Amgen To Present At The Goldman Sachs 39th Annual Global Healthcare Conference

On May 7, 2018 Amgen (NASDAQ:AMGN) reported it will present at the Goldman Sachs 39th Annual Global Healthcare Conference at 9:30 a.m. PT on Tuesday, June 12, 2018, in Rancho Palos Verdes, Calif. Elliott M. Levy, M.D., senior vice president of Research and Development at Amgen, will present at the conference (Press release, Amgen, JUN 7, 2018, View Source;p=RssLanding&cat=news&id=2353772 [SID1234527227]). Live audio of the presentation can be accessed from the Events Calendar on Amgen’s website, www.amgen.com, under Investors. A replay of the webcast will also be available on Amgen’s website for at least 90 days following the event.

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Atreca to Present Immuno-­Oncology Research Findings at 2018 World Preclinical Congress

On June 7, 2018 Atreca, Inc., a biotechnology company focused on developing novel therapeutics based on a deep
understanding of the human immune response, reported that Norman Michael Greenberg, Ph.D., Senior Vice President and Chief Scientific Officer at Atreca, will deliver a presentation highlighting progress of the Company’s advancing immuno- oncology pipeline during the 2018 World Preclinical Congress (WPC) Annual Meeting, which is taking place at Westin Copley Place in Boston, MA, June 18-21, 2018 (Press release, Atreca, JUN 7, 2018, View Source [SID1234527228]). Dr. Greenberg will report on results of Atreca’s R&D engine, Immune Repertoire Capture (IRC), to identify therapeutic antibodies for development based on patients’ responses to cancer immunotherapy.

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"The power of our IRC technology lies in its ability to accurately discover anti-ˇtumorantibodies in patients who have achieved successful outcomes following anti-cancer treatments, such as checkpoint inhibitor immunotherapy," said John A. Orwin, Atreca’s President and Chief Executive Officer. "As highlighted in this promising research, our
recombinantly expressed antibodies were able to cause tumor regression and induce durable immunity in in vivo preclinical cancer models. We are delighted to report on the progress of this and other key research at Atreca as we continue to advance our pipeline toward entry into the clinic next year."

Details regarding the oral presentation are available on the WPC website and are also
as follows:

Presentation Title: Discovery and Characterization of Functional Anti-ˇTumor Antibodies from Non-ˇProgressing Cancer Patients Undergoing Immunotherapy

Session Title: New Targets and Approaches;; Preclinical Strategies, Models & Tools in Oncology: Executive Summit
Presentation Date & Time: Tuesday, June 19, 2018, 11:05 AM ET
Location: Essex South Room, Westin Copley Place

BioXcel Therapeutics Appoints Vincent J. O’Neill M.D., as Senior Vice President and Chief Medical Officer

On June 7, 2018 BioXcel Therapeutics, Inc. ("BTI") (Nasdaq: BTAI), a clinical stage biopharmaceutical development company utilizing novel artificial intelligence to identify the next wave of medicines across neuroscience and immuno-oncology, reported the appointment of Dr. Vincent J. O’Neill as Senior Vice President and Chief Medical Officer of BTI (Press release, BioXcel Therapeutics, JUN 7, 2018, View Source [SID1234527395]). Dr. O’Neill has served as Chief Medical Officer of BTI, on a consulting basis, since July 2017. He will continue to be responsible for the clinical strategy and development of BTI’s pipeline assets.

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Dr. Vimal Mehta, Founder and Chief Executive Officer of BTI, commented, "We are excited to have Dr. O’Neill on the BTI team at this time when we are executing on our pipeline and moving towards clinical data. During his tenure thus far at BTI, Vince made a number of noteworthy contributions to BTI. He played a particularly important role in the success of our recent initial public offering, initiating our first-in-human clinical trial of BXCL501 and laying the foundation for clinical development of BXCL701. Vince has a wealth of experience in the biopharma landscape, particularly his clinical experience at Genentech. This coupled with his significant expertise in therapeutic development will play a crucial role in implementing and advancing BTI’s pipeline programs through clinical development and commercialization."

Dr. O’Neill has over 16 years of therapeutic and diagnostic product development experience. He has held senior leadership roles at global pharmaceutical companies such as Genentech, Sanofi and GlaxoSmithKline. Prior to joining the Company, Dr. O’Neill served as the Senior Vice President and Chief Medical Officer at Mirna Therapeutics, where he was responsible for clinical development and medical affairs. At Genentech and GlaxoSmithKline ("GSK"), he oversaw the clinical and biomarker development programs for multiple oncology therapeutic assets. He was instrumental in the expanded approvals of Genentech’s oncology therapeutics, Avastin and Tarceva. At GSK, he managed the signal transduction discovery unit and led the first IND application and clinical trial of MEK inhibitor MEKINIST.

