On December 9, 2020 Natera, Inc. (NASDAQ: NTRA), a pioneer and global leader in cell-free DNA testing, reported that new data will be presented on its personalized and tumor-informed molecular residual disease (MRD) test, Signatera, in an oral presentation on December 10, 2020 at the 2020 European Society for Medical Oncology Immuno-Oncology (ESMO IO) Virtual Congress (Press release, Natera, DEC 9, 2020, View Source [SID1234572554]). The abstract is available to view here.

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The oral presentation will report results from a prospective circulating tumor DNA (ctDNA) analysis of 581 muscle invasive urothelial carcinoma (MIUC) patients who participated in IMvigor010, an open-label, global, randomized and controlled Phase III study that evaluated adjuvant treatment with the PD-L1 inhibitor atezolizumab compared with observation. Results at an interim analysis show that patients who were ctDNA-positive after surgery (37%) had an increase in overall survival (OS) in the treatment arm, with a median of 25.8 months with Tecentriq, compared with 15.8 months for observation (HR=0.59; 95% CI: 0.41–0.86), while those patients who were ctDNA-negative after surgery derived no benefit. The study also shows that ctDNA clearance was higher in the treatment arm vs. the observation arm (p=0.0048).

"In this study, we show that personalized ctDNA analysis is highly accurate not only for identifying molecular residual disease, but also for predicting better outcomes with immune therapy," said Thomas Powles, M.D., Professor, Barts Cancer Institute, and Principal Investigator of the study. "This opens new avenues for patient selection in the future and is an important step in the drive towards personalized cancer therapy."

"We are honored to partner with Genentech on this groundbreaking study," said Alexey Aleshin, M.D., Natera’s Senior Medical Director of Oncology. "This randomized Phase III study demonstrates for the first time, unequivocally, that Signatera can identify which patients are likely to benefit from adjuvant therapy and which are unlikely to benefit. It also highlights the significance of ctDNA clearance as an early endpoint for the evaluation of drug efficacy."

Details about the presentation are as follows:

Presentation #10 | Presenter: Thomas Powles, M.D. | Date and time: Dec 10, 13:50 – 14:02 CET

Clinical outcomes in post-operative ctDNA-positive muscle-invasive urothelial carcinoma (MIUC) patients after atezolizumab adjuvant therapy

About Signatera

Signatera is a custom-built circulating tumor DNA (ctDNA) test for treatment monitoring and molecular residual disease (MRD) assessment in patients previously diagnosed with cancer. The test is available for clinical and research use, and in 2019, it was granted Breakthrough Device Designation by the FDA. The Signatera test is personalized and tumor-informed, providing each individual with a customized blood test tailored to fit the unique signature of clonal mutations found in that individual’s tumor. This maximizes accuracy for detecting the presence or absence of residual disease in a blood sample, even at levels down to a single tumor molecule in a tube of blood. Unlike a standard liquid biopsy, Signatera is not intended to match patients with any particular therapy; rather, it is intended to detect and quantify how much cancer is left in the body, to detect recurrence earlier and to help optimize treatment decisions. Signatera test performance has been clinically validated in multiple cancer types including colorectal, non-small cell lung, breast, and bladder cancers. Signatera has been developed and its performance characteristics determined by Natera, the CLIA-certified laboratory performing the test. The test has not been cleared or approved by the US Food and Drug Administration (FDA). CAP accredited, ISO 13485 certified, and CLIA certified.

On December 9, 2020 West Pharmaceutical Services, Inc. (NYSE: WST), a global leader in innovative solutions for injectable drug administration, reported that the Company’s Board of Directors has approved a first-quarter 2021 dividend of $0.17 per share (Press release, West Pharmaceutical Services, DEC 9, 2020, View Source [SID1234572495]). The dividend will be paid on February 3, 2021, to shareholders of record as of January 20, 2021.

