Tocagen Closes Previously Announced License Agreement with ApolloBio to Develop and Commercialize Toca 511 & Toca FC in Greater China

On July 9, 2018 Tocagen Inc. (Nasdaq: TOCA), a clinical-stage, cancer-selective gene therapy company, and Beijing Apollo Venus Biomedical Technology Limited, an affiliate of ApolloBio Corp., a biopharmaceutical company focused on oncology (collectively, "ApolloBio"), reported the closing of an agreement providing ApolloBio with the exclusive right to develop and commercialize Toca 511 & Toca FC within the greater China region (Press release, Tocagen, JUL 9, 2018, View Source;p=RssLanding&cat=news&id=2357366 [SID1234527620]). ApolloBio has garnered all regulatory approvals for the agreement and paid Tocagen the upfront payment of $16 million.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

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

                  Schedule Your 30 min Free Demo!

Under the terms of the agreement signed with ApolloBio in April 2018, Tocagen is also eligible to receive potential payments of $4 million in near-term development milestones, including a milestone for the completion of enrollment in the ongoing Phase 3 Toca 5 study. Tocagen will be eligible for additional future payments totaling up to $111 million upon meeting certain development and commercial milestones. In addition, the agreement provides for low double-digit tiered royalty payments based on net sales. ApolloBio will be responsible for all development and commercialization costs in the licensed territory.

"We’re pleased to have completed our strategic partnership agreement with ApolloBio, allowing us to expand the global commercial opportunity for Toca 511 & Toca FC amidst important recent developments in China to facilitate patient access to medical innovations," said Marty Duvall, chief executive officer of Tocagen. "This partnership also strengthens Tocagen’s cash position to fuel our pivotal Phase 3 Toca 5 trial and our pipeline-expanding R&D efforts."

"We are eager to collaborate closely with Tocagen and advance the development of Toca 511 & Toca FC in greater China," said Dr. Weiping Yang, chief executive officer of ApolloBio. "This partnership is an example of our commitment to bringing novel immuno-oncology treatments to the large patient population in China as soon as possible."

About Toca 511 & Toca FC

Tocagen’s lead product candidate is a two-part cancer-selective immunotherapy comprised of an investigational biologic, Toca 511 and an investigational small molecule, Toca FC. Toca 511 (vocimagene amiretrorepvec) is a retroviral replicating vector (RRV) that selectively infects cancer cells and delivers a gene for the enzyme, cytosine deaminase (CD). Through this targeted delivery, infected cancer cells carry the CD gene and produce CD. Toca FC is an orally administered, extended-release formulation of the prodrug, 5-fluorocytosine (5-FC), which is converted into an anti-cancer drug, 5-fluorouracil (5-FU), when it encounters CD. 5-FU kills cancer cells and immune-suppressive myeloid cells in the tumor microenvironment resulting in anti-cancer immune activation and subsequent tumor killing.

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."

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

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

                  Schedule Your 30 min Free Demo!

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.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

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

                  Schedule Your 30 min Free Demo!

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.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

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

                  Schedule Your 30 min Free Demo!

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]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

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

                  Schedule Your 30 min Free Demo!

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.