Dr. O’Neill received his medical degree and B.Sc. in molecular pathology from the University of Glasgow. He has authored several peer-reviewed publications and conference presentations. Dr. O’Neill is also a member of the Royal College of Physicians."

This role offers me a great opportunity to be a part of a team that is developing drugs that address major unmet medical needs," said Dr. O’Neill. "BTI is at a transformative time of clinical development and the opportunity to grow our pipeline. I believe that BTI has the potential to be at the forefront of developing innovative therapies in neuroscience and immuno-oncology. I am looking forward to working closely with the entire team to bring novel therapies to the market."

BioMarin Receives Milestone Payments from Pfizer for Talazoparib

On June 7, 2018 BioMarin Pharmaceutical Inc. (Nasdaq: BMRN) reported that the Company received $20 million in milestone payments from Pfizer Inc (Press release, BioMarin, JUL 7, 2018, View Source [SID1234527230]). These milestone payments were triggered by the U.S. Food and Drug Administration (FDA) acceptance of Pfizer’s New Drug Application (NDA) submission for talazoparib and by the European Medicines Agency (EMA) acceptance of Pfizer’s submission of a Marketing Authorization Application (MAA) for talazoparib. These milestone payments are part of an agreement made with Medivation, Inc. when the company purchased talazoparib. Medivation was acquired by Pfizer.

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In August 2015, Medivation, Inc. and BioMarin Pharmaceutical Inc. entered into an asset purchase agreement under which Medivation acquired all worldwide rights to talazoparib, an investigational, once-daily, oral poly ADP ribose polymerase (PARP) inhibitor, which has been evaluated in clinical studies for the treatment of patients with germline BRCA 1/2-mutated locally advanced or metastatic breast cancer. Under the agreement, Medivation, acquired by Pfizer, is responsible for all research, development, regulatory and commercialization activities for all indications on a global basis.

Under the terms of the agreement, Medivation paid BioMarin $410 million upfront, and BioMarin may receive up to an additional $160 million (in aggregate) upon the achievement of regulatory and sales-based milestones as well as mid-single digit royalties for talazoparib.

Cellectar Granted U.S. Patent for the Treatment of Various Cancers and Cancer Stem Cells with CLR 131

On June 7, 2018 Cellectar Biosciences, Inc. (Nasdaq: CLRB), a clinical-stage biopharmaceutical company focused on the discovery, development and commercialization of targeted treatments for cancer, reported that the U.S. Patent and Trademark Office (USPTO) has granted patent application number 15/099,977 titled, "Ether and Alkyl Phospholipid Compounds for Treating Cancer and Imaging Detection of Cancer Stem Cells (Press release, Cellectar Biosciences, JUN 7, 2018, View Source [SID1234527231])." This new patent enhances the coverage for the use of CLR 131 as a treatment for multiple cancers including gliomas, lung cancer, squamous cell carcinoma, renal cancer, melanoma, colorectal cancer, ovarian cancer, prostate cancer, breast cancer, and pancreatic cancer including cancer stem cells.

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"This patent expands protection for our PDC compounds across a number of significant cancers and importantly cancer stem cells. The ability of our PDC pipeline products, including CLR 131, to target both cancer cells and cancer stem cells for difficult to treat tumors could provide improved therapeutic benefits," stated Jim Caruso, chief executive officer of Cellectar Biosciences. "The patent also provides further coverage for CLR 131’s use in underserved pediatric diseases such as glioma, an indication that we plan to advance into the clinic in the second half of this year."

About Phospholipid Drug Conjugates

Cellectar’s product candidates are built upon a patented delivery and retention platform that utilizes optimized 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.

About CLR 131

CLR 131 is Cellectar’s investigational radioiodinated PDC therapy that exploits the tumor-targeting properties of the company’s proprietary phospholipid ether (PLE) and PLE analogs to selectively deliver radiation to malignant tumor cells, thus minimizing radiation exposure to normal tissues. CLR 131, is in a Phase 2 clinical study in relapsed or refractory (R/R) MM and a range of B-cell malignancies and a Phase 1 clinical study in patients with (R/R) MM exploring fractionated dosing. In 2018 the company plans to initiate a Phase 1 study with CLR 131 in pediatric solid tumors and lymphoma, and a second Phase 1 study in combination with external beam radiation for head and neck cancer.