On July 12, 2023 Tempus, a leader in artificial intelligence and precision medicine, reported its GEMINI Non-small Cell Lung Cancer (NSCLC) study (NCT05236114) (Press release, Tempus, JUL 12, 2023, View Source [SID1234633205]). The Tempus-sponsored study, being run in collaboration with AstraZeneca, aims to create a robust multi-omic dataset for patients with NSCLC to facilitate future novel research related to precision medicine, diagnostic development, and biomarker discovery.

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 study is open for enrollment for two cohorts of patients, one of which will focus on patients who have been recently diagnosed with Stage IV NSCLC and will receive standard of care checkpoint inhibitor therapy, and the other cohort will focus on patients who have early-stage NSCLC and are candidates for surgery. Tempus is leveraging its comprehensive molecular profiling portfolio – including its solid tumor assay, xT, liquid biopsy, xF, and an investigational minimal residual disease (MRD) assay – throughout the study to better understand this high-need patient population on a longitudinal basis. Patients enrolled in the trial will be studied for up to three years to assess the impact of their underlying tumor biology on disease progression and therapy efficacy. The results of this study will be used for biomarker discovery, including potential use of circulating tumor DNA (ctDNA) testing to measure MRD.

"The GEMINI study addresses research gaps in a high-need patient population that the Tempus platform is uniquely positioned to undertake," said Kate Sasser, PhD, Chief Scientific Officer at Tempus. "By taking a multi-omics approach, we believe that we can generate one of the most comprehensive analyses of early and late stage NSCLC patients, and one that will power significant advancements in biomarker discovery."

The study employs the full power of Tempus’ platform, including its intelligent diagnostics, multimodal data library, and clinical trial matching program (TIME), to develop a powerful multi-omic dataset at scale. In leveraging its TIME Trial Network, Tempus is broadening access to patients in communities across the country, while also helping to ensure that the study’s results are representative of this patient population in the United States.

On July 12, 2023 Dr. Reddy’s Laboratories Ltd. (BSE: 500124, NSE: DRREDDY, NYSE: RDY, NSEIFSC: DRREDDY; hereafter referred to as "Dr. Reddy’s"), a global pharmaceutical company, reported that its Biologics License Application (BLA) for its proposed biosimilar rituximab candidate DRL_RI has been accepted for a substantive review by the U.S. Food and Drug Administration (USFDA) (Press release, Dr Reddy’s, JUL 12, 2023, View Source [SID1234633204]). This closely follows acceptance of its rituximab biosimilar dossier for review by two other regulatory agencies – the European Medicines Agency (EMA) and the United Kingdom’s Medicines and Healthcare products Regulatory Agency (MHRA).

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!

In January 2023, Dr. Reddy’s had announced the successful completion of the full set of clinical studies of its proposed rituximab biosimilar candidate, DRL_RI, for filing in highly regulated markets such as the United States, European Union, and other regions. The submission of its dossier in April 2023 was based on a comprehensive data package including robust structural and functional analytical comparison data using multiple orthogonal techniques, pre-clinical, and head-to-head clinical studies that demonstrate similarity in pharmacokinetics, pharmacodynamics, safety, efficacy and immunogenicity with the EU* and U.S.** reference products.

DRL_RI is being developed as a biosimilar of Rituxan / MabThera (rituximab), a cluster of differentiation 20 (CD20) directed cytolytic antibody. Rituxan / MabThera is approved for various indications including for the treatment of adult patients with rheumatoid arthritis, non-Hodgkin’s lymphoma, chronic lymphocytic leukemia, pemphigus vulgaris, granulomatosis with polyangiitis and microscopic polyangiitis.

Dr. Jayanth Sridhar, Global Head of Biologics at Dr. Reddy’s, said: "This milestone underscores our capability for global clinical development of high-quality biosimilar products for highly regulated and global markets. It also reinforces the potential of DRL_RI as a safe and effective treatment option for patients across the globe. Development and commercialisation of biological drugs is an important growth lever for our business. We expect to bring many more biosimilar and other critical biological products to meet patient needs as we work towards our goal of serving over 1.5 billion patients by 2030."

Dr. Reddy’s rituximab biosimilar has already been approved for marketing in India and over 25 emerging markets. The company is currently collaborating with its partner Fresenius Kabi, a global health care company that specializes in biopharmaceuticals, clinical nutrition, medical technologies, and I.V. generic drugs for critical and chronic conditions, to commercialise its proposed biosimilar of rituximab in the United States. The company intends to commercialise the product in Europe and other geographies directly.