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On December 8, 2020, the Company’s Board of Directors authorized a share repurchase program for calendar-year 2021 of up to 631,000 shares of the Company’s common stock from time to time on the open market or in privately-negotiated transactions, as permitted under Exchange Act Rule 10b-18. The number of shares to be repurchased and the timing of such transactions will depend on a variety of factors, including market conditions. The share repurchase program is expected to be completed by December 31, 2021. The Company’s previously-authorized share repurchase program will expire on December 31, 2020.

The Company also announced that management will be presenting an overview of the business at the J.P. Morgan Healthcare Conference at 5:20 p.m. EST on Wednesday, January 13, 2021. A live audio webcast of the presentations and a copy of the presentation materials will be accessible from the Company’s website at www.westpharma.com/en/investors.

On December 9, 2020 Biochain reported that There have been tremendous advances in cancer treatment since President Richard Nixon declared war on malignancies in 1971 (Press release, Biochain, DEC 9, 2020, View Source [SID1234572520]). Despite having treatments such as targeted radiation, estrogen blockers, and CAR-T cell immunotherapies, early detection of cancer remains one of the most important factors. For instance, the five-year relative survival rate for non-small cell lung cancer is 61% when cancer has not yet spread outside the lung. The survival rate drops to 35% once the cancer invades nearby structures, and to 6% once it metastasizes to other organ systems.

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However, early detection of cancer has proven easier said than done, and not without risks. When screening for cancer certain number of patients experience anxiety and undergo unnecessary invasive procedures based on false positives. While some cancers make for relatively easy screening such as cervical cancer via the Pap test, many cancers are inaccessible, and tissue biopsy too invasive for population-level screenings.

The oncologist’s objective is to come up with a less invasive way of screening the healthy population for specific and accurate indications of early-stage cancer. This motivated scientists to develop "liquid biopsy," where doctors hope to detect tumor-specific protein biomarkers or cancer-associated genetic mutations in circulating free DNA (cfDNA) blood samples.

In an article published in the journal Science, Johns Hopkins researchers Bert Vogelstein and Nickolas Papadopoulos and their colleagues appear to have done exactly that.

A leap in early cancer detection

A breakthrough was achieved using a liquid biopsy test called "DETECT-A" ̶̶ Detecting cancers Earlier Through Elective mutation-based blood Collection and Testing ̶ which involved more than 9,911 women who had no history of cancer. The study used a multi-cancer blood test, to identify 26 undiagnosed cancers in 10 different organ systems: appendix, breast, colorectal, kidney, lung, lymphomas, ovary, thyroid, uterine and unknown primary site. The tumors were then localized using techniques such as PET-CT, a combination that was 99.6% specific.

Importantly, 17 of the cancers detected by the blood test were diagnosed at an early stage. Twelve of the 26 patients were in remission and eight were still in treatment or had stable disease nine months post-diagnosis.

This was a landmark result for the liquid biopsy field and the industry took note. A more advanced version of the multi-cancer blood test known as CancerSEEK had been licensed by Johns Hopkins to Thrive Earlier Detection Corp for development. On Oct. 27, Exact Sciences announced it would acquire Thrive for $2.15 billion.

Foundational technology

Although much of the liquid biopsy breakthrough has come from next-generation sequencing (NGS) and machine learning, the fundamentals of the field are still focused on an accurate and successful sampling process. If there is no adequate sample in the first place, no algorithm can support it. The DETECT-A study made use of the cfPure extraction kit from BioChain, a magnetic bead-based technology that demonstrated high yields in extracting cfDNA from blood plasma. "In order to get that cfDNA, you need to have the right tools," says BioChain’s Production and R&D Manager Dr. Franklin Chin, "and we have them. Our extraction kit is the first step in any research that involves cfDNA biomarker discovery"

The cfPure kits are available from BioChain in three different sizes for the extraction of a maximum of 250 ml of cfDNA from human plasma samples. The kit has two different versions: the original cfPure kit which maximizes yield, and the "V2," which minimizes carryover of genomic DNA into the final elution.

Dr. Bert Vogelstein and his colleagues used the original version of cfPure kits, and the fact that such pioneering researchers used BioChain’s technology in a groundbreaking study to process tens of thousands of samples is a source of pride for BioChain. "Dr. Vogelstein is one of the pioneers of liquid biopsy research," Chin says, "that he is using our kit is pretty big for us."

