On September 8, 2020 LIPAC Oncology LLC reported the successful completion of a Phase 2A marker lesion clinical trial designed to predict long-term (two-year) recurrence free survival rates in patients with low-grade highly recurrent Non-Muscle Invasive Bladder Cancer (NMIBC) treated with LiPax (paclitaxel) (Press release, Lipac Oncology, SEP 8, 2020, View Source [SID1234564781]). LiPax, a proliposomal paclitaxel formulation in development for intravesical installation in the treatment of NMIBC, demonstrated a 56 percent responder rate in patients treated with LiPax alone.

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"Non-Muscle Invasive Bladder Cancer is difficult to treat and highly recurrent. By pairing a simple outpatient procedure (Transurethral Resection of Bladder Tumor or TURBT) with LiPax, we have an opportunity to substantially improve both clinical outcomes and quality of life for patients," said Michael Oefelein, M.D., Chief Medical Officer of LIPAC Oncology. "This data adds to the positive evidence observed in our Phase 1 trial, with an 83 percent recurrence free survival rate following one year of treatment."

Persistence of LiPax above therapeutic levels was demonstrated up to 72 hours following intravesical instillation. In the study, LiPax was well tolerated. No significant adverse events were observed, and patients’ urinary health related quality of life was maintained during and after installation of LiPax, as measured by patient reported outcomes.

"Together, the results of our Phase 1 and Phase 2A clinical trials support moving LiPax into Phase 2B development for Non-Muscle Invasive Bladder Cancer," said TR Thirucote, Chairman and CEO of LIPAC. "LiPax’s ongoing promising results in bladder cancer provides further validation of our drug delivery technology that is being used in the development of LIPAC’s other pipeline assets. We look forward to advancing our orphan-designated programs for Upper Tract Urothelial Carcinoma, Ovarian Cancer, Mesothelioma, and malignant plural effusion into the clinic in 2021."

Based on a patient’s biopsy results obtained from TURBT, NMIBC is stratified into three risk categories: low, intermediate, and high risk. To reduce recurrence and prevent progression, the American Urological Association NMIBC guidelines recommend intravesical therapy after TURBT. The low to intermediate risk category targeted by LiPax is estimated to comprise 90,000 Americans, yet no intravesical agent is approved by the U.S. Food and Drug Administration for this disease.

About LiPax
LiPax is a novel, investigational formulation of paclitaxel in Phase 2 development for the treatment of NMIBC. LIPAC Oncology’s proprietary formulation utilizes their proliposomal technology platform to enhance the persistence and penetration of bladder tissue by paclitaxel. LiPax is designed to enhance the standard of care of outpatient endoscopic tumor removal through a histological risk assessment followed by intravesical instillation using a standard urinary catheter. LIPAC Oncology completed a Phase 2A clinical trial in August 2020 and intends to advance the program to a pivotal study to further investigate LiPax in the treatment of this condition.

On September 8, 2020 Jazz Pharmaceuticals plc (Nasdaq: JAZZ) reported that the company will webcast its corporate presentations at the following virtual investor conferences (Press release, Jazz Pharmaceuticals, SEP 8, 2020, View Source [SID1234564780]):

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Morgan Stanley Global Healthcare Conference on Tuesday, September 15, 2020 at 2:45 p.m. EDT / 7:45 p.m. IST. Bruce Cozadd, chairman and chief executive officer, will provide an overview of the company and a business and financial update.

Cantor Global Healthcare Conference on Wednesday, September 16, 2020 at 1:20 p.m. EDT / 6:20 p.m. IST. Bruce Cozadd, chairman and chief executive officer, will provide an overview of the company and a business and financial update.

BofA Global Healthcare Conference on Friday, September 18, 2020 at 4:45 p.m. BST / IST. Daniel Swisher, president and chief operating officer, will provide an overview of the company and a business and financial update.
A live audio webcast of each presentation may be accessed from the Investors section of the Jazz Pharmaceuticals website at www.jazzpharmaceuticals.com. Please connect to the website prior to the start of each presentation to ensure adequate time for any software downloads that may be necessary to listen to the webcast.

An archive of each webcast will be available for at least one week following each presentation on the Investors section of the company’s website at www.jazzpharmaceuticals.com.

