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.

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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.

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]).

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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]).

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"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.

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.

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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.

On December 26, 2018 TRACON Pharmaceuticals (NASDAQ:TCON), a clinical stage biopharmaceutical company focused on the development and commercialization of novel targeted therapeutics for cancer, wet age-related macular degeneration and fibrotic diseases, reported positive top-line clinical results from a Phase 1 study of TRC105 and Opdivo (nivolumab) for the treatment of non-small cell lung cancer (Press release, Tracon Pharmaceuticals, DEC 26, 2018, View Source [SID1234532276]).

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In this Phase 1b trial, patients with refractory metastatic non-small cell lung cancer were enrolled regardless of baseline PD-L1 tumor expression. Patients were treated with 8 mg/kg or 10 mg/kg of TRC105 weekly for four doses and then 15 mg/kg every two weeks, in combination with the approved dose of Opdivo of 240 mg every two weeks. Best response was assessed by immune RECIST 1.1.

The combination of TRC105 and Opdivo was well-tolerated without the development of dose limiting toxicity in six patients who were treated as part of dose escalation. One of these six patients, whose archival tumor did not express PD-L1 and who had not received prior PD-1/PD-L1 checkpoint inhibition treatment, developed a partial response and remains on study after 10 months. Two of the other five patients, one of whom who progressed following prior Opdivo treatment, remain on trial with stable disease. Patients are currently enrolling into two parallel 12 patient expansion cohorts, one that includes patients who have relapsed following prior PD-1/PD-L1 checkpoint inhibition treatment and one that consists of patients who have not received prior PD-1/PD-L1 checkpoint inhibition treatment.

"We initiated this Phase 1 trial based on the potentiation of PD-1 checkpoint inhibition observed with TRC105 in pre-clinical models. We are pleased that TRC105 was well-tolerated with Opdivo, and with the early evidence of activity seen in the study," said Charles Theuer, M.D. Ph.D., President and CEO of TRACON. "We expect to present data from the expansion cohorts in mid-2019."

Further details of the dose escalation portion of the study will be presented at the International Association for the Study of Lung Cancer (IASLC) annual meeting in February 2019 in Santa Monica, CA, by Dr. Francisco Robert of the University of Alabama, Birmingham.

About Carotuximab (TRC105)

TRC105 is a novel, clinical stage antibody to endoglin, a protein overexpressed on proliferating endothelial cells that is essential for angiogenesis, the process of new blood vessel formation. TRC105 is currently being studied in a pivotal Phase 3 trial in angiosarcoma and multiple Phase 2 clinical trials, in combination with VEGF inhibitors, as well as in a Phase 1 trial with Opdivo. TRC105 has received orphan designation for the treatment of soft tissue sarcoma in both the U.S. and EU. The ophthalmic formulation of TRC105, DE-122, is currently in a randomized Phase 2 trial for patients with wet AMD. For more information about the clinical trials, please visit TRACON’s website at www.traconpharma.com/clinical_trials.php.