Detection of early-stage cancer using the DETECT-A test is just the first of many breakthroughs BioChain hopes their technology will enable. Beyond early diagnosis, for instance, there are efforts at precision tumor treatment and companion diagnostics, according to Chin. Many cancers are drug-resistant, and that resistance is based on their mutational profile. Pairing the cfPure kit with NGS using specific biomarker panels can help identify the mutational landscape for a patient, indicating the therapies best suited to treating their specific cancer.

Chin also hopes to see BioChain’s technology used in the creation of biomarker panels to help identify mutations with a strong correlation to oncogenesis. "You need to have a solid foundation," he says. "You need to collect as many samples as possible, analyze them, and come up with a panel of biomarkers." That will expand the reach and accuracy of liquid biopsy, and, ultimately, the success of cancer treatments. That’s something Chin and BioChain are excited to be a part of.

A menu of research solutions

Whatever your research needs, BioChain offers a cfPure cell-free DNA extraction kit providing market-leading yields for the best possible input for NGS or other processing.

BioChain also offers blood plasma and tissue samples for researchers who need inputs to develop and test their technologies and offers the cfPure cell-free DNA extraction process as a service for those who cannot perform the extractions themselves.

On December 9, 2020 Agendia, Inc., a world leader in precision oncology for breast cancer, reported that data from the FOCUS trial that show the clinical utility of MammaPrint in older breast cancer patients at the 2020 San Antonio Breast Cancer Symposium (SABCS 2020) (Press release, Agendia, DEC 9, 2020, View Source [SID1234572539]).

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The poster, The 70-gene signature (MammaPrint) accurately predicts distant breast cancer recurrence risk in older patients, outlines data from the FOCUS trial, a population-based cohort of over 2,000 people that included all consecutive breast cancer patients over 65 years old diagnosed between 1997 and 2004 in the Comprehensive Cancer Center region West, the Netherlands. The purpose of the study was to assess the stratification of breast cancers by MammaPrint in women over 70 years of age.

Treating older breast cancer patients can be challenging, as they generally have more indolent tumors and a higher likelihood of developing additional conditions that negatively affect their health than younger patients. Current treatment guidelines recommend therapy for these patients based on clinicopathological risk, but these factors are insufficient for accurate determination of prognosis. MammaPrint has been shown to accurately predict recurrence in younger women with breast cancer, and for this study, the 70-gene signature was assessed in women 70 years and older with breast cancer. MammaPrint was found to accurately stratify patients according to their 10-year distant recurrence free interval, as previously demonstrated in younger populations.

Further, the results in the poster show that even clinically high risk patients who were classified as MammaPrint UltraLow Risk – meaning they can have excellent survival without chemotherapy and only limited or no tamoxifen treatment – did not develop any recurrent disease 10 years after diagnosis, opening up treatment options and considerations for doctors and their patients, allowing them to make more informed decisions about the path ahead.

"These data show the importance of knowing everything you can about a cancer, especially when you are working with older patients who may be more fragile or susceptible to harsh treatment," said Dr. Gerrit-Jan Liefers, Surgeon, Head of the Department of Surgical Oncology of Leiden University Medical Center and the principal investigator of the FOCUS study. "We see genomically low risk patients do very well long-term, which gives us confidence to de-escalate their treatment to something more tolerable and achieve the same success, even if they are clinically high risk. We are pleased to make these data available to the breast cancer community and show the importance of research in all types of breast cancer patients."

For post-menopausal women who are identified as MammaPrint UltraLow Risk, these results have meaningful implications for their treatment paths.

