Array BioPharma To Present At The LEERINK Partners 7th Annual Global Healthcare Conference

On February 7, 2018 Array BioPharma Inc. (Nasdaq: ARRY) reported that its Chief Executive Officer, Ron Squarer, will speak at the LEERINK Partners 7th Annual Global Healthcare Conference in New York (Press release, Array BioPharma, FEB 7, 2018, View Source;p=RssLanding&cat=news&id=2331057 [SID1234523790]). The public is welcome to participate in the conference through a webcast on the Array BioPharma website.

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Event: LEERINK Partners Annual Global Healthcare Conference

Presenter: Ron Squarer, Chief Executive Officer, Array BioPharma

Date: Wednesday, February 14, 2018

Time: 1:30 p.m. Eastern Time

Webcast: View Source

Xcovery Announces Initiation of Phase 2 Clinical Trial for Ensartinib in Melanoma Patients with ALK Alternations

On February 7, 2018 Xcovery, a developer of targeted therapeutics for cancer, reported the initiation of its Phase 2 clinical trial of ensartinib (X-396), the company’s lead anaplastic lymphoma kinase (ALK) drug candidate, in patients with advanced malignant melanoma harboring alterations in ALK, including ALKATI (Press release, Xcovery, FEB 7, 2018, View Source [SID1234523776]). The trial is being conducted by the renowned Memorial Sloan Kettering Cancer Center (MSK) and led by MSK’s Dr. Alexander Shoushtari.

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"We hope that ensartinib will be a viable treatment option for these patients."

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The primary objective of the study is to determine the clinical benefit rate (CBR) of ensartinib in this patient population. CBR is defined as any confirmed objective response by Response Evaluation in Solid Tumors (RECIST) 1.1 or stable disease until the 24-week assessment. This is an open label, single arm Phase 2 study, enrolling patients with melanoma either currently or previously having received a PD-1 based therapy and, if BRAF V600 mutated, a BRAF-based therapy. The study is comprised of two portions: the screening phase and treatment phase. In the screening phase, archival tumor tissues from patients deemed to be current or future candidates for this trial will be tested for the ALKATI alteration using a Nanostring-based RNA assay at MSK. Patients whose tumors express ALKATI will be eligible for the treatment phase.

"While there has been significant clinical advancements in the treatment of advanced malignant melanoma, 30 to 40 percent of patients do not respond to immune-based therapy or will develop therapeutic resistance. This is a promising trial that uses an RNA-based assay to identify an epigenentically-regulated tumor growth mechanism and if deemed favorable for further study, this trial could represent a new treatment option for patients who currently have few options," said Alexander Shoushtari, M.D., Department of Medicine/Melanoma and Immunotherapeutics Services and principal investigator of the study at MSK.

"We are honored to collaborate with the distinguished scientists and investigators at MSK who were the first to discover this novel ALK alternation in melanoma patients," said Lieming Ding, M.D., Chairman of Xcovery. "We hope that ensartinib will be a viable treatment option for these patients."

For more information on the ensartinib clinical trial, please visit clinicaltrials.gov.

About Ensartinib
Ensartinib (X-396) is a potent anaplastic lymphoma kinase (ALK) inhibitor currently in a global Phase 3 trial in ALK positive non-small cell lung cancer patients. Besides ALK, ensartinib also potently inhibits TRKA fusions, TRKC, ROS1, EphA2, and c-MET.

Cellular Biomedicine Group Announces $30.6 million Investment from Sailing Capital Overseas Investment Ltd.

On February 5, 2018 Cellular Biomedicine Group Inc. (NASDAQ: CBMG) ("CBMG" or the "Company"), a biopharmaceutical firm engaged in the development of immunotherapies for cancer, reported the receipt of a $30.6 million investment from Sailing Capital Overseas Investment Ltd. and its affiliates (collectively "Sailing"), a global private equity firm focused on China cross-border investments in disruptive global companies in the healthcare, technology and consumer sectors (Press release, Cellular Biomedicine Group, FEB 7, 2018, View Source [SID1234523793]). As part of the transaction, Sailing will appoint a representative to the Company’s Board of Directors.

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"Sailing is a highly-regarded growth equity investor which leverages its unique commercial and government relationships to enhance its portfolio companies’ businesses in China and internationally. Sailing’s investment in the Company further validates our proprietary technology platform and independently affirms our prospects for CFDA approval and commercialization in China. We are proud of the demonstrated clinical proof-of-concept of our Chimeric Antigen Receptor ("CAR") T-cell immuno-oncology platform, and Sailing’s investment will enable further clinical development by funding our multiple clinical programs for progressive malignant lymphoma, Acute B lymphocytic leukemia and Hodgkin’s lymphoma, as well as development in novel T Cell Receptor (TCR) therapies to redirect T cells for solid tumors," said Tony (Bizuo) Liu, Chief Executive Officer of CBMG.

