On February 19, 2019 Fusion Pharmaceuticals, a biopharmaceutical company focused on radiotherapeutics (specifically, targeted alpha therapeutics), reported that the first patient was dosed in a Phase 1, first-in-human clinical trial of lead product candidate [225Ac]-FPI-1434 in patients with advanced solid tumors (Press release, Fusion Pharmaceuticals, FEB 19, 2019, View Source [SID1234533468]).

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"The entire Fusion team takes tremendous pride in having developed a new targeted alpha therapeutic and in moving it from the discovery phase to a clinical trial," said John Valliant, Ph.D., Founder and Chief Executive Officer of Fusion Pharmaceuticals. "We are excited to start clinical development of a new generation of radiopharmaceuticals utilizing our Fast-ClearTM Linker to address the need for better cancer treatments."

The Phase 1 clinical study (FPX-01-01) is a dose-escalation study that will characterize the safety and tolerability of a single dose [225Ac]-FPI-1434 Injection in patients with advanced solid tumors. [225Ac]-FPI-1434 is a targeted alpha radioimmunoconjugate that consists of a humanized monoclonal antibody targeting the insulin-like growth factor-1 receptor 1 (IGF-1R), Fusion’s Fast-ClearTM Linker, a bifunctional chelate, and actinium-225. Patients will be screened for target expression with the imaging agent [111In]-FPI-1547. [111In]-FPI-1547 contains the same targeting antibody, Linker, and bifunctional chelate as the [225Ac]-FPI-1434 therapeutic form, however it will contain indium-111 in place of actinium-225. Only those patients who have IGF-1R expression will be receiving the [225Ac]-FPI-1434 therapeutic radioimmunoconjugate. Investigators will evaluate the safety and tolerability of a targeted alpha-emitting radiotherapeutic. Up to 30 patients will be treated and followed for safety and for signs of efficacy. For more information about this study, visit: View Source

About Fusion’s Fast-Clear Technology Platform and FPI-1434

Fusion uses its proprietary Fast-Clear Technology Platform to convert molecules into radiopharmaceuticals. Fast-ClearTM linkers promote increased clearance of radoisotopes – the linkers are engineered to improve the safety of radiopharmaceuticals without impacting efficacy. The predecessor [225Ac]-FPI-1434 antibody (AVE1642) is a humanized antibody against IGF-1R (insulin-like growth factor receptor) that had previously been in Phase I and II clinical trials. Fusion has an exclusive license to AVE1642 from ImmunoGen, Inc. Fusion applied its Fast-Clear linker to convert AVE1642 into a potent radiopharmaceutical, [225Ac]-FPI-1434.

On February 19, 2019 Gamida Cell Ltd. (Nasdaq: GMDA), a leading cellular and immune therapeutics company, reported an agreement with Editas Medicine, Inc., a leading genome editing company, to evaluate the potential use of Editas Medicine’s CRISPR technology to edit NAM-NK cells, which are natural killer cells that have been expanded using Gamida Cell’s proprietary nicotinamide-based, or NAM, technology (Press release, Gamida Cell, FEB 19, 2019, View Source [SID1234533505]). Through this agreement, the companies aim to discover optimized NAM-NK cells that could be used to improve the treatment of hematologic malignancies (blood cancers) and solid tumors.

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"We are encouraged by the early data generated in the Phase 1 study of NAM-NK as an investigational therapy for patients with non-Hodgkin lymphoma and multiple myeloma, and we are pleased to have the opportunity to accelerate and broaden our NAM-NK research efforts through this agreement," stated Julian Adams, Ph.D., chief executive officer of Gamida Cell. "By leveraging the collective expertise of the Gamida Cell and Editas Medicine teams, we hope to enhance the efficacy of NAM-NK cells through CRISPR editing and potentially bring life-changing immunotherapy treatments to patients."

"Natural killer cells are increasingly recognized as a potential breakthrough approach to treating various cancers. This agreement with Gamida Cell enables us to combine our industry-leading genome editing platform with Gamida Cell’s proprietary NAM-NK cells in an effort to develop best-in-class cellular medicines," said Charles Albright, Ph.D., chief scientific officer of Editas Medicine.

Under the terms of the agreement, Gamida Cell and Editas Medicine will engage in joint research to evaluate unnamed targets by combining Gamida Cell’s proprietary NAM-based cell expansion technology with Editas Medicine’s CRISPR technology. The research initiative is focused on exploring the potential to edit NAM-NK cells to further optimize their tumor-killing properties, and compare the function of the edited and unedited cells in inducing NK cell tumor clearance.