On September 8, 2020 CryoLife, Inc. (NYSE: CRY), a leading cardiac and vascular surgery company focused on aortic disease, reported that it will participate in the upcoming 18th Annual Morgan Stanley Global Healthcare Conference (Press release, CryoLife, SEP 8, 2020, View Source [SID1234564779]).

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CryoLife’s management team will present at the virtual investor conference on Wednesday, September 16, 2020. The Company’s virtual fireside chat is scheduled to begin at 11:00 a.m. ET. A live webcast of the virtual fireside chat will be accessible through CryoLife’s website, www.cryolife.com, on the Investor Relations page. An archived copy of the webcast will be available for 90 days on the same website.

On September 8, 2020 Zion Pharma Limited, an emerging Chinese biotechnology company focused on the development of brain-penetrable compounds, reported the initiation of its Phase 1 study, in the United States, for its lead program ZN-A-1041. ZN-A-1041, is a best-in-class, small molecule tyrosine kinase receptor inhibitor targeting HER2 (Press release, Zion Pharma, SEP 8, 2020, View Source [SID1234564778]). ZN-A-1041 is being developed to address the unmet medical need associated with brain metastases accompanying HER2+ advanced breast cancer. The U.S. trial is being conducted at several sites including the Dana Farber Cancer Institute and the Duke Cancer Institute.

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"We are excited to have initiated our Phase 1 trial for ZN-A-1041," stated Zack Cheng, Ph.D., Chairman, CEO and Co-Founder at Zion Pharma Limited. "With dosing of the first patient in our Phase 1 study, Zion becomes a clinical stage company. A feat we are particularly proud of as we achieved this within 30 months of forming the company." Dr. Cheng continued, "We recently completed a $20 million Series A follow-on that will provide us sufficient funding for the next two years. This is an extremely exciting time for our team, and we look forward to advancing highly effective therapies to those patients in need."

Dr. Ding Zhou, Ph.D., CSO and Co-Founder, at Zion Pharma Limited added, "With our recent financing, we expect to complete the ZN-A-1041 Phase 1 study in the U.S. and China and advance several of our other programs into IND-enabling studies."

In addition, the company announced that Wendy Li, M.D. has joined the company as Chief Medical Officer. Dr. Li brings to Zion Pharma 10 years of clinical practice and over 20 years of hands-on experience in providing medical and scientific leadership in clinical research multiple therapeutic areas, with previous experience in oncology clinical development at Genentech, Sanofi, and Pfizer. Previously, Dr. Li has been VP/CMO with Sihuan Pharma/Xuanzhu Shandong and CMO at Exuma Biotech. Dr. Li received her M.D. from the Sun Yat-Sen University of Medical Studies in China.

On September 8, 2020 OncoImmune, Inc. reported the completion of a $56 million financing in Series B equity co-led by HM Capital and a blue-chip investor (Press release, ONCOIMMUNE, SEP 8, 2020, View Source [SID1234564777]). Existing investors, 3E Bioventures Capital and Kaitai Capital, as well as additional new investors, GBA Fund and GF Xinde, also joined the round. Oncoimmune will use the proceeds to support its novel therapeutic programs in late stage clinical trials and to expand its product pipeline.

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OncoImmune currently has two Phase III clinical programs to evaluate its lead product CD24Fc, a first-in-class biologic, in protecting against immune destruction in severe and critical COVID-19 patients in one trial, and in leukemia patients that are prone to acute GVHD after receiving allogeneic hematopoietic stem cell transplant in the second trial. The COVID-19 Phase III trial has been initiated in 17 medical centers nationwide and is enrolling severe and critical COVID-19 patients that either require supplemental oxygen support or high flow oxygen non-invasive ventilation, in addition to ICU patients requiring invasive mechanical ventilation. The trial plans to enroll over 270 patients and is near its enrollment target with topline readouts expected soon.

"We are grateful to our investors for their confidence and continued support," said Yang Liu, PhD, Founder, CEO and Chairman of OncoImmune. "We are delighted to see the significant progress OncoImmune has made in the past few years. It exemplifies how great scientific discovery can be turned into potential novel therapeutics benefiting patients," said Dr. Karen Liu, Partner at 3E Bioventures Capital, which led OncoImmune’s Series A round in 2017.

"HM Capital is delighted to co-lead the investment to support innovations of transformative impact. We very much look forward to OncoImmune’s continuous success," said Robert Luo, the founding partner of HM Capital.