On June 7, 2022 EpimAb Biotherapeutics, a clinical-stage biotechnology company specializing in bispecific antibody development, reported that the U.S. Food and Drug Administration (FDA) has cleared the Investigational New Drug (IND) application for a Phase Ib/II study in patients with non-small cell lung cancer (NSCLC) evaluating the combination of EMB-01, a bispecific antibody designed to simultaneously target EGFR and cMET on tumor cells, and Tagrisso (osimertinib), AstraZeneca’s (LSE/STO/Nasdaq: AZN) third-generation EGFR-TKI (Press release, EpimAb Biotherapeutics, JUN 7, 2022, View Source [SID1234615723]). AstraZeneca is providing Tagrisso for this trial under a non-exclusive clinical trial collaboration agreement.

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"This is an important milestone for EpimAb as we continue on our trajectory to advance our bispecific pipeline and look to explore the potential of our assets for combination therapy," said Dr. Chengbin Wu, founder and CEO of EpimAb. "EMB-01 has demonstrated efficacy in multiple preclinical models as well as in our ongoing clinical trial program. We look forward to evaluating the potential synergies of this asset with Tagrisso in this study, alongside our ongoing global Phase I/II study of EMB-01 as a monotherapy."

"Non-small cell lung cancer is one of the most common oncology indications worldwide, yet there remains a huge unmet need among NSCLC patients with EGFR mutations who develop resistance to third-generation TKIs," said Dr. Bin Peng, CMO of EpimAb. "The combination of EMB-01 and Tagrisso has the potential to synergistically inhibit tumor growth, ultimately expanding treatment options for patients."

The planned Phase Ib/II trial will evaluate the safety and tolerability of EMB-01 in combination with Tagrisso in patients with NSCLC with EGFR mutations. Pharmacokinetics, immunogenicity, and the anti-tumor activity of EMB-01 combined with Tagrisso will also be assessed.

About EMB-01
EMB-01 is a novel bispecific antibody developed based on EpimAb’s proprietary FIT-Ig platform to simultaneously target EGFR and cMet on tumor cells. It is being studied in Phase I/II clinical trials in NSCLC as well as several GI indications in the U.S. and China.

On June 7, 2022 NorthStar Medical Radioisotopes, LLC (‘NorthStar’), a global innovator in the development, production and commercialization of radiopharmaceuticals used for therapeutic applications and medical imaging, and Curie Therapeutics Inc., a therapeutics company dedicated to transforming cancer care with precision radiopharmaceuticals, reported the signing of a long-term priority access supply agreement for the therapeutic medical radioisotope actinium-225 (Ac-225) (Press release, NorthStar Medical Radiostopes, JUN 7, 2022, View Source [SID1234615721]).

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Under the terms of the agreement, NorthStar will provide Curie Therapeutics with priority access to its electron accelerator-produced, n.c.a. Ac-225. Ac-225 is a high energy alpha-emitting radioisotope that, when combined with a targeting ligand, is of increasing interest for the treatment of solid tumors. Ac-225 carries sufficient radiation to cause cell death in a localized area of targeted cells. NorthStar will use its electron accelerator technology to produce n.c.a. Ac-225 that is free of long-lived radioactive contaminants and byproducts associated with other production methods, which pose regulatory and waste management challenges for hospitals and health systems.

"NorthStar is defining the supply chain for commercial-scale, reliable and environmentally preferred therapeutic radioisotope production. We are very excited to be partnering with Curie Therapeutics, an emerging leader in the development of precision radiopharmaceuticals," said Stephen Merrick, President and Chief Executive Officer of NorthStar Medical Radioisotopes. "Clinical research and commercial use of Ac-225 are severely constrained by chronic short supply due to limitations of current production technologies. Our company is positioned to be the first commercial-scale producer of Ac-225, utilizing our n.c.a. Ac-225 production technology which utilizes state-of-the-art electron beam accelerator production that provides increased capacity and scheduling flexibility. Construction of our dedicated Actinium-225 Production facility has begun, with initial production of radiochemical grade Ac-225 planned for late 2023. We expect to submit a Drug Master File to the FDA in 2024, which, upon acceptance, will allow NorthStar to provide cGMP grade Ac-225. We are very pleased to enter this Ac-225 supply agreement with Curie Therapeutics, and we look forward to a productive relationship as we both strive to ensure availability of targeted radiopharmaceutical therapy for patients with cancer."

