On January 22, 2019 Physicians’ Education Resource (PER), a leading resource for continuing medical education (CME), will host a CME-accredited activity, Optimizing Outcomes Through Stem Cell Mobilization: Applying Evidence to Patients With Multiple Myeloma and Non-Hodgkin Lymphoma, on Friday, Feb. 22, at the George R. Brown Convention Center in Houston, Texas (Press release, Physicians’ Education Resource, JAN 22, 2019, View Source [SID1234532822]). The educational program will be chaired by Shaji Kumar, M.D., professor of medicine, Mayo Clinic College of Medicine, and consultant, division of hematology, department of internal medicine, Mayo Clinic.

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This activity is a satellite symposium held adjunct to the TCT (Transplantation and Cellular Therapy Meetings). Formerly the BMT Tandem Meetings, are the combined annual meetings of the American Society of Blood and Marrow Transplantation (ASBMT) and CIBMTR.

"We are excited to present this new CME-certified activity that incorporates recent clinical data to optimize individualized approaches for autologous stem cell transplantation mobilization among patients with hematologic malignancies," said Phil Talamo, president of PER. "Attendees who participate in this symposium will learn how to personalize decision-making to optimize outcomes for their patients with hematologic malignancies."

Faculty members for the educational activity include the following clinical experts:

Sergio A. Giralt, M.D., FACP, chief, adult bone marrow transplant service, Melvin Berlin Family chair in multiple myeloma, Memorial Sloan Kettering Cancer Center.
Paul J. Shaughnessy, M.D., director, adult blood and marrow stem cell transplant program, Methodist Physician Practices, and assistant professor of medicine, University of Texas Health Science Center.
This highly interactive educational CME program will address the rapidly evolving treatment landscape for hematologic malignancies such as multiple myeloma and non-Hodgkin lymphoma. Hematopoietic stem cell transplantation (HSCT) has remained a cornerstone approach for the management of many patients with these conditions, and techniques for optimal stem cell mobilization continue to be investigated, with the goals of minimizing the burden on the patient and maximizing the likelihood of successful stem cell collection for anticipated procedures.

During this exciting case-based format, Kumar along with Giralt and Shaughnessy will review the latest clinical data to help attendees apply the information effectively to the management of their patients who may be candidates for HSCT. Key decision points pertaining to transplantation and stem cell mobilization will also be reviewed in depth during the activity.

On January 22, 2019 Rainier Therapeutics, Inc., a privately-held clinical stage drug development company, reported that data from its ongoing Phase 2 trial of its FGFR3-targeted antibody vofatamab will be presented at the upcoming 2019 ASCO (Free ASCO Whitepaper) Genitourinary Cancers Symposium taking place February 14-16, 2019 at the Moscone West Building in San Francisco (Press release, Rainier Therapeutics, JAN 22, 2019, View Source [SID1234532821]).

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Presentation details:

Title: Fierce-21: Phase II study of vofatamab (B-701), a selective inhibitor of FGFR3, as salvage therapy in metastatic urothelial carcinoma (mUC)
Presenter: Andrea Necchi, M.D., Urologic Oncology, Department of Medical Oncology, Fondazione IRCCS Istituto Nazionale dei Tumori, Milan, Italy
Abstract Number: 409
Session Information: Rapid Abstract Session B: Urothelial Carcinoma and Penile, Urethral, Testicular, and Adrenal Cancers
Date/Time: Friday, February 14, 2019 – 7:00 – 7:15 a.m.

About Vofatamab

Vofatamab is an antibody specifically targeted against the fibroblast growth factor receptor 3 (FGFR3), a known driver of bladder and potentially other FGFR-driven cancers. Vofatamab is the most advanced targeted biologic specific for FGFR3 known by Rainier to be in clinical development.

Rainier Therapeutics has ongoing Phase 1b and Phase 2 clinical trials of vofatamab in metastatic bladder cancer – the Fierce 21 and Fierce 22 trials. In addition, Rainier Therapeutics plans to study vofatamab in non-muscle invasive bladder cancer (NMIBC) – the Fierce 23 trial.

The Fierce 21 trial is evaluating vofatamab alone and in combination with docetaxel, a chemotherapeutic agent, versus docetaxel alone to determine safety and efficacy in the treatment of patients with locally advanced or metastatic bladder cancer with FGFR3 mutant/fusion who have relapsed after, or are refractory to, at least one prior line of chemotherapy. For additional information, please visit www.clinicaltrials.gov (NCT0240542).

The Fierce 22 trial is evaluating vofatamab in combination with pembrolizumab, an immune checkpoint inhibitor, to determine safety, tolerability and efficacy in the treatment of patients with locally advanced or metastatic bladder cancer, who have progressed following platinum-based chemotherapy and who have not received prior immune checkpoint inhibitor therapy. For additional information, please visit www.clinicaltrials.gov (NCT03123055).

The Fierce 23 trial will evaluate vofatamab monotherapy in NMIBC. This trial is planned to start in 2019.

On January 22, 2019 Immunochina Pharmaceuticals reported the closing of its $140 million RMB Series C financing (approximately $20.4 million in US Dollars) (Press release, Immunochina, JAN 22, 2019, View Source [SID1234532820]). This financing will enable the company to expand its GMP-grade manufacturing capabilities while continuing clinical trials for its lead IM19 product targeting B-Cell Acute Lymphoblastic Leukemia (B-ALL) and Non Hodgkin’s Lymphoma, as well as advancing the development of its pipeline targeting multiple solid and liquid tumors. The financing was led by a syndicate of Chinese and international investors including Shougang Fund, Sherpa Venture Capital, Peter Thiel, Qingzhe Capital, and China Resources Innovative Equity Investment Fund.