About Dr. Reddy’s clinical studies for its proposed biosimilar of rituximab, DRL_RI:

RI-01-003: This study demonstrated pharmacokinetic equivalence and similarity in pharmacodynamics, safety and immunogenicity between DRL_RI and EU reference medicinal product* and U.S. reference product**.
RI-01-006 (FLINTER): This study demonstrated efficacy equivalence and similarity in safety and immunogenicity between DRL_RI and EU reference medicinal product* in patients with Low Tumour Burden Follicular Lymphoma
RI-01-007: This study demonstrated similar safety and immunogenicity profile between the DRL_RI, EU reference medicinal product* and U.S. reference product** groups upon single transition from either of them, in subjects with active rheumatoid arthritis.
*EU reference medicinal product is MabThera
**U.S. reference product is Rituxan
MabThera and Rituxan are registered trademarks of Roche.

On July 12, 2023 Immunovia (Nasdaq Stockholm: IMMNOV), the diagnostics company focused on early detection of pancreatic cancer, reported plans to restructure its operations (Press release, Immunovia, JUL 12, 2023, View Source [SID1234633203]). The company will cease commercialization of its IMMray PanCan-d test in the United States to focus its resources on the further development and clinical testing of the Company’s promising next generation pancreatic cancer detection test.

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 next generation assay currently in development is intended to work equally well across multiple patient risk groups. The new test is expected to provide accurate results in patients who do not produce CA19-9, and to reduce reliance on CA19-9, which have been limitations of IMMray PanCan-d. The next generation test will be performed on a widely used commercial platform, enabling the company to better scale production. Immunovia expects to release further details about the next-generation test later this year, with an anticipated launch date in 2024.

Immunovia’s strategic decision to focus on its next generation assay will result in significant layoffs in both Sweden and the United States in multiple functions. Importantly, the staffing reductions and the elimination of other operating expenses will lower the company’s cash burn rate and extend the Company’s cash reserves well into 2024.

"In the current financial climate, we have decided to focus our resources on our next generation pancreatic cancer detection test," said Jeff Borcherding, Immunovia’s CEO. "We are very excited about the potential of the new test to deliver high accuracy across the full spectrum of high-risk individuals. The test currently in development gives us the best opportunity to demonstrate significant improvements in patient outcomes, which is necessary to secure broader reimbursement of our test. In the U.S., Reimbursement is a fundamental driver of value for Immunovia and is foundational for securing the long-term success of the company."

The company will host a conference call to elaborate on the planned changes and answer questions on the changes on Wednesday, July 12, 2023 at 15:00 CET. Log-in details will be available at Immunovia.com prior to the call.

On July 12, 2023 Sirnaomics Ltd. (the "Company", stock code: 2257, together with its subsidiaries, the "Group" or "Sirnaomics"), a leading biopharmaceutical company engaging in discovery and development of advanced RNAi therapeutics, hereby reported that Sirnaomics’ Senior Director of Technology Innovation, Dr. Weterings will present the latest developments on its of GalAhead, GalNAc-RNAi therapeutic platforms and related pipeline programs at international industry conferences taking place in July (Press release, Sirnaomics, JUL 12, 2023, View Source [SID1234633202]). Sirnaomics’ Vice President of Chemistry, Manufacturing, and Controls processes, Dr. Welch will present the Polypeptide Nanoparticle platform’s technology, at international industry conferences taking place in August.

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!

9th Annual Drug Delivery Systems Presentation Details

Presentation Title: GalAhead: A Proprietary GalNAc-RNAi Therapeutic Platform to Downregulate Single and Multiple Genes
Presenter: Jim Weterings, Ph.D., Sirnaomics Senior Director of Technology Innovation
Time/Date: 1:35 pm CEST on Wednesday, July 12, 2023
Location: Holiday Inn Amsterdam Arena Towers, the Netherlands
Presentation content:
Introduction to GalAhead, Sirnaomics’ GalNAc-RNAi therapeutic platform
Validation of technology in vivo and in vitro
Progress report on GalAhead-based programs
2nd Annual Oligonucleotides CMC & Analytical Development Summit Presentation Details

Presentation Title: Challenges for Development, Scale Up & Production of Novel Oligonucleotide
Presenter: Richard Welch, Ph.D., Sirnaomics Vice President of Chemistry, Manufacturing & Controls
Time/Date: 12:15 pm ET on Wednesday, Aug. 30, 2023
Location: Boston, MA
Presentation Content:
Unique supply chain requirement challenges
Sourcing of CDMO support
Evaluating multiple regulatory challenges faced in a global production environment

