1stOncology™: Cancer Intelligence Service – Page 13079 – 1stOncology is recognized as a Top 10 Global Pharma Analytic Provider

ExCellThera’s lead technology, ECT-001, receives FDA Regenerative Medicine Advanced Therapy (RMAT) designation

On April 23, 2019 ExCellThera Inc., an advanced clinical stage biotechnology company delivering molecules and bioengineering solutions to expand stem and immune cells for therapeutic use, reported that the U.S. Food and Drug Administration (FDA) has granted regenerative medicine advanced therapy (RMAT) designation to its lead technology, ECT-001, in the treatment of hematologic malignancies (Press release, ExCellThera, APR 23, 2019, View Source [SID1234535340]). The RMAT designation is based on strong data from Phase I/II clinical trials using ECT-001 to expand stem and immune cells for the treatment of blood cancers.

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!

RMAT designation is granted by the FDA under the 21st Century Cures Act for cell therapies, tissue-engineered or similar products intended to treat or cure a serious disease, and which demonstrate preliminary evidence to address an unmet clinical need. It accords all the benefits of the FDA’s fast track and breakthrough therapy designation programs, including an ability to interact with the agency to discuss the potential acceleration of regulatory approval. Under the auspices of the RMAT designation, FDA will work closely with ExCellThera and provide advice on generating the evidence needed to support approval of ECT-001 in an efficient manner.

"The FDA’s RMAT designation is a clear signal of confidence in the potential of our lead cell therapy drug product, ECT-001, to treat patients with hematologic malignancies," said Dr. Guy Sauvageau, CEO and founder of ExCellThera. "We look forward to working with the FDA within the RMAT framework to advance ECT-001 through the final phases of clinical development in an expedited manner."

Various clinical studies using ECT-001 are currently ongoing in the treatment of multiple myeloma, high-risk leukemia and other hematologic malignancies. In addition, ExCellThera plans to initiate additional clinical trials, including a pivotal trial in the United States and Canada, in the coming months. ECT-001 has also received FDA orphan drug designation for the prevention of graft-versus-host disease.

About ECT-001
The ECT-001 technology is a combination of a small molecule, UM171, and an optimized culture system. The technology, capable of expanding the number of stem and immune cells exponentially in as little as seven days, is used in novel curative cord blood transplant therapies for patients with blood cancers, allowing rapid engraftment, greatly reduced incidence of transplant-related mortality, low risk of chronic graft-versus-host disease and low risk of relapse, resulting in better outcomes for patients.

Halozyme To Host First Quarter 2019 Financial Results Webcast And Conference Call

On April 23, 2019 Halozyme Therapeutics, Inc. (NASDAQ: HALO), a biotechnology company developing novel oncology and drug-delivery therapies, reported that it will webcast its Quarterly Update Conference Call for the first quarter 2019 on Tuesday, May 7 at 4:30 p.m. ET / 1:30 p.m. PT (Press release, Halozyme, APR 23, 2019, View Source [SID1234535337]). Dr. Helen Torley, president and chief executive officer, will lead the call. On the same date, Halozyme will release financial results for the first quarter ended March 31, 2019 following the close of trading.

The call will be webcast live through the "Investors" section of Halozyme’s corporate website and a recording will be made available following the close of the call. To access the webcast and additional documents related to the call, please visit the Investors page of www.halozyme.com approximately fifteen minutes prior to the call to register, download and install any necessary audio software. The live call may be accessed by dialing (866) 393-4306 (domestic callers) or (734) 385-2616 (international callers). A telephone replay will be available after the call by dialing (855) 859-2056 (domestic callers) or (404) 537-3406 (international callers) using replay ID number 3076769.

Jazz Pharmaceuticals to Report 2019 First Quarter Financial Results on May 7, 2019

On April 23, 2019 Jazz Pharmaceuticals plc (Nasdaq: JAZZ) reported that it will report its 2019 first quarter financial results on Tuesday, May 7, 2019, after the close of the financial markets (Press release, Jazz Pharmaceuticals, APR 23, 2019, View Source [SID1234535336]). Company management will host a live audio webcast immediately following the announcement at 4:30 p.m. EDT/9:30 p.m. IST to discuss first quarter 2019 financial results and provide a business and financial update.