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"We are excited about the interest we received in this financing round, and believe the investors we ultimately chose are a great strategic fit for our ambitions. We are not only working toward becoming the leading CAR-T company in China, but as we are observing increasing interest from international companies in our CAR-T cell therapy products and lentiviral manufacturing platform, our Series C financing round enables us to continue growing into a stronger company with potential to enter the global market," says Ting He, PhD, CEO and co-founder of Immunochina.

The company’s financing round was recently increased to incorporate additional investors, supported by new positive clinical results that Immunochina achieved, which were publicly announced on December 2, 2018 at the 60th American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting in San Diego, California, United States.

At ASH (Free ASH Whitepaper), Immunochina presented results from its ongoing clinical study of its lead CD19 chimeric antigen receptor T-Cell (CAR-T) therapy, which comprised a cohort of 110 patients suffering from relapsed or refractory B-ALL. Enrolled patients included several high-risk subgroups such as patients with extramedullary disease (EMD), high leukemia burden, BCR-ABL (+), TP53 mutation, and patients with post-transplant relapse or central nervous system lymphoma (CNSL). Of the 110 subjects, 102 (93%) achieved complete tumor remission with a 1-year relapse free survival rate of 70.5%.

"The study was designed to reflect more diverse, real-world patient groups, in order to gain accurate data on safety and efficacy profiles. These considerations are important toward our mission of developing best-in-class therapies," says Dr. Hai-feng Feng, Medical Director of Immunochina, who was formerly Director of Hematology at Xian-Janssen Pharmaceuticals, a China-based subsidiary of Johnson & Johnson.

As Immunochina expects to receive two IND approvals within China by the end of the year, the company is additionally accelerating construction of its new commercial-scale, GMP-grade manufacturing facility – supported by recent partnerships with German biopharmaceutical manufacturing and equipment supplier Sartorius and American biotechnology product development company Thermo Fisher Scientific.

On January 22, 2019 TC BioPharm (TCB), a developer of CAR-T immuno-oncology products, including Gamma Delta T (GDT) cell therapies, reported it has completed formulation of its first allogeneic GDT cell banks (Press release, TC Biopharm, JAN 22, 2019, View Source [SID1234532819]). The T cell banks provide TCB with core technology to develop a deep portfolio of next-generation CAR-T products directed against a wide variety of different cancer types, both hematological and solid tumors. The project was supported by funding from the European Union’s Horizon 2020 (H2020) Research and Innovation program via a €4million grant, the largest such EU award to any UK company for development of a healthcare therapeutic product.

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The GDT cell banks are collected and stored from healthy donors, providing a source for TCB to manufacture next-generation ‘off-the-shelf’ GDT cell therapies for future clinical product development. Using allogeneic material from healthy donors offers several advantages over conventional autologous CAR-T therapies, which use the patient’s own cells to treat their tumor, as TCB’s proprietary allogeneic CAR-T cells are not prone to ‘on-target, off-tumor’ toxicities. Additionally, a larger population of cancer patients can be treated with a single reproducible product, ‘campaign-manufactured’ in bulk to keep costs lower, consequently increasing accessibility and reducing financial burden for healthcare systems.

Benefitting from H2020 support, TCB is rapidly progressing its clinical evaluation of allogeneic therapies. Having recently demonstrated safety and efficacy of large-dose autologous gamma-delta T cells in cancer patients, TCB is commencing treatment of cancer patients with an allogeneic variant. By building on its exclusive CAR-T platform, the company also plans to treat leukemia patients with an allogeneic CD19-directed GDT CAR-T product.

Angela Scott, Co-Founder and Chief Operating Officer, TCB, said: "I am delighted we have completed manufacture of our first allogeneic cell banks. By combining allogeneic GDT therapy with our unique CAR-T platform it will allow us to develop the next generation of safe, cost-effective immunotherapy for cancer, improving patient outcomes and quality of life."

Dr Michael Leek, Co-Founder and Chief Executive, TCB, commented: "Availability of clinical-grade allogeneic GDT cell banks is an important commercial milestone for TCB. This allows us to transition our therapeutic approach from expensive and complex personalized therapy using patient’s own cells, to a more cost-effective ‘pharmaceuticalized’ approach."

This project has received funding from the European Union’s Horizon 2020 Research and Innovation program.

On January 22, 2019 Vertex Pharmaceuticals Incorporated (Nasdaq: VRTX) reported that it will report its full year and fourth quarter 2018 financial results on Tuesday, February 5, 2019 after the financial markets close (Press release, Vertex Pharmaceuticals, JAN 22, 2019, View Source [SID1234532818]). The company will host a conference call and webcast at 4:30 p.m. ET. To access the call, please dial (866) 501-1537 (U.S.) or +1 (720) 545-0001 (International).

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The conference call will be webcast live and a link to the webcast can be accessed through Vertex’s website at www.vrtx.com in the "Investors" section. To ensure a timely connection, it is recommended that participants register at least 15 minutes prior to the scheduled webcast. An archived webcast will be available on the company’s website.