Panel Discussion: Scaling Up & Meeting Oligonucleotide Demand
Time: 11:30 am
Panel Content:
Moving into non-rare disease areas and producing oligonucleotides at scale for larger populations
Evaluating technologies and the advantages and limitations of scale
Analytical readiness for process change and late phase: strategic, regulatory, and technical perspectives

On July 12, 2023 AstraZeneca and Daiichi Sankyo’s reported that Enhertu (trastuzumab deruxtecan) has been approved in China as a monotherapy for the treatment of adult patients with unresectable or metastatic HER2-low (IHC 1+ or IHC 2+/ISH-) breast cancer who have received a prior systemic therapy in the metastatic setting or developed disease recurrence during or within six months of completing adjuvant chemotherapy (Press release, AstraZeneca, JUL 12, 2023, View Source [SID1234633201]).

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!

Enhertu is a specifically engineered HER2-directed antibody drug conjugate (ADC) being jointly developed and commercialised by AstraZeneca and Daiichi Sankyo.

The approval by China’s National Medical Products Administration (NMPA) is based on the results of the DESTINY-Breast04 Phase III trial, first presented at the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) 2022 Annual Meeting and published in The New England Journal of Medicine.1 It follows the approval granted by China’s NMPA for Enhertu in patients with previously treated unresectable or metastatic HER2-positive breast cancer in February 2023.

In China, breast cancer is the most common cancer in women, with more than 415,000 patients diagnosed in 2020.2 There were nearly 120,000 breast cancer deaths in China in 2020, representing around 18% of global breast cancer deaths.2 Approximately half of all breast cancers are considered HER2-low.3-5

Binghe Xu, MD, Director of the National Clinical Research Center for New Anticancer Drugs, Tenured Professor and Former Director, Department of Medical Oncology, Cancer Hospital Chinese Academy of Medical Sciences and Peking Union Medical College, said: "Historically, breast cancer tumours with low levels of HER2 expression have been classified as HER2-negative and have not been eligible for treatment with HER2-directed therapies. With this approval in China, based on the results of the DESTINY-Breast04 trial, clinicians will now be able to identify and potentially treat a distinct patient population based on HER2-low status."

Dave Fredrickson, Executive Vice President, Oncology Business Unit, AstraZeneca, said: "Patients with HR-positive or HR-negative, HER2-low metastatic breast cancer previously had few effective treatment options beyond chemotherapy. The results from the DESTINY-Breast04 trial show Enhertu provides a significant improvement in outcomes compared to chemotherapy for patients whose tumours are determined to be HER2-low via routine testing. This approval is an important advance in the way breast cancer is classified and treated in China and supports our vision to bring Enhertu to more patients worldwide."

Kiminori Nagao, Head of the Asia, South & Central America (ASCA) Business Unit, Daiichi Sankyo, said: "This approval of Enhertu for patients with HER2-low metastatic breast cancer, which comes shortly after the approval of Enhertu in patients with HER2-positive disease, marks the first time patients with HER2-low tumours will have the opportunity to be treated with a HER2-directed therapy. Enhertu now has the potential to become a new standard of care treatment option in China for a broad range of patients with HER2-expressing metastatic breast cancer."

In DESTINY-Breast04, Enhertu reduced the risk of disease progression or death by 50% versus physician’s choice of chemotherapy (median progression-free survival [PFS] 9.9 vs. 5.1 months; hazard ratio [HR] of 0.50; 95% confidence interval [CI] 0.40-0.63; p<0.0001) in all randomised patients with HER2-low metastatic breast cancer (either hormone receptor (HR)-positive or HR-negative disease). A 36% reduction in the risk of death (HR of 0.64; 95% CI 0.49-0.84; p=0.001) also was seen with Enhertu compared to chemotherapy with a median overall survival (OS) of 23.4 months in patients treated with Enhertu versus 16.8 months in those treated with chemotherapy.

The safety profile observed in patients treated with Enhertu in the DESTINY-Breast04 trial was consistent with that seen in other trials of Enhertu in breast cancer with no new safety signals identified.

Financial considerations
Sales of Enhertu in China are recognised by AstraZeneca and will be recorded as product sales on the profit and loss statement. Further details on the financial arrangements were set out in the March 2019 announcement of the collaboration.

