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China National Medical Products Administration Approves Sinovant’s Clinical Trial Application for Derazantinib

On April 28, 2019 Sinovant Sciences reported that its Clinical Trial Application (CTA) for derazantinib has been accepted by the Center for Drug Evaluation at the China National Medical Products Administration (NMPA), enabling the initiation of a registrational clinical trial in patients with second-line intrahepatic cholangiocarcinoma (iCCA) in the second half of 2019 (Press release, Sinovant Sciences, APR 28, 2019, View Source [SID1234535434]).

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"iCCA is one of the greatest unmet needs in oncology, particularly in China," said Dr. Rae Yuan, President of Sinovant. "Patients in the second-line setting are poorly served by existing treatment options, none of which meaningfully extend survival or reduce disease burden. Derazantinib has the potential to be the first approved treatment in China for this devastating disease state, and we look forward to begin enrolling patients in our registrational program later this year."

Derazantinib is an oral pan-FGFR (fibroblast growth factor receptor) inhibitor being developed as a potential treatment for iCCA and other tumor types with high rates of FGFR mutation. The People’s Republic of China has one of the world’s highest incidence rates of iCCA.

"We are very pleased by the approval of this CTA, which brings Sinovant a step closer to delivering derazantinib to Chinese patients," said Dr. Xinan Chen, Executive Chairman of Sinovant. "Sinovant’s advancement of derazantinib for patients with iCCA underscores our commitment to addressing major public health priorities in China."

About Derazantinib

Derazantinib is a potent, orally administered inhibitor of the fibroblast growth factor receptor (FGFR) family, a key driver of cell proliferation, differentiation, and migration. In a Phase 1/2 study in patients with iCCA harboring FGFR2 gene fusions, treatment with derazantinib resulted in an objective response rate of 21%, nearly 3 times higher than standard-of-care chemotherapy. Sinovant’s partner Basilea is conducting a similar global registrational study of derazantinib in American and European patients with FGFR2 fusion-positive second-line iCCA. More information on that program is available here.

About Intrahepatic Cholangiocarcinoma

Cholangiocarcinoma (CCA) is the most common biliary malignancy and the second most common malignancy in the liver after hepatocellular carcinoma (HCC).1 Depending on the anatomic location, CCA is classified as intrahepatic (iCCA), perihilar (pCCA), and extrahepatic (eCCA). iCCA originates from the intrahepatic biliary ductal system and forms an intrahepatic mass. iCCA is an aggressive cancer, with a median 5-year survival rate of only 15% for patients diagnosed with early-stage disease.2 Reports show that in China’s most populous cities the incidence of cholangiocarcinoma is more than 7 cases per 100,000 people, and a majority of cases are intrahepatic.3

RhoVac reports positive written response from the FDA regarding recently completed pre-IND meeting

On April 26, 2019 RhoVac AB ("RhoVac") reported that the company has received a written response from the Food and Drug Administration (FDA), USA regarding to the recently completed pre-IND meeting on development of the company’s drug candidate RV001 (Press release, RhoVac, APR 26, 2019, View Source [SID1234555931]). The subject of the meeting was to obtain agreement with the Agency regarding the scope of currently available data and the necessary data to support an IND submission for the clinical phase 2 trial in prostate cancer patients. Furthermore, the purpose of the meeting was to discuss with the agency and reach concurrence regarding the initial IND study protocol in the identified study population, the proposed endpoints along with the proposed safety monitoring. The FDA has confirmed that no further preclinical studies are required to support clinical development of the company’s clinical phase II trial in USA and that the design and the defined end-points in the study are relevant to document clinical proof of concept in treatment of prostate cancer patients with the company’s drug candidate RV001.

In alignment with the company’s original development schedule, RhoVac contacted the FDA in early 2019, and in March the company announced that FDA had accepted RhoVac’s request for a pre-IND meeting. A pre-IND meeting is comparable to a Scientific Advice Procedure in the EU, which RhoVac concluded in mid-2018. Following confirmation of the pre-IND meeting, the company submitted a Briefing Package which FDA has now evaluated and the response to our questions is based on this background information.

In conclusion, the FDA agrees that, in relation to USA, no further preclinical studies are required in support of a clinical phase II trial in prostate cancer patients. The identical study protocol is currently under review in Denmark with subsequent review in other European countries. The FDA also commented that the company’s approach in developing the quality specification for the drug candidate RV001 complies with relevant regulatory guidelines. In the response relating to the proposed clinical trial, the FDA agrees that the definition of the patient population, which we plan to recruit for the clinical study, is well-defined and that the clinical end-points set in the study are relevant in order to document clinical proof on concept.

