On December 7, 2017 Alexion Pharmaceuticals, Inc. (NASDAQ:ALXN) and Halozyme Therapeutics, Inc. (NASDAQ:HALO) reported a collaboration and license agreement that enables Alexion to use Halozyme’s ENHANZE drug-delivery technology in the development of subcutaneous formulations for their portfolio of products (Press release, Alexion, DEC 7, 2017, View Source [SID1234522420]). The agreement provides Alexion with the opportunity for exclusive development of up to four targets, including a next generation subcutaneous formulation of ALXN1210 (ALXN1210 SC), the company’s investigational long-acting C5 complement inhibitor, to potentially further extend the dosing interval of ALXN1210 SC to once every two weeks or once per month.

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"Alexion’s goal is to provide continued innovation and more treatment options that can significantly improve the lives of patients with rare diseases," said John Orloff, M.D., Executive Vice President and Head of Research & Development at Alexion. "We are excited to partner with Halozyme and look forward to utilizing its ENHANZE technology, which enables rapid injection of subcutaneous treatments and potentially increases bioavailablity, in our development programs."

"We are delighted to support Alexion’s innovative development initiatives focused on improving the lives of patients with rare diseases," said Dr. Helen Torley, president and CEO of Halozyme. "ENHANZE has become the industry standard for converting intravenous therapies to a subcutaneous delivery, helping partners and health care providers reduce the treatment burden and administration time for patients."

Under the terms of the agreement, Halozyme will receive an initial $40 million with the potential to earn additional payments of up to $160 million for each target developed, subject to achievement of specified development, regulatory and sales-based milestones. Halozyme will also receive mid-single digit royalties on sales of commercialized products.

The Halozyme ENHANZE technology is based on a proprietary recombinant human hyaluronidase enzyme (rHuPH20) that temporarily degrades hyaluronan — a glycosaminoglycan or chain of natural sugars in the body — to aid in the dispersion and absorption of other injected therapeutic drugs. For Halozyme partners, this technology may allow for more rapid delivery of injectable medications through subcutaneous injection (just under the skin). This delivery has been shown in studies to reduce health care practitioner time required for administration and shorten time for drug administration.

Alexion is Halozyme’s eighth global collaboration and license partner for the ENHANZE technology, and the third partnership formed in 2017. These partnerships cover nearly 50 therapeutic targets and include three commercialized products.

On December 6, 2017 Fate Therapeutics, Inc. (NASDAQ:FATE), a clinical-stage biopharmaceutical company dedicated to the development of programmed cellular immunotherapies for cancer and immune disorders, reported a partnership with the University of California San Diego to develop off-the-shelf, chimeric antigen receptor (CAR)-targeted natural killer (NK) cell cancer immunotherapies (Press release, Fate Therapeutics, DEC 6, 2017, View Source [SID1234522400]). The two-year collaboration is being led by Dan S. Kaufman, M.D., Ph.D., Professor of Medicine in the Division of Regenerative Medicine and Director of Cell Therapy at UC San Diego School of Medicine.

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"NK cells have the inherent ability to target a diversity of stress-induced ligands on tumor cells and can be safely administered without the need for individualized patient matching. Additionally, NK cells engineered with chimeric antigen receptors can be targeted to tumors with high specificity. This duality provides CAR NK cells with the unique potential to overcome antigen escape and address tumor heterogeneity, which are distinct advantages over patient-specific CAR T-cell immunotherapies," said Dr. Kaufman. "We have now identified several CAR constructs optimized for NK cell signaling, persistence and cytotoxicity, and combined our targeting content with Fate Therapeutics’ induced pluripotent stem cell product platform for development of off-the-shelf CAR-targeted NK cell products using clonal engineered master pluripotent cell lines."

The CAR constructs identified by the collaborators contain transmembrane and co-stimulatory domains that enhance antigen-specific NK cell activation and improve the effector function of NK cells. Fate Therapeutics holds an exclusive license to the intellectual property covering these CAR constructs and maintains an option to exclusively license intellectual property arising from all research and development activities under the collaboration.

