On November 18, 2021 Daiichi Sankyo Company, Limited (hereafter, Daiichi Sankyo) reported that the first patient was dosed in the global TROPION-Breast01 phase 3 trial evaluating the efficacy and safety of datopotamab deruxtecan (Dato-DXd), a TROP2 directed DXd antibody drug conjugate (ADC) being jointly developed by Daiichi Sankyo and AstraZeneca (LSE/STO/Nasdaq: AZN), in patients with hormone receptor (HR) positive, human epidermal growth factor 2 receptor (HER2) negative inoperable or metastatic breast cancer previously treated with chemotherapy (Press release, Daiichi Sankyo, NOV 18, 2021, View Source [SID1234595808]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

Breast cancer is the most common cancer worldwide with more than two million cases diagnosed in 2020, resulting in nearly 685,000 deaths globally.1 Approximately 70% of all breast cancers are considered HR positive, HER2 negative.2 For patients with HR positive, HER2 negative metastatic breast cancer that progresses on or is not suitable for hormone therapy-based regimens, current standard of care is single-agent chemotherapy, which demonstrates diminishing efficacy with each subsequent line of treatment.3

"There are no TROP2 directed therapies currently approved for HR positive, HER2 negative breast cancer and we are encouraged by the emerging clinical profile of datopotamab deruxtecan in patients with breast cancer," said Gilles Gallant, BPharm, PhD, FOPQ, Senior Vice President, Global Head, Oncology Development, Oncology R&D, Daiichi Sankyo. "TROPION-Breast01 is the first pivotal trial of datopotamab deruxtecan in breast cancer and the third pivotal study in our clinical development program, underscoring our efforts to accelerate development of this TROP2 directed ADC in breast and lung cancer."

"Most patients with HR positive, HER2 negative metastatic breast cancer will inevitably progress on available treatments, including hormonal therapy and standard of care chemotherapy. In this setting, the unmet need is high, and new therapeutic approaches are necessary to delay disease progression and extend survival," said Cristian Massacesi, MD, Chief Medical Officer and Oncology Chief Development Officer, AstraZeneca. "The TROPION-Breast01 trial will evaluate whether datopotamab deruxtecan may be a more effective treatment than chemotherapy for patients with previously treated HR positive, HER2 negative advanced breast cancer previously treated with one to two lines of chemotherapy."

About TROPION-Breast01
TROPION-Breast01 is a global, randomized, open-label, phase 3 trial evaluating the efficacy and safety of datopotamab deruxtecan (6 mg/kg) compared with investigator’s choice of chemotherapy (eribulin, capecitabine, vinorelbine or gemcitabine) in patients with inoperable or metastatic HR positive, HER2 negative breast cancer (per ASCO (Free ASCO Whitepaper)/CAP guidelines, on local laboratory results) who have progressed on or were not suitable for endocrine therapy and previously treated with one or two prior lines of systemic chemotherapy in the inoperable or metastatic setting.

The dual primary endpoints of TROPION-Breast01 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, and patient reported outcomes, as well as safety and pharmacokinetics.

TROPION-Breast01 will enroll approximately 700 patients at sites in Africa, Asia, Europe, North America and South America. For more information visit ClinicalTrials.gov.

About HR Positive, HER2 Negative Breast Cancer
Breast cancer is the most common cancer and is one of the leading causes of cancer-related deaths worldwide. More than two million cases of breast cancer were diagnosed in 2020, resulting in nearly 685,000 deaths globally.1 Approximately 5% to 10% of women diagnosed with breast cancer have metastatic disease at diagnosis, and up to 30% of women with early-stage breast cancer will develop metastatic disease.4

Approximately 70% of all breast cancers are considered HR positive, HER2 negative, meaning tumors test positive for estrogen and/or progesterone hormone receptors and negative for HER2.2 Current standard of care treatment for patients with HR positive, HER2 negative metastatic breast cancer that progresses on hormone therapy-based regimens is sequential single-agent chemotherapy. However, response rates are low with PFS ranging from 4 to 6.3 months with second-line chemotherapy, and 2.4 to 5.5 months with third-line chemotherapy.5,6,7,8 Data in subsequent lines of treatment show decreasing median PFS and OS with each further line of chemotherapy. There remains a need to improve outcomes including survival for patients living with advanced HR positive, HER2 negative breast cancer.9

