On September 15, 2020 DAVITA INC. (NYSE: DVA) ("DaVita"), a health care provider focused on transforming care delivery to improve quality of life for patients globally and one of the largest providers of kidney care services in the United States, reported the preliminary results of its modified "Dutch auction" tender offer for up to $1.0 billion of its common stock at a price per share of not less than $77.00 and not more than $88.00, which expired at 12:00 midnight, New York City time, at the end of the day on September 14, 2020 (Press release, DaVita, SEP 15, 2020, View Source [SID1234565207]).

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Based on the preliminary count by the depositary for the tender offer, a total of 8,000,679 shares of DaVita’s common stock were validly tendered and not validly withdrawn at or below the price of $88.00 per share, including 3,388,259 shares that were tendered through notice of guaranteed delivery.

In accordance with the terms and conditions of the tender offer and based on the preliminary count by the depositary, DaVita expects to purchase a total of 8,000,679 shares of its common stock through the tender offer at a price of $88.00 per share, for a total cost of $704,059,752, excluding fees and expenses related to the tender offer.

The total of 8,000,679 shares that DaVita expects to accept for purchase represents approximately 6.6% of DaVita’s total outstanding shares of common stock as of September 14, 2020.

The number of shares expected to be purchased in the tender offer is preliminary and subject to change. The preliminary information contained in this press release is subject to confirmation by the depositary and is based on the assumption that all shares tendered through notice of guaranteed delivery will be delivered within the required two business day period. The final number of shares to be purchased in the tender offer will be announced following the expiration of the guaranteed delivery period and the completion by the depositary of the confirmation process. Payment for the shares accepted for purchase pursuant to the tender offer will occur promptly following the completion of the confirmation process.

DaVita expects to finance the share purchases in the tender offer with cash on hand.

The dealer manager for the tender offer is BofA Securities, Inc. Georgeson LLC is serving as information agent for the tender offer and Computershare is serving as the depositary for the tender offer.

On September 15, 2020 Caris Life Sciences, a leading innovator in molecular science focused on fulfilling the promise of precision medicine, reported results from a study that could shed new light on the treatment journey of patients with KRAS-mutated epithelial ovarian carcinomas (EOC) (Press release, Caris Life Sciences, SEP 15, 2020, View Source [SID1234565206]). These findings, presented at the European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper) Virtual Congress 2020, demonstrate an unmet need for this patient population and suggest that targeted therapies designed to inhibit KRAS gene response may be effective in treating patients with KRAS-mutated EOC.

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"Inhibitors of KRAS­-mutant disease have previously shown efficacy in non-small cell lung cancer, pancreatic and colon cancers, but more data about targeted therapies for KRAS-mutated ovarian cancer are needed," said Karolina Kilowski, M.D., lead investigator of the study and a gynecologic oncology fellow with the Gynecologic Oncology Program at the AdventHealth Cancer Institute in Orlando, Florida. "These results demonstrate that further investigation into KRAS-mutated ovarian cancer is warranted, as it is now apparent that BRCA1/2 mutations were mutually exclusive from KRAS-mutations, suggesting a separate treatment opportunity for recurrent disease or maintenance therapy," said Rob Holloway M.D., Medical Director of the Gynecologic Oncology Program at AdventHealth.

The full results will be presented today during a poster display session (Abstract #844P) as part of the ESMO (Free ESMO Whitepaper) Virtual Congress 2020. The title of the poster is, "KRAS Mutant Epithelial Ovarian Carcinomas (EOC) Represent Distinct Genomic Genotypes."

Additional Presentations Reveal Potential Impact of Precision Medicine
Caris will present additional data from studies demonstrating the critical role of precision medicine and molecular profiling in driving treatment decisions for people with colorectal cancer and gastrointestinal tumors. Both presentations will be made available online through Caris’ virtual booth on Thursday, September 17.