"With the recent regulatory approvals and commercialization of CAR-T in the US and the CFDA’s issuance of final guidance for the approval of CAR-T in China, we believe an investment in CBMG is timely as the China market opportunity for cell and gene therapy is substantial. We have conducted a deep dive on the cell and gene therapy industry and found CBMG to be not only a leader in China, but also globally, of vertically integrated cell and gene therapy manufacturing know-how, as evidenced by the Company’s strategic and joint development partnerships with both GE and Thermo Fisher. GMP quality manufacturing, market leading capacity (for 10,000 patients) and a focus on GCP standards in China are critical success factors in developing cutting-edge cancer immunotherapies for the global markets. Further, we have found CBMG to have strong innovation and translation medicine sophistication, which is reflected in a strong pipeline of multiple CAR-T and TCR constructs. We also see tremendous opportunity for leading cell and gene therapy companies based outside of China to partner with CBMG, leveraging the Company’s manufacturing expertise and the favorable regulatory environment in China, to rapidly advance development programs into the clinic. We look forward to supporting CBMG’s continued clinical success and believe the Company will emerge as a leader in the cancer medicine fields," said James Xiaodong Liu, Chairman of Sailing Capital.

Cellectar Receives USPTO Notice of Allowance for Patent Covering Use of CLR 131 in Multiple Myeloma

On February 7, 2018 Cellectar Biosciences (Nasdaq: CLRB), a clinical stage biopharmaceutical company focused on the discovery, development and commercialization of drugs for the treatment of cancer, reported that the United States Patent and Trademark Office has issued a notice of allowance for U.S. Patent Application No. 15/095,641, entitled "Alkylphosphocholine Analogs for Multiple Myeloma Imaging and Therapy," which covers a method of use for CLR 131, the company’s lead radiotherapeutic Phospholipid Drug Conjugate (PDC) in multiple myeloma (MM) (Press release, Cellectar Biosciences, FEB 7, 2018, View Source [SID1234523792]).

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CLR 131 is Cellectar’s investigational compound under development for a range of orphan designated cancers. CLR 131 utilizes the company’s patented PDC tumor targeting delivery platform to deliver the cytotoxic radioisotope iodine-131 directly to tumor cells. CLR 131 is currently being evaluated in a Phase 1 clinical trial in patients with relapse or refractory MM, as well as in a Phase 2 clinical trial for relapsed or refractory MM and select relapsed or refractory lymphomas. The U.S. Food and Drug Administration has granted orphan drug designation for CLR 131 in the treatment of MM.

"This patent allowance enhances our intellectual property estate and underscores the novelty of CLR 131 for the treatment of multiple myeloma, a life-threatening disease with high unmet medical need," said James Caruso, chief executive officer of Cellectar Biosciences. "Importantly, upon issuance, this patent will extend our coverage into the mid-2030s."

About Phospholipid Drug Conjugates

Cellectar’s product candidates are built upon a patented delivery and retention platform that utilizes optimized phospholipid ether-drug conjugates (PDCs) to target cancer cells. The PDC platform selectively delivers diverse oncologic payloads to cancerous cells and cancer stem cells, including hematologic cancers and solid tumors. This selective delivery allows the payloads’ therapeutic window to be modified, which may maintain or enhance drug potency while reducing the number and severity of adverse events. This platform takes advantage of a metabolic pathway utilized by all tumor cell types in all cell cycle stages. Compared with other targeted delivery platforms, the PDC platform’s mechanism of entry does not rely upon specific cell surface epitopes or antigens. In addition, PDCs can be conjugated to molecules in numerous ways, thereby increasing the types of molecules selectively delivered. Cellectar believes the PDC platform holds potential for the discovery and development of the next generation of cancer-targeting agents.

Diffusion Pharmaceuticals to Present at the 2018 BIO CEO & Investor Conference

On February 6, 2018 Diffusion Pharmaceuticals Inc. (NASDAQ:DFFN) ("Diffusion" or "the Company"), a clinical-stage biotechnology company focused on extending the life expectancy of cancer patients, reported that David Kalergis, Chairman and Chief Executive Officer, will present an overview of the Company and recent advancements of its lead product candidate, trans sodium crocetinate (TSC), at the BIO CEO & Investor Conference to be held on February 12 – 13, 2018 at the New York Marriott Marquis (Press release, Diffusion Pharmaceuticals, FEB 7, 2018, View Source [SID1234523794]).

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Mr. Kalergis is scheduled to present on Tuesday, February 13, 2018 at 2:45 p.m. Eastern time.

To listen to the presentation live, investors may visit the investor relations section of Diffusion Pharmaceuticals’ website at www.diffusionpharma.com. An archived webcast of the presentation will also be available on the Company’s website for 90 days.