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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.

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]).

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]).

"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.

MabVax Therapeutics and Boehringer Ingelheim Sign Asset Purchase and License Agreement and Related Agreements for an Antibody Development Program Targeting Multiple Solid Tumor Cancers

On July 9, 2018 MabVax Therapeutics Holdings, Inc. (Nasdaq: MBVX), a clinical-stage oncology drug development company and Boehringer Ingelheim reported they have signed an asset acquisition and related agreements centered on MabVax’s program targeting a glycan commonly overexpressed on multiple solid tumor cancers (Press release, MabVax, JUL 9, 2018, View Source [SID1234527613]). Boehringer Ingelheim has acquired all rights in and to the program.

MabVax will receive a total of US $11 million in upfront and near-term milestones as well as downstream regulatory milestone payments plus further earn-out payments. The asset acquisition is separate and distinct from other programs under development at MabVax, enabling MabVax to retain all rights to its lead HuMab-5B1antibody program which is in Phase 1 clinical trials as a therapeutic product and as a diagnostic product, as well as other antibody discovery programs from the Company’s rich antibody discovery portfolio targeting other cancer antigens.

MabVax discovered the antibody series at the center of this transaction from biological samples, originally from patients who were vaccinated against their solid tumors with a glycan antigen-containing vaccine. The discovery of fully human antibodies directly from vaccinated cancer patients has potential advantages which include greater specificity and reduced toxicities. MabVax completed and has reported on early preclinical development activities to establish the utility of the program.

"We are very pleased to have Boehringer Ingelheim as a major industry partner to further develop one of our preclinical antibody assets based on our proprietary HuMab technology," said David Hansen, President and CEO of MabVax Therapeutics. "This agreement with Boehringer Ingelheim recognizes the value of our innovative approach to discovering novel antibodies to diagnose and treat cancer. We have been committed since the founding of the Company to discovering and developing unique fully human antibodies to diagnose and treat patients with cancers where there remain significant unmet medical needs."