"Curie Therapeutics is broadly developing precision targeted radiopharmaceuticals to address high unmet needs in the treatment of solid tumors," said Simon Read, Ph.D., Chief Executive Officer. "Curie Therapeutics’ ligands are engineered to achieve deep, homogeneous tumor distribution combined with rapid clearance. NorthStar is widely recognized for its leadership in cutting-edge radioisotope production technologies. This agreement secures our domestic sourcing of Ac-225, now and in the future, enabling us to pursue our mission to deliver innovative, safe and effective treatment of patients with solid tumor cancers."

On June 7, 2022 Daiichi Sankyo (TSE: 4568) and Sarah Cannon Research Institute (Sarah Cannon) reported that initial results from the first-in-human phase 1 study of DS-6000, a CDH6 directed DXd antibody drug conjugate (ADC), suggest early clinical activity in patients with advanced ovarian cancer or renal cell carcinoma with disease progression following standard of care treatment (Press release, Daiichi Sankyo, JUN 7, 2022, View Source [SID1234615720]). The data were presented today in an oral session (Abstract #3002) at the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) (#ASCO22) Annual Meeting.

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Patients with advanced ovarian cancer or renal cell carcinoma may have disease progression after initial treatments and there is a need for new therapeutic approaches for recurrent disease, as five-year survival rates in the U.S. are low at 30% and 15%, respectively.1,2,3,4 The CDH6 protein is significantly overexpressed in ovarian cancer and renal cell carcinoma and has been identified as a promising therapeutic target.5,6

Preliminary safety and efficacy results of DS-6000 were reported from the dose escalation part of the phase 1 trial in 30 heavily pretreated patients, including 21 patients with advanced ovarian cancer, one of which was missing a primary diagnosis of ovarian cancer, and nine patients with renal cell carcinoma.

The safety and tolerability of DS-6000 was evaluated at increasing dose levels from 1.6 mg/kg to 9.6 mg/kg with two dose-limiting toxicities observed at the 9.6 mg/kg dose (grade 3 febrile neutropenia and grade 4 thrombocytopenia). The most common treatment-related emergent adverse events (TEAEs) (≥ 10% of patients) reported were nausea (60.0%), fatigue (56.7%), vomiting (30.0%), neutrophil count decrease (23.3%), decreased appetite (20.0%), and diarrhea (13.3%). Grade ≥ 3 TEAEs occurred in seven patients (23.3%), the most common of which were neutrophil count decrease (16.7%), anemia (6.7%) and febrile neutropenia (6.7%). One patient experienced grade 2 pneumonitis at the 9.6 mg/kg dose that led to treatment discontinuation.

Preliminary efficacy results in 20 evaluable patients included six partial responses (PRs) in patients with ovarian cancer (n=5) and renal cell carcinoma (n=1). Four PRs were confirmed and two are awaiting confirmation. Stable disease was reported in 12 patients with platinum-resistant ovarian cancer. Eight CA-125 responses were observed in 17 evaluable patients with ovarian cancer, based on the Gynecologic Cancer Intergroup (GCIG) criteria.

"These initial results from the first-in-human trial of DS-6000 suggest early signals of safety and efficacy in patients with advanced renal cell or ovarian cancer with disease progression following multiple standard treatments," said Erika Hamilton, MD, Director, Breast Cancer and Gynecologic Cancer Research, Sarah Cannon Research Institute at Tennessee Oncology, Nashville, Tennessee. "Based on these data, enrollment is underway in the dose expansion phase of the trial to further evaluate safety and efficacy of DS-6000 in patients with platinum-resistant ovarian cancer or clear cell renal cell carcinoma."

All patients enrolled in the study (n=30) had received a median of three prior lines of systemic therapies (range, 1-12), including four (range, 1-12) for patients with ovarian cancer and two (range, 1-6) for patients with renal cell carcinoma. Seventeen of the 20 patients with ovarian cancer had platinum-resistant disease. As of the data cut-off on February 25, 2022, 17 patients (56.7%) were still being treated with DS-6000 including 12 patients with ovarian cancer and five patients with renal cell carcinoma.

"Despite recent additions to the treatment landscapes for recurrent ovarian and renal cell cancer, continued innovation is needed to improve outcomes for these patients. We have combined our DXd ADC technology with a promising therapeutic target, CDH6, with the aim to develop a new class of therapy for patients with cancer," said Gilles Gallant, BPharm, PhD, FOPQ, Senior Vice President, Global Head, Oncology Development, Oncology R&D, Daiichi Sankyo. "We are encouraged by these preliminary data, which suggest that DS-6000 may have the potential to serve as a new type of targeted therapy option for patients with advanced renal cell or ovarian tumors, including platinum-resistant ovarian cancer, and further evaluation is ongoing in the dose expansion part of the trial."