A study evaluating Polo-like Kinase 1 (PLK1) in KRAS-wildtype and KRAS-mutated (MT) colorectal cancer (Abstract #473P) revealed similar levels of PLK1 expression in both groups, suggesting the potential for efficacy of PLK1 inhibitors regardless of KRAS status. In addition, microsatellite instability and tumor mutational burden, both known markers for immunotherapy response, increased along with PLK1 expression. Therefore, researchers suggest that combining an immunotherapy with a PLK1 inhibitor may be a synergistic approach to increase tumor sensitivity in PLK1-overexpressing tumors. The poster is titled, "PLK1 expression and KRAS Mutations in Colorectal Cancer."
A study titled, "Comprehensive profiling of MDM2-amplified gastrointestinal (GI) cancers" (Abstract #1952P), the most extensive profiling study to investigate MDM2-amplified GI tumors, found distinct molecular patterns of MDM2-amplified GI cancers involving WNT pathway genes, upregulation of FGF signaling and an inverse association with tumor mutational burden and microsatellite instability, which may partly explain the lower levels of response of MDM2-amplified tumors to immune checkpoint inhibitors.
"As cancer treatment becomes increasingly personalized, it is vital for physicians and patients to have access to next-generation sequencing and molecular assays in order to have the fullest picture possible to help them determine the proper treatment path," said W. Michael Korn, M.D., Chief Medical Officer at Caris Life Sciences. "Our data at ESMO (Free ESMO Whitepaper) 2020 highlight how Caris’ industry-leading technology can provide guidance for physicians in how they approach KRAS-mutated tumors."

On September 15, 2020 Q BioMed Inc. (OTCQB: QBIO), a commercial stage biotech company, reported initial commercial uptake of Strontium89, its FDA approved drug for the non-opioid treatment of metastatic cancer in the bone (Press release, Q BioMed, SEP 15, 2020, View Source [SID1234565204]).

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Q BioMed announced the US-based launch of Strontium89 (Strontium Chloride Sr-89 Injection, USP), in Q1 of this year. The COVID-19 pandemic slowed the diagnosis and treatment of cancer in many patients throughout spring and into summer, and severely limited the industry’s access to physicians due to restrictions on access and availability. Despite these challenges, the reintroduction of Strontium89 has received a warm response and enthusiasm from physicians who are pleased that it is once again available for the benefit of their patients.

There are now free-standing clinics in at least 8 states that are undergoing the required operational steps to become a ‘Strontium89 practice’, including having it on their radioactive materials license, with several clinics already up and running with patients being treated. Beginning in October, treatment with Strontium89 in the hospital out-patient setting will be fully reimbursed by Medicare and Medicaid, at which point Q BioMed expects to see hospitals more actively treat patients as well.

Q BioMed is deploying a robust multi-channel marketing campaign, driving awareness amongst its target audiences, both on the physician and the patient side. The Company will exhibit Strontium89 at several conferences including ASTRO (American Society of Therapeutic Radiation Oncology) and ONS (Oncology Nursing Society) and will begin speaker programs later this fall. Virtual and live sales calls have been ongoing since June within the confines of COVID-19 access and expanded field force efforts are planned for Q4 2020.

In September, Q BioMed launched its international ‘Named Patient’ program that enables physicians worldwide to order Strontium89 for their patients in need, and the response to this program has been robust with orders already taken in the UK and orders pending from at least 7 other countries. The regulatory registration process for full commercial access in the EU has commenced, with pan-EU approval expected by end of year. In parallel, Q BioMed is midway through the registration process in many other countries, with approvals expected to begin in October and continue through Q1 of 2021.

"We anticipate revenues from Strontium89 to continue to ramp up significantly from our baseline in Q2 as we build capacity and demand worldwide. Looking towards 2021, we are assessing several potential clinical trial programs that may expand the indication beyond palliation into a therapeutic use that may increase patient survival, accessing the much larger therapeutic market," stated Q BioMed CEO Denis Corin.