About TROP2
TROP2 (trophoblast cell-surface antigen 2) is a transmembrane glycoprotein overexpressed in several types of solid tumors, including breast cancer.10 TROP2 expression has been detected in a wide range of breast cancer subtypes, including the HR positive, HER2 negative subtype.11,12 High TROP2 expression is an unfavorable prognostic factor for overall survival in all types of breast cancer.13 There are currently no TROP2 directed therapies approved for treatment of HR positive, HER2 negative breast cancer.

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 lead 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 topoisomerase I inhibitor payload, an exatecan derivative, via a tetrapeptide-based cleavable linker.14

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

About the Daiichi Sankyo and AstraZeneca Collaboration
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.

About Daiichi Sankyo in Oncology
The oncology portfolio of Daiichi Sankyo is powered by our team of world-class scientists that push beyond traditional thinking to create transformative medicines for people with cancer. Anchored by our DXd antibody drug conjugate (ADC) technology, our research engines include biologics, medicinal chemistry, modality and other research laboratories in Japan, and Plexxikon Inc., our small molecule structure-guided R&D center in the U.S. We also work alongside leading academic and business collaborators to further advance the understanding of cancer as Daiichi Sankyo builds towards our ambitious goal of becoming a global leader in oncology by 2025.

On November 18, 2021 NorthStar Medical Radioisotopes, LLC (‘NorthStar’), a global innovator in the development, production and commercialization of radiopharmaceuticals used for therapeutic applications and medical imaging, and IBA (Ion Beam Applications S.A., EURONEXT), the world leader in particle accelerator technology, reported a new contract in which NorthStar will purchase a third Rhodotron TT300 HE electron beam accelerator from IBA (Press release, NorthStar Medical Radiostopes, NOV 18, 2021, View Source [SID1234595806]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

The accelerator will be exclusively used for the production of no-carrier added (n.c.a.) actinium-225 (Ac-225), an important therapeutic radioisotope that is in highly limited supply and for which no commercial-scale production technology currently exists. NorthStar previously purchased two Rhodotron accelerators from IBA for its newly completed molybdenum-99 (Mo-99) production facility.

"We look forward to continuing to work with IBA, who have shown extensive commercial expertise and excellent performance in delivering electron beam accelerators for our Mo-99 production expansion project," said Stephen Merrick, President and Chief Executive Officer of NorthStar. "NorthStar is at the forefront of U.S. radioisotope production as the only commercialized producer of the diagnostic imaging radioisotope molybdenum-99 (Mo-99). We are applying that same development expertise to rapidly advance large-scale availability of the therapeutic radioisotope Ac-225 for use in oncology and other indications, and we are excited about its potential in these disease areas."

Olivier Legrain, Chief Executive Officer of IBA commented, "We are delighted to sign this latest contract with NorthStar Medical Radioisotopes and to continue to deliver innovative solutions for reliable radioisotope supply. IBA’s Rhodotron accelerators provide the most advanced electron accelerator technology in the world, and we are excited for the opportunity to create new therapeutic radioisotopes such as Ac-225. With its radiotheranostic capabilities, combining targeted diagnosis and therapy, we believe that this radioisotope has significant potential in the treatment of cancer."

The final stage of facility design is underway for NorthStar’s state-of-the-art Therapeutic Radioisotope production facility, which will be exclusively dedicated to Ac-225 production, with construction scheduled to begin in early 2022. Initial production of Ac-225 is planned for late 2023, and a Drug Master File will be submitted to the FDA in 2024. NorthStar’s proprietary process for the production of Ac-225 will use IBA’s Rhodotron to enable commercial-scale n.c.a. Ac-225 production that is free of long-life radioactive byproducts associated with other production methods.

