1stOncology™: Cancer Intelligence Service – Page 14423 – 1stOncology is recognized as a Top 10 Global Pharma Analytic Provider

Sesen Bio to Host Conference Call to Review Updated VISTA Trial Data in Non-Muscle Invasive Bladder Cancer

On December 27, 2018 Sesen Bio, Inc. (Nasdaq: SESN), a late-stage clinical company developing targeted fusion protein therapeutics for the treatment of people with cancer, reported that company management will host a conference call on Thursday, Jan. 3, 2018 at 8:30 a.m. ET to review updated data from its Phase 3 VISTA Trial of Vicinium for the treatment of patients with high-grade non-muscle invasive bladder cancer who have been previously treated with bacillus Calmette-Guérin (Press release, Eleven Biotherapeutics, DEC 27, 2018, http://ir.elevenbio.com/news-releases/news-release-details/sesen-bio-host-conference-call-review-updated-vista-trial-data [SID1234532287]).

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!

To participate in the conference call, please dial (844) 831-3025 (domestic) or (315) 625-6887 (international) and refer to conference ID 4263106. The webcast can be accessed in the Investor Relations section of the company’s website at www.sesenbio.com. The replay of the webcast will be available in the investor section of the company’s website at www.sesenbio.com for 60 days following the call.

China’s NMPA Approves Innovent’s Anti-PD-1 Antibody Tyvyt® (Sintilimab injection) for Hodgkin’s Lymphoma

On December 27, 2018 Innovent Biologics, Inc. (Innovent) (HKEX: 01801) and Eli Lilly and Company ("Lilly") jointly reported that the co-developed Tyvyt (fully human anti-PD-1 therapeutic monoclonal antibody, generic name: sintilimab injection) has been granted approval for market authorization by the National Medical Products Administration of China ("NMPA", formerly the China Food and Drug Administration) for the treatment of patients with classical Hodgkin’s lymphoma (cHL) that has relapsed or refractory (r/r) after two or more lines of systemic chemotherapy (r/r cHL) (Press release, Innovent Biologics, DEC 27, 2018, View Source [SID1234532284]). The approval of Tyvyt (sintilimab injection) highlights the emergence of China in the field of Immuno-Oncology.

According to Cancer Today from the WHO’s International Agency for Research for Cancer, China will have about 4.28 million newly diagnosed cancer patients and 2.86 million deaths from cancer in 2018[1]. Thus China faces massive challenges from its growing burden of cancer. Lymphoma is one of the common cancers in China, and cHL, a type of B-cell lymphoma affects young and middle-aged people. Although the combination therapy of chemotherapy and radiation has a good likelihood of inducing a complete response, patients have a 15- 20% chance of recurrence after the first line treatment. Therefore, patients urgently need new innovative medications and treatment solutions. Delivering effective treatment for r/r cHL is a serious challenge for the oncology and hematology community.

Dr. Michael Yu, the Founder, Chief Executive Officer and Chairman of Innovent, said, "Tyvyt (sintilimab injection) is an example of our success with the National Mega Innovation Program, and its approval highlights our achievements in immunotherapy and contributions to China’s efforts to deliver innovative medicines. Innovent has shown its ability to develop large molecule drug and this approval is also a validation and the recognition of Innovent’s R&D capabilities. I have confidence that Tyvyt (sintilimab injection), with its global quality and cost-effectiveness, will bring better treatment to cancer patients in China."

Dr. Wang Li, Senior Vice-President of Lilly China and Head of Lilly China Drug Development and Medical Affairs, said, "The efficacy and safety profile of Tyvyt (sintilimab injection) is well proven in the ORIENT-1 trial. The drug provides a new immuno-oncology treatment option for patients with relapsed/refractory classical Hodgkin’s lymphoma (r/r cHL). Lilly will continue to collaborate with outstanding local pharmaceutical companies to bring more innovative medicines to patients and help in demonstrating local R&D capabilities in global oncology community."

Currently, Tyvyt (sintilimab injection) is being studied in more than twenty clinical trials, including studies in first line non-squamous non-small cell lung cancer (NSCLC), first line squamous NSCLC, second line squamous NSCLC, EGFR mutant NSCLC after EGFR TKI treatment failure, first line gastric cancer, first line liver cancer, first line esophageal cancer, and second line esophageal cancer.

About Tyvyt (sintilimab injection)

Tyvyt (sintilimab injection) is an innovative drug co-discovered by Innovent and Adimab, jointly developed by Innovent and Eli Lilly and Company in China. Tyvyt (sintilimab injection) is a type of immunoglobulin G4 monoclonal antibody, which binds to the PD-1 molecule on the surface of T-cells, blocks the PD-L1 (Programmed Cell Death-1 Ligand-1, PD-L1 pathway) and reactivates T-cells to kill cancer cells. Tyvyt (sintilimab injection) is the only PD-1 antibody in China branded by both a local biopharmaceutical company and a global pharmaceutical company.

