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 Merck (NYSE: MRK), known as MSD outside the United States and Canada, reported that it will hold its fourth-quarter and full-year 2018 sales and earnings conference call with institutional investors and analysts at 8:00 a.m. EST on Friday, Feb. 1 Merck (NYSE: MRK), known as MSD outside the United States and Canada, will hold its fourth-quarter and full-year 2018 sales and earnings conference call with institutional investors and analysts at 8:00 a.m. EST on Friday, Feb. 1. During the call, company executives will provide an overview of Merck’s performance for the quarter.

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Investors, journalists and the general public may access a live audio webcast of the call on Merck’s website at View Source A replay of the webcast, along with the sales and earnings news release and supplemental financial disclosures, will be available at www.merck.com.

Institutional investors and analysts can participate in the call by dialing (706) 758-9927 or (877) 381-5782 and using ID code number 9872199. Members of the media are invited to monitor the call by dialing (706) 758-9928 or (800) 399-7917 and using ID code number 9872199. Journalists who wish to ask questions are requested to contact a member of Merck’s Media Relations team at the conclusion of the call.

. During the call, company executives will provide an overview of Merck’s performance for the quarter.

Investors, journalists and the general public may access a live audio webcast of the call on Merck’s website at View Source A replay of the webcast, along with the sales and earnings news release and supplemental financial disclosures, will be available at www.merck.com.

Institutional investors and analysts can participate in the call by dialing (706) 758-9927 or (877) 381-5782 and using ID code number 9872199. Members of the media are invited to monitor the call by dialing (706) 758-9928 or (800) 399-7917 and using ID code number 9872199. Journalists who wish to ask questions are requested to contact a member of Merck’s Media Relations team at the conclusion of the call.

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 OncoSec Medical Incorporated (OncoSec) (NASDAQ:ONCS), a company developing intratumoral cancer immunotherapies, reported that it will host a 2019 Business Outlook Conference Call and audio webcast on Friday, February 1, 2019 at 9:00 a.m. ET (Press release, OncoSec Medical, JAN 22, 2019, View Source [SID1234532804]). The Company will provide a clinical update from its KEYNOTE-695 study, an overview of its recently announced collaboration registrational-enabled cervical cancer study with the Gynecologic Oncology Group (GOG) Foundation, as well as a review of key value generating milestones the Company expects to achieve in 2019.

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To access the live conference call, please dial (844) 562-3893 (domestic) or (409) 220-9946 (international) at least five minutes prior to the start time, and refer to conference ID 4067388. An accompanying presentation will be referenced during the conference call and can be accessed under "Events and Presentations" in the Investors section of OncoSec’s website at ir.oncosec.com. A replay will be available shortly after the conference call and can be accessed for 30 days following the call.

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.