Comments from RhoVac´s CEO, Anders Ljungqvist

-A pre-IND meeting may be a face-to-face meeting at FDA in Washington DC, a telephone conference or a written response. Based on the questions and the background information we forwarded the FDA, FDA assessed to have adequate background to be able to respond in writing. It is gratifying that the FDA confirms that we have correctly interpreted the regulatory guidelines in USA enabling us to continue our clinical development of RV001 based on the same strategy as used within the EU. A big thank you to employees and external consultants for a very professional and valuable work.

DaVita Inc. Schedules 1st Quarter 2019 Investor Conference Call

On April 26, 2019 DaVita Inc. (NYSE: DVA), a leading provider of kidney care services in the United States and in 10 countries around the world, reported that it will hold its quarterly conference call to discuss first quarter results on Tuesday, May 7, 2019, at 5:00 p.m. Eastern Time (Press release, DaVita, APR 26, 2019, View Source [SID1234535433]). The company plans to release its results after market close the same day.

This call is also being webcast and can be accessed at the DaVita IR web page. You can join this call as follows:

Tuesday, May 7, 2019
Starting at 5:00 p.m. EDT
Dial in number: 877-918-6630
International dial in: 517-308-9042
Webcast: investors.davita.com

When calling in, please provide the operator the password "Earnings" and provide your name and company affiliation. Investors unable to listen to the conference call will be able to access a replay via our website at investors.davita.com. There will be no telephone replay.

Alder BioPharmaceuticals® to Host Conference Call to Discuss First Quarter 2019 Financial and Operating Results

On April 26, 2019 Alder BioPharmaceuticals, Inc. (NASDAQ: ALDR), a biopharmaceutical company focused on developing novel therapeutic antibodies for the treatment of migraine, reported that it will report its first quarter 2019 financial and operating results after the close of U.S. financial markets on Thursday, May 2, 2019 (Press release, Alder Biopharmaceuticals, APR 26, 2019, https://investor.alderbio.com/news-releases/news-release-details/alder-biopharmaceuticalsr-host-conference-call-discuss-first-0 [SID1234535432]). Alder management will host a conference call and live audio webcast to discuss the results and provide a general business update at 5:00 p.m. ET the same day.

The live call may be accessed by dialing (877) 430-4657 for domestic callers or (484) 756-4339 for international callers and providing conference ID number 8162289. The webcast can be accessed from the Events & Presentations page of the Investors section of Alder’s website at www.alderbio.com and will be available for replay following the call for at least 30 days.

CohBar to Announce 2019 First Quarter Financial Results and Provide Business Update on May 7, 2019

On April 26, 2019 CohBar, Inc. (NASDAQ: CWBR), a clinical stage biotechnology company developing mitochondria based therapeutics (MBTs) to treat age-related diseases, reported that the company will release its first quarter 2019 financial results after the market closes on Tuesday, May 7, 2019 (Press release, CohBar, APR 26, 2019, View Source [SID1234535431]). Management will host a conference call with a slide presentation at 5:00 p.m. ET (2:00 p.m. PT) on the same day to provide an update on the company’s business.

Details for the Conference Call and Slide Presentation:

Date: May 7, 2019
Time: 5:00 p.m. ET (2:00 p.m. PT)

Conference Audio

Dial-in U.S. and Canada: (800) 289-0438
Dial-in International: (323) 794-2423
Conference ID No.: 1071020
Slide Presentation

Go to www.webex.com, click on the ‘Join’ button and enter meeting number 924 256 010 and Password CWBR, or
Go to www.cohbar.com and click on Q1 2019 Shareholder Presentation at top of homepage.
We kindly request that you please call into the conference audio approximately 10 minutes prior to the start time so that we can begin promptly.

An audio replay of the call will be available beginning at 8:00 p.m. Eastern Time on May 7, 2019, through 11:59 p.m. Eastern Time on May 28, 2019. To access the recording please dial (844) 512-2921 in the U.S. and Canada, or (412) 317-6671 internationally, and reference Conference ID# 1071020. The audio replay along with the slide presentation will also be available on the homepage at www.cohbar.com from May 7, 2019 through May 28, 2019.