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Friday, January 24, 2020

Kitov Pharma nabs European patent for NT-219; shares up 26% premark

Thinly traded nano cap Kitov Pharma (NASDAQ:KTOV) is up 26% premarket on increased volume in reaction to its announcement that it has received a Notice of Intention to Grant from the European Patent Office regarding a patent covering the use of NT-219, in combination with EGFR antibodies and inhibitors, to treat cancer.
https://seekingalpha.com/news/3534329-kitov-pharma-nabs-european-patent-for-ntminus-219-shares-up-26-premarket

Bellicum up 9% premarket on BPX-601 data

Bellicum Pharmaceuticals (NASDAQ:BLCM) perks up 9% premarket on light volume on the heels of Phase 1 translational data on lead GoCAR-T candidate BPX-601 in patients with advanced pancreatic cancer. The results were presented at the ASCO GI Cancers Symposium in San Francisco.
Data from cohort 5B showed enhanced survival and persistence up to nine months.
Activation of BPX-601 GoCAR-T cells mediated upregulation of immunomodulatory cytokines and infiltrated metastatic pancreatic tumors.
Changes in tumor microenvironment gene expression were consistent with a productive CAR-T cell immune response observed in patients treated with BPX-601 activated by rimiducid.
Development is ongoing.
https://seekingalpha.com/news/3534305-bellicum-up-9-premarket-on-bpxminus-601-data

Coronavirus in China: Officials rush to build hospital in 10 days


Heavy equipment works at a construction site for a field hospital in Wuhan in central China's Hubei Province.
Heavy equipment works at a construction site for a field hospital in Wuhan in central China’s Hubei Province.

China is rushing to build a 1,000-bed hospital in just 10 days to treat patients at the epicenter of the new coronavirus, which has killed at least 26 people, infected about 830 and prompted lockdowns in at least a dozen cities, according to reports.
The 270,000-square-foot in Wuhan is expected to be up and running by Feb. 3 and will aim “to address the insufficiency of existing medical resources,” city officials said, according to the official Xinhua news agency.
On the eve of the Lunar New Year, transportation was shut down Friday in 12 cities with a total of about 35 million, including Wuhan and its neighbors in central China’s Hubei province.
In 2003, China built a hospital on Beijing’s rural outskirts in barely a week to treat a rapidly rising number of people suffering from SARS, or Severe Acute Respiratory Syndrome, which killed 349 people in mainland China and 299 in Hong Kong.
Xiaotangshan Hospital comprised prefabricated structures and Xinhua reported Friday that Wuhan was building the new facility based on the same model.
The city of over 11 million residents has been centralizing its treatment of the coronavirus by isolating patients in 61 clinics and designated hospitals.
Officials have said the news virus probably originated from wild animals at a seafood market in Wuhan but it has since spread to several countries around Asia and beyond.
Meanwhile, at least eight hospitals in Wuhan issued calls for donations of masks, goggles, gowns and other protective gear, according to online notices online.
Officials at Wuhan University People’s Hospital set up a group chat on the popular WeChat messaging app to coordinate the donations.
The “Fever Control Command Center” of the city of Huanggang also issued a call for donations publicized by the state-run People’s Daily, asking for medical supplies, medicine and disinfection equipment. The notice added that for now, they wouldn’t accept supplies from other countries.
The vast majority of cases were reported in and around Wuhan, but people who visited or had personal connections to infected people were among the scattered cases counted beyond the mainland.
South Korea and Japan both confirmed their second cases Friday and Singapore confirmed its third. Cases also have been detected in Hong Kong, Macao, Taiwan, Thailand and Vietnam.
One case also has turned up in the US. A Washington State man in his 30s has been diagnosed after returning from a solo trip to Wuhan.
https://nypost.com/2020/01/24/coronavirus-in-china-officials-rush-to-build-hospital-in-10-days/

Exelixis up 1% premarket on Cabometyx data in liver cancer

Exelixis (NASDAQ:EXEL) perks up 1% premarket on light volume on the heels of results from an open-label Phase 1/2 clinical trial, CheckMate 040, evaluating the combination of Cabometyx (cabozantinib) and Bristol-Myers Squibb’s (NYSE:BMY) Opdivo (nivolumab), with or without Yervoy (ipilimumab), in patients with advanced hepatocellular carcinoma (HCC). The data are being presented today at the ASCO GI Cancers Symposium in San Francisco.
In treatment-naïve patients receiving cabozantinib and nivolumab (n=17) and those receiving prior treatment with Bayer’s Nexavar (sorafenib) (n=19), the objective response rate (ORR) was 19% and the disease control rate (responders + stable cancer) was 75%. Median progression-free survival (PFS) was 5.4 months while median overall survival (OS) was 21.5 months.
In 35 patients receiving cabozantinib, nivolumab and ipilimumab (12 treatment-naïve), including 23 with prior sorafenib therapy, ORR was 29%, DCR was 83% and median PFS was 6.8 months. Median OS had not been reached at data cutoff.
No new safety signals were observed.
https://seekingalpha.com/news/3534313-exelixis-up-1-premarket-on-cabometyx-data-in-liver-cancer

