On March 10, 2020 American Brain Tumor Association (ABTA) reported a new partnership with the Southeastern Brain Tumor Foundation (SBTF) to accelerate brain tumor research (Press release, American Brain Tumor Association, MAR 10, 2020, View Source [SID1234555388]). Through this partnership, the Southeastern Brain Tumor Foundation will invest $50,000 in the ABTA research program to fund one glioblastoma immunotherapy research project. For more than 46 years, the ABTA has served the brain tumor community by funding research and delivering patient programs and services.

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"The Southeastern Brain Tumor Foundation is a critical ally in our joint pursuit of eradicating this devastating disease," said Ralph DeVitto, president and chief executive officer of the American Brain Tumor Association. "Collaborative research partnerships significantly strengthen our ability to accelerate brain tumor research and uncover insights that will one day lead to a cure."

With an established and sophisticated mechanism to evaluate and foster brain tumor research, the ABTA has earned recognition as a trusted and committed research conduit for organizations and foundations who aim to advance brain tumor research. Since 1976, the ABTA has awarded more than $32 million in research grants to scientists from around the world to discover more about the causes, effects, diagnosis and treatment of pediatric and adult brain tumors.

The SBTF founded in 1995, with the mission to improve the quality of life for brain tumor patients and their families, has funded more than 46 projects totaling more than $2.5 million.

"Funding brain tumor research is of paramount importance to each member of the SBTF Board," said Geri-Dee Shaffer, executive director of the Southeastern Brain Tumor Foundation. "Expanding our funding reach through this collaborative effort with the ABTA is very exciting. Together we are stronger and together we can do so much to combat this disease."

The Southeastern Brain Tumor Foundation is an important new partner for the ABTA’s research initiatives. The ABTA is grateful to them and other established research collaborators within the brain tumor community, including the Joel A. Gingras, Jr. Memorial Foundation, Uncle Kory Foundation and Humor to Fight the Tumor, among others.

On March 10, 2020 Zimmer Biomet Holdings, Inc. (NYSE and SIX: ZBH), a global leader in musculoskeletal healthcare, reported that its Board of Directors has approved the payment of a quarterly cash dividend to stockholders for the first quarter of 2020 (Press release, Zimmer Holdings, MAR 10, 2020, View Source [SID1234555387]).

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The cash dividend of $0.24 per share is payable on April 30, 2020 to stockholders of record as of the close of business on March 27, 2020.

On March 10, 2020 Sysmex Inostics has reported the test to provide additional key information for investigation of the validity of ctDNA for molecular monitoring and recurrence surveillance for breast cancer patients who are receiving novel therapies (Press release, Sysmex Inostics, MAR 10, 2020, View Source [SID1234555386]).

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In addition to a high detection rate even for patients with very low frequency mutations, the SafeSEQ Breast Cancer Panel has now also demonstrated the ability to delineate true changes in the level of ctDNA from random sampling or technical variation. This is in contrast to other liquid biopsy methods which report mutations detected along with the ratio of mutant molecules to wildtype molecules (mutant allele frequency, MAF), but are unable to relate changes in MAF to changes in the disease status of the patient with confidence. For instance, clinical data presented at San Antonio Breast Cancer Symposium (SABCS) demonstrated the importance of accurate detection of ctDNA with SafeSEQ testing to monitor tumor response in breast cancer patients receiving neoadjuvant treatment.

As a highly refined clinical development diagnostic, the SafeSEQ breast cancer panel has demonstrated exquisite sensitivity for detecting mutations in ESR1, which are known to arise in patients with estrogen receptor-positive breast cancer who have progressed on adjuvant hormone therapy. Extensive ESR1 ctDNA testing by Sysmex Inostics’ OncoBEAM enhanced digital PCR has shown that these mutations occur at very low frequencies in circulation. Patients who are receiving an investigational ESR1-directed therapy as part of a clinical trial may exhibit an ESR1 mutation well below 1% MAF at baseline which could then decrease further, sometimes below 0.1% MAF, several months after initiation of therapy. Using a traditional qualitative ctDNA next generation sequencing-based test would not only make detection of these low-frequency mutations difficult, but it would also not be possible to determine whether this reduction in MAF represents a true decrease in ctDNA that could reflect a clinical response. This is because the reduction in MAF may result from an increase in wildtype DNA rather than a decrease in tumor-derived DNA, and the magnitude of change in MAF may be within the range of random variation that is inherent to the assay. Quantitative ctDNA detection is also important for other clinical applications such as monitoring tumor response for patients receiving neoadjuvant treatment as illustrated by SafeSEQ data presented at the recent San Antonio Breast Cancer Symposium, Poster P6-10-05.

The updated SafeSEQ Breast Cancer Panel can overcome these challenges by determining whether the change in the absolute number of ESR1 mutant molecules detected at each timepoint, irrespective of the wildtype background, is sufficient to suggest a true biological cause such as a clinical response. This ability for true quantitative mutation detection is based on a rigorous linearity validation study and is especially important given the increasing interest in ctDNA-based monitoring and surveillance to support rapid advancements in therapies for breast cancer patients.

"Without quantitatively measuring ctDNA in a way that is specific for the patient’s disease and instead employing qualitative methods based on mutant allele frequency that have traditionally been used for tissue analysis, you’re neglecting some of the unique aspects of ctDNA testing that can make it an extremely powerful tool for clinical development," noted Matt Ryder, Sysmex’s Associate Director of Biomarkers & Companion Diagnostics. "We are confident that the SafeSEQ Breast Cancer Panel is now one of the most informative tests available to support development of novel therapies for breast cancer, and we look forward to helping our pharma partners explore the clinical validity of ctDNA-based therapeutic monitoring and recurrence surveillance."