Notes

Breast cancer and HER2 expression
Breast cancer is the most common cancer and is one of the leading causes of cancer-related deaths worldwide.6 More than two million patients were diagnosed with breast cancer in 2020, with nearly 685,000 deaths globally.6 In China, breast cancer is the most common cancer in women, with more than 415,000 patients diagnosed in 2020.2

HER2 is a tyrosine kinase receptor growth-promoting protein expressed on the surface of many types of tumours, and is one of many biomarkers expressed in breast cancer tumours.7

Historically, HER2-positive cancers have been defined as HER2 expression measured as immunohistochemistry [IHC] 3+ or IHC 2+/in-situ hybridisation [ISH]+, and HER2-negative cancers are defined as HER2 expression measured as IHC 0, IHC 1+ or IHC 2+/ISH-.4 However, approximately half of all breast cancers are HER2-low, defined as a HER2 score of IHC1+ or IHC 2+/ISH-.3-5 HER2-low occurs in both HR-positive and HR-negative disease.8

Previously, patients with HR-positive metastatic breast cancer and HER2-low disease have had limited effective treatment options following progression on endocrine (hormone) therapy.9 Additionally, few targeted options are available for those with HR-negative disease.10 With this approval of Enhertu, patients with HER2-low tumours may be eligible for HER2-directed therapy.

DESTINY-Breast04
DESTINY-Breast04 is a global, randomised, open-label, Phase III trial evaluating the efficacy and safety of Enhertu (5.4mg/kg) versus physician’s choice of chemotherapy (capecitabine, eribulin, gemcitabine, paclitaxel or nab-paclitaxel) in patients with HR-positive or HR-negative, HER2-low unresectable and/or metastatic breast cancer previously treated with one or two prior lines of chemotherapy. Patients were randomised 2:1 to receive either Enhertu or chemotherapy.

The primary endpoint of DESTINY-Breast04 is PFS in patients with HR-positive disease based on BICR. Key secondary endpoints include PFS based on BICR in all randomised patients (HR-positive and HR-negative disease), OS in patients with HR-positive disease and OS in all randomised patients (HR-positive and HR-negative disease). Other secondary endpoints include PFS based on investigator assessment, objective response rate based on BICR and on investigator assessment, duration of response based on BICR and safety.

DESTINY-Breast04 enrolled 557 patients at multiple sites in Asia, Europe and North America. For more information about the trial, visit ClinicalTrials.gov.

Enhertu
Enhertu is a HER2-directed ADC. Designed using Daiichi Sankyo’s proprietary DXd ADC technology, Enhertu is the lead ADC in the oncology portfolio of Daiichi Sankyo and the most advanced programme in AstraZeneca’s ADC scientific platform. Enhertu consists of a HER2 monoclonal antibody attached to a topoisomerase I inhibitor payload, an exatecan derivative, via a stable tetrapeptide-based cleavable linker.

Enhertu (5.4mg/kg) is approved in more than 50 countries for the treatment of adult patients with unresectable or metastatic HER2-positive breast cancer who have received a (or one or more) prior anti-HER2-based regimen, either in the metastatic setting or in the neoadjuvant or adjuvant setting, and have developed disease recurrence during or within six months of completing therapy based on the results from the DESTINY-Breast03 trial.

Enhertu (5.4mg/kg) is approved in more than 40 countries for the treatment of adult patients with unresectable or metastatic HER2-low (IHC 1+ or IHC 2+/ISH-) breast cancer who have received a prior systemic therapy in the metastatic setting or developed disease recurrence during or within six months of completing adjuvant chemotherapy based on the results from the DESTINY-Breast04 trial.

Enhertu (5.4 mg/kg) is approved in Israel and under accelerated approval in the US for the treatment of adult patients with unresectable or metastatic non-small cell lung cancer (NSCLC) whose tumours have activating HER2 (ERBB2) mutations, as detected by a locally or regionally approved test, and who have received a prior systemic therapy based on the results from the DESTINY-Lung02 trial. Continued approval for this indication in the US may be contingent upon verification and description of clinical benefit in a confirmatory trial.

Enhertu (6.4mg/kg) is approved in more than 30 countries for the treatment of adult patients with locally advanced or metastatic HER2-positive gastric or gastroesophageal junction adenocarcinoma who have received a prior trastuzumab-based regimen based on the results from the DESTINY-Gastric01 trial and/or DESTINY-Gastric02 trial.

Enhertu development programme
A comprehensive global development programme is underway evaluating the efficacy and safety of Enhertu monotherapy across multiple HER2-targetable cancers. Trials in combination with other anticancer treatments, such as immunotherapy, are also underway.