About Actinium-225 (Ac-225) and Therapeutic Radiopharmaceuticals

Ac-225 is a high energy alpha-emitting radioisotope of significant interest by the medical community for extensive use in clinical studies of targeted radiopharmaceutical therapy (RPT). RPT combines select molecules with therapeutic radioisotopes, such as Ac-225, to directly target and deliver therapeutic doses of radiation to destroy cancer cells in patients with serious disease. Ac-225 carries sufficient radiation to cause cell death in a localized area of targeted cells, while minimizing undesired dose to adjacent cells in patients. Clinical research and commercial use of Ac-225 are severely constrained by chronic short supply due to limitations of current production technology. NorthStar’s electron accelerator technology will produce high purity, no-carrier added (n.c.a.) Ac-225, free of long-lived radioactive byproducts. NorthStar is positioned to be the first commercial-scale producer of therapeutic radioisotopes Ac-225 and copper-67 (Cu-67) by applying its production technology expertise to provide reliable supply for advancing clinical research and supplying commercial radiopharmaceutical products.

On November 18, 2021 BAKX Therapeutics reported it closed $25 million in a Series A fundraising led by AB Magnitude Ventures Group with Ipsen Pharma SA and Sherpa Healthcare Partners (Press release, Bakx Therapeutics, NOV 18, 2021, View Source [SID1234595805]). The new funding will enable the company to drive its BAKX Activator Program into the clinic in hematologic malignancies and solid tumors and to advance additional targets for solid tumors and prevention of resistance. The financing comes on the heels of the company’s recent announcement of a partnership comprising up to $852 million in upfront and potential milestone payments with Ipsen, a global biopharmaceutical company, to research, develop, manufacture and commercialize the company’s lead candidate, BKX-001, as a potential treatment for leukemia, lymphoma and solid tumors.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

Sree Kant, founder and CEO of BAKX Therapeutics, said, "BAKX brings together the world’s most comprehensive knowledge of the mitochondrial apoptosis pathway with industry leading structure-based drug design and computational drug discovery techniques. Our pro-apoptotic programs were developed on the innovative work of our scientific co-founders, Loren D. Walensky of Dana-Farber Cancer Institute and Evripidis Gavathiotis of Albert Einstein College of Medicine, who are the world’s leading experts in pro-apoptotic BAX/BAK activation pathway. Together they uncovered novel methods for solving the unique challenges of exploiting conformationally dynamic proteins to induce cancer cell death while sparing healthy cells."

Kant added, "Following on our collaboration with Ipsen announced in July, the new capital will support more rapid advancement into the clinic of our pipeline of novel therapeutic candidates for solid tumors and turbocharge the deployment of our computational platform to drug conformationally dynamic proteins in the mitochondrial apoptosis pathway. We are grateful to our investors who share our vision and are singularly focused on our aim to develop new therapeutics that successfully address for the first time high-value, well validated, apoptosis targets."

"Many companies have focused on targeting the pro-survival proteins, Bcl-2, Bcl-xl and Mcl-1, which have been effective for treatment of certain leukemias. Unfortunately, they have limitations like resistance in hematological malignancies and inability to achieve dosing efficacy in solid tumors," said Yibing Shan, Ph.D., founding managing director of AB Magnitude Ventures Group, who has also joined BAKX in the role of chief computational scientist. "BAKX instead is successfully activating pro-apoptotic proteins such as BAX and BAK using a combination of unsurpassed target and pathway knowledge, deep expertise in conformationally dynamic protein interactions, and new, highly innovative computational methodologies for identifying cryptic sites and simulating protein interactions in the membrane. I am excited to support the company in this round as well as drive the deployment of the BAKX computational drug discovery platform in the field of apoptosis."

Philippe Lopes-Fernandes, executive vice president and chief business officer at Ipsen, said, "At Ipsen we believe great partnerships create great possibilities and our collaboration with BAKX is an example of this with our investment in the future of BAKX, alongside our collaboration on the BKX-001 program. We support and congratulate BAKX on raising additional capital as we work together to advance BKX-001 in what is a groundbreaking approach to inducing cancer cell death. We share BAKX’s ambition to bring this innovation to people living with cancer around the world."