"This analysis of the FOCUS cohort adds to the growing body of data demonstrating the validity of MammaPrint’s UltraLow Risk threshold," said Laura Esserman, M.D., Director of the UCSF Carol Franc Buck Breast Care Center, and winner of this year’s Brinker award for Scientific Distinction in Clinical Research. "The data confirm our findings from the STO-3 Trial, as well as data from the IKA tamoxifen trial cohort presented at ESMO (Free ESMO Whitepaper) earlier this year for node negative hormone positive breast cancer patients. These data should give confidence to patients and their physicians that the UltraLow molecular signature is associated with excellent prognosis even without extended endocrine therapy. De-escalation based on biologic features can be used to reduce the length of treatment, providing more precise treatment. Most important, the UltraLow signature can be used to substantially reduce the burden of treatment in those destined not to benefit. And certainly this can make a huge difference in the quality of life and the anxiety experience over the diagnosis."

These data are part of a large suite of 13 posters, spotlight sessions and an oral presentation on MammaPrint and BluePrint that were accepted to SABCS 2020, and underscore Agendia’s mission to help guide the diagnosis and personalized treatment of breast cancer for all patients throughout their treatment journey.

On December 9, 2020 Bolt Biotherapeutics, a clinical-stage immuno-oncology company developing tumor-targeted therapies that leverage the power of the innate and adaptive immune systems, reported the presentation of a poster detailing the design of its ongoing Phase 1/2 clinical trial for BDC-1001 in patients with HER2-expressing solid tumors at the San Antonio Breast Cancer Symposium (SABCS) 2020 Virtual Meeting, being held Dec. 8-11, 2020 (Press release, Bolt Biotherapeutics, DEC 9, 2020, View Source [SID1234572555]). The poster will be presented today, Wednesday, Dec. 9, at 8:00 a.m. CT/9:00 a.m. ET.

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The in-progress clinical trial poster titled, "Phase 1/2 study of a novel HER2 targeting TLR7/8 immune-stimulating antibody conjugate (ISAC), BDC-1001, as a single agent and in combination with an immune checkpoint inhibitor in patients with advanced HER2-expressing solid tumors," discusses the framework of Bolt’s Phase 1/2 clinical trial. The actively enrolling global clinical study is for patients with refractory HER2-expressing solid tumors and its primary objectives are to evaluate safety, tolerability and to determine the recommended Phase 2 dose for both monotherapy and combination with a checkpoint inhibitor. BDC-1001 is a novel treatment which combines the targeting and antitumor effect of trastuzumab with stimulation of the immune system via TLR 7/8 agonism. Based on initial clinical observations to date, there have been no dose-limiting toxicities and no drug-related severe adverse events.

Edith Perez, M.D., Chief Medical Officer at Bolt, commented, "Preclinical data support that BDC-1001 may enable a patient to recruit their own immune system to fight their cancer with intravenous administration of BDC-1001. We continue to see strong interest in participation in our trial from both investigators and potential patients based on our compelling preclinical data and ongoing clinical observations."

About Bolt Biotherapeutics’ Immune-Stimulating Antibody Conjugate (ISAC) Platform Technology
The Boltbody ISAC platform technology harnesses the ability of innate immune agonists to convert cold tumors into immunologically hot tumors, thereby illuminating tumors to the immune system and allowing them to be invaded by tumor killing cells. Boltbody ISACs have demonstrated the ability to eliminate tumors following systemic administration as monotherapy in preclinical models and have also led to the development of immunological memory, which is predicted to translate into more durable clinical responses for patients.

About the Ongoing BDC-1001 Phase 1/2 Study in Patients with HER2-Expressing Solid Tumors
The Phase 1/2, multi-center, open-label study is evaluating the safety, pharmacokinetics, pharmacodynamics and proof of mechanism of BDC-1001 in patients with HER2-expressing solid tumors. The first portion of the study includes a monotherapy dose-escalation phase in which cohorts of patients will receive ascending intravenous doses of BDC-1001 to determine the maximum tolerated dose and/or the recommended dose to advance into expansion cohorts and Phase 2 based on safety and tolerability. The second portion of the study is a dose expansion phase in which patients will receive BDC-1001 monotherapy to further evaluate the safety, tolerability and clinical antitumor activity of the recommended Phase 2 dose. Please refer to www.clinicaltrials.gov NCT04278144 for additional clinical trial information.