On September 15, 2020 Luminex Corporation (Nasdaq:LMNX) (the "Company"), reported that its board of directors declared a cash dividend for the third quarter of 2020 of $0.09 per share of common stock payable on October 15, 2020 to stockholders of record as of the close of business September 24, 2020 (Press release, Luminex, SEP 15, 2020, View Source [SID1234565203]).

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On September 15, 2020 Taiho Oncology, Inc. reported data from three abstracts for futibatinib (TAS-120) in intrahepatic cholangiocarcinoma (iCCA) and in advanced solid tumors will be presented during the European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper) Virtual Congress 2020 from September 19-21, 2020 (Press release, Taiho, SEP 15, 2020, View Source [SID1234565202]). Key presentations include:

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Efficacy and Safety of Futibatinib in Intrahepatic Cholangiocarcinoma (iCCA) Harboring FGFR2 Fusions/Other Rearrangements: Subgroup Analyses of a Phase 2 Study (FOENIX-CCA2) (Abstract 4493). Results will be shared online as a poster presentation on September 17, 2020. The abstract for this presentation is available on the ESMO (Free ESMO Whitepaper) website: View Source
Quality of Life (QOL) Outcomes With Futibatinib Treatment in FOENIX-CCA2, a Phase 2 Study in Patients (Pts) With Intrahepatic Cholangiocarcinoma (iCCA) Harboring FGFR2 Gene Fusions/Rearrangements (Abstract 4513). Results will be shared online as a poster presentation on September 17, 2020. The abstract for this presentation is available on the ESMO (Free ESMO Whitepaper) website: View Source
Phase 1 Study of the Irreversible FGFR inhibitor (i) Futibatinib (FBN; TAS-120) in Japanese Patients (pts) With Advanced (adv) Solid Tumors (Abstract 2243). Results will be shared online as a poster presentation on September 17, 2020. The abstract for this presentation is available on the ESMO (Free ESMO Whitepaper) website: View Source
Additional information can be found here: View Source

"We are pleased to present these new analyses of futibatinib in intrahepatic cholangiocarcinoma, as well as the results of our Phase 1 experience in Japanese patients," said Martin J. Birkhofer, MD, Senior Vice President and Chief Medical Officer, Taiho Oncology, Inc. "We look forward to further exploration of safety, efficacy and quality of life outcomes of this investigational compound to determine who may see the most benefit from it."

In May 2018, the U.S. Food and Drug Administration Office of Orphan Drug Development granted futibatinib orphan drug status for the treatment of cholangiocarcinoma.

About Cholangiocarcinoma
Cholangiocarcinoma (CCA), also known as bile duct cancer, is not common. About 8,000 people in the U.S. are diagnosed with CCA each year.1 This includes both intrahepatic (inside the liver) and extrahepatic (outside the liver) cancers. CCA can occur at younger ages, but it is seen mainly in older people. The average age of people in the U.S. diagnosed with cancer of the intrahepatic bile ducts is 70, and for cancer of the extrahepatic bile ducts it is 72.2 The five-year survival rates of localized iCCA is 24%.1

The main treatment for CCA is surgery. Radiation therapy and chemotherapy may be used if the cancer cannot be entirely removed with surgery and in cases where the edges of the tissues removed at the operation show cancer cells (also called a positive margin). Both stage III and stage IV cancers cannot be completely removed surgically. Currently, standard treatment options are limited to radiation, palliative therapy, liver transplantation, surgery, chemotherapy and interventional radiology.2

About Futibatinib (TAS-120)
Futibatinib (TAS-120) is an investigational, oral, selective, and irreversible small-molecule inhibitor of FGFR1, 2, 3, and 4 being studied as a potential treatment for patients with advanced solid tumors, with FGFR1-4 genetic aberrations, including cholangiocarcinoma, who were previously treated with chemotherapy or other therapies. Futibatinib selectively and irreversibly binds to the ATP binding pocket of FGFR1-4 resulting in the inhibition of FGFR-mediated signal transduction pathways, reduced tumor cell proliferation and increased tumor cell death in tumors with FGFR1-4 genetic aberrations.