Analyst action, Jan. 24

AzurRx BioPharma (NASDAQ:AZRX) resumed with Buy rating and $7 (554% upside) price target at Roth Capital Partners.
IVERIC bio (NASDAQ:ISEE) initiated with Outperform rating and $15 (123% upside) price target at Cowen and Company.
Matinas BioPharma Holdings (NYSEMKT:MTNB) initiated with Buy rating and $3 (99% upside) price target at SunTrust. Shares up 5% premarket.
Pacira BioSciences (NASDAQ:PCRX) initiated with Buy rating and $60 (37% upside) price target at SunTrust.
Provention Bio (NASDAQ:PRVB) initiated with Overweight rating and $25 (51% upside) price target at Cantor Fitzgerald. Shares up 3% premarket.
BioMarin Pharmaceutical (NASDAQ:BMRN) upgraded to Outperform with a $113 (32% upside) price target at RBC citing bullish prospects for hemophilia gene therapy valrox.
DaVita (NYSE:DVA) upgraded to Buy with a $97 (20% upside) price target at Goldman Sachs. Shares up 2% premarket.
BioNTech SE (NASDAQ:BNTX) downgraded to Market Perform with a $31 (16% downside risk) price target at SVB Leerink. Shares down 2% premarket.
Epizyme (NASDAQ:EPZM) downgraded to Market Perform with an $18 (33% downside risk) price target at SVB Leerink. Shares down 5% premarket.
Tetraphase Pharmaceuticals (NASDAQ:TTPH) downgraded to Hold at Gabelli.
https://seekingalpha.com/news/3534298-rbc-likes-biomarin-in-premarket-analyst-action

Bayer faces fourth U.S. Roundup cancer trial in Monsanto’s hometown

Bayer AG is set to face a fourth U.S. jury trial over allegations that its Roundup weed killer causes cancer, with four cancer patients in the hometown of its agricultural subsidiary Monsanto scheduled to begin making their case on Friday.

The lawsuit marks the first multi-plaintiff trial in the litigation over whether glyphosate, Roundup’s active ingredient, is carcinogenic, and is the first trial outside of California. It is being held in St. Louis, where Monsanto was headquartered before Bayer bought the company in a $63 billion deal in 2018.
Three consecutive juries found the company liable for causing cancer with damages of tens of millions of dollars awarded to each plaintiff. Bayer is appealing those verdicts.
Court-appointed mediator Ken Feinberg has put the number of Roundup cancer claimants at more than 75,000 while Bayer said the claims it has been served with in court were below 50,000.
Bayer’s share price has tumbled since the first verdict in August 2018 but the stock rose 3% on Friday after Bloomberg reported a possible out-of-court settlement with some plaintiffs that could lead to a total payout of about $10 billion.
While traders said the market likes the idea of Bayer settling the litigation, some cautioned that the prospect of a comprehensive deal remained uncertain.
Analysts have estimated the size of any such settlement at $8-$12 billion.
SEE YOU IN COURT
While most plaintiffs’ lawyers have agreed to postpone trials pending negotiations, some have decided to pursue their clients’ day in court.
The case in Missouri’s Circuit Court for the 22nd Judicial Circuit of the City of St. Louis is scheduled to last several weeks, with both sides presenting extensive scientific evidence through expert witnesses.
Bayer denies all allegations that Roundup or glyphosate causes cancer, saying decades of independent studies have shown the world’s most widely used weed killer to be safe for human use and noting that regulators around the world have approved the product.
“At the end of the day, this trial should come down to the weight of the science, and we remain confident in the extensive scientific record and regulatory assessments that support the safety of our glyphosate-based herbicides and that they do not cause cancer,” the company said in a statement.
Several court cases have been postponed by both parties in the past to expedite settlement talks. By pursuing the St. Louis trail The Miller Firm LLC, a key player in the litigation, is seeking to increase pressure on Bayer.
The case involves the claims of Bryce Batiste from Louisiana, Ann Meeks from Florida, Glen Ashelman from Pennsylvania and Christopher Wade, a St. Louis resident. All four have been diagnosed with non-Hodgkin’s lymphoma, a blood cell cancer that plaintiffs in the litigation allege is caused by Roundup.
Some legal experts said Bayer could benefit from a home advantage in the St. Louis trial, where Monsanto has century-old roots. But juries in the city are also known to dole out massive damages awards against large corporations.

https://www.marketscreener.com/BAYER-AG-436063/news/Bayer-faces-fourth-U-S-Roundup-cancer-trial-in-Monsanto-s-hometown-29884415/?countview=0

Genentech Tecentriq Phase III Misses Goal in Muscle-invasive Urothelial Cancer

Genentech, a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY), today announced that the Phase III IMvigor010 study evaluating Tecentriq® (atezolizumab) as an adjuvant (after surgery) monotherapy treatment did not meet its primary endpoint of disease-free survival (DFS) compared to observation in people with muscle-invasive urothelial cancer (MIUC). Safety for Tecentriq appeared consistent with the known safety profile of the medicine, and no new safety signals were identified.
“Reducing the risk that muscle-invasive urothelial cancer will recur after surgery is very difficult, and we are disappointed that we were not able to significantly prolong disease-free survival,” said Levi Garraway, M.D., Ph.D., chief medical officer and head of Global Product Development. “We remain committed to exploring the potential benefits of immunotherapy for more people with early cancers.”
The goal in treating MIUC early is to reduce the risk of the disease recurring or spreading to other parts of the body. More treatment options following surgery are needed as approximately half of people with MIUC will develop a recurrence of their disease within two years of surgery.
In addition to ongoing Phase III studies in early and advanced bladder cancer, Genentech has an extensive development program for Tecentriq, including multiple ongoing and planned Phase III studies across genitourinary, skin, breast, gastrointestinal, gynecological and head and neck cancers. This includes studies evaluating Tecentriq both alone and in combination with other medicines.
https://www.biospace.com/article/releases/genentech-provides-an-update-on-phase-iii-study-of-tecentriq-in-people-with-muscle-invasive-urothelial-cancer/