About the Phase 1 Study

The two-part, multicenter, open-label, first-in-human phase 1 trial is evaluating the safety and efficacy of DS-6000 in adult patients with advanced ovarian cancer and renal cell carcinoma resistant or refractory to standard of care therapy. Patients with ovarian cancer need to be previously treated with platinum-based chemotherapy and a taxane.

The first part of the study (dose escalation) is assessing the safety and tolerability of increasing doses of DS-6000 to determine the maximum tolerated dose (MTD) and/or recommended dose for expansion (RDE). The second part of the study (dose expansion) will further evaluate the safety and efficacy of DS-6000 at the RDE of 8.0 mg/kg in patients with advanced ovarian cancer and in patients with advanced renal cell carcinoma.

The primary objective of the dose escalation part of the study is to assess the safety and tolerability of increasing doses of DS-6000 to determine the maximum tolerated dose (MTD) and/or recommended dose for expansion (RDE) in patients with advanced ovarian tumors or renal cell carcinoma. The primary objective of the second part of the study (dose expansion) is to further evaluate the safety and efficacy of DS-6000 at the RDE in two cohorts including patients with advanced renal cell carcinoma in Cohort 1 and patients with advanced ovarian cancer in Cohort 2. The study will evaluate safety endpoints including dose-limiting toxicities and adverse events and efficacy endpoints including objective response rate, duration of response, disease control rate, clinical benefit rate, time to response and progression-free survival. Pharmacokinetic and exploratory biomarker endpoints also will be assessed.

A total of approximately 102 patients are expected to be enrolled in this study at multiple sites in the U.S. For more information, please visit Clinicaltrials.gov.

About CDH6

CDH6 (human cadherin-6) is a cadherin family protein overexpressed in several cancers, particularly ovarian tumors and renal cell carcinoma.5 Overexpression of CDH6 is associated with tumor growth and proliferation and is correlated with poor prognosis in patients with renal cell carcinoma.5 No CDH6 directed cancer therapies are currently approved for treatment of any cancer.

About Ovarian Cancer and Renal Cell Carcinoma

Approximately 314,000 women were diagnosed with ovarian cancer worldwide in 2020 and more than 207,000 died from the disease.7 The five-year survival rate for patients in the U.S. with advanced ovarian cancer is 30%.3 More than 70% of patients diagnosed with stage III or IV ovarian cancer will have a recurrence of their disease within the first five years following standard treatment with platinum chemotherapy-based regimens.8 For patients who develop resistance to platinum-based chemotherapy, treatment options are especially limited.8

Renal cell carcinoma accounts for approximately 90% of all kidney cancer.9 Approximately 431,000 people were diagnosed with kidney cancer worldwide in 2020 and more than 179,000 people died from the disease.7 The five-year survival rate for patients in the U.S. with advanced renal cell carcinoma is 15%.4 Patients with advanced or metastatic renal cell cancer may progress after first-line treatment with immune checkpoint inhibitor-based regimens and have limited treatment options as disease progression continues.10

The introduction of targeted treatments and immunotherapies in recent years has increased options and improved survival outcomes for some patients with ovarian cancer or renal cell carcinoma, but new therapeutic approaches and options are needed for tumors that progress on available medicines.10,11

About DS-6000

DS-6000 is an investigational potential first-in-class CDH6 directed ADC and one of five ADCs in clinical development in the oncology pipeline of Daiichi Sankyo. Designed using Daiichi Sankyo’s proprietary DXd ADC technology, DS-6000 is comprised of a humanized anti-CDH6 IgG1 monoclonal antibody attached to a number of topoisomerase I inhibitor payloads (an exatecan derivative, DXd) via tetrapeptide-based cleavable linkers.

Daiichi Sankyo is developing DS-6000 through a strategic collaboration with Sarah Cannon Research Institute with study operational oversight and delivery provided through Sarah Cannon’s early phase oncology clinical research organization, Sarah Cannon Development Innovations in Nashville, TN.

DS-6000 is an investigational medicine that has not been approved for any indication in any country. Safety and efficacy have not been established.

