Immunochina Raises $20.4 Million USD in Series C Financing

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.

OncoSec to Host 2019 Business Outlook Conference Call on February 1, 2019

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.

Rainier Therapeutics Announces Oral Abstract Presentation on Fierce 21 Phase 2 Trial of Vofatamab in Metastatic Urothelial Cell Carcinoma (Bladder Cancer) at the 2019 ASCO Genitourinary Cancers Symposium

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.

Physicians’ Education Resource® to Present Optimizing Outcomes Through Stem Cell Mobilization as a Satellite Symposium Adjunct to the Transplantation and Cellular Therapy Meetings (TCT)

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.

UroGen Pharma Announces Proposed Public Offering of Ordinary Shares

On January 22, 2019 UroGen Pharma Ltd. (Nasdaq:URGN), a clinical-stage biopharmaceutical company developing treatments to address unmet needs in the field of urology, with a focus on uro-oncology, reported that it intends to offer and sell $150 million of its ordinary shares in an underwritten public offering (Press release, UroGen Pharma, JAN 22, 2019, View Source [SID1234532807]). The company also intends to grant the underwriters a 30-day option to purchase up to an additional 15 percent of the number of ordinary shares sold in the offering at the public offering price, less the underwriting discounts and commissions. The offering is subject to market and other conditions and there can be no assurance as to whether or when the offering may be completed, or as to the actual size or terms of the offering. All ordinary shares to be sold in this offering will be offered by the company.

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Goldman Sachs & Co. LLC, J.P. Morgan and Jefferies are acting as joint book-running managers for the offering. Oppenheimer & Co. is acting as lead manager for the offering.

A shelf registration statement relating to the ordinary shares was previously filed with the Securities and Exchange Commission (the "SEC") and declared effective on October 26, 2018. A preliminary prospectus supplement and accompanying prospectus relating to the offering will be filed with the SEC and will be available on the SEC’s website at View Source Copies of the preliminary prospectus supplement (when available) and accompanying prospectus may be obtained by contacting:

Goldman Sachs & Co. LLC, c/o Prospectus Department, 200 West Street, New York, New York 10282, or via telephone at 866-471-2526, or via email: [email protected]; or

J.P. Morgan Securities LLC, c/o: Broadridge Financial Solutions, 1155 Long Island Avenue, Edgewood, New York 11717 or via telephone at 866-803-9204, or via email: [email protected]; or

Jefferies LLC, c/o: Equity Syndicate Prospectus Departments, 520 Madison Avenue, 2nd Floor, New York, New York 10022, or via telephone at 877-821-7388, or via email: [email protected].

This press release shall not constitute an offer to sell or the solicitation of an offer to buy these securities, nor shall there be any sale of these securities in any state or other jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such state or other jurisdiction. Any offer, if at all, will be made only by means of the prospectus supplement and accompanying prospectus forming a part of the effective registration statement.