About NAM-NK
Gamida Cell applied the capabilities of its NAM-based cell expansion technology to highly functional NK cells to develop NAM-NK, an innate immunotherapy for the treatment of hematologic and solid tumors in combination with standard-of-care antibody therapies. NAM-NK addresses key limitations of NK cells by increasing the cytotoxicity and in vivo retention and proliferation in the bone marrow and lymphoid organs of NK cells expanded in culture. NAM-NK is in Phase 1 development through an investigator-sponsored study in patients with refractory non-Hodgkin lymphoma and multiple myeloma.1

NAM-NK is an investigational therapy, and its safety and efficacy has not been evaluated by the U.S. Food and Drug Administration or any other health authority.

On February 18, 2019 Clarity Pharmaceuticals, a radiopharmaceutical company focused on the treatment of serious disease, is reported that it has raised a total of $8,965,959.75 (Press release, Clarity Pharmaceuticals, FEB 18, 2019, View Source [SID1234533370]). This includes the previously announced strategic investment of $5,000,002.75 from GenesisCare, the largest private provider of cancer treatment in Australia and Europe, and an additional $3,965,957.00 from the undertaking of a Rights Issue to Clarity’s existing shareholders.

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Clarity is now opening the capital raise to external investors for the remaining $1,034,045.75 to complete a total of $10,000,005.50.

The money raised will fund further development of Cu-64 SARTATE and Cu-67 SARTATE, which are next generation, highly targeted, theranostic pharmaceuticals with increased specificity and in vivo stability. Cu-64 SARTATE allows for diagnostic PET imaging, as well as the potential for personalised dosimetry. Cu-67 SARTATE is a potential therapeutic product which could enable treatment for cancers that express the somatostatin receptor 2 (SSTR-2). Clarity commenced its first therapy trial in July 2018 using SARTATE in a serious brain cancer called meningioma and have now reached 50% of our patient recruitment target. This trial of Cu-67 SARTATE will help to pave the way for the use of Cu-67 SARTATE in this patient group as well as using this data as a basis to help expand other indications that express SSTR-2, such as neuroblastoma, an aggressive children’s cancer, and other cancers. Clarity will also continue the development of Cu-64 SARTATE as a diagnostic product for neuroendocrine tumours (NETs) following a successful first-in-human study, completed in 2016.

The capital raising will also fund the development of two other assets in Clarity’s pipeline: a prostate specific membrane antigen (PSMA) targeting product for the diagnosis and treatment of prostate cancer; and a Bombesin (BBN) product that targets the gastrin-releasing peptide receptor, which is present in a number of serious cancers including lung, ovarian, prostate, and breast.

Dr Alan Taylor, Executive Chairman of Clarity Pharmaceuticals, commented, "We are excited to see such strong support from our existing shareholders in this Rights Issue as well as increased interest from a number of strategic companies. This gives us great confidence in our technology, and to continue growing and developing our Company, its capabilities and pipeline in the future. We are also looking forward to welcoming a small number of new investors to our Company given now is the time when the radiopharmaceutical market is gaining significant traction with a number of multibillion-dollar acquisitions in the last few years."

On February 18, 2019 Exicure, Inc. (OTCQB:XCUR), the pioneer in gene regulatory and immunotherapeutic drugs utilizing spherical nucleic acid (SNA) constructs, reported that its CEO, Dr. David Giljohann, will present at SMi’s RNA Therapeutics 2019 Conference being held February 20-21, 2019 at the Copthorne Tara Hotel in London, UK (Press release, Exicure, FEB 18, 2019, View Source;p=RssLanding&cat=news&id=2387769 [SID1234533371]). Dr. Giljohann’s presentation titled "Spherical Nucleic Acids: Clinical Progress" will occur on Wednesday, February 20, 2019 at 9:10 am GMT.

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On February 18, 2019 BioCryst Pharmaceuticals, Inc. (Nasdaq: BCRX) reported that the company will report its fourth quarter and full year 2018 financial results on Monday, March 4, 2019 (Press release, BioCryst Pharmaceuticals, FEB 18, 2019, View Source [SID1234533373]).

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BioCryst management will host a conference call and webcast at 8:30 a.m. ET that day to discuss the financial results and provide a corporate update.

The live call may be accessed by dialing 877-303-8027 for domestic callers and 760-536-5165 for international callers and using conference ID # 1271286. A live webcast of the call and any slides will be available online at the investors section of the company website at www.biocryst.com. A telephone replay of the call will be available by dialing 855-859-2056 for domestic callers or 404-537-3406 for international callers and entering the conference ID # 1271286.