Presentation of Precigen, Inc. dated December 26, 2018

On December 26, 2018 Precigen, Inc., a wholly-owned subsidiary of Intrexon Corporation presented the corporate presentation (Presentation, Intrexon, DEC 26, 2018, View Source [SID1234532283]).

IMMUNOMEDICS AND JOHNSON MATTHEY ANNOUNCE STRATEGIC MANUFACTURING PARTNERSHIP

On December 26, 2018 Immunomedics, Inc., (NASDAQ: IMMU) and Johnson Matthey (LSE: JMAT), reported the companies have expanded their long-term master supply agreement under which Johnson Matthey will continue to scale the manufacturing of CL2A-SN-38, the drug-linker that is a key component of sacituzumab govitecan, Immunomedics’ lead antibody-drug conjugate currently under priority review by the FDA for accelerated approval as a treatment for patients with metastatic triple-negative breast cancer (Press release, Immunomedics, DEC 26, 2018, View Source [SID1234532281]).

"We are significantly scaling our ongoing partnership with Johnson Matthey," said Dr. Morris Rosenberg, Chief Technology Officer of Immunomedics. "This agreement signifies our continuing commitment to expand our supply-chain strategy as we look to broaden the applicability of sacituzumab govitecan to a multitude of solid cancer indications and expand it to other world markets."

"Immunomedics is one of our largest and most strategic relationships and we are proud to be able to contribute to their efforts in providing viable treatment options to improve cancer patients’ lives," said Jason Apter, Sector Chief Executive, Health at Johnson Matthey.

Financial terms of the agreement were not disclosed.

About Sacituzumab Govitecan

Sacituzumab govitecan, Immunomedics’ most advanced product candidate, is a novel, first-in-class antibody-drug conjugate. It is currently under priority review by the U.S. Food and Drug Administration for accelerated approval as a treatment of patients with metastatic triple-negative breast cancer who have received two prior therapies for metastatic disease. If approved, sacituzumab govitecan would be the first therapy approved for patients with metastatic triple-negative breast cancer.

Delcath Announces Commercial Licensing Agreement for CHEMOSAT®

On December 26, 2018 Delcath Systems, Inc. (OTCQB: DCTH), an interventional oncology company focused on the treatment of primary and metastatic liver cancers, reported that the company has entered into a definitive licensing agreement for CHEMOSAT commercialization in Europe with medac Gesellschaft für klinische Spezialpräparate mbH (medac), a privately held, multi-national pharmaceutical company based in Hamburg area, Germany (Press release, Delcath Systems, DEC 26, 2018, View Source;p=RssLanding&cat=news&id=2381596 [SID1234532279]). Founded in 1970, medac specializes in the treatment and diagnosis of oncological, urological and autoimmune diseases. The company has offices globally, worldwide partner agreements in over 90 countries, and approximately 1,200 employees.

Under the terms of the seven-year agreement, Delcath’s European subsidiary, Delcath Systems, Ltd. exclusively licenses medac to sell and market CHEMOSAT in all member states of the European Union, Norway, Liechtenstein, Switzerland, and the United Kingdom. medac will pay Delcath €6,000,000 in a combination of upfront and success-based milestone payments. Additionally, Delcath will receive a fixed transfer price per unit of CHEMOSAT as well as royalties. The agreement has a projected value of up to $45 million over the first seven-year term and includes an optional five-year extension.

"With offices throughout Europe and a well-established network among oncology key opinion leaders, medac is a well-suited partner to help advance CHEMOSAT commercialization in the European Union and neighboring countries," said Jennifer K. Simpson, Ph.D., MSN, CRNP President and CEO of Delcath. "medac provides the organizational scale, expertise and market reach necessary to help us strive to firmly establish CHEMOSAT in the European treatment landscape for cancers of the liver. Additionally, through this agreement, we obtain immediate resources to support our efforts to advance our clinical development program. This is a highly significant development for Delcath, and we are pleased to be working with a market leader like medac to help this therapy fully realize its potential."

Heiner Will, Chief Marketing Officer of medac, said, "We are excited to build upon the growing customer and revenue base that Delcath has built in Europe to provide patients with liver metastases a promising treatment modality. We are convinced by the assessment of European clinicians about the very meaningful impact CHEMOSAT has on the quality of life of these patients who, because of the safety profile of CHEMOSAT can receive multiple treatments." This substantial new business opportunity strengthens and expands medac’s expertise in the treatment of cancer. medac is currently working diligently with Delcath launching commercial efforts in Europe in January 2019.