination with other therapies to treat various B-cell malignancies. Because new BTK is continuously synthesized, BRUKINSA was specifically designed to deliver complete and sustained inhibition of the BTK protein by optimizing bioavailability, half-life, and selectivity. With differentiated pharmacokinetics compared to other approved BTK inhibitors, BRUKINSA has been demonstrated to inhibit the proliferation of malignant B cells within a number of disease relevant tissues.

BRUKINSA is supported by a broad clinical program which includes more than 3,900 subjects in 35 trials across 28 markets. To date, BRUKINSA has received more than 20 approvals covering 50 countries and regions, including the United States, China, the EU, and Great Britain, Canada, Australia and additional international markets. Currently, more than 40 additional regulatory submissions are in review around the world.

BeiGene Oncology

BeiGene is committed to advancing best- and first-in-class clinical candidates internally or with like-minded partners to develop impactful and affordable medicines for patients across the globe. We have a growing R&D and medical affairs team of approximately 2,900 colleagues dedicated to advancing more than 100 clinical trials that have involved more than 16,000 subjects. Our expansive portfolio is directed predominantly by our internal colleagues supporting clinical trials in more than 45 countries and regions. Hematology-oncology and solid tumor targeted therapies and immuno-oncology are key focus areas for the Company, with both mono- and combination therapies prioritized in our research and development. BeiGene currently has three approved medicines discovered and developed in our own labs: BTK inhibitor BRUKINSA in the United States, China, the EU and U.K., Canada, Australia and additional international markets; and the non-FC-gamma receptor binding anti-PD-1 antibody tislelizumab as well as the PARP inhibitor pamiparib in China.

BeiGene also partners with innovative companies who share our goal of developing therapies to address global health needs. We commercialize a range of oncology medicines in China licensed from Amgen, Bristol Myers Squibb, EUSA Pharma and Bio-Thera. We also plan to address greater areas of unmet need globally through our other collaborations including with Mirati Therapeutics, Seagen, and Zymeworks.

In January 2021 BeiGene and Novartis announced a collaboration granting Novartis rights to co-develop, manufacture, and commercialize BeiGene’s anti-PD1 antibody tislelizumab in North America, Europe, and Japan. Building upon this productive collaboration, including a biologics license application (BLA) under FDA review, BeiGene and Novartis announced an option, collaboration and license agreement in December 2021 for BeiGene’s TIGIT inhibitor ociperlimab that is in Phase 3 development. Novartis and BeiGene also entered into a strategic commercial agreement through which BeiGene is promoting five approved Novartis Oncology products across designated regions of China.