Syntimmune strengthens leadership team with appointment of chief medical officer

On July 9, 2018 Syntimmune, Inc., a clinical-stage biotechnology company developing antibody therapeutics targeting FcRn, reported the appointment of biopharma executive Mario Saltarelli, M.D., Ph.D., as chief medical officer (Press release, Syntimmune, JUL 9, 2018, View Source [SID1234527619]).

Dr. Saltarelli, who most recently served as senior vice president at Vertex, brings broad experience in discovery research, clinical development, pipeline strategy and global regulatory operations. Dr. Donald Johns, who has been acting chief medical officer, will become the executive vice president of medical and scientific affairs for Syntimmune."Mario’s deep expertise in drug development and strong leadership skills will be a tremendous asset to Syntimmune as we advance our pipeline of novel therapies targeting a broad range of autoimmune diseases," said Jean-Paul Kress, M.D., Syntimmune’s president and CEO. "We’re thrilled to have him on board to lead our medical organization. I’d also like to thank Don for his support as acting CMO, and I’m pleased that he’ll be continuing to help Syntimmune strengthen our medical and scientific leadership position."Dr. Saltarelli comes to Syntimmune from Vertex, where he managed clinical development projects across multiple therapeutic areas as senior vice president, early development and neurology. At Vertex, he supported the NDA/MAA preparation and filing of Symdeko (tezacaftor/ivacaftor), leading to FDA approval. He also advanced multiple early development assets. Prior to Vertex, Dr. Saltarelli served as chief medical officer of Annexion Biosciences and as senior vice president and chief science officer at Mallinckrodt Pharmaceuticals. Dr. Saltarelli has also held leadership roles at Shire, Abbott (AbbVie) and Pfizer. Throughout his career, Dr. Saltarelli has worked on the full range of pharmaceutical research and development needs, including translational sciences, clinical strategy, pharmacology and medical affairs. Dr. Saltarelli earned both an M.D. and a Ph.D. in neurosciences from Johns Hopkins University School of Medicine.

"This is an exciting moment for Syntimmune, with multiple clinical trials underway and planned, and I am delighted to be able to contribute," Dr. Saltarelli said. "Syntimmune has a strong vision of leveraging its unique insights into FcRn, honed over 25 years of research, to develop novel therapies that will truly help patients. I’m honored to be part of the team."

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Dr. Johns is an accomplished drug development leader with extensive experience in drug discovery and development. He is a board-certified clinical neurologist and scientific leader with 25+ years of experience in rare and orphan diseases. Prior to joining Syntimmune, Dr. Johns held leadership positions at Biogen, Novartis Institutes for BioMedical Research, the Center for the Integration of Medicine and Innovative Technology and Beth Israel Deaconess Medical Center. He contributed to three successful New Drug Applications (EXELON PATCH: Alzheimer Disease, GILENYA: Relapsing Remitting Multiple Sclerosis, SPINRAZA: Spinal Muscular Atrophy). He is the founding principal of Axon Guidance LLC, a neuroscience-focused drug development consultancy. He has also held teaching positions at Harvard Medical School and Johns Hopkins University School of Medicine. Dr. Johns received his M.D. from the Yale University School of Medicine. He completed his Neurology residency and fellowship at Massachusetts General Hospital.

Regeneron to Report Second Quarter 2018 Financial and Operating Results and Host Conference Call and Webcast on August 2, 2018

On July 9, 2018 Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) reported that it will report its second quarter 2018 financial and operating results on Thursday, August 2, 2018, before the U.S. financial markets open (Press release, Regeneron, JUL 9, 2018, View Source [SID1234527618]). The Company will host a conference call and simultaneous webcast at 8:30 AM Eastern Time that day.

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Conference Call Information
To access this call, dial (800) 708-4539 (U.S.) or (847) 619-6396 (International). A link to the webcast may be accessed from the ‘Investors and Media’ page of Regeneron’s website at www.regeneron.com. A replay of the conference call and webcast will be archived on the Company’s website and will be available for 30 days.

Horizon Pharma plc to Release Second-Quarter 2018 Financial Results and Host Webcast on August 8, 2018

On June 9, 2018 Horizon Pharma plc (Nasdaq: HZNP) reported that its second-quarter financial results will be released on Wednesday, August 8, 2018 (Press release, Horizon Pharma, JUL 9, 2018, View Source [SID1234527617]). Following the announcement, Horizon’s management will host a live webcast at 8 a.m. Eastern Time to review the Company’s financial and operating results.