The updated SafeSEQ Breast Cancer Panel is available now for use as a clinical trial assay in Sysmex Inostics’ Baltimore-based CLIA laboratory.

On March 10, 2020 Syndivia, a research-driven biotechnology company focused on the development of new therapeutic modalities for cancers, reported that it will benefit from €2 m deep tech financing from Bpifrance (Press release, Syndivia, MAR 10, 2020, View Source [SID1234555385]). Proceeds will be used to further fund the advancement of one company’s drug candidate towards the clinic.

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The Deeptech plan was initiated by the French government and has been deployed by Bpifrance since 2019 to support deep tech startups resulting from research based on breakthrough innovations. The main objective is to allow these companies to grow, and to stimulate innovation by strengthening the links between academia and the entrepreneurial world.

Sasha Koniev, CEO of Syndivia, said, "We are very grateful to Bpifrance for this generous support. This financing will largely accelerate the development of our lead immunoconjugate for various cancer indications, which to date have a very limited number of effective treatment options."

Commenting on this news, Alban Stamm, in charge of innovation at Bpifrance, said, "Syndivia, which initially emerged from the research of academic laboratories supported by SATT Conectus and reinforced with iLab 2014 (emergence) and 2015 (development) grants, succeeded in bringing together all the ingredients to meet technological challenges. At Bpifrance, we appreciate Syndivia’s progress to date and especially value the team: initially composed of young researchers with strong entrepreneurial capacity, it surrounded itself with an experienced board bringing together all the key success factors of a biotech startup."

About Bpifrance

Bpifrance is the French national investment bank. It finances businesses – at every stage of their development – through loans, guarantees, equity investments and export insurances. Bpifrance also provides extra financial services such as training and consultancy to help entrepreneurs meet their challenges.

On March 10, 2020 The Janssen Pharmaceutical Companies of Johnson & Johnson reported that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Therapy Designation for JNJ-61186372 (JNJ-6372) for the treatment of patients with metastatic non-small cell lung cancer (NSCLC) with epidermal growth factor receptor (EGFR) Exon 20 insertion mutations, whose disease has progressed on or after platinum-based chemotherapy (Press release, Janssen Pharmaceuticals, MAR 10, 2020, View Source;jnj-6372-for-the-treatment-of-non-small-cell-lung-cancer-301020992.html [SID1234555384]). JNJ-6372 is an EGFR-mesenchymal epithelial transition factor (MET) bispecific antibody that targets activating and resistant EGFR and MET mutations and amplifications.1 Currently, there are no FDA-approved targeted therapies for patients with lung cancer who have EGFR Exon 20 insertion mutations.2

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Patients with NSCLC and EGFR Exon 20 insertion mutations have a form of disease that is generally insensitive to EGFR tyrosine kinase inhibitor (TKI) treatments and carries a worse prognosis compared to patients with more common EGFR mutations (Exon 19 deletions/L858R substitution).3 The current standard of care for this patient population is conventional cytotoxic chemotherapy.4

"JNJ-6372 is a novel bispecific antibody that we believe has the potential to benefit patients with Exon 20 mutation insertions who often do not respond to currently available oral EGFR-targeted or immune checkpoint inhibitor therapies," said Peter Lebowitz, M.D., Ph.D., Global Therapeutic Area Head, Oncology, Janssen Research & Development, LLC. "This Breakthrough Therapy Designation is a significant milestone in our ongoing efforts to advance JNJ-6372 in clinical development and target genetically-defined lung cancer."

The Breakthrough Therapy Designation is supported by data from a Phase 1, first-in-human, open-label, multicenter study (NCT02609776).5 The study evaluates the safety, pharmacokinetics and preliminary efficacy of JNJ-6372 monotherapy and in combination with lazertinibi, a novel third-generation EGFR TKI, in adult patients with advanced NSCLC.5 The study seeks to determine the recommended Phase 2 dose in patients with advanced NSCLC.5 Enrollment into the Part 2 dose expansion cohorts is ongoing, as the study evaluates JNJ-6372 monotherapy activity in multiple NSCLC sub-populations with genomic alterations such as those with C797S resistance mutation or MET amplification.5

A U.S. FDA Breakthrough Therapy Designation is granted to expedite the development and regulatory review of an investigational medicine that is intended to treat a serious or life-threatening condition.6 The criteria for Breakthrough Therapy Designation require preliminary clinical evidence that demonstrates the drug may have substantial improvement on at least one clinically significant endpoint over available therapy.6

i In 2018, Janssen entered into a license and collaboration agreement with Yuhan Corporation for the development of lazertinib.

About JNJ-61186372 (JNJ-6372)
JNJ-6372 is an EGFR-MET bispecific antibody with immune cell-directing activity that targets activating and resistant EGFR and MET mutations and amplifications.5,7 The production and development of the antibody followed Janssen’s licensing agreement with Genmab for use of its DuoBody technology platform.

About Non-Small Cell Lung Cancer (NSCLC)
In the U.S., lung cancer is the second most common cancer in both men and women, after skin cancer; NSCLC makes up 80-85 percent of all lung cancers.8,9 The main subtypes of NSCLC are adenocarcinoma, squamous cell carcinoma, and large cell carcinoma.10 The most common driver mutation for NSCLC is the EGFR genetic alteration, which is a receptor tyrosine kinase that helps cells grow and divide.10 EGFR mutations are present in 10 to 15 percent of patients with NSCLC and occur in 40 to 50 percent of Asian patients who have NSCLC adenocarcinoma.11,12,13 EGFR exon 20 insertion mutations identify a distinct subset of lung adenocarcinomas, accounting for at least nine percent of all EGFR mutations.14 The five-year survival rate for patients with metastatic NSCLC is currently six percent.15