On November 18, 2021 Apollo Therapeutics, a portfolio-based biopharmaceutical company rapidly advancing transformative treatments based on breakthrough discoveries, reported the appointment of Dr. Sanjay Aggarwal as the company’s chief medical officer (Press release, Apollo Therapeutics, NOV 18, 2021, View Source [SID1234595804]). Dr. Aggarwal will be based in the company’s U.S. facility located at the Cambridge Innovation Center in Cambridge, Mass.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

"Sanjay is a highly accomplished clinical leader whose experience developing promising therapeutics through to regulatory approval will be incredibly valuable to Apollo as we move our lead programs forward," said Dr. Richard Mason, CEO of Apollo. "We are proud to have him as a leader of our newly opened Boston facility where we look forward to growing our presence in the United States."

Dr. Aggarwal joins Apollo with more than 20 years in the biopharmaceutical industry, including extensive experience in building and leading clinical development teams, as well as a track record of taking drugs through development to successful regulatory approvals. Dr. Aggarwal was most recently chief medical officer at Angiocrine Bioscience, a clinical-stage cell and gene therapy company. Before this, he was the architect of the Rezurock (belumosudil) Phase 2 and 3 development programs at Kadmon, leading to its FDA approval for chronic graft versus host disease. Prior to joining Kadmon, Dr. Aggarwal was the global development lead for Kyprolis (carfilzomib) at Amgen, leading to its approval in multiple myeloma in the U.S., E.U. and numerous additional countries.

Earlier in his career, Dr. Aggarwal held positions of increasing responsibility in both biotech (Exelixis, Onyx Pharmaceuticals) and pharma (GSK, Novartis and Sanofi), overseeing development of early- and late-stage assets across several therapeutic areas with roles in the U.S., Europe and Asia-Pacific. He studied mathematics and medicine to earn his medical degree from The University of Cambridge. He has an MBA from The University of Chicago Booth School of Business. Clinically, he trained in internal medicine and public health and is a member of the Royal College of Physicians.

"Apollo has built an impressive pipeline of therapeutic programs based on breakthrough discoveries that hold tremendous promise across multiple disease areas," said Dr. Aggarwal. "I look forward to advancing the lead programs into clinical investigation and working with the team to further build the company by acquiring clinical-stage assets."

On November 18, 2021 Lassen Therapeutics, a biotech company developing breakthrough antibody therapeutics as potential treatments for fibrosis, rare diseases and oncology, reported the appointment of Puneet S. Arora, M.D. as Chief Medical Officer (Press release, Lassen Therapeutics, NOV 18, 2021, View Source [SID1234595803]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

"As a highly regarded physician-scientist and drug developer, Puneet’s experience in inflammation and immunology will be instrumental to Lassen as we initiate our clinical program for LASN01, our first-in-class anti-IL-11R antibody," said Mark Barrett Chief Executive Officer of Lassen Therapeutics. "In addition, his expertise in antibody therapeutics and novel targets from his experience across the biotech and pharma industries will be invaluable as we build a robust and innovative pipeline in fibrosis, oncology and other therapeutic areas."

Dr. Arora brings extensive expertise in the development of investigational therapies, having most recently served as Head of Clinical, Inflammation and Immunology at Principia Biopharma, a Sanofi company. At Principia, he led clinical development strategy and the clinical team in the design and execution of clinical studies across the company’s portfolio. Dr. Arora managed clinical development for lead programs including early translational development and proof of concept through late development and regulatory submissions. He played a key role in leading the pivotal study clinical and filing teams for the rilzabrutinib program in pemphigus. Prior to his time at Principia, he was Senior Medical Director of Early Clinical Development and Clinical Team Leader at Genentech Research and Early Development working across multiple therapeutic areas. Dr. Arora received his medical degree from the All India Institute of Medical Sciences, completed his residency in internal medicine at the Southern Illinois University School of Medicine, a fellowship in endocrinology at NYU, and earned a Master’s Degree in Clinical Research at the Mayo Clinic as part of the Clinical Research Training Program.

"I am excited to join Lassen at this pivotal time and advance our mission of developing biotherapeutics against compelling new targets that are central to diseases with significant unmet needs," said Dr. Arora. "Lassen is pursuing compelling targets and novel mechanisms of action with the potential to result in important new therapeutics for patients with limited treatment options."