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The live webcast and replay may be accessed at View Source Please connect to the Company’s website at least 15 minutes before the live webcast to ensure adequate time for any software download that may be needed to access the webcast.

Exact Sciences to host annual meeting, second-quarter 2018 results webcasts and calls

On July 9, 2018 Exact Sciences Corp. (Nasdaq: EXAS) reported that the company will host webcasts and conference calls of its annual stockholders meeting and to discuss its second-quarter 2018 financial results (Press release, Exact Sciences, JUL 9, 2018, View Source [SID1234527615]).

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Date: Thursday, July 26, 2018

Time: 11 a.m. ET, 10 a.m. CT

Webcast: The live webcast can be accessed at www.exactsciences.com

Telephone: Domestic callers, dial 877-201-0168

International callers, dial +1 647-788-4901

Access code for both domestic and international callers: 7198945

The company plans to release its second-quarter 2018 financial results after the close of the U.S. financial markets on Aug. 1, 2018. Following the release, company management will host a webcast and conference call at 5 p.m. ET to discuss financial results and business progress.

Second-Quarter 2018 Webcast & Conference Call Details

Date: Wednesday, Aug. 1, 2018

Time: 5 p.m. ET, 4 p.m. CT

Webcast: The live webcast can be accessed at www.exactsciences.com

Telephone: Domestic callers, dial 877-201-0168

International callers, dial +1 647-788-4901

Access code for both domestic and international callers: 4260268

An archive of the webcasts will be available at www.exactsciences.com. A replay of the annual meeting and second-quarter conference calls will be available by calling 800-585-8367 domestically or 416-621-4642 internationally. The annual meeting replay can be accessed with the code 7198945. The access code for the second-quarter call replay is 4260268. The webcasts, conference calls and replays are open to all interested parties.

Cellectar’s CLR 131 Receives FDA Orphan Drug Designation for Treatment of Ewing’s Sarcoma

On July 9, 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 U.S. Food and Drug Administration (FDA) Office of Orphan Products Development has granted Orphan Drug Designation (ODD) to CLR 131, the company’s lead Phospholipid Drug Conjugate (PDC) product candidate, for the treatment of Ewing’s sarcoma, a rare pediatric cancer (Press release, Cellectar Biosciences, JUL 9, 2018, View Source [SID1234527614]).

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"Ewing’s sarcoma is the second most common bone malignancy among children and adolescents and there are limited treatment options for patients who relapse or become refractive to therapy," said John Friend, M.D., chief medical officer of Cellectar. "The ODD for Ewing’s sarcoma represents another important milestone for our CLR 131 pediatric program as we work to bring new options to patients suffering from rare cancers."

The FDA grants orphan drug designation to therapies targeted at conditions that affect fewer than 200,000 people in the United States. The designation provides seven-year market exclusivity, increased engagement and assistance from the FDA, tax credits for certain research, research grants and a waiver of the New Drug Application user fee. In 2018 the FDA also granted CLR 131 orphan drug and rare pediatric disease designations for the treatment of neuroblastoma and rhabdomyosarcoma.

Cellectar is currently initiating a Phase 1 clinical study evaluating CLR 131 for the potential treatment of pediatric patients with Ewing’s sarcoma, rhabdomyosarcoma, osteosarcoma, neuroblastoma, high grade glioma and lymphomas. Cellectar has received clearance from the FDA to proceed with an accelerated Phase 1 trial, designed to evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of CLR 131 in pediatric patients with these cancer types. Further details about the trial can be found at clinicaltrials.gov using the identifier number NCT03478462.

About Ewing’s Sarcoma

Ewing’s sarcoma is the second most common bone malignancy among children and adolescents. According to a study published in the Journal of Hematology/Oncology, the incidence is about 3 cases per 1 million per year in children younger than age 20. Despite the favorable prognosis, an American Cancer Society study showed that approximately 30-40% of patients develop metastases or local recurrence, and the long-term survival rate for refractory or recurrent disease is only 22-24%. The relapsed and refractory statistics underscore the need for new treatment options.

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. The company is currently initiating a Phase 1 study with CLR 131 in pediatric solid tumors and lymphoma, and is planning a second Phase 1 study in combination with external beam radiation for head and neck cancer.