Interested parties may access the live audio webcast via the Investors section of the Jazz Pharmaceuticals website at www.jazzpharmaceuticals.com. Please connect to the website prior to the start of the conference call to ensure adequate time for any software downloads that may be necessary to listen to the webcast. A replay of the webcast will be archived on the website for at least one week.

Audio webcast/conference call:
U.S. Dial-In Number: +1 855 353 7924
International Dial-In Number: +1 503 343 6056
Passcode: 6667859

A replay of the conference call will be available through May 14, 2019 and accessible through one of the following telephone numbers, using the passcode below:

Replay U.S. Dial-In Number: +1 855 859 2056
Replay International Dial-In Number: +1 404 537 3406
Passcode: 6667859

Zimmer Biomet to Present at Bank of America Merrill Lynch Healthcare Conference

On April 23, 2019 Zimmer Biomet Holdings, Inc. (NYSE and SIX: ZBH), a global leader in musculoskeletal healthcare, reported that it will participate in the Bank of America Merrill Lynch Healthcare Conference at the Encore Hotel in Las Vegas, Nevada (Press release, Zimmer Holdings, APR 23, 2019, View Source [SID1234535335]). Daniel P. Florin, Executive Vice President and Chief Financial Officer and Cole Lannum, CFA, Senior Vice President of Investor Relations, will present for the company on Thursday, May 16, 2019 at 8:00 a.m. Pacific Time.

A live webcast of the presentation can be accessed via Zimmer Biomet’s Investor Relations website at http://investor.zimmerbiomet.com. The webcast will be archived for replay following the conference.

Innovent Announces First Patient Dosed in Phase I Clinical Trial of IBI318 Bispecific Antibody in China

On April 23, 2019 Innovent Biologics, Inc. (Innovent) (HKEX: 01801), a world-class biopharmaceutical company that develops and commercializes high quality medicines, reported that the first patient in China has been successfully dosed in a Phase I clinical trial of a recombinant fully human bispecific antibody targeting programmed cell death receptor-1 (PD-1) and programmed cell death ligand-1 (PD-L1) (IBI318), an innovative antibody developed in collaboration with Eli Lilly and Company (Press release, Innovent Biologics, APR 23, 2019, View Source [SID1234535334]).

CIBI318A101 is a Phase I clinical study conducted in China to evaluate IBI318 in the treatment of patients with advanced malignancies. The primary objectives of the study are to evaluate the safety, tolerability, and initial efficacy of IBI318.

IBI318 is a recombinant fully human IgG1 bispecific antibody targeting PD-1 and PD-L1, and may offer a novel solution to patients’ unmet medical needs. IBI318 simultaneously binds to PD-1 and PD-L1, blocks PD-1 and PD-L1 signaling, bridges PD-1-expressing T cells to PD-L1-expressing tumor cells, and enhances the formation of immune synapses, thereby potentially enhancing anti-tumor activities and increased anti-tumor efficacy.

"Immunotherapies such as checkpoint-blocking antibodies targeting PD-1 and PD-L1 are playing increasingly important roles in oncology therapy. However, there are still many challenges in their clinical application. Particularly, for patients without predictive biomarkers, the clinical response rate is approximately 20%. Many patients also have primary or acquired resistance to anti-PD-1/PD-L1 antibodies. We still need to actively develop the next generation of immunotherapy. We are looking forward to seeing the clinical results of IBI318," said Professor Xu Ruihua, Director of Sun Yat-Sen University Cancer Center.

"IBI318 is the world’s first PD-1/PD-L1 bispecific antibody to enter clinical development. Therefore, the development of IBI318 has unique clinical value. We will evaluate the potential clinical value of this drug candidate and hope to provide a more effective treatment option and ultimately benefit more patients," said Michael Yu, Founder, Chief Executive Officer and Chairman of Innovent.

About IBI318

IBI318, was discovered through the collaboration between Innovent and Eli Lilly and Company and has been developed in China by Innovent. IBI318 is a recombinant fully human immunoglobulin bispecific antibody that blocks both PD-1 binding to PD-L1 and PD-L2 and PD-L1 binding to CD80, which will restore T cell activation and generate anti-tumor activities. In preclinical studies, PD-1-expressing T cells and PD-L1-expressing tumor cells can be bridged by IBI318, which enhances immune synapse formation and anti-tumor activities. The cell bridging induced by IBI318 could further enhance the anti-tumor activities generated through modulating the PD-1/PD-L1 signaling pathway.

About CIBI318A101