Bridge Biotherapeutics Enters into an Exclusive License Agreement with Shaperon to Strengthen Its IPF Franchise

On April 18, 2022 Bridge Biotherapeutics (KQ288330), a South Korean clinical-stage biotechnology company focused on developing novel drugs for fibrosis, inflammation, and cancer, reported that the company has signed an exclusive in-license agreement with Shaperon, a South Korean clinical-stage biotech company, for its GPCR19 (G protein-coupled receptor 19) agonist, coded "BBT-209", in order to develop a novel therapy for the treatment of idiopathic pulmonary fibrosis (IPF) (Press release, Bridge Biotherapeutics, APR 18, 2022, View Source [SID1234612416]).

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Shaperon, the originator, has identified that BBT-209, a first-in-class GPCR19 agonist, controls GPCR19-P2X7 expressions and downregulates component proteins of NLRP3 so that inflammation signaling networks can be significantly suppressed by the compound’s mode of action.

Through IPF animal models, Bridge Biotherapeutics has confirmed that the drug candidate shows treatment efficacy through its robust anti-inflammatory activities. The company will utilize this data when developing monotherapy and/or combination therapy strategies.

By entering into the license agreement, Bridge will make an upfront payment of approximately USD 1.63 million (KRW 2 billion). The potential deal value equates to approximately USD 24.4 million (KRW 30 billion) including upfront, milestone, and royalty payments.

"We are highly excited to in-license BBT-209, which is known to be the first-in-class GPCR19 agonist for the treatment of idiopathic pulmonary fibrosis," said James Lee, CEO of Bridge Biotherapeutics. "By jointly working with Shaperon, our development team will make the best effort to ensure the rapid advancement for our novel drug candidate, along with the other pipeline assets under the company’s IPF franchise," James added.

"We hope that BBT-209 will become a breakthrough therapy for patients with IPF, who are currently lacking treatment options" and "We will accelerate the development of innovative treatments, to help improve the quality of life for patients suffering from rare diseases, such as IPF, through our partnership with Bridge Biotherapeutics, which has a proven track record in both global drug development and business development," said Seung-Yong Seong, M.D., Ph.D., and Myung-Sea Lee M.D., M.B.A., co-CEOs of Shaperon.

Bridge Biotherapeutics reinforces its strategic focus on disease areas with significant unmet medical needs and lacks novel approved therapies, including cancers and various fibrotic diseases. Relating to idiopathic pulmonary fibrosis, the company has been accelerating the development of BBT-877 (an autotaxin inhibitor), BBT-301 (an ion channel modulator), and BBT-209 (a GPCR19 agonist).

FDA Approves Alymsys® (bevacizumab-maly), a Biosimilar of Bevacizumab by Amneal Pharmaceuticals, Inc., developed by mAbxience

On April 18, 2022 Brand Institute reported its successful partnership with Amneal Pharmaceuticals in developing the brand name ALYMSYS, under which the biosimilar approved by the Food and Drug Administration (FDA) on April 13, 2022 will be marketed (Press release, Amneal Pharmaceuticals, APR 18, 2022, View Source [SID1234612415]). This biosimilar represents the third bevacizumab approved in the U.S.

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ALYMSYS was developed by mAbxience, a global biotech company with over a decade of experience in the development, manufacture, and commercialization of biopharmaceuticals. Bevacizumab-maly is a vascular endothelial growth factor inhibitor used in oncology.

"The entire Brand Institute and Drug Safety Institute Team congratulates Amneal Pharmaceuticals and mAbxience on the FDA approval of ALYMSYS," said Brand Institute’s Chairman and C.E.O., James L. Dettore.

Seneca Therapeutics, Inc. to Present at the World Vaccine Congress in Washington, DC April 18-21, 2022

On April 18, 2022 Seneca Therapeutics, Inc. (STI), a clinical-stage biopharmaceutical company dedicated to the development of novel immunotherapies for difficult to treat solid cancers will be presenting on Wednesday, April 20 at 12:10pm at the World Vaccine Congress in Washington, DC (Press release, Seneca Therapeutics, APR 18, 2022, View Source [SID1234612414]). Seneca Therapeutics’ Senior Immunology Consultant, Michael Lacy, PhD will present a summary of prior research and three clinical trials done utilizing Seneca Valley Virus (SVV-001) delivered intravenously as a monotherapy. These clinical trials demonstrated profound tumor selectivity and safety. Dr. Lacy will also discuss Seneca’s upcoming Phase I/II clinical trial in both Neuroendocrine tumor and carcinoma patients. This trial combines intratumoral administration of SVV-001 with anti-PD1 and anti-CTLA4 checkpoint inhibitors. Finally, data will also be presented demonstrating the utility of SVV to express therapeutic transgenes (armed derivatives) and/or cancer antigens.

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Cyteir Therapeutics to Host Virtual Research and Development (R&D) Day on April 26, 2022

On April Cyteir Therapeutics, Inc. ("Cyteir") (Nasdaq: CYT), a company focused on the discovery and development of next-generation synthetically lethal therapies for cancer, reported that will host a virtual R&D Day on April 26, 2022 starting at 8:30 a.m. ET (Press release, Cyteir Therapeutics, APR 18, 2022, View Source [SID1234612413]). Cyteir’s management will discuss the research done to identify the molecular target of CYT-0851 and review the ongoing clinical plan.

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The live audio webcast can be accessed via the Investor Relations section of the Company’s website at www.cyteir.com. The archived webcast will remain available for replay on Cyteir’s website for 30 days.

Fulgent Genetics to Announce First Quarter 2022 Financial Results on Tuesday, May 3, 2022

On April 18, 2022 Fulgent Genetics, Inc. (NASDAQ: FLGT) ("Fulgent Genetics" or the "Company"), a technology-based genetic testing company focused on transforming patient care in oncology, infectious and rare diseases, and reproductive health, reported that it will release its first quarter 2022 financial results after the market closes on Tuesday, May 3, 2022 (Press release, Fulgent Genetics, APR 18, 2022, View Source [SID1234612411]). The company’s Chairman and Chief Executive Officer Ming Hsieh, Chief Financial Officer Paul Kim, Chief Commercial Officer Brandon Perthuis, and Chief Medical Officer Dr. Larry Weiss will host a conference call for the investment community the same day at 4:30 PM ET (1:30 PM PT) to discuss the results and answer questions.

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The call can be accessed through a live audio webcast in the Investors section of the company’s website, View Source, and through a live conference call by dialing (888) 394-8218 using the confirmation code 3761353. An audio replay will be available in the Investors section of the company’s website.