On July 10, 2018 Neurocrine Biosciences, Inc. (NASDAQ: NBIX) reported that it will report second quarter financial results after the Nasdaq market closes on Tuesday, July 31, 2018 (Press release, Neurocrine Biosciences, JUL 10, 2018, View Source;p=RssLanding&cat=news&id=2357693 [SID1234527632]). Neurocrine will then host a conference call and webcast to discuss its financial results and provide a Company update that day at 1:30 p.m. Pacific Time (4:30 p.m. Eastern Time).

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Participants can access the live conference call by dialing 877-876-9177 (US) or 785-424-1669 (International) using the conference ID: NBIX. The webcast can also be accessed on Neurocrine’s website under Investors at View Source A replay of the webcast will be available on the website approximately one hour after the conclusion of the event and will be archived for one month.

On July 10, 2018 Transgene (Paris:TNG), a biotech company that designs and develops virus-based immunotherapies against cancers and infectious diseases, signed a series of agreements with Tasly Biopharmaceuticals Co., Ltd. ("Tasly Biopharmaceuticals") involving T601 and T101, two immunotherapeutics developed by the Transgene-Tasly joint venture in China (Press release, Transgene, JUL 10, 2018, View Source [SID1234527652]). These products incorporate Transgene’s TG6002 and TG1050 technologies, respectively. As a result of these agreements Transgene will receive shares in Tasly Biopharmaceuticals valued at $48 million. These agreements are designed to further deliver the potential of Transgene’s virus-based technologies in China.

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Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

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Philippe Archinard, Chairman and Chief Executive Officer of Transgene, added: "We are delighted to have signed these strategic agreements that create value for Transgene through our share ownership in Tasly Biopharmaceuticals and demonstrate the significant potential of the oncolytic virus T601 and therapeutic vaccine T101 in China. As a long-standing partner of the Tasly group, Transgene will remain involved in the further development of these products in China. We look forward to the first readout of the ongoing Phase 1 trial evaluating T101 against chronic hepatitis B, which is expected early 2019. In addition, a Phase 1 trial with the oncolytic virus T601 in China is actively being prepared."

Kaijin Yan, Holding Group Executive Chairman of the Board of Tasly Pharmaceuticals, commented: "Our mission is to become a world-leading biotechnology company, dedicated to continuously offer high-quality and affordable drugs to patients. These new strategic agreements with Transgene provide us with the full development and commercial rights to T601 (through 100% ownership of the joint venture) and T101 in Greater China and will allow us to build a broad innovative product portfolio. We are very happy to welcome Transgene as a key supportive shareholder of Tasly Biopharmaceuticals."

Structure of the transactions
Transgene is transferring its 50% share of the current Transgene-Tasly joint venture (Transgene Tasly (Tianjin) BioPharmaceutical Co., Ltd.) to Tasly Biopharmaceuticals, making it the 100% owner of the joint venture entity and the greater China patent rights to T601.
In parallel, Transgene is assigning the T101 patent rights in Greater China, to which the joint venture held an option, directly to Tasly Biopharmaceuticals.
As a result of these transactions, which are subject to customary closing conditions including completion of the administrative transfer of the assets contributed by Transgene to Tasly Biopharmaceuticals, Tasly Biopharmaceuticals will control all research, development and commercial rights to T601 and T101 in Greater China. In return, Transgene is receiving an aggregate of $48 million in newly created Tasly Biopharmaceuticals shares, representing 2.53% of the Tasly Biopharmaceuticals capital post completion of the Tasly Biopharmaceuticals’s pre-IPO investment round which priced simultaneously with Transgene’s transactions. Tasly Biopharmaceuticals has announced its intention to list its shares on the Hong Kong Stock Exchange.

Lazard and the Adamas law firm advised Transgene on the transaction.

A conference call in English is scheduled on July 10th at 4:00 p.m. CET.

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.

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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."

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.

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.