At the 59th American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting and Exposition, Dr. Kaufman and Fate Therapeutics will present preclinical data on Saturday, December 9, 2017 highlighting CAR-targeted NK cells derived from an induced pluripotent stem cell (iPSC) engineered with a specific CAR construct containing a NKG2D transmembrane domain, a 2B4 co-stimulatory domain and a CD3ζ signaling domain. In preclinical studies using an ovarian cancer xenograft model, the collaborators have shown that a single dose of CAR-targeted NK cells derived from iPSCs engineered with this specific CAR construct markedly inhibited tumor growth and significantly enhanced survival as compared to NK cells containing a CAR construct commonly used for T-cell immunotherapy. Dr. Kaufman was recently awarded $5.15 million by the California Institute for Regenerative Medicine (CIRM) to advance clinical translation of NK cells derived from pluripotent stem cells into a standardized treatment for treating hematologic malignancies.

iPSCs possess the unique dual properties of unlimited self-renewal and differentiation potential into all cell types of the body. The engineering of iPSCs can be done as a one-time genetic modification event and a single iPSC can be selected for creation of a clonal master pluripotent cell line. Similar to master cell lines used for the manufacture of therapeutic antibodies, a clonal master pluripotent cell line can be used to repeatedly create clonal populations of effector cells. This first-of-kind approach enables large-scale generation of off-the-shelf, targeted, homogeneous cell products that can be administered in repeat doses to mediate more effective pharmacologic activity, including in combination with cycles of other cancer treatments.

Rich Pharmaceuticals has filed a 10-Q – Quarterly report [Sections 13 or 15(d)] with the U.S. Securities and Exchange Commission (Filing, 10-Q, Rich Pharmaceuticals, 2017, DEC 6, 2017, View Source [SID1234522401]).

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On December 6, 2017 Amgen (NASDAQ:AMGN) reported that it will host a webcast call for the investment community at the 59th American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting & Exposition on Saturday, Dec. 9, 2017, at 11:30 a.m. ET (Press release, Amgen, DEC 6, 2017, View Source;p=RssLanding&cat=news&id=2321467 [SID1234522402]). David M. Reese, M.D., senior vice president of Translational Sciences and Oncology at Amgen, together with other members of Amgen’s management team and a clinical investigator, will participate to discuss the Company’s oncology program, including our BiTE immunotherapy platform.

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Live audio of the investor call will be simultaneously broadcast over the Internet and will be available to members of the news media, investors and the general public.

The webcast, as with other selected presentations regarding developments in Amgen’s business given by management at certain investor and medical conferences, can be found on Amgen’s website, www.amgen.com, under Investors. Information regarding presentation times, webcast availability and webcast links are noted on Amgen’s Investor Relations Events Calendar. The webcast will be archived and available for replay for at least 90 days after the event.

On December 6, 2017 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 company will increase the targeted patient enrollment in the relapsed/refractory (R/R) multiple myeloma (MM) cohort of its currently enrolling Phase 2 clinical trial of CLR 131. Data from the MM cohort of the study demonstrated that the treatment exceeded pre-specified criteria for clinically meaningful benefit (Press release, Cellectar Biosciences, DEC 6, 2017, View Source [SID1234522403]). As a result, the cohort will be expanded up to as many as 40 patients.

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"The initial results from the multiple myeloma arm of this Phase 2 study underscore the potential for CLR 131 to benefit these heavily pre-treated and relapsed patients. We continue to see clinical benefit with CLR 131 in both our Phase 1 and Phase 2 clinical studies and look forward to reporting additional data from the both of these clinical studies next year.," stated James Caruso, president and chief executive officer of Cellectar Biosciences. "Furthermore, we are pleased to have achieved this key clinical milestone within our projected timelines" added Mr. Caruso.