On June 7, 2022 Twist Bioscience Corporation (NASDAQ: TWST), a company enabling customers to succeed through its offering of high-quality synthetic DNA using its silicon platform, reported the launch of the Twist MRD Rapid 500 Panel1, a custom solution that can be added to a standard next generation sequencing (NGS) workflow, offering fully customizable and highly cost effective panels to detect minimal residual disease (MRD) in as few as five days (Press release, Twist Bioscience, JUN 7, 2022, View Source [SID1234615719]).

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Twist’s customers develop MRD tests that can be used in a variety of ways for patients with cancer. MRD testing is a non-invasive method for tracking and predicting cancer progression over time, using simple blood draws to track low levels of circulating tumor DNA (ctDNA) in the blood. MRD testing can be used during cancer treatment to determine if there are tumor cells remaining and to assess whether a treatment plan needs to be adjusted. This testing can also be used after a patient achieves remission to monitor for recurrence of cancer cells.

"When it comes to monitoring minimal residual disease, which can inform treatment options for patients with cancer, there is no time to waste. With the Twist MRD Rapid 500 Panel, we are able to rapidly create custom panels for our research customers, including panels specific to each sample’s unique genetic variance of cancer in as few as five days," said Emily M. Leproust, Ph.D., CEO and co-founder of Twist Bioscience. "MRD is becoming the gold standard for monitoring cancer and informing personalized treatments for patients. Through this panel, we facilitate the research and development of our customers in developing new MRD solutions that clinicians can use to benefit their patients."

The Twist MRD Rapid 500 Panel can be incorporated into a standard NGS workflow and applies hybrid capture technology to sequence specific regions that may provide customized disease insights to researchers. This technology provides broader coverage than PCR or amplicon sequencing methods, potentially improving sequencing sensitivity and expands utility.

To develop the custom panels, Twist receives targets of interest that have been identified by the customer through sequencing specific tumor cells. Twist then designs the probe sequence in a single day, manufactures and ships the panel in five business days, drastically reducing the waiting period typical of custom products and enabling quick response times. The Twist MRD Rapid 500 Panel leverages Twist’s existing protocols for target enrichment, allowing it to be performed simultaneously with established Twist whole exome NGS workflows.

About Twist MRD Rapid 500 Panel

The Twist MRD Rapid 500 Panel is the latest product in Twist’s expanding portfolio of research use only sequencing products dedicated to improving the performance and accessibility of research tools for advancing R&D in oncology solutions. Paired with Twist’s cfDNA pan cancer reference standards, UMI adapter system, and leading Exome 2.0 product line, the Twist MRD Rapid 500 Panels bridge the gap between costly comprehensive sample screening and small fixed content tests.

On June 7, 2022 To help molecular diagnostic manufacturers and clinical testing laboratories adapt to higher-standard In Vitro Diagnostic Requirements (IVDR) now in effect in the European Union, Thermo Fisher Scientific reported that it is offering an IVDR version of the Applied Biosystems QuantStudio 5 Dx Real-Time PCR System globally (Press release, Thermo Fisher Scientific, JUN 7, 2022, View Source [SID1234615718]). The innovative qPCR system simplifies molecular diagnostic workflows for infectious disease and oncology.

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Molecular diagnostic kit manufacturers and clinical testing labs that develop their own assays need open qPCR platforms that meet IVDR requirements. The IVDR-compliant QuantStudio 5 Dx System will enable molecular diagnostic manufacturers to develop new IVDR-compliant tests under the new regulations. The system will also help clinical labs running diagnostic tests switch to IVDR qPCR testing.

"Molecular diagnostic manufacturers and laboratories that lack appropriately validated and CE-labelled instruments and tests may face delays under the new IVDR regulations," said Marty Murawski, vice president, regulatory and quality assurance, at Thermo Fisher Scientific. "We are committed to helping our customers maintain high patient safety standards, meet new requirements, and obtain proper accreditation to remain competitive in today’s market. By making the Applied Biosystems QuantStudio 5 Dx Real-Time PCR System IVDR-compliant, we can now provide a high-performance, reliable qPCR system to support new testing workflows."

Among the system’s updates, the multi-mode software is now IVDR compliant, providing dual functionality for running diagnostic tests and developing new assays in today’s regulatory environment. The qPCR system comes with an intuitive touchscreen and simplified, efficient workflow that minimizes steps to deliver quality results in as little as 30 minutes. In addition, a security, auditing, e-signature module provides secure operation.

The updated QuantStudio 5 Dx Real-Time PCR System is available in all regions that recognize CE-IVD certification and is also listed with the U.S. Food and Drug Administration (FDA).